Summary:
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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D 12/8/17 and review of 2017 American Proficiency Institute (API) proficiency testing results 2/2/18 during the onsite recertification survey, the laboratory failed to achieve satisfactory performance for the subspecialty of bacteriology in two of three consecutive testing events, resulting in unsuccessful participation. See the deficiency cited at D2028. D2028 BACTERIOLOGY CFR(s): 493.823(e) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D 12/8/17 and review of 2017 American Proficiency Institute (API) proficiency testing results and interview with staff 2/2/18 during the onsite recertification survey, the laboratory failed to achieve satisfactory performance for the subspecialty of Bacteriology in two of three consecutive testing events, resulting in unsuccessful participation. Findings: 1. Desk review of CMS Casper reports 153D and 155D 12/8/17 revealed the laboratory received a score of 0% for the subspecialty of bacteriology on the 2017 Microbiology 1st event, and a score of 20% on the 2017 Microbiology 3rd event. 2. Review of 2017 API proficiency testing results 2/2/18 during the onsite recertification survey revealed: a. The laboratory failed to participate and received an overall score of 0% on the 2017 Microbiology 1st event. b. The laboratory received a score of 20% for Gardnerella vaginalis, a score of 60% for Trichomonas vaginalis, and a score of 80% for Candida species, resulting in an overall score of 20% on the 2017 Microbiology 3rd event. During interview at approximately 9:30 a.m., the office manager stated that one of the former testing personnel observed TP #2 during the process of testing the samples. She stated the former testing personnel did not notice any problems, so it was not clear what happened. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory's IQCP (Individualized Quality Control Plan) and review of 2016 and 2017 quality assessment records 2/2/18, the laboratory director failed to review and approve the IQCP before use. Review of the laboratory's IQCP revealed it was originally established sometime in March 2016. A notation by the TC (technical consultant) 10/27/16 states "After reviewing 22 patients that have been done since January until September and QC was performed each day of testing - QC can now be done each time an Affirm kit is opened." There was no documentation that the laboratory director reviewed and approved the update prior to implementation. The "Laboratory Quality Assessment Review" completed 4/10/17 by the TC states in a notation at the bottom of the form "... talked with (the office manager) about getting IQCP review signed ...". On May 22, 2017, the "Laboratory Quality Assessment Review" noted "QC/Calibration Review: Lab director needs to sign QA annual review of IQCP for Affirm..." D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- -- 2 of 5 -- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures and review of 2016 and 2017 quality control and patient test logs 2/2/17, the laboratory failed to perform and document quality control with each new Affirm VPIII kit as specified by their IQCP (Individualized Quality Control Plan) for the Affirm VPIII Microbial Identification Test. The laboratory's IQCP (effective 10/27/16) states "... Manufacturer's suggested External Quality Control frequency will continue and two levels of external controls - positive and negative for Gardnerella, Candida, and Trichomonas - will be performed with each new kit opened. All will be documented accordingly. Compliance will be monitored by the technical consultant. ... Patient test logs will also be reviewed monthly to assure correct interpretation of patient and quality control results. The TC will monitor for compliance. ..." An untitled 1-page document located in the notebook with the Affirm VPIII logs states "When doing AFFIRM testing make sure of the following items: ... 2. External QC is done each time a kit it opened and acceptable results achieved before patients can be reported out. ..." Review of 2016 and 2017 quality control and patient test logs revealed: 1. The laboratory tested positive and negative external controls for Affirm VPIII lot #6138725 on 11/3/16. Results of the positive control were recorded on the log as "neg" (negative), and results of the negative control were recorded as "pos" (positive) for Trichomonas, Gardnerella, and Candida. 14 patients were tested from 11/14/16 to 1/27/17. 2. The laboratory started using Affirm VPIII lot #7019600 for patient testing 4/28/17. There was no documentation that external positive and negative controls were tested until 6/24/17. 15 patients were tested from 4/28/17 to 6/23/17. 3. The laboratory started using Affirm VPIII lot #7018754 for patient testing 7/28/17. There was no documentation that external positive and negative controls were tested until 8/1/17. 3 patients were tested on 7/28/17. D5783