Maryland Administrative Code

.05 Personnel. A. Operators of Magnetic Resonance Imager (MRI) Equipment. Operators of MRI equipment shall demonstrate competency to successfully and safely complete magnetic resonance procedures. B. Operators of Radiation-Producing Equipment. The licensee shall ensure that opera…

.06 Quality Assurance Program. A. A facility operating major medical equipment shall develop and implement: (1) A quality assurance program in compliance with the guidelines outlined in COMAR 10.05.01.08; and (2) Additional quality assurance requirements of this regulation. B. Sc…

.07 Operating Standards for Safety. A. A person may not operate major medical equipment unless the operator uses safety measures to protect the patient and the operator in accordance with the requirements of this chapter. B. The administrator shall ensure that all equipment: (1) …

.08 Medical Records. A. A facility operating major medical equipment shall comply with all requirements of COMAR 10.05.01.09 and the requirements of this regulation. B. A facility operating major medical equipment shall maintain a medical record for each patient on whom a test is…

.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…

.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 dial…

.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.

.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; and (2) Develop a written organizational plan. B. Administrator…

.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 …

.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) Pr…

.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.

.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 transplant…

.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…

.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 s…

.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 o…

.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 standa…

.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) …

.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 service…

.01 Definitions. A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Allied health professional” means an individual who is licensed, certified, or otherwise authorized under Health Occupations Article, Annotated Code of Maryland, to provid…

.02 License Requirements. A. A freestanding ambulatory surgical facility 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 licensur…

.03 Licensing Procedure. In addition to meeting all of the requirements of COMAR 10.05.01.03A—C, the applicant shall submit a nonrefundable fee of $1,000 for a 3 year period, with an application for initial licensure, or submit a nonrefundable fee of $1,000 with an application fo…

.04 Administration. The medical director shall develop protocols for the management of surgical patients and emergency situations. These protocols shall be available on site at all times for reference. The medical director shall review these protocols annually and make revisions …

.05 Personnel. A. Credentialing of Physicians, Dentists, Podiatrists. (1) As part of the formal written appointment process, the administrator, in consultation with the medical director, shall collect, review, and document the following information concerning a physician, dentist…

.06 Surgical Services. A. Surgical procedures shall be performed in a safe manner by qualified physicians, dentists, or podiatrists who have been granted clinical privileges by the administrator. B. The administrator, in consultation with the medical director, shall develop and i…

.07 Anesthesia Services. A. Anesthetics shall be administered by health practitioners who are licensed, certified, or otherwise authorized to do so under the Health Occupations Article, Annotated Code of Maryland. B. Anesthetics shall be administered only by a: (1) Qualified anes…

.08 Emergency Services. A. Basic Life Support. Licensed personnel employed by the freestanding ambulatory surgical facility shall have certification in basic life support. A licensed staff individual trained in basic life support shall be on duty whenever there is a patient in th…

.09 Hospitalization. A. The freestanding ambulatory surgical facility shall have an effective procedure for the transfer of patients to a hospital when care beyond the capabilities of the facility is required. B. Procedures for emergency transfer to a hospital shall include, at a…

.10 Pharmaceutical Services. A. The freestanding ambulatory surgical facility shall: (1) Provide drugs and biologicals under the direction of an authorized prescriber; and (2) Develop and implement policies and procedures for pharmacy services in accordance with accepted professi…

.11 Laboratory and Radiologic Services. A. The administrator shall develop and implement policies and procedures for obtaining routine and emergency laboratory and radiologic services to meet the needs of patients. Policies and procedures shall include: (1) Turn-around time; (2) …

.12 Medical Records. A. The facility shall comply with COMAR 10.05.01.09 and the requirements of this regulation. B. Each medical record shall include, at a minimum: (1) Preoperative diagnostic studies, entered before surgery, if performed; (2) Findings and techniques of the oper…

.13 Physical Environment. A. The administrator shall ensure that the facility has a safe, functional, and sanitary environment for the provision of surgical services. B. Each operating room shall be designed and equipped to ensure that surgical procedures conducted can be perform…

.01 Scope. A. This chapter does not apply to human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) surveillance, reporting, record maintenance, or confidentiality, which are covered by COMAR 10.18.02 and 10.18.03. B. This chapter applies to hum…

.01-1 Incorporation by Reference. In this chapter, the following documents are incorporated by reference: A. Control of Communicable Diseases Manual (American Public Health Association, Twentieth Edition, 2015); B. Compendium of Measures to Control Chlamydia psittaci Infection Am…

.02 Definitions. A. The definitions of terms used in the Control of Communicable Diseases Manual are accepted as official and applicable to the control of diseases within this State under this chapter. B. Terms Defined. (1) Body Fluid. (a) “Body fluid” means an excretion or fluid…

.03 Reportable Diseases, Conditions, Outbreaks, and Unusual Manifestations; Submitting Clinical Materials. A. A person, as set forth in Regulation .04 of this chapter, shall report the diseases or conditions listed in §C of this regulation, or any other condition as requested by …

.04 Reporting Procedures. A. Sources of Reports and to Whom to Report. (1) An institution, as specified in Health-General Article, §18-202, Annotated Code of Maryland, and a health care provider who knows of a case of a reportable disease, condition, outbreak, or unusual manifest…

.05 Record Maintenance and Confidentiality. A. The custodian of a report identifying an individual that was filed by a reporting source (Regulation .04A) in compliance with the provisions of Health-General Article, §§18-201, 18-202, and 18-205, Annotated Code of Maryland: (1) Sha…

.06 General Control Measures. A. Necessary Action. The Secretary or health officer shall: (1) Take any action or measure necessary to prevent the spread of communicable disease or to control a reportable disease and condition; and (2) Issue, when necessary, special instructions f…

.07 Minimum Control Measures for Specific Diseases or Conditions. A. The definitions of terms used in the text and the recommendations for control included in the Control of Communicable Diseases Manual are accepted as official and applicable to the control of disease within this…

.08 Amebiasis. A. Control of a Case. A case may not participate in an occupation involving patient care, care of young children or the elderly, and food handling until chemotherapy is completed and 24 hours after diarrhea has ceased. B. Control of Contacts. (1) A health officer s…

.08-1 Campylobacteriosis. A. Control of a Case. (1) For a case with diarrhea due to or presumed due to campylobacteriosis, a health officer shall restrict or exclude a case from: (a) Attending a child care facility; or (b) Participating in an occupation involving: (i) Food handli…

.08-2 Cholera (Vibrio cholera O1 or O139). A. Control of a Case. (1) For a case with diarrhea due to or presumed due to cholera, a health officer shall restrict or exclude a case from: (a) Attending a child care facility; or (b) Participating in an occupation involving; (i) Food …

.08-3 Escherichia coli O157:H7 and Other Shiga-Like Toxin Producing Escherichia coli (STEC). A. Control of a Case. (1) A case may not attend a child care facility until: (a) The case’s fecal cultures or stool Shiga-like toxin tests are free of E. coli O157:H7 and other Shiga-Like…

.09 Foodborne and Waterborne Diseases. A. Control of a Case or Contacts. If one of the following diseases is identified, a health officer shall follow the procedures detailed in this chapter for the specific disease: (1) Campylobacteriosis; (2) Cholera; (3) Escherichia coli O157:…

.10 Hepatitis, Viral Type A. A. Control of a Case. A case may not participate in an occupation involving food handling, patient care, or care of young children or the elderly for 1 week after onset of jaundice, or for 2 weeks after the onset of illness, if not jaundiced. B. Contr…

.11 Hepatitis, Viral Type B. A. Control of a Case. A physician in attendance upon a case having viral hepatitis type B shall educate that case on the: (1) Risks of sexual transmission, household contact transmission, maternal-infant transmission, and transmission by the sharing o…

.11-1 Hepatitis, Viral Type C. A. Control of a Case. A physician in attendance upon a case of viral hepatitis type C shall educate that case on: (1) The risks of transmission of viral hepatitis type C by: (a) Sharing hypodermic needles and other injecting drug paraphernalia; (b) …