Warrington Clinic - Shelby

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 testing records for the Healgen COVID-19 IgG/ IgM Rapid Test Cassette, lack of documentation of verification of the performance specifications, and interview with staff on 11/11/20 at 2:30 pm, the laboratory failed to ensure that performance specifications were verified before reporting patient test results. The lab started using this antibody test on 9/18/20. Findings: 1. No documentation of verification of performance specifications for the Healgen COVID-19 IgG/IgM Rapid Test Cassette was available for review on the day of survey. 2. Interview with laboratory staff on 11/12/20 at 2:30 pm revealed no verification of performance specifications was completed before testing patients. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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 for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. 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 -- This STANDARD is not met as evidenced by: Based on review of quality control (QC) and patient records for the Healgen COVID- 19 IgG/IgM Rapid Test Cassette from 9/18/20 through 11/11/20 and an interview with the laboratory staff on 11/11/20 at 2:30 pm, the laboratory failed to include a positive and negative control on each day of patient testing for antibodies to SARS-CoV-2. Findings Include: 1. Review of the QC and patient records for the Healgen COVID -19 IgG/IgM Rapid Test Cassette performed from 9/18/20 through 11/11/20 revealed that two levels of QC (positive or negative) were not performed on each day of patient testing. 2. Interview with the laboratory testing personnel and TC on 11/11/20 at 2: 300 pm, confirmed that laboratory testing personnel were not performing two levels of QC each day of patient testing with the Healgen COVID-19 IgG/IgM Rapid Test Cassette. 3. Review of the patient COVID -19 Antibody test log from 9/18/20 through 11/11/20 revealed a total of 21 patient specimens were tested and reported with no documentation of the performance of 2 levels of controls each day of testing. -- 2 of 2 --

Summary Statement of Deficiencies 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 Cell Dyn Emerald analyzer records from last survey, 6/15/16, through day of this survey and confirmation with staff at 3:00 pm, the laboratory failed to retain the quality control (QC) assay sheets to include but not limited to acceptable ranges, storage requirements, lot numbers and standard deviations for at least 2 years. Findings include: Review of the Cell Dyn Emerald QC assay sheet in use the day of survey and other hematology records, it was determined the laboratory did not retain all QC assay sheets with the change of a new lot number of hematology low, normal and high controls. On the day of survey the following lot numbers of QC assay sheets were not available: Cell Emerald Control Lot Numbers: #6130, #7352, #7268, #7184, #6298 and #6214. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as 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 -- acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on Cell Dyn Emerald calibration documentation and interview with testing personnel at 4:00 pm on the day of survey, 5/9/18, the laboratory failed to perform the required calibration on the Medonic Cell Dyn Emerald hematology analyzer at least once every 6 months according to the frequency required by the manufacturer. Since the last survey, 6/15/16, calibration was documented as performed on 7/14/16 and 4/21 /17. This time frame exceeds the 6 month manufacturer's calibration requirement. 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 surveyor review of written quality assessment (QA) policies and procedures, it was determined the laboratory director failed to ensure that a comprehensive QA program designed to monitor and evaluate the overall quality of the total testing process ( general laboratory, preanalytic, analytic and postanalytic systems) was maintained and followed to assure the quality of the laboratory services provided. Based on surveyor review of written quality assessment (QA) policies and procedures, it was determined the laboratory director failed to ensure that a comprehensive QA program designed to monitor and evaluate the overall quality of the total testing process (general laboratory, preanalytic, analytic and postanalytic systems) was maintained and followed to assure the quality of the laboratory services provided. Findings include: The laboratory director had not ensured that the following parts of the written laboratory QA program were being followed: 1. Proficiency Testing - Technical consultant did not review results within one week of receipt as stated in the QA Plan for the following: 2016--2nd and 3rd events, 2017--all 3 events, and 2018-- 1st event. 2. Performance and Periodic Review of Quality Control, Proficiency Testing And Patient Results-Technical consultant failed to review and sign every 3 months as stated in the QA policy for the following: quality control, proficiency testing, temperature logs, quality control records, calibration and maintenance 6/15/16 through 5/9/18. THIS IS A REPEAT DEFICIENCY D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on review of laboratory records (including quality control, calibrations, temperatures, maintenance and proficiency results) since the last survey on 6/15/16, through the day of survey, 5/9/18, and confirmation with staff at 4:30 pm, the technical consultant listed on the CMS(Centers For Medicare & Medicaid) 209 Personnel form before the day of survey, failed to document as reviewed the laboratory records. The following records were not reviewed by the technical consultant appointed during that time: 1. Refrigerator,humidity and room temperature records from 5/16/16 through 5/9/18. 2. Cell Dyn Emerald QC (quality control), calibration, maintenance - 6/15/16 through 5/9/18. 3. Proficiency testing event results- 3rd event of 2016, 1st and 2nd events of 2017 and 1st event of 2018. -- 3 of 3 --

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 Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider) on 1/23/2018, the laboratory had not successfully participated in proficiency testing for WHITE BLOOD CELL (WBC) DIFFERENTIAL. Findings include: Our records indicate the following proficiency testing scores for your laboratory for WBC DIFFERENTIAL. PROFICIENCY TESTING PROVIDER: American Proficiency Institute WBC DIFFERENTIAL: Year 2017 2nd Event 0% Year 2017 3rd Event 33% Scores less than 80% for this analyte or 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 -- parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. D2130 HEMATOLOGY CFR(s): 493.851(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 Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider) on 1/23/2018, the laboratory had not successfully participated in proficiency testing for WHITE BLOOD CELL (WBC) DIFFERENTIAL. Findings include: Our records indicate the following proficiency testing scores for your laboratory for WBC DIFFERENTIAL. PROFICIENCY TESTING PROVIDER: American Proficiency Institute WBC DIFFERENTIAL: Year 2017 2nd Event 0% Year 2017 3rd Event 33% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. -- 2 of 2 --