Current through Reg. 50, No. 26; June 27, 2025
Pathological and clinical services shall be provided or
made available when appropriate to meet the needs of the patients and
adequately support the ambulatory surgical center's (ASC's) clinical
capabilities.
(1) Pathology and
clinical laboratory services shall include, but are not limited to:
(A) conducting laboratory procedures that are
appropriate to the needs of the patients;
(B) performing tests in a timely
manner;
(C) distributing test
results within 24 hours after completion of a test and maintaining a copy of
the results in the laboratory; and
(D) performing and documenting appropriate
quality assurance procedures, including, but not limited to, calibrating
equipment periodically and validating test results through use of standardized
control specimens or laboratories.
(2) Preoperative laboratory procedures may be
required as follows.
(A) It shall be at the
discretion of the governing body upon the recommendation of the medical staff
to require preoperative laboratory orders.
(B) 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 advanced practice registered
nurse and written on the patient's chart.
(C) These services shall be provided either
directly within or through an effective contract arrangement with a
Medicare-approved reference laboratory.
(D) 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 ASC, and shall be available for review.
(3) The patient may be instructed to go
directly to the Medicare-approved reference laboratory, or the specimen may be
collected on the ambulatory surgical center's premises and then referred to the
Medicare-approved reference laboratory.
(4) If the specimens are collected on the
premises only, the following shall be maintained:
(A) procedures and policies governing the
Medicare-approved reference laboratory specimen requirements; identification,
collection, labeling, storage, and transportation of the specimen, and
preventive maintenance of equipment used in processing and storage of
specimen;
(B) a log book which
shall include patient name and identification number, doctor's name, date the
specimen was drawn and sent to the Medicare-approved reference laboratory,
laboratory tests ordered, date the final report came back from the reference
laboratory, and condition of the specimen. The final report shall be on the
patient's chart, with copies kept in the ASC's laboratory.
(5) If laboratory tests are performed on the
premises, the following shall be maintained:
(A) procedures governing identification,
collection, labeling, and storage of specimens;
(B) a log book, which shall include patient
name and identification number, practitioner's name, date the specimen was
drawn, test ordered, and results;
(C) procedures for each test procedure
performed by the laboratory, including source of reagents, standards, and
calibration procedures, and information concerning the basis for the tested
normal ranges;
(D) procedures and
documentation of performed maintenance on equipment used to process laboratory
work;
(E) dated reports of all
examinations performed and made a part of the patient's medical record;
and
(6) Quality
control of the laboratory shall be monitored through the quality assurance
committee.
(7) If the ASC
designates its laboratory to perform as an independent laboratory, it shall be
surveyed according to 42 Code of Federal Regulations, §§493.1 -
493.1780.
(8) The ASC can allow
laboratory work to be performed and brought in from other Medicare-approved
reference laboratories or practitioners' offices, and the reports shall be on
the patient's charts before surgery.
(A)
Written criteria describing the length of time tests can be done prior to
surgery shall be developed by the medical staff and approved by the governing
body.
(B) Laboratory work shall be
performed in a Medicare-approved reference laboratory or in the patient's
healthcare practitioner's office. This shall be written in a policy accepted by
the medical staff and governing body.
(9) If it is the ASC's policy to administer
blood, policies shall be developed on administration of blood transfusions to
include autologous blood units in accordance with the ASC's operative
procedures. If the operative procedure(s) performed in the ASC requires or may
require the necessity for transfusions, policies and procedures shall include
provisions for stat and routine transfusions. These policies and procedures
shall include, but are not limited to, collection, labeling, and transportation
of specimen in accordance with the ASC or contract service policies. All
patient results shall appear in the patient's chart.
(10) If the ASC performs surgery which
incorporates the removal of a tissue specimen or the freezing of a tissue
specimen, the specimen shall be submitted to a Medicare-approved reference
laboratory. The following shall be maintained:
(A) procedures governing the
Medicare-approved reference laboratory specimen requirements, identification,
collection, labeling, storage, and transportation of the specimen;
(B) documentation to include patient name and
identification number, practitioner's name, date the tissue specimen was
collected and referred to the Medicare-approved reference laboratory, and date
the final report came back from the Medicare-approved reference laboratory.
Final copies shall be placed in the patient's chart, with copies kept in the
ASC; and
(C) the medical staff
bylaws may exempt tissue specimens from pathology examination, and the list of
exemptions shall be available for review.
(11) The medical staff bylaws shall define
those specimens for macroscopic pathology examination only and both macroscopic
and microscopic pathology examinations.
(12) The original pathology report shall be
included in the patient's chart.
(13) Pathology tissue reports and positive
cytology reports shall have the authorized signature of the pathologist
interpreting the report.
