Complete Emergency Care I, Llc

Summary Statement of Deficiencies D5813 TEST REPORT CFR(s): 493.1291(g) (g) The laboratory must immediately alert the individual or entity requesting the test and, if applicable, the individual responsible for using the test results when any test result indicates an imminently life-threatening condition, or panic or alert values. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, review of patient test records from August 2026, review of the laboratory's critical values log from 2025 and 2026, and staff interview, the laboratory failed to have documentation of the notification of 3 of 3 critical values. The findings included: 1. The laboratory's policy titled "Review and Release of Patient Results Verification" (approved 7/16/2019) under the section titled "Documentation" stated: "All critical values, notified personnel, date and time of notification and tech initials are documented on the Critical Value Log..." 2. The laboratory's chart titled "Hematology Reference Range Values" defined the laboratory's critical values requiring notification as: White blood cell less than 3 greater than 20 Hemoglobin less than 6 greater than 20 Hematocrit less than 18 greater than 60 Platelet less than 90 greater than 1000 3. A random sampling of patient test records from August 2026 identified 3 patient results with critical values: a) Date: August 2, 2026 Sample ID: 080201 White blood cell value: 21.1 b) Date: August 24, 2026 Sample ID: 082411 White blood cell value: 29.8 c) Date: August 24, 2026 Sample ID: 082409 White blood cell value: 2.7 4. A review of the laboratory's Critical Value Log from November 29, 2025 to September 16, 2026 determined the laboratory did not have documentation of the 3 identified critical values as stated in its policy. 5. The technical consultant confirmed the findings in an interview conducted on 10/06/2026 at 1115 hours in the laboratory. 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 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative at the entrance and exit conferences. The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on a review of the laboratory's API (American Proficiency Institute) proficiency testing (PT) attestation statements, review of instrument printout results for PT samples from 2016, 2017, and 2018, and confirmed in interview of facility personnel, the laboratory failed to test proficiency testing samples the same number of times as patient samples. The findings were: 1. A review of API proficiency testing attestation statements from 2016 (event 3), 2017 (events 1, 2, and 3), and 2018 (events 1, 2, and 3) revealed that testing person 6 (as listed on Form CMS-209) and testing person 8 (as listed on Form CMS-209) had each signed the attestation statement. The attestation statement revealed that both of the testing persons performed testing on the following samples: HEM-11 HEM-12 HEM-13 HEM-14 HEM-15 2. Testing Person 6 signed the attestation statement November 13, 2018. 3. Testing Person 8 signed the attestation statement November 14, 2018. 4. A review of Horiba instrument print out results for PT records from 2016 (event 3), 2017 (events 1, 2, and 3), and 2018 (events 1, 2, and 3) revealed that each hematology sample for Hematology (2018-Event 3) was tested on 2 different days. Sample ID: HEM-11 Performed by Testing Person 8 (as listed on Form CMS-209) Date: 11-13-2018 Sample ID: HEM-11 Performed by Testing Person 6 (as listed on Form CMS-209) Date: 11-14-2018 Sample ID: HEM- 12 Performed by Testing Person 8 (as listed on Form CMS-209) Date: 11-13-2018 Sample ID: HEM-12 Performed by Testing Person 6 (as listed on Form CMS-209) Date: 11-14-2018 Sample ID: HEM-13 Performed by Testing Person 8 (as listed on Form CMS-209) Date: 11-13-2018 Sample ID: HEM-13 Performed by Testing Person 6 (as listed on Form CMS-209) Date: 11-14-2018 Sample ID: HEM-14 Performed by Testing Person 8 (as listed on Form CMS-209) Date: 11-13-2018 Sample ID: HEM- 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 -- 14 Performed by Testing Person 6 (as listed on Form CMS-209) Date: 11-14-2018 Sample ID: HEM-15 Performed by Testing Person 8 (as listed on Form CMS-209) Date: 11-13-2018 Sample ID: HEM-15 Performed by Testing Person 6 (as listed on Form CMS-209) Date: 11-14-2018 5. An interview with the Nurse Manager on January 16, 2019 at 11:30 hours in his office confirmed the findings. Key: CMS - Centers for Medicare and Medicaid Services D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor observations, and interview of facility personnel, the laboratory failed to ensure that expired items were not available for use in patient testing. The findings were: 1. At 09:00 hours on January 16, 2019, the surveyor observed the following expired blood culture bottles on the top shelf in the laboratory in a clear plastic container. BACTEC Peds Plus IF Culture vials Lot 8024759 Expiration Date: 11-30-18 Quantity of 2 2. An interview with the technical consultant on January 16, 2019 at 09:05 hours the above findings were confirmed. -- 2 of 2 --