Rainbow Pediatric Clinic

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the manufacturer instructions, review of the laboratory's procedures, review of patient test records from May 2025 and August 2025, and staff interview, the laboratory failed to following its procedures for: A) Flagged Complete Blood Count results B) Repeat Complete Blood Count results The findings included: A) Flagged Results 1. A review of the the manufacturer's instructions for the Sysmex XN-330 hematology analyzer (Code no. AK803790, Revision: June 2017) under the section titled "5.11.2 Display of analysis result data" determined: Display: [*] Meaning: Low Reliability Description: Indicates that the reliability of the data is low 2. A review of the laboratory's procedure titled "Policy for Handling Abnormal CBC's and their Flags" (approved 12/30/2020) determined: "It will be the policy if [sic] this laboratory to evaluate every CBC and handle any flags displayed prior to releasing the result. Post evaluating the CBC, the lab staff can repeat the analysis if enough sample is collected or performed a re-collection. A normal CBC will include normal cells: Lymphocytes, Monocytes, Basophils, Neutrophils, Eosinophils and normal size and shape RBC's and Platelets. If you CBC instrumentation is showing alarms or flags, it will be considered abnormal. The lab will send out the specimen for peripheral smear or manual diff if quantity is sufficient to the Reference Lab. All abnormal flagged results will be crossed out." 3. A sampling of patient test results from May 2025 and August 2025 identified the following patient results reported the provider with flags (see patient alias list): a) May 30, 2025 Patient 1 Flag: [*] Analytes: White blood cell Neutrophil count Neutrophil percent Lymphocyte count Lymphocyte percent Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Monocyte count Monocyte percent Eosinophil count Eosinophil percent Basophil count Basophil percent Immature granulocyte count Immature granulocyte percent Patient 2 Flag: [*] Analytes: White blood cell Neutrophil count Neutrophil percent Lymphocyte count Lymphocyte percent Monocyte count Monocyte percent Eosinophil count Eosinophil percent Basophil count Basophil percent Immature granulocyte count Immature granulocyte percent b) August 21, 2025 Patient 3 Flag: [*] Analytes: Platelet Mean Platelet Volume c) August 22, 2025 Patient 4 Flag: [*] Analytes: Platelet Mean Platelet Volume d) August 26, 2025 Patient 5 Flag: [*] Analytes: Neutrophil count Neutrophil percent Lymphocyte count Lymphocyte percent Monocyte count Monocyte percent Immature granulocyte count Immature granulocyte percent e) August 29, 2025 Patient 6 Flag: [*] Analytes: Platelet Mean Platelet Volume Patient 7 Flag: [*] Analytes: Neutrophil count Neutrophil percent Lymphocyte count Lymphocyte percent Monocyte count Monocyte percent Immature granulocyte count Immature granulocyte percent Patient 8 Flag: [*] Analytes: White blood cell Platelet Mean Platelet Volume Neutrophil count Neutrophil percent Lymphocyte count Lymphocyte percent Monocyte count Monocyte percent Immature granulocyte count Immature granulocyte percent 4. The technical consultant confirmed the findings in an interview conducted on 09/23/2025 at 1015 hours in the break room. B) Repeat CBC results 1. A review of the laboratory's procedure titled "Policy for repeating CBC's and Communicating Critical Values" (approved 12/30 /2020) determined: "In an effort to ensure accuracy in patient CBC testing, it is the policy of this laboratory to repeat tests when these are critical." The procedure then defined the follow ranges for repeat testing: WBC: less than 2 or greater than 20 HGB: less than 7.5 or greater than 18 HCT: less than 25 or greater than 55 PLT: less than 50 or greater than 800 2. A review of patient test records from August 2025 identified the following result which met the laboratory's criteria for repeat testing, however the laboratory failed to have documentation of repeating the test (see patient alias list: a) August 25, 2025 Patient 9 Analytes: HGB: 24.5 HCT: 70.4 3. The technical consultant confirmed the findings in an interview conducted on 09/23/2025 at 1015 hours in the break room. Key WBC: white blood cell HGB: hemoglobin HCT: hematocrit PLT: platelet D5779

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies, the laboratory's American Proficiency Institute (API) proficiency testing results from 2022, the laboratory's records, and staff interview, it was revealed that the laboratory failed to have documentation of performing

Summary Statement of Deficiencies D0000 The laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCY: D5400 - 42 C.F.R. 493.1250 Condition: Analytic Systems Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representative was given an opportunity to provide evidence of compliance with noted deficiencies and no such evidence was provided prior to survey exit. 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 D0000 The laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCY: D5400 - 42 C.F.R. 493.1250 Condition: Analytic Systems Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representative was given an opportunity to provide evidence of compliance with noted deficiencies and no such evidence was provided prior to survey exit. 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 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 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 --