Novant Health Northwest Family Medicine

Summary Statement of Deficiencies 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 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 laboratory's quality assessment plan, review of quality assessment records, and interview with the TC (technical consultant) 8/4/21, the laboratory director failed to ensure that the quality assessment plan was followed to assure the quality of laboratory services provided. The laboratory's "Quality Assessment Plan" states "... V. PROCESSES / PROGRAM COMPONENTS Quality Assessment Activities 1. Quality Assessment Activities, also known as monitors, will be completed by the testing personnel throughout each year in moderately and highly complex laboratories. 2. Each activity (monitor) will include instructions for completion and reporting. 3. All laboratory personnel must be familiar with and follow the written quality assessment plan and safety policies. ..." The plan includes monitors for each quarter (1st, 2nd, 3rd, 4th) and an "Annual General Laboratory Assessment". The monitors for each quarter include different items to monitor the preanalytic, analytic, and postanalytic portions of the testing process. Review of quality assessment records revealed the laboratory had completed monitors for 2019 and 2021, but there were no records available for 2020. During interview at approximately 12:10 p.m., the TC confirmed that quality assessment monitors were not completed by testing personnel during 2020 as required in the quality assessment plan. 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 desk review of CMS(Centers for Medicare and Medicaid Services) Casper Reports 153D and 155D and desk review of 2020 and 2021 API(American Proficiency Institute) proficiency testing results 4/9/21, the laboratory failed to successfully participate in proficiency testing for Endocrinology in two consecutive testing events. See the deficiency cited at D2108. D2108 ENDOCRINOLOGY CFR(s): 493.843(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 3 -- 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 desk review of CMS(Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2020 and 2021 API (American Proficiency Institute) proficiency testing results 4/9/21, the laboratory failed to achieve satisfactory performance for the subspecialty of Endocrinology on two consecutive proficiency testing events, resulting in unsuccessful participation. Findings: 1. Desk review of CMS Casper report 155D and 2020 API Proficiency testing results revealed the laboratory failed to participate and received a score of 0% for HCG(human chorionic gonadotropin), resulting in an overall score of 0% for the subspecialty of Endocrinology on the 2020 Chemistry Core 3rd test event. 2. Desk review of CMS Casper report 155D and 2021 API Proficiency testing results revealed the laboratory failed to participate and received a score of 0% for HCG, resulting in an overall score of 0% for the subspecialty of Endocrinology on the 2021 Chemistry Core 1st test event. 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 desk review of CMS(Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2020 and 2021 API(American Proficiency Institute) proficiency testing results 4/9/21, the laboratory director failed to provide overall management and direction to ensure successful proficiency testing participation. See the deficiency cited at 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 desk review of CMS(Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2020 and 2021 API(American Proficiency Institute) proficiency testing results 4/9/21, the laboratory director failed to ensure successful participation as required in Subpart H. Findings: 1. Desk review of CMS Casper report 155D and 2020 API Proficiency testing results revealed the laboratory failed to participate and received a score of 0% for HCG(human chorionic -- 2 of 3 -- gonadotropin), resulting in an overall score of 0% for the subspecialty of Endocrinology on the 2020 Chemistry Core 3rd test event. 2. Desk review of CMS Casper report 155D and 2021 API Proficiency testing results revealed the laboratory failed to participate and received a score of 0% for HCG, resulting in an overall score of 0% for the subspecialty of Endocrinology on the 2021 Chemistry Core 1st test event. -- 3 of 3 --

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, review of 2017 and 2018 API (American Proficiency Institute) proficiency testing records, and interview with the TC (technical consultant) 12/19/18, the laboratory failed to test proficiency samples in the same manner as patient specimens are routinely tested. Findings: The laboratory's "Quality Assessment Plan" states "... III. Proficiency Testing 1. Proficiency testing (PT) samples are tested, to the extent possible, exactly like patient specimens; the same number of times and using the same personnel and methods as for patient testing. ..." Review of 2017 and 2018 API proficiency testing records revealed: 1. On the 2017 1st, 2nd, and 3rd hematology test events and the 2018 1st, 2nd, and 3rd hematology test events, the laboratory provided responses for provider- performed microscopy tests they do not perform on patients. For example, on the 2018 3rd hematology test event, the laboratory provided responses for fecal leukocytes, fern test, nasal smear, pinworm preparation, sperm presence/absence, and urine sediment identification. The TC confirmed during interview at approximately 9: 50 a.m. that the laboratory does not routinely perform these tests on patients. 2. Proficiency sample test results were not documented in the same manner as patient test results. Examples: a. On the 2017 1st hematology test event, proficiency sample 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 -- results for vaginal wet prep and vaginal wet prep/ KOH (potassium hydroxide) were documented on API report forms by three different providers, but were not documented on the paper test result forms routinely used to document patient results. All three providers signed the attestation statement, so it was unclear whose results were designated to be submitted. The TC stated during interview at approximately 10: 10 a.m. that one of the providers does not perform wet prep tests on patients, but the provider thought she still had to participate in proficiency testing. b. Hemocue WBC (white blood cell count) test results for proficiency testing samples were documented on sticky notes for the 2017 2nd and 3rd hematology test events and the 2018 1st hematology test event, but not on the paper test result forms routinely used to document patient results. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of personnel records 12/19/18 and the deficiency cited at D6065, the laboratory failed to ensure that 1 of 4 testing personnel (TP #2) met the minimum education requirements for performing moderate complexity testing. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of personnel records and interview with the TC (technical consultant) 12/19/18, the laboratory failed to ensure that 1 of 4 testing personnel (TP #2) met the minimum education requirements for performing moderate complexity testing. Review of personnel records for TP #2 revealed an associate degree in medical assisting. There was no documentation of a high school diploma or GED (high school graduation equivalency diploma). During interview at approximately 11: 00 a.m., the TC stated that TP #2 had been asked to provide a copy of her high school diploma or GED. The TC confirmed the requested credentials were not available for review during the survey. -- 2 of 2 --