Urgent Care Lakewood

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 a review of proficiency testing (PT) records and an interview with testing personnel 1 (TP1), the laboratory failed to test their hematology PT samples from the American Proficiency Institute (API) by all personnel who routinely test patient samples for the three hematology testing events in 2024. Findings include: 1. A review of the API PT documents from Event 1 in 2024, event 2 in 2024, and event 3 in 2024, revealed one of the nine testing personnel (TP) competent to perform hematology testing was performing the PT testing for their hematology samples in 2024. 2. An interview with TP1 on January 24, 2025, at approximately 11:30 AM, confirmed the laboratory failed to rotate the testing of hematology PT samples among the nine testing personnel who are competent to perform normal patient tests in hematology. 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 proficiency testing (PT) results, and an interview with testing personnel 1 (TP1), the laboratory director failed to review and evaluate PT results 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 -- obtained on American Proficiency Institute (API) PT performed by the laboratory. Findings include: 1. Based on an onsite records review, the laboratory director failed to review or evaluate PT results obtained on API PT performed by the laboratory for the following events: 2024, Hematology, Event 1 2024, Hematology, Event 2 2024, Hematology, Event 3 2. Based on an interview with TP1, on January 24, 2025 at approximately 10:45 AM, confirmed that the laboratory director did not review or evaluate PT results obtained on API PT for the following events: 2024, Hematology, Event 1 2024, Hematology, Event 2 2024, Hematology, Event 3 D5785

Summary Statement of Deficiencies 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 an onsite records review, and interview with the office manager on August 4, 2023, the laboratory failed to establish a written policy to annually assess competency of the Clinical Consultant. Findings include: 1. Based on an onsite records review on August 4, 2023, it was determined the laboratory failed to establish a written policy to annually assess competency of the Clinical Consultant. 2. An interview with the office manager on August 4, 2023, at approximately 11:00 am confirmed that the laboratory failed to have a policy and assess competency of the Clinical Consultant. 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: Based on direct observation of the laboratory, an interview with the office manager, and an interview with testing personnel (TP) #3 on August 4, 2023, the laboratory failed to have a procedure written and approved by the laboratory director for the Medonics M CBC analyzer. Findings include: 1. Based on a direct observation of the laboratory space on August 4, 2023 at approximately 09:00 AM, the laboratory failed 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 -- to produce a written procedure approved by the laboratory director for their Medonics M CBC analyzer. 2. An interview with the office manager, and TP #3 on August 4, 2023, at approximately 10:30 AM confirmed that there was no written or approved procedure by the laboratory director for the Medonics M CBC analyzer. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on an onsite records review, and interview with the office manager on August 4, 2023, it was determined that the technical consultant (TC) was not ensuring that competency evaluations for staff were being performed at least semiannually on testing personnel (TP) in their first year of patient testing. Findings include: 1. Based on records reviewed on August 4, 2023, it was determined that the TC failed to evaluate competency at least semiannually in their first year of testing for 3 out of 8 TP. 2. Based on an interview with the office manager on August 4, 2023, at approximately 10:30 am, it was confirmed that the TC was not ensuring that TP were being evaluated at least semiannually in their first year of testing for 3 out of 8 TP. -- 2 of 2 --

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 routine desk review of the CMS-155 report for Proficiency Testing (PT) performance and email communications with the laboratory director of operations, the laboratory failed to achieve satisfactory performance scores for the American Proficiency Institute (API) PT for Cell I.D or WBC Diff testing for two out of three PT events in 2022 (events 1 and 2). See D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- 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 routine desk review of the CMS-155 report for Proficiency Testing (PT) performance and email communications with the laboratory director of opertions, the laboratory failed to achieve a score of 80% for the American Proficiency Institute (API) PT for Cell I.D. or WBC Diff for events 1 and 2 in 2022. Findings: 1. A review of the CMS-155 Individual Laboratory Profile on 10/11/2022, at 12:30 pm, revealed the API PT for Cell I.D. or WBC Diff testing scores for 2022 event 1 was 47% and for event 2 was 7%. 2. Email received from the laboratory director of operations on 10 /13/2022, at 11:32 am, confirmed two consective unsuccessful PT scores for Cell I.D. or WBC Diff testing due to clerical errors. -- 2 of 2 --