New Jersey Department of Health Long Term Care

New Jersey Department of Health Long Term Care Regulatory Update for QAPI , Facility Assessment & Infection Control Presented by, Pamela Lebak Program Manager Health Facility Survey & Field Operations Shereef Elnahal, MD, MBA Commissioner Department of Health

Presented by: Pamela Lebak, Program Manager, Long-Term Care Survey & Certification & ICF/IID Programs (Pamela. Lebak@doh. nj. gov) New Jersey Department of Health Facility Survey and Field Operations

DISCLAIMER This power point presentation is an educational tool prepared by the Department of Health that is general in nature. It is not intended to be an exhaustive review of the Department’s administrative code and is not intended as legal advice. Materials presented should not substitute for actual statutory or regulatory language. Always refer to the current edition of a referenced statute, code and/or rule or regulation for language.

Objectives Provide clarity of Quality Assurance and Performance Improvement (QAPI) rollout and implementation • Provide transparency on the future of the survey process • Gain insight into how QAPI regulations will impact the survey process • Provide a greater understanding of changes in new regulatory language and tips on proactive approaches to implementing QAPI initiatives • Review of the new LTC infection control regulations • Better understanding of the changes to the infection control regulations • Infection Control survey task • Understanding of top deficiencies cited • Share with partners

How is CMS going to Implement the new regulations? Implementation Date Type of Change Details of Change Phase 1: November 28, 2016 (Implemented) Nursing Home Requirements for Participation New Regulatory Language was uploaded to the Automated Survey Processing Environment (ASPEN) under current F Tags Phase 2: November 28, 2017 F Tag numbering Interpretive Guidance (IG) Implement new survey process New F Tags Updated IG Begin surveying with the new survey process Phase 3: November 28, 2019 Requirements that need more time Requirements that need more to implement time to implement

Phase 1 -3 Phase 1 -new regulatory language added to existing Ftags. Effective November 28, 2016 Phase 2 -will include new F-tag renumbering and some additional effective regulations and interpretive guidance. Effective November 28, 2017 New Survey Process Phase 3 -will bring additional regulatory language into effect. November 28, 2019 www. cms. gov

Phase 2 of LTC Regulations • Implement by November 28, 2017 • Providers must be in compliance with Phase 2 regulations • All States will use new computer – based survey process for LTC surveys

Phase 2 of LTC Regulations Phase 2 includes: Behavioral Health Services Quality Assurance and Performance Improvements (QAPI Plan Only) Infection Control and Antibiotic Stewardship Physical Environment – smoking policies • •

Traditional Quality Indicator Survey New Survey Process Data/Study/ Test Regulatory Changes

What Hasn’t Changed • • • Life Safety Code and Complaint surveys: traditional survey process; however, complaints can be added to the standard survey and then would follow new survey process. Three (3) methods of information gathering, observation, interview and record review. Exit conference

Begins and Ends with QAPI • • QA is the process of meeting quality standards and assuring that care reaches an acceptable level. PI (also called quality improvement) is a pro-active and continuous study of processes within the intent to prevent or decrease the likelihood of problems by identifying areas of opportunity and testing new approaches to fix underlying causes of persistent/systemic problems.

QAPI Implementation • Majority of the requirements for QAPI effective November 28, 2019 with some exceptions • QAPI plan effective November 28, 2017 • QAA committee effective November 28, 2016 (phase 1), with exceptions: • Infection Preventionist-November 28, 2019 • Analysis of QAPI Data-November 28, 2019 • The language related to implementation of QAPI program. November 28, 2019 • Disclosure of Information and Sanctions (Good faith Attempt) effective November 28, 2016 (phase 1) • Expanded guidelines for QAPI/QAA effective November 28, 2017

Phase 1 -3 Timeline • November 28, 2016 -Phase 1 (F 520) Quality Assessment and Assurance • November 28, 2017 -Phase 2 QAPI Plan (F 865), QAA Activities (F 867), QAA Committee (F 868) November 28, 2019 -Phase 3 • QAPI Program/Plan (F 865), QAPI Feedback. Data & Monitoring (F 866), full implementation of QAA Committee (F 868)

F 865 QAPI Plan • • § 483. 75(a) Quality assurance and performance improvement (QAPI) program…The facility must§ 483. 75(a)(2) Present its QAPI plan to the State Survey Agency no later than 1 year after the promulgation of this regulation; • § 483. 75(h) Disclosure of information. Effective November 28, 2017 A State or the Secretary may not require disclosure of the records of such committee except in so far as such disclosure is related to the compliance of such committee with the requirements of this section. • § 483. 75(i) Sanctions. Good faith attempts by the committee to identify and correct quality deficiencies will not be used as a basis for sanctions.

F 865 -What Facilities Should Know • The QAPI plan is the written plan containing the process that will guide nursing home’s efforts in assuring care and services are maintained at acceptable levels of performance, and continually improved. The plan describes how the facility will conduct required QAPI and QAA committee functions

F 865 -QAPI Plan should include: • The QAPI plan must describe the process for identifying and correcting quality deficiencies. Key components of the process include: • Tracking and measure performance; • Establishing goals and thresholds for performance measurement; • Identifying and prioritizing quality deficiencies; • Systematically analyzing underlying causes of systemic quality deficiencies; • Developing and implementing corrective action or performance improvement activities; and • Monitoring or evaluating the effectiveness of corrective action/performance improvement activities, and revising as needed.

F 865 QAPI Disclosure Protection from disclosure is generally afforded documents generated by the QAA committee, such as minutes, internal papers, or conclusions-unless those documents contain evidence necessary to determine compliance with QAPI/QAA

F 865 QAPI Good Faith Attempts • • Good faith Attempt- A diligent and honest attempt to identify and correct an issue. Considerations include: Severity of issue Timing Action taken

F 866 QAPI Feedback, Data & Monitoring Phase 3; 11/28/2019 • • • § 483. 75(c) Program feedback, data systems and monitoring. (§ 483. 75(c) will be implemented during Phase 3) A facility must establish and implement written policies and procedures for feedback, data collections systems, and monitoring, including adverse event monitoring.

F 867 -QAPI/QAA Improvement Activities • • The quality assessment and assurance committee… must… Develop and implement appropriate plans of action to correct quality deficiencies

F 867 -QAPI/QAA Activities • A quality deficiency is a deviation in performance resulting in an actual or potential undesirable outcome, or an opportunity for improvement. A quality deficiency is anything the facility considers to be in need of further investigation and correction or improvement.

F 867 -QAPI/QAA Activities • Corrective Action is a written plan of action for correcting or improving performance in response to an identified quality deficiency.

F 868 -QAA Committee • • § 483. 75(g) Quality assessment and assurance. § 483. 75(g)(1) A facility must maintain a quality assessment and assurance committee consisting at a minimum of: (i) The director of nursing services; (ii) The Medical Director or his/her designee; (iii) At least three other members of the facility's staff, at least one of who must be the administrator, owner, a board member or other individual in a leadership role; and …

F 868 -QAA Committee • • § 483. 75(g)(2) The quality assessment and assurance committee… The committee must: (i) Meet at least quarterly…to… identify[ing] issues with respect to which quality assessment and assurance activities, including performance improvement projects required under the QAPI program, are necessary.

F 868 -QAA Committee Composition • • • Director of Nursing Medical Director or designee At least 3 other staff, one of whom must be the administrator, owner, board member, or other individual in leadership role with knowledge of facility systems and authority to change those systems.

F 868 -QAA Committee Frequency of Meetings • Meet at least quarterly to identify issues with respect to which QAA activities are necessary, and develop and implement appropriate plans of action to correct identified quality deficiencies.

Survey Quality Assessment & Assurance & QAPI Plan review • QAA review • Team discussions • QAA Committee • Good Faith Attempt

Survey Process related to Infection Control • • Mandatory tasks – investigated on every survey (inclusive of Infection Control) Triggered tasks – investigated if information gathered through observation, interview and record review prompts one of tasks. (Environment, Personal Funds & RAI)

Entrance Conference Worksheet: Information needed within four (4) hours • Completed matrix for all other residents • Admission packet • Contracts Dialysis / Hospice (if applicable) • Infection control – antibiotic stewardship • QAA committee information • QAPI plan

21 Federal Regulatory Groups for Long Term Care Facilities • • • • • • Resident Rights Freedom from Abuse, Neglect and Exploitation Admission Transfer and Discharge Rights Resident Assessment Comprehensive Person-Centered Care Planning Quality of Life Quality of Care Physician Services Nursing Services Behavioral Heath Services Pharmacy Services Laboratory Services Dental Services Food and Nutrition Services Specialized Rehabilitative Services Administration Quality Assurance and Performance Improvement Infection Control Compliance and Ethics Program Physical Environment Training Requirements

New LTCSP-deficiency summary Top 10 of 2017 • • • 1. F 281/(F 658) 2. F 441/(F 880, 881, 882, 883) 3. F 371/(F 812, F 813)) 4. F 323/(F 689) 5. F 431/(F 761) 6. F 309/(F 697, F 698, F 744) 7. F 425/(F 755) 8. F 279/(F 639, F 656) 9. F 278/ (F 641, F 642) 10. F 514/(F 842) Top 10 of 2018 1 st quarter • • • 1. F 880/ (F 441) 2. F 658/(F 281) 3. F 812/ (F 371) 4. F 656/(F 279) 5. F 755 /(F 425) 6. F 761/(F 431) 7. F 684/(F 309) 8. F 689 /F 323) 9. F 641 /(F 278) 10. F 758/ F 329 & F 428)

Background/Benefit to the Residents • • • F 441 - frequently cited 1. 6 -3. 8 million healthcare-associated infections (HAIs) in nursing homes every year 40 to 75 percent of antibiotics prescribed are potentially inappropriate

New F Tags • • • Regulatory Group: Infection Control F Tags F 880: Infection Prevention and Control (“Old. F 441”) • § 483. 80 (a)(1 -2)(4)(e-f) F 881: Antibiotic Stewardship Program (New) • § 483. 80 (a)(3) F 882: Infection Preventionist Qualifications/Role (New) • § 483. 80 (b-c) Phase 3; 11/28/2019 F 883: Influenza and Pneumococcal Immunizations (“Old. F 334”) • § 483. 80 (d)

F 880: Overview of Changes to Regulatory Language • • • Regulatory language added emphasis on a system for identifying and reporting of infections and communicable diseases The IPCP applies to residents, staff, volunteers, visitors, and contractors Based upon the facility assessment and national standards

Facility Assessment • (1) The facility’s resident population • (2) The facility’s resources • (3) A facility-based and community-based risk assessment, utilizing an all-hazards approach.

F 880: Overview of Changes to Regulatory Language • Surveillance • Reporting • Standard and Transmission-based Precautions • Isolation (added emphasis on considering the appropriateness and least restrictive use) Annual review of the IPCP and update as needed

F 880: Overview of Changes to Regulatory Language • Surveillance (Process and Outcome) • Facility Assessment • Ensuring staff are aware of policies and procedures

F 880: Overview of Changes in Interpretive Guidance • • Antibiotic Review has been moved to F 881 Policies and Procedures are reviewed annually and incorporate facility risk assessment.

F 880: Overview of Changes in Interpretive Guidance • • Medical Device Safety ------Point of Care Devices (fingerstick devices –single user, Blood glucose meters) Safe Medication Administration ---------Insulin Pens, SDV, MDV Standard & Isolation ------Hand Hygiene, PPE, Respiratory hygiene, and cough etiquette

Hand Hygiene and Glove use with Colostrum Difficile Infections (CDI) • Alcohol-based hand rub or soap and water?

Transmission Based Precautions • When should they be used? • Based on the likelihood of transmission • Pathogen • Resident risk factors • Psychological impact • Other residents

Implementing Contact Precautions • • When should I put on personal protective equipment (PPE)? “Contact precautions …require the use of appropriate PPE, including a gown and gloves upon entering the room. ”

PPE For Droplet Precautions • • When should I apply a facemask when caring for a resident on droplet precautions? “Facemasks are to be used upon entry into a resident’s room or cubicle with respiratory droplet precautions. ”

Blood Glucose Meters • How should blood glucose meters be cleaned and disinfected? • Dedicated or multi-patient use? • EPA-registered disinfectant • Identified deficient practices can rise to immediate jeopardy

Linens • How should the laundry be surveyed to assess for compliance? • Manufacturer’s instructions for use • Washing machines and dryers • Detergents • Linens

F 880 - Severity Level 4 • • Non-Compliance: Immediate Jeopardy to Resident Health or Safety Facility staff failed to handle soiled linens using safe and sanitary techniques. A resident was observed to have an acute onset of vomiting and diarrhea resulting in soiled clothing and linens. The nursing staff removed the soiled/contaminated clothing and linens, rinsed them out in the bathroom sink, and placed the wet/soiled linen onto the floor. The bathroom was shared with a roommate who utilized the sink for oral hygiene purposes and stored his/her toothbrush and glass on the sink. The roommate, subsequently developed vomiting and diarrhea, with the development of severe dehydration, resulting in hospitalization.

F 881: Antibiotic Stewardship Program • Part of the infection prevention and control program (IPCP) • Antibiotic use protocols • System to monitor antibiotic use and resistance

F 881: Antibiotic Stewardship Program Cont. • • • System to monitor antibiotic use and resistance, for example: Medical record reviews Laboratory tests Prescription documentation Outcome metrics

F 881: Severity Level 2 • Non-Compliance: No Actual Harm with Potential for more than Minimal Harm that is not Immediate Jeopardy The facility failed to implement its protocol for antibiotic use and failed to monitor actual antibiotic use. Record review indicated that the facility developed a protocol which indicated “residents with multi-drug resistant organism (MDRO)s are not to be treated with antibiotics for colonization”. However, record review revealed one resident colonized with an MDRO receiving an antibiotic to eliminate colonization. As a result, the potential exists for residents to develop antibiotic resistance.

Changes to the Infection Control Facility Task • Personal protective equipment • Transmission-based precautions • Laundry • Policies and procedures • Surveillance • • Antibiotic Stewardship

Paid Feeding Assistant • • The regulations in F 811 for paid feeding assistants exempts families and volunteers. NOTE: The regulation uses the term “paid feeding assistant. ” While we are not using any other term, facilities and States may use whatever term they prefer, such as dining assistant, meal assistant, resident assistant, nutritional aide, etc. in order to convey more respect for the resident. Facilities may identify this position with other titles; however, the facility must be able to identify those employees who meet the requirements under the paid feeding assistant regulation. While the facility is still responsible for ensuring the safety and care of all residents, this regulation does not apply to family members or to volunteers.

Resources • CMS Appendix PP • Long Term Care Survey (LTCSP) Process Procedure Guide • The Quality, Safety & Oversight Letters (formerly known as Survey and Certification Letters) www. cms. gov