Hope Primary & Urgent Care

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The laboratory was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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 proficiency testing desk review of the Certification and Survey Provider 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 -- Enhanced Reporting (CASPER)-0155 and Wisconsin State Laboratory of Hygiene (WSLH) Proficiency Testing 2023 records (1st and 2nd events), the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of Hematology for the Hematocrit (HCT) analyte. (Refer to D2130) D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER-0155 and WSLH Proficiency Testing records 2023 (1st and 2nd events), the laboratory failed to achieve satisfactory performance (80% or greater) for two (2) consecutive testing events in the specialty of Hematology for the Hematocrit (HCT) analyte. 1. A review of the CASPER-0155 report revealed the following: Hematology 2023- 1st Event The Laboratory received an unsatisfactory score of 60% for the HCT analyte. Hematology 2023- 2nd Event The Laboratory received an unsatisfactory score of 0% for the HCT analyte. 2. A review of proficiency testing records from WSLH Proficiency Testing 2023 confirmed the above findings. 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 a proficiency testing desk review of the CASPER-0155 Individual Laboratory Report and WSLH Proficiency Testing 2023 records (1st and 2nd events), the laboratory director failed to provide overall management and direction of the laboratory services. (Refer to D6016) D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER-0155 and WSLH Proficiency Testing 2023 records (1st and 2nd events), the laboratory director failed to -- 2 of 3 -- ensure successful participation in an HHS approved proficiency testing program. (Refer to 2130) -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Recertification Survey was initiated on 05/24/2023 and concluded on 05/24/2023. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. 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 on document reviews and interviewwith the Technical Consultant (TC), the laboratory failed to review graded proficiency testing (PT) results for 3 of 6 PT events in hematology from 2021 and 2022. Findings included: Review of the graded reports for 2022-A, 2022-B, 2022-C from the American Academy of Family Physicians (AAFP), revealed the graded PT reports were not signed or noted as having been reviewed by the laboratory Director and/or their designee. During an interview on 05 /24/2023 at 12:45 PM, the Technical Consultant confirmed the PT reports were not signed or otherwise noted as being reviewed by the laboratory Director and/or their designee. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: 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 -- Based on policy review, document reviews, and interview, the laboratory failed to ensure competency assessments included the six mandated criteria for 4 of 4 testing personnel (TP) reviewed. Findings included: Review of a policy titled, "Quality Assurance Plan for Laboratory," last revised 06/30/2022, indicated, "Each employee working in the laboratory must complete a training program along with proficiency testing prior to performing laboratory procedures." The policy did not address the frequency, method, or criteria for personnel competency assessments. A review of the competency evaluations for TP #1 dated 10/22/2022 and 02/03/2023, TP #2 dated 09 /15/2022, TP #3 dated 01/09/2023, and TP #4 dated 03/16/2022 and 07/08/2022, did not address the following six mandated competency assessment requirements: - Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing, and testing. - Monitoring the recording and reporting of test results. - Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. - Direct observation of performance of instrument maintenance. - Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. - Assessment of problem-solving skills. In an interview on 05/24/2023 at 11:10 AM, the Technical Consultant stated there was no formal written policy on the frequency of competency assessments or how the competency assessments should be performed. -- 2 of 2 --

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (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. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and staff interview on 10/13/2020, the laboratory failed to perform at least two levels of quality control samples on two of five days of Complete Blood Count (CBC) testing reviewed on the Sysmex Pochi Hematology instrument. Findings include: 1. One patient CBC was tested on 07/03/2020 according to the In- house CBC log. Review of quality control data failed to reveal quality control results. 2. One patient CBC was tested on 09/03/2020 according to the In-house CBC log. Review of quality control data failed to reveal quality control results. Interview with the Technical Consultant at 3:00 PM on 10/13/2020, revealed the facility failed to have a system in place to ensure at least two levels of quality control samples were tested prior to testing patient samples. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. 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 -- This STANDARD is not met as evidenced by: Based on staff interview and record review on 10/13/2020, the Technical Consultant failed to perform and document annual competency using the 6 mandated competency assessment requirements for one testing personal responsible for moderate complex testing from 10/15/2018 to 10/12/2020. Findings include: 1. Record review failed to reveal competency assessments for Testing Personnel #1 listed on the CMS 209 for direct observation of routine patient test performance, direct observation of performance of instrument maintenance function checks and calibration, monitoring the recording and reporting of test results, review of worksheets, review of quality control records, review of proficiency test results, review of maintenance records, assessment of testing external proficiency testing samples and problem solving skills. Interview with the Technical Consultant at 3:00 PM on 10/13/2020, revealed the facility failed to have a system in place to ensure competency was performed using the six (6) mandated competency assessment requirements for testing personnel performing Complete Blood Counts on the Sysmex Pochi-100 hematology instrument. -- 2 of 2 --