Little Buddies Pediatrics Pa

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. 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 the surveyor's direct observation, the review of the manufacturer's package insert, the instrument instructions for use, CMS 116 application, and confirmed in an interview, the laboratory failed to document the open dates and revised expiration dates on one of one lot number in use for one of one Sysmex pocH-100i hematology Analyzer. The findings were: 1. Review of the manufacturer's instructions for use titled Sysmex AUTOMATED HEMATOLOGY ANALYZER pocH-100i INSTRUCTIONS FOR USE (Code No. 461-2387-2 PRINTED IN JAPAN Date of Last Revision: September 2006 Software Version: 00-23 and onwards) under EIGHTCHECK 3WP X-TRA revealed "Once opened, the product is stable for 14 days if returned to the refrigerator promptly after use." 2. Review of the manufacturer's package insert titled Sysmex EIGHTCHECK-3WP X-TRA Hematology control for Sysmex analyzers with 3-part differentials under Storage and shelf life after first opening revealed "Opened and recapped vials and vials whose caps have been pierced will retain stability for 14 days if stored at 2-8C after being re- capped." 3. Direct observation of the surveyor on 1/11/2024 at 10:11 am in the laboratory revealed no open dates and revised expiration dates documented on the 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 -- pierced QC vials for one of one lot number in use for one of one Sysmex pocH-100i hematology Analyzer. EIGHTCHECK-3WP X-TRA L (low): Lot# 33330710 Exp. 3/6 /2024 N (normal): Lot# 33330711 Exp. 3/6/2024 H (High): Lot# 33330712 Exp. 3/6 /2024 4. An interview with the TP#2 on 1/11/2024 at 10:14 am in the laboratory confirmed the TP#2 did not know the opened dates of QC vials currentlt in use and stated QC vials were changed every 3 weeks. 5. Review of the CMS 116 application signed by the laboratory director on 1/10/2024 revealed the annual CBC volume was 2346. 6. Another interview with the manager on 1/11/2024 at 12:56 pm in the laboratory confirmed the above findings. Key: CMS=Center of Medicare and Medicaid Services C=Celsius Degree QC=Quality Control CBC=Complete Blood Count TP=Testing personnel 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 the review of the instrument instructions for use, the laboratory's maintenance logs from January 2023 to December 2023, Patient results from 11/17 /2023 to 1/10/2024, and confirmed in an interview, the laboratory failed to document one of four Quartly maintenance for one of one Sysmex pocH-100i hematology Analyzer. The findings were: 1. Review of the manufacturer's instructions for use titled Sysmex AUTOMATED HEMATOLOGY ANALYZER pocH-100i INSTRUCTIONS FOR USE (Code No. 461-2387-2 PRINTED IN JAPAN Date of Last Revision: September 2006 Software Version: 00-23 and onwards) under Cleaning revealed "Clean waste Chamber. Every 3 months or 1500 samples. 2. Review of the laboratory's maintenance logs from January 2023 to December 2023 revealed the laboratory failed to document one of four Quart maintenance for one of one Sysmex pocH-100i hematology Analyzer. Last quartly maintenance documented: 8/16/2023 Next quartly maintenance due: 11/16/2023 3. Review of the patient results from 11/17/2023 to 1/10/2024 revealed 12 patients had CBC testing performed. Date: 11/17/2023 Patient ID: 17806 Date: 11/29/2023 Patient ID: 18127 Date: 11/29/2023 Patient ID: 19357 Date: 12/01/2023 Patient ID: 19137 Date: 12/01/2023 Patient ID: 19274 Date: 12/05/2023 Patient ID: 17496 Date: 12/08/2023 Patient ID: 16427 Date: 12/11/2023 Patient ID: 18541 Date: 12/12/2023 Patient ID: 17306 Date: 12/12/2023 Patient ID: 18994 Date: 12/13/2023 Patient ID: 16449 Date: 12/22/2023 Patient ID: 18351 4. An interview with the manager on 1/11/2024 at 12:10 pm in the break room confirmed the above findings. Key: CBC=Complete Blood Count -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed on May 11, 2022 and found to be in compliance with the conditions of participation found in the CLIA regulations at 42 CFR 493 and recertification is recommended. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, review of personnel records, and confirmed in interview of laboratory personnel, the laboratory failed to follow the manufacturer's instructions to ensure testing persons were trained prior to performing SARS-CoV-2 testing for 1 of 3 testing personnel. The findings included: 1. Review of the manufacturer's instructions for the Sophia SARS-CoV-2 test kit stated, "All operators using your product must be appropriately trained in performing and interpreting the results of your product, use appropriate personal protective equipment when handling this kit, and use your product in accordance with the authorized labeling." 2. Review of personnel record for testing personne #1, #2, and #3 found no documentation of training for the Sophia SARS-CoV-2 test kit. 3. The laboratory was asked to provide documentation of following the manufacturer's instructions to ensure testing persons were trained prior to performing SARS-CoV-2 testing. No documentation was provided. 4. The findings were confirmed in interview with the office administrator on May 11, 2022 at 0920 hours in the break room. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute (API) proficiency testing records and confirmed in interview of laboratory personnel, the laboratory failed to ensure 2 of 4 attestation statements were signed by required personnel for 2 of 4 events reviewed. The findings included: 1. Reverie of API's Attestation Statement stated, "Signatures Required: For all PT results, an attestation statement must by signed by the testing personnel and the laboratory director and retained for a minimum of 2 years. Either the attestation statement below or the form provided online may be used. Electronic signatures must have evidence that only the authorized persone can utilize the signature." 2. Review of the laboratory's API proficiency testing records for 2020 (event 3) and 2021 events (1, 2, and 3) found attestation statements were not signed by all required persons: 2021 (event 3) Hematology - not signed by laboratory director 2021 (event 2) Hematology - not signed by laboratory director - not signed by testing person 3. The findings were confirmed in interview with the office administrator on May 11, 2022 at 10:00 a.m. hours in the break room. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute (API) proficiency testing records and confirmed in interview of laboratory personnel, the laboratory failed to attain a score of at least 80% for White Blood Cell Differential resulting in unsatisfactory performance in 1 of 4 events reviewed. The findings included: 1. Review of the laboratory's API proficiency testing records for 2020 (event 3) and 2021 (events 1, 2, and 3) found the laboratory received the following unsatisfactory score: 2021 (event ) White Blood Cell Score: 33% 2. The findings were confirmed in interview with the office administrator at 10:00 hours in the break room. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute (API) proficiency testing records from 2020 (event 3) and 2021 (events 1, 2, and 3) the laboratory failed to retain required proficiency testing records for 2 years in 1 of 4 events reviewed. The findings included: 1. Review of the laboratory's API proficiency testing records for 2020 (event 3), 2021 (events 1, 2, and 3) found the following records were not retained for a 2 years: 2021 (event 2) Hematology - Instrument records 2. The laboratory was asked to provide documentation of the retaining the instrument records for 2021 (event 2). No documentation was provided. 3. The findings were confirmed -- 2 of 4 -- in interview of the office administrator on May 11, 2022 at 10:00 a.m. in the break room. D5781

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 surveyed on March 19, 2018 and found to be in compliance with the CLIA regulations. Recertification is recommended. 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