Fairview Regional Medical Center

Summary Statement of Deficiencies D0000 The recertification survey was performed on 12/3,4,5/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the chief nursing officer, human resources director, and laboratory manager during an exit conference performed at the conclusion of the survey. 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 records, observation, and interview with the laboratory manager, the laboratory failed to follow manufacturer's directions to ensure Abbott Affinion hemoglobin A1C cartridges had not exceeded their room temperature expiration date for one of one cartridge type observed. Findings include: (1) On 12/03/2024 at 11:28 am, laboratory director stated hemoglobin A1C testing was performed on the Abbott Affinion analyzer; (2) Observation of the laboratory on 12/03/2024 at 11:30 am identified 12 hemoglobin A1C cartridges (Lot #10229258) stored at room temperature, without documentation of when they were removed from refrigeration; (3) Review of the manufacturer's storage requirements showed the following: (a) The cartridges were stable at 2-8 degrees C (Centigrade) until the expiration date listed on the box; (b) The cartridges were stable at room temperature (18-30 degrees C) for 90 days. (4) Interview with the laboratory manager on 12/03/2024 at 11:30 am confirmed the cartridges had been placed at room temperature without a method to monitor if they exceeded the manufacturer's room temperature expiration date. D3025 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(d) 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 -- Investigation of transfusion reactions. The facility must have procedures for preventing transfusion reactions and when necessary, promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory and, as appropriate, to Federal and State authorities. This STANDARD is not met as evidenced by: Based on a review of records, nursing policy, and interview with the laboratory manager, the facility failed to ensure written policies were followed for preventing transfusion reactions for two of seven units of packed red-blood cells transfused. Findings include: (1) On 12/5/2024 at 11:55 am, the laboratory manager stated blood transfusions were performed by nursing staff; (2) A review of the hospital policy titled, "Administration of Blood Products" stated: (a) "Vital signs are taken immediately prior to infusing the blood" (b) "Every 15 minutes twice, then" (c) "30 minutes then" (d) "Every hour for the remainder of the transfusion, then" (e) "On hour after infusion is complete." (3) A review of transfusion records for seven units transfused, identified the policy had not been followed for two of seven units as follows: (a) Unit #W091024143368 - The transfusion started on 07/24/2024 at 02:25 pm and ended at 04:52 pm. Vital signs had not been taken as follows; (i) One hour post-transfusion vital signs - Not taken between 04:50 pm and 07:01 pm. (b) Unit #W091024214384 - The transfusion started on 06/04/2024 at 12:21 pm and ended at 02:15 pm. Vital signs had not been taken as follows; (i) One hour post transfusion vital signs not taken. (4) The records were reviewed with the laboratory manager who stated on 12/05/2024 at 11:55 am, the vital signs had not been documented according to policy. 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 (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 laboratory manager, the laboratory failed to evaluate the accuracy of testing when proficiency results had not been graded by the proficiency program for one of five Hematology/Coagulation events reviewed. Findings include: (1) On 12/04/2024 at 01:00 pm, he laboratory manager stated that prothrombin time testing was performed using the Hemochron Signature Elite analyzer; (2) A review of proficiency testing records for 2023 (first, second, and third event) and 2024 (first and second events) identified three of five results had not been graded by the proficiency testing program and the laboratory's reported result for one of the three results did not agree with the "Expected" result for the first 2024 event: (a)Sample HCP-03 was reported as 12.0 and the expected range was 12.6-17.6 (3) There was no evidence in the records proving

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and from the proficiency testing provider. The laboratory was found out of compliance with the following CLIA Conditions: 493.803; D2016: Successful Participation 493.1441; D6076: Laboratory Director, High Complexity 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 a desk review of proficiency testing scores obtained from the Casper 0155D report, and Performance Summary and Comparative Evaluation obtained from American Proficiency Institute, the laboratory failed to successfully participate in a 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 program for the subspecialty of ABO Group. Findings include: (1) The laboratory failed to achieve satisfactory performance for two consecutive testing events for ABO Group. Refer to D2162. D2162 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(f) Failure to achieve satisfactory performance for the same analyte 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 a desk review of proficiency testing scores obtained from the Casper 0155D report, and Performance Summary and Comparative Evaluation obtained from American Proficiency Institute, the laboratory failed to achieve satisfactory performance for ABO Group for two consecutive testing events. Findings include: (1) The laboratory received a score of 80% on the third 2023 event and a score of 0% on the first 2024 event. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report, and Performance Summary and Comparative Evaluation obtained from American Proficiency Institute, the laboratory failed to achieve satisfactory performance for ABO Group in two consecutive testing events. The laboratory failed to achieve a passing score of 100% for the third 2023 event and first 2024 event. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report, and the American Proficiency Institute, the laboratory failed to achieve satisfactory performance for ABO Group in two consecutive testing events. The laboratory failed to achieve a passing score of 100% for the third 2023 event and first 2024 event. Refer to D2162. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/17,18/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the chief executive officer and laboratory manager during an exit conference performed 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 laboratory manager, the laboratory failed to have a written policy to assess the competency of the general supervisor and technical supervisor, based on the position responsibilities as listed in Subpart M, for three of three persons serving as general supervisor and two of two persons serving as technical supervisor. Findings include: (1) On 01/17/2023, a review of the competency assessment policy identified no guidance, including the frequency, for assessing the competency of the general supervisors and technical supervisors; (2) A review of the Form CMS-209 and personnel records for competency assessments performed during the review period of 2021 through the current date in 2023 identified competencies, based on job responsibilities, had not been performed as follows: (a) General Supervisor - Not performed during the review period for three of three persons listed on Form CMS- 209; (c) Technical Supervisor - Not performed during the review period for two of two persons listed on Form CMS-209. (3) The findings were reviewed with the laboratory manager who stated on 01/17/2023 at 01:45 pm a policy had not been written and competencies had not been performed for the positions as shown above. 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 -- D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to verify the accuracy of Qualitative Semen Analysis (presence or absence of sperm) at least twice annually for one of two years reviewed. Findings include: (1) On 01/17/2023 at 10:50 am, the laboratory manager stated the laboratory performed Qualitative Semen Analysis to detect presence or absence of sperm; (2) A review of records for testing performed during 2021 and 2022 identified the testing had not been verified for accuracy since 09/14/2021; (3) The records were reviewed with the laboratory manager who stated on 01/18/2023 at 09:04 am, Qualitative Semen Analysis had not been verified for accuracy at least twice annually in 2022. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of records, observation, and interview with the laboratory manager, the laboratory failed to ensure materials were stored as required for 12 of 12 months reviewed. Findings include: (1) On 01/18/2023 at 01:30 pm, observation of the contents of the American BioTech Supply freezer identified the following materials: (a) One box of LGC Maine Standards GC1 test set materials for calibration verification of Direct Bilirubin and Total Bilirubin, lot #10613613 - the storage requirement as stated on the box was -25 to -10 degrees C (Centigrade); (b) One box of LGC Maine Standards GC4 test set materials for calibration verification of HDL (High Density Lipoprotein), lot #10640560 - the storage requirement as stated on the box was -25 to -10 degrees C (2) A review of temperature records for 12 months (January 2022 through December 2022) identified the documented temperatures were colder than -25 degrees C (the coldest temperature allowed for the materials) during 12 of 12 months as follows: (a) January 2022 - 31 of 31 temperatures were documented as colder than -25 degrees C (b) February 2022 - 28 of 28 temperatures were documented as colder than -25 degrees C (c) March 2022 - 30 of 31 temperatures were documented as colder than -25 degrees C (d) April 2022 - 30 of 30 temperatures were documented as colder than -25 degrees C (e) May 2022 - 30 of 31 temperatures were documented as colder than -25 degrees C (f) June 2022 - 28 of 30 temperatures were documented as colder than -25 degrees C (g) July 2022 - 28 of 31 temperatures were documented as colder than -25 degrees C (h) August 202 - 29 of 31 temperatures were documented as colder than -25 degrees C (i) September 2022 - 26 of 30 temperatures were documented as colder than -25 degrees C (j) October 2022 - -- 2 of 5 -- 25 of 31 temperatures were documented as colder than -25 degrees C (k) November 2022 - 17 of 30 temperatures were documented as colder than -25 degrees C (l) December 2022 - 23 of 31 temperatures were documented as colder than -25 degrees C (3) The records were reviewed with the laboratory manager who stated on 01/18 /2023 at 02:10 pm, the materials were not being stored as required by the manufacturer. 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 laboratory manager, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures for the Sysmex XS 1000i analyzer during two of 12 months reviewed from January 2022 through December 2022. Findings include: (1) On 01/17/2023 at 10:40 am, the laboratory manager stated CBC (Complete Blood Count) testing was performed using the Sysmex XS 1000i analyzer; (2) On 01/18 /2023 a review of the manufacturer's maintenance log showed the following required weekly maintenance procedure: (a) "Power Down IPU" (3) A review of maintenance logs from January 2022 through December 2022 identified weekly maintenance had not been documented as performed between: (a) 07/22/2022 and 08/05/2022 (b) 09/02 /2022 and 09/16/2022 (c) 09/16/2022 and 09/30/2022 (4) The records were reviewed with the laboratory manager who stated on 01/18/2023 at 11:45 am, the weekly maintenance had not been documented as performed as shown above. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) 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: (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. (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 and interview with the laboratory manager, the laboratory failed to ensure the urine centrifuge was functioning properly for two of two years. Findings include: (1) On 01/17/2023 at 10:50 am, the laboratory manager stated the following: (a) Urine sediment examinations were performed in the laboratory; (b) The specimens were processed in the Horizon Model 642 VES centrifuge at a speed of 1500 rpm (revolutions per minute) for five minutes; (c) The laboratory checked the speed and timer annually. (2) On 01/18/2023 a review of the centrifuge records from 2021 through the current date identified the following: (a) Check performed on 05/21/2021 - The documentation stated "pass" and the actual -- 3 of 5 -- speed and time that had been obtained had not been recorded; (b) Check performed on 11/22/2021 - The documentation stated "pass" and the actual speed and time that had been obtained had not been recorded; (c) There was no documentation to prove the centrifuge speed and timer had been checked during 2022. (3) The records were reviewed with the laboratory manager who stated on 01/18/2023 at 09:06 am, the laboratory had not ensured the centrifuge was functioning properly as stated above. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected 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 records and interview with the laboratory manager, the laboratory failed to perform calibration verification procedures at least once every six months for one of four test systems reviewed from January 2021 through December 2022. Findings include: (1) On 01/17/2023 at at 10:50 am, the laboratory manager stated the laboratory performed D-dimer testing using the Biosite Triage Meter Pro analyzer; (2) On 01/18/2023 a review of records for the test system from January 2021 through December 2022 identified calibration verification had not been performed between 06/11/2021 and 06/29/2022; (3) The records were reviewed with the laboratory manager who stated on 01/18/2023 at 11:41 am, calibration verification had not been performed every six months for D-dimer testing. 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: -- 4 of 5 -- Based on a review of records and interview with the laboratory manager, the laboratory failed to follow their policy for monitoring the effectiveness of their QCP (quality control plan) for two of four test systems. Findings include: (1) On 01/17 /2023 at 10:45 am, the laboratory manager stated the following: (a) PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing were performed using the Hemochron Signature Elite analyzer; (b) An IQCP (Individualized Quality Control Plan) had been developed for the test system. (2) A review of the IQCP identified that QA (Quality Assessment) reviews of the QCP were to be performed on an annual basis; (3) A review of records for the test system from November 2020 through the current date identified no documentation QA reviews had been performed between 11/23/20 and 12/30/22; (4) The records were reviewed with the laboratory manager who stated on 01/17/2023 at 05:34 pm, the annual QA review for 2021 had not been documented as performed. -- 5 of 5 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 05/12,13,14/2021. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory manager and technical consultant #3 at the conclusion of the survey. 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 (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 laboratory manager and technical consultant #3, the laboratory failed to evaluate the accuracy of testing when proficiency results had not been graded by the proficiency program for 1 of 3 Immunohematology events. Findings include: (1) On 05/12/2021, the surveyor reviewed the first, second, and third Immunohematology proficiency testing events for 2020. The review showed the laboratory did not address results that were not graded by the proficiency testing program for 1 of 3 events as follows: (a) Third Event 2020 (i) Antibody Screen - 1 of 5 results (sample SER-11) had not been evaluated by the proficiency testing program. Under "Expected Result" it stated, "See Data Summary." There was no evidence the laboratory reviewed the data summary to evaluate their result. (2) The surveyor reviewed the records with the laboratory manager and technical consultant #3. Both stated on 05/12/2021 at 04:40 pm, the laboratory had not evaluated the result that was not graded by the proficiency testing program. D5409 PROCEDURE MANUAL 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 -- CFR(s): 493.1251(e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in 493.1105(a)(2). This STANDARD is not met as evidenced by: Based on a review of the procedure manual and interview with the laboratory manager and technical consultant #3, the laboratory failed to ensure that written procedures no longer in use had been discontinued. Findings include: (1) On 05/14/2021, the surveyor reviewed the manual titled, "Policies & Procedures" and identified a procedure titled, "CLIA Waived iSTAT Chem 8+"; (2) The surveyor reviewed the procedure with the laboratory manager and technical consultant #3. Both stated on 05 /14/2021 at 12:40 pm, the procedure should have been indicated as discontinued when the when the Chem 8+ cartridge had been discontinued in February 2020. NOTE: 493.1105(a)(2) requires that discontinued procedures be maintained for at least 2 years. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, observation, and interview with the laboratory manager, the laboratory failed to ensure materials were stored as required for 5 of 5 months. Findings include: (1) On 05/12/2021 at 10:00 am, the laboratory manager stated to the surveyor Lipase testing was performed using the Vital Diagnostics Envoy 500 analyzer; (2) On 05/13/2021 at 01:40 pm, the surveyor observed the following stored in the white ABS freezer: (a) ELI Tech Group ELICAL 2, lot #06-6080-01, which had been reconstituted and aliquoted into 5 vials. (3) The laboratory manager stated to the surveyor on 05/13/2021 at 01:43 pm, the material was used to perform calibration procedures for Lipase testing; (4) The surveyor reviewed the manufacturer's package insert for the calibrator. Under "After Reconstitution", it stated, "Stability of the components: Between -25 and -15 C; 4 weeks (when frozen once)"; (5) The surveyor then reviewed the temperature records from January 2021 through the current date for the ABS freezer, and identified the materials were being stored at temperatures colder than -25 degrees C (Centigrade) for 132 of 132 days reviewed as follows: (a) January - 31 of 31 documented temperatures were colder than -26 degrees C (b) February - 28 of 28 documented temperatures were colder than -26 degrees C (c) March - 31 of 31 documented temperatures were colder than -26 degrees C (d) April - 30 of 30 documented temperatures were colder than -26 degrees C (e) May 12 of 12 documented temperatures were colder than -26 degrees C (6) The surveyor reviewed the records with the laboratory manager who stated on 05 /13/2021 at 03:00 pm, the freezer temperatures were unacceptable for the materials as shown above. -- 2 of 3 -- D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) 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 a review of records, and interview with the laboratory manager and technical consultant #3, the laboratory failed to ensure the demonstrated reportable range was utilized for a new test method. Findings include: (1) On 05/12/2021 at 10: 00 am, the laboratory manager stated to the surveyor, the laboratory began using the TOSOH AIA-900 analyzer to perform PSA (Prostate Specific Antigen) testing June 2020; (2) On 05/13/2021, the surveyor reviewed the performance specification records and identified the laboratory had demonstrated a reportable range of 0.05-91.7 ng/ml; (3) The surveyor requested the reportable range that was being utilized by the laboratory. The laboratory manager and technical consultant provided the surveyor with the manufacturer's reportable range of 0.05-96.5 ng/dl; (4) The surveyor reviewed the findings with the laboratory manager and technical consultant #3. Both stated on 05/13/2021 at 04:35 pm, the laboratory was not using the reportable range that had been demonstrated by the laboratory. -- 3 of 3 --