Saint Francis Lab-Warren Clinic Elm Urgent Care

Summary Statement of Deficiencies D0000 The recertification survey was performed on 08/06,07/2025. 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. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D0000 The recertification survey was performed on 12/05/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director during an exit conference performed at the conclusion of the survey. D5409 PROCEDURE MANUAL 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 director, the laboratory failed to ensure that one of one written procedure no longer in use had been discontinued. Findings include: (1) A review of the manual titled, "Procedures" identified the following procedure: (a) "Complete Blood Counts, Abbott Cell-Dyn Emerald" (2) The procedure was reviewed with the laboratory director who stated on 12/05/2023 at 03:15 pm, the laboratory discontinued the use of the Cell-Dyn Emerald analyzer in April 2023 and the procedure should have been indicated as discontinued. 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: 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 -- Based on observation and interview with the laboratory supervisor, the laboratory failed to ensure an expired material was not available for use. Findings include: (1) On 12/05/2023 at 11:15 am, the laboratory supervisor stated CBC (Complete Blood Count) testing was performed using the Beckman Coulter DxH 520 hematology analyzer; (2) Observation of the laboratory on 12/05/2023 at 11:25 am identified one box of 10L DxH 500 Series Diluent that had exceeded the manufacturer's expiration date as follows: (a) Lot #0086170 with an expiration date of 10/29/2023 (3) Interview with the laboratory supervisor on 12/05/2023 at 11:23 am confirmed the expired materials were available for use. 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 director, the laboratory failed to ensure the performance specification data had been evaluated prior to implementing the new testing for one of one new test methods introduced into the laboratory. Findings include: (1) On 12/05/2023 at 03:20 pm, the laboratory director stated the laboratory began using the Cepheid GeneXpert DX analyzer to perform COVID-19, Influenza A, Influenza B, and RSV (Respiratory Syncytial Virus) testing on 10/23/2023; (2) A review of the performance specification records for the new test system identified no evidence the data had been signed and dated as approved by the laboratory prior to putting into use for patient testing; (3) Interview with the laboratory director on 12/05/2023 at 05:08 pm confirmed there was no documentation to prove the performance specification data had been reviewed and approved by the laboratory prior to putting into use. 47979 Based on a review of records and interview with the laboratory director and laboratory supervisor, the laboratory failed to utilize the demonstrated reportable range for one of one new test method. Findings include: (1) On 12/05/2023 at 11:15 am, the laboratory supervisor stated the laboratory began performing CBC (complete blood count) testing using the Beckman Coulter DxH 520 hematology analyzer on 05/23/2023; (2) A review of the performance specification records identified the laboratory had demonstrated the following reportable range: (a) Hemoglobin - 0.00 -19.40 g/dL (3) An interview with the laboratory director on 12/05 /2023 at 3:00pm confirmed the laboratory was using the following manufacturer's reportable range instead of the range that had been demonstrated by the laboratory: (a) Hemoglobin - 0.20 - 25.00 g/dL 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 -- 2 of 4 -- 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, policies and procedures, and interview with the laboratory director, the laboratory failed to follow their written protocol for ensuring the urine centrifuge was functioning properly for two of two function checks performed during the review period of January 2022 through the current date. Finding include: (1) On 12/05/2023 at 11:30 am, the technical consultant stated the following: (a) Urine sediment examinations were performed; (b) The specimens were processed in Horizon Mini 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 the following: (a) "To ensure the centrifuge is functioning properly in an acceptable standardized manner, its speed and timer is be checked annually"; (b) "Acceptable Limits Urine Centrifugation" - Horizon 642 VES is equivalent to 1500 rpm +/- 25 rpm; 5 minutes +/- 5 sec". (3) A review of centrifuge function check records during 2022 through the current date identified the centrifuge speed and/or timer had not been checked at the speed and times urines were processed for two of two checks performed as follows: (a) 10/29/2022 - The speed had been checked at 2511 rpm and the timer had been checked at 10 minutes; (b) 07/05/2023 - The speed had been checked at 3328 rpm. (4) The records were reviewed with the laboratory director who stated on 12/05/2023 at 04:00 pm, the laboratory had not followed their policy. 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 laboratory director, the laboratory failed to ensure one of two IQCP's (Individualized Quality Control Plan) included the required components; failed to perform quality control as stated in the IQCP; and failed to ensure data supported the (QC) Quality Control frequency as defined in the IQCP for one of two test systems. Findings include: REQUIRED COMPONENTS OF IQCP (1) On 12/05/2023 at 03:20 pm, the laboratory director stated the following: (a) The laboratory began using the Cepheid GeneXpert DX analyzer to perform COVID- 19, Influenza A, Influenza B, and RSV (Respiratory Syncytial Virus) testing on 10/23 /2023; (b) An IQCP had been developed for the test system. (2) A review of the IQCP identified a Risk Assessment and QA (Quality Assessment) plan had not been included in the IQCP; (3) The records were reviewed with the laboratory director who stated on 12/05/2023 at 04:45 pm, a Risk Assessment and QA plan had not been -- 3 of 4 -- included in the IQCP. QUALITY CONTROL (1) Interview with the laboratory director on 12/05/2023 at 03:20 pm and a review of the QCP (Quality Control Plan) for the above IQCP identified the QCP required QC (quality control) testing be performed on a monthly basis; (2) A review of QC records for the testing performed from October 2023 through November 2023 identified no documentation to prove QC testing had been performed as stated in the QCP for 13 of 13 days of patient testing (QC had not been documented as performed since 10/05/2023); (3) The records were reviewed with the laboratory director who stated on 12/05/2023 at 04:55 pm, QC had not been documented as performed as shown above. DATA DID NOT SUPPORT QC FREQUENCY (1) A review of the QCP supporting documentation for the above IQCP identified the laboratory had not tested external QC materials to support the QC frequency of monthly as required by the QCP. Positive and negative QC materials for COVID-19, Influenza A, Influenza B, and RSV had been tested for 12 days (not at least 30-31 days); (2) The records were reviewed with the laboratory director who stated on 12/05/2023 at 04:55 pm, the QC had not been tested for at least 30 -31 days. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/26/2021. The findings were reviewed with the laboratory director and technical consultant #2 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 technical consultant #2, the laboratory failed to retain records for at least 2 years for 2 of 3 months. Findings include: (1) On 10/26/2021 at 10:30 am, technical consultant #2 stated to the surveyor: (a) CBC (Complete Blood Count) testing was performed using the Abbott Cell-Dyn 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) The surveyor reviewed Levy Jenning records between January 2021 through March 2021 with the following identified: (a) Records between 02/01 /2021 and 03/31/2021 were not available for the high level of quality control material. (3) The surveyor ask technical consultant #2 if the records between 02/01/2021 and 03 /31/2021 could be located; (4) Technical consultant #2 stated on 10/26/2021 at 03:41 pm records between 02/01/2021 and 03/31/2021 for CBC testing could not be located. Therefore, the surveyor could not determine if the records for the above months had been monitored and evaluated for shifts and trends for 2 of 3 months. D5445 CONTROL PROCEDURES 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): 493.1256(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 laboratory director the laboratory failed to follow written quality control policies for 1 of 20 months. Findings include: (1) On 10/26/2021 at 10:30 am, technical consultant #2 stated the following to the surveyor: (a) PT/INR (Prothrombin Time/International Normalized Ratio) testing was performed in the laboratory using the PT/INR cartridge and two iSTAT analyzers (serial number 307964 and 302678); (b) An IQCP (Individualized Quality Control Plan) had been developed for the above test systems. (2) The surveyor reviewed the IQCP 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 every 30 days; (3) The surveyor reviewed QC (quality control) records for 20 months (January 2020 through August 2021) and identified the laboratory failed to follow the written QCP of performing quality control testing every 30 days. Quality control testing had not been performed as follows: (a) PT/INR (i) Between 06/03/2020 and 08/23/2020 (4) The findings were reviewed with technical consultant #2 who stated on 10/26/2021 at 03:40 pm, the laboratory had not performed quality control testing as required by the QCP. D5775 COMPARISON OF TEST RESULTS 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 technical consultant #2, the laboratory failed to evaluate the relationship between test results using two different analyzers at least twice a year. Findings include: (1) On 10/26 /2021 at 10:30 am, technical consultant #2 stated to the surveyor PT/INR (Prothrombin Time/International Normalized Ratio) testing was performed using two iSTAT 1 analyzers (serial numbers 307964 and 302678); (2) The surveyor reviewed the written procedure titled, "Six Month ISTAT Comparison" which stated,"Every 6 months all non-waived POC iSTAT instruments on site are compared/correlated with each other."; (3) The surveyor reviewed the iSTAT comparison records between 08/02 /2019 through the day of the survey (10/26/2021) but could not locate the comparison between between the analyzers for PT/INR testing; (4) The surveyor asked technical consultant #2 if the relationship between the analyzers for PT/INR testing had been -- 2 of 3 -- evaluated twice annually during the review period of 08/02/2019 through the day of the survey (10/26/2021). Technical consultant #2 stated on 10/26/2021 at 03:30 pm the relationship between the analyzers had not been evaluated during the review period. D5781

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/17/2019. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director, technical consultant #1, and testing person #1 at the conclusion of the survey. 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 technical consultant #1, the laboratory failed to thoroughly review and evaluate proficiency testing results. Findings include: BIASES NOT IDENTIFIED (1) At the beginning of the survey, technical consultant #1 stated to the surveyor the laboratory performed Hemogram (i. e, WBC (White Blood count), RBC (Red Blood count), Hemoglobin, Hematocrit. MCV (Mean Corpuscular Volume), MCHC (Mean Corpuscular Hemoglobin Concentration), RDW (Red Cell Distribution Width), and Platelet count) testing on the Abbott Emerald analyzer; (2) The surveyor reviewed proficiency testing records for 2018 through the date of the survey in 2019. The surveyor identified in the First 2018 Event, 4 of the laboratory's 5 Hemoglobin proficiency testing results obtained biases (the biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency testing program): (a) Hemoglobin - 4 of 5 results exhibited a Negative bias: (i) HEM-02: SDI -1.9 (ii) HEM-03: SDI -2.2 (iii) HEM-04: SDI -2.1 (iv) HEM-05: SDI -2.2 (3) The surveyor reviewed the records again and identified there was no documentation the laboratory had identified the biases or had taken

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database. 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, 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 consecutive testing events for the analyte Hematocrit. 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, the laboratory failed to achieve successful performance for the analyte RBC (Red Blood Cell). Findings include: (1) The laboratory failed to achieve satisfactory performance on the third event in 2018 and the first event in 2019. Refer to D2130. NOTE: The only acceptable