Current through Register Vol. XLI, No. 43, October 25, 2024
Section 64-12-7 - Paramedical Storage7.1. Pharmaceutical Service.7.1.1. A licensed pharmacist shall be responsible for developing, supervising, and coordinating all pharmacy services, including the distribution of samples, provided at the hospital.7.1.2. The pharmacist may be employed on a full-time, part-time, or consulting basis.7.1.3. All compounding, packaging, and dispensing of drugs and biologicals shall be under the supervision of a pharmacist and performed consistent with federal and state laws.7.1.4. All drugs, including drugs stored outside the pharmacy, shall be stored in locked cabinets, medication rooms, or medication carts approved by the Director of Pharmacy. This shall ensure the integrity of the medications and safety for the patients and the general population. It shall further ensure medications are only accessible to authorized personnel according to hospital policy.7.1.5. When a pharmacist is not available, drugs and biologicals may be removed from the pharmacy or storage area only by personnel authorized in accordance with federal and state law and hospital and medical staff policies.7.1.6. Drugs and biologicals not specifically prescribed as to a time or number of doses shall be stopped after a reasonable period of time which is pre-determined by medical staff policy.7.1.7. All medication storage areas shall have a designated area or compartment for the separate storage of external medications.7.1.8. The medication preparation area shall be clean, well illuminated and have adequate space for the storing and preparation of medications.7.1.9. Narcotics and controlled drugs which are required to conform to federal or state regulations or rules shall be kept within a secure storage area accessible only to authorized personnel.7.1.10. Surplus narcotics or narcotics with an expired date shall be disposed of according to applicable federal and state regulations.7.1.11. A record shall be maintained, or a system developed, to track the receipt and distribution of controlled drugs.7.1.12. Outdated, mislabeled, or otherwise unusable drugs and biologicals shall not be accessible for patient use.7.1.13. Except for medication packaged for unit doses, all unused medications shall be discarded when orders have been discontinued or the patient has been discharged from the hospital.7.1.14. Drug administration errors, adverse drug reactions, and incompatibilities shall be immediately reported to the attending practitioner and Director of Pharmacy and investigated using current and readily accessible drug and patient information. This information shall be evaluated as part of the hospital quality improvement program.7.1.15. The medical staff shall establish a formulary system and review it as necessary.7.1.16. The Director of Pharmacy shall provide a system for the recognition and treatment of any drug/drug product or food/drug interactions and incompatibilities.7.1.17. Drugs and biologicals shall be prepared and administered in accordance with: 7.1.17.a. Federal and state law;7.1.17.b. The orders of the practitioner or practitioners responsible for the patient's care; and7.1.17.c. Accepted standards of practice.7.2. Medical Records Department and Information System. 7.2.1. The hospital shall maintain a medical records department and information system sufficient to support the maintenance of patient records, including computer generated medical records, and quality improvement activities. The medical records department shall be under the supervision of a person qualified by training and experience as defined by hospital policy.7.2.2. The hospital shall ensure that a coding and indexing system is used that allows for retrieval of medical records by diagnosis and procedures.7.2.3. The hospital shall employ adequate personnel to ensure prompt completion, filing, and retrieval of records.7.2.4. The hospital shall maintain a medical record for every individual evaluated or treated in the hospital on an inpatient and an outpatient basis.7.2.5. The hospital shall use a system of author identification and record maintenance that ensures the integrity of the authentication and protects the security of all record entries.7.2.6. The hospital shall preserve medical records, including records of patients treated in the emergency room or outpatient department, for a minimum of five years in their original form or in a legally reproduced form.7.2.7. The hospital shall have procedures in place for ensuring the confidentiality of patient records and for ensuring that only authorized can gain access to or alter patient records.7.2.8. The hospital shall only release originals or copies of medical records in accordance with federal and state laws or upon receipt of an order from a court of competent jurisdiction.7.2.9. The hospital shall provide copies of medical records and any other pertinent data within 48 hours of a written request by the Office of Health Facility Licensure and Certification.7.2.10. The inpatient medical record shall include at a minimum the following:7.2.10.a. Documentation to justify admission and support the diagnosis;7.2.10.b. Patient identification;7.2.10.c. The date of admission and discharge;7.2.10.d. Advance directives information;7.2.10.e. A history of present illness;7.2.10.f. A personal and family history;7.2.10.g. A physical examination completed within 30 days prior to admission or within 48 hours after admission. If the history and physical was performed within the 30 days prior to admission there shall be an updated note addressing the patient's current status, any changes in the patient's status, or both. This note shall be on or attached to the history and physical. A history and physical performed within seven days prior to admission does not require an updated note;7.2.10.h. Practitioner's orders;7.2.10.i. Examinations and consultations;7.2.10.j. Clinical laboratory and imaging results;7.2.10.k. Provisional or working diagnosis;7.2.10.l. Treatments and medications provided;7.2.10.m. Surgical reports including operative and anesthesia records;7.2.10.n. Gross and microscopic pathological findings;7.2.10.o. Progress and nurses' notes;7.2.10.p. Any assessments implemented;7.2.10.q. Final diagnosis and condition on discharge;7.2.10.r. Multi-disciplinary discharge planning and the physician's discharge summary;7.2.10.s. Properly executed informed consent forms for procedures and treatments specified by the medical staff, or by federal or state law, if applicable, to require written patient consent;7.2.10.t. Death certificate when the hospital considers it necessary; and7.2.10.u. Autopsy findings, if an autopsy is performed.7.2.11. The hospital shall maintain a medical record for each newborn infant separate from the mother's record.7.2.12. A short form medical record may be used for patients who are in the hospital less than 48 hours except in the case of maternity and newborn infants. The short form shall contain a minimum of the following: 7.2.12.a. Documentation of a history and physical;7.2.12.c. Any treatment and services provided.7.2.13. All entries shall be legible and shall be authenticated and dated promptly by the person, identified by name and discipline, who is responsible for ordering, providing, or evaluating the service furnished.7.2.14. Authentication may include signatures which may be electronic.7.2.15. All clinical information pertaining to each patient shall be filed in the patient's medical record.7.2.16. All orders for medication or treatment shall be recorded in writing or validated by a secure electronic system and filed in the patient's medical record or appropriately filed in the patient's electronic record. The use of signature stamps or electronic identification is acceptable when a mechanism is in place to ensure the stamp or identifier is limited to use by the identified person only.7.2.17. The hospital shall ensure that verbal and telephone orders shall be given to registered professional nurses and other licensed or registered health care professionals, in their area of training and professional expertise, when authorized by the medical staff policies: Provided, That any verbal or telephone order received by a licensed or registered health care professional shall also be communicated to the registered professional nurse responsible for the overall care of that patient.7.2.18. Physicians shall countersign and date all verbal and telephone orders at the next hospital visit in which a patient visit occurs and an entry is written in the chart.7.2.19. A plan of care shall be developed and maintained for each patient through the coordinated efforts of the registered professional nurses and other health care professionals involved in the care of the patient. The plan of care shall be maintained as part of the patient's medical record.7.2.20. Only abbreviations approved by the medical staff shall be used in medical records.7.2.21. Medical records shall be completed, authenticated, and signed by the physician or dentist within 30 days following the discharge of the patient.7.2.22. The hospital shall report a complete list of all births, deaths, and fetal deaths occurring within each month in licensed hospitals by the tenth of the following month on forms approved by the Director or on a comparable computer printout approved by the Director to the state registrar of vital statistics.7.2.23. The hospital shall send all completed birth certificates to the state registrar of vital statistics within 10 days following the birth.7.2.24. Licensed hospitals shall comply with the Department of Health Legislative Rule, Reportable Diseases, Events, and Conditions, 64CSR7; AIDS-Related Medical Testing and Confidentiality, 64CSR64; and any other applicable rules regarding the reporting of diseases, infections, or laboratory test results to the state.7.2.25. The hospital shall have a procedure to provide information to the cancer registry as defined in W. Va. Code §16-5A-2a.7.2.26. In the event of closure, a hospital shall make arrangements for medical record retention and retrieval. The hospital shall provide written documentation of this arrangement to the Director.7.2.27. The hospital shall have a mechanism in place to supply to any patient who has received services from the hospital, whether on an inpatient or outpatient basis, upon request, one itemized statement which describes with specificity the exact service or medication for which a charge is assessed to the patient at the institution, at no additional cost to the patient. In the event of the death of the patient, an authorized individual to be determined on a case by case basis may make the request and shall receive the statement at no additional cost.7.3. Dietetic Services.7.3.1. The hospital dietetic service shall comply with the Department of Health Legislative Rule, Food Establishments, 64CSR17.7.3.2. There shall be an organized dietetic service, planned, equipped, and staffed to meet the nutritional needs of the patient population.7.3.3. The hospital shall have a full-time employee who: 7.3.3.a. Serves as supervisor of the dietetic services;7.3.3.b. Is responsible for daily management of the dietetic services; and7.3.3.c. Is qualified by experience or training.7.3.4. Provisions shall be made for continued in-service training of the designated dietetic service supervisor.7.3.5. The food services department shall be under the direction of a full-time dietician or a person with training and experience in food service administration. Only a qualified dietician or other person with suitable training may direct the food services department.7.3.6. Responsibilities of the Director of the Dietetic Services shall include:7.3.6.a. Approval of menus;7.3.6.b. Establishment of policies and procedures;7.3.6.c. Patient and family counseling; and7.3.6.d. Maintenance of liaison with other services.7.3.7. There shall be a qualified dietician available on a full-time, part-time, or a consultant basis. A qualified dietician shall be registered or eligible for registration with the Commission on Dietetic Registration of the American Dietetic Association and be licensed in the state of West Virginia by the Board of Licensed Dietitians.7.3.8. The dietetic service department shall maintain records which include the following: 7.3.8.a. A staffing schedule for all persons employed full-time or part-time in the food service department indicating the number of hours each employee works weekly; and7.3.8.b. A job description for each type of food service department position with verification that each employee has been familiarized with his or her duties and responsibilities.7.3.9. The dietetic service department shall post written and dated menus planned at least 14 days in advance for both therapeutic and general diets in appropriate places in the food preparation area and be available to administrative personnel.7.3.10. Menus, as served, with all substitutions noted, shall be filed in the dietetic service department for at least four weeks.7.3.11. All therapeutic diets, including between meal nourishments, shall be prepared and served as recommended by a qualified dietician.7.3.12. A current therapeutic diet manual approved by the dietitian and medical staff shall be readily available to the medical, nursing, and dietetic service personnel.7.3.13. The hospital shall employ adequate personnel to perform the functions of the dietetic service department.7.3.14. The hospital shall provide procedures to prevent the contamination of meals and other items prepared or served by the dietetic service department employees.7.3.15. The hospital shall provide an in-service training program designed to meet the needs of dietetic service employees, including training in proper food sanitation practices and personal hygiene.7.3.16. The hospital may contract with an outside company for the dietetic service if the outside company has a qualified dietitian who serves the hospital on a full-time or part-time consulting basis, and if the company complies with the Department of Health Legislative Rule, Food Establishments, 64CSR17.7.3.17. Dry or staple food items shall be stored at least six inches off the floor in well-ventilated rooms which are not subject to contamination by sewage, water backflow, contaminated water, leakage, rodents, or vermin.7.3.18. Potentially perishable foods shall be maintained at a temperature of 45 degrees Fahrenheit or below. Refrigerators and storerooms used for perishable foods shall be equipped with reliable thermometers.7.3.19. All ice used in contact with food or drink shall comply with the Department of Health Legislative Rule, Public Water Systems, 64CSR3.7.3.20. The dietetic service department shall retain a sample of potentially hazardous foods from the menu of each meal under adequate refrigeration for a period of at least 24 hours after serving. By this method, proper samples of food are available for laboratory examination in the event of a food borne disease outbreak.7.3.21. Poisonous and toxic materials shall bear warning labels, be stored separately from food or equipment used on preparing and serving food and shall be used only in ways that shall neither contaminate food nor be hazardous to employees.7.3.22. Food being served or transported shall be protected from contamination and held at the proper temperature in clean containers, cabinets, or serving carts.7.3.23. Garbage and refuse shall be placed in impervious containers equipped with tightly fitting covers.7.3.24. Garbage containers shall be stored in a safe area or refrigerated space pending removal and shall be removed from the premises and sanitized daily.7.4. Infection Control. 7.4.1. The hospital shall provide a sanitary environment to avoid sources and transmission of infections and communicable diseases.7.4.2. The hospital shall have an active surveillance and education program for the prevention, early detection, control, and investigation of infections and communicable diseases.7.4.3. The program shall include implementation of a nationally recognized system of infection control guidelines.7.4.4. The program shall be both hospital-wide and program-specific and enforced by the individual designated by the medical staff.7.4.5. The hospital shall designate a person or persons as infection control officer or officers to develop and implement policies governing control of infections and communicable diseases for patients and personnel.7.4.6. The infection control professional or designee shall maintain a log of incidents related to infections and communicable diseases.7.4.7. The hospital administrator, medical staff, and the Director of Nursing shall ensure that the quality improvement program and training programs address problems identified by the infection control officer or officers and be responsible for the implementation of successful corrective action plans in affected problem areas.