Classen Urgent Care Clinic

Summary Statement of Deficiencies D0000 A complaint investigation (OK00083247) was performed on 07/14/2025. The complaint was substantiated with a standard-level deficiency cited. The findings were reviewed with the laboratory supervisor at the conclusion of the survey. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 review of policy, direct observation, and interview with the laboratory supervisor, the laboratory failed to follow their policy for blood specimen labeling to ensure specimen identification. Findings include: (1) On 07/14/2025 at 09:15 am, the laboratory supervisor stated CBC (Complete Blood Count) testing was performed using the using the Sysmex XN-330 analyzer; (2) On 07/14/2025 at 09:20 am the laboratory supervisor stated the following: (a) Following a blood specimen collection in the clinic room, the phlebotomist would use a sharpie to label the tube containing patient blood specimen with the patient's last name and the first name; (b) The specimens would then be carried to the laboratory where a printed label would be affixed to the patient's specimen tube prior to testing. (2) On 07/14/2025 at 09:30 am, an observation of 24 previously tested BD Vacutainer K2 EDTA tubes containing patient specimens and being stored in the refrigerator, showed no evidence of sharpie marking for 24 of 24 tubes; (3) A review of the procedure titled, "Blood Specimen Collection and Processing Procedure" stated, "All samples must be received by the laboratory with a legible label containing at least two (2) unique identifiers. The specimens must be labeled with the patient's full name (preferably last name first, then first name last; Patient's full date of birth (must include the month, day, and year); 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 -- Unique requisition identifier/label." (4) Interview with the laboratory supervisor on 07 /14/2025 at 09:40 am, confirmed the laboratory failed to follow their policy for specimen labeling to ensure specimen identification. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 05/06/2025. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the technical consultant at the conclusion of the survey. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of the procedure manual and interview with the technical consultant, the laboratory failed to ensure one of one procedure manual had been approved, signed, and dated by the current laboratory director. Findings include: (1) On 05/06/2025 at 09:45 am, the technical consultant stated the following were performed in the laboratory: (a) CBC (Complete Blood Count) testing using the Sysmex XN-330 analyzer; (b) Manual Differential testing (2) A review of the manual titled, "Laboratory Procedures" identified no evidence the manual had been approved signed, and dated by the current laboratory director; (3) The manual was reviewed with the technical consultant who stated on 05/06/2025 at 12:15 pm, the manual had not been signed and dated as approved by the current laboratory director. 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 recertification survey was performed on 08/17/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the technical consultant at the conclusion of the survey. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on interview with the technical consultant, the laboratory failed to provide written instructions to clients from Classen Family Medicine, for CBC testing performed on the Sysmex XN 330 analyzer. Findings include: (1) On 08/17/2023 at 10:50 am, the technical consultant stated the following: (a) CBC testing was performed using the Sysmex XN-330 analyzer; (b) Specimens were transported to the laboratory for STAT analysis from Classen Family Medical Clinic. (2) Interview with the technical consultant 08/17/2023 at 10:25 am confirmed the laboratory did not provide written instructions (i.e.,client service manual) to the client to explain the laboratory's specimen handling policies. 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. 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 -- (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 and interview with the technical consultant (TC), the laboratory failed to ensure three of three Vacutainer brand tubes were stored as required by the manufacturer, in a room denoted as the nursing supply room. Findings include: (1) Observation of the nursing supply room and interview with the TC on 08/17/2023 at 09:50 am, identified the following: (a) 11 BD Vacutainer SST tubes, lot # 3041180, storage temperature of 4-25 degrees Celsius; (b) Eight BD Vacutainer LiHep tubes, lot # 216068, storage temperature of 4-25 degrees Celsius; (c) Six BD Vacutainer K2, EDTA tubes, lot # 2347067, storage temperature of 4-25 degrees Celsius. (2) Interview with the technical consultant on 08/17/2023 at 09:50 am confirmed the laboratory was not monitoring the temperature of the nursing supply room. 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: Based on observation and interview with the technical consultant, the laboratory failed to ensure expired Wright's stain was not available for use. Findings include: (1) Observation of the laboratory on 08/17/2023 at 09:50 am, identified the following expired reagents, used for manual differential staining, that appeared to be available for use: (a) One bottle of MCC Wright's Dip Stat stain - lot #2424-02 with an expiration date of 01/31/2023; (b) One bottle of MCC Wright's Dip Stat stain - lot #1369-01 with an expiration date of 03/31/2022; (2) Interview with the technical consultant on 08/17/2023 at 09:50 a.m. confirmed the MCC Wright's Dip Stat stain was available for use. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 07/23/2021. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the technical consultant and clinic manager 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 technical consultant, the laboratory failed to evaluate the accuracy of testing when proficiency results had not been graded by the proficiency program for 4 of 4 Hematology events reviewed. Findings include: (1) On 07/23/2021, the surveyor reviewed proficiency testing records for the first, second, and thirds events in 2020; and the first event in 2021. The following was identified for 4 of 4 Hematology events: (a) First 2020 Hematology Event for Blood Cell ID (Educational) - 5 of 5 results had not been graded by the proficiency testing program: (i) For 1 of 5 results (ECI-01), the following was identified: (aa) ECI-01 - Under "Expected Results" it stated, "See Commentary". There was no evidence the laboratory reviewed the commentary contained in the "Participant Summary Report" to evaluate their result. (ii) For 1 of 5 results (ECI-04), the program's expected result was included on the report which showed the following: (aa) ECI-04 - The laboratory's reported result of Spherocyte did not agree with the "Expected Result" of Microcytic red blood cell. There was no documentation to indicate