Inova Lab At Isci

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at INOVA Lab at ISCI on March 4-5, 2024 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiency cited is as follows: D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: A. Based on a tour of the laboratory, review of the laboratory's policy and procedures, manufacturer's package insert and interviews, the laboratory failed to label two (2) of 2 StatSensor Creatinine Control Solution quality control (QC) solutions with an expiration date as described in the policies and procedures on the date of the survey on March 5, 2024. The findings include: 1. During a tour of the Magnetic Resonance Imaging (MRI) department on March 5, 2024, at approximately 10:15 AM, the surveyor noted 2 boxes of StatSensor Creatinine Control Solution. Box 1 contained a vial labeled as StatSensor Creatinine Control Solution Level 1 (lot number 5023130241 with manufacturer's expiration date of 5/10/2025) and a handwritten "Discard Date" of "5/10/2025", greater than 90 days. Box 2 contained a vial labeled as StatSensor Creatinine Control Solution Level 3 (lot number 5022103243 with manufacturer's expiration date of 4/13/2024) and a handwritten "Discard Date" of "5 /10/2025", past manufacturer's expiration date and greater than 90 days. 2. Review of the laboratory's policies and procedures revealed a policy, "ILS StatSensor Creatinine POCT Procedure", with the following statements, "EQUIPMENT, REAGENTS & 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 -- SUPPLIES-StatSensor Creatinine Control Solutions: Levels 1 and 3... Once opened the control is stable for up to 90 days or until the expiration date, whichever comes first. Bottles should be marked with new expiration date upon opening." 3. Review of the StatSensor Creatinine Control Solution QC package insert revealed the following statement, "Precautions: Use only for 90 days after first opening. When you open a new vial of control solution, count forward 90 days and write that date on the control solution vial." 4. In an exit interview with the Laboratory Director, Technical Supervisor, and Technical Consultant on March 5, 2024, at approximately 12:15 PM, the above findings were confirmed. B. Based on a tour of the laboratory, review of the laboratory's policy and procedures, manufacturer's package insert and interview, the laboratory failed to label one (1) of 1 Nova StatSensor Creatinine Test Strips with an expiration date as described in the policies and procedures on the date of the survey on March 5, 2024. The findings include: 1. During a tour of the Magnetic Resonance Imaging (MRI) department on March 5, 2024, at approximately 10:15 AM, the surveyor noted 1 container of Nova StatSensor Creatinine Test Strips (lot number 4923177129 manufacturer's expiration date 6/26/2024) with a handwritten "Open Date" of "2/5/2024". The reagent test strip vial lacked a handwritten date in the "Discard Date" space. 2. Review of the laboratory's policies and procedures revealed a policy, "ILS StatSensor Creatinine POCT Procedure", with the following statements, "EQUIPMENT, REAGENTS & SUPPLIES StatSensor Creatinine Test Strips... Once opened the StatSensor test strips are stable for 90 days at room temperature 15 to 40C (59 to 104F), or the expiration date, whichever comes first. Bottles should be marked with new expiration date upon opening." 3. Review of the StatSensor Creatinine Test Strip's package insert revealed the following statement, "Expiration: The expiration date is printed on the vial of test strips. Once opened, the StatSensor Test Strips are stable for up to 90 days at room temperature or until the expiration date, whichever comes first." 4. In an exit interview with the Laboratory Director, Technical Supervisor, and Technical Consultant on March 5, 2024, at approximately 12:15 PM, the above findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Inova Lab at ISCI on June 16, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The inspector noted that the laboratory is performing COVID-19 testing and is in compliance with the applicable COVID-19 reporting requirements. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D5429 MAINTENANCE AND FUNCTION CHECKS 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: A. Based on review of procedures, available maintenance records, lack of documentation, and an interview, the laboratory failed to document required weekly maintenance protocols for the Abbott iSTAT chemistry analyzer for twenty-seven (27) of thirty-nine (39) weeks reviewed (timeframe of review: analyzer installation date September 21, 2021 to the date of the inspection on June 16, 2022). Findings include: 1. Review of the laboratory's procedures and maintenance guidelines revealed the following Abbott iSTAT maintenance protocol outlined in Procedure 10137027 "Pleural Fluid pH with iSTAT": Weekly - External Electronic Simulator Procedure: "Perform weekly on each analyzer. After performing the electronic simulator test, when PASS is displayed, press key to display thermal probe result. Record the thermal probe delta result." 2. Review of the laboratory's available iSTAT Electronic Simulator log records from September 2021 to 6/16/22 revealed documentation of the maintenance outlined above on the following dates: 9/21/21, 9/27/21, 9/29/21, 9/30 /21, 10/12/21, 10/14/21, 10/19/21, 12/3/21, 12/14/21, 1/11/22, 1/28/22, 2/8/22, 3/1/22, 6/7/22. The inspector requested to review additional documentation of the weekly 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 -- external simulator protocol maintenance. No additional records or

Summary Statement of Deficiencies D0000 An unannounced off-site proficiency testing desk review of INOVA Laboratories at INOVA Schar Cancer Institute was conducted on August 12, 2020 by a Medical Facilities Inspector of the Virginia Department of Health's Office of Licensure and Certification. The laboratory was inspected under 42 CFR Part 493 CLIA regulations. Specific deficiencies cited are as follows: 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 Proficiency Testing (PT) desk review of the laboratory's College of American Pathologists PT records (2020 First Event, 2020 Second Event) and email interview, the laboratory failed to attain a score of at least eighty percent of 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 -- acceptable responses for Fibrinogen in two consecutive 2020 Hematology testing events resulting in unsuccessful PT performance. See 2123. 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 an off-site desk review of the laboratory's College of American Pathologists (CAP) proficiency testing (PT) records, CASPER Report 0155D, and email interview, the laboratory failed to participate in two (2) consecutive Fibrinogen testing events in 2020. Findings include: 1. Review of the laboratory's CAP 2020 1st Event and 2020 2nd Event PT records, a total of two (2) events, revealed the following statements: Fibrinogen 2020 1st Event - "Per your reporting preferences, this analyte is currently identified as being tested by your laboratory. A score of zero has been given due to the lack of response."; Fibrinogen 2020 2nd Event, "Per your reporting preferences, this analyte is currently identified as being tested by your laboratory. A score of zero has been given due to the lack of response." The score of zero for the events resulted in unsuccessful PT performance. 2. Review of the laboratory's CASPER Report 0155D revealed the following 2020 Fibrinogen events with results of less than 80%: 2020 1st Event=0%; and 2020 2nd Event=0%; resulting in unsatisfactory performance. 3. In a email from the Technical Consultant (TC) on August 12, 2020 at 11:00 AM, the TC confirmed the findings and stated they were not performing Fibrinogen testing in 2020. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at INOVA Laboratories at INOVA Schar Cancer Institure on January 14, 2019 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiency is as follows: D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: A. Based on the review of the laboratory's procedures, quality control (QC) records, lack of documentation and interviews, the laboratory failed to follow their procedure and perform ProThrombin Time and Internal Normalized Ratio (PT/INR) coagulation QC materials every 8 hours of operation for twenty-two (22) days in June 2019 and twenty-six (26) days in July 2019 while reporting two-hundred sixty seven (267) patients. Findings include: 1. Review of the laboratory's procedure manual revealed a procedure, "IL at Inova Schar Cancer Institute STAGO Compact Operation", which stated "QUALITY CONTROL-Two levels of controls will be run with each test at eight hour intervals." 2. An interview with General Supervisor at approximately 11:00 AM revealed the laboratory is open for approximately 13 hours and there is one (1) STAGO Compact/STA coagulation instrument utilized for PT/INR patient testing. 3. Review of the Compact/STA PT/INR QC records from June 2019 until December 2019 revealed 22 days in June 2019 and 26 days in July 2019 with no documentation of PT/INR QC being assayed every 8 hours on the STAGO Compact while reporting 267 patients. The surveyor requested documentation of the PT/INR QC material being assayed every 8 hours for 22 days in June 2019 and 26 days in July 2019. 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 2 -- laboratory provided no documentation of the QC material being assayed. 4. An interview with the Technical Supervisor, General Supervisor and Lab Director at approximately 2:30 PM, the above listed findings were confirmed. B. Based on the review of the laboratory's procedures, quality control (QC) records, lack of documentation and interviews, the laboratory failed to follow their procedure and perform Activated Partial Thromboplastin Time (APTT) coagulation QC materials every 8 hours of operation for sixteen (16) days in June 2019 and sixteen (16) days in July 2019 while reporting sixty-five (65) patients. Findings include: 1. Review of the laboratory's procedure manual revealed a procedure, "IL at Inova Schar Cancer Institute STAGO Compact Operation", which stated "QUALITY CONTROL-Two levels of controls will be run with each test at eight hour intervals." 2. An interview with General Supervisor at approximately 11:00 AM revealed the laboratory is open for approximately 13 hours and there is one (1) STAGO Compact/STA coagulation instrument utilized for APTT patient testing. 3. Review of the Compact/STA APTT QC records from June 2019 until December 2019 revealed 16 days in June 2019 and 16 days in July 2019 with no documentation of APTT QC being assayed every 8 hours on the STAGO Compact while reporting 65 patients. The surveyor requested documentation of the PT/INR QC material being assayed every 8 hours for 16 days in June 2019 and 16 days in July 2019. The laboratory provided no documentation of the QC material being assayed. 4. An interview with the Technical Supervisor, General Supervisor and Lab Director at approximately 2:30 PM, the above listed findings were confirmed. -- 2 of 2 --