Summary:
Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on 6/28/18. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D6053 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of laboratory procedures, review of laboratory personnel records, and interview with the lead office laboratory assistant, the technical consultant whose role is fulfilled by the laboratory director, failed to perform and document the six- month competency evaluation for a testing personnel who began performing complete blood counts (CBC) in 8/2017. Findings include: One of nine testing personnel did not have the semi-annual competency evaluation documentation during the first year of patient specimen testing for CBC. The laboratory procedure, "Procedures for Laboratory Personnel Training and Evaluation," stated, "The laboratory director evaluates the competency of testing personnel once within 6 months after beginning a new procedure, then again at 12 months and yearly thereafter." The lead office laboratory assistant stated during the on-site survey on 6/28/18 at approximately 3:15 PM that the six-month evaluation could not be found in the personnel records for the personnel who began testing in 8/2017. The laboratory performs approximately 72,000 hematology tests annually. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 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 annually, after the first year. This STANDARD is not met as evidenced by: Based on review of laboratory personnel records and interview with the lead office laboratory personnel, the technical consultant failed to evaluate and document the performance of individuals responsible for moderate complexity at least annually, after the first year. Findings include: There was no 2017 annual competency assessment documentation for one of nine testing personnel performing CBC. The lead office laboratory assistant confirmed the finding during the on-site survey on 6/28 /18 at approximately 3:00 PM. The laboratory performs approximately 72,000 hematology tests annually. D6064 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(a) Each individual performing moderte complexity testing must possess a current license issued by the State in which the laboratory is located, if such licensing is required. This STANDARD is not met as evidenced by: Based on review of laboratory personnel records and interview with the lead office laboratory assistant, one of nine testing personnel did not possess a current license from the State of Nevada. Findings include: One of nine testing personnel did not possess a current office laboratory assistant certification from the State of Nevada. The lead office laboratory assistant confirmed the finding during the on-site survey on 6/28/18 at approximately 2:45 PM. The testing personnel's certification expired on 5 /24/18 and continued performing CBC on patient specimens. The laboratory performs approximately 72,000 hematology tests annually. 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 review of laboratory personnel records and interview with the lead office -- 2 of 3 -- laboratory assistant, two of nine testing personnel performing moderately complex CBC did not have evidence of a high school diploma or equivalent in the personnel files reviewed. Findings include: Review of laboratory personnel records revealed that two of nine testing personnel performing moderately complex CBC did not have evidence of a high school diploma or equivalent in their personnel files. The lead office laboratory assistant confirmed the finding during the on-site survey on 6/28/18 at approximately 3:15 PM and stated that the practice manager may have the diplomas in his records. The laboratory performs approximately 72.000 hematology tests annually. D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. This STANDARD is not met as evidenced by: Based on review of laboratory personnel records and interview with the lead office laboratory assistant, the laboratory failed to have training documentation for testing personnel prior to analyzing patient specimens. Findings include: There was no training documentation prior to analyzing patient specimens for CBC for a testing personnel who began employment in 11/2017 . Both the initial training and competency evaluations were dated 6/14/18, seven months after employment. The lead office laboratory assistant confirmed the findings during the on-site survey on 6 /28/18 at approximately 3:00 PM. The laboratory performs approximately 72,000 hematology tests annually. -- 3 of 3 --