Summary:
Summary Statement of Deficiencies 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 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 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 -- 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 a lack of available identification and documentation confirmed during an interview with the laboratory director (LD) and technical consultant (TC), the laboratory failed to have identified and or qualified TC reviewing the room, refrigerator and freezer monthly temperature logs for five of five months in 2021 at time of survey. 1. Upon review of the laboratory room temperature monthly logs, documents of three different laboratory testing personnel reviewed monthly temperature logs for August, September, October, November and December 2021 without being identified and/or meeting the TC qualifications. 2. Upon review of the laboratory refrigerator temperature monthly logs, documents of three different laboratory testing personnel reviewed monthly temperature logs for August, September, October, November and December 2021 without being identified and/or meeting the TC qualifications. 3. Upon review of the laboratory freezer temperature monthly logs, documents of three different laboratory testing personnel reviewed monthly temperature logs for August, September, October, November and December 2021 without being identified and/or meeting the TC qualifications. 4. Interview with the LD and TC on January 12, 2022 at 2:00 p.m. confirmed the laboratory failed to have identified and or qualified TC reviewing the room, refrigerator and freezer monthly temperature logs for five of five months in 2021 at time of survey. -- 2 of 2 --