Summary:
Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on record review and an interview with the Laboratory Director, the laboratory failed to ensure that written competency assessment (CA) and proficiency testing (PT) policies and procedures were established and available for the testing conducted in the subsubspecialties of Bacteriology, Mycology, Parasitology and Virology. This deficient practice had the potential to affect 2,360 out of 2,360 patient tests performed in this laboratory from when testing began on 08/14/2024 through 12/03/2024. Findings Include: 1. Review of the laboratory's policies and procedures provided on the date of the inspection did not find any mention of CA or PT policies and procedures. 2. The Inspector requested the laboratory's CA and PT policies and procedures from the Laboratory Director. The Laboratory Director confirmed the laboratory did not establish written CA and PT policies and procedures and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 12/03/2024 at 9:57 AM. 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. 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 record review and an interview with the Laboratory Director, the Technical Consultant (TC) failed to evaluate and document the competency of five out of five Testing Personnel (TP) in 2024, assuring their competency was maintained in order to perform moderately complex testing in the subspecialties of Bacteriology, Mycology, Parasitology and Virology and to report the test results promptly, accurately, and proficiently. This deficient practice had the potential to affect 2,360 out of 2,360 patient tests conducted by all TP in this laboratory from when testing began on 08/14 /2024 through 12/03/2024. Findings Include: 1. Review of the laboratory's policies and procedures provided on the date of the inspection did not find any mention of a competency assessment policy and procedure. 2. Review of the laboratory's Form CMS-209, approved via signature and date by the Laboratory Director on 11/22/2024, revealed one individual listed and credentialed by the Laboratory Director as a TC and five individuals listed and credentialed by the Laboratory Director as moderate complexity TP. 3. Review of the laboratory's competency assessment documentation provided on the date of the inspection found competency assessments were conducted by the Laboratory Director who was not qualified and listed as a TC due to not directing or supervising a non-waived laboratory for at least one year. 4. The Inspector requested the laboratory's 2024 competency assessment documentation for TP#1, TP#2, TP#3, TP#4 and TP#5 that were assessed by the qualified and listed TC from the Laboratory Director. The Laboratory Director confirmed the TP competency assessments were not conducted by the TC and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 12/03/2024 at 8:28 AM. -- 2 of 2 --