Health North Family Medicine Llc

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 an off-site desk review of the laboratory's 2021 American Proficiency Institute (API) proficiency testing (PT) records and phone interview with the laboratory manager, the laboratory failed to successfully participate in PT. See D-tag 2130, unsatisfactory performance for the same analyte in two out of three consecutive hematology PT events. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(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 events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on proficiency testing desk review, the laboratory's graded PT results from American Proficiency Institute (API), and phone interview with the laboratory manager, the laboratory failed to achieve satisfactory performance for the White Blood Cell Differential analyte in two out of three consecutive testing events. Findings: 1. The laboratory is subscribed to the American Proficiency Institute for Hematology proficiency testing. 2. The laboratory received the following scores for White Blood Cell Differential: 2020 Third Testing Event = 0% 2021 Second Testing Event = 0% -- 2 of 2 --

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 proficient testing record review and Technical Consultant interview during a routine survey, the laboratory failed to successfully participate in proficiency testing (PT) for the analytes Free Thyroxin (T4), Free T3, and Thyroid Stimulating Hormone (TSH). Refer to D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on proficiency testing record review and technical consultant interview, the laboratory failed to achieve success performance for Free T3 (THY), Free Thyroxin (T4),and Thyroid Stimulating Hormone (TSH) in 2 out of 3 testing events. Findings: Analyte/Event/Score THY 2019-3 = 0% THY 2020-2 = 0% T4 2019-3 = 0% T4 2020- 2 = 0% TSH 2019-3 = 0% TSH 2020-2 = 0% D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review of and Technical Consultant interview, the laboratory failed to twice annually verify the accuracy of Vitamin D in 2019; Estradiol in 2020; and PSA and Testosterone in 2019 and 2020. Findings: 1. The laboratory did not have records verifying the accuracy of Vitamin D twice annually in 2019, and Estradiol, PSA, and Testosterone in 2019 and 2020. 2. The laboratory performs approximately 40 Vitamin D tests, 65 Estradiol tests, 40 PSA tests, and 115 Testosterone tests annually. 3. The Technical Consultant confirmed these findings on 3/17/2021 at 12:30 pm. -- 2 of 2 --

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of verification records and technical consultant interview, the laboratory did not verify the accuracy, precision, and reportable ranges of microalbumin and creatinine on the Bayer DCA 2000 Analyzer prior to reporting patient test results. Findings: 1. The laboratory uses the DCA Microalbumin /Creatinine cartridges on the Bayer DCA 200 analyzer to measure albumin, creatinine, and the albumin/creatinine ratio in urine. 2. The lab began testing patient microalbumin and creatinine on the Bayer DCA 2000 on November 1, 2018, and tests approximately 3 microalbumins and creatinines per month. 3. The verification documents showed 2 levels of liquid controls were performed. Missing were documentation verifying accuracy, precision, and reportable ranges. 4. The technical consultant confirmed these findings during an interview on 4/9/19 at 11:00 am. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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-- At least once a day patient specimens are assayed or examined perform the following 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 -- for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of quality control logs and technical consultant interview, the laboratory did not test, at a minimum, two levels of external quality control (QC) material to monitor the accuracy and precision of the Bayer DCA 2000 microalbumin and creatinine tests. Findings: 1. A review of the Bayer DCA 2000 quality control logs from 11/1/2019 to the present revealed the laboratory had performed two levels of external quality control material every 30 days and with each new lot and/or shipment of microalbumin/creatinine cartridges. 2. The laboratory performs approximately 3 microalbumin/creatinines per month. 3. The technical consultant confirmed these findings during an interview on 4/16/19 at 1:00 pm. -- 2 of 2 --