Laboratory Corporation Of America Holdings

Summary Statement of Deficiencies D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: Based on a review of Personnel Records, the Training and Competency Assessment Policy, and an interview with the Laboratory Supervisor, the Technical Consultant failed to assure training and evaluations were documented initially for moderate complexity testing (Vaginal Wet Preparation and Clinitek Adventus for Urine Analysis) before performing patient testing. This was noted for one out of three Testing Personnel listed on the CMS - 209 Laboratory Personnel Report. The findings include: 1. A review of Personnel Records revealed Testing Personnel #3's initial training was not documented before performing patient testing (starting in November 2021). 2. A review of the Training and Competency Assessment Policy revealed, " Training 1. An employee who is new to the job function must receive training before being allowed to test independently. This includes employees new to the laboratory, employees who have transferred or have been promoted to different job duties... 4. There must be documentation of training...". 3. During an interview on 05/05/2022 at 1:15 PM, the Laboratory Supervisor confirmed initial training was not documented, and Testing Personnel started patient testing in November 2021. D6054 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 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 -- annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of Personnel Records, the Training and Competency Assessment Policy, and an interview with the Laboratory Supervisor, the Technical Consultant failed to document evaluations for moderate complexity testing (Vaginal Wet Preparation and Clinitek Adventus for Urine Analysis) at least annually, after the first year. This was noted for two out of three Testing Personnel listed on the CMS - 209 Laboratory Personnel Report. The findings include: 1. A review of Personnel Records revealed the Testing Personnel #1 and #2 did not have annual evaluations documented for 2020 and 2021. 2. A review of the Training and Competency Assessment Policy revealed, "...Competency Schedule 1. Competency for nonwaived tests is assessed at the following times: a. after training, b. semi-annually during the first year, c. annually after the first year...". 3. During an interview on 05/05/2022 at 10:15 AM. the Laboratory Supervisor confirmed annual competencies were not documented for Testing Personnel #1 and #2 for 2020 and 2021. -- 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 a review of the BHCG (Beta Human Chorionic Gonadotropin) calibration verification (C-V) records and an interview with the Laboratory Supervisor, the laboratory failed to ensure the calibrator verification kit was used before its expiration date. This was observed on one of three 2018-2019 C-V's reviewed. The findings include: 1. A review of records for the Tosoh AIA-900 analyzer revealed calibrations of BHCG utilize a two-point calibration curve. Analytes calibrated with less than three calibrators require semi-annual calibration verification studies. 2. A review of the BHCG C-V records revealed the laboratory verified their calibration on 2/27/2019 using samples from the Audit Microcontrols kit Lot number 06696. However, a review of the manufacturer's package insert revealed the kit expired on 2/24/2019. 3. During an interview on 8/21/2019 at 12:55 PM, the Laboratory Supervisor reviewed the C-V records with the testing personnel, and confirmed the above noted findings. SURVEYOR ID #32558 Licensure and Certification Surveyor 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 --