Kidz Medical Services Inc

Summary Statement of Deficiencies D0000 A recertification survey conducted on 05/11/2023 found KIDZ MEDICAL SERVICES INC clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to have all testing personnel (TP) rotate through the testing of Proficiency Testing (PT) for the Hematology specialty in five out of five events reviewed. Findings included: Review of FORM CMS-209 signed and dated by the Laboratory Director (LD) on 05/11/2023 revealed the laboratory had three TP listed (TP#A, TP# B and TP#C). Personnel files review revealed that TP# A and TP#C were TP during 2021, 2022 and 2023. TP#B started as TP in 2023. Review of American Proficiency Institute (API) PT records for 2021 (third event), 2022 (first, second and third event) and 2023 (first event) , revealed that TP#A was the TP that performed all five events. During an interview on 05/11/2023 at 3:00 PM, TP#A A confirmed that TP#C failed to perform PT for the period of reference. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) 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 -- Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on record review and interview, the Technical Supervisor (TS) failed to evaluate the annual competency for two out of two testing personnel (TP) during 2022. Findings included: -Review of the FORM CMS-209 signed by the Laboratory Director (LD) on 05/11/2023 revealed that the LD was also the Clinical Consultant (CC) and TS; the General Supervisor (GS) was also TP#C. The laboratory had three TP (TP#A, TP#B and TP#C). -Review of personnel records revealed that TP#A and TP#C were employed during 2022. No records of competencies found for TP#A and TP#C for 2022. During an interview on 05/11/2023 at 11:30 AM with TP#A, she confirmed that the TS failed to perform the competencies listed above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey conducted, 9/10/2019 found that Kidz Medical Services Inc; Dba clinical laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) 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 record review and staff interview, the facility failed to have the laboratory director (LD) signature on the attestation for 1 out of 5 events reviewed for the Hematology specialty from 2017 to 2019 The findings include: A review of the American Proficiency Institute (API) proficiency testing record revealed that there was no LD signature in the attestation for the 1st event in 2019. During an interview on 09/10/2019 at 12:30 PM, the technical supervisor confirmed that the laboratory failed to have a signed attestation by the LD of the event of reference. 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 competency assessment record review and staff interview, 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 -- failed to have annual assessment competencies that covered the six required procedure points for the testing personnel (TP) and to document the annual competency for the technical (TS) and general supervisor (GS) for 2 out of 2 years reviewed (2017-2019). The findings include: A review of personnel competency assessment records for 2017 and 2018 revealed the following: a) TP competencies failed to include the six required points that asses: skill, knowledge and experience to perform their laboratory duties. b) No documentation of the annual competency for the TS and the GS for 2 out of 2 years reviewed During an interview on 09/10/2019 at 12:30 PM, the technical supervisor confirmed that the laboratory failed to asses the technical skills of the TP and have no documentation of the annual competencies for the TS and GS. -- 2 of 2 --