Kidz Medical Services Inc D/B/A

Summary Statement of Deficiencies D0000 A recertification survey was conducted on December 10, 2024 to January 8, 2025. Kidz Medical Services Inc DBA Childrens Hematology and Oncology Associates clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical 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 review of the Medical Laboratory Evaluation (MLE) proficiency testing (PT) records and interview, the laboratory testing personnel failed to sign the attestation for three (2023 1st, 3rd, 2024 2nd) of four (2023 1st, 2nd, 3rd; 2024 2nd) events reviewed. Findings: Review of the MLE PT records showed the attestation signatures for the testing personnel were missing for the 2023 1st, 3rd, and 2024 2nd events, On 12/10/2024 at 11:10 AM, Testing Personnel A acknowledged attestation forms were not signed by the testing personnel. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing 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 -- samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the Medical Laboratory Evaluation (MLE) proficiency testing (PT) records and interview, the laboratory failed to retain the instrument printouts for the hematology testing for one (2023 1st) of four (2023 1st, 2nd, 3rd; 2024 2nd) events reviewed. Findings: Review of the MLE PT records showed there were five samples sent to the laboratory to test for each event. Review of the laboratory's PT records revealed the instrument printout for the 2023 1st event was missing. On 12/10 /2024 at 11:15 AM, Testing Personnel A acknowledged the instrument printouts were missing. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of patient reports and interview, the laboratory failed to include the normal values for hematology test results for five of five (#1 - #5) patients' reports reviewed. Findings: Review of patient test reports revealed the normal ranges were not listed on the reports for five patient reports reviewed. On 12/10/2024 at 1:15 PM, Testing Personnel A acknowledged the reports were given to patients if they requested a copy, and the normal ranges were not listed on the reports. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on record review and interview, the Laboratory Director failed to provide management of the laboratory's proficiency testing (PT) for 2 of 2 (2023 - 2024) years. Findings: The Laboratory Director failed to ensure PT was performed as required by Subpart H for three of four (2023 1st, 2nd, 3rd, 2024 2nd) events reviewed. (See D6016) The Laboratory Director failed to sign the PT performance evaluation for three (2023 1st, 3rd, 2024 2nd) of four (2023 1st, 2nd, 3rd; 2024 2nd) events reviewed. (See D6018) D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of -- 2 of 4 -- 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 record review, and interview, the Laboratory Director failed to ensure proficiency testing (PT) was performed as required by Subpart H for three of four (2023 1st, 2nd, 3rd, 2024 2nd) events reviewed. Findings The Laboratory Director failed to ensure Testing Personnel signed the attestation for three (2023 1st, 3rd, 2024 2nd) of four (2023 1st, 2nd, 3rd; 2024 2nd) events reviewed. (See D2009) The Laboratory Director failed to ensure the laboratory retained the instrument printouts for the hematology testing for one (2023 1st) of four (2023 1st, 2nd, 3rd; 2024 2nd) events reviewed. (See D2015) D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on November 14, 2022 for Kidz Medical Services Inc. Kidz Medical Services Inc, is not in compliance with the Code of Federal Regulations (CFR), Part 493, Laboratory Requirements. . D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the laboratory's proficiency testing records for 2022, the laboratory did not have successful performance in proficiency testing for analytes in the specialty of hematology. Refer to D2130. Findings include: Review of the American Society of Internal Medicine (MLE) proficiency testing records and 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 3 -- review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on November 14, 2022 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, electronic white blood cell differential for two consecutive testing events in 2022. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful performance in proficiency testing for analytes in the specialty of hematology. Findings include: On November 14, 2022 on or about 10:00 AM the American Society of Internal medicine (MLE) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analyte, electronic white blood cell differential, as shown below. Event #2, 2022 electronic white blood cell differential- 8% Event ##3, 2022 electronic white blood cell differential-12% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score in proficiency testing for analytes found in the specialty of hematology. Findings include: On November 14, 2022, on or about 10:00 AM, the American Society of Internal Medicine (MLE) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two consecutive testing events for the analyte, electronic white blood cell differential, in the specialty of hematology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2130. 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; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing for analyte(s) found in the specialty of hematology Findings Include: The review of the American Society of Internal Medicine (MLE) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on November 14, 2022, on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores for two consecutive testing events for the analytes shown below. Event #2, 2022 electronic white blood cell differential-8% Event #2, 2022 electronic white blood cell differential-12% -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Kidz Medical Services Inc. DBA Childrens Hematology & Oncology Associates on 09/27/2022. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Condition was cited: D6063 Laboratory Testing Personnel 493.1421 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 record review and interview with the Laboratory Manager the laboratory failed to perform competency evaluations on 1 (Testing Person #A) out of 3 (Testing Personnel #A-#C) Testing Personnel. Findings Included: Review of competency evaluations for 2020, 2021, and 2022 revealed that Testing Person #A did not have any competency evaluations. Interview on 09/27/2022 at 11:00 AM the Laboratory Manager confirmed that no competencies had been done on Testing Person #A. 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. 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 -- This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to monitor the room temperature and humidity in the laboratory where testing was being done on the Sysmex XN-330 CBC (Complete Blood Count) Hematology analyzer since installed 02/16/2022. Findings Included: Review of instrument validation on the Sysmex XN- 330 revealed that it was installed on 02/16/2022. Review of the performance specifications for the Sysmex XN-330 revealed that the room temperature must be 15- 36 degrees Celsius and have a relative humidity of 20-85%. Review of temperature charts revealed no documentation of room temperature or humidity. Interview on 09 /27/2022 at 11:12 AM the Laboratory Manager confirmed that room temperature and humidity had not been documented. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on record review and interview the laboratory failed to verify the education of 1 (Testing Person #B) out of 3 (Testing Personnel #A-#C) Testing People reviewed (See D6065). D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to verify the education of 1 (Testing Person #B) out of 3 (Testing Personnel #A-#C) Testing People reviewed. Findings Included: Review of Testing Person #B revealed that they had a diploma from Columbia. There was no foreign diploma equivalency performed. She was hired on 05/26/2022. Interview on 09/27/2022 at 11:00 AM the Laboratory Manager confirmed that there was no foreign diploma equivalency. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 7/29/20 at Kidz Medical Services Inc. dba Children's Hematology & Oncology Associates, a clinical laboratory in West Palm Beach, Florida. Kidz Medical Services Inc. dba Children's Hematology & Oncology Associates is not in compliance with Code of Federal Regulations (CFR) 42, Part 493, Laboratory Requirements. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved