Saint Francis Lab - Warren Clinic Springer

Summary Statement of Deficiencies D0000 The recertification survey was performed on 03/05,06/2025. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director and the technical consultant at the conclusion of the survey. 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 records, written policies and procedures, and interview with the technical consultant, the laboratory failed to have a written policy to assess the competency of the clinical consultant, based on the job responsibilities as listed in Subpart M, for one of one persons. Findings include: (1) On 03/05/2025, a review of the laboratory policy and procedure manual identified no evidence of a policy for assessing the competency of the clinical consultant, including the frequency of the assessments; (2) A review of the Form CMS-209 (Laboratory Personnel Report) and personnel records for competency assessments performed during the review period of March 2023 through the current date identified competencies, based on job responsibilities, had not been performed for one of one person listed as the clinical consultant after 06/26/2023; (3) The findings were reviewed with the technical consultant who stated on 03/05/2025 at 12:45 pm, a policy was not available and competencies had not been performed for the position as stated above. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing 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 -- performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to review and evaluate proficiency testing results for one of six Hematology/Coagulation proficiency testing events reviewed in 2023 and 2024. Findings include: (1) On 03/05/2025, a review of Hematology/Coagulation proficiency testing records for 2023 (first, second, and third events) and 2024 (first, second and third events) identified the following ungraded results tht had not been evaluated by the laboratory: (a) API Hematology/Coagulation 2023 third event (i) Educational blood cell identification (aa) Sample DIF-03 (ii) Immature Cells - Reported Result 70, expected results 0 - 1; (iii) Lymphocytes - Reported Result 9, expected results 44 - 90; (iii) Neutrophils - Reported Result 21, expected results 12 - 38; (iv) Platelet estimate - Reported Result normal, expected result Decreased. (2) There was no evidence in the records to prove the reported results had been identified and addressed; (3) The records were reviewed with the technical consultant who stated on 03/05/2025 at 01:40 pm, the results that did not agree with the expected results had not been identified and addressed. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of records, policies and procedures, and interview with the technical consultant and testing person #1, the laboratory failed to follow their written protocol for ensuring the urine centrifuge was functioning properly during the review period of March 2023 through the current date. Finding include: (1) On 03/05/2025 at 11:00 am, the testing person #1 stated the following: (a) Urine sediment examinations were performed; (b) The specimens were processed in the Horizon 642 VES centrifuge at a speed of 1500 rpm (revolutions per minute) for 5 minutes. (2) A review of the centrifuge function check policy titled, "Centrifuge Function Check Procedure" stated, "To ensure the centrifuge is functioning properly in an acceptable standardized manner, its speed and timer is being checked annually"; (3) A review of centrifuge records from 03/01/2023 through the current date identified the speed and timer checks had not been documented as performed prior to 06/10/2024; (4) The records were reviewed with the technical consultant who stated on 03/05/2025 at 02:25 pm, the laboratory had not followed their policy. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the technical consultant failed to ensure personnel performing moderate complexity testing had been evaluated at least annually for two of 11 testing persons during the review period of March 2023 through the current date. Findings include: (1) On 03/05/2025, a review of personnel records for 11 persons performing moderate complexity testing during 2023 and to date in 2025 identified no evidence an annual competency evaluation had been performed for two 11 testing persons as follows: (a) Testing Person #5 - Prior to 10/23/2024 (b) Testing Person #11 - Prior to 10/14/2024 (2) The records were reviewed with the technical consultant who stated on 03/05/2025 at 01: 55 pm, the annual evaluations had not been documented as performed. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 02/22/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director and technical consultant at the conclusion of the survey. 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 records, written policy, and interview with the technical consultant, the laboratory failed to follow their policy for performing clinical consultant competencies based on the position responsibilities as listed in Subpart M for one of one clinical consultant. Findings include: (1) A review of the competency assessment policy and interview with the technical consultant on 02/22/2023 at 01:05 pm identified that competencies for the clinical consultant, based on the position responsibilities were required to be performed annually; (2) A review of personnel records for competency assessments performed during 2021 and to date in 2023 identified no evidence of competencies performed after 01/22/2021; (3) The findings were reviewed with the technical consultant who stated on 02/22/2023 at 01:20 pm the competencies had not been documented as performed. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. 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 -- This STANDARD is not met as evidenced by: Based on a review of procedure manuals and interview with the technical consultant, the laboratory failed to ensure two of two procedure manuals had been approved, signed, and dated by the laboratory director. Findings include: (1) A review of two procedure manuals identified no evidence they had been signed and dated as approved by the laboratory director. Examples of policies and procedures contained in the manuals were: (a) One manual titled, "Procedures" contained procedures such as: (i) "Routine urinalysis Procedure and Guidelines" (ii) "Wet Prep Procedure" (iii) "Mono Test Serum" (b) A second manual titled, "Procedures" contained policies and procedures such as: (i) "Critical Result Reporting" (ii) "Quality Assurance Program" (iii) "iSTAT General Procedure" (2) The manuals were reviewed with the technical consultant who stated on 02/22/2023 at 01:25 pm, the two procedure manuals had not been signed and dated as approved by the laboratory director. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the technical consultant and testing person #5, the laboratory failed to ensure the manufacturer's instructions were followed for performing maintenance procedures for one of three instruments reviewed from January 2022 through the current date. Findings include: (1) On 02/22/2023 at 10:05 am, the technical consultant stated the Hardy Diagnostics Quick Slide Hemapro slide stainer was used to stain patient blood smears to perform manual differentials; (2) A review of the Hemapro "Users Operation Manual" on page 22 under the title, "Tubing Kit Replacement" stated, "The orange pump tubes and the clear lines with color coded cannulas must be replaced every six (6) months to ensure the Hemapro is operating under normal operating conditions"; (3) A review of records from 01/01/2022 through the current date identified no documentation to prove the tubing kit replacement procedure had been performed before or after 07/29/2022; (4) The records were reviewed with the technical consultant and testing person #5. Both stated on 02/22/2023 at at 02:40 pm the maintenance procedure had not been performed as stated above. 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. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to ensure one of one IQCP (Individualized Quality Control Plan) included the required components; and failed to perform quality control as stated in the IQCP for four of four cartridge types. Findings include: REQUIRED COMPONENTS OF IQCP (1) On 02/22/2023 at 11:00 am, the technical consultant stated the following were performed using three iSTAT 1 handheld analyzers (serial numbers 410170, 304488, and 347704); (a) BUN, Ionized Calcium, Chloride, CO2, Creatinine, Glucose, Potassium, and Sodium testing using the Chem 8+ cartridge; (b) Troponin I testing using the cTnI cartridge; (c) BNP (B-type Natriuretic Peptide) testing using the BNP cartridge; (d) PT/INR (Prothrombin Time/International Normalized Ratio) testing using the PT/INR cartridge (only performed on Serial Numbers 304488 and 347704). (e) An IQCP had been developed for the test systems. (2) A review of the IQCP identified a QA (Quality Assessment) plan had not been included in the IQCP; (3) The records were reviewed with the technical consultant who stated on 02/22/2023 at 03:45 pm, a QA plan had not been included in the IQCP. QUALITY CONTROL (1) A review of the QCP (Quality Control Plan) for the above IQCP identified the QCP (Quality Control Plan) required QC (quality control) testing be performed on a monthly basis; (2) A review of QC records for the testing performed from January 2022 through December 2022 identified no documentation to prove QC testing had been performed as stated in the QCP for four of four cartridge types as follows: (a) Chem 8+ (i) Serial Number 410170 - QC not documented as performed: (aa) Between 07/19/2022 and 09/16/2022 (bb) After 11/24/2022 (ii) Serial Number 304488 - QC not documented as performed: (aa) Between 05/28/2022 and 07 /13/2022 (bb) Between 07/19/2022 and 09/16/2022 (iii) Serial Number 347704 - QC not documented as performed: (aa) Between 05/28/2022 and 07/13/2022 (bb) Between 07/19/2022 and 09/16/2022 (b) Troponin I (i) Serial Number 410170 - QC not documented as performed: (aa) Between 07/19/2022 and 09/19/2022 (bb) After 11 /30/2022 (ii) Serial Number 304488 - QC not documented as performed: (aa) Between 05/20/2022 and 07/19/2022 (bb) Between 07/19/2022 and 09/19/2022 (cc) After 11/30 /2022 (iii) Serial Number 347704 - QC not documented as performed: (aa) Between 05 /20/2022 and 07/19/2022 (bb) Between 07/19/2022 and 09/19/2022 (cc) After 11/30 /2022 (c) BNP (i) Serial Number 410170 - QC not documented as performed: (aa) Between 07/23/2022 and 09/25/2022 (bb) Between 09/25/2022 and 11/01/2022 (ii) Serial Number 304488 - QC not documented as performed: (aa) Between 07/23/2022 and 09/25/2022 (bb) Between 09/25/2022 and 11/01/2022 (iii) Serial Number 347704 - QC not documented as performed: (aa) Between 07/23/2022 and 09/25/2022 (bb) Between 09/25/2022 and 11/01/2022 (c) PT/INR (i) Serial Number 304488 - QC not documented as performed: (aa) Between 07/07/2022 and 09/05/2022 (ii) Serial Number 347704 - QC not documented as performed: (aa) Between 07/07/2022 and 09 /05/2022 (3) The records were reviewed with the technical consultant who stated on 02 /22/2023 at 04:15 pm, QC had not been documented as performed as shown above. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for -- 3 of 4 -- acceptability. This STANDARD is not met as evidenced by: Based on a review of patient reports and interview with the laboratory director and technical consultant, the laboratory failed to ensure patient test reports included the address of the laboratory location where the test was performed for three of three patient reports. Findings include: (1) On 02/22/2023 at 10:05 am, the technical consultant stated the following were performed: (a) CBC (Complete Blood Count) testing using the Cell Cyn Ruby analyzer; (b) Urinalysis testing using the Clinitek Advantus analyzer; (c) PT/INR (Prothrombin Time/International Normalized Ratio) testing using the iSTAT 1 analyzer and the PT/INR cartridge. (2) A review of patient reports identified the address of the laboratory location where the test was performed was not included for three of three reports: (a) CBC testing reported on 02/22/2023 at 03:23 pm; (b) Urinalysis testing reported on 02/22/2023 at 02:39 pm; (c) PT/INR testing reported on 02/11/2023 at 04:20 pm. (3) The reports were discussed with the laboratory director and technical consultant. Both stated on 02/22/2023 at 05:50 pm, the reports did not include the address of the laboratory where the testing had been performed. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on March 08, 2021 through March 09, 2021. The findings were reviewed with the technical supervisor and testing person #14 during an exit conference performed at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on a review of manufacturer's instructions, patient reports, and interview with the technical supervisor and testing person #14, the laboratory failed to follow the manufacturer's instructions for waived testing for 5 of 10 reports. Findings include: (1) On 03/09/2021, the technical supervisor and testing person #14 stated the following at 10:00 am to the surveyor: (a) COVID-19 testing was performed on 4 Abbott ID-NOW analyzers (serial number C345D91C, serial number F543D91C, serial number G857D91C, and serial number CF3ED91C); (b) Patient specimens were routinely collected in the urgent care patient rooms and transported to the laboratory. (2) The surveyor then reviewed the manufacturer's instructions which stated, "ID NOW (Trademark) COVID-19 is a rapid (13 minutes or less), instrument-based isothermal test for the qualitative detection and diagnosis of SARS-CoV-2 from nasal, nasopharyngeal and throat swabs." (3) The surveyor reviewed 10 patient COVID-19 nasopharyngeal specimen reports received and tested in the laboratory and identified the following: (a) For 3 of the 10 reports, the time of collection was the same as the time of receipt into the laboratory: (i) Testing performed 11/24/2020- The collection and laboratory receipt time was 9:47 am; (ii) Testing performed 11/24/2020- The collection and laboratory receipt time was 10:14 am; (iii) Testing performed 12/18 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 -- /2020- The collection and laboratory receipt time was 08:10 am. (b) For 2 of 10 reports, the time of receipt into the laboratory was the same or within one minute of the verified results: (i) Testing performed 11/19/2020 - The receipt and verified time was 04:20 pm. (ii) Testing performed 12/21/2020 - The receipt time was 03:09 pm and verified time was 03:10 pm. (4) The surveyor reviewed the findings with the technical supervisor and testing person #14 who stated on 03/09/2021 at 11:10 am the collection time, receipt time and verified result time were not accurate as indicated above. 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 on a review of records and interview with the technical supervisor and testing person #14, the laboratory failed to perform quality control as stated in the IQCP for 3 of 24 months. Findings include: (1) On 03/08/2021, the technical supervisor and testing person #14 stated at 02:15 pm the following to the surveyor: (a) Three Abbott iSTAT 1 analyzers (serial number 304488, serial number 383654, and serial number 347704), were used to perform BNP (Brain Natriuretic Peptide) and Troponin I testing; (b) An IQCP (Individualized Quality Control Plan) had been developed for the test system and external QC (quality control) was performed monthly and with new lot numbers of cartridges. (2) The surveyor reviewed QC records from January 2019 through January 2021 and identified that QC had not been tested monthly, as stated in the IQCP. QC had not been tested between: (a) BNP (i) 10/25/2019 and 12/13 /2019 (ii) 11/25/2020 and 01/22/021 (b) Troponin I (i) 11/13/2020 and 01/07/2021 (3) The surveyor reviewed the records with the technical supervisor and testing person #14, and asked if QC had been performed monthly. Both stated to the surveyor QC on 03/09/2021 at 11:30 am QC had not been performed monthly as indicated above. D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the technical supervisor, testing person #7, and testing person #14, the laboratory failed to follow the manufacturer's quality control instructions. Findings include: (1) On 03/09 /2021, at 10:15 am, the technical supervisor and testing person #14 stated the -- 2 of 3 -- following to the surveyor: (a) CBC (Complete Blood Count) testing was performed using the Abbott Cell Dyn Ruby analyzer; (b) Three levels of Cell-Dyn 26 Plus quality control (QC) materials were performed each day of patient testing. (2) On 03 /09/2021, the surveyor reviewed the following manufacturer's instructions: (a) The QC package insert stated, "The mean range does not represent standard deviations (SD)"; (b) Product information sheet provided by the manufacturer titled, "Establishing Quality Control Means and Limits" provided instructions to the laboratory for establishing laboratory means and limits for new lot numbers of control materials. (3) The surveyor then reviewed QC records for testing performed from January 10, 2020 through December 31, 2020. It was identified the laboratory had used the package insert ranges, instead of laboratory established ranges, to determine acceptability of QC results for 2 of 7 lot numbers: (a) Low, Normal, and High control lot #0055 used from 03/11/2020 through 03/29/2020 (b) Low, Normal, and High control lot #0083 used from 05/01/2020 through 05/26/2020 (4) The surveyor reviewed the findings with the technical supervisor, testing person #7, and testing person #14 who stated on 03/09/2021 at 03:00 pm the laboratory had used the package insert ranges instead of laboratory established ranges for determining acceptability of QC results as indicated above. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 11/15/18. The findings were reviewed with the general supervisor at the conclusion of the survey. The laboratory was found to be in compliance with standard-level deficiencies cited. 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. This STANDARD is not met as evidenced by: Based on a review of records and interview with the general supervisor, the laboratory failed to review and evaluate proficiency testing results. Findings include: (1) At the beginning of the survey, surveyor #2 reviewed 2017 and 2018 proficiency testing records. The following biases were identified (biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency program): (a) First 2017 Hematology Event (i) RDW (Red Cell Distribution Width) - 3 of 5 results exhibited a negative bias (aa) Sample AST-03- SDI of -2.2 (bb) Sample AST-04- SDI of -2.1 (cc) Sample AST-05- SDI of -2.3 (b) First 2018 Hematology Event (i) RDW - 5 of 5 results exhibited a negative bias (aa) Sample AST-01- SDI of -2.5 (bb) Sample AST-02- SDI of -2.1 (cc) Sample AST-03- SDI of -2.9 (dd) Sample AST-04- SDI of -2.9 (ee) Sample AST-05- SDI of -2.2 (2) Surveyor #2 could not locate evidence in the records proving the biases had been identified and addressed; (3) The records were reviewed with the general supervisor who stated the biases had not been addressed. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance 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 -- (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of records and interview with the general supervisor, the laboratory failed to evaluate the accuracy of testing when a proficiency result had not been graded by the proficiency program. Findings include: (1) At the beginning of the survey, surveyor #2 reviewed 2017 and 2018 proficiency testing records and identified the following had not been evaluated by the proficiency testing program: (a) Hematology (i) 2017 second event (aa) Urobilinogen UA-03 (2) Surveyor #2 further reviewed the records and could not locate documentation verifying the laboratory had performed a self-evaluation of the non-graded results; (3) Surveyor #2 asked the general supervisor if the results had been documented as evaluated. The general supervisor reviewed the records and stated the non-graded results had not been documented as reviewed. 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 on a review of records, written policies, and interview with the general supervisor, the laboratory failed to follow written quality control policies. Findings include: (1) At the beginning of the survey, the general supervisor stated the following to surveyor #1: (a) The laboratory performed patient PT/INR (Prothrombin Time /International Normalized Ratio) testing using the PT/INR test cartridge and three iSTAT 1 analyzers (serial numbers 304488, 383684, and 347704); (b) An IQCP (Individualized Quality Control Plan) had been developed for the test system. (2) Later during the survey, surveyor #1 reviewed the IQCP (Individualized Quality Control Plan) that had been developed for the test system. The QCP (Quality Control Plan) portion of the IQCP required 2 levels of external quality control materials be tested once a month and with each new lot or shipment of test cartridges for each analyzer; (3) Surveyor #1 then reviewed QC (quality control) records for 10 months (January 2018 through October 2018) and identified the laboratory failed to follow the written QCP of performing quality control testing once a month for each analyzer. Quality control testing had not been performed as follows: (a) Between 03/14/18 and 06/12/18 for serial numbers 304488 and 383684; (b) Between 06/12/18 and 08/13/18 for serial numbers 304488 and 383684. (4) The findings were reviewed with the general supervisor who stated the laboratory had not performed quality control testing for each analyzer as required by the QCP. D5775 COMPARISON OF TEST RESULTS -- 2 of 3 -- CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on a review of records, policies and procedures, and interview with the general supervisor, the laboratory failed to have a system that twice a year evaluated and defined the relationship between test results using three different analyzers. Findings include: (1) At the beginning of the survey, the general supervisor stated to surveyor #1 BNP (B-Type Natriuretic Peptide), Troponin I, and PT/INR (Prothrombin Time /International Normalized Ratio) testing were performed using three iSTAT 1 analyzers (serial numbers 304488, 383684, and 347704); (2) Later during the survey, surveyor #1 asked the laboratory general supervisor if the relationship between the analyzers for BNP, Troponin I, and PT/INR testing had been evaluated twice annually during the review period of April 2017 through the day of the survey. The general supervisor verified the relationship between the analyzers had not been evaluated during the review period; (3) Surveyor #1 then reviewed the procedure manual and could not locate a policy/procedure describing the laboratory's method to compare the testing performed on the three iSTAT 1 analyzers. Surveyor #1 asked the general supervisor if the laboratory had a written policy/procedure describing the laboratory's method for comparing the BNP, Troponin I, and PT/INR testing performed on the analyzers, including the criteria defining acceptable differences between the testing performed on the three analyzers. The general supervisor stated a policy/procedure had not been written. -- 3 of 3 --