Summary:
Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the CLIA regulations. The conditions not met were: D5024 - 42 C.F.R. 493.1215 Condition: Hematology; 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; D6033 - 42 C.F.R. 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant; 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. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: A. Based on review of 2017 and 2018 laboratory records and confirmed in interview, the laboratory failed to retain laboratory records for wet prep testing. Findings were: 1. Review of all the laboratory records from 2017 and 2018 revealed no documentation of the patient test records for wet prep testing. 2. An interview with the laboratory manager on 11/6/18 at 1100 hours in the break room confirmed the above findings. He stated that the physicians rarely performed them, but he was unsure where they kept the results. B. Based on review of 2018 quality control records and confirmed in interview, the laboratory failed to retain CBC (complete blood count) patient instrument records on the Cell Dyn Emerald hematology analyzer. Findings include: 1. Review of all the laboratory records revealed no documentation of the instrument patient records for 7 of 7 patients when the laboratory performed CBC Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- (complete blood count) patient testing on the Cell Dyn Emerald hematology analyzer. 2. An interview with the laboratory manager on 11/6/18 at 1100 hours in the break room confirmed the above findings. He stated that the laboratory scanned the reports onto their computer system but they discarded the original printout. He was also unaware that the scanned copies were unreadable. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of Hematology records, patient test results, observations, and interviews, the laboratory failed to meet applicable requirements in the specialty of hematology as evidence by: 1. The laboratory failed to follow manufacturer's instructions for suspected R flags on the Cell Dyn Emerald for the complete blood counts (CBCs) (see D5405). 3. The laboratory failed to monitor over time the accuracy and precision of the Cell Dyn Emerald hematology analyzer (See D5441). 4. The laboratory failed to establish their own control means and acceptable ranges (see D5469). 5. The laboratory failed to have a mechanism in place to review the analytical systems for the Cell Dyn Emerald (See D5793). D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory procedures and laboratory records and confirmed in an interview, the laboratory failed to document at least twice annually the accuracy of 1 of 2 tests. (wet mount) Findings were: 1. A review of laboratory proficiency testing records from 2016 & 2017 revealed no documentation of the laboratory verifying the accuracy of the following test: wet mount. 2. An interview with the lab manager on 11 /6/18 at 1110 hours in break room confirmed the above findings. He stated that it was hard to perform the accuracy assessment when they rarely performed the test. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: A. Based on review of the manufacturer's instructions, patient records, and confirmed in interview, the laboratory failed to follow the manufacturer's instructions to ensure -- 2 of 6 -- system flags were verified prior to reporting patient results from the Cell-Dyn Emerald hematology analyzer. Findings were: 1. Review of the manufacturer's instructions for the Cell-Dyn Emerald hematology analyzer (9140847E-June 2010) under "Section 3: Principles of Operations" subsection "Instrument Alarms, Operational alerts, and Measured Data Flags" revealed the following result flags and