| (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.
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