Greene County Health System

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: D5429 Based on review of maintenance records for the Hematology instrument Beckman Coulter DxH 520, and an interview with the Technical Consultant (TC), the laboratory failed to document monthly maintenance as per the manufacturer's requirements. This was noted for 3 out of 12 months in 2025. The findings include: 1. A review of maintenance records for the Beckman Coulter DxH 520 revealed no evidence of monthly maintenance documentation for the following months in 2025: a. July, October, and November. 2. A further review of the DxH 520 Maintenance Checklist revealed, "Monthly ... Perform Bleach cycle and clean the white blood cell bath filter." 3. During an interview on 6/17/26 at 2:02 PM, the TC noted that monthly maintenance was not documented. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. 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 -- This STANDARD is not met as evidenced by: D5441 Based on a review of Vitros XT 3400 Chemistry analyzer Quality Control (QC) records and an interview with the Technical Consultant, the laboratory failed to have a procedure in place that monitors the accuracy and precision of test performance over time. This was noted from the date of the previous survey 5/30/24 to the date of the current survey 6/17/26. The findings include: 1. A review of Vitros XT 3400 Chemistry QC records revealed no evidence of correct Levy Jennings charts or peer group data available for review during the time of survey. 2. A further review revealed Levy Jenning charts but inaccurate ranges per manufacturer requirements. 3. During an interview on 6/17/26 at 2:02 PM, the Surveyor inquired about the review of Levy Jennings charts for the Vitros XT 3400 Chemistry analyzer. The TC confirmed the above findings. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) 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 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. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: D5445 Based on a review of the Ortho Quidel Triage QC (Quality Control) records, the QuickChek Clostridium Difficile (C. diff) QC records, the serum hCG (Human Chorionic Gonadotropin) QC records, the IQCP (Individualized Quality Control Plan), and an interview with the Technical Consultant (TC), the Laboratory failed to ensure Testing Personnel (TP) performed the Triage, C.Diff, and serum hCG QC every 30 days as per the IQCP. The surveyor noted the following QC was not performed as required by the IQCP: a) Triage QC 41 days of 17 months reviewed in 2025-2026, b) C. diff QC February 2025, c) Serum hCG QC February 2025. The findings include: 1. A review of the Ortho Quidel Triage QC records, QuickChek C. diff QC records, and serum hCG QC records revealed the following QC not performed every 30 days or monthly per IQCP: a) Triage Cardiac QC performed 2/15 /25 and then 38 days later on 3/31/25; also Cardiac and Ddimer performed 2/1/26 and then 29 days later on 3/31/26, b) C.diff QC performed 1/15/25 and then not again until 3/15/25, c) Serum hCG QC performed 1/15/25 and then not again until 3/15/25. 2. A review of the Triage IQCP revealed, "Perform external Quality Control at least every 30 days." A review of the C.diff and serum hCG IQCP revealed, "Perform QC monthly ..." 3. During an interview on 6/17/26, at 2:02 PM, the TC confirmed the above findings. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratorys and, as applicable, the -- 2 of 3 -- manufacturers 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: D5481 Based on a review of the 2025 Cardiac quality control (QC) records, and an interview with the Technical Consultant (TC), the laboratory failed to ensure at least two levels of QC were run and acceptable, prior to analyzing patient specimens and reporting the results. This was noted 1 day out of 12 months reviewed in 2025. The findings include: 1. A review of the QC records for the Quidel Triage Cardiac analyzer revealed the following dates QC was out prior to patient testing: a) Level 2 out on 2/15/2025. 2. During an interview on 6/17/26 at 2:02 PM, the TC confirmed the above findings. -- 3 of 3 --

Summary Statement of Deficiencies D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of maintenance records and an interview with Testing Personnel #1, the laboratory failed to document inspections of the audible alarm system of the Blood Bank refrigerator. This was noted from the date of the last survey, 8/9/2022, to the date of the current survey, 5/29/2024. The findings include: 1. A review of Blood Bank maintenance records revealed a lack of documented alarm checks for the Blood Bank refrigerator. 2. During an interview on 5/30/2024 at 11:45 AM, Testing Personnel #1 explained that the laboratory was monitoring the refrigerator routinely for acceptable temperatures, however, no maintenance check has been performed and documented for the alarm system. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: 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 -- Based on a review of Personnel records and an interview with the Technical Consultant, the Technical Consultant failed to assess competency on an annual basis for all non waived testing systems for Testing Personnel #1. This was noted for one of two opportunities for competency assessment from 2023 to 2024. The findings include: 1. A review of Personnel records revealed Testing Personnel #1 to have a complete annual competency assessment dated 5/29/2024. No evidence of an annual competency assessment for 2023 was available for review at the time of survey. 2. During an interview on 5/30/2024 at 12:00 PM, the Technical Consultant confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of the Biosite Triage Meter Quality Control (QC) records and an interview with Testing Personnel #1, the laboratory failed to retain the manufacturer's QC assay information sheets for control materials. This was noted from 6/18/2021 to 7 /15/2022. The findings include: 1. A review of Biosite Triage Meter Cardiac and D- Dimer QC records revealed only instrument print outs were retained. The QC records did not include all manufacturer's assay sheets or documentation of acceptable ranges for each QC lot number. 2. During an interview on 08/10/2022 at 11:15 AM, Testing Personnel #1 confirmed the laboratory had not retained the manufacturer's assay sheets with acceptable QC ranges. 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 a review of personnel records, a review of the Policies and Procedures, and an interview with Testing Personnel #1, the laboratory failed to follow written policies and procedures to assess employee competency. This was noted for eight out of eight 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 -- Testing Personnel from September 2020 to August 2022. The findings include: 1. A review of the personnel records revealed a lack of acceptable documentation of competency assessment for each employee. The "Annual Evaluation" form in use evaluated performance overall as a hospital employee, not specifically assessing competency for moderate complexity testing performed within the laboratory. The form used for competency assessment did not evaluate all six competency assessment criteria as specified by CLIA. 2. A review of Policies and Procedure revealed the following under a section titled, "Laboratory Competency Program", "...A yearly competency assessment will be done including Survey participation, demonstration, simulation, observation, and CEU participation.". 3. During an interview on 08/10 /2022 at 12:01 PM, the surveyor reviewed and confirmed the above findings with Testing Personnel #1 and the Technical Consultant. D5449 CONTROL PROCEDURES 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 reviews of the patient and quality control (QC) records for Serum HCG (Human Chorionic Gonadotropin) and C. Diff (Clostridium difficile), and an interview with Testing Personnel #1, the surveyor determined the laboratory failed to ensure two levels of qualitative QC were performed each day of patient testing, in the absence of an IQCP (Individualized Quality Control Plan). Twelve days were noted between July 2021 and July 2022 when patient tests were performed with no documentation of QC. The findings include: 1. A review of patient records revealed the following: a) Serum hCG was performed on patients on 07/17/2021, 07/26/2021, 09/23/2021, 09/25/2021,10/08/2021, 11/20/2021, 12/22/2021, 01/28/2022, and 02/17 /2022. b) C. Diff was performed on patients on 10/13/2021, 10/18/2021, and 12/20 /2021. 2. A review of Quality Control records revealed the following: a) Serum hCG- No acceptable QC was documented. This was noted for 12 out of 12 months reviewed. d) C. Diff- No acceptable QC was documented. This was noted for 12 out of 12 months reviewed. 3. During an interview on 08/09/2022 at 3:00 PM, Testing Personnel #1 confirmed QC for both Serum hCG and C. Diff were only performed with each new lot number. The surveyor explained both of these tests are moderate complexity, and QC must be performed each day of patient testing unless the laboratory has implemented an IQCP. The Supervisor confirmed there was no documentation of QC from July 2021 to July 2022 and the laboratory had not implemented an IQCP. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the 2016 - 2018 API (American Proficiency Institute) Proficiency Testing records and an interview with the Laboratory Manager (also the Testing Personnel), the laboratory failed to ensure attestation statements for 16 out of 23 surveys were signed by the Laboratory Director and testing personnel. The findings include: 1. A review of the API Proficiency Testing (PT) records revealed no signatures of the Laboratory Director (LD) (or designee) and/or the Testing Personnel (TP) on the attestation statements for the following surveys: A) 2016-Group #1 Chemistry, 2nd and 3rd Events : No LD B) 2016-Group #2 Chemistry, 1st, 2nd and 3rd Events : No LD C) 2016-Bacteriology, 3rd Event : No LD D) 2017-Hematology, 1st and 2nd Events: No LD E) 2017-Hematology, 3rd Event: No LD or TP F) 2017- Bacteriology, 1st and 2nd Events : No LD G) 2017-Chemistry, 1st and 3rd Events : No LD H) 2017-Chemistry, 2nd Event : No LD or TP I) 2018-Bacteriology, 1st Event : No LD J) 2018-Hematology, 1st Event: No LD or TP 2. In an interview on 7/6/2018 at 10:10 AM, the Laboratory Manager reviewed the PT records with the surveyor, and confirmed the above noted findings. . 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records and an interview with the Laboratory Manager (also the Testing Personnel), the surveyor determined the laboratory failed to either participate in proficiency testing or implement another method of semi-annual accuracy verification for four non-regulated Chemistry /Toxicology analytes, and eight analytes on the I-Stat used for back-up Chemistry testing in 2016-2107. The findings include: 1. A review of the API PT records revealed the laboratory failed to perform PT at least twice annually due to reagent shortages for four non-regulated Chemistry/Toxicology analytes, and eight analytes on the I-Stat used for back-up Chemistry testing, as follows: A) Phosphorus: 2016 #1 (Not performed-No reagent [NR]); 2016 #3 NR B) Troponin I: 2016 #1 NR; 2016 #3 NR C) Back-up tests performed on the I-Stat: TCO2 (Total Carbon Dioxide), Sodium, Potassium, Chloride, Glucose, Urea, Creatinine, and Ionized Calcium: 2016 #2 NR; 2016 #3 NR; 2017 #1 NR; 2017 #2 NR D) Acetaminophen: 2017 #2 NR; 2017 #3 NR E) Salicylate: 2017 #1 NR; 2017 #2 NR There was no evidence the laboratory had implemented an alternative method to ensure accuracy verification for the above analytes. 2. In an interview on 7/6/2018 at 10:10 AM, the Laboratory Manager reviewed the PT records with the surveyor, and explained the reagent shortages were due to monetary problems in the hospital. The Manager then confirmed they did not have another method of semi-annual accuracy verification. Thus, the above noted findings were confirmed. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of the 2017 - 2018 API (American Proficiency Institute) Proficiency Testing records and an interview with the Laboratory Manager (also the Testing Personnel), the laboratory failed to document reviews of eight out of 23 of the returned survey evaluations results, and failed to document