Neighborhood Health Source - Fremont Clinic

Summary Statement of Deficiencies D0000 The Neighborhood Health Source Fremont Clinic laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the recertification survey performed on March 13, 2024. The following standard-level deficiencies were cited: 493.1254 Maintenance and function checks . D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to perform and document manufacturer required quarterly maintenance for the single Hematology analyzer in use in 2022, 2023, and 2024. Findings are as follows: 1. The laboratory performed moderate complexity Hematology testing as confirmed by Technical Consultant (TC) during a tour of the laboratory at 1:00 p.m. on 03/13/24. 2. A Sysmex XP-300 hematology analyzer was observed as present and available for use during the tour of the laboratory. 3. Quarterly maintenance of the sample rotor valve (SRV) on the Sysmex XP-300 analyzer was required as established in the Analytic: Sysmex XP-300 Operation and Maintenance procedure found in the Fremont Clinic Laboratory Manual and on the manufacturer's XP-300 Maintenance Log in use by the laboratory. 4. Documentation of the above required maintenance was not found on the laboratory's XP-300 Maintenance Log for the time period reviewed, March 2022 - March 2024. SRV maintenance documentation completed approximately every six months by a Sysmex service representative was found in service records - see below. Date performed Time elapsed 05/16/22 N/A 10/20/22 5 months, 7 days 04/10/23 5 months, 21 days 10/03 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 -- /23 5 months, 24 days Date of survey Time elapsed 03/13/24 5 months, 11 days The laboratory was unable to provide the missing quarterly maintenance documentation upon request. 5. The laboratory performed approximately 2994 hematology tests annually as indicated on documentation provided by the laboratory on date of survey. 6. In an interview at 3:35 p.m. on 03/13/24, the TC confirmed the above findings. . -- 2 of 2 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: . Based on observation and interview with laboratory personnel, the laboratory failed to ensure a blood collection vacutainer used for Hematology testing was not used after the expiration date had been exceeded. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory at 10:10 a.m. on 08/26/20. 2. Becton Dickinson Vacutainer Serum Separator Blood Collection Tubes with lot number 9191914 and expiration date 07/31/20 were observed as present and available for use in the patient draw area during the tour. 3. In an interview at 10:15 a.m., the TC confirmed the above finding. . 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. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the technical consultant failed to perform semiannual competency assessments during the first year of patient specimen testing for 3 of 3 new testing personnel hired in 2019. Findings are as follows: 1. The laboratory performed Microscopic Examinations and 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 -- Hematology testing as confirmed by Technical Consultant (TC) during a tour of the laboratory at 10:10 a.m. on 08/26/20. 2. Laboratory records indicated three testing personnel (TP) received initial training in 2019. TP Training date TP1 09/13/19 TP2 09/16/19 TP3 07/18/19 3. Testing Personnel 5 (TP5) completed the semiannual competency assessments for the above TP in 2020. TP Competency date TP1 03/11 /20 TP2 03/11/20 TP3 01/15/20 4. A high school diploma and a Medical Assistant certificate were found in personnel records for TP5. This education did not meet the minimum required to perform competency assessments. 5. In an interview at 11:15 a. m. on 08/26/20, the TC confirmed the above finding. -- 2 of 2 --