Summary:
Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on record review and laboratory staff interview, the laboratory did not test proficiency test samples the same number of times it tests patient samples for two of six chemistry events reviewed. (College of American Pathologists second event 2016 and first event 2017). The findings include: Review of the laboratory's College of American Pathologists (CAP) proficiency testing records showed the following for the third testing event of 2016: DAI-4, DAI-5, and DAI-6 were tested on 8/10/16 at 8: 06am, 8/11/16 at 8:13am, 8/12/16 at 8:48am and 11:34am. The tests performed were: Creatinine quantitative and Specific Gravity quantitative. Review of the laboratory's CAP proficiency testing records showed the following for the first event of 2017: UDS-01, UDS-02, UDS-03, UDS-04, UDS-05 were tested on 3/15/17 at 9:05am and 14:54. The tests performed were: Ethanol and Methadone. Interview with the technical consultant on 5/30/18 at 9:23am confirmed that the laboratory does not routinely test patient samples more than once and proficiency testing samples for the events were tested multiple times. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on record review and staff interview, the facility failed to have a program in place that evaluates the competency of its testing personnel, general supervisor, technical supervisor, and technical consultant for two of two years reviewed (2016- 2018). The findings include: The facility was unable to provide documentation of a personnel competency program. The interview with the technical consultant on 5/30 /18 at 12:30 PM confirmed that the competency program in place did not meet the CLIA requirements of competency assessment. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of College of American Pathologists (CAP) proficiency testing results and staff interview, the laboratory failed to verify the accuracy of analytes that did not receive a grade for 7 testing events in 2016 and 4 events in 2017. The findings include: Review of CAP proficiency testing results showed the laboratory did not investigate the exception reason codes that appeared as scores for the evaluation of the results submitted for the following events: UDC-B 2016, UDC-C 2016, UDC-D 2016, DAI-B 2016, UDS-A 2016, UDS-B 2016, UDS-C 2016, DMPM-A 2017, UDS-A 2017, UDS-B 2017, and UDS-C 2017. The interview with the technical consultant on 5/30/18 at 10:00am confirmed the laboratory did not look into why CAP issued exception reason codes for the testing scores. 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)