Grant Memorial Hospital

Summary Statement of Deficiencies D0000 An offsite proficiency testing (PT) desk review was conducted for Grant Memorial Hospital on December 4, 2025, by the West Virginia Office of Laboratory Services. The laboratory PT evaluations were reviewed for successful participation and compliance with the CLIA regulations under 42 CFR 493, Requirements for Laboratories. The identified unsuccessful participation in PT is an initial occurrence and 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 CASPER 155D proficiency testing (PT) report and laboratory PT evaluations from the American Proficiency Institute (API), the laboratory failed to 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 -- perform successfully in two of three consecutive testing events in 2025 for the analyte #0295 AST (SGOT), resulting in an initial occurence of unsuccessful participation. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (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 CASPER 155D proficiency testing (PT) report and laboratory evaluation reports from the American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance for the analyte #0295 AST(SGOT) in two of three consecutive testing events in 2025, resulting in an initial occurrence of unsuccessful participation in PT. Findings: 1. Review of CASPER 155D PT individual laboratory report revealed the following unsatisfactory scores for analyte #0295 AST(SGOT): 40% 2025 event 1 20% 2025 event 3 2. Review of 2025 API Chemistry evaluations for testing events 1 and 3, confirmed the unsatisfactory performance for the analyte #0295 AST(SGOT) in two of three consecutive testing events and the resulting occurrence of unsuccessful participation. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A routine recertification survey was completed at Grant Memorial Hospital on July 30, 2025, by the West Virginia Office of Laboratory Services. The laboratory was assessed for compliance with the CLIA regulations under 42 CFR 493, Requirements for Laboratories. Specific deficiencies cited are explained below. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of three analyzer verification records, lack of documentation, and interview with the technical supervisor (TS), the laboratory failed to (b)(1)(ii) verify the appropriateness of reference intervals (RI) for the laboratory population during the verification of the Sysmex XN-450, Sysmex XN-550, and Alinity i analyzers in 2024 and 2025. Findings: 1. Review of the hematology Sysmex XN-450 analyzer verification records (go live 9/24/2024) revealed no documentation that published or laboratory established RI for the complete blood count with differential (CBC/DIFF) parameters had been evaluated for suitability to the laboratory population. 2. Review of the hematology Sysmex XN-550 analyzer verification records (go live 9/24/2024) revealed no documentation that published or laboratory established RI for the CBC /DIFF parameters had been evaluated for suitability to the laboratory population. 3. Review of the chemistry Abbott Alinity i analyzer verification records (go live 7/22 /2025) revealed no documentation that published or laboratory established RI for 12 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 -- of 12 analytes had been evaluated for suitability to the laboratory population. 4. During an interview, 7/29/25 at 11:15 AM, the TS stated no documentation could be located for the verification of the RI for the two Sysmex analyzers put into use in September 2024. 5. During an interview, 7/30/25 at 10:19 AM, the TS stated no documentation could be located for the verification of the RI for analytes on the Alinity i analyzer put into use in July 2025. 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. This STANDARD is not met as evidenced by: Based on review of manufacturer instructions, microbiology policies and procedures, quality assurance (QA) records, lack of documentation, and an interview with the technical supervisor (TS), the laboratory failed to (b) establish the number, type, and frequency of external quality control testing for the moderate complexity BioFire Respiratory Panel (RP 2.1) and the high complexity MicroScan Gram Positive Panel (PM38). Findings: A. 1. The manufacturer instructions for the BioFire RP 2.1 directs users to perform external quality controls in accordance with the laboratory's protocol and any accreditation requirements. 2. The "Biofire Panels Quality Assessment and Quality Control Plan" microbiology policy directs personnel to perform two levels of external QC (positive and negative) when a new test kit is opened, when new personnel are trained, laboratory temperatures fall outside of established ranges, or if a patient results are questionable. 3. Review of QA records identified current, approved Individual Quality Control Plan (IQCP) for the BioFire blood culture identification and gastrointestinal panels. No IQCP or policy validating external QC performance that is less stringent than the regulatory requirements for the RP 2.1 panel could be located. B. 4. Review of QA records identified documentation that the MicroScan PM38 panel was validated and put into use 2/19/2025. 5. Review of microbiology policies and procedures identified the MicroScan Positive panel PM38 manufacturer instructions as the procedure for performing patient testing, stating that external quality control (QC) should be performed per the laboratory's established policy. 6. No IQCP or policy establishing the laboratory's performance of external QC (number, type, and frequency requirements) for the PM38 could be located. 7. During an interview, 7/29/25 at 3:30 PM, the TS agreed that no IQCP, plan, or policy establishing the number, type, and frequency of external QC for the BioFire RP2.1 and MicroScan PM38 panels could be located. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e)(4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for -- 2 of 4 -- its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. This STANDARD is not met as evidenced by: Based on a tour of the laboratory, review of microbiology media quality control (QC) records, lack of documentation, and an interview with the technical supervisor (TS), the laboratory failed to document the performance of sterility checks and the ability to support growth for one of one batch of Cary Blair media in 2025. Findings: 1. During a tour of the laboratory, 7/29/25 at approximately 4:00 PM, the surveyor identified lot number 263564 (expiry 10/19/26) of Cary Blair transport media in use for testing stool specimens with the Biofire FilmArray Torch Gastrointestinal (GI) panel. 2. Review of microbiology media QC records (January 2024 thru date of survey) revealed no documentation of sterility checks or the ability of the Cary Blair media (lot #263564) to support growth. 3. During an interview with the TS, 7/29/25 at approximately 4:00 PM, the TS agreed no QC for the lot of Cary Blair media currently in use could be located. D5543 HEMATOLOGY CFR(s): 493.1269(a)(d) (a) For manual cell counts performed using a hemocytometer-- (a)(1) One control material must be tested each 8 hours of operation; and (a)(2) Patient specimens and control materials must be tested in duplicate. This STANDARD is not met as evidenced by: Based on review of quality control (QC) log sheets for manual fluid cell counts, lack of documentation, and interview with the technical supervisor (TS), the laboratory failed to (a)(2) perform and document the duplicate testing of external quality control (QC) for two of 9 manual fluid cell counts performed from January 2025 thru date of survey (DOS). This is a repeat deficiency. Findings: 1. Review of "Log Sheets for Cell Counts" (January 2025 thru DOS) identified 9 manual fluid cell counts performed in the time period reviewed. 2. Review of QC documentation for the manual fluid cell counts revealed no documentation of the QC performed in duplicate for two of the nine fluid specimens (E929602 and E2706211). 3. During an interview with the TS, 7/30/25 at 7:30 AM, the TS agreed the QC had not been documented as performed in duplicate for two of the nine fluid specimens. 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 review of policies and procedures, Sysmex hematology analyzer verification records, EPIC laboratory information system (LIS) patient reports, and interview with the technical supervisor (TS), the laboratory failed to ensure accurate reference -- 3 of 4 -- intervals (RI) are provided to clients for all 27 parameters in a complete blood count with differential (CBC/DIFF). Findings: 1. Review of the hematology "Sysmex 550" and "Sysmex 450" procedures identified stated reference intervals in "X. Reporting Results" for 27 of 27 parameters tested and stated reference intervals in "XVI. Appendix A Reference Ranges" for 23 of 27 parameters tested with a CBC/DIFF. 2. Review of the Sysmex XN-450 and Sysmex XN-550 analyzer verification records (go live 9/24/2024) revealed no documentation of the verification of the appropriateness, for the laboratory population, of the 27 reference intervals tested with a CBC/DIFF. Refer to D5421. 3. Review of four EPIC patient CBC/DIFF reports ( E4217336, E516887, E2161184, E4208859) from the Sysmex XN-550 identified 4 parameters lacking a stated reference interval: Neutrophil %, Lymphocyte %, Monocyte %, Eosinophil % 4. Review of EPIC patient CBC/DIFF report (E2161184, 11 yo male) identified a reference interval of 10.7-20.0 g/dL for Hemoglobin (HGB). Review of the "Sysmex 550" procedure stated reference intervals (RI) identified a RI of 10.7- 13.4 g/dL for HGB on an 11 yo male. 5. During an interview 7/29/25 at 12:10 PM, the TS agreed the 4 CBC/DIFF parameters lacked a stated reference interval on the final report and stated the EPIC reference interval for HGB on an 11 yo male was discrepant from the procedure. -- 4 of 4 --

Summary Statement of Deficiencies D0000 An announced, on site, routine recertification survey was performed at Grant Memorial Hospital on June 27 and 28, 2023, by the West Virginia Office of Laboratory Services. The laboratory was assessed for compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. Specific deficiencies cited are explained below. D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to perform and document the biannual accuracy evaluation for testing procedures not included in Subpart I for 2022 and 2023. Findings: 1. Review of proficiency testing (PT) records (January 22 thru date of survey) revealed no commercial enrollment for semen analysis and the GI panel and Blood Culture panel testing on the Biofire Torch test system. 2. No documentation of alternate testing to maintain the accuracy of semen analysis and the GI panel and Blood Culture panel testing on the Biofire could be located. 3. An interview with the general supervisor, on 6/27/23 at approximately 9:30 AM, confirmed the lack of enrollment and/or biannual verification of accuracy for semen analysis and the GI panel and Blood Culture panel testing on the Biofire Torch. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to test proficiency testing (PT) specimens only the same number of times as patient samples are tested for all three specimens in the CM-A 1st testing event 2023. Findings: 1. Review of PT records revealed two analyzer printouts for each PT specimen (CM-01, CM-02, and CM-03) from the 1st event of 2023. Documentation on the printouts by the testing personnel state "these samples were ran 5 minutes apart w/ slight variations in results." 2. An interview with testing personnel 1 (TP1), on 6/27/23 at approximately 10:30 AM, established that patient specimens are only tested one time for a routine urinalysis. 3. An interview with the general supervisor (GS), on 6/27/23 at approximately 10:35 AM, confirmed the PT specimens had been analyzed twice and that the standard practice for the laboratory was to perform one urinalysis per patient specimen. 4. An exit interview with the GS, TP1, and laboratory administration, 6/28 /23 at approximately 3:30, confirmed the findings. D2025 BACTERIOLOGY CFR(s): 493.823(c) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to return proficiency testing (PT) results within the required timeframe for the 1st Bacteriology testing event of 2023. Findings: 1. Review of American Proficiency Institute (API) PT evaluations revealed a score of 0% failure to participate for the 1st event of 2023 in Bacteriology. 2. Review of the laboratory self evaluation identified a failure to submit the PT results for the 1st event within the timeframe required. 3. An interview with the general supervisor, 6/27/23 at approximately 9:00 AM, confirmed the findings. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of written policies and procedures (P&P), quality control (QC) records, calibration records, patient test records, observation, and interview the laboratory failed to ensure the overall quality of the analytic systems and correct identified problems. Findings: 1. P&P lacked required elements. See D5403 2. Results released outside established performance specifications. See D5411. 3. No process to track and ensure quality of reagents and control materials. See D5417. 4. No calibration verification of the chemistry analytes on the Alinity analyzer. See D5439. -- 2 of 6 -- 5. No external QC performed for manual cell counts and semen analysis. See D5543. 6. No documented alarm checks for the storage of blood and blood products. See D5555. 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 announced, on site, recertification survey was conducted at Grant Memorial Hospital Laboratory on July 14, 2021, by the West Virginia Office of Laboratory Services. The laboratory was surveyed to assess compliance with the Federal Clinical Laboratory Improvement Amendment (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 score for the analyte Uric Acid in the American Proficiency Institute (API) 2021 1st proficiency testing (PT) event. Findings: 1. Review of API records identified an unsatisfactory score of 60% for the analyte #0515 Uric Acid for the 2021 1st testing event. 2. An interview with the general supervisor, 7/13/21 at approximately 9:30 AM, confirmed the findings. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. 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 -- This STANDARD is not met as evidenced by: Based on a tour of the laboratory and interview the laboratory failed to document expiration dates on quality control materials. Findings: 1. A tour of the Hematology department, 7/14/21 at approximately 10:00 AM, revealed no expiration date on 3 levels of Hematology quality control (QC) that is currently in use. The manufacturer instructions state opened QC vials are stable for 8 days. 2. A tour of the Chemistry department, 7/14/21 at approximately 9:40 AM, revealed 2 levels of Lipase calibrator (lot in use) that had no open or expiration date. The manufacturer instructions state reconstituted lipase calibrator is stable for 60 days at 2-8 C. 3. An interview with the technical supervisor, 7/14/21 at approximately 10:00 AM, confirmed the findings. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to perform and document all of the laboratory established maintenance protocol for 12 of 13 analyzers and ancillary equipment in the laboratory. Findings: 1. Review of monthly maintenance sheets for January 2021 thru June 2021 identified the following: Plasma Thawer Water Bath (serial #14035) 1/21 could not be located 2/21 no temperatures documented for 28 of 28 days, no weekly or monthly maintenance 3/21 no temperatures for 31 of 31 days, no weekly or monthly maintenance 4/21 no temperatures for 30 of 30 days, no weekly or monthly maintenance 5/21 no temperatures for 31 of 31 days, weekly documented 1 time, no monthly 6/21 no temperatures for 30 of 30 days, no weekly or monthly maintenance Platelet Rocker (serial #201608B) 1/21 could not be located 2/21 no temperatures for 28 of 28 days 3 /21 no temperatures for 31 of 31 days 4/21 no temperatures for 28 of 30 days 5/21 no temperatures for 31 of 31 days 6/21 no temperatures for 30 of 30 days Hematology Fridge (0908051) 1/21 no temperatures for 14 of 31 days, no monthly maintenance 3 /21 no monthly maintenance 4/21 no monthly maintenance Sorvall Cell Washer (9906106) 1/21 no weekly maintenance documented 2/21 no weekly maintenance documented 3/21 no weekly maintenance documented 4/21 no weekly maintenance documented 5/21 no weekly maintenance documented 6/21 no weekly maintenance documented Phlebotomy Fridge (model LR454A) 1/21 no monthly maintenance 3/21 no monthly maintenance Plasma Freezer (serial #XA107870) 1/21 no weekly or monthly maintenance 2/21 no monthly maintenance 3/21 no monthly maintenance 4 /21 no weekly or monthly maintenance 6/21 no monthly maintenance Allegra X-30 Centrifuge 1/21 no weekly maintenance 3/21 no weekly maintenance 4/21 weekly maintenance documented 3 times 5/21 weekly maintenance documented 1 time 6/21 no weekly maintenance documented Allegra X-22 Centrifuge 1/21 no weekly maintenance 2/21 no weekly maintenance Cell-Dyn Ruby 1/21 no weekly or monthly maintenance 2/21 weekly maintenance documented 1 time 3/21 weekly maintenance documented 2 times 5/21 weekly maintenance documented 1 time 6/21 weekly maintenance documented 1 time Access 2 (serial #572762) 1/21 daily documented 26 -- 2 of 5 -- of 31 days AU480 2/21 weekly maintenance documented 1 time, no monthly maintenance 4/21 weekly maintenance documented 3 times, no monthly 5/21 no monthly maintenance documented 6/21 weekly maintenance documented 2 times AU480 ISE 1/21 every other week maintenance documented 1 time 2/21 every other week maintenance documented 1 time, weekly documented 2 times 3/21 no weekly maintenance documented, no 3 month maintenance documented 6/21 weekly maintenance documented 1 time, every other week maintenance documented 1 time 2. An interview with the general supervisor, 7/13/21 at approximately 3:30 PM, confirmed the findings. 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 record review and interview the laboratory failed to ensure that (c) platelets and plasma thawing water bath temperatures were monitored. Findings: 1. Review of "Transfusion Log for Blood & Blood Products" from January 2020 thru July 13, 2021, identified 4 dates platelets were issued from the laboratory: 5/14/21,4/13/21, 4/14/21, and 3/1/21. 2. Review of Platelet Rocker monthly maintenance logs (January 2021 thru June 2021) revealed no room temperature recorded for 2 of 4 days platelets were issued; 3/1/21 and 5/14/21. 3. Review of "Transfusion Log for Blood & Blood Products" from January 2020 thru July 13, 2021 identified 1 date fresh frozen plasma (FFP) was issued from the laboratory: 1/14/21. 4. Review of the plasma thawing water bath maintenance logs (January 2021 thru June 2021) revealed that the log for January 2021 could not be located. 5. Interview with the general supervisor, on 7/14/21 at approximately 8:00 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) document Immunohematology quality control (QC) for 2 of 194 days of patient testing in 2021. -- 3 of 5 -- Findings: 1. Review of QC (1/1/21 thru 7/13/21) for Immunohematology revealed 2 days of patient testing that no QC was documented- 3/21/21 and 2/21/21. 2. Review of the Immunohematology testing log revealed the following: 3/20/21- 1 patient had 2 units crossmatched, 1 patient had a type and screen, 1 patient had 2 units crossmatched 2/21/21- 1 patient had a type and screen, 1 patient had a type/Rh 3. An interview with the general supervisor, 7/14/21 at approximately 8:00 AM, confirmed the findings. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to monitor and correct problems regarding the lack of documentation for maintenance, temperature logs, and specimen storage conditions as a part of the analytic systems quality assessment. Findings: 1. Review of maintenance logs identified 12 of 13 laboratory analyzers and ancillary equipment with incomplete documentation. Refer to D5433. 2. A tour of the laboratory identified quality control materials without an opened expiration date. Refer to D5415. 3. Review of Immunohematology quality control (QC) records identified 2 days no daily QC was documented. Refer to D5559. 4. Review of the Immunohematology log book identified 3 days platelets or fresh frozen plasma was issued to patients with no documentation of storage conditions. Refer to D5555. 5. An exit interview with the general supervisor, 7/14/21 at approximately 12:00 PM, confirmed the findings. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) The laboratory director must ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. This STANDARD is not met as evidenced by: Based on record review and interviews the laboratory director failed to ensure the overall quality of the laboratory's analytic test systems. Findings: 1. A tour of the laboratory identified quality control materials with no opened expiration date. Refer to D5415. 2. A review of maintenance records identified a lack of documentation. Refer to D5433. 3. A review of the Immunohematology patient log identified 3 days temperatures were not documented and blood products issued from the laboratory. Refer to D5555. 4. A review of Immunohematology quality control (QC) records identified 2 days of patient testing that no QC was documented. Refer to D5559. 5. A review of analytic systems quality assurance identified no

Summary Statement of Deficiencies D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on Proficiency Testing (PT) record review and interview with Testing Personnel 1 (TP1), the laboratory failed to verify accuracy 2 times a year for tests that are not included in Subpart I. Findings: 1. A review of PT records from 2018 and 2019 established that the laboratory had not performed commercial PT, or utilized other methods, to verify accuracy on Direct Antiglobulin Testing (DAT) in immunohematology. 2. An interview with TP1, on 07/15/19 at approximately 1135 AM, confirmed that no verification of DAT testing to establish and maintain accuracy had occurred. 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 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 -- 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 Quality Control (QC) records, calibration records, and an interview with Testing Personnel 1 (TP1) the laboratory failed to perform and document calibration verification of Chemistry analytes twice a year. Findings: 1. A review of 2018 and 2019 QC and calibration records established that no documentation of the calibration verification of Chemistry analytes occurred twice a year. 2. A review of 2018 and 2019 QC records demonstrated that Chemistry QC was being performed twice a day with 2 levels of QC material, BioRad MultiQual Levels 1 and 2 for general chemistry analytes. 2. An interview with TP1, 7/16/19 at approximately 800 AM, confirmed that no performance of calibration verification occurred twice a year in chemistry. 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 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 upon a review of Quality Control (QC) records, written laboratory policies and procedures, and an interview with Testing Personnel 2 (TP2) the laboratory failed to follow the written QC procedures for API 20A, HNID, and GP ID test systems. Findings: 1. The written QC procedure for the API 20A states that "both Clostridium perfringens ATCC 13124 and Clostridium histolyticum ATCC 19401 are to be ran with the arrival of each new lot. One of these organisms is to be ran weekly if the lot has been previously QC'd." a. QC (both organisms) was ran for each new lot 6/24/19, 3/14/19, 7/6/18, 4/21/18, and 11/25/17. b. No documentation of weekly QC being performed could be located. c. An interview with TP2, 7/16/19 at approximately 918 AM, confirmed that QC was not being performed on a weekly basis. 2. The written QC procedure for the HNID system states "all 5 organisms are to be ran with the arrival of each new lot. One of these organisms is to be ran weekly if the lot has been previously QC'd." a. QC (all 5 organisms) was ran for each new lot 4/1/19, 4/12/18, and 11/22/17. b. No documentation of weekly QC being performed could be located. c. An interview with TP2, 7/16/19 at approximately 923 AM, confirmed that QC was not being performed on a weekly basis. 3. The written procedure for the GP ID test -- 2 of 3 -- system states that all 5 organisms are to be ran with each new lot opened and one organism is to be ran as QC weekly for the life of the lot. a. QC (all 5 organisms) were ran 7/3/19, 3/20/19, and 1/30/19. b. No documentation of weekly QC being performed could be located. c. An interview with TP2, 7/16/19 at approximately 943 AM, confirmed that QC was not being performed on a weekly basis. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on a review of laboratory records and an interview with Testing Personnel 1 (TP1), the laboratory failed to ensure that calculated results from Chemistry Tests were accurate and reliable. Findings: 1. A review of laboratory documents established that no manual verification of calculated Chemistry test results could be located. 2. An interview with TP1, 7/16/19 at approximately 810 AM, confirmed that no electronic Laboratory Information System calculations are verified for accuracy and reliability. -- 3 of 3 --