This chapter applies to all freestanding ambulatory care facilities. An applicant or licensee shall also comply with the regulations of one of the following chapters as appropriate: COMAR 10.05.02; COMAR 10.05.03; COMAR 10.05.04; or COMAR 10.05.05. In this subtitle, the following terms have the meanings indicated. Terms Defined. “Department” means the Maryland Department of Health. “Facility” means a freestanding ambulatory care facility as defined in §B(4) of this regulation. “FDA” means the Food and Drug Administration of the U.S. Department of Health and Human Services. “Freestanding ambulatory care facility” means a: Freestanding surgical facility; Freestanding endoscopy facility; Freestanding facility utilizing major medical equipment; Freestanding birthing center; or Freestanding kidney dialysis center. “Health care practitioner” means a person who is licensed, certified, or otherwise authorized under the Health Occupations Article, Annotated Code of Maryland, to provide health care services in the ordinary course of business or practice of a profession. “License” means a document issued by the Secretary to a person to operate a freestanding ambulatory care facility. “Physician” means an individual licensed to practice medicine in this State under Health Occupations Article, Title 14, Annotated Code of Maryland. “Secretary” means the Secretary of Health or the Secretary's designee. "Unexpected adverse outcomes” means unanticipated negative outcomes, related to a patient's medical treatment and not related to the natural course of the patient’s illness or underlying disease condition. A person may not establish or operate a freestanding ambulatory care facility without obtaining a license from the Secretary. License Period. A license is valid for 3 years from the date of issuance, unless suspended or revoked by the Secretary. A license issued under this chapter is not transferable. A person desiring to operate a facility shall: Be in compliance with all applicable federal, State, and local laws and regulations; File an application on a written or electronic form provided by the Department; Submit documentation that the Maryland Health Resources Planning Commission has determined that the facility either received a certificate of need or is exempt from certificate of need requirements; and Submit a written description of its quality assurance program as required by Regulation .08 of this chapter. An officer of a corporation or association shall apply for a license on behalf of the entity. The owner shall apply on behalf of a sole proprietorship. An applicant shall submit the names of the entity's board members, owners, and investors having at least 2 percent ownership. An authorized individual of a government unit or agency shall apply for a license on behalf of the government unit or agency. For an existing Medicare-certified facility, the Department shall issue a license within 90 days of receiving: A license application; The license fee; and Evidence of compliance with applicable regulations. Based on information provided to the Department by the applicant and the Department's own investigation, the Secretary shall: Approve the application unconditionally if the applicant complies with all requirements of this chapter; Approve the application conditionally; or Deny the application if the applicant: Has been convicted of: A felony that relates to Medicaid or Medicare, or A crime involving moral turpitude; or Does not comply with the requirements of this chapter. Denial of License for Prior Revocation or Consent to Surrender License. The Secretary may deny a license to: A corporate applicant if the corporate entity has an owner, director, or officer: Whose conduct caused the revocation of a prior license, or Who held the same or similar position in another corporate entity which had its license revoked; An individual applicant: Whose conduct caused the revocation of a prior license, or Who held a position as owner, director, or officer in a corporate entity which had its license revoked; or An individual or corporate applicant that has consented to surrender a license as a result of a license revocation action. The Secretary shall also consider the factors identified in Regulation .15D of this chapter when deciding whether to deny a license. A person aggrieved by a decision of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .16 of this chapter. Renewal of License. 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. The Secretary shall renew the license for an additional 3-year period for a licensee that meets the requirements of this chapter. Open for Inspection. A licensed facility or an entity proposing to operate such a facility shall be open during normal business hours, or any other times that the facility is serving patients, for inspection by the Department and by any other agency designated by the Department to: Survey freestanding ambulatory care facilities as directed by the Centers for Medicare and Medicaid Services; Verify compliance with licensing regulations; or Investigate complaints. Noncompliance. If the Secretary determines that a licensee fails to meet any provision of this chapter, the Secretary shall: Advise the licensee of the exact nature of the violation; and Require that the facility specify what corrective action it is taking and monitor the facility to ensure that it takes corrective action. This section does not preclude the Secretary from imposing any of the sanctions set forth in this chapter. Records and Reports. The facility shall make its records and reports available to the Department or its designee for inspection. On the written request of the Department, the facility shall immediately provide photocopies of records and reports, including clinical records of patients. The licensee is responsible for the overall conduct of the facility and for compliance with applicable laws and regulations. Governing Body. The governing body shall identify the administrator who has been given the authority and responsibility for overall policy and fiscal management of the facility. The governing body shall develop a written organizational plan. Administrator. The administrator is responsible for the daily operation of the facility, including but not limited to: Implementing the facility's policies and coordinating the provision of services that the facility provides; Organizing and coordinating the administrative functions of the facility; Establishing procedures for the accountability of those personnel involved in patient care; Familiarizing the staff with the facility's policies and procedures, and with applicable federal, State, and local laws and regulations; Participating in the development, negotiation, and implementation of agreements or contracts into which the facility enters; and Participating in the development of organizational and fiscal planning for the facility. Policies and Procedures. The administrator, in consultation with the medical director, shall develop and implement policies and procedures governing the operation of the facility which include at a minimum: A description of the scope and delivery of services provided by the facility either directly or through contractual arrangements; A description of the provision of complete and partial charity care for indigent and Medicaid patients to promote access to all services regardless of an individual's ability to pay; Personnel practices; Discharge protocols and aftercare plans; Postoperative recovery, if applicable; The transfer or referral of patients who require services that are not provided by the facility; The transportation of a patient to the nearest appropriate hospital in the event of an emergency situation; Infection control for patients and staff; Pertinent safety practices, including the control of fire and mechanical hazards; and Preventive maintenance for equipment to ensure proper operation and safety. The administrator shall ensure that all: Policies and procedures are reviewed by staff at least annually and are revised as necessary; Policies and procedures are available at all times for staff inspection and use; and Appropriate personnel implement all policies and procedures as adopted. The administrator shall ensure that all personnel: Receive orientation and have experience sufficient to demonstrate competency to perform assigned patient care duties; Are licensed or certified by an appropriate occupational licensing board to practice in this State, if required by law; and Perform or delegate duties and responsibilities in accordance with standards of practice as defined by the Health Occupations Article, Annotated Code of Maryland. The administrator shall have a sufficient number of qualified professional staff on duty at all times to ensure safe operation and maintenance of the facility. The facility shall have job descriptions on file for all personnel. The administrator shall ensure that all personnel are free from active reportable airborne communicable disease as evidenced by a physician's or other qualified health care practitioner's statement. The administrator shall ensure that the facility develops and maintains a quality assurance program which includes: Monitoring and evaluation of the quality of patient care; Identification, evaluation, and resolution of care problems; and A peer review process. The facility shall conduct ongoing quality assurance activities and document the activities on a continuous basis, but not less than quarterly. Peer Review. The administrator shall ensure that the facility establishes a peer review process that includes: A mechanism to evaluate the clinical performance of each health care practitioner on a continuous basis, but not less than annually; Procedures, approved by a qualified health care practitioner to identify and minimize risks to the patient; and Documentation of each health care practitioner's annual evaluation. Practitioner Performance Evaluation in a Facility. The administrator shall ensure that the facility establishes a practitioner performance evaluation process that includes a review of care which shall: Be undertaken for cases chosen at random and for cases with unexpected adverse outcomes; Be based on objective review standards; Include a review of the appropriateness of the plan of care for the patient, particularly any medical procedures performed on the patient, in relation to the patient’s condition; and Be conducted by at least two members of the medical staff who: As appropriate, are of the same specialty as the member of the medical staff under review; and Have been trained in the freestanding ambulatory care facility’s policies and procedures regarding practitioner performance evaluation. A review of the care provided by a member of the medical staff who is a solo practitioner shall be conducted by an external reviewer. A freestanding ambulatory care facility shall take into account the results of the practitioner performance evaluation process for a member of the medical staff in the reappointment process. Equipment Quality Control. The administrator shall ensure that the facility develops a quality control procedure to monitor the safety and performance of all biomedical equipment. In developing its procedures, the administrator shall consider: FDA recommendations; and The equipment manufacturer's recommendations. Documentation. At the time of application, the applicant shall submit a written description of the facility's quality assurance program which includes, at a minimum: A description of how the facility will comply with §A of this regulation; and The manner in which information will be collected. The facility shall submit any revisions to its quality assurance program at the time of licensure renewal. Quality Assurance Records. The facility shall document the following information for all quality assurance activities: A description of identified problems; Findings; Conclusions; Recommendations; Actions taken; Results; and Follow-up. The facility shall maintain a complete, comprehensive, and accurate medical record for each patient. Each patient's medical record shall include at least the following: Patient identifier; Significant medical history and results of a physical examination; Documentation of care or services provided; Evidence of consent; and Discharge diagnosis. The facility shall: Send a copy of the medical record with the patient on referral to another health care provider or on transfer to a hospital; Use the medical record, if appropriate, in instructing the patient and the family; and Comply with all disclosure requirements as set forth in Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland. The administrator shall ensure that the facility develops and implements written policies and procedures concerning patients' rights and responsibilities. The facility shall make the policies and procedures available to patients, guardians, or other health care decision makers, as defined by Health-General Article, Title 5, Subtitle 6, Annotated Code of Maryland, and the public. The policies and procedures shall ensure that: The facility informs patients of services that are available and the charges for services not covered by third-party payors; A physician, dentist, podiatrist, or other qualified health care practitioner informs patients of their medical conditions unless medically contraindicated as documented in their medical records; All patients are afforded an opportunity to participate in planning their medical treatments and to refuse to participate in experimental research; and All patients are ensured confidential treatment of their medical records, and may approve or refuse release of records to any individual outside the facility, except as provided by federal or State law. The facility shall meet all federal, State, and local laws, ordinances, and regulations for construction. The facility shall meet all safety requirements of the National Fire Protection Association, NFPA 101 “Life Safety Code”, which is incorporated by reference at COMAR 29.06.01.06. The facility shall meet the requirements for handling, treatment, and disposal of special medical wastes as provided in COMAR 10.06.06. The Secretary may inspect a facility to investigate and resolve any complaint concerning patient care and safety. If the complaint concerns the performance of a health care practitioner or standards of practice, the Department shall refer the complaint to the board that licenses, certifies, or otherwise authorizes the health care practitioner to provide services under the Health Occupations Article, Annotated Code of Maryland. The Secretary may immediately suspend a license on a finding that the public health, safety, or welfare requires emergency action. The Department shall deliver a written notice to the licensee informing the licensee of the emergency suspension, giving the reasons for the action and the regulation or regulations with which the licensee has failed to comply that forms the basis for the emergency suspension, and notifying the licensee of the licensee's right to request a hearing and to be represented by counsel. The filing of a hearing request does not stay the emergency action. When a license is immediately suspended, the licensee shall: Immediately return the license to the Department; and Stop providing services immediately. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .16 of this chapter. The Office on Administrative Hearings shall conduct a hearing as set forth in Regulation .16 of this chapter and issue a proposed decision within 10 business days of the close of the hearing record. Exceptions may be filed by an aggrieved person pursuant to COMAR 10.01.03. The Secretary shall make a final decision pursuant to COMAR 10.01.03. If the Secretary's final decision does not uphold the emergency suspension, the licensee may resume operation. Revocation of License. The Secretary, for cause shown, shall notify the licensee of the Secretary's decision to revoke the facility's license. The revocation shall be stayed if a hearing is requested. The Secretary may revoke a license if the licensee: Has been convicted of: A felony that relates to Medicaid or Medicare, or A crime involving moral turpitude; or Does not comply with the requirements of this chapter. The Secretary shall also consider the factors identified in Regulation .15D of this chapter when deciding whether to revoke a license. The Secretary shall notify the licensee in writing of the following: The effective date of the revocation; The reason for the revocation; The regulations with which the licensee has failed to comply that form the basis for the revocation; That the licensee is entitled to a hearing if requested, and to be represented by counsel; That the facility shall stop providing services on the effective date of the revocation if the licensee does not request a hearing; That the revocation shall be stayed if a hearing is requested; and That the licensee is required to surrender the license to the Department if the revocation is upheld. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .16 of this chapter. Criminal Penalty. A person who violates any provision of this chapter is guilty of a misdemeanor and on conviction is subject to a penalty not exceeding $1,000, or imprisonment not exceeding 1 year, or both. Each day that a violation is continued after the first conviction is a separate offense. Administrative Penalty. The Secretary may impose an administrative penalty of up to $1,000 for a violation of any provision of this chapter. When considering whether to impose an administrative penalty and the amount of the penalty, the Secretary shall consider the following factors: The number, nature, and seriousness of the violations; The extent to which the violation or violations are part of an ongoing pattern during the preceding 24 months; The degree of risk, caused by the violation or violations, to the health, life, or safety of the patients of the facility; The efforts made by, and the ability of, the licensee to correct the violation or violations in a timely manner; and Such other factors as justice may require. A person aggrieved by the action of the Secretary under §C of this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .16 of this chapter. A request for a hearing shall be filed with the Office of Administrative Hearings, with a copy to the Licensing and Certification Administration of the Department, not later than 30 days after receipt of notice of the Secretary's action. The request shall include a copy of the Secretary's action. A hearing requested under this chapter shall be conducted in accordance with State Government Article, §10-201 et seq., Annotated Code of Maryland, and COMAR 28.02.01 and 10.01.03. The burden of proof is as set forth in COMAR 10.01.03.28. Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in COMAR 28.02.01. The aggrieved person may file exceptions as set forth in COMAR 10.01.03.35. The Secretary shall issue a final decision in accordance with COMAR 10.01.03.35. Health-General Article, §19-3B-01 et seq., Annotated Code of Maryland Effective date: August 23, 1999 (26:17 Md. R. 1322) Regulation .02B amended effective April 16, 2012 (39:7 Md. R. 491) Regulation .04A, I amended effective March 13, 2017 (44:5 Md. R. 292) Regulation .05A amended effective March 14, 2016 (43:5 Md. R. 385) Regulation .08 amended effective April 16, 2012 (39:7 Md. R. 491) Regulation .08C amended effective February 27, 2017 (44:4 Md. R. 252)