(Donna) Thank you for joining us for our webinar
First-Timer's Roadmap to Laboratory Accreditation.
My name is Donna Rutkowski, and I'll be your moderator today.
Before we get started,
I'd like to go over a few items just so you know how to participate.
In the upper right corner of your screen, you'll have a webinar control panel.
You selected to join by either phone or computer audio.
If you'd like to change that selection,
you can do that by accessing the Audio pane in your control panel.
We have two Joint Commission staff members with us today
that will answer your questions.
So feel free to submit a question
by typing them into the Questions pane of the control panel.
You can send them in at any time during the presentation.
We'll address them if we can during the Q&A session at the end.
If we don't know the answer at the time,
we'll get back to you offline after the webinar.
A few days after today's webinar,
you'll receive a copy of the presentation slides
and a link to the recording via e-mail.
Today, we're going to introduce you to the team
that you have behind you every step of the way
for Laboratory Accreditation,
and how they'll be helping you
and your team go through the accreditation process.
Sharon Hibbe is a Business Development Manager
for The Joint Commission's Laboratory Accreditation
and Patient Blood Management Certification Programs.
Stephanie Scott is a Senior Account Executive
and Laboratory Quality Control Specialist at The Joint Commission.
With that, I'm going to turn it over to our first presenter, Sharon Hibbe.
(Sharon) Thank you, Donna. Next slide, please.
Within our Department of Business Development,
we will work together with you to determine your eligibility for surveys.
Provide you trial access to the Electronic Standards Manual
called E-dition.
Share pricing, and assist you to obtain a free quote.
Discuss your accreditation goals, including review of the timeline
to pursue an accreditation survey.
Provide you free resources
to help you prepare for your initial announced survey.
And, finally, grant you access to complete an electronic application
called the E-App.
Next slide.
We will review laboratories interested in pursuing
domestic laboratory accreditation to make sure they are eligible.
Specifically, you must be a clinical laboratory
with a facility license if required by law,
and have a CLIA number assigned as applicable.
An exception would be embryology,
which does not require a CLIA number assignment.
You must provide, at least, one non-waived service.
If you also provide a waived service,
this will be included within the scope of your laboratory accreditation survey.
We will be serving a minimum
of a four-month history look back of testing,
and you may apply in advance of meeting the score
among testing history.
For those converting to us from another accrediting body
who provide proficiency testing,
we will also be looking back at a full 24-month history
for proficiency testing.
Next slide, please.
The Comprehensive Accreditation Manual
for Laboratory and Point of Care Testing, known as the CAMLAB,
includes the standards that we will survey against
and is available either by hardcopy or electronically, known as the E-dition.
Before you apply, we can grant a 90-day free trial access
to E-dition for laboratory employees.
To request trial access, you can e-mail us
at qualitylabs@jointcommission.org.
We are available to provide demonstrations of the E-dition,
including how to filter the standards based on your specialties,
and we'll also help you navigate.
Once you have submitted your application for survey,
we will provide your laboratory ongoing access to E-dition
on your Joint Commission Connect site
with security for one user access at a time.
To purchase either a hard copy or electronic E-dition manual,
you can visit Joint Commission resources at jcrinc.com.
Next slide.
We will share our fee structure with you,
including an Excel estimator form to complete and return back
to receive a customized fee quote.
The laboratory accreditation cycle is a separate two-year process.
The cost for the laboratory accreditation cycle
is based on the length of the on-site survey,
plus an annual fee due in each year.
We estimate the length of survey
based on the types of specialties you provide
and the number of locations where testing is being performed.
This is independent of the number of CLIA certificates you hold
or the volume of tests you perform.
Annual fees are based on several factors,
including your organization size and the services that you offer.
Next slide.
To help you with your survey goals,
we will review together with you an accreditation timeline
to assist in determining when to complete your initial survey with us.
For those who are just starting up,
you need to be at operation at least four months
for us to survey the minimum four-months look back of testing required.
For those of you coming from another accrediting body
or the state,
let's take a look on this timeline at the far right.
We use your current laboratory accreditation renewal date
as your starting point to determine next steps.
Ideally, you'd want to accept an initial survey with us,
approximately 3 to 4 months in advance
to avoid any lapse in accreditation.
So you should try to target completing your application with us
about 6 to 9 months in advance
of your current accreditation renewal date.
You may identify your ready timeframe on your application,
and we will schedule you, typically, within 30 to 60 days,
following your requested ready timeframe.
The first initial survey will be announced,
and you will receive an email notification
30 days before your survey start date.
Next slide.
We provide several complimentary resources to assist you
to prepare for your first laboratory accreditation survey.
I'll go through each of these and where to locate.
Next slide.
Within the CAMLAB,
each chapter has a series of worksheets available
to select from at the top.
The prompts to assess your compliance allows you
to review some prompts and tips to help you gain insight
for how to meet standards compliance.
Next slide.
Within the CAMLAB, you also have access
to a written documentation checklist for each chapter.
This will help you track documentation that you currently have
or may need to implement prior to survey.
Next slide.
Our unique on-site survey process includes our tracer methodology,
where we assess your compliance with our standards
by observing how your laboratory services interact with areas
that provide direct patient care.
The Joint Commission surveyor
will most likely begin the laboratory tracer with a test result,
and then follow the entire testing process for that patient
from pre-analytic to post-analytic processes.
We have put together the Tracer Methodology Toolkit
as a guidance for how to prepare for survey.
It includes a mock tracer worksheet with sample questions to ask your staff,
and allows you to track your progress.
Next slide.
The Survey Activity Guide is your go-to resource
for how to prepare for survey.
It includes what to expect during each survey activity,
provides sample agendas, a list of suggested participants,
and a document list displaying all documentation-based requirements
in one place.
Next slide.
We will grant you access to our electronic application
called the E-App,
which is located within a secure extranet site,
called Joint Commission Connect.
On this dashboard,
on the bottom left corner is a Print Center
where you have the ability to print out a blank E-app
before getting started, and it will also track all saved entries.
On the far bottom right corner is a video tour section
that is also available.
It typically takes an hour or less to add-in your information,
and we are here to assist you to complete the process together.
We can see your updates live and help talk you through the screens.
Once you have submitted your application and deposit as applicable,
you will be assigned a laboratory Account Executive
who will contact you to assist you with the next steps.
With that, I'd like to turn the presentation over to Stephanie Scott.
(Stephanie) Thank you, Sharon.
As an Account Executive, I work with lab customers
as a primary contact for any questions
after completing the initial survey application
and for re-surveys.
Account Executives are divided by program.
So a hospital program with a lab seeking accreditation
will have a separate contact for hospital and for lab in most cases.
We may need to get back to you on a question
or refer you to our standards clinicians',
but we will be your main point of contact for any survey-related questions.
Next slide.
We have a secure Joint Commission Connect portal,
as Sharon mentioned.
Each customer has access to this organization-specific information
and the organizations' control who has access to this portal.
This is where current and past survey reports live
and a static link along with survey event information,
agendas, and other preparatory tools and resources.
Next slide, please.
Here's an image overview of the customer portal on the homepage.
I have this numbered.
There's a few things to point out.
In the upper right corner is the organization name,
address, and each HCO ID number, that's a healthcare organization ID number
which is how Joint Commission identifies your facility.
The tabs across the top of the page,
each has links to resources and other information.
Below those headers links, you'll find the contact information
for your Account Executive.
The screen shows a Lab Accreditation Account Executive only.
But if your lab also has a hospital program
or other certification programs,
you would see their contact information listed in addition.
The Survey Process tab, we'll look at a little closer in a moment.
But this is where you'll find many links related to pre and post-survey activities.
A Continuous Compliance tab has additional resources
and repeat some of the same links as Survey Process
so information can be more easily found.
Communication will list any official emails
sent to the listed primary contacts if they need to be referred back to.
A history of general posted correspondence
also remains here for reference, as well as E-alert messages.
The Resources and Tools tab is where to find the link
to our standards listed as E-dition.
The monthly perspectives publication can be found here as well,
both current and archived issues,
where accreditation program updates are provided.
Information on Publicity Kit's, Award Certificates,
and additional tools are also linked here.
And a key contact point,
Standard's Interpretation has an FAQ and also a question form link.
If someone with your lab program has a more technical question on a standard,
this resource can be accessed to review frequent questions
or submit a question of your own.
I talk up our lab program quite a bit.
Our standards clinicians have many years of experience
and a wealth of information.
The Security Admin tab is the one that we get,
as Account Executives, questions pretty often on.
This is where your facility has the ability to control
who has access to this site and the information.
You can add and control contacts, add and remove contacts,
and then, control what access they have to which pieces of the website.
The What's Due section in the middle
shows any items due for lab,
it usually will note the lab beside the item.
And then under Official Documents Posted in the Last 30 days,
will be any recent survey reports or communication there.
And then important updates would be anything
that may have gone out in email communication,
but we want to leave up for a longer period of time
in case users see that on the website.
The notification of scheduled events is where survey activity is posted.
Lab initial events are announced, so the survey date will show here
at least 30 days prior to the survey event.
For re-surveys, the Survey will show the day of the survey
at 7:30 AM your local time.
A surveyor bio and a photo will show up once the link is accessed.
Next slide, please.
This is a little closer look at some of the tabs that we use often,
so that's Survey Process tab and the Resources and tools.
These are different links that we'll show
specific to lab accreditation.
So the Survey Process, I've marked a few star items
that customers use often.
Pre-Survey, where a sample agenda is posted.
And the Survey Activity Guide that Sharon mentioned.
And that's updated each year with documents and checklists
to review ahead of the survey.
And the Post-Survey lists, any post-survey reports,
and various items from post-survey that you can reference from years to come.
The Application for Accreditation
when the E-app is not due for submission or review,
you can still review it, or access it,
or even make updates during the mid-survey cycle.
So Continuous Compliance Tools is another header down there.
We link some of this information in more than one place.
And you'll find links to Laboratory Tools and IQCP resources accessed here.
The Resources and Tools tab, again,
is where you'll find the online standards and the standard's question form.
Next slide please.
Here's a form view of the E-app.
It has the similar numbers across the top of the screen,
the same format so that we have some consistency
as the homepage on your portal.
So these are numbered 1 through 9 and can be accessed in or out of order.
In the upper right, we have the organization name,
address, and ID number again.
And then the page has navigation buttons at the top and bottom
of the screen that you'll see in point 3.
And then on 4, is a left rail navigation,
or some pages have subheadings
and you'll be able to see in orange which screen that you're looking at,
which information.
The middle section will show content specific to the page.
One we get often is Accreditor of Record,
where you list the type of lab testing that you perform.
So there are labs-specific questions in here
related to the type of testing you do and who accredits your lab.
There's also a Help tab on every page
with some pre-populated text about information on that page.
Next slide, please.
So as far as the application,
when your lab submits the first survey application,
your assigned Account Executive
will review the information with you on a call.
Key points to verify include the number of sites,
and corresponding CLIA numbers, hours of operation, testing,
and any dates to avoid for the upcoming survey.
Re-surveys include all the same information.
The one difference on Tab 4 for Initials
is where an initial customer chooses a soonest ready date for survey
and answers some additional questions for a first time survey.
The Medical Director, years of experience, education,
and specialties are entered into our survey application.
So when a Medical Lab Director changes for a non-waived CLIA certificate,
changes are made in our Survey Application,
and then Joint Commission will communicate this change to CMS.
Next slide, please.
The Account Executives work with scheduling
based on the information you provide and that we will review with you.
For re-surveys, IVF labs, and labs with fewer than 25,000 annual tests
receive a short notice email notification sent to the listed primary contact.
If you know a contact will be out or changing
during your survey timeframe,
just communicate that to your Account Executive.
We want to make sure everyone gets the correct updates.
And then, as mentioned before,
notification is posted the morning of the survey
with the survey information on notification of scheduled events.
Next slide, please.
After the survey, we post a preliminary report.
It's usually up that same day of the survey,
and we'll either fully post the next day,
or it may be in review for a few days from our central office.
This will be replaced by the final report, as soon as it's reviewed by us.
It's usually the next day or a short review period.
If a lab has findings scored from a survey,
they will complete post-survey work
that we call the Evidence of Standards Compliance.
It's an online form on the website,
and you have up to 60 days to complete your corrective actions.
We also have an optional 10-day clarification
with some restrictions on things that can be clarified from the survey,
where we would review and potentially remove them
from the survey report.
Or they would remain for corrective action.
Also, there's our award letter that we'll post
after the Evidence of Standards Compliance
has been reviewed, approved, and processed.
And then your award certificate is usually mailed out
within about two--
we say 2 to 4 weeks from the approval date.
Next slide.
The lab is considered accredited after survey findings are reviewed
and accepted by The Joint Commission, final reports are posted,
and the primary program contact and CEO are alerted by the email.
Post-survey award letters can be viewed on the portal
under Post-Survey and Important Documents.
So we do get a lot of notification to you out there.
Next slide.
The Lab Program has a few unique processes post-survey,
including updating the CMS CLIA 116 form online.
So The Joint Commission, once surveyed,
we verify that we have reviewed your CLIA numbers,
and marked that The Joint Commission is your accreditor of record,
along with the survey date, and the specialties that we review.
So one note to consider if your lab is switching
from one accrediting agency to another or to Joint Commission,
to contact your state CLIA office and inform them
your lab will be accredited by The Joint Commission.
The State CLIA Office enables The Joint Commission
to be able to update that CMS website with survey codes and information.
For new certificates of registration that have not been surveyed before,
you would also inform the state CLIA Office
that Joint Commission would be your intended accrediting agency.
Next slide, please.
For continued support, we have an Intracycle Monitoring tool,
which is an online interactive standard's tool
that you can access at any time to prepare for survey.
You can add notes and provide access to staff
as an alternate way of viewing the lab standards.
On the off-year from survey, you may be prompted
for an optional self-review of the standards using this tool.
No formal submission is required,
but we are keeping the tool up for anyone to be able to use.
Our Standards Group has a Frequently Asked Questions section
and an online question form
if you have a unique individual question that you need answered.
All the questions are tracked, so you're ensured a response.
As well as we have perspectives which were mentioned earlier,
accreditation and certification program updates are published here
as well as most frequently cited standards per program,
including the lab each year.
And that's it for me, so I'll hand this back to Donna.
(Donna) Next slide, please.
Thank you, Stephanie, and thank you, Sharon.
Before we get to your questions,
I just wanted to alert all of our attendees
to just a couple of more resources that we have,
and also let you know how to contact some key persons if you don't.
As Sharon mentioned earlier,
she's there to help you as you begin the process,
and on the slide, you'll see a picture of Sharon,
and also her partner, Caleb, and how to reach them.
So they'll be your business development contacts.
Next slide, please.
And then if you need to reach your Account Executive,
which is Stephanie and her colleagues, their information is there as well.
So that's how you'll reach them.
Next slide, please.
I just also wanted to call your attention to two very important resources
that you may know about.
But if not, we want to make sure that you always--
please do refer to our website for up and coming information.
We do have actually a covered webinar for laboratories this Thursday
if you want to go to the website and look under there on Webinars,
you can register if you haven't already.
But it's also a great place where you can always learn more
about our lab program and what's happening.
Also, at Joint Commission Resources,
they have a lot of information about resources
to help through the accreditation process.
So I wanted to just make sure that you are aware of that.
With that, we are going to take your questions.
So you can certainly submit a question in the question box if you haven't.
But our first question is for Sharon.
Sharon, this sounds like someone
who hasn't undergone their first survey yet.
And the question is:
"Is the laboratory survey announced or unannounced?"
(Sharon) Thank you, Donna.
The first initial survey will be announced.
You will receive 30-days advance notice of the start date.
(Donna) Thank you.
Sharon, actually, another question for you:
"How can I find those standards?"
(Sharon) Prior to application submission,
we can give you a trial access if you email us
at qualitylabs@jointcommission.org.
Once you have submitted your application, if you're listed as a content
on the Secure Joint Commission Connect site,
you will automatically be granted access to E-dition
under the Resources and Tools tab to view the standards.
(Donna) OK.
Now we have a very general question, Stephanie,
I'm going to see if you can answer this, please.
"Which documents should I have available for the surveyor?"
(Stephanie) The Pre-Survey checklist, we have those under the Pre-Survey.
Survey Activity Guide has a document list,
and then working with your Account Executive,
they can provide any updates if you have questions.
(Donna) Thank you. Question for Sharon:
"Sharon, how often is the lab inspection?
Is it every two or every three years?"
(Sharon) Every two years.
And that is a federal requirement for every two years.
(Donna) Thank you.
Another one for Sharon.
"Sharon, my laboratory will be a brand new startup.
When will the surveyors come?"
(Sharon) So, it's really up to you
when you apply and get your CLIA certificates.
Federally, CLIA typically grants you up to 11 months
to show a success of a survey.
We have to survey you back a four-month test history,
so most initial start-ups,
after they get their CLIA number and apply with us,
they're usually asking for a survey about 4 to 7 months
after they have started services.
And that gives you enough time to become surveyed,
correct your information, and become accredited
before that deadline was clear.
But it's always wise to contact CLIA
to find out what that drop-dead deadline is,
and then work towards meeting accreditation prior.
Thank you, Sharon.
A question for you, Stephanie.
I think this is actually about Joint Commission Connect.
"How do I add and remove users on the laboratory websites?"
(Stephanie) Yes. So, the prime listed primary contacts
are automatically listed as having the ability
to add and remove contacts.
So the view when you login will either say Admin
or it will say, Contacts.
So, internally, you can give other users permission
to be able to add and remove contacts.
So the CEO will always have it, and then the listed primary contacts will,
so you can enable that for other users.
I get questions on that a lot,
so you can always call us to help you with it,
though we specifically don't add people for you
just to make sure that it's secure for you,
that you are controlling who you allow to access that,
and what information they can see.
(Donna) I have another question, Stephanie,
that I'm hoping you can answer.
"If the laboratory survey is announced, does that mean it doesn't go
with the unannounced tap Behavioral Home Care?
(Stephanie) The lab has its own separate survey
from a hospital program or tailored program survey.
So since hospital and the other programs
are surveyed every three years and lab has every two,
they don't automatically match up.
And they also have separate accreditation decisions.
So sometimes people want their hospital and lab surveys to match up.
It depends on the survey ranges and the due dates.
So sometimes we can look at that a little more closely,
but they would be separate survey events with separate decisions.
(Donna) Thank you, Stephanie.
I have another one for you.
This is very general: "How long is the inspection process?"
(Stephanie) Well, the survey itself
depends on the scope of services that you have.
So, we have lab surveys that are anywhere from one day to five days.
I'm not sure if that's what is being asked,
but that depends on the number of sites, the number of non-waived CLIAs,
and the complexity of testing,
and a lot of that through the survey application.
Once-- I don't know if that addresses what it is.
So the surveys themselves can be a number of days long.
As far as--
Sharon had covered timeframes of applying.
Once you're surveyed, you have a survey report
that is either posted right away, or if it's in review,
it's within about 10 days.
And then you have 60 days to review
any of your findings and submit corrective actions.
So once that 60 days comes up, we review the survey responses,
usually within a week to maybe 2, 3 weeks at the most,
and return a survey decision to you.
(Donna) Thank you, Stephanie.
I think that covered it, and thanks for taking a shot at that.
Sharon, I think this is one for you.
I think this was actually asked already, but probably good to ask again.
"Will the laboratory survey happen at the same time as the hospital survey?"
(Sharon) Lab will be done separately every two years.
The hospital is done every three years.
So you have separate survey teams,
separate survey records, separate decisions.
(Donna) Thank you.
Another one for you, I think, Sharon,
"When should I transition to The Joint Commission
if I'm currently with another accreditor?
(Sharon) So your goal, when converting to us,
is to successfully complete the accreditation process
before your current expiration.
So if you take back a look at that timeline in the slides,
usually, organizations are putting their preferred ready-timeframe
on their application with us,
about 3 to 4 months before their current accreditation expiration.
That allows you to get through the survey, get through the review period internally,
complete the submission of the correction action
before you become accredited.
So the goal is to not have any lapse in accreditation,
become accredited before you leave your current accreditor.
(Donna) Thank you, Sharon.
Here's one for Stephanie,
"Who needs to be present at the time of survey?"
(Stephanie) This is mainly up to each facility,
but usually it should, at least, concludes some lab staff,
the Medical Lab Director, if possible,
quality staff, other lab staff.
It depends if it's an initial survey.
If it's announced, then you can have time to plan who's there.
For re-surveys, since the process is unannounced
that can change sometimes.
We're able to have the survey without some key people present,
understanding that life happens, and people are sometimes out.
We just would need access to documents.
So something that could be an issue is
if there are binders or physical things
that are locked in someone's office, who's away.
So communication prior to a survey on things like that,
making sure that backup people have access to documents can be helpful.
(Donna) Thank you.
And I think our last question that just came in
is probably also best for you, Stephanie.
The question is:
"Do we receive a phone call prior to inspection when unannounced?"
(Stephanie) No. So there are the labs that qualify
for a short notice, and it's an email.
So those are IVF labs,
and then labs that have fewer than 25,000 annual tests
across all non-waived CLIAs that Joint Commission accredits.
So in the survey application,
those labs get an email notification to the CEO
and the primary lab contact, but they will not receive a phone call.
(Donna) OK.
And then there's one more,
which I think perhaps you can try to answer, Stephanie.
It's: "With the pandemic is the survey going to be on-site or online?"
(Stephanie) All of that is dependent on different circumstances with each lab.
So Account Executives are reaching out to labs
to see if they qualify for a virtual survey,
otherwise we will work on on-site surveys
so we have multiple processes going on.
And the best way for re-surveys, really, or anything,
is to work with your Account Executive.
The process is changing quite a bit, so it may be different in a few weeks,
but we are trying to keep it as consistent as we can
and keeping our customers updated.
(Donna) Thank you.
Thank you, Stephanie. Thank you, Sharon.
And thank all of you for listening today.
That concludes our webinar for today.
We do want to thank you for your time, and we hope it's been valuable.
We hope you'll reach out for us as needed.
Thank you, and have a great afternoon.