Blue Mountain Clinic Family Practice

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 routine desk audit of CMS-155 reports of proficiency testing performance and interview, the laboratory failed to achieve satisfactory performance for ABO /RHO and D (Rho) typing performed on the EldonCard 2521 for three of four events (2021 Event 1, Event 3 and 2022 Event 1), resulting in unsuccessful proficiency testing performance. See D2162. D2162 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(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 3 -- Failure to achieve satisfactory performance for the same analyte 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 review of proficiency testing scores and interview with testing personnel (TP) # 1, the laboratory failed to achieve a score of 100% for ABO/RHO typing and 100% for D (Rho) typing for three of four events (2021 Event 1, Event 3 and 2022 Event 1). Findings: 1. Review of the CMS-155 report on 2/16/2022 at 7:45 AM and 6 /13/2022 at 3:40 PM revealed that the American Proficiency Institute (API) ABO /RHO and D (Rho) typing scores for 2021 Event 1 was 80%, 2021 Event 3 was 60% and 2022 Event 1 was 0%. 2. An interview with TP#1 on 05/17/2022 at 12:51 PM, confirmed the failed scores were due to technical and clerical errors. 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 routine desk audit reports of proficiency testing performance, previwous deficiency reports and interviews, the laboratory director failed to ensure the quality assessment (QA) program was maintained for verification of correct data entry and submission for proficiency testing results for three of four proficiency testing events for ABO/RHO and D (Rho) typing. See D6018. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

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 routine desk audit of CMS-153 and 155 reports for proficiency testing performance and interview with laboratory testing personnel (TP)#1, the laboratory failed to achieve satisfactory performance scores of ABO/RHO and D(Rho) typing for two out of three events (2021 Event 1 and 2021 Event 3), resulting in unsuccessful proficiency testing performance. See D2162 D2162 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(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 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 review of proficiency testing scores and interview with testing personnel (TP) #1, the laboratory failed to achieve a score of 100% for ABO/RHO typing and 100% for D (Rho) typing for two of three events (2021 Event 1 and Event 3). Findings: 1. Review of CMS-153 Unsuccessful Proficiency Testing Report on 02/16 /2022 at 7:30 AM included Blue Mountain Clinic Family with unsuccessful proficiency testing scores for ABO/RHO and D (Rho) Typing 2. Review of the CMS- 155 Individual Laboratory Profile on 2/16/2022 at 7:45 AM revealed ABO/RHO typing scores for 2021 Event 1 was 80% and 2021 Event 3 was 60%; and D(Rho) typing scores for 2021 Event 1 was 80% and 2021 Event 3 was 60%. 3. Interview with laboratory TP#1 on 02/16/2022 at 12:51 PM confirmed unsuccessful proficiency scores for ABO/RHO and D(Rho) typing due to clerical errors upon entry of results. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) records and interview with Testing Personnel (TP) #1, the laboratory director failed to review, sign and date the Proficiency Testing Performance Evaluations for 4 of 12 events in 2019, 1 of 10 in 2020 and one Attestation Statement in 2020. (See D5221) Findings: 1. Review of API's Proficiency Testing Performance Evaluations lacked Laboratory Director's review,