We spoke with Jane Oates, Administrative Laboratory Director of Salem Medical Center, about how implementing CLSI standards in the lab can help with emergency preparedness.
What extra steps has your laboratory taken during the COVID-19 outbreak that might serve as useful advice to our customers?
In addition to the Hospital Disaster Plan, we developed a laboratory-specific disaster plan, using CLSI’s GP36, Planning for Operations During a Disaster. This document defines the actual testing that will be performed in-house, based on the consensus of the medical technologists I supervise. If my staff is not able to work due to the pandemic, defined testing will be sent to our reference lab.
Are there other CLSI documents that you’ve found particularly helpful now?
Some documents that I think may be useful for the laboratory are:
EP12, User Protocol for Evaluation of Qualitative Test Performance
EP15, User Verification of Precision and Estimation of Bias
M29, Protection of Laboratory Workers from Occupationally Acquired Infections
MM03, Molecular Diagnostic Methods for Infectious Diseases
MM06, Quantitative Molecular Methods for Infectious Diseases
MM13, Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods
You mentioned your laboratory recently passed its Joint Commission inspection. Were there any CLSI documents that were helpful?
Having recently successfully passed our Laboratory Joint Commission inspection the week of March 13, 2020, we used nearly all of CLSI’s standards, but to name a few:
GP41, Collection of Venous Blood Specimens
POCT12, Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities
QMS01, A Quality Management System Model for Laboratory Services
QMS03, Training and Competency Assessment
Jane Oates began her laboratory career in 1979 at Fitzgerald Mercy Hospital as a Medical Technologist in Hematology. She worked for 19 years in Lankenau Hospital’s Hematology and STAT labs and 9 years at Dade Behring in Chemistry Technical Support and R&D, validating customer software. She oversaw CLSI’s Chemistry and Evaluation Protocol committees and subgroups and served as Secretary for ISO Working Group 1. She was a Quality Assurance Manager for Mercy Health Laboratories, where she oversaw QA and CAP Accreditation for three hospitals. As Administrative Laboratory Director for Hahnemann Hospital she oversaw operations for all laboratories. Presently, she is employed as the Administrative Laboratory Director of Salem Medical Center. She has been assigned as hospital point person for ancillary departments for Salem Medical Center on the South New Jersey Working Group in preparation for COVID-19.