Saint Francis Lab-South Memorial

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/20/2025 through 10/21/2025. The laboratory was found in compliance with standard-level deficiencies cited. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) 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 director, the laboratory failed to ensure the manufacturer's instructions were followed for performing maintenance procedures for one of one analyzer reviewed from September 2024 through September 2025. Findings include: (1) On 10 /20/2025 at 09:40 am, the laboratory director stated the laboratory performed hemogram (WBC (White Blood Cell), RBC (Red Blood Cell), Hgb (Hemoglobin), Hct (Hematocrit), MCV (Mean Corpuscular Volume), MCHC (Mean Corpuscular Hemoglobin Concentration), RDW (Red Cell Distribution Width), Plt (Platelet Count), and MPV (Mean Platelet Volume)) testing using the Beckman Coulter DxH 520 analyzer; (2) On 10/20/2025, a review of the manufacturer's maintenance log showed the following required monthly maintenance procedure: (a) Clean the WBC Bath Filter (3) A review of maintenance logs from September 2024 through September 2025 identified monthly maintenance had not been documented as performed as follows: (a) Between 05/29/2025 and 07/03/2025; (b) Prior to 10/31 /2024. (4) The records were reviewed with the laboratory director who stated on 10/20 /2025 at 02:45 pm, the monthly maintenance procedure had not been documented as performed as stated 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 1 --

Summary Statement of Deficiencies D0000 The initial survey was performed on 02/07/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the technical consultant and incoming technical consultant during an exit conference performed at the conclusion of the survey. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 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 regulations: 493.803; D2016: Successful Participation 493.1407; D6000: Laboratory Director, Moderate 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 the proficiency testing graded evaluations obtained from American Proficiency Institute, the laboratory failed to successfully participate in a proficiency 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 -- testing program for the specialty of Hematology. Findings include: (1) The laboratory failed to achieve satisfactory performance for three of four proficiency testing events for the analyte Platelets. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from American Proficiency Institute, the laboratory failed to achieve satisfactory performance for the analyte Platelets for three of four consecutive testing events. Findings include: (1) The laboratory received the following scores for Platelets: (a) First 2021 Event - 60% (b) Third 2021 Event - 40% (c) First 2022 Event - 40% 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 a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from American Proficiency Institute, the laboratory demonstrated non-initial unsuccessful participation for the analyte Platelets. The laboratory failed to achieve a passing score of 80% for the First 2021 Event, Third 2021 Event, and First 2022 Event. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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 a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from American Proficiency Institute, the laboratory demonstrated non-initial unsuccessful participation for the analyte Platelets. The laboratory failed to achieve a passing score of 80% for the First 2021 Event, Third 2021 Event, and First 2022 event. Refer to D2130. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 04/15/2022. The findings were reviewed with the technical consultant at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to retain records for at least two years for two of nine months. Findings include: (1) On 04/15/2022 at 10:30 am, the technical consultant stated the following: (a) Routine CBC (Complete Blood Count) was performed on the Abbott Emerald analyzer; (b) Three levels (Low, Normal, and High) of Cell-Dyn 18 Plus quality control materials were tested each day that patient testing was performed on the analyzer. (2) A review of the Levy Jenning records between May 2020 through January 2021 showed the following: (a) Quality Control records between 11/13/2020 and 01/01/2021 were not available. (3) The records were reviewed with the technical consultant, The technical consultant stated on 04/15/2022 at 03:40 pm records between 11/13/2020 and 01/01/2021 for CBC testing could not be located. Therefore, there was no evidence the records for the above months had been monitored and evaluated for shifts and trends for two of nine months. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by 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 3 -- laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of records, written procedures, and interview with the technical consultant, the laboratory failed to follow competency assessment procedures for one of eight testing persons. Findings include: (1) On 04/15/2022 at 10:30 am, the technical consultant stated the following: (a) Routine CBC (Complete Blood Count) was performed on the Abbott Emerald analyzer; (b) Chemistry testing was performed using the CG8+ cartridge on the Abbott iSTAT analyzer; (c) PT/INR (Prothrombin Time/International Normalized Ratio) testing was performed using the PT/INR cartridge on the Abbott iSTAT analyzer; (d) Serum pregnancy testing was performed using the Beckman Icon 25 kit; (e) Mononucleosis testing was performed using the Remel Colorslide II kit. (2) A review of the laboratory's written procedure manual under the section titled, "EMPLOYEE ASSESSMENT FOR COMPETENCY" stated: (a) "1. Competency evaluation is ongoing with review of results. However, competency will formally be addressed at semiannual and annually from initial training date.". (3) A review of the personnel records revealed the following: (a) Testing person #2 (i) The initial training evaluation had been documented as performed on 05/15/2020; (ii) The semiannual evaluation had been documented as performed on 11/13/2020; (iii) The annual evaluation had been documented as performed on 11/03/2021 (18 months after the initial training). (4) The findings were reviewed with the technical consultant. The technical consultant stated on 04/15/2022 at 12:10 pm, the competency assessment procedure had not been followed as indicated above. 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, and interview with the technical consultant, the laboratory failed to ensure an analyzer was stored as required by the manufacturer for two of two months. Findings include: (1) On 04/15/2022 at 10: 30 am, the technical consultant stated the following: (a) Routine CBC (Complete Blood Count) was performed on the Abbott Emerald analyzer;(2) A review of the manufacturer's environmental requirements for the analyzer required the relative humidity be maintained within a range of 20-80%; (3) A review of the laboratory humidity records from January 2022 through February 2022 revealed the humidity readings were less than 20% for two of two months as follows: (a) January 2022 - 13 of 31 humidity readings were documented as less than 20% (days 2,3,5,6,7,19,21,22,23,25,26,29,30); (b) February 2022 - 10 of 28 humidity readings was documented as less than 20% (days 3,4,5,12,13,18,23,24,25,26). (4) The records -- 2 of 3 -- were reviewed with the technical consultant who stated on 04/15/2022 at 02:20 pm the laboratory humidity had been maintained below 20% as indicated above. -- 3 of 3 --

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 laboratory. 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 the proficiency testing graded evaluations obtained from laboratory, the laboratory failed to successfully participate in a proficiency testing program for the specialty of Hematology. Findings include: (1) The laboratory failed to achieve satisfactory performance for two of three testing events for Platelet Count testing. Refer to D2128 and D2130. 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 -- D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. 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 proficiency testing graded evaluation obtained from the laboratory, the laboratory failed to achieve successful performance for Platelet Count testing. Findings include: (1) The laboratory failed to achieve satisfactory performance on the first event in 2021 and the third event in 2021. Refer to D2130. NOTE: The only acceptable

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/15/19. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director/technical consultant #2 and technical consultant #1 at the conclusion of the survey. 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, observation, and interview with technical consultant #1, the laboratory failed to demonstrate the performance specification of reportable range for a new analyzer. Findings include: (1) At the beginning of the survey, the surveyor observed the laboratory and identified two i-STAT 1 analyzers (SN (Serial Number) #373250 and SN #400564). Technical consultant #1 stated the i-STAT 1 analyzer, SN #400564 was put into use on 06/28/18 and both analyzers were used to perform the following patient testing: (a) BNP (Brain Natriuretic Peptide) with the BNP test cartridge (b) PT/INR (Prothrombin Time/International Normalized Ratio) using the PT /INR cartridge (c) Troponin I using the cTnI cartridge (2) The surveyor reviewed the implementation records for the i-STAT 1 analyzer, SN #400564. There was no documentation the laboratory had demonstrated the reportable range for each test cartridge type prior to putting the analyzer into use for patient testing; (3) The surveyor reviewed the findings with technical consultant #1 who stated to 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 -- surveyor the laboratory failed to demonstrate the reportable range for each cartridge type. D5783

Summary Statement of Deficiencies D0000 The findings were reviewed with technical consultant #1 at the conclusion of the survey. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #1, the laboratory failed to ensure a proficiency testing attestation statement had been signed by the analyst. Findings include: (1) During the survey, surveyor #1 reviewed 2016 and 2017 proficiency testing records. The following was identified for 1 of 6 Chemistry proficiency testing events: (a) First 2016 Chemistry Group 2 Event - The attestation statement had not been signed and dated by the analyst. (2) Surveyor #1 reviewed the records with technical consultant #1, who stated the attestation statement had not been signed and dated by the analyst. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) 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 -- Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with technical consultant #1, the laboratory failed to retain quality control records for at least 2 years. Findings include: (1) At the beginning of the survey, technical consultant #1 stated to the surveyors CBC (Complete Blood Count) testing was performed using the Cell-Dyn Emerald; (2) Later during the survey, surveyor #2 reviewed quality control records (lot #7240) with the following identified: (a) October 2017 records were not available (3) The surveyors ask technical consultant #1 if the quality control records for October 2017 could be located; (4) Technical consultant #1 stated the October 2017 quality control records for CBC testing could not be located. The surveys could not determine if the quality control records for the above month had been monitored and evaluated. 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 technical consultant #1, the laboratory failed to evaluate proficiency testing results that had not been evaluated by the proficiency testing program. Findings include: (1) During the survey, surveyor #1 reviewed 2016 and 2017 proficiency testing records. The review indicated the laboratory did not address results that were not evaluated by the proficiency testing program for 2 of 6 Hematology events as follows: (a) Third 2016 Event (i) Urobilinogen - 1 of 1 result 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. (b) Second 2017 Event (i) Urobilinogen - 1 of 1 result 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) Surveyor #1 reviewed the records with technical consultant #1, who stated the laboratory had not evaluated the results that were not graded by the proficiency testing program. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) -- 2 of 4 -- Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (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, written procedure, and interview with technical consultant #1, the laboratory failed to ensure control procedures monitored the accuracy and precision of the analytic process. Findings include: (1) At the beginning of the survey, technical consultant #1 stated to the surveyors: (a) CBC (Complete Blood Count) testing was performed on the Abbott Cell-Dyn Emerald analyzer; (b) Three levels (Low, Normal and High) of Abbott Cell- Dyn 18 Plus Control quality control (QC) materials were performed each day of patient testing. (2) Later during the survey, surveyor #2 reviewed the following: (a) The laboratory's written quality control procedure which stated,"Follow Procedure to establish acceptable +/- 2SD ranges". Technical consultant #1 explained to the surveyors each new lot of QC materials were tested 20 times to establish a mean and 2 SD (standard deviations) range; (b) Package insert, which stated "The MEAN RANGE does not represent standard deviations (SD)". (3) The surveyors reviewed the records for 3 lot numbers of quality control materials used from 12/16/17 to date. It was identified that, although the laboratory had established their own means and ranges for each lot number, they did not utilized their calculated averages as their means and limits of acceptability. Examples were as follows: (a) Low control (lot #L7324), normal control (lot #N7324) and high control (lot #H7324) put into use 12 /16/17 to date; (i) RBC (red blood cell) (aa) Low control (i) The laboratory established a mean of 2.23, but the mean of 2.22 had been used to evaluate quality control results; (ii) The laboratory established a lower limit of 2.14, but the lower limit of 2.09 had been used to evaluate quality control results; (iii) The laboratory established an upper limit of acceptability was 2.32, but the upper limit of 2.37 had been used to evaluate quality control results. (ii) Platelet (aa) Normal control (i) The laboratory established mean was 215, but the mean 207 had been used to evaluate quality control results; (ii) The laboratory established lower limit of acceptability was 195, the lower limit of 172 had been used to evaluate quality control results; (iii) MCHC (mean corpuscular hemoglobin concentration) (aa) High control (i) The laboratory established mean was 32.1, but the mean 32.4 had been used to evaluate quality control results; (3) The surveyors reviewed the findings with technical consultant #1 who stated the laboratory did not follow the laboratory's quality control policy to ensure control procedures monitored the accuracy and precision for CBC testing. 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 acceptability. -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on a review of a patient test report and interview with technical consultant #1, the laboratory failed to ensure patient test reports included the name and address of the laboratory location. Findings include: (1) On the second day of the survey, the surveyors reviewed a patient test report as follows: (a) PT/INR (Prothombin Time /International Normalized Ratio) testing was performed with the results reported on 03 /01/2018. (2) The surveyors identified that the name of the laboratory on the reports was "OL SO Memorial Urgent", which did not match the name on the Clia certificate. The name on the Clia certificate was "Saint Francis Lab-South Memorial". In addition, the report did not include the address of the laboratory location; (3) The surveyors reviewed the reports with technical consultant #1, who stated the name on the report did not match the name on the Clia certificate, and the laboratory address was not included on the report. -- 4 of 4 --