Revere Health Urology

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 review of proficiency testing documentation and interview with the office manager, the laboratory failed to ensure personnel who routinely perform patient testing also performed the Prostate Specific Antigen (PSA) proficiency testing for the Qualigen Total PSA FastPack. The laboratory performs approximately 1465 PSA tests annually. Findings include: 1. A review of proficiency testing records on 6/13/22 at 3: 00 pm revealed that the laboratory failed to include documentation that 2 of 3 testing personnel that routinely perform patient testing also performed proficiency testing for 4 of 4 American Proficiency Institute (API) events including the 2nd event of 2021, 3rd event of 2021, 1st event of 2022, and the 2nd event of 2022. 2. In an interview on 6/13/22 at approximately 3:30 pm, the office manager confirmed that 2 of 3 testing personnel had not participated in 4 of 4 American Proficiency Institute (API) events including the 2nd event of 2021, 3rd event of 2021, 1st event of 2022, and the 2nd event of 2022. This is a REPEAT Deficiency. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on a review of procedure manuals and an interview with the office manager, the laboratory failed to have a written procedure available for the Qualigen Total PSA FastPack test. The laboratory performs approximately 1465 PSA tests annually. Findings include: 1. A review of the procedure manuals on 6/13/22 at 4:45 pm revealed that, at the time of survey, the laboratory failed to have a written procedure available for the Qualigen Total PSA FastPack test. 2. In an interview on 6/13/22 at 4: 50 pm with the office manager, it was confirmed that, at the time of survey, the laboratory failed to have a written procedure available for the Qualigen Total PSA FastPack test. -- 2 of 2 --

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 proficiency testing records review and interview with staff, the laboratory failed to ensure personnel routinely performing patient testing also performed Prostate Specific Antigen (PSA) proficiency testing. The laboratory performed approximately 3 PSA tests per day. Findings include: 1. Proficiency testing records review failed to include documentation 2 of 3 testing staff members routinely performing patient testing also performed proficiency testing for 4 of 4 American Proficiency Institute (API) reviewed from the 2nd event of 2017 through the first event of 2019. 2. In an interview conducted on 08/16/2019 at approximately 11:15 A.M., the laboratory manager confirmed the two other testing personnel had not participated in proficiency testing form the second event of 2017 through the 1st event of 2019. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on the laboratory's Individualized Quality Control Plan (IQCP) review, lack of documentation, and confirmation by staff, the laboratory failed to follow the IQCP to Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- review Prostate Specific Antigen (PSA) quality control performance, in conjunction with proficiency tests results to ensure reducing the frequency of quality control performance to each new lot number or shipment was sufficient. The laboratory performed approximately 3 PSA tests per day. Findings include: 1. The laboratory IQCP lacked documentation the director had reviewed QC performance frequency adequacy since the plan was approved on 06/02/2017. 2. In an interview conducted on 08/16/2019 at approximately 11:15 A.M. staff confirmed the laboratory failed to re- evaluate the IQCP to ensure once per lot number of PSA test kits was sufficient to ensure the Qualigen PSA test system was capable of producing accurate and reliable results. -- 2 of 2 --

Summary Statement of Deficiencies No Tags No deficiency details available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --