AT THE BRINK OF DEATH SURVIVING TERMINATION · (including their curriculum vitae); - Acquire expertise in the development and implementation of an effective ... (JFL), St. Croix –

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M O N I C A A R R O W S M I T H A N D D I A N A S A L I N A S

AT THE BRINK OF DEATH SURVIVING TERMINATION


Agenda:

Negotiating a System Improvement Agreement (SIA) – Diana Salinas

Assessing your compliance with all relevant Conditions of Participation (CoPs) – Monica Arrowsmith and Diana Salinas

Gathering the troops and implementing plan of correction, and preparing organization for survey – Monica Arrowsmith and Diana Salinas

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Negotiating a System Improvement Agreement (SIA)

What is an SIA? The Centers for Medicare and Medicaid Services (CMS) has begun to expand the

use of a quality improvement tool to gain compliance from hospitals with repeat or multiple Immediate Jeopardy (IJ) findings on compliance or validation surveys: the Systems Improvement Agreement (SIA).

A time limited contractual agreement between Medicare-accredited healthcare organizations and CMS

Traditionally, SIAs have been used for nursing homes and organ transplant centers but recently CMS has implemented SIAs in hospitals.

An SIA allows hospitals to continue receiving CMS funding while a third-party monitors its policies, facilities, and patient care until the serious problems that caused the non compliance are corrected.

The agreement grants the hospital additional time to make sustainable improvements in complex quality, cultural, policy, and procedural deficiencies in light speed time.



• The alternative to an SIA is what's called Medicare Decertification, meaning CMS cuts off funding completely in as few as 23 days if the problem is not corrected.

• For most hospitals, CMS funding may account for 40-70% of revenue for the hospital, thus Medicare Decertification is critical, it can close the hospital.

• In addition, not only can Decertification or termination have devastating effects on the hospital but also on the communities they serve.

• In the interest of ensuring the availability of health care services, this CMS tool has been used reluctantly in the past but currently its use is being expanded by CMS.

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What to Expect in an SIA: SIA reads much like a legal document and stipulates the terms under which the healthcare organization agrees to:

- Obtain independent consultative review (at the hospital’s expense);- Submit the names of the proposed consultant companies and/or individuals

(including their curriculum vitae);- Acquire expertise in the development and implementation of an effective

quality assessment and performance improvement program;- Engage the services of an independent, full-time, on-site compliance officer

for the duration of the agreement; - Other terms specified by CMS including resurvey by CMS within six to 12

months; and - Increased staffing ratios



In return for entering into an SIA, CMS agrees to:

• Suspend the execution of the scheduled termination order pending the healthcare organization's fulfillment of the agreement.

• The SIA specifies the qualifications and responsibilities of the independent consultant and stipulates the content and frequency of the reports that are to be submitted to CMS.

• Consultants' reports are released to the healthcare organization only after they are approved by CMS.

• At their discretion, CMS may elect to discuss the findings from the reports with the independent consultant by phone or in person at the healthcare organization's expense.

• The agreement itself is a public document — some examples of SIAs executed in the past couple of years are available on the Internet.

• Reports from the independent consultant, though, are subject to federal and state privacy protections.

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Negotiating a System Improvement Agreement (SIA) • SIA considerations:

1. The time and expense of entering into a SIA and affecting wide-scale organizational changes must be taken into consideration.

2. Should the hospital opt not to accept or amend the terms of the SIA, the alternatives are to voluntarily withdraw from participating in the Medicare program or have CMS terminate the organization's participation.

3. Either option, the result is devastating, creating a large healthcare vacuum in the surrounding community.



Current SIAs: • Cape Fear Valley Medical Center in Fayetteville, NC – released January

2013 • Red River Regional Hospital, Bonham, Texas - November 21, 2014• Brattleboro Retreat Hospital, Vermont – released December 2015 • The Juan F. Luis Hospital and Medical Center (JFL), St. Croix – SIA

extended for an additional month to 1/31/2016 – released 1/4/2016 • Texoma Medical Center Behavioral Health Center , Sherman, Texas –

entered into an SIA August 2015 • St. Joseph Medical Center, Houston, Texas – Entered in an SIA January

2016

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Negotiating a System Improvement Agreement (SIA) • Between July 2014 and July 2015, CMS had issued 19 immediate jeopardy notices

for hospitals in Texas. Of those, 10 returned to compliance and retained funding, two are operating under Systems Improvement Agreements in lieu of termination, another two lost funding, and five are pending a final determination (per a CMS regional administrator)

• SIAs seem to be on the rise from 2012 where half a dozen SIAs had been implemented.

• All indications are that CMS's use of SIAs will increase. CMS has awarded a software development contract for a national SIA tracking and monitoring system. Clearly, such a system is required only if a volume increase in SIA implementations is anticipated.


Negotiating a System Improvement Agreement (SIA) • A CMS inspector general's report from 2011, which contains considerable

commentary about the failure to assure sustainability of corrective actions after immediate jeopardy sanctions have been addressed successfully.

• This finding was acknowledged and even endorsed by then CMS leader Donald Berwick, M.D. Berwick asserted a renewed commitment by CMS to ensuring sustainability of improvements in participating organizations' compliance with CoPs.

• And the tool for sustainable change would appear to be the longer-term implementation of oversight through an SIA as opposed to the more limited and focused response to immediate jeopardy findings.

• Quality failures, failure to meet or sustain a corrective action plan may trigger false claims.

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Assessing your compliance with all relevant CoPs It is important to recognize the conditions that may place the hospital in

immediate jeopardy.

Immediate Jeopardy is defined as "a situation in which the provider's non-compliance with one or more requirements of participation has caused or is likely to cause serious injury, harm, impairment or death" (42 CFR 489.3, 2010).

Note: Harm does NOT have to occur before considering Immediate Jeopardy. Surveyors are instructed to consider both potential and actual harm when reviewing the triggers in the IJ Trigger table:


Assessing your compliance with all relevant CoPs:Non-compliance with the following issues may trigger immediate jeopardy (IJ Trigger Table): a) Failure to protect from abuseb) Failure to prevent neglectc) Failure to protect from psychological harmd) Failure to protect from undue adverse medication consequences

and/or failure to provide medications as orderede) Failure to follow nationally accepted standards of practice for

infection preventionf) Failure to correctly identify patientsg) Failure to safely administer blood or blood productsh) Failure to provide safety from fire, smoke and environmental hazardsi) Failure to comply with EMTALA requirements

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Gathering the troops and implementing plan of correction, and preparing the organization for survey

Resources and Structure

Implementing the Action plan

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Gatheringthetroopsandimplementingplanofcorrection,andpreparingtheorganizationforsurvey

TheRespiratoryProtectionPlanProgressReport:Action Steps CompletionDevelop Rideout Health Respiratory Protection Plan compliant with OSHA required elements.

April 2, 2015

Revise Rideout Health Illness and Injury Prevention Program compliant with OSHA required elements.

April 2, 2015

First Responder Awareness (FRA) and First Receiver Operations (FRO) training developed. First FRO/ FRA class complete including OSHARespirator Medical Evaluation prior to training for ED techs and ED Charge Nurses.

April 29 th and 30 th , 2015

FRO/ FRA classes scheduled including OSHA Medical Evaluation reviewed by NP or PA prior to training.

June 11 th , 2015July 9 th , 2015August 26 th , 2015October 27 th , 2015

PAPR training program developed including :§ OSHA Respirator Medical Evaluation

Questionnaire§ Annual PAPR evaluation & re ‐certification

form created§ Revised Annual Respiratory Fit test

screening form§ Respirator Medical Clearance Form§ PAPR Cart developed and supplied.

Inventory list created.§ Rideou t Health Group PAPR training Power

Point for education§ 3M Versaflo PAPR competency checklist

and training slides.

May 1, 2015

PAPR training classes scheduled to begin with all STARRT nurses, Respiratory Therapy, nursing unit Clinical Coordinators and will include OSHA Medical Evaluation prior to training.

June 19 th , 2015June 26 th , 2015July 24 th , 2015Future dates for August and September TBD.

Respiratory Protection Plan approved by Physician Champion Dr. Nijjar/ Infection Control Committee.Training for volunteer Medical Staff Physicians and LIP’s will be conducted utilizing a one on onetraining schedule based on Physician availability.

Approved April 30 th , 2015

Physician training by appointment with Employee Health based on Physician availability. To date one Physician / LIP in progress. Training will continue


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Keeping The Board Informed

• Special Oversight Sub-Committee

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ANESTHESIA SERVICES

0%

20%

40%

60%

80%

100%

July August September

100%77%

55%

0%23%

45%

0% 0% 0%

GreenYellowRed

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GATHERING THE TROOPS AND IMPLEMENTING PLAN OF CORRECTION, AND PREPARING THE ORGANIZATION FOR SURVEY

INFECTION CONTROL – OTHER SIGNIFICANT ISSUES (E.G. RED)Item# Description Status Barrier Action Required Due

36, 67 Equipment must be maintained to ensure safety and quality

• BioMed manager in place• Hospital wide policy to include systematic method to

identify and remove broken equipment; needed Bio Med contract metrics

• None Complete; Yellow in Dec.

44, 46, Employee TB/BBB exposure control plan, sharps safety plan.

• Staff wre unable to speak correctly to TB/BBB plan. • None Complete; Yellow in Dec.

50, 69 Identify procedures in IR and other areas requiring staff to wear Powered Air Purifying Respirator (PAPRs).

• PAPRs ordered on or about 10/3/14 & carts ordered 10/13/2014

• Location/placement plan in draft• Broad-based education plan in process

• Plan needs to be finalized;

• Education needs to be completed

71, 72 Hand Hygiene program • Hand Hygiene program in place• Needed evidence of staff and physician education

• Need % of Physician’s / anesth educated.

77,79,80 Infection Control program and oversight; Number of IP’s.

• IP workload study and analysis needed to be conducted.

• Study completed Nov; Reviewed by ECRI in Dec.


83,84 Communicable exposure prevention plan

• Plan in place• Needed evidence of staff education in ED • Needed evidence of tracers


86 Replace use of daily tissue tests on airborne isolation rooms with moreeffective engineering controls

• Response plan to individual alarms needed edclarification

• Contract for Johnson Controls signed and moving forward.

• Ball in the Wall installation completed


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GATHERING THE TROOPS AND IMPLEMENTING PLAN OF CORRECTION, AND PREPARING THE ORGANIZATION FOR SURVEY

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Things to look for: Governing Board: What is your governing board’s main focus, financial

condition or quality data? Administration: Is your CEO overlooking day to day problems? Medical Staff: Is there a decline in the relationship between medical staff

and leadership? Is distrust growing? Nursing: Is there ongoing nursing leadership vacancies? Is there

significant use of agency/traveler staff? Quality Infrastructure: what does your quality/risk management structure

look like? Does your quality data swim upstream to the executive team and governing board?

What does the relationship between Compliance Program, Quality, Performance Improvement departments and Risk Management look lilke?


EXCERPT FROM PARKLAND SIA

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Gathering the troops and implementing plan of correction, and preparing the organization for surveyChief Compliance Officer’s involvement:- Become familiar with CMS Conditions of Participation - Become familiar with your Quality infrastructure, leaders, and quality reporting

mechanisms such as data abstraction, etc. - Participate in the Quality committees to understand your organization’s

metrics, performance improvement, corrective action plans - Include Quality in your Annual Compliance Program Work Plan - May include managing the SIA- Oversight of Policy Development - Oversight of training impact - Oversight, oversight, oversight- Certainly more to come from regulators on SIAs

Documents

AT THE BRINK OF DEATH SURVIVING TERMINATION · (including their curriculum vitae); - Acquire expertise in the development and implementation of an effective ... (JFL), St. Croix –