Highlands Oncology Group Lab Ii

Summary Statement of Deficiencies 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: Through review of the CMS 209 form, review of laboratory documentation of competency assessment, lack of documentation and interview with laboratory staff it was determined that the laboratory failed to assess testing personnel competency on an annual basis for two of four testing personnel listed on the CMS 209 form. Findings follow: A) Review of the CMS 209 form revealed that four testing personnel were employed by the laboratory. B) Review of competency assessment records revealed that the employee (# 2 on the CMS 209 form) had a date of hire of February 2013 and no record of competency evaluation was present for calendar year 2021 and 2022; employee (# 3 on the CMS 209 form) had a hire date of August 2020 and the only competency asseessments were dated February 2021 and July 2023. C) Upon request, the laboratory was unable to provide competency assessments for the year 2021, and 2022 for employee (#2 on the CMS 209 form), and competency assessments for the year 2022 for employee (#3 on the CMS 209 form). D) In an interview on 5/22/24 at 2:30 pm, the laboratory staff member (# 1 on the separate employee identification list) confirmed that competency assessments for the dates and employees identified above were not performed and the employees had performed testing in the laboratory since their dates of hire. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic 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 -- systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Lack of documentation, review of laboratory policies and procedures, quality control policy and procedure, review of the BioRad Control manufacturer's requirements, user's intructions for the Excyte MiniSed Erythrocyte Sedimentation Rate (ESR) instrument, chemistry assay Levey-Jennings reports, result listing by patient reports, review of the Beckman Coulter AU 680 and TOSOH AIA - 2000 quality control (QC) documentation, and interviews with laboratory staff determined the laboratory failed to meet analytic systems requirements as evidenced by: D5445 - the laboratory failed to perform quality control on each day of ESR testing D5469 - the laboratory failed to use statistical parameters to calculate criteria for acceptability of QC for nine of nine tests reviewed for the AU 680 and two of two tests reviewed for the TOSOH AIA in which BioRad Controls were the quality control material D5481 - the laboratory did not follow its policy of taking

Summary Statement of Deficiencies D1002 REPORTING OF SARS-CoV-2 TEST RESULTS During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Through interview it was determined that the laboratory failed to report results of Covid-19 testing to the Arkansas Department of Health within twenty-four hours of test performance. Findings follow: A) In an interview on 8/10/2022 at 1:20 pm a staff member (#2 on personnel identification list) confirmed that Covid-19 positive results were not reported to the health department. B) When asked how many Covid-19 had been performed, a staff member (#2 on personnel identification list) said records indicated 113 Covid-19 tests had been performed in 2022 with 25 of those tests indicating positive results. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) 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: Through a review of proficiency test documentation for 2021 and 2022 it was determined the laboratory failed to document a review or

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Through review of the manufacturer's instrument manual, laboratory temperature and humidity records, tour of the laboratory, lack of documentation and interview it was determined that the laboratory failed to maintain appropriate operating humidity levels on 87 of 152 days of operation in January 2020 through May 2020 and failed to monitor temperature in three of five rooms in which supply items with a storage temperature requirement were stored. Findings follow: I: The laboratory failed to maintain appropriate operating humidity levels required for the operation of the Beckman AU 680 chemistry analyzer. A) Review of the manufacturer's instrument manual for the Beckman AU 680 chemistry analyzer revealed an operating humidity level requirement of 40% to 80%. B) Review of the laboratory's room temperature and humidity records revealed that acceptable humidity level was defined as 20% to 80%. The lower limit of the laboratory's range is below the manufacturer's requirement for the Beckman AU 680. C) Review of laboratory room temperature and humidity level records for January 2020 through May 2020 revelealed that room humidity level was recorded as less than 40% on 87 of 152 days recorded. D) In an interview on 9/25/20 at approximately 10:30 AM, the laboratory staff member, identified as number five on the CMS 209 form, confirmed that the laboratory's defined acceptable humidity range did not conform to the manufacturer's requirements Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- for the Beckman AU 680 chemistry analyzer and that recorded room humidity was less than manufacturer's defined requirement on 87 of 152 days in January 2020 through May 2020. II: The laboratory failed to monitor temperature in three of five rooms in which supply items with a storage temperature requirement were stored. A) On a tour of the laboratory on 9/24/20 at approximately 08:45 AM, it was observed that the laboratory had five separate rooms ( main laboratory, main laboratory separate storage room, phlebotomy area, two separate phlebotomy area storage rooms) in which supply items with a storage temperature requirement were stored. B) Review of the laboratory temperature records for 2020 revealed temperatures recorded for the main laboratory and the phlebotomy area but no temperature records for the main laboratory storage room, or the two separate phlebotomy area storage rooms. C) On a tour of the laboratory on 9/25/20 at approximately 11:00 AM, two cases of BacT/Alert blood culture bottles lot# 00405592 with a temperature requirement of 15 degrees C. to 30 degrees C. were observed in phlebotomy storage room number 1; 80 Vacuette 5cc EDTA blood collection tubes lot# B200833C. 60 Vacuette Heparin blood collection tubes lot# B20073KA and 80 BD 15cc serum separator blood collection tubes lot# 01764 all with a storage temperature requirement of 4 degrees C. to 25 degrees were observed in phlebotomy storage room number 2 and 4 bottles of Coulter ISE mid standard solution lot# M008099 with a storage temperature requiirement of 2 degrees C. to 29 degrees C. were observed in the main laboratory storage room. D) Upon request, the laboratory was unable to provide room temperature records for the main laboratory storage room or the two phlebotomy area storage rooms identified above. E) In an interview on 9/25/20 at approximately 11:30, the laboratory staff member identified as number five on the CMS 209 form confirmed that temperature measurements were not recorded in the three rooms identified above. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Through a review of the laboratory's quality control policy and procedure, daily quality control printouts for the Beckman AU 680 Clinical Chemistry System utilizing Biorad Lyphocheck lot number 26440 quality control material, a review of patient test reports, and interviews with laboratory staff, it was determined that patient results were reported when results of control materials failed to meet the laboratory's criteria for acceptability. Survey findings follow: A) The laboratory's quality control policy and procedure states that quality control is unacceptable when both levels of control are plus/minus 2SDI from target values B) A review of the Beckman AU 680 daily quality control printouts for 9/24/19 revealed the ALT result on the Level 1 and Level 2 Chemistry Control (26440) was outside of the acceptable criteria. The acceptable range listed for ALT for Level 1 is 26 plus/minus 2 and Level 2 is 80 plus/minus 4. Results documented for 9/24/29 are 23 for Level 1 (-2SDI) and 75 for Level 2 (-2 SDI). C) Through a review of patient chemistry reports it was determined 136 patients had ALT results reported on 9/24/20, when the chemistry control was unacceptable. D) A review of the Beckman AU 680 daily quality control printouts for 1/17/20 revealed the PO4 result on the Level 1 and Level 2 Chemistry Control (26440) was outside of the acceptable criteria. The acceptable range listed for PO4 for Level 1 is 3.5 plus/minus 0.4 and Level 2 is 7.4 plus/minus 0.7. Results documented for 1/17/20 -- 2 of 4 -- are 4.0 for Level 1 (+2SDI) and 8.1 for Level 2 (+2SDI). E) Through a review of patient chemistry reports it was determined 127 patients had PO4 results reported on 1 /17/20, when the chemistry control was unacceptable. F) A review of the Beckman AU 680 daily quality control printouts for 1/27/20 revealed the PO4 result on the Level 1 and Level 2 Chemistry Control (26440) was outside of the acceptable criteria. The acceptable range listed for PO4 for Level 1 is 3.5 plus/minus 0.4 and Level 2 is 7.4 plus/minus 0.7. Results documented for 1/27/20 are 4.0 for Level 1 (+2SDI) and 8.1 for Level 2 (+2SDI). G) Through a review of patient chemistry reports it was determined 151 patients had PO4 results reported on 1/27/20, when the chemistry control was unacceptable. H) In an interview on 9/25/20 at approximately 11:30 AM the laboratory employee number 5 (as listed on the form CMS-209) confirmed that quality control results were not acceptable for the tests and dates listed above. She further confirmed that patients were reported on those dates. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

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: . Through a review of new instrument validation documentation for the Beckman Coulter Au680 Chemistry Analyzer, Sysmex XN-1000i Hematology Analyzer, TOSOH Endocrinology Analyzer, lack of documentation, as well as interviews with staff, it was determined the Laboratory failed to have the director approve verification procedures to ensure they are adequate to determine the accuracy, precision, and other pertinent performance characteristics as evidenced by: A. A review of the verification documentation for the Beckman Coulter Au680 Chemistry Analyzer, Sysmex Hematology Analyzer and the TOSOH Endocrinology Analyzer revealed the verification procedures were not approved and signed by the Laboratory Director. B. A review of the verification documentation for Beckman Coulter Au680 Chemistry Analyzer revealed the signature page of the procedure was signed on 12/27/2016 by Laboratory personnel #3 (as listed on CMS form 209). C. A review of the verification documentation for TOSOH Endocrinology Analyzer revealed the signature page of the procedure was signed by Laboratory personnel #2 (as listed on CMS form 209). D. A review of the verification documentation for Sysmex XN-1000i Hematology Analyzer revealed the signature page of the verification procedure was not signed. E. 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 -- In an interview on 04/04/2018 at 1330, Laboratory personnel #3 (as listed on CMS form 209) confirm the verification procedure for the Chemistry, Hematology and Endocrinology Analyzers were not approved or signed by the Laboratory Director. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of