[Federal Register Volume 60, Number 162 (Tuesday, August 22, 1995)]
[Notices]
[Pages 43602-43606]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-20692]



Health Care Financing Administration


Health Standards and Quality Bureau; Statement of Organization, 
Functions, and Delegations of Authority

    Part F of the Statement of Organization, Functions, and Delegations 
of Authority for the Department of Health and Human Services, Health 
Care Financing Administration (HCFA), (Federal Registers, Vol. 59, No. 
60, pp. 14659-14662, dated Tuesday, March 29, 1994, and Vol. 59, No. 
187, pp. 49406-49407, dated Wednesday, September 28, 1994) is amended 
to reflect changes in the organizational structure of the Health 
Standards and Quality Bureau (HSQB), Associate Administrator for 
Operations and Resource Management. The HSQB functional statement has 
not been changed; however, it is being republished to reflect the new 
administrative code.

    The specific amendments to part F are as follows:

     Section F.10.D.7. (Organization) is amended to read as 
follows:

    7. Health Standards and Quality Bureau (FLH)

    a. Survey Training Improvement Team (FLH1)

    b. Center for Information Systems (FLH2)

    c. Center for Operations Management (FLH3)

    d. Center for Laboratories (FLH4)
    e. Center for Hospital and Community Care (FLH5)
    f. Center for Long Term Care (FLH6)
    g. Center for Health Education and Promotion (FLH7)
    h. Center for Clinical Measurement and Improvement (FLH8)
     Section F.20.D.7. (Functions) is amended by deleting all 
functional statements in their entirety and replacing them with the 
following:

7. Health Standards and Quality Bureau (FLH)

     Provides leadership and overall programmatic direction for 
implementation and enforcement of health quality and safety standards 
for providers and suppliers of health care services and evaluates their 
impact on the utilization, quality and cost of health care services.
     Plans, develops, and establishes procedures and guidelines 
for administering and evaluating the nationwide Medicare and Medicaid 
survey and certification program.
     Monitors and validates the process for certifying that 
participating 

[[Page 43603]]
providers and suppliers are in compliance with established conditions 
and standards.
     Responsible for implementation and operation of 
professional review and other medical review programs.
     Administers a comprehensive system for assessment of 
individual professional and medical review organizations to determine 
compliance with program requirements and to document the effectiveness 
and impact of their activities.
     Establishes specifications for information and data 
reporting, collection and systems requirements for the survey and 
certification, professional review and other medical review activities.

a. Survey Training Improvement Team (FLH1)

     Responsible for the national surveyor training system.
     Directs and coordinates development, measurement and 
improvement of an integrated surveyor training program for HCFA 
regional office and State agency personnel on interpretation of 
regulations, surveyor protocols, procedures, techniques and 
certification issues.
     In conjunction with the specific program groups, insures 
that training materials and techniques are current and comprehensive 
and meet the needs of the HCFA regional office and State survey 
agencies.
     Evaluates program-related data and develops approaches for 
improvements to program management and operations.
     Evaluates customer service and systems performance data 
and develops approaches for improvement to the training programs.
     Serves as the focal point for the operation of all 
training including scheduling, logistical support, enrollment, etc. 
Coordinates, as necessary, with State agencies, regional offices, and 
other HCFA organizations, provider and supplier groups and other 
stakeholder groups who may require the program training.
     Communicates with professional groups, providers, and 
consumers to obtain information for the development and implementation 
of training initiatives.
     Serves as focal point for administering the certification 
of Continuing Education Units under the auspices of the International 
Association for Continuing Education and Training.

b. Center for Information Systems (FLH2)

     Manages day-to-day operations of the Bureau's data 
systems, including the Peer Review Organization, End-Stage Renal 
Disease Network, Health Care Quality Improvement Program, On-line 
Survey and Certification and Reporting and Clinical Laboratory 
Improvement Amendment activities.
     In conjunction with other Centers, designs, operates, 
documents, and maintains system applications used in the administration 
of Bureau programs, and/or provides technical assistance in 
implementing and maintaining program-related ADP systems.
     Designs, develops, and produces management reports to 
support effective and efficient operation of Bureau program systems.
     Provides expert technical support to the Bureau's 
information technology infrastructure; i.e., local area network end-
users, telecommunications, personal computers, etc.
     Develops and implements Bureau-wide information technology 
policies and procedures to support the Bureau's information technology 
objectives.
     Prepares specifications for programming the On-line Survey 
and Certification and Reporting system to include changes to 
interpretive guidelines, survey procedures and forms.
     Coordinates and monitors the transmission of data to and 
from proficiency testing organizations, accrediting programs, common 
working files and Medicaid State Agencies.
     Directs and monitors the Bureau's system security and LAN 
administration programs.
     Provides technical support in development and evaluation 
of ADP sections of contractor proposals; establishes procedures 
regarding systems operations and security.
     Maintains liaison with the Bureau of Data Management and 
Strategy, user groups, and workgroups within and outside of the Agency.
     Maintains liaison with internal and external customers and 
stakeholders to assess needs and satisfaction and to coordinate 
development of IRM strategies, budget, and implementation plans.
     Oversees systems support contracts.
     Participates in meetings with data standards 
organizations.
     Develops and/or evaluates program-related data, including 
approaches and recommendations for improvements to program management 
and operations.
     Evaluates customer service and system performance data and 
develops approaches for improvement.

c. Center for Operations Management (FLH3)

     Develops, coordinates, manages, and evaluates Bureau 
budget, procurement, contract, personnel management, correspondence, 
and administrative support systems.
     Develops and implements a Bureau staff development plan to 
ensure that the current and future training needs of all employees is 
addressed. Coordinates all internal and external training and staff 
development initiatives.
     Directs and manages the Bureau's management and 
administrative operations including the administrative budget and 
information collection budget. Coordinates Bureau responses to GAO and 
OIG reports.
     Manages the Bureau's correspondence, printing, manual 
issuance, and regulation management processes, including managing a 
bureau-wide automated library and other communication systems.
     Responds to program-related public and congressional 
inquiries and to freedom of information and privacy act requests 
related to bureau programs.
     Coordinates contract development, evaluation of contract 
proposals, and negotiation for Bureau contracts. Acts as project 
officer for contracts affecting multiple bureau components.
     In partnership with central and regional office staff, 
coordinates and oversees systems for assessing contractor performance.
     Administers the State grants process for Medicare and 
Medicaid State certification and CLIA program payments. Reviews 
periodic State agency expenditure reports and estimates to evaluate 
budget execution and determine allowability of costs.
     Prepares annual operating plans for States to assure 
sufficient resources are available for program operations on a 
quarterly basis.
     Develops justifications for program operating requirements 
for Medicare State certification, Medicaid State certification, Peer 
Review Organization, End-Stage Renal Disease Networks, CLIA, and 
support contracts.
     Establishes and maintains systems to control program funds 
and ensure that the Anti-Deficiency Act is not violated.
     Manages the Bureau procurement plan.
     Coordinates with HCFA central and regional office staff, 
state agencies, and the contractor community concerning contract and 
financial management and issues.
     Evaluates budget, contract, correspondence, and 
administrative 

[[Page 43604]]
data, including approaches and recommendations for improvements to 
their management and operations.
     Evaluates customer service and performance data and 
develops approaches for improvement.

d. Center for Laboratories (FLH4)

     Directs and coordinates development, measurement and 
improvement of program strategies that implement, enforce, and monitor 
the Clinical Laboratory Improvement Program. Scope of the program 
administered includes all clinical laboratories, conducting testing of 
human specimens for the purpose of diagnosis and/or treatment for 
residents of the United States.
     Prepares regulation specifications and evaluates comments.
     Serves as the HCFA liaison with the Public Health Service, 
Centers for Disease Control and Prevention (CDC) and the Food and Drug 
Administration, professional groups, standards setting organizations, 
and consumer and advocate groups, in the development and administration 
of laboratory standards.
     Prepares and implements interpretive guidelines, survey 
procedures, and forms.
     Develops, implements, and monitors quality indicators for 
the assessment of quality of laboratory services.
     Directs and coordinates development, implementation, and 
improvement of the CLIA User Fee Plan, including the administration of 
the collection process.
     Reviews and approves applications by States for 
``exemption'' and private accrediting bodies for deemed status.
     Develops and administers proficiency testing programs and 
monitors their performance.
     In conjunction with CDC, develops and administers the 
cytology proficiency testing program.
     Develops and/or evaluates program-related data, including 
approaches and recommendations for improvements to program management 
and operations.
     Evaluates customer service and system performance data and 
develops approaches for improvement.
     Contributes to/participates in budget development, 
direction, execution, and review.
     Provides support to and communicates with other HCFA and 
HHS components, and other governmental agencies such as the Veterans' 
Administration and the Department of Defense on program-related issues.
     Represents HCFA in presentations and meetings with public 
and professional organizations and CLIAC on matters involving 
laboratory standards, enforcement and performance. Provides public 
education as needed.
     Assists in the development of functional requirements and 
specifications required for the design of information systems and 
evaluates the effectiveness of information systems.
     Through communication with the regional offices, assists 
in the review of State agency performance, in these program areas, by 
developing appropriate assessment techniques and protocols.
     Assumes primary responsibility for assessing training 
needs, developing instructional material, and training State Agency and 
regional office staff in these program areas.
     Develops assessment techniques and protocols for the 
evaluation and improvement of established policy by State survey 
agencies, exempt States and accrediting organizations whose standards 
are deemed to meet Federal requirements for clinical laboratories.
     Manages mission specific contracts.

e. Center for Hospital and Community Care (FLH5)

     Directs and coordinates development, measurement and 
improvement of program strategies that implement, enforce, and monitor 
health quality and safety standards and other health care procedures 
for other than CLIA and Long Term Care providers and suppliers under 
Medicare and Medicaid, e.g., Hospitals, Psychiatric Hospitals, 
Ambulatory Surgical Centers, End-Stage Renal Disease Facilities, Home 
Health Agencies, etc.
     Develops and implements provider and supplier specific 
quality indicators and outcome measures in order to improve care 
provided to beneficiaries. Directs program efforts to assure the 
improvement of health care delivery in all settings.
     Develops and implements program strategies to improve the 
quality of health care delivery through the education of the 
beneficiary, public, providers, suppliers and other concerned parties 
about the standards and methods for delivery of quality health care; 
e.g., education about standards or care, publication of monographs, 
etc.
     Manages mission specific contracts.
     Develops and/or evaluates program-related data, including 
approaches and recommendations for improvements to program management 
and operations.
     Evaluates customer service and system performance data and 
develops approaches for improvement.
     Contributes to/participates in budget development, 
direction, execution, and review.
     Communicates with professional groups, consumer and 
advocate groups, and standards setting organizations and serves as the 
HCFA focal point for implementation of compliance, enforcement, health 
quality and safety procedures relative to these providers and 
suppliers.
     Prepares regulation specifications and evaluates comments.
     In partnership with the Bureau of Policy Development, 
reviews and analyzes existing health and safety standards to determine 
their initial and continued effectiveness and impact on utilization, 
quality, and cost of provider and supplier services.
     Prepares and implements interpretive guidelines, survey 
procedures, forms, and related sections of the Regional Office, State 
Medicaid and State Operations Manuals.
     Through communication with the regional offices, assists 
in the review of State agency performance, in these program areas, by 
developing appropriate assessment techniques and protocols.
     Assumes primary responsibility for assessing training 
needs, developing instructional material, and training State Agency and 
regional office staff in these program areas.
     Develops assessment techniques and protocols for the 
evaluation and improvement of established policy by State survey 
agencies and accrediting organizations whose standards are deemed to 
meet Federal requirements for the Medicare Programs.
     Serves as HCFA liaison with other government 
organizations, professional groups, and standards setting 
organizations, consumer and advocate groups and beneficiaries.
     Serves as the focal point for responding to regional 
office, State agency, Congressional, organizational, and individual 
inquiries related to the application of health and safety requirements 
and certification procedures for participating providers.
     Assists in the development of functional requirements and 
specifications required for the design of information systems and 
evaluates the effectiveness of information systems.

f. Center for Long Term Care (FLH6)

     Directs and coordinates development, measurement and 
improvement of program strategies that implement, enforce and monitor 
health quality and safety standards and other health care procedures 
for long-term care facilities under Medicare and 

[[Page 43605]]
Medicaid. These facilities include skilled nursing facilities/nursing 
facilities (including swing beds) and intermediate care facilities for 
the mentally retarded.
     Develops and implements provider specific quality 
indicators and outcome measures in order to improve care provided to 
beneficiaries. Directs program efforts to assure the improvement of 
health care delivery in all settings.
     Coordinates the development of the Resident Assessment 
Instrument that includes the Minimum Data Set (MDS).
     Develops and implements program strategies to improve the 
quality of health care delivery through the education of the 
beneficiary, public, providers, suppliers and other concerned parties 
about the standards and methods for delivery of quality health care.
     Develops and/or evaluates program-related data, including 
approaches and recommendations for improvements to program management 
and operations.
     Evaluates customer service and system performance data and 
develops approaches for improvement.
     Contributes to/participates in budget development, 
direction, execution, and review.
     Communicates with professional groups, consumer and 
advocate groups, and standards setting organizations and serves as the 
HCFA focal point for implementation of compliance, enforcement, health 
quality and safety procedures relative to these facilities.
     Prepares regulation specifications and evaluates comments.
     In partnership with the Bureau of Policy Development, 
reviews and analyzes existing standards to determine their initial and 
continued effectiveness and impact on utilization, quality, and cost of 
provider and supplier services.
     Manages mission specific contracts.
     Leads/oversees surveyor minimum qualifications testing 
program.
     In partnership with the Medicaid Bureau reviews and 
analyses existing standards for ICFs/MR to determine their continue 
effectiveness and prepares regulation specifications addressing changes 
to those requirements.
     Leads in the development and implementation of clinical 
data information for improving the coordination of care between health 
care settings.
     Prepares and implements interpretive guidelines, survey 
procedures, forms, and related sections of the Regional Office, State 
Medicaid and State Operations Manual.
     Through communication with the regional offices and the 
Medicaid Bureau, assists in the review of State agency performance, in 
these program areas, by developing appropriate assessment techniques 
and protocols.
     Assumes primary responsibility for assessing training 
needs, developing instructional material, and training State Agency and 
regional office staff in these program areas.
     Develops assessment techniques and protocols for the 
evaluation and improvement of State survey agencies and accrediting 
organizations whose standards are deemed to meet Federal requirements 
for the Medicare Programs.
     Serves as HCFA liaison with other government 
organizations, professional groups, and standards setting 
organizations, consumer and advocate groups and beneficiaries.
     Serves as the focal point for responding to regional 
office, State agency, Congressional, organizational, and individual 
inquiries related to the application of health and safety requirements 
and certification procedures for participating providers.
     Develops and coordinates procedures and guidelines for 
implementing and evaluating inspection of care under Medicaid.
     Through communications with the regional offices, develops 
appropriate assessment techniques and protocols to determine the 
effectiveness of Medicaid State agency performance in the area of 
utilization control.
     Provides the documentation and analyses necessary to 
initiate and support actions on disallowances, sanctions, and 
corrective action requirements, and on adjudication of appeals of 
disallowances and sanctions resulting from national quality control 
programs that determines the effectiveness of Medicaid State agency 
performance in the area of utilization control.
     Assists in the development of functional requirements and 
specifications required for the design of information systems and 
evaluates the effectiveness of information systems.

g. Center for Health Education and Promotion (FLH7)

     Undertakes communications and quality improvement 
activities to support the Medicare Peer Review and End-Stage Renal 
Disease programs, and HCFA's Consumer Information Strategy.
     Coordinates development and measurement of Health Care 
Quality Improvement Program (HCQIP) communication strategies and 
implementation approaches to promote behavior changes which result in 
improved health care quality.
     Serves as the HCQIP communications focal point with 
internal and external customers and stakeholders including beneficiary 
and provider groups, regional offices, Peer Review Organizations, ESRD 
Networks, and other contractors and State entities.
     Coordinates development of quality improvement 
communications and information dissemination guidelines and mechanisms 
and implementing instructions for HCQIP contractors.
     Plans, develops; and issues operating policy, 
specifications, procedural requirements, and other materials to 
implement, maintain, and oversee the HCQIP communication process.
     Manages mission specific contracts.
     Coordinates HCFA Consumer Information Strategy.
     Develops, implements and interprets data driven 
performance measurement and quality improvement efforts to assess/
improve quality of care provided to Medicare beneficiaries. Areas of 
concentration include prevention, consumer choice, and beneficiary 
education about health care options and healthy behavior.
     Coordinates and promotes participation of public and 
private sector individuals, and groups within HCFA in the development 
of performance measures and quality improvement strategies of mutual 
benefit and interest.
     Coordinates the preparation of manuals and other policy 
issuances required to meet the PRO and ESRD-related instructional and 
informational needs of providers, contractors, State agencies, regional 
offices, Peer Review Organizations, ESRD Network organizations, managed 
care organizations, Social Security Administration and other audiences 
directly involved in the administration of HCFA quality improvement/
management programs.
     In partnership with central and regional office staff, 
coordinates and oversees systems for assessing contractor performance.
     Maintains an ongoing review system, including clearance of 
instructions, to ensure clarity and consistency. Identifies 
instructional needs and initiates development of instructions by HCFA 
components.
     Maintains liaison with the regional offices, and other 
internal and external HCQIP customers and stakeholders to assess needs 
and satisfaction and to coordinate development of HCQIP program policy, 
regulations, legislative 

[[Page 43606]]
proposals and communication strategy and implementation.
     Develops, implements, and interprets program policy and 
guidance pertaining to the implementation of the HCQIP and other Peer 
Review Organizations and End-Stage Renal Disease program statutory and 
regulatory responsibilities.
     Monitors legislative, regulatory and operational 
developments related to the HCQIP, and coordinates development of 
related regulations and legislative proposals.
     Develops and/or evaluates program-related data, including 
approaches and recommendations for improvements to program management 
and operations.
     Evaluates local project related data and develops 
communication strategies and tools for improvements to program 
management and operations (e.g., benchmarking and best practices.
     Evaluates customer service and system performance data and 
develops approaches for improvement.
     Assists in the development of functional requirements and 
specifications required for the design of information systems and 
evaluates the effectiveness of information systems.

h. Center for Clinical Measurement and Improvement (FLH8)

     Undertakes quality monitoring and improvement activities, 
studies and projects to support the Medicare Peer Review and End-Stage 
Renal Disease programs.
     Coordinates the development and measurement of improvement 
strategies and implementation approaches for the Health Care Quality 
Improvement Program (HCQIP) including the development, assessment, 
compilation, preparation, and dissemination of information on the 
quality and efficiency of care.
     Coordinates development of quality improvement project 
guidelines and mechanisms and implementing instructions for HCQIP 
contractors. Areas of concentration for the project process include 
identifying opportunities for improvement, developing project plans, 
and evaluating the effectiveness, efficiency, and appropriateness of 
projects.
     In partnership with central and regional office staff, 
coordinates and oversees systems for assessing contractor performance.
     Develops, implements, interprets, and oversees data driven 
performance measurement and quality improvement efforts to assess/
improve quality of care provided to Medicare beneficiaries in all 
populations. Areas of concentration include clinically-oriented 
projects in the areas of managed care, acute care, ambulatory care, and 
ESRD.
     Collaborates with customers and stakeholders, public and 
private sector individuals, and groups in the development of 
performance measures and quality improvement strategies of mutual 
benefit and interest.
     Manages the Clinical Data Abstraction Centers and other 
mission-specific contracts.
     Manages the Medicare Quality Indicator System.
     Maintains liaison with the regional offices, and other 
internal and external HCQIP customers and stakeholders to assess needs 
and satisfaction and to coordinate development of HCQIP program policy, 
regulations, legislative proposals and quality measurement and 
improvement plans.
     Assists in the development of functional requirements and 
specifications required for the design of information systems and 
evaluates the effectiveness of information systems.
     Develops and implements quality monitoring and improvement 
studies/projects. Serves as content experts within the Bureau and 
partners with other Bureaus and regional office components to ensure 
full completion of all aspects of these studies/projects, including 
evaluation, follow-up, communication, marketing and intervention 
strategies.
     Develops, implements, and interprets program policy and 
guidance pertaining to the implementation of the HCQIP.
     Develops and/or evaluates program-related data, including 
approaches and recommendations for improvements to program management 
and operations.
     Evaluates customer service and system performance data and 
develops approaches for improvement.

    Dated: July 31, 1995.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
[FR Doc. 95-20692 Filed 8-21-95; 8:45 am]
BILLING CODE 4120-01-P