Summary:
Summary Statement of Deficiencies D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to ensure one (SP-1) of one person performing the duties of a technical consultant (TC) was qualified, from December 2016 thru May 10, 2023 (refer to D6035). D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's 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 -- degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to ensure one (SP-1) of one person performing the duties of a technical consultant (TC) met qualification requirements, from December 2016 to May 10, 2023. Finding(s) included: 1) Review of "Laboratory Personnel Report (CLIA)", signed by the laboratory director on 5/8/23 indicated SP-1 is the Technical Consultant. 2) On 5/8/23 at 10:09am, an interview with SP-1 (Technical Consultant) and SP-2 (Executive Director) confirmed the date of hire for SP-1 was December of 2016. 3) Review of education for SP-1 (Technical Consultant) revealed a copy of Bachelor of Science (B.S.) Degree that did not specify a major. Transcripts provided for the B.S. identified the major as Health Arts with a transfer of 80 credits from associate degree in medical laboratory technology, with no science courses (chemical, physical, or biological) taken during the completion of the B.S. which does not qualify SP-1 as Technical Consultant. 4) Review of Policy, "Procedure: Beckman Coulter DxH 600 Operation", signed by the laboratory Director on 02/20/2023 listed the Technical Consultant (TC) under Owner, as the" Manager- Lab". Further review of Policy, "Hematopathology Procedure for running CICC Specimens at IUHPL" signed by the laboratory Director on 05/04/2023 also listed the Technical Consultant (TC) under Owner, as the "Manager-Lab". A Review of the "Attendance Sheet" provided to person(s) involved in the survey was signed "Manager, Technical Consultant" by SP-1 under Title, that acknowledge their position as the Technical Consultant (TC). 5) On 5/9/23 at 1:43pm, upon request via email for additional bachelor's degree credits information, SP-1 (Technical Consultant) sent a copy of an Associate of Science (A.S) Degree transcript on 5/10/23 at 3:43pm. -- 2 of 2 --