Health North Family Medicine Llc

Summary Statement of Deficiencies D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on record review and an interview with the technical consultant, the laboratory did not evaluate and document the performance of one (1) of one (1) testing persons in 2023. Findings include: 1. A request was made to review the competency assessments for the testing person for 2023, and the documentation could not be provided. 2. In an on-site interview on 11/22/2024 at 12:00 PM, the technical consultant confirmed that competency assessments were not performed in 2023. 3. The laboratory reports performing approximately 5,900 patient tests annually. 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 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 2023 and 2024 American Proficiency Institute (API) proficiency testing (PT) records and a phone interview with the testing person, it was determined the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for the analyte Free Thyroxin and the subspecialty Endocrinology in two (2) out of three (3) Endocrinology testing events resulting in unsuccessful PT performance. Refer to D2107 and D2108. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 or test 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 an off-site desk review of the laboratory's 2023 and 2024 American Proficiency Institute (API) proficiency testing (PT) records and a phone interview with the testing person, it was determined the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for the analyte Free Thyroxin in two (2) out of three (3) Endocrinology testing events resulting in unsuccessful PT performance. Findings include: 1. Desk review of the laboratory's 2023 and 2024 API PT records revealed Free Thyroxine scores of less than eighty percent for the following Endocrinology events: a. 2023 API Chemistry Core 3rd event: 0% b. 2024 API Chemistry Core 1st event: 40% 2. In a phone interview with the testing person on 3/20/2024 at 2:10 PM, it was confirmed that the laboratory was unsuccessful in the PT events listed above. D2108 ENDOCRINOLOGY CFR(s): 493.843(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 an off-site desk review of the laboratory's 2023 and 2024 American Proficiency Institute (API) proficiency testing (PT) records and a phone interview with the testing person, it was determined the laboratory failed to attain a score of at least eighty (80) percent of overall testing event score for the subspecialty Endocrinology in two (2) out of three (3) Endocrinology testing events resulting in unsuccessful PT performance. Findings include: 1. Desk review of the laboratory's 2023 and 2024 API PT records revealed Endocrinology scores of less than eighty percent for the following events: a. 2023 API Chemistry Core 3rd event: 50% b. 2024 API Chemistry Core 1st event: 70% 2. In a phone interview with the testing person on 3/20/2024 at 2:10 PM, it was confirmed that the laboratory was unsuccessful in the PT events listed above. -- 2 of 2 --

Summary Statement of Deficiencies D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on procedure review and interview with the laboratory manager, the laboratory failed to have a procedure to establish the number, type, and frequency of control materials, detect immediate errors, and monitor the accuracy and precision of tests performed on the Beckman Coulter Access 2 Immunoassay system. Findings include: 1. The laboratory's policy and procedure manual and Beckman Coulter Access 2 Operator's Guide were reviewed. 2. No documentation or policy or procedure was found that describes the number, type, and frequency of control materials for TSH, Free T4, Free T3, Progesterone, Prostate Specific Antigen, Estradiol, Vitamin D, and Testosterone or how the accuracy and precision of controls material are monitored for these tests. 3. The laboratory reports performing 1000 endocrinology tests annually on their CMS-116 form. 4. The laboratory manager confirmed these findings in an interview at 11:30 am on 2/2/2023. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) 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 -- 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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of quality control records and an interview with the laboratory manager, the laboratory failed to establish and monitor statistical parameters for control materials for tests performed on the Beckman Coulter Access 2 Immunoassay system. Findings include: 1. The laboratory used Biorad Liquichek Immunoassay Controls for the Beckman Coulter Access 2 Immunoassays. 2. The laboratory maintained no documentation of the review of current or historical control lot numbers, in-use dates, or expiration dates for procedure was found that describes the number, type, and frequency of control materials for TSH, Free T4, Free T3, Progesterone, Prostate Specific Antigen, Estradiol, Vitamin D, and Testosterone. 3. The laboratory had no documentation to establish or monitor the statistical parameters such as laboratory-specific mean or standard deviations and their review. 4. The laboratory reports performing 1000 endocrinology tests annually on their CMS-116 form. 5. The laboratory manager confirmed these findings in an interview at 11:30 am on 2/2/2023. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory is in substantial compliance with the CMS Interim Final Rule (CMS- 3401-IFC) on Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE) effective August 25, 2020. No deficiencies were cited. 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. 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 -- D2107 ENDOCRINOLOGY CFR(s): 493.843(f) Failure to achieve satisfactory performance for the same analyte or test 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 proficiency testing (PT) 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 not enrolled in PT, no alternate verification of accuracy documented 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 60 Vitamin D tests, 85 Estradiol tests, 75 PSA tests, and 150 Testosterone tests annually. 3. The Technical Consultant confirmed these findings on 4/15/2021 at 3:00 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 4/16/19 at 1:00 pm. 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 --