Chilton 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 a review of the proficiency testing records and an interview with Testing Personnel #1 (also the team leader for the laboratory), the Laboratory Director failed to sign the attestation statements provided by American Proficiency Institute (API). This was noted on three of eight 2018 - 2020 Hematology proficiency testing events, reviewed by the surveyor. The findings include: 1. A review of the proficiency testing records revealed Hematology Event #2 2019, Event #3 2019, and Event #3 2020 attestation statements were not signed by the Laboratory Director/delegate. 2. During an interview on 12/31/2020 at 12:20 PM, Testing Personnel #1 confirmed attestations were not signed by the Laboratory Director/delegate. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- the PT event. This STANDARD is not met as evidenced by: Based on a review of the proficiency testing records and an interview with Testing Personnel #1, the laboratory failed to maintain a copy of instrument printouts for the testing performed. This was noted on two of eight 2018 - 2020 Hematology proficiency testing events, reviewed by the surveyor. The findings include: 1. A review of the proficiency testing records revealed the staff failed to retain instrument printouts of the testing performed for Hematology events #1 and #2 of 2020. 2. During an interview on 12/31/2020 at 12:20 PM, Testing Personnel #1 confirmed instrument printouts were not retained for the events listed in paragraph 1. 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 the proficiency testing records and an interview with Testing Personnel #1, the Laboratory Director failed to review and evaluate the results received from American Proficiency Institute (API). This was noted on three of eight 2018 - 2020 Hematology proficiency testing events, reviewed by the surveyor. The findings include: 1. A review of the API proficiency testing records revealed 2019 Event #1, Event #2, and Event #3 performance evaluations with results, obtained on the above mentioned testing events, were not reviewed and evaluated by the Laboratory Director. 2. During an interview on 12/31/2020 at 12:20 PM, Testing Personnel #1 confirmed the above events were not reviewed and evaluated by the Laboratory Director. At 12:30 PM, the surveyor discussed the notes for Event #3, 2019, added by a former employee, who referenced the samples were retested and found acceptable, but no probable cause of error documented. Testing Personnel #1 stated the staff's note would not be the laboratory director's review. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of American Proficiency Institute (API) proficiency testing records and an interview with Testing Personnel #1, the laboratory failed to document

Summary Statement of Deficiencies 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 review of API (American Proficiency Institute) proficiency testing evaluations and CASPER reports (#153/#155), the surveyor determined the laboratory failed to perform successfully in proficiency testing for the WBC Differential (White Blood Cell Differential) for two consecutive testing events, Events #2 and #3 of 2018. The findings include: 1. The laboratory scored sixty percent (60 %) for the WBC Differential for Event #2, 2018 and 33 % for Event #3. 2. The above noted failures resulted in an initial unsuccessful proficiency testing participation for the laboratory. D2130 HEMATOLOGY 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 -- CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of API (American Proficiency Institute) proficiency testing evaluations and CASPER reports (#153/#155), the surveyor determined the laboratory failed to achieve satisfactory performance for the WBC Differential (White Blood Cell Differential) for two consecutive testing events, Events #2 and #3 of 2018. These failures resulted in an initial unsuccessful proficiency testing participation for the laboratory. The findings include: 1. The laboratory scored sixty percent (60 %) for the WBC Differential for Event #2, 2018 and 33 % for Event #3. 2. The above noted failures resulted in an initial unsuccessful proficiency testing participation for the laboratory. -- 2 of 2 --

Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of the 2017 - 2018 API (American Proficiency Institute) Proficiency Testing records and an interview with Testing Personnel #1, the laboratory failed to document reviews of two of four of the returned survey evaluations results, and failed to document