Highlands Hospital Toxicology Laboratory

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 the Laboratory's Quality Assessment (QA) Plan policy, QA documents, and interview with General Supervisor (GS) #1, the laboratory failed to follow established written policies to ensure the laboratory's QA Plan was maintained to monitor, assess, and correct problems identified in the general laboratory systems (493.1231 through 493.1236) for 2 of 2 years from 3/5/2024 to 11/17/2025. Findings include: 1. The laboratory's Quality Assessment Plan policy stated, "The QA plan will be implemented by review of the following monitors at the frequency and method of review specified. Proficiency Testing: PT surveys including Alt PT, CAP surveys or any other PT provider. Frequency-Biannual. Annual Calendar of QA Reviews: Review the monitor(s) assigned for each month. Document the review on the appropriate form and attach all supporting data and information. Biannually: complete the Proficiency checklists." 2. On the day of the survey, 11/17/2025 at 12:30 pm, the laboratory failed to provide documentation of the biannual QA assessment review performed for all PT surveys performed for 2 of 2 years from 3/5/2024 to 11/17/2025. 3. GS #1 confirmed the above findings on 11/17/2025 at 12:45 pm. 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, 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 -- 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 in the laboratory, review of laboratory temperature records, and interview with General Supervisor (GS) #1, the laboratory failed to monitor temperatures to ensure acceptable reagent storage temperatures were maintained on weekends and holidays for 425 of 623 days from 3/5/2024 to 11/17/2025. Findings include: 1. On the day of survey, 11/17/2025, at 2:30 pm, during the tour of the laboratory, the surveyor observed the following reagents stored in the laboratory: - Supelco Isopropanol. Storage requirements 2C to 30C. - Carolina Wash Concentrate. Storage requirements 8C to 30C. - Fast Detergent 1. Storage requirements 8C to 30C. - Fast Detergent 2. Storage requirements 8C to 30C. - Agilent ESI Low Conc Tuning Mix. Storage requirements 2C to 8C. - Rapid Hydrolysis Buffer. Storage requirements 2C to 8C. - IMCSzyme. Storage requirements 2C to 8C. 2. Review of the laboratory's temperature records revealed the laboratory failed to monitor and document temperatures to ensure acceptable reagent storage temperatures were maintained for 425 of 623 days from 3/5/2024 to 11/17/2025 when the laboratory was closed. 3. The laboratory performed 784,905 toxicology examinations in 2024 (CMS 116, estimated volume, dated 10/27/2025). 4. GS #1 confirmed the findings above on 11/17/2025 at 2: 45 pm. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the laboratory and interview with the Lighthouse Consultant (LC), the laboratory failed to label 3 of 3 aliquoted reagents (methanol, isopropanol, and water) with the pertinent information required for proper use from 3/5/2024 to 11 /17/2025. Findings include: 1. On the day of survey, 11/17/2025 at 2:30 pm, during the laboratory tour, observation of the laboratory revealed 3 of 3 containers used to aliquot reagents were not properly labeled with the following when toxicology examinations were performed from 3/4/2024 to 11/17/2025: - Storage requirements - Preparation and expiration dates 2. The laboratory performed 784,905 toxicology examinations in 2024 (CMS 116, estimated volume, dated 10/27/2025). 3. The LC confirmed the findings above on 11/17/2025 at 2:45 pm. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an -- 2 of 3 -- 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 record review, lack of documentation, and interview with the Lighthouse Consultant (LC), the laboratory failed to ensure written procedures were followed to to monitor, assess, and correct problems in the analytic systems (493.1251 through 493.1283) when biannual result comparisons performed for 2 of 2 Chem Agilent 6400 analyzers failed to meet the laboratory's established acceptable criteria from 3/4/2024 to 11/17/2025. Findings include: 1. The laboratory's Instrument/Method Comparison policy stated: "5.1.3: Review the data for each instrument and analyte to determine if the correlation is acceptable. For quantitative testing, the results are acceptable when the deviation does not exceed 20% for each positive analyte tested/compared. 5.2: Lab Director or designee: Review/

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the general supervisor (GS) (CMS 209 personnel # 2), the laboratory failed to perform calibration verification at least once every six months for 1 of 1 CLC 720 Carolina Liquid Chemistries analyzer from 01/01/2023 to 08/07/2023. Findings include: 1. On the date of the survey, 03/05/2024 at 02:30 pm, the laboratory could not provide calibration verification records for the required analytes tested on 1 of 1 CLC 720 Carolina Liquid Chemistries analyzer 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 -- from 01/01/2023 to 08/07/2023. 2. According to the laboratory's calibration verification procedure, calibration verification should be performed bi-annually on the CLC 720 Carolina Liquid Chemistries analyzer. 3. The GS confirmed the finding above on 03/05/2024 at 4:20 pm. -- 2 of 2 --

Summary Statement of Deficiencies D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of comparison study records and interview with Laboratory Consultant (LC), the laboratory failed to have a system that evaluates twice a year the relationship between test results for 2 of 2 Liquid Chromatography Mass Spectrometry (LCMS) from 04/08/2021 to 04/14/2022. Findings include: 1. On the day of survey 06/09/2022 at 11:00 am, record review revealed, the laboratory only performed comparison studies for LCMS analyzer once a year from 04/08/2021 to 04 /14/2022. 2. This finding was confirmed by interview with Laboratory Consultant on 06/09/2022 at 11:30 am. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. 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 -- This STANDARD is not met as evidenced by: Based on review of the final patient test result and interview with the Laboratory Consultant (LC), the final patient test report failed to have the correct address of the laboratory where the toxicology test was performed from 06/18/2020 to 06/09/2022. Findings include: 1. On the day of survey 06/09/2022 at 10:54am, review of the final patient report revealed that the address on the final resulting report was not correct. 2. The address on the final report was 401 E. Murphy Avenue, Connellsville, Pa 15425 3. The LC confirmed the findings above on 06/09/2022 at 11:45am. D6121 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(i) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. This STANDARD is not met as evidenced by: Based on review of competency assessment records and interview with the Laboratory Consultant (LC), the technical supervisor (TS) failed to perform direct observation of routine patient testing, specimen handling and processing for 1 of 1 testing personnel (TP) from 06/18/2020 to the day of survey. Findings Include: 1. On the day of survey 06/09/2022 at 11:00 a.m., review of 1 of 1 TP competency assessment records for toxicology indicated "direct observation through FaceTime on 12/29/2020 and 03/18 /2021". 2. Interview with the LC revealed that the TS has not been on site to perform direct observations for the competency assessment. 3. The LC confirmed the findings above on 06/09/2022 around 11:15 a.m. * Please note: Virtual observations are unacceptable. 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: Based on review of competency assessment records and interview with the Laboratory Consultant (LC), the technical supervisor (TS) failed to perform direct observation of performance of instrument maintenance and function checks.for 1 of 1 testing personnel (TP) from 06/18/2020 to the day of survey. Findings Include: 1. On the day of survey 06/09/2022 at 11:00 a.m., review of 1 of 1 TP competency assessment records for toxicology indicated "direct observation through FaceTime on 12/29/2020 and 03/18/2021". 2. Interview with the LC revealed that the TS has not been on site to perform direct observations for the competency assessment form. 3. The LC confirmed the findings above on 06/09/2022 around 11:15 a.m. * Please note: Virtual observations are unacceptable. -- 2 of 2 --