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10.05.04.00.htm 10.05.04.00. Title 10 MARYLAND DEPARTMENT OF HEALTH Subtitle 05 FREESTANDING AMBULATORY CARE FACILITIES Chapter 04 Freestanding Kidney Dialysis Centers Authority: Health-General Article, §19-3B-01 et seq. Annotated Code of Maryland
10.05.04.01.htm 10.05.04.01. 01 Definitions.. A. In this chapter, the following terms have the meanings indicated.. B. Terms Defined.. 1) "Center administrator" means an individual appointed by the governing body who is responsible for the center's daily operation and the duties set forth in Regulation .04 of this chapter.2) "Certified nursing assistant―dialysis technician (CNA-DT) means an individual certified by the Maryland Board of Nursing as a certified nursing assistant―dialysis technician (CNA-DT)
10.05.04.02.htm 10.05.04.02. 02 License Requirements.. A. A kidney dialysis center shall meet all general licensing requirements for a facility as provided in COMAR 10.05.01 and all requirements of this chapter.B. An applicant shall obtain Medicare certification as a condition of licensure for a kidney dialysis center.
10.05.04.03.htm 10.05.04.03. 03 Licensing Procedure.. A kidney dialysis center shall submit a nonrefundable fee of $700 with an application for initial licensure or $700 with an application for license renewal.
10.05.04.04.htm 10.05.04.04. 04 Administration.. A. Governing Body. The governing body shall:. 1) Identify the center administrator who has been given the authority and responsibility for the overall policy and fiscal management of the facility; and2) Develop a written organizational plan.. B. Administrator.. 1) Qualifications.. a) The kidney dialysis center administrator, if not the chief executive officer, shall at a minimum:. i) Be 21 years old or older;. ii) Possess a high school diploma or a high school
10.05.04.05.htm 10.05.04.05. 05 Quality Assurance Program.. A. The Administrator shall ensure that the kidney dialysis center has a quality assurance program as required under COMAR 10.05.01.08.B. The quality assurance team shall document information regarding the quality assurance activities in accordance with COMAR 10.05.01.08F and provide a report to the administrator.C. The administrator shall:. 1) Review the report specified in §B of this regulation;. 2) Implement any necessary corrective actions; and.
10.05.04.06.htm 10.05.04.06. 06 Personnel.. A. Medical Director.. 1) The medical director shall:. a) Be a nephrologist or other physician with at least 12 months experience in the treatment of patients requiring chronic hemodialysis;b) Be responsible for the development of patient care policies; and. c) Provide medical guidance in the provision of patient care.. 2) If the medical director is not available to provide medical guidance, the administrator shall ensure the availability of an alternate physician wit
10.05.04.07.htm 10.05.04.07. 07 Affiliations.. In addition to the requirements in 42 CFR §405.2136(e) as amended, which is incorporated by reference, for affiliations, the facility shall provide, make referrals, or have access to a certified home dialysis training program.
10.05.04.08.htm 10.05.04.08. 08 Patient Long-Term Program.. A. The facility’s interdisciplinary team shall develop and maintain an individualized interdisciplinary comprehensive assessment for each patient to ensure that each patient receives the appropriate treatment modality, whether dialysis or transplantation.B. Patient Comprehensive Assessment. The patient’s comprehensive assessment shall be developed by a multidisciplinary team.C. The health care team described in §B of this regulation shall review, do
10.05.04.09.htm 10.05.04.09. 09 Patient Care Plan.. A. Patient Care Plan. A health care team, consisting of at least the physician, nurse practitioner, or physician assistant responsible for the patient's end-stage renal disease care, a nurse responsible for nursing services, a social worker, and a dietitian, shall develop an individualized care plan for each patient.B. The patient or health care decision maker shall be involved in developing the care plan..
10.05.04.10.htm 10.05.04.10. 10 Dialyzer Reuse.. A. Patient Information.. 1) The kidney dialysis center shall:. a) Provide information to the patient or, if appropriate, the patient's health care decision maker concerning the center's reuse of dialysis supplies, including hemodialyzers and tubing and their suitability for home dialysis; andb) Obtain the patient's or, if appropriate, the patient's health care decision maker's informed consent regarding the reuse of dialysis supplies.
10.05.04.11.htm 10.05.04.11. 11 Physical Plant.. A. Floor Space.. 1) The kidney dialysis center shall have usable floor space of at least 80 square feet per patient station.2) Floor space may include bed or chair space, nursing space, and work area, but excludes storage space.3) At least 20 square feet of the patient station floor space shall be available on the side of the patient to be occupied by the dialysis assembly.4) Arrangement of space shall be sufficiently flexible to provide access to
10.05.04.12.htm 10.05.04.12. 12 Water Standards.. A. The kidney dialysis center shall:. 1) Comply with 42 CFR §405.2140(a)5) as amended, which is incorporated by reference; and. 2) Assure that the quality of water provided by a municipal water supply meets the federal Environmental Protection Agency standards for dissolved solutes.B. Water Treatment System Safeguards.. 1) The kidney dialysis center shall use a water treatment system that offers satisfactory safeguards to patients, including:
10.05.04.13.htm 10.05.04.13. 13 In-Center Nocturnal Hemodialysis.. Before performing in-center nocturnal hemodialysis, the facility’s interdisciplinary team shall:. A. Determine the patient’s appropriateness for in-center nocturnal hemodialysis by considering the patient’s:1) Overall medical condition;. 2) Expectations for care;. 3) Response to in-center day-time hemodialysis; and. 4) Availability of transportation;. B. Document the patient’s appropriateness for in-center nocturnal hemodialy
10.05.04.14.htm 10.05.04.14. 14 Emergency Management.. A. A kidney dialysis center shall have an emergency plan.. B. An emergency plan shall include policies and procedures that will be followed before, during, and after an emergency to address:1) The safe management of individuals who are receiving services at the kidney dialysis center when an emergency occurs;2) Notification of patients, families, staff, and licensing authorities regarding actions that will be taken concerning the provision of dialysis serv
10.05.04.9999.htm 10.05.04.9999. Administrative History Effective date: February 7, 2000 (27:2 Md. R. 144) ―. Chapter revised effective November 17, 2008 (35:23 Md. R. 2013). Regulation .01B amended effective February 18, 2013 (40:3 Md. R. 217). Regulation .06C amended effective February 18, 2013 (40:3 Md. R. 217). Regulation .08 amended effective February 18, 2013 (40:3 Md. R. 217). Regulation .09A, C amended effective February 18, 2013 (40:3 Md. R. 217).
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