Internists Associated

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to twice annually verify the accuracy of Vitamin-D testing for two of two years reviewed, 2018 and 2019. Findings include: 1) Review of the "ENCLOSURE I TEST METHODOLOGY AND ANNUAL TEST VOLUME LOG," indicated the laboratory had Vitamin-D listed as a testing analyte. 2) Medical record review indicated the following patients were tested for Vitamin-D in 2018 and 2019: PT=patient ng/mL=nanograms per milliliter PT Date Result (Vitamin-D) a) PT#1 7/17/19 41.6 ng/mL b) PT#2 8/30/19 60.0 ng/mL c) PT#11 12/3/18 22.23 ng/mL d) PT#12 12/18/18 16.64 ng/mL 3) In interview on 11/23 /20 at 10:35 am, SP-1 confirmed their laboratory has never twice annually verified the accuracy of Vitamin-D testing and no documentation for 2018 and 2019 was available for review. 4) Total annual test volume for Vitamin-D=3,936. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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 quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: 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 -- Based on record review and interview, the laboratory failed to document two different levels of quality control concentrations every day of patient testing and no IQCP (Individualized Quality Control Plan) has been implemented for one of seventeen analytes tested (Vitamin-D) and four of four Vitamin-D patient reports reviewed. Findings include: 1) Review of the "ENCLOSURE I TEST METHODOLOGY AND ANNUAL TEST VOLUME LOG," indicated the laboratory had Vitamin-D listed as a testing analyte. 2) Review of policy titled, "Roche cobas 6000 501 and 601 Analyzers - Calibration and QC Policy," read on page 1 of 1, "Quality Control Policy:...2. Two levels of controls for each analyte are used to establish control. (per shift)..." 3) Medical record review indicated the following patients were tested for Vitamin-D in 2018 and 2019: PT=patient ng/mL=nanograms per milliliter PT Date Result a) PT#1 7 /17/19 41.6 ng/mL b) PT#2 8/30/19 60.0 ng/mL c) PT#11 12/3/18 22.23 ng/mL d) PT#12 12/18/18 16.64 ng/mL 4) In interview on 11/23/20 at 1:15 pm, SP-1 confirmed there was no quality control documentation available for review on the above patients tested for Vitamin-D and there was no IQCP implemented. 5) Total annual test volume for Vitamin-D=3,936. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(4)(iv) Ensure that an approved

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 document review and interview, the laboratory failed to successfully participate in the American Proficiency Institute (API) proficiency testing (PT) program for the analyte total protein during PT testing events 1 and 2, 2020 (Refer to D2096). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on document review and interview, the laboratory failed to achieve a proficiency testing (PT) score of 80% or higher for total protein testing during two consecutive PT events (Event 1, 2020 and Event 2, 2020), resulting in unsatisfactory performance. Findings included: 1. Review of "CASPER Report 0155D" and the "Performance Summary" from "American Proficiency Institute" indicated the laboratory received a score of 20% during event 1, 2020 and a score of 60% during event 2, 2020 for total protein testing. 2. In interview on 7-28-2020 at 10:45 AM, SP1, Laboratory Manager, acknowledged the laboratory received a score of 20% during PT event 1, 2020 and a score of 60% during PT event 2, 2020 for total protein testing. -- 2 of 2 --