Woodall, Wilson & Manley Md Llp

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on November 19, 2020. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the proficiency testing (PT) records and staff interview, the lab failed to rotate PT samples among all testing personnel (TP). Findings include: 1. Review of the PT documents: 2019 testing event #2 through 2020 testing event #3 revealed the same TP (#1 CMS 209 form) performed all PT testing. 2. Interview with testing personnel #1 (CMS 209 form) on 11/19/20 at approximately 12:05 PM in the breakroom, confirmed the same TP performed the aforementioned PT. **REPEAT DEFICIENCY** D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: 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 -- Based on review of testing personnel(TP) documents and staff interview, the technical consultant failed to perform semiannual competency on all testing personnel. Findings include: 1. No documents were available to review for personnel semiannual competency on TP #2 in the month of April 2020. 2. Interview with testing personnel #1 (CMS 209 form) on 11/19/20 at approximately 11:55 AM in the breakroom, confirmed the lack of the aforementioned personnel semiannual competency. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on May 16, 2018. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the proficiency testing (PT) records and staff interview, the lab failed to rotate PT samples among all testing personnel (TP). Findings include: 1. Review of the PT documents: 2016 testing event #3 through 2018 testing event #1 revealed the same TP (#2 CMS 209 form) performed all PT testing. 2. Interview with testing personnel #2 (CMS 209 form) on 5/16/18 at approximately 10:30 AM in the nurses' office, confirmed the same TP performed the aforementioned PT. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on procedure manual review and staff interview, the lab failed to establish and 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 -- follow a written procedure to assess personnel competency. Findings include: 1. Review of the procedure manual revealed the lack of a competency assessment procedure. 2. Interview with testing personnel #2 (CMS 209 form) on 5/16/18 at 10: 30 AM in the nurses' office, confirmed the lack of the aforementioned procedure. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation and interview with testing personnel (TP), the lab failed to calibrate the AO one-fifty (150) microscope per the manufacturer. Findings include: 1. Observation during the lab tour revealed the AO 150 microscope did not have documentation of calibration. 2. Interview with TP #2 (CMS 209 form) on 05/16/18 in the procedure room at approximately 1035 AM, confirmed the microscope had not been calibrated. 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 quality control (QC) document review, procedure review, and staff interview, the lab failed to monitor over time the accuracy and precision of test performance. Findings include: 1. Review of QC documents revealed the lab was not monitoring, printing, or reviewing QC over time (Levey-Jennings charts or peer comparisons). No long term QC documents available for patient testing period of August 2016-2018 thus far. 2. Review of the procedure manual revealed the controls were to be reviewed weekly for shifts and trends. 3. An interview with testing personnel #2 (CMS 209 form) on 5/16/18 at 11:30 AM in the nurses office, confirmed the QC was not monitored over time. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on the lack of testing personnel (TP) documents and staff interview , the technical consultant (lab director) failed to perform annual competency on testing personnel. Findings include: 1. No documents were available to review for personnel competencies during the time period of 2016-2018. 2. Interview with testing personnel #2 (CMS 209 form) on 5/16/18 at 10:30 AM in the nurses' office, confirmed the lack of the aforementioned personnel competencies. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on May 3, 2018. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's College of American Pathologist (CAP) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two consecutive events 3rd event of 2017 and 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 -- 1st event of 2018), resulting in the first unsuccessful occurrence for hematocrit(HCT) # 785 and hemoglobin (HGB) # 795. Findings include: Refer to D 2130 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's College of American Pathologist (CAP) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two consecutive events 3rd event of 2017 and 1st event of 2018), resulting in the first unsuccessful occurrence for hematocrit(HCT) # 785 and hemoglobin (HGB) # 795. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analytes #785 hematocrit and analyte # 795 hemoglobin on event 3 of 2017 with scores of 0% and event 1 of 2018 with scores of 0%. 2. Desk review of the laboratory's proficiency testing reports from CAP confirmed the laboratory failed HGB & HCT on event 3 of 2017 and event 1 of 2018 resulting in the first unsuccessful performance. -- 2 of 2 --