Summary:
Summary Statement of Deficiencies 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 record review of the patient results report, testing personnel records, and interview with General Supervisor (GS) #1, the laboratory failed to ensure that seven out of the 14 testing personnel listed on the CMS-209 Personnel Report Form had the appropriate educational background and training prior to performing moderate-level diagnostic tests on the Abbott i-STAT analyzer. (See D6065 and D6066) 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 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 -- This STANDARD is not met as evidenced by: Based on a record review and an interview with the General Supervisor (GS) #1, the laboratory failed to ensure that seven out of the 14 testing personnel (TP) listed on the CMS-209 Personnel Report Form were qualified to perform moderate-level diagnostic testing on the Abbott i-STAT analyzer from January 1, 2021, to December 20, 2022. Findings: 1. A review of accession #21-139-2850 patient results report for venous blood gas performed on 5/19/2021 revealed that the test was performed by testing personnel in the Respiratory Care Unit. 2. The laboratory failed to provide documentation of appropriate education and experience for seven out of the 14 testing personnel (TP #8, TP #9, TP #10, TP #11, TP #12, TP #13, and TP #14) listed on the CLIA CMS-209 form. 3. A review of the test volume report for Abbott i-STAT CG4+ analytes revealed 291 pH, 270 pCO2, and 270 pO2 tests were performed from December 14, 2021, to December 14, 2022. 4. An interview with GS #1 on December 20, 2022, at 1:00 PM confirmed the laboratory failed to verify the qualifications of seven of the 14 testing personnel that performed blood gas analyses from January 1, 2021, to December 20, 2022 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 a record review and an interview with the General Supervisor (GS) #1, the laboratory failed to ensure that seven out of the 14 testing personnel (TP) listed on the CMS-209 Personnel Report Form had documentation of training applicable to the types and complexity of testing performed on the Abbott i-STAT analyzer from January 1, 2021, to December 20, 2022. Findings: 1. A review of accession #21-139- 2850 patient results report for venous blood gas performed on 5/19/2021 revealed results were reported for analytes pH, pCO2, pO2, SO2, HCO3 and Base Excess (BE). 2. The laboratory failed to provide documentation of training for seven out of the 14 testing personnel (TP #8, TP #9, TP #10, TP #11, TP #12, TP #13, and TP #14) listed on the CLIA CMS-209 form for the Abbott i-STAT analyzer prior to analyzing patient specimens. 3. An interview with GS #1 on December 20, 2022, at 1:00 PM confirmed the laboratory failed to verify the seven of the 14 testing personnel were properly trained to performed blood gas analyses prior to patient testing from January 1, 2021, to December 20, 2022 -- 2 of 2 --