Summary:
Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at the Bon Secours Maryview Medical Center (Portsmouth) on May 15, 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: D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on the review manufacturer instructions, maintenance records, procedures and interviews, the laboratory failed to maintain the Sysmex XP-300 analyzer maintenance records from June 1, 2016 through December 31, 2016. Findings include: 1. Review of the manufacturer instructions for the Sysmex XP-300 analyzer maintenance revealed the following: - Daily maintenance- perform shut down, verify background, verify vacuum pressure, check trap chamber, and perform quality control. - Weekly maintenance- clean sample rotator valve (SRV) tray. - Monthly or every 1500 samples- clean RBC and WBC transducer and clean waste chamber. - Quarterly or every 4500 samples- clean SRV. 2. Review of the maintenance records revealed that there was no documentation of the required maintenance from June 1, 2016 through December 31, 2016. 3. Review of the laboratory's procedure of moderate and high complexity testing revealed the following statement: "F. Maintain all QC records for at least two year. They need to be easily retrievable. QC records need to include: 1. calibrations 2. control results 3. required maintenance 4. remedial actions 5. Any relevant records that monitor test systems or testing personnel. 4. An 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 -- interview with the office manager, point of care supervisors and primary testing personnel at approximately 12:30 PM confirmed that the laboratory failed to maintain the above-specified records from June 1, 2016 through December 31, 2016. D5781