S.C. Code Regs. § § 61-16.1201

Current through Register Vol. 48, 12, December 27, 2024

Section 61-16.1201 - Basic Facility Functions (I)

A.Pharmaceutical Services.

The Facility must have pharmaceutical services that meet the needs of the patients. The Facility must have a pharmacy directed by a registered pharmacist or a drug storage area under competent supervision. The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the Facility's organized pharmaceutical service.

1. Pharmacy management and administration. The pharmacy or drug storage area must be administered in accordance with accepted professional principles.

a. A full-time, part-time, or consulting pharmacist must be responsible for developing, supervising, and coordinating all the activities of the pharmacy services.

b. The pharmaceutical service must have an adequate number of personnel to ensure quality pharmaceutical services, including emergency services.

c. Current and accurate records must be kept of the receipt and disposition of all drugs.

2. Delivery of services. In order to provide patient safety, drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law.

a. All compounding, packaging, and dispensing of drugs and biologicals must be under the supervision of a pharmacist and performed consistent with State and Federal laws.

b. All drugs and biologicals must be kept in a secure area and locked when appropriate.

c. Drugs listed in Schedules II, III, IV, and V of the State and Federal controlled substances laws must be kept locked within a secure area.

d. Only authorized personnel may have access to locked areas.

e. Outdated, discontinued, mislabeled, or otherwise unusable drugs and biologicals shall not be available for patient use and shall be returned to the pharmacy for proper disposition in accordance with good pharmaceutical practice and facility policy.

f. Multi-dose vials shall be labeled with the date and time when opened or the date and time the vial should expire, as defined by facility policy and/or manufacture guidelines, whichever timeframe is shorter.

g. When a pharmacist is not available, drugs and biologicals must be removed from the pharmacy or storage area only by personnel designated in the policies of the medical staff and pharmaceutical service, in accordance with Federal and State law.

h. Drugs and biologicals not specifically prescribed as to time or number of doses must automatically be stopped after a reasonable time that is predetermined by the medical staff.

i. Drug administration errors, adverse drug reactions, and incompatibilities must be immediately reported to the attending physician and, if appropriate, to the hospital's quality assessment and performance improvement program.

j. Abuses and losses of controlled substances must be reported, in accordance with applicable Federal and State laws, to the individual responsible for the pharmaceutical service, and to the chief executive officer, as appropriate.

k. Information relating to drug interactions and information of drug therapy, side effects, toxicology, dosage, indications for use, and routes of administration must be available to the professional staff.

3. Student nurses may only administer medications under the direct supervision of a registered nurse who is the student's instructor and/or preceptor. The medical record must be signed/authenticated by both parties.

4. Self-administration of medications by patients may be permitted only when specifically ordered by the legally authorized healthcare provider in writing and the medications have been reviewed by a Registered Pharmacist prior to administration.

5. Medication variances and adverse drug reactions shall be reported immediately to the prescriber, supervising nurse and pharmacist, and recorded in the patient's medical record.

B.Radiological Services.

The Facility must maintain, or have available, diagnostic radiologic services. If therapeutic services are also provided, the therapeutic services and diagnostic services must meet professionally approved standards for safety and personnel qualifications.

1. The Facility must maintain, or have available, radiologic services according to needs of the patients.

2. The radiologic services, particularly ionizing radiology procedures, must be free from hazards for patients and personnel.

a. Proper safety precautions must be maintained against radiation hazards. This includes adequate shielding for patients, personnel, and facilities, as well as appropriate storage, use, and disposal of radioactive materials.

b. Periodic inspection of equipment must be made and hazards identified must be promptly corrected.

c. Radiation workers must be checked periodically, by the use of exposure meters or badge tests, for amount of radiation exposure.

d. Radiologic services must be provided only on the order of practitioners with clinical privileges or, consistent with State law, of other practitioners authorized by the medical staff and the governing body to order the services.

3. Personnel must adhere to the following:

a. A qualified full-time, part-time, or consulting radiologist must supervise the ionizing radiology services. For purposes of this section, a radiologist is a doctor of medicine or osteopathy who is qualified by education and experience in radiology.

b. Only personnel designated as qualified by the medical staff may use the radiologic equipment and administer procedures.

4. Records of radiologic services must be maintained.

a. The radiologist or other practitioner who performs radiology services must sign reports of his or her interpretations.

b. The Facility must maintain the following for at least 5 years:

i. Copies of reports and printouts.

ii. Films, scans, and other image records, as appropriate.

C.Laboratory Services.

The Facility must maintain, or have available, adequate laboratory services to meet the needs of its patients. The Facility must ensure that all laboratory services are provided in accordance with Clinical Laboratory Improvement Act (CLIA) requirements.

1. The Facility must have laboratory services available, either directly or through a contractual agreement with a CLIA-certified laboratory.

2. Emergency laboratory services must be available 24 hours a day.

3. A written description of services provided must be available to the medical staff.

4. The laboratory must make provision for proper receipt and reporting of tissue specimens.

5. The medical staff and a pathologist must determine which tissue specimens require a macroscopic (gross) examination and which require both macroscopic and microscopic examinations.

6. The Facility must maintain:

a. Records of the source and disposition of all units of blood and blood components for at least 10 years from the date of disposition in a manner that permits prompt retrieval; and

b. A fully funded plan to transfer these records to another Facility or other entity if such Facility ceases operation for any reason.

D.Emergency Services.

1. No person, regardless of his ability to pay or county of residence, may be denied emergency care if a member of the admitting hospital's medical staff or, in the case of a transfer, a member of the accepting hospital's medical staff determines that the person is in need of emergency care.

2. Hospitals that do not offer Obstetrical services shall have readily available in the emergency department a precipitous delivery kit, to include at a minimum: bulb suction syringe, cord clamp, scissors, sterile towels, and emergency telephone numbers for the appropriate Regional Perinatal Center.

3. If the care required for any patient is not available at the hospital, arrangements must be made for transfer to a more appropriate hospital. Prior to the transfer of a patient to another hospital, the receiving hospital shall be notified of the impending transfer.

4. On its initial and renewal licensure applications, each hospital shall classify itself to indicate its capability in providing emergency care. Such classification will be for the hospital's on-campus emergency service and, if applicable, its off-campus emergency service. General Hospitals shall be classified as a Type I, II, or III, except that an existing General Hospital that was approved and licensed without either a Type I, II, or III emergency service may classify itself as a Type IV emergency service. Specialized Hospitals shall be classified as a Type I, II, III, or IV. Off-campus emergency services may be the same Type as or a lower-level Type than the hospital's on-campus emergency service (e.g., if a hospital's on-campus emergency service is a Type II, the off-campus emergency service may not be a Type I).

a. Type I means a hospital that offers comprehensive emergency care 24 hours per day, with at least one physician experienced in emergency care on duty in the emergency care area. There is in-hospital physician coverage by members of the medical staff or by senior-level residents for at least medical, surgical, orthopedic, obstetric/gynecologic, pediatric, and anesthesia services. Other specialty consultation is available within approximately 30 minutes.

b. Type II means a hospital that offers emergency care 24 hours per day, with at least one physician experienced in emergency care on duty in the emergency care area. Specialty consultation is available within 30 minutes by members of the medical staff or senior-level residents. The hospital's scope of services includes in-house capabilities for managing physical and related emotion problems, with provision for patient transfer to another organization when needed.

c. Type III means a hospital that offers emergency care 24 hours per day, with at least one physician available to the emergency care area within 30 minutes through a medical staff call roster. Specialty consultation is available by request of the attending medical staff member or by transfer to a designated hospital where definitive care can be provided.

d. Type IV means a hospital that offers reasonable care in determining whether an emergency exists, renders lifesaving first aid, and makes appropriate referral to the nearest organization that is capable of providing needed services. Type IV Hospitals do not represent or hold themselves out to the public as offering emergency care 24 hours per day. The mechanism for providing physician coverage at all times is defined by the medical staff.

5. A hospital licensed in South Carolina may open and operate freestanding emergency services within a 35-mile radius of its hospital campus. This freestanding emergency service shall be an extension of the existing hospital's on-campus emergency service.

6. For Types I, II, and III, the emergency service entrance shall be separated from the main entrance, well-marked and illuminated, easily accessible from the street and sufficiently covered or enclosed to protect ambulance patients from the elements during the unloading process.

7. For Types I, II, and III, the hospital shall post rosters designating medical staff members on duty or on call for primary coverage and specialty consultation in the emergency care area.

8. For Type IV, hospitals shall provide physician and registered nurse coverage 24 hours per day. Nursing and other allied health professionals shall be readily available in the hospital. Staff may have collateral duties elsewhere in the hospital, but must be able to respond when needed without adversely affecting patient care or treatment elsewhere in the hospital. Type IV hospitals shall have trained staff to screen patients, staff, and visitors, to render lifesaving first aid, and transfer to an appropriately licensed facility.

9. Diversion Status - Inability to Deliver Emergency Services.

a. Types I, II, and III hospitals shall develop and implement a diversion policy which describes the process of handling those times when the hospital must temporarily divert ambulances from transporting patients requiring emergency services to the hospital. The policy must include the following: when diversion is authorized to be called; who is authorized to call and discontinue diversion; efforts the hospital will make to minimize the usage of diversion; and how diversion will be monitored and evaluated.

b. Types I, II, and III hospitals shall notify local ambulance providers and/or other appropriate parties when the hospital is temporarily unable to deliver emergency services and is declaring itself on diversion.

10. As part of its quality assessment and performance improvement program, a hospital with a Type I, II, or III emergency service shall on at least an annual basis evaluate its emergency service staffing utilizing appropriate emergency services metrics, which may include door to doctor times, patients leaving without being seen, boarding hours, lengths of stay, and patient experience. The hospital must document the findings and recommendations of its evaluation and, when appropriate, implement measures to improve its emergency services staffing.

E.Central Supply.

1. The department head shall be qualified for the position by education, training and experience as determined by the Facility policies and procedures. (II)

2. The number of supervisory and other personnel shall be related to the scope of the services provided. (II)

3. There shall be written policies and procedures for the decontamination and sterilization activities performed in central supply and elsewhere in the Facility. These policies and procedures shall address the following:

a. The use of sterilization process monitors, including temperature and pressure recordings, and the use and frequency of appropriate chemical indicator and bacteriological spore tests for all sterilizers.

b. Designation of the shelf life for each hospital-wrapped and hospital-sterilized medical item and, to the maximum degree possible, for each commercially prepared item, by a specific expiration date that sets a limit on the number of days an item will be considered safe for use. When possible, load control numbers shall be used to designate the sterilization equipment used for each item, including the sterilization date and cycle.

4. A recognized method of checking sterilizer performance shall be used. A chemical indicator of some type should be included in the largest package of each load. Biological indicators (live bacterial spores) should be included in all steam and hot air sterilizers at least once per week or more often depending upon the degree of sterilizer usage. Gas sterilizers should employ such indicators on at least a weekly basis and preferably on a daily basis. Further, the gas sterilization of implants, prosthetic devices, etc., should be accompanied by a biological monitor in each load. Monthly checks shall be made to ensure the above, and a written report retained.

5. Adequate precautions shall be taken to ensure that sterile supplies and equipment are not mixed with unsterile material. Suitable space shall be provided for keeping equipment and supplies in a clean, convenient and orderly manner.

6. All packaged supplies and containers for solutions, drugs, medicated supplies, etc., shall be labeled so as to remain plainly legible before and after sterilization. Labels shall include at least the expiration date of the contents.

7. Outdated medical supplies, solutions, etc., shall be returned to central supply for resterilization or disposal.

S.C. Code Regs. § 61-16.1201

Replaced and amended by State Register Volume 38, Issue No. 6, eff 6/27/2014; State Register Volume 48, Issue No. 06, eff. 6/28/2024.