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10.12.01.00.htm 10.12.01.00. Title 10 DEPARTMENT OF HEALTH AND MENTAL HYGIENE Subtitle 12 ADULT HEALTH Chapter 01 Surgical Abortion Facilities Authority: Health-General Article, §20-209, Annotated Code of Maryland
10.12.01.01.htm 10.12.01.01. 01 Definitions.. A. In this chapter, the following terms have the meanings indicated.. B. Terms Defined.. 1) “Department” means the Department of Health and Mental Hygiene.. 2) "Facility" means a surgical abortion facility.. 3) Health Professional.. a) "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.
10.12.01.02.htm 10.12.01.02. 02 License Required.. A. A person may not establish or operate a surgical abortion facility without obtaining a license from the Secretary.B. License Period. A license is valid for 3 years from the date of issuance, unless suspended or revoked by the Secretary.C. A license issued under this chapter is not transferable..
10.12.01.03.htm 10.12.01.03. 03 Licensing Procedures.. A. A person desiring to operate a facility shall:. 1) Be in compliance with all applicable federal and State laws and regulations;. 2) File an application as required and provided by the Department; and. 3) Submit a written description of its quality assurance program as required by Regulation .16 of this chapter.B. In addition to meeting all of the requirements of Regulation .03A and F of this chapter, the applicant or licensee shall s
10.12.01.04.htm 10.12.01.04. 04 Inspections by the Department.. A. 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:1) Verify compliance with this chapter; and. 2) Investigate a complaint concerning patient care and safety as described in §B of this chapter.. B. Complaints..
10.12.01.05.htm 10.12.01.05. 05 Administration.. A. Administrator.. 1) Each facility shall have an administrator, who is responsible for the daily operation of the facility, including but not limited to:a) Consulting with the staff to develop and implement the facility's policies and procedures required under §C of this regulation;b) Organizing and coordinating the administrative functions of the facility;. c) Coordinating the provision of services that the facility provides;. d) Training the staff on
10.12.01.06.htm 10.12.01.06. 06 Personnel.. A. 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.B. Credentialing of Physicians. The facility shall collect, review, and document the following information concerning a physician licensed under Health Occupations Article, Ti
10.12.01.07.htm 10.12.01.07. 07 Surgical Abortion Services.. A. Surgical abortion procedures shall be performed in a safe manner by a physician credentialed by the facility under Regulation .06 of this chapter.B. 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:1) Personnel;. 2) Pre-operative testing and examinations;. 3) Surgical procedures;.
10.12.01.08.htm 10.12.01.08. 08 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 anesthesiologist;. 2) A physician qualified to administer anesthesia; or. 3) A certified registered nurse anesthetist in accordance with:. a) Health Occupations Article, §8-205, Annotated Code of Maryland; and.
10.12.01.09.htm 10.12.01.09. 09 Emergency Services.. A. 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.B. The facility shall have:. 1) A registered nurse available on site for emergency treatment whenever there is a post-operative surgical abortion patient in the facility; and
10.12.01.10.htm 10.12.01.10. 10 Hospitalization.. A. 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.B. Procedures for emergency transfer to a hospital shall include, at a minimum:. 1) Written protocols and procedures related to emergency transfer procedures;. 2) A mechanism for notifying the hospital of a pending emergency case;.
10.12.01.11.htm 10.12.01.11. 11 Pharmaceutical Services.. A. The surgical abortion facility shall:. 1) Provide drugs under the direction of an authorized prescriber; and. 2) Develop and implement policies and procedures for pharmacy services in accordance with accepted professional practice.B. Administration of Drugs.. 1) Staff shall prepare and administer drugs according to established policies and acceptable standar2) Staff shall report adverse drug reactions to the licensee's medical director or physician..
10.12.01.12.htm 10.12.01.12. 12 Laboratory and Radiologic Services.. A. 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:1) Turn-around time;. 2) Review of laboratory reports; and. 3) Documentation of laboratory results.. B. Laboratory facilities shall be:. 1) Approved under the Clinical Laboratory Improvement Act (CLIA) and.
10.12.01.13.htm 10.12.01.13. 13 Medical Records.. A. The facility shall maintain a complete, comprehensive, and accurate medical record for a patient.. B. A patient's medical record shall include at least the following:. 1) Patient identifier;. 2) Significant medical history and results of a physical examination;. 3) Documentation of care or services provided;. 4) Evidence of consent; and. 5) Discharge diagnosis.. C. With the patient's consent or to the extent that information in a record
10.12.01.14.htm 10.12.01.14. 14 Patients’ Rights and Responsibilities. The administrator shall ensure that the facility develops and implements written policies and procedures concerning patients’ rights and responsibilities, including but not limited to:A. The opportunity to participate in planning their medical treatment; and. B. 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.
10.12.01.15.htm 10.12.01.15. 15 Physical Environment.. A. The administrator shall ensure that the facility has a safe, functional, and sanitary environment for the provision of surgical services.B. 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.C. The facility shall have a separate recovery room and waiting area.. D. The facility shall meet the requirements for ha
10.12.01.16.htm 10.12.01.16. 16 Quality Assurance Program.. A. The administrator shall ensure that the facility develops and maintains a quality assurance program which includes:1) Monitoring and evaluation of the quality of patient care; and. 2) Identification, evaluation, and resolution of care problems.. B. The facility shall conduct ongoing quality assurance activities and document the activities on a continuous basis, but not less than quarterly.C. The administrator shall ensure that the facilit
10.12.01.17.htm 10.12.01.17. 17 Emergency Suspension.. A. The Secretary may immediately suspend a license on a finding that the public health, safety, or welfare requires emergency action.B. The Department shall deliver a written notice to the licensee:. 1) Informing the licensee of the emergency suspension;. 2) 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; and3) Notifying the licensee
10.12.01.18.htm 10.12.01.18. 18 Revocation of License.. A. 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.B. The Secretary may revoke a license if the licensee:. 1) Has been convicted of:. a) Fraud or a felony that relates to Medicaid or Medicare; or. b) A crime involving moral turpitude; or. 2) Does not comply with the requirements of this chapter.. C. The Secretary shall co
10.12.01.19.htm 10.12.01.19. 19 Penalties.. A. Administrative Penalty. The Secretary may impose an administrative penalty of up to $1,000 for a violation of any provision of this chapter.B. When considering whether to impose an administrative penalty and the amount of the penalty, the Secretary shall consider the following factors:1) The number, nature, and seriousness of the violation or violations;. 2) The extent to which the violation or violations are part of an ongoing pattern during the precedi
10.12.01.20.htm 10.12.01.20. 20 Hearings.. A. 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.B. A hearing requested under this chapter shall be conducted in accordance with:. 1) State Government Article, §10-201―10-227, Annotated Code of Maryland;. 2) COMAR 28.02.01; and.
10.12.01.9999.htm 10.12.01.9999. Administrative History Effective date: July 23, 2012 (39:14 Md. R. 835).
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