Regional Health Services Of Howard County

Summary Statement of Deficiencies D5783

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 proficiency records and reports, the laboratory fails to successfully participate in a proficiency testing program for the analyte, compatibility testing, for two consecutive testing events: 2021 events 1 and 3 (refer to D2181). D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful 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 -- performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing reports and records, the laboratory fails to achieve satisfactory performance for the analyte, compatibility testing, for two out of two testing events for unsuccessful participation. The laboratory received unsatisfactory performance scores of 80% for 2021 testing event 1 and 60% for 2021 testing event 3. -- 2 of 2 --

Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of the Cepheid GeneXpert operator's manual, maintenance records, and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report), the laboratory failed to perform an annual calibration of the Cepheid GeneXpert analyzer for two out of three time periods (2/14/2018 - 7/29/2020). The findings include: 1. The Cepheid GeneXpert operator's manual indicated it is necessary to calibrate the analyzer annually. 2. The laboratory calibrated the analyzer upon installation on 2/14/2018. 3. Laboratory personnel identifier #1 confirmed that laboratory had not calibrated the analyzer since the installation. 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 --

Summary Statement of Deficiencies 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-- 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 patient testing and quality control (QC) records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 1:00 pm on 06/27/2018, the laboratory failed to perform and document a negative and positive control at least each day of patient testing for rheumatoid factor testing for 16 days of patient testing from 09/08/2017- 05/25/2018. The findings include: 1. The laboratory's rheumatoid factor procedure stated that two levels of quality control are to be performed each day of patient testing. 2. Review of the laboratory's patient testing and QC records indicated that the laboratory performed rheumatoid factor patient testing but did not document QC performance on the following dates: 09/08/2017 (1 patient test), 09/12/2017 (1 patient test), 09/19/2017 (1 patient test), 10/05/2017 (1 patient test), 10/12/2017 (1 patient test), 10/20/2017 (1 patient test), 11/30/2017 (1 patient test), 02/01/2018 (1 patient test), 02/13/2018 (1 patient test), 03/01/2018 (1 patient test), 03/12/2018 (1 patient test), 03/27/2018 (1 patient test), 04/09/2018(2 patient tests), 04/20/2018 (1 patient test), 04/23/2018 (1 patient test), and 05/25/2018 (1 patient test). 2. At the time of the survey, the laboratory did not have QC documentation for the previously listed dates of patient testing. 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 --