Summary:
Summary Statement of Deficiencies 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 a review of the laboratory's policies, proficiency testing (PT) records and staff interview, the laboratory failed to ensure PT attestation statements were signed by the appropriate personnel for the chemistry testing module in 2018. Findings include: a. The laboratory's policy for proficiency testing states, "Laboratory director and all staff performing the testing should sign in the attestation spaces provided on the data sheet." b. PT records for the 1st Event of 2018 did not contain signed attestation statements by the laboratory director or testing personnel. c. On 8/20/18 at around 12 p.m., the testing personnel confirmed the attestation statements had not been signed by appropriate personnel as required by laboratory policy. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test 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 -- system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies, proficiency testing (PT) records and staff interview, the laboratory failed to document each step in the testing and reporting of results by not retaining a duplicate copy of the PT results sent to the PT provider for the 1st Event of 2018. Findings include: a. The laboratory's policy for proficiency testing states, "Retain all data sheets, attestation sheets, worksheets, and instrument printouts for two years." b. PT records for the 1st Event of 2018 did not contain a copy of the test results reported to the PT provider. c. On 8/20/18 at around 12 p.m., the testing personnel confirmed the laboratory staff did not maintain a copy of all records required for proficiency testing in 2018. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the quality assurance (QA) Plan, review of personnel competency assessment records and staff interview, the laboratory failed to establish and follow written policies for assessing the competency of 2 of 2 testing personnel in 2018 for testing Prostate Specific Antigen (PSA) and testosterone on the Qualigen Fast Pack IP System. Findings include: a. The QA Plan states personnel should be qualified and trained in performance. b. There is no documentation on the intervals and criteria of assessing competency for testing personnel. c. The competency assessments for 2 of 2 testing personnel (#2 and #3 on Form CMS-209) signed by the laboratory director on 8 /17/2018 does not contain all required elements for assessing competency. d. There is no documentation of assessing competency for 2 of 2 testing personnel (#2 and #3) prior to patient testing on 4/26/18. c. On 8/20/18 at around 11 am, the testing personnel confirmed there was no established policies to follow for assessing competency on testing personnel. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the quality assessment (QA) plan, personnel competency records and staff interview, the laboratory failed to establish an ongoing mechanism to monitor and assess problems to ensure competency is performed on all testing personnel who test for Prostate Specific Antigen (PSA) and testosterone using the Qualigen Fast Pack IP System in 2018. Findings include: a. The QA plan states -- 2 of 6 -- personnel will be trained and qualified. b. There were no initial competencies for 2 of 2 testing personnel (#2 and #3 on Form CMS-209) prior to reporting patients in April 2018. c. Competency assessments performed on 2 of 2 testing personnel (#2 and #3) were signed off by the laboratory director on 8/17/18 and failed to include: direct observation of routine patient test performance; monitoring the recording and reporting of test results; review of intermediate test results, worksheets, quality control records, proficiency testing results, and preventative maintenance records; direct observation of performance of instrument maintenance and function checks; assessment of test performance through previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and assessment of problem solving skills. d. On 8/20/18 at around 11 am, the testing personnel confirmed the laboratory failed to establish and follow their QA plan and did not evaluate testing personnel for competency in 2018. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of