Broaddus Hospital

Summary Statement of Deficiencies D0000 A routine recertification survey was conducted at Broaddus Hospital on April 1 and April 2, 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. 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 laboratory personnel records, lack of documentation, interview with the technical supervisor (TS), and interview with the laboratory director (LD), the laboratory failed to document the competency of 9 of 9 testing personnel (TP) for the performance of a white blood cell count with manual differential in 2023 and 2024. Findings: 1. Review of 2023 and 2024 hematology TP competency assessment records revealed no documented competency for the performance of a white blood cell count with manual differential for 9 of 9 TP in hematology. 2. During an interview with the TS, 4/1/25 at 9:00 AM, the TS agreed that no documented competency assessment for the performance of a white blood cell count with manual differential could be located for the TP. 3. An exit interview with the LD, 4/2/25 at 4: 00 PM, confirmed the findings. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H 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 5 -- This STANDARD is not met as evidenced by: Based on a review of American Proficiency Institute (API) proficiency testing (PT) records, lack of documentation, an interview with the technical supervisor (TS), and an interview with the laboratory director (LD), the laboratory failed to document the evaluation of ungraded results received from API in 3 of 3 Hematology events and 3 of 3 Microbiology events of 2024. Findings: 1. Review of API 2024 PT records for the three Hematology events revealed no evaluation of the educational RBC Morphology (DIF-01, DIF-02, DIF-03) results in the three events. 2. Review of API 2024 PT records for Microbiology revealed no evaluation of the ungraded results for Educational Susceptibility (Events 1,2, and 3), Blood Culture Susceptibility Interpretation (Event 2), and Gram Stain results (Events 1,2, and 3). 3. During an interview with the TS, 4/1/25 at 10:00 AM, the TS agreed that no documented evaluation could be located for the ungraded results received from API. 4. An exit interview with the LD, 4/2/25 at 4:00 PM, 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 surveyor review of laboratory quality control (QC) and calibration records, laboratory analyzer records, final patient reports, reagent verification documents, direct observation in the laboratory, and staff interviews, the laboratory failed to ensure quality control materials were not used after the expiration date in Chemistry (refer to D5417); failed to document verification of PT and APTT reference intervals (refer to D5421); failed to perform and document the calibration of pipettes used to prepare reagents and perform patient testing in Chemistry and Immunohematology (refer to D5433); and failed to ensure patient results were not released until quality control was acceptable (refer to D5481). 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 direct observation, review of Abbott Alinity ci chemistry analyzer records, interview with the technical supervisor (TS), and interview with the laboratory director (LD), the laboratory failed to ensure that external quality control (QC) and calibration materials were not used beyond the expiration date established by the manufacturer for 11 of 15 vials in use. Findings: 1. During a tour of the Chemistry -- 2 of 5 -- laboratory, 4/2/25 at 8:00 AM, the state surveyor examined the chemistry QC and calibration materials currently in use from the refrigerator and identified 15 opened vials that had the date opened on the container. None of the vials had a labeled expiration date. The TS stated there was a reference chart attached to the chemistry Alinity ci analyzer that states how many days opened QC and calibration materials have before they are expired. Comparison between the opened QC and calibration materials and the reference chart identified that 11 of 15 vials of QC materials were expired. 1. Bilirubin Calibrator (65189FD01A) opened 2/22/25, stable for 7 days 2. Bilirubin Calibrator (65189FD01B) opened 2/22/25, stable for 7 days 3. CO2 Calibrator (72065FD01A) opened 3/1/25, stable for 30 days 4. CO2 Calibrator (72065FD01B) opened 3/1/25, stable for 30 days 5. Immunoassay Plus QC (10501T) opened 3/16/25, stable for 10 days 6. Immunoassay QC (64990T) opened 3/21/25, stable for 10 days 7. Immunoassay QC ( 64991T) opened 3/21/25, stable for 10 days 8. Immunology QC (85753T) opened 3/16/25, stable for 10 days 9. Immunology QC (85751T) opened 3/16/25, stable for 10 days 10. Multiqual QC (45971T) opened 3/20 /25, stable for 2 days 11. Multiqual QC (45973T) opened 3/20/25, stable for 2 days 2. Review of daily QC and calibration records on the Abbott Alinity ci chemistry analyzer revealed daily QC and routine calibrations were performed using expired materials and accepted for patient testing purposes in March and April 2025. Refer to D5481. 3. During an interview with the TS, 4/2/25 at 8:45 AM, the TS confirmed that expired QC and calibration materials had been used and stated that patient chemistry results had been released. 4. An exit interview with the LD, 4/2/25 at 4:00 PM, confirmed the findings. 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 a review of the Sysmex CA-660 coagulation analyzer quality control (QC) records, reagent verification records, lack of documentation, and interview with the technical supervisor (TS), and an interview with the laboratory director (LD), the laboratory failed to document the (b)(1)(ii)verification of the reference interval/range for one of one new lot of Innovin PT and one of one new lot of Actin APTT reagents in 2025. Findings: 1. Review of coagulation QC records (March 2025) for coagulation testing identified Innovin lot 564667A (expiry 8/1/27) for PT testing and Actin lot 575016A (expiry 10/14/26) for APTT testing currently in use on the Sysmex CA-660 analyzer 2. Review of the performance specification verification records (January 2025) for the current Innovin (lot 564667A) and Actin (lot 575016A) reagents revealed no verification documentation for the appropriateness of the reference intervals for the laboratory's patient population. 3. During an interview with the technical supervisor (TS), 4/2/25 at 9:00 AM, the TS agreed that no verification documentation for the reference intervals used in PT and APTT testing could be located. 4. An exit interview with the LD, 4/2/25 at 4:00 PM, confirmed the findings. -- 3 of 5 -- D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) (b)(1)(i) 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. (b)(1)(ii) 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 direct observation, interview with the technical supervisor (TS), and interview with the laboratory director (LD), the laboratory failed to ensure the established maintenance protocol for calibration of equipment was followed for 17 of 17 pipettes in use Findings: 1. A tour of the laboratory, 4/1/25 at 11:00 AM, identified 17 pipettes in use in the chemistry and Immunohematology departments (12 fixed volume MLA, 4 adjustable volume MLA, 1 ID Tipmaster). 15 of 17 pipettes had a label attached stating "last calibration 4/28/24, calibration due 10/28/24", one had a label attached stating "last calibrated 5/1/24, calibration due 11/1/24", and the ID Tipmaster pipette had no label. 2. During an interview with the TS, 4/1/25 at 11:30 AM, the TS stated that no documentation of current pipette calibrations could be located. 3. An exit interview with the LD, 4/2/25 at 4:00 PM, confirmed the findings. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratorys and, as applicable, the 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: Based on direct observation, review of Abbott Alinity chemistry analyzer quality control (QC) and calibration records, interview with the technical supervisor (TS) and interview with the laboratory director (LD), the laboratory failed to ensure the quality control material evaluated in Chemistry did not exceed the acceptability criteria (expiration date) before releasing patient results in March and April 2025. Findings: 1. A tour of the chemistry laboratory, 4/2/25 at 8:00 AM, identified 11 expired quality control and calibration materials in use. Refer to D5417. 2. Review of March and April 2025 daily QC and calibration records on the Abbott Alinity ci analyzer revealed the following daily QC and routine calibrations performed using expired materials and accepted for patient testing: 1.Bilirubin Calibrator (65189FD01A, 65189FD01B) opened 2/22/25, expired 3/1/25, calibrations accepted on 3/2/25, 3/9 /25, 3/10/25, 3/24/25, and 3/25/25 2. CO2 Calibrator (72065FD01A, 72065FD01B) opened 3/1/25, expired 4/1/25, calibration accepted on 3/28/25 3. Immunoassay Plus QC (10501T) opened 3/16/25, expired 3/26/25, accepted on 3/27/25, 3/28/25, 3/29/25, 3/30/25, 3/31/25, 4/1/25 4. Immunoassay QC (64990T, 64991T) opened 3/21/25, expired 3/31/25, accepted on 4/1/25 5. Immunology QC (85753T, 85751T) opened 3 /16/25, expired 3/26/25, accepted on 3/27/25, 3/28/25, 3/29/25, 3/30/25, 3/31/25, 4/1 /25 6. Multiqual QC (45971T, 45973T) opened 3/20/25, expired 3/22/25, accepted on 3/23/25, 3/24/25, 3/25/25, 3/26/25, 3/27/25, 3/28/25, 3/29/25, 3/30/25, 3/31/25, 4/1/25 3. During an interview with the TS, 4/2/25 at 8:45 AM, the TS confirmed that expired -- 4 of 5 -- QC and calibration materials had been used and stated that patient chemistry results had been released. 4. An exit interview with the LD, 4/2/25 at 4:00 PM, 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 a review of Paragon laboratory information system (LIS) final patient reports, Chemistry laboratory policies and procedures, and interview with the laboratory director (LD), the laboratory failed to ensure comments provided to authorized persons for estimated glomerular filtration rate (eGFR) result interpretation were accurate and reflective of the method performed. Findings: 1. Review of 3 Paragon LIS patient reports from day of survey revealed the following comment for the eGFR test result: "If patient is African American multiply eGFR by 1.210." 2. Review of "Reference Interval(s), Clinical Decision Point(s), or Cutoff(s), & Result Comments" laboratory policy identified the final report comment for eGFR as stating "The CKD-EPI equation was used to calculate this eGFR result. Result reporting will go to 90 mL/min/BSA to aid in interpretation according to CKD classification grades" and lists 6 classification stages. 3. During an interview with the laboratory director (LD), 4/2/25 at 2:20 PM, the LD agreed the result comment for eGFR in Paragon was inconsistent with the race-free equation comment stated in the current policy. 4. An exit interview with the LD, 4/2/25 at 4:00 PM, confirmed the findings. -- 5 of 5 --

Summary Statement of Deficiencies D0000 An announced, on site, routine recertification survey was conducted at Broaddus Hospital on May 23 and May 24, 2023. The laboratory was assessed for compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. Specific deficiencies are explained below. 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 record review and interview, the laboratory failed to document the competency of 9 of 9 testing personnel (TP) in hematology for 2022. Findings: 1. Review of personnel records revealed no documented competency in hematology for 9 of 9 TP in 2022. 2. An interview with the technical supervisor, 5/23/23 at approximately 9:10 AM, confirmed the lack of hematology competencies for the 9 TP in the laboratory. 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 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 -- laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform external quality control (QC) on each day of patient testing on the MicroScan for two of two months reviewed. Findings: 1. Review of MicroScan QC records for December 2022 and January 2023 identified external QC being performed on a weekly basis. 2. No IQCP to allow for equivalent quality testing on a weekly basis could be located. 3. An interview with the technical supervisor, 5/23/23 at approximately 11:00 AM, confirmed that QC was not being run each day of patient testing on the MicroScan and no IQCP could be located. 4. An exit interview with the laboratory director, 5/24 /23 at approximately 10:45 AM, confirmed the findings. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to document the verification of the MultiChem S Plus quality control (QC) material before being put into use for patient testing in Chemistry. Findings: 1. Review of manufacturer instructions for assayed QC material in Chemistry identified a current lot 011007210 with an expiration date of 12/31/23. 2. Review of QC records established lot 011007210 to have been put into use April 2022. No documentation of the verification of the MultiChem S Plus assayed, stated values could be located. 3. An interview with the technical supervisor, 5/24/23 at approximately 8:30 AM, confirmed no documentation for the verification of the new lot of QC values could be located. 4. An exit interview with the laboratory director, 5/24/23 at approximately 10:45 AM, confirmed the findings. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (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 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 -- 2 of 4 -- manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to document the quality control (QC) performed on microbiology media when a new lot or new shipment is put into use for two of two months reviewed. Findings: 1. Review of December 2022 and January 2023 QC records identified no documentation for (i)sterility checks and (ii)ability to support growth checks for Macconkey, SBA, Chocolate media plates and Bactec blood culture bottles. 2. An interview with the technical supervisor, 5/23/22 at approximately 12:00 PM, confirmed that no external QC for growth or sterility were being performed on new lots/shipments of media plates and blood culture bottles. 3. An exit interview with the laboratory director, 5/24/23 at approximately 10:45 AM, confirmed the findings. D5781

Summary Statement of Deficiencies D0000 An unannounced, off site, Proficiency Testing (PT) desk review was conducted for Broaddus Hospital on September 22, 2021, by the West Virginia Office of Laboratory Services. The laboratory PT evaluations with the 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 the CASPER Report 155D and evaluations from the American Proficiency Institute (API) the laboratory failed to successfully participate in 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 -- proficiency testing (PT) for the analyte #0895 Compatibility Testing for two out of three consecutive testing events. Findings: #0895 Compatibility Testing 3rd event 2020- 80% 2nd event 2021- 80% D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for 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 American Proficiency Institute (API) proficiency testing (PT) evaluation reports and the CASPER Report 155D, the laboratory failed to successfully participate in 2 of 3 consecutive testing events for the analyte #0895 Compatibility Testing in Immunohematology. Findings: #0895 Compatibility Testing 3rd event 2020- 80% 2nd event 2021- 80% -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced, on site, recertification survey was performed at Broaddus Hospital on April 20 and 21, 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. D2098 ENDOCRINOLOGY CFR(s): 493.843(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 of at least 80% for the analytes 0585 TSH and 0595 TY in 1 of 3 American Proficiency Institute (API) 2020 testing events for Endocrinology. Findings: 1. API testing documentation identified the following unsatisfactory scores for the 2nd 2020 testing event: - 0% for 0585 TSH - 0% for 0595 TY 2. CASPER Report 0155D confirmed the API scores of 0% for 0585 TSH and 0595 TY. 3. The technical supervisor confirmed the findings on 4/20/2021 at approximately 10:00 am. D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to achieve an overall test 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 -- event score of 100% for the American Proficiency Institute (API) in 1 of 3 2020 testing events for Immunohematology. Findings: 1. API documentation identified a score of 80% for Immunohematology (blood bank) Compatibility testing in the 3rd 2020 testing event. a. SER-11 reported as NOT COMPATIBLE b. Expected result for SER-11 was COMPATIBLE 2. CASPER Report 0155D confirmed the 80% unsatisfactory performance for Compatibility testing. 3. The laboratory manager confirmed the findings on 4/20/2021 at approximately 10:15 AM. D3015 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103 A facility that provides transfusion services must meet all of the requirements of this section and document all transfusion-related activities. This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to perform and document external quality control (QC) in Immunohematology for 4 of 41 days of patient testing reviewed from January 1, 2020 thru April 21, 2021. Findings: 1. Immunohematology QC was reviewed from January 1, 2020 thru April 21, 2021. 2. Immunohematology patient testing log was reviewed from January 1, 2020 thru April 21, 2021. 3. Documentation revealed that 4 of 41 days (7/1/2020, 8/14/2020, 12/21/2020, 2/27 /2021) of patient testing in Immunohematology had no external QC performed and documented. 4. The laboratory manager confirmed the findings April 21, 2021 at 9:35 am. -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on Proficiency Testing (PT) record review and interview with Testing Personnel (TP1), the laboratory failed to enroll and perform PT on all specialty, subspecialties, and analytes listed in Subpart I for which it performs patient testing. Findings: 1. A record review of PT test events for 2018 and 2019 established the laboratory had not enrolled in or performed PT for serum HCG testing. 2. An interview with TP1, on 6/25/19 at approximately 120 PM, confirmed that there was no PT performed on serum HCG testing. 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: 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 upon a review of Proficiency Testing (PT) records and an interview with Testing Personnel (TP1), the laboratory failed to enroll and perform PT for tests that are not included in Subpart I. Findings: 1. A review of PT records from 2018 and 2019 revealed the laboratory had not performed PT on C-Reactive Protein (CRP). 2. Interview with TP1, on 6/25/19 at approximately 120 PM, confirmed that no testing of CRP to establish and maintain accuracy had occurred. -- 2 of 2 --