26 Tex. Admin. Code § 511.45 - Laboratory Services
(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.
Notes
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