26 Tex. Admin. Code § 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.
Notes
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