LEVEL 2 REPORTING IN PACE.

MEDICAL DIRECTOR

ROLE AND RESPONSIBILITIES,

Stephen Ryan, MD, MPH

Sr Medical Director PACE & Managed LTC

Medical Director ElderONE, RRH

viaHealthIndependent Living for Seniors

WHO ARE WE?

WHAT IS OUR

ROLE?

Geriatrician

Primary Care Physician

provider

Advance Practice Provider (APP)

Medical Director

Nurse Practitioner (NP)

Physician Assistant (PA)

Audience : PACE Medical Directors and Colleagues

Objectives. All attendee will be able to:

> Articulate an overview of the CMS Level 2 reporting

requirements, assessment process, and their role in that

process

> Review an illustrative Level II case including initial report,

evaluation, IDT work and Root Cause Analysis.

> Have a reference understanding with the specifics of the CMS

revised Level 2 definitions

> Describe the overall process a PO is expected to go through

when a Level 2 event occurs

3

Progress NOT Perfection

"If you can't fly then run,

if you can't run then walk,

if you can't walk then crawl,

but whatever you do you have to keep moving

forward."

— Martin Luther King Jr.

PACE Level II Report: Case 1 > Issue: PACE Level II Repot

> Type of incident and date incident occurred: Unwitnessed fall with fracture and hospitalization.

> Location of incident: Incident occurred in participant’s bedroom at the congregate setting where she resides.

> Participant’s Current Status: Participant is currently hospitalized at RG Hospital where she is undergoing surgery on 4/23 for a compression hip screw for a closed left hip fracture.

> Significant diagnoses: Dementia, GERD, HTN, Depression, Hypothyroidism, Hypercholesterolemia, Osteoporosis, Hx Trigeminal Neuralgia, Glaucoma, Macular Degeneration.

> Summary of the care history: Participant enrolled in PLAN 10/1/12. She resides in the ___Mother House where she receives services of home health aides 2 hours per day 7 days per week, Restorative Physical Therapy 1-2 times per week, and Skilled Nursing visits once per month and additionally as needed. She has a history of falls and is an identified falls risk due to unsteady gait and poor vision. She is independent with dressing and eating, requires assistance with bathing and toileting. She is 1 assist with transfer and ambulation, uses an ATW, but does not always call for assistance. She has a chair alarm and hip saver pads.

PACE Level II Report: Case 1

Summary of the event:

> On 4/22/15 Participant was found on the floor at 8:15 AM in

her bedroom. She stated she was going into the bathroom

and had not called for assistance. She was assisted up by 2

staff into the wheelchair. She complained of left groin pain

and had a laceration to the back of the head. She was sent to

___ ED where she was admitted and diagnosed with closed

left hip fracture, closed left Olecranon Avulsion fracture, and a

1 cm laceration on the scalp. Surgery is underway for hip

screw currently as of 4/23. She received 2 sutures to the

scalp wound and a left arm sling. No further intervention is

currently deemed necessary for the elbow.

PACE Level II Report: Case 1

> Was case presentation clear?

> What level 2 definition was the report based on?

> What the underlying causal reason(s) clear from

the report?

> What would you as the PACE Medical Director

feel should happen next?

> Does this happen at your program today?

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW:

This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated,

distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law.

8

What is a “Level II Event”?

• Definition

• “discrete subset of unusual incidents…in which the occurrence has a

significant impact on the health and/or safety of a PACE participant, or the

PACE program in the case of media-related events”

• Replaces “sentinal events”, revised Q 2-3 yrs

• Difference between Level I and II

• Significance

• Objective for CMS

• Monitor health & safety of the PACE participants and the effectiveness of the

PACE organization’s risk management and quality assurance programs

(PACE Level Two Reporting Guidance; CMS, July 2015)

You reported it, now what . . . .

Data Gathering

> Immediate action?

> Compliance with existing

polices ?

> What were potential causes

Root Cause

> Conduct with IDT and

relevant partners

o System factors

o Leading factors

o WHY? , WHY?

Many tools to consider ( fishbone)

9

Rules/Techniques of Fishbone Analysis

Basic Steps:

1. Draw the fishbone diagram....

2. List the problem/issue/goal to be studied in the "head of the fish". (1st level – main line)

3. Label each "bone" of the "fish". (2nd level). List each 2nd level cause to the 1st level.

4. The major categories for the 2nd level are typically utilized as:

An example of a fishbone

diagramAn example: Problem - Not meeting deadline

How is data interpreted?

HPMS (DataPACE 2) Data - FALLS

> “Baseline” data (PMPM) for FALLS is being

established for national PACE

> Limited to those programs submitting HPMS

data

NPA Survey Jan – April 2011 (61 / 75 sites participated)

194 Level II incidents

> Pressure ulcers (Stage III/IV) =

> Falls with injury =

> Unexpected deaths =

> Infectious disease outbreaks =

> Other (traumatic injuries, etc.) =

44%

33%

7%

5%

16%

PACE LEVEL II REPORT: CASE 1 FINAL REPORT

Immediate Actions Taken: As noted above.

IDT main concerns related to participant prior to event:

> Participant has had a history of frequent falls, with 2 falls without injury occurring in 3/2015.

> In March 2015, physical therapy noted mild functional decline and poor transfer status.

Restorative PT being provided.

> On 4/1/15, IDT noted difficulty transferring and added pressure alarm and hip saver pads to

her care plan. Care plan revised to 1 assist for transfer and ambulation.

> Participant was refusing to wear the hipsters because of bulkiness, snaps, general discomfort

with them. Physical therapy was working to solve the problems and had ordered a second

set which had not yet arrived at the time of the fall.

> Precipitating/Contributing Factors: The participant had evidenced a mild functional

decline. She did not want to call for the assistance of 1 that had been ordered because she

was used to being independent. She did not want to wear the hipsters and the team had not

been able to solve this issue before the fall occurred, since her noted mild decline had been

only of approximately 3 weeks duration. She had had no changes in her medical status or

medications that could have been contributory.

14

PACE LEVEL II REPORT: CASE 1 FINAL REPORT

Participant’s involvement/actions surrounding the event: As noted. Following the fall, the

participant voiced wishing she had had the hipsters on.

Participant’s degree of involvement in PACE program: As previously described.

Working relationship with contracted facility/contracted services (if applicable): N/A

Compliance with organization’s established policies and procedures: Compliant with

the falls policy and procedure.

Identification of risk points and their potential contribution to the event:

> The participant had been on every 2 hour checks but there appeared to be no

documentation of any check between 3:15 AM and 8:15 AM, the time she was found on the

floor.

> The refusal of the hipsters was a risk point and risks of refusal were reportedly discussed

with the participant but not documented. The team felt the waiting period for the second set

of hipsters was too long.

> The team felt there could have been clearer education with caregivers regarding the use of

the hipsters, with a demonstration.

> The care plan did not specify exactly what hours the hipsters should have been worn.

15

PACE LEVEL II REPORT: CASE 1 FINAL REPORT

As appropriate, proposed improvements in policies, training, procedures, systems,

processes, physical plant, staffing level, etc. to reduce future risks.

> Re-education with caregivers regarding the requirements of safety checks and improved

documentation of these checks, including what was done or offered to the participant during

the check (i.e.—toileting)

> Both medical staff and physical therapy staff will firm up the discussion of risks of not

following the care plan with participants, and document these discussions in the medical

record.

> Physical and occupational therapy staff will bring the issue of the wait time for receiving the

hipsters with the Director of Rehabilitation to see what can be done.

> The team will check with other participants who have hipsters ordered to check on

compliance and to also be sure clear instructions are documented in the care plan and on

the caregiver’s care card regarding hours they need to be worn. Verbal instructions with

demonstration will be provided to caregiver

16

PART II:

INCIDENTS AND REPORTING

THRESHOLDS

17

Incidents and Reporting Thresholds

> 17 Incident-specific thresholds

> For incidents meeting the threshold,

reporting to CMS is required within 2

working days.

> CMMS responds with a tracking ID

number (32char) which is included with all

subsequent documentation

> A final report is submittedafter the root

cause analysis is completed

18

Incidents and Reporting

Thresholds (cont’d)

> Most of the incidents will require a root

cause analysis (RCA)

> After consultation with the Regional Office

may decide to conduct a less rigorous

internal investigation

> Described in detail in Table 1 of the

guidance on pages 4 to 6

> Appendix B provides specific examples

19

Incidents and Reporting Thresholds

Incident

Death

Thresholds

> Homicide/ Suicide

> Unexpected and with active

coroner investigation

> Unexpected outcome from

any Level II incident

> Delay or suspected

inappropriate care

20

Incidents and Reporting Thresholds

(cont’d)

Incident

Falls

ThresholdsResulted in:

> Death

> Fracture requiring surgery

> Injury requiring hospitalization [admission or observation stay more than 23

hours] related directly to a fall

21

Incidents and Reporting Thresholds (cont’d)

Incident

> Infectious Disease

Outbreak

Thresholds

> Resulted in Death

> Three or more cases

> Linked to the same infectious

disease agent

> Occur within the same time

frame

> Reportable to the State and local

public health authority

> May also be reportable to CDC

(www.cdc.gov)

22

Incidents and Reporting Thresholds (cont’d)

Incident

> Pressure ulcer

Thresholds

> Unstageable

> Stage IV

o Necrosis of soft tissue

o Involves underlying

> Muscle, Tendon, Bone

> Stage III

o Full thickness skin loss

o Subcutaneous tissue damage

or necrosis

23

Increases in Level II reporting

Prior (2013)

A: 100/1000

B: 5.2/2000

C: 8/site

E: 14 (Jan–Jun 2013)

Current (2014 / 15)

> 500/1

> 16.7/2000

> 18/site

> 42 (2014)

24

Medical Quality Assurance Data – non-discoverable

RCA OVERVIEW 2016 YTD

25

26

11

2 1 1 1

1 1

12 3

31

2

12

24

2

45

3

6

7

2 35

3

1

1

1

1

1

3

2

11

1 1 1 1

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2015_1 2015_2 2015_3 2015_4 2015_5 2015_6 2015_7 2015_8 2015_9 2015_10 2015_11 2015_12

Level II TrendSource: Level II Tracking Worksheet

Adverse Drug Reaction Adverse Outcome Burn

Elopement Fall Injury requiring hospitalization

Outbreak Pressure ulcer Restraint Injury

Suicide Attempt Fire/ Other Disaster Abuse

Medical Quality Assurance Data – non-discoverable

2015 LEVEL 2 EVENT BY CATEGORY

27

An Engaged TEAM

• Teamwork is the ability to work together toward a

common vision.

• The ability to direct individual accomplishments

toward organizational objectives.

• It is the fuel that allows common people to attain

uncommon results.

- Andrew Carnegie

28