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Center for Healthcare Quality

Kathleen Billingsley, R.N.Deputy Director

December, 2007

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Presentation Outline

• California Department of Public Health

• Program Notes

• Legislation

• CALS Surveys / Complaint Investigations

• Health Facility Consumer Information System

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Creating the Department of Public Health

California Department of Health Services“Protect and Improve the Health of all Californians”

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CA Department of Public Health

• Five new principle centers in CDPH:▫ Center for Chronic Disease Prevention and Health

Promotion▫ Center for Infectious Disease▫ Center for Family Health▫ Center for Environmental Health▫ Center for Healthcare Quality

Licensing & Certification Program

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California Patient Safety Advisory CouncilCDPH Licensing and Certification Role• Member of Council• Program mission is compatible with CAPSAC

charter:▫ Primary activities of the L&C program are related

to evaluation of systems, processes and procedures that support the provision of quality care and services, by individuals, while minimizing potential for unintended outcomes, including medical errors.

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LICENSINGAND

CERTIFICATION

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Training

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L&C developed a “Training Advisory Committee.”

This committee spearheaded the following changes:

• The “New Surveyor Academy”▫ restructured and reformatted from a 5-week to 3-week

program.▫ Five new surveyor academies offered from November

2006 to November 2007. • As of August 2007, 171 new surveyors have completed

the new surveyor academy.

Training Advisory Committee

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LEGISLATION

Senate Bill 1301

Senate Bill 1312

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Senate Bill 1301 “Adverse Events”

• Authored by Senator Alquist and signed into law Sept 26, 2006

• Effective as of July 1, 2007

• Defines 28 “Adverse Events” that should never occur in hospitals, and

• Specifies that those adverse events shall be reported to the CDPH by the hospitals.

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Senate Bill 1301Reporting “Adverse Events”

• Adverse Events must be reported within 5-days of being detected, provided that the event is not an “ongoing urgent or emergent threat”

• Failure to report these events within 5 days results in a civil money penalty of $100 dollars per day for each day after the “initial 5 day period”

• “Ongoing urgent or emergent threats to the welfare, health, or safety of patients, personnel, or visitors”must be reported within 24 hours after being detected.

• Failure to report these within 24-hours results in the same civil money penalty of $100/day

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Reporting “Adverse Events” Cont.

• CDPH must make the outcome of inspections, investigations, compliance histories and substantiated adverse events:▫ readily available to consumers by January 1, 2009▫ posted on CDPH Internet web site by January 1,

2015

• Some language in the statute will need to be clarified through regulations, e.g. “low risk pregnancy”, the “wrong person” (as in, “an infant discharged to the wrong person”), “after surgery”, “on the grounds of the facility”, etc.

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Senate Bill 130128 “Adverse Events”Health & Safety Code §1279.1Seven categories:

1. Surgical Events (1-5)2. Product / Device Events (6-8)3. Patient Protection Events (9-11)4. Care Management Events (12-18)5. Care Management Events (19-23)6. Criminal events (24-27)7. Other events (28)

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SB 1301

Senate Bill 1301 Requires:

• CDPH must perform on-site inspections for reported adverse events and increase the frequency of licensing inspections of facilities that report adverse events.

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Adverse Events

Report Date: 11/27/2007Data Source: ASPEN

1Hemolytic reaction

3Death/injury from a physical assault

7Death/disability due to use of restraints/bedrails

1Death/disability due to intravascular air embolism

1Death/disability due to disappearance

2Death/disability due to a burn

1Death/disability directly related to hypoglycemia

2Death/disability due to labor/delivery/postdelivery

12Death due to a fall

16Death after induction of anesthesia

1Care by impersonating licensed provider

7/1/07 to 11/27/07Adverse Event Categories

328Grand Total

33Adverse event or series of adverse events

7Wrong surgical procedure performed on a patient

1Use of device other than as intended

2Use of contaminated drug, device, or biologic

1Surgery performed on the wrong patient

14Surgery performed on a wrong body part

7Suicide/attempted suicide

125Stage 3 or 4 ulcer acquired after admission

18Sexual assault on a patient

59Retention of a foreign object in a patient

1Oxygen line used for wrong gas/toxic substance

13Death/disability due to a Medication error

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Tips for Reporting Adverse Events

• Develop Policy and Procedures to promote objective determination of reportable events.▫ May decrease confusion and increase reporting

consistency.• Designate a primary coordinator for reporting

events.▫ May increase consistency as to what is reported.

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Next Steps: SB1301 Adverse Event Reporting• Advisory Group ▫ Help us define the next steps

• Develop Collaborative QI initiatives

• Share Best Practices

• Technical Assistance

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Senate Bill 1312 “Immediate Jeopardy”

• Authored by Senator Alquist, and signed into law in September 2006;

• Portions of this bill affecting hospitals became effective on January 1, 2007.

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Immediate Jeopardy: Definition & Penalty• ’Immediate Jeopardy’ (IJ): ▫ A situation in which the (hospital’s) noncompliance with

one or more requirements of licensure has caused, or is likely to cause, serious injury or death to the patient.

• Today civil money penalties for IJ are $25,000 per event.

• In the future, after regulations are developed establishing the criteria for penalty assessment, the penalties will range from $17,500 to $50,000.

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Immediate Jeopardy: First 11 Penalties Announced

• October 25 – CDPH announced the issuance of the first eleven penalty assessments to nine hospitals

• Pharmacy: Immediate Jeopardy

• Not all 1301 Adverse Events are IJ events!

• Not all IJ events are 1301 Adverse Events!

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Do All SB-1301 adverse events that rise to the level of an IJ mean a yearly unannounced inspection?SB-1301 section 2 - H&S §1279.2(a)

(1) In any case (of an adverse event) that indicates an ongoing threat of imminent danger of death or serious bodily harm…onsite inspection or investigation within 48 hours…

(2) Until the department has determined by onsite inspection that the adverse event has been resolved, the department shall, not less than once a year, conduct an unannounced inspection of any health facility that has reported an adverse event pursuant to Section 1279.1

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Pharmacy: Immediate Jeopardy• Frequency – Since January 1, 2007 - #20• Issues / Problems Identified▫ Unsafe use of High Alert Meds (e.g. Meds with a boxed warning)▫ Failure to ensure safe distribution and administration of

medications (med errors)• Actions Taken By the Department▫ AFL issued 11/5/07 on safe use of boxed warning meds▫ Convened a DPH Hospital Medication Safety Team▫ Increased collaboration with stakeholders to increase awareness

on medication safety strategies and findings of DPH surveys▫ Initiated monitoring on the implementation of facility’s Medication

Error Reduction Plan submitted to DPH 2001

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CALs Survey• L&C is gearing up for hospital inspections and

surveys▫ New state legislative mandates that require

inspections and surveys (SB-1312 & SB-1301)

▫ 150+ new hospital trained surveyors (>8/DO)

▫ L&C surveyors look at both federal and state regulations and laws

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L & C Attendance• L&C will be attending CALS surveys in 2008 and

beyond▫ In the recent past, L&C hasn’t had sufficient hospital

trained surveyors to attend CALS surveys• L&C is recruiting and training new surveyors▫ 150 new surveyors are scheduled for the CMS

Basic Hospital course in January 2008▫ As the individual district offices become fully staffed

with hospital trained surveyors you will begin seeing them at the CALS surveys

• By the end of 2008 expect all CALS teams to include L&C

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Title 22 & CMS RegulationsTypical Survey IssuesOn CALS survey who does Title 22?

• L&C not present during a CALS survey▫ IMQ will look at Title 22 compliance

• L&C is present during a CALS survey▫ L&C will look at Title 22 compliance▫ By contract L&C must report to CMS any observed

CMS regulatory deficiencies▫ Since SB-1312, whenever L&C is surveying

a hospital it must always look for compliance with state regulations

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Health Facilities Consumer

Information System

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Health Facilities Consumer Information System

The consumer information service system will include:

• Long-term Health Care Facility Profiles

• Information regarding Substantiated Complaints

• Information regarding the State citations assessed

• Any Appeal Resolution Pertaining to a Citation or Complaint

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Health Facilities Consumer Information System

• Project Kick-off ▫ October 4, 2007

• Initial Requirements Analysis Completed

• Stakeholder Meeting for feedback▫ December 10, 2007

• “Go Live” Dates▫ LTC Facilities Information - January 23, 2008▫ Hospitals - March 26, 2008

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QUESTIONS & ANSWERS