| (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.
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