Baptist Health Floyd At Jefferson Ridge

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was completed on 12/30/2024. The following condition-level deficiencies were found to be out of compliance: D2016- 42 C.F.R. 493.803 Condition: Successful participation (proficiency testing) D6000-42 C. F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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 surveyor proficiency testing (PT) desk review of the laboratory PT records, the College of American Pathologists (CAP) Evaluation Reports, and CASPER Report 0155D from the Centers for Medicare and Medicaid Services (CMS) data 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 -- system, and emails from the Technical Consultant (SP-1) on 12/19/2024 and 12/30 /2024, the laboratory failed to achieve satisfactory performance in four consecutive events (one of three events in 2023, and three of three events in 2024) resulting in unsuccessful participation in the subspecialty of Routine Chemistry for the analyte of Amylase in 2023 and 2024. (Refer to D2089). D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) (c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on surveyor proficiency testing (PT) desk review of the laboratory PT records, the College of American Pathologists (CAP) Evaluation Reports, and CASPER Report 0155D from the Centers for Medicare and Medicaid Services (CMS) data system, and emails from the Technical Consultant (SP-1) on 12/19/2024 and 12/30 /2024, the laboratory failed to achieve satisfactory performance in four consecutive events (one of three events in 2023, and three of three events in 2024) resulting in unsuccessful participation in the subspecialty of Routine Chemistry for the analyte of Amylase in 2023 and 2024. Findings included: 1. Review of the "CASPER Report 0155D," run date 8/20/2024 indicated a score of 0% for event 3 2023, 0% for event 1 2024 and 0% for event 2 2024 for amylase as reported by CAP. 2. Upon request for information on PT for 2023 and 2024 for amylase, via email on 8/22/2024 at 3:16 pm, SP-1 (Technical Consultant) provided a document "Proficiency Testing - Unsuccessful Event Investigation Report". 3. The "Proficiency Testing - Unsuccessful Event Investigation Report", reviewed by the laboratory director on 4/30/2024, documented on page 3 of 4 in the conclusion/ summary that the "site had ceased testing in August of 2023..." 4. Review of the "Clinical Laboratory Improvement Amendments (CLIA) Application for Certification" Form CMS 116, signed by the laboratory director on 3/8/2024, indicated amylase was listed as being performed by the laboratory. 5. Upon request for additional information on PT scores for amylase, via email on 9/11/2024 at 12:22 pm, SP- 1 (Technical Consultant) provided CAP evaluations for C-B 2024. 6. Review of the CAP Evaluation report for "C-B 2024 General Chemistry/Therapeutic Drugs", original evaluation date 7/2/2024, detailed the following for amylase: a) Page 8 of 10 "CMS Performance Summary for Analytes Regulated under the Clinical Laboratory Improvement Amendments of 1988": 1.) Proficiency Event 2023 3 had a score of 0/5 for 0%. 2.) Proficiency Event 2024 1 had a score of 0/5 for 0%. 3.) Proficiency Event 2024 2 had a score of 0/5 for 0% b) Page 5 of 10 "Evaluation and Comparative Method Statistics" indicated five specimens had been submitted to the laboratory and had noted "See Note [42]". c) Page 1 of 10 elaborated on exception code "[42]" equals "No credit assigned due to absence of response." 7. Review of the "Casper Report 0155D," run date 12/17/2024 indicated a score of 0% for event 3 2023, 0% for event 1 2024, 0% for event 2 2024, and 0% for event 3 2024 for amylase as reported by the CAP. 8. Upon request for additional -- 2 of 4 -- information on proficiency testing scores for amylase, via email on 12/17/2024 at 2:59 pm, SP-1 (Technical Consultant) confirmed the 0% score and indicated they had not communicated with CAP that they were no longer testing for amylase. 9. Upon requests for a copy of the CAP summary for event 3, 2024, via emails sent on 12/17 /2024 at 4:39 pm, 12/19/2024 at 10:43 am, and 12/30/2024 at 8:40 am, SP-1 (Technical Consultant) provided the results on 12/30/204 at 11:54 am. 10. Review of the CAP Evaluation for "C-C 2024 General Chemistry/Therapeutic Drugs", original evaluation date 11/1/2024, detailed the following for amylase: a) Page 8 of 10 "CMS Performance Summary for Analytes Regulated under the Clinical Laboratory Improvement Amendments of 1988": 1.) Proficiency Event 2023 3 had a score of 0/5 for 0%. 2.) Proficiency Event 2024 1 had a score of 0/5 for 0%. 3.) Proficiency Event 2024 2 had a score of 0/5 for 0% 4.) Proficiency Event 2024 3 had a score of 0/5 for 0% b) Page 5 of 10 "Evaluation and Comparative Method Statistics" indicated five specimens had been submitted to the laboratory for Amylase, serum and had noted "See Note [42]". c) Page 1 of 10 elaborated on exception code "[42]" equals "No credit assigned due to absence of response." D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on surveyor proficiency testing (PT) desk review of the laboratory PT records, the College of American Pathologists (CAP) Evaluation Reports, CASPER Report 0155D from the Centers for Medicare and Medicaid Services (CMS) data system, and emails from the Technical Consultant (SP-1) on 12/19/2024 and 12/30/2024, the laboratory director failed to ensure that the laboratory successfully participated in four consecutive events (one of three events in 2023, and three of three events in 2024) in the subspecialty of Routine Chemistry for the analyte of Amylase in 2023 and 2024, and failed to provide overall management and direction of the laboratory services. Refer to D6016 & D6019. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on surveyor proficiency testing (PT) desk review of the laboratory PT records, the College of American Pathologists (CAP) Evaluation Reports, CASPER Report 0155D from the Centers for Medicare and Medicaid Services (CMS) data system, and emails from the Technical Consultant (SP-1) on 12/19/2024 and 12/30/2024, the laboratory director failed to failed to ensure successful participation in an HHS approved proficiency testing program. and failed to ensure the overall quality of the laboratory services provided. Refer to D2089. D6019 LABORATORY DIRECTOR RESPONSIBILITIES -- 3 of 4 -- CFR(s): 493.1407(e)(4)(iv) (e)(4)(iv) An approved

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was completed on 9/12/2024. It was determined that the following condition-level deficiencies existed: 42 Code of Federal Regulation (CFR) 493.803(a)(b)(c) Successful Participation 42 CFR 493.1403 Laboratory Director 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 record review and interview, the laboratory failed to successfully participate in a proficiency testing program for three consecutive events for amylase and two out of three events for prothrombin time in 2023 and 2024. The laboratory failed to successfully participate in three consecutive testing events in 2023 (event 3, 2023) and 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 -- 2024 (event 1 and event 2) resulting in a score of 0% for the analyte amylase as reported by the College of American Pathologist (CAP) (Refer to D2089). The laboratory failed to achieve satisfactory performance of 80% or greater for two out of three testing events in 2023 (event 2, 2023) and in 2024 (event 1). Results the analyte prothrombin time was 60% for event 2, 2023, and 60% for event 1, 2024 as reported by CAP (Refer to D2130). D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to successfully participate in a proficiency testing program for three consecutive events for amylase in 2023 and 2024. The laboratory failed to successfully participate in three consecutive testing events in 2023 (event 3, 2023) and 2024 (event 1 and event 2) resulting in a score of 0% for the analyte amylase as reported by the College of American Pathologist (CAP) (Refer to D2089). Findings included: 1. Review of the "Casper Report 0155D," run date 8/20/2024 indicated a score of 0% for event 3 2023, 0% for event 1 2024 and 0% for event 2 2024 for amylase as reported by the CAP. 2. Upon request for information on proficiency testing for 2023 and 2024 for amylase, via email on 8/22/2024 at 3:16 pm, SP-1 (Technical Consultant) provided a document "Proficiency Testing - Unsuccessful Event Investigation Report". 3. The "Proficiency Testing - Unsuccessful Event Investigation Report", reviewed by the laboratory director on 4/30/2024, documented on page 3 of 4 in the conclusion/ summary that the "site had ceased testing in August of 2023..." and CAP had not been notified. 4. Review of the "Clinical Laboratory Improvement Amendments (CLIA) Application for Certification" Form CMS 116, signed by the laboratory director on 3/8/2024, indicated amylase was listed as being performed by the laboratory. 5. Upon request for additional information on proficiency testing scores for amylase, via email on 9/11 /2024 at 12:22 pm, SP- 1 (Technical Consultant) provided CAP evaluations for C-B 2024. 6. Review of the CAP Evaluation for "C-B 2024 General Chemistry /Therapeutic Drugs", original evaluation date 7/2/2024, detailed the following for amylase: a) Page 8 of 10 "CMS Performance Summary for Analytes Regulated under the Clinical Laboratory Improvement Amendments of 1988": 1.) Proficiency Event 2023 3 had a score of 0/5 for 0%. 2.) Proficiency Event 2024 1 had a score of 0/5 for 0%. 3.) Proficiency Event 2024 2 had a score of 0/5 for 0% b) Page 5 of 10 "Evaluation and Comparative Method Statistics" indicated five specimens had been submitted to the laboratory and had noted "See Note [42]". c) Page 1 of 10 elaborated on exception code "[42]" equals "No credit assigned due to absence of response." D2130 HEMATOLOGY CFR(s): 493.851(f) -- 2 of 5 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to achieve satisfactory performance of 80% or greater for two out of three testing events in 2023 (event 2, 2023) and in 2024 (event 1, 2024). Results the analyte prothrombin time were 60% for event 2, 2023, and 60% for event 1, 2024 as reported by CAP. Findings included: 1. Review of the "Casper Report 0155D," run date 8/20/2024 indicated a score of 60% for event 2 2023, 60% for event 1 2024 for prothrombin time as reported by the CAP. 2. Upon request for information on proficiency testing for 2023 and 2024 for prothrombin time, via email on 8/22/2024 at 3:16 pm, SP-1 (Technical Consultant) provided four documents "Proficiency Testing - Unsuccessful Event Investigation Report" for WP3-B 2023, the CAP evaluations for WP3-B 2023 page 2 of 2, "Proficiency Testing - Unsuccessful Event Investigation Report" for WP3- A 2024 and the CAP evaluation for WP3-A 2024 page 2. 3. The "Proficiency Testing - Unsuccessful Event Investigation Report", reviewed by the laboratory director on 6/23 /2023, documented on page 1 of 4 under unacceptable results that two out of five samples had been unacceptable. for event 2, 2023. 4. The CAP evaluation for WP3-B 2023 WB Prothrombin time/INR, I-Stat original evaluation date 5/30/2023, showed two out of five specimens were unacceptable. Giving a score of 60%. 5. The "Proficiency Testing - Unsuccessful Event Investigation Report", reviewed by the laboratory director on 4/30/2024, documented on page 1 of 4 under unacceptable results that two out of five samples had been unacceptable. for event 1, 2024. 6. The CAP evaluation for WP3-A 2024 WB Prothrombin time/INR, I-Stat original evaluation date 3/4/2024, showed two out of five specimens were unacceptable. Giving a score of 60%. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory director failed to ensure the laboratory successfully participated in a proficiency testing program for three consecutive events for amylase and two out of three events for prothrombin time in 2023 and 2024. The laboratory failed to successfully participate in three consecutive testing events in 2023 (event 3, 2023) and 2024 (event 1 and event 2) resulting in a score of 0% for the analyte amylase as reported by the College of American Pathologist (CAP) and failed to achieve satisfactory performance of 80% or greater for two out of three testing events in 2023 (event 2, 2023) and in 2024 (event 1). Results the analyte prothrombin time was 60% for event 2, 2023, and 60% for event 1, 2024 as reported by CAP (Refer to 6016). D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) -- 3 of 5 -- 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. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory director failed to ensure the laboratory successfully participated in a proficiency testing program for three consecutive events for amylase and two out of three events for prothrombin time in 2023 and 2024. The laboratory failed to successfully participate in three consecutive testing events in 2023 (event 3, 2023) and 2024 (event 1 and event 2) resulting in a score of 0% for the analyte amylase as reported by the College of American Pathologist (CAP) and failed to achieve satisfactory performance of 80% or greater for two out of three testing events in 2023 (event 2, 2023) and in 2024 (event 1). Results the analyte prothrombin time was 60% for event 2, 2023, and 60% for event 1, 2024 as reported by CAP. Findings included: 1. Review of the "Casper Report 0155D," run date 8/20/2024 indicated the following scores: a) 0% for event 3 2023, 0% for event 1 2024 and 0% for event 2 2024 for amylase as reported by the CAP. b) 60% for event 2 2023, 60% for event 1 2024 for prothrombin time as reported by the CAP. 2. Upon request for information on proficiency testing for 2023 and 2024 for amylase, via email on 8/22/2024 at 3:16 pm, SP-1 (Technical Consultant) provided the following documents: a) "Proficiency Testing - Unsuccessful Event Investigation Report" for amylase reviewed by the laboratory director on 4/30/2024. b) Proficiency Testing - Unsuccessful Event Investigation Report" for WP3-B 2023 for prothrombin time, c) The CAP evaluations for WP3-B 2023 page 2 of 2 for prothrombin time, d) "Proficiency Testing - Unsuccessful Event Investigation Report" for WP3- A 2024 for prothrombin time, and e) the CAP evaluation for WP3-A 2024 page 2 for prothrombin time. 3. The "Proficiency Testing - Unsuccessful Event Investigation Report", reviewed by the laboratory director on 4/30/2024, documented on page 3 of 4 in the conclusion/ summary that the "site had ceased testing in August of 2023..." and CAP had not been notified. 4. The "Proficiency Testing - Unsuccessful Event Investigation Report", reviewed by the laboratory director on 6/23/2023, documented on page 1 of 4 under unacceptable results that two out of five samples had been unacceptable. for event 2, 2023. 5. The CAP evaluation for WP3-B 2023 WB Prothrombin time/INR, I- Stat original evaluation date 5/30/2023, showed two out of five specimens were unacceptable. Giving a score of 60%. 6. The "Proficiency Testing - Unsuccessful Event Investigation Report", reviewed by the laboratory director on 4/30/2024, documented on page 1 of 4 under unacceptable results that two out of five samples had been unacceptable. for event 1, 2024. 7. The CAP evaluation for WP3-A 2024 WB Prothrombin time/INR, I-Stat original evaluation date 3/4/2024, showed two out of five specimens were unacceptable. Giving a score of 60%. 8. Review of the "Clinical Laboratory Improvement Amendments (CLIA) Application for Certification" Form CMS 116, signed by the laboratory director on 3/8/2024, indicated amylase was listed as being performed by the laboratory. 9. Upon request for additional information on proficiency testing scores for amylase, via email on 9/11 /2024 at 12:22 pm, SP- 1 (Technical Consultant) provided CAP evaluations for C-B 2024. 10. Review of the CAP Evaluation for "C-B 2024 General Chemistry /Therapeutic Drugs", original evaluation date 7/2/2024, detailed the following for amylase: a) Page 8 of 10 "CMS Performance Summary for Analytes Regulated under the Clinical Laboratory Improvement Amendments of 1988": 1.) Proficiency Event -- 4 of 5 -- 2023 3 had a score of 0/5 for 0%. 2.) Proficiency Event 2024 1 had a score of 0/5 for 0%. 3.) Proficiency Event 2024 2 had a score of 0/5 for 0% b) Page 5 of 10 "Evaluation and Comparative Method Statistics" indicated five specimens had been submitted to the laboratory and had noted "See Note [42]". c) Page 1 of 10 elaborated on exception code "[42]" equals "No credit assigned due to absence of response." . -- 5 of 5 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 observation, record review and interview, the laboratory failed to ensure one of one level 1 control (lot 223810) and one of one level 2 control (Lot 22381402) in use did not exceed the expiration date for one of one Hematology Analyzers (Sysmex XN-550) and one out of four patients (PT#4) reviewed. Findings Included: 1.) During a tour of the laboratory on 11/2/2022 at 9:56 am, revealed an American Biotech Supply (ABS) refrigerator that contained the following controls: a.) Level 1 lot 2238140 was opened on 10/16/2022 and expired on 10/31/2022 b.) level 2 lot 22381402 opened on 10/16/2022 and expired on 10/31/2022 There were no other open controls in the fridge. XN-L controls are used in Sysmex XN-550. 2.) Review of "XN-L Check Hematology Control for Sysmex XN-L Analyzer" revision 11/2018, stated, "Storage and shelf life after first opening ... Open vials and vials which have been sampled by cap piercing will retain stability for 15 days if stored at 2-8 C after re-capped." 3.) Review of patient records indicated PT#4 was tested for complete blood count (CBC) on 11/1/2022 using the Sysmex XN-550 analyzer when level 1 and level 2 controls were expired. 4.) The annual test volume for Hematology is 8,652. 5.) During an interview on 11/2/2022 at 9:57 am, SP#2 (Clinical Administrative Manager) confirmed the controls level 1 and leve1 2 had expired on 10 /31/2022 D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) 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 -- Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (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 observation, record review and interview, the laboratory failed to ensure the documentation was completed for the certificate of carryover verification and certificate of reportable ranges for one of one Hematology analyzers (Sysmex XN- 550) in use for patient testing since August 15, 2022, and for four of four patients (PT#1-PT#4) reviewed. Findings Included: 1.) During a laboratory tour on 11/2/2022 at 9:56 am, revealed a Sysmex XN-550 used in Hematology testing. 2.) Review of "XN-Series XN-L Method Verification Manual" revision 2, December 2016 states "Section 3 Method Verification Protocols ... The CAS is to verify that the analyzer meets manufacture's performance claims by performing the following studies: Reportable Range Carryover" 3.) Review of the "Certificate of Reportable Range Verification" revealed the wrong instrument model number "XN-450" was listed and the name on the laboratory was incorrect. The laboratory director signed the document on 7/12/2022. 4.) Review of the "Certificate of Carryover Verification" revealed the wrong instrument model number "XN-450" was listed and the name of the laboratory was incorrect. The laboratory director signed the document on 7/12/2022. 5.) Review of patient records indicated the follow patients were tested for complete blood count (CBC) using the Sysmex XN-550 analyzer: a. PT#1 was tested for CBC on 8/22/2022. b. PT#2 was tested for CBC on 9/6/2022. c. PT#3 was tested for CBC on 10/8/2022. d. PT#4 was tested for CBC on 11/1/2022. 6.) The annual test volume for Hematology is 8,652. 7.) During an interview on 11/2/2022 at 1:45 PM, SP#2 confirmed the validation paperwork was not complete for XN-550 -- 2 of 2 --