Storybook Pediatrics, Pc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on February 23, 2023. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on observation and staff interview, the laboratory established a written policy and procedure that ensured postitive identification for the patient specimens, but did not follow the policy, which states to have 2 identifier's on the patient's specimen. The Findings include: 1. Lab tour and observation revealed that the laboratory did not have two identifier's on 3 out of 3 patient specimens. 2. Laboratory document policy and procedure review revaled the laboratory established a procedure for the positive identification for the patient's specimen, but did not follow the policy. 3. During an inteview with Testing Personnel#4(CMS-209) on February 24, 2023 at 10:45 AM, in the laboratory, confirmed that 3 out of 3 patient's specimen's did not contain 2 identifier's on the patient specimens. 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 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 -- least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on laboratory review and interview with testing personnel (TP), the laboratory failed to perform and document maintenance on Horriba Micros60 for hematology. The Findings include: 1. Laboratory document review revealed the monthly maintenance was not performed and documented on Horriba Micros60 for hematology for August 2021. The Septemer 2021 maintenance indicated that the Micros60 was not in use and was documented as such. 2. During an interview with Testing Personnel#4 (CMS-209), on February 24, 2023, at 12:20 PM, confirmed that the monthly maintenance for Horriba Micros60 was not performed for August 2021. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on October 09, 2018. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory policy and procedure manual (SOP) and staff interview, the laboratory failed to establish and follow a written policy and procedure for assessing employee and, if applicable, consultant competency. Findings include: 1. SOP review revealed the laboratory failed to establish and follow a written policy and procedure for assessing employee competency. 2. An interview with Staff #1 (CMS 209) and the office manager in the lab on 10/09/18 at approximately 1:00 p.m. confirmed the laboratory SOP did not have the aforementioned policy and procedure. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. 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 -- (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)