Kidmed West End

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Kidmed West End on March 13, 2025 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Kidmed West End was not in compliance with the applicable Conditions and Standards under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows: D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D0000 An announced CLIA Recertification on-site survey was conducted at the Kidmed West End on May 12, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The initial contact and entrance interview with laboratory conducted on April 19, 2021 with off-site record review of documentation on May 6, 2021 and a follow-up phone conference on May 10, 2021. Specific deficiencies cited are as follows: The laboratory is performing COVID-19 testing and in compliance with the applicable COVID-19 reporting requirements. D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on the review of proficiency testing (PT) records and an interview, the laboratory failed to participate in one (1) of 7 Complete Blood Count (CBC) events reviewed. Record review included all three events in 2019, 2020 and the first event in 2021. Findings include: 1. Review of the CASPER 0155D Individual Laboratory Profile Report and the American Proficiency Institute (API) PT records for the third event in 2020 revealed the laboratory received a score of 0%. 2020 Event C- 0%- for the CBC module (Notation by API-failure to participate). 2. An exit interview with 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 -- the technical consultant on 05/12/21 at approximately 10:30 AM confirmed the findings. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of policy and procedures (P&P), Abbott Emerald calibration records, and interviews, the laboratory failed to document Abbott Emerald calibration procedures for hematology Complete Blood Count (CBC) testing according to their written policy in the calendar year 2020. Findings include: 1. Review of the P&P revealed a calibration policy (signed by the lab director 1/11/17) that outlined to calibrate CBC testing on the Abbott Emerald at a frequency of every six (6) months. 2. Review of the laboratory's 2020 and 2021 (up to the date of survey) calibration records revealed calibrations were performed on the Abbott Emerald on 08/07/2019, 05/13/2020 and 01/21/2021. The surveyor requested additional documentation for calendar year of 2020 demonstrating calibration for the Abbott Emerald every 6 months. The laboratory provided no additional calibration documentation between 05 /13/2020 to 01/21/21. 3. An exit interview with the technical consultant at approximately 10:30 AM on 5/12/21 confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at KidMed West End on January 24, 2019 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a review of the laboratory's proficiency testing (PT) records and interview, the laboratory failed to attain a testing event score of at least eighty (80) percent (%) for one (1) of six (6) Hematology testing events reviewed. **REPEAT DEFICIENCY Findings include: 1. Review of the laboratory's 2017 and 2018 American Proficiency Institute (API) PT records, a total of 6 events, revealed unsatisfactory performance for the following event: 2017 API 3rd Event - Hematology overall score of sixty-five (65) %-with Red Blood Cell count scored sixty (60) %, Hematocrit scored 60%, Hemoglobin scored 60%, White Blood Cell count scored 60%, Platelet count scored 60%. 2. In an interview with the Lab Coordinator, Project Coordinator, and Technical Consultant at approximately 12:30 PM, it was confirmed that the laboratory failed to attain a satisfactory score for the PT event listed above. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by 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 -- manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of analyzer validation records, patient test logs, and interviews, the laboratory failed to evaluate and verify operational performance of the relocated Abbott Emerald Hematology analyzer prior to reporting six hundred sixty-seven (667) patient Complete Blood Count (CBC) panels from October 1, 2017 to the date of the survey, January 24, 2019. Findings include: 1. Review of the laboratory's hematology analyzer records revealed an instrument installation occurred on 10/1/17. The inspector noted no records of accuracy, precision, reportable and reference range verification documented for the Abbott Emerald (SN 032211-002733) after the installation and prior to patient testing. The inspector requested to review performance specifications. No documentation was available for review. The Project Coordinator stated: "we moved the Emerald from another office location and we were not aware that the system had to be revalidated after moving". 2. Review of the patient test log from the laboratory's electronic medical record, DOCUTAP, and Project Coordinator's notes revealed that the laboratory had reported 667 patient CBC reports from 10/1/17 to the date of the survey on 1/24/19 utilizing the Emerald (SN 032211-002733). 3. In an interview with the Lab Coordinator, Project Coordinator, and Technical Consultant at approximately 12:30 PM, it was confirmed that the laboratory failed to evaluate performance specifications as outlined above. 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 a review of the laboratory's analyzer validation records, patient test logs, Center for Medicare and Medicaid Services Laboratory Personnel Report Form (CMS 209), personnel files, and an interview, the laboratory director (LD) failed to perform competency assessments for one (1) of two (2) technical consultants in calendar years 2017 and 2018 (Cross Reference D6030 -REPEAT DEFICIENCY). D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or -- 2 of 3 -- continuing education to improve skills; This STANDARD is not met as evidenced by: Based on a review of the laboratory's Center for Medicare and Medicaid Services Laboratory Personnel Report Form (CMS 209), personnel files, and interview, the laboratory director (LD) did not perform competency assessments for one (1) of two (2) technical consultants in calendar years 2017 and 2018. **REPEAT DEFICIENCY Findings: 1. Review of the laboratory's CMS 209 form revealed that the LD identified two technical consultants (TC). (See Personnel Code Sheet.) 2. Review of the laboratory's available personnel files revealed no competency assessment documentation for TC B in 2017 and 2018. The inspector requested to review competency assessment documentation for TC B. The documentation was not available for review. 3. In an interview with the Lab Coordinator, Project Coordinator, and TC A at approximately 3:00 PM, it was confirmed that the LD failed to document competency assessments for TC B as outlined above. -- 3 of 3 --