Assisted Living Licensure Presentation Notes - Minnesota ...

Assisted Living Licensure Presentation Notes
Date: Thursday, June 3, 2021
Time: 10-11:30 a.m.

Agenda
Kelly Siegel (MDH) – CLIA Waiver
Lindsey Krueger (MDH) – Required Policies, ALL Rules, Background Studies, Misc.

Welcome
Lindsey Krueger, program manager in the Health Regulation Division, welcomed everyone to
the Minnesota Department of Health’s Home Care and Assisted Living Teleconference for June
3, 2021. She thanked everyone for joining as we continue our WebEx series regarding Assisted
Living Licensure.
Assisted Living Licensure can be found in MN Statute Chapter 144G. There is also special
session language from December of 2020 that will be incorporated into 144G by the Revisor
after this current legislative session is over. The Revisor will combine it all together when
language from this session is signed by Governor Walz.
New Home Care and Assisted Living Laws book is available to order here: Minnesota
Government Publications DBA Allegra Eagan (www.mngovpublications.com/home.asp).
MDH continues to build out the Assisted Living Licensure webpage and we encourage you check
it out. We will highlight added content in the Announcements section of the main ALL webpage.
We have added a Resources and FAQ page with over 80 of your frequently asked questions
posted with answers, grouped by topic. Your questions let us know what you want to hear
more about. Thank you for your feedback as we work towards the successful implementation
of Assisted Living Licensure.
MDH is mindful of the amount of information that 144G and Assisted Living Licensure brings
and the time it takes to review, think about, and discuss. MDH is committed to helping you
understand and prepare. We will be holding weekly WebEx presentations from here until the
end of July to dig deeper into the statutes. Through the month of May we have been heavily
focused on the application process. As we move through June and July you will see our focus
shift to operationalizing ALL.
Besides attending the Informational Sessions hosted by MDH, we need you to do your part by
connecting with your provider organizations and reading (and re-reading) the statutes yourself
to ensure you are familiar with the requirements that go into effect come August.

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Participants were encouraged to place questions into the chat feature. What you place in the
chat helps inform us of future topics or areas in which MDH can help to provide better clarity
on.
Please take some time to review the PowerPoint slides and Presentation Notes from our
previous Informational WebEx Sessions if you were unable to join us. Continue to review the
statutes and our webpages for information as you prepare for the new licensure.

Payment Notification Email
For those of you who have already paid and received confirmation of payment (THANK YOU!)
– this will not apply to you. MDH sent out a notice to providers who were “Open to Pay” or
“Paid” with messaging around next steps including payment and signing up with DHS for
background studies. If you have already checked those items off your list, thank you. There are
several applications that are still “Open to Pay”, as far back as May 7th. Please take care of this
ASAP.
We are getting a lot of questions regarding payments. Do not worry, MDH will be reaching out
for payment, or following up with you if you need to pay or have not paid. Once MDH
determines it has all the required application information, signatures, and attachments, MDH
will contact the applicant to request payment of the application fee. Email will come from the
donotreply@state.mn.us email address. Payment is all electronic for both conversion and
provisional applications. No checks to be sent into the office. There is an option to pay with a
credit card or by ACH.

CLIA Waiver
CLIA stands for Clinical Laboratory Improvement Amendments. Today we will go over what CLIA
is, whether you need a CLIA certificate, how to apply for a CLIA certificate and how to update a
current CLIA certificate.
Any place interpreting tests performed on human samples is considered a lab in the eyes of
CLIA. For example: Blood glucose testing performed on residents in assisted living facilities.
Solely collecting samples is not considered lab testing. For example: A nursing home collecting
urine and sending it out to a hospital for culture.
Often find waived tests in assisted living facilities, nursing homes, home care, and ambulance
services. Defined as so simple to perform, even if the test was performed incorrectly, there is
little or no risk of harm to patient.
Please note that the issuance of a certificate of waiver is by location and not through state
issued licenses. You can find the link to the CMS 116 form on our MDH CLIA website.
Any trained employee may perform a waived test. Other processes and policies are at the
laboratory director’s discretion, although we recommend implementation of good laboratory
practices. The selection of the laboratory director is at the facility management’s discretion.
The laboratory director may be an employee of the company or a contracted employee.

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CLIA Application
Next, we will go over what sections you need to fill out on the application if you are applying for
a CLIA certificate or updating a certificate. MDH must enter the information exactly how it is
written/typed in on the application. Please review the application thoroughly before you send
it in. The application needs to be filled out before it is approved and processed. Only one box
can be checked in certain sections. Only one lab director can be listed. The Facility address must
reflect the physical location where the laboratory testing is being performed. The address may
include a floor, suite and/or room location but cannot be a PO Box or mail stop.
The top of page 2 is the type of laboratory that is the most descriptive of the facility type. Hours
of Laboratory Testing needs to be filled in. Each location specifically needs a CLIA certificate
that is performing testing.
On the top of page 3 you must provide the specific name and manufacturer of the tests you
intend to perform. Examples: Glucose, Bayer Contour, BAYER; Hemoglobin, HemoCue hb 801,
Hemocue; Influenza a/b, Medline Influenza A&B test, Alere/Binax Inc. For example, we will not
accept glucose testing; everything needs to be specific. Annual test volume can be an estimate.
What type of ownership is the facility? Does the lab director oversee any other CLIA
certificates? If yes, list CLIA ID numbers here; if no, leave blank. The Lab Director needs to sign
and date the bottom of page 5.
All CLIA fee coupons and certificates are generated and sent from CMS in Maryland. Because of
this, the state agencies do not have access to them. To save time you can pay online at pay.gov.
MDH can send the instructions once the application has been processed.

Search for a CLIA Laboratory
You can go to CMS laboratory demographics look up to see if a CLIA certificate is already in
place (S&C QCOR (https://qcor.cms.gov)). Type in either the facility name, CLIA id number (if
known), city or zip code. It will list the valid certificates that was found within your search
criteria. Once you click on a lab, you will see the facility name, address, phone number, type of
certificate, expiration dates and what type of lab it is classified as. The search does not list the
lab director or tax ID number associated with the lab. You can always email MDH at
health.clia@state.mn.us to look up a CLIA certificate. If you do not know if you have a CLIA
certificate, be sure to include the name, address, telephone, and tax ID number. If there is a tax
ID number change, the CMS 116 form needs to be completed in its entirety.

Policies
144G.41 Subd. 2
Policies are found in 144G.41 Subd. 2 (Page 130 of your statute book). If you do not have a
statute book, it may be beneficial to order one so you can highlight and tab as necessary for
future review. This is one of those places that you should put a tab. There are 15 numbers in
subd. 2 and I am not going to be able to cover them in depth. If I were to cover everything in
144G you would be here listening to me for hours. That is why I mentioned earlier that you
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really need to review the statutes, plug into your provider organizations, and make sure you
have the knowledge you need for this new licensure.
Each assisted living facility MUST have policies and procedures in place to address and keep
current. The first one listed refers to 626.557, the Vulnerable Adults Act. You must have a
policy on reporting of maltreatment of vulnerable adults. Now, you are in luck if you have a
statute book, because you can flip to page 239 where the Vulnerable Adults Act starts. You
should be very familiar with this statute. It is policy in Minnesota to require the immediate
reporting of suspected maltreatment of vulnerable adults, to provide for the voluntary
reporting of maltreatment of vulnerable adults, to require the investigation of the reports, and
to provide protective and counseling services in appropriate cases. Subd. 3 of 626.557 discusses
timing of report and 626.5572 houses the definitions for the VAA where you will be able to find
the definition of a mandated reporter (subd. 16) and the definition of immediately (subd. 10).
Others found in 144G.41 Subd. 2 include:
      conducting and handling background studies on employees (number 2)
      orientation, training, and competency evaluations of staff, and a process for evaluating
       staff performance (number 3) - this is an area frequently cited on surveys - you can have
       policies in place, but you must also ensure staff are following the policies
      handling complaints regarding staff or services provided by staff (number 4)
      conducting initial evaluations of residents' needs and the providers' ability to provide
       those services (number 5)
      conducting initial and ongoing resident evaluations and assessments of resident needs,
       including assessments by a registered nurse or appropriate licensed health professional,
       and how changes in a resident's condition are identified, managed, and communicated
       to staff and other health care providers as appropriate (number 6)
      orientation to and implementation of the assisted living bill of rights (number 7)
       144G.90 talks about required notices for the assisted living bill of rights - please make
       sure you are familiar with those requirements
      infection control practices (number 8)
      reminders for medications, treatments, or exercises, if provided (number 9)
      conducting appropriate screenings, or documentation of prior screenings, to show that
       staff are free of tuberculosis, consistent with current US Centers for Disease Control and
       Prevention standards (number 10)
      ensuring that nurses and licensed health professionals have current and valid licenses to
       practice (number 11)
      medication and treatment management; medication management policies and
       procedures must be developed under the supervision and direction of a registered
       nurse, licensed health professional, or pharmacist consistent with current practice
       standards and guidelines (number 12) - [144G.71 (Medication Management) Subd. 1 (b)]
       and [144G.72 (Treatment and Therapy Management Services) Subd. 2]

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      delegation of tasks by registered nurses or licensed health professionals (number 13)
      supervision of registered nurses and licensed health professionals (number 14)
      supervision of unlicensed personnel performing delegated tasks (number 15)

Other Chapters
There are also Policies found under other Chapters. Under 144G.50 (ALL Contract
Requirements) Subd. 2 (e) (5) is a description of the facility's policies related to medical
assistance waivers under chapter 256S and section 256B.49 and the housing support program
under chapter 256I. Under 144G.71 MEDICATION MANAGEMENT. Subd. 10. (a) An assisted
living facility that is providing medication management services to the resident must develop
and implement policies and procedures for giving accurate and current medications to
residents for planned or unplanned times away from home according to the resident's
individualized medication management plan.
Rule 4659.0110 Missing Resident Plan is a topic that will be covered later in the presentation.
Nursing and Staffing are topics we will be covered in WebEx sessions later this month.

Assisted Living Facilities with Dementia Care
144G.82 ADDITIONAL RESPONSIBILITIES OF ADMINISTRATION FOR ASSISTED LIVING FACILITIES
WITH DEMENTIA CARE. Subd. 3.Policies. If you are an ALF facility, there are 10 numbers under
subd. 3 (Page 171 of your statute book).
In addition to the policies and procedures required in the licensing of all facilities, the assisted
living facility with dementia care licensee must develop and implement policies and procedures
that address the:
(1) philosophy of how services are provided based upon the assisted living facility licensee's
values, mission, and promotion of person-centered care and how the philosophy shall be
implemented;
(2) evaluation of behavioral symptoms and design of supports for intervention plans, including
nonpharmacological practices that are person-centered and evidence-informed;
(3) wandering and egress prevention that provides detailed instructions to staff in the event a
resident elopes;
(4) medication management, including an assessment of residents for the use and effects of
medications, including psychotropic medications;
(5) staff training specific to dementia care;
(6) description of life enrichment programs and how activities are implemented;
(7) description of family support programs and efforts to keep the family engaged;
(8) limiting the use of public address and intercom systems for emergencies and evacuation
drills only;
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(9) transportation coordination and assistance to and from outside medical appointments; and
(10) safekeeping of residents' possessions.
The policies and procedures must be provided to residents and the residents' legal and
designated representatives at the time of move-in.

Orientation and Annual Training Requirements
Next, I want to highlight 144G.63. This is on page 157 of your statute book.
144G.63 ORIENTATION AND ANNUAL TRAINING REQUIREMENTS. Subd. 2.Content of required
orientation. (2) an introduction and review of the facility's policies and procedures related to
the provision of assisted living services by the individual staff person.
And then in Subd 5. (5) indicates a review of the facility's policies and procedures relating to the
provision of assisted living services and how to implement those policies and procedures.
You will see person-centered planning and service delivery in 144G.63, sub 2 (6) (one of the
places it is found in 144G). This topic will be covered by DHS in next week’s (6/10) WebEx.

Rules Governing Assisted Living Facilities
The Rules are very close to being adopted and we know you are anxiously awaiting them to be
completed. The rules are not published yet, but they are posted on our webpage in draft form
with strikeouts and underlines (how we sent them over to the revisors office) and there were a
few final tweaks. If you haven’t already seen them you can view on our webpage Request for
Final Approval of Assisted Living Rules
(www.health.state.mn.us/facilities/regulation/assistedliving/docs/hearing/requestforapproval.
pdf), The document is a bit over 100 pages (rules start on page 4) and there are some strikeouts
and some formatting challenges. When they come back from the revisors office they will look
much more pristine. We had this information over to the Revisors Office about 3 weeks ago and
are anxiously awaiting their final draft so we can file the Order of Adoption with the Secretary of
State. We will send out a GovDelivery message when the process has been finalized. Stay
tuned for more information on this topic.

Approvals by OAH
We would like to highlight some of what has been approved by OAH.
Definition of elopement changed a bit from the initial proposed rules so we want to review it for
you. "Elopement" means when a secured dementia unit resident leaves the secured dementia
unit, including any attached outdoor space, without the level of staff supervision required by
the resident’s most recent nursing assessment.
Person-centered planning and service delivery is found definitions under subp. 20. Make sure
you join us next week (6/10) when we highlight this topic with additional training from DHS.
When we get to the point when we are sending out licenses, 4659.0040 subp. 2 indicates what
to do with your license. For a license issued - the facility must post the original license
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certificate issued by the commissioner at the main public entrance of the facility. If you are a
campus - A campus with multiple buildings must post the original license certificate issued by
the commissioner at the main public entrance of each building licensed as a facility on the
campus. A separate license certificate shall be issued for each building on the campus.
4659.0090 UNIFORM CHECKLIST DISCLOSURE OF SERVICES. The checklist developed and posted
by the commissioner - Means you CANNOT create your own; you must use the created
template. Whoever filled out your ALL application knows where this is located on the MDH
website. If there are changes in your services, you need to keep this form up to date. You must
also provide an up-to-date checklist to each prospective resident and each prospective
resident's representative who requests information about the facility.
4659.0100 EMERGENCY DISASTER AND PREPAREDNESS PLAN; INCORPORATION BY REFERENCE.
Assisted living facilities shall comply with the Federal Emergency Preparedness Regulations for
Long-term Care Facilities under Code of Federal Regulations, title 42, section 483.73, or
successor requirements. We will be covering Emergency Preparedness and Appendix Z during
future WebEx sessions. We know there are questions around this topic and will be covering it
in depth. I also encourage you to follow up with your provider organizations as well. I know
they have been busy developing resources, education, and training for their members on this
topic.
4659.0110 MISSING RESIDENT PLAN. A missing resident plan is required to contain several
items I will not mention here, so make sure you read the Rule closely when developing your
plan.
4659.0140 INITIAL ASSESSMENTS AND CONTINUING ASSESSMENTS. We have been receiving
questions on assessments, reassessments, monitoring. This will be a topic for future WebEx
sessions.
4659.0150 UNIFORM ASSESSMENT TOOL. An applicant for an assisted living facility license or a
licensee renewing an assisted living facility license must attest to the commissioner, in a
manner determined by the commissioner, that the uniform assessment tool used by the
applicant or licensee complies with this part.
4659.0210 TERMINATION APPEALS; PROCEDURES AND TIMELINES FOR APPEALS. Upon receipt
of the facility’s written notice of an assisted living contract termination, a resident has:
   A. 30 calendar days to appeal a termination based on nonpayment of rent or services, or
      violating the assisted living contract
   B. 15 calendar days to appeal an expedited termination of housing or services under
      Minnesota Statutes.

Background Studies
Once the application fee has been paid, the Authorized Agent receives an email with a
hyperlink to access the NetStudy 2.0 onboarding tool. If you are not the authorized agent,
please let whoever know they need to be on the lookout for this email. The Authorized Agent

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must create a new SIP record even if the SIP will not be changing. This is to set up the new ALL
license in the NetStudy 2.0 system. SIPs must ensure that background study orders are
followed, such as immediately removing a person when required. Every person designated a SIP
will receive an email link to the Onboarding system to complete the Background Study Sensitive
Information Person NETStudy 2.0 User Agreement. This must be completed and submitted by
the SIP before a NETStudy 2.0 user account will be activated. Setting up your BGS at DHS is
going to be a very important next step after you have paid. We will have more information for
you next week on how you go about notifying MDH that all BGS have cleared. MDH cannot
issue a license until these BGS steps have been completed so please be mindful of that. If MDH
cannot issue your license you will be unable to get paid for the waivered services you provide
from DHS.

Tidbits
Application is Frozen
If you are trying to get back into your conversion application to complete something MDH staff
have asked you to do, you may get a notice that your application has been frozen. Please do not
panic and send an email to MDH. You can either contact the MDH staff who directed you to
make the correction or send an email to the assisted living email box. Because of statutory
requirements, and June 1st being the deadline for submitted applications, we cannot allow
anymore applications to come in. We are unfreezing applications that need errors corrected or
documents uploaded.

Conversion Application Stats
Application numbers as of yesterday (6/2):
      2446 potential conversion applications
      2005 have been submitted to MDH
      354 are ready for provider payment (why communication is being sent from MDH on
       payment - we need these paid and moved to the next step in the process)
      670 have been paid
From the numbers we shared with you two weeks ago, this is a HUGE change. Thank you to
those conversion applicants who got your applications in timely. We appreciate your attention
to this and hope that the resources we made available were helpful along the way.

Application Process
Once the application is submitted, it may take a few days before a pre-review person will get a
chance to review it. Then, if they find any issues that need correcting, they will email the
applicant indicating they reopened the application and request the applicant fix the issues and
re-submit. Pre-reviewer looks again to ensure completeness. Once it passes that point and all is
fixed, the pre-reviewer opens it up for payment. The applicant will receive an email to the
permanent business email address provided within the application indicating the application is
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ready for payment. Do not forget to check your check spam folders. Once MDH receives the
payment the applicant will get a confirmation email from US bank (may take a couple of
business days), then it moves to a credentialer for final review. Then you wait…the entire
process can take up to 60 days, but of course we are working on a heightened timeline.

Minnesota Department of Health
Assisted Living Licensure
Health Regulation Division
PO Box 3879
St. Paul, MN 55101
651-539-3049 or 844-926-1061
health.assistedliving@state.mn.us
www.health.state.mn.us

06/03/2021
To obtain this information in a different format, call: 651-201-4101.

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