QUALITY ASSURANCE PROCESS



Purpose:

The purpose of the Annual Quality Assurance Review by the Developmental Disabilities Program (DDP) is to serve as a comprehensive review of contract monitoring, licensing, accreditation, and other collateral / external sources.

Quality Assurance Specialists endeavor to maintain an ongoing presence at provider organizations and to ensure the Waiver Assurances of Health / Safety, Design and Implementation of Individual Plans, Services Provided by Qualified Providers, and Fiscal Accountability.

Through the course of ongoing service delivery, Quality Improvement Specialists work with provider organizations and Individual Planning Teams to ensure quality, adherence to administrative rules, federal regulations, waiver assurances, and compliance with a provider organization’s contract with the Department.

Introduction and History:

In July 2002, the Developmental Disabilities Program implemented a new Quality Assurance Review process. The process was updated from feedback received during the first year. This document reflects the process for use beginning July 1, 2003.

This document reflects procedures for Quality Improvement Specialists to use in the initial, annual, and ongoing quality assurance reviews of Qualified Providers providing services to adults with developmental disabilities, and to children living in community homes. These procedures were developed from the CMS Waiver Review Protocol, the State of Montana Administrative Rules, the Code of Federal Regulations and the Department contract(s) with Qualified Providers.

Initial Quality Assurance Review of Qualified Providers:

Once standards for Qualified Provider status are met, service contracts/ service agreements can be initiated (see Standards and Procedures for Qualified Providers). Within nine months of the initiation of providing services, a full Quality Assurance review will be completed and an annual review conducted thereafter.

Annual Quality Assurance Review of Qualified Providers:

Qualified Providers will have a full Quality Assurance review no less than once per year. In order to allow for possible scheduling conflicts (i.e., another Quality Assurance Review, or extenuating circumstance of the provider), the timeline for an annual visit may be extended 2 months (past the one-year) in order to complete a Quality Assurance review. To extend the timeline, the provider organization must make a request in writing to the Regional Office, justifying the need for an extension. If a Quality Assurance Team cannot complete the necessary QA review within the annual time frame, the Quality Improvement Specialist will notify the provider organization, in writing, of the extension of dates.

These visits are conducted at the service site. The purpose of the visit is to determine whether the provider organization is meeting state and federal regulatory requirements, providing quality services, and providing services as specified in Individual Plans. Aspects of the provider organization and services are reviewed using specific protocols. Regulatory compliance in all areas is required.

Quality Assurance Observation Sheets (QAOS):

Quality Assurance Observations Sheets are the primary documentation to record exemplary practices and indicate deficiencies (See Appendix A). Quality Assurance Observation Sheets are used during routine visits and for documentation review during Quality Assurance Reviews.

Use of the QAOS for Annual Quality Assurance Reviews:

Quality Assurance Observation Sheets record what was observed, what Administrative Rule, Policy, or Contract requirement is surpassed or deficient, and the effect on the consumer/provider organization. For exemplary practices, no response to DDP is required. For deficiencies, a response date of no longer than 10 calendar days from the date of receipt of the Quality Assurance Observation Sheet is required.

Procedures for Quality Assurance Review:

Quality Assurance Reviews utilize three techniques, which are incorporated throughout the review process and throughout the year: observation, interview and documentation review. All provider organizations are visited and reviewed within their initial nine months of service provision, and annually thereafter.

Quality Assurance Teams may be comprised of one or more members. The lead member is the Quality Improvement Specialist assigned to work with the provider organization. The other member(s) could include a second Quality Improvement Specialist, a Regional Manager, the Quality Assurance Specialist or Waiver Training Specialist from the central office, a consumer/advocate, or other professional. The size and composition of the team will be at the discretion of the Department.

For organizations that provide services across regions/large geographic areas, or where multiple QIS’s are assigned to specific services/service areas, the Quality Assurance Review will be coordinated among the QIS’s and be completed during the same time frame. For provider organizations operating services in different regions, with local administrators, the Quality Assurance Reviews will be completed as separate reviews.

Consumer Sample:

Except for Community Supports Services (where 100% of all consumer surveys completed by the Case Managers are reviewed by the QIS), a sample of 10% of service recipients (no less than 5) is selected for review (Appendix F). The sample should include one person from each service category and geographical area (group home, congregate residential, supported living, community employment, facility-based employment, facility-based day, senior day, recreation, etc.). The QIS will review the Consumer Survey conducted by the Case Manager during the annual IP process. Review of Individual Plans and the implementation of these should be conducted throughout the year. If there have been issues noted during the year, Quality Assurance Observation Sheets should have been submitted with follow-up from the provider organization. At the annual quality assurance visit, a small sample of Individual Plan reviews should be completed and reviewed to ensure the issues noted throughout the year are not systemic or pervasive.

For Community Supports Services at least five individuals will be reviewed. If the agency serves less than five in this service, then all individuals will be reviewed. Of the five, three individuals reviewed must be Title XIX Waiver funded.

The QA process is defined as (see Appendices for forms):

I. Data collected throughout the year including but not limited to:

• Assessment of incident reporting trends, medication errors, Adult Protective Services issues, Client Rights issues, IP issues, etc.;

• Completed Quality Assurance Observation Sheets (QAOS) from the year regarding exemplary practices or follow up from previously recorded problems;

• A consumer sample selected as described above (Appendix F); and

• Review of consumer surveys conducted by Case Managers during the annual IP process.

II. Prior to Review:

• Notification is made to the Executive Director, or designee, at the provider organization two weeks prior to the annual Quality Assurance (on-site) review.

III. During the Review:

• Verify trends and administrative standards (Form A);

• Verify service site standards (Form B); and

• Interview one staff from each service area using the staff interview/questionnaire.

IV. Exit Interview/Conference:

• Review commendations and findings (Quality Assurance Observation Sheets) with staff at the provider organization. Within one week copies of Quality Assurance Observation Sheets are given to the provider organization and timelines for those requiring a response to Quality Improvement Specialist are jointly negotiated (not to exceed 10 calendar days).

• Within one month of the on-site review, the Quality Improvement Specialist will complete the Annual Report Summary to include the information as outlined in the Format, page 10. The Summary is sent to the President of the Board of Directors, Executive Director, Regional Manager, Community Services Bureau Chief, and the Quality Assurance Specialist.

The QIS does not copy Forms A or B to the provider organization. Quality Assurance Observation Sheets are numbered during the review for ease in reference in the summary letter. In filling out Forms A and B, the QIS places a “+” in the box for items which are met. Identifying numbers should appear on Forms A & B in boxes for exemplary practice or deficient items. These numbers should correspond to the identifying numbers on the Quality Assurance Observation Sheets.

Trends in exemplary practices and deficiencies are easily identifiable vertically across Forms A & B. For a trend, it is not necessary to write separate Quality Assurance Observation Sheets. One QAOS can be used to summarize the commendation/deficiency referenced; in this case be sure to include specific site or initials of consumer reviewed.

For exemplary practices and deficiencies identified throughout the year, the Quality Improvement Specialist will correspond immediately with the agency using the Quality Assurance Observation Sheets. The on-site review period should be used to increase the sample size to verify that corrections throughout the year were generalized to the larger population served.

Response to Issues/Deficiencies noted during the Quality Assurance Review :

• The Quality Assurance Observation Sheets are issued to the Executive Director, or designee, of the provider organization.

• The provider responds in writing by the negotiated Response Due Date to the Quality Improvement Specialist at the regional or satellite DDP office. The response documents the issue and what action was taken to address prevention of recurrence of the problem.

• The Quality Improvement Specialist accepts the action taken or requests further review by the provider organization. If further review is requested, the Quality Improvement Specialist documents further concerns regarding the follow-up and returns the Quality Assurance Observation Sheet to the provider organization with a new timeline for response.

• Once the responses are accepted, the Quality Improvement Specialist documents that it as accepted, copies the form (and any supporting documentation) to the provider organization for their files, and maintains a copy at the regional office with the contract file. Completed Quality Assurance Observation Sheets documenting Imminent Danger or Systemic/Pervasive Deficiencies additional copies may be routed to: the Quality Assurance Specialist, the Community Services Bureau Chief, and/or the DDP Program Director. The Quality Improvement Specialist may visit a site to ensure the response has been implemented/completed.

Staff Interview:

Staff interviews are conducted during the on-site review. A 10% sample (no less than 5) of direct service staff should be interviewed using the staff survey (Appendix I). Staff who are selected for interview are selected based on those consumers selected for review to ensure that staff interviewed correlate to the consumers’ particular services. Attempts should be made to interview direct service staff from a variety of shifts and with differing tenure at the site/agency. The staff survey questions cover the following areas: Abuse/Neglect Reporting, Client Rights, Behavior Support Plans and Protocols, Orientation Training, Abuse Prevention, Supervising Medications, Behavior Interactions, Individual Plans, DDCPT/CBT (for intensive services), and Incident Reporting.

There are multiple questions under each heading. If a staff is unable to answer up to two probe questions, that area will be considered unmet for that staff member. Trends will be identified if multiple staff miss questions for the same topic area, or multiple staff miss various topic areas.

During the review of administrative records, the Quality Improvement Specialist should work with the Executive Director or Human Resources Manager to select the random sample of staff for staff interviews and review of training attendance documentation. Verification of Criminal Background checks will be completed for a sample, no less than 5, of individuals hired since the last Quality Assurance Review.

Expansion of the Review Process

If, during the course of a visit, the QA Team finds a situation where imminent danger or systemic / pervasive deficiencies are identified, a Quality Assurance Observation Sheet is issued to the provider organization immediately. The QA Team must review the data and trends from the consumer surveys and IP reviews from the year to determine whether the sample size will be expanded to encompass additional consumers from the provider organization.

Other Visits:

At the discretion of DDP, announced or unannounced visits to any provider organization may occur as specified in the “Access to Premises” section of the Department’s contract. These visits may occur for a variety of reasons including: the provision of training and technical assistance to provider organization staff; to inspect, monitor or otherwise evaluate; and/or in response to complaints received from consumers, family, staff, or the general public. Prior approval for visits to individuals’ community work sites or homes may be necessary. All visits should be conducted with sensitivity and attempts to keep disruption of daily routines or work schedules to a minimum.

Use of the QAOS as a tool for ongoing Quality Assurance:

Quality Assurance Observation Sheets record what was observed, what Administrative Rule, Policy, or Contract requirement is surpassed or deficient, and the effect on the consumer/provider organization. For exemplary practices, no response to DDP is required. For deficiencies, a response date no longer than 10 calendar days from the date of receipt of the Quality Assurance Observation Sheet is required.

Response to Issues/Deficiencies:

• A Quality Assurance Observation Sheet is issued to the Executive Director, or designee, of the provider organization.

• The provider responds in writing by the Response Due Date to the Quality Improvement Specialist at the regional or satellite DDP office. The response documents the issue and what action was taken to address prevention of recurrence of the problem.

• The Quality Improvement Specialist accepts the action taken or requests further review by the provider organization. If further review is requested, the Quality Improvement Specialist documents further concerns regarding the follow-up and returns the Quality Assurance Observation Sheet to the provider organization with a new timeline for response.

• Once the response to a Quality Assurance Observation Sheet is accepted, the Quality Improvement Specialist documents it has been accepted, copies the form (and any supporting documentation) to the provider organization for their files, and maintains a copy at the regional office with the contract file. The Quality Improvement Specialist may visit a site to ensure the response has been implemented/completed. Completed Quality Assurance Observation Sheets documenting Imminent Danger or Systemic/Pervasive Deficiencies additional copies may be routed to: the Quality Assurance Specialist, the Community Services Bureau Chief, and/or the DDP Program Director. The Quality Improvement Specialist may visit a site to ensure the response has been implemented/completed.

Imminent Danger:

Imminent danger, or a serious and imminent threat, is defined as any situation in which it is determined that conditions or practices exist which, if allowed to continue, have a high probability of causing serious harm. Imminent danger need not result in actual harm to a person if the threat of probable harm is perceived as being serious or significant. Below are guidelines clarifying when a situation is to be considered one of imminent danger:

• The threat could result in severe temporary or permanent injury, disability, or death and it is likely to occur in the very near future.

• Mental abuse can be as damaging as physical abuse and may constitute imminent danger.

• Only one individual needs to be jeopardized; the entire or large

percentage of the population does not have to be threatened or injured.

• The situation is severe enough that it outweighs potential concerns of a move to another facility.

• Elimination of the danger is the only response to the problem.

The identification of a serious and immediate threat always results in the issuance of a Quality Assurance Observation Sheet (QAOS). The danger must be immediately eliminated and the provider organization’s response must ensure that the situation will be addressed systemically in order to prevent recurrence. The provider organization’s response must include time lines for completion and the name of the staff member(s) responsible for completion.

Systemic or Pervasive Deficiencies:

Systemic and/or pervasive deficiencies are those deficiencies that are found to occur throughout a provider organization or service area, which affect a provider organization or service overall. Deficiencies may be identified in the provision of services, the promotion of consumer-valued outcomes, and the provision of required safeguarding. They are determined to be systemic/ pervasive and have significant negative consequences for an individual and/or individuals receiving services.

Examples of systemic/pervasive deficiencies include:

• Individuals do not attend or rarely attend meetings to develop their program plans nor are other provisions made for them to participate in program development.

• Staff interviews and reviews of records confirm that habilitation plans are only sporadically implemented for the majority of people in the sample.

• A review of incident reports shows that the follow-up of incidents is almost always inadequate. Either reports are not timely or thorough or the incident reporting process does not comply with state and/or provider organization requirements.

• Timely follow-up of referrals for medical appointments is found to be lacking for many individuals in the sample.

• Individuals’ opportunities to participate in the life of the community, including use of stores, banks, libraries, parks, restaurants, movies, etc., are rare, non-existent or unnecessarily restricted. The service supports fail to teach individuals needed skills to participate in community life.

• Individuals have almost no opportunity to make choices about any aspect of their lives/treatment. They do not have the opportunity to participate productively in the life of the home and/or practice skills learned.

• Failure of a provider organization to follow or implement internal policies and state administrative rules and codes regarding reporting abuse, neglect or exploitation.

• A facility is observed to be insect or rodent infested.

• A staff member documented as having physically abused service recipients continues to work with them, with no corrective measures taken.

• A consumer exhibits a pattern of behaviors (assaults, SIB) dangerous to himself and/or others. There is no plan in place to address the behaviors and staff is unclear as to how to work with the person.

Generally, if a review reveals a systemic/pervasive deficiency, it is necessary to investigate further to confirm the finding. This will usually mean expanding the sample size to determine whether the identified issues apply beyond the original sample. It is not necessary that there be many issues identified at a provider organization for a Corrective Action Plan to be requested. It is not necessary that a Quality Assurance Review be in progress for a Quality Improvement Specialist to submit a Quality Assurance Observation Sheet that requires a Corrective Action Plan.

Levels of Corrective Action:

Level One: Request for Corrective Action Plan

This is the first level of action for providers of DD services that have been found to have serious/systemic deficiencies. The Quality Assurance Observation Sheets (QAOS) summarize the issues of deficiency including reference to administrative rule or contract and formally request that a Corrective Action Plan (CAP) be completed. The Quality Assurance Observation Sheets requesting corrective action are sent via mail to the Executive Director and the President of the Board of Directors. Corrective Action Plans (CAP’s) are developed by the provider organization and negotiated with the regional office. A working draft of a Corrective Action Plan must be initially negotiated within 10 calendar days of the original request.

Minimally, Corrective Action Plans must include a description of how the immediacy of the issue was addressed, how the provider organization plans to address the issue systemically, time lines for completion, and the name of the staff member(s) at the provider organization who are responsible for completion. The Corrective Action Plan is verified and followed up by the assigned Quality Improvement Specialist, other members of the original survey team and/or the Regional Manager. When a Corrective Action Plan is requested, the Quality Improvement Specialist may request that a Caregiving Assessment be completed as a part of the action plan.

Upon successful completion of the Corrective Action Plan, the Quality Improvement Specialist notifies the provider organization, in writing, of the completion of the plan. Failure to comply or cooperate with development or completion of a Corrective Action Plan may lead to more significant adverse actions. Those actions may include, but are not limited to: a Notification of Deficiency letter, a moratorium on any new placements, or fiscal consequences. It is possible for a provider organization to have their community home licensed or to achieve successful accreditation status while working under a Corrective Action Plan.

Level Two: Notification of Deficiency

This is a more serious action. Based on the survey, the provider organization has such serious deficiencies that a Corrective Action Plan must be developed and implemented immediately. Serious and systemic deficiencies are identified on Quality Assurance Observation Sheets and summarized in a Notification of Deficiency letter. The letter will require that a Corrective Action Plan be developed and returned within 10 calendar days of the receipt of the Notification of Deficiency letter.

The Notification of Deficiency letter is sent via certified mail to the Executive Director and all members of the Board of Directors. The Corrective Action Plan must indicate a completion date within 45 calendar days of the receipt of the Notification of Deficiency. Re-visits will occur every 15 days to ensure implementation and success of the Corrective Action Plan.

A Notification of Deficiency letter may be written in response to the failure to submit or successfully implement a Corrective Action Plan. Under this circumstance, a more serious adverse action could follow. That action may be fiscal consequences, or notification of termination of the contract within the 30-day time frame specified by the contract.

FORMAT FOR ALL QUALITY ASSURANCE REVIEWS

Scope of Review

General Areas

A. ADMINISTRATIVE

Significant Events from the agency

Policies & administrative (DDP) directives

Licensing

Accreditation

Agency internal communication systems

Fiscal (results of A133 audit, referrals to Medicaid Fraud or QAD review, client funds & record keeping).

Appendix I

Specific Services Reviewed

A. Residential

Accomplishments

Programmatic Deficiencies

Corrections to Deficiencies

i. HEALTH AND SAFETY

Vehicles

Consumers

Medication Safety (psychotropics, training, programs, prns, certification,errors)

Sites (appearance, evacuation drills, SL apartments, emergency back-up, etc.)

ii. SERVICE PLANNING AND DELIVERY

Individual Planning (Assessment, implementation, monitoring)

Leisure / Recreation

Client Rights (restrictions/promotion of rights, grievance procedure)

Medical / health care

Emotionally Responsible Care Giving

Consumer Surveys

Agency’s consumer satisfaction surveys (do you? what info? what do you do to address?) (accreditation requirement)

iii. STAFFING

Screening/Hiring

Orientation/training

Ratios

Staff Surveys

iv. INCIDENT MANAGEMENT

APS

Incident Reporting

B. Work/Day/Community Employment

Accomplishments

Programmatic Deficiencies

Corrections to Deficiencies

i. HEALTH AND SAFETY

Vehicles

Consumers

Medication Safety (psychotropics, training, programs, prns, certification, errors)

Sites (appearance, evacuation drills, SL apartments, emergency back-up, etc.)

ii. SERVICE PLANNING AND DELIVERY

Individual Planning (Assessment, implementation, monitoring)

Leisure / Recreation

Client Rights (restrictions/promotion of rights, grievance procedure)

Medical / health care

Emotionally Responsible Care Giving

Consumer Surveys

Agency’s consumer satisfaction surveys (do you? what info? what do you do to address?) (accreditation requirement)

iii. STAFFING

Screening/Hiring

Orientation/training

Ratios

Staff Surveys

iv. INCIDENT MANAGEMENT

APS

Incident Reporting

C. Community Supports

Accomplishments

Programmatic Deficiencies

Corrections to Deficiencies

i. HEALTH AND SAFETY

Vehicles

Consumers

Medication Safety (psychotropics, training, programs, prns, certification, errors)

Sites (appearance, evacuation drills, SL apartments, emergency back-up, etc.)

ii. SERVICE PLANNING AND DELIVERY

Individual Planning (Assessment, implementation, monitoring)

Leisure / Recreation

Client Rights (restrictions/promotion of rights, grievance procedure)

Medical / health care

Emotionally Responsible Care Giving

Consumer Surveys

Agency’s consumer satisfaction surveys (do you? what info? what do you do to address?) (accreditation requirement)

ii. STAFFING

Screening/Hiring

Orientation/training

Ratios

Staff Surveys

iv. INCIDENT MANAGEMENT

APS

Incident Reporting

D. Transportation

Accomplishments

Programmatic Deficiencies

Corrections to Deficiencies

Conclusion

Findings Closed

Findings Open / Plan of Correction

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