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 review of laboratory records and interview with the laboratory technical consultant (TC) #3; the laboratory failed to employ personnel who fail to met the qualification requirements of 493.1411. Findings Include: 1. The laboratory director delegated the role of technical consultant to 3 of 3 individuals, listed on the CMS-209, who failed to meet the qualification requirements of a TC. See 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 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 -- 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 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 review of laboratory records and interview with the laboratory technical consultant (TC) #3; 3 of 3 personnel listed on the CMS-209, as technical consultants, failed to meet the qualification requirements for the position. Findings Include: 1. Review of the CMS-209 identified 3 individuals designated as technical consultants. Review of personnel records for 3 of 3 TC's found they failed to meet the educational requirements. a. TC#1 - Associate's degree (Respiratory Therapy Technology) b. TC#2 - Technical Certificate (Respiratory Therapy Technology) c. TC#3 - Bachelor of Science (Health Administration) 2. On survey date 03-07-2018, at 3:15 pm the above findings were confirmed by TC#3. 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 review of laboratory records and interview with the laboratory technical consultant (TC) #3; the laboratory failed to employ testing personnel (TP) who met the qualification requirements of 493.1423. Findings Include: 1. 3 of 24 TP, listed on the CMS-209, failed to meet the qualification requirements for moderate complexity testing. 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 -- 2 of 3 -- 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 records and interview with the laboratory technical consultant (TC) #3; 3 of 24 testing personnel (TP) failed to meet the qualification requirements of 493.1423. Findings Include: 1. Review of laboratory personnel records found 3 of 24 TP, listed on the CMS-209, failed to qualify as moderate complexity TP. a. TP#7 - No degree or high school diploma b. TP#15 - No degree or high school diploma c. TP#17 - Foreign degree and no United States foreign equivalency documentation. 2. On survey date 03-07-2018, at 3:15 pm, TC#3 confirmed the laboratory failed to have qualifying documentation for TP#7, TP#15, and TP#17. -- 3 of 3 --