(a) A limited services rural hospital (LSRH) shall provide basic laboratory services essential to the immediate diagnosis and treatment of the patient consistent with nationally recognized standards of care for emergency services, patient population, and services offered.
(b) The LSRH must ensure laboratory services are available, either directly or through a contractual agreement with a certified laboratory that complies with the Clinical Laboratory Improvement Amendments of 1988 (CLIA 1988) in accordance with the requirements specified in Code of Federal Regulations Title 42 (42 CFR) Part 493 (relating to Laboratory Requirements). CLIA 1988 applies to all hospitals with laboratories that examine human specimens for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.
(c) The LSRH shall ensure that all laboratory services provided to its patients through a contractual agreement are performed in a facility certified in the appropriate specialties and subspecialties of service in accordance with the requirements specified in 42 CFR Part 493 to comply with CLIA 1988.
(d) Emergency laboratory services shall be available on the premises, including at least the following:
  (1) assays for cardiac markers;
  (2) hematology;
  (3) chemistry; and
  (4) pregnancy testing.
(e) A written description of services provided shall be available to the medical staff.
(f) The laboratory shall ensure proper receipt and reporting of tissue specimens.
(g) The medical staff and a pathologist shall determine which tissue specimens require a macroscopic (gross) examination and which require both macroscopic and microscopic examination.
(h) When blood and blood components are stored, the LSRH shall have written procedures readily available containing directions on how to maintain the blood and blood components within permissible temperatures and include instructions to follow in the event of a power failure or other disruption of refrigeration.
  (1) Blood transfusions shall be prescribed in accordance with LSRH policy and administered in accordance with a written protocol for the administration of blood and blood components and the use of infusion devices and ancillary equipment.
  (2) A label or tray with the recipient's first and last names and identification number, donor unit number and interpretation of compatibility, if performed, shall be attached securely to the blood container.
  (3) Personnel administering blood transfusions and intravenous medications shall have special training for this duty according to adopted, implemented, and enforced LSRH policy.
  (4) Blood and blood components shall be transfused through a sterile, pyrogen-free transfusion set that has a filter designed to retain particles potentially harmful to the recipient.
  (5) LSRH staff must observe the patient for potential adverse reactions during the transfusion and for an appropriate time thereafter, and document the observations and patient's response as defined in the LSRH's blood transfusion policy.
  (6) Pretransfusion and posttransfusion vital signs shall be recorded.
  (7) Following the transfusion, the blood transfusion record or a copy shall be made a part of the patient's medical record.
(i) The LSRH shall establish a mechanism for ensuring that the patient's physician or other licensed health care professional is made aware of critical value lab results, as established by the medical staff, before or after the patient is discharged.
(j) An LSRH that provides laboratory services shall adopt, implement, and enforce written policies and procedures to manage, minimize, or eliminate the risks to laboratory personnel of exposure to potentially hazardous chemicals in the laboratory that may occur during the normal course of job performance.
(k) Pathology and clinical laboratory services shall include at least the following:
  (1) conducting laboratory procedures that are appropriate to the needs of the patients;
  (2) performing tests in a timely manner;
  (3) distributing test results within 24 hours after completion of a test and maintaining a copy of the results in the laboratory; and
  (4) performing and documenting appropriate quality assurance procedures, including calibrating equipment periodically and validating test results through use of standardized control specimens or laboratories.
(l) Preoperative laboratory procedures may be required as follows.
  (1) It shall be at the discretion of the governing body upon the recommendation of the medical staff to require preoperative laboratory orders.
  (2) If specific preoperative laboratory work is required, the medical staff shall approve them in accordance with the medical staff bylaws. Other laboratory work shall be performed only on the order of a physician, podiatrist, dentist, or other practitioner, practicing within the scope of their license and education, and written on the patient's chart.
  (3) These services shall be provided either directly within or through an effective contract arrangement with a Medicare-approved reference laboratory.
  (4) The contractual agreement with the Medicare-approved reference laboratory shall provide for routine and stat work to include pathology, clinical, and blood bank services, if blood is authorized by the LSRH, and shall be available for review.

Source Note: The provisions of this §511.45 adopted to be effective October 5, 2023, 48 TexReg 5668