Summary:
Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the CLIA regulations. The conditions not met were: D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems; D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; D8100 - 42 C.F.R. 493.1771 Condition: Inspection requirements applicable to all CLIAcertified and CLIA-exempt laboratories. The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, American Board of Bioanalyts (AAB) proficiency testing records, and confirmed in interview, the individual testing the proficiency testing samples and the lab director failed to attest to the routine integration of proficiency samples into the patient workload for 2 of 3 testing events in 2019. The findings included: 1. Review of the AAB proficiency testing records from 2019 revealed no documentation of the individual testing person and lab director signing the attestation statements for the following 2 of 3 events in 2019. 2019 NonChemistry 1st, 2nd 2. An interview with the laboratory director on 10/7/19 at 1020 hours in the laboratory confirmed the above findings. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of the laboratory's American Association of Bioanalyst (AAB) proficiency testing (PT) records and staff interview, the laboratory failed to document the review of the PT results for all 2019 test events. The findings were: 1. A review of the laboratory's 2019 AAB proficiency testing records revealed that the laboratory failed to document the review of the results for all events in 2019. 2019 NonChemistry 1, 2, 3 events 2. An interview with the laboratory director on 10/7/19 at 1020 hours in the laboratory confirmed the above findings. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the laboratory records, patient test records, and confirmed in interview, the laboratory failed to establish written policies and procedures for specimen processing for CBC (complete blood count) testing on the Beckman Coulter Act diff 2 hematology analyzer. Findings were: 1. Review of the laboratory records revealed no documentation of a policy or procedure for patient preparation, collection, storage and preservation, acceptability and rejection for CBC testing on the Beckman Coulter Act diff 2 hematology analyzer. 2. An interview with the laboratory director on 10/7/19 at 1020 hours in the laboratory confirmed the above findings. He was unaware his laboratory policies were missing specimen processing. D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on review of the laboratory patient test records and confirmed in interview, the laboratory failed to document the date and time it received specimens for CBC (complete blood count) testing on the Beckman Coulter Act diff2 hematology analyzer for 97 of 97 patients reviewed. Findings were: 1. Random review of the laboratory records from 2018 and 2019 revealed no documentation of the date and time for 97 of 97 patient specimens analyzed for CBC on the Beckman Coulter Act diff2 hematology analyzer. Refer to patient alias list. 2. An interview with the laboratory director on 10/7/19 at 1030 hours in the laboratory confirmed the above findings. He was unaware the laboratory was required to document the date and time it received specimens. -- 2 of 11 -- D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of the laboratory policy, laboratory records, and confirmed in interview, the laboratory failed to follow its policy and document the quality assessment in the preanalytical systems. Findings were: 1. Review of the laboratory policy Quality Assurance Program revealed "the QA program monitors and evaluates the quality for the service we provide. The laboratory director oversees the implementation of our plan and helps identify and correct problems as they occur. We periodically review our QA plan to minimize the possibility of recurrence of problems. When problems are identified, they are corrected and areas for improvement to this plan may be implemented where applicable." 2. Review of the laboratory records revealed the laboratory QA failed to detect and correct problems in the preanalytical systems. Refer to D5311, D5313. 3. An interview with the laboratory director on 10/7/19 at 1220 hours in the laboratory confirmed the above findings. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of laboratory policies, review of quality control records, review of patient final reports, and confirmed in interview, the laboratory failed to monitor and evaluate the overall quality of its analytic systems. Refer to D5403, D5421, D5469 D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)