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) In this chapter, the following terms have the meanings indicated. Terms Defined. “Board” means the Board of Nursing. “Certified nurse midwife” has the meaning stated in COMAR 10.27.05.01. Freestanding Birthing Center. “Freestanding birthing center” means a facility that provides nurse midwife services through individuals licensed to practice under Health Occupations Article, Title 8, Subtitle 6, Annotated Code of Maryland. “Freestanding birthing center” does not include: Birthing services that are licensed or accredited as a unit of a hospital; or The private residence of the patient. “Immediate action” means all actions the freestanding birthing center has taken or will take to immediately address the noncompliance that resulted in or made serious injury, serious harm, serious impairment, or death likely. Immediate Jeopardy. “Immediate jeopardy” means a situation in which immediate corrective action is necessary because the freestanding birthing center's noncompliance with one or more licensure requirements has already caused, is causing, or is likely to cause, at any time, serious injury or harm, or death, to individuals served by the freestanding birthing center or to the health or safety of the general public. “Immediate jeopardy” consists of three components: Noncompliance with this chapter; Serious injury, harm, or death; and The need for immediate action. “Informal dispute resolution (IDR)” means an informal process that provides a freestanding birthing center the opportunity to dispute one or more deficiencies cited in a written Statement of Deficiencies issued by the Department or the Department’s designee related to a recent survey. “Licensed certified midwife” has the meaning stated in Health Occupations Article, §8-6D-01, Annotated Code of Maryland. “Licensed direct-entry midwife” has the meaning stated in COMAR 10.64.01.01. “Midwifery” means the antepartum, intrapartum, and postpartum management and care of birthing persons and their newborns. “Need for immediate action” means that immediate corrective action is necessary to remove the jeopardy. “Newborn” means an infant in the first 28 days of life. “Noncompliance” means the freestanding birthing center is non-compliant with one or more licensure requirements of this chapter. Normal Maternity. “Normal maternity” means a low risk, uncomplicated prenatal course as determined by adequate prenatal care and prospects for a normal, uncomplicated birth as defined by reasonable and generally accepted criteria of maternal and fetal health. “Normal maternity” does not include the use of drugs for induction or augmentation of labor, general and regional anesthesia, vacuum extractors, forceps, recorded electronic fetal monitors, cesarean section, surgical procedures other than episiotomy or perineal repair, intrapartum care provided prior to 36 weeks gestation, or intrapartum care provided after 42 weeks gestation. “Office of Health Care Quality (OHCQ)” means the Office of Healthcare Quality of the Maryland Department of Health. “Plan of Correction” means a written plan submitted by the freestanding birthing center to the OHCQ which documents steps the freestanding birthing center will take to come into compliance with the licensure requirements. “Removal of the immediate jeopardy” means that the freestanding birthing center has implemented the removal plan, and the OHCQ has verified that all actions the freestanding birthing center took were effective in removing the likelihood that serious injury, serious harm, serious impairment, or death would occur or recur. “Serious injury, harm, or death” means a situation which has already caused, is causing, or is likely to cause, at any time, serious injury or harm, or death, to individuals served by the freestanding birthing center or to the health or safety of the general public. “Statement of Deficiencies” means the written notification that the OHCQ issues to the free standing birthing center that contains a listing of deficiencies cited that require correction. In this chapter, the following document is incorporated by reference, National Fire Protection Association (NFPA) 101 Life Safety Code (2018 Edition), which is incorporated by reference in COMAR 29.06.01.06. A freestanding birthing center shall only provide normal maternity care and shall meet all general licensing requirements for a facility as provided in COMAR 10.05.01 and all requirements of this chapter. An applicant shall submit: An application on a written or electronic form provided by the Department; All other reasonable documents as required by the Department; and A business email address for the applicant or their organization. License Application Administratively Closed. An application is not complete until the Department has received the completed license application and all required documents. After 180 calendar days from the date of initial receipt, the Department may deem an incomplete license application inactive and administratively close the application. An applicant whose application is administratively closed may reapply for a license by submitting a new application. Voiding of License. Maryland State Department of Assessments and Taxation (SDAT). A freestanding birthing center shall remain in good standing with (SDAT). If the freestanding birthing center fails to return to good standing 60 calendar days after receipt of notification of noncompliance from SDAT or another government agency, the Department may void the freestanding birthing center's license. Ceases the Provision of Services. A license is void if the freestanding birthing center ceases to provide services to patients for a period of 180 consecutive days. The owner shall immediately cease all use of the previously issued freestanding birthing center license when the license is voided. Current Business Email Address. A freestanding birthing center is required to maintain a current business email address on file with the OHCQ. A licensee operating a freestanding birthing center shall undergo a routine annual survey. A licensee shall allow an on-site survey by the Department at any time during the center’s normal hours of operation to evaluate the center’s compliance with the applicable requirements and standards of this chapter. Center employees shall make data and records accessible within a reasonable time during the on-site survey. Notice of Deficiencies. If a survey identifies noncompliance with a requirement, the Secretary shall: Issue a written Statement of Deficiencies that cites each deficiency; Require the freestanding birthing center to submit an acceptable Plan of Correction within 10 calendar days of receipt of the Statement of Deficiencies; Notify the freestanding birthing center of any sanctions or that failure to correct the violation may result in sanctions; and Offer the freestanding birthing center the opportunity for IDR. Plan of Correction. The freestanding birthing center shall submit a written Plan of Correction to the OHCQ that documents steps the licensee will take to come into compliance, including: How the freestanding birthing center will correct each deficiency; The date by which each deficient practice will be corrected; How the freestanding birthing center will prevent the deficient practice from recurring; and Who will be responsible for ensuring the deficiency will not reoccur. Failure to return an acceptable Plan of Correction within the allotted time frame may result in a sanction. A request for an IDR does not change the freestanding birthing center's requirement to submit a Plan of Correction for all deficiencies within 10 calendar days after receipt of the notice of deficiency. Immediate Jeopardy. Declaration of Immediate Jeopardy. When the OHCQ identifies a situation in which immediate corrective action is necessary because the freestanding birthing center's noncompliance with one or more licensure requirements has already caused, is causing, or is likely to cause, at any time, serious injury or harm, or death, to individuals served by the freestanding birthing center or to the health or safety of the general public, an immediate jeopardy will be declared. The OHCQ shall provide the freestanding birthing center with a written notice that includes a description of the situation that constitutes an immediate jeopardy. Removal Plan. The freestanding birthing center shall submit a written removal plan to the OHCQ that includes: The immediate action a freestanding birthing center will take to prevent serious harm from occurring or recurring; All actions to remove past, present, and future jeopardy; and The date by which the freestanding birthing center asserts the likelihood for serious harm to any recipient no longer exists. OHCQ's Review of the Removal Plan. The OHCQ shall review the freestanding birthing center's removal plan to determine that the removal plan, if implemented appropriately, will remove the likelihood that serious harm will occur, or recur. The OHCQ shall verify that the freestanding birthing center has implemented the removal plan. OHCQ's Approval of the Removal Plan. The OHCQ shall approve the removal plan after verifying that all actions the freestanding birthing center took were effective in removing the likelihood that serious injury, serious harm, serious impairment or death would occur or reoccur. Plan of Correction. If an immediate jeopardy is identified during a survey, the Plan of Correction must completely correct all noncompliance associated with the immediate jeopardy. Informal Dispute Resolution (IDR). A freestanding birthing center may request an IDR to dispute one or more deficiencies in a Statement of Deficiencies. The freestanding birthing center shall submit the request for an IDR to the Department within 10 calendar days of receiving the Statement of Deficiencies. The written request for an IDR shall fully describe the disagreement with the Statement of Deficiencies and be accompanied by all evidence for the Department’s consideration. At the discretion of the Department, the IDR may be held in person, by telephone, by video conference, or in writing. IDRs are informal in nature and are not attended by legal counsel representing the freestanding birthing center or the Department. The IDR process may not delay the effective date of any enforcement action. In the event a freestanding birthing center requests an IDR of a deficiency written by a designee of the Department, the Department shall request the designee to participate in the IDR process. There is no appeal of the Department’s decision in an IDR. Administrator. The licensee shall appoint an administrator of the freestanding birthing center who is responsible for the: Daily administration of the center; and Training and supervision of all nonprofessional staff, unlicensed staff, and volunteers. Director of Midwifery Services. The administrator shall appoint a certified nurse midwife or licensed certified midwife as director of midwifery services who is responsible for the employment, training, and supervision of the licensed professional staff Clinical Director. The clinical director shall: Be a certified nurse midwife; Be a licensed certified midwife; or Be a physician with: Board certification in a specialty that provides services for pregnant and postpartum patients; or Appropriate experience in the care of pregnant and postpartum patients; and Be responsible for advising and consulting with the center staff on all matters related to medical management of pregnancy, birth, postpartum, newborn, and gynecologic health care. The same individual may be clinical director and the director of midwifery services. Two licensed staff individuals in midwifery, one of whom shall be a certified nurse midwife or licensed certified midwife, shall: Attend each birth; and Be currently certified in: Adult cardiopulmonary resuscitation equivalent to the American Heart Association Class C basic life support; and Neonatal resuscitation by a course endorsed by the American Academy of Pediatrics and the American Heart Association. The clinical director and director of midwifery shall develop clinical practice guidelines for the management of routine and emergency care of the patient and the fetus or newborn during pregnancy, birth, and postpartum through discharge, whether through completion of the pregnancy or referral or transfer to other levels of care. The clinical practice guidelines shall include, at a minimum, procedures for the: Transfer of patients or newborns for appropriate hospital obstetric and newborn care; Monitoring of fetal heart tones consistent with the current standards of care; and Use of ultrasound imaging that is: Consistent with the current standards of care; and Within the scope of practice for a: Physician; Certified nurse midwife; or Licensed certified midwife. The administrator shall: Ensure that all clinical practice guidelines are fully implemented by the clinical staff; Periodically review the non-clinical policies and revise them when necessary; and Make the [protocols] clinical practice guidelines available to staff for reference on site at all times. A licensed direct-entry midwife, certified nurse midwife, and licensed certified midwife practicing in a birthing center shall remain in compliance with applicable practice guidelines including but not limited to: Health Occupations Article, §8-6C-08, Annotated Code of Maryland; COMAR 10.64.01.10; COMAR 10.27.05.04; and COMAR 10.27.05.01(a)(8). A licensed direct-entry midwife, licensed certified midwife, certified nurse midwife, or physician shall consult or collaborate with another health care practitioner who has the knowledge, skills, and expertise to manage a clinical issue, as needed or as required in Health Occupations Article, §8-6C-04, Annotated Code of Maryland. A licensed direct-entry midwife, licensed certified midwife, certified nurse midwife, or physician shall refer and transfer patients with complications beyond their scope of practice to a health care practitioner with the knowledge, skills, and experience to manage the client. A freestanding birthing center shall have a written 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 minimum: Written clinical practice guidelines 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; and Protocols for transmitting a copy of the patient’s medical record to the hospital. A freestanding birthing center shall conduct a transfer drill with staff that may be involved in patient transfers at least once a year. A freestanding birthing center shall develop and implement a quality assurance program. A freestanding birthing center shall collect the following evaluative data in addition to that required in COMAR 10.05.01.08: Number of births; Intrapartum transfer rates and indications for transfer; and Postpartum maternal and neonatal hospital admissions. A freestanding birthing center shall conduct a quarterly review of all patients transferred to an emergency department or a hospital. Process of Filing a Complaint. The freestanding birthing center shall have a written process that describes how patients are notified of how to file a complaint with the OHCQ and, if applicable, an accreditation organization. Bedrooms. A freestanding birthing center shall: Locate bedrooms so as to provide unimpeded, rapid access to an exit of the building where emergency transportation vehicles may be accommodated; Have bedrooms that can accommodate: A double bed or a bed large enough to safely accommodate patient and baby, Birth attendants and support persons, Space for supplies, equipment, and family belongings, and Access to a sink with hot and cold running water equipped with elbow-wrist controls such as are common in home kitchens. Toilet Facilities. A freestanding birthing center shall make available separate fixed toilet facilities to the laboring patient and separate toilet facilities for family and staff use. Bath Facilities. A freestanding birthing center shall make bath and shower facilities available to the laboring patient and have separate washing facilities available for staff and family. Storage, Utility, and Laundry Facilities. A freestanding birthing center shall have facilities that are designed and equipped for washing, sterilizing, storing, and handling equipment, linens, and medical supplies in a manner which ensures separation of clean linen, and sterile supplies and equipment from those that are soiled or contaminated. Heating and Ventilation. A freestanding birthing center shall have a safe and adequate source of heat and ventilation capable of maintaining temperature in the birthing unit between 75°F and 85°F. Lighting and Power. A freestanding birthing center shall have adequate lighting in the birthing rooms. Fire Safety Protection. Smoke Alarms. A freestanding birthing center shall place smoke alarms on each floor and at points as recommended by the State Fire Marshal or local fire authority. A freestanding birthing center shall have alarms that are audible throughout the center. Fire Extinguishers. A freestanding birthing center shall provide at least one approved fire extinguisher on each floor, including below ground level. Lighting and Power. A freestanding birthing center shall ensure that: Exits are illuminated during time of occupancy; and Emergency lighting is located to provide illumination in event of a power failure. Power Outage. A freestanding birthing center shall have: A written plan to address power outages; and Annual staff training relating to power outages. Evacuation. A freestanding birthing center shall make written copies of its fire evacuation plan available to all personnel and instruct all personnel in the implementation of the evacuation plan. A freestanding birthing center shall keep all personnel informed of their responsibilities under the plan and conduct a supervised evacuation drill at least once a year. Equipment and furnishings shall be constructed of materials that are easily cleaned and maintained and shall include, at a minimum: A heat source for infant examination or resuscitation; A transfer isolette or demonstrated capability of ready access to a transfer isolette; A sterilizer or demonstration of sterilizing capability; Blood pressure equipment, thermometers, and fetoscope or doptone; Intravenous equipment; Adult and neonatal resuscitation equipment including, but not limited to, oxygen equipment for patient and newborn that is stored in accordance with Standards for Health Care Facilities, NFPA 99; and Instruments for delivery, episiotomy, and repair. Laundry. A freestanding birthing center shall provide for the sanitary handling of soiled linens in accordance with 29 CFR §1910.1030, which is incorporated by reference. A freestanding birthing center may have on-site laundry facilities or use a laundry service that is experienced in handling linens for health care facilities. When a freestanding birthing center uses on-site laundry facilities, the center shall disinfect soiled linens by using one of the following methods: Hot water at 160°F; or A low-temperature wash formula which specifies time, temperature, concentration, and pH control in conjunction with chlorine bleach as recommended by the detergent manufacturer for use in a health care setting. A freestanding birthing center shall maintain an adequate linen supply. In addition to meeting the requirements of this regulation, a freestanding birthing center shall comply with the requirements of COMAR 10.05.01.09. The health record of each patient shall contain documentation of all services provided while the patient and the fetus or newborn are under the care of the freestanding birthing center, including reports by outside providers who have examined or treated the patient at the request of the center. A freestanding birthing center shall: Send a copy of the health record with the patient or newborn, or both, on referral to another health care provider or on transfer to a hospital; and Maintain birth and death certificates on file, as required by Health-General Article, Title 4, Subtitle 2, Annotated Code of Maryland. Health-General Article, §19-3B-01 et seq., Annotated Code of Maryland Effective date: August 23, 1999 (26:17 Md. R. 1322) Chapter revised effective February 15, 2016 (43:3 Md. R. 272) Regulation .01B amended effective December 8, 2016 (43:24 Md. R. 1350) Regulation .06A amended effective December 8, 2016 (43:24 Md. R. 1350) Chapter revised effective October 13, 2025 (52:20 Md. R. 1000) In this chapter, the following terms have the meanings indicated. Terms Defined. Freestanding Facility Operating Major Medical Equipment. “Freestanding facility operating major medical equipment” means a facility using major medical equipment. “Freestanding facility operating major medical equipment” does not include any freestanding ambulatory care facilities or service owned or operated by a hospital and regulated under COMAR 10.07.01. “JCAHO” means the Joint Commission on Accreditation of Healthcare Organizations, a private organization that creates standards, surveys, and accredits hospitals and health-related facilities. “Major medical equipment” means: All cardiac catheterization equipment necessary to perform heart catheterization; A computed tomography (CT) scanner; A lithotriptor; Radiation therapy equipment, including a linear accelerator; or A magnetic resonance imager (MRI). “Supervisor” means a physician who is licensed by the Board of Physician Quality Assurance and who has expertise in the operation of major medical equipment. A facility operating major medical equipment shall meet all general licensing requirements for a facility as provided in COMAR 10.05.01 and all requirements of this chapter. An owner of mobile major medical equipment shall obtain a license under this chapter. A facility operating major medical equipment that is engaged exclusively in biomedical research is not required to be licensed under this chapter if: Charges for any health care service provided with the equipment will not be paid by any patient or third-party payor; and The capital costs associated with the equipment and any related construction or renovation are not included in patient charges. A person desiring to establish or operate a facility that operates major medical equipment shall submit an application for licensure. The following information for each piece of equipment shall accompany the application: Manufacturer and model of the equipment; Address where the equipment is to be located; and Qualifications of the licensed physician who will be supervising the use of the equipment. The applicant or licensee shall submit a nonrefundable fee of $700 with an application for: Initial licensure; or License renewal. The Secretary may verify compliance with licensing requirements through on-site random sample record reviews. For the purpose of verifying compliance, the Secretary shall have access to: The facility or office where the equipment is located; Patients' medical records, including image or scan records; Quality assurance records, including peer review documentation; Records documenting in-service training on use of the equipment; Records verifying personnel training; Equipment quality control and inspection records; Radiation safety reports; Records of referrals and evidence of appropriate use of equipment; Policies and procedures that ensure safe operation of equipment; and Qualifications of personnel: Permitted to supervise use of the major medical equipment, Permitted to operate the major medical equipment, and Responsible for maintenance of the major medical equipment. Operators of Magnetic Resonance Imager (MRI) Equipment. Operators of MRI equipment shall demonstrate competency to successfully and safely complete magnetic resonance procedures. Operators of Radiation-Producing Equipment. The licensee shall ensure that operators of radiation-producing equipment are qualified in accordance with Health Occupations Article, §§14-306 and 14-606, Annotated Code of Maryland. Students and Graduate Technologists. This regulation does not prohibit students or graduate technologists from operating equipment, if the students or technologists are directly monitored by a supervisor. A facility operating major medical equipment shall develop and implement: A quality assurance program in compliance with the guidelines outlined in COMAR 10.05.01.08; and Additional quality assurance requirements of this regulation. Scope. The quality assurance program shall apply to all personnel supervising or operating major medical equipment. Appropriate Use. The administrator shall develop a procedure to monitor referral and appropriate use for each procedure performed using the major medical equipment, ensuring that: Referrals are consistent with the health care practitioner's scope of practice as defined in the Health Occupations Article, Annotated Code of Maryland; The supervisor of major medical equipment is available to a referring health care practitioner to discuss appropriate use; and If the supervisor of major medical equipment questions the appropriateness of a requested procedure, the supervisor shall contact the referring health care practitioner for additional information relating to the appropriateness of using the equipment. When considering appropriate use, the supervisor of major medical equipment shall consider the patient's risks for undergoing specific testing, and the effectiveness of the particular equipment modality to aid in diagnosis. The supervisor of the major medical equipment shall monitor the quality assurance program to determine the effectiveness of the delivery of services. 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. The administrator shall ensure that all equipment: Is manufactured according to the requirements of 21 CFR 800—1299, which is incorporated by reference; Is appropriately labeled and includes an operating manual; Is considered safe and effective and approved for marketing by receipt of an FDA classification or a letter of approval according to 21 CFR 800—1050.10, which is incorporated by reference; and Meets all applicable standards for equipment adopted by the Division of Radiation Control of the Department of the Environment. Safe Operation of Equipment. To ensure safe operation of the equipment, the administrator shall: Develop safety and performance testing procedures; Maintain records of inspection and test results; Develop procedures for identifying equipment malfunctions; Provide instruction and training for equipment operators; Develop policies and procedures that include the following safety rules: Proper safety precautions against fire, explosion, and electrical or mechanical hazards, Guidelines for the management of patients developing emergency situations while undergoing testing, and Safety precautions for equipment that emits radiation and magnetic fields; Develop protocols and procedures to ensure that patients, operators, and individuals are not exposed to unnecessary hazards; and Ensure that operators are familiar with the most current safety procedures. A facility operating major medical equipment shall comply with all requirements of COMAR 10.05.01.09 and the requirements of this regulation. A facility operating major medical equipment shall maintain a medical record for each patient on whom a test is performed and make the information available to the Secretary on request. Each patient's medical record shall include the following information: Symptoms exhibited by the patient; Suspected diagnosis before the test or procedure; and Nature of findings. Health-General Article, §19-3B-01 et seq., Annotated Code of Maryland Effective date: August 23, 1999 (26:17 Md. R. 1322) Regulation .04A amended effective February 27, 2017 (44:4 Md. R. 252) In this chapter, the following terms have the meanings indicated. Terms Defined. "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 this chapter. “Certified nursing assistant—dialysis technician (CNA-DT)” means an individual certified by the Maryland Board of Nursing as a certified nursing assistant—dialysis technician (CNA-DT). “Chief executive officer” means an individual who meets the requirements set forth in 42 CFR §405.2102, as amended, which is incorporated by reference. “In-center daytime hemodialysis” means a hemodialysis treatment that: Usually lasts 3 to 5 hours; Is performed on a routine basis, usually three times a week, to treat a chronic condition; and Is provided in a kidney dialysis center during daytime hours. “In-center nocturnal hemodialysis” means a hemodialysis treatment that: Lasts 6 to 9 hours; Is performed on a routine basis, usually three times a week, to treat a chronic condition; and Is provided in a kidney dialysis center. “Interdisciplinary team (IDT)” means a multidisciplinary team: Consisting of, at a minimum: The patient or the patient’s designee, if the patient chooses; A registered nurse; A physician; A nurse practitioner or physician assistant treating the patient for ESRD; A social worker; and A dietitian; and Whose professional members have dialysis experience. Kidney Dialysis Center. “Kidney dialysis center” means a facility that provides hemodialysis or chronic peritoneal dialysis. “Kidney dialysis center” does not include a center or service owned or operated by a hospital and regulated under Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland. “Patient comprehensive assessment” means an individualized comprehensive assessment that reflects the patient’s psychological, social, medical, dietary, and rehabilitation needs and identifies the care required to meet those needs as well as individualized modifications in the approaches required to meet the patient’s goals. “Patient plan of care” means a written plan that includes all of the care, services, and treatment interventions the interdisciplinary team decides to implement to meet the specific needs of the patient. 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. An applicant shall obtain Medicare certification as a condition of licensure for a kidney dialysis center. 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. Governing Body. The governing body shall: Identify the center administrator who has been given the authority and responsibility for the overall policy and fiscal management of the facility; and Develop a written organizational plan. Administrator. Qualifications. The kidney dialysis center administrator, if not the chief executive officer, shall at a minimum: Be 21 years old or older; Possess a high school diploma or a high school equivalency diploma and have experience to conduct the responsibilities specified in §B(2) of this regulation; Have at least 1 year of dialysis experience; and Have no criminal conviction or other criminal history that indicates behavior that is potentially harmful to patients, documented through either a criminal history records check or a criminal background check completed within 1 month before employment. The administrator, if not the chief executive officer, shall have knowledge in: Infection control; Principles of dialysis; Water treatment; Reuse; Data collection and quality assurance; Emergency procedures; Fiscal operations, including business management and personnel; Regulations; and Policies and procedures. Duties. The administrator shall be on site or available on call. The administrator shall have overall responsibility for: 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; Participating in the development of organizational and fiscal planning for the facility; Implementing and evaluating, under the direction of the clinical team, the patient care plan and the long-term care program for each patient; and Informing patients of the availability of emergency services. Waiver of Requirements for Administrator. The Department may grant a kidney dialysis center a waiver, with or without conditions, for a center that operates an administrator-in-training program. A center with an administrator-in-training program shall submit to the Department the: Administrator-in-training curriculum, including course outline and supporting materials; Center's requirements for individuals who are selected to participate in the administrator-in-training program; and Protocols in place that assure that the approval of the waiver will not adversely affect the quality of care received by patients. In evaluating a waiver request submitted under this regulation, the Department shall review the statements in the application and may: Inspect the kidney dialysis center; or Confer with the governing body. Grant or Denial of Waiver. The Department may grant a waiver request if it determines that: The administrator-in-training program sufficiently meets the requirements of this regulation; and A waiver will not adversely affect patients. If the Department determines that the conditions of §B(3)(d) of this regulation are not met, the Department shall deny the request for a waiver. The denial of a waiver may not be appealed. Written Decision. The Department shall issue and mail to the licensee a final written decision regarding a waiver request submitted under this regulation within 45 days from receipt of the request. If the Department grants a waiver, the written decision shall include the waiver's duration and any conditions imposed by the Department. If a licensee violates any condition of the waiver, or if it appears to the Secretary that the health or safety of patients will be adversely affected by the continuation of the waiver, the waiver may be revoked. The revocation of a waiver may not be appealed. Any substantive changes to the administrator-in-training program shall be submitted to the Department for prior approval. Policies and Procedures. The administrator, in consultation with the governing body, shall develop and implement policies and procedures governing the operation of the facility, which includes at a minimum those items in COMAR 10.05.01.06D and the following: The provision of dialysis and other end-stage renal disease services; The reuse of dialysis supplies including hemodialyzers and blood tubing, if reuse of supplies is practiced by the facility; Implementing and evaluating the patient care plan and the long-term care program for each patient; and Informing patients of the availability of emergency services. The administrator shall ensure that all: Policies and procedures are: Reviewed by staff at least annually and are revised as necessary; and Available at all times for staff inspection and use; and Appropriate personnel implement all policies and procedures adopted. The Administrator shall ensure that the kidney dialysis center has a quality assurance program as required under COMAR 10.05.01.08. The quality assurance team shall document information regarding the quality assurance activities in accordance with COMAR 10.05.01.08F and provide a report to the administrator. The administrator shall: Review the report specified in §B of this regulation; Implement any necessary corrective actions; and Notify the quality assurance team when corrective actions have been implemented. Medical Director. The medical director shall: Be a nephrologist or other physician with at least 12 months experience in the treatment of patients requiring chronic hemodialysis; Be responsible for the development of patient care policies; and Provide medical guidance in the provision of patient care. If the medical director is not available to provide medical guidance, the administrator shall ensure the availability of an alternate physician with the same qualifications of the medical director as specified in §A(1)(a) of this regulation. Charge Nurse. The charge nurse shall be a registered nurse with training in the provision of kidney dialysis services and at least 6 months experience in a dialysis center. Dialysis Monitoring. Staffing Ratio. In-Center Daytime Hemodialysis. When in-center daytime hemodialysis is performed, the monitoring individual-to-patient ratio at each center shall be: A minimum of one staff member to three participants; and Sufficient to meet the needs of patients. In-Center Nocturnal Hemodialysis. When in-center nocturnal hemodialysis is performed, the monitoring individual-to-patient ratio at each center for in-center nocturnal hemodialysis shall be: A minimum of one staff member to five participants; and Sufficient to meet the needs of the patients. The center shall establish provisions for back-up staff coverage during unexpected illnesses, vacations, and holidays. The charge nurse may not be included in the staffing ratio except: When there are nine or fewer patients; or In the event of an emergency. Staffing Exception Reporting. The center shall have a staffing exception reporting protocol in a format approved by the Department for reporting to the governing body when emergency staffing situations arise that require the charge nurse to be included in the staffing ratio. The report shall include, at a minimum: The date and shift of the exception; A description of the emergency staffing situation; Actions taken in response; and Any measures taken to ensure the center's future compliance. The exception reporting protocol shall be included in the center's quality assurance process. The staffing exception reports shall be made available to the Office of Health Care Quality and the Commission on Kidney Disease when they are conducting an inspection or survey of the center to assure compliance with §C(1) of this regulation. Monitoring individuals shall be trained in dialysis procedures and may be a: Physician; Physician assistant; Registered nurse; Licensed practical nurse; or Certified nursing assistant — dialysis technician. The kidney dialysis center shall also provide dietetic and social work services and consultation by individuals with experience or training in caring for dialysis and transplant patients sufficient to meet the needs of patients. 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. 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 transplantation. Patient Comprehensive Assessment. The patient’s comprehensive assessment shall be developed by a multidisciplinary team. The health care team described in §B of this regulation shall review, document, and make appropriate revisions to each patient's comprehensive assessment at least every 12 months or more often as indicated by the patient's response to treatment. When a patient is transferred to another kidney dialysis center, the facility shall ensure that a copy of the patient's comprehensive assessment accompanies the patient, or is sent to the new kidney dialysis center within 1 working day after transfer. 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, shall develop an individualized care plan for each patient. The patient or health care decision maker shall be involved in developing the care plan. The health care team shall review the patient care plan: At least monthly for a patient whose condition has not stabilized, as determined by a physician's assessment of the patient's laboratory values and physical condition; or Annually for a patient whose condition has stabilized. The health care team shall revise the patient care plan as necessary to ensure that it meets the patient's ongoing needs. Patient Information. The kidney dialysis center shall: 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 suitability for home dialysis; and Obtain the patient's or, if appropriate, the patient's health care decision maker's informed consent regarding the reuse of dialysis supplies. The signed informed consent form shall be maintained in the patient's medical record. Standards. If the kidney dialysis center reuses dialysis supplies, the medical director shall: Develop a dialysis reuse policy in accordance with 42 CFR §§405.2139(a), 405.2140(a)(5), (b), and (c), and 405.2150, which are incorporated by reference; and Ensure compliance with the policy. Floor Space. The kidney dialysis center shall have usable floor space of at least 80 square feet per patient station. Floor space may include bed or chair space, nursing space, and work area, but excludes storage space. At least 20 square feet of the patient station floor space shall be available on the side of the patient to be occupied by the dialysis assembly. Arrangement of space shall be sufficiently flexible to provide access to any of the patient's four extremities. Treatment Area. The treatment area shall be designed and equipped to: Provide privacy and comfort for patients; Facilitate staff monitoring of patients receiving dialysis services; and Provide for the adequate isolation of hepatitis-positive patients. The kidney dialysis center shall have sufficient space for maintenance and storage of equipment and supplies, and for preparing and testing dialyzers. The kidney dialysis center shall: Comply with 42 CFR §405.2140(a)(5), as amended, which is incorporated by reference; and Assure that the quality of water provided by a municipal water supply meets the federal Environmental Protection Agency standards for dissolved solutes. Water Treatment System Safeguards. The kidney dialysis center shall use a water treatment system that offers satisfactory safeguards to patients, including: Appropriate prefiltration for particulate matter; Reverse osmosis monitored by resistivity or conductivity, or an equivalent method, or both; or A mixed-resin bed deionizer with a one megohm monitors light, or an equivalent method. Prefiltration shall be followed by charcoal filtration before reverse osmosis, or deionization, or both. The kidney dialysis center shall monitor microbial levels described in §B(1) of this regulation on a monthly basis. The kidney dialysis center shall maintain a log of water treatment system function and monitor the values on each occasion the machine is operated. The kidney dialysis center shall record in a log system malfunctions or temporary failures to meet standards. The kidney dialysis center shall report any system malfunction greater than 1 working day's duration, within 24 hours of discovery of the malfunction, to: The Office of Health Care Quality; The supplier as to the unprotected state of the dialysis facility; and The Commission on Kidney Disease. If the kidney dialysis center experiences a water system failure that may threaten patient health or safety, the center shall cease operations and implement its policies and procedures for handling emergencies, as provided in 42 CFR §405.2140(d), as amended which, is incorporated by reference. Before performing in-center nocturnal hemodialysis, the facility’s interdisciplinary team shall: Determine the patient’s appropriateness for in-center nocturnal hemodialysis by considering the patient’s: Overall medical condition; Expectations for care; Response to in-center day-time hemodialysis; and Availability of transportation; Document the patient’s appropriateness for in-center nocturnal hemodialysis in the patient’s medical record; and Obtain an order from a physician, nurse practitioner, or physician assistant for in-center nocturnal hemodialysis. A kidney dialysis center shall have an emergency plan. An emergency plan shall include policies and procedures that will be followed before, during, and after an emergency to address: The safe management of individuals who are receiving services at the kidney dialysis center when an emergency occurs; Notification of patients, families, staff, and licensing authorities regarding actions that will be taken concerning the provision of dialysis services to the individuals served by the kidney dialysis center; Staff coverage, organization, and assignment of responsibilities; and The continuity of operations, including procedures to secure access to essential goods, equipment, and dialysis services. This regulation does not prohibit a kidney dialysis center from applying for and receiving reimbursement: Under any applicable insurance policy; or From any State or federal funds that may be available due to a declared State or federal emergency. A kidney dialysis center is solely responsible for any financial obligation arising from voluntary or mandatory activation of any aspect of the emergency plan developed by the kidney dialysis center under this regulation. For purposes of coordinating local emergency planning efforts, a kidney dialysis center shall provide access to the emergency plan developed under this regulation to local organizations for emergency management. A dialysis provider shall provide the Office of Health Care Quality a 24/7 live operational contact phone number. Information Regarding the Status of Generators. A kidney dialysis center shall provide one of the following regarding the status of generators: Evidence of an on-site generator; The capacity to hook up a generator; or A copy of the contract with a company who will provide a generator in the event of an emergency, if there is no on-site generator. If the center has no plan to use the services of a generator, the center shall provide a copy of the center's emergency plan to the Office of Health Care Quality that will demonstrate that all measures possible are in place to avoid disruption of dialysis services to patients. Health-General Article, §19-3B-01 et seq., Annotated Code of Maryland Effective date: February 7, 2000 (27:2 Md. R. 144) Chapter revised effective November 17, 2008 (35:23 Md. R. 2013) Regulation .01B amended effective February 18, 2013 (40:3 Md. R. 217) Regulation .06C amended effective February 18, 2013 (40:3 Md. R. 217) Regulation .08 amended effective February 18, 2013 (40:3 Md. R. 217) Regulation .09A, C amended effective February 18, 2013 (40:3 Md. R. 217) Regulation .13 adopted effective February 18, 2013 (40:3 Md. R. 217) Regulation .14 adopted effective February 18, 2013 (40:3 Md. R. 217) In this chapter, the following terms have the meanings indicated. Terms Defined. “Allied 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, except those individuals who are licensed to practice medicine, dentistry, or podiatry under the Health Occupations Article, Annotated Code of Maryland. Freestanding Ambulatory Surgical Facility. “Freestanding ambulatory surgical facility” means a facility, service, office facility, or other entity that: Operates exclusively for the purpose of providing surgical services to patients requiring a period of postoperative observation but not requiring hospitalization and in which the expected duration of services would not exceed 24 hours following admission; and Seeks reimbursement from payors as a freestanding ambulatory surgical facility. “Freestanding ambulatory surgical facility” does not include: The office of one or more health care practitioners seeking only professional reimbursement for the provision of medical services unless the office operates under contract or other agreement with a payor as a freestanding ambulatory surgical facility, regardless of whether it is paid a technical or facility fee, or the office is designated to receive ambulatory surgical referrals in accordance with utilization review or other policies adopted by a payor; A facility or service owned or operated by a hospital and regulated under Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland; The office of a health care practitioner with not more than one operating room if the office does not receive a technical or facility fee, and the operating room is used exclusively by the health care practitioner for patients of the health care practitioner; The office of a group of health care practitioners with not more than one operating room if the office does not receive a technical or facility fee, and the operating room is used exclusively by members of the group practice for patients of the group practice; or An office owned or operated by one or more dentists licensed under the Health Occupations Article, Annotated Code of Maryland, for the sole purpose of practicing dentistry. Freestanding Endoscopy Facility. “Freestanding endoscopy facility” means a facility: For the testing, diagnosis, or treatment of a medical disorder in conjunction with the use of microscopic, endoscopic, or laparoscopic equipment that is inserted in a naturally occurring orifice of the body; and That seeks reimbursement as a freestanding endoscopy facility from third-party payors. “Freestanding endoscopy facility” does not include: The office of one or more health care practitioners unless the office operates under a contract or other agreement with a payor as a freestanding endoscopy facility, regardless of whether it is paid a technical or facility fee, or the office is designated to receive endoscopic referrals in accordance with utilization review or other policies adopted by a payor; or A facility or service operated by a hospital and regulated under Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland. “Payor” means: A health insurer, nonprofit health service plan, or health maintenance organization that holds a certificate of authority to offer health insurance policies or contracts in this State in accordance with Health-General Article, Title 19, Subtitle 7, and the Insurance Article, Annotated Code of Maryland; A third-party administrator or any other entity, under contract with a Maryland business to administer health benefits; or A self-insured group. Surgery. “Surgery” means a procedure conducted for the purpose of structurally altering the human body by the incision or destruction of tissues and is part of the practice of medicine. “Surgery” includes: The diagnostic or therapeutic treatment of conditions or disease processes by any instruments causing localized alteration or transposition of live human tissue which include, lasers, ultrasound, ionizing radiation, scalpels, probes, and needles; Cut, burned, vaporized, frozen, sutured, probed, or manipulated tissue by closed reductions for major dislocations or fractures, or otherwise altered by mechanical, thermal, light-based, electromagnetic, or chemical means; or Injection of diagnostic or therapeutic substances into body cavities, internal organs, joints, sensory organs, and the central nervous system. “Surgical services” means surgical procedures performed in a safe manner by qualified physicians who have been granted clinical privileges by the governing body of the ambulatory surgical center in accordance with approved policies and procedures of the ambulatory surgical center. 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. An applicant shall obtain Medicare certification as a condition of licensure for a freestanding ambulatory surgical facility. 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 for license renewal for a 3 year period. 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 as necessary. Credentialing of Physicians, Dentists, Podiatrists. 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, or podiatrist licensed under the Health Occupations Article, Annotated Code of Maryland: The physician's, dentist's, or podiatrist's education; The professional experience of the physician, dentist, or podiatrist, including: Any board certification or specialty training of the physician, dentist, or podiatrist, and Any post-graduate training; Any license or registration to practice a health occupation ever held by the physician, dentist, or podiatrist, including DEA registration; Whether any license or registration to practice a health occupation ever held by the physician, dentist, or podiatrist has been: Suspended, or Revoked; Any hospital where the physician, dentist, or podiatrist 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, dentist's, or podiatrist's professional liability insurance for the last 5 years, including: The physician's, dentist's, or podiatrist's present carrier, The physician's, dentist's, or podiatrist's current limits of coverage, The physician's, dentist's, or podiatrist's current types of coverage, and Restrictions on the physician's, dentist's, or podiatrist's coverage; Any claim that has been made against the physician, dentist, or podiatrist 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, dentist's, or podiatrist'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. The administrator shall consider the delineation of services requested by each physician, dentist, or podiatrist and approve, deny, or modify the request as the administrator deems appropriate. For a physician, dentist, or podiatrist who has privileges in a licensed Maryland hospital, the administrator may verify, through the hospital, the credentials described in §A(1) of this regulation. The administrator shall establish a procedure for the biennial reappointment of each physician, dentist, or podiatrist. The procedures shall include an evaluation of the following for all physicians, dentists, or podiatrists: An update of the information required in §A(1) of this regulation; and An assessment of the physician's, dentist's, or podiatrist's performance pattern based on an analysis of: Complaints filed with the freestanding ambulatory surgical facility, Malpractice claims filed, Utilization, quality, and risk data, Adherence to policies, bylaws, and procedures, and Physician, dentist, or podiatrist practice patterns as reviewed through the freestanding ambulatory surgical facility's quality assurance program. Credentialing of Allied Health Professionals. Direct Hires. The Administrator, in consultation with the medical director, shall collect, review, and verify evidence of the following information for all licensed or certified allied health professionals that are employed by the freestanding ambulatory surgical 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 each allied health professional. Nondirect Hires. When a licensed physician, dentist, or podiatrist uses an allied health practitioner to provide services at the freestanding ambulatory surgical facility, and that person is not employed by the facility, the licensed physician, dentist, or podiatrist who employs the allied health practitioner is responsible for verifying the information required in §D(1) of this regulation. Medical Director. The freestanding ambulatory surgical 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, dentist, or podiatrist licensed to practice in the general areas for which the freestanding ambulatory surgical facility provides services. Surgical procedures shall be performed in a safe manner by qualified physicians, dentists, or podiatrists who have been granted clinical privileges by the administrator. The administrator, in consultation with the medical director, shall develop and implement policies, procedures, and protocols for the provision of surgical 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. Before conducting a surgical procedure, a physician or other qualified health care practitioner shall conduct a history and physical examination. If anything other than an unsupplemented local anesthetic is needed to accomplish a surgical procedure, a qualified anesthetist shall conduct a pre-anesthesia evaluation and document the anesthetic risk to the patient. If the assessments required by §§C and D of this regulation are performed before the day of surgery, a qualified health care practitioner shall on the day of surgery reassess and document 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 anesthetist or, if local anesthesia is administered, the physician, dentist, or podiatrist who performed the surgery shall evaluate each patient for proper anesthesia recovery and document that evaluation. The physician, dentist, podiatrist, or anesthesiologist shall discharge each patient from the facility to a responsible adult, except those patients for whom no supervision is required as determined by the health care practitioner. 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; Physician or dentist qualified to administer anesthesia; Certified registered nurse anesthetist in accordance with Health Occupations Article, §8-205, Annotated Code of Maryland, and COMAR 10.27.06; or Podiatrist in accordance with Health Occupations Article, §16-101, Annotated Code of Maryland. 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 the facility. The licensee shall have: A registered nurse available on site for emergency treatment whenever there is a patient in the freestanding ambulatory surgical facility; At least one physician available by phone 24 hours a day to respond to emergency situations; and Formal arrangements to obtain radiology and laboratory services at all times in case of emergencies. The freestanding ambulatory surgical facility shall have at least the following emergency equipment available to the operating rooms: Emergency call system; Oxygen; Mechanical ventilatory assistance including airways, manual breathing bag, and ventilator; Cardiac defibrillator; Cardiac monitoring equipment; Tracheostomy set; Laryngoscopes and endotracheal tubes; Suction equipment; and Emergency medical equipment and supplies specified by the medical staff. 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. Procedures for emergency transfer to a hospital shall include, at a minimum: Having a written transfer agreement with a local Medicare participating hospital or requiring all physicians, dentists, or podiatrists performing surgery in the freestanding ambulatory surgical facility to have admitting privileges at such a hospital; Having a mechanism for notifying the hospital of a pending emergency case; Having a mechanism for arranging appropriate transportation to the hospital; and The manner in which a facility sends a copy of the patient's medical record to the hospital. The freestanding ambulatory surgical facility shall: Provide drugs and biologicals 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 reactions to the patient's health care practitioner and document these reactions in the patient's medical record. Only physicians or registered nurses shall administer blood and blood products. Orders given orally for drugs and biologicals 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 radiologic services to meet the needs of patients. 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 be licensed by this State. The freestanding ambulatory surgical facility shall include laboratory and radiologic reports in the patient's medical records. The facility shall comply with COMAR 10.05.01.09 and the requirements of this regulation. Each medical record shall include, at a minimum: Preoperative diagnostic studies, entered before surgery, if performed; Findings and techniques of the operation, including a pathologist's report on all tissues removed during surgery, except those tissues exempted by the medical director; Any allergies and abnormal drug reactions; and Entries related to anesthesia administration. The administrator shall ensure that the facility has a safe, functional, and sanitary environment for the provision of surgical services. Each operating room shall be designed and equipped to ensure that surgical 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. Health-General Article, §19-3B-01 et seq., Annotated Code of Maryland Effective date: August 23, 1999 (26:17 Md. R. 1322) Regulation .01B amended effective March 14, 2016 (43:5 Md. R. 385) Regulation .03 amended effective August 19, 2013 (40:16 Md. R. 1343); December 21, 2015 (42:25 Md. R. 1542)