Family Medicine Group Pllc (The)

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 facility 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 desk review of proficiency testing (PT) records from the Certification and 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 -- Survey Provider Enhanced Reporting (CASPER) 0155 report and Wisconsin State Laboratory of Hygiene (WSLH) 2024 and 2025 records, 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 and the Hemoglobin analyte. Refer to D2130 and D2131. D2130 HEMATOLOGY CFR(s): 493.851(f) (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 CASPER 0155 report and WSLH Proficiency Testing 2024 Event Two and 2025 Event One records, the laboratory failed to achieve satisfactory performance (80% or better) for the same analytes for two of three consecutive testing events in the specialty of Hematology for the Hemoglobin analyte. Findings included: 1. Review of the CASPER 0155 report revealed the following results: Hematology 2024-2nd Event: The laboratory received an unsatisfactory score of 60% for the Hemoglobin analyte. Hematology 2025-1st Event: The laboratory received an unsatisfactory score of 0% for the Hemoglobin analyte. 2. A review of the WSLH Proficiency Testing records confirmed the laboratory received the above results. D2131 HEMATOLOGY CFR(s): 493.851(g) (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 proficiency testing desk review of CASPER 0155 report and WSLH proficiency testing 2024 and 2025 records, the laboratory failed to achieve an overall satisfactory performance (80% or better) for the specialty of Hematology for two of three consecutive testing events. Findings included: 1. A review of the CASPER 0155 report revealed the following results: Hematology 2024-2nd Event the laboratory received an unsatisfactory score of 76% for overall Hematology. Hematology 2025- 1st Event the laboratory received an unsatisfactory score of 61% for overall Hematology. 2. A review of the WSLH proficiency testing records confirmed the laboratory received the above results. 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 a proficiency testing desk review of CASPER 0155 report and WSLH 2024 and 2025 records, the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure proficiency testing samples were tested as required. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) 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 CASPER 0155 report and the laboratory's WSLH 2024 and 2025 PT records, the laboratory director failed to ensure proficiency testing samples were tested as required. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2130 and D2131. -- 3 of 3 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of Department of Health and Human Services Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS-209), lack of records and policy, and staff interview, the laboratory failed to establish and follow a personnel competency policy for personnel that performed Provider Performed Microscopy (PPM) vaginal wet preparation patient testing in 2021, 2022, and 2023. The findings include 1. Review of Form CMS-209 revealed TP seven listed for PPM vaginal wet prep patient testing. 2. Review of laboratory personnel records revealed no documetation of competency assessments for TP seven for vaginal wet prep patient testing in 2021, 2022, or 2023. 3. Review of laboratory policy and procedure manual revealed the laboratory did not have a competency assessment policy or procedure for testing personnel that provided PPM patient testing. 4. Interview on 06/07/2023 at 1: 00 pm with laboratory lead and laboratory director confirmed TP seven did not have competency assessments for PPM patient testing and further confirmed the laboratory did not have a policy and procedure for testing personnel that provided PPM patient testing in 2021, 2022, or 2023. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS-209), the laboratory's proficiency testing records, and interview with the laboratory director, the laboratory failed to rotate proficiency testing samples among personnel who perform patient testing for wet prep and complete blood count (CBC) in 2018 and 2019. The finding include: 1) Review of the form CMS-209 revealed three providers who perform wet prep microscopy and six personnel who perform CBCs. 2) Review of the laboratory proficiency testing records revealed the following: Provider number two performed four of five proficiency testing events for wet prep microscopy. CBCs proficiency testing was performed by testing personnel number two for events 2018 C, 2019 A, and 2019 C; and by testing personnel number four for event 2019 B. 3) Interview with the laboratory liaison on November 12, 2019 at 1:30 p.m. confirmed proficiency testing was not performed by all personnel who routinely perform patient testing in 2018 and 2019. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records and interview with the laboratory liaison, the laboratory director and testing personnel failed to sign proficiency testing attestation statements in 2018 and 2019. The findings include: 1) Review of the laboratory's proficiency testing attestation statements revealed the following: The handwriting on the attestation statements for each event in 2018 and 2019 was the same for the lab director, provider who performed the microscopy, and the testing personnel for complete blood count (CBC). The name of the lab director that was written in on the attestation statements did not match the lab director signature on the Centers for Medicare and Medicaid (CMS) survey forms for four proficiency testing surveys (2018 event B, 2018 event C, 2019 event B, 2019 event C). No lab director signature was present for 2019 event A. No testing personnel signature for 2018 event B for CBC. 2) Interview with the laboratory liaison on November 12, 2019 at 1:30 p.m. confirmed the attestation statments did not include the actual signature of the laboratory director and testing personnel for five of five events in 2018 and 2019. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manual, proficiency testing records, and interview with the laboratory liaison, the laboratory failed to test proficiency testing samples the same number of times it tests patient samples in 2019. The findings include: 1) Review of the laboratory's procedure manual revealed the laboratory is to repeat testing of patient complete blood count (CBC) if the result is flagged with an asterisk or an X, or if it is an alert value. 2) Review of the laboratory's proficiency testing records revealed repeat testing of proficiency testing samples that did not meet the laboratory's criteria for repeat testing of patient samples for 2019 event C, sample numbers 11 and 14. 3) Interview with the laboratory liaison on November 12, 2019 at 1:30 p.m. confirmed the laboratory failed to test proficiency testing samples in the same manner as patient samples for 2019 event C. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. -- 2 of 6 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records and interview with the laboratory liaison, the laboratory failed to retain all proficiency testing records in 2019. The findings include: 1) Review of the laboratory's proficiency testing records revealed the following: No paper trail for provider responses to microscopy for 2019 event B. No identity of the person who performed the microscopy 2019 event A. 2) Interview with the laboratory liaison on November 12, 2019 at 1:30 p.m. confirmed the laboratory failed to retain all proficiency testing records in 2019. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality control records and interview with the laboratory liaison, the laboratory failed to retain quality control package insert for lot numbers 06880, 07880, 08880 in 2018. 1) Review of the laboratory's quality control records revealed lot numbers 06880, 07880, and 08880 in use on 12.21.2018. No package insert was present in the quality control records. 2) Interview with the laboratory liaison on November 12, 2019 at 1:30 p.m. confirmed the laboratory failed to retain quality control package inserts for two years in 2018. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient test reports for complete blood count (CBC) and interview with the laboratory liaison, the final patient test reports did not include the laboratory address or units of measure for CBC. The findings include: 1) Review of patient numbers one, two, three, and four final report in the electronic medical record revealed no units of measure for any of the CBC parameters, and no facility address. 2) Interview with the laboratory liaison on November 12, 2019 at 1:30 p.m. confirmed the laboratory final patient test report did not include the facility address or units of measure for CBC parameters. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) The laboratory director is responsible for the overall operation and administration of -- 3 of 6 -- 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)(iv) Ensure that an approved

Summary Statement of Deficiencies D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the complete blood count (CBC) instrument records and interview with the laboratory director, the laboratory director failed to ensure the new CBC instrument verification of performance specifications were adequate for accuracy, precision and linearity, in 2017. The findings include: 1) Observation of the laboratory on May 22, 2018 at 9:15 a.m. revealed a new CBC instrument in use for patient testing, serial number BA43407. 2) Review of the CBC instrument records revealed installation of serial number BA43407 CBC instrument on December 8, 2017 and that no verification of performance specification records and no installation records were available. 3) Interview on May 22, 2018 at 11:30 a.m. with the laboratory director confirmed the new CBC instrument was installed December 8, 2017 and that the December 8, 2017 CBC instrument records were not available. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform 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 -- 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the monthly quality assurance (QA) records, the QA review and checklist procedure and interview with testing personnel number one, the laboratory director failed to ensure the monthly QA was maintained, in 2017 and 2018. The findings include: 1) Review of the 2017 monthly QA records revealed no monthly QA checklist performed for November, December 2017, and January 2018 to current date. 2) Review of the QA review and checklist procedure revealed, "The QA Checklist Form will be used to assess (1) Patient Test Management (2) Quality Control and Calibration Data and (3) Instrument Checks. This form should be completed monthly by reviewing 1-2 Patient Charts. 3) Interview on May 22, 2018 at 10:45 a.m. with testing personnel number one confirmed the November, December 2017, January, February, March and April 2018 QA checklist monthly reviews were not performed. -- 2 of 2 --