44:76:09:01.  Laboratory services. Laboratory services performed in an ambulatory surgery center shall be under the supervision of a qualified director or shall be done by a laboratory that has a valid Clinical Laboratory Improvement Amendment (CLIA) certificate. Laboratory examinations necessary for diagnosis and treatment of the patient shall be performed in the facility or by arrangement. Laboratory examinations required on facility admissions are determined by the medical staff and bylaws. The original laboratory report shall be made a part of the patient's medical record.

          Source: 42 SDR 51, effective October 13, 2015.

          General Authority: SDCL 34-12-13(11).

          Law Implemented: SDCL 34-12-13(11).

          Note: CLIA applications are obtained from the South Dakota Department of Health, Office of Licensure and Certification, 615 East 4th Street, Pierre, SD 57501. Telephone (605) 773-3356, Division of Laboratory Standards and Performance, Health Standards and Quality Bureau, Centers for Medicare/Medicaid Services, 7500 Security Boulevard S-2-11-07, Baltimore, MD 21244-1850. Telephone (410)-786-3531, or online at www.phppo.cdc.gov/clia/default.osp.

          44:76:09:02.  Pathology services. Each laboratory shall have the services of a pathologist available within the facility or by arrangement. Any tissue removed from a patient shall be handled as outlined in facility policy. Pathology services by arrangement shall be governed by written policies and procedures establishing guidelines for the prompt transportation of specimens and submission of reports.

          Source: 42 SDR 51, effective October 13, 2015.

          General Authority: SDCL 34-12-13(11).

          Law Implemented: SDCL 34-12-13(11).

          44:76:09:03.  Technical laboratory operations. Each laboratory shall have a policy and procedural manual for each phase of operation. There shall be a quality control program to insure the reliability of laboratory test data. Each item of diagnostic test equipment shall be routinely checked and shall be precise in terms of calibration as shown by records maintained in the laboratory.

          Source: 42 SDR 51, effective October 13, 2015.

          General Authority: SDCL 34-12-13(11).

          Law Implemented: SDCL 34-12-13(11).

          44:76:09:04.  Blood transfusion services. Each facility providing transfusion services shall provide facilities and equipment for the procurement, storage, and administration of blood products. Blood, blood products, and equipment required for their administration shall be provided to meet the needs of the patients. The transfusion service shall be under the supervision of the medical staff. There shall be written policies and procedures regarding administration of blood products, as well as the investigation of possible transfusion reactions.

          Source: 42 SDR 51, effective October 13, 2015.

          General Authority: SDCL 34-12-13(11).

          Law Implemented: SDCL 34-12-13(11).

          44:76:09:05.  Diagnostic x-ray services. Each facility shall be able to provide or arrange with an outside service for the provision of diagnostic radiology services in connection with surgery to be performed. Safety and sanitation procedures as required by the department for the radiological service which will protect the patient and the radiological worker shall be established and enforced. There shall be a quality control program with records maintained in the facility.

          Source: 42 SDR 51, effective October 13, 2015.

          General Authority: SDCL 34-12-13(11).

          Law Implemented: SDCL 34-12-13(11).

          Cross-Reference: Radiation safety, art 44:03.

          44:76:09:06.  Radiological service policies and manuals required. There shall be a policy and procedural manual for all phases of the radiological services. If radioactive isotopes are to be used within the facility, policies which are approved by the medical staff shall be established.

          Source: 42 SDR 51, effective October 13, 2015.

          General Authority: SDCL 34-12-13(11).

          Law Implemented: SDCL 34-12-13(11).

          44:76:09:07.  Radiological department personnel. There shall be trained personnel to provide the scope of services offered by the facility. If therapeutic radiological services are provided, the services shall be under the direct supervision of a radiologist.

          Source: 42 SDR 51, effective October 13, 2015.

          General Authority: SDCL 34-12-13(11).

          Law Implemented: SDCL 34-12-13(11).

          44:76:09:08.  Radiological reports. Complete signed reports of the interpretations of all radiological examinations made by practitioners shall be made a part of the patient's clinical record. The radiological department shall have a policy that requires any record to be retained for at least ten years and any film to be retained for at least five years.

          Source: 42 SDR 51, effective October 13, 2015.

          General Authority: SDCL 34-12-13(10).

          Law Implemented: SDCL 34-12-13(10).