Prime Care Medical Center

Summary Statement of Deficiencies 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 observation of the laboratory, review of patient number eleven test report, the laboratory records and interview with the lead testing personnel, the laboratory failed to verify the accuracy of wet prep and potassium hydroxide (KOH) testing twice a year in 2018 and 2019. The findings include: 1) Observation of the laboratory on November 18, 2019 at 8:15 am revealed a microscope on the counter in use for patient testing for urine microscopy, wet prep and KOH. 2) Review of patient number eleven test report revealed patient testing for wet prep performed on 08.20.2019. 3) Review of the laboratory records revealed no documentation that verification of accuracy had been done for wet prep or KOH in 2018 or 2019. 4) Interview with the lead testing personnel on November 18, 2019 at 3:30 p.m. confirmed the laboratory performs testing for both wet prep and KOH and no records were present for verifying the accuracy twice a year in 2018 and 2019. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of verification of performance specifications studies (VoPS) for the Sysmex KX-21N complete blood count (CBC) instrument and interview with the lead testing personnel, the laboratory failed to verify the reportable range of the Sysmex KX-21N complete blood count (CBC) instrument in 2019. The findings include: 1) Observation of the laboratory on November 18, 2019 at 8:15 am revealed the Sysmex KX-21N (serial # F3396) on the counter in use for patient testing for CBC. This instrument was new since the last survey. 2) Review of the VoPS studies for the Sysmex KX-21N CBC instrument revealed no documents were present verifying the reportable range of the instrument. 3) Interview with the lead testing personnel on November 18, 2019 at 3:30 p.m. confirmed no reportable range verification study had been performed for the Sysmex KX-21N CBC instrument in 2019. Patient testing began on August 26, 2019. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: The laboratory director failed to maintain compliance with previous

Summary Statement of Deficiencies 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 laboratory's Quality Assurance Program procedure and interview with testing personnel number one, the laboratory failed to establish written policies to assess testing personnel competency as specified in the personnel requirements in subpart M. The findings include: 1. Review of the laboratory's policy titled "Quality Assurance Program" revealed the following statement "Personnel are evaluated annually or when new methodologies are incorporated." Required competency assessment elements and appropriate frequency were not included in the policy. Required competency assessment elements and frequencies as specified in the personnel requirements in subpart M include: Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; Monitoring the recording and reporting of test results; Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; Direct observation of performance of instrument maintenance and function checks; Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and Assessment of problem skills; and Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. thereafter, evaluations must be performed at least annually. 2. Review of six of six testing personnel competency assessments for 2017 and 2018 revealed problem solving was not included as part of competency assessment. 3. Interview with testing personnel number one on February 6, 2018 at 10:00 am confirmed that the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- laboratory's policy for testing personnel competency did not include all elements as specified in subpart M. _______________________________________ D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's Medical Laboratory Evaluation (MLE) proficiency testing reports for 2016, the policy titled "Quality Assurance Program" and interview with testing personnel number one, the laboratory failed to follow policy for evaluation of proficiency testing results in 2016. The findings include: 1. Review of the 2016 MLE proficiency testing reports revealed the following events with unacceptable results for urine sediment: Event MLE-M1-Specimen US-2; Event MLE-M3-Specimen US-5. Both reports were signed by the laboratory director with no