Tanner Clinic - Syracuse

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 lack of documentation, reagent quality control records review, and interview with staff, the laboratory failed to document human chorionic gonadotrophin (hCG) test cartridges and Medonic complete blood cell (CBC) counter reagent cell diluent and red blood cell lyse reagent were not used past their expiration dates. Medonic complete blood cell (CBC) counter reagent cell diluent and red blood cell (RBC) lyse reagent reviewed from April 2019 to November 2020 and hCG test kits reviewed from July 2019 to November 2020 lacked a record of the lot number and expiration dates and the dates the cartridges were placed in use. The laboratory performed approximately 3 to 5 hCG tests per month and 3 to 5 CBC tests per day. Finding include: 1. Quality control records review for hCG testing for patient 621424 on 07/02 /2020 and for patient 689985 on 01/07/2020 failed to include the hCG test cartridge lot number, expiration date and the date the test kit was in use to match quality control to the timeframe the patient tests were performed. 2. The laboratory lacked documentation they recorded the lot number, expiration date and date the reagents were placed in use for the Medonic cell counter reagents (RBC Lyse and cell diluent). 3. In an interview with staff on 11/13/2020 at approximately 4:50 P.M., the laboratory director confirmed the hCG and cell counter diluent and lyse reagents were not recorded. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) 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 -- 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 personnel records review, competency records review, lack of documentation, and confirmation by staff, the laboratory technical consultant failed to evaluate 2 of 2 new testing personnel semiannually the first year of testing for complete blood count and serum human chorionic gonadotrophin (hCG) testing. Findings include: 1. Personnel records review included 2 new testing personnel were hired in 2019 (testing person A and testing person B). 2. Competency records review lacked documentation new testing person A, and new testing person B lacked semiannual competency evaluations in 2019. 3. In an interview with the laboratory director on 11/13/2020 at approximately 4:45 P.M. the laboratory director confirmed semiannual competency was not performed for 2 new testing persons in 2019. -- 2 of 2 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on Micros ABX manufacturer's instructions review, lack of documentation and interview with staff, the laboratory failed to follow the hematology cell counter manufacturer's instructions to perform calibration every six months for 2 of 2 six month time frames reviewed from April 2016 through April 2018. The laboratory performed approximately 4 complete blood counts per day. Findings include: 1. The ABX micros CBC instrument reviewed included instructions for calibration performance once every 6 months of use. 2. The laboratory failed to record calibration performance from May 2016 to July 1, 2017. 3. In an interview conducted on 04/25 /2018 at approximately 1:00 P.M. staff confirmed calibration documentation for ABX calibrations were not available on the day of survey. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; 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 patient test records review, Individualized Quality Control Plan (IQCP) review, quality control records review, lack of documentation, and interview with staff, the technical consultant failed to ensure the laboratory maintained the quality control plan for 1 of 2 test systems reviewed, serum pregnancy tests, (hCG) for 1 of 3 months of hCG test results reviewed. The laboratory tests approximately 3 samples per month for serum hCG tests. Findings include: 1. Patient test records review included documentation the laboratory performed serum hCG testing for patient 776714 on 07/25/2017. 2. IQCP review included, in the quality control plan states to perform external liquid positive and negative controls monthly and with each new lot number of hCG test kit. 3. Quality control records review failed to include documentation the laboratory performed external liquid positive and negative controls from 06/26/2017 to 09/01/2017. 4. In an interview with staff on 04/25/2018 at approximately 1:15 P.M., staff confirmed the IQCP was not maintained for this time period for serum hCG testing. -- 2 of 2 --