Cumberland County Hospital

Summary Statement of Deficiencies D0000 A recertification survey was initiated on 05/28/2025 and concluded on 05/29/2025. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with standard deficiencies cited. 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 direct observation, review of procedure manual, review of manufacturer's package inserts, and confirmed in an interview with the General Supervisor 3 (GS3), the laboratory failed to label 21 of 21 in-use reagents with revised expiration dates. Findings Included: Observed on 05/28/2025 at 1:45 PM, in the testing area, a sampling of 8 open reagents stored in the refrigerator included: a. One open bottle of Liquichek Diabetes control Level 3, Lot number 89243 b. One open bottle of Ethanol /Ammonia control Level 3, Lot number 54463 c. One open bottle of DOA Total control Level 5, Lot number DAT26085A d. One open bottle of Liquichek Urine Chemistry Control Level 2, Lot number 97452 e. One open bottle of Liquid Assayed Multiqual Level 1, Lot number 45981 f. One open bottle of Liquichek Immunoassay Plus control Level 1, Lot number 85371 g. One open bottle of Lyphochek Specialty Immunoassay control Level 1, Lot number 88751 h. One open bottle of Liquichek Cardiac Markers Plus control LT Level 1, Lot number 67711 The laboratory failed to label the bottles with revised expiration dates specified by the manufacturer. Review of the procedure manual titled, "Cumberland County Hospital Laboratory Policy and Procedure Manual", approved by director on 7/22/2024, stated, "All reagents must be 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 -- labeled with name, date received, and expiration date according to manufacturer's specifications." Review of Manufacturer's instructions titled "Storage and Stability" stated: a. Liquichek Diabetes Control Levels 1,2, and 3: "Once thawed, opened, and stored tightly capped at 2 to 8C, this product will be stable for 45 days." b. Ethanol /Ammonia Control: "20 day open-vial stability at 2-8C." c. MAS DOA Total: "Once opened, vials of control are stable for 30 days when stored tightly capped at 2-8C." d. Liquichek Urine Chemistry Control Levels 1 and 2: "Once opened and stored tightly capped at 2 to 8 C, this product will be stable as follows: All analytes: 30 days." e. Liquid Assayed Multiqual Levels 1,2, and 3: "Thawed Opened: Once thawed, opened, and stored tightly capped at 2 to 8C, this product will be stable as follows: All analytes: 14 days, Except: Alkaline Phosphatase, AST/SGOT, Bilirubin (Neonatal) and Bilirubin (Total): 9 days - Bilirubin (Direct), Cholesterol (HDL), Cholinesterase, Creating Kinase (CK), Phosphorus and Triglycerides: 7 days - LAP Arylamidase: 3 days f. Liquichek Immunoassay Plus Control Levels, 1, 2, and 3: "Once thawed, opened, and stored tightly capped at 2 to 8C, this product will be stable as follows: All analytes: 30 days, Except: Androstenedione, 25 days - Prolactin, PSA (Free) and PSA (Total): 14 days - Estradiol: 8 days - Folate: 4 days g. Lyphochek Specialty Immunoassay Specialty Immunoassay Control Levels 1,2, and 3: "After reconstituting and storing tightly capped at 2 to 8C, this product will be stable as follows: All analytes: 30 days, Except: PTH (Intact): 4 days -Procalcitonin: 3 days." h. Liquichek Cardiac Markers Plus Control LT Levels 1,2,3,1A,1B, and 1C: "Once thawed, opened, and stored tightly capped at 2 to 8C, this product will be stable as follows: All analytes: 20 days, Except: Myoglobin: 10 days - N-terminal pro-Brain Natriuretic Peptide (NT-proBNP), B-type Natriuretic Peptide (BNP) and Troponin I: 5 days - Troponin T: 4 days." In an interview on 5/29/2025, at 10:25 AM, the General Supervisor 3 (GS3) in the office area, was asked if expiration dates were placed on the open controls. GS3 stated the dates were not placed on the vials. This confirmed the findings. D5807 TEST REPORT CFR(s): 493.1291(d) (d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to monitor accuracy of patient test reference ranges within the procedure when compared to reference ranges in patient test reports for years 2024 and 2025 for 1 of 2 patient test reports. Findings included: Record review on 05/29/2025 at 11:15 p.m. revealed reference ranges in a patient test report did not match reference ranges in the laboratory's procedure for Red Blood Cell (RBC), Hemoglobin (HGB), Hematocrit (HCT), and Mean Corpuscular Volume (MCV). a.) Patient test report 72115,dated 09/09/2024, revealed the following ranges for an adult female: RBC: 4.20-5.40 microliters per milliliter (M/uL) HGB: 12.0-16.0 grams per deciliter (g/dL) HCT: 37.0-47.0 percentage (%) MCV: 81- 99 femtoliters (fL) b.) Review of the Cumberland County Hospital Laboratory Infection Control Policy and Procedure Manual titled "Table of Normal Ranges" had the following ranges not based on gender: RBC: 4.7-5.6.1 M/uL HGB: 14.0-18.0 g/dL HCT: 42.0-52.0 % MCV: 80-94 fL During an interview on 05/29/2025 at 11:25 p.m. in an office adjacent to the main laboratory, the General Supervisor 3 (GS3) confirmed that the reference ranges on the patient test reports did not match reference -- 2 of 3 -- ranges in the laboratory's procedure for RBC, HGB, HCT, and MCV. This confirmed the findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Recertification Survey was initiated on 06/14/2023 and concluded on 06/15/2023. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on document review and interview, the laboratory failed to provide evidence of a self-evaluation of 5 proficiency testing (PT) results that were returned as not graded by the PT provider. Findings included: Review of the American Proficiency Institute report, titled "Proficiency Testing Performance Evaluation" for the 2021 Hematology /Coagulation - 3rd Event, revealed the vaginal wet preparation for sample VKP-03 was not graded. Review of the American Proficiency Institute report, titled "Proficiency Testing Performance Evaluation" for the 2022 Microbiology - 1st Event, revealed the gram stain for sample GS-05 was not graded. Review of the American Proficiency Institute report, titled "Proficiency Testing Performance Evaluation" for the 2022 Immunology / Immunohematology - 1st Event, revealed the compatibility for sample SER-05 was not graded. Review of the American Proficiency Institute report, titled "Proficiency Testing Performance Evaluation" for the 2022 Immunology /Immunohematology - 2nd Event, revealed the compatibility for SER-06 was not graded. Review of the American Proficiency Institute report, titled "Proficiency Testing Performance Evaluation" for the 2022 Hematology/Coagulation - 3rd Event, revealed the blood cell identification for sample BCI-14 was not graded. During an 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 -- interview on 06/14/2023 at 2:25 PM, General Supervisor #1 confirmed the above findings. 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 procedure manual review and interview, the laboratory failed to establish a written procedure for the performance and review of external proficiency testing (PT). Findings included: Review of the laboratory's procedure manual, revealed there was not a procedure that specified the performance and review of PT. During an interview on 06/14/2023 at 2:25 PM, General Supervisor #1 confirmed the laboratory did not have a written PT procedure. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on desk review of chemistry proficiency testing results from the American Proficiency Institute (API) proficiency testing agency on 05/10/2021 the laboratory failed to successfully participate in the human chorionic gonadotropin (HCG) certified analyte in two (2)consecutive testing events. See D2087 and D2096 D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte 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 -- in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on desk review of Chemistry proficiency testing results from the American Proficiency Institute (API) testing agency on 05/10/2021, the laboratory failed to attain a satisfactory score of at least 80 percent on the human chorionic gonadotropin (HCG) Findings include: 1. The laboratory failed to achieve a satisfactory score for the human chorionic gonadotropin (HCG) analyte in the third (3rd) testing event of 2020 with a score of sixty (60) percent. 2. The laboratory failed to achieve a satisfactory score for the human chorionic gonadotropin (HCG) analyte in the first (1st) testing event of 2021 with a score of forty (40) percent. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of Chemistry proficiency testing results from the American Proficiency Institute testing agency on 05/10/2021, the laboratory failed to successfully achieve satisfactory performance for the human chorionic gonadotropin (HCG) analyte in two (2) consecutive testing events. Findings include: 1. The laboratory failed to achieve a satisfactory performance for the human chorionic gonadotropin (HCG) in the third (3rd) testing event of 2020. 2. The laboratory failed to achieve a satisfactory performance for the human chorionic gonadotropin (HCG) in the first (1st) testing event in 2021. -- 2 of 2 --

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 record review and staff interview on 11/06/2018, 11/07/2018, and 11/08 /2018, the laboratory failed to monitor and document external humidity for the performance of blood gases on the AVL OPTI CCA from 11/16/2016 through 11/07 /2018. Findings include: The Individualized Quality Control Plan (IQCP) written for the AVL OPTI CCA blood gas instrument included the daily monitoring of humidity under the Risk Assessment for performing blood gases Review of laboratory documentation for the blood gas analyzer failed to reveal daily recordings of humidity from 11/16/2016 through 11/07/2018. Testing personnel revealed in an interview at 9: 45 AM on 11/08/2018, the laboratory failed to have a system in place to ensure humidity readings were recorded daily. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 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 -- 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control records and staff interview on 11/06/2018, 11/07 /2018, and 11/08/2018, the laboratory failed to perform three levels of external controls every fifteen (15) days from 01/07/2017 to 11/01/2017 on the AVL OPTI CCA Blood Gas Analyzer. Findings include: Review of the Quality Control Plan adopted 11/16/2016, revealed three levels of external quality control are performed and recorded in the quality control log book every fifiteen (15) days and must be within acceptable range per manufacturer's packet insert. Review of laboratory records failed to reveal quality control documentation from 01/07/2017 thru 02/15 /2017, 03/01/2017 thru 04/12/2017, and 10/01/2017 thru 11/01/2017. Interview with the General Supervisor at 9:45 AM on 11/08/2018, revealed the laboratory failed to have a system in place to ensure established policy was followed for the performance of external quality control on the blood gas analyzer. 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