CENTERS FOR MEDICARE & MEDICAID SERVICES
Survey Management, Analysis, Reporting, and Technical Support
Office of Management and Budget
Paperwork Reduction Act Supporting
Information
Patient Safety Survey Under the 9th SOW:
Nursing Homes in Need (NHIN)
Submitted January 20, 2010
Revised November 9, 2010
Table of Contents
a.
Background ............................................................................................................................. 1
b.
Justification – NHIN Survey ................................................................................................... 3
1.
Need and Legal Basis...................................................................................................... 3
2.
Information Users............................................................................................................ 3
3.
Use of Information Technology ...................................................................................... 3
4.
Duplication of Information.............................................................................................. 3
5.
Small Businesses ............................................................................................................. 4
6.
Less Frequent Collection................................................................................................. 4
7.
Special Circumstances..................................................................................................... 4
8.
Federal Register/Outside Consultation............................................................................ 4
Table 1-1. Personnel Consultation .......................................................................................... 4
9.
Payment/Gifts to Respondents ........................................................................................ 5
10. Confidentiality................................................................................................................. 5
11. Sensitive Questions ......................................................................................................... 5
12. Burden Estimate (Hours and Wages) .............................................................................. 5
Table l-2. Estimated annual burden – Years 1 and 2 of the 9th SOW ..................................... 6
Table l-3. Estimated annual burden – Year 3 of the 9th SOW................................................. 6
13. Capital Costs ................................................................................................................... 6
14. Cost to the Federal Government...................................................................................... 6
15. Program/Burden Changes ............................................................................................... 6
16. Publication and Tabulation Duties .................................................................................. 7
17. Expiration Date ............................................................................................................... 7
18. Certification Statement.................................................................................................... 7
c.
Collection of Information Employing Statistical Methods ..................................................... 7
1.
Respondent Universe and Sampling ............................................................................... 7
2.
Procedures for Collecting Information............................................................................ 7
3.
Non-Response Follow-up................................................................................................ 8
4.
Tests of Procedures ......................................................................................................... 8
5.
Personnel Consultation.................................................................................................... 8
Table 1-4. Personnel Consultation .......................................................................................... 8
6.
Survey Materials ............................................................................................................. 9
Attachment 1. Office of Management and Budget Federal Register Notice ...............................1-1
Attachment 2. Nursing Homes in Need Survey ...........................................................................2-1
Survey Management, Analysis, Reporting, and Technical Support (SMART)
Office of Management and Budget (OMB) Paperwork Reduction Act
Supporting Information
Patient Safety Survey
Nursing Homes in Need (NHIN)
a.
Background
The Centers for Medicare & Medicaid Services (CMS) and the U.S. Department of
Health and Human Services (DHHS) are requesting OMB clearance for the Nursing
Homes in Need (NHIN) Survey. The NHIN is a component of the Patient Safety Theme
of the Quality Improvement Organization (QIO) Program’s 9th Scope of Work (SOW).
The statutory authority for this scope of work is found in Part B of Title XI of the Social
Security Act (the Act) as amended by the Peer Review Improvement Act of 1982. The
Act established the Utilization and Quality Control Peer Review Organization Program,
now known as the Quality Improvement Organization (QIO) Program.
The statutory mission of the QIO Program, as set forth in Section 1862(g) of the Act, is to
improve the effectiveness, efficiency, economy, and quality of services delivered to
Medicare beneficiaries.
Based on statutory language and the experience of CMS in administering the QIO
Program, CMS has identified the following requirements for the QIO Program:
•
•
•
Improve quality of care for beneficiaries;
Protect the integrity of the Medicare Trust Fund by ensuring that Medicare pays
only for services and goods that are reasonable and medically necessary and that
are provided in the most appropriate setting;
Protect beneficiaries by expeditiously addressing individual complaints, such as
beneficiary complaints; provider-based notice appeals; Emergency Medical
Treatment and Labor Act (EMTALA) violations; and other related statutory QIO
responsibilities.
As a general matter, Section 1862(g) of the Act mandates the Secretary enter into
contracts with QIOs for the purpose of determining that Medicare services are reasonable
and medically necessary, and for the purposes of promoting the effective, efficient, and
economical delivery of health care services, and of promoting the quality of services of
the type for which payment may be made under Medicare. CMS interprets the term
“promoting the quality of services” to involve more than QIOs reviewing care on a caseby-case basis, but as covering a broad range of proactive initiatives that will promote
higher quality. CMS has, for example, included in the SOW Themes in which the QIO
will provide technical assistance to Medicare-participating providers and practitioners in
order to help them improve the quality of the care they furnish to Medicare beneficiaries.
Additional authority for these activities appears in Section 1154(a)(8) of the Act, which
Page | 1
requires that QIOs perform such duties and functions and assume such responsibilities
and comply with such other requirements as may be required by the Medicare statute.
CMS regards these activities as appropriate if they will directly benefit Medicare
beneficiaries.
Section 1154(a)(10) of the Act specifically requires QIOs “coordinate activities,
including information exchanges, which are consistent with economical and efficient
operation of programs among appropriate public and private agencies or organizations,
including other public or private review organizations as may be appropriate.” CMS
regards this as specific authority for QIOs to coordinate and operate a broad range of
collaboratives and community activities among private and public entities, as long as the
predicted outcome will directly benefit the Medicare program. In addition, Section
1156(c) of the Act states that it is the duty of each QIO to use such authority or influence
as it may possess as a professional organization, and to enlist the support of any other
professional or governmental organization having influence or authority over healthcare
practitioners or entities furnishing services in its area, in assuring that each practitioner or
entity shall comply with all obligations imposed on them under Section 1156(a). Under
these obligations, providers and practitioners must assure that they will provide services
of a quality that meets professionally recognized standards of care.
The QIO Program aims to improve the quality of care and protect Medicare beneficiaries
through the following themes and sub-national requirements:
•
•
•
•
•
•
Beneficiary Protection;
Patient Safety;
Prevention;
Prevention: Disparities;
Care Transitions; and
Prevention: Chronic Kidney Disease (CKD).
The NHIN program exists under the Patient Safety Theme. The QIO in each state will
provide special technical assistance to a small number of nursing homes in need of
assistance with quality improvement efforts. This is a mandatory component of the QIO
SOW under Patient Safety.
This special technical assistance will be for the QIO to conduct a root cause analysis
(RCA) with one nursing home in its state per year (three over three years). Under this
component, it is expected that within the first quarter of each year of the 9th SOW
contract period, CMS will assign one nursing home to each QIO. The determination of
which nursing homes are eligible under this component will be made by CMS. Some of
these facilities may meet criteria for Special Focus Facilities (SFF). The intent of this
component is that each state QIO will work with three nursing homes over the three-year
contract period; these assignments are expected to be spaced out so that each state QIO
will get one nursing home assigned approximately every 12 months.
Page | 2
b.
Justification – NHIN Survey
1.
Need and Legal Basis
As mentioned in Section 1, the legal basis for this data collection is contained in
Section 1862(g) of the Act. The CMS designee, QualMed Surveys, LLC, (QMS)
of Rockville, MD, will administer the NHIN Survey to nursing homes to evaluate
nursing home satisfaction with the technical assistance process (NHIN Survey
data) and their perception of effectiveness of QIO technical assistance.
Note that the NHIN Survey is not intended to generate statistics about the nursing
home population. The NHIN Survey is being used as a tool for obtaining feedback
for performance improvement activities. The goal is to collect information from
the nursing homes participating in the QIO program to help CMS and the QIOs
improve the interventions.
2.
Information Users
The NHIN Survey constitutes a new information collection that will be used by
CMS to obtain information on nursing home satisfaction with technical assistance
strategies delivered as a component of the NHIN. The information collected
through this survey will allow CMS to help focus the NHIN task to maximize the
benefit to participating nursing homes.
3.
Use of Information Technology
The NHIN Survey will be administered via telephone by trained and experienced
interviewers. Responses will be entered into a pre-programmed ComputerAssisted Telephone Interviewing (CATI) interface.
The NHIN Survey is being administered via telephone for three main reasons.
First, the population size (53 nursing homes surveyed one time each during Years
1 and 2 of the 9th SOW and twice during Year 3) is not large enough to justify the
cost of programming a Web survey. Second, respondents to the NIHN Surveys
are to be the most knowledgeable respondent in each respective nursing home.
Telephone screening would be required to identify this person. Due to agency
turnover, this individual may not be the same person at each data collection
interval. Finally, data collections coordinated during the 8th SOW have found that
not all nursing homes use the internet for conducting business. To maximize
response rates, we will collect data via the telephone.
4.
Duplication of Information
This is a new data collection measuring the satisfaction with technical assistance
offered to nursing homes as a component of the NHIN program. The information
Page | 3
collected does not duplicate any other effort and the information cannot be
obtained from any other source.
5.
Small Businesses
While the administration of the NHIN Survey may have an impact on small
nursing homes, this impact will be minimal as the survey is expected to take no
more than 20 minutes to administer.
6.
Less Frequent Collection
The NHIN Survey will be used to evaluate nursing homes’ satisfaction with
technical assistance received as a component of the NHIN program. Given that
technical assistance is delivered to participating nursing homes based on
individual need, it has been deemed, in consultation with CMS that a bi-annual
data collection will serve to meet the needs of the NHIN participants in providing
feedback on technical assistance and the needs of CMS in refining their technical
assistance delivery.
QIOs will use the results as a process improvement tool to note areas for
improvement during the 9th SOW and inform the 10th SOW.
7.
Special Circumstances
There are no special circumstances.
8.
Federal Register/Outside Consultation
The 60-day Federal Register Notice was published on March 22, 2010. The
development of the NHIN Survey was conducted in consultation with CMS
personnel and QMS personnel. Please see Attachment 1 for a copy of the Federal
Register Notice.
Table 1-1. Personnel Consultation
Organization
Name
Contact Information
Centers for Medicare &
Medicaid Services
Robert Kambic
Phone: 410-786-1515
Email: Robert.Kambic@cms.hhs.gov
Centers for Medicare &
Medicaid Services
Francina Spencer
Phone: 410-786-4614
Email: Francina.Spencer@cms.hhs.gov
Centers for Medicare &
Medicaid Services
Maaden Eshete
Phone: 410-786-0045
Email: Maaden.Eshete@cms.hhs.gov
Centers for Medicare &
Medicaid Services
Jade Perdue
Phone: 410-786-5611
Email: Jade.Perdue@CMS.hhs.gov
Page | 4
9.
Organization
Name
Contact Information
QualMed Surveys, LLC
William Strang
Phone: 301-251-0300, x212
Email: Bill.Strang@amsaq.com
QualMed Surveys, LLC
David Bercham
Phone: 301-251-0300, x215
Email: David.Bercham@amsaq.com
QualMed Surveys, LLC
Vasudha Narayanan
Phone: 510-204-9920
Email: Narayav1@wesatat.com
QualMed Surveys, LLC
Stephanie Fry
Phone: 301-294-2872
Email: Frys1@westat.com
QualMed Surveys, LLC
Sherman Edwards
Phone: 301-294-3993
Email: ShermanEdwards@westat.com
Payment/Gifts to Respondents
There will be no payments or gifts to respondents.
10.
Confidentiality
All data collected via the NHIN Survey will be kept in physically secured storage
areas. All electronic data and related databases will be password protected and
maintained on secure servers.
The institutional review board (IRB) convened by Westat, Inc., of Rockville,
Maryland, has granted approval for this data collection under the auspices of U.S.
Department of Health and Human Services (DHHS) regulation 45 CFR § 46.
11.
Sensitive Questions
The proposed data collection contains no questions of a sensitive nature.
12.
Burden Estimate (Hours and Wages)
The total estimated annualized hour burden of this data collection is
approximately 17.5 hours based on 53 respondents (one respondent each from the
53 nursing homes participating in the NHIN program annually) being surveyed
annually during Years 1 and 2 of the 9th SOW. Average survey administration
time is estimated to be 20 minutes, or 0.33 burden hours. The respondents will be
interviewed over the telephone.
Page | 5
Table l-2. Estimated annual burden – Years 1 and 2 of the 9th SOW
Respondents by
Role/occupation
Estimated
Number of
Respondents
Estimated
Burden per
Respondent
(Hours)
Total Burden
Estimate (Hours)
Annualized
Cost Estimate
Administrators of
nursing homes
participating in the
NHIN program.
53
.33
17.5 annually
$1050 annually
(@$30/hr)
The total estimated annualized hour burden of this data collection is
approximately 35 hours based on 53 respondents (one respondent each from the
53 nursing homes participating in the NHIN program annually) being surveyed
bi-annually during Year 3 of the 9th SOW. Average survey administration time is
estimated to be 20 minutes, or 0.33 burden hours. The respondents will be
interviewed over the telephone.
Table l-3. Estimated annual burden – Year 3 of the 9th SOW
13.
Respondents by
Role/occupation
Estimated
Number of
Respondents
Estimated
Burden per
Respondent
(Hours)
Total Burden
Estimate (Hours)
Annualized
Cost Estimate
Administrators of
nursing homes
participating in the
NHIN program.
53
.33
17.5 hours per round
35 hours annually
$1050 per round
$2100 annually
(@$30/hr)
Capital Costs
There are no capital and startup nor operation and maintenance cost associated
with this data collection.
14.
Cost to the Federal Government
The annualized cost to the Federal Government is $90,598 for the contractor
(QMS) to conduct, analyze, and report on this data collection activity. This figure
includes the following costs as outlined in the budget submitted by QMS and
approved by CMS: direct labor, fringe, computer, telephone, overhead, and
general and administrative costs.
15.
Program/Burden Changes
This is a new data collection.
Page | 6
16.
Publication and Tabulation Duties
There are no publication or tabulation agreements in place other than CMSmandated reporting duties.
17.
Expiration Date
The expiration date and the PRA disclosure notice will be printed on all hard copy
versions of the survey. Survey respondents will be notified that the NHIN Survey
has been approved by OMB and will be provided with the expiration date of the
approval.
18.
Certification Statement
The certification is included in this submission. No exceptions apply.
c.
Collection of Information Employing Statistical Methods
1.
Respondent Universe and Sampling
The NHIN Survey will be a census of 53 nursing homes (one respondent at each
nursing home) working with their respective QIOs. The survey will be conducted
one time for each of the nursing homes assisted in the first two years under the 9th
SOW and twice with nursing homes assisted in the third year yielding a total of
approximately 159 nursing homes. The survey will elicit satisfaction data only
and will not involve sampling. Nursing home contact information will be
provided by the QIOs. The response rate for the NHIN Survey is expected to be
80%.
2.
Procedures for Collecting Information
The NHIN Survey will be a census administered to administrators of the 53
nursing homes taking part in the NHIN program during each year of the 9th SOW.
The data collection protocol for the NHIN Survey will be a telephone- based
survey with telephone followup reminders to maximize the response rate. QIOs
are present in 53 states and territories. Through the NHIN program, QIOs are
working with one nursing home per year in their state/territory. The NHIN survey
respondent will be the person who interacts with the QIO most frequently,
typically the nursing home administrator or a member of the senior management
staff.
Sample file. CMS will receive a list containing respondent contact information.
Data Collection. Data collection will begin with telephone calls to the
respondents who will be asked if they would like to take the survey at the present
time of the phone call or if they would like to schedule an appointment at a later
Page | 7
time. CMS contact information will be given to the respondents should they have
any questions regarding NHIN Survey itself. The respondents will also be
provided with the OMB expiration date for the NHIN Survey.
3.
Non-Response Follow-up
One week after the nursing home administrator receives the initial phone call,
CMS will make a reminder phone call. A notice will also be sent to the Quality
Improvement Coordinator at the respective QIO informing him/her that the
nursing home administrator has not responded to the initial phone call. The
Quality Improvement Coordinator will then remind the nursing home
administrator about the survey. During the remaining data collection period, CMS
will conduct followup telephone calls using experienced and well-trained
telephone interviewers. The Quality Improvement Coordinator at the respective
QIOs will receive a notice every time a followup phone call is made.
4.
Tests of Procedures
No tests of procedures will be carried out.
5.
Personnel Consultation
Individuals contained in Table 1-4 consulted on the development of the NHIN
Survey and administration procedures.
Table 1-4. Personnel Consultation
Organization
Name
Contact Information
Centers for Medicare &
Medicaid Services
Robert Kambic
Phone: 410-786-1515
Email: Robert.Kambic@cms.hhs.gov
Centers for Medicare &
Medicaid Services
Francina Spencer
Phone: 410-786-4614
Email: Francina.Spencer@cms.hhs.gov
Centers for Medicare &
Medicaid Services
Maaden Eshete
Phone: 410-786-0045
Email: Maaden.Eshete@cms.hhs.gov
Centers for Medicare &
Medicaid Services
Jade Perdue
Phone: 410-786-5611
Email: Jade.Perdue@CMS.hhs.gov
QualMed Surveys, LLC
William Strang
Phone: 301-251-0300, x212
Email: Bill.Strang@amsaq.com
QualMed Surveys, LLC
David Bercham
Phone: 301-251-0300, x215
Email: David.Bercham@amsaq.com
QualMed Surveys, LLC
Vasudha Narayanan
Phone: 510-204-9920
Email: Narayav1@wesatat.com
QualMed Surveys, LLC
Stephanie Fry
Phone: 301-294-2872
Email: Frys1@westat.com
Page | 8
Organization
QualMed Surveys, LLC
6.
Name
Contact Information
Sherman Edwards
Phone: 301-294-3993
Email: ShermanEdwards@westat.com
Survey Materials
Please see Attachment 2 for a copy of the Patient Safety NHIN Survey.
Since there are no sensitive data being collected through the NHIN survey and
there is little to no risk to respondents, CMS has requested and received a waver
of formal informed consent from the IRB of record for the study. Passive consent
will be implied as respondents choose to participate in the voluntary telephone
study. Respondents are informed that they may skip any questions they do not
wish to answer and they may terminate the interview at any time.
The NHIN Survey will include questions to determine if the QIO has conducted a
root cause analysis and developed an action plan. These will be followed by
questions about their satisfaction with the QIO and their perceived value of the
QIO’s assistance. The NHIN Survey will address the following:
•
•
•
•
•
•
Background information;
Current work;
Satisfaction with QIOs;
Value of QIO assistance;
Sources of information; and
Respondent comments.
All survey protocol and correspondence will be translated into Spanish and bilingual telephone interviewers will be used as needed.
Page | 9
CENTERS FOR MEDICARE & MEDICAID SERVICES
Survey Management, Analysis, Reporting, and Technical Support
Attachment 1
Office of Management and Budget
Federal Register Notice
Page | 1-1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: <#########>]
Agency Information Collection Activities: Proposed Collection; Comment Request
AGENCY: Centers for Medicare & Medicaid Services
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of
1995, the Centers for Medicare & Medicaid Services (CMS) is publishing the following
summary of proposed collections for public comment. Interested persons are invited to send
comments regarding this burden estimate or any other aspect of this collection of information,
including any of the following subjects: (1) The necessity and utility of the proposed information
collection for the proper performance of the agency's functions; (2) the accuracy of the estimated
burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected;
and (4) the use of automated collection techniques or other forms of information technology to
minimize the information collection burden.
1.
Type of Information Collection Request: New
Title of Information Collection: Survey Management, Analysis, Reporting and Technical
Support (SMART) Patient Safety Nursing Homes in Need (NHIN) Survey.
Use: The Centers for Medicare & Medicaid Services (CMS) and the U.S. Department of
Health and Human Services (DHHS) are requesting OMB clearance for the Nursing
Homes in Need (NHIN) Survey. The NHIN is a component of the Patient Safety Theme
of the Quality Improvement Organization (QIO) Program’s 9th Scope of Work (SOW).
The statutory authority for this scope of work is found in Part B of Title XI of the Social
Security Act (the Act) as amended by the Peer Review Improvement Act of 1982. The
Act established the Utilization and Quality Control Peer Review Organization Program,
now known as the Quality Improvement Organization (QIO) Program.
The QIO in each state will provide special technical assistance to a small number of
nursing homes in need of assistance with quality improvement efforts. This special
technical assistance will be for the QIO to conduct a root cause analysis (RCA) with one
nursing home in its state per year (three over three years). Under this component, it is
expected that within the first quarter of the contract period, CMS will assign one nursing
home to each QIO. The determination of which nursing homes are eligible under this
component will be made by CMS. Some of these facilities may meet criteria for Special
Focus Facilities (SFF). The intent of this component is that each state QIO will work with
three nursing homes over the three-year contract period; these assignments are expected
to be spaced out so that each state QIO will get one nursing home assigned approximately
every 12 months.
Page | 1-2
The NHIN Survey is a new information collection to be used by CMS to obtain
information on nursing home satisfaction with technical assistance strategies delivered as
a component of the NHIN. The NHIN Survey will be a census of 53 nursing homes
working with their respective QIOs. The survey will be conducted one time for each of
the nursing homes assisted in the first two years under the 9th SOW and it will be
conducted twice with nursing homes assisted in the third year. The information collected
through this survey will allow CMS to help focus the NHIN task to maximize the benefit
to participating nursing homes. The NHIN Survey will be administered via telephone by
trained and experienced interviewers. Responses will be entered into a pre-programmed
Computer-Assisted Telephone Interviewing (CATI) interface.
The NHIN Survey will include questions to determine if the QIO has conducted a root
cause analysis and developed an action plan. These will be followed by questions about
their satisfaction with the QIO and their perceived value of the QIO’s assistance. The
NHIN Survey will address the following:
•
•
•
•
•
•
Background information;
Current work – information and assessment;
Satisfaction with QIOs;
Value of QIO assistance;
Sources of information; and
Respondent comments.
All survey protocol and correspondence will be translated into Spanish and bi-lingual
telephone interviewers will be used as needed.
Form Number: <##########>
Frequency: 4 times in 3 years
Affected Public: Businesses and other for-profit and not-for-profit institutions.
Number of Respondents: 53
Total Annual Respondents: 53
Total Annual Hours (years 1 and 2 of the 9th SOW): 17.5 hours
Total Annual Hours (year 3 of the 9th SOW): 35 hours
To obtain copies of the supporting statement and any related forms for the proposed paperwork
collections referenced above, access CMS' Web Site at
http://www.cms.hhs.gov/PaperworkReductionActof1995, or E- mail your request, including your
address, phone number, OMB number, and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the Reports Clearance Office at (410) 786-1326.
Page | 1-3
In commenting on the proposed information collections please reference the document identifier
or OMB control number. To be assured consideration, comments and recommendations must be
submitted in one of the following ways by :
1.
Electronically. You may submit your comments electronically to
http://www.regulations.gov. Follow the instructions for ``Comment or Submission'' or
``More Search Options'' to find the information collection document(s) accepting
comments.
2.
By regular mail. You may mail written comments to the following address: CMS, Office
of Strategic Operations and Regulatory Affairs, Division of Regulations Development,
Attention: Document Identifier/OMB Control Number, Room C4-26-05, 7500 Security
Boulevard, Baltimore, Maryland 21244-1850.
Dated:
[FR Doc. <##-#####>, Filed ,
File Type
application/pdf
File Title
Microsoft Word - PRA - PATIENT SAFETY REVISED 11-9-10.doc