Below is a checklist used by Laboratory Consultation Services to assess CLIA compliance during a “mock inspection.”
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1. Has a CLIA certificate been obtained? If not, has an application been submitted?
2. Does the laboratory’s classification accurately reflect testing done i.e. waived, moderate complexity or high complexity?
3. Have all personnel (director, clinical consultant, technical consultant{general/technical supervisor if high complexity} and testing personnel) been listed on the CLIA application form?
4. Are all personnel qualified by CLIA regulations for the duties they perform in the laboratory?
5. Is documentation available for education, experience and special training for all positions covered by the regulations as listed above?
6. Is there a written job description detailing the responsibilities of all personnel in the laboratory?
7. Are there sufficient appropriate personnel to perform the testing workload?
8. Is a system in place and a written procedure available for initial and continued evaluation of the competence of laboratory personnel?
9. Are the Director and Technical Consultant available as required for consultation?
10. Is the size and location of the area used for testing appropriate to the testing being done?
11. Is there sufficient work and storage areas for testing to be performed properly and safely?
12. Is there an Exposure Control Plan for Bloodborne Pathogens for the laboratory?
13. Is it readily available to employees and have they been familiarized with its contents?
14. Are universal precautions used in the laboratory?
15. Is appropriate personal protective equipment readily available?
16. Have the staff been trained in their application and use?
17. Is there a Chemical Hygiene Plan for hazardous materials, if needed?
18. Is it readily available to employees and have they been familiarized with its contents?
19. Are Material Safety Data Sheets available for all hazardous materials used in the laboratory?
20. Are all hazardous materials stored appropriately e.g. flammables cabinets, acids and alkali stored separately, etc. and labeled properly?
21. Are all disposable sharps discarded in an appropriate sharps container?
22. Are “red-bag” containers and sharps containers readily available?
23. Is eating, drinking, smoking, application of cosmetics and handling of contact lenses strictly forbidden in laboratory areas?
24. Are pipetting devices available to avoid mouth pipetting?
25. Are refrigerators used for food separate and apart from those used for specimens i.e. no storage of food in laboratory refrigerators or laboratory areas?
26. Are all electrical equipment or appliances up to generally accepted standards of electrical safety?
27. Are fire extinguishers available and in proper working order?
28. Do staff personnel know how to use them?
29. Are laboratory personnel familiar with alternate routes of escape?
30. Are all tests requested in writing?
31. If a test is ordered orally, is it followed with a written request within 30 days?
Does the written requisition contain
32. The patient’s name and/or other unique identifier?
33. The name or other identifier of the person requesting the test?
34. The test to be performed?
35. The date (and time, if appropriatof specimen collection?
36. Any additional information to assure accurate and timely testing and reporting of results?
Does the laboratory have and follow written procedures for
37. preparation of the patient?
38. Collection of the specimen?
39. Labeling of the specimen?
40. Preservation and/or transportation of the specimen?
41. Processing of the specimen?
Do laboratory records show
42. Patient’s name or other unique identifier through all phases of testing?
43. Date and time specimen was received in the laboratory?
44. Condition of unacceptable specimen and disposition thereof?
45. Date that all testing was performed?
46. Identity of all personnel performing testing?
Are the results of laboratory testing
47. released only to authorized persons?
48. reported in timely fashion?
Does the laboratory report contain
49. the name and address of the laboratory?
50. the test performed?
51. the result?
52. the unit of measurement?
53. the pertinent “normal range” for the test?
54. Does the laboratory have and follow written procedures for reporting imminently life-threatening results?
55. Does laboratory policy prohibit reporting results which exceed the reportable range for the instrument or system?
56. Are test reports maintained in a manner which permits ready identification and timely accessibility?
57. Does the laboratory notify the appropriate person of any errors?
58. Is a corrected report issued?
Are the following records maintained for two years?
59. test requisitions?
60. test reports, including instrument printouts and worksheets, and reports from reference laboratories?
61. corrected reports?
62. documentation of all quality control activities?
63. documentation of all quality assurance activities?
64. Are immunohematology reports (including those from reference laboratories) maintained for five years?
65. Are pathology and Pap smear reports (including those from reference laboratories) maintained for ten years?
66. Is the laboratory registered with an approved PT provider?
67. Are all regulated assays proficiency tested?
Are PT specimens handled exactly the same way as patient specimens?
68. Introduced into the normal work flow?
69. Assayed same number of replicates as patients?
70. Assayed by same testing personnel as patients?
71. Reported in the same manner as patient specimens i.e. > or < etc.
72. Are copies of PT submissions filed together with applicable instrument printouts to facilitate QA followup?
73. Are PT results reviewed by the director?
74. Are deficiencies investigated and remediation instituted if indicated based on this review?
75. Is an instrument log maintained for each instrument used in the laboratory?
Is the following recorded in the instrument log:
76. Daily and periodic maintenance: procedure and log?
77. Function checks: procedure and log?
78. Scheduled and unscheduled manufacturer’s preventive maintenance?
79. Instrument problems and attempts to rectify?
80. Are automatic or semi-automatic pipets checked regularly for accuracy?
81. Are all moderate complexity procedures calibrated or calibration verified every six months?
Is recalibration performed
82. when quality control shows out of control values, shifts or trends?
83. when a complete change of reagents occurs?
84. after major preventive maintenance procedures?
85. after a critical part of the instrument is changed?
86. more often than every six months if required by the manufacturer?
87. Does the laboratory have a procedure manual?
88. Does it contain all procedures performed in the laboratory?
89. Is it accessible and understandable to testing personnel?
90. Do procedures accurately reflect actual laboratory practice?
91. Is the procedure manual reviewed and signed by the director?
92. Are all new procedures or changes in procedure signed by the director?
Does each procedure contain
93. procedure for obtaining specimens for the test?
94. any special instructions to the patient which may be required?
95. procedure for handling, preservation and storage?
96. criteria for rejection of unacceptable specimens?
97. directions for preparation of reagents, standards, controls, etc. for the test?
98. directions for storing and storage stability of these prepared components?
99. directions for performing the test?
100. special procedural notes or cautions?
101. calculations or other manipulations necessary to obtain the result?
102. normal or expected ranges for the test, panic values, etc.?
103. procedure to follow if quality control is out of range?
104. limits of the procedure, including hemolysis, lipemia, and other preanalytical variables such as drug or disease interferences?
105. linearity or calibration limits?
106. procedure to follow if linearity is exceeded?
107. lowest detectable concentration?
108. literature references?
109. sample handling in the event of instrument or system malfunction?
110. Is each procedure reviewed and signed annually by the director?
111. Are discontinued procedures maintained for two years?
112. Is a quality control program maintained for all analytes?
Does the QC program specify
113. which controls to assay?
114. how often the controls are run?
115. how acceptable limits are derived?
116. procedures to follow if limits are exceeded?
117. Are temperature controlled spaces monitored each day of use?
118. For room temperature tests, is room temperature monitored?
119. Are acceptable ranges defined for temperature controlled spaces?
120. for room temperature?
121. Are thermometers checked regularly for accuracy?
122. Are timers checked regularly for accuracy?
123. Are controls run in the same manner as patients?
124. Are control values verified as in range prior to commencing patient testing?
125. If not, are patient specimens since the last successful control rerun in case of control failure?
126. Are quality control results reviewed by the director?
127. Are mean, standard deviation and coefficient of variation calculated regularly for quantitative assays?
128. Are Levy-Jennings or other graphs generated regularly for quantitative assays?
129. Are prepared controls, standards, reagents, stains, etc, labeled as to content, preparation date, storage requirements and expiration date?
130. Are all expired materials discarded on or before the expiration date?
131. Are two levels of controls run every eight hours for automated hematology assay?
132. For automated differential counts, have criteria been established for determining when a manual count must be performed (in house or sendout)?
133. Are these criteria followed by the staff?
For sedimentation rates:
134. Are ESR’s set up within two hours of blood being drawn?
135. If not, is the blood refrigerated and then brought to room temperature before setting up?
136. Is the rack set up in a place free of vibration/other disturbances?
137. Is the rack leveled before use?
For coagulation:
138. Are two levels of controls run every eight hours?
139. Are two levels of controls run with change of reagents?
140. If coagulation is run manually, are they run in duplicate?
141. If automated, has the validity of running single testing been verified statistically?
142. Are positive and negative controls assayed for each patient run?
143. Is each new lot of reagent checked for reactivity against previous lots?
144. Is the speed of the rotator monitored for each day of use?
145. Are media inspected visually for defects before use?
146. Are sterility and growth support checks performed?
147. If performed by manufacturer to NCCLS standards, are these checks documented for each batch of media?
148. Are results of cultures reported only according to the manufacturer’s directions?
149. If identification (definitivis performed, are catalase, coagulase, oxidase, etc. reagents checked daily for positive and negative reactivity with appropriate control organisms?
For antibiotic sensitivity testing:
150. Is the concentration of organisms in the inoculum standardized?
151. Is each new batch of media or discs checked for reactivity prior to use?
152. Are zones of inhibition sizes checked each day with appropriate control organisms?
153. Does the laboratory have a written quality assurance program?
154. Are the effectiveness of policies and procedures periodically evaluated?
155. Does the evaluation identify problems and suggest solutions?
156. Are the solutions monitored to ensure their effectiveness?
157. Are the results of the evaluations discussed with the laboratory staff?
158. Are breakdowns in communications between physicians and laboratory personnel recorded?
159. Are corrective actions taken to remedy these breakdowns?
160. Does the laboratory have a procedure for documenting, investigating and correcting complaints about the laboratory?
161. Are regular QA meetings held with laboratory staff?
162. When tests are run on more than one system, is a system in place to evaluate their correlation twice yearly?
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