Baystate Reference Laboratories

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Baystate Reference Laboratories laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: . Based on record review and interview with the general supervisor (GS) on 3/3/22, the TS failed to evaluate and document the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tested patient specimens as evidenced by the following: 1. A review of the CMS 209 Laboratory Personnel Report on 3/3/22 revealed that there was one (1) new testing person (TP) hired since the last CLIA recertification survey on 11/20/19. 2. A review of the training and competency documentation for the new TP revealed that there was no documentation of semiannual competency evaluations for TP who had been working for over a year. 3. The GS confirmed in an interview on 3/3/22 at 8:55 AM that no semiannual competency evaluations had been performed on the new TP. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated 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 -- to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on record review interview, the technical supervisor TS failed to evaluate and document the performance of individuals responsible for high complexity testing at least annually as evidenced by the following: a) A review of calendar years 2020 and 2021 annual competencies on testing personnel (TP)revealed that the TS failed to evaluate the competency of one (1) out of three (3) testing personnel in calendar year 2021 (testing person 2). b) General supervisor 1 confirmed in an interview on 3/3/22 at 8:55 AM that an annual competency for calendar year 2021 had not been performed on testing person 2. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for Baystate Reference Laboratories pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on observation and interview, the laboratory failed to follow a maintenance protocol for all laboratory microscopes as evidenced by the following: a) The laboratory utilizes five (5) microscopes in the various specialty areas of the laboratory. b) Interview with one laboratory technologist revealed that the microscopes were serviced on an annual basis c) Review of mainteance stickers on each of the microscopes on 11/20/19 at 12:31 PM revealed that one (1) of the five (5) microscopes utilized in hematology for white blood cell differential examinations had not been serviced since July of 2017. d) The laboratory technologist confirmed in an interview on 11/20/19 at 12:35 PM that the microscope in use had not been serviced along with the other four. e) The laboratory performs approximately 14,101 white blood cell differential annually. . D5449 CONTROL PROCEDURES 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 -- CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform positive and negative controls each day qualitative serum pregnancy was performed as evidenced by the following: a) A review of serum and urine qualitative pregnancy testing for calendar year 2019 revealed that when serum pregnancy testing was performed positive and negative controls were not being performed concurrently with the patient serum samples Review of quality control revealed that external controls were run only on the following dates during 2019: 1/17/19, 1/30/19, 2/13/19, 2/21/19, 3/6/19, 3/20 /19, 4/4/19, 4/23/19, 5/1/19, 5/14/19, 5/28/19, 6/5/19, 6/18/19, 6/27/19, 7/8/19, 7/29 /19, 8/5/19, 8/14/19, 8/27/19, 9/5/19, 9/12/19, 10/2/19, 10/15/19, and 10/22/19. c) The general supervisor interviewed on 11/20/19 at 11:20 AM confirmed that external control testing was done only when a new box or shipment was opened not each day when patient serum pregnancy testing was performed. d) The laboratory performs approximately 154 serum pregnancy tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D0000 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 --