Wv Office Of Laboratory Services

Summary Statement of Deficiencies D5785

Summary Statement of Deficiencies D0000 Federal surveyors from the Centers for Medicare & Medicaid Services (CMS) Survey Branch conducted an announced CLIA recertification survey at WV OFFICE OF LABORATORY SERVICES on August 26, 2024 to August 29, 2024. The laboratory was surveyed under 42 CFR part 493 CLIA regulations and found to not be in compliance with the following condition-level CLIA requirements: 42 C.F.R. 493.1240 Condition: Preanalytic systems. 42 C.F.R. 493.1250 Condition: Analytic systems. 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 review of laboratory policies, competency assessments (2023 and 2024), and confirmed in an interview with Technical Supervisor (TS) -1, the laboratory failed to have a policy to address competency for 6 of 6 Technical Supervisors, 4 of 4 General Supervisors (GS) and 4 of 4 Testing Personnel (TP). Findings Include: 1. Review of laboratory documents revealed no documentation of a policy to address competency for the Technical Supervisors and General Supervisors in 2023 and 2024. 2. Review of laboratory competency assessments revealed no annual competency documentation in 2023 and 2024 for TS-1, TS-2, TS-3, TS-4, TS-5, GS-1, GS-2, GS- 3, GS-4, and TP-1, TP-2, TP-3, TP-4. 3. In an interview on 8/27/2024 at 2:12pm, TS- 1 corroborated that the laboratory did not have a policy to address competency for 6 of 6 TSs, 4 of 4 GSs and 4 of 4 TPs in 2023 and 2024. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual and interview with Technical supervisor (TS) #1, the laboratory failed to follow their quality assessment (QA) procedure for 2 of 2 years (August 2022 to August 2024). The findings included: 1. The Quality assessment plan, 5.5 Quality assessment review: 5.5.1 "A random review of quality assessment for each unit is perform by either the section supervisor or a designated laboratory scientist from the section. 5.5.2 The section supervisor or designated laboratory scientist will choose one specimen from each unit and complete a QA quarterly review form". 2. The laboratory sections were unable to provide QA quarterly reviews performed for 2 of 2 years from August 2022 to August 2024. 3. Interview with TS#1 confirmed the findings above on August 29, 2024 at 1: 00 pm. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, 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 preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on direct observation, review of manufacturer's instructions, laboratory's procedure manuals, and patient reports, the laboratory failed to meet the requirements for the preanalytical systems evidenced by: 1. The laboratory failed to follow the manufacturer's instructions for the pre-analytical requirements of laboratory testing. Please see D5311, I. 2. The laboratory failed to follow manufacturer's instructions, written policies and procedures, for documenting pre-analytical specimen acceptability requirements of laboratory testing. Please see D5311, II. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on direct observation, manufacturer's instructions for transport and processing, -- 2 of 11 -- and confirmed in interview, the laboratory failed to follow manufacturer's instructions for processing 5 of 5 Hologic Aptima Combo 2 Assay Tubes run on the Hologic Panther analyzer on August 27, 2024. Findings include: 1. A review of manufacturers instruction for the Aptima Combo 2 Assay Panther System (502446 Rev. 009) stated the following on page 5: "Avoid cross-contamination during the specimen handling steps. Specimens can contain extremely high levels of organisms. Ensure that specimen contains do not contact one another, and discard used materials without passing over open containers." 2. In direct observation, on 8/27/2024 at 10:21 AM, in the Laboratory Support Unit of the facility, 3 Hologic Aptima Combo 2 Assay Tubes for CT/GC were placed horizontally, physically touching one another by the specimen handler during intake, once removed from packaging, for counting and accessioning purposes. Additionally 2 CT/GC Hologic Aptima tubes for different patients were received together in one pack with 5 total specimens, touching one another. The patients observed are as follows: a. MRN 3536591, DOB 9/12/1983. b. MRN 3555722, DOB 7/10/1972. c. MRN 3558952, DOB 8/08/1991. d. MRN 3335016, DOB 5/01/1998. e. MRN 3347119, DOB 2/07/1974. 3. In an interview on 8/27/2024 at 10:25 AM, the supervisor of the Laboratory Support Unit corroborated these findings. Word Key: GC - Gonorrhea CT - Chlamydia Trachomatis 47272 II. Based on observation, manufacturer's instructions, laboratory written policy and procedure, patient submission forms, patient test reports, and interview with the supervisor of laboratory support, technical supervisor #1 (TS #1), and technical supervisor #3 (TS #3), the laboratory failed to document specimen acceptability for three of three Campylobacter specimens, one of one Salmonella specimens, one of one Escherichia coli specimens, two of two Rubella specimens, and eight of eight Syphilis specimens. Findings include: 1. On 08/27/2024 TS #1 confirmed the laboratory performed Campylobacter testing, Salmonella testing, and Escherichia coli testing submitted by outside clients using the Remel Cary Blair Transport Medium. 2. On 08/28/2024 TS #3 confirmed the laboratory performed the following testing from outside patient samples: a. Rubella testing using the Fisher Scientific Biokit Sure-Vue Rubella kit. b. Syphilis testing using the Becton Dickinson Macro-Vue RPR kit 3. Review on 08/27 /2024 of manufacturer's instructions for specimen submitted using the Remel Cary Blair Transport Medium (Campylobacter testing, Salmonella testing, and Escherichia coli testing) and Rubella testing revealed the following instructions: a. Remel Cary Blair Transport Medium with an indicator (Campylobacter testing, Salmonella testing, and Escherichia coli testing) under section, "LIMITATIONS" stated, "4. Transport and storage of fecal specimens at 2-8C are very important for the recovery of certain enteric pathogens (e.g., Shigella, Campylobacter)." b. Fisher Scientific Biokit Sure- Vue Rubella kit (Rubella testing) under section "SPECIMEN COLLECTION AND STORAGE" stated, "2. If the test cannot be carried out on the same day, the serum must be stored between 2-8C for no longer than 8 days after collection. For longer periods the samples must be frozen (-20C)." 4. Observation on 08/28/2024 at 10:20 am of specimens arriving at the laboratory's specimen receiving department revealed the laboratory did not have a mechanism to ensure specimens were maintained according to manufacturer instructions for Campylobacter patient specimens: a. Patient E1791848 - Date of collection on 08/21/2024, received into the laboratory on 08/28/2024 for Campylobacter testing. 5. Review of laboratory specimen submission forms and patient reports on 08/28/2024 revealed the laboratory failed to document the specimen acceptability for the following: a. Campylobacter testing: i. Patient E24M0168990-01 - Specimen collected on 06/05/2024, received into the laboratory on 06/17/2024, and reported on 07/03/2024. ii. Patient E24M016888-01- Specimen collected on 06/13/2024, received into the laboratory on 06/14/2024, and reported on 06/21/2024. b. Salmonella testing: i. Patient E24M016996-01 - Specimen collected on 06/15/2024, received into the laboratory on 06/17/2024, and reported on 07/03/2024. -- 3 of 11 -- c. Escherichia coli testing: i. Patient E24M016702-01 - Specimen collected on 06/07 /2024, received into the laboratory on 06/14/2024, and reported on 07/10/2024. d. Rubella testing: i. Patient E24016951-01 - Specimen collected on 06/14/2024, received into the laboratory on 06/17/2024, and reported on 06/18/2024. ii. Patient E24D021350-01 - Specimen collected on 08/01/2024, received into the laboratory on 08/02/2024, and reported on 08/06/2024. 6. Review on 08/27/2024 of the laboratory's written policy and procedure titled, "Rapid Plasma Reagin (RPR) 18 mm Circle Test for the Detection of Syphilis Qualitative and Quantitative Using DB Macro-Vue Reagents" under section, "6.0 SAMPLE REQUIREMENTS" stated, "6.4 Sample is stable for 7 days from collection at room, refrigerated, or frozen temperature." 7. Review of laboratory specimen submission forms and patient reports on 08/28/2024 revealed the laboratory failed to document the specimen acceptability for eight of eight Syphilis specimens: a. Patient E24D016941-01 - Specimen collected on 06/11 /2024, received into the laboratory on 06/17/2024, and reported on 06/18/2024. b. Patient E24D017074-01 - Specimen collected on 06/13/2024, received into the laboratory on 06/18/2024, and reported on 06/18/2024. c. Patient E24D017004-01 - Specimen collected on 06/13/2024, received into the laboratory on 06/18/2024, and reported on 06/18/2024. d. Patient E24D020745 - Specimen collected on 07/24/2024, received into the laboratory on 07/30/2024, and reported on 07/30/2024. e. Patient E24D020695-01 - Specimen collected on 07/24/2024, received into the laboratory on 07/30/2024, and reported on 07/30/2024. f. Patient E24D020698-01 - Specimen collected on 07/24/2024, received into the laboratory on 07/30/2024, and reported on 07/30/2024. g. Patient E24D020800-0 1- Specimen collected on 07/26/2024, received into the laboratory on 07/31/2024, and reported on 07/31/2024. h. Patient E24D021401-01 - Specimen collected on 07/30/2024, received into the laboratory on 08/05/2024, and reported on 08/06/2024. 8. Interview on 08/29/2024 at 09:30 am with TS #1 and TS #3 confirmed the laboratory failed to document specimen acceptability as indicated above. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic 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: Based on observations of the laboratory, interview with technical supervisor (TS) #1, and review of laboratory records, the laboratory failed to meet the applicable analytic systems requirements in 493.1251 through 493.1283 from August 2022 to August 2024. Refer to: 1. The laboratory failed to follow established procedures. Please see D5401. 2. The laboratory failed to establish complete procedures. Please see D5403. 3. The laboratory failed to signed all procedures. Please see D5407. 4. The laboratory failed to follow manufacturer's instructions. Please see D5411. 5. The laboratory failed to establish and document temperature and humidity conditions. Please see See D5413. 6. The laboratory failed to label reagents, solutions and chemical with expiration dates. Please see See D5415. 7. The laboratory failed to discard supplies that have exceeded their expiration. Please see D5417. 8. The laboratory failed to perform function checks. Please see D5435. 9. The laboratory failed to complete -- 4 of 11 -- Individualized Quality Control Plan (IQCP) in use. Please see D5445. 10. The laboratory failed to complete the Individualized Quality Control Plans (IQCP) in use. Please see D5449. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on the laboratory's procedure, observation and interview with Testing Personnel (TP) -6, the laboratory failed to follow their own written policy in ensuring proper Panther Fusion Mag Wash intervals after testing 2,007 of 2,458 Chlamydia (CT)/Gonorrhea (GC) patient specimens from June 2024 to August 2024. Findings Include: 1. A review of the laboratory's procedure titled, "WV DHHR|BPH|OLS Diagnostic Immunology Section Standard Operating Procedure Revised 05/04/2023" revealed on page 17 of 23 the following: "14.6. Mag Wash Clean - The Mag Wash Clean maintenance task removes deposits that can build up inside the aspirators and associated tubing. This task can be run at any time the system is in the Setup or Ready state. The task takes 31 minutes to complete. It is required that this task be performed daily after testing ..." 2. A review of the laboratory's test volume records (Panther Fusion Serial Number 03373) between June 1, 2024 and August 29, 2024 showed daily Mag Wash Clean maintenance was not performed after testing 623 of 645 CT /GC specimens in June, 703 of 986 CT/GC specimens in July, and 681 of 827 CT/GC specimens in August. 3. In an interview on 8/27/24 at 2:30pm, TP-6 confirmed the Panther Fusion Mag Wash settings were not set as per the laboratory section's policy, corroborating the findings. Word Key: GC - Gonorrhea CT - Chlamydia Trachomatis D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies 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, lack of documentation, and interview the laboratory failed to perform and document maintenance for the Beckman Coulter Centrifuge instrument used in the General Immunology laboratory. Findings include: a. A tour of the General Immunology laboratory on September 22, 2022, at 10:30 am, revealed it was 1 SX4750A Swinging-Bucket Rotor Beckman Coulter Centrifuge used in the laboratory. b. The Beckman Coulter, Instructions for use Maintenance policy under Care and Maintenance stated, "Periodically (at least monthly) inspect the rotor yoke, buckets, and/or multiwell-plate carriers, especially inside cavities, for rough spots or pitting, white powder deposits-frequently aluminum oxide-or heavy discoloration. Approximately every 400 runs, and after cleaning and/or autoclaving, wipe the rotor pins and pin sockets with a paper towel, then coat the sockets with paint on Graphite Lubricant". c. There were no documents available for maintenance of the Beckman Coulter Centrifuge used in the General Immunology laboratory for 2021 and 2022. d. During the interview on September 22, 2022, at 10:35 am, the General Immunology lab technical supervisor TS confirmed that the laboratory didn't perform maintenance for Beckman Coulter Centrifuge. 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 D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: 1.Based on interview and review of documentations the laboratory failed to document daily maintenance checklist for GeneXpert System Maintenance Log: a.The GeneXpert System Maintenance Log on "Daily Maintenance" on "clean work area, close all module doors and discard used cartridge" the boxes did not check. Eight out of ten months range from October 2020 to February 2021 reviewed. For the months of November and December 2020 & January and February 2021, the maintenance logs for GeneXpert Serial Number 838589-Rana & Serial Number 838594-Q missing daily maintenance check boxes. b.During an interview on 2/23/2021 at approximately 11 AM, the laboratory' Virology Technical Supervisor # 3 stated that the testing personnel completed the task daily but did not document the activity. 2.Based on observation, staff interview and lack of documentation, the laboratory failed to perform and document maintenance for the Evolis prep area and Rapid Plasma Reagin (RPR) section Ranin pipettes in the diagnostic immunology section of the laboratory. Finding include: a.A tour of the laboratory on February 22, 2021 at approx. 10:45am, revealed pipettes in the Evolis prep area and RPR without service labels and lack of documentation for last calibration of pipettes. i.7 of 7 pipettes lacked a service maintenance label. b.During an interview at approx. 10:50am with technical supervisor (TS1), the CMS surveyor requested maintenance documents for the 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 -- pipettes in the testing area of the diagnostic immunology section of the lab. TS1 stated, "I guess we don't have a schedule on the pipettes, since they are new. We don't have any documents from the contractor". c.During the exit interview on February 24, 2021 at appox. 2:30 pm, the Laboratory Director confirmed the above findings. 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: Based on review of laboratory's Quality Assurance (QA) documentation in Diagnostic Immunology section, interview with the section supervisor, the laboratory failed to document actual Quality Control (QC) reaction results for RPR (rapid plasma reagin) for Rotator Quality Assurance, control cards results on July, August, September, October, November and December 2019 as evidenced by: 1. In review of the laboratory's Rotator QA, the laboratory did not document the actual reactions of the QC tested, they check marked the following: Control card, NR; normal range NR: QC check marked Control card, R Min.; normal range R: QC check marked Control card, R; normal range R: QC check marked 2. In interview with the Diagnostic Immunology section supervisor, on 2/22/2021 at 12:30 PM she confirmed the finding. D6124 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(iv) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observation of performance of instrument maintenance and function checks. This STANDARD is not met as evidenced by: 1. Based on staff interview and review of Quality Assessment (QA) Plan, the technical supervisor failed to perform maintenance and calibration function checks on the Evolis and Rapid Plasma Reagin (RPR) section testing pipettes. Findings include: a. During an interview at approx. 10:50am on February 22, 2021 with technical supervisor (TS1), the CMS surveyor requested maintenance documents for the pipettes in the testing area of the diagnostic immunology section of the lab. TS1 stated, "I guess we don't have a schedule on the pipettes, since they are new. We don't have any documents from the contractor". b. The Authority and Responsibility for QA Plan: Supervisor section in the West Virginia OLS QA Manual states, "Monitoring all phases of laboratory sample/specimen integrity, instrument calibration and maintenance , analytical procedures, controls and

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of records and interview with staff, the laboratory failed to establish written policies and procedures for verification of accuracy of tests being performed that are not included in subpart I as required at 493.1236(c). Findings include: 1. Testing person #7 stated during interview at 11:10 am on 4/4/2018 that there had been no proficiency testing challenges for the Zika ELISA (enzyme-linked immunosorbent assay). 2. Review of Zika IgM Capture ELISA records revealed no written policy in place for twice yearly verification of accuracy of the Zika ELISA test. 3. Technical supervisors #1 and #4 stated during interview at 10:40 am on April 5, 2018 that there had been no proficiency challenges for the Eastern Equine Encephalitis (EEE) test during 2016 or 2017. 4. Review of EEE records revealed no written policy in place for twice yearly verification of accuracy of the EEE test. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. 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 -- (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)