Grand Ave Urgent Care

Summary Statement of Deficiencies 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: Based on review of proficiency testing records, lack of documentation, and staff interview, the laboratory failed to ensure the individual testing the proficiency samples and the laboratory director attested to the routine integration of the American Proficiency Institute (API) proficiency tests into the patient workload for 3 of 5 proficiency testing events reviewed from February 2023 through July 2024. The findings were: 1. Review of the 2023 API Chemistry Core Event #3, 2024 Chemistry Core Event #1, and 2024 Chemistry Core Event #2 records showed the testing personnel and laboratory director failed to sign the attestation statements. 2. Interview with the clinic manager on 8/19/24 at 10:38 AM confirmed no further documentation was available. . 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- 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 review of proficiency testing records, staff interview, and policy and procedure review, the laboratory failed to maintain a copy of each step in the testing and reporting of the API (American Proficiency Institute) proficiency samples for 3 out of 5 proficiency testing events reviewed from February 2023 through July 2024. The findings were: 1. Review of the API 2023 Chemistry Core Event #3, 2024 Chemistry Core Event #1, and the 2024 Chemistry Core Event #2 proficiency testing events failed to include the attestation statement, data submission forms, the performance summary, the comparative evaluation, and the laboratory director's signed peformance evaluation form. 2. Interview with the clinic manager on 8/19/24 at 10:38 AM revealed she was unable to locate any additional documentation and confirmed the proficiency testing records were incomplete. 3. Review of the Proficiency Testing Standard Operating Procedure, with an origination date of 3/30 /22, showed "...2. General Guidelines...2.3 Upon receipt of any proficiency testing materials, they should be inspected to ensure that all expected materials were received. They should then be stored according to the instructions included with the package. 2.4 PT specimens should be processed and analyzed according to patient specimen protocols throughout the process. Specimens will be rotated amongst all staff performing testing...2.6 The Laboratory Supervisor will review the data sheet and inspect the worksheets for any transcription errors. 2.7 The Laboratory Director or designee and any staff performing testing should sign and date 2.8 A copy of any data sheets, worksheets, and instrument printouts should be retained for two years in the designated Proficiency Testing binder...4. Assessment of the Proficiency Testing Report...The Laboratory Supervisor and testing personnel should review PT scores, and if all are satisfactory, the forms are signed and dated. The Laboratory Director and testing personnel must sign the forms as reviewed and reports are kept in the Proficiency Testing Manual..." . 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 lack of documentation and staff interview, the laboratory failed to retain the quality control data for the analytes Troponin I and D-dimer performed on the Quidel Triage instrument from January 2023 until February 2024. The laboratory performed approximately 730 D-dimer and 730 Troponin I patient tests per year. The findings were: 1. Review of the laboratory's quality control documentation showed no evidence quality control had been performed between January 2023 until February 2024. 2. Interview with the clinic manager on 8/19/24 at 11:35 AM confirmed no further documentation was available. . D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 -- 2 of 8 -- Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of personnel files, review of the Centers for Medicare and Medicaid Services 209 Personnel Report, review of policy and procedure, lack of documentation, review of proficiency testing records, procedure manual review, and staff interview, the laboratory failed to complete the required competency assessments (D5209), failed to review and evaluate proficiency testing results (D5211), and failed to monitor, assess, and correct problems in the general laboratory system (D5291). . D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish 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 personnel files, review of the Centers for Medicare and Medicaid Services 209 Laboratory Personnel Report, lack of documentation, review of policy and procedure, and staff interview, the laboratory failed to complete competency assessments for 3 of 3 testing personnel (TP #1, TP #2, TP #3) as required for 18 months reviewed from March 2023 through July 2024. The findings were: 1. Review of the laboratory's personnel files showed the following concerns: a. Review of the personnel file for TP #1 showed an initial competency assessment was completed on 8 /30/22. There was no evidence the laboratory had completed any subsequent assessments. b. Review of the personnel file for TP #2 showed an unsigned and undated quiz related to the Quidel Triage analyzer. Interview with the clinic manager on 8/19/24 at 11:44 AM revealed TP #2's date of hire was 11/15/23. There was no evidence the laboratory had completed any of the required competency assessments. c. Review of the personnel file for TP #3 showed an unsigned and undated quiz related to the Quidel Triage analyzer. Interview with the clinic manager on 8/19/24 at 11:44 AM revealed TP #3's date of hire was 12/21/23. There was no evidence the laboratory had completed any of the required competency assessments. 2. Interview with the clinic manager on 8/19/24 at 11:44 AM confirmed no further documentation was available. 3. Review of the Personnel Training Plan Policy with an origination date of 3/30/22 showed "...3. Training and Competency... Personnel will be trained upon hire, and when new tests or processes are brought into the laboratory. This will be documented in their personnel binders. Personnel must be evaluated for competency in all of their respective duties initially, after the first 6 months, then annually thereafter. Competency will be evaluated in a minimum of four categories: Problem solving, Performing Quality Control, Processing Patient Specimens, and Proficiency testing (or other blind specimens)." . D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) -- 3 of 8 -- 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 proficiency testing records, staff interview, and policy and procedure review, the laboratory failed to review and evaluate proficiency testing results for 4 of 5 testing events reviewed from February 2023 through July 2024. The findings were: 1. Review of the American Proficiency Institute proficiency testing (PT) documentation failed to include documentation the laboratory had reviewed and evaluated the PT results for the following events: a. 2023 Chemistry Core Event #1 b. 2023 Chemistry Core Event #3 c. 2024 Chemistry Core Event #1 d. 2024 Chemistry Core Event #2 2. Interview with the clinic manager on 8/19/24 at 10:38 AM revealed she was unable to locate any additional documentation and confirmed the proficiency testing documentation was incomplete. 3. Review of the Proficiency Testing Standard Operating Procedure with an origination date of 3/30/22 showed "...The Laboratory Supervisor and testing personnel should review PT scores, and if all are satisfactory, the forms are signed and dated. The Laboratory Director and testing personnel must sign the forms as reviewed and reports are kept in the Proficiency Testing Manual..." . 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 procedure manual review, lack of documentation, and staff interview, the laboratory failed to establish a quality assessment plan for general laboratory, pre- analytic, and post-analytic systems for the Quidel Triage test system for the analytes of D-dimer and Troponin I. The laboratory estimated it would perform approximately 730 D-dimer and 730 Troponin I patient tests per year. The findings were: 1. Review of the laboratory's records showed no evidence an ongoing quality assessment program was in place which included the items the laboratory reviewed, the frequency of the review, and the method used to document the review in the following areas: a. General laboratory tasks which include proficiency testing review, testing personnel competency procedures, and complaint documentation and resolution. b. Pre-analytic tasks which include specimen collection, patient identification verification, and specimen labeling. c. Analytic tasks which include review of quality control and test record logs. d. Post-analytic tasks which include test report accuracy. 2. Interview with the clinic manager on 8/19/24 at 11:35 AM confirmed no further documentation was available. . 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. -- 4 of 8 -- This STANDARD is not met as evidenced by: Based on review of the CMS (Centers for Medicare and Medicaid Services)-116 form, procedure manual review, and staff interview, the current laboratory director failed to sign, and date as approved, 8 out of 12 policies and procedures (Standard Operating Procedures, FDA Adverse Event Reporting, Reportable Pathogens Policy, Personnel Job Description, Personnel Training Plan, IQCP policy, Proficiency Testing policies, Delegation of Duties) reviewed. The findings were: 1. Review of the CMS-116 form showed a change of the laboratory director, effective 5/9/23, was approved on 5/15 /23. 2. Review of the laboratory's procedure manual showed 8 out of 12 policies and procedures reviewed had not been signed by the current laboratory director. 3. Interview with the clinic manager on 8/19/24 at 11:35 AM confirmed the procedures had not been signed by the current laboratory director. . 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 Review of the CMS (Centers for Medicare and Medicaid Services)-209 Laboratory Personnel Report, review of the laboratory's records, review of proficiency testing records, review of policy and procedures, personnel file review, and staff interview, the laboratory director failed to attest to the routine integration of the American Proficiency Institute proficiency tests into the patient workload (D6016), failed to review and evaluate proficiency testing results (D6018), failed to establish a quality assessment plan (D6021), failed to ensure competency assessments were completed as required (D6029), and failed to sign and date as approved the laboratory's policy and procedures (D6031). . 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 review of proficiency testing records, lack of documentation, and staff interview, the laboratory director failed to attest to the routine integration of the American Proficiency Institute proficiency tests into the patient workload for 3 of 5 proficiency testing events reviewed from February 2023 through July 2024. Refer to D2009. . D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) -- 5 of 8 -- 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies 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)