Black Hills Urgent Care - Haines

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 3/26/25. The Black Hills Urgent Care - Haines laboratory was found not in compliance with this requirement: D5445. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) 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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493. 1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to conduct a risk assessment as part of their Individual Quality Control Plan (IQCP) to verify the accuracy of two of two non-waived test methods (Troponin I and D-Dimer) reviewed. The risk assessment would identify and evaluate the potential failures and sources of error in the testing process which could adversely affect patient results. Findings include: 1. Review on 3/26/25 of the laboratory's Quidel Triage Troponin I (biomarker for the detection of cardiac damage) IQCP revealed: *The Troponin I IQCP had been instituted on 3/3/24. *The IQCP had been reviewed again on 6/7/24 by laboratory director A when she took over as laboratory director. *The IQCP plan had not included a risk assessment. *A request was made at that time for any documentation related to the risk assessment evaluation. Laboratory staff were unable to provide the requested documentation during the survey. Review on 3/26/25 of the laboratory's 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 -- Quidel Triage D-Dimer (biomarker for the detection of blood clots) IQCP revealed: *The D-Dimer IQCP had been instituted on 4/5/24. *The IQCP had been reviewed again on 6/7/24 by laboratory director A when she took over as laboratory director. *The IQCP plan had not included a risk assessment. *A request was made at that time for any documentation related to the risk assessment evaluation. Laboratory staff were unable to provide the requested documentation during the survey. Review on 3/26/25 of the annual test volume form revealed: *The laboratory had reported 139 Troponin I patient specimens in 2024. *The laboratory had reported 182 D-Dimer patient specimens in 2024. Interview on 3/26/25 at 2:30 p.m. with laboratory director A revealed: *She confirmed the laboratory performed external quality control (QC) for both analytes as set forth in their IQCPs. *She confirmed the laboratory did not have a risk assessment as a part of either of the IQCPs. Interview on 3/26/25 at the same time with laboratory supervisor B revealed: *He had reviewed the IQCP procedures when he was hired as the laboratory supervisor in 2024. *He confirmed the laboratory did not have a risk assessment as a part of either of the IQCPs. *He was not aware of any documentation related to the performance of a risk assessment for the Quidel Triage analyzer. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 1/20/23. Black Hills Urgent Care - Haines laboratory was found not in compliance with the following requirements: D6053 and D6054. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on record review and interview, the technical consultant failed to ensure one of seven newly hired laboratory personnel (testing personnel [TP] B) had received two competency evaluations during their first year of patient testing for the test methods, they had been performing. Competency assessment ensures the testing personnel are competent to perform test procedures and report test results promptly, accurately, and proficiently. Findings include: 1. Review on 1/20/23 at 8:10 a.m. of the employee competency assessments for TP B revealed: *She had started working in the laboratory on 1/26/22. *Her annual competency had been completed on 1/16/23. *Documentation of any additional competency assessments had been requested. *There had been no additional competency evaluations available for review. Review on 1/20/23 of the laboratory's Quality Assessment Program policy, last revised 1/9/23, revealed: *"The technical consultant(s) will document personnel assessment on all lab personnel (normally at the 4th quarter visit). Evaluations which are based on job descriptions will be conducted semiannually the first year and annually there after." *" Note: New personnel will also have lab training documentation for each laboratory test they perform. Also, new personnel will have personnel assessment done at 6 months as well as annually." On 1/20/23 at 8:15 a.m. a request had been made of laboratory director A and technical consultant D for a copy of the laboratory's 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 -- competency assessment policy. No additional policies or procedures had been provided for review. Review on 1/20/23 of the laboratory's 2022 Consultative Reports revealed no documentation competency assessment evaluations had been reviewed during 2022. Interview on 1/20/23 at 8:15 a.m. with the laboratory director A revealed: *He confirmed the technical consultant had completed only one competency assessment for TP B since her date of hire. *There had been a change in technical consultants in 2022. *The six-month assessment was "probably missed." D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on record review and interview, the technical consultant failed to ensure one of sixteen laboratory personnel (testing personnel [TP] C) had received an annual competency evaluation after their first year of patient testing for the test methods, they had been performing. Competency assessment ensures the testing personnel are competent to perform test procedures and report test results promptly, accurately, and proficiently. Findings include: 1. Review on 1/20/23 at 8:10 a.m. of the employee competency assessments for TP C revealed: *She had started working in the laboratory on 6/15/21. *She had an initial competency assessment on 12/15/21. *Her first annual competency had been completed on 1/18/23. *Documentation of any additional competency assessments had been requested. *There had been no documentation of additional competency evaluations performed in 2022 available for review. Review on 1/20/23 of the laboratory's Quality Assessment Program policy, last revised 1/9/23, revealed, "The technical consultant(s) will document personnel assessment on all lab personnel (normally at the 4th quarter visit). Evaluations which are based on job descriptions will be conducted semiannually the first year and annually there after." On 1/20/23 at 8:15 a.m. a request had been made of laboratory director A and technical consultant D for a copy of the laboratory's competency assessment policy. No additional policies or procedures had been provided for review. Review on 1/20/23 of the laboratory's 2022 Consultative Reports revealed no documentation competency assessment evaluations had been reviewed during 2022. Interview on 1/20/23 at 8:15 a.m. with the laboratory director A revealed: *He confirmed the technical consultant had not completed an annual competency assessment for TP C in 2022. *There had been a change in technical consultants in 2022. *The annual assessment was "probably missed." -- 2 of 2 --