Cabin Creek Health Center

Summary Statement of Deficiencies D0000 An unannounced, off site, proficiency testing (PT) desk review was conducted for Cabin Creek Health Center on August 24, 2021, by the West Virginia Office of Laboratory Services. The laboratory's PT evaluations with the American Academy of Family Physicians (AAFP) were reviewed for compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. The unsuccessful PT performance deficiencies are explained below. 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 an off site desk review of the laboratory's 2021 American Academy of Family Physicians (AAFP) proficiency testing (PT) evaluation records and the 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 -- CASPER 155D Individual Laboratory Profile Report, the laboratory failed to (c) successfully perform in a program approved by CMS for the analyte #0315 (Blood Gas pH) for 2 of 2 consecutive testing events in 2021. Findings: #0315 Blood Gas pH AAFP PT 2021-A 40% AAFP PT 2021-B 60% D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 an off site desk review of the laboratory's 2021 American Academy of Family Physicians (AAFP) proficiency testing (PT) evaluation records and the CASPER 155D Individual Laboratory Profile Report, the laboratory failed to attain a score of at least 80 percent of acceptable responses for analyte #0315 Blood Gas pH in 2 of 2 consecutive testing events for 2021. Findings: 1. Desk review of the CASPER 155D Individual Laboratory Report revealed the following unsatisfactory scores for analyte #0315 Blood Gas pH: 2021-A 40% 2021-B 60% 2. Review of AAFP PT evaluation records confirmed the unsatisfactory performance for analyte #0315 Blood Gas pH in 2 of 2 consecutive testing events of 2021. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of the American Academy of Family Physicians (AAFP) proficiency testing (PT) evaluation reports and the CASPER 155D Individual Laboratory Profile report, the laboratory director failed to ensure successful participation in a program approved by CMS for the analyte #0315 Blood Gas pH for 2 of 2 consecutive testing events of 2021. Findings: 1. Refer to D2016 and D2096. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced, on site, recertification survey was conducted at Cabin Creek Health Center on September 9, 2020, by the West Virginia Office of Laboratory Services. The laboratory was surveyed to assess compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. Specific deficiencies are explained below. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on a review of the laboratory written policies and procedures (P&P) and an interview with the testing personnel (TP) and laboratory director (LD), the laboratory failed to establish a written P&P for the positive identification of patients and patient's specimens through specimen collection, labeling, accessioning, processing, testing, and reporting of results. Findings: 1. A review of written P&P could not locate a process for the positive identification of patients from specimen collection through reporting of patient results. 2. During interviews with TP1 and TP2, on 9/9/2020 at approximately 10:00 AM, they both explained the laboratory process for the positive identification of patient samples from specimen collection through reporting results. 3. During an interview with the LD, on 9/9/2020 at approximately 10:10 AM, the LD stated that no written P&P could be located. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) 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 -- 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 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 review of the laboratory's proficiency testing records and interview with the Laboratory Director (LD), the laboratory failed to perform twice annual verification of accuracy of the KOH and Wet prep procedures from November 2016 to March 2018. The findings include: 1. Review of the laboratory's records from November 2016 until March 2018 identified no documentation of twice annual verification of accuracy of the KOH and Wet prep procedures performed in the laboratory. 2. On 3/6/18 at approximately 10:20 AM, the LD confirmed the findings. 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 the laboratory's quality control records, "KOH/Wet Prep Log" and interview with the Laboratory Director (LD), the laboratory failed to perform a positive and negative control each day of patient testing for KOH/Wet Prep procedures. Record review was from November 2016 until March 2018. The findings 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 -- include: 1. Review of the laboratory's "KOH/Wet Prep Log"November 2016 to March 2018 identified KOH and Wet Prep patient testing performed on 3/21/17, 6/27/17, and 6/29/17. 2. Review of the laboratory's quality control records from November 2016 to March 2018 identified no quality control performed for KOH and Wet Prep testing. 3. On 3/6/18 at approximately 11:30 AM, the LD confirmed the findings. -- 2 of 2 --