Grafton City Hospital

Summary Statement of Deficiencies D0000 A routine recertification survey was conducted at Grafton City Hospital on January 9- 10, 2024, by the West Virginia Office of Laboratory Services. The laboratory was assessed for compliance with the Federal Clinical Laboratory Improvement Amendments (CLIA) regulations under 42 CFR 493. Specific deficiencies cited are explained below. 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)

Summary Statement of Deficiencies D0000 An unannounced, off site, proficiency testing (PT) desk review was conducted for Grafton City Hospital on July 25, 2022, by the West Virginia Office of Laboratory Services. The laboratory PT evaluations from American Proficiency Institute (API) were reviewed for compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. Specific deficiencies are explained below. 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 review of American Proficiency Institute (API) proficency testing (PT) evaluations and the CLIA 155D report for Grafton City Hospital, the laboratory failed 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 -- to successfully participate in a program approved by CMS for the analyte #0325 PO2 Blood Gas for two of 3 consecutive PT events. Findings: 1. PO2 Blood Gas (#0325) 3rd Event 2021- 60% 2nd Event 2022- 0% 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 review of the CLIA 155D report and the failures summary report from the American Proficiency Institute (API) proficiency testing (PT) evaluations, the laboratory failed to achieve satisfactory performance for the analyte PO2 Blood Gas (#0325) in two of three consecutive PT events. Findings: 1. Review of 155D revealed the following unsatisfactory scores for PO2 Blood Gas (#0325): 3rd event 2021- 60% 2nd event 2022- 0% 2. Review of API failures summary report confirmed the unsuccesful performance and unsatisfactory analyte scores for PO2 Blood Gas (#0325). D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(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, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, 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 record review, the laboratory director failed to assure compliance with the the regulation requiring successful participation in proficiency testing (PT) for the analyte PO2 Blood Gas (#0325) in two of three consecutive PT events. Findings: 1. Refer to D2000 2. Refer to D2096 -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced, on site, recertification survey was conducted at Grafton City Hospital on November 30 and December 1, 2021, by the West Virginia Office of Laboratory Services. The laboratory was surveyed to assess compliance with the Federal Clinical Laboratory Improvement Amendments (CLIA) regulations under 42 CFR 493. Specific deficiencies are explained below. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to achieve a satisfactory performance score for the analytes PO2 and Total Bilirubin in one of three proficiency testing (PT) events in 2021. Findings: 1. Review of America Proficiency Institute (API) PT records revealed the following unsatisfactory scores for the Chemistry Core 3rd event 2021: PO2= 60% Total Bilirubin= 60% 2. An interview with the general supervisor, 11/30/21 at approximately 11:30 AM, confirmed the unsatisfactory analyte performance for PO2 and Total Bilirubin. 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. 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: Based on record review and interview the laboratory failed to (c) maintain the required storage temperature of red blood cell products for 65 of 164 hours during temporary storage. Findings: 1. Review of P&P identified a required storage temperature of 2-6 degrees Celsius for red blood cell products. 2. Review of the Emergency Blood Bank Temperature log for incident I22-2021 (4/30/21 at 1600 thru 5 /7/21 at 1200) identified storage temperatures taken for the temporary storage of packed red blood cells and reagents documented at hour intervals. 3. Review of the temperatures documented identified out of range temperatures (greater than 6 degrees Celsius) for 65 of the 164 hours that the storage temperature was monitored (4/30/21 at 1600 thru 5/3/21 at 0800). 4. Review of the blood product tracking logs identified 19 units of packed red blood cells that were potentially affected by the out of range storage temperatures. 5. An interview with the general supervisor. 12/1/21 at approximately 11:30 AM, confirmed the findings. D5559 IMMUNOHEMATOLOGY CFR(s): 493.1271(e)(f) (e) Investigation of transfusion reactions. (e)(1) According to its established procedures, the laboratory that performs compatibility testing, or issues blood or blood products, must promptly investigate all transfusion reactions occurring in facilities for which it has investigational responsibility and make recommendations to the medical staff regarding improvements in transfusion procedures. (e)(2) The laboratory must document, as applicable, that all necessary remedial actions are taken to prevent recurrences of transfusion reactions and that all policies and procedures are reviewed to assure they are adequate to ensure the safety of individuals being transfused. (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 record review and interview, the laboratory failed to (f) perform and document quality control (QC) for Immunohematology for 4 of 93 days of patient testing. Findings: 1. Review of the Transfusion Service Testing Record (1/1/21 thru date of survey) identified 93 days of patient testing. 2. Review of QC records (1/01/21 thru date of survey) identified 4 days of patient testing that no Immunohematology QC was documented as performed. 3. An interview with the general supervisor, 12/1 /21 at approximately 9:15 AM, confirmed the findings. D5785

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the laboratory American Proficiency Institute (API) proficiency testing (PT) records and an interview with Technical Supervisor 1 (TS1), the laboratory failed to attain a score of at least 80 percent for the analyte Ammonia in the 1st Chemistry Miscellaneous 2019 testing event. Findings: 1. A review of PT records identified an unsatisfactory performance of 67 percent for the analyte Ammonia in the Chemistry Miscellaneous 2019 1st testing event. 2. An interview with TS1, on 9/11 /19 at approximately 10:00 AM, confirmed the findings. 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 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 -- 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 laboratory Quality Control (QC) records, calibration records, and an interview with Technical Supervisor 1 (TS1), the laboratory failed to perform and document calibration verification for the Sodium, Potassium, and Chloride analytes in chemistry testing. Findings: 1. A review of QC and calibration records from 2018 and 2019 established that no calibration verification of Sodium, Potassium, and Chloride analytes had been performed and documented on the Vitros 350 chemistry analyzer. 2. A review of QC records identified the laboratory ran 2 levels of Quality Control materials once each day of testing on the Vitros 350 chemistry analyzer. 3. An interview with TS1, on 9/12/19 at approximately 10:25 AM, confirmed that the laboratory had not performed or documented calibration verification for the Sodium, Potassium, and Chloride analyte testing on the Vitros 350. 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 a review of Quality Control (QC) records, laboratory written policies and procedures, and an interview with Technical Supervisor 1 (TS1), the laboratory failed to perform and document an external negative and positive control for the MedTox urine drug screen test kit daily. Findings: 1. Review of the laboratory QC records identified MedTox external negative and positive controls were ran 1/6/19, 1/13/19, 1 /20/19, 1/27/19, 2/3/19, 2/10/19, 2/17/19, 2/24/19, 3/3/19, 3/10/19, 3/17/19, 3/19/19, 3 /24/19, 3/31/19, 4/7/19, 4/14/19, 4/21/19, 4/28/19, 5/5/19, 5/12/19,5/19/19, 5/20/19, 5 /26/19, 6/2/19, 6/9/19, 6/16/19, 6/23/19, 6/30/19, 7/5/19, 7/7/19, 7/14/19, 7/21/19, and 7/28/19. Patient MedTox urine drug testing was performed on a routine/daily basis, with approximately 300 MedTox urine drug screen tests on patients from 1/1/19 to 8/1 /19. 2. The written policy/procedure for the MedTox urine drug screen test kit states "2 levels of external QC will be ran daily" and with any new lot or new shipment. 3. No IQCP could be located for the MedTox urine drug screen test. 4. An interview with TS1, on 9/12/19 at approximately 10:45 AM, confirmed that MedTox urine drug screen testing is performed on patients daily, that external negative and positive controls are ran on the MedTox urine drug screen test kit weekly and with each new lot/shipment, and that no IQCP for the MedTox urine drug screen could be located. -- 2 of 2 --

Summary Statement of Deficiencies No Tags No deficiency details available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --