Camc Greenbrier Physicians Ronceverte

Summary Statement of Deficiencies D0000 An unannounced, off site, proficiency testing (PT) desk review was conducted at Greenbrier Physicians Inc on March 19, 2021, by the West Virginia Office of Laboratory Services. The laboratory proficiency testing evaluations with the American Proficiency Institute (API) were reviewed for compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. Specific 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 review of the American Proficiency Institute (API) proficiency testing (PT) records and the CLIA 155D Individual Laboratory Profile for Greenbrier Physicians Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Inc, the laboratory failed to successfully participate in a program approved by CMS for the analytes of FREE TY (# 0545) and TSH (# 0585). The findings include: 1. FREE TY (# 0545) Event 2 (2020) - 60% Event 1 (2021) - 0% 2. TSH (# 0585) Event 2 (2020)- 60% Event 1 (2021)- 0% D2100 ENDOCRINOLOGY CFR(s): 493.843(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) proficiency testing (PT) records and the CASPER 155D Individual Laboratory Profile report for Greenbrier Physicians Inc, the laboratory failed to successfully participate in a program approved by CMS for the analytes FREE TY (#0545) and TSH (#0585) for the 1st testing event of 2021. The findings include: 1. FREE TY (#0545) Event 1 (2021)- 0% 2. TSH (#0585) Event 1 (2021)- 0% D2108 ENDOCRINOLOGY CFR(s): 493.843(g) 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 a review of the CASPER 155D Individual Laboratory Profile Report and the Failures Summary report from the American Proficiency Institute (API), the laboratory failed to perform satisfactorily in proficiency testing (PT) for the specialty of endocrinology in 2 of 3 consecutive testing events. Findings: 1. Review of CASPER 155D Individual Laboratory Profile Report revealed the following unsatisfactory test event scores for specialty # 0525 ENDOCRINOLOGY: 2nd event 2020 - 73% 1st event 2021 - 0% 2. Review of API Failures Summary report confirmed the following unsatisfactory test event scores for the specialty ENDOCRINOLOGY (#0525): 2nd event 2020 - 73% 1st event 2021- 0% 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. -- 2 of 3 -- This CONDITION is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing (PT) records and the CLIA 155D Individual Laboratory Profile for Greenbrier Pysicians Inc, the laboratory director failed to ensure successful participation in a program approved by CMS for the analytes of FREE TY (# 0545) and TSH ( # 0585) in 2 of 3 consecutive testing events. The findings include: 1. FREE TY (# 0545) Event 2 (2020) - 60% Event 1 (2021) - 0% 2. TSH (# 0585) Event 2 (2020)- 60% Event 1 (2021)- 0% D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) proficiency testing (PT) records and the CASPER 155D report for Greenbrier Physicians Inc, the laboratory director failed to assure compliance with the regulation requiring successful participation in PT testing for the analytes FREE TY (# 0545) and TSH (# 0585) in the specialty of ENDOCRINOLOGY (# 0525). Findings: 1. FREE TY (# 0545) Event 2 (2020)- 60% Event 1 (2021)- 0% 2. TSH (# 0585) Event 2 (2020)- 60% Event 1 (2021)- 0% 3. ENDOCRINOLOGY (# 0525) Event 2 (2020)- 73% Event 1 (2021)- 0% -- 3 of 3 --

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based upon a review of Proficiency Testing (PT) records and an interview with Testing Personnel 1 (TP1), the laboratory failed to review and evaluate unsuccessful results for 1 of 3 PT testing events in Hematology and Coagulation for 2018. Findings: 1. A review of PT records for 2018 identified the lack of an investigation for the unsuccessful identification of urine sediment cells in the 1st event of Hematology and Coagulation for 2018. 2. An interview with TP1, on 8/21/19 at approximately 11:00AM, confirmed that no review or investigation of the unsuccessful result could be located. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based upon a review of of laboratory written policies and procedures and an interview with Testing Personnel 1 (TP1), the laboratory failed to establish a written policy /procedure for Quality Assessment (QA) of the general laboratory systems. Findings: 1. No written policy or procedure for QA of the general laboratory systems could be Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- located. This includes the monitoring and assessment of confidentiality, specimen identification and integrity, complaint investigations, communications, personnel competency, and proficiency testing evaluation. 2. The laboratory is performing QA monitoring of all general laboratory systems, documented on monthly QA forms that are reviewed and signed by the laboratory director. 3. An interview with TP1, on 8/21 /19 at approximately 10:30 Am, confirmed there is no written policy or procedure for the QA of the general laboratory systems. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based upon a review of of laboratory written policies and procedures and an interview with Testing Personnel 1 (TP1), the laboratory failed to establish a written policy /procedure for Quality Assessment (QA) of preanalytic systems. Findings: 1. No written policy or procedure for QA of preanalytic systems could be located. This includes the following: test request and specimen submission, handling, and referral. 2. The laboratory is performing QA monitoring of all preanalytic systems, documented on monthly QA forms that are reviewed and signed by the laboratory director. 3. An interview with TP1, on 8/21/19 at approximately 10:30 Am, confirmed there is no written policy or procedure for the QA of the preanalytic systems. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a review of laboratory records and an interview with Testing Personnel 1 -- 2 of 4 -- (TP1), the laboratory failed to perform calibration verification for testing Chloride, Potassium, and Sodium analytes every 6 months. Findings: 1. A review of quality control and calibration records identified that no calibration verification was being performed and documented for the Chloride, Potassium, and Sodium analytes. The other analytes in Chemistry testing all had a four point calibration performed at least monthly, meeting the requirements for CFR 493.1255. 2. An interview with TP1, on 8 /21/19 at approximately 11:15 AM, confirmed that Chloride, Potassium, and Sodium do not use 3 levels of calibrator and no other calibration verification was performed every 6 months. 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 upon a review of of laboratory written policies and procedures and an interview with Testing Personnel 1 (TP1), the laboratory failed to establish a written policy /procedure for Quality Assessment (QA) of analytic systems. Findings: 1. No written policy or procedure for QA of analytic systems could be located. This includes the following: procedure manual, test systems/equipment/supplies, establishment and verification of performance specifications, maintenance and function checks, calibration and calibration verification procedures, control procedures, comparison of test results,