New CoPs - Overview -

Similar documents
New Homecare CoPs 5/1/2017. Intro. Objectives - Participants Will Understand the: A Patient- Centered, Data-Driven, Outcome Oriented Philosophy

CMS-3819-F Condition of participation: Reporting OASIS information. (a) Standard: Encoding and transmitting OASIS data. An HHA must encode

HOME HEALTH CARE PROPOSED CONDITIONS OF PARTICIPATION

Home Health Agency Updated Conditions of Participation. Thursday, December 7, :00 4:00 PM EST

Contact Evelyn Knolle, AHA senior associate director of policy, at (202) or American Hospital Association 1

Comparison of the current and final revisions to the Home Health Conditions of Participation

Is your Home Health Agency ready for the Final Rule to the Conditions of Participation?

March 2017 HOME HEALTH CONDITIONS OF PARTICIPATION (COPS) FAQ

CMS Proposed Rule. The IMPACT Act. 3 Overhaul Discharge Planning Processes to Comply With New CoPs. Arlene Maxim VP of Program Development, QIRT

QAPI Quality Assurance Process Improvement

CMHC Conditions of Participation

Session 4. Non-Core Services

(a) Licensure. A facility must be licensed under applicable State and local law.

Selman Holman & Associates, LLC PATIENT RIGHTS: Four New CoP s. Objectives

CMS-3819-F Medicare and Medicaid Program: Conditions of Participation for Home Health Agencies Interpretive Guidelines--DRAFT

COPs 2018 Now is the Time. HCAC 2017 Conference PreConference 2017 The Crag Business Group, Inc.

CoP Series. Care Planning & Care Coordination

Conditions of Participation for Hospice Programs

COPs 2018 Now is the Time. HCAC 2017 Conference PreConference 2017 The Crag Business Group, Inc.

Subpart C Conditions of Participation PATIENT CARE Condition of participation: Patient's rights Condition of participation: Initial

Comments for CMS Draft Conditions of Participation (CoPs) Interpretive Guidelines (IG)

FLORIDA LICENSURE SURVEY PREP

CMS-3819-F Medicare and Medicaid Program: Conditions of Participation for Home Health Agencies Interpretive Guidelines--DRAFT

CMS OASIS Q&As: CATEGORY 2 - COMPREHENSIVE ASSESSMENT

Q&A REVISED MEDICARE CoPs

DIA COMPLIANCE OVERVIEW FOR HOME HEALTH AGENCIES

2017 Home Health Conditions of Participation: Executive Update

The Medicare Regulations for Hospice Care, Including the Conditions of Participation for Hospice Care 42 CFR418

How to Overhaul your Internal Structure to be Prepared for the New Home Health CoPs. Program Objectives

5/1/2017 THE BEST DEFENSE IS A GOOD OFFENSE OBJECTIVES. Preparing for a Home Health Medicare Recertification Survey

Home Health Agency or a Home Care Agency?

TABLE OF CONTENTS CAHSAH. Medicare Conditions of Participation & Interpretive Guidelines

DEPARTME SERVICES [CMS-3819-P] RIN 0938-AG81. Agencies. Medicare and. publication in ADDRESSE

(i) That individual is competent to provide nursing and nursing related services; and

Transfer and Discharge Issues 4/6/2017. How the Mega Rule Affects (and Will Affect) What You Do Every Day

Managing employees include: Organizational structures include: Note:

9/8/2017. Making the Connection: Linking the Facility Assessment and QAPI Plan. Cindy Mason VP Provider Services. Final Rule. Providigm, LLC,

HOSPICE CONTRACTING CHECKLIST FOR INPATIENT SERVICES, RESPITE CARE AND VENDOR AGREEMENTS

Get Moving on QAPI and Infection Control

Organization and administration of services

Prepublication Requirements

CATEGORY 2 - COMPREHENSIVE ASSESSMENT

HCCA South Central Regional Annual Conference November 21, 2014 Nashville, TN. Post Acute Provider Specific Sections from OIG Work Plans

Applicable State Licensing Requirements for Combined Federal and Comprehensive HHA Survey

ADMISSION CONSENTS. 1. Yes No Automobile Medical or No Fault insurance due to an accident?

Jeffrey N. Gregg, Bureau Chief Anne Menard, Home Care Unit Manager Bureau of Health Facility Regulation Agency for Health Care Administration July 30

DEFINITIONS (c)(1) Discharge Planning : Home Health Agency (HHA) : Inpatient Rehabilitation Facility (IRF) : Local Contact Agency :

State Operations Manual. Appendix M - Guidance to Surveyors: Hospice - (Rev. 1, )

Home Health Agency Requirements CMS Emergency Preparedness Final Rule

4/3/2018. Nursing Facility Changes to Conditions of Participation (& Enforcement): What You Need to Know. Revisions to State Operations Manual

256B.0943 CHILDREN'S THERAPEUTIC SERVICES AND SUPPORTS.

Added Section 1557 Patient Protection and ACA No change in intent

Mary Massey, BSN, MA, CHEP California Hospital Association

IS YOUR QAPI COP READY?

ASHE Resource: Implications of the CMS emergency preparedness rule

CATEGORY 4 - OASIS DATA SET: FORMS and ITEMS. Category 4A - General OASIS forms questions.

Standard Changes Related to EP Review Phase IV

Care Coordination in the New CoP s. Teresa Northcutt BSN RN COS-C HCS-D HCS-H WiAHC June 2017

Medicare Home Health Prospective Payment System (HHPPS) Calendar Year (CY) 2013 Final Rule

Tag Description Page. F607 Policies to Prohibit and Prevent Abuse, Neglect, Exploitation 125. F622 Transfer & Discharge 155

OASIS ITEM ITEM INTENT TIME POINTS ITEM(S) COMPLETED RESPONSE SPECIFIC INSTRUCTIONS DATA SOURCES / RESOURCES

Agency for Health Care Administration

Minnesota Hospice Bill of Rights PER MINNESOTA STATUTES, SECTION 144A.751

a. Principles of administration including budgeting, accounting, records management, organization, personnel, and business management.

Request for an Amendment to a 1915(c) Home and Community-Based Services Waiver

KANSAS MEDICAL ASSISTANCE PROGRAM. Fee-for-Service Provider Manual. Local Education Agency

Home & Community Based Services Waiver Member Handbook

Federal Requirements of Participation for Nursing Homes Summary of Key Changes in the Final Rule Issued September 2016 Phase 2

State Operations Manual. Appendix M - Guidance to Surveyors: Hospice (Rev.)

907 KAR 1:044. Coverage provisions and requirements regarding community mental health center behavioral health services.

Take Your CoPs to the Next Level. Part 2 QAPI, Infection Control, Services and Administration

Prepublication Requirements

HUNTINGTON S DISEASE SOCIETY OF AMERICA CENTERS OF EXCELLENCE 2018 Program Description

EMERGENCY PREPAREDNESS Hospice

TABLE OF CONTENTS SAMPLE

MEMORANDUM Texas Department of Human Services * Long Term Care/Policy

KENTUCKY. Downloaded January 2011

PATIENT INFORMATION. In Case of Emergency Notification

Medicaid RAC Audit Results

Quality Performance: The Central Focus of Home Health Care Policy

Lou Eckart, Ph.D. and Associates Licensed Clinical Psychologists 22 Mill St. Suite 305 Arlington, MA

Home Health and Hospice Aides and Compliance: Improve Quality by Reducing Risk

3/30/2015. Objectives. Cooking Up a QAPI: Recipe for Success Under the new COPs Part 1

PROVIDER REQUIREMENTS. Providers must meet the following requirements in order to participate in the program:

5D QAPI from an Operational Approach. Christine M. Osterberg RN BSN Senior Nursing Consultant Pathway Health Pathway Health 2013

Medications: Defining the Role and Responsibility of Physical Therapy Practice

ALABAMA MEDICAID AGENCY ADMINISTRATIVE CODE CHAPTER 560-X-45 MATERNITY CARE PROGRAM TABLE OF CONTENTS

Ryan White Part A Quality Management

INSTITUTE ON MEDICARE/MEDICAID PAYMENT ISSUES MEDICARE CONDITIONS OF PARTICIPATION: WHAT IS YOUR GRADE?

Delegation Oversight 2016 Audit Tool Credentialing and Recredentialing

Medicare General Information, Eligibility, and Entitlement

Effective Date: January 1, 2014

Hospice Clinical Record Review

79th OREGON LEGISLATIVE ASSEMBLY Regular Session. Enrolled. Senate Bill 58

Underlined text is being added. Strikethrough text is being deleted.

Program Description / Disclosure Statement for CWC s Acquired Brain Injury Services 2017

Wellness Director. FLSA Status: Salaried, Exempt Updated: SUMMARY OF POSITION FUNCTIONS

NEVADA. Downloaded January 2011

Medicare Conditions for Coverage 2009 Crosswalk

Subchapter 13 Staff Requirements

Transcription:

New CoPs - Overview - A Patient- Centered, Data-Driven, Outcome Oriented Philosophy P r e s e n te d b y : Sharon M. Litwin, RN, BSHS, MHA, HCS-D Senior Managing Partner 5 Star Consultants Objectives Participants will learn and understand: The New Conditions: Infection Control and QAPI The Major changes in the Conditions, including Patient Rights, Care planning/comprehensive Assessment/Coordination of Care, Aide Services and Plan of care and More Rationale in the Responses to Comments in the Final Rule to explain some of the changes made Intro After a Long wait, CMS issued the final rule January 13, 2017 that includes the new CoPs and the responses to comments from the proposed CoPs. The revised CoPs go into effect July 13, 2017 January 13, 2018! You must prepare Now as it will take that much extra time to prepare, implement and be compliant! There have been several revisions to the CoPs throughout the years, including OASIS and HIPAA, but many of the current CoPs have never changed! These is the First Major revision in COPs in 3 decades! These CoPs have significant changes so Agencies must start immediately to educate their staff and add and/or revise processes in order to comply. The surveyors will be held by CMS to perform surveys using these new COPS beginning Jan 13, so you will Not want to wait until implementation time to learn what it means for your agency! 1

Where do we find the New COPs? 2017 Final Rule in the Federal Register of January 13, 2017 https://www.gpo.gov/fdsys/pkg/fr-2017-01-13/pdf/2017-00283.pdf COPs actually start on page 75 of 88 pages! Prior to that is Summary, Background information, Responses to Comments on proposed rule and Answers, Cost information and More. Important info. There are no interpretive guidelines in place may not be until June! Patient- Centered, Data-Driven, Outcome Oriented Process that promotes high quality patient care at all times for all patients. Continuous, integrated care process across all services, based on patient centered assessment, care planning, service delivery and quality assessment / performance improvement. Interdisciplinary approach recognizing skills of all of the team- think Case Management! Outcome oriented- make quality improvements through QAPI specific to each HHA Eliminates administrative processes that are not predictive of achieving clinically relevant outcomes for patients or preventing harmful outcomes for patients Safeguard Patient Rights CoPs Include Requirements to: Assure patients and caregivers have written information about: Upcoming visits Medication instructions Treatments administered Instructions for care that the patient and caregivers perform Name and contact information of a home health agency clinical manager 2

CoPs Include Requirements to: Have an integrated communication system that ensures that patient needs are Identified and addressed Care is coordinated among all disciplines Active communication between the home health agency and the patient s physician(s) Data-driven, agency-wide quality assessment and performance improvement (QAPI) program that continually evaluates and improves agency care for all patients at all times. Final Rule- Phase in of 12 months to allow HHAs the time necessary to collect data prior to implementing performance improvement projects CoPs Include Requirements to: Have a new infection prevention and control program to: Use standard infection control practices, Patient/caregiver education and teaching. Have an integrated skilled professional services that focuses on patient care activities and supervision across all disciplines. Expand patient care coordination that makes a licensed clinician responsible for all patient care services to assure that care meets each patient s needs at all times. Increase qualifications for home health agency administrators and clinical managers. CoPs - Costs CMS states that implementation of CoPs could be up to $234 million in annual costs! That comes out to about $30,000 per agency, according to the NAHC! 3

The 16 Conditions: Subpart A--General Provisions 484.1 Basis and scope. 484.2 Definitions. Subpart B--Patient Care 484.40 Condition of participation: Release of patient identifiable OASIS information. 484.45 Condition of participation: Reporting OASIS information. 484.50 Condition of participation: Patient rights. 484.55 Condition of participation: Comprehensive assessment of patients. 484.60 Condition of participation: Care planning, coordination of services, and quality of care. 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). 484.70 Condition of participation: Infection prevention and control. 484.75 Condition of participation: Skilled professional services. 484.80 Condition of participation: Home health aide services. The 16 Conditions Subpart C--Organizational Environment 484.100 Condition of participation: Compliance with Federal, State, and local laws and regulations related to health and safety of patients. 484.102 Condition of participation: Emergency preparedness. 484.105 Condition of participation: Organization and administration of services. 484.110 Condition of participation: Clinical records. 484.115 Condition of participation: Personnel qualifications. Eliminates Conditions: Group of Professional Personnel PAC Committee Evaluation of Agency s Program- Annual Agency Evaluation Standards: Quarterly Record Reviews 60 Day summary to physicians Subunits eliminated 4

Key Changes Parent / Branch relationship redefined in standard New Condition Grouping Care planning, coordination of services and quality of care takes the place of the previous condition: Acceptance of patients, plan of care and medical supervision and Standard- Coordination of patient services. Patient Rights Condition Expanded Significantly Increases Governing body and Administrator roles Aide services- adds flexibility in the revisions re training and supervision Discharge and Transfer summary requirements New Conditions: QAPI and Infection Control New in COPs from Rule 2016- Emergency Preparedness 484.2 Definitions - Revised Branch Office An approved location or site from which a home health agency provides services within a portion of the total geographic area served by the parent agency. The parent home health agency must provide supervision and administrative control of any branch office. Removed located sufficiently close RESPONSE: The concept of an adequate level of supervision on a DAILY BASIS is longstanding, and refers to the parent HHA s ability to demonstrate administrative control over branch. We are not giving any specific requirements for communication because our primary concern relates to the evidence of control rather than the process for achieving it. It is essential for the parent to exercise adequate control, supervision and guidance for all branches under its leadership. 484.2 Definitions - Eliminates Sub-Units All current subunits will have to be eliminated and converted to a parent or branch by 7/13/2017 RESPONSE: Subunits are already the equivalent of stand alone HHAs and will be able to continue functioning as such, relieving the need to change to branches. Since there would be no threat to an HHA s ability to function and service its patients, we do not agree that it would be appropriate for CMS to allocate survey resources to those HHAs that desire to, but do not need to, convert a subunit to a branch. Thus, the current process and priority levels will remain the same. Unclear at this time what steps will be needed to convert sub-unit to parent. MUST START NOW IF YOU HAVE ANY SUBUNITS! 5

5/1/2017 484.45 -Reporting OASIS information- 4 Standards HHAs must electronically report all OASIS data collected in accordance with 484.55. a. Standard: Encoding and Transmitting OASIS Data. An HHA must encode and electronically transmit each completed OASIS assessment to the CMS system within 30 days of completing the assessment b. Standard: Accuracy of Encoded OASIS Data. The encoded OASIS data must accurately reflect the patient s status at the time of assessment. c. Standard: Transmittal of OASIS Data. (2) Successfully transmit test data to the QIES ASAP System or CMS OASIS contractor. d. Standard: Data Format 484.50 - Patient Rights The patient and representative (if any), have the right to be informed of the patient s rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. 6 Standards: Notice of Rights Exercise Rights Rights of the Patient Transfer and Discharge Investigation of Complaints Accessibility 484.50 - Patient Rights Standard- (a) Notice of Rights 1) Provide the patient and the patient s legal representative (if any), the following information during the initial evaluation visit, in advance of furnishing care to the patient: Written notice of the patient s rights and responsibilities under this rule, and the HHA s transfer and discharge policies -in paragraph (d). Written notice must be understandable to persons who have limited English proficiency and accessible to individuals with disabilities; ii. Contact information for the HHA administrator, including the administrator s name, business address, and business phone number in order to receive complaints. RESPONSE: The notice of patient rights must be provided to both the patient and his or her representative. If a patient has a legally appointed or designated representative that has health care decision making authority, the HHA must provide notice of the patient s rights prior to initiating care. If the representative is pt-selected and doesn t possess legal health care decision making authority, a patient may decline the provision of the notice of rights to the pt-selected representative. i. 6

484.50- Patient Rights Standard- (a) Notice of Rights 2. Obtain the patient s or legal representative s signature confirming that he or she has received a copy of the notice of rights and responsibilities. 3. Provide verbal notice of the patient s rights and responsibilities in the Individual s primary or preferred language and in a manner the individual understands, free of charge, with the use of a competent interpreter if necessary, no later than the completion of the second visit from a skilled professional. 4. Provide written notice of the patient s rights and responsibilities under this rule and the HHA s transfer and discharge policies in paragraph (d) to a patient selected representative within 4 business days of the initial evaluation visit. RESPONSE: Staff are not required to read the notice word-for word to the patient. There is Flexibility to provide comprehensive and accurate summaries of each right in conversational language and tone in order to engage patients and representatives in this discussion. HHAs may conduct a thorough conversation with the patient and representative regarding the content and meaning of the notice of patient rights over the first two visits by a skilled professional. 484.50- Patient Rights Standard- (a) Notice of Rights Key Changes: Requires both written and verbal notice under specified timetables Prescribed notice process when there is a authorized patient representative Information on how to communicate the information Current patient rights notices and HHA policies & procedures will need to be revised to comply Education to staff is key on how to present the information Standard- (b) Exercise of Rights- Courts rights to appoint representative to patient adjudged to lack mental capacity. Standard- (c) Rights of the patient to: (4) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to: (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits (vii) Any factors that could impact treatment effectiveness (5) Receive all services outlined in the plan of care. (On-going Updates) Response: The Intent is that pts can be informed about and involved in establishing and revising their plan of care as a whole. We believe the patient has a right to be involved with all facets of the care they receive. It is the HHA s responsibility to discuss the level of involvement that patients and their representatives want to have in the plan of care. This would include factors such as how much the patient is capable of understanding and the extent they wish to be involved with the development and updates to the plan of care. HHAs should make all reasonable attempts to respect patient wishes. (7)(iv) Any changes in the information provided in accordance with 7 (payment etc.). The HHA must advise the patient and representative (if any), of these changes as soon as possible, in advance of the next home health visit. 7

484.50- Patient Rights Standard- (c) Rights of the patient to: (10) Be advised of the names, addresses, and telephone numbers of the following Federally-funded and state-funded entities that serve the area where the patient resides: (i) Agency on Aging, (ii) Center for Independent Living, (iii) Protection and Advocacy Agency, (iv) Aging and Disability Resource Center; and (v) Quality Improvement Organization. RESPONSE: CMS originally proposed a generalized obligation to provide a listing of relevant organizations. The Final Rule limits the requirement to the specifically listed organizations. (12) Be informed of the right to access auxiliary aids and language services as described in paragraph (f) of this section, and how to access these services. 484.50- Patient Rights Standard- (d) Transfer and Discharge The patient and representative (if any), have a right to be informed of the HHA s policies for transfer and discharge. The HHA may only transfer or discharge the patient from the HHA if: 1. The transfer or discharge is necessary for the patient s welfare because the HHA and the physician responsible for the HH POC agree that the HHA can no longer meet the patient s needs, based on the patient s acuity. The HHA must arrange a safe and appropriate transfer to other care entities when the needs of the patient exceed the HHA s capabilities; 2. The patient or payer will no longer pay for the services provided by the HHA; 484.50- Patient Rights Standard- (d) Transfer and Discharge 3. The transfer or discharge is appropriate because the physician responsible for the HH POC & the HHA agree that the measurable outcomes and goals in the POC have been achieved, agree that the patient no longer needs the HHA s services; 4. The patient refuses services, or elects to be transferred or discharged; 5. The HHA determines, under a policy set by the HHA for the purpose of addressing discharge for cause that meets the requirements of paragraphs (d)(5)(i) through (d)(5)(iii) of this section, that the patient s (or other persons in the patient s home) behavior is disruptive, abusive, or uncooperative to the extent that delivery of care to the patient or the ability of the HHA to operate effectively is seriously impaired. 8

484.50- Patient Rights Standard- (d) Transfer and Discharge 5. (cont.) The HHA must do the following before it discharges a patient for cause: i. Advise the patient, representative (if any), the physician(s) issuing orders for the HH POC, and the patient s primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) that a discharge for cause is being considered; ii. iii. iv. Make efforts to resolve the problem(s) presented by the patient s behavior, the behavior of other persons in the patient s home, or situation; Provide the patient and representative (if any), with contact information for other agencies or providers who may be able to provide care; and Document the problem(s) and efforts made to resolve the problem(s), and enter this documentation into its clinical records 484.50- Patient Rights Standard- (d) Transfer and Discharge 6. The patient dies; or 7. The HHA ceases to operate Policies HHAs are required to provide physical or electronic documents for the patient s keeping that outline the acceptable reasons for DC or TX Any revisions related to plans for the patient s discharge must be communicated to the patient, rep, and caregiver(s). 484.50- Patient Rights Standard- (e) Standard: Investigation of complaints (2) Any HHA staff (whether employed directly or under arrangements) in the normal course of providing services to patients, who identifies, notices, or recognizes incidences or circumstances of mistreatment, neglect, verbal, mental, sexual, and/or physical abuse, including injuries of unknown source, or misappropriation of patient property, must report these findings immediately to the HHA and other appropriate authorities in accordance with state law. 9

484.50- Patient Rights Standard- (f) Accessibility Information must be provided to patients in plain language and in a manner that is accessible and timely to 1. Persons with disabilities, including accessible Web sites and the provision of auxiliary aids and services at no cost to the individual in accordance with the Americans with Disabilities Act and Section 504 of the Rehabilitation Act. 2. Persons with limited English proficiency through the provision of language services at no cost to the individual, including oral interpretation and written translations. RESPONSE: the alternate formats expectation includes, but is not limited to, the provision of qualified interpreters, large print documents, Braille, digital versions of documents, and audio recording. 484.105 - Organization & Administration of Services Standard - (b) Administrator 1. The Administrator must: I. Be appointed by and report to the governing body; II. Be responsible for all day-to-day operations of the HHA; III. Ensure that a clinical manager as described in paragraph (c) of this section is available during all operating hours; IV. Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. 2. When the administrator is not available, a qualified, pre-designated person, authorized in writing by the administrator & governing body, assumes the same responsibilities and obligations as the administrator (may be the clinical manager). NOTE: See changes in qualifications under personnel qualifications 484.105 - Organization & Administration of Services Standard - (c) Clinical Manager Clinical manager: One or more qualified individuals must provide oversight of all patient care services and personnel. Oversight must include the following 1. Making patient and personnel assignments, 2. Coordinating patient care, 3. Coordinating referrals, 4. Assuring that patient needs are continually assessed, 5. Assuring the development, implementation, and updates of the individualized plan of care. Replaces standard for supervising nurse, therefore, the general duties described above are already required of home health agencies 10

484.105 - Organization & Administration of Services (d) Standard Parent-branch relationship - As Discussed in Definitions (e) Services under arrangement- No change (h) Institutional planning-the HHA, under the direction of the governing body, prepares an overall plan and a budget that includes an annual operating budget and capital expenditure plan. 484.115 - Personnel Qualifications Any new Administrator to an HHA must now have an undergraduate degree if not an RN or physician. Grandfathers current Administrators An administrator who begins working for an HHA after the effective date of this final rule, even if he or she was previously employed as an administrator for a different HHA, is required to be a licensed physician, a registered nurse, or hold an undergraduate degree. 484.115 - Personnel Qualifications Standard - (c) Clinical manager A person who is a licensed physician, PT, OT, SLP, MSW, Audiologist, or RN. The proposed rule had that a clinical manager be either a licensed physician or RN. RESPONSE: Commenters suggested a therapist or social worker could fill this role. CMS agreed that those professionals may also be qualified to fulfill the duties of the clinical manager. 11

5/1/2017 484.55 Comprehensive Assessment of Patients Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient s eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. 4 Standards: 1. Initial assessment of patients 2. Completion of the comprehensive assessment 3. Contents of the comprehensive assessment 4. Update of the comprehensive assessment 484.55 - Comprehensive assessment of Patients Standard: (a) Initial assessment visit Standard: (b) Completion of the comprehensive assessment Same Requirements as current Including that if nursing is on case, RN must do assessment. 484.55 - Comprehensive assessment of Patients Standard: (c) Contents of the comprehensive assessment The comprehensive assessment must accurately reflect the patient s status, and would assess or identify the following: 1. The patient s current health, psychosocial `functional (NEW) and cognitive (NEW), status RESPONSE - Assessing a patient s psychosocial status refers to an evaluation of mental health, social status, & functional capacity within the community by looking at issues surrounding both a patient s psychological and social condition. We are not requiring the use of any particular tool, nor are we prescribing the extent of the cognitive status assessment Our goal is to make cognitive assessment a routine practice in HHAs so that HHAs can use this information in developing and implementing the pt-specific POC 12

484.55 - Comprehensive assessment of Patients Standard: (c) Contents of the comprehensive assessment 2. The patient s strengths, goals, and care preferences, including the patient's progress toward achievement of the goals identified by the pt & the measurable outcomes identified by the HHA (NEW) RESPONSE- The HH POC has been developed with a focus on pt deficits that require treatment. This model of care places pt in a passive recipient role that does not optimize the achievement of positive patient outcomes & does not take into account pt-strengths that can be harnessed by the HHA staff and POC to facilitate patient well-being Each patient has their own set of care preferences, and we require HHAs to identify and respect these care preferences to the greatest degree possible. Our goal is to assure that HHAs plan for and provide care that is both patient-directed and in accordance with the physician ordered plan of care. 484.55 - Comprehensive assessment of Patients Standard: (c) Contents of the comprehensive assessment 3. The patient's continuing need for home care 4. The patient's medical, nursing, rehabilitative, social, and discharge planning needs 5. A review of all medications the patient is currently using 6. The patient s primary caregiver(s), if any, and other available supports (NEW), caregiver ability and willingness to assist 7. The patient s representative (if any) (NEW) 8. Incorporation of the current version of the Outcome and Assessment Information Set (OASIS) items 484.55 - Comprehensive Assessment of Patients (d) Update of the Comprehensive Assessment - Resumption of Care (2) Within 48 hours of the patient s return to the home from a hospital admission of 24 hours or more for any reason other than diagnostic tests, or on physician-ordered resumption date (NEW) 13

484.60 - Care Planning, Coordination of Services, and Quality Of Care Combines: 484.18 Acceptance of patients, plan of care medical supervision and 484.14 Coordination of care. 484.60 - Care Planning, Coordination of Services, and Quality Of Care 5 Standards Plan of Care Conformance with physician orders Review and revision of the plan of care Coordination of care Written information to the patient 484.60 - Care Planning, Coordination of Services, and Quality Of Care Standard - (a) Plan of Care Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician is consulted to approve additions or modifications to the original plan. 14

5/1/2017 484.60 Care Planning, Coordination of Services, and Quality Of Care Standard - Plan of Care The individualized plan of care must include the following (xii)...a description of the patients risk for emergency department visits and readmission... RESPONSE- We removed the terms low, medium, high, and are not suggesting a specific tool or process at this time. If HHA services are initiated following a patient s hospital discharge the HHA performs an assessment of the patient s level of risk for hospital emergency department visits and hospital re-admission HHAs are required to include in the patient s individualized plan of care all appropriate interventions that are necessary to address and mitigate identified risk factors 484.60 Care Planning, Coordination of Services, and Quality Of Care Evolving Plan of Care 3) All patient care orders, including verbal orders must be recorded in the plan of care RESPONSE- (Page 4536) The plan of care is an evolving document that outlines the patient s journey throughout HHA care and treatment. It is essential that the plan of care be reflective of past orders and current orders that are actively ongoing. As new orders are given to initiate or discontinue an intervention, the plan of care is updated to reflect those changes. New versions of the plan of care are created as needed to assure that each clinician is working on the most recent plan of care, with older versions being filed away in the clinical record in any manner that meets the needs of the HHA. 484.60 Care Planning, Coordination of Services, and Quality Of Care Standard (b) Conformance with Physician Orders (4) physician s verbal orders, an RN, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law and the HHA s policies, must document the orders in the patient s clinical record, and sign, date, and TIME the orders. RESPONSE- We believe that timing the receipt of verbal orders is necessary. There are times when a patient s condition rapidly changes... Therefore, we believe that it is necessary and appropriate to proactively record the time of day that each verbal order is received by an HHA clinician from a physician. This requirement corresponds with the clinical record authentication requirements at 484.110(b), which requires all entries in the clinical record to be timed. 15

484.60 - Care Planning, Coordination of Services, and Quality Of Care (3) Revisions to the plan of care must be communicated as follows: (i) Any revision to the plan of care due to a change in patient health status must be communicated to the patient, representative (if any), caregiver, and the physician who is responsible for the HHA plan of care. (ii) Any revisions related to plans for the patient s discharge must be communicated to the patient, representative, caregiver, all physicians issuing orders for the HHA plan of care, and the patient s primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any). COMMENT: The commenter requested that CMS clarify whether all changes to the plan of care require the plan of care to be re-signed by the physician, and if not, explicitly when that would and would not be required. RESPONSE: The signature of the physician who is responsible for issuing orders related to the condition(s) that led to the initiation of home health services should be on all iterations of the individualized plan of care for each patient in accordance with the requirements of 484.60(a). 484.60 - Care Planning, Coordination of Services, and Quality Of Care Standard (d) Coordination of Care Coordination of care, requires the HHA integrate services to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness, the coordination of care provided by all disciplines, and communication with the physician. 484.60 Care Planning, Coordination of Services, and Quality Of Care Standard - Care Delivery Require the HHA to coordinate care delivery to meet each patient s needs, and to involve the patient, representative (if any), and caregiver(s), as HHA ensures that each patient and caregiver receive ongoing training and education regarding the care and services identified in the plan of care that the patient and caregiver are expected to implement. 16

484.60 - Care Planning, Coordination of Services, and Quality Of Care Standard - Written information to the patient The HHA must provide the patient and caregiver with a copy of written instructions outlining: 1. Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA. 2. Patient medication schedule/ instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. 3. Any treatments to be administered by HHA personnel and personnel acting on behalf of the HHA, including therapy services. 4. Any other pertinent instruction related to the patient s care and treatments that the HHA will provide, specific to the patient s care needs. 5. Name and contact information of the HHA clinical manager. 484.75 - Skilled Professional Services Individual Conditions for each: SN, Therapy, MSW are now combined into this One, emphasizing the integrated team. 3 Standards : a)provision of services by skilled professionals b)responsibilities of skilled professionals c) Supervision of skilled professional assistants Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. 484.75 - Skilled Professional Services a) Provision of services by skilled professionals Skilled professional services are authorized, delivered, and supervised only by health care professionals who meet the appropriate qualifications and who practice according to the HHA s policies and procedures. 17

484.75: Skilled Professional Services Standard - (b) Responsibilities of skilled professional Skilled professionals must assume responsibility for, but not be restricted to, the following: 1. Ongoing interdisciplinary assessment of the patient 2. Development and evaluation of the plan of care in partnership with the patient, representative (if any), and caregiver(s) 3. Providing services that are ordered by the physician as indicated in the plan of care 4. Patient, caregiver, and family counseling 5. Preparing clinical notes 6. Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care 7. Participation in the HHA s QAPI program 8. Participation in HHA-sponsored in-service training. 484.75 Skilled professional services Standard - (c) Supervision of Skilled Professional Assistants 1. Nursing services are provided under the supervision of a registered nurse that meets the requirements of 484.115(k). 2. Rehabilitative therapy services are provided under the supervision of an occupational therapist or physical therapist that meets the requirements of 484.115(f) or (h), respectively. 3. Medical social services are provided under the supervision of a social worker that meets the requirements of 484.115(m). 484.80 Home Health Aide Services 18

484.80 Home Health Aide Services 9 Standards 1. Home health aide qualifications; 2. Content and duration of home health aide classroom and supervised practical training; 3. Competency evaluation; 4. In-service training; 5. Qualifications for instructors conducting classroom and supervised practical training; 6. Eligible training and competency evaluation organizations; 7. Home health aide assignments and duties; 8. Supervision of home health aides; 9. Individuals furnishing Medicaid personal care aide-only services under a Medicaid personal care benefit. Aide Services Key Changes o HHA s must take action when there is a potential or verified deficiency in aide services o Aides must be integrated into the Patient care team o Aides must recognize and report changes in skin condition o Therapists can now complete aide assignments and supervise aides even when nursing is on the case. o Addition of CNA as a qualifier for a Home Health Aide o Documentation of the aide training and competency 484.80 Home Health Aide Services Standard - (a) Home Health Aide Qualifications A qualified home health aide is a person who has successfully completed: (iii) A nurse aide training and competency evaluation program approved by the state as meeting the requirements of 483.151 through 483.154 of this chapter, and is currently listed in good standing on the state nurse aide registry 19

484.80 Home health aide services (a) Standard: Home health aide qualifications (2) A home health aide or nurse aide is not considered to have completed a program, as specified in paragraph (a)(1) of this section, if, since the individual s most recent completion of the program(s), there has been a continuous period of 24 consecutive months during which none of the services furnished by the individual as described in 409.40 of this chapter were for compensation. If there has been a 24-month lapse in furnishing services for compensation, the individual must complete another program, as specified in paragraph (a)(1) of this section, before providing services. 484.80 Home Health Aide Services Standard - (b) Content and Duration of Home Health Aide Classroom and Supervised Practical Training (3) A home health aide training program must address each of the following subject areas: (i) Communication skills, including the ability to read, write, and verbally report clinical information to patients, representatives, and caregivers, as well as to other HHA staff. (xiii) Recognizing and reporting changes in skin condition (4) The HHA must maintain documentation that demonstrates that the requirements of this standard have been met. 484.80 Home Health Aide Services Standard (c) Competency Evaluation (3) The competency evaluation must be performed by a registered nurse in consultation with other skilled professionals, as appropriate. (4) A home health aide is not considered competent in any task for which he or she is evaluated as unsatisfactory. An aide must not perform that task without direct supervision by a registered nurse until after he or she has received training in the task for which he or she was evaluated as unsatisfactory, and has successfully completed a subsequent evaluation. A home health aide is not considered to have successfully passed a competency evaluation if the aide has an unsatisfactory rating in more than one of the required areas. (5) The HHA must maintain documentation which demonstrates that the requirements of this standard have been met. 20

484.80 Home Health Aide Services Standard - (d) In-service Training Retains 12 as the minimum number of hours of in-service training required for a 12-month period. The training could occur while an aide was furnishing care to a patient. 484.80(b) describes the elements that must comprise home health aide classroom and supervised practical training Those elements of training should form a basis for ongoing in-service training. 484.80 Home Health Aide Services Standard (e) Qualifications for Instructors Conducting Classroom and Supervised Practical Training Classroom and supervised practical training must be performed by a registered nurse who possesses a minimum of 2 years nursing experience, at least 1 year of which must be in home health care, or by other individuals under the general supervision of the registered nurse. RESPONSE- We continue to believe that RNs with nursing experience in the home health field should be the principal instructors in the basic training of home health aides. While other individuals could provide instruction to home health aides, classroom and practical training would be required to be under the general supervision of an RN who meets qualifications above. 484.80 Home Health Aide Services Standard - (f) Eligible Training and Competency Evaluation Organizations A home health aide training program and competency evaluation program may be offered by any organization except by an HHA that, within the previous 2 years: Was out of compliance with the requirements of paragraphs (b), (c), (d), or (e) of this section; or Permitted an individual who does not meet the definition of a qualified home health aide as specified in paragraph (a) of this section to furnish home health aide services (with the exception of licensed health professionals and volunteers); or Was subjected to an extended (or partially extended) survey as a result of having been found to have furnished substandard care (or for other reasons as determined by CMS or the state); or Was assessed a civil monetary penalty of $5,000 or more as an intermediate sanction; or Was found to have compliance deficiencies that endangered the health and safety of the HHA s patients, and had temporary management appointed to oversee the management of the HHA; or 21

484.80 Home Health Aide Services Standard - (f) Eligible Training and Competency Evaluation Organizations A home health aide training program and competency evaluation program may be offered by any organization except by an HHA that, within the previous 2 years: - Had all or part of its Medicare payments suspended; or Was found under any federal or state law to have: Had its participation in the Medicare program terminated; or Been assessed a penalty of $5,000 or more for deficiencies in federal or state standards for HHAs; or Been subjected to a suspension of Medicare payments to which it otherwise would have been entitled; or Operated under temporary management that was appointed to oversee the operation of the HHA and to ensure the health and safety of the HHA s patients; or Been closed, or had its patients transferred by the state; or Been excluded from participating in federal health care programs or debarred from participating in any government programs 484.80 Home Health Aide Services Standard: (g) Home Health Aide Assignments and Duties 1. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). 2. A home health aide provides services that are: (iv) Consistent with the home health aide training. (4) Aides must be members of the interdisciplinary team, must report changes in the patients condition to an RN or other appropriate skilled professional, and must complete appropriate records in compliance with the HHA s policies and procedures. 484.80 Home Health Aide Services Standard - (h) Supervision of Home Health Aides (1) (i) if aide services are provided to a pt who is receiving skilled nursing, PT or OT or SLP services, an RN or other appropriate skilled professional who is familiar with the patient, the pt s plan of care, and the written pt care instructions, must make an onsite visit to the pt s home no less frequently than every 14 days. The aide does not have to be present during this visit. (ii) if an area of concern in aide services is noted by the supervising RN or other appropriate skilled professional, then the supervising individual must make an on-site visit to the location where the patient is receiving care in order to observe and assess the aide while he or she is performing care. (iii) An RN or other appropriate skilled professional must make an annual on-site visit to the location where a pt is receiving care in order to observe and assess each aide while he or she is performing care. 22

484.80 Home Health Aide Services Standard - (h) Supervision of Home Health Aides (2) If home health aide services are provided to a pt who is not receiving skilled nursing care, PT or OT or SLP services, the RN must make an on-site visit to the location where the pt is receiving care no less frequently than every 60 days in order to observe and assess each aide while he or she is performing care. (3) If a deficiency in aide services is verified by the RN or other appropriate skilled professional during an on-site visit, then the agency must conduct, and the aide must complete a competency evaluation 484.80-484.80 Home Health Aide Services Standard - (h) Supervision of Home Health Aides (4) HH Aide supervision must ensure that aides furnish care in a safe and effective manner, including, but not limited to the following elements: (i)following the patient s plan of care for completing of tasks assigned to an aide by RN or other appropriate skilled professional (ii) Maintaining an open communication process with the patient, representative (if any), caregivers and family (iii) Demonstrating competency with assigned tasks (iv) complying with infection prevention and control policies and procedures (v) reporting changes in the patient's condition (vi) honoring patient rights Response- All elements set forth in paragraph (h)(4) need to be accounted for in each and every supervisory visit. 484.70 - Infection Prevention and Control In current COPs, the home health regulations only briefly addressed infection control procedures, with no specifics. 3 Standards in the Condition: Prevention Control Education 23

484.70 -Infection Prevention and Control Standard (a) Prevention The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. (a) Standard: Prevention The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. 484.70: Infection Prevention and Control Standard- (b) Control The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA s quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. 484.70 - Infection Prevention and Control Standard: (c) Education The HHA must provide infection control education to staff, patients, and caregiver(s). 24

484.65 - QAPI QA... QI...CQI...TQC...PI.. CASPER-OBQI, OUTCOMES and so on... For Years our home health industry, as the rest of the healthcare industry has done some form or another of quality improvement. Therefore, the New CoP for Quality Assessment and Performance Improvement Program (QAPI) should not be brand new for most agencies! In fact, in any accredited agency, the AO standards are very similar to the Condition! PI Projects Not into effect until July 13, 2018. BUT START to develop, implement, and collect data July 13, 2017! 484.65 - QAPI QAPI CoP is specific and prescriptive, which should help agencies to develop their programs. The following is language in the Condition, although it is grouped together in a different manner: The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. Program must involve all HHA services (including those under contract) and focus on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions. Program must take actions that address performance across the spectrum of care, including the prevention and reduction of medical errors. 484.65 - QAPI The Governing Body is given a major role in ensuring that the HHA has a compliant QAPI program that focuses on improving patient outcomes. The Governing Body must ensure that the program reflects the complexity of the organization and its services. They are responsible for ensuring the following: QAPI is an ongoing program for quality improvement and patient safety is defined, implemented and maintained The HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness That clear expectations for patient safety are established, implemented, and maintained That any findings of fraud or waste are appropriately addressed. The frequency and detail of the data collection must be approved by the HHA s governing body. 25

484.65 - QAPI The QAPI program must be capable of showing measurable improvement in indicators that reflect improved health outcomes, patient safety, and quality of care. The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance in order to assess processes of care, HHA services, and operations and to identify opportunities for improvement. Performance improvement activities must track adverse patient events, analyze their causes, and implement preventive actions. 484.65 - QAPI The HHA s performance improvement activities must: Focus on high risk, high volume, or problem prone areas Consider incidence, prevalence, and severity of problems in those areas Lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. The HHA must take actions aimed at performance improvement, and, after implementing those actions, the HHA must measure its success and track performance to ensure that improvements are sustained. Effective July 2018: The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA s services and operations. The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. 484.102 - EMERGENCY PREPAREDNESS Applies to 17 provider types, including home health HHA must comply with all applicable Federal, State, and local emergency preparedness requirements. 4 Required Elements (Standards) of the Emergency Preparedness Plan: Emergency plan Policies and Procedures Communication plan Training and testing program 26

484.102 - Emergency Preparedness Standard- (a) Emergency plan The emergency preparedness program must include, but not be limited to, the following elements: The HHA must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do all of the following: Be based on and include a documented, facility-based and community-based risk assessment, utilizing AN ALL-HAZARDS approach Include strategies for addressing emergency events identified by the risk assessment Address patient population, including, but not limited to, the type of services the HHA has the ability to provide in an emergency and continuity of operations, including delegations of authority and succession plans Include for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials efforts to maintain an integrated response during a disaster or emergency situation, including documentation of the HHA s efforts to contact such officials and, when applicable, of its participation in collaborative and cooperative planning efforts. 484.102 - Emergency Preparedness Standard- (b) Policies and Procedures The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. At a minimum, the policies and procedures must address the following: (1) The plans for the HHA s patients during a natural or man-made disaster. Individual plans for each patient must be included as part of the comprehensive patient assessment, which must be conducted according to the provisions at 484.55. 484.102 - Emergency Preparedness Standard- (b) Policies and Procedures (2) The procedures to inform State and local emergency preparedness officials about HHA patients in need of evacuation from their residences at any time due to an emergency situation based on the patient s medical and psychiatric condition and home environment. (3) The procedures to follow up with on-duty staff and patients to determine services that are needed, in the event that there is an interruption in services during or due to an emergency. The HHA must inform State and local officials of any on-duty staff or patients that they are unable to contact. 27

484.102 - Emergency Preparedness Standard- (b) Policies and Procedures (4) A system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains the availability of records. (5) The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State or Federally designated health care professionals to address surge needs during an emergency. 484.102 - Emergency Preparedness Standard - (c) Communication Plan The HHA must develop and maintain an emergency preparedness communication plan that complies with Federal, State, and local laws and must be reviewed and updated at least annually. The communication plan must include all of the following: (1) Names and contact information for the following: Staff, Entities providing services under arrangement, Patients, Physicians, Volunteers (2) Contact information for the following: (i) Federal, State, tribal, regional, or local emergency preparedness staff. (ii) Other sources of assistance. (3) Primary and alternate means for communicating with the HHA s staff, Federal, State, tribal, regional, and local emergency management agencies. 484.102 - Emergency Preparedness Standard - (c) Communication Plan (4) A method for sharing information and medical documentation for patients under the HHA s care, as necessary, with other health care providers to maintain the continuity of care. (5) A means of providing information about the general condition and location of patients under the facility s care as permitted under 45 CFR 164.510(b)(4). (6) A means of providing information about the HHA s needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. 28

484.102 - Emergency Preparedness Standard - (d) Training and Testing The HHA must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan. The training and testing program must be reviewed and updated at least annually. (1) Training program. The HHA must do all of the following: Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. Provide emergency preparedness training at least annually. Maintain documentation of the training. Demonstrate staff knowledge of emergency procedures. 484.102 - Emergency Preparedness Standard - (d) Training and Testing (2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) (ii) Participate in a full-scale exercise that is community-based or when a community-based exercise is not accessible, an individual, facility-based. If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in a community-based or individual, facility-based full-scale exercise for 1 year following the onset of the actual event. 484.102 - Emergency Preparedness Standard - (d) Training and Testing (ii) Conduct an additional exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility based. (B) A tabletop exercise that includes a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA s emergency plan, as needed. 29

484.102 - Emergency Preparedness Standard - (e) Integrated Healthcare Systems If a HHA is part of a healthcare system consisting of multiple separately certified healthcare facilities that elects to have a unified and integrated emergency preparedness program, the HHA may choose to participate in the healthcare system s coordinated emergency preparedness program. If elected, the unified and integrated emergency preparedness program must do all of the following: (1) Demonstrate that each separately certified facility within the system actively participated in the development of the unified and integrated emergency preparedness program. (2) Be developed and maintained in a manner that takes into account each separately certified facility s unique circumstances, patient populations, and services offered. (3) Demonstrate that each separately certified facility is capable of actively using the unified and integrated emergency preparedness program and is in compliance with the program. 484.102 - Emergency Preparedness Standard - (e) Integrated Healthcare Systems (4) Include a unified and integrated emergency plan that meets the requirements of paragraphs (a)(2), (3), and (4) of this section. The unified and integrated emergency plan must also be based on and include all of the following: (i) A documented community-based risk assessment, utilizing an all-hazards approach. (ii) A documented individual facility based risk assessment for each separately certified facility within the health system, utilizing an all-hazards approach. (5) Include integrated policies and procedures that meet the requirements set forth in paragraph (b) of this section, a coordinated communication plan and training and testing programs that meet the requirements of paragraphs (c) and (d) of this section, respectively. 484.100 Condition of participation: Compliance with Federal, State, and local laws and regulations related to the health and safety of patients 30

484.100- Compliance With Laws and Regulations Related to the Health and Safety of Patients Standard: (a) Disclosure of ownership and management information The HHA and its staff must operate and furnish services in compliance with all applicable federal, state, and local laws and regulations related to the health and safety of patients. If state or local law provides licensing of HHAs, the HHA must be licensed. (a) Standard: Disclosure of ownership and management information The HHA must disclose the following information to the state survey agency at the time of the HHA s initial request for certification, for each survey, and at the time of any change in ownership or management: SEE CoP page 82 of 88 484.100- Compliance With Laws and Regulations Related to the Health and Safety of Patients Standard - (b) Licensing The HHA, its branches, and all persons furnishing services to patients must be licensed, certified, or registered, as applicable, in accordance with the state licensing authority as meeting those requirements. 484.100- Compliance With Laws and Regulations Related to the Health and Safety of Patients Standard: (c) Laboratory services (1) If the HHA engages in laboratory testing outside of the context of assisting an individual in self-administering a test with an appliance that has been cleared for that purpose by the Food and Drug Administration, the testing must be in compliance with all applicable requirements of part 493 of this chapter. The HHA may not substitute its equipment for a patient s equipment when assisting with selfadministered tests. (2) If the HHA refers specimens for laboratory testing, the referral laboratory must be certified in the appropriate specialties and subspecialties of services in accordance with the applicable requirements of part 493 of this chapter. 31

Re: Lab Services - CLIA Waiver RESPONSE TO COMMENTS If the HHA is only assisting an individual in self-administering a test with an appliance that has been cleared for that purpose by the Food and Drug Administration (regardless of appliance ownership status), the testing self-administration assistance is not required to be in compliance with the applicable requirements of part 493 of this chapter (CLIA). However, if the HHA engages in laboratory testing outside of the context of assisting an individual in self-administering a test with an appliance that has been cleared for that purpose by the Food and Drug Administration, then the testing must be in compliance with all applicable requirements of part 493 of this chapter. 484.110 - Clinical Records 5 Standards: (a) Standard: Contents of clinical record (b) Standard: Authentication (c) Standard: Retention of records (d) Standard: Protection of records (e) Standard: Retrieval of clinical records 484.110 - Clinical Records Standard: (a) Contents of Clinical Record The record must include: (4) Contact information for the patient, the patient s representative if any), and the patient s primary caregiver(s) (5) Contact information for the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA 32

484.110 - Clinical Records Standard - (a) Contents of Clinical Record (6) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient s discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient s care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. 484.110 - Clinical Records Standard - (b) Standard: Authentication All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. 484.110 - Clinical Records Standard - (c) Retention of Records (1) Clinical records must be retained for 5 years after the discharge of the patient, unless state law stipulates a longer period of time. (2) The HHA s policies must provide for retention of clinical records even if it discontinues operation. When an HHA discontinues operation, it must inform the state agency where clinical records will be maintained. 33

484.110 - Clinical Records Standard: (d) Protection of records The clinical record, its contents, and the information contained therein must be safeguarded against loss or unauthorized use. The HHA must be in compliance with the rules regarding protected health information set out at 45 CFR parts 160 and 164. 484.110 - Clinical Records Standard: (e) Retrieval of clinical records A patient s clinical record (whether hard copy or electronic form) must be made available to a patient, free of charge, upon request at the next home visit, or within 4 business days (whichever comes first). PREPARE NOW FOR THE JANUARY 13 th IMPLEMENTATION! Don t wait thinking that you have 6 more months! Be on Look Out for interpretive guidelines Read the comments and responses in final rule- very informative Educate all of your agency staff Have all staff involved in Policy and Procedure Development, QAPI, Emergency Plan, etc. 34

THANK YOU!!! Sharon M. Litwin, RN, BSHS, MHA, HCS-D Senior Managing Partner 5 Star Consultants, LLC slitwin@5starconsultants.net www.5starconsultants.net 35