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LABORATORY
COMPLIANCE PROGRAM (LCP)
Have
an existing lab but missing key elements or just starting
out we have the solution to make the process easy and
stress free. This comprehensive program is the keystone to
a quality lab. For over 25 years our Program continues to
be successfully field proven by multiple regulatory agencies
during formal inspections. This service can be provided on
site or remotely or a combination of both.
- Customized
to your facility and manner of operations.
- Based
on all applicable current regulations or requirements.
- Includes
all components for a comprehensive Quality Assurance /
Quality Assessment Program.
- Logical
record keeping process that provides for all required documentation.
- Staff
training on the Program, the expectations of their specific
job performance in the lab.
-
On-site services - training performed by licensed /
certified professionals.
-
Remote services - mechanism provided for self-administered
training.
- Present
for initial inspection.
Available
only if on-site service is selected or as "add-on".
LABORATORY
MAINTENANCE PROGRAM (LMP)
Now that you have a lab, don't you want to keep it healthy?
If you have an existing lab, set up by us or someone else,
we have the solution to keep it running smoothly and inspection
ready at all times. This service can be provided onsite or
remotely or a combination of both.
- Monthly
QA reviews with a formal written report.
- Development
of required corrective or remedial measures.
- Implementation
of corrective or remedial measures, for onsite service
only.
- Staff
training and time specified competency assessments per regulations.
-
Onsite services - training performed by licensed / certified
professionals.
-
Remote services - mechanism provided for self-administered
training and assessments.
- Preparation
of all documents as needed.
- Available
for consultation as needed.
- Present
for all inspections, when scheduled thorough us
-
If remote service is in use, this is an add-on onsite provision.
- Receive
periodic relevant updates via e-mail.
LABORATORY
CHECKUP (LCU)
Whether you're getting ready for an inspection or just want
to know how your lab is doing in meeting compliance requirements
and providing you with quality testing, let us give you the
prognosis first.
- Review
of your operations including policy manuals, procedures
and records.
- Perform
mock inspections to prepare your staff and facility.
- Provide
you with detailed information on how healthy your lab is
compared with current applicable regulations.
LAB POST-SURVEY
SUPPORT (LPS)
OK, you’ve
had an inspection and it didn’t go so well. Did your lab receive
a few deficiencies or a full sanction with possible patient
jeopardy? The regulatory agency has given you a strict timeline
to respond, develop corrective measures, prove your lab has
implemented effective remedial measures and the clock is ticking!
Take a deep breath and know that we are here to help you.
Over the years, this is an area where our expertise has repeatedly
proven that the services we provide really are the best and
we really stand out. Call us to see how we can help you.
CONSULTATION
(C)
Sometimes you just need someone to talk with. And since we
are not obligated to any special interest group, we will give
you objective information. We are interested in what works
best for you. You might have a single question,
many questions or not even know what all the questions are.
We can help you sort out your ideas, provide answers
and give guidance that will allow you to make the best decisions
for you and your practice.
- Call
us toll free, e-mail us or have us onsite to see your facility
and operations.
FEASIBILITY
ANALYSIS (FA)
Thinking about adding, expanding or optimizing lab services
but not sure if it makes sense for you. We know what lab operations
require. Let us provide you with objective, knowledgeable
information.
- Analysis
of test menu and volume vs total cost of operations (including
"hidden" expenses).
- Recommendations
for methodology and analytical equipment needs.
DOCUMENT
AND CORRESPONDENCE PREPARATION (DCP)
Submitting your initial application, making changes to existing
records or renewing the lab's credentials. Locating the current
forms, completing them correctly and getting them to the right
person is a critical process. Minor mistakes can create unnecessary
delays and huge nightmares. Need to write to or reply to regulatory
agencies but don't know how to compose an appropriate correspondence.
By allowing us to assist you, it will be done right the first
time.
- Enrollment
/ renewal with CMS/CLIA (Federal).
- Enrollment
/ renewal with State agencies.
- Enrollment
/ renewal with proficiency testing providers.
- Any correspondence
with regulatory agencies.
LIS
/ eMR PROJECT MANAGEMENT (LMR)
Moving to a "paperless" lab and integrating lab
generated records with the patients' medical records is the
current goal of most facilities. But actually attaining that
goal, particularly in a smaller facility, can be the grandest
migraine of all times. EHR vendors may say that they have
lab modules to provide for order entry and result retrieval.
LIS vendors may say that they can provide compliant and working
interfaces for eMR. This is new to you. You don't know what
you don't know and is everyone speaking the same language?
Even with an in-house IT person, working with lab specific
regulations, requirements and operations you need someone
who truly knows lab and understands how this all needs to
fit together for your practice. We've participated in successful
integration's assisting with facilitating the process between
vendors and clients. We aren't programmers but we can provide
the essential link between both sides of the integration.
- Facilitate
initial (kick off) meeting with all parties.
- Develop
a realistic project time line with critical check points.
- Assist
with template development for order entry and result reporting.
- Assist
with validation of the interface.
- Preparation
of all documentation necessary for inspections.
- Mechanism
for ongoing quality checks.
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