CMS Requirements of Participation

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Transcription:

CMS Requirements of Participation

Goals Reflect substantial changes in theory, service delivery and improvements Address requirements of Affordable Care Act Align with current HHS quality initiatives Reduce avoidable hospitalization Health Information Technology and Exchange Reduce incidence of healthcare associated infections Behavioral health (National Partnership to Improve Dementia Care in Nursing Homes) Training and competency-based approach www.federalregister.gov

Background Medicare and Medicaid Program Requirements for Long- Term Care Facilities (80 FR 42168) Initiative to reduce avoidable hospitalizations among nursing facility residents (www.innovation.cms.gov) National partnership to improve dementia care in nursing homes (www.cms.gov) Connecting Health and Care for the Nation A Shared Nationwide Interoperability Road Map (www.healthit.gov) Action plan to prevent HAIs (www.hhs.gov)

Themes Facility Responsibility Evidence-based practice & culture change Person-centered care planning Competency-based care delivery Assessment of need Workforce engagement Relevant & current QoC & QoL- Patient directed goals of care and discharge planning Patient population (facility assessment) Monitoring of progress (QAPI) Antibiotics Adverse events Compliance

Timeline October 4, 2016- Final rule posted to Federal Register November 28, 2016- Effective date of rule & implementation of Phase 1 November 28, 2017- Implementation of Phase 2 November 2017- Implementation of new survey protocol (new tags) November 28, 2019 Implementation of Phase 3

Cost Total: $831 million CMS projects $62,900 / center year 1 CMS projects $55,000 / center year 2

Basis & Scope ( 483.1) Entire section will be implemented in Phase 1 Adds statutory authority citations to allow for the inclusion of requirements related to compliance and ethics program, quality assurance and performance improvement (QAPI) and reporting of suspicion of a crime.

Definitions ( 483.5) Entire section will be implemented in Phase 1 Section 483.5 is amended by a. Inserting the definitions for: Abuse Adverse event Exploitation Misappropriation of resident property Mistreatment Neglect Person-centered Care Resident representative Sexual abuse b. Composite distinct part- used to separate by payer source or for any reason other than care needs is prohibited http://www.ecfr.gov/cgi-bin/text-idx?sid=9ac6cd5cffc5e487f1cb8814cf82bc68&mc=true&node=20161004y1.93

Considerations / Recommendations 1. Review language & definitions 2. Review existing P&P to identify any conflicting language or terms 1. Resident representative versus legal representative 2. Review admission agreement 3. Modify or update as needed 4. Educate all staff on requirements to include definitions and reporting requirements (serious injuries-2 hours) 5. https://www.ssa.gov/op_home/ssact/title11/1150b.htm 6. https://www.cms.gov/medicare/provider-enrollment-and- Certification/SurveyCertificationGenInfo/downloads/SCLetter11_30.pdf

Resident Rights ( 483.10) This section will be implemented in Phase 1 with the following exception: (g)(4)(ii) (v) Providing contact information for State and local advocacy organizations, Medicare and Medicaid eligibility information, Aging and Disability Resources Center and Medicaid Fraud Control Unit Implemented in Phase 2. a. Includes parallel facility responsibilities b. Resident must receive information in a language he or she understands c. Resident representative d. Planning & implementing care e. Policy & procedure for and notification of visitation rights f. Attending physician g. Fiduciary of deposited personal resident funds h. Right to share a room with roommate of choice when practicable i. Reasonable access to and privacy in use of electronic communications j. Facility must have a grievance policy and a Grievance Official

Considerations / Recommendations 1. Develop, review or modify P&P related to Advance Directives (483.10(b)(8) 2. Identify grievance official and develop P&P related to grievance policy 3. Provide a written description of legal rights to resident & representative O.C.G.A. 31-32-(1)-(14) (2016) 4. Develop, review or modify P&P related to visitation rights of residents 5. Update resident rights notifications to reflect new language/requirements 6. Provide education related to accommodation of needs of LGBT residents and families CMS S&C Memo: Learning Tool for Building Respect for LGBT Older Adults

Considerations / Recommendations 7. Review guidelines and processes associated with patient / resident education, privacy, informed consent, refusal of care and documentation requirements. Consider how you evaluate resident / patient health literacy. Health Literacy and Older Adults HIPAA 8. Review guidelines and processes related to medical staff, credentialing process and attending physician selection by resident/patient. The intent is to support and facilitate resident and patient choice if the physician can meet requirements for medical staff. Review guidelines and processes related to medical staff, credentialing process and attending physician selection by resident/patient. The intent is to support and facilitate resident and patient choice if the physician can meet requirements for medical staff. 9 Visitation should not be restricted unless there is a clinical or safety reason for doing so. Consider how this is communicated to residents, families and friends

Freedom from abuse, neglect and exploitation ( 483.12) These requirements will be implemented in Phase 1 with the exception of (b) (4) Coordination with QAPI plan (Phase 3) and (b) (5) Reporting crimes/1150b (Phase 2) A. Requires facilities to investigate and report all allegations of abusive conduct B. Facilities may not employ individuals who have had a disciplinary action against a professional license as a result of finding of abuse, neglect or mistreatment of residents or misappropriation of resident property C. Requires written policies and procedures to address the following: Prevention & Prohibition Investigation of allegation Training (483.95) Coordination with QAPI program Reporting of crimes (section 1150B of the Act)

Considerations / Recommendations 1. Closely review definitions related to abuse, neglect, exploitation and mistreatment and develop, modify and/or review related P&P Willful versus intent Prevention Reporting Training https://www.ssa.gov/op_home/ssact/title11/1150b.htm Annually notifying covered individuals, as defined at section 1150B(a)(3) of the Act, of that individual's obligation to comply with reporting requirements (Elder Justice Act). 2. Process for checking license & certification (disciplinary action by state licensure body) 3. Consider procedural guidelines related to use of electronic devices and social media

Admission, Discharge and Transfers( 483.15) Requirements must be implemented in Phase 1 with the exception of (c) (2) Transfer / Discharge Documentation (Phase 2) Admission, transfer and discharge rights A. Reorganized and modified existing language and process related to admission rights B. Must meet discharge criteria that is documented by a physician in the medical record C. Comprehensive discharge summary and who it must be shared with D. Process for, information required and communication of discharge

Considerations / Recommendations 1. Develop, review and / or modify language in P&P related to admissions policy, bed holds, return to facility, discharges (align with care plan requirements) to incorporate new requirements and language 2. Provide education to staff to ensure understanding of requirements and facility specific guidelines 3. Consider development of a discharge template to ensure requirements are met and to guide documentation Needs cannot be met Sufficient improvement Safety of others Health of others Failure to pay after reasonable and appropriate notice Facility has ceased to operate Resource: https://www.cms.gov/outreach-and-education/medicare-learning-network- MLN/MLNProducts/Downloads/Discharge-Planning-Booklet-ICN908184.pdf

Resident assessment ( 483.20) Requirements will be implemented in Phase 1 A. Clarifying appropriate coordination of resident assessment and PASARR B. Added references to statutory requirements that were inadvertently omitted (sections 1819 and 1919 of the Act) C. Expanded to include resident strengths, goals, life history and preferences D. Discharge planning versus discharge potential E. Assessment must include direct observation and communication with resident and communication with licensed and non-licensed direct care staff on all shifts *Cross-reference to Behavioral Health (483.40)

Considerations / Recommendations Documentation should reflect resident s involvement in completing the RAI Develop, modify and / or review procedural guidelines related to assessment process to ensure it is comprehensive and captures resident s needs, strengths, goals, life history and preference. Consider a standardized form to assess resident s strengths and goals of care.

Comprehensive person-centered care planning ( 483.21) Requirements will be implemented in Phase 1 with the exception of requirements related to baseline care plan (Phase 2) and (b) (3) (iii) Trauma informed care (Phase 3) Gold Standard Care and service services that assist resident to attain or maintain the highest practicable physical, mental, and psychosocial well-being A. Baseline care plan within 48 hours of admission which includes six specified elements B. Addition of nurse aide and food & nutrition representative to ID Team responsible to develop comprehensive plan of care; should reflect resident s strengths and weaknesses; right to receive care outlined in plan of care; documentation if resident/rep do not attend care plan meeting C. Discharge and transition in care plan that is focused on resident s goals Discharge planning requirements mandated by IMPACT Reduce preventable hospital re-admissions Effective transitions Discharge summary Medication reconciliation of all pre-discharge meds with post-discharge meds

Considerations / Recommendations The facility should, in collaboration with the resident and resident representative, document in the care plan the patient s goals for admission and desired outcomes. Patient preferences for discharge and desire to return to the community will need to be documented in the care planning process. https://www.cms.gov/outreach-and-education/medicare-learning-network- MLN/MLNProducts/Downloads/Discharge-Planning-Booklet-ICN908184.pdf Care plan must be holistic and address required elements Review process for inviting residents and reps to care plan meeting and consider requirement to document if they do not attend. Provide education to staff related to requirement to provide trauma informed care (phase 3). Review and revise policies and practices to support requirements. Resources are available through DHHS: Trauma Informed Care

Quality of Life ( 483.24) All requirements will be implemented in Phase 1 A. Gold Standard- Consistent with resident s comprehensive plan of care B. Applies to all care and services C. Activities- The facility must provide, based on the comprehensive assessment and care plan and the preferences of each resident, an ongoing program to support residents in their choice of activities, both facility-sponsored group and individual activities and independent activities, designed to meet the interests of and support the physical, mental, and psychosocial well-being of each resident, encouraging both independence and interaction in the community.

Quality of Care ( 483.25) Requirements will be implemented in Phase 1 except (m) Trauma-informed care (Phase 3) A. Gold Standard Includes all aspects of treatment and care Professional standards of practice Competent staff B. Review specific areas of care C. Trauma-informed care- (Phase 3) culturally competent, trauma-informed care such to mitigate risk of triggers and re-traumatization D. Bed Rails The facility must attempt to use appropriate alternatives prior to installing a side or bed rail. If a bed or side rail is used, the facility must ensure correct installation, use, and maintenance of bed rails, including but not limited to the following elements. (1) Assess the resident for risk of entrapment from bed rails prior to installation. (2) Review the risks and benefits of bed rails with the resident or resident representative and obtain informed consent prior to installation. (3) Ensure that the bed's dimensions are appropriate for the resident's size and weight. (4) Follow the manufacturers' recommendations and specifications for installing and maintaining bed rails.

Considerations / Recommendations Review procedural guidelines that govern evaluation of staff competency, training plan and education to ensure provision of care and treatment in accordance with professional standards of practice. Consider that admission decisions should be based upon ability to provide competent care. Review current processes, training and guidelines related to: Vision and hearing Skin integrity Mobility Incontinence Colostomy Urostomy and ileostomy Assisted nutrition and hydration Parenteral fluids Respiratory care Prosthesis Pain management Dialysis Trauma informed care Bed rails

Resources www.cdc.gov www.ahrq.gov www.wocn.org www.paltc.org http://www.paltc.org/newsroom/ltc-advise-against-incontinence-catheters http://www.cdc.gov/hicpac/cauti_fastfacts.html http://www.cdc.gov/hicpac/cauti/008_evidencereview.html

Physician services ( 483.30) Requirements will be implemented in Phase 1 A. Attending physician may delegate writing of orders to (clinically qualified) Dietician and to therapists per their state s scope of practice. NPs and PAs may not delegate authority B. Physician must approve an admission; however, NP or PA can now write admitting orders

Considerations / Recommendations Review procedural guidelines and state scope of practice to ensure no conflict with change in requirements if center intends to utilize advance practice nurses and physician assistants. Educate practitioners accordingly. CMS survey & Certification memo Review scope of practice for dietitians to ensure policy and guidelines are aligned with scope of practice http://www.eatrightpro.org/resources/practice/quality-management/scope-of-practice Review scope of practice for therapists to ensure policy and guidelines are aligned with scope of practice http://www.apta.org/scopeofpractice/ http://ajot.aota.org/article.aspx?articleid=1934867 http://www.asha.org/policy/sp2016-00343/

Nursing services ( 483.35) Requirements will be implemented in Phase 1 except specific usage of the Facility Assessment at 483.70 (e) in the determination of sufficient number and competencies for staff (Phase 2) A. Sufficient staff- Gold Standard B. Assure resident safety C. Other nursing personnel includes nurses

Considerations / Recommendations Review job descriptions and other written material and update as necessary related to assuring resident safety Review procedural guidelines that govern evaluation of staff competency, training plan and education to ensure provision of care and treatment in accordance with professional standards of practice. Consider that admission decisions should be based upon ability to provide competent care Review the Facility Assessment data to determine competency requirement for nursing staff. Review Nurse Orientation Program to determine if competencies are reflective of patients being cared for in the facility. Review and evaluate the competency of the staff upon hire, annually and as needs of resident care changes based on outcomes of the Facility Assessment (Phase 2)

Behavioral health services ( 483.40) Requirements will be implemented in Phase 2 with the following exceptions: (a) (1) As related to residents with history of trauma and / or post-traumatic stress disorder (PTSD) (Phase 3); (b) (1), (b) (2) and (d) Comprehensive assessment and medically related social services (Phase 1) Focuses on necessary behavioral health care and services for residents based upon their comprehensive assessment and plan of care A. Appropriate care and treatment for residents with mental disorder, psychosocial adjustment difficulty or a history of trauma and / or PTSD to meet Gold Standard B. If assessment does not reveal mental or psychosocial adjustment difficulty or a history of trauma and / or PTSD, resident does not develop decreased social interaction, become withdrawn or exhibit depressive behaviors unless clinical condition demonstrates unavoidable C. Staff must have appropriate competencies and skills D. Medically-related social services to meet Gold Standard

Considerations / Recommendations National Partnership to Improve Dementia Care in Nursing Homes (Ref: S&C: 16-28-NH) National Partnership to Improve Dementia Care in Nursing Homes - Centers for Medicare & Medicaid Services Review processes and guidelines associated with medically related social services to include identification of need, care planning and provision of service Facility should review current policies and assessment tools to determine gaps in ability to assess for history of PTSD, trauma, or other psychosocial disorders. When complete, the facility assessment should help to determine if there are patients requiring special service based on the number of patients, the acuity level and the diagnosis of the facilities population. Review policies and procedures to ensure that non-pharmacological interventions are in place to reduce behaviors associated with mental illness. Individuals should have patient centered interventions identified and incorporated into the plan of care. Staff must be trained and knowledgeable on providing appropriate care and services to patients with mental illnesses. Center must prevent the development of a mental or psychosocial adjustment difficulty if not previously identified on comprehensive assessment. Develop plan to ensure appropriate training and competency evaluation to identify and provide care for residents with a history of trauma and / or PTSD

Considerations / Recommendations Facility should examine their ability to meet the comprehensive needs of the patient to include rehabilitative services. If services are needed to care for the patient and the facility can not provide these internally, they must obtain the services using outside resources. Facility should seek outside resources and obtain proper contracted services for those not available internally. Examples may include psych or mental health services. Mental Health Services https://www.cms.gov/outreach-and-education/medicare-learning- Network-MLN/MLNProducts/Downloads/Mental-Health-Services-Booklet-ICN903195.pdf

Pharmacy services ( 483.45) Requirements will be implemented in Phase 1 except (c) (2) Medical chart review (Phase 2) and (e) Psychotropic drugs (Phase 2) A. Pharmacist must review medical chart during each monthly drug regimen review Policy & procedure on monthly drug regimen review Reporting irregularities to include facility s medical director Expands on how pharmacist must document irregularities and how the attending must respond B. Antipsychotic drugs now refer to psychotropic drugs and define this as any drug that affects brain activities associated with mental processes and behavior Includes provisions intended to reduce or eliminate the need for psychotropic drugs Adds limitations to PRN psychotropic drug use

Considerations / Recommendations Develop, review and / or modify documents and procedural guidelines to ensure consistency with new definition of psychotropic drug. Develop, review and / or modify processes and / or procedural guidelines for monthly drug regimen review to include required information. Anticipate medical chart review that will be required in Phase 2. Ensure protocols are consistent with new requirement related to PRN orders for psychotropic drugs. Educate staff related to changes in processes, guidelines and requirements CMS State Operations Manual (SOM) Appendix PP, pharmacy related F-tag (F-425) www.ahcancal.org/facility Resources/Survey and Regulations/Electronic Code of Federal Regulations/Pharmacy Services ASCP.com/Practice Resources/Inappropriate Medications/Beers List

Laboratory, radiology and other diagnostic services ( 483.50 ) Requirements will be implemented in Phase 1 A. Physician assistants, nurse practitioners or clinical nurse specialists may order laboratory, radiology and other diagnostic services in accordance with state laws and scope of practice B. Facility is responsible for timeliness and quality of diagnostic services C. Facility must assist with making transportation arrangements if needed D. Promptly communicate results to ordering practitioner and file in clinical record E. Facility or any lab providing lab services must meet requirements in 42 CFR Part 493 F. If a facility provides its own diagnostic services must meet conditions of participation for hospitals contained in 482.26. Contracted service providers must be approved by Medicare to provide service

Considerations / Recommendations These changes relate primarily to inclusion of physician extenders (NPs, PAs CNSs) who may order labs and diagnostics specific to the state scope of practice. To better understand the role of the physician and extender in the skilled nursing center, recommend to review new requirements and the CMS survey & Certification memo that addresses delegation of duties and required visits and review of orders. It is recommended that you review any pertinent policies or guidelines specific to medical services, diagnostics and notification of change in condition. You should ensure that you do not have any P&P that prohibits the utilization of physician extenders in your center, if you intend to utilize. Also, educate staff about requirements associated with notification of physician when abnormal results are received. For example, do you have a protocol in place when critical lab values are received. Remind staff they should be aware of any specific orders associated with a diagnostic. For example, does the order state, Obtain H&H and call results to physcian. Again, staff should understand any facility procedure and/or guideline related to notification of physician with lab results. Discuss what prompt notification means relative to normal results, abnormal values, or critical results. Consider documentation requirements relative to physician notification (how is notification of physician reflected in the medical record). What is center s position on faxed or electronic transmission of results. Diagnostics typically require a physician order and the order should be noted in the medical record prior to performance of test. This is also important related to billing requirements.

Dental services ( 483.55) Requirements will be implemented in Phase 1 except for (a) (3) and (a) (5) related to loss or damage of dentures and policy for referral (Phase 2) and (b) (3) and (b) (4) related to referral for dental services regarding loss or damaged dentures (Phase 2) A. Facility must develop a policy regarding the loss or damage of dentures, detailing when the loss is the facility s responsibility B. SNFs are prohibited from charging a Medicare resident for the loss or damage of dentures in accordance with facility policy determined to be facility s responsibility C. SNFs are required to assist residents who are eligible to apply for reimbursement under the Medicaid state plan D. Referrals for lost or damaged dentures must be promptly made (within 3 business days unless extenuating circumstances are documented)

Considerations / Recommendations Review the center s policy and guidelines related to property loss and recommend have section that addresses what would be considered facility s responsibility. Guidance should include consideration for application for reimbursement (IME), transportation needs, timeliness of intervention and plan of care while awaiting intervention. Any changes to this policy should be reviewed with any current residents and families. Recommend on admission provide written education to families related to this policy and guideline as well as when residents may go out for dental services that may or may not include administration of new dentures.

Food and nutrition services ( 483.60) Requirements will be implemented in Phase 1 with the following exceptions: (a) As linked to Facility Assessment at 483.70 (e), implemented in Phase 2 (a) (1) (iv) Dietitians hired or contracted prior to effective date five years following effective date of the final rule (a) (2) (i) Director of food & nutrition services designated to serve prior to effective date five years following effective date of the final rule A. Focus on resident preferences B. Staff with adequate skills and competencies to carry out functions of dietary services in consideration of resident assessments and plans of care, acuity and census C. Procurement of food from locally grown sources and facility gardens D. Meals & snacks outside scheduled or non-traditional times

Considerations / Recommendations This includes language change for dietary services to food and nutrition services which matches the current standard language in this industry. Recommend developing or modifying polices and guidelines to reflect this language. The policies and guidelines should address how the resident s preferences are obtained and how the facility staff will honor these preferences and use and storage of foods brought to residents by family and other visitors. Requirement of certification for food services managers not previously specified under this rule. Recommend review requirements of qualifications for a food service manager and assess how they align with your current food service manager. Incorporate into QAPI how this rule will be addressed within the recommended time frame by either your current food service manger obtaining the correct certification or the addition of a food service manager that meets these requirements. Procedures for obtaining certification or finding managers with certification can be found at http://www.anfponline.org/. http://sos.ga.gov/plb/acrobat/laws/40_dietitians_43-11a.pdf

Considerations / Recommendations Review policy and guidelines to reflect how the residents religious, cultural and ethnic needs are evaluated and reviewed on an individual basis and frequency of which they are reviewed with the resident council. Recommend this discussion be reflected both in the resident council minutes as well as QAPI. Recommend include in both resident s council meeting minutes when menus are changed and/or updates as well as include in QAPI minutes. Recommend review facility policy and guidelines on providing meals and/or snacks during nontraditional meal times. Recommend address the availability of food during non-traditional periodically and resident/family meetings and include this is the resident council minutes. Recommend for patients that prefer to have non-traditional meal patterns, to document this in their resident plan of care including how the facility is meeting their nutritional needs and preferences. Review policy and guidelines related to feeding assistants. Consider how assignments are made for feeding assistants and how education is provided if residents experience change in condition.

Specialized rehabilitative services ( 483.65) Requirements will be implemented in Phase 1 A. Identifies respiratory therapy as specialized rehabilitative service B. Contracted providers must not be on federal or state health care program exclusion list C. The addition of respiratory services requires the center to provide or obtain these services when necessary to meet the residents respiratory needs Refer to the scope of services for the individual therapy disciplines. Recommend address in the policy and guidelines related to outpatient services how the facility will monitor that therapists are working within the scope of practice. http://www.apta.org/scopeofpractice/ http://ajot.aota.org/article.aspx?articleid=1934867 http://www.asha.org/policy/sp2016-00343/

Administration ( 483.70) Requirements implemented in Phase 1 except (d) (3) Governing body responsible for QAPI program (Phase 3) and (e) Facility Assessment (Phase 2) A. Facilities may not enter into a binding arbitration agreement with a resident or their representative until after a dispute arises between the parties. Pre-dispute binding arbitration agreements are prohibited Voluntary- right to remain in center must not be contingent upon entering into agreement Neutral arbitrator and convenient venue Cannot prohibit or discourage communication with federal, state or local officials Copy retained for five years and available for CMS inspection Signed only by individuals allowed by state law and who has no interest in the facility B. Annual Facility Assessment to determine necessary resources to competently care for residents during day to day operations and emergencies Facility population (acuity, cultural aspects, census, etc.) Resources (equipment and staff) Facility-based and community-based risk assessment Must be updated if significant changes occur to service model, building or population

Considerations / Recommendations Review admissions policy / guidelines to ensure a predispute agreement for binding arbitration agreement is not included.

Facility Assessment- Phase 2 The requirement for a facility assessment is a significant change to requirements. Presumably, this assessment will guide provision of staff and resources, staff training and competency and physical plant adaptations / modifications. You may consider use of the CMS QAPI resources to guide this assessment. Ensure the assessment addresses all required components. To assist with review, consider referencing / reviewing the following: Average daily census report and mix for one year period. Case Mix Report (trending of CMI for prior 12 months) ADL score average over 12 month look back period Primary diagnoses served Physical lay-out of building (secure unit, number nurses stations, dining rooms, rehab gym) Special services (vent care, trach care, dialysis,etc) Average # of admissions and discharges per month (12 month look back period) Prevalence of cognitive impairment Prevalence of pressure ulcers / wounds Staffing patterns

Facility Assessment considerations After careful development and review of facility service model, analyze training program specific to service model. For example, if you offer trach care, is education on trach care and competency evaluation conducted during orientation and on a regular basis (annually or bi-annually) and documented in personnel record. Consider if a specialized consultant is needed for special services that are offered. For example, if trach care or vent care is provided, does a pulmonologist visit or consult. In light of service model, are there specialized equipment needs, physical plant waivers or adaptations that are necessary to safely and comprehensively deliver care. Consider if process are in place to evaluate ethnic, cultural and religious preferences. How is this documented? How are special considerations communicated? Has staff education been provided on cultural competency? How is verification of competency addressed with contract staff? How is education of contract staff and / or contractors specific to facility assessment and service model addressed / documented?

Facility Assessment considerations Recommend to incorporate a risk assessment using all hazards approach in your QAPI and review on an annual basis or anytime there is a significant change in service or operational model. Consider review of these resources to guide assessment. Recommend full contract review. Review policies / procedural guidelines relating to HIT, security of systems, and frequency of audits. QAPI- Governing body Consider language in QAPI P&P or framework that reflects the responsibility of the governing body for QAPI program. Who participates in QAPI? How is governing body informed of QAPI focuses and center needs.

Quality assurance and performance improvement ( 483.75 ) Requirements will be implemented in Phase 3 except for: (a) (2) Initial QAPI plan must be provided to State Agency at annual survey (Phase 2) (g) (1) QAA committee- all requirements will be implemented in Phase 1 except subparagraph (iv), which requires ICPO (Phase 3) (h) Disclosure of information (Phase 1) (i) Sanctions (Phase 1) QAPI Program- Facilities must develop, implement and maintain an effective comprehensive, data driven program that focuses on systems of care, outcomes of care and quality of life 1. Address full range of care and service 2. Effective systems to identify, collect and use data and information from all departments, including facility assessment, to monitor performance 3. Plans must be actionable, measured and re-evaluated to ensure improvements are achieved and sustained 4. QAPI activities must include medical errors and adverse resident events

Considerations / Recommendations Review current guidelines and processes related to QAPI relative to new requirements and update accordingly. Develop or modify QAPI plan in preparation for submission to SSA by November 27, 2017. Recommend to align facility assessment with QAPI plan CMS QAPI at a Glance: A Step by Step Guide to Implementing QAPI in Your Nursing Home. https://www.cms.gov/medicare/provider-enrollment-and- Certification/QAPI/Downloads/QAPIAtaGlance.pdf CMS QAPI Process Framework: https://www.cms.gov/medicare/provider-enrollment-and- Certification/QAPI/Downloads/ProcessToolFramework.pdf CMS QAPI site all tools and resources. https://www.cms.gov/medicare/provider-enrollment-and-certification/qapi/nhqapi.html

QAPI considerations / resources AHCA QAPI Design and Scope Recommendations:https://www.ahcancal.org/quality_improvement/QAPI/Pages/DesignScope.aspx CMS QAPI Guide for Developing Purpose, Guiding Principles and Scope https://www.cms.gov/medicare/provider-enrollment-and- Certification/QAPI/Downloads/QAPIPurpose.pdf AHCA Tips/Tools for Feedback, Data Systems and Monitoring https://www.ahcancal.org/quality_improvement/qapi/pages/feedback.aspx AHCA Systematic Analysis and Action https://www.ahcancal.org/quality_improvement/qapi/pages/pips.aspx 2. Think Reliability Root Cause Analysis Basis, Tools and examples http://www.thinkreliability.com/root-cause-analysis-cm-basics.aspx 3. CMS QAPI at a Glance: Training Handout (pp. 18-19) 4. VA National Center for Patient Safety Root Cause Analysis Tools, Step- by-step Guide and Flow Chart http://www.patientsafety.va.gov/professionals/onthejob/rca.asp

QAPI considerations / resources AHCA Performance Improvement projects https://www.ahcancal.org/quality_improvement/qapi/pages/pips.aspx CMS QAPI at a Glance: Training Handout (pp. 16-17; and 37-38) AHCA Governance and Leadership tips https://www.ahcancal.org/quality_improvement/qapi/pages/governanceleadership.aspx

Infection control ( 483.80 ) Requirements will be implemented in Phase 1 with the following exceptions: (a) As linked to Facility Assessment at 483.70 (Phase 2) (a) (3) Antibiotic stewardship (Phase 2) (b) Infection preventionist (IP) (Phase 3) (c) IP participation on QAA committee (Phase 3) Requires center to develop an Infection and Prevention Control Program (IPCP) that includes an antibiotic stewardship program and designates at least one Infection Preventionist) Annual review Qualifications of IP IP must be member of QAA committee and report on IPCP on a regular basis

Considerations / Recommendations Develop, review and / or modify procedural guidelines to ensure compliance with new requirements (483.80 (2) (i)-(iv) for infection prevention and control program (IPCP) Refer to CDC guidelines for Standard and transmission-based precautions. www.cdc.org Phase 2- Ensure alignment with facility assessment and incorporate antibiotic stewardship program. Incorporate into the IPCP Antibiotic Stewardship Program that includes antibiotic use protocols and a system to monitor antibiotic use. Include Pharmacy collaboration and assistance. Refer to Antibiotic Stewardship tools www.cdc.org Phase 3- Identify an Infection Prevention and Control Officer (IP) at the facility level with responsibility for Infection Prevention and Control Program (IPCP). The IPCO must have specialized training beyond initial professional degree. Refer to APIC, Alliant, Georgia IPN for further education and information. The IPCO should become a regular member of the QAPI Committee and report regularly on status of program, trends and analysis of surveillance data.

Compliance and ethics program ( 483.85) Requirements will be implemented in Phase 3 Requires the operating organization of each center to have a compliance and ethics program that has established written compliance and ethics standards, policies and procedures that reduce the prospect of criminal, civil and administrative violations in accordance with section 1128I(b) of the Act. The requirements outlined at 483.85 address the requirement for a formal compliance and ethics program. Determine if a formalized compliance and ethics program exists within your center. If so, conduct a careful review to ensure the program addresses requirements outlined at 483.85 (c) (1)-(8). Document review of program in QAPI and annually thereafter. Provide education to staff to ensure understanding of program and who the compliance officer is.

Considerations / Recommendations If a formalized compliance & ethics program is not in place, consider the following (please note the different requirements for a operating organization that operates five or more facilities at 483.85 (d)(1)-(3) High level personnel and operating organization should collaborate in the development of a formal compliance & ethics program. The development of the program should, at a minimum, include all of the components addressed at 483.85 (c) (1) (8). The program contact or compliance officer should be identified and job description updated to reflect responsibilities. Staff should receive education on the program and understand who serves as the program contact or compliance officer and how to report concerns and their right to do so anonymously and without fear of retribution. Annual review of the program and education is a best practice. Resource: AHCA- Compliance Programs

Physical environment ( 483.90) Requirements will be implemented in Phase 1 except (f)(1) call system from each resident s bedside (Phase 3) and (h)(5)policies regarding smoking (Phase 2) Requires center to be safely designed, constructed, equipped and maintained to protect health and safety of residents, personnel and the public Two residents per bedroom after effective date Bathroom equipped with a commode and sink for each room Resident needs, preferences and choices are considered in space and equipment Regular inspection of bed frames, mattresses, and bed rails Communication system that allows residents to call a staff member or centralized work space from bedside, toilet and bathing facilities Smoking policy (smoking areas, safe smoking) in accordance with federal, state and local laws and regulations

Training requirements ( 483.95) Requirements will be implemented in Phase 3 with the exception of: (c) Abuse, neglect and exploitation training (Phase 1) (g) (1) Inservice training for dementia management, abuse prevention and care of cognitively impaired (Phase 1) (h) Training of feeding assistants (Phase 1) Requires development, implementation and maintenance of an effective training program for new and existing staff, contractors and volunteers 1. Communication 2. Resident Rights & Facility Responsibilities 3. Abuse, neglect and exploitation 4. QAPI 5. Infection Control 6. Compliance & ethics 7. Behavioral health 8. Other-based upon identified needs per Facility Assessment

Considerations / Recommendations Develop and / or review existing training for the following and incorporate into new hire orientation and annual training plan : Abuse, neglect and exploitation training Dementia management, abuse prevention and care of cognitively impaired Training of feeding assistants Phase 2- Ensure training plan is aligned with needs identified in facility assessment Phase 3- Develop and implement required training for staff, contractors and volunteers: communication; resident rights; facility responsibilities; abuse/neglect/exploitation; QAPI; infection control; compliance and ethics; and, behavioral health

Resources Staffing to Acuity AHCA Summary of Final Rule AHCA Timeline for Final Rule AHCA Playbook and other resources Code of Federal Regulations Alliant Quality Advisors GHCA 59

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