In this chapter, the following terms have the meanings indicated. Terms Defined. “Department” means the Maryland Department of Health. “Facility” means a surgical abortion facility. Health Professional. “Health professional” means an individual who is licensed, certified, or otherwise authorized under Health Occupations Article, Annotated Code of Maryland, to provide health care services. “Health professional” does not include a physician. “Physician” means an individual licensed to practice medicine in this State under Health Occupations Article, Title 14, Annotated Code of Maryland. “Regular service” means that surgical abortion procedures are performed on site on a routine basis. “Surgical abortion facility” means an outpatient facility that provides surgical termination of pregnancy as a regular service except if the facility is regulated by the Department under: Health General Article, Title 19, Subtitle 3, Annotated Code of Maryland; Health General Article, Title 19, Subtitle 3A, Annotated Code of Maryland; or Health General Article, Title 19, Subtitle 3B, Annotated Code of Maryland. A person may not establish or operate a surgical abortion 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 and State laws and regulations; File an application as required and provided by the Department; and Submit a written description of its quality assurance program as required by Regulation .16 of this chapter. In addition to meeting all of the requirements of Regulation .03A and F of this chapter, the applicant or licensee shall submit a nonrefundable fee of $1,500 with an application for: An initial license; or A license renewal. Based on information provided to the Department by the applicant and the Department's own investigation, the Secretary shall: Approve the application unconditionally; Approve the application conditionally; or Deny the application if the applicant: Has been found liable for or has been convicted of: Fraud or 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 .19B 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 .20 of this chapter. Renewal of License. At least 60 days before a license expires, the licensee shall submit to the Secretary: A renewal application; and The fee as specified in §B of this regulation. 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: Verify compliance with this chapter; and Investigate a complaint concerning patient care and safety as described in §B of this chapter. Complaints. In response to a complaint, the Department may: Require the facility to perform and submit its own investigation; or In its discretion, conduct an on-site investigation of a complaint. In order to determine whether an on-site investigation as described in §B(1)(b) of this regulation is appropriate, the factors the Department shall consider include, but are not limited to: Whether the complainant has first-hand knowledge of the alleged incident; The facility's regulatory history, including the number of verified prior complaints; Whether the Department has recently inspected the facility, and whether the incident would have been observed during the prior review; and The nature of the complaint, including degree of potential serious harm to patients. If the complaint concerns the performance of a physician, health professional, or standards of practice, the Department shall refer the complaint to the board that licenses, certifies, or otherwise authorizes the physician or health professional to provide services under Health Occupations Article, Annotated Code of Maryland. The Department shall: Comply with the requirements for medical review committees as described in Health Occupations Article, §1-401, Annotated Code of Maryland; and Keep patient information confidential in accordance with State and federal laws. Noncompliance. If the Department determines that a facility fails to meet any provision of this chapter, the Department shall: Advise the facility 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. Records and Reports. The facility shall make its records and reports available to the Department on site at the facility during an inspection. Administrator. Each facility shall have an administrator, who is responsible for the daily operation of the facility, including but not limited to: Consulting with the staff to develop and implement the facility's policies and procedures required under §C of this regulation; Organizing and coordinating the administrative functions of the facility; Coordinating the provision of services that the facility provides; Training the staff on the facility's policies and procedures and applicable federal, State, and local laws and regulations; and Ensuring that all personnel: Receive orientation and have experience sufficient to demonstrate competency to perform assigned patient care duties, including proper infection control practices; 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 ensure that: The facility's policies and procedures as described in §C of this regulation are: Reviewed by staff at least annually and are revised as necessary; and Available at all times for staff inspection and reference; and All appropriate personnel implement all policies and procedures as adopted. Medical Director. The surgical abortion facility shall have a medical director who: Is responsible for the overall medical care that is provided by the facility; and Advises and consults with the staff of the facility on all medical issues relating to services provided by the facility. The medical director shall be a physician licensed to practice in Maryland. Policies and Procedures. The facility shall have policies and procedures concerning the following: The scope and delivery of services provided by the facility either directly or through contractual arrangements; Personnel practices, including but not limited to: Procedures for the accountability of personnel involved in patient care; Job descriptions on file for all personnel: and Procedures to ensure personnel are free from communicable diseases; Postoperative recovery, if applicable; The transfer or referral of patients who require services that are not provided by the facility; Infection control for patients and staff; Pertinent safety practices, including the control of fire and mechanical hazards; Preventive maintenance for equipment to ensure proper operation and safety; and The services and procedures specified in Regulations .07—.12 of this chapter. Qualifications of Physicians and Staff. A facility shall ensure that all physicians and other health professionals who are employees or contractual staff have been appropriately trained and licensed or certified under the Health Occupations Article, Annotated Code of Maryland. Credentialing of Physicians. The facility shall collect, review, and document the following information concerning a physician licensed under Health Occupations Article, Title 14, Annotated Code of Maryland: The physician's education; The professional experience of the physician, including: Any board certification or specialty training of the physician; and Any post-graduate training; Any license or registration to practice a health occupation ever held by the physician, including DEA registration; Any hospital where the physician was appointed or employed during the last 10 years, including: The name of the hospital; The term of appointment or employment; and Privileges held and any disciplinary action taken, including suspension, revocation, limitation, or voluntary surrender; The physician's professional liability insurance for the last 5 years, including: The physician's present carrier; The physician's current limits of coverage; The physician's current types of coverage; and Restrictions on the physician's coverage; Any claim that has been made against the physician in the practice of a health occupation in the last 5 years, and the status of the claim; Any physical or mental condition that currently impairs the physician's ability to exercise privileges; Any complaint or report, permitted to be disclosed by law, which has been filed with any state licensing or disciplinary body, or comparable body of the armed forces; and Data provided by the National Practitioner Data Bank. For a physician who has privileges in a licensed Maryland hospital, the administrator may verify, through the hospital, the credentials described in §B of this regulation. The administrator shall establish a procedure for the biennial reappointment of a physician which includes: An update of the information required in §B of this regulation; and An assessment of the physician's performance pattern based on an analysis of: Complaints filed with the facility; Malpractice claims filed; Utilization, quality, and risk data; Adherence to policies, bylaws, and procedures; and Physician practice patterns as reviewed through the facility's quality assurance program. Credentialing of Health Professionals. Direct Hires. The facility shall collect, review, and verify evidence of the following information for all licensed or certified health professionals that are employed by the facility: A current license or certificate to practice in this State; and Malpractice insurance, if required by the facility. The administrator shall approve the delineation of services to be provided by the health professional. Nondirect Hires. When a licensed physician uses a health professional to provide services at the facility, and that person is not employed by the facility, the licensed physician who employs the health professional is responsible for verifying the information required in §E(1) of this regulation. Surgical abortion procedures shall be performed in a safe manner by a physician credentialed by the facility under Regulation .06 of this chapter. An administrator, in consultation with the medical director, shall develop and implement policies, procedures, and protocols for the provision of surgical abortion services including but not limited to: Personnel; Pre-operative testing and examinations; Surgical procedures; Post-anesthesia care and observation; Discharge planning; Emergency services; Informed consent; and Safety. The administrator shall ensure that the policies, procedures and protocols referenced in §B of this regulation are: Available on site at all times for reference; and Reviewed annually and revised as necessary. Before conducting a surgical procedure, a physician or other qualified health professional shall conduct a history and physical examination. If anything other than an unsupplemented local anesthetic is needed to accomplish a surgical procedure, a health practitioner as described in Regulation .08 of this chapter shall conduct a pre-anesthesia evaluation and document the anesthetic risk to the patient. If the assessments required by §§D and E of this regulation are performed before the day of surgery, on the day of surgery a physician or qualified health professional shall reassess and document on the patient’s medical record any change in the patient's clinical status that could have an effect on the surgical procedure to be performed and the anesthesia to be used. Discharge. Before discharge from the facility, the patient shall be evaluated by a physician or an appropriately trained health professional. This evaluation shall be documented in the patient’s record. 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. Anesthetics shall be administered only by a: Qualified anesthesiologist; A physician qualified to administer anesthesia; or A certified registered nurse anesthetist in accordance with: Health Occupations Article, §8-205, Annotated Code of Maryland; and COMAR 10.27.06. Basic Life Support. Licensed personnel employed by the 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 the facility. The facility shall have: A registered nurse available on site for emergency treatment whenever there is a post-operative surgical abortion patient in the facility; and At least one physician available by phone 24 hours a day to respond to emergency situations. When sedation or general anesthesia is administered, the facility shall have at least the following emergency equipment available to the procedure rooms: Oxygen; Mechanical ventilatory assistance including airways and manual breathing bag; Automated external defibrillator (AED); Equipment to monitor blood pressure, pulse, and oxygen levels; Suction equipment; and Emergency medical equipment and supplies specified by the medical staff. When general anesthesia is administered, a facility shall have available in the procedure room: Laryngoscopes; Endotracheal tubes; and Cardiac monitoring equipment. The surgical abortion facility shall have an effective procedure for the transfer of patients to a nearby hospital when care beyond the capabilities of the facility is required. Procedures for emergency transfer to a hospital shall include, at a minimum: Written protocols and procedures related to emergency transfer procedures; A mechanism for notifying the hospital of a pending emergency case; A mechanism for arranging appropriate transportation to the hospital; Protocols for transmitting a copy of the patient's medical record to the hospital; and Appropriate training for staff in the facility’s written protocols and procedures. The surgical abortion facility shall: Provide drugs under the direction of an authorized prescriber; and Develop and implement policies and procedures for pharmacy services in accordance with accepted professional practice. Administration of Drugs. Staff shall prepare and administer drugs according to established policies and acceptable standards of practice. Staff shall report adverse drug reactions to the licensee's medical director or physician. Orders given orally for drugs shall be followed by a written order which is signed by the authorized prescriber. The administrator shall develop and implement policies and procedures for obtaining routine and emergency laboratory and radiological services to meet the needs of the patient. Policies and procedures shall include: Turn-around time; Review of laboratory reports; and Documentation of laboratory results. Laboratory facilities shall be: Approved under the Clinical Laboratory Improvement Act (CLIA); and Licensed by the State under COMAR 10.10.03. The facility shall include in the patient's medical records: Laboratory reports; and Radiological findings. The facility shall maintain a complete, comprehensive, and accurate medical record for a patient. A 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. With the patient's consent or to the extent that information in a record is necessary for a patient's care in an emergency transfer, the facility shall: Send a copy of the medical record with the patient on: Referral to another physician or other licensed health professional; or Transfer to a hospital; If appropriate, and with the patient's consent, use the medical record when 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, including but not limited to: The opportunity to participate in planning their medical treatment; and Confidentiality of medical records and the right to approve or refuse release of records to any individual outside the facility, except as provided by federal or State law. The administrator shall ensure that the facility has a safe, functional, and sanitary environment for the provision of surgical services. A procedure room shall be designed and equipped to ensure that surgical abortion procedures conducted can be performed in a manner that ensures the safety of all individuals in the area. The facility shall have a separate recovery room and waiting area. The facility shall meet the requirements for handling, treatment, and disposal of special medical wastes as provided in COMAR 10.06.06. 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; and Identification, evaluation, and resolution of care problems. The facility shall conduct ongoing quality assurance activities and document the activities on a continuous basis, but not less than quarterly. The administrator shall ensure that the facility develops a quality control procedure to monitor and document the safety and performance of all biomedical equipment. 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 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 surgical abortion procedures 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 .20 of this chapter. Hearing. The Office on Administrative Hearings shall: Conduct a hearing as set forth in Regulation .20 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. Final Decision. The Secretary shall make a final decision in accordance with COMAR 10.01.03. If the Secretary's final decision does not uphold the emergency suspension, the licensee may resume operation. 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: Fraud or 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 consider the factors identified in Regulation .19B 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 surgical abortion 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 .20 of this chapter. 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 violation or 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 §A of this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .20 of this chapter. A request for a hearing shall be filed with the Office of Administrative Hearings, with a copy to the Office of Health Care Quality 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—10-227, Annotated Code of Maryland; COMAR 28.02.01; and COMAR 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, §20-209, Annotated Code of Maryland Effective date: July 23, 2012 (39:14 Md. R. 835)