Pediatric Center One Colonial Place

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pediatric Center-One Colonial Place on December 5, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The inspector noted that the laboratory performs COVID- 19 testing and was in compliance with the applicable COVID-19 reporting requirements. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows and includes a Condition under 42 CFR part 493 CLIA Regulation: D5400 -42 CFR. 493.1250 Analytic Systems. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a review of manufacturer's operations manual, hematology analyzer maintenance records, procedures, instrument calibration records, lack of documentation, and an interview, the laboratory failed to: 1. document performance of twice annual Abbott Emerald hematology instrument syringe piston preventative maintenance as required during the twenty-three months reviewed (timeframe January 2021 to December 5, 2022). See D5429; and 2. perform Complete Blood Count calibration procedures for patient testing on the Emerald analyzer every six months, according to their procedure, during calendar year 2021. See D5437 *REPEAT DEFICIENCY. D5429 MAINTENANCE AND FUNCTION CHECKS 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 -- 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 least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of manufacturer's operations manual, hematology analyzer maintenance records, lack of documentation, and an interview, the laboratory failed to document performance of twice annual Abbott Emerald hematology instrument syringe piston preventative maintenance as required during the twenty-three months reviewed (timeframe January 2021 to December 5, 2022). Findings include: 1. Review of the laboratory's hematology procedures revealed an Abbott Emerald Operations Manual with manufacturer's instructions to "perform Lubricating Syringe Pistons maintenance procedure twice annually" (under heading: Preventative Maintenance: Semi-Annual). 2. Review of the laboratory's available Emerald analyzer's maintenance logs from January 2021 to 12/05/22 revealed semi annual syringe piston maintenance was documented once (dated 5/14/21). 3. The inspector requested to review documentation of additional semi annual maintenance for the Abbott Emerald analyzer in calendar year 2021 and year to date in 2022. No additional records were available for review. 4. An exit interview with the Lead Laboratory/Floor Nurse on 12/05/22 at approximately 1:30 PM confirmed the above 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 procedures, instrument calibration records, lack of documentation, and an interview, the laboratory failed to perform Complete Blood Count (CBC) calibration procedures for patient testing on the Abbott Emerald analyzer every six months, according to their procedure, during calendar year 2021. *REPEAT DEFICIENCY Findings include: 1. Review of the laboratory's procedure manual revealed a Hematology Calibration policy that outlined to calibrate CBC testing at a frequency of every six months. The policy stated: "Calibration is a procedure that confirms the accuracy and precision of the Emerald equipment and is performed every six months or more frequently as needed." 2. Review of the laboratory's 2021 Abbott Emerald instrument calibration documentation revealed one calibration record dated 03/25/21. 3. The inspector requested to review additional calibration records for the Abbott Emerald analyzer in calendar year 2021. No additional calibration -- 2 of 3 -- documentation was available for review. 4. An exit interview with the Lead Laboratory/Floor Nurse on 12/05/22 at approximately 1:30 PM confirmed the above findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An unannounced, off-site CLIA proficiency testing desk review was conducted for Pediatric Center One Colonial Place on April 25, 2022 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 (note: the laboratory was not in compliance with the following Condition under 42 CFR part 493 CLIA Regulations: D2016 - 42 CFR. 493.803 Condition: Successful Participation): 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 an off-site desk review of the laboratory's proficiency testing (PT) records 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 -- and interviews, the laboratory failed to attain a score of at least eighty percent of acceptable responses for the Complete Blood Count with Auto Differential module (Cell Identification, Red Blood Cell Count, Hematocrit, Hemoglobin, White Blood Cell Count, Platelet) on two (2) consecutive hematology testing events, reviewed on April 25, 2022, resulting in unsuccessful PT performance. See 2130. 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 an off-site desk review of the laboratory's proficiency testing (PT) records and interviews, the laboratory failed to attain a score of at least eighty percent (80%) of acceptable responses for Cell Differential Identification (Cell ID), Red Blood Cell (RBC), Hematocrit (HCT), Hemoglobin (HGB), White Blood Cell (WBC), and Platelet (PLT) counts for two (2) consecutive Complete Blood Count (CBC) hematology testing events resulting in unsuccessful PT performance as reviewed on the date of the inquiry April 25, 2022. Findings include: 1. Desk review of the laboratory's College of American Pathologists (CAP) PT records revealed Cell ID, RBC, HCT, HGB, WBC, and PLT scores of less than 80% for the following 2 consecutive CAP FH-1 Hematology Auto Differentials hematology events: 2021 Event 3 - Hematology Module scored at 0% Unsatisfactory Performance (CBC challenge samples FH1-11, FH1-12, FH1-13, FH1-14, FH1-15 all scored as 0% for Cell ID, RBC, HCT, HGB, WBC, and PLT) 2022 Event 1 - Hematology Module scored at 0% Unsatisfactory Performance (CBC challenge samples FH1-01, FH1-02, FH1-03, FH1-04, FH1-05 all scored as 0% for Cell ID, RBC, HCT, HGB, WBC, and PLT) resulting in unsuccessful PT performance. 2. Interviews on 4/25/22 with the primary testing personnel at approximately 2:00 PM, and lab lead at approximately 4: 30 PM confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted for Pediatric Center-One Colonial Place on January 12, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The survey included an entrance interview on 1/6/2021 and virtual record review conducted on 1/11/2021. The inspector noted that the laboratory performs COVID-19 testing and was in compliance with the applicable COVID-19 reporting requirements. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows: 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 review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report Form (CMS 209), proficiency testing (PT) records, policies, Centers for Medicare and Medicaid Services 2019 Statement of Deficiencies and

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pediatric Center-One Colonial Place on August 29, 2018 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: 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 review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), proficiency testing (PT) records, policies, and an interview, the laboratory failed to rotate PT among personnel performing patient complete blood count (CBC) testing for the six (6) PT events reviewed. Findings include: 1. Review of the CMS 209 revealed a total of seven (7) laboratory testing personnel (TP). (See attached Personnel Code Sheet.) 2. Review of the laboratory's College of American Pathologists (CAP) hematology PT documentation, a total of six (6) events, revealed that TP A signed and performed the following five (5) events: 2016 Event 3, 2017 Event 1, 2017 Event 2, 2017 Event 3, 2018 Event 1. 3. Review of the laboratory's policies revealed a proficiency testing policy that stated: "PT samples will be tested using staff members who routinely performs patient testing". 4. In an interview with the primary testing personnel at approximately 3:30 PM, it was confirmed that the laboratory failed to rotate the proficiency testing among the personnel performing CBC testing for the six (6) events reviewed as outlined above. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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 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