Champion Healthcare Llc

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of the laboratory test menu, the laboratory procedure manual, a lack of documentation, and staff interviews, the laboratory failed to verify the accuracy of 49 toxicology confirmation tests using liquid chromatography-tandem mass spectrometry (LC-MS/MS) at least twice a year in 2023 and 2024. The findings include: 1. A review of the laboratory test menu revealed the following 49 toxicology confirmation tests performed using LC/MS/MS: 6-MAM, a-Hydroxyalprazolam, Alprazolam, Amphetamine, Benzoylecgonine, Buprenorphine, Carisoprodol, Clonazepam, Codeine, Diazepam, Codeine, Diazepam, EDDP, Fentanyl, Flunitrazepam, Flurazepam, Gabapentin, Hydrocodone, Hydromorphone, JWH-018, Lorazepam, MDA, MDFA, Meperidine, Meprobamate, Methamphetamine, Methadone, Methylone, Methylphenidate, Morphine, Naloxone, Naltrexone, Norbuprenorphine, Norfentanyl, Norhydrocodone, Normeperidine, Noroxycodone 1, O-Desmethyltranadol, Oxazepam, Oxycodone, Oxymorphone, Phencyclidine, Phentermine, Prebabalin, THC-COOH, Temazepam, Tramadol, Tapentadol, and Zolpidem. 2. A review of the laboratory procedure titled "Proficiency Testing Protocols" revealed the following requirement: "Alternative Performance Assessment - This laboratory will perform split-sample testing with its reference laboratory for any assay which CLIA does not require PT testing at least semi-annually to determine the reliability of analytical testing. - Store all split-sample testing records in the designated PT manual." 3. No twice-yearly verification of accuracy documentation was available for all 49 analytes on the day of the survey, 06/04/2025. 4. The laboratory director and facility administrator confirmed the survey findings in an interview on 06/04/2025 at 3:00 p.m. . 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 -- 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 a review of the laboratory's quality assessment (QA) policy and QA schedule, a review of laboratory records, and staff interviews, the laboratory failed to follow the quality assessment plan when the laboratory director did not review the required documents in 2023, 2024, and 2025. The findings include: 1. A review of the laboratory QA policy revealed, in addition to monthly quality control (QC) review, the following calendar for LC-MS/MS monthly QA reviews: January- Personnel files, LIS Validations February- Auto-Tune Review, QQA March- Complaints April- Master Stock, Incident Mgmt. May- Instrument Maintenance, Turnaround time June- Calibration Review, Glassware Cleaning July- Test Method review, Policy/Procedure review August- Standards Review, Check QC Review September- Target STD Review, ISTD Review October- Proficiency testing review November- QQA December- Yearly QA review 2. A review of laboratory records revealed no documentation of monthly QA assessments performed in 2023, 2024, and 2025. 3. The laboratory director and facility administrator confirmed the survey findings in an interview on 06/04/2025 at 3:00 p.m. . D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 observation of the laboratory, review of laboratory records, and staff interviews, the laboratory failed to monitor room temperature and humidity in the area where Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) patient testing occurred in 2023, 2024, and 2025. The findings include: 1. Observation of the laboratory on 06/04/2025 at 08:45 a.m. revealed the Sciex 3200 LC-MS/MS (Serial Number- AA24771112) test system in use for drugs of abuse confirmatory patient testing. 2. A review of laboratory temperature logs revealed no documentation for room temperature for 182 of 365 days in 2023, 39 of 366 days in 2024, 30 of 154 days in 2025, and no documentation for humidity for 150 of 365 days in 2023, 169 of 366 days in 2024, and 31 of 154 days in 2025. 3. The laboratory director and facility administrator confirmed the survey findings in an interview on 06/04/2025 at 3:00 p. m. . -- 2 of 4 -- D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation of the laboratory and staff interviews, the laboratory failed to ensure they did not use expired reagents for their Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) system used for confirmatory drugs of abuse testing from March 1, 2025, to the day of the survey, June 4, 2025. The findings include: 1. Observation of the laboratory on 06/04/2025 at 08:45 a.m. revealed a Mystaire Basic Workstation Fume Hood (Serial Number MY241-308) in use for storing reagents and the Sciex 3200 LC-MS/MS (Serial Number- AA24771112) test system in use for drug of abuse confirmatory patient testing. The hood contained one solution labeled "MPAP, D 1-29-25, X 2-29-25". Two solutions, labeled "MPA Exp 3/14/25" and "MPB Exp 3/14/25," were observed to be in use on the LC-MS/MS system. 2. The laboratory director and facility administrator confirmed the survey findings in an interview on 06/04/2025 at 3:00 p.m. . D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on observation of the laboratory, a review of laboratory procedures, a lack of records, and staff interviews, the laboratory failed to follow its procedure for calibration checks and annual pipette calibration for pipettes used to prepare patient samples and reagents for toxicology testing in 2023 and 2024. The findings include: 1. Observation of the laboratory on 06/04/2025 at 08:45 a.m. revealed eight racked pipettes, including an Eppendorf Repeater M4 (Serial Number 138318E) and a Biopette Plus (Identification Number 0197). 2. A review of the laboratory procedure titled "Pipette Calibration" revealed the following requirements: " - For pipettes already in service, calibration checks are to be performed every six month using at least ten data points for each calibration run. - Automatic pipets, re-pipettes and automatic diluters must be checked for accuracy and precision before first put in use; at least annually after first use; if control (QC) problems develop. - Pipettes are sent to a reference laboratory for Calibration. Documentation of Calibration verification is filed with Pipette Calibration Schedule." 3. There was no documentation of calibration checks or pipette calibrations for 2023 and 2024 available on the survey date, 06/04 /2025. 4. The laboratory director and facility administrator confirmed the survey findings in an interview on 06/04/2025 at 3:00 p.m. . D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT -- 3 of 4 -- CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of laboratory procedures, review of laboratory records, lack of documentation, and staff interviews, the laboratory failed to follow its policy for documenting

Summary Statement of Deficiencies D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare & Medicaid Services Clinical Laboratory Improvement Amendments (CLIA) Application for Certification (Form CMS-116), Aspen Web 116, the CLIA certificate posted in the laboratory, CMS form 209, and interview with the laboratory's technical supervisor (TS), the laboratory director failed to ensure compliance with 493.51 which requires notification to HHS or designee of changes in director and/or technical supervisor be communicated within 30 days of the change when the laboratory director and technical supervisor changed in March 2022 and did not notify the State Agency. The findings include: 1. Review of the Form CMS-116 submitted as part of the survey process revealed the name of a laboratory director that was different from the name of the laboratory director as listed in the Aspen Web 116 database. 2. Review of the Form CMS-116 submitted as part of the survey process revealed the name of a laboratory director that was different from the name of the laboratory director as listed on the CLIA certificate posted in the laboratory. 3. Review of the Form CMS-116 submitted as part of the survey process revealed the name of a laboratory director that was different from 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 -- name of the laboratory director as listed on the CMS Form 209. 4. Interview with technical supervisor on 2/22/23 at 1200 pm confirmed the laboratory director failed to ensure the State Agency was notified of the change in laboratory director within 30 days of the change in March of 2022. -- 2 of 2 --