Chesapeake Healthcare Center, Llc

Summary Statement of Deficiencies D0000 A routine recertification survey was conducted at Chesapeake Healthcare Center LLC. on June 25, 2025, by the West Virginia Office of Laboratory Services. The laboratory was assessed for compliance with the CLIA regulations at 42 CFR 493, Requirements for Laboratories. Specific deficiencies cited are explained below. 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 and procedures, testing personnel files, lack of documentation, and interview with testing personnel (TP3), the laboratory failed to document the initial competency assessment (CA) for two of two laboratory testing personnel in 2024. Findings: 1. Review of laboratory policies and procedures identified "Quality Assessment Plan" stating "Employees will be authorized to run tests only after completion of training and documentation of competency at initial, 6 months, and annual intervals." 2. Review of 2024 and 2025 testing personnel CA files revealed no documentation for the initial competency of TP1 and TP2. TP1 began testing February 2024, 6 month CA 7/10/24 TP2 began testing November 2024, 6 month CA 5/20/25 3. During an interview with TP3, 6/25/25 at 9:50 AM, TP3 agreed that no documentation of TP1 and TP2 initial competency assessments could be located. 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 D0000 An announced, on site, routine recertification survey was conducted at Chesapeake Healthcare Center on June 6, 2023, by the West Virginia Office of Laboratory Services. The laboratory was surveyed to assess compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. Specific deficiencies cited are explained below. D6064 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(a) Each individual performing moderte complexity testing must possess a current license issued by the State in which the laboratory is located, if such licensing is required. This STANDARD is not met as evidenced by: Based on review of personnel files, primary source verification, and interview one of two laboratory testing personnel (TP1) performing moderate complexity testing failed to possess a current West Virginia laboratory license as required by the West Virginia 64 CSR 57 Clinical Laboratory Practitioner Licensure and Certification. Findings: 1. A review of testing personnel records and the WV licensure primary source verification portal identified that one of two laboratory testing personnel (TP1) had an expired laboratory license at the time of survey (expired 5/1/23). 2. An interview with the laboratory manager, 6/6/23 at approximately 9:45, confirmed the findings. 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 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: Based on a review of laboratory policies and procedures, a tour of the laboratory, and an interview with testing personnel 1 (TP1), the laboratory failed to monitor and document the (2) temperature and (3) humidity for reliable test system operation with an NIST certified calibrated thermometer. Findings: 1. The written policy/procedure of the laboratory states "Temperature and humidity will be documented daily...NIST traceable or certified thermometers will be used and replaced if damaged or faulty." 2. A review of the "Laboratory Temperature/Humidity Log" identifies acceptable temperature and humidity ranges for the laboratory and provides a form for the documentation of the daily temperatures and humidity. a. Room Temperature 20 to 24 degrees Celsius b. Refrigerator Temperature 2 to 8 degrees Celsius c. Humidity 20 to 80 percent d. Freezer Temperature -20 degrees Celsius or colder 3. A review of the laboratory temperature and humidity logs showed the daily documentation of temperature and humidity conditions. 4. No documentation of the thermometers and hydrometers NIST certified calibration or traceability could be located. 5. An interview with TP1, on 12/4/19 at approximately 11:00 AM, confirmed that no NIST certified documentation could be located on site at the time of survey. D5449 CONTROL PROCEDURES 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 -- 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. This STANDARD is not met as evidenced by: Based on a review of the laboratory written policies and procedures, quality control (QC) records, patient testing logs, and an interview with testing personnel 1 (TP1), the laboratory failed to perform and document an external negative and positive control for the Quidel Triage Tox Drug Screen test kit daily. Findings: 1. Review of the laboratory written policies and procedures established that external negative and positive controls were ran with "each new lot and every 30 days." 2. Review of the laboratory QC records identified external negative and positive controls were ran on the Quidel Triage Tox Drug Screen test kit 10/31/19, 11/15/19, 11/18/19. 3. A review of patient testing logs revealed that patient testing on the Quidel Triage Tox Drug Screen test kit occurred 10/17/19, 10/18/19, 10/23/19,10/24/19, 10/25/19, 10/26/19, 10 /30/19, 10/31/19, 11/1/19, 11/2/19, 11/3/19, 11/15/19, 11/18/19, 11/19/19, 11/21/19, 11/22/19, 11/25/19, 11/26/19, 11/27/19, 12/2/19, and 12/3/19. 4. No Individual Quality Control Plan (IQCP) could be located for the Quidel Triage Tox Drug Screen testing for the laboratory. 5. An interview with TP1, on 12/4/19 at approximately 10: 00 AM, confirmed that external negative and positive controls were only ran every 30 days or with a new lot for the Quidel Triage Tox Drug Screen test kit. D6064 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(a) Each individual performing moderte complexity testing must possess a current license issued by the State in which the laboratory is located, if such licensing is required. This STANDARD is not met as evidenced by: Based upon review of laboratory personnel files, West Virginia licensure verification source, and interviews with testing personnel, there were no individuals performing laboratory testing that possess a current West Virginia laboratory license as required by the West Virginia state rule WV 64 CFR 57 Clinical Laboratory Technician and Scientist Licensure and Certification Rule. Findings: 1. The 2 testing personnel of the laboratory had no knowledge or documentation of a West Virginia Laboratory license. 2. Interviews with the 2 testing personnel, 12/4/19 at approximately 9:00 AM, confirmed they had no current West Virginia laboratory license or knowledge that they were required to have one. 3. The laboratory immediately began the process of acquiring West Virginia laboratory licenses for testing personnel while surveyor was on site. -- 2 of 2 --