My Family Healthcare, Llc

Summary Statement of Deficiencies D0000 The recertification survey was performed on 06/25/2024. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the technical consultant at the conclusion of the survey. D5401 PROCEDURE MANUAL CFR(s): 493.1251(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 a review of records, policies and procedures, and interview with the technical consultant and testing person #1, the laboratory failed to follow their written policy for verifying the stated values of control materials prior to implementation for three of 15 lot numbers used during the review period of 06/01/2023 through 04/30 /2024. Findings include: (1) On 06/25/2024 at 10:50 am, the technical consultant and testing person #1 stated the following: (a) The laboratory performed CBC (Complete Blood Count) testing using the Medonic M Series analyzer; (b) Three levels of Boule Con-Diff Tri-Level (Quality Control) materials were tested each day of patient testing; (c) The manufacturer's provided ranges were used to determine acceptability of quality control results. (2) A review of the "Laboratory Procedure Manual" identified a policy titled "QC Policy and Calibration", in section IV- Medonic M Series, Part F - Control Range Verification stated "Boule Con-Diff Controls should be run for 5 runs over 5 days to ensure that the new lot number of control is performing according to package insert ranges before being put into use. If a 5 day verification is unable to be performed, document the reason for the shortened new lot verification study and run a minimum of 3 times before putting into use." (3) A review of records for 15 control lot numbers used from 06/01/2023 through 04/30/2024 identified no 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 -- documentation to prove three of the 15 lot numbers had been implemented per policy: (a) Level 1 lot #2231101, level 2 #2231102, and level 3 lot #2231103 used from 01/02 /2024 through 03/21/2024 - The controls had been tested as follows: (i) Once on 12/20 /2023 (ii) Once on 12/21/2023 (4) The findings were reviewed with the technical consultant who stated 06/25/2024 at 3:30 pm, the laboratory did not follow their written policy. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 04/28/2022. The findings were reviewed with the technical consultant, testing person #1 and testing person #3 at the conclusion of the survey. The laboratory was found in compliance with a standard-level deficiency cited. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to review and evaluate proficiency testing results for one of four events. Findings include: (1) On 04/28/2022, a review of 2021 and 2022 proficiency testing records and revealed the following biases (biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency program): (a) 2022 First Hematology Event (i) Red Blood Cells - three of five results exhibited a negative bias (aa) Sample HSY-01 - SDI of -2.3 (bb) Sample HSY-02 - SDI of -2.1 (cc) Sample HSY-03 - SDI of -3.2 (2) There was no evidence in the records proving the biases had been identified and addressed; (3) The records were reviewed with the technical consultant. The technical consultant stated on 04/28/2022 at 10:35 am the bias had not been addressed. 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 The recertification survey was performed on 10/02/2020. The findings were reviewed with the technical consultant and clinic manager at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. D5401 PROCEDURE MANUAL CFR(s): 493.1251(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 a review of the policy and procedure manual and interview with the technical consultant, the laboratory failed to follow written CBC quality control procedures for 3 of 6 days; and failed to follow the written policy for verifying flagged results for 2 of 3 patient records. Findings include: QUALITY CONTROL (1) On 10/02/2020 at 10:00 am, the technical consultant stated to the surveyors CBC (Complete Blood Count) was performed on the Medonic M-Series analyzer; (2) Surveyor #2 reviewed written QC procedure titled, "QUALITY CONTROL GUIDELINES" which stated, (a) "7.1 3 levels of Quality Control (QC) materials should be tested in both modes each day of patient testing prior to testing patient samples." (b) "7.2 The QC material used for the Medonic M-Series is the CDS Boule Con-Diff, provided in 3 levels (Low, Normal, and High)." (c) "7.3 QC may be analyzed via any of the sample modes. At this facility, all 3 levels of QC will be performed in the Open Tube/Closed Tube AND the Micro Capillary mode each day of patient testing. The Micro Capillary mode utilizes the Micro Pipette Assembly (MPA)." (d) "7.4 Results of QC testing must be acceptable for two of the three levels tested before patient test results can be reported." (3) Surveyor #2 reviewed 6 days of QC records between 09/02/2020 and 09/11/2020. For 3 of 6 days QC records there 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 -- was no indication the laboratory staff followed their written procedure as follows: (a) MC (Micro Capillary) QC on 09/08/2020 (i) QC Low Control (lot# 2200521) tested at 09:50 am failed (aa) RBC (Red Blood Cell) (ii) QC Normal Control (lot# 2200522) tested at 09:46 am failed (aa) RBC (bb) Hematocrit (cc) Hemoglobin (dd) WBC (White Blood Cell) (ee) Platelets (iii) 6 patients test results were reported with 1 level of MC QC within acceptable range (aa) Patient tested at 11:52 am (bb) Patient tested at 12:59 pm (cc) Patient tested at 02:11 pm (dd) Patient tested at 03:56 pm (ee) Patient tested at 04:27 pm (ff) Patient tested at 04:32 pm (b) MC QC on 09/10/2020 (i) QC Low Control (lot# 2200521) tested at 09:24 am failed (aa) RBC (ii) QC High Control (lot# 220053) tested at 09:25 am failed (aa) Hemoglobin (iii) 6 patients test results were reported with 1 level of MC QC within acceptable range (aa) Patient tested at 09: 36 am (bb) Patient tested at 10:55 am (cc) Patient tested at 12:50 pm (dd) Patient tested at 02:15 pm (ee) Patient tested at 02:48 pm (ff) Patient tested at 02:53 pm (c) MC QC on 09/11/2020 (i) QC Low Control (lot# 2200521) tested at 10:02 am failed (aa) RBC (ii) QC Normal Control (lot# 220052) tested at 09:59 am failed (aa) Hemoglobin (iii) QC High Control (lot# 220053) tested at 09:54 am failed (aa) RBC (bb) Hematocrit (cc) Hemoglobin (dd) WBC (ee) Lymphocytes (ff) Platelets (iv) 1 patient test result was reported with no level of MC QC within acceptable range (aa) Patient tested at 10:08 am (3) Surveyor #2 reviewed the findings with the technical consultant who stated on 10/02/2020 at 01:00 pm that the QC procedure had not been followed as indicated above before testing patients. FLAGGED RESULTS (1) On 10 /02/2020 at 10:00 am, the technical consultant stated to surveyor #1 the laboratory performed CBC (Complete Blood Count) testing using the Medonic M Series analyzer; (2) Surveyor #1 reviewed the manufacturer's instructions for verifying flagged results obtained on the analyzer. The following were examples of flags, with the corresponding instructions: (a) BD - "Blood sample too old or pathological sample. Follow laboratory's protocol for verification of results." (b) OM - "Blood sample too old or pathological sample. Follow laboratory's protocol for verification of results." (3) Surveyor #1 then reviewed the laboratory's written policy and procedure for verifying flags which stated: (a) "Performing a slide review or referring the specimen for further study is required when flags are attached to the differential WBC for the OM and TM flags." (3) Surveyor #1 randomly reviewed 3 patient records which contained flagged results from CBC testing performed during September 2020. For 2 of the records, there was no evidence the laboratory followed their written instructions for verifying the flags. The findings for the 2 records were: (a) Patient testing was performed on 09/21/20 at 03:32 pm, with BD flags obtained; (b) Patient testing was performed on 09/30/2020 at 05:06 pm, with OM flags obtained. (4) Surveyor #1 reviewed the records with the technical consultant, who stated on 10/02 /2020 at 11:53 am that the laboratory failed to follow their policy for verifying the flags obtained for the above 2 patients. 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 a review of manufacturer's instructions and interview with the technical consultant and testing person #1, the laboratory failed ensure quality control materials were not used beyond open vial stability. Findings include: (1) On 10/02/2020 at 10: -- 2 of 3 -- 00 am, the technical consultant stated to surveyor #1 the laboratory performed CBC (Complete Blood Count) testing using the Medonic M Series analyzer; (2) Surveyor #1 observed the following control material stored in the laboratory refrigerator, that had not been dated when opened: (a) Boule Con-Diff Tri-Level control materials: (i) 1 bottle of low control lot# 22008-31 (ii) 1 bottle of normal control lot# 22008-32 (iii) 1 bottle of high control lot# 22008-33 (3) Surveyor #1 asked the technical consultant and testing person #2 to explain what the controls were used for. The technical consultant explained the following: (a) Boule Con-Diff Tri-Level controls were used to perform quality control procedures for CBC testing performed on the Medonic M Series analyzer. (4) Surveyor #1 reviewed the manufacturer's open date stability instructions, which required the following: (a) Boule Con-Diff Tri-Level controls - Open vial stability 14 days after opening when returned to refrigerator after each use. (5) Surveyor #1 reviewed the instructions and the lack of dates on the control bottles with the technical consultant and testing person #1, who stated on 10/02/20 at 10:00 am the controls had not been dated with the open vial expiration date; (6) Since the bottles had not been dated, surveyor #1 could not determine if they had been used beyond their open vial expiration dates. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The findings were reviewed with the technical consultant, testing person #1 and the clinic office manager at the conclusion of the survey. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the technical consultant, the laboratory failed to ensure an analyzer was stored as required by the manufacturer. Findings include: (1) At the beginning of the survey, the technical consultant stated the following to the surveyor: (a) CBC (Complete Blood Count) testing was performed on the Medonic M Series analyzer. (2) The surveyor reviewed the manufacturer's environmental requirements for the analyzer. The manufacturer required the room temperature be maintained within the range of 18 - 32 degrees celsius (C); (3) The surveyor reviewed laboratory temperature records from November 2016 through May 2018 which verified the room temperature readings were less than 18 degrees C for 3 of 18 months as follows: (a) December 2017 - 1 of 31 room temperature readings were documented as less than 18 degrees C (day 26 ); (b) January 2018 - 14 of 31 room temperature readings were documented as less than 18 degrees C (days 2,3,4,5,8,9,10,11,12,16,22,24,25,26); (c) February - 2 of 28 room temperature readings were documented as less than 18 degrees C (days 5,13); (4) The surveyor reviewed the records with the technical consultant who stated the room 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 -- temperature of the laboratory had been maintained below 18 degrees C as indicated above. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the technical consultant, the laboratory failed to ensure equipment maintenance was performed as required by the manufacturer. Findings include: (1) At the beginning of the survey, the technical consultant stated to the surveyor CBC (Complete Blood Count) testing was performed on the Medonic M Series analyzer; (2) The surveyor reviewed October 2016 through May 2018 (19 months) manufacturer's maintenance logs for the analyzer with the following identified: (a) Monthly Cleaning (Hypochlorite) and Clot Prevention (Enzymatic) (i) The monthly cleaning procedure had not been documented as performed during: (aa) December 2016 (bb) October 2017 (3) The surveyor reviewed the records with the technical consultant who stated there was no evidence the above maintenance had been performed as required. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory director or designee failed to attest that, at the time of testing, proficiency testing samples were tested in the same manner as patient specimens as required under Subpart H. Findings include: (1) At the beginning of the survey, the surveyor reviewed 2016, 2017, and 2018 proficiency testing records. It was identified for 1 of 5 events, the attestation statement had been signed approximately 2 months after the samples had been tested (not within a timeframe for the director to attest that, at the time of testing, the proficiency samples had been tested as required) as follows: (a) First 2018 Hematology Event - The samples had been tested on 03/23/18 and the attestation statement had not been signed by the laboratory director or designee until 05/06/18. (2) The surveyor reviewed the findings with the technical consultant that the attestation statement must be signed within a timeframe to definitively attest to the fact that proficiency samples were tested in the same manner as patient specimens. -- 2 of 2 --