final tissue toolkit

Tissue Management Tool Kit

Lead authors:

Todd Henderson

Jessica Vasquez

1

Instructions

Standards

Welcome to the Tissue Management Tool Kit! This document

was made for compliance with Joint Commission Standards, AORN recommendations, BMH policy & procedure, and to provide clear and concise instructions on how the O.R. handle tissues. The subsequent guidelines represent each step of the tissue process as it applies to the

O.R. at BMH. Use the guidelines and reference regulations for any questions in the handling process.

2

How to Use this Took Kit

Identify

Solve

Sustain

3

Identify

Standards

• Identify the Problem Areas that are contributing to non- compliance

• Identify areas where compliance can be improved

4

Solve

Standards

• Utilize the toolkit for the Problem Areas identified

• Review key questions, steps to identify solutions, recommended solutions, key success factors and barriers in proper tissue handling

5

Sustain

Standards

• Create a sustainability plan to solidify results over time

• Use the checklist provided in the toolkit as the basis for the plan

• Provision of oversight to make sure we remain in compliance

6

Tissue Management Toolkit Structure

Standards

Instructions and Checklist

This toolkit provides instructions for use along with a 6-week checklist to guide you through implementation and sustainability.

The tools have been divided into 4 key sections:

StandardsRoles and Responsibilities Education and CoachingCommunication

Common findings that result in less than desirable Tissue Management issues are grouped into these key sections.

Supplemental Documents –additional documents are being provided to augment the toolkit

7

Task

Meet with Director, Educator, and Coordinator

Identify Problem Areas

Establish TSOC (Tissue Service Oversight Committee)

Select TSOC team members

Secure meeting room and send dates to team members

Ensure team members are scheduled off for meetings

Communicate with OR team, physicians, facility leadership team

Obtain metric baselines and secure a way to measure progress on-going

Week 1 Checklist

8

Task

Review the Toolkit Templates and Solutions for the Problem Areas Identified

Draft charter, problem statement, & scope

Obtain metric baselines and secure a way to measure progress on-going

Select the solutions to test for the problem areas

Meet with OR team/physicians to discuss solutions and changes


Week 2 Checklist

9

Task

Implement solutions immediately

Measure changes in metrics

Meet with staff to discuss what is going well, what needs to be adjusted/tweaked

Make adjustments and continue to test on small scale


Week 3 Checklist

10

Task

Full scale implementation

Measure changes in metrics

Meet with staff to discuss concerns, celebrate wins, discuss any changes

Make adjustments and continue to test

Identify any action items that need follow-up and assign owner if appropriate

Create Standard Work, include job aides, pictures, as appropriate

Create visual management tool for metrics and incorporate into huddles


Week 4 Checklist

11

Task

Verify that any new standard work sequences and standard processes are being

maintained

Conduct random surveys

Discuss random survey results with staff

Ensure visual management tools are being used

Follow-up and report on open action items. Elevate concerns to next level of

leadership


Week 5 Checklist

*GEMBA = Literal translation for gemba is “the real place” – it is where the work is actually performed. Gemba could be

a patient unit, a registration area, a cubicle, a conference room. In truly lean organizations, managers and supervisors

are required to spend a significant amount of time at “gemba.” It is about listening not telling or offering solutions.

12

Task

Verify that any new standard work sequences and standard processes are being

maintained

Conduct *GEMBAs and invite Senior Leaders to join (involve PE Directors)

Publicize event results

Ensure visual management tools are being used

Follow-up and report on open action items. Elevate concerns to next level of

leadership

Draft Formal Sustainability Plan, involve PE Director


Week 6 Checklist

*GEMBA = Literal translation for gemba is “the real place” – it is where the work is actually performed. Gemba could be

a patient unit, a registration area, a cubicle, a conference room. In truly lean organizations, managers and supervisors

are required to spend a significant amount of time at “gemba.” It is about listening not telling or offering solutions.

13

Tissue Management Tools

StandardsRoles &

Responsibilities Education &

Coaching

14

Common findings that affect Compliance

• Difficulty finding/accessing guidance for standards• Incorrectly interpreting standards (ex. 10 year record- keeping)• Not knowing standards

Standards

• Lack of detailed work roles and responsibilities specific to executing standards (Lab, Engineering)

• Little knowledge of standard of work (SOW)• Roles have been mixed up• No oversightRoles/Res-

ponsibilities

• Lack of education (specifically for maintenance of freezers and the cleaning of) • Lack of education on temperature ranges • Lack of education on alarm testing

Education & Coaching

Communication

Standards

15

16

Joint Commission Accreditation of Healthcare Organizations (JCAHO)Transplant Safety Standards

The following standards apply to hospitals that store or issue tissue. This

includes any areas outside of the clinical laboratory that store or issue

tissue; for example, surgery and outpatient centers or tissue banks. They

apply to human and nonhuman cellular-based transplantable and

implantable products whether classified by the U.S. Food and Drug

Administration (FDA) as a tissue or a medical device. Collagen and tissue

products derived from plastics and polymers are not considered cellular-

based products and are not evaluated under these standards.

Specific tissue transplant requirements apply to autologous tissue. This

includes policies and procedures for identifying, tracking, storing, and

handling autologous tissue, in addition to investigating tissue adverse

events. Also, if the state in which an organization resides classifies

something as tissue that falls outside the scope of The Joint Commission

definition, the standards would apply.

17

Examples of Tissue and Cell Products

Amnion/Amniotic Membrane

Arteries

Autologous Cells

Autologous Tissue

Bone

Bone Marrow

Bone Paste

Bone Powder

Bone Putty Cancellous Chips

Cardiac (Heart) Valves (Aortic,

Pulmonary)

Cartilage

Chondrocytes

Cornea

Demineralized Bone Matrix

Dendritic Cells

Dermal Matrix

Dermis

Dura Mater

Embryo

Fascia/Fascia Lata

Hematopoietic Stem

Cells

Leukocytes

Ligaments

Limbal Graft

Limbal Stem Cells

Lymphocytes

Marrow

Membrane

Meniscus

Nerves

Non-valved Conduits

Oocyte/Ovarian Cells

Ovarian Tissue

Pancreatic Islet Cells

Parathyroid

Pericardium

Peripheral Blood Stem

Cells

Progenitor Cells

Sclera

Semen, Sperm

Skin

Somatic Cells

Tendons

Testicular Tissue

Therapeutic Cells (T-Cell

Pheresis)/T-Cells

Tissue (also Synthetic Tissue)

Trachea

Umbilical Cord Blood Stem

Cells

Vascular Graft

Veins (Saphenous, Femoral,

Iliac)

Other cellular- and tissue-

based transplant or implant

products whether classified

by the FDA as a tissue or a

medical device

Other tissues that are

classified as tissues by state

law and regulation

18

Transplant Safety: TS.03.01.01Joint Commission Standards

The Hospital Uses Standardized Procedures for Managing Tissue

19


Transplant Safety: TS.03.01.01

TS.03.01.01, EP 1

Elements of Performance:

The hospital assigns responsibility to one or more individuals for overseeing the acquisition, receipt,

storage, and issuance of tissues throughout the hospital.

*Responsibility for this oversight involves coordinating efforts to provide standardized practices throughout

the hospital. A hospital may have a centralized process (one department responsible for the ordering, receipt,

storage, and issuance of tissue throughout the hospital) or a decentralized process (multiple departments

responsible for the ordering, receipt, storage, and issuance of tissue throughout hospital.

EP Attributes

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New FSA CMS MOS CR DOC SC ESP

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Transplant A ESP-1

Services

BMH Applicable Roles

Scheduler, Materials Management, and Materials Management Information Systems Coordinator

20



TS.03.01.01, EP 2

The hospital develops and maintains standardized written procedures for the acquisition, receipt,

storage, and issuance of tissues. (See also TS.03.02.01, EP 5)(BMH Policies #AD-TS 103, 104, & #DP-WC 127)

EP Attributes

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Transplant D A ESP-1

Services


Scheduler, Materials Management, and Materials Management Information Systems Coordinator

21



TS.03.01.01, EP 3

The hospital confirms that tissue suppliers are registered with the U.S. Food & Drug Administration

(FDA) as a tissue establishment and maintain a state license when required**.

This element of performance does not apply to autologous tissue or cellular-based products considered

tissue for the purposes of these standards but classified as medical devices by the FDA.

**For FDA registration, the supplier registration status may also be checked annually by using the FDA’s

online database: www.fda.gov/cber/tissue/tissregdata.htm

EP Attributes

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Transplant A ESP-1

Services


Materials Management, Materials Management Information Systems Coordinator

http://www.fda.gov/cber/tissue/tissregdata.htm

22



TS.03.01.01, EP 4

The hospital coordinates its acquisition, receipt, storage, and issuance of tissues throughout the

hospital.

EP Attributes

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Transplant A

Services


Materials Management Information Systems Coordinator

23



TS.03.01.01, EP 5

The hospital follows the tissue suppliers’ or manufacturers’ written directions for transporting, handling

storing, and using tissue. (BMH Policies #AD-TS 103, 104, & #DP-WC 127)

EP Attributes

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Transplant A

Services



3

24



TS.03.01.01, EP 6

The hospital documents the receipt of all tissues. (See also TS.03.02.01, EP 3 & 6)

(BMH Policies #DP-WC 127 & #AD-TS 103)

EP Attributes

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Transplant M D C

Services



25



TS.03.01.01, EP 7

The hospital verifies at the time of receipt that package integrity is met and transport temperature

range was controlled and acceptable for tissues requiring a controlled environment. This verification is

documented. (See also TS.03.02.01, EP 6)

If the distributor uses validated shipping containers, then the receiver may document that the shipping

container was received undamaged and within the stated time frame.

Tissues requiring no greater control than “ambient temperature” (generally defined as the temperature of

the immediate environment) for transport & storage would not need to have the temperature verified on

the receipt.

EP Attributes

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Transplant M D C

Services


Materials Management

26



TS.03.01.01, EP 8

The hospital maintains daily records to demonstrate that tissues requiring a controlled environment

are stored at the required temperatures. (See also TS.03.02.01, EP 5)

(BMH Policies #AD-TS 104)

Types of tissue storage include room temperature, refrigerated, frozen (for example, deep freezing colder

than -40 degrees Celsius), and liquid nitrogen storage.

Tissues requiring no greater control than “ambient temperature” (defined as the temperature of the

immediate environment) for storage would not require temperature monitoring.

EP Attributes

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Transplant M D C

Services



27



TS.03.01.01, EP 9

The hospital continuously monitors the temperature of refrigerators, freezers, nitrogen tanks, and

other storage equipment used to store tissues. (BMH Policies #AD-TS 104)

Continuous temperature recording is not required but may be available with some continuous

temperature monitoring systems.

For tissue stored at room temperature, continuous temperature monitoring is not required

EP Attributes

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Transplant A

Services


CPD, Center Core

28



TS.03.01.01, EP 10

Refrigerators, freezers, nitrogen tanks, and other storage equipment used to store tissues at a

controlled temperature have functional alarms & an emergency back-up plan.

(BMH Policies #AD-TS 104 & #DP-WC 127)

For tissue stored at room temperature, alarm systems are not required.

EP Attributes

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Transplant 3 A ESP-1

Services


CPD, Center Core

29



TS.03.01.01, EP 11

The hospital complies with state and/or federal regulations when it acts as a tissue supplier**

The FDA considers the routine policy or practice of shipping tissue to another facility as distribution which

requires FDA registration. Returning unused tissue back to the tissue supplier is not considered distribution

& does not require FDA registration.

**Please refer to the following website: www.fda.gov/cber/tissue/tisreg.htm

EP Attributes

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Transplant A

Services


Laboratory, Director

http://www.fda.gov/cber/tissue/tisreg.htm

30


The Hospital Traces All Tissues Bi-directionally

31

The Hospital Traces All Tissues Bi-directionallyTransplant Safety: TS.03.02.01

TS.03.02.01, EP 1


The hospital’s records allow any tissue to be traced from the donor or tissue supplier to the

recipient(s) or other final disposition, including discard, and from the recipient(s) or other final

disposition back to the donor or tissue supplier. (BMH Policies #AD-TS 104)

EP Attributes

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Transplant 3 D A

Services



32


TS.03.02.01, EP 2


The hospital identifies, in writing, the materials and related instructions used to prepare or process

tissues.

EP Attributes

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Transplant M D C ESP-1

Services



33


TS.03.02.01, EP 3


The hospital documents the dates, times, and staff involved when tissue is accepted, prepared, and

issued. (See also TS.03.01.01, EP 6)

EP Attributes

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Transplant M D C

Services


Materials Management, Materials Management Information Systems Coordinator, Front Desk, RNs

34


TS.03.02.01, EP 4


The hospital documents in the recipient’s medical record the tissue type and its unique identifier

EP Attributes

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Transplant A

Services


RNs, Materials Management Information Systems Coordinator

35


TS.03.02.01, EP 5


The hospital retains tissue records on storage temperatures, outdated procedures, manuals, and

publications for a minimum of 10 years. If required by state and/or federal laws, hospitals may

have to retain tissue records longer than 10 years. (See also TS.03.01.01, Eps 2 & 8)

EP Attributes

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Transplant A

Services


Materials Management Information Systems Coordinator, Peri-Operative Services Coordinator, Director

36


TS.03.02.01, EP 6


The hospital retains tissue records for a minimum of 10 years beyond the date of distribution,

transplantation, disposition, or expiration of tissue (whichever is latest). If required by state

and/or federal laws, hospitals may have to retain tissue records longer than 10 years. Records are

kept on all of the following:

1. The tissue supplier*For medical devices, the manufacturer may be the tissue supplier.

2. The original numeric or alphanumeric donor and lot identification

3. The name(s) of the recipient(s) or the final disposition of each tissue

4. The expiration dates of all tissues

(see also TS.03.01.01, Eps 6 & 7)

EP Attributes

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Transplant A

Services


Materials Management Information Systems Coordinator, Peri-Operative Services Coordinator, Director

37


The Hospital Investigates Adverse Events Related to Tissue Use or Donor Infections

38


Transplant Safety: TS.03.03.01TS.03.03.01, EP 1


The hospital has a written procedure to investigate tissue adverse events, including disease

transmission or other complications that are suspected of being directly related to the use of tissue. (BMH Policy #AD-TS 103)

EP Attributes

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Services


Surgeons, Materials Management Information Systems Coordinator

39




The hospital investigates tissue adverse events, including disease transmission or other

complications that are suspected of being directly related to the use of tissue. (See also IC.01.03.01,

EP3). (BMH Policy #AD-TS 103)

EP Attributes

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Services


Surgeons

40




As soon as the hospital becomes aware of a post-transplant infection or other adverse event related

to the use of tissue, it reports the infection or adverse event to the tissue supplier. (BMH Policy #AD-TS 103)

EP Attributes

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Transplant 3 A

Services


Surgeons, Materials Management Information Systems Coordinator, Materials Management

41




The hospital sequesters tissue whose integrity may have been compromised or that is reported by the

tissue supplier as a suspected cause of infection. (BMH Policy #AD-TS 103)

EP Attributes

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Transplant 3 A

Services

BMH Applicable Roles Materials Management, Materials Management Information Systems Coordinator

42




The hospital identifies and informs tissue recipients of infection risk when donors are subsequently

found to have human immunodeficiency virus (HIV), human T-lymphotropic virus-I/II (HTLV-I/II), viral

hepatitis, or other infectious agents known to be transmitted through tissue(BMH Policy #AD-TS 103. Surgery Tissue Look-Back Data Sheet. Must make a minimum of three (3) attempts to notify the

recipient & completed within 12 weeks)

EP Attributes

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Transplant 3 A

Services

BMH Applicable Roles Surgeons, Medical Director, Peri-Op Director, Infection Control, Risk Management, Blood Bank

43




The hospital identifies and informs tissue recipients of infection risk when donors are subsequently

found to have human immunodeficiency virus (HIV), human T-lymphotropic virus-I/II (HTLV-I/II), viral

hepatitis, or other infectious agents known to be transmitted through tissue(BMH Policy #AD-TS 103. Surgery Tissue Look-Back Data Sheet. Must make a minimum of three (3) attempts to notify the

recipient & completed within 12 weeks)

EP Attributes

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Transplant 3 A

Services

BMH Applicable Roles Surgeons, Medical Director, Peri-Op Director, Infection Control, Risk Management, Blood Bank

44

Standards: Common Findings

Staff responsible for recording temps, do not know the acceptable temp ranges.1

• Document Tissue from arrival to hospital to actual use2

Standards

Complete the template

No template necessary, however

this area was raised as a concern,

address locally as needed

KEY

45

Temperature Recording Logs1

Description: Tightening up the procedures to ensure compliance

Standards

Objective: 100% compliance in daily monitoring of temperature recording logs

Personnel for solution building

Key questions

Key success factors

Solutions– Education of Center Core staff on their responsibilities– Identify fixed temperatures on freezers – Provide oversight to ensure the temps are being

recorded/accountability– Provide oversight to make sure temp logs are being kept. Use PI

data to monitor compliance– Provide Manufacturer manual to follow maintenance protocols– - Establish competencies on tissue standards

– CPD staff & Center Core – OR leadership including MMIS Coordinator

– 100% compliance on monthly PIs– Completion of annual competencies– Employee confusion decrease due to education – Random audits.

– Does center core & CPD staff understand their responsibilities?– Does CPD staff know the temp ranges for each freezer?– Who is responsible for recording temps daily? – What oversight is provided to ensure daily temps & quarterly

alarm testing is being done? Where do the logs reside?

Barriers and mitigating strategies– Time – To meet, learn and educate all involved– Staff accountability—need ownership

Steps to identify and implement solutions– Utilize LEAN methodology to organize equipment and assign

roles and responsibilities– Define acuity level for use of equipment (freq, rarely and

define storage areas based on distance to OR and acuity)– Place signs on movable freezer so that it does not get

moved

46

Temperature Recording LogsTissue Standards Compliance and adherence to BMH, local, and federal policies

AD-TS 103-104; DP-SS 103; DP-WC 127

1

Standards

Tissue Storage Performance Improvement Summary

2014 2015 2016

January 100% 98%

February 100% 100%

March 100%

April 100%

May 100%

June 100%

July 100%

August 81%

September 100%

October 100%

November 100%

December 99%

47

Temperature Recording Logs1

Standards

0%

20%

40%

60%

80%

100%

2014

2015

Linear(2014)

Roles and Responsibilities

48

Solution Examples

49

SchedulingMaterials

ManagementRN Doctor CPD Engineering Lab

MMIS

CoordinatorOR Front Desk Center Core

Receives case

Requisition &

provides slip

to MM for

Precuts

Receives slip

from Scheduler,

verifies with

Dr.’s office on

product request.

Inventory is

checked for

product &

ordered from

Vendor if not in

stock.

Receive in-

service of new

Tissue

products.

Creates

Case

Requisition

Daily

recordings of

Freezer/Stora

ge/Alarm

temps &

provide

MMIS Coord.

w/ temp logs

Responds to

work orders on

Freezers

Tissue bank

License

Renewal

Super User: Maintains

all uploads of all

users, Surgeons,

Vendors, Vendor

credentials, Vendor

products;

Troubleshoots TTC &

Meditech; Inventory

count; Data entry of

Freezer Temps; works

w/ Lab to renew

licensing

Receives Tissue

products already

checked for package

integrity & notifies

MM of product

arrival , including

the provision of

product tracking/

received by Lawson

process flow, or by

the Rep

Is notified if

alarm goes off on

a freezer or

Refrigerator.

Calls

Engineering &

documents work

order number

Receives Tissue

products- Checks

integrity of

packaging

Retrieves and

logs out tissue

in TTC

Notifies of

Adverse

Effects

Quarterly

Alarm

Testing

Is notified as

the backup

when alarm

goes off & is

unattended by

OR

Back-up

Freezers located

in Wound Care

Receives Tissue

products & Checks

integrity of packaging,

temperature, &

expiration date. Item

entered into TTC &

attaches TTC label

Receives call from

PBX during alarm

testing & notifies

Center Core

Reorders tissue Opens tissue,

writes tissue

info into PT

chart, Gives

package w/

label to OR

Front desk

Stores tissue Bills for Tissue

usage once tissue

package is submitted

to OR Front Desk;

Submits package to

MM for reordering

Regularly monitors

TTC implantation log

against ORM

documentation;

Regular inventory

check for outdates.

Tissue Management Roles and ResponsibilitiesRoles

50

Roles and Responsibilities: Common Findings

1. Lack of detailed work roles and responsibilities, specifically who is responsible for ‘what’

2. Little knowledge of Policies & Procedures pertaining to Tissue management

• Need education & policies, especially pertaining to normal freezer/refrigerator temps; alarm testing; maintenance

Roles

1

2


KEY

51

Unclear roles and responsibilities specific to room tissue management1

Description: Lack of detailed work roles and responsibilities specific to alarm testing & knowing normal temperature ranges

Objective: Establish standard roles and responsibilities for all team members to ensure tissue safety

Roles


Key questions Key success factors

Solutions– Define standard roles and responsibilities for

all team members – Use Policies & Procedures as backbone to

define roles– Education & Competencies

– CPD & Center Core– Engineering– Front Desk Staff

– 100% completion of daily alarm monitoring logs

– Quarterly alarm testing– Staff knowledgeable of acceptable temp ranges

– Does a lack of clear roles and responsibilities contribute cause any non-compliance?

– Does the lack of manufacturer-recommended alarm testing procedures affect the alarm testing process?

Barriers and mitigating strategies– No acceptable temp ranges listed on logs– No direct oversight of tissue management

Steps to identify and implement solutions– List acceptable temp ranges on logs– Learn Manufacturer’s instructions for alarm

testing & cleaning– Clearly identify the roles responsible

52

Policy Education2

Description: Refresher competencies of policies & procedures

Objective: Knowledge of policies

Roles



Solutions– Define standard roles and responsibilities for

all team members – Use Policies & Procedures as backbone to

define roles– Education & Competencies

– CPD & Center Core– Educator

– 100% competencies– Is staff familiar with policies?– Does staff know where the temp logs & records

can be found?

Barriers and mitigating strategies– No acceptable temp ranges listed on logs– No direct oversight of tissue management

Steps to identify and implement solutions– List acceptable temp ranges on logs– Learn Manufacturer’s instructions for alarm

testing & cleaning– Clearly identify the roles responsible

Education and Coaching

53

Solution Examples

54

Education and Coaching: Common Findings

Lack of staff education

1. Minimal education on roles and responsibilities

2. Lack of assertiveness

1

2

3

Education


No template necessary, however

this area was raised as a concern,

address locally as needed

KEY

Education of staff

55

Lack of Staff Education1

Description: Lack of knowledge on Standards & Policies

Objective:

Education



Solutions– Annual competencies– Cross-train

– OR Director/Managers– Education Staff

– Implementation of competencies– Knowledgeable Directors/Managers – Consistent regulatory compliance

Barriers and mitigating strategies– Time– Resources– Depth of information needed

Steps to identify and implement solutions– Collaborate with other teams to attain

informational input.– Develop review team to validate data.

What information is needed?Will this truly benefit the tissue management process?

56

Minimal Education on Roles and Responsibilities 2

Description: In regard to tissue management, but also OR Roles and Responsibilities in general we need to develop consistent expectation and best practices of all OR staff.

Objective: Create consistent staff expectations and training throughout our facilities.

Education



Solutions– Through consistent training, best practices will

be established and shared with all facilities.– Improved, consistent expectation and training.

– OR Director, Educator, Coordinator– Actual staff members

– All staff members having a clear understanding of not only procedures but the value of improvement associated with Tissue compliance

–Barriers and mitigating strategies– Time constraints– Varied expectations

Steps to identify and implement solutions– Need to include and educate any regulatory

issues– Build consistency in tissue management

procedures

Is it possible to create consistent training and expectations for OR staff?

Example: CPD, Center Core, RNs..

57

Education and Coaching: Solutions

• Improved, consistent resource availability to all facilities

• Consistent/accurate information easily accessible

• Education on standardized work

• Training/In-service on proper instrumentation care/use

• Training on current regulatory guidelines

• Cross-train CPD & Center Core for alarm testing & temperature readings

• Changes in Huddles to include daily assignments

Education

58

Tissue Management Tools

StandardsRoles &

Responsibilities Education &

Coaching