Mana Urgent Care Wedington

Summary Statement of Deficiencies 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 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: Through a review of proficiency test documentation for 2021, 2022, and 2023 it was determined the laboratory director failed to sign attestation statements for two of five testing events in 2021, 2022 and 2023 and testing personnel failed to sign attestation sheets for five of five testing events in 2021, 2022, and 2023. Survey findings follow: A. A review of the Attestation Statement for 3rd Hematology / Coagulation Proficiency Testing Event of 2021, 1st and 3rd Hematology / Coagulation Proficiency Testing Event of 2022, and the 1st Hematology Testing Event of 2023 revealed that the testing personnel were listed in the same handwriting. B. A review of the Attestation Statements for the 2nd Hematology / Coagulation Proficiency Testing Event of 2022 and the 1st Hematology / Coagulation Proficiency Testing Event of 2023 revealed that the laboratory director failed to sign the Attestation Statements. C. A review of the Attestation Statements for the 2nd Hematology / Coagulation Proficiency Testing Event of 2022 revealed that all testing personnel failed to sign the Attestation Statement. D. In an interview at 10:13am on 4/13/2023, laboratory employee #3 (as listed on CMS 209 form) confirmed that the 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 2 -- failed to sign the Attestation Statement for one proficiency testing event in 2022 and one in 2023 and that testing personnel failed to sign Attestation Statements for all examined events in 2021, 2022, and 2023. D5407 PROCEDURE MANUAL CFR(s): 493.1251(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: . Through a review of the laboratory procedure manual, lack of documentation, and interviews with laboratory staff, it was determined the laboratory director failed to approve, sign, and date the laboratory procedures. Survey findings include: A. During a review of the laboratory procedures it was determined the procedure manual and individual procedures lacked the directors approval signature and date of approval. B. In an interview at 12:46pm on 4/13/23, laboratory employee #2 (as listed on the form CMS-209) confirmed the laboratory directors written approval of the laboratory procedures was not available. -- 2 of 2 --

Summary Statement of Deficiencies 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: Through review of the manufactuer's package insert, observation and interview it was determined that the laboratory failed to note the amended expiration date or the date opened was not present for hematology control material. A) Review of the package insert for Coulter 4C hematology controls revealed that expiration date should be changed to ten days after the control material vials were opened and placed into use. B) During a tour of the laboratory on 5/19/21 at 02:30 PM three vials of Coulter 4C hematology controls lot numbers 069900, 079900, and 089900 were observed in the laboratory refrigerator without a date opened or amended expiration date. C) In an interview on 5/19/21 at 02:30 PM, the laboratory staff member, identified as number two on the CMS 209 form, confirmed that the hematology control material, identified above, were currently in use and the date of opening or amended expiration date was not present on the control vials. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform 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 -- 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)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Through a review of laboratory personnel files, lack of documentation, and interviews with staff, it was determined the laboratory director failed to authorize personnel #8 through #14 (as listed on CMS-209) to perform testing without direct supervision. Survey findings follow: A. Surveyor reviewed personnel records of twelve personnel. Personnel #8 through #14 (as listed on CMS-209) did not include a signed authorization to perform moderate complexity testing by laboratory director. The authorizations to test were signed by the personnel, identified as number seven on the CMS 209 form who is not the laboratory director. B. In an interview at 02:30 PM on 5 /19/21, laboratory #2 (as listed on the form CMS-209) confirmed there were no written authorizations to perform testing signed by the laboratory director. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Through review of the laboratory's personnel records, the CMS 209 form, and interview it was determined that testing personnel competency evaluations for seven of twelve testing personnel were not performed by the technical consultant or personnel identified on the CMS 209 form with the qualifications of a technical consultant. Findings follows: A.) The CMS-209 form completed for the survey lists employee number two on the CMS 209 form as the laboratory's technical consultant. B) Review of fifteen competency evaluations for laboratory testing personnel identified as numbers eight through fourteen on the CMS 209 form revealed that they were evaluated and signed by the laboratory personnel, identified as a testing personnel number seven on the CMS 209 form C) Review of the personnel qualifications for testing personnel, identified as number seven on the CMS 209 form, revealed that the personnel lacked the required qualifications to serve as technical consultant. D) In an inteview on May 19, 2021 at 02:10 PM, the Laboratory Technical Consultant identified as number two on the CMS 209 form confirmed that the person identified as number seven on the CMS 209 form evaluated the competencies and signed the competency evaluations for the testing personnel identified as numbers eight through fourteen on the CMS 209 form. -- 2 of 2 --

Summary Statement of Deficiencies D0000 This reflects findings of a recertification survey performed on 10/11/18 . Mediserve Wedington Walk-In Clinic Laboratory is in compliance with the applicable Standards and conditions of 42 CFR Part 493, Laboratory Requirements. The following standard level deficiencies were cited on current survey: D2009: CFR 493.801(b) The laboratory director did not attest to the routine integration of proficiency testing samples into the patient workload in three of five events reviewed. D6032: CFR493. 1407(e)(14) The laboratory director did not sign an authorization to perform testing for two of eight testing personnel. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Through review of proficiency testing attestation forms, API proficiency testing instructions and interview with laboratory staff it was determined that the laboratory director did not attest that the proficiency testing was performed in the same manner as patient testing in three of five events reviewed. Survey findings follow: A. The instructions for API proficiency testing states, "signatures required: testing personnel and the laboratory director must physically sign an attestation statement for all proficiency testing results". B. API proficiency testing Hematology/Coagulation first event 2017, lacked signature of the laboratory director attesting that testing was performed in the same manner as patient testing . C. API proficiency testing Hematology/Coagulation second event 2017, lacked signature of the laboratory director attesting that testing was performed in the same manner as patient testing . D. API proficiency testing Hematology/Coagulation first event 2018, lacked signature of the laboratory director attesting that testing was performed in the same manner as 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 -- patient testing . E. In an interview at 10:45 AM on 10/11/18, the technical consultant identified as number two on the CMS 209 form confirmed that the laboratory director's signature was not present on the API proficiency testing Hematology /Coagulation testing events identified above. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Through review of the CMS 116 form supplied by the laboratory, the CMS 209 form supplied by the laboratory, personnel files and lack of documentation it was determined that two of eight testing personnel performed testing without the written authoritization of the Laboratory Director. Findings follow: A. The CMS 116 form stated that 2394 moderately complex hematology tests were performed. B. The testing personnel identified as number eight and number ten on the CMS 209 form were identified as testing personnel performing hematology testing. C. Review of the personnel files for testing personnel identified as number eight and number ten on the CMS 209 form did not include written authorization by the laboratory director to perform hematology testing. D. Upon request, the laboratory was unable to provide an authorization to test, signed by the laboratory director, for the personnel identified above. E. In an interview on 10/11/18 at approximately 11:00 AM the technical consultant identified as number two on the CMS 209 form confirmed that the personnel identified above performed hematology testing and lacked an authorization to test signed by the laboratory director. -- 2 of 2 --