Summary:
Summary Statement of Deficiencies D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a review of personnel records, a review of quality control and assessment records, and interviews with Testing Personnel (TP) #5 and the office manager (also a testing personnel, as needed, although not listed on the CMS form #209), the surveyor determined the Laboratory Director (LD) failed to ensure a quality assessment program was maintained to ensure all testing personnel of moderate complexity testing were trained and their competency assessed. The laboratory did not provide a Quality Assessment policy and procedure for review by the surveyor. The LD further failed to ensure testing personnel did not perform patient testing of Complete Blood Counts (CBCs), prior to ensuring quality control testing was acceptable. This affected eight of eight testing personnel, and greater than fifty patient specimens on at least six days of testing. The findings include: 1. A review of the personnel records revealed the following training and/or competency evaluations without signature of the LD or either Technical Consultant (TC), to signify review and approval: a) The Emerald training, dated 2/21/19, and the semiannual competency evaluation, dated 8/21/19 for TP #1. b) The Emerald training, dated 12/5/18, and the semiannual competency evaluation (dated 6/5/19), and remedial Hematology training, dated 9/25/19, for TP #2. c) For TP #3, the initial training, dated 6/25/19, and the remedial training, dated 9 /24/19 were not signed by the LD or either of the TCs. d) TP #4's initial training was documented as completed on 7/6/19, and remedial Hematology training on 9/24/19. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- None of these personnel records were signed by the LD or TC to signify appropriate and adequate training. e) The annual competency evaluation, dated 4/16/19, for TP #5 was not signed by the LD or either TC. f) For TP #6, the initial training (Emerald), dated 2/12/19, and the semiannual competency evaluation, dated 8/12/19. g) The annual competency evaluation, dated 7/6/19, for TP #7 was not signed by the LD or TC. h) The office manager's competency was documented as being assessed on 5/1 /18, although the record was not signed by the LD or TC. 2. In an interview on 10/29 /19 at 10:30 AM, the surveyor inquired of the office manager her extent of testing in the laboratory. The office manager confirmed she occasionally performs moderate complexity testing when needed. The office manager had previously been considered solely testing personnel, prior to becoming the office manager. The surveyor stated to the office manager and TP #5 the requirement to list all personnel of moderate complexity testing on the CMS personnel report (form #209). 3. In an interview on 10 /29/19, 10:17 AM - 10:30 AM, the surveyor discussed with TP #5 and the office manager, the lack of the LD's or TC's signature on the training and/or competency assessments, to indicate the personnel had received appropriate and adequate training and found to be competent in laboratory skills performed by each testing personnel. 4. Refer to D6028. 5. A review of the quality control and quality assessent records revealed 10/21/17, two of the three quality controls were outside of acceptable limits. The testing personnel performed patient CBC (Complete Blood Count) testing and reported the results of at least 12 patients. On 6/20/19, the testing personnel failed to ensure at least two of three levels of quality control were acceptable, prior to tesing patient specimens and reporting the results. The quality assurance records indicated the patients' reports were reviewed by the physician to determine how and if the patients were affected by the test runs without acceptable quality control. The quality assurance records also indicated the testing personnel had received remedial training, after this June incident. Again in August of 2019 [8/16 (18 patients), 8/17 (13 patients), 8/18 (13 patients), and 8/19 (26 patients)], the testing personnel ran patient specimens and reported the results, although the quality control was found unacceptable, and no