Hematology Oncology Associates Of Fredericksburg

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Hematology Oncology Associates of Fredericksburg on November 5, 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 deficiencies are as follows: D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual, Medica EasyRA chemistry analyzer validation records and interview with the Technical Consultant (TC), the Laboratory Director (LD) failed to approve, sign and date the written procedure for the Medica EasyRA chemistry analyzer prior to reporting patients from August 17, 2019 until the date of the survey on November 5, 2019. Findings include: 1. Review of the policy and procedure manual revealed a lack of a procedure for the Medica EasyRA chemistry analyzer. In an interview with the TC, he/she stated they have a procedure but it was not signed by the LD. The TC provided an EasyRA procedure that was not signed and dated by the LD for the surveyor's review. 2. Review of the Medica EasyRA (serial number 08107609) validation records (signed by the LD on August 8, 2019) revealed the instrument was installed on July 7, 2019 and patient testing began on August 17, 2019. 3. In an exit interview with the TC at approximately 1:45 PM, the TC confirmed the findings. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at Hematology Oncology Associates of Fredericksburg on July 25, 2018 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: 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 review of the laboratory's performance verification records and interviews, the laboratory failed to verify reference (normal) ranges for Complete Blood Cell counts (CBC) performed on the Sysmex XN-L hematology analyzer prior to reporting patient results from May 8, 2018 until July 26, 2018. Findings include: 1. Review of the laboratory's Sysmex XN-L (serial number 11008, installed 5/8/18) hematology analyzer's performance verification documentation revealed the documentation did not include verification of the reference (normal) ranges for CBCs after the instrument was installed. The surveyor requested to review documentation that the laboratory evaluated and verified the reference (normal) ranges for the Sysmex XN-L prior to patient testing. The laboratory provided no documentation for review. 2. An interview with the Technical Consultant and Testing Personnel A at approximately 10:30 AM, 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 -- confirmed that the laboratory failed to document the verification of the normal ranges for CBCs performed on the Sysmex XN-L analyzer prior to patient testing that began in May 2018. -- 2 of 2 --