SOM Appendix C (Rev. 166, 2017)
CFR 42, Part 493
APHL CLIA Audit Checklist | General Laboratory Systems & Retention Requirements | Page 43
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Laboratory Director (LD)
Clinical Consultant (CC)
General Supervisor (GS)
Technical Supervisor (TS)
Laboratory Director: Date:
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9. GENERAL LABORATORY SYSTEMS & RETENTION REQUIREMENTS
9.1 General Laboratory Systems §493.1230
# SOM/CFR* Requirement Examples of Compliance Notes
9.1.a
D5787, D5789
§493.1283
(a)(1-4)(b)
Does the laboratory maintain an
information or record system that
includes the following:
• Positive identification of the
specimen?
• Date and time of specimen receipt into
the laboratory?
• The condition and disposition of
specimens that do not meet the
laboratory’s criteria for specimen
acceptability?
• Records and dates of specimen
testing, including the identity of the
personnel who performed the test(s)?
• Records of patient testing including, if
applicable, instrument printouts?
• Unique identifiers to provide positive
identification of specimens from
accessioning through storage.
• Receipt date and time is recorded for
all specimens.
• Condition of specimens and
disposition is recorded.
• Verify procedure for positive specimen
identification, log date, time of receipt
and log rejected specimens.
• Worksheets should indicate date and
time of testing and include the identity
of the individual performing the test
(initials, signature or electronically
logged).
• Instruments printouts maintained, if
applicable.
Requirement met?
Yes
No
Notes:
9.1.b
D5201
§493.1231
Does the laboratory ensure
confidentiality of patient information
throughout all phases of the total testing
processes that are under its control?
• Controlled access of laboratory
areas where patient info may easily
be viewed in a hard copy format or
electronically.
• Required security awareness training
for all employees.
• Observe during walkthrough if patient
reports are lying out in open view.
• Staff access permissions forms, if
applicable.
Requirement met?
Yes
No
Notes:
9.1.c
D5203
§493.1232
Has the laboratory established and does
it follow written policies and procedures
that ensure positive identification and
optimum integrity of patient samples
from time of receipt through completion
of testing and reporting of results?
• Policy/procedure to ensure
compliance.
• Unique identifiers to provide positive
identification of specimens from
accessioning through storage.
• Observe during walkthrough how
aliquots are labeled on the bench.
Requirement met?
Yes
No
Notes:
9.1.d
D5205
§493.1233
Does the laboratory have a system in
place to document all complaints and
problems reported to the laboratory
and does the laboratory conduct and
document investigations of complaints,
when appropriate?
• Log of communications and
complaints including follow up and
date closed, reviewed for trends of
problems and corrective action taken
(NCEs)
• Policy and procedure on how to define
and address complaints.
Requirement met?
Yes
No
Notes:
9.1.e
D5207
§493.1234
Does the laboratory have a system in
place to identify and document problems
that occur as a result of a breakdown in
communication between the laboratory
and an authorized person who orders or
receives test results?
Review communication logs, NCE logs
and reports for problems that may be
related to communication.
Example: Ongoing inquiries from submitters
for clarification concerning appropriate
specimen, proper collection, transport, etc.
Requirement met?
Yes
No
Notes: