Summary:
Summary Statement of Deficiencies D0000 An unannounced CLIA complaint investigation (VA 00041226) was conducted at Chesapeake Internists, LTD on April 10 & 11, 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: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on the tour of the reception and specimen draw area, review of policies, and an interview, the laboratory failed to follow their written safety policy to place biohazard containers out of the reach of a child. Findings include: 1. During a tour of the specimen draw area, the inspectors noted two (2) biohazard sharps containers on the floor beside the patient phlebotomy chair. Due to the small area, an inspector tripped on one (1) of the two (2) containers and noted that one (1) of the two (2) containers did not have a secure top and that both were within patient reach. 2. Review of the laboratory's Universal Precautions and Safety Policy and Venipuncture Guidelines revealed stated instructions to "Place the sharps container close to the collection site, but not within reach of a child." 3. In an interview with the Chesapeake Practice Manager on April 10, 2018 at approximately 4:00 PM, it was confirmed that the laboratory failed to follow their written safety policy to place biohazard containers out of the reach of a child. D5201 CONFIDENTIALITY OF PATIENT INFORMATION CFR(s): 493.1231 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 must ensure confidentiality of patient information throughout all phases of the total testing process that are under the laboratory's control. This STANDARD is not met as evidenced by: Based on the tour of the reception and specimen draw area, review of policies, personnel training records, Athena Electronic Medical Record (EMR) end user identification tracking, and interviews, the laboratory did not follow their written policy prohibiting sharing of passwords to access patient information during the timeframe of October 27, 2017 to November 10, 2017. Findings include: 1. During a tour of the laboratory draw station and reception area, the inspectors noted the two (2) phlebotomists log into Chesapeake Internists Athena EMR with unique logon IDs. The tour and initial interview with the phlebotomists revealed the phlebotomists were employees of Laboratory Corporation of America Chesapeake (CLIA 49D0229024) and that they had been given access to Chesapeake Internists' EMR limited to and for patient laboratory orders. 2. Review of the laboratory's Patient Specimen Collection Confidentiality Agreement and Limited Access policy revealed the statement "unique logon IDs are assigned to ensure individual accountability. Only one login ID per person or process is allowed in the EMR". 3. Review of the Phlebotomist A and B training records revealed that Phlebotomist A signed the Lab Corp HIPPA Confidentiality Agreement & Acknowledgement document on October 2, 2011 and completed the annual LabCorp HIPPA electronic training on January 10, 2018. Phlebotomist B signed the Lab Corp HIPPA Confidentiality Agreement & Acknowledgement document on November 21, 2016 and completed the training on December 14, 2017. Phlebotomist C signed the Lab Corp HIPPA Confidentiality Agreement & Acknowledgement document on May 20, 2015 and completed annual training on July 28, 2017. 4. Review of the laboratory's Athena EMR end user identification/tracking for five (5) randomly selected patients A-E from October 27, 2017 to November 10, 2017 revealed that while Phlebotomist C was on medical leave, her Athena password was utilized for patient processing. In an interview with the Chesapeake Practice Manager while reviewing the documentation, it was confirmed that Phlebotomist C did not adhere to the Patient Specimen Collection Confidentiality Agreement and the Limited Access policy as she had shared her assigned individual password with Phlebotomist A to access patient lab orders in the timeframe of October 27, 2017 to November 10, 2017. The practice manager stated "Phlebotomist A could not remember her password and called her co-worker (Phlebotomist C) at home to ask for a login password". During this interview, it was revealed that Phlebotomist B was a recent replacement for Phlebotomist C. 5. In an interview with the Chesapeake Practice Manager on April 10, 2018 at approximately 4:00 PM it was confirmed that the laboratory did not follow their written policy prohibiting sharing of passwords to access patient information during the timeframe of October 27, 2017 to November 10, 2017. -- 2 of 2 --