Unc Oral Microbiology Laboratory

Summary Statement of Deficiencies D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of personnel records and interview with the GS (general supervisor) 9 /17/24, the laboratory director failed to specify in writing the duties and responsibilities for the GS, the CC (clinical consultant), and 1 of 1 TP (testing personnel). Findings: Review of personnel records revealed there were no job descriptions / lists of duties and responsibilities available for duties delegated to the GS, the CC, and TP #1 by the laboratory director. During interview at approximately 9:25 a.m., the GS confirmed they did not have job descriptions for the GS, the CC, and TP #1 and they did not have duties delegated in writing by the laboratory director. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (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, 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 -- accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of personnel records and interview with the GS 9/17/24, TS (technical supervisor) #1 failed to perform and document competency evaluations for TS #2 and the CC during 2022, 2023, and 2024. Findings: Review of personnel records for TS #2 and the CC revealed no documentation of competency evaluations for 2022, 2023, or 2024. During interview at approximately 9:30 a.m., the GS confirmed that TS #1 (laboratory director) had not documented competency evaluations for TS #2 and the CC during 2022, 2023, or 2024. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on review of personnel records and interview with the GS 9/17/24, TS #1 (laboratory director) failed to perform and document an annual competency evaluation for TP #1 during 2022, and for the GS during 2023. Findings: 1. Review of personnel records for TP #1 revealed competency evaluations documented in February 2023 and August 2024. There was no documentation of a competency evaluation performed in 2022. 2. Review of personnel records for the GS revealed competency evaluations documented in June 2022 and September 2024. There was no documentation of a competency evaluation performed in 2023. During interview at approximately 9:45 a. m., the GS stated her 2023 competency evaluation was missed. -- 2 of 2 --

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of 2019, 2020, 2021, and 2022 laboratory records and interview with the GS (general supervisor) 5/9/22, the laboratory failed to perform and document quality control each day of patient testing or establish an IQCP (Individualized Quality Control Plan) for antibiotic sensitivitity testing. Review of 2019, 2020, 2021, and 2022 laboratory records revealed the laboratory had not performed quality control for Kirby-Bauer (disc diffusion) and E-test (minimum inhibitory concentration) each day of patient testing. The laboratory had performed quality control testing with ATCC (American Type Culture Collection) organisms weekly and with new lot numbers of discs or strips. There was no documentation available to indicate that the laboratory had established an IQCP to allow for weekly testing, including for new antibiotics added: a. Doripenem added to Kirby-Bauer 3/6/20 b. Linezolid added to Kirby-Bauer 9/10/20 c. Clindamycin added to E-test 1/8/21 d. Cefoxitin added to Kirby-Bauer 6/4/21 During interview at approximately 11:10 a.m., the GS confirmed that the laboratory did not have an IQCP in place. D6086 LABORATORY DIRECTOR RESPONSIBILITIES 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 -- CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on review of 2019, 2020, 2021, and 2022 laboratory records and interview with the GS (general supervisor) 5/9/22, the laboratory director failed to ensure that verification procedures were adequate to determine all pertinent performance characteristics for media made in-house. Findings: Review of 2019, 2020, 2021, and 2022 laboratory records revealed the laboratory started making some media in-house during the pandemic. The laboratory had an "In-House Media Preparation" procedure which including specific instructions for each type of media. The procedure stated "... Regardless of the expiration date of the individual components in a batch of media, a new expiration date will be assigned as follows: a. Agar plates: 60 days b. Tubed media: 6 months ...". There was no documentation available to indicate when the laboratory started the in-house media preparation, and no documentation that the process (including media expiration dates) was validated and approved by the laboratory director. During interview at approximately 3:20 p.m., the GS stated they started making media in-house because of price increases and lack of availability. She verified they did not perform a validation. She stated they tried to find information about expiration dates, but there was nothing definite in the literature references or from the manufacturers of the ingredients used to make the media. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of personnel records, the absence of records, and interview with the GS (general supervisor) 5/9/22, the TS (technical supervisor) failed to evaluate the competency of the GS at least twice during the first year of testing. Review of personnel records revealed the GS was hired and was trained in August 2019. There was no documentation that the competency of the GS was evaluated semiannually during her first year of testing. During interview at approximately 2:45 p.m., the GS confirmed that there were no competency evaluations documented during her first year of testing patient specimens. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of personnel records, the absence of records, and interview with the GS (general supervisor) 5/9/22, the TS (technical supervisor) failed to evaluate the competency of the GS at least annually after the first year of testing. Review of personnel records revealed the GS was hired and was trained in August 2019. There was no documentation of an annual competency evaluation for the GS during 2021. During interview at approximately 2:45 p.m., the GS confirmed that she did not have a competency evaluation in 2021. -- 3 of 3 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of CMS (Centers for Medicare and Medicaid Services) Casper report 155D and review of 2017, 2018 and 2019 AAB (American Association of Bioanalysts) proficiency testing records 6/5/19, the laboratory failed to successfully participate in proficiency testing for the subspecialty of bacteriology in two consecutive testing events. See the deficiency cited at D2020. D2020 BACTERIOLOGY CFR(s): 493.823(a) 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 -- Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of CMS (Centers for Medicare and Medicaid Services) Casper report 155D and review of 2017, 2018 and 2019 AAB (American Association of Bioanalysts) proficiency testing records 6/5/19 and review of email from AAB 7/5/19, the laboratory failed to successfully participate in proficiency testing for the subspecialty of bacteriology in two consecutive testing events. Findings: 1. On the 2018 Q3 Nonchemistry test event, the laboratory provided an incorrect response for 1 of 4 samples, resulting in a score of 75% for Bacteriology culture identification. 2. On the 2019 Q1 Nonchemistry test event, the laboratory provided an incorrect response for 1 of 4 samples, resulting in a score of 75% for Bacteriology culture identification. An AAB representative stated in email dated 7/5/19 "Each of the four samples reported were weighted 25% since they reported Extent 0 for one sample in each event." D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies No Tags No deficiency details available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --