Afc Urgent Care Castle Rock

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 performance and review of proficiency testing evaluation reports from the proficiency testing provider, AAB-MLE, the laboratory failed to achieve satisfactory performance scores for the AAB-MLE proficiency testing for HCT (Non-waived) for two consecutive proficiency testing events, (event 1 in 2024 and event 2 in 2024), see D2130. 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 routine desk review of the CMS-155 report for Proficiency Testing (PT), and review of PT evaluation reports from the PT provider, AAB-MLE, the laboratory failed to achieve a satisfactory score for HCT (Non-waived) for event 1 in 2024 and event 2 in 2024. Findings include: 1. A review of the CMS-155 Individual Laboratory Profile on September 19, 2024, at approximately 11:02 AM, revealed the AAB-MLE PT results for HCT (Non-waived) testing scores for event 1 in 2024 was 60%, and 0% for event 2 in 2024. 2. A review of the PT evaluation reports from the PT provider, AAB-MLE, on November 22, 2024, at 1:24 PM, confirmed that the laboratory failed to achieve satisfactory PT scores for HCT (Non-waived for event 1 in 2024 and event 2 in 2024. -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on the deficiencies cited herein, the laboratory failed to enroll in a CMS approved Proficiency Testing (PT) program for the specialty of hematology since testing began in July of 2023. The laboratory performs approximately 1,800 hematology tests annually (Refer to D2001). D2001 ENROLLMENT CFR(s): 493.801(a)(1)(2)(i) The laboratory must-- (1) Notify HHS of the approved program or programs in which it chooses to participate to meet proficiency testing requirements of this subpart. (2)(i) Designate the program(s) to be used for each specialty, subspecialty, and analyte or test to determine compliance with this subpart if the laboratory participates in more than one proficiency testing program approved by CMS; This STANDARD is not met as evidenced by: 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 -- Based on an onsite records review, and interview with the laboratory director (LD), the laboratory failed to enroll in a CMS approved Proficiency Testing (PT) program for the specialty of hematology since testing began in July of 2023. The laboratory performs approximately 1,800 hematology tests annually. Findings include: 1. Based on an onsite records review, it was revealed that the laboratory failed to enroll in a CMS approved PT program for the following analytes in hematology since testing began in July of 2023: Cell ID or White Blood Cell Differential Red Blood Cell count Hematocrit (non-waived) Hemoglobin (non-waived) White Blood Cell count Platelets 2. Based on an interview with the LD on November 3, 2023, at approximately 10:00 AM, confirmed that the laboratory failed to enroll in a CMS approved PT program for hematology since testing began in July of 2023. 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 a review of the laboratories policies and procedures manual, and an interview with the Laboratory Director (LD), the laboratory failed to establish policies or procedures to evaluate competency of Clinical Consultants (CC), Technical Consultants (TC), or testing personnel (TP), since testing began in July of 2023. The laboratory performs approximately 1,800 tests annually. Findings include: 1. Based on a review of the laboratory's policies and procedures manual, it was revealed that the laboratory failed to establish a written policy or procedure to evaluate the competency of CC, TC, or TP employed by the laboratory. 2. Based on an interview with the LD on November 3, 2023, at approximately 10:30 AM, confirmed that the laboratory failed to establish a written policy or procedure to evaluate the competency of CC, TC, or TP employed by the laboratory. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on an onsite records review, and an interview with the laboratory director (LD), the laboratory failed to document instrument maintenance for their Medonics M hematology analyzer as specified by the manufacturer since testing began in July of 2023. The laboratory performs approximately 1,800 hematology tests annually. Findings include: 1. Based on an onsite records review, it was revealed that the laboratory failed to document the instrument maintenance for their Medonic M series hematology analyzer as specified by the manufacturer. 2. Based on an interview with the LD, on November 3, 2023, at approximately 09:50 AM, confirmed that the laboratory failed to document the instrument maintenance for their Medonic M series hematology analyzer as specified by the manufacturer. -- 2 of 2 --