Regulatory Issues for Comprehensive Home Care in Assisted Living*

Transcription

1 MN DONA Spring Conference 4/16/2015 Regulatory Issues for Comprehensive Home Care in Assisted Living* MN-DONA Spring Conference April 16, 2015 Doug Beardsley Vice-President of Member Services Care Providers of Minnesota * Plus Bonus CMS Nursing Home Five-Star Update! Copyright 2015 by Care Providers of Minnesota Why Does the Regulatory Environment for Home Care in Assisted Living Matter? MN-DONA is growing their representation of Directors of Nursing leading licensed Home Care Agencies providing services in Registered Housing with Services settings using the term Assisted Living Home Care began to change starting July 1, 2014 on paper, the change transition will be completed July 1, New Home Care and Assisted Living Provider division at MDH Increased frequency of home care surveys (initial and every 3 years) Increased home care survey fines Decreased opportunities to correct home care correction orders before actions are taken against the license Lines of service delivery continue to get blurred home care in the private home, home care in an AL, post-acute care, transitional care, memory care, care suites, traditional nursing facility care, swing beds, etc. Standards of Practice are crossing service delivery lines. (952)

2 MN DONA Spring Conference 4/16/2015 License Changes Class A Class F Licensed Only, or Medicare Certified Able to provide services anywhere Licensed Only Limited to providing services to within a HWS setting Comprehensive or Basic The Basics Red-Roof Assisted Living Red Roof Assisted Living is actually the following: An apartment with all the landlord/tenant rights of any apartment A Registered Housing With Services Establishment registered with MDH s Health Regulation Division. Annual registration is required. Has an Arranged Home Care Provider (internal or external) identified with MDH May have elected with MDH to operate a Special Care Unit or Special Program for Alzheimer s or Related Disorders May have elected with MDH to use the term Assisted Living Has filed a Uniform Consumer Information Guide (UCIG) (952)

3 MN DONA Spring Conference 4/16/2015 The Basics Red-Roof Assisted Living Red Roof Assisted Living has identified an Arranged Home Care Provider. The home care provider may or may not have common ownership with Red Roof. Tenants have the right to choose their own home care agency. Care Agency The Basics HWS 1 HWS 4 Home Care HWS 2 HWS 3 Care Agency Home Care 1 Home Care 2 OR Home Care 3 Home Care 4 The home care provider may provide home care services at multiple sites, including other Assisted Living locations. The home care provider may provide home care services to persons in the community residing in individual apartments or homes. If the home care provider provides arranged home care services at multiple HWS/Assisted Living locations, management must decide if each location will have their own license or if one license can cover multiple locations. Distance can be an issue Oversight Cost can be an issue Licensing Fees and other costs Survey implications Liability implications (952)

4 MN DONA Spring Conference 4/16/2015 The Basics MDH s Home Care and Assisted Living survey staff will survey the Home Care Agency. Care Agency Beginning July 1, 2015, all Minnesota home care providers will be surveyed at least every 3 years. All NEW home care agencies will be given a temporary license, and will be surveyed within 12 months of opening. A successful survey will switch the license from temporary to a real license beginning the 3 year survey cycles. OHFC staff will conduct investigations at home care providers as reports and complaints are received by the Common Entry Point under the MN Vulnerable Adults Act. Tenants have the right to choose their own home care agency. The Basics Comprehensive or Basic Care Agency Home care services that can be provided with a basic home care license are assistive tasks provided by licensed or unlicensed personnel that include: 1. Assisting with dressing, self-feeding, oral hygiene, hair care, grooming, toileting, and bathing; 2. Providing standby assistance; 3. Providing verbal or visual reminders to the client to take regularly scheduled medication, which includes bringing the client previously set-up medication, medication in original containers, or liquid or food to accompany the medication; 4. Providing verbal or visual reminders to the client to perform regularly scheduled treatments and exercises; 5. Preparing modified diets ordered by a licensed health professional; and 6. Assisting with laundry, housekeeping, meal preparation, shopping, or other household chores and services if the provider is also providing at least one of the above services. (952)

5 MN DONA Spring Conference 4/16/2015 The Basics Comprehensive or Basic Care Agency Does a home care agency licensed as a Basic Home Care Provider need a nurse on staff? The Basics Comprehensive or Basic Care Agency Home care services that can be provided with a comprehensive license include any Basic tasks and one or more of the following: 1. Services of an advanced practice nurse, registered nurse, licensed practical nurse, physical therapist, respiratory therapist, occupational therapist, speechlanguage pathologist, dietitian or nutritionist, or social worker; 2. Tasks delegated to unlicensed personnel by a registered nurse or assigned by a licensed health professional within the person's scope of practice; 3. Medication management services; 4. Hands-on assistance with transfers and mobility; 5. Assisting clients with eating when the clients have complicating eating problems as identified in the client record or through an assessment such as difficulty swallowing, recurrent lung aspirations, or requiring the use of a tube or parenteral or intravenous instruments to be fed; or 6. Providing other complex or specialty health care services. (952)

6 MN DONA Spring Conference 4/16/2015 The Basics Comprehensive or Basic Care Agency Fully rewritten regulations for both types of licenses. In affect when the provider opens a new licensed home care agency or when the Class F or Class A agency transitions to a Comprehensive or Basic through license renewal (July 1, 2014 through July 1, 2015). MDH ALHCP Surveyors are now surveying to the new Comprehensive and Basic requirements (plus conducting resurveys on Class A and Class F surveys already conducted) When the license switches the expectations are that all new requirements are in place as of day one. The regulations and survey process are also new to surveyors. Red-Roof Assisted Living The vast majority of tenants living in an assisted living environment will be receiving services from a. Comprehensive home care agency/provider who must have a RN available (inperson, via phone, text, etc.) when delegated nursing services are being provided. (952)

7 MN DONA Spring Conference 4/16/2015 The Basics MDH has ramped up with new HCAL Program Grown from 4 home care surveyors (licensed only home care) to over 20 surveyors plus supervisory and support staff Busy with the transition and review of new licenses Licenses as of 3/25/14: LICENSE TYPE NUMBER OF MN AGENCIES Class F 264 Class A 454 Basic 38 Temporary Basic 15 Comprehensive 712 Temporary Comprehensive 43 Medicare Certified HHA* 207 Significant Changes for those going from Class F or Class A to Comprehensive: Staff Issues Annual performance reviews required Many volunteers now have similar requirements to home care staff New staff supervisory visit within 30 days of employment Revised list of orientation topics Emergency preparedness Three new topics to the required 8 hours of annual training (mandated reporting, review of the Home Care Bill of Rights, and review of policies and procedures) Service Delivery Issues Statement of Home Care Services Different Client Monitoring and Assessment Schedules Ability to provide medications for unanticipated leaves Removes limitations on medications provided by Unlicensed Personnel Annual prescription renewals Must have prescriptions available for managed medications (952)

8 MN DONA Spring Conference 4/16/2015 Significant Changes for those going from Class F or Class A to Comprehensive: Administrative Changes Disaster and Emergency Preparedness Planning Updated UCIGs Availability of RN or Therapist when providing services Therapies Quality Management (Performance Improvement) plan Complaint Policies and Procedures Service delivery is not limited to the HWS setting (Class F) Survey Changes Three-year cycles Full Survey, Core Survey, Follow-Up Survey Draft survey results at exit, final within 30 days Follow-up survey within 90 days Level and Scope of findings New fine schedules Reconsideration process Increased surveyor training Most regulatory requirements did not change significantly or at all! This means if the home care provider was out of compliance with Class A or Class F requirements, they most likely will also be out of compliance with Comprehensive requirements. (952)

9 MN DONA Spring Conference 4/16/2015 What are the new surveys finding? (952)

10 MN DONA Spring Conference 4/16/2015 What are the current Comprehensive Home Care Survey issues? #1 TB Prevention and Control 144A.4798 EMPLOYEE HEALTH STATUS Subdivision 1. Tuberculosis (TB) prevention and control. A home care provider must establish and maintain a TB prevention and control program based on the most current guidelines issued by the Centers for Disease Control and Prevention (CDC). Components of a TB prevention and control program include screening all staff providing home care services, both paid and unpaid, at the time of hire for active TB disease and latent TB infection, and developing and implementing a written TB infection control plan. Failed to screen employees for TB symptoms Failed to conduct a two-step Tuberculin Skin Test (TST) upon hire (no client contact until results of first step is read) TST documentation did not include induration and determination of negative or positive TB screening and TST results not in employee/health files What are the current Comprehensive Home Care Survey issues? #1 TB Prevention and Control (continued) Failed to establish and maintain a TB prevention and infection control program, including: Documentation of a current community TB risk assessment A TB infection control team or identified infection control individual Written infection control procedures for handling infectious TB clients Content of TB training for health care workers Documentation showing initial and ongoing TB education for health care workers Verify your policies and procedures are in alignment with the 2005 CDC guidelines, not the 1994 CDC guidelines Remember that TSTs are not required to be conducted on home care clients Resource: MDH TB Guide for TB in healthcare Resource: MDH TB Survey Form Resource: Care Providers of Minnesota self-audit tool (952)

11 MN DONA Spring Conference 4/16/2015 What are the current Comprehensive Home Care Survey issues? #2 Accepted Standards of Practice (Bill of Rights) 144A.44 HOME CARE BILL OF RIGHTS (2) The right to receive care and services according to a suitable and up-to-date plan, and subject to accepted health care, medical or nursing standards, to take an active part in developing, modifying, and evaluating the plan and services Infection Control Observations: Not hand washing between glove changes Not hand washing after providing peri-care Siderail Issues: Lacked evidence the RN completed an assessment of the client s functional status and the need for a siderail, and lacked evidence that the risk versus benefits of side rails use was reviewed with the client and/or responsible persons Siderails used were non-compliant with the 2006 FDA dimensional guidance, and this risk had not been identified or communicated with the client and/or responsible persons (staff did not know how long the siderails had been in place or where they came from) Lacked manufacturer s instructions for the use of the siderail What are the current Comprehensive Home Care Survey issues? #2 Accepted Standards of Practice (Bill of Rights) (continued) Alarms/Restraints: Used inconsistent with manufacturer s recommendations No policy for alarm use No assessments for the use of alarms No assessment for use and risks/benefits of restraint ( lap hugger ) Falls, Bruises, & Skin Tears: Lack of evaluations or re-evaluations completed by a RN to assess for causative factors to determine individualized interventions to reduce client injuries (look at incident reports and communication books) Oxygen: 18 tanks of oxygen in the middle of the client s apartment/room. 16 were empty and two were full with an additional one in-use. None were secured in any manner. No policy or procedures for oxygen storage. Resource: Care Providers of Minnesota Siderail Brochure for Home Care in Assisted Living and Self Audit tool (952)

12 MN DONA Spring Conference 4/16/2015 What are the current Comprehensive Home Care Survey issues? #3 Statement of Home Care Services 144A.4791 HOME CARE PROVIDER RESPONSIBILITIES WITH RESPECT TO CLIENTS Subd. 3. Statement of home care services. Prior to the initiation of services, a home care provider must provide to the client or the client's representative a written statement which identifies if the provider has a basic or comprehensive home care license, the services the provider is authorized to provide, and which services the provider cannot provide under the scope of the provider's license. The home care provider shall obtain written acknowledgment from the clients that the provider has provided the statement or must document why the provider could not obtain the acknowledgment. Failure to ensure a written statement of Comprehensive (or Basic) Home Care Services was provided to the each client or client s representative prior to the initiation of services. Resource: MDH Statement of Comprehensive Home Care Services (sample) (952)

13 MN DONA Spring Conference 4/16/2015 What are the current Comprehensive Home Care Survey issues? #4 Contents of Service Plan 144A.4791 HOME CARE PROVIDER RESPONSIBILITIES WITH RESPECT TO CLIENTS Subd. 9 (f) The service plan must include: 1. A description of the home care services to be provided, the fees for services, and the frequency of each service, according to the client's current review or assessment and client preferences; 2. The identification of the staff or categories of staff who will provide the services; 3. The schedule and methods of monitoring reviews or assessments of the client; 4. The frequency of sessions of supervision of staff and type of personnel who will supervise staff; and 5. A contingency plan that includes: a. The action to be taken by the home care provider and by the client or client's representative if the scheduled service cannot be provided; b. Information and a method for a client or client's representative to contact the home care provider; c. Names and contact information of persons the client wishes to have notified in an emergency or if there is a significant adverse change in the client's condition, including identification of and information as to who has authority to sign for the client in an emergency; and d. The circumstances in which emergency medical services are not to be summoned, and declarations made by the client under those chapters. What are the current Comprehensive Home Care Survey issues? #4 Contents of Service Plan (continued) Service Plans failed to contain all nine required elements of a Service Plan Resource: Care Providers of Minnesota self-audit tool (952)

14 MN DONA Spring Conference 4/16/2015 What are the current Comprehensive Home Care Survey issues? #5 Documentation of Medication Administration 144A.4792 MEDICATION MANAGEMENT Subd. 8. Documentation of administration of medications. Each medication administered by comprehensive home care provider staff must be documented in the client's record. The documentation must include the signature and title of the person who administered the medication. The documentation must include the medication name, dosage, date and time administered, and method and route of administration. The staff must document the reason why medication administration was not completed as prescribed and document any follow-up procedures that were provided to meet the client's needs when medication was not administered as prescribed and in compliance with the client's medication management plan. Physician orders were not implemented as ordered Discontinued medication continued to be given Incorrectly transcribed physician medication orders resulting in incorrect medication administration Medication not given as ordered eye drops, oral meds, insulin, etc. PRNs Given but not documented No indications for use No effectiveness of medication documented What are the current Comprehensive Home Care Survey issues? #5 Documentation of Medication Administration (continued) Medications given but not documented properly Oral and/or inhalant medications given but not documented Medications documented as given before they are administered Sloppy documentation by ULPs (lacking required elements of medication administration documentation) I don t document when giving meds. Resource: Care Providers of Minnesota self-audit tool (952)

15 MN DONA Spring Conference 4/16/2015 What are the current Comprehensive Home Care Survey issues? #6 Service Plan: Implementation and Revisions 144A.4791 HOME CARE PROVIDER RESPONSIBILITIES WITH RESPECT TO CLIENTS Subd. 9. Service plan, implementation, and revisions to service plan (a-e) a. No later than 14 days after the initiation of services, a home care provider shall finalize a current written service plan. b. The service plan and any revisions must include a signature or other authentication by the home care provider and by the client or the client's representative documenting agreement on the services to be provided. The service plan must be revised, if needed, based on client review or reassessment. The provider must provide information to the client about changes to the provider's fee for services and how to contact the Office of the Ombudsman for Long-Term Care. c. The home care provider must implement and provide all services required by the current service plan. d. The service plan and revised service plan must be entered into the client's record, including notice of a change in a client's fees when applicable. e. Staff providing home care services must be informed of the current written service plan. (952)

16 MN DONA Spring Conference 4/16/2015 What are the current Comprehensive Home Care Survey issues? #6 Service Plan: Implementation and Revisions (continued) Services plans not completed within 14 days of service delivery This one fell through the cracks. Services outlined in the service plan were not provided as described or not provided at all Emergency pendant Monitoring and ordering of diabetic supplies Services being provided were not identified in the service plan Diabetic management (including blood glucose monitoring and insulin administration) Catheter care services Required elements of service plan were missing (note: issued incorrectly these should be cited under Contents of Service Plan ) Date Signature of home care agency representative Signature of client or client s representative Any other required elements We use care plans not Service Plans. Resource: See previous Care Providers of Minnesota self-audit tool What are the current Comprehensive Home Care Survey issues? #7 Assessment and Monitoring 144A.4791 HOME CARE PROVIDER RESPONSIBILITIES WITH RESPECT TO CLIENTS Subd. 8. Comprehensive assessment, monitoring, and reassessment. a. When the services being provided are comprehensive home care services, an individualized initial assessment must be conducted in person by a registered nurse. When the services are provided by other licensed health professionals, the assessment must be conducted by the appropriate health professional. This initial assessment must be completed within five days after initiation of home care services. b. Client monitoring and reassessment must be conducted in the client's home no more than 14 days after initiation of services. c. Ongoing client monitoring and reassessment must be conducted as needed based on changes in the needs of the client and cannot exceed 90 days from the last date of the assessment. The monitoring and reassessment may be conducted at the client's residence or through the utilization of telecommunication methods based on practice standards that meet the individual client's needs. (952)

17 MN DONA Spring Conference 4/16/2015 What are the current Comprehensive Home Care Survey issues? #7 Assessment and Monitoring (continued) Reassessments not completed as a result of changes in condition Falls Injuries Bruising Skin Tears Change in condition Return from ER or Hospitalization Move to secured unit due to change in cognitive function Note: relationship to incident reports and communication books Failure to conduct a nursing assessment within 5 days after initiation of services Failure to conduct a re-assessment within 14 days after initiation of services. Monitoring and Reassessments not completed at least every 90 days from the date of the last assessment Resource: Care Providers of Minnesota self-audit tools (3) What are the current Comprehensive Home Care Survey issues? #8 Medication Management Policies and Procedures 144A.4792 MEDICATION MANAGEMENT Subd. 1 b) A comprehensive home care provider who provides medication management services must develop, implement, and maintain current written medication management policies and procedures. The policies and procedures must be developed under the supervision and direction of a registered nurse, licensed health professional, or pharmacist consistent with current practice standards and guidelines. c) The written policies and procedures must address requesting and receiving prescriptions for medications; preparing and giving medications; verifying that prescription drugs are administered as prescribed; documenting medication management activities; controlling and storing medications; monitoring and evaluating medication use; resolving medication errors; communicating with the prescriber, pharmacist, and client and client representative, if any; disposing of unused medications; and educating clients and client representatives about medications. When controlled substances are being managed, the policies and procedures must also identify how the provider will ensure security and accountability for the overall management, control, and disposition of those substances in compliance with state and federal regulations. (952)

18 MN DONA Spring Conference 4/16/2015 What are the current Comprehensive Home Care Survey issues? #8 Medication Management Policies and Procedures (continued) Home care agency did not have any medication policies or procedures Unaware that medication management policies and procedures had to be developed It was something we were working on. Medication management policies and procedures did not contain all the required elements (see previous slide) The licensee did not have policies and procedures in place to prevent diversion, ensure security, and accountability of each clients controlled substances Resource: Care Providers of Minnesota self-audit tool What are the current Comprehensive Home Care Survey issues? #9 Individual Abuse Prevention Plans 144A.479 HOME CARE PROVIDER RESPONSIBILITIES; BUSINESS OPERATION. Subd. 6(b). Each home care provider must develop and implement an individual abuse prevention plan for each vulnerable minor or adult for whom home care services are provided by a home care provider. The plan shall contain an individualized review or assessment of: 1. The person's susceptibility to abuse by another individual, including other vulnerable adults or minors. 2. The person's risk of abusing other vulnerable adults or minors. 3. Statements of the specific measures to be taken to minimize the risk of abuse to that person and other vulnerable adults or minors. For purposes of the abuse prevention plan, the term abuse includes self-abuse. (952)

19 MN DONA Spring Conference 4/16/2015 What are the current Comprehensive Home Care Survey issues? #9 Individual Abuse Prevention Plans (continued) Individual abuse prevention plans had not been completed for clients Keeping them updated and current is a challenge: Changes in condition vulnerabilities of client viewed during survey does not match what is identified in the abuse prevention plan (falls, memory impairment/cognitive function, decline in condition, violent or threatening behaviors, elopement, unsafe smoking, etc.) Required elements of an individual abuse prevention plan were missing, such as interventions for identified vulnerabilities Resource: Care Providers of Minnesota self-audit tool Remember it s not just HCALP surveyors, it is also OHFC Investigators Complaints SFY 2010 SFY 2011 SFY 2012 SFY 2013 Home Care Agency Self-Reports to the CEP SFY 2010 SFY 2011 SFY 2012 SFY 2013 Home Care TOTAL SFY 2010 SFY 2011 SFY 2012 SFY 2013 Home Care WOW (952)

20 MN DONA Spring Conference 4/16/2015 Remember it s not just HCALP surveyors, it is also OHFC Investigators Theft = 44% OHFC Substantiated Findings Against MN Licensed Home Care Providers in % 21% 25% 35% Abuse Exploitation - $ Neglect of Health Care Exploitation - Medications Home Care Survey Questions (952)

21 MN DONA Spring Conference 4/16/2015 Update on CMS Nursing Home Five-Star Rating Methodology (952)

22 MN DONA Spring Conference 4/16/2015 Update on CMS Nursing Home Five-Star Rating System The basic 5-Star overall methodology has not changed: Step 1: Start with the Health Inspections Rating (1-5 stars). Step 2: Add 1 star if the Staffing rating is 4 or 5 stars and greater than the Health Inspections Rating. Subtract 1 star if the Staffing rating is 1 star. Step 3: Add 1 star if the Quality Measures rating is 5 stars; subtract 1 star if the Quality Measures rating is 1 star. Step 4: If the Health Inspections rating is 1 star, then the Overall rating cannot be upgraded by more than 1 star based on the Staffing and Quality Measure ratings. Step 5: If a nursing home is a Special Focus Facility, the maximum Overall rating is 3 stars. Update on CMS Nursing Home Five-Star Rating System However, the following changes did occur on February 20, 2015: Change 1: Added 2 new Quality Measures: Long-Stay Antipsychotic Medication Measure Short-Stay Antipsychotic Medication Measure This gives a new total of Quality Measures of 11 measures Change 2: Increased the number of points necessary to earn a Quality Measure Star Rating of 2 or more stars Change 3: Changed the scoring method for the Staffing star rating. Nursing homes must earn a 4-star rating on either the RN or total Staffing rating to achieve an overall Staffing rating of 4- stars (952)

23 MN DONA Spring Conference 4/16/2015 Update on CMS Nursing Home Five-Star Rating System The February 20, 2015 changes had the following effect on Minnesota facility s Overall Star Ratings: # of MN Overall Star Rating Nursing Facilities Affected Dropped by 2 stars 13 Dropped by 1 star 86 Star rating stayed the same 263 Increased by 1 star Star Questions (952)

24 MN DONA Spring Conference 4/16/2015 THANK YOU (952)

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27 A Regulations for Tuberculosis Control in Minnesota Health Care Settings A guide for implementing tuberculosis (TB) infection control regulations in your facility Tuberculosis Prevention and Control Program PO Box St. Paul, MN Phone: or July 2013

28 Table of Contents A Introduction...1 Chapter 1. Background...3 Determining which regulations to follow...3 Chapter 2. TB Infection Control Program...5 TB infection control team...5 Facility TB risk assessment...5 Written TB infection control procedures...6 HCW education...7 Chapter 3. Screening Health Care Workers (HCWs)...9 Definition of a HCW...9 General principles...10 Baseline TB screening...10 Serial TB screening...11 Special situations HCW with signs or symptoms of active TB disease...11 HCW with a newly-identified positive TST or IGRA...12 HCW with written documentation of a previous positive TST or IGRA...13 HCW with verbal (undocumented) history of a previous positive TST or IGRA...13 Pregnant HCW...13 Conversions...13 HCW with TST results between 5 and 9 mm of induration...14 Students...14 Volunteers...14 HCW with previous history of severe adverse reaction to TST...14 HCW refusal...14 HCW who travels outside of the United States...15 Baseline TB Screening Tool for HCWs...16 Serial TB Screening Tool for HCWs...18 Exemption Form for Tuberculin Skin Testing of a Pregnant HCW...20 Information for Health Care Workers with Tuberculin Skin Test (TST) Results between 5 and 9 mm...21 Chapter 4. Screening Residents...23 General principles...23 Baseline TB screening of residents in boarding care homes and nursing homes...23 Baseline TB screening of residents in residential hospices...24 Special situations Resident with newly identified positive TST or IGRA...24 Resident with written documentation of previous positive TST or IGRA...24 Resident with verbal (undocumented) history of previous positive TST or IGRA...25 Residents with signs or symptoms of active TB disease...25 Residents with previous history of severe adverse reaction to TST...26 Resident refusal...26 Baseline TB Screening Tool for Nursing Home and Boarding Care Home Residents...27 Baseline TB Screening Tool for Residents in Residential Hospice...29 Glossary...31

29 Introduction A The purpose of this manual is to assist health care facilities in Minnesota to understand what is needed to be in compliance with Minnesota laws revised in 2013 regarding TB prevention and control, and to provide tools for implementing legal regulations and best practices in their settings. Minnesota laws governing tuberculosis (TB) prevention and control regulations in health care settings (including TB screening of health care workers and residents) have historically consisted of a variety of separate rules written for specific settings at various times. Many of them were based on national recommendations published in the 1990s or earlier. In 2005, the U.S. Centers for Disease Control and Prevention (CDC) published revised guidelines* ( Since that time, the Minnesota Department of Health (MDH) has recognized that legal regulations and best practices for TB infection control in Minnesota needed to be revised to meet these guidelines and to incorporate current knowledge and technology. The TB waivers, issued by MDH on March 9, 2009, were an interim step in this process to address the outdated TB laws for boarding care homes, home care providers, nursing homes, and supervised living facilities. The TB waivers stated that licensees were required to follow the 2005 CDC guidelines. As a final step, MDH proposed new legislation in 2013, which was adopted by the Minnesota Legislature and takes effect on August 1, These laws are based on the 2005 national guidelines and replace the 2009 TB waivers. They apply to settings licensed by MDH, including boarding care homes, home care providers, hospices, nursing homes, outpatient surgical centers, and supervised living facilities. *Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Facilities, From CDC, MMWR, December 30, 2005, 54(RR17); Regulations for Tuberculosis Control in Minnesota Health Care Settings July 2013 Page 1

30 Chapter 1 Background A Determining which regulations to follow All state-licensed or federally-certified health care settings in Minnesota are required by law to follow certain measures to prevent and control TB in their facilities. In addition, facilities should follow the regulations of the Minnesota Occupational Safety and Health Administration (MN-OSHA). (see Resources) There are three categories of regulations related to TB: 1. TB infection control program 2. Process for screening health care workers (HCWs) 3. Process for screening residents This manual provides specific information about each type of regulation. To determine which of these regulations apply to your facility, see the table below. If you are unsure what type of license your facility has, you can look it up at Health care setting Assisted living facility Boarding care home (MDH licensed) Home care provider (MDH licensed) Hospice (MDH licensed) Nursing home (MDH licensed) Outpatient surgical center (MDH licensed) TB infection control program (Chapter 2) Screening HCWs (Chapter 3) Screening residents (Chapter 4) Regulatory authority Yes Yes No Minnesota Statutes, section 144A.4798, Subd. Yes Yes Yes Minnesota Statutes, section , Subd. 2c 2 Yes Yes No Minnesota Statutes, section 144A.4798, Subd. Yes Yes Yes (residential hospice only) Minnesota Statutes, section 144A.753, Subd.4 3 Yes Yes Yes Minnesota Statutes, section 144A.04, Subd. 3b 4 Yes Yes No Minnesota Statutes, section , Subd. 3c Regulations for Tuberculosis Control in Minnesota Health Care Settings July 2013 Page 3

31 Background Chapter 1 A Health care setting Supervised living facility (MDH licensed) Supplemental nursing services agency (MDH licensed) TB infection control program (Chapter 2) Screening HCWs (Chapter 3) Screening residents (Chapter 4) Regulatory authority Yes Yes No Minnesota Statutes, section , Subd. 6a 6 Education program only Yes No Minnesota Statutes, section 144A.72, Subd. 1 7 All other settings Yes Yes No MN-OSHA Page 4 July 2013 Regulations for Tuberculosis Control in Minnesota Health Care Settings

32 Chapter 2 A TB Infection Control Program All health care settings in Minnesota should have an up-to-date TB infection control program that includes: A team responsible for TB infection control A facility TB risk assessment Written TB infection control procedures Health care worker (HCW) education TB infection control team Identify a qualified person or a team of persons in your facility and assign them primary responsibility and authority for TB infection control. This person or team will conduct your setting s facility TB risk assessment; develop, implement, and enforce TB infection control policies (including HCW and resident TB screening); and ensure that HCWs receive adequate TB-related training and education. Facility TB risk assessment The facility TB risk assessment is a structured evaluation of a health care facility or setting s risk for transmission of M. tuberculosis. The infection control team determines the setting s TB risk classification based on the results of the facility TB risk assessment. All health care settings in Minnesota should perform an initial facility TB risk assessment. Medium-risk settings should update their assessment yearly; low-risk settings should update theirs every other year. Keep your facility s completed TB risk assessment worksheets on file for future reference. Your facility TB risk assessment should be conducted by your infection control team. In general, oneassessment encompasses an entire setting. However, in certain settings it may be appropriate to do separate assessments for specific areas within the setting. Information on the number of TB cases by county for the previous year are posted on MDH s web site in May of each year. Risk assessments conducted early in the calendar year (before new data are posted) should use data from the previous year. Please do not contact MDH before May to obtain TB data for the previous year. Choose one of the following three methods to conduct your risk assessment(s): 1. Use the Facility TB Risk Assessment Worksheet for Health Care Settings Licensed by the Minnesota Department of Health (MDH). This worksheet was developed by MDH and can be used by boarding care homes, home care providers, hospices, nursing homes, outpatient surgical centers, and supervised living facilities (see html#ch2). 2. Use the Appendix B: Tuberculosis (TB) risk assessment worksheet from the Centers for Disease Control and Prevention (CDC). (see html#ch2). 3. Create your own assessment tool using the criteria listed on pages 9-12 of CDC s Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, Regulations for Tuberculosis Control in Minnesota Health Care Settings July 2013 Page 5

33 TB Infection Control Program Chapter 2 A Use the results from your facility TB risk assessment to determine your TB risk classification. The three risk classifications are: Low risk, in which persons with active TB disease are not expected to be encountered and exposure to TB is unlikely. Medium risk, in which HCWs will or might be exposed to persons with active TB disease or clinical specimens that might contain M. tuberculosis. Potential ongoing transmission, in which there is evidence of person-to-person transmission of M. tuberculosis. This is a temporary classification. If you determine that this classification applies to your setting, please consult with MDH s TB Prevention and Control Program at for guidance. If the infection control team is unsure whether to classify your setting as low or medium risk, the medium risk classification should be used. When updating your facility TB risk assessment, you should confirm and document actions that were taken to address any problems identified during the previous risk assessment. In addition, you should conduct a problem evaluation to address any situations that may have occurred since your last risk assessment was done. Examples might include: A person with suspected or confirmed active TB disease was not promptly recognized and appropriate airborne precautions were not initiated, Certain administrative, environmental, or respiratory-protection controls failed, and Infection control lapses were identified (for example, HCWs were not adequately screened for TB; baseline TB screening of residents [if applicable] was not consistently done and documented; there were delays in transferring of patients with symptoms of active TB disease; or TB-related education and training of HCWs was not done or needs to be updated). Written TB infection control procedures Each facility should have written procedures to address TB infection control. Medium-risk settings should review their procedures annually and update, if necessary. Low-risk settings should review their procedures every other year and update, if necessary. Procedures should address: Early recognition: All HCWs should know the signs and symptoms of TB and their role in their facility s TB infection control program. Isolation: Place a potentially infectious TB patient in an airborne infection isolation (AII) room if available; If not, place patient in separate room with door shut. Referral: If your setting does not handle TB patients, transfer potentially infections TB patients to a setting that is equipped to evaluate and treat TB patients. The procedures should include information about working with the local or state public health department to conduct a TB contact investigation if health care-associated transmission of M. tuberculosis is suspected. Page 6 July 2013 Regulations for Tuberculosis Control in Minnesota Health Care Settings

34 TB Infection Control Program Chapter 2 A In addition, settings that expect to encounter (admit) patients with suspected or confirmed active TB disease are required to: Implement and maintain environmental controls, including AII rooms, Develop a respiratory protection program, and Develop a plan for accepting patients with suspected or confirmed active TB disease. HCW education TB training is required at time of hire for all HCWs. The content of the training should be appropriate to the job responsibilities and educational or professional background of the HCW. In medium-risk settings, TB training should be conducted annually. Low-risk settings should annually evaluate the need for TB training, and conduct training as needed. Content should focus on basic information about: TB pathogenesis and transmission, Signs and symptoms of active TB disease, and Your health care setting s infection control plan (i.e., how to implement your early recognition, isolation, and referral procedure), especially any sections that employees are responsible for implementing. Regulations for Tuberculosis Control in Minnesota Health Care Settings July 2013 Page 7

35 Chapter 3 A Screening Health Care Workers (HCWs) Definition of a HCW: For purposes of TB infection control procedures, the following staff should be considered HCWs and should be included in your TB screening program: Administrators and managers Bronchoscopy Chaplains Clerical Computer programmers Construction Correctional officers Dental Dietician or dietary Educators Engineers Food service Health aides Health and safety Housekeeping or custodial Homeless shelter Infection control Janitorial, maintenance Laboratory Morgue Nurses Outreach Patient transport staff, including EMS Pharmacists Phlebotomists Physical and occupational therapists Physicians and other clinicians Public safety Radiology Respiratory therapists Social workers Students (e.g., medical, nursing, technicians, and allied health) Technicians (e.g., health, laboratory, radiology, and animal) Volunteers Regulations for Tuberculosis Control in Minnesota Health Care Settings July 2013 Page 9

36 Screening Health Care Workers (HCWs) Chapter 3 A In addition, HCWs who perform any of the following activities should also be included in your TB screening program: Entering patient rooms or treatment rooms whether or not a patient is present, Participating in aerosol-generating or aerosol-producing procedures (e.g., bronchoscopy, sputum induction, and administration of aerosolized medications), Participating in suspected or confirmed M. tuberculosis specimen processing, or Installing, maintaining, or replacing environmental controls in areas in which persons with active TB disease are encountered. General principles There are two methods available to screen for TB infection: the tuberculin skin test (TST) and the Interferon Gamma Release Assay (IGRA). Information about these methods is available at and diseases/tb/bloodtests.html. All reports or copies of TST or IGRA results and any related chest X-ray and medical evaluations should be maintained in the employee s record. TST documentation should include the date of the test (i.e., month, day, year), the number of millimeters of induration (if no induration, document 0 mm) and interpretation (i.e., positive or negative). IGRA documentation should include the date of the test (i.e., month, day, year), the qualitative results (i.e., positive, negative, indeterminate or borderline) and the quantitative assay (i.e., Nil, TB and Mitogen concentrations or spot counts). Indeterminate or borderline results indicate an uncertain likelihood of M. tuberculosis infection and should be further evaluated by a physician. HCWs should be encouraged to keep copies of the results of their TB screening for future use. Disregard a HCW s history of BCG vaccination when administering and interpreting a TST. It is the responsibility of the infection control team to ensure that written procedures are in place and are followed by staff to ensure that employees are free of infectious TB disease before beginning employment. Questions regarding the significance of an individual s medical test results (e.g., chest X-ray reports) should be referred to the appropriate medical or nursing staff in your facility. Baseline TB screening Baseline TB screening is required for all HCWs (Table 3.1). Baseline TB screening consists of three components: 1. Assessing for current symptoms of active TB disease, 2. Assessing TB history, and 3. Testing for the presence of infection with Mycobacterium tuberculosis by administering either a two-step TST or single IGRA. Page 10 July 2013 Regulations for Tuberculosis Control in Minnesota Health Care Settings

37 A Screening Health Care Workers (HCWs) Chapter 3 An employee may begin working with patients after a negative TB symptom screen (i.e., no symptoms of active TB disease) and a negative IGRA or TST (i.e., first step) dated within 90 days before hire. The second TST may be performed after the HCW starts working with patients. Available tool: Baseline TB Screening Tool for HCWs Template on pages Serial TB screening Serial TB screening refers to TB screening performed at regular intervals following baseline TB screening. The frequency of serial TB testing is based on your facility s TB risk classification (Table 3.1). Serial TB screening consists of three components: 1. Assessing for current symptoms of active TB disease, 2. Assessing TB history, and 3. Testing for the presence of infection with Mycobacterium tuberculosis by administering either a onestep TST or single IGRA. HCWs who have positive TSTs or IGRAs and who work in medium-risk settings do not need additional TSTs or IGRAs but should be assessed for current TB symptoms on an annual basis and instructed to seek medical evaluation if TB symptoms develop at any time. Available tool: Serial TB Screening Tool for HCWs Template on pages Table 3.1: Baseline and serial TB screening regulations for HCWs Risk classification Baseline screening Serial screening Low Required Not required Medium Required Annual Potential ongoing transmission (usually temporary) Special Situations Required HCW with signs or symptoms of active TB disease May require testing on a quarterly or twice-yearly basis. Consult with the MDH TB Prevention and Control Program at regarding the frequency of testing under these circumstances. A HCW with infectious TB disease poses a special risk in the workplace because of the potential to spread the infection to vulnerable patients. TB is not commonly found in Minnesota HCWs, but it does occur. In , a total of 12 HCWs in Minnesota were diagnosed with active TB disease. Do not wait for the results of a TST or IGRA before referring a person with TB symptoms for a medical evaluation. Approximately 25 percent of persons with active TB disease have a negative TST or IGRA because the body s immune system is not strong enough to respond to the test. Regulations for Tuberculosis Control in Minnesota Health Care Settings July 2013 Page 11

38 Screening Health Care Workers (HCWs) Chapter 3 A Persons with active TB disease may have one or more of the following symptoms: Prolonged cough ( three weeks ) Hemoptysis Weight loss Night sweats Fatigue Fever, chills Poor appetite Chest pain Other symptoms may be present, depending on the site of disease Active TB disease most commonly affects the lungs (pulmonary). However, TB disease can occur in other parts of the body (most commonly, pleural or lymphatic). Any HCW with symptoms of active TB disease, regardless of the results of the TST or IGRA, should be promptly evaluated to exclude a diagnosis of active TB disease. This should include a medical evaluation, a chest X-ray, and collection of sputum specimens for mycobacterial smear and culture or additional testing if indicated. If active TB disease is confirmed or suspected, the diagnosing clinician should notify MDH at within one working day. HCWs with suspected or confirmed infectious TB disease or a draining TB skin lesion should be excluded from the workplace. They should be allowed to return to work only after a physicianknowledgeable and experienced in managing TB has determined that they are no longer infectious (this may be done in consultation with the health department). HCWs with extrapulmonary TB disease usually do not need to be excluded from the workplace as long as the respiratory tract is not involved and the HCW has been cleared for work by a physician. HCW with a newly-identified positive TST or IGRA Before the HCW has direct patient contact, the following should be documented in their record: 1. Test result, 2. Assessment for current TB symptoms, 3. Chest X-ray to rule out infectious TB disease. The chest X-ray should be done after the date of the positive TST or IGRA; however, a chest X-ray done within the three months prior to the TST/IGRA is acceptable, provided that the HCW has not been exposed to infectious TB disease since the chest X-ray was done, and 4. Medical evaluation to rule out a diagnosis of infectious TB disease. After the negative baseline chest X-ray is done and the results are documented, additional chest X-rays are not needed unless the HCW develops symptoms of active TB disease or a clinician recommends a repeat chest X-ray. HCWs who work in medium-risk settings should be assessed for current TB symptoms on an annual basis and instructed to seek medical evaluation if TB symptoms develop at any time. Page 12 July 2013 Regulations for Tuberculosis Control in Minnesota Health Care Settings