G Athanasi Orfanos Md Pediatrics

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) (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 review of the laboratory's policies, review of the laboratory's American Proficiency Institute's proficiency testing records from 2024 and 2025, and staff interview, the laboratory failed to ensure proficiency testing samples were tested the same number of times as patient samples. The findings included: 1. A review of the laboratory's policy titled "Critical Values/Repeat Criteria Policy" (approved 06/12 /2015) determined complete blood count results were to be repeated when they fell outside the following criteria: White Blood Cell less than 2.0 and greater than 25.0 Hemoglobin less than 7.5 and greater than 18 Hematocrit less than 25 and greater than 55 Platelet less than 50 or greater than 800 2. A review of the laboratory's American Proficiency Institute's proficiency testing records from 2024 (events 1, 2 and 3) and 2025 (events 1 and 2) identified the following proficiency testing results which met the facility's criteria for repeat testing, however the laboratory failed to have documentation of repeat testing: a) 2024 Event 1 Sample: HSY-02 Tests: Hemoglobin 5.9 Hematocrit 17.2 Sample: HSY-03 Tests: Hemoglobin 19.1 Hematocrit 61.2 b) 2024 Event 3 Sample: HSY-14 Tests: Hemoglobin 5.8 Hematocrit 15.6 c) 2025 Event 2 Sample: HSY-09 Tests: Hemoglobin 5.8 Hematocrit 16.3 3. The technical consultant confirmed the findings in an interview conducted on 10/07/2025 at 0945 hours in the office. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed 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 3 -- 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 laboratory's policies, review of patient test records from September 2025, and staff interview, the laboratory failed to following its policy for ensuring flagged Complete Blood Count (CBC) results were not reported to the provider for 2 of 3 results. The findings included: 1. A review of the laboratory's policy titled "Policy for Handling Flagged CBC's" (approved 02/17/2022) determined: "It will be the policy of this laboratory to rerun flagged CBC results. If the second run still shows flags, then the lab will evaluated flagged differential according to procedures in the unit's operator's manual. Lab staff must ensure sample requirements are met, that the unit is in good condition order, and that the testing procedure is correctly followed. Sometimes the flags will disappear when the sample is allowed to equilibrate at room temperature for 15 to 20 minutes, or by recollecting the sample. If the flags disappear, then report that result. If the flags persist, then the laboratory will confirm the abnormal differential by sending out to a reference laboratory or crossing out the flagged values. Crossing out of the flagged parameters has to occur prior to handing the results to the provider. These results cannot be used to diagnose the condition of the patient. Flagged results will not be reported at any time." 2. A sampling of patient results from September 2025 identifed the following 2 of 3 flagged CBC results which were reported to the provider: a) Account number: 33024 Date: 09/12/2024 Flagged Results: Neutrophil percent Lymph percent Monocytes percent b) Account number: 5631 Date: 09/29/2025 Flagged Results: Neutrophil percent Lymph percent Monocytes percent Neutrophil count Lymph count Monocytes count 3. The technical consultant confirmed the findings in an interview conducted on 10/07/2025 at 1100 hours in the laboratory. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratorys and, as applicable, the manufacturers test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, review of the laboratory's quality control records from August 2025 and September 2025, review of patient test records, and staff interview, the laboratory failed to ensure quality control results for Complete Blood Count were acceptable prior to reporting patient results. The findings included: 1. A review of the laboratory's policy titled "CONTROL POLICY" (approved 1/4/11) found: "Control results shall be recorded and if controls are beyond the expected range then remedial actions must also be recorded. All control results and remedial actions must be recorded and records kept for at least two (2) years. Patient testing must not be performed or reported when control test results are outside the expected range." 2. A review of the laboratory's Complete Blood Count quality control results from August 2025 and September 2025 identified two days when the laboratory reported patient results without at least two levels of acceptable quality control results. They were: a) Date: 08/31/2025 Level 1: not tested Level 2: quality control failed (flagged results) Level 3: acceptable b) Date: 09/07/2025 Level 1: acceptable Level 2: -- 2 of 3 -- quality control failed (flagged results) Level 3: quality control failed (flagged results) 3. A review of patient results from August 31, 2025 and September 9, 2025 identified the following patients who's results were reported without acceptable quality control: a) August 31, 2025 Account no.: 30979 b) September 7, 2025 Account no.: 14419 Account no.: 35559 Account no.: 26093 4. The technical consultant confirmed the findings in an interview conducted on 10/07/2025 at 1100 hours in the office. 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 the laboratory's patient test results from August 2025 and September 2025, review of the laboratory Panic/Critical Value log and staff interview, the laboratory failed to have documentation of the notification of 2 of 2 critical values. The findings included: 1. A review of the laboratory's policy titled "Critical Values/Repeat Criteria Policy" (approved 06/12 /2015) determined the laboratory defined the following Critical Values: a) White Blood Cell less than 2.0 and greater than 25.0 b) Hemoglobin less than 7.5 and greater than 18.0 c) Hematocrit less than 25 and greater than 55 d) Platelet less than 50 or greater than 800 2. A review of the laboratory policy titled "Reporting Critical Values" (approved 01/04/2011) determined: "It is the policy of this laboratory to document the reporting of Critical Values. Document: 1. Who was notified 2. When was the person notified 3. By whom was the person notified" 3. A review of the patient results from August 2025 and September 2025 identified the follow 2 patient results which met the laboratory's critical value criteria: a) Date: 08/11/2025 Account no.: 31992 Hemoglobin: 7.1 Hematocrit: 19.1 b) Date: 09/29/2025 Account no.: 11425 Hemoglobin: 18.1 4. A review of the laboratory's Critical Value Log determined the two critical values were not documented on the log as required by the facility. 5. An interview with the technical consultant on 10/07/2025 at 1100 hour in the laboratory confirmed the findings. a) Date: -- 3 of 3 --

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions for the Boule Con-Diff Tri-Level hematology controls, surveyor observation of control material currently in use, and staff interview, the laboratory failed to document expiration dates for three of three opened hematology controls currently in use. The findings included: 1. Review of the manufacturer's instructions for the Boule Con-Diff Tri-Level hematology controls hematology control ( 201043L R03.31.15) found under the heading STORAGE AND STABILITY: "Open vial stability 14 days after opening when returned to refrigerator after each use." 2. Observations made during the inspection found three vials of controls in a cup in the refrigerator. Low control lot 22305-01 expiration 2023-09- 2023 with an opened date of 08/21/2023 Normal control lot 22305-02 expiration 2023- 09-26 with an opened date of 08/24/2023 High control level 22305-03 expiration 2023-09-28 with an opened date of 8/23/2023 The controls did not have a date documented for the new expiration date defined by the open date on the vials in use. 3. During interview of testing person two conducted on August 23, 2023 at 10:35 AM, she confirmed the lab had not documented the new open vial expiration date and used no other means of documenting how long the controls were used. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based upon review of policies and procedures, quality control records and interview of facility personnel, the laboratory reported eighteen patient specimens when Hematology controls failed to meet the laboratory's acceptable limits on nine of thirteen days in June 2023. The findings included: 1. Review of the policy titled CONTROL POLICY (dated 1/4/11) found: "Control results shall be recorded and if controls are beyond the expected range then remedial actions must also be recorded. All control results and remedial actions must be recorded and records kept for at least two (2) years. Patient testing must not be performed or reported when control test results are outside the expected range. Use the "QC Out-Of-Limits Log Sheet" to record controls and remedial actions when controls are outside the expected range. Additionally, use the "Daily Sample Troubleshooting Checklist" found in this section, to help you resolve daily control problems. All control records and Remedial Action Sheets will be reviewed, signed/initialed and dated monthly by the Laboratory Technical Consultant. Every month the Technical Consultant will report to the Laboratory Director and the Testing Personnel his findings about the laboratory's performance of quality control, quality assurance, and proficiency testing." 2. Review of Hematology Quality Control records for June 1, 2023 through June 13, 2023 found: a. The laboratory had control failures for Boule Con-Diff Tri-Level lot 2230201 on six of thirteen days : I. June 7, 2023 - White Blood Cell (WBC)- the lab obtained a result of 3.0, with an acceptable result of 3.1 - 3.7 and no documentation of

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representatives at the entrance and exit conferences. The facility representatives were 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 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 --