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: Review of Personnel records and discussion with the staff the laboratory's Technical Consultant (TC) failed to perform competency assessment of 4 testing personnel (TP). Findings include: 1. The surveyor requested and the laboratory failed to provide documentations of competency for four (4) out of the sixteen (16) testing personnel (TP) performing moderate complexity testing using the Coaguchek XS Pro PT/INR Analyzer at the time of survey. 2. The Technical Consultant (TC) concur with these findings on 12/20/2018 at 15:30 PM. 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: Review of Personnel Records and discussion with the Staff reveals testing personnels performing moderate complexity testing do not have their diplomas or transcripts of records on file. Refer to D6065. D6065 TESTING PERSONNEL QUALIFICATIONS 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): 493.1423(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: Review of Personnel records reveals 6 testing personnels performing moderate complexity testing do not have their diplomas or transcripts of records on file. Findings include: 1. Six (6) out of sixteen (16) Medical Assistants Performing Point of Care PT/INR using the Coaguchek Pro Analyzer do not have their diploma or transcript of records at the time of survey. 2. The Technical Consultant (TC) concur with these finding on 12/20/2018 at 15:30 PM. -- 2 of 2 --