Summary:
Summary Statement of Deficiencies D0000 The laboratory was found to be out of compliance with 42 CFR Part 493, Requirements for Laboratories following a survey completed on 04/16/2026 resulting in a finding of IMMEDIATE JEOPARDY. The following condition(s) were not met: D2000 - 42 C.F.R. 493.801 Condition: Enrollment and Testing of Samples [Proficiency Testing] D2016 - 42 C.F.R. 493.803 (a)(b)(c) Condition: Successful Participation [Proficiency Testing] D5300 - 42 C.F.R. 493.1240 Condition: Preanalytic systems; D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems; D6000 - 42 C.F.R. 493.1290 Condition: Postanalytic systems; D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director; D6168 - 42 C.F.R. 493.1487 Condition: Laboratories performing high complexity testing; testing personnel; 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 surveyor observation, review of laboratory policy, proficiency testing (PT) records, and confirmed in interview, the laboratory failed to enroll in a Centers for Medicare and Medicaid Services (CMS) approved PT program for chemistry analysis on the i-STAT EG7+ cartridge for seven of seven analytes in the subspecialty of Routine Chemistry from the years of 2024, 2025, and 2026. Refer to D2001. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 27 -- 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; and This STANDARD is not met as evidenced by: Based on surveyor observation, review of laboratory policy, proficiency testing (PT) records, patient annual testing volumes, and confirmed in interview, the laboratory failed to enroll in a CMS approved PT program for seven of seven analytes in the subspecialty of Routine Chemistry from the years of 2024, 2025, and 2026. Findings included: 1. During a tour of the facility respiratory therapy testing areas on 04/14 /2026 at 09:40 AM, the surveyor observed multiple i-STAT testing devices (Serial Numbers: 372601 and 368434) available for patient testing. Also available for use in all respiratory testing areas were i-STAT EG7+ cartridges (Lot Number: 101944417). In the intensive care unit at 09:45 AM, the respiratory therapy technical consultant (TC-3) confirmed EG7+ cartridges were the only i-STAT testing cartridges used for patient blood gas analysis by respiratory therapists. TC-3 further confirmed all regulated analytes tested on the EG7+ cartridge were reported to patient physicians. 2. Review of laboratory policy, "Individualized Quality Control Plan (IQCP) for i-STAT I" (reviewed by the laboratory director on 02/17/2025) revealed the following: " ...I. Policy: The Quality Control Plan (IQCP) is for the i-STAT testing performed in the following areas: EG7+ in ER EG7+ in MICU EG7+ in SICU EG7+ in NICU" Review of laboratory policy, "Ancillary Testing Program" (approved by the laboratory director on 10/2019) revealed the following: " ...2. Proficiency test samples will be utilized on a regular basis. Results of the evaluations received will be reviewed and