Wilmington Health Associates

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of personnel records, review of IFU (instructions for use), and interview with TS (technical supervisor) 4/27/21, the laboratory failed to follow manufacturer's instructions for the SARS-CoV-2 testing performed to ensure 7 of 7 TP (testing personnel) had received appropriate training for the performance of SARS- CoV-2 testing and to ensure authorized Fact Sheets for patients and providers were included with SARS-CoV-2 test result reports. The laboratory began testing for SARS- CoV-2 using the Quidel Sophia2 Flu and SARS test system 1/29/21 and the Cepheid GeneXpert Xpress SARS-CoV-2 test system on 6/30/20. 1. The laboratory failed to ensure 7 of 7 TP received appropriate training for the performance of SARS-CoV-2 testing. Findings: Review of IFU for Quidel Sophia2 Flu and SARS test system revealed on page 14 "Conditions of Authorization for the Laboratory and Patient Care Settings...All operators using your product must be appropriately trained in performing and interpreting the results of your product...and use your product in accordance with the authorized labeling." Review of IFU for Cepheid GeneXpert Xpress SARS-CoV-2 revealed under section 21 "Conditions of Authorization for Laboratories...All operators using your product must be appropriately trained in performing and interpreting the results of your product...and use your product in accordance with the authorized labeling." Review of personnel records for TP #1, TP #2, TP #3, TP #4, TP #5, TP #6 and TP #7 revealed no documentation of training for the SARS-CoV- 2 testing performed. Interview with TS at approximately 9:00 a.m. confirmed the personnel records did not contain documentation of training. She stated that all TP were trained but she was unaware the training for SARS-CoV-2 testing Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 14 -- needed to be documented. 2. The laboratory failed to ensure authorized Fact Sheets for patients and providers were included with SARS-CoV-2 test result reports. Findings: Review of IFU for Quidel Sophia2 Flu and SARS test system revealed on page 14 "Conditions of Authorization for the Laboratory and Patient Care Settings... Authorized laboratories using your product will include with test result reports, all authorized Fact Sheets." Review of IFU for Cepheid GeneXpert Xpress SARS-CoV-2 revealed under section 21 "Conditions of Authorization for Laboratories...Authorized laboratories using your product must include with test result reports all authorized Fact Sheets." Interview with TS at approximately 9:00 a.m. confirmed the laboratory does not provide the authorized Fact Sheets to patients and providers with the SARS- CoV-2 test result reports. She stated they distribute information to patients regarding infection control for SARS-Cov-2 after they have been swabbed for testing, but no authorized Fact Sheets are provided to patients or providers with the test result reports. 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 2019, 2020, and 2021 QC (quality control) records, the absence of documentation, review of manufacturer's instructions, and interview with the TS and TP 4/28/21, the laboratory failed to retain QC assay sheets in 2019, 2020, and 2021. Findings: A. Review of 2019, 2020 and 2021 QC records revealed the laboratory failed to retain copies of the QC assay sheets for the following: 1. TOSOH G8 HgbA1c (glycosylated hemoglobin) analyzer- normal and abnormal control set lot numbers: a. lot # 7082; b. lot #7085; c. lot #7090; d. lot #7097. 2. Siemens CA660 Coagulation analyzer- Citrol 1 and 3 control lot numbers: a. Citrol 1 lot # 548058/ Citrol 3 lot # 548440; b. Citrol 1 lot # 548086A/ Citrol 3 lot # 556512A. 3. Alcor iSED ESR (Erythrocyte Sedimentation Rate) analyzer- Seditrol Sed Rate control level 1 and level 2. a. Seditrol level 1 lot # C131/ Seditrol level 2 lot# C231; b. Seditrol level 1 lot # C133/ Seditrol level 2 lot # C233; c. Seditrol level 1 lot # C136/ Seditrol level 2 lot # C236; d. Seditrol level 1 lot # C137/ Seditrol level 2 lot # C237. At approximately 1:30 pm on 4/28/21, the TS confirmed the QC assay sheets are not kept for older lot numbers after values are stored in the Orchard LIS (laboratory information system). B. The laboratory installed a replacement Phadia 250 in February 2020 and the instrument was approved for use by the TS 2/18/20. The Phadia 250 online instructions state "... Quality Control Targets and Limits When a new QC is introduced, use limits stated in the Directions for Use, on the QC bottle label, or on the certificate that the QC bottle contains. ..." There were no QC assay sheets available for the Phadia 250 from 2/18/20 (the date the replacement analyzer was installed) to 4/28/20. During interview 4/28/21 at approximately 12:55 p.m., TP #1 stated that they use the manufacturer's QC ranges printed on the bottles. She stated they do not receive assay sheets with each new lot number of control material, and the only documentation of QC ranges for each lot number is in the instrument. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) -- 2 of 14 -- 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 review of 2019, 2020, and 2021 API (American Proficiency Institute) PT (proficiency testing) records and interview with the TS 4/27/21, the laboratory failed to evaluate all ungraded and unacceptable PT testing results. Findings: Review of API proficiency testing results revealed the laboratory failed to evaluate all ungraded and proficiency testing results. Examples: a. On the 2019 Hematology/Coagulation 1st event, there was no documentation that the laboratory evaluated 5 of 5 educational blood cell identification samples to determine whether

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 9/5/19 and desk review of 2018 and 2019 API (American Proficiency Institute) proficiency testing results 11/5/19, the laboratory failed to successfully participate in the subspecialty of endocrinology in two of three consecutive testing events. See the deficiency cited at D2099. D2099 ENDOCRINOLOGY CFR(s): 493.843(b) 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 attain an overall testing event score of at least 80 percent is unsatisfactory 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 9/5/19 and desk review of 2018 and 2019 API (American Proficiency Institute) proficiency testing results 11/5/19, the laboratory failed to achieve satisfactory performance for the subspecialty of endocrinology in two of three consecutive testing events, resulting in unsuccessful performance. Findings: 1. Desk review of 2018 API proficiency testing results revealed the laboratory failed to participate for all analytes and received a score of 0% for the subspecialty of endocrinology on the 2018 Chemistry Core 3rd event. 2. Desk review of 2019 API proficiency testing results revealed the laboratory received a score of 0% for cortisol, resulting in a score of 75% for the subspecialty of endocrinology on the 2019 Chemistry Core 2nd 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 9/5/19 and desk review of 2018 and 2019 API (American Proficiency Institute) proficiency testing records 11/5/19, the laboratory director failed to provide overall management and direction to ensure successful participation in proficiency testing. 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 9/5/19 and desk review of 2018 and 2019 API (American Proficiency Institute) proficiency testing results 11/5/19, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: 1. Desk review of 2018 API proficiency testing results revealed the laboratory failed to participate for all analytes and received a score of 0% for the subspecialty of endocrinology on the 2018 Chemistry Core 3rd event. 2. Desk review -- 2 of 3 -- of 2019 API proficiency testing results revealed the laboratory received a score of 0% for cortisol, resulting in a score of 75% for the subspecialty of endocrinology on the 2019 Chemistry Core 2nd event. -- 3 of 3 --