Embed Size (px)
Citation preview
Subcommittee to Conduct a Study of Postacute Care (Assembly Bill 242 [Chapter 306, Statutes of Nevada 2015])
WORK SESSION DOCUMENT (Includes Exhibits)
July 6, 2016
Prepared by the Research Division Legislative Counsel Bureau
i
Subcommittee to Conduct a Study of Postacute Care
Assembly Bill 242 (Chapter 306, Statutes of Nevada 2015)
Work Session July 6, 2016
Page
“Work Session Document” .............................................................................. 1
Recommendation 1 ........................................................................................ 5
Recommendation 2 ...................................................................................... 26
Recommendation 4 ...................................................................................... 27
Recommendation 5 ...................................................................................... 50
Recommendation 6 ...................................................................................... 51
WORK SESSION DOCUMENT
Subcommittee to Conduct a Study of Postacute Care Assembly Bill 242 (Chapter 306, Statutes of Nevada 2015)
July 6, 2016
The following “Work Session Document” (WSD) was prepared by the Chair and staff of the Subcommittee to Conduct a Study of Postacute Care. This document contains a summary of recommendations that were presented during public hearings, through communication with individual Subcommittee members, or through correspondence or communications submitted to the Subcommittee. The WSD is designed to assist the Subcommittee members in making decisions during the work session. Actions available to the Subcommittee members include: (1) legislation to amend the Nevada Revised Statutes (NRS); (2) transitory sections that do not amend the statutes; (3) resolutions; (4) statements in the Subcommittee’s final report; and (5) letters of recommendation or support.
The Subcommittee may accept, reject, modify, or take no action on any of the proposals. The recommendations contained herein do not necessarily have the support or opposition of the Subcommittee. Rather, these recommendations are compiled and organized so the members may review them to decide whether they should be adopted, changed, rejected, or further considered. They are not preferentially ordered.
Legislative Counsel Bureau staff may, at the direction of the Chair, coordinate with interested parties to obtain additional information for drafting purposes or for information to be included in the final report. The recommendations may have been modified by being combined with similar proposals or by the addition of necessary legal or fiscal information. It should also be noted that some of the recommendations may contain an unknown fiscal impact.
The Subcommittee may request the drafting of not more than five legislative measures that relate to the matters within the scope of the study. The approved recommendations for
1
legislation resulting from these deliberations will be prepared as bill draft requests (BDRs) and submitted for introduction to the 2017 Legislature.
RECOMMENDATIONS
Proposals Relating to Funding for Postacute Care
1. Submit a BDR requiring the Division of Health Care Financing and Policy (DHCFP),Department of Health and Human Services (DHHS), to review Medicaid waiver programsand revamp them to ensure that funding covers the actual cost of personal care provided inpersonal residences, assisted living facilities, or residential facilities for groups.
(Recommendation proposed by Lucia Mathis, Vice President, Nevada Assisted LivingCenters, and Connie McMullen, Personal Care Association of Nevada)
2. Submit a BDR requiring Medicaid reimbursement rates to be consistent for equivalentservices provided in similar settings. Specifically, the same services, whether providedin residential facilities for groups, supported living arrangements (SLAs), orCommunity-based Living Arrangements, should be reimbursed at the same level.
(Recommendation proposed by Helen Foley on behalf of the Residential Care HomeCommunity Alliance of Nevada and the Association of Homecare Owners ofNorthern Nevada)
3. Send a letter to the Governor of the State of Nevada, the Director of DHHS, and the Chairsof the Senate Committee on Finance and Assembly Committee on Ways and Means duringthe 2017 Legislative Session recommending and expressing support for:
a. A review of the rate methodology for postacute care facilities and personal care andhome health care services;
b. Inclusion of an appropriation in the Governor’s recommended budget and thelegislatively-approved budget that supports payment rates that are sufficient toensure that Medicaid beneficiaries have access to covered Medicaid services; and
c. Indexing the rate to increase with inflation in future biennia.
(Recommendation proposed by Daniel Mathis, President/Chief Executive Officer (CEO), Nevada Health Care Association)
2
Proposals Relating to Quality of Postacute Care
4. Submit a BDR to establish consistent standards for all facilities providing 24-hour,long-term care for individuals who need supervision, assistance with personal careand medication management, including residential facilities for groups, SLAs, andCommunity-Based Living Arrangements. Specifically provide consistency by establishingthe following essential standards:
a. State Oversightb. Annual State Inspectionsc. Enforceable Penaltiesd. State’s Ability to Impose Finese. Transparency and Disclosure
Following are additional standards for consideration:
f. Certified Administratorsg. Liability Insuranceh. Minimum High School Diploma Requirement for Staffi. Minimum Staffing Ratiosj. Internet Access to Inspection Date and Survey Resultsk. Residential Sprinklers
(Recommendation proposed by Helen Foley on behalf of the Residential Care Home Community Alliance of Nevada and the Association of Homecare Owners of Northern Nevada)
5. Draft a BDR expanding the authority of the long-term care ombudsmen authorizing them toadvocate for residents of the following arrangements and facility types:
a. Living Arrangements
i. Supported Living Arrangements, Aging and Disability Services Division(NRS 435.3315)
ii. Community-based Living Arrangements, Division of Public andBehavioral Health
b. Facilities for the Care of Adults During the Day
Currently the long-term care ombudsmen advocate for residents in homes for individual residential care, residential facilities for groups, and skilled nursing facilities (nursing homes).
3
(Recommendation resulted from discussions at the November 17, 2015, Subcommittee meeting)
Proposals Regarding Alternatives to Institutionalized Care
6. Submit a BDR to authorize certain employees or members of the staff, who are unlicensedassistive personnel to complete basic Centers for Medicare and Medicaid Services (CMS)training in defined vital signs for certain residents. The vital signs defined by CMS includetaking a resident’s temperature, blood pressure, pulse, apical heart rate, respirations,oxygen saturation, and finger-stick glucose.
Staff of the following facilities and agencies are proposed to receive this authority:
a. Residential facility for groups (NRS 449.017);b. Agency to provide personal care services in the home (NRS 449.0021);c. Intermediary service organization (NRS 449.4304); andd. Facility for the care of adults during the day (NRS 449.004).
(Recommendation proposed by Lucia Mathis, Vice President, Nevada Assisted Living Centers, Connie McMullen, Personal Care Association of Nevada, and Christopher A. Vito, President and CEO, Nevada Adult Day Healthcare Centers)
7. Include in the Subcommittee report the following policy statements:
a. The Subcommittee strongly supports the ability for senior adults and individualswith disabilities to remain in their homes or in community-based settings.The Subcommittee recognizes that delivering home- and community-based,postacute care services and supports plays a major role in helping individuals avoidmore institutional settings, resulting in social and financial benefits.
b. The Subcommittee encourages the DHHS to establish a “no wrong door”philosophy as it relates to members of the public accessing information aboutpostacute care services and supports. The Subcommittee encourages the DHHS toincrease collaboration and coordination among the variety of postacute care entitiesand programs licensed and managed by the State and other public and privateresources to increase access by members of the public to timely and appropriateinformation and services.
(Recommendation proposed by Assemblywoman Titus, Chairperson, Subcommittee to Conduct a Study of Postacute Care)
WSDPostacuteCare2015-2016
4
RECOMMENDATION 1
5
Personal Care Association of NV P.O. Box 11412 Reno, NV 89510 PCANV.org
Subcommittee to Conduct a Study of Postacute Care Chair, Assemblywoman Robin L. Titus Work Session Document
Recommendation: Require the Division of Health Care Financing and Policy to review Medicaid waiver programs and revamp the programs to ensure that funding covers the actual cost of personal care provided in the home (which may include personal residence, residential facility for groups, and assisted living setting), as personal care agency caregivers (NRS 449.1935) provide nonmedical services that include activities of daily living such as elimination of body waste, dressing and undressing, bathing, grooming, preparation of eating meals, laundry, shopping, cleaning, transportation, and other related needs to maintenance of personal hygiene.
Justification: Medicaid Personal Care Services (PCS) Reimbursement Rate Increase. The current Medicaid reimbursement rate for Personal Care Services is $4.25 for 15 minutes, which equates to $17 per hour. This rate has not changed since 2002. In 2009, the State of Nevada did approve an increase to $18.50 per hour but repealed it.
Desired New Reimbursement Rate: $5.25 for 15 minutes or $21 per hour.
1.) The national average for Private Pay home care is $21 per hour (source – Genworth study). The average total costs on this $21 per hour are about 80% or $16.80 per hour. This means that with a reimbursement rate of $17 per hour Nevada Medicaid PCS providers just break-even. They do not have a reasonable profit margin or incentive to participate in the Nevada PCS program. The labor and operating costs for Private Pay and/or Medicaid providers are basically the same.
2.) Since 2002, the total inflation rate has risen almost 30%. Source - (http://www.usinflationcalculator.com/inflation/historical-inflation-rates/)
3.) Medicaid does not reimburse travel costs between clients, yet it is a Federal requirement to pay caregivers travel time between assignments. Most
6
Medicaid clients have only a few hours a day of time, so most caregivers see multiple clients in a day.
4.) PCS Hourly wages now average about $10 per hour in Nevada. 5.) In 2015, Employers have had to comply with Affordable Care Act insurance
requirements, which have increased insurance and overhead costs for providers.
6.) A new reimbursement rate would need to be tied to the minimum wage and any future increases because there is a direct correlation between reimbursement and the labor cost. PCS care is one-on-one; it is labor intensive. Currently, the State of Nevada minimum wage is $8.25 (without health benefits), which is 48% of $17 (existing reimbursement rate). However, the current market hourly wage is $10 per hour or 48% of $21 (proposed reimbursement rate). Consequently, if for example the minimum wage gets increased to $13 per hour, the reimbursement rate would need to increase in tandem to $27 per hour (which is 48%) in order to maintain financial viability of the providers. Without being tied to the minimum wage requirement, any increases to wages without a similar increase in rates can cause providers to stop providing Medicaid services.
7
Medicaid Personal Care Services (PCS) Reimbursement Rate increase
Expense Information from PCA Industry
To further support our earlier comments regarding costs and expense ratios, please see the following:
1.) Home Care Pulse’s (www.homecarepulse.com) 2014 Private Duty Benchmarking Study. 2.) Genworth Financial’s (a long term insurance provider) 2015 Cost of Care Survey for Nevada.
The following deductions can be made from these two studies:
1.) Per the Genworth study, one can see that the average hourly rate for homemaker services is $21 per hour in Nevada.
2.) On page 43 of the Home Care Pulse study, it provides expense information per region. The last column is the Pacific region. One can see that the Total Direct Care Expense is 62.7% of Revenue; therefore, the Gross Profit Margin is 37.3%. The Revenue would be $21 as defined in the Genworth study and Total Direct Care Expense cost would equal $13.17. One must use the $21 for these expenses because the percentages are based on the $21 (not $17). In addition, expenses are not different for Medicaid or private providers. In fact, many providers who do both would argue that Medicaid costs (namely in the administrative and billing areas) are higher.
3.) Also on page 43, it provides the Total Indirect Care Expenses percentage of 13.4% or $2.81 (of $21).
4.) To show how unreasonable the current Medicaid rate of $17 per hour is: $17.00 Medicaid Reimbursement Rate currently -$13.17 Total Direct Care Expense -$ 2.81 Total Indirect Care $1.02 Estimated Net Ordinary Income which is 4.85%.
5.) According to the Home Care Pulse study (second sheet), Estimated Net Ordinary Income is BEFORE profit used to pay owners, make charitable contributions, and pay other non-operating expenses.
6.) Consequently, one can see there is a big difference between the Estimated Net Ordinary Income of 23.9% when doing Private Pay business at $21 per hour versus the 4.85% when doing Nevada Medicaid business at $17 per hour.
8
7.) To further evidence our point, at the recent Legislative Committee on Health Care, it was reported by Medicaid staff that given the Medicaid service type about 95% of private or conventional providers are also Medicaid providers. However, for the Personal Care Service only about 50% (104 out of 200) of the licensed Personal Care Agencies are Medicaid providers.
9
Genworth 2015 Cost of Care Survey Nevada
https://www.genworth.com/dam/Americas/US/PDFs/Consumer/corporate/cost-of-care/118928NV_040115_gnw.pdf
10
DO’S AND DON’TS FOR PERSONAL CARE AGENCIES IN THE STATE OF NEVADA:
Do complete the licensing application and submit to the State of Nevada Department of Health, Health Care Quality and Compliance Division along with the appropriate fees and all the necessary requirements.
Do make sure all caregivers hired are at least 18 years of age, understand the provisions of the regulations, can communicate effectively with clients, have the ability to meet the needs of the clients, and receive annually not less than 8 hours of training.
Do set up personnel files with the proper documentation including name, address, telephone number, and date employee began working for the agency. Include documentation of tests and certificates required by NAC 441A.375 including TB test and physical, references checked, certificate of First Aid and CPR, proof of age, proof of minimum liability insurance on vehicle, and background check information thru NABS.
Do set up client files with all required documents including a written plan of care as well as State required documents.
Do pay all employees overtime for hours worked over 8 hours in a 24-hour period and for hours worked over 40 hours per week.
Don’t provide medical case management, including accompanying client to physical office to provide medical information.
Don’t do any task in Chapter 632 of NRS and regulation of the State Board of Nursing requiring skilled nursing care
Don’t administer medication, including insertion of suppositories, prescribed lotion, or eye drops
Don’t do any injections, apply a dressing with prescription medication or aseptic techniques.
Don’t do any irrigation of any body cavity or insertion of catheter
Don’t monitor vital signs, use specialized feeding techniques, perform digital rectal exams, or trim or cut toenails.
Don’t provide massage.
11
12
13
14
15
16
17
18
RECOMMENDATION 2
19
The Post Acute Care Committee requested the DHCFP to provide information on the recommendation requiring Medicaid have reimbursement rates that are consistent for equivalent service provided in Residential Facilities for Groups, Supportive Living Arrangements and community based living arrangements. Unfortunately, the listed settings do not include equivalent Medicaid services and the settings are not similar, therefore setting consistent rates may not be possible.
Medicaid pays for different services based on an individual’s program eligibility and service needs however, Medicaid is prohibited from paying for room and board for any Medicaid recipients receiving community based care. Residential Facilities for Groups are licensed under NRS 449 and are required to provide certain activities through their room and board payment received from the individual living in the facility. Medicaid funds additional care needs above the required room and board on a per diem basis based on the individual’s level of care needs (example would be: minimal, moderate or maximum assistance with basic activities of daily living). There is a tiered daily payment based on the individual.
Medicaid funds a package of supported living arrangement services (SLA) for individuals with intellectual disabilities that are provided based on an individual’s person centered care plan. Some individuals may only receive a few service hours a couple times a week and others many hours a day. These services are provided where the individual lives and are not tied to a specific location qualification, i.e. they may be in a home with family, in an individual apartment or in a setting where more than one individual lives. Medicaid also funds other community based services that are/may be provided in a recipient’s home. In the Medicaid program, there is no setting identified as a community based living arrangement. Medicaid provides services such as attendant care (personal care services (PCS)), homemaker services, home delivered meals, basic skills training (BST) and psycho-social rehabilitation (PSR). Please see attached service grid.
I hope this information is helpful in understanding the various programs offered by the DHHS but if additional information or clarification is needed, please let me know.
Thanks,
Marta Jensen Acting Administrator Division of Health Care Financing and Policy (775) 684-3677
20
RECOMMENDATION 4
21
CE
RT
AIN
PO
ST A
CU
TE
CA
RE
LIV
ING
AR
RA
NG
EM
EN
TS
AN
D F
AC
ILIT
Y T
YP
ES
Res
iden
tial
Fac
ility
for
G
roup
s
Supp
orte
d L
ivin
g A
rran
gem
ents
for
P
erso
ns w
ith
Inte
llect
ual
Dis
abili
ty
Com
mun
ity
Bas
ed
Liv
ing
Arr
ange
men
ts
for
Per
sons
wit
h M
enta
l Il
lnes
s
Con
greg
ate
Liv
ing
Arr
ange
men
ts f
or
Indi
vidu
als
Rec
eivi
ng
Cer
tain
Med
icai
d Se
rvic
es
Age
ncy
Res
pons
ible
for
Ove
rsig
ht
DP
BH
/Hea
lth
Car
e Q
ualit
y an
d C
ompl
ianc
e
Agi
ng a
nd D
isab
ility
Se
rvic
es
Div
isio
n of
Pub
lic
and
Beh
avio
ral
Hea
lth
Thi
s is
not
a
regu
late
d or
ser
vice
se
ttin
g.
Adm
inis
trat
or C
erti
fica
tion
Req
uire
d Y
es,
NA
C 4
49.1
57,
NA
C 4
49.1
94
NR
S 43
5 an
d N
AC
435
N
o
Lia
bilit
y In
sura
nce
Req
uire
men
ts
NA
C 4
49.1
5335
,
NR
S 44
9.06
5 A
ttach
ed
Yes
, by
con
trac
t
Staf
fing
Edu
cati
on R
equi
rem
ents
N
AC
449
.196
, N
AC
44
9.27
59 –
NA
C
449.
2768
Atta
ched
Y
es,
by c
ontr
act
Min
imum
Sta
ffin
g R
atio
s N
AC
449
.199
N
one
No
Fre
quen
cy o
f St
ate
Insp
ecti
on o
r Su
rvey
A
nnua
lly (
12 m
onth
s)
NR
S 44
9.13
1 C
ertif
icat
ion:
1-3
yea
rs
Hom
e In
spec
tions
for
24
hou
r sh
ift h
omes
:
Ann
ually
No
less
than
2x/
year
Acc
ess
to I
nspe
ctio
n an
d Su
rvey
N
RS
449.
124,
NR
S 44
9.13
1 &
NR
S 44
9.13
2
Upo
n R
eque
st
Yes
Enf
orce
able
Pen
alti
es a
nd I
mpo
sabl
e F
ines
N
RS
449.
163N
AC
44
9.27
702,
NA
C
449.
9986
– N
AC
44
9.99
939
No
No,
onl
y co
ntra
ct
canc
elat
ion
Tra
nspa
renc
y an
d D
iscl
osur
e N
RS
449.
133
No
Yes
R
esid
enti
al S
prin
kler
s Y
es,
NA
C 4
49.2
11
No
No
Not
e:
Med
icai
d do
es n
ot c
over
roo
m a
nd b
oard
for
res
iden
tial s
ervi
ces.
M
edic
aid
prov
ides
rei
mbu
rsem
ent f
or s
peci
fic
serv
ices
pro
vide
d in
thes
e re
side
ntia
l set
ting
by
empl
oyee
s.
In a
dditi
on,
“Sup
port
ed L
ivin
g A
rran
gem
ents
” ar
e no
t a “
plac
e” it
is a
ser
vice
.
22
Direct Support Staff Qualifications (MSM Chapter 2100, ADSD Policy):
1. All contract provider employees and individual contract providers providing direct servicesand support services must be a least 18 years of age, unless this is waived by ADSD.
2. All contract provider employees and individual contract providers providing direct servicesand supports must have at least a high school diploma or equivalency, unless this has beenwaived by ADSD.
3. All contract provider employees and individual contract providers must have a State andFederal Bureau of Investigation (FBI) criminal history clearance obtained from the CentralRepository for Nevada Records of Criminal History through the submission of fingerprints.
4. Must complete required training which includes First Aid Training and CPR training andcertification within 30 days of hire
23
Description: A Contract Provider QIDP, (Qualified Intellectual Disability Professional), is responsible for implementing strategies which: support the regional centers’ and the contract provider’s mission; follow regional center policies and procedures; comply with Home and Community-Based Waiver Services regulations; align with Person-Centered values and principles of self-determination.
All provider organizations must employ, or contract with, a QIDP to provide required plan development, coordination of services, and oversight duties as outlined below. The number of QIDPs employed, or amount of contract hours required, by a provider organization is dependent on the needs of the individuals served, the expertise of provider staff working with the QIDP and the ability of the QIDP to fulfill all functions of the position as measured by outcomes and fulfillment of waiver regulations.
Qualifications: To qualify as a QIDP, an individual must have at least one year of experience working directly with persons with intellectual disability or other development disabilities; and is one of the following:
• Doctor of medicine or osteopathy;• Registered nurse;• An individual who holds at least a bachelor’s degree in a “human services
field” from an accredited university/college.o “Human services field” includes the professional disciplines of:
Occupational therapy; Physical Therapy; Psychologist; Social Worker; Speech-Language Pathologist; Audiologist; Recreation Professional (degree in recreation, art, dance,
music or physical education); Dietician.
o “Human services field” also includes academic disciplines relatedto: Human behavior (e.g. psychology, sociology, speech
communication, gerontology, etc.); Human skill development (e.g. education, counseling,
human development, etc.); Humans and their cultural behavior (e.g. anthropology, etc.); Any other study of services related to basic human care
needs (e.g. rehabilitation counseling, etc.);
24
Any other study of services related to the human condition(e.g. literature, the arts, etc.).
Any exceptions to these requirements must have prior written approval from the Regional Center Director. The director of a contracted provider agency may not serve as the sole QIDP for their agency without the written consent of the Regional Center Director.
Functions:
a) Supervise and coordinate the implementation of supports to all individuals,inclusive of developing or supervising the development of objectives andplans that have been recommended in the ISP. Ensure service design anddelivery of the various supports maximizes positive outcomes for eachindividual.
b) Observe and assess individuals’ responses to services and supports toinclude: satisfaction with services and quality of life; review of data andprogress; alert team members to the changing needs of an individual; andrevise supports in accordance with those changes upon approval of the ISPTeam.
c) Ensure staff receives required training related to: the person-centeredplanning process; rights and due process; positive behavioral interventions;the process for development of outcome-based support plans;implementation of plans and required documentation/data collection.
d) Monitor and ensure that staff are alerted to and trained on all new andrevised support plans for each individual so as to facilitate consistency inimplementation.
e) Monitor and ensure all necessary current information/ documentation ispresent in the home files for staff review.
f) Ensure consistency with implementation of the provision of supports toindividuals across all settings (i.e., JDT, residential, recreational, medical,etc.), through monitoring activities and facilitating communication betweenteam members.
g) Ensure that adequate environmental, medical, social supports and assistivedevices are in place to promote health and welfare and increasedindependence.
h) Knowledge and ability to implement behavioral plans developed viaconsultation with behavioral specialists; knowledge of and ability tofunctionally implement plans and objectives that reinforce positivebehavioral supports. Supervise and monitor the implementation of
25
behavioral support plans and data collection, staff training regarding implementation of behavioral support plans and those plans that may have restrictive intervention procedures ensuring that restrictions are viewed as temporary and that plans include a training component for restoring right(s).
i) The QIDP or designee should act as the Agency liaison and representativeto the regional center’s Behavioral Intervention Committee and the HumanRights Committee and should ensure appropriate oversight is in place.
26
DEPARTMENT OF HEALTH AND HUMAN SERVICES
AGING AND DISABILITY SERVICES DIVISION
2014 POLICY MANUAL
POLICY # REVISED TITLE EFFECTIVE DATE PAGE
41 - 2
Certification Process for Contracted Providers of Supported Living and Jobs and Day Training
Services Upon Approval 1 of 8
POLICY Nevada Developmental Services (DS) is committed to providing quality integrated community based services designed to maximize individuals’ potential, support desired outcomes, and deliver services in a manner that leads to enriched and meaningful lives for individuals served. The Provider Certification process will act as a mechanism for assessing and verifying that contracted providers are meeting standards of service delivery based on best practices which promote the health and welfare of those individuals they support.
All providers of Supported Living Arrangement (SLA) and Jobs and Day Training (JDT) services, hereinafter referred to as providers, for persons with developmental disabilities must be certified, per NAC 435, in order to be eligible to receive payment from the Aging and Disability Services Division (ADSD) for the provision of supported living arrangement and jobs and day training services. Provider Certification is determined by Developmental Services (DS) Regional Centers and is based on requirements set forth under: ADSD; DS Regional Centers; Medicaid Waiver Chapter 2100; NRS 449.176; and NAC 435.
PURPOSE The purpose of this policy is to identify the standards upon which Provider Certification is based, establish guidelines for the quality assurance (QA) review process utilized to determine compliance with set standards and to establish sanctions for failure to comply with set standards.
REFERENCE NRS 435 NRS 449.122 (Substituted in revision for NRS 449.176) NAC 435 Nevada Medicaid Manual Chapter 2100
PROCEDURE
BASIC STANDARDS OF QUALITY SERVICES A.
The basic standards of quality services, delineated in all Provider Agreements, upon which1.Certification is determined, includes but is not limited to:
Compliance with State and Federal regulatory requirements, including but not limiteda.to, pertinent requirements as set forth by the Centers for Medicare and Medicaid(CMS), Nevada;
Compliance with Division of Health Care Finance and Policy (DHCFP), and otherb.funding sources;
Compliance with ADSD policies and procedures, local DS Regional Center policiesc.and procedures;
Assurance of health and welfare of individuals;d.
Compliance in service delivery for individualized support plans inclusive ofe.assessing, plan development and implementation; and
Effective internal quality assurance (QA) activities.f.
27
DEPARTMENT OF HEALTH AND HUMAN SERVICES
AGING AND DISABILITY SERVICES DIVISION
2014 POLICY MANUAL
POLICY # REVISED TITLE EFFECTIVE DATE PAGE
41 - 2
Certification Process for Contracted Providers of Supported Living and Jobs and Day Training
Services Upon Approval 2 of 8
Details of specific requirements and performance indicators are outlined in: 2.
DS-QA-01 (ci) Jobs and Day Training Standards of Service Provision; anda.
DS-QA-01 (ii) Supported Living Services Standards of Service Provision.b.
GENERAL PROCESS OF CERTIFICATION B.
Provisional Certification1.
New providers are initially accepted on Provisional Certification status upon review andapproval of a completed application packet, successful interview, submission of requireddocuments and completion of DS Regional Center training as outlined in DS ProviderApplication, Enrollment and Provisional Certification Policy. A comprehensive QAReview for Certification will be completed within 9 to 12 months after commencement ofservice provision.
Based on the findings of the QA Review for Certification, providers may be certified for any2.period not to exceed three years. QA Reviews for Certification may also result in theissuance of a probationary certificate, if warranted, to correct deficiencies found during thereview process.
Multi-Regional Certification of Providers3.
In situations where a provider is in a contractual relationship in more than one region,the DS Regional Centers have the option to coordinate the QA review for Certification inorder to develop a statewide report of findings and request for plan of improvement.
Dual Certification4.
The DS Regional Center may complete a single QA Review for Certification for providerswho operate both SLA and JDT programs.
QUALITY ASSURANCE REVIEW PROCESS C.
Outcome Focused1.
The certification process utilizes an outcome focused, multidimensional approach ina.assessing the provider’s capacity to deliver services that promote health and welfare,as well as maximize individual potential, desired outcomes, and full participation inintegrated community settings.
Review Team2.
The local DS Regional Center will select and assign a review team. A team leadera.will be assigned by the DS Regional Center’s QA Department.
Provider Self-Assessment3.
Provider organizations may be required to submit a Self-Assessment of theira.program prior to their QA review. The Self-Assessment is an opportunity for the
28
DEPARTMENT OF HEALTH AND HUMAN SERVICES
AGING AND DISABILITY SERVICES DIVISION
2014 POLICY MANUAL
POLICY # REVISED TITLE EFFECTIVE DATE PAGE
41 - 2
Certification Process for Contracted Providers of Supported Living and Jobs and Day Training
Services Upon Approval 3 of 8
organization to evaluate their operation for positive outcomes as well as identification of areas that require improvement.
Scope of the Review 4.
The QA Review for Certification will encompass all aspects of the service deliverya.system at any site and may include, but is not limited to:
1) Administrative Review2) Policies and procedures;3) Liability protections;4) Personnel files and clinical records;5) Administrative, personnel and other documentation from the administrative site
as deemed necessary;6) Fiscal information on the organization and/or people receiving services;7) Quality Assurance/Management Systems; and8) Other information related to assessing quality of support services, such as
incident reports, investigation reports, rights review, environmental QA reviews,previous plans of correction/responses, satisfaction surveys and outcomeinterview findings, complaints, and response to complaints.
Interviews, which may include conversations with:5.
Individuals, direct support staff, management staff, ISP team members, families,a.friends or advocates of individuals receiving services from the provider agency;
DS Regional Center staff; andb.
Other persons or organizations the DS Regional Center deems important to thec.process.
Review of Homes and JDT Sites6.
Environmental QA Review of selected homes and/or JDT sites will be conducted.a.
Review Sample Selection7.
The review team will select a sample of at least 5% of both individuals receivinga.services and provider staff for an interview and record review.
At the discretion of the DS Regional Center the sample may be expanded.b.
For recertification, the review team may select a smaller sample size to enable anc.abbreviated review, if applicable.
Review Process8.
The initial QA Review for Certification will be conducted by the DS Regional Centera.team who will be responsible to ensure a thorough review of the contractedprovider’s service delivery system. Upon the completion of the initial QA Review forCertification, and receipt of a certificate, subsequent reviews for recertification, mayutilize an abbreviated QA review process.
29
DEPARTMENT OF HEALTH AND HUMAN SERVICES
AGING AND DISABILITY SERVICES DIVISION
2014 POLICY MANUAL
POLICY # REVISED TITLE EFFECTIVE DATE PAGE
41 - 2
Certification Process for Contracted Providers of Supported Living and Jobs and Day Training
Services Upon Approval 4 of 8
The review process shall include the following: b.
1) Notification to provider of pending review with request for specific information thatmust be made available either prior to, or at the time of, the review. The providerwill generally be given at least 72 hours advance notice, however, the DSRegional Centers reserve the right to conduct a review without prior notification;
2) The DS Regional Center may request the provider to assign a liaison to thereview team who will coordinate scheduling of visits, interviews, and prepare therequired documentation for review;
3) Review team will conduct interviews, home visits, and administrative office visitsof contracted provider; and
4) Observations and findings relevant to the Standards of Service Provision that areapplicable to the type of services delivered shall be recorded in the establishedreview format.
Any findings made in the course of the reviews that represent an immediatec.jeopardy, such as abuse, neglect or exploitation, or, possible civil or criminal lawviolations will be provided, without delay, to the appropriate authorities, the provider,the DS Regional Center Director and ADSD Administrative Office.
At the discretion of a DS Regional Center, additional reviews may be conductedd.announced, or unannounced, at any given time.
The QA Review for Recertification will be outcome focused and utilize data from QAe.activities completed throughout the previous year. Should a QA Review forRecertification identify concerns with health and welfare, the DS Regional Centerreserves the authority to expand sample sizes or revert to a full QA review processprior to the development of a request for a plan of improvement (POI), as outlined insection III.H.
Review findings and assessment of compliance with standards of service provisionf.will be impacted by severity, scope and repeated patterns of noncompliance and/orfailure to sustain adequate plans of improvement.
Scoring Methodology9.
Data collected from the review process will be entered into a certification score card.a.Performance indicators aligning with standards of service provision are assessed aseither “met; partially met; or not met” based on percentage of compliance related toeach performance indicator as follows:
1) Met = 86.0% - 100%2) Partially Met = 74.0% - 85.9%3) Not Met = Under 74.0%
Individual performance indicators on the scoring card are categorized as eitherb.“Administrative” or “Health and Welfare” standards. Performance indicators relatedto the maintenance of Medicaid provider requirements are also categorized as being“Non-Negotiable.” Each performance standard is assigned a weighted severity levelthat when multiplied by the rating determines the amount of points applied. Pointswill be totaled for each category – “Administrative, Health and Welfare, and Non-Negotiable” – as well as an overall total of review points.
30
DEPARTMENT OF HEALTH AND HUMAN SERVICES
AGING AND DISABILITY SERVICES DIVISION
2014 POLICY MANUAL
POLICY # REVISED TITLE EFFECTIVE DATE PAGE
41 - 2
Certification Process for Contracted Providers of Supported Living and Jobs and Day Training
Services Upon Approval 5 of 8
Summary of Findings 10.
Provider Certification is established based on the findings of the Quality Assurancea.Review and Score Card. The Review Team will complete a Summary of Findingsindicating overall performance of the provider organization.
The results will be reviewed by the DS Regional Center Program Manager, orb.designee, and ADSD Administrative Office, as applicable, prior to submitting to theprovider organization.
Upon completion of the report, the findings will be reviewed with the provider withinc.30 days and may include recommendations based on the team’s findings and arequest to follow up with a plan of improvement (POI).
Certification review findings may be shared with Medicaid.d.
Review findings and score cards may be posted on a public website.e.
Based on certification scores, a one (1) - three (3) year certificate will be issued uponf.receipt and acceptance of a POI, if applicable. Failure to submit an approved POI,will result in issuance of sanctions, as outlined in NAC 435 and section V.
Plan of Improvement (POI)11.
If findings of the QA Review identify deficiencies in the provision of services relateda.to the health and welfare of individuals receiving services, a formal POI may berequired depending on type and severity of deficiency.
Non-negotiable performance indicators that score at 91.9% or below must beb.corrected immediately prior to the issuance of a certificate.
Health and Welfare grades of B or C will require a POI. Depending on type andc.severity of deficiencies, the QA team may elect to validate the POI prior to issuanceof a certificate.
In the event a POI is requested:d.
1) The POI shall address each standard as requested by the QA department;2) The POI shall contain specific measures and timelines for correction of the
deficiencies. With prior agreement the plan may reference technical assistancethat will be provided by the DS Regional Center;
3) The provider must submit the requested proposed POI to the DS RegionalCenter QA Department within 15 working days of the receipt of the request;
4) Per NAC 435, failure of a provider to submit a POI may result in sanctions unlessthe provider documents good cause and/or has requested an extension which isaccepted by the DS Regional Center; and
5) The DS Regional Center’s QA Department will be responsible for the review ofthe POI and for coordinating any follow-up action as required.
Validation Review12.
A validation review may be conducted by the DS Regional Center QA Department toa.verify that plans of improvement have been fully implemented and are consistent inpractice.
31
DEPARTMENT OF HEALTH AND HUMAN SERVICES
AGING AND DISABILITY SERVICES DIVISION
2014 POLICY MANUAL
POLICY # REVISED TITLE EFFECTIVE DATE PAGE
41 - 2
Certification Process for Contracted Providers of Supported Living and Jobs and Day Training
Services Upon Approval 6 of 8
Upon completion of a validation review the QA Department will submit a final report b.and recommendation to the DS Regional Program Manager.
Issuance of Certificate13.
Upon completion of the QA Review for Certification, the duration of certification willa.be determined based on total review grade, as follows:
1) 3-year Certificate = Grade A or 92.0% and above2) 2-year Certificate = Grade B or 83.0% - 91.9%3) 1-year Certificate = Grade C or 74.0% - 82.9%4) Probationary Certificate or Provider Termination = Grade D or 65.0% - 73.9%5) Probationary Certificate or Provider Termination = Grade F or 64.9% and below
A Provider’s current Certificate will remain in effect during the recertification andb.active validation process.
Sanctions14.
Upon determination that a deficiency places, or contributes to placing, individuals ora.other persons at probable risk of harm, the DS Regional Center may impose uponthe provider immediate measures of correction, or may immediately end theprovision of the services by the provider. DS Regional Centers may take protectivemeasures to include the removal of those individuals at risk either for an interimperiod or permanently. This decision will be determined by the DS Regional CenterProgram Manager, with notification to the Administrator and Deputy Administrator ofADSD.
Providers may, at the discretion of the DS Regional Center or ADSD, be subjected tob.a variety of sanctions up to and including termination of the contractual relationship.If immediate jeopardy exists, actions may be taken prior to the written report beingissued.
Providers who receive a grade of D or below in any category will be subjected to anc.automatic sanction up to and including provider termination.
Sanctions may be imposed as stipulated in NAC 435.d.
The DS Regional Center and/or ADSD will work with individuals, guardians and ISPe.teams as necessary to assure the continuity of service provision to people whoseprovider is the subject of sanctions, which may include the provision of services byother providers.
Sanctions imposed by a DS Regional Center may impact a provider’s certificationf.status in other DS regions in which they do business.
Appeals15.
Sanctionsa.
1) Per NAC 435, a provider may appeal sanctions by submitting a written request tothe Administrator of ADSD, or their designee, within 15 calendar days of the dateof notification of the sanction. Any supporting information must be submitted at
32
DEPARTMENT OF HEALTH AND HUMAN SERVICES
AGING AND DISABILITY SERVICES DIVISION
2014 POLICY MANUAL
POLICY # REVISED TITLE EFFECTIVE DATE PAGE
41 - 2
Certification Process for Contracted Providers of Supported Living and Jobs and Day Training
Services Upon Approval 7 of 8
the time of the request. The appeals process shall not delay or hinder actions taken by the DS Regional Center to assure health and welfare of individuals.
2) The Administrator of ADSD, or their designee, will review the findings and submita written decision within 30 calendar days of receipt of the written request ofappeal. The decision of the Administrator of ADSD, or their designee, is a finaldecision.
Provider Terminationb.
1) Per NAC 435, a provider may appeal the decision to revoke a certificate bysubmitting a written request to the Administrator of ADSD, or their designee,within 15 calendar days of the date of notification of the revocation. Anysupporting information must be submitted at the time of the request. The appealprocess shall not delay or hinder actions taken by the DS Regional Center toassure health and welfare of individuals.
2) The Administrator of ADSD, or their designee, will review the findings and submita written decision within 30 calendar days of receipt of the written request ofappeal. The decision of the Administrator of ADSD, or their designee, is a finaldecision.
33
34
35
36
37
38
39
40
Serv
ices
Fr
ail/
Elde
rly W
aive
r Pe
rson
s with
Phy
sica
l Di
sabi
litie
s Wai
ver
Indi
vidu
als w
ith
Inte
llect
ual D
isab
ilitie
s or
Rel
ated
Con
ditio
ns
Wai
ver
Stat
e Pl
an/1
915(
i)
Adul
t Com
pani
on
X Ad
ult D
ay C
are
X Ad
ult D
ay H
ealth
care
X
Adul
t Res
iden
tial C
are
X As
sist
ed L
ivin
g Se
rvic
es
X At
tend
ant C
are
Serv
ices
X
X Be
havi
oral
Con
sulta
tion
X Be
havi
oral
Hea
lth B
ST/P
SR
X Ca
reer
Pla
nnin
g X
Chor
e X
X Co
unse
ling
Indi
vidu
al
Grou
p
X
Day
Habi
litat
ion
X En
viro
nmen
tal A
cces
sibi
lity
Adap
tatio
ns
X Ho
me
Deliv
ered
Mea
ls X
Hom
e He
alth
X
Hom
emak
er
X X
Jobs
and
Day
Tra
inin
g X
Non
-Med
ical
Tra
nspo
rtat
ion
X N
ursi
ng S
ervi
ces
X N
utrit
ion
Coun
selin
g X
Pers
onal
Em
erge
ncy
Resp
onse
Sys
tem
X
X Pr
evoc
atio
nal S
ervi
ces
X Re
side
ntia
l Sup
port
Man
agem
ent
X Re
side
ntia
l Sup
port
Ser
vice
s In
term
itten
t or R
esid
entia
l X
Resp
ite
X X
Spec
ializ
ed M
edic
al E
quip
men
t and
Sup
plie
s X
Supp
orte
d Em
ploy
men
t X
Trai
ning
and
Inte
rven
tion
X
41
RECOMMENDATION 5
42
Om
buds
man
Pro
gram
Bud
gete
d C
osts
FY 2
016
Gen
eral
Fun
dFe
dera
l Fun
ds
Oth
er F
unds
Tot
al G
F To
tal F
eder
al
Fund
s To
tal O
ther
Fu
nds
Bud
get A
cct
Cat
egor
yTo
tal E
xp25
01Va
rious
Vario
usTo
tal
DIF
F31
5101
- P
erso
nnel
Ser
v. (s
ee P
erso
nnel
Fun
d M
ap)
1,63
3,98
3
1,00
6,54
0
619,
912
7,
531
1,
633,
983
-
3151
03 -
In-S
tate
Tra
vel
883
88
3
- -
883
-
3151
04 -
Ope
ratin
g E
xpen
ses
13,1
97
13
,197
-
- 13
,197
-
3151
05 -
Equ
ipm
ent
12,9
00
12
,900
-
- 12
,900
-
3151
11 -
Title
VII
Om
buds
man
82,7
21
-
82,7
21
- 82
,721
-
3151
19 -
Title
VII
Eld
er A
buse
2,06
6
- 2,
066
-
2,06
6
-
3151
26 -
Info
rmat
ion
Ser
vice
s9,
639
9,
639
-
- 9,
639
-
31
5187
- P
urch
asin
g A
sses
smen
t28
8
- 28
8
- 28
8
-
31
5188
- S
tate
wid
e C
ost A
lloca
tion
100,
287
- 10
0,28
7
- 10
0,28
7
-
3151
89 -
AG
Cos
t Allo
catio
n50
,936
- 50
,936
-
50,9
36
-
To
tal C
ost:
1,90
6,90
0
1,
043,
159
85
6,21
0
7,53
1
1,90
6,90
0
-
I:\Interim
(Studies)\20
15‐201
6\Po
stacute Care\W
ork Session\5 PA
C Re
commen
datio
n\FY16
Ombu
dsman
Bud
get.x
lsxCO
MPLETE RO
LLUP Summary
7/1/20
16 11:43
AM
43
RECOMMENDATION 6
44
BRIAN SANDOVAL Governor
RICHARD WHITLEY, MS Director
STATE OF NEVADA CODY L. PHINNEY, MPH
Administrator
LEON RAVIN, MD Acting Chief Medical Officer
DEPARTMENT OF HEALTH AND HUMAN SERVICES DIVISION OF PUBLIC AND BEHAVIORAL HEALTH
June 29, 2016
Assemblywoman Titus, M.D., Chair Subcommittee to Conduct a Study of Postacute Care
Re: Medical Laboratory Review - Waived Glucose Testing
Dear Assemblywoman Titus:
It is my understanding that the Subcommittee to Conduct a Study of Postacute Care is considering recommendations concerning the provision of waived blood glucose testing within residential facilities for groups and other dependent care facilities. As such, I am submitting the following information for your reference:
Federal Requirements: “CLIA requires all entities that perform even one test, including waived test on ... "materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings" to meet certain Federal requirements. If an entity performs tests for these purposes, it is considered under CLIA to be a laboratory and must register with the CLIA program.” Source: Centers for Medicare & Medicaid Services, CMS.gov website: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/How_to_Apply_for_a_CLIA_Certificate_International_Laboratories.html
Nevada State Law: Per Nevada law, a facility that meets the definition of a medical laboratory (NRS 652.060) is required to be licensed. Dependent care facilities such as residential homes for groups and adult day care centers who perform waived blood glucose testing meet this definition. For these dependent care facilities, an exempt laboratory license (NAC 652.175) may be issued as long as they meet the criteria in NAC 652.175. This includes having a laboratory director who is a licensed physician, including a doctor of medicine, a doctor of osteopathic medicine, a chiropractic physician or a pediatric physician (NAC 652.155 subsection 5).
Proposed Regulation Changes Currently medical facilities and facilities for the dependent such as residential facilities for groups and adult day care centers can perform waived testing, such as waived glucose testing in their facilities as long as they submit an application to become an exempt medical laboratory and meet all of the regulatory and statutory requirements. In speaking to industry, one of the largest barriers to becoming an exempt medical laboratory is the cost of paying for a physician to act as the laboratory director to oversee the quality assurance of the one, waived glucose test to be performed at the facility. Current regulations require that a physician act as the laboratory director, including those laboratories that only perform one waived test such as a waived glucose test.
45
To reduce this burden, so that these facilities can financially afford to become an exempt medical laboratory, proposed regulations are being moved forward that would allow a nurse licensed pursuant to Chapter 632 of NRS, a pharmacist licensed pursuant to Chapter 639 of NRS or any laboratory personnel licensed or certified pursuant to Chapter 652 of NRS, except that a certified office laboratory assistant or laboratory assistant would not be able to serve as a laboratory director, to serve as the laboratory director in which only one waived test, such as a glucose waived test is performed. CLIA regulations allow anyone to serve in this capacity, including an individual with no healthcare background, for example someone right out of high school. Approximately half of the country only has CLIA regulations in which anyone can serve as a laboratory director. In order to ensure quality of services, it was determined that a minimum, a licensed/certified healthcare professional in Nevada should serve in this capacity and therefore, the proposed regulations are more stringent than the federal regulations, while at the same time reducing the financial burden for facilities. In addition, one person that meets the laboratory director qualifications for an exempt laboratory in the proposed regulations would be able to serve as the director of multiple exempt medical laboratories.
In summary and under current federal and state laws, facilities for the dependent such as residential facilities for groups and adult day care facilities who want to perform waived blood glucose testing must obtain a CLIA certificate of waiver from the Center for Medicare and Medicaid Services (current cost is $150/2 years), obtain a State license as an exempt medical laboratory, and meet the regulatory requirements for an exempt medical laboratory in order to perform blood glucose testing for its residents. Current efforts are under way to revise regulations with the purpose of expanding the medical professionals who may serve as a Director of an exempt medical laboratory to reduce the burden on dependent care facilities who want to provide blood glucose testing for their residents. If State law is changed to exempt such facilities from licensure, they would still need to obtain a CLIA certificate of waiver.
Please see below for all applicable federal and state laws.
Clinical Laboratory Improvement Amendments (CLIA) 42 USC 263a (a) “Laboratory” or “clinical laboratory” defined As used in this section, the term “laboratory” or “clinical laboratory” means a facility for the biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.
(b) Certificate requirement No person may solicit or accept materials derived from the human body for laboratory examination or other procedure unless there is in effect for the laboratory a certificate issued by the Secretary under this section applicable to the category of examinations or procedures which includes such examination or procedure.
(c) Issuance and renewal of certificates (1) In general The Secretary may issue or renew a certificate for a laboratory only if the laboratory meets the requirements of subsection (d) of this section.
(2) Term A certificate issued under this section shall be valid for a period of 2 years or such shorter period as the Secretary may establish.
(d) Requirements for certificates (1) In generalA laboratory may be issued a certificate or have its certificate renewed if— (A) the laboratory submits (or if the laboratory is accredited under subsection (e) of this section, the accreditation body which accredited the laboratory submits), an application— (i) in such form and manner as the Secretary shall prescribe, (ii) that describes the characteristics of the laboratory examinations and other procedures performed by the laboratory including— (I) the number and types of laboratory examinations and other procedures performed, (II)
46
the methodologies for laboratory examinations and other procedures employed, and (III) the qualifications (educational background, training, and experience) of the personnel directing and supervising the laboratory and performing the laboratory examinations and other procedures, and (iii) that contains such other information as the Secretary may require to determine compliance with this section, and the laboratory agrees to provide to the Secretary (or if the laboratory is accredited, to the accreditation body which accredited it) a description of any change in the information submitted under clause (ii) not later than 6 months after the change was put into effect, (B) the laboratory provides the Secretary— (i) with satisfactory assurances that the laboratory will be operated in accordance with standards issued by the Secretary under subsection (f) of this section, or (ii) with proof of accreditation under subsection (e) of this section, (C) the laboratory agrees to permit inspections by the Secretary under subsection (g) of this section, (D) the laboratory agrees to make records available and submit reports to the Secretary as the Secretary may reasonably require, and (E) the laboratory agrees to treat proficiency testing samples in the same manner as it treats materials derived from the human body referred to it for laboratory examinations or other procedures in the ordinary course of business, except that no proficiency testing sample shall be referred to another laboratory for analysis as prohibited under subsection (i)(4). (2) Requirements for certificates of waiver (A) In general A laboratory which only performs laboratory examinations and procedures described in paragraph (3) shall be issued a certificate of waiver or have its certificate of waiver renewed if— (i) the laboratory submits an application— (I) in such form and manner as the Secretary shall prescribe, (II) that describes the characteristics of the laboratory examinations and other procedures performed by the laboratory, including the number and types of laboratory examinations and other procedures performed, the methodologies for laboratory examinations and other procedures employed, and the qualifications (educational background, training, and experience) of the personnel directing and supervising the laboratory and performing the laboratory examinations and other procedures, and (III) that contains such other information as the Secretary may reasonably require to determine compliance with this section, and (ii) the laboratory agrees to make records available and submit reports to the Secretary as the Secretary may require. (B) Changes If a laboratory makes changes in the examinations and other procedures performed by it only with respect to examinations and procedures which are described in paragraph (3), the laboratory shall report such changes to the Secretary not later than 6 months after the change has been put into effect. If a laboratory proposes to make changes in the examinations and procedures performed by it such that the laboratory will perform an examination or procedure not described in paragraph (3), the laboratory shall report such change to the Secretary before the change takes effect.
(C) Effect Subsections (f) and (g) of this section shall not apply to a laboratory to which has been issued a certificate of waiver.
(3) Examinations and procedures The examinations and procedures identified in paragraph (2) are laboratory examinations and procedures that have been approved by the Food and Drug Administration for home use or that, as determined by the Secretary, are simple laboratory examinations and procedures that have an insignificant risk of an erroneous result, including those that— (A)
47
employ methodologies that are so simple and accurate as to render the likelihood of erroneous results by the user negligible, or (B) the Secretary has determined pose no unreasonable risk of harm to the patient if performed incorrectly.
Relevant Nevada Revised Statutes: NRS 652.060 “Medical laboratory” defined. “Medical laboratory” means any facility for microbiological, serological, immunohematological (blood banking), cytological, histological, chemical, hematological, biophysical, toxicological, or other methods of examination of tissues, secretions or excretions of the human body. The term does not include a forensic laboratory operated by a law enforcement agency.
NRS 652.080 License required; term; renewal; inactive status; licensure of laboratory located outside state. 1. Except as otherwise provided in NRS 652.217 and 652.235, no person may operate, conduct, issue a report from or
maintain a medical laboratory without first obtaining a license to do so issued by the Division pursuant to the provisions of this chapter.
2. A license issued pursuant to the provisions of subsection 1 is valid for 24 months and is renewable biennially on orbefore the date of its expiration.
3. No license may be issued to a laboratory which does not have a laboratory director.4. A license may be placed in an inactive status upon the approval of the Division and the payment of current fees.5. The Division may require a laboratory that is located outside of this state to be licensed in accordance with the
provisions of this chapter before the laboratory may examine any specimens collected within this state if the Division determines that the licensure is necessary to protect the public health, safety and welfare of the residents of this state.
Relevant Nevada Administrative Code:
NAC 652.155 Applicability; exemptions from compliance. (NRS 439.200, 652.123, 652.125, 652.130) 1. Except as otherwise provided in this section and NRS 652.230, the provisions of this chapter:
(a) Apply to: (1) A laboratory which is licensed pursuant to NRS 652.080 and which provides services to the public; and
(2) A nonexempt laboratory which is registered pursuant to NAC 652.175; and (b) Do not apply to an exempt laboratory which is registered pursuant to NAC 652.175. 2. Except as otherwise provided in subsection 3, a person who is employed by a laboratory that is licensed by or
registered with the Division pursuant to chapter 652 of NRS may perform a test without complying with the provisions of this chapter if:
(a) The test has been classified as a waived test pursuant to 42 C.F.R. Part 493, Subpart A; and (b) The director, a designee of the director or a licensed physician at the laboratory at which the test is performed:
(1) Verifies that the person is competent to perform the test; (2) Ensures that the test is performed in accordance with instructions of the manufacturer of the test; and (3) Validates and verifies the manner in which the test is performed by using controls which ensure that the results of
the test will be accurate and reliable. 3. Except as otherwise provided in subsection 4, the provisions of subsection 2 do not relieve a person who performs a
test from the requirement to: (a) Comply with the policies and procedures that the director of the laboratory at which the test is performed has established pursuant to NAC 652.280; or
(b) Obtain certification pursuant to NAC 652.470 and pay the applicable fees as set forth in NAC 652.488. 4. An advanced practice registered nurse as defined in NRS 632.012 or a physician assistant as defined in NRS
630.015 who is employed by a laboratory that is licensed by or registered with the Division pursuant to chapter 652 of NRS and who has not received certification pursuant to NAC 652.470 may perform a test without complying with the provisions of this chapter if the test:
(a) Has been classified as a waived test pursuant to 42 C.F.R. Part 493, Subpart A; or (b) Is a provider-performed microscopy categorized pursuant to 42 C.F.R. § 493.19. 5. As used in this section, “licensed physician” includes:
(a) A physician licensed as a doctor of medicine pursuant to chapter 630 of NRS; (b) A physician licensed as a doctor of osteopathic medicine pursuant to chapter 633 of NRS;
48
(c) A chiropractic physician licensed pursuant to chapter 634 of NRS; and (d) A podiatric physician licensed pursuant to chapter 635 of NRS. (Added to NAC by Bd. of Health, eff. 1-4-88; A 10-22-93; R177-97, 1-30-98; R078-04, 8-5-2004; R176-07, 1-30-2008)
NAC 652.175 Laboratory operated by licensed physician: Registration as exempt or nonexempt laboratory. (NRS 439.200, 652.123, 652.130)
1. A laboratory operated by a licensed physician pursuant to NRS 652.235 must register with the Division as anexempt laboratory or a nonexempt laboratory.
2. A laboratory operated by a licensed physician pursuant to NRS 652.235 may register with the Division as an exemptlaboratory if: (a) The operating physician submits an application for registration as an exempt laboratory on a form provided by the Division;
(b) The operating physician pays the applicable fees set forth in NAC 652.488; (c) Each test performed by personnel other than the physician has been classified as a waived test pursuant to 42 C.F.R. Part 493, Subpart A; and
(d) Either: (1) The operating physician performs tests on his or her own patients and makes his or her own readings of the results of the tests; or (2) Any manipulation of a person for the collection of a specimen is made by an employee of the laboratory who is qualified pursuant to NRS 652.210.
NAC 652.488 Fees; assessed expenses. (NRS 439.150, 439.200, 652.100, 652.125) The following fees will be charged: …
5. Registration of laboratory operated pursuant to NRS 652.235 which is exemptpursuant to NAC 652.155
Initial..................................................................................................................... $500 Biennial renewal.................................................................................................... 300
Related Information and Studies of Interest • In 2014, staff using single patient use only penlet devices on multiple patients was found in one exempt medical
laboratory licensed by the Division. • In 2015, staff using single patient use only penlet devices on multiple patients was found in 5 different exempt
medical laboratories licensed by the Division.
Studies Multiple Outbreaks of Hepatitis B Virus Infection Related to Assisted Monitoring of Blood Glucose Among
Residents of Assisted Living Facilities – Virginia, 2009-2011:http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6119a3.htm?s_cid=mm6119a3_w
Survey Findings from Testing Sites Holding a Certificate of Waiver Under the Clinical Laboratory ImprovementAmendments of 1988 and Recommendations for Promoting Quality Testing:http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5413a1.htm
Sincerely,
Kyle Devine, M.S.W Chief Bureau of Health Care Quality and Compliance
Cc: Cody Phinney, Administrator Joe Pollock, Deputy Administrator
49
NAC 449.0072 “Treatment” defined. “Treatment” means any medication, drug, test or procedure conducted or administered to diagnose or remedy a physical or mental illness or condition.
NAC 449.197 Medical services may be provided only by medical professional. (NRS 449.0302) A member of the staff of a residential facility shall not provide medical services to a resident of the facility unless the member of the staff is a medical professional.
(Added to NAC by Bd. of Health by R003-97, eff. 10-30-97)
(Y 0080) Medical services may be provided only by medical professional. A member of the staff of a residential facility shall not provide medical services to a resident of the facility unless the member of the staff is a medical professional. Per NAC 449.169, a medical professional is a physician or a physician assistant, nurse practitioner, registered nurse (RN), physical therapist, occupational therapist, speech pathologist or practitioner or respiratory care who is trained and licensed in Nevada to perform medical procedures and care prescribed by a physician.*Notice Licensed Vocational Nurses (LVNs) are not in the list because Nevada doesnot license LVNs.Licensed Practical Nurses (LPNs) must work under the direct supervision of a Nevada Licensed RN to be considered a medical professional. At odds with NAC 449.2726
(No employees of the facility may assist residents with their blood glucose testing, unless the facility has obtained a medical laboratory license.) delete
(No employees of the facility may give a medication to a resident by injection or IV, including nurses or other medical professionals.) delete) from NAC REGULATIONS AND
INTERPRETIVE GUIDELINES FOR ASSISTED LIVING FACILITIES
NAC 449.2726 Residents having diabetes. (NRS 449.0302) 1. A person who has diabetes must not be admitted to a residential facility or be
permitted to remain as a resident of a residential facility unless: (a) The resident’s glucose testing is performed by:
(1) The resident himself or herself with out assistance; (2) A medical laboratory licensed pursuant to chapter 652 of NRS; and
(b) The resident’s medication is administered: (1) By the resident himself or herself with out assistance;
(2) By a medical professional, licensed practical nurse, or UAP who is: (I) Not employed by the residential facility; delete
(II) Acting within his or her authorized scope of practice and in accordance with all
50
applicable statutes and regulations; and (III) Trained to administer the medication; or
(3) If the conditions set forth in subsection 2 are satisfied, with the assistance of a caregiver
employed by the residential facility. 2. A caregiver employed by a residential facility may assist a resident in the
administration of the medication prescribed to the resident for his or her diabetes if:
(a) The resident’s physical and mental condition is stable and is following a predictable
course. (b) The amount of the medication prescribed to the resident for his or her
diabetes is at a maintenance level and does not require a daily assessment.
(c) A written plan of care by a physician or registered nurse has been established that: (1) Addresses possession and assistance in the administration of the medication for the
resident’s diabetes; and (2) Includes a plan, which has been prepared under the supervision of a registered nurse or
licensed pharmacist, for emergency intervention if an adverse condition results. (d) The medication prescribed to the resident for his or her diabetes is not administered by injection or intravenously. delete (e) The caregiver has successfully completed training and examination approved by the
Division regarding the administration of such medication. 3. The caregivers employed by a residential facility with a resident who has
diabetes shall ensure that:
(a) Sufficient amounts of medicines, equipment to perform tests, syringes, needles and other
supplies are maintained and stored in a secure place in the facility; (b) Syringes and needles are disposed of appropriately in a sharps container which is stored in a safe place; and (c) The caregivers responsible for the resident have received instruction in the recognition of
51
the symptoms of hypoglycemia and hyperglycemia by a medical professional who has been trained in the recognition of those symptoms. 4. The caregivers employed by a residential facility with a resident who has diabetesand requires a special diet shall provide variations in the types of meals served and make available food substitutions in order to allow the resident to consume meals as prescribed by the resident’s physician. The substitutions must conform with the recommendations for food exchanges contained in the Exchange Lists For Meal Planning, published by the American Diabetes Association, Incorporated, and the American Dietetic Association, which is hereby adopted by reference.
(Added to NAC by Bd. of Health by R003-97, eff. 10-30-97; A by R073-03, 1-22-2004)
NAC 449.2728 Residents requiring regular intramuscular, subcutaneous or intradermal injections. (NRS 449.0302)
1. A person who requires regular intramuscular, subcutaneous or intradermalinjections must not be admitted to a residential facility or be permitted to remain as a resident of the facility unless the injections are administered by:
(a) The resident; or (b) A medical professional, licensed practical nurse, or UAP acting within his or her authorized scope of practice and in accordance with all applicable statutes and regulations, who has been trained to administer those injections. 2.The caregivers employed by a residential facility with a resident who requires regular intramuscular, subcutaneous or intradermal injections shall ensure that:
(a) Sufficient amounts of medicines, equipment to perform tests, syringes, needles and other
supplies are maintained and stored in a secure place in the facility; and (b) Syringes and needles are disposed of appropriately in a sharps container
which is stored in a safe place.
(Added to NAC by Bd. of Health by R003-97, eff. 10-30-97; A by R073-03, 1-22-2004)
52
