Christian Family Medicine

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 a desk review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and the laboratory's 2018 proficiency testing (PT) records, the laboratory failed to maintain satisfactory performance for the albumin, total bilirubin, calcium, creatinine, glucose, total protein, blood urea nitrogen (BUN), and uric acid analytes for 2018 events one and two resulting in the first unsuccessful occurrence. (Refer to D2096) D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- Failure to achieve satisfactory performance for the same analyte or test in 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 a desk review of the CMS 155 and the laboratory's 2018 PT records, the laboratory failed to maintain satisfactory performance for the albumin, total bilirubin, calcium, creatinine, glucose, total protein, blood urea nitrogen (BUN), and uric acid analytes for 2018 events one and two resulting in the first unsuccessful occurrence. The findings include: 1. Review of the CMS 155 report revealed the following unsatisfactory scores: 2018 event one: albumin 0%, total bilirubin 0%, calcium 0%, creatinine 0%, glucose 0%, total protein 0%, BUN 0%, uric acid 0%. 2018 event two: albumin 0%, total bilirubin 0%, calcium 0%, creatinine 0%, glucose 0%, total protein 0%, BUN 0%, uric acid 0%. 2. Review of the 2018 event one PT evaluation report revealed sample numbers CH-1, CH-2, CH-3, CH-4, CH-5 scored as "Failure to participate" for albumin, total bilirubin, calcium, creatinine, glucose, total protein, BUN and uric acid analytes. 3 Review of the 2018 event two PT evaluation report revealed sample numbers CH-6, CH-7, CH-8, CH-9, CH-10 scored as "Failure to participate" for albumin, total bilirubin, calcium, creatinine, glucose, total protein, BUN and uric acid analytes. -- 2 of 2 --

Summary Statement of Deficiencies D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the 2017 and 2018 chemistry quality control (QC) records, the laboratory quality assessment plan and interview with the technical consultant, the laboratory failed establish and follow written policies to assess the acceptability of the daily chemistry QC, in 2017 and 2018. The findings include: 1) Observation of the laboratory on February 20, 2018 revealed the Vitros 250 in use for patient routine chemistry testing. 2) Review of the December 2017 and January 2018 routine chemistry QC records revealed the acceptable QC limits were not included on the reports. The technical consultant documented review of the records with the monthly quality assessment (QA). 3) Review of the laboratory QA plan revealed the process to monitor and access the acceptability of the chemistry QC was not included. 4) Interview on February 20, 2018 at 2:30 p.m. with the technical consultant confirmed the routine QC monthly QA review did not include the acceptable limits for the QC. The QA policy does not include the mechanism on how to monitor and assess the acceptability of the daily chemistry QC. 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 --