Capitol Building Maryland Register

Issue Date: January 6, 2017

Volume 44 • Issue 1 • Pages 1-74

IN THIS ISSUE

Judiciary

Division of State Documents

Open Meetings and Compliance Board

Regulations

Errata

Special Documents

General Notices

Pursuant to State Government Article, §7-206, Annotated Code of Maryland, this issue contains all previously unpublished documents required to be published, and filed on or before December 19, 2016 5 p.m.
 
Pursuant to State Government Article, §7-206, Annotated Code of Maryland, I hereby certify that this issue contains all documents required to be codified as of December 19, 2016.
 
Brian Morris
Administrator, Division of State Documents
Office of the Secretary of State

Seal

Information About the Maryland Register and COMAR

MARYLAND REGISTER

   The Maryland Register is an official State publication published every other week throughout the year. A cumulative index is published quarterly.

   The Maryland Register is the temporary supplement to the Code of Maryland Regulations. Any change to the text of regulations published  in COMAR, whether by adoption, amendment, repeal, or emergency action, must first be published in the Register.

   The following information is also published regularly in the Register:

   • Governor’s Executive Orders

   • Attorney General’s Opinions in full text

   • Open Meetings Compliance Board Opinions in full text

   • State Ethics Commission Opinions in full text

   • Court Rules

   • District Court Administrative Memoranda

   • Courts of Appeal Hearing Calendars

   • Agency Hearing and Meeting Notices

   • Synopses of Bills Introduced and Enacted by the General Assembly

   • Other documents considered to be in the public interest

CITATION TO THE MARYLAND REGISTER

   The Maryland Register is cited by volume, issue, page number, and date. Example:

• 19:8 Md. R. 815—817 (April 17, 1992) refers to Volume 19, Issue 8, pages 815—817 of the Maryland Register issued on April 17, 1992.

CODE OF MARYLAND REGULATIONS (COMAR)

   COMAR is the official compilation of all regulations issued by agencies of the State of Maryland. The Maryland Register is COMAR’s temporary supplement, printing all changes to regulations as soon as they occur. At least once annually, the changes to regulations printed in the Maryland Register are incorporated into COMAR by means of permanent supplements.

CITATION TO COMAR REGULATIONS

   COMAR regulations are cited by title number, subtitle number, chapter number, and regulation number. Example: COMAR 10.08.01.03 refers to Title 10, Subtitle 08, Chapter 01, Regulation 03.

DOCUMENTS INCORPORATED BY REFERENCE

   Incorporation by reference is a legal device by which a document is made part of COMAR simply by referring to it. While the text of an incorporated document does not appear in COMAR, the provisions of the incorporated document are as fully enforceable as any other COMAR regulation. Each regulation that proposes to incorporate a document is identified in the Maryland Register by an Editor’s Note. The Cumulative Table of COMAR Regulations Adopted, Amended or Repealed, found online, also identifies each regulation incorporating a document. Documents incorporated by reference are available for inspection in various depository libraries located throughout the State and at the Division of State Documents. These depositories are listed in the first issue of the Maryland Register published each year. For further information, call 410-974-2486.

HOW TO RESEARCH REGULATIONS

An Administrative History at the end of every COMAR chapter gives information about past changes to regulations. To determine if there have been any subsequent changes, check the ‘‘Cumulative Table of COMAR Regulations Adopted, Amended, or Repealed’’ which is found online at http://www.dsd.state.md.us/PDF/CumulativeTable.pdf. This table lists the regulations in numerical order, by their COMAR number, followed by the citation to the Maryland Register in which the change occurred. The Maryland Register serves as a temporary supplement to COMAR, and the two publications must always be used together. A Research Guide for Maryland Regulations is available. For further information, call 410-260-3876.

SUBSCRIPTION INFORMATION

   For subscription forms for the Maryland Register and COMAR, see the back pages of the Maryland Register. Single issues of the Maryland Register are $15.00 per issue.

CITIZEN PARTICIPATION IN
THE REGULATION-MAKING PROCESS

   Maryland citizens and other interested persons may participate in the process by which administrative regulations are adopted, amended, or repealed, and may also initiate the process by which the validity and applicability of regulations is determined. Listed below are some of the ways in which citizens may participate (references are to State Government Article (SG),

Annotated Code of Maryland):

   • By submitting data or views on proposed regulations either orally or in writing, to the proposing agency (see ‘‘Opportunity for Public Comment’’ at the beginning of all regulations appearing in the Proposed Action on Regulations section of the Maryland Register). (See SG, §10-112)

   • By petitioning an agency to adopt, amend, or repeal regulations. The agency must respond to the petition. (See SG §10-123)

   • By petitioning an agency to issue a declaratory ruling with respect to how any regulation, order, or statute enforced by the agency applies. (SG, Title 10, Subtitle 3)

   • By petitioning the circuit court for a declaratory judgment

on the validity of a regulation when it appears that the regulation interferes with or impairs the legal rights or privileges of the petitioner. (SG, §10-125)

   • By inspecting a certified copy of any document filed with the Division of State Documents for publication in the Maryland Register. (See SG, §7-213)

 

Maryland Register (ISSN 0360-2834). Postmaster: Send address changes and other mail to: Maryland Register, State House, Annapolis, Maryland 21401. Tel. 410-260-3876; Fax 410-280-5647. Published biweekly, with cumulative indexes published quarterly, by the State of Maryland, Division of State Documents, State House, Annapolis, Maryland 21401. The subscription rate for the Maryland Register is $225 per year (first class mail). All subscriptions post-paid to points in the U.S. periodicals postage paid at Annapolis, Maryland and additional mailing offices.

Lawrence J. Hogan, Jr., Governor; John C. Wobensmith, Secretary of State; Brian Morris, Administrator; Gail S. Klakring, Senior Editor; Mary D. MacDonald, Editor, Maryland Register and COMAR; Elizabeth Ramsey, Editor, COMAR Online, and Subscription Manager; Tami Cathell, Help Desk, COMAR and Maryland Register Online.

Front cover: State House, Annapolis, MD, built 1772—79.

Illustrations by Carolyn Anderson, Dept. of General Services

 

     Note: All products purchased are for individual use only. Resale or other compensated transfer of the information in printed or electronic form is a prohibited commercial purpose (see State Government Article, §7-206.2, Annotated Code of Maryland). By purchasing a product, the buyer agrees that the purchase is for individual use only and will not sell or give the product to another individual or entity.

 

Closing Dates for the Maryland Register

Schedule of Closing Dates and Issue Dates for the
Maryland Register ..........................................................................  5

 

COMAR Research Aids

Table of Pending Proposals ...............................................................  6

 

Index of COMAR Titles Affected in This Issue

COMAR Title Number and Name                                                  Page

08        Department of Natural Resources ........................................  14

09        Department of Labor, Licensing, and Regulation .................  17

10        Department of Health and Mental Hygiene ....................  12, 18

11        Department of Transportation ..............................................  46

13A     State Board of Education ......................................................  54

19A     State Ethic Commission .......................................................  12

21        State Procurement Regulations .............................................  57

31        Maryland Insurance Administration .....................................  58

36        Maryland State Lottery and Gaming Control
               Agency ..............................................................................  63

 

PERSONS WITH DISABILITIES

Individuals with disabilities who desire assistance in using the publications and services of the Division of State Documents are encouraged to call (410) 974-2486, or (800) 633-9657, or FAX to (410) 974-2546, or through Maryland Relay.

 

The Division of State Documents

DEPOSITORIES FOR DOCUMENTS INCORPORATED BY
   REFERENCE .  9

 

Open Meetings Compliance Board

SUMMARY OF OPINIONS ISSUED FROM OCTOBER 1
     DECEMBER 31, 2016 ....................................................  10

 

The Judiciary

COURT OF APPEALS OF MARYLAND 11

DISCIPLINARY PROCEEDINGS ........................................  11

 

Final Action on Regulations

10  DEPARTMENT OF HEALTH AND MENTAL HYGIENE

HEALTH SERVICES COST REVIEW COMMISSION

Rate Application and Approval Procedures ..............................  12

Rate Application and Approval Procedures ..............................  12

19A STATE ETHICS COMMISSION

PROCEDURES

General Provisions ...................................................................  12

Advisory Opinions ...................................................................  12

Enforcement Procedures ...........................................................  12

LOCAL GOVERNMENT ETHICS LAW

General Provisions .  12

Review Criteria .  12

Review Procedures .  12

Appendix A — Model Ethics Law A ..  12

Appendix B — Model Ethics Law B ..  12

BOARD OF EDUCATION ETHICS REGULATIONS

Review Criteria .  12

Appendix A — Model Board of Education Ethics
   Regulations .  12

Appendix B — Model Board of Education Ethics
   Regulations .  12

BLIND TRUSTS

General Provisions .  12

Criteria for Certification .  12

Procedural Requirements .  12

LOBBYING

General  12

 

Proposed Action on Regulations

08  DEPARTMENT OF NATURAL RESOURCES

BOATING

Definitions ................................................................................  14

BOATING—SPEED LIMITS AND OPERATION OF
   VESSELS

General .....................................................................................  14

Chesapeake Bay .  15

Potomac River  16

South River  16

09  DEPARTMENT OF LABOR, LICENSING, AND
   REGULATION

BOARD OF PUBLIC ACCOUNTANCY

General Regulations .  17

10  DEPARTMENT OF HEALTH AND MENTAL HYGIENE

FREESTANDING AMBULATORY CARE FACILITIES

General Requirements .  18

HOSPITALS

Acute General Hospitals and Special Hospitals .  18

Health Care Staff Agencies .  18

Related Institutions — Residential Treatment Centers for
   Emotionally Disturbed Children and Adolescents .  18

Residential Service Agencies .  18

Nursing Referral Service Agencies .  18

Freestanding Medical Facilities .  18

Residents’ Bill of Rights: Comprehensive Care Facilities and
   Extended Care Facilities .  18

Home Health Agencies .  18

Health Maintenance Organizations .  18

Health Care Facilities Within Correctional Institutions .  18

Assisted Living Programs .  18

Limited Private Inpatient Facilities .  18

Limited Service Hospital  18

Comprehensive Rehabilitation Facilities .  18

Intermediate Care Facilities for Individuals with
   Intellectual Disabilities and Persons with Related
   Conditions (ICF/IID)  18

Hospice Care Programs .  18

LABORATORIES

Medical Laboratories — Licenses .  18

MENTAL HYGIENE REGULATIONS

Community Mental Health Programs — Application,
   Approval, and Disciplinary Processes .  18

DEVELOPMENTAL DISABILITIES

Administrative Requirements for Licensees .  18

ALCOHOL AND DRUG ABUSE ADMINISTRATION

Certification Requirements .  18

FORENSIC LABORATORIES

Licenses .  18

LABORATORIES

Medical Laboratories — Testing for Hereditary and Congenital Disorders in Newborn Infants    23

PREVENTIVE MEDICINE

Newborn Screening .  23

HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION
    AND ACQUIRED IMMUNODEFICIENCY SYNDROME
   (AIDS)

HIV Testing for Pregnant Women Receiving Prenatal
   Care .......................................................................................  31

DEVELOPMENTAL DISABILITIES

Definitions ................................................................................  34

Community Supported Living Arrangements Payment
   System ..  34

PREVENTIVE MEDICINE

Opioid-Associated Disease Prevention and Outreach
   Programs .  36

BOARD OF ENVIRONMENTAL HEALTH SPECIALISTS

General Regulations .  40

Licensing Procedures .  40

Continuing Education .  40

Rules of Procedure for Board Hearings .  40

Fee Schedule .  40

COMMUNITY-BASED BEHAVIORAL HEALTH
   PROGRAMS AND SERVICES

Outpatient Civil Commitment (OCC) Pilot Program ..  43

11  DEPARTMENT OF TRANSPORTATION

MOTOR VEHICLE ADMINISTRATION—LICENSING OF
   BUSINESSES AND OCCUPATIONS

Dealers and Salesmen .  46

13A STATE BOARD OF EDUCATION

SPECIFIC SUBJECTS

Education That Is Multicultural  54

21  STATE PROCUREMENT REGULATIONS

STATE PROCUREMENT ORGANIZATION

Board of Public Works .  57

31  MARYLAND INSURANCE ADMINISTRATION

INSURANCE PRODUCERS AND OTHER INSURANCE
   PROFESSIONALS

Public Adjusters .  58

PROPERTY AND CASUALTY INSURANCE

Liability of Insurer — Failure to Act in Good Faith .  59

UNFAIR TRADE PRACTICES

15 Liability of Insurer — Failure to Act in Good Faith .  59

LIFE INSURANCE AND ANNUITIES

Contracts on a Variable Basis .  62

Group Annuity Contracts .  62

36  MARYLAND STATE LOTTERY AND GAMING
   CONTROL AGENCY

GAMING PROVISIONS

Video Lottery Facility Minimum Internal Control
   Standards .  63

 

Errata

COMAR 03.11.01 .  65

COMAR 21.05.08 .  65

COMAR 21.11.13 .  65

 

Special Documents

DEPARTMENT OF THE ENVIRONMENT

SUSQUEHANNA RIVER BASIN COMMISSION

Projects Approved for Consumptive Uses of Water .............  66

Actions Taken at December 8, 2016, Meeting ......................  66

MARYLAND HEALTH CARE COMMISSION

SCHEDULE FOR CERTIFICATE OF ONGOING
   PERFORMANCE REVIEWS .  68

DEPARTMENT OF STATE POLICE

HANDGUN ROSTER BOARD

Proposed Additions to Handgun Roster and Notice of Right
   to Object or Petition ...........................................................  69

 

General Notices

ATHLETIC COMMISSION

Public Meeting .  70

ADVISORY COUNCIL ON CEMETERY OPERATIONS

Public Meeting .  70

MARYLAND INSTITUTE FOR EMERGENCY MEDICAL
   SERVICES SYSTEMS

Public Meeting .  70

DEPARTMENT OF HEALTH AND MENTAL HYGIENE

Public Meeting .  70

DEPARTMENT OF HEALTH AND MENTAL
   HYGIENE/OFFICE OF HEALTH SERVICES

Public Notice Waiver for Children with Autism Spectrum
   Disorder Amendment  70

MARYLAND STATE LOTTERY AND GAMING CONTROL
   COMMISSION

Public Meeting .  70

MARYLAND HEALTH CARE COMMISSION

Public Meeting .  70

Public Meeting .  70

Receipt of Application .  71

Formal Start of Review ..  71

MINORITY BUSINESS ENTERPRISE ADVISORY
   COMMITTEE

Public Meeting .  71

Public Meeting .  71

Public Meeting .  71

Public Meeting .  71

Public Meeting .  71

Public Meeting .  71

DEPARTMENT OF NATURAL RESOURCES/FISHING AND
   BOATING SERVICES

Public Notice — 2017 Atlantic Coast Recreational and
   Charter Boat Striped Bass Fishery Changes .  71

Public Notice — 2017 Commercial Atlantic Menhaden Quota
   and Season .  72

Public Notice — 2017 Summer Flounder Season, Size Limit
   and Creel Limit  72

Public Notice — 2017 Recreational Black Sea Bass
   Fishery .  72

BOARD OF OCCUPATIONAL THERAPY PRACTICE

Public Meeting .  72

STATE ADVISORY COUNCIL ON QUALITY CARE AT
   THE END OF LIFE

Public Meeting .  72

MARYLAND DEPARTMENT OF
   TRANSPORTATION/MARYLAND BOARD OF AIRPORT
   ZONING APPEALS

Public Hearing .  72

MARYLAND COLLEGE COLLABORATION FOR
   STUDENT VETERANS COMMISSION

Public Meeting .  73

BOARD OF WATERWORKS AND WASTE SYSTEMS
   OPERATORS

Public Meeting .  73

BOARD OF WELL DRILLERS

Public Meeting .  73

WORKERS' COMPENSATION COMMISSION

Public Meeting ..........................................................................  73

 

 

COMAR Online

        The Code of Maryland Regulations is available at www.dsd.state.md.us as a free service of the Office of the Secretary of State, Division of State Documents. The full text of regulations is available and searchable. Note, however, that the printed COMAR continues to be the only official and enforceable version of COMAR.

        The Maryland Register is also available at www.dsd.state.md.us.

        For additional information, visit www.dsd.state.md.us, Division of State Documents, or call us at (410) 974-2486 or 1 (800) 633-9657.

 

Availability of Monthly List of
Maryland Documents

        The Maryland Department of Legislative Services receives copies of all publications issued by State officers and agencies. The Department prepares and distributes, for a fee, a list of these publications under the title ‘‘Maryland Documents’’. This list is published monthly, and contains bibliographic information concerning regular and special reports, bulletins, serials, periodicals, catalogues, and a variety of other State publications. ‘‘Maryland Documents’’ also includes local publications.

        Anyone wishing to receive ‘‘Maryland Documents’’ should write to: Legislative Sales, Maryland Department of Legislative Services, 90 State Circle, Annapolis, MD 21401.

 

CLOSING DATES AND ISSUE DATES through JULY 21, 2017

Issue
Date

Emergency

and Proposed

Regulations

5 p.m.*

Final

Regulations

10:30 a.m.

Notices, etc.

10:30 a.m.

January 20**

December 30

January 11

January 9

February 3**

January 13

January 25

January 23

February 17

January 30

February 8

February 6

March 3**

February 13

February 22

February 17

March 17

February 27

March 8

March 6

March 31

March 13

March 22

March 20

April 14

March 27

April 5

April 3

April 28

April 10

April 19

April 17

May 12

April 24

May 3

May 1

May 26

May 8

May 17

May 15

June 9**

May 22

May 31

May 26

June 23

June 5

June 14

June 12

July 7

June 19

June 28

June 26

July 21

July 3

July 12

July 10

 

*   Due date for documents containing 8 to 18 pages — 48 hours before date shown; due date for documents exceeding 18 pages — 1 week before date shown

NOTE:  ALL DOCUMENTS MUST BE SUBMITTED IN TIMES NEW ROMAN, 9-POINT, SINGLE-SPACED FORMAT. THE REVISED PAGE COUNT REFLECTS THIS FORMATTING.

** Note closing date changes

***   Note issue date and closing date changes

The regular closing date for Proposals and Emergencies is Monday.

 

 



Cumulative Table of COMAR Regulations
Adopted, Amended, or Repealed

   This table, previously printed in the Maryland Register lists the regulations, by COMAR title, that have been adopted, amended, or repealed in the Maryland Register since the regulations were originally published or last supplemented in the Code of Maryland Regulations (COMAR). The table is no longer printed here but may be found on the Division of State Documents website at www.dsd.state.md.us.

Table of Pending Proposals

   The table below lists proposed changes to COMAR regulations. The proposed changes are listed by their COMAR number, followed by a citation to that issue of the Maryland Register in which the proposal appeared. Errata pertaining to proposed regulations are listed, followed by “(err)”. Regulations referencing a document incorporated by reference are followed by “(ibr)”. None of the proposals listed in this table have been adopted. A list of adopted proposals appears in the Cumulative Table of COMAR Regulations Adopted, Amended, or Repealed.

 


02 OFFICE OF THE ATTORNEY GENERAL

 

02.06.03.01—.10 • 42:13 Md. R. 798 (6-26-15)

 

07 DEPARTMENT OF HUMAN RESOURCES

 

07.02.10.01,.02,.04,.09 • 43:26 Md. R. 1452 (12-23-16)

07.02.10.08,.18 • 43:24 Md. R. 1352 (11-28-16)

07.02.11.03,.05,.16 • 43:24 Md. R. 1353 (11-28-16)

07.02.14.01—.14 • 43:2 Md. R. 143 (1-22-16)

07.02.15.01—.11 • 43:17 Md. R. 964 (8-19-16)

07.02.17.03,.04,.06—.08 • 43:17 Md. R. 968 (8-19-16)

07.02.18.02,.04,.06—.14 • 43:17 Md. R. 969 (8-19-16)

07.02.19.01—.08,.10,.12—.14,.16 • 43:17 Md. R. 971 (8-19-16)

 

08 DEPARTMENT OF NATURAL RESOURCES

 

08.02.01.05 • 43:23 Md. R. 1282 (11-14-16)

08.02.01.09 • 43:25 Md. R. 1388 (12-9-16)

08.02.01.13 • 43:16 Md. R. 903 (8-5-16)

08.02.05.22 • 43:23 Md. R. 1283 (11-14-16)

08.02.10.01 • 43:23 Md. R. 1283 (11-14-16)

08.02.11.01,.04 • 43:25 Md. R. 1389 (12-9-16)

08.02.21.03 • 43:26 Md. R. 1453 (12-23-16)

08.03.01.01 • 43:16 Md. R. 904 (8-5-16)

08.04.01.01 • 44:1 Md. R. 14 (1-6-17)

08.04.16.01—.03 • 43:2 Md. R. 162 (1-22-16)

08.18.01.03 • 44:1 Md. R. 14 (1-6-17)

08.18.07.01,.02 • 44:1 Md. R. 15 (1-6-17)

08.18.21.03 • 44:1 Md. R. 16 (1-6-17)

08.18.25.02 • 44:1 Md. R. 16 (1-6-17)

 

09 DEPARTMENT OF LABOR, LICENSING, AND REGULATION

 

09.12.43.02,.05 • 43:26 Md. R. 1453 (12-23-16)

09.24.01.09 • 44:1 Md. R. 17 (1-6-17)

09.35.02.02,.03 • 43:21 Md. R. 1170 (10-14-16)

09.38.01.01 • 43:18 Md. R. 1022 (9-2-16)

 

10 DEPARTMENT OF HEALTH AND MENTAL HYGIENE

 

     Subtitles 01—08 (1st volume)

 

10.02.01.04 • 43:26 Md. R. 1454 (12-23-16)

10.03.01.08 • 43:23 Md. R. 1284 (11-14-16)

10.05.01.04 • 44:1 Md. R. 18 (1-6-17)

10.05.01.08 • 43:26 Md. R. 1457 (12-23-16)

10.05.03.04 • 43:26 Md. R. 1458 (12-23-16)

10.06.01.01,.02,.17,.18 • 43:26 Md. R. 1458 (12-23-16)

10.06.02.02,.04,.13 • 43:25 Md. R. 1392 (12-9-16)

10.07.01.01,.31 • 43:26 Md. R. 1460 (12-23-16)

10.07.01.04,.21 • 44:1 Md. R. 18 (1-6-17)

10.07.03.05 • 44:1 Md. R. 18 (1-6-17)

10.07.04.03 • 44:1 Md. R. 18 (1-6-17)

10.07.05.04 • 44:1 Md. R. 18 (1-6-17)

10.07.07.04 • 44:1 Md. R. 18 (1-6-17)

10.07.08.04,.05 • 44:1 Md. R. 18 (1-6-17)

10.07.09.08 • 44:1 Md. R. 18 (1-6-17)

10.07.10.04 • 44:1 Md. R. 18 (1-6-17)

10.07.11.04,.05,.09,.10 • 44:1 Md. R. 18 (1-6-17)

10.07.12.04,.20 • 44:1 Md. R. 18 (1-6-17)

10.07.14.07 • 44:1 Md. R. 18 (1-6-17)

10.07.16.05 • 44:1 Md. R. 18 (1-6-17)

10.07.17.03.04 • 44:1 Md. R. 18 (1-6-17)

10.07.18.04 • 44:1 Md. R. 18 (1-6-17)

10.07.20.04 • 44:1 Md. R. 18 (1-6-17)

10.07.21.04 • 44:1 Md. R. 18 (1-6-17)

 

     Subtitle 09 (2nd volume)

 

10.09.01.01—.10 • 43:26 Md. R. 1462 (12-23-16)

10.09.02.07 • 43:26 Md. R. 1454 (12-23-16) (ibr)

10.09.06.01—.18 • 43:26 Md. R. 1464 (12-23-16)

10.09.08.04 • 43:26 Md. R. 1487 (12-23-16)

10.09.08.07,.10 • 43:26 Md. R. 1454 (12-23-16)

10.09.09.07 • 43:26 Md. R. 1454 (12-23-16)

10.09.14.07 • 43:25 Md. R. 1393 (12-9-16)

10.09.15.07 • 43:26 Md. R. 1454 (12-23-16)

10.09.17.06 • 43:25 Md. R. 1393 (12-9-16)

10.09.20.09—.11,.14 • 43:23 Md. R. 1284 (11-14-16)

10.09.21.01—.11 • 43:26 Md. R. 1462 (12-23-16)

10.09.23.01-1,.07 • 43:25 Md. R. 1393 (12-9-16) (ibr)

10.09.23.03 • 43:24 Md. R. 1354 (11-28-16)

10.09.21.01—.11 • 43:26 Md. R. 1462 (12-23-16)

10.09.24.08-2 • 43:26 Md. R. 1488 (12-23-16)

10.09.38.06 • 43:26 Md. R. 1454 (12-23-16)

10.09.39.01—.10 • 43:26 Md. R. 1462 (12-23-16)

10.09.49.11 • 43:26 Md. R. 1454 (12-23-16)

10.09.50.07 • 43:26 Md. R. 1454 (12-23-16)

10.09.51.07 • 43:25 Md. R. 1393 (12-9-16)

10.09.54.13—.19,.22 • 43:23 Md. R. 1285 (11-14-16)

10.09.60.01—.08 • 43:24 Md. R. 1355 (11-28-16)

10.09.62.01 • 43:26 Md. R. 1489 (12-23-16)

10.09.65.19 • 43:25 Md. R. 1394 (12-9-16)

10.09.65.19-3 • 43:24 Md. R. 1354 (11-28-16)

10.09.67.01,.07,.12 • 43:24 Md. R. 1354 (11-28-16)

10.09.67.20 • 43:26 Md. R. 1454 (12-23-16)

10.09.67.28 • 43:26 Md. R. 1489 (12-23-16)

10.09.68.01—.03 • 43:26 Md. R. 1489 (12-23-16)

10.09.70.02 • 43:25 Md. R. 1398 (12-9-16)

10.09.76.01—.11 • 43:26 Md. R. 1489 (12-23-16)

10.09.77.04,.06 • 43:26 Md. R. 1487 (12-23-16)

10.09.80.01,.05,.06,.08 • 43:25 Md. R. 1402 (12-9-16)

10.09.84.14—.20,.23,.24 • 43:23 Md. R. 1286 (11-14-16)

10.09.87.07 • 43:26 Md. R. 1454 (12-23-16)

10.09.88.07 • 43:26 Md. R. 1454 (12-23-16)

10.09.92.01—.14 • 43:26 Md. R. 1464 (12-23-16)

10.09.93.01—.16 • 43:26 Md. R. 1464 (12-23-16)

10.09.94.01—.13 • 43:26 Md. R. 1464 (12-23-16)

10.09.95.01—.13 • 43:26 Md. R. 1464 (12-23-16)

 

     Subtitles 10 — 22 (3rd Volume)

 

10.10.03.02 • 44:1 Md. R. 18 (1-6-17)

10.10.13.02—.04,.12—.18,.20,.21,
     .23—.27
• 44:1 Md. R. 23 (1-6-17)

10.11.03.14 • 43:26 Md. R. 1454 (12-23-16)

10.14.01.01,.02,.02-1,.07 • 43:25 Md. R. 1404 (12-9-16) (ibr)

10.14.06.02—.06 • 43:25 Md. R. 1406 (12-9-16)

10.15.05.01,.01-1,.13,.14,.20-1,.21,
     .24—.26-2
• 43:25 Md. R. 1407 (12-9-16) (ibr)

10.15.06.01-.07,.10,.12—.20 • 43:25 Md. R. 1407 (12-9-16)

10.15.08.02,.03 • 43:25 Md. R. 1407 (12-9-16)

10.16.07.03,.14 • 43:25 Md. R. 1415 (12-9-16)

10.18.04.01—.03 • 43:26 Md. R. 1458 (12-23-16)

10.18.09.01—.08 • 44:1 Md. R. 31 (1-6-17)

10.21.16.04 • 44:1 Md. R. 18 (1-6-17)

10.21.25.03-2,.05—.13 • 43:19 Md. R. 1077 (9-16-16)

10.22.01.01 • 44:1 Md. R. 34 (1-6-17)

10.22.02.02 • 44:1 Md. R. 18 (1-6-17)

10.22.10.05 • 43:23 Md. R. 1287 (11-14-16)

10.22.18.04 • 44:1 Md. R. 34 (1-6-17)

 

     Subtitles 23 — 36 (4th Volume)

 

10.24.15.01 • 43:25 Md. R. 1417 (12-9-16) (ibr)

10.24.19.01 • 43:18 Md. R. 1027 (9-2-16) (ibr)

10.27.01.04—.18 • 43:24 Md. R. 1357 (11-28-16)

10.27.21.02—.05,.07 • 43:25 Md. R. 1418 (12-9-16)

10.29.09.02—.06,.11,.14 • 43:26 Md. R. 1492 (12-23-16)

10.29.15.02—.05,.07,.08 • 43:26 Md. R. 1494 (12-23-16)

10.33.01.14 • 43:25 Md. R. 1419 (12-9-16)

 

     Subtitles 37—65 (5th Volume)

 

10.38.12.01—.04 • 43:23 Md. R. 1287 (11-14-16)

10.39.01.03—.09 • 43:24 Md. R. 1357 (11-28-16)

10.39.04.04 • 43:24 Md. R. 1357 (11-28-16)

10.41.03.08 • 43:25 Md. R. 1420 (12-9-16)

10.41.08.02 • 43:25 Md. R. 1420 (12-9-16)

10.41.11.02 • 43:25 Md. R. 1420 (12-9-16)

10.47.04.04,.05 • 44:1 Md. R. 18 (1-6-17)

10.48.01.07 • 43:26 Md. R. 1454 (12-23-16)

10.51.03.02,.03 • 44:1 Md. R. 18 (1-6-17)

10.52.01.01—.09 • 44:1 Md. R. 36 (1-6-17)

10.52.12.03—.15 • 44:1 Md. R. 23 (1-6-17)

10.53.02.01—.10 • 43:24 Md. R. 1357 (11-28-16)

10.54.03.03,.04,.07—.11,.13—.16,.18,
     .19
• 43:26 Md. R. 1495 (12-23-16)

10.60.01.02—.05 • 44:1 Md. R. 40 (1-6-17)

10.60.02.03—.05 • 44:1 Md. R. 40 (1-6-17)

10.60.03.03 • 44:1 Md. R. 40 (1-6-17)

10.60.04.09—.13 • 44:1 Md. R. 40 (1-6-17)

10.60.06.01 • 44:1 Md. R. 40 (1-6-17)

10.62.01.01 • 43:22 Md. R. 1245 (10-28-16)

10.62.08.03,.05—.07 • 43:22 Md. R. 1245 (10-28-16)

10.62.09.03 • 43:22 Md. R. 1245 (10-28-16)

10.62.12.02 • 43:22 Md. R. 1245 (10-28-16)

10.62.15.04—.07 • 43:22 Md. R. 1245 (10-28-16)

10.62.19.02,.04—.06 • 43:22 Md. R. 1245 (10-28-16)

10.62.20.03 • 43:22 Md. R. 1245 (10-28-16)

10.62.22.02 • 43:22 Md. R. 1245 (10-28-16)

10.62.25.03,.05—.07 • 43:22 Md. R. 1245 (10-28-16)

10.62.26.03 • 43:22 Md. R. 1245 (10-28-16)

10.62.28.02 • 43:22 Md. R. 1245 (10-28-16)

10.63.01.02,.04,.05 • 43:23 Md. R. 1289 (11-14-16)

10.63.03.14,.18,.19 • 43:23 Md. R. 1289 (11-14-16)

10.63.04.03 • 43:23 Md. R. 1289 (11-14-16)

10.63.06.10 • 43:23 Md. R. 1289 (11-14-16)

10.63.07.01—.12 • 44:1 Md. R. 43 (1-6-17)

 

11 DEPARTMENT OF TRANSPORTATION

 

     Subtitles 01—10

 

11.01.18.01,.02 • 43:22 Md. R. 1251 (10-28-16)

11.12.01.01—.25 • 44:1 Md. R. 46 (1-6-17)

 

12 DEPARTMENT OF PUBLIC SAFETY AND CORRECTIONAL SERVICES

 

12.04.01.01,.16 • 43:26 Md. R. 1500 (12-23-16)

 

13A STATE BOARD OF EDUCATION

 

13A.02.08.01—.03 • 43:22 Md. R. 1252 (10-28-16)

13A.03.07.01—.05 • 43:22 Md. R. 1252 (10-28-16)

13A.04.03.01—.11 • 43:22 Md. R. 1253 (10-28-16)

13A.04.05.01—.08 • 44:1 Md. R. 54 (1-6-17)

13A.04.19.01—.09 • 43:26 Md. R. 1502 (12-23-16)

13A.04.20.02,.04,.05,.07 • 43:26 Md. R. 1503 (12-23-16)

13A.06.07.01,.08—.10 • 43:26 Md. R. 1503 (12-23-16)

13A.07.11.01—.05 • 43:10 Md. R. 595 (5-13-16) (ibr)

13A.12.04.04 • 43:26 Md. R. 1505 (12-23-16)

 

13B MARYLAND HIGHER EDUCATION COMMISSION

 

13B.01.01.03,.15 • 43:25 Md. R. 1421 (12-9-16)

13B.02.02.08 • 43:25 Md. R. 1422 (12-9-16)

13B.05.01.05 • 43:25 Md. R. 1423 (12-9-16)

13B.05.01.06 • 43:25 Md. R. 1424 (12-9-16)

13B.06.01.02,.02-1,.04—.10 • 43:26 Md. R. 1505 (12-23-16)

13B.07.02.07 • 43:23 Md. R. 1290 (11-14-16)

13B.08.09.01—.11 • 42:22 Md. R. 1398 (10-30-15)

13B.08.13.01—.10 • 43:8 Md. R. 506 (4-15-16)

13B.08.14.01—.15 • 43:6 Md. R. 421 (3-18-16)

13B.08.15.01—.16 • 43:9 Md. R. 546 (4-29-16)

 

14 INDEPENDENT AGENCIES

 

14.06.03.05,.06 • 42:26 Md. R. 1638 (12-28-15)

14.35.01.01,.02 • 43:18 Md. R. 1039 (9-2-16)

14.35.07 • 43:19 Md. R. 1092 (9-16-16) (err)

14.35.07.01—.21 • 43:18 Md. R. 1039 (9-2-16)

14.36.04.01,.03—.08 • 43:4 Md. R. 342 (2-19-16)

 

15 DEPARTMENT OF AGRICULTURE

 

15.05.01.02 • 43:19 Md. R. 1088 (9-16-16)

15.06.04.06 • 43:21 Md. R. 1171 (10-14-16)

 

20 PUBLIC SERVICE COMMISSION

 

20.31.01.02 • 43:23 Md. R. 1291 (11-14-16)

20.31.03.01 • 43:23 Md. R. 1291 (11-14-16)

 

21 STATE PROCUREMENT REGULATIONS

 

21.02.01.04,.05 • 44:1 Md. R. 57 (1-6-17)

 

26 DEPARTMENT OF THE ENVIRONMENT

 

     Subtitles 01—07 (Part 1)

 

26.04.02.09 • 43:25 Md. R. 1424 (12-9-16)

 

     Subtitles 08—12 (Part 2)

 

26.08.07.04 • 43:24 Md. R. 1361 (11-28-16)

 

     Subtitles 19—27 (Part 4)

 

26.19.01.01—.61 • 43:23 Md. R. 1293 (11-14-16) (ibr)

 

29 DEPARTMENT OF STATE POLICE

 

29.01.02.01,.02,.11,.16 • 43:10 Md. R. 609 (5-13-16)

29.05.02.01—.08 • 43:12 Md. R. 693 (6-10-16)

 

30 MARYLAND INSTITUTE FOR EMERGENCY MEDICAL SERVICES SYSTEMS (MIEMSS)

 

30.08.15.03 • 43:23 Md. R. 1316 (11-14-16)

 

31 MARYLAND INSURANCE ADMINISTRATION

 

31.03.06.10 • 43:26 Md. R. 1508 (12-23-16)

31.03.18.01—.03 • 44:1 Md. R. 58 (1-6-17)

31.04.15.03 • 43:25 Md. R. 1425 (12-9-16)

31.05.11.02 • 43:25 Md. R. 1425 (12-9-16)

31.05.12.01 • 43:25 Md. R. 1425 (12-9-16)

31.08.01.02 • 43:24 Md. R. 1362 (11-28-16)

31.08.02.02 • 43:24 Md. R. 1362 (11-28-16)

31.08.03 • 43:24 Md. R. 1362 (11-28-16)

31.08.08.07 • 43:24 Md. R. 1362 (11-28-16)

31.08.09.06—.08,.13,.14 • 43:24 Md. R. 1362 (11-28-16)

31.08.10.02 • 43:24 Md. R. 1362 (11-28-16)

31.08.11.01—.07 • 44:1 Md. R. 59 (1-6-17)

31.08.13.03,.04,.06 • 43:20 Md. R. 1146 (9-30-16)

31.09.04 • 44:1 Md. R. 62 (1-6-17)

31.09.08 • 44:1 Md. R. 62 (1-6-17)

31.10.11.14 • 43:24 Md. R. 1365 (11-28-16)

31.13.01.22 • 43:23 Md. R. 1318 (11-14-16)

31.14.01.13,.24,.36 • 43:26 Md. R. 1509 (12-23-16)

31.14.02.03—.06,.06-1 • 43:26 Md. R. 1509 (12-23-16)

31.14.03.06 • 43:24 Md. R. 1365 (11-28-16)

31.15 • 43:2 Md. R. 128 (1-22-16) (err)

31.15.15.01—.07 • 44:1 Md. R. 59 (1-6-17)

31.16.08.06 • 43:24 Md. R. 1366 (11-28-16)

 

33 STATE BOARD OF ELECTIONS

 

33.01.01.01 • 43:4 Md. R. 345 (2-19-16)

33.05.04.05 • 43:4 Md. R. 346 (2-19-16)

33.13.07.06 • 43:24 Md. R. 1367 (11-28-16)

33.13.08.06,.07 • 43:24 Md. R. 1367 (11-28-16)

33.13.10.02—.04 • 43:24 Md. R. 1367 (11-28-16)

33.13.13.08 • 43:24 Md. R. 1367 (11-28-16)

33.14.02.03 • 43:24 Md. R. 1369 (11-28-16)

33.16.01.01 • 43:4 Md. R. 346 (2-19-16)

33.16.02.05 • 43:4 Md. R. 346 (2-19-16)

33.16.03.01,.02 • 43:4 Md. R. 346 (2-19-16)

33.16.04.01 • 43:4 Md. R. 346 (2-19-16)

33.16.05.03,.04 • 43:4 Md. R. 346 (2-19-16)

33.16.06.01 • 43:4 Md. R. 346 (2-19-16)

33.20.06.01 • 43:24 Md. R. 1369 (11-28-16)

 

35 DEPARTMENT OF VETERANS’ AFFAIRS

 

35.03.01.05 • 43:26 Md. R. 1515 (12-23-16)

 

36 MARYLAND STATE LOTTERY AND GAMING CONTROL AGENCY

 

36.03.10.23,.28,.50 • 44:1 Md. R. 63 (1-6-17)

 


The Division of State Documents

DEPOSITORIES FOR DOCUMENTS
INCORPORATED BY REFERENCE

Depositories for Documents Incorporated by Reference
into the Code of Maryland Regulations (COMAR)

 


Annapolis

MD Department of Legislative Services

90 State Circle (21401)

Contact: Cynthia Stiverson

410-946-5400, 301-970-5400,

800-492-7111 x5400 (MD only)

FAX 410-946-5405

 

MD State Archives

350 Rowe Blvd. (21401)

Contact: Christine Alvey

410-260-6438

FAX 410-974-3895

 

MD State Law Library

Robert C. Murphy Courts of Appeal

Bldg. 361 Rowe Blvd. (21401)

Contact: Mary Jo Lazun

410-260-1430, 888-216-8156

FAX 410-974-2063

 

Baltimore

State Library Resource Center

Enoch Pratt Free Library

400 Cathedral St. (21201)

Contact: State Depository and Distribution  Program

410-396-1789

FAX 410-396-4570

 

Law Library

University of Baltimore

1415 Maryland Ave.

(21201)

Contact: Patricia Behles

410-837-4559

FAX 410-837-4570

 

Thurgood Marshall Law Library

University of Md. Francis King     Carey School of Law

501 W. Fayette Street (21201)

410-706-2736

FAX 410-706-2372

 

Charlotte Hall

Southern MD Regional Library

37600 New Market Rd.

(20622)

P.O. Box 459 (20622)

Contact: Susan Grant

301-934-9442

FAX 301-884-0438

 

College Park

Hornbake Library

University of MD

Marylandia and Rare Books Department (20742)

Contact: Amber Kohl

301-405-9210

FAX 301-314-2709

 

Frostburg

Frostburg State University

Lewis J. Ort Library

1 Susan Eisel Drive (21532)

Contact: Lisa Hartman

301-687-4734

FAX 301-687-7069

 

Hagerstown

Government Reference Service of Washington County Free Library

100 South Potomac Street (21740)

Contact: Harry Sachs

301-739-3250 x 149

FAX 301-739-5839

 

Princess Anne

Frederick Douglass Library

University of MD Eastern Shore

(21853)

Contact: Cynthia Nyirenda

410-651-7540

FAX 410-651-6269

 

Rockville

Montgomery County Public Library

Rockville Branch 21

Maryland Avenue (20850)

Contact: Caren Genison-Perilman

240-777-0170

FAX 240-777-0155

 

Salisbury

Salisbury University

Blackwell Library

College and Camden Avenues (21801)

Contact: Martha Zimmerman

410-543-6234

FAX 410-543-6203

 

Towson

Albert S. Cook Library

Towson University

8000 York Road (21252)

Contact: Carl Olson

410-704-3267

FAX 410-704-3829

Washington, D.C.

Library of Congress

Anglo-American Acquisitions Division

Government Documents Section101 Independence Ave., S.E. (20540)

Contact: Richard Yarnall

202-707-9470

FAX 202-707-0380

Open Meetings Compliance Board

 

SUMMARY OF OPINIONS ISSUED FROM OCTOBER 1 —
DECEMBER 31, 2016*

10 Official Opinions of the Compliance Board 104 (2016)

Baltimore City Board of School Commissioners (Reginald L. Lee, Complainant)

October 6, 2016

Topics discussed: Scope of administrative function exclusion, in context of various stages of superintendent hiring process; notice

 

10 Official Opinions of the Compliance Board 110 (2016)

Howard County Board of Education (Craig O’Donnell, Complainant)

October 13, 2016

Topic discussed: Acknowledgment of violation

 

10 Official Opinions of the Compliance Board 112 (2016)

City of Greenbelt Forest Preserve Advisory Board (Brian Almquist, Complainant)

November 2, 2016

Topics discussed: Timeliness of notice posted on website; timeliness of minutes

 

10 Official Opinions of the Compliance Board 115 (2016)

 Montgomery Planning Board of the Maryland National Park and Planning Commission (Steve Hull, Bethesda Magazine, Complainant)

November 5, 2016

Topics discussed: Content of notice; complaint procedures

 

10 Official Opinions of the Compliance Board 117 (2016)

Cumberland Economic Development Corporation (Jeff Shaw, Nicholas Redding, Woodrow H. Gordon, Diane M. Gilmore, Debra Darby, Lawrence Darby, and Susan Bolyard, Complainants)

November 3, 2016

Topics discussed: Scope of the Act (applicability to non-profit corporation created by city); notice

 

10 Official Opinions of the Compliance Board 126 (2016)

Board of Commissioners, Housing Authority of the City of Annapolis (Richard Hutzell, Capitol Gazette Communications, Complainant)

November 9, 2016

Topics discussed: Notice; closed-session requirements

 

10 Official Opinions of the Compliance Board 128 (2016)

Anne Arundel County Board of Appeals (Sara Shoemaker and Laura Scalise, Complainants)

November 21, 2016

Topics discussed: “Legal advice” exception; sufficiency of closing statements; sufficiency of facts for resolution of complaint

 

 

10 Official Opinions of the Compliance Board 134 (2016)

Mardela Springs Town Commissioners (Donald L. Singleton, Ph.D., Complainant)

December 8, 2016

Topics discussed: Administrative function exclusion; notice

 

     * The Compliance Board’s opinions for this quarter are posted in full in Volume 10, accessible at http://www.marylandattorneygeneral.gov/Pages/OpenGov/OpenMeetings/index.aspx.

[17-01-32]

 

 


The Judiciary
COURT OF APPEALS OF MARYLAND

DISCIPLINARY PROCEEDINGS

     This is to certify that by an Order of the Court of Appeals dated December 14, 2016, ERIC JOHN PARHAM, 10008 Raritan Way, Thornton, Colorado 80260, has been disbarred, effective immediately, from the further practice of law in this State, and his name as an attorney at law has been stricken from the register of attorneys in this Court (Maryland Rule 19-761).

*   *   *   *   *   *   *   *   *   *

     This is to certify that by an Order of the Court of Appeals dated December 15, 2016, EDWIN ATTEH QUARTEY, 8605 Cameron Street, Suite 316, Silver Spring, Maryland 20910, has been suspended by consent for six (6) months, from the further practice of law in this State, and his name as an attorney at law has been stricken from the register of attorneys in this Court (Maryland Rule 19-761).

*   *   *   *   *   *   *   *   *   *

     This is to certify that by an Opinion and Order of the Court of Appeals dated December 15, 2016, ANDREW NDUBISI UCHEOMUMU, 4938 Hampden Lane, Bethesda, Maryland 20814, has been indefinitely suspended, effective immediately, from the further practice of law in this State, and his name as an attorney at law has been stricken from the register of attorneys in this Court (Maryland Rule 19-761).

*   *   *   *   *   *   *   *   *   *

     This is to certify that by an Order of the Court of Appeals dated December 15, 2016, JING TAN, 401 N. Washington Street, Suite 500, Rockville, Maryland 20850, a non-admitted attorney has been reinstated in this Court to be eligible to practice law in this State as of December 16, 2016. Notice of this action is certified in accordance with Maryland Rule 19-751(g)(2).

*   *   *   *   *   *   *   *   *   *

     This is to certify that by an Order of the Court of Appeals dated December 16, 2016, LEONARD HAL ADOFF, 552 Stellman Road, Rivervale, New Jersey 07675-6126, has been disbarred by consent, effective immediately, from the further practice of law in this State, and his name as an attorney at law has been stricken from the register of attorneys in this Court (Maryland Rule 19-761).

*   *   *   *   *   *   *   *   *   *

     This is to certify that by an Order of the Court of Appeals dated December 16, 2016,

ELEANOR NACE, 1666 Connecticut Avenue, Suite 225, Washington, DC 20009, has been indefinitely suspended, effective immediately, from the further practice of law in this State, and her name as an attorney at law has been stricken from the register of attorneys in this Court (Maryland Rule 19-761).

*   *   *   *   *   *   *   *   *   *

     This is to certify that by an Opinion and Order of the Court of Appeals dated December 19, 2016, WILLIE JAMES MAHONE, 129-7 West Patrick Street, Frederick, Maryland 21701, has been indefinitely suspended, effective immediately, from the further practice of law in this State, and his name as an attorney at law has been stricken from the register of attorneys in this Court (Maryland Rule 19-761).

[17-01-34]

 

 


Final Action on Regulations

 

Symbol Key

   Roman type indicates text already existing at the time of the proposed action.

   Italic type indicates new text added at the time of proposed action.

   Single underline, italic indicates new text added at the time of final action.

   Single underline, roman indicates existing text added at the time of final action.

   [[Double brackets]] indicate text deleted at the time of final action.

 

 


Title 10
DEPARTMENT OF HEALTH AND MENTAL HYGIENE

Subtitle 37 HEALTH SERVICES COST REVIEW COMMISSION

10.37.10 Rate Application and Approval Procedures

Authority: Health-General Article, §§19-207, 19-219, and 19-222, Annotated Code of Maryland

Notice of Final Action

[16-248-F]

On December 14, 2016, the Health Services Cost Review Commission adopted amendments to Regulation .03 under COMAR 10.37.10 Rate Application and Approval Procedures. This action, which was proposed for adoption in 43:20 Md. R. 1115 (September 30, 2016), has been adopted as proposed.

Effective Date: January 16, 2017.

NELSON SABATINI
Chairman
Health Services Cost Review Commission

 

Subtitle 37 HEALTH SERVICES COST REVIEW COMMISSION

10.37.10 Rate Application and Approval Procedures

Authority: Health-General Article, §§19-201 and 19-211, Annotated Code of Maryland

Notice of Final Action

[16-277-F]

On December 14, 2016, the Health Services Cost Review Commission adopted amendments to Regulation .07-2 under COMAR 10.37.10 Rate Application and Approval Procedures. This action, which was proposed for adoption in 43:22 Md. R. 1244—1245 (October 28, 2016), has been adopted as proposed.

Effective Date: January 16, 2017.

NELSON SABATINI
Chairman
Health Services Cost Review Commission

 

Title 19A
STATE ETHICS COMMISSION

Notice of Final Action

[16-246-F]

On December 15, 2016, the State Ethics Commission adopted:

(1) Amendments to Regulations .02 and .04 under COMAR 19A.01.01 General Provisions;

(2) Amendments to Regulations .02 and .05 under COMAR 19A.01.02 Advisory Opinions;

(3) Amendments to Regulations .02, .09, and .10 under COMAR 19A.01.03 Enforcement Procedures;

(4) Amendments to Regulation .03 under COMAR 19A.04.01 General Provisions;

(5) Amendments to Regulations .04 and .05 under COMAR 19A.04.02 Review Criteria;

(6) Amendments to Regulation .01 under COMAR 19A.04.03 Review Procedures;

(7) Amendments to Appendix A and Appendix B under COMAR 19A.04 Local Government Ethics Law;

(8) Amendments to Regulations .04 and .06 under COMAR 19A.05.02 Review Criteria;

(9) Amendments to Appendix A and Appendix B under COMAR 19A.05 Board of Education Ethics Regulations;

(10) Amendments to Regulation .03 under COMAR 19A.06.01 General Provisions;

(11) Amendments to Regulation .04 and the repeal of Regulation .05 under COMAR 19A.06.02 Criteria for Certification;

(12) Amendments to Regulation .05 and the repeal of Regulation .07 under COMAR 19A.06.03 Procedural Requirements; and

(13) Amendments to Regulations .04 and .06—.08 under COMAR 19A.07.01 General.

This action, which was proposed for adoption in 43:20 Md. R. 1140—1144 (September 30, 2016), has been adopted with the nonsubstantive changes shown below.

Effective Date: January 16, 2017.

Attorney General's Certification

In accordance with State Government Article, §10-113, Annotated Code of Maryland, the Attorney General certifies that the following changes do not differ substantively from the proposed text. The nature of the changes and the basis for this conclusion are as follows:

COMAR 19A.04.02.04 and .05: In response to comments received, the Commission agreed the addition of the language "as applicable" in each regulation would provide clarification without altering the substance of the proposed text.

 

Subtitle 04 LOCAL GOVERNMENT ETHICS LAW

19A.04.02 Review Criteria

Authority: General Provisions Article, §§5-206 and 5-209 and Title 5, Subtitle 8, Annotated Code of Maryland

.04 Conflicts of Interest.

A. Similarity to Public Ethics Law.

(1) Unless the Commission grants the county or municipality a modification or exemption as provided in COMAR 19A.04.03.03 in accordance with General Provisions Article, §§5-209 and 5-808, Annotated Code of Maryland, as applicable, to be equivalent to the requirements of and similar to the Public Ethics Law, the local ethics law shall address conflicts of interest restrictions as described in this regulation.

(2) (proposed text unchanged)

B. — H. (proposed text unchanged)

.05 Financial Disclosure.

A. Unless the Commission grants a county or municipality a modification or exemption as provided in COMAR 19A.04.03.03 in accordance with General Provisions Article, §§5-209 and 5-809, Annotated Code of Maryland, as applicable, the local law shall include financial disclosure requirements as described in this regulation.

B. — E. (proposed text unchanged)

MICHAEL W. LORD
Executive Director

 

 


Proposed Action on Regulations

 


 



Title 08
DEPARTMENT OF NATURAL RESOURCES

Subtitle 04 BOATING

08.04.01 Definitions

Authority: Natural Resources Article, §§8-703 and 8-704[(c)], Annotated Code of Maryland

Notice of Proposed Action

[17-014-P]

The Secretary of Natural Resources proposes to amend Regulation .01 under COMAR 08.04.01 Definitions.

Statement of Purpose

The purpose of this action is to correct technical errors in existing definitions to make them user friendly and easier to understand. When terms are not clearly defined, the cited individual must appear in court instead of being offered the pre-pay option. Modifying definitions will assist the individual and NRP in their mission of keeping the waterways safe.

Comparison to Federal Standards

There is no corresponding federal standard to this proposed action.

Estimate of Economic Impact

The proposed action has no economic impact.

Economic Impact on Small Businesses

The proposed action has minimal or no economic impact on small businesses.

Impact on Individuals with Disabilities

The proposed action has no impact on individuals with disabilities.

Opportunity for Public Comment

Comments may be sent to Michael Grant, Regulations Coordinator, Department of Natural Resources, 580 Taylor Avenue, Annapolis, MD 21401, or call 410-260-8013, or email to michael.grant@maryland.gov, or fax to 410-260-8453. Comments will be accepted through February 6, 2017. A public hearing has not been scheduled.

.01 Definitions.

A. (text unchanged)

B. Terms Defined.

(1)—(41) (text unchanged)

(42) Time Periods:

(a)—(d) (text unchanged)

(e) “Saturdays, Sundays, and State holidays” means the period beginning at 12:01 a.m. each Saturday, and ending at 12 midnight each succeeding Sunday, and during the period beginning at 12:01 a.m. and ending at 12 midnight each holiday officially recognized by the State of Maryland as listed by the Maryland Department of Budget and Management. For the purposes of this subtitle, the terms “holiday” and “State holiday” are to be considered equivalent.

(f)—(h) (text unchanged)

(43)—(49) (text unchanged)

MARK J. BELTON
Secretary of Natural Resources

 

Subtitle 18 BOATING—SPEED LIMITS AND OPERATION OF VESSELS

08.18.01 General

Authority: Natural Resources Article, §§8-703 and 8-704, Annotated Code of Maryland

Notice of Proposed Action

[17-015-P]

The Secretary of Natural Resources proposes to amend Regulation .03 under COMAR 08.18.01 General.

Statement of Purpose

The purpose of this action is to correct technical errors in existing definitions to make them user friendly and easier to understand. When terms are not clearly defined, the cited individual must appear in court instead of being offered the pre-pay option. Modifying definitions will assist the individual and NRP in their mission of keeping the waterways safe.

Comparison to Federal Standards

There is no corresponding federal standard to this proposed action.

Estimate of Economic Impact

The proposed action has no economic impact.

Economic Impact on Small Businesses

The proposed action has minimal or no economic impact on small businesses.

Impact on Individuals with Disabilities

The proposed action has no impact on individuals with disabilities.

Opportunity for Public Comment

Comments may be sent to Michael Grant, Regulation Coordinator, Department of Natural Resources, 580 Taylor Avenue, Annapolis, MD 21401, or call 410-260-8013, or email to michael.grant@maryland.gov, or fax to 410-260-8453. Comments will be accepted through February 6, 2017. A public hearing has not been scheduled.

.03 Definitions.

A. (text unchanged)

B. Terms Defined.

(1)—(41) (text unchanged)

(42) Time Periods:

(a)—(d) (text unchanged)

(e) “Saturdays, Sundays, and State holidays” means the period beginning at 12:01 a.m. each Saturday, and ending at 12 midnight each succeeding Sunday, and during the period beginning at 12:01 a.m. and ending at 12 midnight each holiday officially recognized by the State of Maryland as listed by the Maryland Department of Budget and Management. For the purposes of this subtitle, the terms “holiday” and “State holiday” are to be considered equivalent.

(f)—(h) (text unchanged)

(43)—(49) (text unchanged)

MARK J. BELTON
Secretary of Natural Resources

 

Subtitle 18 BOATING—SPEED LIMITS AND OPERATION OF VESSELS

08.18.07 Chesapeake Bay

Authority: Natural Resources Article, §§8-703 and 8-704, Annotated Code of Maryland

Notice of Proposed Action

[17-011-P]

The Secretary of Natural Resources proposes to amend Regulations .01 and .02 under COMAR 08.18.07 Chesapeake Bay.

Statement of Purpose

The purpose of this action is to update and clarify existing boating laws and coordinates of certain boundaries and to ensure safe boating on Maryland’s waterways.

Comparison to Federal Standards

There is no corresponding federal standard to this proposed action.

Estimate of Economic Impact

The proposed action has no economic impact.

Economic Impact on Small Businesses

The proposed action has minimal or no economic impact on small businesses.

Impact on Individuals with Disabilities

The proposed action has no impact on individuals with disabilities.

Opportunity for Public Comment

Comments may be sent to Michael Grant, Regulations Coordinator, Department of Natural Resources, 580 Taylor Avenue, Annapolis, MD 21401, or call 410-260-8013, or email to michael.grant@maryland.gov, or fax to 410-260-8453. Comments will be accepted through February 6, 2017. A public hearing has not been scheduled.

.01 Eastern Shore.

A.— C. (text unchanged)

D. Kent Island Narrows Channel North Area.[—All the navigation channel at the northerly approach to Kent Island Narrows enclosed by a line beginning at a point at or near marker 12, ] This area is enclosed by a line beginning at or near Lat. 38° 58.705’N., Long. 76° 14.620’ W., then running 60° (True) to [marker 8, ] a point at or near Lat. 38° 58.753’N., Long. 76° 14.513’ W., then running 15° (True) to [marker 6,] a point at or near Lat. 38° 58.828’N., Long. 76° 14.488’ W., then running 330° (True) to [marker 4, ] a point at or near Lat. 38° 59.017’N., Long. 76° 14.625’ W., then running 329° (True) to [marker, 2K,] a point at or near Lat. 38° 59.212’N., Long. 76° 14.775’ W., then running 57° (True) to [marker, 1K,] a point at or near Lat. 38° 59.225’N., Long. 76° 14.748’ W., then running 150° (True) to [marker 3,] a point at or near Lat. 38° 59.028’N., Long. 76° 14.603’ W., then running 150° (True) to [marker 5,] a point at or near [Lat. 38° 8.830’N., ] Lat. 38º58.830’N., Long. 76° 14.455’ W., then running 198° (True) to [marker 9,] a point at or near Lat. 38° 58.738’N., [Long. 76° 4.493’ W.,] Long. 76º14.493’W., then running 243° (True) to [marker 11,] a point at or near Lat. 38° 58.707’N., Long. 76° 14.573’ W., then running 231° (True) to a point[,] at or near Lat. 38° 58.677’N., Long. 76° 14.620’ W., then running approximately 358° (True) to the point of beginning. In the event of shoaling in the channel the regulated area will shift to encompass the channel marked by the United States Coast Guard or its agent(s). [This area has a 6-knot speed limit all year. ] Except as otherwise restricted, the speed limit for this area is 6 knots.

E. Knapps Narrows Area. This area is enclosed by a line beginning [encompasses the area west of a line beginning at a point on shore at the east end of Knapps Narrows, ] at or near Lat. 38° 43.030’N., Long. 76° 19.623’ W., then running 218° (True) to a point on shore at the southeast end of Knapps Narrows, at or near Lat. 38° 42.950’N., Long. 76° 19.703’ W., and [west] east of a line beginning at the west end of Knapps Narrows, at or near Lat. 38° 43.232’N., Long. 76° 20.398’ W., then running 44° (True) to a point on shore, at or near Lat. 38° 43.293’N., Long. 76° 20.323’ W. [This area has a 6- knot speed limit all year.] Except as otherwise restricted, the speed limit for this area is 6 knots.

F.—K. (text unchanged)

.02 Western Shore.

A.—C. (text unchanged)

D. Flag Harbor area. This area is enclosed by a line beginning [encompasses the area beginning at a point] at or near [Lat. 38° 7.875’N.,] Lat. 38º27.875’N., Long. 76° 28.278’ W., then running 149° (True) to a point, at or near Lat. 38° 27.855’N., Long. 76° 28.263’ W., and running to the head of the harbor. [This area has a 6-knot speed limit all year.] Except as otherwise restricted, the speed limit for this area is 6 knots.

E.—N. (text unchanged)

MARK J. BELTON
Secretary of Natural Resources

 

Subtitle 18 BOATING—SPEED LIMITS AND OPERATION OF VESSELS

08.18.21 Potomac River

Authority: Natural Resources Article, §§8-703 and 8-704, Annotated Code of Maryland

Notice of Proposed Action

[17-012-P]

The Secretary of Natural Resources proposes to amend Regulation .03 under COMAR 08.18.21 Potomac River.

Statement of Purpose

The purpose of this action is to update and clarify existing boating laws and coordinates of certain boundaries and to ensure safe boating on Maryland’s waterways.

Comparison to Federal Standards

There is no corresponding federal standard to this proposed action.

Estimate of Economic Impact

The proposed action has no economic impact.

Economic Impact on Small Businesses

The proposed action has minimal or no economic impact on small businesses.

Impact on Individuals with Disabilities

The proposed action has no impact on individuals with disabilities.

Opportunity for Public Comment

Comments may be sent to Michael Grant, Regulations Coordinator, Department of Natural Resources, 580 Taylor Avenue, Annapolis, MD 21401, or call 410-260-8013, or email to michael.grant@maryland.gov, or fax to 410-260-8453. Comments will be accepted through February 6, 2017. A public hearing has not been scheduled.

.03 Potomac River North Shore.

A. (text unchanged)

B. Mattawoman Creek Area. [encompasses the area beginning at a point, at or near Lat. 38° 34.493’N., Long. 77° 10.720’ W., then running 91° (True) to a point, at or near Lat. 38° 34.485’N., Long. 77° 10.277’ W. and running to the head of the creek. This area has a 6-knot speed limit all year.] This area is enclosed by a line beginning at a point at or near Lat. 38º34.848’N., Long. 77º10.375’W., then running 137º (True) to a point, at or near Lat. 38º34.702’N., Long. 77º10.200’W. Except as otherwise restricted, the speed limit for this area is 6 knots.

C.—J. (text unchanged)

MARK J. BELTON
Secretary of Natural Resources

 

Subtitle 18 BOATING—SPEED LIMITS AND OPERATION OF VESSELS

08.18.25 South River

Authority: Natural Resources Article, §§8-703 and 8-704, Annotated Code of Maryland

Notice of Proposed Action

[17-013-P]

The Secretary of Natural Resources proposes to amend Regulation .02 under COMAR 08.18.25 South River.

Statement of Purpose

The purpose of this action is to update and clarify existing boating laws and coordinates of the Upper South River Controlled Ski Area. Last year, extensive research was done to standardize the controlled ski areas. Inadvertently, the speed limit change limited this area to certified water ski vessels displaying a DNR sticker. This change pushed the regular water ski community into smaller creeks which caused many complaints. Limiting the area to only controlled water ski usage was not the intent of the regulation. This modification was requested by the Maryland Boat Act Advisory Committee to allow the area to be used by the larger water ski community.

Comparison to Federal Standards

There is no corresponding federal standard to this proposed action.

Estimate of Economic Impact

The proposed action has no economic impact.

Economic Impact on Small Businesses

The proposed action has minimal or no economic impact on small businesses.

Impact on Individuals with Disabilities

The proposed action has no impact on individuals with disabilities.

Opportunity for Public Comment

Comments may be sent to Michael Grant, Regulations Coordinator, Department of Natural Resources, 580 Taylor Avenue, Annapolis, MD 21401, or call 410-260-8013, or email to michael.grant@maryland.gov, or fax to 410-260-8453. Comments will be accepted through February 6, 2017. A public hearing has not been scheduled.

.02 South River Proper.

A.—E. (text unchanged)

F. Upper South River Controlled Ski Area. This encompasses the area upstream of a line beginning at a point at or near Lat. 38° 58.085’ N., Long. 76° 36.013’ W., then running 65° (True) to a point, at or near Lat. 38° 58.168’ N., Long. 76° 35.780’ W., and downstream of a line beginning at a point at or near Lat. 38° 58.637’ N., Long. 76° 36.365’ W., then running 72° (True) to a point, at or near Lat. 38° 58.685’ N., Long. 76° 36.177’ W. Except as otherwise restricted, the speed limit for this area [is 6 knots] are:

(1) 35 knots from sunrise to sunset during the boating season; and

(2) 20 knots from sunset to sunrise during the boating season;

(3) This area may have a controlled ski course as set forth in COMAR 08.04.16.

(4) Minimum wake zone when vessels displaying a DNR Ski Sticker are using the permitted controlled ski course.

G. (text unchanged)

MARK J. BELTON
Secretary of Natural Resources

 

Title 09
DEPARTMENT OF LABOR, LICENSING, AND REGULATION

Subtitle 24 BOARD OF PUBLIC ACCOUNTANCY

09.24.01 General Regulations

Authority: Business Occupations and Professions Article, §§2-102, 2-207,
2-209, 2-304—2-307, 2-309, 2-311, 2-315, 2-410, and 2-416, Annotated Code of Maryland

Notice of Proposed Action

[17-016-P]

The Maryland Board of Public Accountancy proposes to amend Regulation .09 under COMAR 09.24.01 General Regulations. This action was considered by the Board at a public meeting held on October 4, 2016, notice of which was published on the Board’s website, pursuant to General Provisions Article, §3-302(c), Annotated Code of Maryland.

Statement of Purpose

The purpose of this action is to amend the regulations governing fees to reflect the section fees assessed to candidates who take the Uniform CPA Examination. The fees charged for the four examination sections would reflect the fees established by the examination vendors for the administration of the candidate database, test development, test-taking, security, and grading of the exam. The regulations would eliminate the need for the Board to enact new regulations every time the examination is modified and improved. The regulation also renumbers the remaining regulations to reflect the amendments.

Comparison to Federal Standards

There is no corresponding federal standard to this proposed action.

Estimate of Economic Impact

I. Summary of Economic Impact. The economic impact of the regulatory change allowing the Board to adjust fees based on changes in the cost of the examination cannot be determined at this time. Fees for examination administration, test development, testing, security, and grading vary and may increase over time, due to psychometric evaluation and test improvement. Examination section fees are collected by the Board and paid directly to the vendors.

 

 

Revenue (R+/R-)

 

II. Types of Economic Impact.

Expenditure
(E+/E-)

Magnitude

 


A. On issuing agency:

NONE

B. On other State agencies:

NONE

C. On local governments:

NONE

 

 

Benefit (+)
Cost (-)

Magnitude

 


D. On regulated industries or trade groups:

 

CPA Examination candidates

(+)

Indeterminable

E. On other industries or trade groups:

NONE

F. Direct and indirect effects on public:

NONE

III. Assumptions. (Identified by Impact Letter and Number from Section II.)

D. The Board cannot calculate the magnitude of changes to the examination by the National Board of CPA Examiners. The Uniform CPA Examination is constantly changed to reflect the evolving skills and standards of the profession both nationally and internationally. Changes are often required in test development, grading, and security of this professional examination necessitating an increase in cost to candidates.

Economic Impact on Small Businesses

The proposed action has minimal or no economic impact on small businesses.

Impact on Individuals with Disabilities

The proposed action has no impact on individuals with disabilities.

Opportunity for Public Comment

Comments may be sent to Dennis L. Gring, Executive Director, Board of Public Accountancy, 500 N. Calvert Street, Baltimore, MD 21202, or call 410-230-6224, or email to dennis.gring@maryland.gov, or fax to 410-962-8482. Comments will be accepted through February 6, 2017. A public hearing has not been scheduled.

Open Meeting

Final action on the proposal will be considered by the Board of Public Accountancy during a public meeting to be held on March 7, 2017 at 9 a.m., at 500 N. Calvert Street, 3rd Floor Conference Room, Baltimore, MD 21202.

.09 Fees.

[Fees charged by the Board are as follows:]

A. [Original examination application fee — $67.] An applicant for a licensing examination shall pay to the Board the examination fee in an amount or amounts set by one or more entities selected by the Board to develop, administer, or score the examination.

B. [Examination section fees:] Other fees to be charged by the Board are as follows:

[(1) Auditing and Attestation — $200;

(2) Financial Accounting and Reporting — $200;

(3) Regulation — $180

(4) Business Environment and Concepts — $180;

C.] (1) Original examination application fee— $67;

(2) Application for reciprocity — $67;

[D.] (3) — [P.] (15) (text unchanged)

ARTHUR E. FLACH
Chair
Maryland Board of Public Accountancy

 

Title 10
DEPARTMENT OF HEALTH AND MENTAL HYGIENE

Notice of Proposed Action

[17-020-P]

The Secretary of Health and Mental Hygiene proposes to:

(1) Amend Regulation .04 under COMAR 10.05.01 General Requirements;

(2) Amend Regulation .04 and repeal Regulation .21 under COMAR 10.07.01 Acute General Hospitals and Special Hospitals;

(3) Amend Regulation .05 under COMAR 10.07.03 Health Care Staff Agencies;

(4) Amend Regulations .03 under COMAR 10.07.04 Related Institutions — Residential Treatment Centers for Emotionally Disturbed Children and Adolescents;

(5) Amend Regulation .04 under COMAR 10.07.05 Residential Service Agencies;

(6) Amend Regulation .04 under COMAR 10.07.07 Nursing Referral Service Agencies;

(7) Amend Regulations .04 and .05 under COMAR 10.07.08 Freestanding Medical Facilities;

(8) Amend Regulation .08 under COMAR 10.07.09 Residents’ Bill of Rights: Comprehensive Care Facilities and Extended Care Facilities;

(9) Amend Regulation .04 under COMAR 10.07.10 Home Health Agencies;

(10) Amend Regulations .04, .05, .09, and .10 under COMAR 10.07.11 Health Maintenance Organizations;

(11) Amend Regulations .04 and .20 under COMAR 10.07.12 Health Care Facilities Within Correctional Institutions;

(12) Amend Regulation .07 under COMAR 10.07.14 Assisted Living Programs;

(13) Amend Regulation .05 under COMAR 10.07.16 Limited Private Inpatient Facilities;

(14) Amend Regulations .03 and .04 under COMAR 10.07.17 Limited Service Hospital;

(15) Amend Regulation .04 under COMAR 10.07.18 Comprehensive Rehabilitation Facilities;

(16) Amend Regulation .04 under COMAR 10.07.20 Intermediate Care Facilities for Individuals with Intellectual Disabilities or Persons with Related Conditions (ICF/IID);

(17) Amend Regulation .04 under COMAR 10.07.21 Hospice Care Programs;

(18) Amend Regulation .02 under COMAR 10.10.03 Medical Laboratories — Licenses;

(19) Amend Regulation .04 under COMAR 10.21.16 Community Mental Health Programs — Application, Approval, and Disciplinary Processes;

(20) Amend Regulation .02 under COMAR 10.22.02 Administrative Requirements for Licensees;

(21) Amend Regulations .04 and .05 under COMAR 10.47.04 Certification Requirements; and

(22) Amend Regulations .02 and .03 under COMAR 10.51.03 Licenses.

Statement of Purpose

The purpose of this action is to improve regulatory efficiency of various health licensing requirements and standards. These amendments will:

(1) Enable the Department to accept electronic submissions of both initial applications and renewal applications and thereby improve efficiency and decrease the administrative burden on providers and the Department;

(2) Eliminate obsolete provisions concerning preauthorization requirements in hospitals;

(3) Streamline application requirements for residential treatment centers and otherwise clarify requirements;

(4) Update the visitation requirements in nursing homes to reflect the statutory requirement that a resident has the right to visit privately with the resident’s domestic partner;

(5) Update and clarify provisions applicable to health maintenance organizations regarding facility inspection, patient access, medical records and certified nurse practitioners;

(6) Eliminate the application of obsolete dietary standards to health care facilities within correctional institutions; and

(7) Enable certain laboratory tests to be conducted under a letter of exception rather than requiring a license.

Comparison to Federal Standards

There is no corresponding federal standard to this proposed action.

Estimate of Economic Impact

I. Summary of Economic Impact. The proposed regulatory changes will have an indeterminable economic impact. This is due to the fact that they eliminate or modify a variety of requirements that simplify application procedures, update obsolete pre-authorization requirements for surgical procedures and dietary standards, and enable certain laboratory tests to be performed without need for licensure across a variety of facilities and provider types. The specific economic impact of these changes cannot be accurately measured as they generally simplify administrative procedures.

 

 

Revenue (R+/R-)

 

II. Types of Economic Impact.

Expenditure (E+/E-)

Magnitude

 


A. On issuing agency:

NONE

B. On other State agencies:

NONE

C. On local governments:

NONE

 

 

Benefit (+)

Cost (-)

Magnitude

 


D. On regulated industries or trade groups:

(+)

Indeterminable

E. On other industries or trade groups:

NONE

F. Direct and indirect effects on public:

NONE

III. Assumptions. (Identified by Impact Letter and Number from Section II.)

D. Allowing licensure and re-licensure via electronic submissions may reduce the amount of time and supplies needed to complete these processes. In addition, eliminating obsolete standards and freeing licensees from certain restrictions may lessen administrative burdens on licensees. However the actual economic impact resulting from these amendments is indeterminable.

Economic Impact on Small Businesses

The proposed action has minimal or no economic impact on small businesses.

Impact on Individuals with Disabilities

The proposed action has no impact on individuals with disabilities.

Opportunity for Public Comment

Comments may be sent to Michele Phinney, Director, Office of Regulation and Policy Coordination, Department of Health and Mental Hygiene, 201 West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to dhmh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through February 6, 2017. A public hearing has not been scheduled.

 

Subtitle 05 FREESTANDING AMBULATORY CARE FACILITIES

10.05.01 General Requirements

Authority: Health-General Article, §19-3B-01, et seq., Annotated Code of Maryland

.04 Licensing Procedure.

A. A person desiring to operate a facility shall:

(1) (text unchanged)

(2) File an application on a written or electronic form provided by the Department;

(3)—(4) (text unchanged)

B.—H. (text unchanged)

I. Renewal of License.

(1) At least 60 days before a license expires, the licensee shall submit a renewal application to the Secretary on a written or electronic form provided by the Department.

(2) (text unchanged)

 

Subtitle 07 Hospitals

10.07.01 Acute General Hospitals and Special Hospitals

Authority: Health-General Article, §§19-308, 19-320, and 19-323, Annotated Code of Maryland

.04 Licensure Application Procedure.

A. A person desiring to open a hospital, to continue the operation of an existing hospital, or to change the classification of an existing hospital shall file an application with the Secretary, on a written or electronic form provided by the Secretary. An application shall state the classification of hospital for which a license is sought.

B. (text unchanged)

C. License Renewal. An application for the renewal of the license on a written or electronic form provided by the Secretary shall be made:

(1)—(2) (text unchanged)

D.—F. (text unchanged)

 

10.07.03 Health Care Staff Agencies

Authority: Health-General Article, Title 19, Subtitle 20, Annotated Code of Maryland

.05 Licensing Procedure.

A. Application for Licensure.

(1) A person desiring to refer a health care practitioner to a health care facility to render temporary health care services in this State shall file an application with the Secretary, on a written or electronic form provided by the Secretary.

(2)—(3) (text unchanged)

B.—C. (text unchanged)

D. License Renewal.

(1) (text unchanged)

(2) Before a license expires, the agency may renew its license for an additional term by submitting a renewal application on a written or electronic form provided by the Secretary, if the agency:

(a)—(b) (text unchanged)

(3) (text unchanged)

E.—G. (text unchanged)

 

10.07.04 Related Institutions — Residential Treatment Centers for Emotionally Disturbed Children and Adolescents

Authority: Health-General Article, §19-308, Annotated Code of Maryland

.03 Licensing Procedure.

A. Application. Applicants shall conform to the following:

(1) An applicant desiring to open or to continue the operation of an existing center shall file with the Secretary, on a written or electronic form provided by the Secretary, a notarized application:

(a)—(c) (text unchanged)

(2)—(3) (text unchanged)

(4) The applicant for an original license shall submit the following, and insure that current copies are on file with the [department] Department:

[(a) Copy of constitution and by-laws;

(b) List of officers and Board members with addresses;

(c) The operating budget for the current year;

(d) Copies of publicity;

(e) Statement of area, number, age, and sex of children to be served;

(f) Definition and description of service;

(g) Plan for medical, dental, psychological, and psychiatric service;

(h) An educational plan, that is, educational objectives and methodology;

(i) Personnel policies, including definition of jobs, qualifications, salaries, hours, vacation, sick leave, and retirement;

(j) Admission policies;]

[(k)] (a)[(l)] (b) (text unchanged)

[(m) A procedure for providing services for the transfer of a resident to a suitable facility in the event of accident or development of other acute condition;]

(c) A current food service permit; and

[(n)] (d) Copy of signed agreement between the center and the principal somatic physician [including the name of the “relief”] and psychiatrist.

(5) Renewal. Application for the renewal of the license shall be made each year at least 30 days before expiration of issued license, submitted on written or electronic forms provided by the Secretary.

B.—C. (text unchanged)

D. Licenses for Less Than 12 Months for the Operation of Hospitals and Related Institutions.

[(1) Article 43, §559(b)(1), Annotated Code of Maryland, provides inter alia, that licenses to operate a hospital or related institution “be issued for a term not to exceed one year and shall be provisional in nature pursuant to rules and regulations...” ]

[(2)] (1) Criteria for Issue. [Whenever a regular license cannot be issued, under conditions as set forth in these regulations,] The Secretary may issue a provisional license [may be issued], pending accreditation by The Joint Commission, valid for a period not to exceed 12 months. [In order to implement the statute, consideration

for a provisional license to hospitals or related institutions will be based upon one of the following departmental regulations:

(a) When an institution has substantial deficiencies which, in the opinion of the Department, do not constitute a life-safety or health hazard but the institution is unable to correct by the scheduled license renewal date;

(b) When an institution has substantial deficiencies which, in the opinion of the Department, have no adverse effect on the life-safety or health status of patients but require construction or remodeling to correct and, the institution has a bona fide commitment to correct these deficiencies by a prescribed date;

(c) When Departmental administrative delays have occurred which are beyond the control of the hospital or related institution;

(d) When new construction is completed to the point of being able to provide all necessary services to its patients or residents, but certain substantial items of equipment or optional services, which in the opinion of the Department have no adverse effect on the safety or health of its patients or residents, are lacking temporarily.

(3) Duration of License.

(a) The licensing period for licenses of less than 12 months may vary from a minimum of 1 month to a maximum of 6 months.

(b) Only one license of less than 12 months will be issued during a given licensure period unless the institution can demonstrate that extenuating circumstances exist which are beyond the control of the institution in meeting a prescribed deadline, or unless it is necessary to allow the Department to coordinate and unify its annual licensing dates with federal certification dates. On this basis, a one-time renewal may be granted for a maximum period of 6 months.

(c) However, if it is demonstrated to the Department’s satisfaction that whatever modifications are necessary to correct the deficiencies will take more than 1 year to complete, the Department may issue as many renewals as are necessary. Each renewal shall be approved by the Secretary.

E. Return of License to the Secretary. When the facility is sold, leased, discontinued, the operation moved to a new location, the license has been revoked, or its renewal denied, the license immediately becomes void and shall be returned to the Secretary.

F. Obligation of New Licensee. The new licensee, before taking over operation of an existing center or activating a new center shall obtain a license from the Secretary. The licensee shall conform to all currently applicable regulations.]

 

10.07.05 Residential Service Agencies

Authority: Health-General Article, Title 19, Subtitle 4A, Annotated Code of Maryland

.04 Licensing Procedures.

A. Application for License.

(1) (text unchanged)

(2) An applicant shall submit:

(a) An application on a written or electronic form developed by the Department;

(b)—(k) (text unchanged)

B.—H. (text unchanged)

I. License Renewal. A licensee shall submit to the Department:

(1) An application for license renewal on a written or electronic form developed by the Department;

(2)—(5) (text unchanged)

J.—K. (text unchanged)

 

10.07.07 Nursing Referral Service Agencies

Authority: Health-General Article, Title 19, Subtitle 4B, Annotated Code of Maryland

.04 Licensing Procedures.

A. Application for License.

(1) A person desiring to conduct, operate, or maintain a nursing referral service agency in this State shall file an application with the Secretary, on the written or electronic form provided by the Secretary.

(2)—(3) (text unchanged)

B.—D. (text unchanged)

E. License Renewal.

(1) The agency shall file an application for relicensure on the written or electronic form provided by the Secretary at least 60 days before the expiration of its current license.

(2) (text unchanged)

 

10.07.08 Freestanding Medical Facilities

Authority: Health-General Article, §2-104 and Title 19, Subtitle [19-3A] 3A, Annotated Code of Maryland

.04 Licensing Application Procedure.

A. (text unchanged)

B. A hospital desiring to establish a freestanding medical facility shall apply to the Department for initial licensure on a written or electronic form provided by the Secretary.

C.—E. (text unchanged)

.05 Renewal of License.

A. A licensee shall file an application for license renewal with the Secretary on a written or electronic form provided by the Secretary.

B.—C. (text unchanged)

 

10.07.09 Residents’ Bill of Rights: Comprehensive Care Facilities and Extended Care Facilities

Authority: Health-General Article, §19-344, Annotated Code of Maryland

.08 Resident’s Rights and Services.

A.—B. (text unchanged)

C. A resident has the right to:

(1)—(21) (text unchanged

(22) Visit privately with the resident’s spouse or domestic partner;

(23)—(32) (text unchanged

D.—F. (text unchanged)

 

10.07.10 Home Health Agencies

Authority: Health-General Article, §19-404, Annotated Code of Maryland

.04 General Licensure Provisions.

A. (text unchanged)

B. Application for License. An agency desiring to conduct, operate, or maintain a home health agency in the State shall file an application with the Secretary, on a written or electronic form provided by the Secretary.

C. Renewal of License. An agency shall file an application on the written or electronic form provided by the Secretary for renewal of the license at least 60 days before expiration of the issued license and submit it on forms provided by the Secretary.

D.—G. (text unchanged)

 

10.07.11 Health Maintenance Organizations

Authority: Health-General Article, §19-705.1, Annotated Code of Maryland

.04 Peer Review.

A. (text unchanged)

B. External Review.

(1)—(3) (text unchanged)

(4) The external review shall consist of a review and evaluation of the following:

(a)—(c) (text unchanged)

(d) The grievances relating specifically to the delivery of medical care, including their final disposition; and

[(e) The physical facilities and equipment; and]

[(f)] (e) (text unchanged)

(5) (text unchanged)

.05 Medical Records.

[A. The HMO shall maintain an individual record for each patient according to accepted professional principles and the provisions of these regulations, with entries kept current, dated, and signed by a physician or other medical professional.]

[B.] A.[H.] G. (text unchanged)

.09 Access and Availability of Services.

A. Regular Hours.

(1) With respect to all services it furnishes, whether direct or through contractual arrangements, an HMO shall provide for regular hours during which an enrollee may receive services. [It is also required to]

(2) An HMO that provides services directly to its enrollees through its staff members shall have an orderly system for scheduling the provision of services to enrollees in a timely manner, taking into account the immediacy of need for services.

(3) An HMO that provides services to its enrollees through independent licensed health care providers under contract with the HMO shall ensure that the providers have an orderly system for scheduling the provision of services to enrollees in a timely manner, taking into account the immediacy of need for services.

B. (text unchanged)

.10 Physician Availability.

A. The HMO shall have a physician available at all times to provide diagnostic and treatment services. The HMO shall assure that every enrollee seen for a medical complaint is evaluated under the direction of a physician and that every enrollee receiving diagnostic evaluation or treatment is under the direct medical management of an HMO physician or certified nurse practitioner who provides continuing medical management.

B. Each enrollee shall have an opportunity to select a primary physician or certified nurse practitioner from among those available to the HMO.

 

10.07.12 Health Care Facilities Within Correctional Institutions

Authority: Health-General Article, §19-308, Annotated Code of Maryland

.04 License Procedure.

Applicants for licensure shall conform to the following:

A. Any person desiring to open and operate a health care facility within a correctional institution or to continue the operation of an existing health care facility, shall file [an] a written or electronic application with the Department giving the information required by the [Division of Licensing and Certification] Office of Health Care Quality;

B. (text unchanged)

.20 Dietary Services.

A. Adequacy of Diet.

[(1)] (text unchanged)

[(2) To the extent medically possible, the current recommended Dietary Allowance of the Food and Nutrition Board of the National Research Council, adjusted for age, sex, and activity, shall be observed.]

B.—F. (text unchanged)

 

10.07.14 Assisted Living Programs

Authority: Health-General Article, Title 19, Subtitle 18, Annotated Code of Maryland

.07 Licensing Procedure.

A. Application for License.

(1) (text unchanged)

(2) An applicant shall submit:

(a) An application on a written or electronic form developed by the Department;

(b)—(c) (text unchanged)

(3)—(5) (text unchanged)

B. (text unchanged)

C. Duration of License.

(1) (text unchanged)

(2) License Renewal. A licensee shall apply for license renewal:

(a) (text unchanged);

(b) On written or electronic forms provided by the Department; and

(c) (text unchanged)

D. (text unchanged)

 

10.07.16 Limited Private Inpatient Facilities

Authority: Health-General Article, §§10-501—10-511, Annotated Code of Maryland

.05 Licensure Process.

A. (text unchanged)

B. Initial and Renewal Licensure. In order to be licensed as a limited private inpatient facility, the facility shall:

(1) File an initial application with the Department that:

(a) Is on the written or electronic form approved by the Department with the requirement that all questions are answered and all required documents are attached; and

(b) (text unchanged)

(2)—(4) (text unchanged)

C.—F. (text unchanged)

G. Renewal of License.

(1) An application on the written or electronic form provided by the Department for the renewal of the license shall be made by an accredited facility within 30 calendar days of the exit date of the triennial survey conducted by the Joint Commission.

(2) (text unchanged)

H. (text unchanged)

I. License Fees.

(1) A facility shall submit [an] a written or electronic application on a form approved by the Department along with the fee established in this regulation.

(2)—(3) (text unchanged)

J. (text unchanged)

 

10.07.17 Limited Service Hospital

Authority: Health-General Article, §§19-308 and 19-319, Annotated Code of Maryland

.03 Application Procedure.

A. A person desiring to convert an existing facility, or to change the classification of an existing hospital to a limited service hospital, shall file an application with the Secretary, on a written or electronic form provided by the Secretary.

B.—E. (text unchanged)

.04 License Renewal.

A. The licensee shall file an application for license renewal on a written or electronic form provided by the Secretary at least 60 days before the current license expires.

B. (text unchanged)

 

10.07.18 Comprehensive Rehabilitation Facilities

Authority: Health-General Article, §19-1203, Annotated Code of Maryland

.04 License Provisions.

A. (text unchanged)

B. To obtain a comprehensive rehabilitation facility license, a person shall:

(1) Submit an application on the written or electronic form provided by the Secretary;

(2)—(3) (text unchanged)

C.—D. (text unchanged)

E. An application for the renewal of the license shall be made on the written or electronic form provided by the Secretary at least 60 days before expiration of the issued license.

F. (text unchanged)

 

10.07.20 Intermediate Care Facilities for Individuals with Intellectual Disabilities and Persons with Related Conditions (ICF/IID)

Authority: Health-General Article, §19-318, Annotated Code of Maryland

.04 Licensing Procedure.

A. (text unchanged)

B. An applicant for a license shall:

(1) Submit to the Secretary an application:

(a) In the form and manner prescribed by the Secretary on the written or electronic form provided by the Secretary; and

(b) Signed and verified by the applicant; and

(2) (text unchanged)

C.—D. (text unchanged)

E. Term and Renewal of License.

(1) (text unchanged)

(2) Before the license expires, the licensee may renew it for another 1-year term, if the licensee submits to the Secretary:

(a) A renewal application in the form and manner prescribed by the Secretary on the written or electronic form provided by the Secretary;

(b)—(c) (text unchanged)

F. (text unchanged)

 

10.07.21 Hospice Care Programs

Authority: Health-General Article, §19-903, Annotated Code of Maryland

.04 Application Procedure.

A. (text unchanged)

B. The applicant shall submit an application for an initial license or renewal of a license on a written or electronic form provided by the Secretary.

C.—E. (text unchanged)

 

Subtitle 10 Laboratories

10.10.03 Medical Laboratories — Licenses

Authority: Health-General Article, §§17-202 and 17-205, Annotated Code of Maryland

.02 Letters of Exception.

A. (text unchanged)

B. Excepted Tests. A POL or POCL operating under a letter of exception may perform one or more of the following excepted tests or types of tests:

(1)—(34) (text unchanged)

(35) CLIA waived blood lipid analysis for cholesterol, HDL, LDL, and triglycerides; [and]

(36) Whole blood lead testing on a CLIA waived analyzer with the additional requirements:

(a)—(d) (text unchanged)

(e) Reporting requirements stated in §C of this regulation shall be followed; and

(37) CLIA Waived Urine Drug Screens with the following additional requirements:

(a) The licensee shall enroll into a proficiency testing program offered by an entity that has been approved by the Centers for Medicare and Medicaid Services; and

(b) When the numerical score is less than 80 percent, the licensee shall submit the official proficiency test result to the Office of Health Care Quality for review and monitoring with evidence of documented remedial actions taken.

C.—D. (text unchanged)

 

Subtitle 21 MENTAL HYGIENE REGULATIONS

10.21.16 Community Mental Health Programs — Application, Approval, and Disciplinary Processes

Authority: Health-General Article, §7.5-205, Annotated Code of Maryland

.04 Application Process.

A.—B (text unchanged)

C. Application. An applicant for approval of a program shall:

(1) Submit an application to the Department’s designated approval unit;

(2) Submit the application on the written or electronic form approved by the Department, with all questions answered and all required documents attached;

(3)—(4) (text unchanged)

D.—F. (text unchanged)

 

Subtitle 22 DEVELOPMENTAL DISABILITIES

10.22.02 Administrative Requirements for Licensees

Authority: Health-General Article, §7-904, Annotated Code of Maryland

.02 Application for Initial License or Renewal.

A. (text unchanged)

B. An applicant shall file an application for a license or license renewal on a written or electronic form provided by the Administration. An existing licensee shall file an application for renewal at least 60 days before expiration of its existing license. The license does not expire until the Director takes an action under §D of this regulation and the time for seeking judicial review or any judicial stay of the final action expires.

C.—F. (text unchanged)

 

Subtitle 47 ALCOHOL AND DRUG ABUSE ADMINISTRATION

10.47.04 Certification Requirements

Authority: Health-General Article, §7.5-205, Annotated Code of Maryland

.04 Type and Duration of Certification.

A. Initial Certification.

(1) After receipt of the completed written or electronic application provided by the Administration and after inspection by the Office of Health Care Quality, if there are no deficiencies, the Administration shall grant an initial certification.

(2) The initial certification is valid for a period in the discretion of the Administration, not to exceed 6 months.

B. Provisional Certification.

(1) (text unchanged)

(2) If upon review of a written or electronic renewal application provided by the Administration, the Office of Health Care Quality finds deficiencies which are not life threatening, the Administration may grant a provisional certification to permit the program to correct the deficiencies as set forth in the plan of correction.

(3) (text unchanged)

C.—D. (text unchanged)

 

.05 Application Process and Evaluation.

A. Application. An applicant for certification of a program or renewal of certification shall submit to the Office of Health Care Quality:

(1) A completed application on a written or electronic form approved by the Administration;

(2)—(4) (text unchanged)

B.—E. (text unchanged)

 

Subtitle 51 FORENSIC LABORATORIES

10.51.03 Licenses

Authority: Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland

.02 License — Requirements.

A. Requirements. A person operating a forensic laboratory that performs one or more forensic analyses shall:

(1) Obtain, complete, and submit written or electronic permit applications as prescribed in this subtitle;

(2)—(3) (text unchanged)

B. (text unchanged)

.03 License — Administrative Procedures.

A. Application — Filing.

(1) A person shall:

(a) (text unchanged)

(b) File an application for a license using written or electronic forms provided by the Department; and

(c) (text unchanged)

(2) (text unchanged)

B.—E. (text unchanged)

F. Expiration and Renewal.

(1)—(2) (text unchanged)

(3) In order to renew a license, a licensee shall file an application to renew the license using written or electronic forms provided by the Department and following the same procedures prescribed in §§A and B of this regulation.

(4) (text unchanged)

G.—H. (text unchanged)

VAN T. MITCHELL
Secretary of Health and Mental Hygiene

 

Notice of Proposed Action

[17-001]

The Secretary of Health and Mental Hygiene proposes to:

(1) Amend Regulations .02—.04, .12—.18, .20, .21, and .23—.27 under COMAR 10.10.13 Medical Laboratories — Testing for Hereditary and Congenital Disorders in Newborn Infants; and

(2) Amend Regulations .03—.07, .09—.13, and .15, repeal existing Regulations .08 and .14, and amend and recodify existing Regulations .09—.13 and .15 to be Regulations .08—.12 and .13, respectively, under COMAR 10.52.12 Newborn Screening.

Statement of Purpose

The purpose of this action is to:

(1) Align regulations with the addition of severe combined immunodeficiency (SCID) to the Maryland Newborn Screening Program; and

(2) To make general clarifying changes to existing language.

Comparison to Federal Standards

There is no corresponding federal standard to this proposed action.

Estimate of Economic Impact

I. Summary of Economic Impact. The DHMH Newborn Screening and Childhood Division will not require additional funding to add SCID to the State’s newborn screening panel (implementation began during the spring 2016). In 2015, the newborn screening and follow-up fee was increased from $100 to $106 specifically to cover the costs associated with incorporating SCID into the newborn screening program.

Since some well infants will incur abnormal SCID test results (false positives), additional testing will also be required to determine the underlying cause of the abnormal result. Therefore, abnormal results and the costs for follow-up testing will be covered by public resources (Medicaid) and/or private insurers.

The Newborn Screening and Childhood Division is further aided by the Department’s Newborn Screening Follow-Up Unit which investigates each abnormal test result by contacting health care providers, parents and guardians (if necessary) regarding abnormal results and the need for follow-up testing and treatment. The Follow-Up Unit can use existing staff to absorb required duties as a result of adding SCID to the newborn screening panel.

 

 

Revenue (R+/R-)

 

II. Types of Economic Impact.

Expenditure
(E+/E-)

Magnitude

 


A. On issuing agency:

NONE

B. On other State agencies:

(E+)

Indeterminable

C. On local governments:

NONE

 

 

Benefit (+)
Cost (-)

Magnitude

 


D. On regulated industries or trade groups:

Insurance

(-)

Indeterminable

E. On other industries or trade groups:

NONE

F. Direct and indirect effects on public:

(+)

Indeterminable

III. Assumptions. (Identified by Impact Letter and Number from Section II.)

B. Expenditures will increase for Medicaid, as they will cover the costs of additional testing in the case of abnormal results for children insured by their program.

D. Insurers will cover the costs for follow-up testing performed in the case of abnormal results.

F. This change will benefit families and parents as they will receive SCID diagnosis information earlier.

Economic Impact on Small Businesses

The proposed action has minimal or no economic impact on small businesses.

Impact on Individuals with Disabilities

The proposed action has no impact on individuals with disabilities.

Opportunity for Public Comment

Comments may be sent to Michele Phinney, Director, Office of Regulation and Policy Coordination, Department of Health and Mental Hygiene, 201 West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to dhmh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through February 6, 2017. A public hearing has not been scheduled.

 

Subtitle 10 LABORATORIES

10.10.13 Medical Laboratories — Testing for Hereditary and Congenital Disorders in Newborn Infants

Authority: Health-General Article, §§13-102, 13-103, and 13-108—13-110, Annotated Code of Maryland

.02 Scope.

This chapter:

A. Identifies standards and requirements for a medical laboratory performing screening tests, diagnostic tests, or both, for hereditary and congenital disorders on blood-spot specimens from newborn infants; and

B. (text unchanged)

.03 Definitions.

A. (text unchanged)

B. Terms Defined.

(1)—(4) (text unchanged)

[(5) “Blood-spot” means a specimen of blood taken by heel stick from a newborn infant and applied to a circle on a special filter paper collection test requisition card for use in testing for hereditary and congenital disorders.]

(5) Blood-Spot Specimen.

(a) “Blood-spot specimen” means a whole-blood specimen collected from a newborn infant’s heel and applied to the designated area on a blood-spot collection test requisition card for the purpose of performing screening tests.

(b) “Blood-spot specimen” includes:

(i) The first screening blood-spot specimen collected from a newborn infant, usually in the birthing facility or other place where the newborn infant was born, within 48 hours after the newborn infant’s birth;

(ii) The second screening blood-spot specimen collected from a newborn infant, usually collected when the newborn infant is between 10 and 14 days of age; and

(iii) A blood-spot specimen collected subsequent to a blood-spot specimen specified in §B(5)(b)(i) and (ii) of this regulation as required to meet the medical needs and condition of the newborn infant and any additional specific screening blood-spot specimen collection and screening test requirements of this chapter and COMAR 10.52.12.

(6)—(9) (text unchanged)

(10) “Courier” means an entity employed by a person to convey a blood-spot specimen from the site of blood-spot specimen collection to the laboratory where the blood-spot specimen will be tested.

(11)—(13) (text unchanged)

(14) “First screening” means a screening performed on the first [blood] blood-spot specimen collected from a newborn infant after birth.

(15) “First–tier test” means a blood test performed on a newborn infant’s [blood] blood-spot specimen that:

(a)—(b) (text unchanged)

(16) “Follow-Up Unit” means the follow-up component and staff of the Department’s Newborn Screening Program, which carries out the duties set forth in COMAR [10.52.12.13] 10.52.12.12.

(17) (text unchanged)

(18) “Home birth” means the birth of an infant which occurs intentionally outside of a birthing facility.

(19) “Home birth attendant” means a physician who is licensed to practice under Health Occupations Article, Title 14, Annotated Code of Maryland, a nurse midwife who is licensed and certified under Health Occupations Article, Title 8, Annotated Code of Maryland, or a direct-entry midwife who is licensed under Health Occupations Article, Title 8, Subtitle 6C, Annotated Code of Maryland, who is caring for the mother and infant at delivery during a home birth as defined in §B(18) of this regulation.

[(18)] (20) (text unchanged)

[(19)] (21) “Newborn” or “newborn infant” means an infant:

(a)—(c) (text unchanged)

(d) From whom a [blood] blood-spot specimen was collected and submitted to the Department’s public health laboratory for newborn screening by a birthing facility or other health care provider located in Maryland, regardless of the infant’s place of birth;

(e)—(f) (text unchanged)

[(20)] (22) Newborn Screening or Screening.

(a) (text unchanged)

(b) “Newborn Screening” or “screening” includes:

(i) First-tier testing on a first, second, or subsequent blood-spot specimen; and

(ii) (text unchanged)

[(21] (23) Newborn Screening Program.

(a) (text unchanged)

(b) “Newborn Screening Program” includes:

(i)—(iii) (text unchanged)

(iv) The [Department’s Newborn Screening] Follow-Up Unit; and

(v) (text unchanged)

[(22)] (24)[(26)] (28) (text unchanged)

[(27) Screening Specimen.

(a) “Screening specimen” means a whole-blood specimen collected from a newborn infant’s heel and applied to the designated area on a blood-spot collection test requisition card for the purpose of performing screening tests.

(b) “Screening specimen” includes:

(i) The first screening specimen collected from a newborn infant, usually in the birthing facility or other place where the newborn was born, within 7 days after the newborn infant’s birth;

(ii) The second screening specimen collected from a newborn infant, usually during a well-baby visit in a physician’s office, between 1 and 4 weeks after the infant’s birth; and

(iii) A specimen collected subsequent to the specimens specified in §B(27)(b)(i) and (ii) of this regulation as required to meet the medical needs and condition of the newborn infant and any additional specific specimen collection and screening test requirements of this chapter and COMAR 10.52.12.]

[(28)] (29) Screening Test.

(a) (text unchanged)

(b) “Screening test” includes a test performed on a:

(i) First screening blood-spot specimen;

(ii) Second screening blood-spot specimen; or

(iii) Subsequent screening blood-spot specimen.

(c) (text unchanged)

[(29)] (30) “Second screening” means a test performed on a routine second blood-spot specimen collected when the newborn infant is between [1 week and 4 weeks] 10 and 14 days old even though the test results from the newborn’s first blood-spot specimen were normal.

[(30)] (31) Second-Tier Test.

(a) “Second-tier test” means a test performed on a newborn screening blood-spot specimen when a first-tier test provides an abnormal screening test result or a borderline abnormal screening test result.

(b) (text unchanged)

[(31)] (32) (text unchanged)

[(32)] (33) “Supplemental test” means a test performed on a blood-spot specimen collected from a newborn infant that is:

(a)—(b) (text unchanged)

[(33)] (34) “Unsatisfactory blood-spot specimen” means a blood-spot specimen that may produce an inaccurate or unreliable test result because the blood-spot specimen exhibits one of the problems of collection as specified in Regulation .21B and C of this chapter.

.04 Permit.

A. (text unchanged)

B. Requirements. Before offering to perform or performing a first-tier, supplemental, or second-tier test on a blood-spot specimen collected from a newborn infant, a person shall:

(1)—(2) (text unchanged)

.12 First-Tier, Supplemental, and Second-Tier Tests.

A. First-Tier Tests; Requirement. The Department’s public health laboratory shall perform first-tier tests on all screening blood-spot specimens collected from a newborn infant.

B. (text unchanged)

C. First-Tier Tests. The Department’s public health laboratory shall perform a first-tier test on a newborn infant to screen for the following [metabolicor] hereditary and congenital disorders, which are approved for screening by the Council and the Secretary:

(1)—(51) (text unchanged)

(52) [Dienoyl CoA] 2,4-dienoyl-CoA reductase deficiency (DE RED); [and]

(53) Cystic fibrosis; and

(54) Severe combined immunodeficiency (SCID).

D. Approved Methods:

(1) A permittee shall use:

(a)—(d) (text unchanged)

(e) Tandem mass-spectrometry when testing for the [hereditary or congenital] metabolic disorders listed in §C(11)—(52) of this regulation; [and]

(f) IRT/IRT (immunoreactive trypsinogen/immuno-reactive trypsinogen) when testing for cystic fibrosis, which is the disorder listed in §C(53) of this regulation[.]; and

(g) Real time polymerase chain reaction method when testing for severe combined immunodeficiency, which is listed in §C(54) of this regulation.

(2) (text unchanged)

.13 Screening Test Blood-Spot Specimens — Collection and Test Requisition.

A. Blood-Spot Specimen Collection.

(1) A person shall collect a newborn infant’s [blood] blood-spot specimen for testing under this chapter by using only the special blood-spot specimen collection test requisition card provided by the Department.

(2) The Department shall provide the special blood-spot specimen collection test requisition card to the:

[(a) Birthing facility to collect a specimen on a newborn infant born in an institution; and

(b) Person responsible for having newborn screening administered to a newborn infant born outside a birthing facility.]

(a) Individual in charge of a birthing facility or the individual’s designated representative; or

(b) Home birth attendant.

(3) [A birthing facility or person responsible for having newborn screening administered to a newborn infant born outside a birthing facility] The individual in charge of a birthing facility or the individual’s designated representative, or the home birth attendant shall collect a blood-spot specimen consisting of heel-stick whole blood obtained:

(a) When a newborn infant is 24 to [(72)] 48 hours old;

(b) On a blood-spot specimen collection test requisition card provided by the Department; and

(c) (text unchanged)

B. Blood-Spot Specimen Collection Test Requisition Card Information. [A person] An individual shall record the following information as specified on the Department-supplied blood-spot specimen collection test requisition card:

(1) (text unchanged)

(2) Blood-spot specimen information including:

(a)—(b) (text unchanged)

(c) Initials or other identifier of the individual who collected the blood-spot specimen;

(3)—(5) (text unchanged)

.14 Screening Test Blood-Spot Specimens — Procedures, Submission, and Delivery Requirements.

A. Standard Operating Procedure. [A birthing facility or person responsible for having blood collected from a newborn infant born outside a birthing facility] The individual in charge of a birthing facility or the individual’s designated representative, or the home birth attendant shall maintain written standard operating procedures for the collection, handling, storage, and transport of newborn infant blood-spot specimen collection test requisition cards, including instructions for staff to:

(1) Ensure and maintain blood-spot specimen integrity, quality, and acceptability;

(2) (text unchanged)

(3) Identify precautions against:

(a) Milking or squeezing the blood-spot specimen collection site;

(b) Layering successive drops of blood on the same circle on the blood-spot specimen collection test requisition card;

(c) (text unchanged)

(d) Touching or smearing a blood-spot specimen before it is fully air-dried;

(e) Scratching or abrading the blood-spot specimen;

(f) Not allowing a blood-spot specimen to dry thoroughly before sending the blood-spot specimen collection test requisition card to a laboratory; and

(g) Damaging, stretching, or wrinkling the filter paper before, during or after blood-spot specimen collection;

(4) (text unchanged)

(5) Handle and temporarily store a blood-spot specimen collection test requisition card, including the procedures and techniques for:

(a) (text unchanged)

(b) Stacking of blood-spot specimen collection test requisition cards; and

(c) Temporarily storing blood-spot specimen collection test requisition cards.

B. Submission and Delivery Requirements. [A birthing facility or person responsible for having newborn screening administered to a newborn infant born outside a birthing facility] The individual in charge of a birthing facility or the individual’s designated representative, or the home birth attendant shall transport and deliver to the Department’s public health laboratory a newborn infant blood-spot specimen collection test requisition card using:

(1)—(4) (text unchanged)

.15 Test Blood-Spot Specimens — Use, Research, Storage, and Retention.

A. Use. A permittee may use a newborn infant blood-spot specimen from a newborn infant to test for only the conditions listed in Regulation .12C of this chapter.

B. Research. A researcher may not use a Maryland newborn infant’s blood spot specimen or test results for research purposes unless the:

(1) (text unchanged)

(2) The researcher acknowledges in writing that the researcher will return all untested [blood-spots] blood-spot specimens to the Department’s public health laboratory within 6 months of completing the approved research.

C. Storage. A permittee or researcher shall store a newborn infant blood-spot specimen in a sealed, moisture-proof container at between [] 2ºC and [23ºC] 6ºC.

D. Retention.

(1) A permittee shall:

[(1)] (a) Retain a newborn infant’s[:]

[(a) Gel,] gel, produced when testing for hemoglobin disorders, for at least 90 days after testing is complete; and

[(b) Blood-spot for 25 years after the blood-spot is received for screening, supplemental, or diagnostic testing; and]

[(2)] (b) Return to the State’s public health laboratory all untested [blood-spots] blood-spot specimens received from the Department’s public health laboratory for supplemental or diagnostic testing within 90 days after testing is completed by the permittee.

(2) The Department’s public health laboratory shall retain and maintain for 25 years a newborn infant’s blood-spot specimen after the blood-spot specimen is received for screening, supplemental testing, or diagnostic testing.

.16 Test Records — Retention.

The Department’s public health laboratory shall retain and maintain electronically or as a hard copy for 25 years the:

A. Top copy of the requisition portion of the blood-spot specimen collection test requisition card;

B.—D. (text unchanged)

.17 Testing — First-Tier.

A. The Department’s public health laboratory shall test, using first-tier tests, appropriately timed and collected blood-spot [screening specimens] specimen of a newborn infant’s blood for the disorders listed in Regulation .12C of this chapter.

B. Full-Term Healthy Newborn Infants.

(1) If a newborn infant is born at term and is healthy, the Department’s public health laboratory shall conduct a:

(a) First screening using first-tier tests to detect the disorders listed in Regulation .12C of this chapter on a blood-spot specimen collected when the full-term healthy newborn infant is between 24 and 48 hours [and 7 days] old; and

(b) Second screening using first-tier tests on a blood-spot specimen collected when the full-term healthy infant is between [1 and 4 weeks] 10 and 14 days old.

(2) If the first blood-spot specimen is collected when a full term healthy newborn infant is younger than 24 hours old, the Department’s public health laboratory shall conduct a:

(a) Second screening using first-tier tests to detect the disorders listed in Regulation .12C of this chapter on a blood-spot specimen collected when the newborn infant is between 24 hours and 7 days old; and

(b) Third screening using first-tier tests on a blood-spot specimen collected when the full-term healthy infant is between 1 and 4 weeks old.

C. Premature or Ill Newborn Infant.

(1) If a newborn infant who is born prematurely or [is] expected to be ill for more than 14 days was younger than 24 hours old when the blood-spot specimen was collected for a first screening, the Department’s public health laboratory shall conduct a:

(a) Second screening using first-tier tests to detect the disorders listed in Regulation .12C of this chapter when the newborn infant is between 24 hours and 3 days old; and

(b) Third screening using first-tier tests when the newborn infant is between 7 days and 14 days old to screen for:

(i) (text unchanged)

(ii) [Aclycarnitine] Acylcarnitine disorders as specified in Regulation .12C(25)—(52) of this chapter; [and]

(iii) Congenital hypothyroidism as specified in Regulation .12C(4) of this chapter[.]; and

(iv) Severe combined immunodeficiency, as specified in Regulation .12C(54) of this chapter.

(2) If a newborn infant who is born prematurely or [is] expected to be ill for more than 14 days was 24 hours old or older at the time the newborn infant’s [blood] blood-spot specimen was collected for a first screening, the Department’s public health laboratory shall perform a second screening [using first-tier tests on a specimen collected when the newborn infant is between 7 days and 14 days old] to screen for:

(a) (text unchanged)

(b) [Aclycarnitine] Acylcarnitine disorders as specified in Regulation .12C(25)—(52) of this chapter; [and]

(c) Congenital hypothyroidism as specified in Regulation .12C(4) of this chapter[.]; and

(d) Severe combined immunodeficiency, as specified in Regulation .12C(54) of this chapter.

(3) If a newborn infant was transfused before the blood-spot specimen was collected for a first screening, the Department’s public health laboratory shall conduct, in addition to any other screenings specified in §B(1) and (2) of this regulation, a fourth screening using first-tier tests on a blood-spot specimen collected 4 months after a newborn infant’s last transfusion to screen for:

(a)—(c) (text unchanged)

.18 Testing — Second-Tier and Supplemental.

A. (text unchanged)

B. A permittee:

(1) (text unchanged)

(2) Shall complete a second-tier or supplemental test on a blood-spot specimen within 3 working days after the blood-spot specimen arrives at the laboratory; and

(3) (text unchanged)

.20 Quality Control.

A. Quality Control Program.

(1) A permittee shall develop, establish, implement, maintain and follow written quality control policies, procedures, and techniques that provide and ensure accurate, reliable, and valid test results and reports.

[(1)] (2) (text unchanged)

(3) (text unchanged)

B. (text unchanged)

C. Supplies, Reagents, and Materials.

(1) A permittee shall ensure that supplies, reagents, and other materials used in the collected, handling, testing, and storing of newborn [blood-spots] blood-spot specimens are stored, labeled, checked for proper reactivity, and used according to the provisions of this chapter.

(2) A permittee shall:

(a)—(b) (text unchanged)

(c) Test representative samples of each lot of materials used for or in the process of testing blood-spot specimens on a regularly scheduled basis to determine that each lot of test material is capable of performing as required; and

(d) (text unchanged)

(3) (text unchanged)

.21 Quality Assessment and Quality Assurance.

A. A permittee shall:

(1)—(2) (text unchanged)

(3) Have an accessioning mechanism or system that:

(a) Tracks blood-spot specimens and allows first and subsequent blood-spot specimens and test results from the same newborn infant to be linked for testing and analysis; and

(b) (text unchanged)

B. A permittee may not test a blood-spot specimen exhibiting:

(1)—(6) (text unchanged)

C. A permittee may not test a blood-spot specimen:

(1) (text unchanged)

(2) That is unaccompanied by information necessary for the testing to be meaningful, including the:

(a)—(b) (text unchanged)

(c) Date and time of blood-spot specimen collection;

(d)(f) (text unchanged)

(3) If an infant was transfused before the first screening and the repeat blood-spot specimen collected to test for hemoglobin was drawn earlier than 4 months after the last transfusion; or

(4) (text unchanged)

D. Within 24 hours of receipt of an unsatisfactory blood-spot specimen, the permittee shall notify the submitter of the unsatisfactory blood-spot specimen by telephone, facsimile, or electronic mail:

(1) That the blood-spot specimen cannot be tested; and

(2) To submit another blood-spot specimen as soon as possible.

E. If a permittee reports a test result on a newborn infant and later discovers that the test result was erroneous or questionable, the permittee shall:

(1) Give prompt notice of the erroneous or questionable patient test result to the:

(a)—(b) (text unchanged)

(c) [Newborn Screening] Follow-Up Unit;

(2)—(5) (text unchanged)

(6) Take any additional measures necessary to reduce or eliminate the threat to the health and safety of the patient including:

(a) (text unchanged)

(b) Retesting the same blood-spot specimen;

(c) Testing a new blood-spot specimen; and

(d) Retesting the same blood-spot specimen and testing a new blood-spot specimen.

.23 Reporting Test Results.

A. All Test Results. For a newborn infant, a permittee shall:

(1) Report all first-tier, supplemental, and second-tier results to:

(a) (text unchanged)

(b) [A person] An individual who will use the test results in identifying, tracking, caring for, and treating the newborn infant, including:

(i) (text unchanged)

(ii) Personnel in the [Department’s Newborn Screening] Follow-Up Unit;

(2) Report to the persons listed in §A(1) of this regulation within 3 working days after the laboratory obtains the blood-spot specimen, all test results that are within normal limits;

(3) (text unchanged)

(4) Include with each report the following information:

(a) Date the blood-spot specimen was received in the laboratory;

(b)—(c) (text unchanged)

(5) Report all abnormal test results to the [Department’s Newborn Screening] Follow-Up Unit on the same day that a test result is obtained and reviewed.

B. Specific Test results. A permittee may not report a test result as being within normal limits for:

(1) Amino acid levels for disorders specified in Regulation .12C(11)—(24) of this chapter and for a total galactose level for galactosemia as specified in Regulation .12C(3) of this chapter if:

(a) A newborn infant was not on milk or formula feeding at least 24 hours before the blood-spot specimen was collected; or

(b) (text unchanged)

(2) (text unchanged)

.24 Reporting Abnormal Test Results to the [Newborn Screening] Follow-Up Unit.

A. Reporting Requirements. A permittee shall immediately report an abnormal or diagnostic test result to the [Newborn Screening] Follow-Up Unit by:

(1)—(3) (text unchanged)

B.—C. (text unchanged)

D. Reporting Requirements; Sickle Cell Disease Hemoglobin [Requirements]. A permittee shall report results for hemoglobin disorders as specified in Regulation .12C(7)—(10) of this chapter for sickle cell disease in terminology that includes:

(1)—(2) (text unchanged)

.25 Reporting System and Communication Software.

A permittee shall:

A. Have available and use a reliable and accurate electronic information system that is capable of collecting, compiling, transferring, and communicating all normal and abnormal test results to the [Newborn Screening] Follow-Up Unit; and

B. Provide the [Newborn Screening] Follow-Up Unit, where applicable, with:

(1) The necessary information system and electronic communications software or interface to be used by the [Newborn Screening] Follow-Up Unit to receive from the permittee the newborn screening test results and reports required in this chapter; and

(2) (text unchanged)

.26 Availability of Statistical and Scientific Data.

A. Statistical Reports. The State’s public health laboratory, the [Newborn Screening] Follow-Up Unit, or both, on request, shall provide Newborn Screening Program statistical data for official State and national reports to:

(1)—(3) (text unchanged)

B. (text unchanged)

.27 Sanctions.

A.—B. (text unchanged)

C. The Secretary may impose a directed plan of correction, limit testing, deny a permit renewal, or suspend or revoke a current permit if a permittee has:

(1) (text unchanged)

(2) Conducted research on newborn infant blood-spot specimens within the Newborn Screening Program’s approval as required in Regulation .15 of this chapter; or

(3) (text unchanged)

D.F. (text unchanged)

 

Subtitle 52 PREVENTIVE MEDICINE

10.52.12 Newborn Screening

Authority: Health-General Article, §§13-109 and 13-111, Annotated Code of Maryland

.03 Definitions.

A. (text unchanged)

B. Terms Defined.

(1) Birthing Facility.

(a) (text unchanged)

(b) “Birthing facility” includes a:

(i)—(ii) (text unchanged)

(2) Blood-Spot Specimen.

(a) “Blood-spot specimen” means a whole-blood specimen collected from a newborn infant’s heel and applied to the designated area on a blood-spot specimen collection test requisition card for the purpose of performing screening tests.

(b) “Blood-spot specimen” includes:

(i) The first screening blood-spot specimen collected from a newborn infant, usually in the birthing facility or other place where the newborn infant was born, within 48 hours after the newborn infant’s birth;

(ii) The second screening blood-spot specimen collected from a newborn infant, usually collected when the newborn infant is between 10 and 14 days of age; and

(iii) A blood-spot specimen collected subsequent to a specimen specified in §B(2)(b)(i) and (ii) of this regulation as required to meet the medical needs and condition of the newborn infant and any additional specific screening blood-spot specimen collection and screening test requirements of this chapter and COMAR 10.10.13.

[(2)] (3)—[(3)] (4) (text unchanged)

[(4)] (5) “Courier” means an entity employed by a person to convey a blood-spot specimen from the site of blood-spot specimen collection to the laboratory where the blood-spot specimen will be tested.

[(5)] (6)[(6)] (7) (text unchanged)

[(7)] (8) “First screening” means a screening performed on the first [blood] blood-spot specimen collected from a newborn infant after birth.

[(8)] (9) (text unchanged)

[(9)] (10) “Follow-Up Unit” means the follow-up component and staff of the Department’s Newborn Screening Program, which carries out the duties set forth in Regulation [.13] .12 of this chapter.

[(10)] (11) (text unchanged)

(12) “Home birth” means the birth of an infant which occurs intentionally outside of a birthing facility.

(13) “Home birth attendant” means a physician who is licensed to practice under Health Occupations Article, Title 14, Annotated Code of Maryland, a nurse midwife who is licensed and certified to practice under Health Occupations Article, Title 8, Annotated Code of Maryland, or a direct-entry midwife who is licensed under Health Occupations Article, Title 8, Subtitle 6C, Annotated Code of Maryland, who is caring for the mother and infant at delivery during a home birth as defined in §B(12) of this regulation.

[(11)] (14)—[(12)] (15) (text unchanged)

[(13)] (16) “Newborn” or “newborn infant” means an infant:

(a)—(c) (text unchanged)

(d) From whom a [blood] blood-spot specimen was collected and submitted to the State’s public health laboratory for newborn screening by a birthing facility or other health care provider located in Maryland, regardless of the infant’s place of birth;

(e)—(f) (text unchanged)

[(14)] (17) Newborn Screening or Screening.

(a) (text unchanged)

(b) “Newborn screening” or “screening” includes:

(i) First-tier testing on a first, second, or subsequent blood-spot specimen; and

(ii) (text unchanged)

[(15)] (18) Newborn Screening Program.

(a) (text unchanged)

(b) “Newborn Screening Program” includes:

(i)—(iii) (text unchanged)

(iv) The [Department’s Newborn Screening] Follow-Up Unit; and

(v) (text unchanged)

[(16) Screening Specimen.

(a) “Screening specimen” means a whole-blood specimen collected from a newborn infant’s heel and applied to the designated area on a blood-spot collection test requisition card for the purpose of performing screening tests.

(b) “Screening specimen” includes:

(i) The first screening specimen collected from a newborn infant, usually in the birthing facility or other place where the newborn infant was born, within 7 days after the newborn infant’s birth;

(ii) The second screening specimen collected from a newborn infant, usually collected when the newborn infant is between 1 and 4 weeks of age; and

(iii) A specimen collected subsequent to a specimen specified in §B(16)(b)(i) and (ii) of this regulation as required to meet the medical needs and condition of the newborn infant and any additional specific screening specimen collection and screening test requirements of this chapter and COMAR 10.10.13.]

[(17)] (19) “Second screening” means a test performed on a routine second blood-spot specimen collected when the newborn infant is between [1 week and 4 weeks] 10 and 14 days old even though the test results from the newborn’s first blood-spot specimen were normal.

[(18)] (20) Second-Tier Test.

(a) “Second-tier test” means a test performed on a newborn screening blood-spot specimen when a first-tier test provides an abnormal screening test result or a borderline abnormal screening test result.

(b) (text unchanged)

[(19)] (21) “Supplemental test” means a test performed on a blood-spot specimen collected from a newborn infant that is:

(a)—(b) (text unchanged)

[(20)] (22) “Unsatisfactory blood-spot specimen” means a blood-spot specimen that may produce an inaccurate or unreliable test result because the blood-spot specimen exhibits one of the problems of collection as specified in COMAR 10.10.13.21B and C.

.04 Responsibilities of the Department.

A.—B. (text unchanged)

C. Notification. The Department shall notify the parents and guardians of newborn infants that laboratories other than the Department’s public health laboratory may perform post screening confirmatory or diagnostic tests on newborn infants for hereditary and congenital disorders.

.05 Selection of Disorders for Screening.

A. (text unchanged)

B. The selected disorders are:

(1)—(51) (text unchanged)

(52) [Dienoyl CoA] 2,4-dienoyl-CoA reductase deficiency (DE RED); [and]

(53) Cystic fibrosis; and

(54) Severe combined immunodeficiency (SCID).

C. Supplemental Tests. The State’s Newborn Screening Program may not request or perform a supplemental test until the public health laboratory has confirmed there is sufficient blood-spot specimen to test for the required panel of disorders set forth in §B of this regulation.

.06 Pre-Test Information.

Before a blood-spot specimen is sent for newborn screening, a health care provider or the individual’s designated representative shall provide to the newborn infant’s parent or guardian an explanation of newborn screening that includes:

A.—B. (text unchanged)

.07 [Births in a Birthing Facility] Initial Screening.

The individual in charge of a birthing facility or the individual’s designated representative, or the home birth attendant shall:

A. [Specimen Collection and Screening.] If the parent or guardian of the newborn infant does not object to newborn screening[, the individual in charge of a birthing facility or the individual’s designated representative shall]:

(1) Collect a [blood] blood-spot specimen:

(a)—(b) (text unchanged)

(2) Submit the collected [blood] blood-spot specimen to the Department’s public health laboratory[.];

B. [Parental Objection.] When a parent or guardian objects to newborn screening[, the individual in charge of a birthing facility or the individual’s designated representative shall]:

(1) (text unchanged)

(2) Inform the [Department’s] Follow-Up Unit by telephone, fax, or email of the objection within 12 hours after the objection[.];

C. [Full-Term Healthy Newborn Infants.] For full-term healthy newborn infants:

(1) [The individual in charge of a birthing facility or the individual’s designated representative shall collect from each full-term healthy newborn infant to be tested] Collect a blood-spot specimen to test for the disorders set forth in Regulation .05 of this chapter not sooner than 24 hours after the onset of milk feeding, regardless of whether the newborn is breast-fed or formula-fed[.]; and

(2) If the newborn infant is discharged before 24 hours after the onset of milk feeding, [the individual in charge of the birthing facility or the individual’s designated representative shall] collect the blood-spot specimen as late as practical before the newborn infant is discharged from the birthing facility[.]; and

D. [Ill or Premature Newborn Infants. If] For a newborn infant [to be tested is] born prematurely or [is] expected to be ill for longer than 14 days, [the individual in charge of the birthing facility or the individual’s designated representative shall] if the newborn infant’s medical condition permits, collect:

(1) A [blood] blood-spot specimen for the newborn screening test upon admission, before the administration of blood products[, if the newborn infant’s medical condition permits] or antibiotics;

(2) A subsequent blood-spot specimen [24] 48 to 72 hours after birth, regardless of milk feeding status;

(3) A subsequent blood-spot specimen by 10 days of age when milk feeding[, as set forth on §C(2) of this regulation,] is established or the infant has been receiving additional protein through intravenous fluids; and

(4) An additional subsequent blood-spot specimen at one month of age or at discharge, whichever comes first.

[E. Hearing Screening. The individual in charge of the birthing facility or the individual’s representative shall:

(1) Record results of a newborn infant’s hearing screening test;

(2) Record any risk factors for hearing loss;

(3) Record demographic, clinical, and health care provider information required by the Early Hearing Detection and Intervention Program in the Maternal and Child Health Bureau; and

(4) Transmit the information recorded in §E(1)—(3) of this regulation to the Early Hearing Detection and Intervention Program in the Maternal and Child Health Bureau in the format specified by the Early Hearing Detection and Intervention Program.]

[.09] .08 Second Screening.

A health care provider shall have a [blood] blood-spot specimen collected for a second screening for the disorders set forth in Regulation .05 of this chapter when the newborn is between [1 week and 4 weeks] 10 and 14 days old.

[.10] .09 Transport of Blood-Spot Specimens to a Licensed Laboratory.

A. A birthing facility representative, physician, or other health care provider or, in the case when a birth occurs outside a birthing facility, the individual required to prepare and file the certificate of birth, shall send newborn screening blood-spot specimens only to the Department’s public health laboratory for the performance of newborn screening, as set forth in COMAR 10.10.13.14B.

B. The individual responsible for collecting and submitting a blood-spot specimen for a newborn screening test shall ensure that[:

(1) Specimens] blood-spot specimens are forwarded by courier to the Department’s public health laboratory within 24 hours after collection[; and

(2) Couriers deliver specimens to the Department’s public health laboratory within 24 hours after the courier receives the specimen].

[.11] .10 Results.

A. Normal Screening Results.

(1) The Department’s public health laboratory shall report normal newborn screening test results to the submitter of the blood-spot specimen [and to the Department’s Newborn Screening Follow-Up Unit] within 3 business days after receipt of the blood-spot specimen.

(2) A birthing facility representative, health care provider, or the individual who is responsible for filing the certificate of birth if the birth occurs outside a birthing facility, or other submitter of the blood-spot specimen shall:

(a)—(b) (text unchanged)

B. Abnormal Screening Results.

(1) The Department’s public health laboratory shall immediately report abnormal newborn screening test results to the [Department’s Newborn Screening] Follow-Up Unit.

(2) The Department’s public health laboratory shall report to the [Department’s Newborn Screening] Follow-Up Unit all known demographic and clinical data on the newborn infant in an electronic format compatible with the Department’s information system databases operated by the Department’s public health laboratory, as set forth at COMAR 10.10.13.25.

(3) The [Department’s Newborn Screening] Follow-Up Unit shall enter results in the Department’s database and initiate follow-up procedures as specified in Regulation [.13] .12 of this chapter.

(4) The submitter of the blood-spot specimen shall:

(a)—(b) (text unchanged)

[.12] .11 Referral Procedures.

The individual in charge of a birthing facility or the individual’s designated representative, or the home birth attendant shall:

[A. Newborn Infants Born in a Birthing Facility.]

[(1) The individual in charge of a birthing facility or the individual’s designated representative shall develop]

A. Develop collection and transport procedures to ensure against collecting and submitting unsatisfactory blood-spot specimens for each of the categories of newborn infant listed in [§A(2)—(4)] §B of this regulation.

B. Collect or otherwise have collected:

[(2) Newborn Infants Discharged Before 24 hours of Milk Feeding. In]

(1) An additional blood-spot specimen before the newborn is 7 days old for newborn infants discharged before 24 hours of milk feeding in addition to the blood-spot specimen collected before discharge, as set forth in Regulation .07C(2) of this chapter[, the individual in charge of a birthing facility or the individual’s designated representative shall collect an additional specimen before the newborn is 7 days old].

[(3) Newborn Infants Discharged Before a Specimen is Collected. If]

(2) The blood-spot specimen before the newborn is 7 days old if a newborn infant is discharged from a birthing facility before a newborn screening blood-spot specimen is collected[, the individual in charge of the birthing facility or the individual’s designated representative shall collect the specimen before the newborn is 7 days old].

[(4) Newborn Infants with an Unsatisfactory Specimen. If]

(3) An additional blood-spot specimen within 7 days after notification if the laboratory reports to a birthing facility or a home birth attendant that the [laboratory has received an unsatisfactory specimen, the individual in charge of a birthing facility or the individual’s designated representative, within 7 days after notification that the initial specimen was unsatisfactory, shall collect or otherwise have collected an additional specimen] initial blood-spot specimen was unsatisfactory.

[(5) Newborn Infants Who Are Transfused Before Specimen Collection. If]

(4) A blood-spot specimen to be tested for hemoglobins, biotinidase, and galastose -1 phosphate uridyl transferase (GALT) only, four months after the last transfusion if the initial blood-spot specimen was not collected until after the infant was transfused[, the individual in charge of the birthing facility or individual’s designated representative shall collect a specimen to be tested for hemoglobins, biotinidase, and galactose -1 phosphate uridyl transferase (GALT) only, 4 months after the last transfusion].

[B. Newborn Infants Born Outside a Birthing Facility. If the birth of a newborn infant occurs outside a birthing facility, the individual required to prepare and file the certificate of birth shall:

(1) Collect and submit an additional specimen to the State’s public health laboratory for each newborn infant reported by the public health laboratory to have an unsatisfactory specimen; and

(2) Submit the additional specimen within 7 days after notification that the initial specimen was unsatisfactory.]

[.13] .12 Follow-Up Procedures.

A. Department’s Responsibilities.

(1) The [Department’s Newborn Screening] Follow-Up Unit shall investigate each abnormal result indicative of increased risk for a hereditary or congenital disorder by contacting the infant’s health care provider, or other appropriate individual to notify the parent or guardian, or if the health care provider cannot be contacted, by contacting the infant’s parent or guardian directly [or directing the designated representative of the appropriate birthing facility, the infant’s health care provider, or other appropriate individual to notify the parent or guardian] regarding:

(a)—(d) (text unchanged)

(2) If the parent or guardian fails to respond to the birthing facility, health care provider, or other responsible individual acting as set forth in §B(1) of this regulation, the individual in charge of the birthing facility or the individual’s designated representative, health care provider, or other responsible individual shall notify the [Department’s Newborn Screening] Follow-Up Unit, which shall then try to notify the parent or guardian of the need for follow-up by using at least one of the following means, in the indicated order of priority:

(a)—(d) (text unchanged)

(3) The [Department’s Newborn Screening] Follow-Up Unit shall provide recommendations to the responsible birthing facility, health care provider, and the parent or guardian, as appropriate, regarding the appropriate follow-up and diagnostic evaluation of the newborn infant.

(4) The [Department’s Newborn Screening] Follow-Up Unit shall recommend:

(a) (text unchanged)

(b) That no treatment be administered to the newborn infant until the results of the follow-up evaluation have established that the infant has a hereditary or congenital disorder.

(5) The [Department’s Newborn Screening] Follow-Up Unit shall inform health care personnel and parents or guardians of:

(a)—(b) (text unchanged)

B. Responsibilities of the Birthing Facility or Health Care Provider. The individual in charge of the birthing facility or individual’s designated representative or health care provider shall:

(1) Evaluate the infant for signs, symptoms, and biochemical evidence of a hereditary or congenital disorder;

(2) (text unchanged)

(3) Collect and submit any required [blood] blood-spot specimens for repeat screening or diagnostic testing; and

(4) Report the results of diagnostic testing to the [Department’s Newborn Screening] Follow-Up Unit.

[.15] .13 Records.

A. (text unchanged)

B. [Upon] On request, a laboratory or health care provider shall make available to the [Department’s Newborn Screening] Follow-Up Unit medical records, records of laboratory tests, and any other medical information the [Department’s Newborn Screening] Follow-Up Unit considers necessary to:

(1)—(3) (text unchanged)

C. (text unchanged)

VAN T. MITCHELL
Secretary of Health and Mental Hygiene

 

Subtitle 18 HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION AND ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS)

10.18.09 HIV [Counseling and] Testing for Pregnant Women Receiving Prenatal Care

Authority: Health-General Article, §§18-102, 18-201.1, 18-202.1, 18-205, 18-207, 18-208, 18-336, 18-337, 18-338.2, and 20-102, Annotated Code of Maryland

Notice of Proposed Action

[17-018-P]

The Secretary of Health and Mental Hygiene proposes to amend Regulations .01 and .02, repeal existing Regulations .03 — .07, adopt new Regulations .03—.05, and amend and recodify existing Regulation .08 to be Regulation .06 under COMAR 10.18.09 HIV Testing for Pregnant Women Receiving Prenatal Care.

Statement of Purpose

The purpose of this action is to:

(1) Update language in COMAR 10.18.09 to make language in this chapter parallel to COMAR 10.18.08 (HIV Testing Procedures);

(2) Add requirements for HIV testing in the 3rd trimester of pregnancy according to HB 180 (2016);

(3) Add language clarifying that the testing requirements in these regulations apply only to pregnant women receiving regular prenatal care;

(4) Combine consent, counseling, and pre-test requirements in Regulation .03; and

(5) Move information on confidentiality of test results from its own regulation to Regulation .04 Testing Requirements.

Comparison to Federal Standards

There is no corresponding federal standard to this proposed action.

Estimate of Economic Impact

I. Summary of Economic Impact. As a result of the changes to streamline pre-test activities related to HIV testing of pregnant women, health care providers may note an indeterminable positive economic impact. As clinical settings implement changes to the testing process, the time they spend with each patient to provide the required information prior to testing will be reduced. This may allow a provider to see more patients, which may increase revenue generated by the additional patients. The insurance industry may face increased costs to cover screening pregnant women for HIV in the 3rd trimester.

 

 

Revenue (R+/R-)

 

II. Types of Economic Impact.

Expenditure (E+/E-)

Magnitude

 


A. On issuing agency:

NONE

B. On other State agencies:

NONE

C. On local governments:

(E+)

Indeterminable

 

 

Benefit (+)
Cost (-)

Magnitude

 


D. On regulated industries or trade groups:

(1) Health Care Providers

(+)

Indeterminable

(2) Insurance

(-)

Indeterminable

E. On other industries or trade groups:

NONE

F. Direct and indirect effects on public:

NONE

III. Assumptions. (Identified by Impact Letter and Number from Section II.)

C. Local governments have, within their local health departments, health care providers who may be impacted by the changes to the HIV testing process for pregnant women. As noted above, providers may see an increase in the number of patients they are able to see. The magnitude of the impact is not measurable as it will be dependent on the number of patients that can be seen, the number of providers who offer testing, and the volume of reimbursable services that are paid for by both public and private insurers.

 

D(1). Health care providers who provide prenatal care will be impacted by the changes to the HIV testing process for pregnant women. As noted above, providers may see an increase in the number of patients they are able to see. The magnitude of the impact is not measurable as it will be dependent on the number of patients that can be seen, the number of providers who offer testing, and the volume of reimbursable services that are paid for by both public and private insurers.

D(2). Additionally, insurance companies may be impacted by the changes in the number of HIV tests to be provided to women during pregnancy. The magnitude of the impact is not measurable as it will be dependent on the number of patients that accept third-trimester testing, the cost of paying the provider (as this may vary from provider to provider), and the associated laboratory costs (which may vary from lab to lab and based on the type of test conducted). Additionally, an estimate of the number of women already being screened during the third-trimester cannot be provided because the number of tests with negative results is not available. Therefore, this information cannot be used to estimate the magnitude of the impact from changes in the number of HIV tests.

Economic Impact on Small Businesses

The proposed action has minimal or no economic impact on small businesses.

Impact on Individuals with Disabilities

The proposed action has no impact on individuals with disabilities.

Opportunity for Public Comment

Comments may be sent to Michele Phinney, Director, Office of Regulation and Policy Coordination, Department of Health and Mental Hygiene, 201 West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to dhmh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through February 6, 2017. A public hearing has not been scheduled.

.01 Scope.

A. Except as provided in [§§B—E] §§C—F of this regulation, this chapter governs [counseling] pre-test and post-test information, requirements for reporting and control efforts, and requirements for informed consent and counseling when HIV testing is performed on pregnant women.

B. In cases exempt from the requirements for consent throughout this chapter, as specified in §§C—F of this regulation, it is not necessary to obtain written informed consent for HIV testing on the form approved by the Secretary.

[B.] C.[D.] E. (text unchanged)

[E.] F. HIV testing of specimens for research is not governed by this chapter if:

(1)—(2) (text unchanged)

(3) The HIV test result cannot be linked to the individual from whom the specimen was taken; and

(4) (text unchanged)

[F.] G. This chapter pertains to [all] pregnant women receiving prenatal care for whom a diagnostic test for the presence of HIV infection is conducted, including minors.

.02 Definitions.

A. (text unchanged)

B. Terms Defined.

(1) “Acquired immunodeficiency syndrome (AIDS)” means the medical condition caused by the human immunodeficiency virus.

(2) “Centers for Disease Control and Prevention (CDC)” means the federal Centers for Disease Control and Prevention of the United States Department of Health and Human Services.

[(1)] (3) “Counseling” means providing education on:

(a) (text unchanged)

(b) Recognized methods of reducing the risk of transmission of HIV to the fetus during pregnancy[, including the use of pharmaceuticals known to reduce the risk of transmission of HIV to the fetus]; and

(c) The topics set forth in [COMAR 10.18.08.06B(3)] Health-General Article, §18-336(b), Annotated Code of Maryland.

[(2)] (4) (text unchanged)

[(3)] (5) “Health care facility” means a facility or office where health or medical care is provided to patients by a health care provider, including:

(a) A hospital or related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland;

(b) A facility operated by the Department or a health officer; [and]

(c) The office of a health care provider;

(d) A health maintenance organization as defined in Health-General Article, §19-701, Annotated Code of Maryland;

(e) The Department of Public Safety and Correctional Services; or

(f) A program approved by the Department to provide human immunodeficiency virus testing services, as described in COMAR 10.18.08.03 and .04.

[(4)] (6) (text unchanged)

[(5)] (7)Human immunodeficiency virus (HIV)” means [the human immunodeficiency] a virus that causes [acquired immune deficiency syndrome (AIDS)] AIDS.

[(6) “HIV infection” means an infection with HIV.]

(8) “Indeterminate HIV test result” means an HIV test result that did not establish either the presence or absence of HIV infection as defined by the CDC’s laboratory criteria.

[(7)] (9) “Informed consent” means the voluntary permission by the individual to be tested for HIV, after the individual receives [counseling] pre-test information as specified in Regulation .03 of this chapter.

(10) “Institutional review board” means a group of individuals designated by an institution in compliance with 45 CFR Part 46, to review the use of human subjects in proposed research.

(11) “Negative HIV test result” means an HIV test result that failed to detect the presence of HIV as defined by the CDC’s laboratory criteria.

(12) Partner.

(a) “Partner” means an individual with whom:

(i) One has, or has had, oral, anal, or vaginal sexual contact; or

(ii) One has shared hypodermic needles or other similar drug paraphernalia.

(b) “Partner” includes any individual who:

(i) Is the marriage partner of an HIV-infected patient; or

(ii) Has been the marriage partner of that patient at any time within the 10-year period before the diagnosis of HIV infection.

(13) “Positive HIV test result” means an HIV test result that documented the presence of HIV as defined by the CDC’s laboratory criteria.

(14) “Post-test information” means notifying an individual about HIV test results and providing an individual with other relevant information after an HIV test has been performed, as required by Regulation .05 of this chapter.

[(8)] (15) “Prenatal care” means obstetric and gynecologic service performed as part of a [prenatal care program, including] medical care program for a pregnant woman and her unborn child, and may include:

(a)—(b) (text unchanged)

(c) Laboratory and diagnostic testing procedures and interpretation; [and] or

(d) (text unchanged)

(16) “Pre-test information” means information provided to an individual before a specimen is tested for the presence of HIV infection, as required by Regulation .03 of this chapter.

(17) “Research” means an investigation carried out according to a protocol approved by an institutional review board;

(18) “Secretary” means the Secretary of the Department of Health and Mental Hygiene;

[(9)] (19) (text unchanged)

(20) “Surrogate consent” means consent given by an individual who is not the patient, as permitted under Health-General Article, §5-605, Annotated Code of Maryland.

.03 Consent, Counseling, and Pre-test Requirements.

A. General medical consent is sufficient to perform HIV testing.

B. Consent for HIV testing is only required to be obtained one time during a patient’s visit.

C. A health care provider who obtains consent for HIV testing shall:

(1) Obtain consent as a part of a patient’s general consent for medical care in the same manner as for other screening and diagnostic tests;

(2) Document all declinations of an HIV test in the medical record of the patient; and

(3) Obtain consent from a health care agent designated as per Health-General Article, §5-602, Annotated Code of Maryland, or surrogate consent as per Health-General Article, §5-605 Annotated Code of Maryland.

D. The general informed consent for medical care may specify that an HIV test will be performed.

E. A health care provider may not be required to obtain consent for HIV testing on a separate consent form.

F. Pre-test information and counseling shall be provided to the patient to be tested for HIV before each specimen is tested.

G. A health care provider providing pre-test information and counseling shall:

(1) Provide HIV-specific information:

(a) Verbally;

(b) In writing;

(c) Through video; or

(d) Through any combination of §G(1)(a)—(c) of this regulation;

(2) Provide HIV information in a manner that protects the confidentiality of the patient being tested;

(3) Using layman’s terms, provide at minimum, the following information to the patient being tested:

(a) That the patient is being tested for HIV;

(b) That the patient has the right to:

(i) Ask questions; or

(ii) Decline the test without penalty;

(c) An explanation of HIV infection;

(d) That a negative HIV test result means that:

(i) A patient is not infected with HIV or that the test was unable to detect the presence of HIV because a patient is in the early stage of infection and has not yet developed detectable evidence of HIV infection; and

(ii) If the patient has had recent potential exposures, the patient should be retested within an appropriate time frame based on the type of testing used; and

(e) That a positive HIV test result means the patient:

(i) Is infected with HIV; and

(ii) Will be linked with medical treatment and other supportive services;

(4) Provide education to the pregnant woman about:

(a) The effect of a positive HIV test result on:

(i) The pregnant woman; and

(ii) The risk of transmission of HIV to the fetus; and

(b) Recognized methods of reducing the risk of transmission of HIV to the fetus, including the use of pharmaceuticals during pregnancy known to reduce the risk of transmission of HIV to the fetus;

(5) Include an opportunity for the pregnant woman being testing to:

(a) Ask and receive answers to questions about HIV and other topics described in this regulation; and

(b) Decline an HIV test; and

(6) Make necessary accommodations with respect to language or disability to ensure that the patient being tested understands the information presented.

.04 Testing Requirements.

A. Unless a patient declines, a health care provider shall test a pregnant woman under the health care provider’s care for HIV:

(1) During the first and third trimesters; and

(2) In the third trimester of pregnancy if the woman’s HIV status is unknown.

B. A health care provider who provides labor and delivery services to a pregnant woman shall offer:

(1) A rapid HIV test to a pregnant woman with unknown or undocumented HIV status during labor and delivery; and

(2) Antiretroviral prophylaxis before receiving the results of the confirmatory test if a rapid HIV test performed during labor and delivery is positive.

C. Confidentiality of HIV test results for pregnant women shall be maintained pursuant to Health-General Article, §18-338.2, Annotated Code of Maryland.

.05 Post-Test Requirements.

A. If a patient’s HIV test result is negative, the individual providing testing shall provide post-test information to the patient tested that includes:

(1) That the HIV test result is negative; and

(2) The meaning of a negative result.

B. If a patient’s HIV test result is indeterminate, the individual providing testing shall provide post-test information to the patient tested and in the presence of the patient tested that includes:

(1) That the HIV test result is indeterminate;

(2) The meaning of an indeterminate HIV test result; and

(3) A recommendation that the patient:

(a) Return in a medically appropriate time frame for another test; and

(b) Take precautions as if the patient’s HIV test result had been positive until the patient is retested.

C. If a patient’s HIV test result is positive:

(1) The individual providing testing shall provide post-test information to the patient tested and in the presence of the patient tested that includes:

(a) That the HIV test result is positive;

(b) The meaning of a positive HIV test result;

(c) How HIV infection may affect a pregnancy, fetus, or newborn;

(d) That there is a potential that the newborn would have HIV infection;

(e) Information regarding recognized methods of reducing the risk of transmission of HIV to the fetus; and

(f) Information regarding the patient’s responsibility to:

(i) Notify all known sexual and needle-sharing partners of possible exposure themselves; or

(ii) Request assistance from the local health department to notify all known sexual and needle-sharing partners of possible exposure; and

(2) The health care provider shall:

(a) Ensure the patient is linked to an appropriate source of HIV medical care and supportive services; and

(b) If necessary, provide the patient with information about mental health services for HIV-infected individuals;

(3) For contact control, the health care provider shall:

(a) Endeavor to bring an individual with whom the patient has had potentially infectious contact to examination and, as appropriate, prophylaxis by:

(i) Requesting the health officer to conduct a contact investigation of any case of HIV; or

(ii) Interviewing the patient in order to ascertain the names, descriptions, addresses, telephone numbers, and email addresses of those with whom the patient has had potentially infectious contact; and

(b) Report immediately to the health officer an individual identified as having had potentially infectious contact with a patient with a positive HIV test result;

(4) A health officer shall:

(a) Investigate and notify immediately an individual reported under the provisions of §C(3)(b) of this regulation, who is within the health officer’s jurisdiction, of the individual’s exposure and advise the individual to undergo a medical examination to ascertain whether the individual is infected with HIV; and

(b) Immediately forward to the Secretary all reports of individuals who are outside the health officer’s territorial jurisdiction for referral to the health officer of the proper jurisdiction; and

(5) A reported individual shall, within 1 week of notification, be examined to ascertain whether the individual has been infected with HIV.

[.08] .06 Immunity.

A health care provider or a health care facility acting in good faith to provide [the counseling required under Regulation .03 of] HIV testing and information as required under this chapter may not be held liable in any cause of action related to a woman’s decision to consent or not to consent to have an HIV test.

VAN T. MITCHELL
Secretary of Health and Mental Hygiene

 

Subtitle 22 DEVELOPMENTAL DISABILITIES

Notice of Proposed Action

[17-021-P]

The Secretary of Health and Mental Hygiene proposes to amend:

(1) Regulation .01 under COMAR 10.22.01 Definitions; and

(2) Regulation .04 under COMAR 10.22.18 Community Supported Living Arrangements Payment System.

Statement of Purpose

The purpose of this action is to incorporate Personal Support services as part of Community Supported Living Arrangements (CSLA) services under COMAR 10.22.01.01 and adopt FY17 reimbursement rates for Personal Support services as part of CSLA services under COMAR 10.22.18.04.

Comparison to Federal Standards

There is no corresponding federal standard to this proposed action.

Estimate of Economic Impact

I. Summary of Economic Impact. The proposed action increases the rate paid to providers.

 

 

Revenue (R+/R-)

 

II. Types of Economic Impact.

Expenditure
(E+/E-)

Magnitude

 


A. On issuing agency:

(E+)

$3,994,813

B. On other State agencies:

NONE

C. On local governments:

NONE

 

 

Benefit (+)
Cost (-)

Magnitude

 


D. On regulated industries or trade groups:

(+)

$3,994,813

E. On other industries or trade groups:

NONE

F. Direct and indirect effects on public:

NONE

III. Assumptions. (Identified by Impact Letter and Number from Section II.)

A. A 3.5 percent increase in rates will cause the expenditures of the Developmental Disabilities Administration (DDA) for community services to increase by an estimated $3,994,813 in total funds. The total general funds impact of these changes is $2,291.004.

D. Regulated provider agencies will benefit from increases to rates by an estimated $3,994,813 in total funds ($2,291,004 in general funds).

Economic Impact on Small Businesses

The proposed action has minimal or no economic impact on small businesses.

Impact on Individuals with Disabilities

The proposed action has no impact on individuals with disabilities.

Opportunity for Public Comment

Comments may be sent to Michele Phinney, Director, Office of Regulation and Policy Coordination, Department of Health and Mental Hygiene, 201 West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to dhmh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through February 6, 2017. A public hearing has not been scheduled.

 

10.22.01 Definitions

Authority: Health-General Article, §§2-104(b) and 7-904, Annotated Code of Maryland

.01 Definitions.

A. (text unchanged)

B. Terms Defined.

(1)—(13) (text unchanged)

(14) Community Supported Living Arrangements.

(a) (text unchanged)

[(b) “Community supported living arrangements (CSLA)” include:

(i) Personal assistance services;

(ii) Supports that enhance the individual’s opportunity for community participation and to exercise choice and control over the individual’s own life;

(iii) Training and other services necessary to assist the individual in achieving and maintaining increased integration, interdependence, and productivity;

(iv) 24-hour emergency assistance;

(v) Assistive technology;

(vi) Adaptive equipment;

(vii) Resource coordination;

(viii) Environmental modifications;

(ix) Respite services; and

(x) Other services as approved by the Secretary or the Secretary’s designee.]

(b) “Community supported living arrangements (CSLA)” includes personal support services, as defined under the Administration’s Home and Community-Based Services Waiver with the Centers for Medicare and Medicaid Services, including but not limited to the following services:

(i) Personal assistance services;

(ii) Supports that enhance the individual’s opportunity for community participation and to exercise choice and control over the individual’s own life;

(iii) Training, habilitation, and other services necessary to assist the individual in achieving and maintaining increased integration, interdependence, and productivity; and

(iv) 24-hour emergency assistance.

(c) “Community supported living arrangements (CSLA)” also includes other services set forth in the Administration’s Home and Community-Based Services Waiver with the Centers for Medicare and Medicaid Services as distinct from personal support services, including but not limited to the following:

(i) Assistive technology;

(ii) Adaptive equipment;

(iii) Resource coordination;

(iv) Environmental modifications;

(v) Respite; and

(vi) Other services as approved by the Secretary or the Secretary’s designee.

(15)—(64) (text unchanged)

 


 

10.22.18 Community Supported Living Arrangements Payment System

Authority: Health-General Article, §§2-104(b), 7-306.1, 7-307, 15-105, and 15-107, Annotated Code of Maryland

.04 Rates.

A.—H. (text unchanged)

[I.][K.] (proposed for repeal)

I. Fiscal Year 2017 Tables for CSLA’s Personal Supports Hourly Rates.

(1) State Fiscal Year 2017 CSLA’s Personal Supports Rates: Table for One Individual in a Dwelling Receiving CSLA Services.

Hourly Rate Per Individual

Hours of Service Per Week

Baltimore City and Allegany, Anne Arundel, Baltimore, Caroline, Carroll, Dorchester, Garrett, Harford, Howard, Kent, Queen Anne’s, St. Mary’s, Somerset, Talbot, Washington, Wicomico, and Worcester Counties

Cecil County

Calvert, Charles, Frederick, Montgomery,
and Prince George’s Counties

1—19

$28.99

$30.00

$30.26

20—22

$27.72

$28.69

$28.94

23-24

$26.79

$27.73

$27.97

25

$25.93

$26.84

$27.07

26

$25.11

$25.99

$26.22

27

$24.37

$25.22

$25.45

28—82

$24.01

$24.85

$25.07

(2) State Fiscal Year 2017 CSLA’s Personal Supports Rates: Table for Two Individuals in a Dwelling Receiving CSLA Services.

 

Hourly Rate Per Individual

Hours of Service Per Week

Baltimore City and Allegany, Anne Arundel, Baltimore, Caroline, Carroll, Dorchester, Garrett, Harford, Howard, Kent, Queen Anne’s, St. Mary’s, Somerset, Talbot, Washington, Wicomico, and Worcester Counties

Cecil County

Calvert, Charles, Frederick, Montgomery,
and Prince George’s Counties

1—19

$26.97

$27.91

$28.16

20—22

$25.99

$26.90

$27.13

23—24

$25.11

$25.99

$26.22

25

$24.30

$25.15

$25.37

26

$23.54

$24.36

$24.57

27

$22.83

$23.63

$23.84

28—82

$22.50

$23.29

$23.49

(3) State Fiscal Year 2017 CSLA’s Personal Supports Rates: Table for Three Individuals in a Dwelling Receiving CSLA Services.

 

Hourly Rate Per Individual

Hours of Service Per Week

Baltimore City and Allegany, Anne Arundel, Baltimore, Caroline, Carroll, Dorchester, Garrett, Harford, Howard, Kent, Queen Anne’s, St. Mary’s, Somerset, Talbot, Washington, Wicomico, and Worcester Counties

Cecil County

Calvert, Charles, Frederick, Montgomery,
and Prince George’s Counties

1—19

$21.61

$22.37

$22.56

20—22

$20.82

$21.55

$21.75

23—24

$20.11

$20.81

$20.99

25

$19.47

$20.15

$20.33

26

$18.87

$19.53

$19.70

27

$18.29

$18.93

$19.10

28—82

$18.04

$18.67

$18.84

J. State Fiscal Year 2017 CSLA’s Personal Supports Rates: Table for 1:1 Support or Not More than 8 Hours of Awake-Overnight Support per Residence for Individuals Receiving CSLA Services Regardless of the Number of Individuals in a Dwelling.

 

Hourly Rate Per Individual

Hours of Service Per Week

Baltimore City and Allegany, Anne Arundel, Baltimore, Caroline, Carroll, Dorchester, Garrett, Harford, Howard, Kent, Queen Anne’s, St. Mary’s, Somerset, Talbot, Washington, Wicomico, and Worcester Counties

Cecil County

Calvert, Charles, Frederick, Montgomery,
and Prince George’s Counties

Hours in Excess of 82

$18.04

$18.67

$18.84

K. State Fiscal Year 2017 CSLA’s Personal Supports Rates: Table for Professional Services for Individuals Receiving CSLA Services Regardless of the Number of Individuals in a Dwelling.

 

Hourly Rate Per Individual

Hours of Service Per Week

Baltimore City and Allegany, Anne Arundel, Baltimore, Caroline, Carroll, Dorchester, Garrett, Harford, Howard, Kent, Queen Anne’s, St. Mary’s, Somerset, Talbot, Washington, Wicomico, and Worcester Counties

Cecil County

Calvert, Charles, Frederick, Montgomery, and Prince George’s Counties

As preauthorized and approved

$31.51

$32.61

$32.89

VAN T. MITCHELL
Secretary of Health and Mental Hygiene

 


 

Subtitle 52 PREVENTIVE MEDICINE

10.52.01 Opioid-Associated Disease Prevention and Outreach Programs

Authority: Health-General Article, §§24-901—24-909, Annotated Code of Maryland

Notice of Proposed Action

[17-019-P]

The Secretary of Health and Mental Hygiene proposes to adopt new Regulations .01—.09 under a new chapter, COMAR 10.52.01 Opioid-Associated Disease Prevention and Outreach (OADPO) Programs.

Statement of Purpose

The purpose of this action is to adopt new regulations that will establish:

(1) Procedures for establishing an OADPO program;

(2) The application and appeals processes for establishing an OADPO program;

(3) Requirements for OADPO program design and operation;

(4) Requirements and procedures for ensuring the security of program locations, staff, and equipment;

(5) Requirements for monitoring and evaluation;

(6) Requirements for conducting research using OADPO program data; and

(7) Procedures for revocation of approval of OADPO programs.

Comparison to Federal Standards

There is no corresponding federal standard to this proposed action.

Estimate of Economic Impact

I. Summary of Economic Impact. This proposal may have an economic impact on local health departments or community-based organizations if a local health department or a community-based organization applies to establish an OADPO program. Local health departments and community-based organizations that are approved to establish OADPO programs will need funding for their programs. They may use existing resources, apply for outside grants, or fund the programs by other means.

 

 

Revenue (R+/R-)

 

II. Types of Economic Impact.

Expenditure (E+/E-)

Magnitude

 


A. On issuing agency:

NONE

B. On other State agencies:

NONE

C. On local governments:

(E+)

Indeterminable

 

 

 

Benefit (+)
Cost (-)

Magnitude

 


D. On regulated industries or trade groups:

(+)

Indeterminable

E. On other industries or trade groups:

NONE

F. Direct and indirect effects on public:

NONE

III. Assumptions. (Identified by Impact Letter and Number from Section II.)

C. Costs for local governments are indeterminable, as each local health department will decide whether to apply to establish an OADPO program. If a local health department applies and the application is approved, the source of the funding and the amount needed would vary by program based on available resources and program design and operation.

D. Costs for regulated industry are indeterminable, as a community-based organization will decide whether to apply to establish an OADPO program. If a community-based organization applies and the application is approved, the source of the funding and the amount needed would vary by program based on available resources and program design and operation.

Economic Impact on Small Businesses

The proposed action has minimal or no economic impact on small businesses.

Impact on Individuals with Disabilities

The proposed action has no impact on individuals with disabilities.

Opportunity for Public Comment

Comments may be sent to Michele Phinney, Director, Office of Regulation and Policy Coordination, Department of Health and Mental Hygiene, 201 West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to dhmh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through February 6, 2017. A public hearing has not been scheduled.

.01 Purpose and Scope.

This chapter:

A. Defines an opioid-associated disease prevention and outreach program; and

B. Sets forth:

(1) The responsibilities of the Department of Health and Mental Hygiene and local health departments in establishing opioid-associated disease prevention and outreach programs; and

(2) Requirements for:

(a) Monitoring and evaluating opioid-associated disease prevention and outreach programs; and

(b) Research conducted in collaboration with an opioid-associated disease prevention and outreach program.

.02 Definitions.

A. In this chapter, the following terms have the meaning indicated.

B. Terms Defined.

(1) “Applicant” means a local health department or community-based organization seeking to establish an opioid-associated disease prevention and outreach program.

(2) Body Fluid.

(a) “Body fluid” means any fluid containing visible blood, semen, or vaginal secretions.

(b) “Body fluid” does not include cerebrospinal fluid, synovial fluid, breast milk, amniotic fluid, saliva, stool, nasal secretions, sputum, tears, urine, or vomitus.

(3) “Community-based organization (CBO)” means a public or private organization that:

(a) Is representative of a community or significant segments of a community; and

(b) Provides educational, health, or social services to individuals in the community.

(4) “Department” means the Department of Health and Mental Hygiene.

(5) “Harm reduction education” means education on practical strategies:

(a) To reduce negative consequences associated with drug use; and

(b) That reflect specific individual and community needs.

(6) “HIV” means the human immunodeficiency virus that causes acquired immune deficiency syndrome (AIDS).

(7) “Infection control” means infection prevention and control measures that ensure the protection of individuals who are vulnerable to acquiring an infection both in the general community and while receiving health care services in a range of settings.

(8) “Injection supplies” means materials used to inject drugs including, but not limited to:

(a) Cookers;

(b) Water; and

(c) Cotton.

(9) “Naloxone” means an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory or central nervous system depression.

(10) “OADPO program” means an opioid-associated disease prevention and outreach program established by a local health department or community-based organization that provides services including:

(a) Dissemination of hypodermic needles or syringes and other preventive means for curtailing the spread of HIV and viral hepatitis;

(b) Overdose prevention education; and

(c) Harm reduction education.

(11) “Participant” means an individual who has registered with an OADPO program.

(12) “Sexually transmitted infection (STI)” means an infection passed from one person to another person through sexual contact.

(13) “Viral hepatitis” means inflammation of the liver caused by the hepatitis A, B, C, D, and E viruses.

(14) “Wound care” means treatment of the symptoms of infections that may result from using drugs.

.03 Program Establishment.

A. Effective October 1, 2016, a local health department or CBO may establish an OADPO program with approval from the:

(1) Department; and

(2) Local health officer of the county in which OADPO program operations are proposed.

B. When proposing an OADPO program, a local health department may collaborate with:

(1) A CBO; or

(2) Another local health department.

C. A CBO may operate an OADPO program in multiple counties if approved by the local health officer in each county where the OADPO program proposes to operate.

.04 Application Process.

A. An applicant:

(1) Shall submit an application to establish an OADPO program to the Department that includes:

(a) Responses to all applicable questions; and

(b) Any supporting documentation indicated on the application;

(2) May voluntarily withdraw an application at any time; and

(3) May submit a new application at any time.

B. The Department shall:

(1) Distribute the application to establish an OADPO program to the local health officer in each jurisdiction where the OADPO program proposes to operate;

(2) Request additional information or changes to the application if necessary; and

(3) Respond in writing to the applicant within 60 calendar days indicating the disposition of the application and explanation of the decision.

C. The Department and the local health officer in each jurisdiction where the OADPO program proposes to operate shall jointly:

(1) Review the application; and

(2) Either:

(a)Approve the application if the:

(i) Application is complete; and

(ii) OADPO program meets the requirements of Regulations .05 and .06 of this chapter; or

(b) Disapprove the application if the:

(i) Application does not provide sufficient information or documentation on the OADPO program; or

(i) OADPO program does not meet the requirements of Regulations .05 and .06 of this chapter.

D. An applicant whose application is disapproved may appeal the decision to the Deputy Secretary for Public Health Services by submitting the request in writing to the Deputy Secretary for Public Health Services within 30 calendar days of the date postmarked on the notice of disapproval.

E. If an applicant submits an appeal, the Deputy Secretary for Public Health Services shall within 60 days:

(1) Grant or deny the appeal; and

(2) Respond in writing to the applicant:

(a) Indicating whether the appeal has been granted or denied; and

(b) Providing an explanation of the decision.

.05 Program Design and Operation.

A. The CBO or local health department approved to operate an OADPO program:

(1) Shall provide protocols for the safety and security of OADPO program locations, equipment, and staff in accordance with Regulation .06 of this chapter that:

(a) Control the dissemination of hypodermic needles and syringes; and

(b) Allow for a full accounting of the number of hypodermic needles and syringes managed by the program;

(2) Shall offer participants:

(a) Overdose prevention education;

(b) Access to or a referral to obtain naloxone; and

(c) Harm reduction education;

(3) Shall ensure that all OADPO program staff have:

(a) Appropriate levels of expertise in working with individuals who inject drugs;

(b) Knowledge of harm reduction strategies; and

(c) Skills in implementing harm reduction strategies;

(4) Shall ensure that all OADPO program staff receive training approved by the Department to work with injection drug users and to provide referrals to:

(a) Community services;

(b) Counseling; and

(c) Preventative education;

(5) Shall ensure that all OADPO program staff demonstrate sensitivity to participant differences including:

(a) Cultural;

(b) Behavioral; and

(c) Values;

(6) Shall ensure that information collected to identify OADPO program participants is kept confidential according to:

(a) Health-General Article, §24-906(b), Annotated Code of Maryland; and

(b) 42 CFR Part 2;

(7) Shall ensure that there is a method of identification and authorization for OADPO program staff members who have access to:

(a) Hypodermic needles;

(b) Syringes; and

(c) OADPO program records;

(8) Shall develop and provide a protocol for linking participants to:

(a) Substance abuse treatment services;

(b) Testing for:

(i) HIV;

(ii) Viral hepatitis; and

(iii) STIs;

(c) Reproductive health services;

(d) Wound care; and

(e) Naloxone;

(9) Shall disseminate hypodermic needles or syringes and other preventive means for curtailing the spread of HIV and viral hepatitis at no cost to participants, including but not limited to:

(a) Injection supplies; and

(b) Safer sex supplies; and

(10) May not discriminate against participants based on factors including but not limited to:

(a) Culture;

(b) Language;

(c) Ability;

(d) Socioeconomic status;

(e) Sexual orientation;

(f) Gender identity;

(g) Age;

(h) Religion;

(i) Race; and

(j) Ethnicity.

B. Identification Card. OADPO program staff shall:

(1) Give each participant an identification card that includes the participant’s OADPO program identification number;

(2) Advise participants to carry the identification card with them at all times; and

(3) If the identification card is lost by a participant, re-issue an identification card to the participant.

C. The CBO or local health department approved to operate an OADPO program may offer other services to OADPO program participants, including:

(1) Testing for:

(a) HIV;

(b) Viral hepatitis; and

(c) STIs;

(2) Wound care;

(3) Reproductive health services; and

(4) Substance abuse counseling, treatment, and recovery services.

.06 Program Security.

A. An OADPO program shall implement protocols for the safety and security of program locations, equipment, and staff.

B. OADPO program staff shall:

(1) Wear suitable clothing, including closed footwear, at all times;

(2) Treat all body fluids as potentially infectious and follow infection control protocols at all times including:

(a) Use of barriers including gloves;

(b) Immediate washing of hands and other skin surfaces after contact with body fluids; and

(c) Careful handling and disposal of sharp instruments during and after use;

(3) When working off-site, have access to a communications system that allows staff to stay in contact with:

(a) Other staff; and

(b) Emergency support;

(4) Obtain consent of the owner or occupier of private property to enter the property to dispense or collect syringes or hypodermic needles; and

(5) Transport biohazardous waste to the disposal facility using a method that does not put any individuals at risk.

C. OADPO programs shall:

(1) Have a critical incident procedure that outlines processes and responsibilities of program staff for managing incidents including:

(a) Participant aggression;

(b) Threats of violence; and

(c) Other hazardous situations;

(2) Have available the following safety equipment during program operations:

(a) Puncture resistant utility gloves;

(b) Bleach; and

(c) Forceps or tongs;

(3) Have facilities that:

(a) Have adequate lighting; and

(b) Are free from clutter; and

(4) Have a contract with a licensed biohazardous waste disposal facility to receive biohazardous waste.

D. To prevent needlestick injuries, OADPO program participants, staff, volunteers, and any other individuals present at the facility in an occupational capacity shall:

(1) Receive education on safety protocols for:

(a) Carrying and handling:

(i) Syringes;

(ii) Hypodermic needles; and

(iii) Other sharps;

(b) The transport and disposal of biohazardous waste; and

(c) Infection control;

(2) Refrain from touching, without safety equipment, used:

(a) Hypodermic needles;

(b) Syringes; and

(c) Injection supplies; and

(3) Be encouraged to wear clothing at all times that provides protection against needlestick injuries including:

(a) Long pants; and

(b) Long-sleeved shirts.

E. Use of Sharps Containers.

(1) Used hypodermic needles, syringes, and injection supplies collected by the program from participants shall be placed in sharps containers.

(2) Sharps containers:

(a) Shall be leak proof;

(b) Shall be rigid;

(c) Shall be puncture resistant;

(d) Shall be labeled as containing sharps;

(e) Shall be placed on a level, secure surface that is a safe distance between participants and staff or volunteers during syringe exchange transactions; and

(f) May not be more than 75 percent full.

(3) Participants shall:

(a) Place into the sharps container all used:

(i) Hypodermic needles;

(ii) Syringes; and

(iii) Injection supplies;

(b) When possible, retrieve supplies that fall outside of the sharps container, including:

(i) Hypodermic needles;

(ii) Syringes; and

(iii) Injection supplies; and

(c) When possible, cover supplies used by the participant including:

(i) Hypodermic needles;

(ii) Syringes; and

(iii) Injection supplies.

F. Needlestick Injuries.

(1) OADPO programs shall implement protocols for handling needlestick injuries.

(2) OADPO programs shall designate at least one needlestick manager who shall:

(a) Assist injured individuals present at the facility including:

(i) Participants;

(ii) Staff;

(iii) Volunteers; and

(iv) Any other individuals present in an occupational capacity;

(b) Follow established procedures for accident or incident reporting; and

(c) Immediately notify the ranking supervisor of any needlestick injuries.

(3) Participants, staff, volunteers, and any other individuals present at the facility in an occupational capacity shall:

(a) Report a needlestick injury to the on-site needlestick manager immediately; and

(b) Visit the emergency room or a private physician within 24 hours of the occurrence.

G. Post-Exposure Management. OADPO programs shall implement protocols for post-exposure management including:

(1) Testing; and

(2) Post-exposure prophylaxis.

.07 Monitoring and Evaluation.

A. OADPO programs shall:

(1) Submit all data for each reporting period on a quarterly basis as required by the Department, including:

(a) The number of:

(i) Participants served by the OADPO program;

(ii) New participants registered by the OADPO program;

(b) Demographic data of participants served by the OADPO program, including:

(i) Age;

(ii) Gender identity;

(iii) Sexual orientation;

(iv) Race;

(v) Ethnicity;

(vi) Zip code; and

(vii) Types of drugs the participant reports using;

(c) The number of hypodermic needles and syringes distributed and collected;

(d) Each location where hypodermic needles and syringes were distributed; and

(e) The number of referrals to services provided to participants listed in Health-General Article, §24-903(A)(6), Annotated Code of Maryland, and Regulation .05A(4) of this chapter; and

(2) Collect data using methods that will not deter participants from utilizing OADPO program services.

B. The Department may conduct site visits to monitor and evaluate an OADPO program.

.08 Research.

A. An individual researcher or institution shall apply for and receive approval from the Department before starting research in collaboration with an OADPO program.

B. The Department shall:

(1) Review each request; and

(2) Approve or disapprove the proposed research based on whether the proposed research:

(a) Advances scientific knowledge or practice related to opioid-associated disease prevention and outreach;

(b) Has approaches, aims, and methods that will allow the researcher to perform descriptive analyses or test hypotheses;

(c) Has one or more investigators who have training and experience with the approaches and methods;

(d) Will impede or interfere with the operations of the OADPO program;

(e) Is approved by the Department’s Institutional Review Board to ensure that the research will be conducted according to established ethical guidelines for research in the field of opioid-associated disease prevention and outreach; and

(f) Will keep any data used for the research confidential as required by:

(i) Health-General Article, §24-906(B), Annotated Code of Maryland;

(ii) 42 U.S.C. §290dd-2; and

(iii) 42 CFR Part 2.

.09 Revocation of Approval and Appeals.

A. The Department and the local health officer may revoke the approval of an OADPO program if the OADPO program does not:

(1) Meet the requirements of Health-General Article, Title 24, Subtitle 9, Annotated Code of Maryland; or

(2) Operate in accordance with the requirements of Regulations .05 and .06 of this chapter.

B. The Department shall:

(1) Notify the OADPO program in writing of the revocation of approval; and

(2) Provide an explanation of the decision.

C. An OADPO program may appeal the decision to revoke approval to the Deputy Secretary for Public Health Services by submitting the request in writing to the Deputy Secretary for Public Health Services within 30 calendar days of the date postmarked on the notice of revocation of approval.

D. If an applicant submits an appeal, the Deputy Secretary for Public Health Services shall within 60 days:

(1) Grant or deny the appeal; and

(2) Respond in writing to the applicant:

(a) Indicating whether the appeal has been granted or denied; and

(b) Providing an explanation of the decision.

VAN T. MITCHELL
Secretary of Health and Mental Hygiene

 

Subtitle 60 BOARD OF ENVIRONMENTAL HEALTH SPECIALISTS

Notice of Proposed Action

[17-002-P]

The Secretary of Health and Mental Hygiene proposes to:

(1) Amend Regulations .02 — .05 under COMAR 10.60.01 General Regulations;

(2) Amend Regulations .03 — .05 under COMAR 10.60.02 Licensing Procedures;

(3) Adopt new Regulation .03 under COMAR 10.60.03 Continuing Education;

(4) Adopt new Regulation .09 and recodify existing Regulations .09 — .12 as Regulations .10 — .13 under COMAR 10.60.04 Rules of Procedure for Board Hearings; and

(5) Amend Regulation .01 under COMAR 10.60.06 Fee Schedule.

This action was considered at a public meeting on October 5, 2016, notice of which was given by publication on the Board’s website at http://dhmh.maryland.gov/behs/Pages/BoardMeeting.aspx pursuant to General Provisions Article, §3–302(c), Annotated Code of Maryland.

Statement of Purpose

The purpose of this action is to:

(1) In accordance with statute, prohibit an individual from using a certain title unless licensed by the Board with the intent to represent that the individual is licensed to practice as an environmental health specialist;

(2) Add a degree in chemical science, soil science, or geographic information systems to the required combination of education and experience needed to be approved to take a required examination;

(3) Clarify the requirements for being recognized as outstanding in the field of environmental health as being defined in COMAR;

(4) Clarify the responsibilities for the sponsor of an environmental health specialist-in-training program;

(5) Clarify that as part of the implementation of the in-training program, the environmental health specialist-in-training shall meet certain requirements;

(6) Require the Board to notify an applicant whose application has been denied by the Board by first-class mail and electronic means of the reason for denial;

(7) Require that an environmental health specialist-in-training program be approved by the Board;

(8) Authorize the Board to put an environmental health specialist-in-training certificate on inactive status at the request of the certificate holder for reasons acceptable to the Board, authorizing the reactivation of the certificate within a certain time period upon request from the certificate holder and with a letter of support from a sponsor;

(9) Provide that pre-approved providers of continuing education shall be entities that meet certain requirements;

(10) Require the Board to post and maintain a list of pre-approved providers on its website; and

(11) Repeal the late license renewal fee.

Comparison to Federal Standards

There is no corresponding federal standard to this proposed action.

Estimate of Economic Impact

I. Summary of Economic Impact. The Board is repealing the late renewal fee. The Board cannot estimate how many individuals would be charged the fee because it cannot estimate how many will apply late each year.

 

 

Revenue (R+/R-)

 

II. Types of Economic Impact.

Expenditure (E+/E-)

Magnitude

 


A. On issuing agency:

(R-)

Indeterminable

B. On other State agencies:

NONE

C. On local governments:

NONE

 

 

Benefit (+)
Cost (-)

Magnitude

 


D. On regulated industries or trade groups:

(+)

Indeterminable

E. On other industries or trade groups:

NONE

F. Direct and indirect effects on public:

NONE

III. Assumptions. (Identified by Impact Letter and Number from Section II.)

A. and D. The Board is repealing the late renewal fee. The Board cannot estimate how many individuals would be charged the fee because it cannot estimate how many will apply late each year.

Economic Impact on Small Businesses

The proposed action has minimal or no economic impact on small businesses.

Impact on Individuals with Disabilities

The proposed action has no impact on individuals with disabilities.

Opportunity for Public Comment

Comments may be sent to Michele Phinney, Director, Office of Regulation and Policy Coordination, Department of Health and Mental Hygiene, 201 West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to dhmh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through February 6, 2017. A public hearing has not been scheduled.

 

10.60.01 General Regulations

Authority: Health Occupations Article, §21–101, 21–205, 21–304, and 21–401, Annotated Code of Maryland

.02 Prohibitions.

A.—B. (text unchanged)

C. Pursuant to Health Occupations Article, §21–401, Annotated Code of Maryland, unless an individual is licensed under this chapter, an individual may not use the title “environmental health specialist” or “licensed environmental health specialist” or the initials “E.H.S.” or “L.E.H.S.” after the name of the individual or any other title with the intent to represent that the individual is licensed to practice as an environmental health specialist.

.03 Licensing and Examination.

A. (text unchanged)

B. An applicant is eligible to take the examination if the applicant has satisfied one of the following combinations of education and experience:

(1) Combination 1:

(a) Graduated from an accredited college or university with a baccalaureate degree in the chemical, physical, biological or environmental sciences including:

(i) A minimum of 60 semester credits or the equivalent quarter credits of chemical, physical, biological, and environmental sciences acceptable to the Board, which includes at least one laboratory course in two of the following fields: chemistry, physics, [and] biology, geographic information systems, and soil science; and

(ii) (text unchanged)

(b) (text unchanged)

(2) Combination 2:

(a) Graduated from an accredited college or university with a baccalaureate degree that includes:

(i) 30 semester credits or the equivalent in quarter credits in the chemical, physical, biological, and environmental sciences acceptable to the Board, which includes at least one laboratory course in two of the following fields: chemistry, physics, [and] biology, geographic information systems, and soil science; and

(ii) (text unchanged)

(b) (text unchanged)

(3) Combination 3:

(a) Graduated from an accredited college or university with a master’s degree in public or environmental health science that includes:

(i) 30 semester credits or 45 quarter credits of chemical, physical, biological, or environmental sciences acceptable to the Board, which includes at least one laboratory course in two of the following fields: biology, chemistry, [and] physics, geographic information systems, and soil science; and

(ii) (text unchanged)

(b) (text unchanged)

.04 Waivers.

A. The Board may waive any examination requirement under this chapter if:

(1) The Board considers the applicant to be recognized as outstanding in the field of environmental health as stated in COMAR 10.60.02.04G; or

(2) (text unchanged)

B. (text unchanged)

.05 Environmental Health Specialist-In-Training Program.

A. (text unchanged)

B. At a minimum, an environmental health specialist-in-training program shall:

(1) Provide the environmental health specialist-in-training with approved experience that is in accordance with [§D] §E of this regulation and which includes the following:

(a)—(c) (text unchanged)

(d) Reviewing and approving plans for compliance or process changes; and

(2) Provide the environmental health specialist-in-training with an opportunity for education and training in the:

(a) (text unchanged)

(b) Subject areas included in the recognized examination approved by the Board[; and

(3) Be approved by the Board].

C. The environmental health sponsor of [a Board-approved] an environmental health specialist-in-training program shall [ensure]:

(1) Ensure that the program complies with §B of this regulation;

(2) Provide in house training and opportunities for outside training events; and

(3) Define and track progress through the performance evaluation process.

D. As part of the implementation of the in-training program, the environmental health specialist-in-training shall:

(1) Review recommended resource materials;

(2) Attend recommended training events to improve breadth and depth of knowledge;

(3) Receive satisfactory or above performance evaluation ratings for the entire in-training program; and

(4) With the sponsor’s input, establish a timeline for when to take the examination.

[D.] E. (text unchanged)

 

10.60.02 Licensing Procedures

Authority: Health Occupations Article, §§21–205, 21–302, and 21–304, Annotated Code of Maryland

.03 Action on an Application.

A.—B. (text unchanged)

C. Denial of an Application.

(1) (text unchanged)

(2) If the Board denies an application, the Board shall:

(a) Notify the applicant by [certified] first-class mail and electronic means of the reasons for denial;

(b)—(c) (text unchanged)

D. (text unchanged)

.04 Examination.

A.—F. (text unchanged)

G. To be recognized as outstanding by the Board, an applicant shall:

(1)—(2) (text unchanged)

(3) Demonstrate at least one of the following career pathways with a minimum of 15 years of progressive responsibilities with:

(a)—(b) (text unchanged)

(c) A combination of §G(3)(a) or (b) of this regulation; and

(4) Has demonstrated and documented involvement in an area listed in §G(2) of this regulation, in at least one of the following activities:

(a)—(c) (text unchanged)

(d) Has teaching experience [in an area covered by the Board]; or

[(5)] (e) Where applicable, received a professional license through a Maryland or other recognized licensure body in the candidate’s field.

.05 Certificates.

A. (text unchanged)

B. Environmental Health Specialist-In-Training Certificates.

(1) The Board shall issue an environmental health specialist-in-training certificate to an applicant who has been employed to practice as an environmental health specialist under a certificate of eligibility for obtaining employment issued by the Board if the applicant:

(a) (text unchanged)

(b) Is participating in an environmental health specialist-in-training program [approved by the Board].

(2) The environmental health specialist-in-training certificate shall expire 36 months after its effective date unless the expiration date has been extended in writing by the Board in accordance with §B(4) or (6) of this regulation.

(3)—(4) (text unchanged)

(5) The Board may place the environmental health specialist-in-training certificate on inactive status due to reasons acceptable to the Board upon a written request from the holder of an environmental health specialist-in-training certificate.

(6) The Board may reactivate the environmental health specialist-in-training certificate within the original 36 month period with an expiration date that reflects the balance of remaining time for training:

(a) Upon a written request from an individual whose environmental health specialist-in-training certificate is inactive; and

(b) Along with a letter of support from a sponsor.

[(5)] (7)[(6)] (8) (text unchanged)

 

10.60.03 [Approved Training] Continuing Education

Authority: Health Occupations Article, §§21–205 and 21–309, Annotated Code of Maryland

.03 Pre-Approved Providers and Courses.

A. Pre-Approved Providers.

(1) Pre-approved providers shall offer continuing education programs that meet the objectives set forth in Regulations .01A and C of this chapter.

(2) The following are pre-approved providers:

(a) National, regional, or State accredited academic institutions offering academic courses programs recognized as acceptable environmental health specialist subject areas as defined by COMAR 10.60.01B(19);

(b) State regional, national, or international, environmental health specialist associations offering educational programs recognized as acceptable environmental health specialist subject areas as defined by COMAR 10.60.01B(19); and

(c) State, regional, national, or international non-environmental health speciliast associations offering educational programs recognized as acceptable environmental health specialist subject areas as defined by COMAR 10.60.01B(19).

B. The Board shall maintain a list of pre-approved providers and pre-approved continuing education courses on its website.

 

10.60.04 Rules of Procedure for Board Hearings

Authority: Health Occupations Article, §§21–205, 21-312, 21–313, and 21-401; State Government Article, §10-201―10-226; Annotated Code of Maryland

.09 Right of Appeal.

A. An individual whose certificate has been revoked or suspended by the Board, or an individual placed on probation or reprimand under the regulations in this chapter, may appeal the Board’s decision as provided by the law.

B. A licensee or certificte holder shall pay to the Board a penalty imposed under this chapte