Summary:
Summary Statement of Deficiencies D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on a review of the laboratory testing personnel (TP) competency records, and an interview with the Lead Technical Consultant (TC-1), the laboratory failed to evaluate testing personnel (TP) for competency which included the six elements required for competency assessment. Findings include: 1. 13 of the 13 TP did not have documentation of competency assessments for troubleshooting, proficiency testing evaluations, and reporting of test results for 2021, 2022, and to the date of survey 2023. 2. The laboratory TC-1 confirmed by an interview on June 21, 2023, at 11:20 am, the lack of documentation of review of all six elements for TP competency assessments. 3. The laboratory reports performing 214 Activated Clotting Time (ACT) tests annually. 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 a review of the laboratory's testing personnel educational records and an interview with the laboratory Technical Consultant (TC-1) on 6/21/2023, the 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 -- laboratory failed to ensure that all testing personnel meet the educational qualification requirements. See D6065. 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 have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on a review of the laboratory testing Personnel Form CMS-209, a review of the laboratory's personnel education records, and an interview with the technical consultant (TC-1), the laboratory failed to ensure that all testing personnel (TP) had the educational requirements to qualify as testing personnel. Finding include: 1. Review of the education records revealed one of four new TP educational diplomas was from outside of the United States. 2. The laboratory lacked documentation from an HHS-approved international Equivalency Agency evaluation of the new TP-5 educational equivalency. 3. The laboratory TC-1 confirmed by interview on 06/21 /2023 at 11:25 pm, the lack of documentation of international equivalency evaluation for TP-5. 4. The laboratory reports performing 214 Activated Clotting Time (ACT) patient samples annually. -- 2 of 2 --