SECTION 509.49. Laboratory and Pathology Services

(a) A facility shall maintain directly, or have immediately available on the premises, adequate laboratory services to meet the needs of its patients.

(b) Laboratory services shall comply 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 facilities with laboratories that examine human specimens for the diagnosis, prevention, or treatment of any disease or impairment, or for health assessment.

(c) A facility 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 during hours of operation, including:

(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 facility shall have written procedures readily available containing directions on how to maintain the blood and blood components within permissible temperatures and including instructions to follow in the event of a power failure or other disruption of refrigeration.

(1) Blood transfusions shall be prescribed in accordance with facility policy and administered in accordance with a written protocol for administering blood and blood components and using infusion devices and ancillary equipment.

(2) Personnel administering blood transfusions and intravenous medications shall have special training for this duty according to adopted, implemented, and enforced facility policy.

(3) 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.

(4) Facility staff shall observe the patient for potential adverse reactions during the transfusion and for an appropriate time thereafter and document the observations and patient's response.

(5) Pre-transfusion and post-transfusion vital signs shall be recorded.

(6) Following the transfusion, the blood transfusion record or a copy shall be made a part of the patient's medical record.

(i) The facility 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. A physician shall read, date, sign, and authenticate all laboratory reports.

(j) A facility 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.

Source Note: The provisions of this §509.49 adopted to be effective December 4, 2023, 48 TexReg 7064