Crowley Walkin Clinic Corporation

Summary Statement of Deficiencies D0000 A Recertification survey was performed on February 11, 2025 at Crowley Walk-In Clinic, CLIA ID #19D0461155. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were 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 review of the laboratory's policies and proficiency testing (PT) records as well as interview with personnel, the laboratory failed to ensure the Laboratory Director and/or designee reviewed the PT performance evaluation results for one (1) of five (5) events. Findings: 1. Review of the laboratory's "Proficiency Testing" policy revealed "The technical consultant and/or laboratory director will review and sign all surveys and all related documentation will be retained for at least two years." 2. Review of the laboratory's American Proficiency Institute (API) proficiency testing records revealed the Laboratory Director and/or Technical Consultant did not document review of the 2023 Hematology/Coagulation 2nd Event. 3. In interview on February 11, 2025 at 9:56 a.m., the Technical Consultant confirmed the evaluation was not signed as identified above. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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 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 -- applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 observation, review of manufacturer's storage requirements and laboratory temperature records, as well as interview with personnel, the laboratory failed to monitor refrigerator temperatures for one (1) of one (1) refrigerators where laboratory supplies were stored. Findings: 1. Observation by surveyor during the laboratory tour on February 11, 2025 at 9:20 a.m. revealed the laboratory stored Sysmex Eightcheck- 3WP X-TRA quality control materials in a refrigerator located in the laboratory. 2. Review of the manufacturer's package insert for the Sysmex Eightcheck-3WP X-TRA revealed "EIGHTCHECK - 3WP X - TRA is to be stored closed at 2 - 8 degrees Celsius." 3. Review of the laboratory's temperature monitoring records revealed the laboratory did not monitor the temperature of the refrigerator containing the quality control materials identified above. 4. In interview on February 11, 2025 at 10:15 a.m., the Technical Consultant confirmed the laboratory did not monitor the temperature of the refrigerator as identified above. 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: **Repeat deficiency from previous survey June 27, 2023** Based on observation, review of the manufacturer's operator's manual and the laboratory's maintenance records, as well as interview with personnel, the laboratory failed to ensure maintenance for the Sysmex pocH-100i was performed and documented every two weeks for five (5) of eleven (11) months reviewed. Findings: 1. Observation by surveyor during the laboratory tour on February 11, 2025 at 9:20 a.m. revealed the laboratory utilized the Sysmex pocH-100i for complete blood count testing. 2. Review of the manufacturer's operator's manual for the Sysmex pocH-100i section "Routine Maintenance Procedures" revealed "Every 2 Week Maintenance (or every 150 samples): Clean Tranducer." 3. Review of the laboratory's maintenance logs revealed "Every 2 weeks: Clean transducer." 4. Further review of the laboratory's maintenance records from March 2024 through January 2025 revealed the laboratory failed to perform and document maintenance every two weeks for the following months: a) March 2024: One (1) of two (2) cleanings not performed b) April 2024: One (1) of three (3) cleanings not performed c) August 2024: One (1) of two (2) cleanings not performed d) September 2024: One (1) of three (3) cleanings not performed e) November 2024: One (1) of two (2) cleanings not performed 5. In interview on February 11, 2025 at 10:28 a.m., the Technical Consultant confirmed the maintenance was not performed as identified above. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an -- 2 of 4 -- ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the laboratory failed to establish complete procedures to monitor, assess, and correct problems identified with the analytic system. Findings: 1. The laboratory failed to monitor refrigerator temperature for one (1) of one (1) refrigerators where laboratory supplies were stored. Refer to D5413. 2. The laboratory failed to ensure maintenance for the Sysmex pocH-100i was performed and documented every two weeks for five (5) of eleven (11) months reviewed. Refer to D5429. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results; This STANDARD is not met as evidenced by: Based on observation, review of manufacturer's instructions, and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Refer to D5413. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require

Summary Statement of Deficiencies D0000 A Recertification survey was performed on June 27, 2023 at Crowley Walk-In Clinic, CLIA ID #19D0461155. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the laboratory's CMS 209 (Laboratory Personnel Report) form, proficiency testing records, and the laboratory's policy and procedure manual, as well as interview with personnel, the laboratory failed to ensure that proficiency testing (PT) was performed by personnel who routinely perform laboratory testing for five (5) of five (5) events reviewed. Findings: 1. Review of the laboratory's CMS 209 form revealed the laboratory listed the following Testing Personnel: Testing Personnel 1 Testing Personnel 2 2. Review of the laboratory's American Academy of Family Physicians (AAFP) and American Proficiency Institute (API) proficiency testing records revealed Testing Personnel 2 tested all PT samples for the following events: a) AAFP 2021 Event C b) AAFP 2022 Event A c) AAFP 2022 Event B d) AAFP 2022 Event C e) API 2023 1st Event 4. Review of the laboratory's policy "Proficiency Testing" revealed "Proficiency testing will be rotated among all licensed laboratory personnel." 5. In interview on June 27, 2023 at 10:04 a.m., the Technical Consultant confirmed proficiency testing samples were not rotated between all testing personnel for the events identified above. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of proficiency testing records and interview with laboratory personnel, the laboratory failed to test proficiency testing (PT) samples the same number of times as patients are routinely tested for five (5) of five (5) events reviewed. Findings: 1. Review of the laboratory's American Academy of Family Physicians (AAFP) and American Proficiency Institute (API) records with raw data revealed the laboratory tested PT samples multiple times as follows: a) AAFP 2021 Event C: Sample 11- tested two (2) times Sample 12- tested two (2) times Sample 13- tested two (2) times Sample 14- tested two (2) times Sample 15- tested two (2) times b) AAFP 2022 Event A: Sample 2 - tested two (2) times Sample 4 - tested three (3) times Sample 5 - tested two (2) times c) AAFP 2022 Event B: Sample 6 - tested three (3) times Sample 8 - tested two (2) times Sample 10 - tested two (2) times d) AAFP 2022 Event C: Sample 11- tested two (2) times Sample 12- tested two (2) times Sample 13- tested two (2) times Sample 14- tested two (2) times Sample 15- tested two (2) times e) API 2023 1st Event: Sample 3 - tested two (2) times 2. In interview on June 27, 2023 at 10:04 a.m., the Technical Consultant stated the Laboratory Director reviews all patient results and decides if a rerun is needed. He further stated the Laboratory Director had testing personnel repeat the proficiency testing identified above. The Technical Consultant confirmed the laboratory did not have a policy stating the Laboratory Director reviews all results. He also confirmed the proficiency testing samples identified above were tested multiple times. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of proficiency testing records and interview with personnel, the laboratory failed to retain proficiency testing records for one (1) of five (5) events reviewed for at least two (2) years. Findings: 1. Review of the laboratory's American Academy of Family Physicians (AAFP) and American Proficiency Institute (API) proficiency testing records revealed the performance evaluation report for the platelet count of AAFP 2022 Event B sample SYX-8 had "Fail" in the "Comments" column. 2. Further review of the performance evaluation revealed the laboratory documented "Passed on repeat" next to the "Fail" comment. 3. Review of the laboratory's American Academy of Family Physicians (AAFP) proficiency testing records with raw data for AAFP 2022 Event B revealed the laboratory did not retain documentation of repeat testing for the platelet count of sample SYX-8. 4. In interview of June 27, 2023 at 10:54 a.m., the Technical Consultant confirmed the laboratory did not have the raw data to support the documentation of repeat testing for the PT sample identified above. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish -- 2 of 12 -- and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual and interview with personnel, the laboratory failed to establish a complete written policy for competency assessment that included problem solving. Findings: 1. Review of the laboratory's policy and procedure manual revealed a "Personnel Competency" policy that did not include assessment of problem solving skills as part of the competency assessment requirements for testing personnel. 2. In interview on June 27, 2023 at 11:50 a.m., the Technical Consultant confirmed the laboratory's competency assessment policy did not include assessment of problem solving skills. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual and proficiency testing (PT) records as well as interview with laboratory personnel, the laboratory failed to follow their proficiency testing policy for review of proficiency testing evaluations for four (4) of five (5) events. Findings: 1. Review of the laboratory's policy "Proficiency Testing" revealed "The technical consultant and the laboratory director will review and sign all surveys." 2. Review of the laboratory's American Academy of Family Physicians (AAFP) and American Proficiency Institute (API) records with raw data revealed the laboratory director did not document review of the following proficiency testing evaluations: a) AAFP 2022 Event A b) AAFP 2022 Event B b) AAFP 2022 Event C d) API 2023 1st Event 3. In interview June 27, 2023 at 10:29 a.m., the Technical Consultant confirmed the proficiency testing evaluations were not reviewed by the laboratory director. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the 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 observation, review of the laboratory's policy and procedure manual and quality control records, as well as interview with personnel, the laboratory failed to follow their policy for new lots of hematology quality control for three (3) of three (3) lots reviewed. Findings: 1. Observation by surveyors during the laboratory tour on June 27, 2023 at 8:49 a.m. revealed the laboratory utilized Eightcheck-3WP X-TRA hematology quality controls on the Sysmex pocH-100i. 2. Review of the laboratory's -- 3 of 12 -- "Complete Blood Count Policy" revealed "Starting a New Lot of Controls...Parallel test new controls by analyzing the three (3) levels of control a minimum of twice a day for 5 days, prior to expiration of the previous lot. After a minimum of 10 data points are accumulated, enter the new targets using the mean of the analyzed points (optional)."" 3. Review of quality control records for the following lots of Eightcheck- 3WP X-TRA hematology quality control revealed the laboratory did not test new lots of quality control per laboratory policy for the following lots of quality control: a) Lot 23610710 Low Abnormal, Lot 23610711 Normal, 23610712 High Abnormal; Expiration Date April 5, 2023: Ten (10) runs on January 10, 2023 b) Lot 30800710 Low Abnormal, Lot 30800711 Normal, 30800712 High Abnormal; Expiration Date June 8, 2023: Ten (10) runs on March 31, 2023 c) Lot 31640710 Low Abnormal, Lot 31640711 Normal, 31640712 High Abnormal; Expiration Date September 20, 2023: Ten (10) runs on June 20, 2023 4. In interview on June 27, 2023 at 11:28 a.m., the Technical Consultant confirmed the laboratory was not following their policy for parallel testing new lots of quality control. 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 A Recertification survey was performed on August 5, 2021 at Crowley Walk-In Clinic, CLIA ID # 19D0461155. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 record review and interview with personnel, the laboratory failed to document remedial action for unacceptable Hematology scores. Findings: 1. Review of the laboratory's 2020 and 2021 Proficiency Testing (PT) results revealed the laboratory received the following unacceptable results: a) 2020 Event 3: Score for Red Blood Cell (RBC) - 80% b) 2021 Event 1: Score for Red Blood Cell (RBC) - 80% c) 2021 Event 1: Score for Platelets - 80% 2. Further review revealed no documentation of

Summary Statement of Deficiencies D0000 A Recertification survey was conducted at Crowley Walk-In Clinic-CLIA ID # 19D0461155 on March 27, 2019. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard deficiencies were cited. D5783