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July 2016

Core and Specialty Lab Self-Inspection

Sixteen Core and Specialty lab professionals volunteered and conducted the 2016 Core Lab Self- Inspection. They included two CLS-1 from the pre-analytical area, fellows, residents, and medical technologists.

Inspectors' preparations included a 4-hour CAP Inspector Training online (where they received a CAP inspector certificate), Core Lab Self-Inspection Orientation and review of pre-prepared checklist questions.

The Core Lab Self-Inspection spanned over 3 days with 18 lab sections inspected to include the Green Spring lab, the Rubenstein lab, and the Bio-Containment Unit laboratory.

The inspection was followed by a Self- Inspection Summation Conference and later a Debriefing and Inspector Recognition meeting.

Results from the Core Lab Self- inspection identified a few opportunities for improvements and also showed that the Core Lab is prepared for the upcoming CAP inspection next year.

Areas we must improve:

  • Proper use of Personal Protective Equipment (PPE)
  • Reagent labelling and discarding expired reagents
  • Updating policies and procedure

Front row (left to right): Palak Patel. Vilma Saavedra, Rachel Osborne, Amalia Stern
Middle row (left to right): Lexi Miller, Felicia Malin, Tori DiPinto, Megan Hurry, Hailan Zhou, and Lona Small
Back row (left to right): Dr. Ventzi Hristova, Alan Frazier
Missing: Lisa Mains, Dr. Allison Chambliss, Krystelle Marie Banno, Dr. Judd Fite

The volunteer inspectors benefited from this experience in that they:

  • gained knowledge and insight regarding CAP inspection expectations
  • are equipped to prepare evidence of compliance and answer questions from inspectors for the upcoming CAP inspection
  • are equipped to assist other labs in the Johns Hopkins Health System with CAP inspection preparations
  • can add to the database of inspectors Johns Hopkins sends to inspect other labs

Volunteering for quality improvement projects and other laboratory enhancement projects will not only add value to the Core Lab but will be an investment in ourselves as we gain valuable knowledge and growth opportunities.

Lona Rose Small, MBA, MT (ASCP)
Quality Assurance Specialist
Core and Specialty Laboratories
Pathology Department
Johns Hopkins Hospital
Baltimore, Maryland

January 2015

New Osler-8 Special Precautions/Ebola Unit
Supported by Core Lab Clinical Laboratory Scientists

In the late summer of 2014 the world and Johns Hopkins Hospital (JHH) became acutely aware of the Ebola epidemic in Liberia, Guinea and Sierra Leone. With international travel it was not long before the first suspect cases arrived in our Johns Hopkins Emergency Department, setting off a chain of events that would test our epidemiologic preparedness for handling such cases. Fortunately, our first two suspect cases of Ebola had a less serious diagnosis and we were able to learn from our weaknesses.

These cases and concerns for epidemiologic precautions prompted the JHH Pathology Emergency Preparedness Team (Howey Gown, HEIC leaders, Barbara Parsons, Al Valentine, Karen Carroll, Nicki Perish, William Clarke, Lori Sokoll, Marek Marzinke, Thomas Kickler, and Mike Borowitz) to create three plans for handling of Ebola patient samples. The first plan was for the immediate handling of Ebola patient samples that required laboratory testing. The second plan was a lab decontamination procedure in the event of a breach of protocol and the third was a long range plan for handling Ebola patients and samples arriving at JHH.

In the immediate plan, Ebola patients are contained in our Emergency Department holding area, HEIC directs collecting samples and contacting lab directors for appropriate test protocols. Once a suspect Ebola diagnosis has been established, HEIC determines if a patient goes to the MICU for adults or the PICU for children. Samples are sent to the Microbiology BSL-3 laboratory for point of care testing (Heme-8, CMP, Cogs, Blood gasses, etc.) and containment of biologic wastes. For the second part of our plan, we recognized a need to be prepared for the improper triaging of samples, so we developed a detailed procedure for the decontamination of our Core Laboratory in the event of a breach of protocol. The final challenge involved the establishment of a permanent JHH unit to care for patients throughout their illness. This required pulling together a multidisciplinary team for patient care and laboratory testing. With this concern in mind, the Osler-8 Special Precautions Unit was created.

Knowing a hospital wide team approach was needed to care for Ebola patients a collaboration of multiple disciplines from nursing, HEIC, patient transport, laboratory, facilities and waste management planned a long term solution for providing care and management for confirmed Ebola patients. It was decided a section of Osler-8 would be the new special precautions isolation unit. Drs. William Clarke, Mark Marzinke, Lori Sokoll, Thomas Kickler, and Mike Borowitz were the Core Lab advisors for the Ebola specialty laboratory within the total care unit.

The new Osler-8 unit will be a three patient bed unit with a laboratory area which contains two BSL-3 hoods for housing test instruments, computer work stations, freezer/ refrigerator, table space for testing and an area for PPE donning and doffing.

Below is a schematic diagram of the new Osler-8 unit. A few construction pictures of the unit as it looks in January 2015. A summary of the Ebola Lab test menu and instruments used for testing patient samples.

Diagram of the Osler 8 Special Precautions Lab (Ebola Lab). Lab located within red box.

Jeanne Mumford (POCT Supervisor) on left and Polly Trexler (Director of Operations HEID) inspecting lab site construction.

Polly Trexler pointing out one of the 3 patient bed areas on the new Osler -8 unit

The Osler-8 special precautions lab, test panel, instrument menu and tube types needed are listed in the chart below.

The Special Precautions lab instruments include from Left to Right - the Abaxis Piccolo, Sysmex poclt-100i, Radiometer ABL 90, and Hemochron Signature.

The most amazing part of the Special Precautions/Ebola lab are the amazing people who self-selected to be on the lab team. This extraordinary team of people are the "Core Lab Persons of the Year for 2014". core persons 2014

They will train on multiple point of care instruments and advanced PPE procedures. Testing in the Special Precautions Lab will take place at set time intervals, mainly, early mornings and there may be a need for on-call testing. Training, competency and regulatory practices have been supported by a large team of people such as Polly Trexler, Jenn Hurley, Mike Englstadt, Jackie Cooke, Danna Anderson, Greg Gerhardt, Jayesh Jani, Jeanne Mumford's Point of Care Team, Lois Berk, Dr. Nikki Parrish, Brandon Ellis and Kim Dionne, to mention just a few of the many people who contributed to the training and instrument validations to support this amazing team. The current plan is that the Osler-8 unit will be completed by the end of February 2015 and training for personnel has started and will continue once the unit opens.

The men and women who have self-selected to work in this lab are truly our heroes. They will be involved with frontline care and treatment of a disease that is currently crippling nations. To quote Time magazine, "Not the glittering weapons fights the fight, says the proverb, but rather the hero's heart. Maybe this is true in any battle, it is surely true of the war that is waged with bleach and a prayer".

As we grow and learn with the Ebola epidemic, we will face other challenges in the world of epidemic diseases and perhaps pandemic diseases. The Osler-8 Precautions Lab is a very important step in the direction of protecting all of us and truly making a difference in the lives of those we serve. Further information on Ebola can be obtained on the CDC website and the NIOSH website.