Kidmed Southside

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Kidmed Southside 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. 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 Southside on May 11, 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 and a follow-up phone conference on May 10, 2021. Specific deficiencies cited are as follows: The laboratory was not in compliance with the following 42 CFR part 493 CLIA Regulations: D2016 - 42 C.F.R. 493-803 Condition: Successful Participation. The laboratory is performing COVID-19 testing and in compliance with the applicable COVID-19 reporting 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. 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 -- This CONDITION is not met as evidenced by: Based on the review of the proficiency testing (PT) scores for the third event in 2020 and the first event in 2021, the CASPER 0155D Individual Laboratory PT report, and an interview with the primary testing personnel and technical consultant, the laboratory failed to achieved satisfactory performance of at least 80% for two consecutive events for the Platelet Count (PLT) parameter, in which the laboratory received scores of 0% and 60% respectively, resulting in unsuccessful performance (Cross Reference D 2130). 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 the technical consultant on 05/11/21 at approximately 2 PM confirmed the findings. 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 the proficiency testing (PT) scores for the third event in 2020 and the first event in 2021, the CASPER 0155D Individual Laboratory PT report and interview with the technical consultant, the laboratory failed to achieve satisfactory performance of at least 80% for two consecutive events for the Platelet Count (PLT) parameter, resulting in unsuccessful performance. Findings include: 1. Review of the API hematology PT scores and the CASPER 0155D Individual Laboratory PT report revealed the following scores: 2020 3rd event PLT- 0% 2021 1st event PLT- 60% The laboratory received an unsuccessful API PT score for the above listed analyte. 2. An exit interview with the technical consultant on 05/11/21 at approximately 2 PM confirmed the findings. -- 2 of 3 -- 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), Horiba Micros 60 calibration records, and interviews, the laboratory failed to document Horiba Micros 60 calibration procedures for hematology Complete Blood Count (CBC) testing according to their written policy in the calendar year 2019. 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 Horiba Micros 60 at a frequency of every six (6) months. 2. Review of the laboratory's 2018 and 2019 calibration records revealed calibrations were performed on the Horiba Micros 60 on 10/17/2018 and 8/5 /2019. The surveyor requested additional documentation for calendar year of 2019 demonstrating calibration for the Horiba Micros every 6 months. The laboratory provided one (1) additional calibration documentation performed on 10/19/19 but no additional documents between 10/17/2018 to 8/5/2019. 3. An exit interview with the technical consultant at approximately 3:30 PM on 5/11/21 confirmed the findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Kidmed Southside, PLLC on January 23, 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: 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 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, user guide, patient test logs, and an interview, the laboratory director (LD) failed to verify the normal values (reference ranges) for Complete Blood Count (CBC) testing prior to reporting eight hundred sixty-six (866) patient CBC panels from September 27, 2017 to the date of the survey, January 23, 2019. Findings include: 1. Review of hematology analyzer records revealed a new instrument installation, by a Horiba field service technical specialist, occurred on 9/27/17. The inspector noted that the validation documentation contained no verification of the CBC patient normal values by the LD for the new Horiba Micro 60 instrument (Serial Number 702CS96721). No normal value verification documentation was available for review upon request. 2. Review of the Micro 60 Users Guide for new instrument installation revealed the instruction: "The patient reference range must be validated by the Lab Director". 3. Review of the patient test 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 -- log from the laboratory's electronic medical record, DOCUTAP, and Project Coordinator's notes revealed that the laboratory had reported 866 CBC reports from 9 /27/17 to the date of the survey on 1/23/19. 4. An interview with the Lab Coordinator, Project Coordinator, and Technical Consultant, at approximately 3:00 PM, confirmed that the laboratory director failed to validate patient CBC reference ranges prior to reporting patient results 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 continuing education to improve skills; This STANDARD is not met as evidenced by: Based on a review of the 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 documentation was not available for review upon request. 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. D6055 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) -- 2 of 3 -- The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing whenever test methodology or instrumentation changes. The individual's performance must be reevaluated to include the use of the new test methodology or instrumentation prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on a tour, review of the Center for Medicare and Medicaid Services Laboratory Personnel Report Form (CMS 209), analyzer installation validation records, users guide, personnel files, and an interview, a technical consultant (TC) failed to document training and competency evaluations for one (1) of seven (7) testing personnel after a hematology instrument change on September 27, 2017. Findings include: 1. During a laboratory tour, at approximately 1:00 PM, the inspector noted a Horiba Micros 60 hematology analyzer in use for Complete Blood Count (CBC) testing. The Project Coordinator stated: "we replaced our Abbott Emerald with the Micros 60 in 2017". 2. Review of the laboratory's CMS 209 revealed that the LD identified two technical consultants (TC) and seven (7) hematology testing personnel (TP). 3. Review of the laboratory's instrument validation records revealed the Micros 60 analyzer installation (Serial Number 702CS96721) was performed by a Horiba field service technical specialist on 9/27/17. 4. Review of the Horiba User's Guide revealed manufacturer's instructions that the "Training Checklist is to be completed prior to patient testing for operators". 5. Review of the laboratory's personnel files revealed no Horiba operator training checklist for TP A. No TP A competency was available for review when requested by the inspector. The Project Coordinator stated: "I am not able to provide the documentation that the initial training checklist was completed". (See Personnel Code Sheet.) 6. An interview with the Lab Coordinator, Project Coordinator, and TC A, at approximately 3:00 PM, confirmed that the TC failed to document training competency evaluations for TP A as outlined above. -- 3 of 3 --