Summary:
Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing (PT) records for the 3rd event of 2017, all 3 events of 2018 and the 1st and 2nd events of 2019, the (CMS) Centers for Medicare & Medicaid Services 209 personnel form and confirmation by laboratory testing personnel (TP) #1 at 12:00 pm on 10/10/19, the laboratory failed to ensure that TP #2 who routinely examines wet mounts on patient samples participated in proficiency testing for since the last survey for the wet mount section of proficiency testing. Findingd include: 1. Review of proficiency records since the last survey revealed that TP #2 who routinely examines wet mounts on patients failed to participate for the 3rd event of 2017, all 3 events of 2018 and the 1st and 2nd events of 2019. According to the attestation statements for each event, testing personnel #1 performed both the wet mount and microscopic urine portions of the proficiency testing events. 2. According to an interview with TP #1 at 12:00 pm on the day of survey, she performed both wet mount and urine microscopics sections on all proficiency testing events since the last survey, 10/17/17. TP #1 confirmed that all wet mounts on patient specimens during this time frame were performed by TP #2. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. 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 -- This STANDARD is not met as evidenced by: Based on review of laboratory personnel records and the Centers of Medicare and Medicaid Services (CMS) 209 personnel form, the technical consultant failed to evaluate and document the competency of testing personnel #2 who performs moderate complexity (wet mount) testing, at least semiannually during the first year of employment. Testing personnel #2 began performing wet mounts on patient specimens since the last survey, 10/17/17. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of testing personnel (TP) records since the last survey (10/17/17) and confirmation with the technical consultant at 12:00 pm, the technical consultant failed to evaluate annually and document the performance competency of testing personnel #2, as listed on the CMS 209 form for 2018 and 2019. Findings include: 1. Review of the personnel records for TP #2 revealed no annual evaluation/competency for 2018 and 2019 performed by the technical consultant was available on the day of survey, 10 /17/17. 2. Interview with the laboratory technical consultant at 12:00 pm on the day of survey, confirmed no annual evaluation was performed on TP #2 for competency for performing wet mount examinations for 2018 and 2019. D6067 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) Each individual performing moderate complexity testing must have training to ensure that the individual has-- (A) the skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (B) the skills required for implementing all standard laboratory procedures; (C) the skills required for performing each test method and for proper instrument use; (D) the skills required for performing preventive maintenance, troubleshooting and calibration procedures related to each test performed; (E) a working knowledge of reagent stability and storage; (F) the skills required to implement the quality control policies and procedures of the laboratory; (G) an awareness of the factors that influence test results; and (H) the skills required to assess and verify the validity of patient test results through the evaluation of quality control sample values prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on lack of personnel training documentation available on the day of survey and interview with the technical consultant, the laboratory testing personnel listed on the Centers of Medicare and Medicaid Services 209 form as testing personnel #2 had no documentation of training for performing wet prep testing on the microscope. All laboratory personnel expected to perform any moderate complexity testing such as -- 2 of 3 -- microscopic wet mount must have documented training. Testing personnel #1 began testing since the last survey, 10/17/17. Findings include: 1. Review of the testing personnel records on the day of survey revealed no wet prep training documentation for TP #2 was available the day of survey, 10/17/19. 2. Interview with the technical consultant revealed no written documentation of training was performed before TP #1 began examinations of wet mount on patient specimens. -- 3 of 3 --