APHL 2019 POSTER ABSTRACTS
Conclusions: Rotation-molded coolers and frozen water bottles
give samples longer transit times at the target temperature range
between the collection site and laboratory. These studies emphasize
the importance laboratory quality research can have on improving
sample quality from remote locations.
Presenter: David Lowe, Centers for Disease Control and Prevention,
Atlanta, GA, [email protected]
Determining a Sustainability Path for the Public Health
Laboratories of the Puerto Rico and US Virgin Islands
Departments of Health
D.M. Rivera Nazario 1 , M. Toro 2 , G. Gonzalez 2 , K. Kines 1 , J. Pompey 1 ,
B. Ellis 3 , E. O’Neill 1 ; 1 Centers for Disease Control and Prevention,
2
Puerto Rico Department of Health, 3 US Virgin Islands Department
of Health
Presenter: Danisha Rivera Nazario, Centers for Disease Control and
Prevention, Atlanta, GA, [email protected]
Development of a Multi-Certification Laboratory Quality
Management Program in a Complex Laboratory Structure
K. Maldonado Mena 1 , D.M. Rivera Nazario 1 , K.A. Torres 1 , J. Perez 1 ,
J. Pompey 1 , K. Kines 1 , A. Muehlenbachs 1 , M. Korth 1 , G. Gonzalez 2 ,
M. Toro 2 , E. O’Neill 1 ; 1 Centers for Disease Control and Prevention,
Puerto Rico Department of Health
The Puerto Rico Department of Health (PRDOH) laboratories
monitor public health threats among the island and through the
Caribbean. The conglomerate of these laboratories is known as the
Public Health Laboratories of Puerto Rico (LSPPR for its acronym
in Spanish). The LSPPR is composed of two externally certified
units (clinical testing with 15 laboratories and hygiene testing
with 12 laboratories), two non-externally certified testing areas
(Alcohol Toxicology and Rabies laboratories), and a Proficiency
Testing Program. The LSPPR has several regional facilities located
in San Juan (Central Region), Arecibo (North Region), Mayagüez
(West Region) and Ponce (South Region). The LSPPR has four
different quality assurance certifications, the Clinical Laboratory
Improvement Amendments (CLIA), Auxiliary Secretariat for
Regulation and Accreditation of Health Facilities (SARAFS for its
80
LAB MATTERS Summer 2019
Presenter: K. Maldonado Mena, Centers for Disease Control and
Prevention, Atlanta, GA, [email protected]
Validation? Verification? We Have a Template for That!
C. Campion, C. Grimes and S. Blosser, Indiana State Department of
Health Laboratories
The Indiana State Department of Health Laboratories (ISDHL)
Validation Team was founded in 2016 with the goal of providing
both study design assistance and a streamlined review process
for assay validations, verifications, and method comparisons.
Prior to 2016, validations were reviewed ad hoc and only after the
study was completed. Upon review, several studies were found
with fundamental design errors that required the departments to
perform additional testing. ISDHL administrators decided to develop
a team to review the study plans before testing starts to ensure
that the study is fundamentally sound and to minimize the need for
additional testing.
Since 2016, the Validation Team has formalized the process for the
design, execution, summary and review of validations, verifications
and method comparisons, including templates for each step of the
process. A study plan outlines the use and justification of the new
or altered assay, the cost of the study, and the validation strategy,
which includes an isolate list, type of samples, range of results,
acceptable limits and a detailed discrepancy analysis plan. By
writing a study plan, departments save money on validations as
troubleshooting steps and specimen lists are specified and agreed
upon ahead of time. This level of planning also helps to eliminate
interpretation bias and excessive retesting, which are red flags
for QA-review and laboratory audits. Then, after the testing is
completed, a write-up is created and submitted to the Validation
PublicHealthLabs
@APHL
APHL.org
Development of a sustainable public health laboratory (PHL) system
is crucial for a Department of Health (DOH) to maintain services
in the event of unexpected circumstances such as decreased
funding or natural disasters. Strategic planning that includes writing
grant proposals to fund multidisciplinary programs (Epidemiology,
Laboratory and others) within the public health system with a focus
on revenue generating activities (e.g., high volume testing that can
be reimbursed by health insurance, proficiency testing, and others),
will enhance their preparedness to restore or continue operations.
With the help of subject matter experts in health economics, a
detailed study on sample processing costs to the Puerto Rico and
US Virgin Islands DOH-PHLs is necessary to determine which tests
would generate the highest revenue, taking into consideration
processing costs, volume of samples received, and the jurisdiction’s
testing priorities. Given the current financial situation of these
United States territories, a proposed sustainability path for the
Puerto Rico and US Virgin Islands’ Public Health Laboratories is of
utmost importance.
acronym in Spanish), Environmental Protection Agency (EPA), and
Food and Drug Administration (FDA). In addition, all laboratory
facilities must comply with the corresponding Occupational
Safety and Health Administration (OSHA) regulations. Therefore
it is necessary to develop a Multi-Certification Laboratory Quality
Management Program (MC-LQMP) that will help standardize
procedures and policies among all LSPPR, maximize resources
(such as staff, reagents, materials, funds, etc.) while strengthening
communication between all laboratories and ensuring compliance
of all certification and regulatory agencies. Our project plan is
divided in three phases: assessment, recommendations and
re-assessment. During phase 1, we developed a gap analysis
tool with a scoring system to assess all laboratories before any
implementation. Overall, the LSPPR complies with all certifications,
but needs improvement and strengthening on some parameters.
We identified several parameters not in compliance that needed to
be addressed immediately; some had easy solutions while others
required a more complex approach. We were able to identify
overlapping requirements like documentation policies, preventive
maintenance, decontamination and disinfection, quality control
verifications, biosafety, etc., between the different laboratory
certifications and regulatory agencies. This information will be used
for the development of MC-LQMP policies and procedures manual.
Future work will focus on developing recommendations regarding
an implementation plan (phase 2). Finally, the re-assessment
(phase 3) will let us know the feasibility and sustainability of all
implementations while evaluating if any improvements or a different
approach is needed. An MC-LQMP will assure sample integrity,
results reliability and harmonization of laboratory processes.