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10.07.01.00.htm 10.07.01.00. Title 10 DEPARTMENT OF HEALTH AND MENTAL HYGIENE Subtitle 07 HOSPITALS Chapter 01 Acute General Hospitals and Special Hospitals Authority: Health-General Article, §19-307.2, 19-308, 19-308.6, 19-308.8, 19-318―19-320, 19-323, and 19-349.1; Insurance Article, Title 4, Subtitle 4; Public Safety Article, §14-110.1; Annotated Code of Maryland
10.07.01.01.htm 10.07.01.01. 01 Definitions.. A. In this chapter, the following terms have the meanings indicated.. B. Terms Defined.. 1) "Accredited hospital" means a hospital accredited by The Joint Commission or other accreditation organization approved by the Department.2) "Accredited special rehabilitation hospital" means a hospital that is accredited by the Commission on Accreditation of Rehabilitation Facilities for providing comprehensive physical rehabilitation services.2-1) "Accreditation organ
10.07.01.02.htm 10.07.01.02. 02 Incorporation by Reference.. The Guidelines for the Design and Construction of Hospitals and Outpatient Facilities, The Facilities Guidelines Institute (2014 Edition) is incorporated by reference, with the following exceptions:A. 2.3 Specific Requirements for Freestanding Emergency Department, pp. 211―213;. B. 3.3 Specific Requirements for Freestanding Outpatient Diagnostic and Treatment Facilities, pp. 295―296;
10.07.01.03.htm 10.07.01.03. 03 Hospital Classification.. A. General Hospital. A hospital shall be classified as a general hospital if the hospital at least has the facilities and provides the services that are necessary for the general medical and surgical care of patients.B. Special Hospital. A hospital shall be classified as a special hospital if the hospital:. 1) Defines a program of specialized services, such as obstetrics, mental health, tuberculosis, orthopedy, chronic disease, or communicable disease;
10.07.01.04.htm 10.07.01.04. 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. Applications on behalf of a corporation, association, or governmental unit or agency shall be mad
10.07.01.05.htm 10.07.01.05. 05 Duration of License.. A. The Secretary shall issue a license to an accredited hospital or special rehabilitation hospital for the term of the facility's accreditation.B. The Secretary shall issue a license to a nonaccredited hospital for a term not to exceed 1 year..
10.07.01.06.htm 10.07.01.06. 06 Separate License Required.. A. Separate licenses are required for institutions maintained on separate premises, even though both institutions are operated under the same management.B. Separate licenses are not required for separate buildings on the same grounds..
10.07.01.06-1.htm 10.07.01.06-1. 06-1 Licensed Bed Capacity.. A. On or before July 1, 2000, and each July 1 thereafter, the Secretary shall determine the authorized licensed bed capacity for each hospital classified as a general hospital.B. Methodology for Calculating Total Authorized Licensed Bed Capacity.. 1) The average daily census for each general hospital shall be obtained from the most current Health Services Cost Review Commission inpatient utilization data for a 12-month period.2) The calculation of ave
10.07.01.07.htm 10.07.01.07. 07 Inspections.. A. New Hospitals. A hospital that began initial operation on or after July 1, 1982, shall be inspected for compliance with the safety and sanitation components of the regulations promulgated by the Department until the hospital receives accreditation by an accreditation organization approved by the Department. If the hospital has not applied for accreditation by an accreditation organization approved by the Department within 1 year after beginnin
10.07.01.08.htm 10.07.01.08. 08 Complaint Investigations.. A. Notwithstanding any other provisions of this subtitle, each hospital and residential treatment center shall be open to inspections by the Department to investigate and resolve any complaint concerning patient care, safety, medical and nursing supervision, physical environment, sanitation, or dietary matters.B. Complaints.. 1) To resolve expeditiously a complaint that alleges the existence of any non-life-threatening deficiency, the Department sha
10.07.01.09.htm 10.07.01.09. 09 Service Standards ― Nonaccredited Hospitals.. A. Acute General Hospitals and Special Hospitals.The 2013 Hospital Accreditation Standards (July Update, The Joint Commission, One Renaissance Blvd. Oakbrook, Illinois 60181) is incorporated by reference.B. Waiver Authority. The Secretary may, for good cause, waive compliance with the incorporated Joint Commission standards. The hospital shall justify the need for the waiver in the manner prescribed by the Department.
10.07.01.10.htm 10.07.01.10. 10 Service Standards ― Special Rehabilitation Hospitals.. A. Before a special rehabilitation hospital can provide or hold itself out as providing comprehensive physical rehabilitation services, the special rehabilitation hospital shall:1) Except as otherwise provided in this regulation, be accredited by the Commission on Accreditation of Rehabilitation Facilities; and2) Meet the standards of the Commission on Accreditation of Rehabilitation Facilities as set forth i
10.07.01.11.htm 10.07.01.11. 11 Special Rehabilitation Programs ― Hospitals.. A. Except as otherwise provided in this regulation, before a hospital can provide or hold itself out as providing any specialized rehabilitation program, the hospital shall be accredited by the Commission on Accreditation of Rehabilitation Facilities to provide the program.B. The requirement that a hospital be accredited by the Commission on Accreditation of Rehabilitation Facilities before the hospital can provide any s
10.07.01.12.htm 10.07.01.12. 12 Records and Reports ― Inspection.. Licensees shall keep such records and make reports in the manner and form as the Secretary shall prescribe by regulation, and all these records shall be open to inspection by the Secretary.
10.07.01.13.htm 10.07.01.13. 13 Utilization Review Plan.. A. Before October 1, 1985, each hospital shall submit a proposed utilization review plan to the Secretary.B. Effective October 1, 1985, each hospital shall have in effect a utilization review plan approved by the Secretary pursuant to this chapter.C. The purpose of the hospital's utilization review program, as defined by the plan, shall be to determine for patients included in the hospital's review responsibilities the:
10.07.01.14.htm 10.07.01.14. 14 Utilization Review Agent.. A. Each hospital shall appoint a utilization review agent to carry out the requirements of the utilization review plan. When the agent is composed of hospital related personnel the hospital's plan shall expressly designate the positions and the organizational structure within the hospital that constitute the utilization review agent for that institution.B. Each utilization review plan shall set forth the manner in which the agent:.
10.07.01.15.htm 10.07.01.15. 15 Performance Standards for Utilization Review.. The hospital's program shall apply to all patients with the exceptions of those noted in Regulation .17, below. Except when noted for certain types of review, the program may delineate certain types and kinds of cases to be reviewed, so as to most efficiently carry out the purposes of these regulations. As a minimum, the hospital utilization review program shall satisfy the following performance standards:A. Pre-admission Review..
10.07.01.16.htm 10.07.01.16. 16 Protection of Patients ― Patient Liability.. A. Charges for any days disallowed as a result of retrospective review by the agent or by a payer conducting utilization review under these regulations shall be deducted from the gross charges in the bill to the patient as a contractual allowance unless the patient refuses or has refused to leave the hospital when it is medically appropriate to do so, and the disallowed days occur:
10.07.01.17.htm 10.07.01.17. 17 Exemptions from Hospital Utilization Review.. A. A hospital shall be exempt from carrying out utilization review procedures for a given patient if the:1) Person, corporate entity, or insurance plan paying for the patient's hospitalization has a utilization review program that is determined by the Insurance Commissioner and the Secretary to substantially meet the minimum standards described in these regulations, including the reporting requirements detailed in Regulation .
10.07.01.18.htm 10.07.01.18. 18 Record Maintenance by Utilization Review Agents.. A. The plan shall describe how, in addition to maintaining documents which describe its utilization review procedures, the agent shall maintain the following records for each individual patient for whom any aspect of the utilization review procedure has been applied:1) The patient's name, hospital history number, source of payment, and other demographic information capable of identifying the patient.2) The principal diagnosi
10.07.01.19.htm 10.07.01.19. 19 Reports to the Secretary.. A. Each hospital shall report annually to the Secretary the following summary statistics on the activity of its utilization review program:1) The number of discharges and total patient days reviewed under the program;. 2) For each of the procedures requiring pre-authorization for inpatient treatment, the number of patients:a) Reviewed; and. b) Approved for inpatient treatment;.
10.07.01.20.htm 10.07.01.20. 20 Penalties.. If a hospital fails to submit a utilization review plan or fails, after adequate discussion with the Department, to develop an approvable plan, or fails to operate a plan which has been approved, then the Secretary may impose upon the hospital the following penalties:A. Delicensure of the hospital; or. B. A fine of $500 for each day that the hospital is in violation of these regulations..
10.07.01.21.htm 10.07.01.21. 21 Procedures for Which Preauthorization is Required ― Repealed..
10.07.01.22.htm 10.07.01.22. 22 Practitioner Performance Evaluation.. A. Consistent with the standards of the Joint Commission for focused and ongoing professional performance evaluations, the hospital shall establish a practitioner performance evaluation process that objectively evaluates the performance of each member of the medical staff.B. The hospital’s practitioner performance evaluation process shall include a review of care which shall:1) Be undertaken for cases:. a) Chosen at random; and.
10.07.01.23.htm 10.07.01.23. 23 Guidelines Governing the Transfer of Patients Between Hospitals.. A. If a hospital is able to provide adequate care to a patient, the hospital may not transfer the patient to another hospital unless:1) One or more of the following circumstances is present:. a) The patient does not have a physician with privileges at the hospital and the patient refuses treatment by any physician with privileges at the hospital;
10.07.01.24.htm 10.07.01.24. 24 Physician Credentialing Process.. A. General. In accordance with this regulation, a hospital shall have in effect a credentialing process.B. Scope of Credentialing Process. The credentialing process shall apply to any physician who shall admit or treat patients in the hospital.C. Specific Standard ― Appointment and Employment Process.. 1) In accordance with this section, a hospital shall establish a formal written process for the appointment or employment of
10.07.01.25.htm 10.07.01.25. 25 Medical Professional Liability Closed Claim Form.. A. A hospital shall complete and submit to the Department the approved Medical Professional Liability Closed Claim form, DHMH form #4668, for each medical liability claim filed regarding the care or services received by a patient under the care of that hospital.B. Regardless of the result of a closed claim, the hospital shall submit the Medical Professional Liability Closed Claim form to the Department within
10.07.01.26.htm 10.07.01.26. 26 Anatomical Donations.. A. This regulation does not:. 1) Limit the right of an individual to make a gift under the Anatomical Gift Act, Estates and Trusts Article, Title 4, Subtitle 5, Annotated Code of Maryland; or2) Interfere with the duties of the office of the Chief Medical Examiner.. B. A hospital shall develop and follow a protocol in accordance with this regulation for the procurement of organs and tissues.C. Requests for Donation on Death of Patient..
10.07.01.27.htm 10.07.01.27. 27 Discharge Planning Requirements.. A. Discharge Options. A hospital may discharge a patient:. 1) Entirely;. 2) To another level of care, treatment, or services;. 3) To different health care professionals; or. 4) To settings for continued services.. B. A hospital's process for transfer or discharge shall be based on a patient's assessed needs at the time of discharge.C. To facilitate discharge or transfer, the hospital shall:. 1) Assess the patient's needs beginning at an earl
10.07.01.28.htm 10.07.01.28. 28 Emergency and Disaster Plan.. A. A licensed acute general hospital or special hospital shall comply with the Emergency Management standards outlined in the Hospital Accreditation Standards (2009 Edition) pages 47―68 with the exception of standard EM.02.02.13, pages 61―65.B. A licensee shall prepare an executive summary of the hospital's evacuation procedures to provide to a patient, family member, or legal representative upon request. The summary shall:1) Describe the hospital'
10.07.01.29.htm 10.07.01.29. 29 Notice to Patients of Outpatient on Observation Status.. A. A hospital shall provide both an oral and written notice to a patient of:. 1) The patient’s outpatient on observation status;. 2) The billing implications of the outpatient on observation status; and. 3) The impact of the outpatient on observation status on the patient’s eligibility for Medicare rehabilitation services if:a) The patient received on-site services from the hospital for more than 23 consecutive hours;.
10.07.01.30.htm 10.07.01.30. 30 Physical Environment.. A. The facility shall be in compliance with:. 1) Guidelines for the Design and Construction of Hospitals and Outpatient Facilities (2014) and. 2) All applicable State and local governing laws, regulations, standards, ordinances, and codes for fire safety, building, and zoning requirements.B. Any waiver or other modification of these requirements shall be addressed by the appropriate State or local authority having jurisdiction in accord
10.07.01.31.htm 10.07.01.31. 31 Hospital Palliative Care Programs.. A. Acute general hospitals and special hospitals-chronic care with 50 or more beds shall establish an active hospitalwide palliative care program that provides consultation services to patients suffering from pain and symptoms due to serious illnesses or conditions.B. The hospital shall:. 1) Promote the palliative care program;. 2) Provide information and referrals to patients and families when appropriate regarding the availab
10.07.01.32.htm 10.07.01.32. 32 Penalties ― General.. A. The Secretary shall deny a license to a person who has been convicted of a felony that relates to Medicaid or to a nursing home.B. The Secretary shall revoke the license of any licensee convicted of a felony that relates to Medicaid or to a nursing home.C. The Secretary may deny or revoke a license if the hospital does not meet the requirements of:. 1) Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland;. 2) Any regulation adopted
10.07.01.32-1.htm 10.07.01.32-1. 32-1 Civil Money Penalties ― Imposition.. A. The Department may impose a civil money penalty not to exceed $10,000 for each failure of a hospital to comply with the requirements of Regulation .27 of this chapter.B. In determining whether to impose a civil money penalty, the Department may consider the following factors:1) The number of failures to comply;. 2) The nature and seriousness of the failure to comply;. 3) The degree of risk to the health, life, or safe
10.07.01.32-2.htm 10.07.01.32-2. 32-2 Civil Money Penalties ― Payment of Penalty.. A. If a hospital owes a civil money penalty to the Department, the hospital shall adhere to the procedures of this regulation.B. A civil money penalty payment is due to the Department 15 calendar days after:. 1) The time period for requesting a hearing has expired if a request for hearing is not received; or. 2) Receipt of a written request from the hospital to waive its right to a hearing and reduce the amo
10.07.01.32-3.htm 10.07.01.32-3. 32-3 Civil Money Penalties ― Hearings.. A. A hospital aggrieved by the imposition of a civil money penalty may appeal the action by filing a request for a hearing in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.B. The Secretary has the burden of proof with respect to the imposition of civil money penalties..
10.07.01.33.htm 10.07.01.33. 33 Uniform Emergency Codes.. A. Each hospital shall adopt and implement the following set of uniform codes for the identified emergency situations as part of its emergency or disaster plans:1) Fire ― Code Red;. 2) Infant or Child Abduction ― Code Pink;. 3) Cardiac Respiratory Arrest ― Code Blue ― Adult;. 4) Cardiac Respiratory Arrest ― Code Blue ― Child;. 5) Cardiac Respiratory Arrest ― Code Blue ― Infant;. 6) Combative Person ― Code Green;. 7) Bomb Threat ― Code Gold;.
10.07.01.34.htm 10.07.01.34. 34 Infection Prevention and Control Program.. A. The hospital shall have an active hospital-wide program for the prevention, control, and investigation of communicable diseases and infections.B. Staffing.. 1) The hospital shall designate qualified staff with training in infection prevention and control to be responsible for the implementation of the infection prevention and control program.2) Additional clinical and support staff shall be provided for the infectio
10.07.01.9999.htm 10.07.01.9999. Administrative History Effective date: December 19, 1946. Amended effective March 20, 1959. Amended effective September 1, 1964. Regulations .03C, G, I, K; .04B, D; .05A, B; .06C; .07B, E; .08A, B; .09B, C; .10F; .11A, B; .12F amended effective February 24, 1978 (5:4 Md. R. 226) ―Regulations .01―13 repealed and new Regulations .01―10 adopted effective August 1, 1983 (10:15 Md. R. 1350)Regulation .01 amended as an emergency provision effective August 12, 1985
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