Summary:
Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: . Based on review of American Proficiency Institute (API) proficiency testing (PT) documentation for 2017, 2018 and 2019 and laboratory personnel records, confirmed by staff interview, the laboratory failed to test PT samples utilizing personnel who routinely perform blood gas testing in the facility. Findings: 1. API attestation statements showed the following testing personnel (TP-CMS form 209) participated in PT in the testing events indicated: 2nd Event 2017 Sample Tested By BG-06 TP 3 BG- 07 TP 3 BG-08 TP 1 BG-09 TP 1 BG-10 TP 1 3rd Event 2017 BG-11 TP 1 BG-12 TP 1 BG-13 TP 1 BG-14 TP 1 BG-15 TP 1 1st Event 2018 BG-01 TP 2 BG-02 TP 2 BG- 03 TP 1 BG-04 TP 3 BG-05 TP 1 2nd Event 2018 BG-06 TP 1 BG-07 TP 1 BG-08 TP 1 BG-09 TP 1 BG-10 TP 1 3rd Event 2018 BG-11 TP 2 BG-12 TP 2 BG-13 TP 1 BG-14 TP 6 BG-15 TP 4 1st Event 2019 BG-01 TP 1 BG-02 TP 1 BG-03 TP 1 BG- 04 TP 3 BG-05 TP 3 2nd Event 2019 BG-06 TP 3 BG-07 TP 3 BG-08 TP 1 BG-09 TP 1 BG-09 TP 1 2. The laboratory's CMS form 209 lists 17 testing personnel. Of these, five participated in proficiency testing in the previous seven events. In an interview at the site on 09-04-2019, testing persons 1 and 3 verified the attestation forms were correct. . D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the 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 -- laboratory's routine methods. This STANDARD is not met as evidenced by: . Based on review of API PT documentation for 2017, 2018 and 2018, confirmed by staff interview, laboratory personnel failed to attest to the routine integration of PT samples into the patient workload by providing signatures of testing personnel on the attestation forms provided. Findings: 1. API attestation forms for PT events in 2017, 2018 and 2019 showed some signatures to indicate attestation, but in other cases the names of testing personnel were written in as follows: 2nd Event 2017 Sample Tested by Signed or written in BG-06 TP 3 Written in BG-07 TP 3 Written in BG-08 TP 1 Written in BG-09 TP 1 Written in BG-10 TP 1 Written in 3rd Event 2017 BG-11 TP 1 Written in BG-12 TP 1 Written in BG-13 TP 1 Written in BG-14 TP 1 Written in BG- 15 TP 1 Written in 1st Event 2018 BG-01 TP 2 Signed BG-02 TP 2 Signed BG-03 TP 1 Signed BG-04 TP 3 Signed BG-05 TP 1 Signed 2nd Event 2018 BG-06 TP 1 Written in BG-07 TP 1 Written in BG-08 TP 1 Written in BG-09 TP 1 Written in BG- 10 TP 1 Written in 3rd Event 2018 BG-11 TP 2 Written in BG-12 TP 2 Written in BG- 13 TP 1 Written in BG-14 TP 6 Written in BG-15 TP 4 Written in 1st Event 2019 BG- 01 TP 1 Signed BG-02 TP 1 Signed BG-03 TP 1 Signed BG-04 TP 3 Written in BG- 05 TP 3 Written in 2nd Event 2019 BG-06 TP 3 Signed BG-07 TP 3 Signed BG-08 TP 1 Signed BG-09 TP 1 Signed BG-09 TP 1 Signed 2. In an interview at the site on 09-04-2019, testing person 1 stated he had, in the events listed, written in the names of some testing personnel as a matter of expediency but that the information regarding who had performed the actual testing was accurate. He further stated that he had been unaware that signatures were required to complete the form rather than a listing of participating personnel. . 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: . Based on review of competency verification documentation for 2018, confirmed by staff interview, the laboratory technical consultant (CMS form 209) failed to evaluate the competency of all testing personnel. Findings: 1. A review of competency verification documentation revealed that, for the year 2018, competency verification forms for all testing personnel were signed by TP 3 with the exception of her own, which was signed by TP 1. 2. Review of personnel education and training documentation showed that TP 1 and TP 3 did not meet the qualifications for laboratory technical consultant and were therefore not eligible to evaluate personnel competency for moderate complexity testing. In an interview at the site on 09-04- 2019, both TP 1 and TP 2 stated they were not aware that the laboratory director, who also serves as technical consultant, could not delegate this duty to them. -- 2 of 2 --