Middle Park Health - Winter Park

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing provider. The facility was found to be out of compliance with the conditions of the CLIA program. The following condition level deficiencies were found to be out of compliance: 42 C.F.R. 493.803 Condition: Successful Participation [proficiency testing]; 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 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 -- testing provider, American Proficiency Institute, the laboratory failed to achieve satisfactory performance scores for two consecutive events in the American Proficiency Institute proficiency testing for the analyte: pO2, Blood Gas, in event 3 in 2024 and event 1 in 2025, see D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing 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 evaluation reports provided by the PT provider, American Proficiency Institute (API), the laboratory failed to achieve a satisfactory PT score for two consecutive events for the analyte: pO2, Blood Gas for event 2 in 2024 and event 3 in 2024. Findings include: 1. A review of the CMS-155 Individual Laboratory Profile on March 13, 2025, at 10:30 AM, revealed the API PT results for pO2, Blood Gas testing scores for event 3 in 2024 was 0%, and 60% for event 1 in 2025. 2. A review of the PT performance summary provided by API, confirmed the laboratory failed to achieve satisfactory testing scores for two consecutive events for the analyte: pO2, Blood Gas. Scores were 0% in event 3 of 2024, and 60% for event 1 in 2025. -- 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 routine chemistry during years 2022 and 2023. The laboratory performs approximately 224 routine chemistry 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: Based on an onsite records review, and interview with general supervisor #1 (GS #1), 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 -- the laboratory failed to enroll in a CMS approved Proficiency Testing (PT) program for the specialty of routine chemistry during years 2022 and 2023. The laboratory performs approximately 224 routine chemistry 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 routine chemistry during years 2022 and 2023: pH, Blood Gas pCO2, Blood Gas pO2, Blood Gas Sodium Potassium Calcium Chloride Glucose Creatinine 2. Based on an interview with GS #1 on April 3, 2024, at approximately 10:15 AM, confirmed that the laboratory failed to enroll in a CMS approved PT program for routine chemistry during the years 2022 and 2023. -- 2 of 2 --

Summary Statement of Deficiencies No Tags No deficiency details available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --