Abc Pediatrics

Summary Statement of Deficiencies D1000 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(c) (c) Certificate of waiver tests. A laboratory may qualify for a certificate of waiver under section 353 of the PHS Act if it restricts the tests that it performs to one or more of the following tests or examinations (or additional tests added to this list as provided under paragraph (d) of this section) and no others: (1) Dipstick or Tablet Reagent Urinalysis (non-automated) for the following: (i) Bilirubin; (ii) Glucose; (iii) Hemoglobin; (iv) Ketone; (v) Leukocytes; (vi) Nitrite; (vii) pH; (viii) Protein; (ix) Specific gravity; and (x) Urobilinogen. (2) Fecal occult blood - non-automated (3) Ovulation tests visual color comparison tests for human luteinizing hormone; (4) Urine pregnancy tests - visual color comparison tests; (5) Erythrocyte sedimentation rate-non-automated; (6) Hemoglobin-copper sulfate-non-automated; (7) Blood glucose by glucose monitoring devices cleared by the FDA specifically for home use; (8) Spun microhematocrit; and (9) Hemoglobin by single analyte instruments with self-contained or component features to perform specimen/reagent interaction, providing direct measurement and readout. (d) Revisions to criteria for test categorization and the list of waived tests. HHS will determine whether a laboratory test meets the criteria listed under paragraph (b) of this section for a waived test. Revisions to the list of waived tests approved by HHS will be published in the FEDERAL REGISTER in a notice with opportunity for comment. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions for the Consult Strep A Test Dipsticks, the Consult COVID-19/Flu A&B Antigen Test, the Quidel QuickVue SARS Antigen Test, surveyor observation and staff interview, the laboratory failed to have documentation of monitoring the storage temperature for the identified waived test kits. The findings included: 1. Manufacturer's instructions for the Consult Strep A Test Dipsticks stated kits were required to be stored at 36 - 86F (2 - 30C). 2. Manufacturer's instructions for the Consult COVID-19/Flu A&B Antigen Test stated 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 -- kits were required to be stored at 36 - 86F (2 - 30C). 3. Manufacturer's instructions for the Quidel QuickVue SARS Antigen Test stated kits were required to be stored at 59 - 86F (15 - 30C). 4. Surveyor observation on July 28, 2026 at 0915 hours in the store room identified the following kits: a) Consult Strep A Test Dipsticks 1 box of 50 tests b) Consult COVID-19/Flu A&B Antigen Tests 20 boxes of 25 tests each c) Quidel QuickVue SARS Antigen Test 10 boxes of 25 tests each 5. The laboratory did not have documentation of monitoring the temperature of the storage room. 6. The technical consultant confirmed the findings in an interview conducted on July 28, 2026 at 0925 hours in the storage room. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 surveyor observation blood collection devices contained in the storage room, and staff interview, the laboratory failed to have documentation of establishing and monitoring the temperature of the blood collection tubes. The findings included: 1. Surveyor observation on July 28, 2026 at 0915 hours in the store room identified the following blood collection devices: a) Blood collection devices 47,500 blood capillary tubes The collection devices were labeled as "K2 EDTA Blood Collection Tubes"and had a documented expiration date. The packaging did not contain manufacturer information or storage requirements. 2. The laboratory did not have documentation of establishing or monitoring the temperature of the storage room. 3. The technical consultant confirmed the findings in an interview conducted on July 28, 2026 at 0925 hours in the storage room. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy, manufacturer's quality control (QC) package inserts and confirmed in interview, the laboratory failed to retain manufacturers' QC package inserts for six of six lot numbers on the Sysmex XN-L hematology analyzer from September 2023 to May 2024. Findings include: 1. Review of the laboratory's policy titled "CONTROL POLICY" approved by the laboratory director on 02/26/1998 stated: " ...records kept for at least two years." 2. Review of historical QC data for the Sysmex XN-L hematology analyzer from September 2023 to May 2024 determined the following QC lots were used by the laboratory: a) Master lot: 232314 b) Master lot: 304214 c) Master lot: 312614 d) Master lot: 321014 e) Master lot: 329414 f) Master lot: 401314 3. The laboratory was asked to provide manufacturer's package inserts for listed lots. On 06/24/2024 at 1042 hours in room 10, testing person-1 stated the laboratory does not have the package inserts for previous QC lots in use. 4. Testing person-1 and the technical consultant confirmed the findings in an interview on 06/24/2024 at 1043 hours in room 10. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, 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 2 -- 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 review of the laboratory's maintenance logs from December 2023 to May 2024, and confirmed in interview, the laboratory failed to document monthly maintenance five of six months, and quarterly maintenance for one of two months for the Cepheid GeneXpert Xpress analyzer. Findings include: 1. Review of the laboratory's maintenance logs titled "GeneXpert Xpress System Maintenance Log" (302-5611 Rev. D August 2023) from December 2023 to May 2024 determined manufacturer-specified monthly maintenance was not documented on the following months: a) December 2023 b) February 2024 c) March 2024 d) April 2024 e) May 2024 Further review of the laboratory's maintenance logs determined manufacturer- specified quarterly maintenance was required on the following months: a) February 2024 (documented) b) May 2024 (not documented) 2. The technical consultant confirmed the findings during an interview on 06/25/2024 at 1303 hours in room 10. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid (CMS)-209 form, review of the laboratory's competency documentation, and confirmed in interview, the laboratory failed to ensure two semi-annual competency assessments were documented within the first year of training for two of two testing personnel performing moderate complexity testing. Findings include: 1. Review of the CMS-209 form determined testing person-3 and testing person-4 were listed as testing personnel performing moderate complexity testing. 2. Review of the laboratory's training and competency documentation determined: a) Testing person-3: Training date: 11/03 /2021 Semi-annual competency: 03/14/2022 (4 months, 12 days from training) Semi- annual competency: 03/07/2023 (1 year, 4 months, 5 days from training) b) Testing person-4: Training date: 08/18/2022 Semi-annual competency: 10/28/2022 (2 months, 11 days from training) Semi-annual competency: 11/21/2023 (1 year, 3 months, 4 days from training) 3. The technical consultant confirmed the findings in an interview on 06/25/2024 at 0950 hours in room 10. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D6063 - 42 C.F.R. 493.1412 Condition: Testing Personnel; moderate complexity 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