Novant Health Hillsdale Medical Associates

Summary Statement of Deficiencies D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of personnel records 9/30/26 and deficiency cited at D6065, the laboratory failed to verify that 1 of 4 TP (testing personnel #3) met the minimum education requirements for performing moderate complexity testing. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; or (b)(2) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology, or nursing from an accredited institution; or (b)(3) Meet the requirements in 493.1405(b)(3)(i)(B), (b)(4)(i)(B), (b)(4)(i)(C) or (b)(5)(i)(B); or (b)(4) Have earned an associate degree in a chemical, biological, clinical or medical laboratory science, or medical laboratory technology or nursing from an accredited institution; or (b)(5) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least a duration of 50 weeks and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(6)(i) Have earned a high school diploma or equivalent; 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, review of personnel records, and interview with the TC (technical consultant) 9/30/26, the laboratory failed to verify that 1 of 4 TP (testing personnel #3) met the minimum education requirements for performing moderate complexity testing. Findings: Review of the laboratory's "Personnel Competency Assessment" policy revealed, "...Before any non- waived testing begins, the team member must present a copy of their high school diploma or transcript with graduation date, General Educational Development(GED), Associate's in Sciences Degree, or Bachelor's Degree, to be stored in the personnel file in the lab or in the Online Competency software..." Review of the personnel records revealed TP #3 was trained for non-waived testing on 5/5/26. There was no education documentation on file for TP #3. During interview at approximately 10:15 a.m., the TC confirmed that there was no acceptable diploma or transcript on file for TP #3. She stated TP #3 was trying to obtain a copy of the high school education credentials from the county where she attended school, but the documentation was not available at time of the survey. The TC confirmed TP #3 was testing patient samples. -- 2 of 2 --

Summary Statement of Deficiencies D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures and review of 2021, 2022, and 2023 HemoCue WBC quality control records 1/19/24, testing personnel failed to follow the laboratory's policy for validation of 7 of 9 lot numbers of control material used on the HemoCue WBC analyzer from 3/26/21-1/18/24. Findings: Review of the "HemoCue WBC Analyzer" procedure revealed on page 4 "... 6. Validation of new lots of control material a. The following actions are taken prior to implementation of a new lot number of quality control material: i. The new lot number of control material is to be tested in parallel with the existing control material for a minimum of one time prior to placing the new lot number into routine use. ii. The results must be compared to the manufacturer's assay ranges and confirmed that the values are within acceptable limits. Document results on the 'HemoCue WBC QC Lot Validation Study' log. b. At the end of the validation study, if the controls have performed as expected, the validation has been completed and the material is ready for routine quality control testing. c. The manufacturer's package insert, all instrument correlation documentation from the validation study, and any other information regarding the study will be secured together (stapled or paper clipped) and maintained for a minimum of 2 years. ..." Review of 2021, 2022, and 2023 HemoCue WBC quality control records revealed there was no documentation the following lot numbers of control material were validated prior to use: a. HC03221, HC03222, HC03223, expiration date 6/5/22; b. HC06221, HC06222, HC06223, expiration date 9/5/22; c. HC09221, HC09222, HC09223, expiration date 12/5/22; d. HC12221, HC12222, HC12223, expiration date 3/5/23; e. HC03231, HC03232, HC03233, expiration date 6/5/23; f. HC06231, 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 -- HC06232, HC06233, expiration date 9/5/23; g. HC09231, HC09232, HC09233, expiration date 12/5/23. -- 2 of 2 --

Summary Statement of Deficiencies D5779