These regulations are applicable to all health care facilities within correctional institutions and include those services provided inmates who report to the health care facility on an out-patient basis. These regulations do not include infirmaries which do not house patients overnight. “Communicable disease programs” means the provision of services that will assist in the prevention of communicable disease. “Department” means the Maryland Department of Health. “Health care facility” means a specified area within the correctional institution in which general and clinical health care services are provided to inmates in the custody of the Division of Corrections. “Health care program” means a document prepared by the facility and approved by the Department which lists the following: The number of beds; Organizational structure; A description of the care, treatment, and services provided for inmates; Admission policies; Discharge and referral policies and procedures; The staffing pattern by shifts; The job classification and job descriptions of each employee. “Inpatient” means an inmate not requiring acute hospital care but requiring services of licensed nursing personnel or supportive services which he cannot perform for himself. “Referred services” means those appropriate services provided to inmates based on individual medical needs in the area of psychiatric services, dental care, or emergency care. “Sick call” means the medical care provided to inmates not classified as inpatients but who have expressed a need for medical attention or who have been referred to the health care facility by the appropriate personnel in the correctional institution. Each correctional facility shall demonstrate to the Department its compliance with applicable State and local ordinances, laws, regulations, and orders as they apply to the use of facilities for health, welfare and safety. Fire code requirements shall be: In accordance with the NFPA 101 Life Safety Code as adopted as part of the State Fire Prevention Code of Maryland; Annual inspection and approval by the State fire authority. Applicants for licensure shall conform to the following: Any person desiring to open and operate a health care facility within a correctional institution or to continue the operation of an existing health care facility, shall file a written or electronic application with the Department giving the information required by the Office of Health Care Quality; The applicant shall submit a synopsis of the health care program to be offered with the application; each subsequent application shall include a list of changes in the original program. Transfer or assignment of the license is prohibited. A separate license shall be required for each health care facility operated within the correctional institution. Health Care Facility to be Open for Inspection. Health care facilities, and any premise proposed to be operated by an applicant for a license, shall be open at all reasonable times to inspection by the Secretary of Health and by any agency designated by the Secretary of Health. Frequency of Inspection. Health care facilities shall be inspected by the Secretary of Health at least once during each 1-year period for which a license is granted to determine whether the health care facility is complying with the minimum standards established pursuant to these regulations. Records and Reports. All records shall be open to inspection by authorized representatives of the Department. Except where authentication may be required, the disclosure of patient names to the Division of Licensing and Certification surveyor may not be required. The representatives of the Department shall maintain confidentiality of all the data disclosed to them. Written policies and procedures shall be established for the following services: Physician services; Health care services; Staffing; Emergency care; Medical research; Communicable diseases; Medical examinations and evaluation process; Pharmacy services; Dietary services; Nursing Services. There shall be a telephone in the health unit and additional telephones or extensions or communication systems as required by the Department to summon help in case of fire or other emergency. Medical Examination. Each newly received inmate to the health facility shall be examined within 2 working days after his admission as to his medical condition. A record of each examination shall be kept as part of the permanent medical record. Availability. A licensed physician shall be readily available to take care of the medical needs of the inmates. Physician services may be provided through the following arrangements: A contract with a local physician to provide coverage on specified hours and for emergencies; or Affiliation with a local hospital to provide medical services required by the health care facility. Psychiatric services shall be provided according to the needs of the patients. Each health care facility desiring to perform surgical procedures shall first obtain approval from the Department. Health care services shall be provided according to the needs of the inmates and shall be designed to maintain the highest possible degree of function, self-care, and independence. A health care program shall be developed to insure prompt treatment of injury or illness. The health care facility shall provide equipment necessary for medical care according to the needs of the patients. An individual medical record shall be maintained for each patient. The record shall indicate their condition at the time of admission, reports of illness and injury, medical treatment provided, results of treatment, and their condition at the time of discharge. The health facility shall provide the number and level of personnel sufficient to meet the total needs of the patient. Health facilities shall employ licensed personnel to provide medical services when applicable. The facility shall provide personnel who are qualified by both training and experience in the handling of health emergencies. Each health facility in cooperation with the facility physician shall set forth in writing, to all personnel, the routine procedure for summoning appropriate medical care personnel. Each health facility involved in medical research shall follow standards developed by the American Correctional Association for the safety and well-being of the inmate population. Cross-infection shall be guarded against by prompt isolation of diagnosed and suspected cases of communicable disease. Room furnishings, equipment, and supplies shall be kept clean at all times, properly cleaned after use, and disinfected. Reports of Disease. The occurrence of an infectious disease, food poisoning, or dysentery, shall be reported immediately by the examining physician to the local health department and to the Division of Licensing and Certification. Written policies and procedures shall be developed and maintained in consultation with representatives of the medical staff, nursing service, and administration governing the provisions for the control of the sick call process and referral services. They shall address the following: Screening Procedures. Routine handling of patient complaints; Non-routine handling of patient complaints. Reporting Procedure. A responsible staff member to whom an inmate can report injuries, symptoms of illness, and emergencies shall be on duty at all times and be immediately accessible. Complaint Procedure. Complaints of illness or injury shall be recorded in the inmate's clinical record together with the treatment prescribed. Examination Procedure. The procedure shall specify where the examination area is located as well as who is to perform the examination. Procedures to be followed by the correctional officer in attendance. There shall be a combined orientation and continuing education program at least every 2 months for all personnel. Documentation shall be available to include date, time, topic discussed, speaker, and members present. A coordinated training program with a local hospital is encouraged. There shall be health care orientation and training for correctional officers assigned to medical facilities. Assignments and activities of correctional officers in medical areas shall be established. Procedures for Administration of Pharmaceutical Services. Each facility shall comply with all federal, State, and local laws, ordinances, standards and codes regulating the purchasing, storage, dispensing, administration, and recording of drugs. Each health care facility shall: Ensure that pharmaceutical services are provided; Make provision for prompt and convenient acquisition of prescribed drugs; Record all supplies and drugs requisitioned and received from the pharmacy; Record all prescriptions dispensed; Obtain a permit to operate a pharmacy from the Board of Pharmacy in the State if the pharmacy is located within the correctional facility; If the facility has no pharmacy, there shall be a written agreement for qualified pharmacy services, including provision for emergency service and consultation. Staff Requirements. Pharmaceutical service, when provided within the health care facility, shall be under the direction and supervision of a pharmacist licensed to practice pharmacy in the State. The staff or consultant pharmacist at each correctional facility shall participate in planned inservice education programs for the facility on topics related to pharmaceutical services. The consultant pharmacist shall be available to assist in formulating the procedures, rules, and regulations for the acceptable distribution of drugs throughout the correctional system and shall visit the facility on a regular basis to review all aspects of the services provided and to ensure that proper controls are maintained. Formulary. There shall be a formulary system, approved by the institutional physician and pharmacist and by other appropriate facility staff. Copies of the formulary shall be located and available as appropriate to the institution. Space and Equipment. If the pharmacy is located within the health care facility there shall be adequate space and equipment to house the drugs and supplies. The pharmacist and pharmacy personnel, under the direct supervision of the pharmacist, may not dispense medications, make label changes, or transfer medications on other than the original containers. Documentation of the qualifications of the pharmacy personnel shall be available. Emergency Kit. There shall be an emergency drug kit immediately available at each nursing or service area for use by medical personnel. Written policies and procedures establishing the contents of the supply and procedures establishing the contents of the supply and procedures for use, restocking, and sealing of the emergency drug supply shall be available. A list of drugs shall be signed by the pharmacist and physician and attached to the kit. Stop Order Policy. Automatic stop orders on all drugs shall be maintained by the medical and pharmacy staff. These orders may not apply when the physician indicates a specific period of time a drug is to be used, or a specific number of dosages. Medication Release. All medications to be released to the patient shall be approved in writing by the physician. A notation concerning their disposition shall be made on the patient's clinical record. Administration of Medications. All medications shall be administered by licensed medical or nursing personnel or by personnel who possess written documentation of training in theory and practice in the administration of medications. This written documentation shall be available for review by the Department. The person assigned the responsibility of administering medications to inpatients shall complete the procedure by: Personally preparing the dose; Observing the act of swallowing the oral medications; Recording the act of administration. In the case of unit dose medications the person administering medication shall: Open the unit dose package; Observe the taking and swallowing of the medication; Record the administration of the medication. Medication shall be given only to the individual patient for whom the prescription was issued and shall be given according to directions as prescribed. Medication cards and lists, or acceptable substitutes, shall be used and checked against the physician's orders when administering medications to inpatients. Self-administration of medications by patients shall be permitted only when specifically ordered by the attending physician. Medication errors and drug reactions shall be reported to the physician responsible for the resident. An entry of the medication error or the drug reaction or a combination of both, shall be recorded in the patient's record. Current pharmaceutical reference materials shall be provided in order to furnish the medical, pharmacy, and nursing staffs with current information concerning the drugs used in the hospital. Investigational Drugs. Investigational drugs, properly labeled according to federal regulations, may be used only under the direct supervision of the principal investigator and after written consent is obtained from the patient. The drugs shall be approved by an appropriate medical staff committee acting according to established policies and procedures. Only physicians and nurses may administer investigative drugs after they have been made aware of the essential pharmacologic information necessary for them to discharge their professional responsibilities. A central location shall be established where information on investigational drugs being used is maintained. Labeling and Storing of Medication. All medications shall be properly labeled and stored in a locked cabinet at the medical unit. The key to this cabinet shall be in the possession of authorized personnel. The labels shall bear the name and strength of the drug, expiration date of all time-dated drugs, name of the pharmacy issuing the drug, name of patient, and federal and State cautionary statements. Necessary labels shall be affixed to the labeled container. Medications requiring refrigeration shall be kept in a locked refrigerator. Poisons and medication for “external use only”, including rubbing alcohol, shall be kept in a locked cabinet or compartment separate and apart from internal medications. Discontinued and outdated drugs, and containers with worn, illegible, or missing labels, shall be returned to the pharmacy for proper disposition. A drug recall procedure shall be established that can be readily implemented. Drug cabinets on the medical units shall be checked by the pharmacist at least every 2 months. Control of Schedule II and Legend Drugs. All Schedule II drugs shall be kept in a separately locked, securely fastened compartment within the locked medicine cabinet. All Schedule II drugs retained on each nursing unit shall be counted at the termination of each tour of duty. This record shall be signed by both the outgoing and incoming professional nurse or authorized person. Schedule II drugs which are outdated and no longer in use shall be disposed of according to federal regulations. All other discontinued or outdated drugs shall be disposed of according to State regulations. Adequacy of Diet. The food and nutritional needs of patients shall be met according to physician's orders. Therapeutic Diets. The therapeutic diet prescribed by the attending physician shall be prepared and served as part of the course of treatment of the patient. If the dietary requirement is beyond the capability of the facility, other arrangements for the nutritional needs shall be made by the health care facility physician. A diet manual approved by the physician or dietitian shall be available. Frequency and Quality of Meals. At least three meals or their equivalent shall be served daily, at regular times, with not more than a 14-hour interval between the evening meal and breakfast. Planning of Menus. Menus shall be planned in advance and food sufficient to meet the nutritional needs of residents shall be prepared as planned for each meal. When menu changes are necessary, substitutions shall provide equal nutritional value. Preparation of Food. Food shall be prepared by methods that conserve nutritive value, flavor, and appearance, and shall be served at proper temperature. Compliance with COMAR 10.15.03 Food Service Facilities. Food service personnel shall comply with Maryland Department of Health COMAR 10.15.03 Food Service Facilities. The following shall be observed: The building and all its parts shall be kept in good repair, neat, clean, attractive, and safe. Housekeeping shall meet the highest possible standards of hygiene and cleanliness. All walls, floors, ceilings, windows, and fixtures shall be kept clean. Interior walls and floors shall be of a character to permit frequent and easy cleaning. The facility shall be kept free of unnecessary accumulations of unused furniture, equipment, linen, clothing, and similar items. The facility shall be maintained free of insects, rodents, and harborages, by operation of an active pest-control program, either by use of facility personnel or by contract with a pest-control company. Care shall be exercised in the usage and storage of toxic and flammable insecticides and rodenticides. All outside doors, windows, and other outside openings shall be screened with wire screen or its equal of at least 16 meshes per linear inch. Health-General Article, §§19-307, 19-308, 19-320, and 19-323, Annotated Code of Maryland Effective date: June 16, 1978 (5:12 Md. R. 967) Regulation .04A amended effective March 13, 2017 (44:5 Md. R. 292) Regulation .20A amended effective March 13, 2017 (44:5 Md. R. 292)