John Paul Jones Hospital

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 American Proficiency Institute (API) Proficiency Testing (PT) records, and an interview with the Technical Consultant (TC), the laboratory failed to implement a mechanism to verify the accuracy of the Ammonia (NH3+), urine Total Protein (uTP) and C-Reactive Protein (C-RP), all non-regulated analytes. The surveyor noted the PT evaluation failures occurred in two of the seven Specialties /Subspecialties from 2023-2025. The findings include: 1. A review of the API PT records revealed the laboratory had unsuccessful evaluations for the Chemistry and Immunology specialties for the following events: A) 2023 Chemistry 2nd Event; NH3+ 67% and uTP 33% B) 2024 Chemistry 1st Event; NH3+ 33% and uTP 33% C) 2023 Immunology 1st Event; C-RP 50% D) 2023 Immunology 2nd Event, C-RP 0% 2. A further review revealed no evidence of accuracy verification for the failing analytes. 3. An interview with the TC on 05-20-2025 at approximately 1:43 PM revealed the PT unsuccessful evaluations for these events resulted when the reported values were not converted to the correct units and improper mixing techniques. The same reasons were documented under the Laboratory Director's (or designee) review of PT evaluations. 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 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 -- 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 reviews of the 2023-2025 Freezer Temperature (FT) logs, the Policy and Procedure Manual (P&P), the Laboratory Information System (LIS) patient testing history data and an interview with Technical Consultant (TC), it was determined the laboratory failed to monitor and document the FT for 6 of the 30 days in November 2023. The findings include: 1) A review of the FT logs revealed the laboratory failed to monitor and document the FT where reagents/materials for patient testing were stored for the following days: A) November 2023; 4, 11-12, 18-19, 25. 2) A review of the P&P revealed the test cartridges for the D-Dimer and Troponin testing were in this freezer and had to be maintained at minus 20 degrees Celsius or colder for storage requirement. 3) The LIS patient testing history data revealed there was one patient D- Dimer test completed on 11-12-2023. 4) The TC confirmed the above findings on 05- 21-2025 at 3:25 PM during the day 2 exit conference. 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 reviews of the Blood Bank (BB) patient records, BB Reagent logs and an interview with the Technical Consultant (TC), the surveyor determined the laboratory had utilized reagents/materials after expiration date for patient testing. The surveyor noted the expired materials were used for 1 of the 30 days in April 2025. The findings include: 1. A review of the BB patient records revealed the following reagent /materials with Lot number CNF383, Expiration Date of 04-29-2025 were used for one patient testing on 04-30-2025. A) Confidence Cell 1 B) Confidence Cell 2 C) Confidence Antibody 2. A review of the BB Reagent logs revealed the laboratory had not added these reagent/materials on the log. 3. TC confirmed the above findings during Day 2 exit conference with the TC and hospital CEO on 05-21-2025 at 3:25 PM. 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: Based on a review of the Beckman Coulter (BC) DxH 560 maintenance records, and an interview with the Technical Consultant (TC), the laboratory failed to document the monthly and 8-month maintenance. This was noted for 5 of the 23 months -- 2 of 4 -- reviewed from 2023-2025. The findings include: 1. A review of the BC DxH 560 maintenance records revealed no evidence of monthly and 8 month maintenance documentation for the following months: A) April and October 2023 B) January and August 2024 C) February 2025 2. A further review of the BC DxH 560 Maintenance Log revealed the following maintenance specifications. A) Monthly (Clean WBC Bath Filter) B) 8-Months (Lubricate Pistons and Replace Rinsing Head O-Ring) 3. During the day 2 exit conference with the TC and hospital CEO on 05-21-2025 at 3: 25 PM, the TC confirmed the above findings. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) (d)(3)(i) Each quantitative procedure, include two control materials of different concentrations; This STANDARD is not met as evidenced by: Based on reviews of the Chemistry Quality Control (QC) logs, Patient records, Policy and Procedure Manual (P&P) and an interview with the Technical Consultant, the laboratory failed to ensure two levels of QC were performed and documented each day of patient testing. The surveyor noted one of the two Bio-Rad Multiqual (BRM) QC levels was not performed for 1 of 31 days reviewed for January 2024. The findings include: 1. A review of the Chemistry QC logs revealed the laboratory failed to perform the BRM QC level 3 prior to patient testing on 01-21-2024. There were five patients tested and results reported that day. 2. A review of the laboratory's P&P manual revealed the laboratory's requirement to run two levels of QC each day of patient testing. 3. The TC confirmed the above findings on 05-21-2025 at 3:25 PM during the day 2 exit conference with the hospital CEO. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of personnel records and an interview the Technical Consultant (TC), the TC failed to assess competency at least semi-annually in the first year of patient testing. This was noted for 2 of the 14 Testing Personnel (TP) listed on the CMS 209 (Laboratory Personnel Report) from 2023-2025. The findings include: 1. A review of personnel records revealed TP4 and TP14 had the semi-annual competency assessment performed and signed by TP3. There was no documentation the TC assessed TP4 and TP14 during the first year of patient testing. 2. The TC confirmed the above findings on 05-21-2025 at 3:25 PM during the day 2 exit conference with the hospital CEO. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on a review of personnel records and an interview the Technical Consultant (TC), the TC failed to assess competency annually after the first year of patient testing. This was noted for 2 of the 14 Testing Personnel (TP) listed on the CMS 209 (Laboratory Personnel Report) from 2023-2025. The findings include: 1. A review of personnel records revealed TP4 and TP14 had the annual competency assessment performed and signed by TP3. There was no documentation the TC assessed TP4 and TP14 when the annual competency evaluation was due. 2. The TC confirmed the above findings on 05-21-2025 at 3:25 PM during the day 2 exit conference with the hospital CEO. -- 4 of 4 --

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of the GEM Premier 3500 SOP (Standard Operating Procedures), and an interview with Testing Personnel #3 (the Respiratory Therapy [RT] Supervisor), the laboratory failed to ensure the Laboratory Director reviewed /approved the procedures before the testing personnel utilized the new instrument for patient testing on 4/28/2021. The findings include: 1. A review of the GEM Premier 3500 SOP reviewed no documentation of review/approval (as indicated by a signature and date) of the procedures by the Laboratory Director. The testing personnel began using the instrument for patient tests on 4/28/2021. 2. In an interview on 9/9/2021 at 10:12 AM, Testing Personnel #3 (the RT Supervisor) stated the IL (Instrumentation Laboratory) Technician had emailed the procedures, however she did not realized the significance of the document, and failed to forward the SOP to the Laboratory Director for his review/approval and signature/date. . 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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 a review of the calibration verification (C/V) records for the GEM 3000 Blood Gas analyzer, and an interview with Testing Personnel #3 (the Respiratory Therapy Supervisor), the laboratory failed to perform C/V's every six months in 2020 and early 2021, as required by CLIA regulations. The findings include: 1. A review of the records for the GEM 3000 revealed the each new reagent cartridge on the instrument was calibrated using GEM CVP (Calibration Valuation Product) 1 and 2. As per CLIA regulations, tests calibrated with less than three calibrators require semi- annual C/V. 2. A review of 2018-2021 GEM 3000 Blood Gas analyzer records revealed C/V's were performed on 2/5/2019 and 8/6/2019, however there was no documentation of C/V's performed in 2020 or early 2021. (A new instrument was installed April 2021.) 3. In an interview on 9/9/2021 at 11:55 AM, Testing Personnel #3 confirmed C/V's should be performed every six months, and no C/V's were performed on the GEM 3000 in 2020-2021. . D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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 quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of Triage Meter installation documents, D-Dimer quality control (QC) records and an interview with the Laboratory Manager, the surveyor determined the laboratory failed to perform QC every day of patient testing in the absence of an IQCP (Individualized Quality Control Plan). This occurred eight months (February thru September) in 2021. The findings include: 1. During the entrance tour on 9/8 /2021 at approximately 10:30-11:00 AM, the Laboratory Manager listed the Triage Meter as a new instrument; D-Dimer (a moderate-complexity Hematology test) was performed on the Triage Meter. The surveyor asked how often the laboratory performed D-Dimer QC; the Manager stated QC was performed every thirty days and with each new lot numbers of cartridges, as per manufacturer's instructions. When asked if the laboratory had implemented an IQCP to allow for decreased frequency of QC testing, the Manager stated the Triage technician had not told her about this requirement. 2. A review of the validation study for the Triage D-Dimer revealed the -- 2 of 5 -- Laboratory Director approved the test on 2/1/2021; at approximately 3:20 PM on 9/8 /2021 the Laboratory Manager confirmed patient testing began on the same date (2/1 /2021). 3. A review of the Triage D-Dimer records revealed the laboratory performed QC on 1/29, 3/2, 4/13, 5/23, 5/26, 6/24, 7/26, and 8/23/2021. During the exit summation on 9/9/2021 from 2:25 to 2:45 PM, the Laboratory Manager confirmed patient D-Dimers were run on other days when QC was not performed, and the laboratory had not implemented an IQCP. . D6053 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on reviews of personnel files and interviews with Testing Personnel #3 (the Respiratory Therapy [RT] Supervisor) and the Laboratory Manager / Technical Consultant, the Technical Consultant failed to perform and document the semi-annual competency evaluation due mid-2019 for one of one new Testing Personnel (TP) who had performed patient Arterial Blood Gas (ABG) testing. [Not performing and documenting competency assessments on Testing Personnel performing ABG's is a repeat deficiency.] The findings include: 1. A review of the Form CMS-209 (Laboratory Personnel Report) revealed one new moderate-complexity TP who only performed ABG testing; TP #8 was hired and trained in February 2019. 2. A review of the personnel file for TP #8 revealed the GEM Premier 3500 training, dated 4/29 /2021, and the 2/14/2019 training on the Gem 3000 ABG analyzer in use when he was hired. There was no documentation of a semi-annual competency assessment due around August 2019. 3. During an interview on 9/8/2021 at 4:20 PM, the surveyor requested the competency evaluations for the testing personnel who performed ABG's. TP #3 (the RT Supervisor) stated they only did "competencies" when they trained the staff. 4. During the Day 2 entrance interview on 9/9/2021 at 9:40 AM the surveyor discussed concerns related to competency assessments for the RT testing personnel. The surveyor asked the Laboratory Manager / Technical Consultant (TC) if she was aware that in the

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)