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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:
Standards
Roles and Responsibilities
Education and Coaching
Communication
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
Communicate with OR team, physicians, facility leadership team
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
Communicate with OR team, physicians, facility leadership team
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
Communicate with OR team, physicians, facility leadership team
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
Communicate with OR team, physicians, facility leadership team
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
Communicate with OR team, physicians, facility leadership team
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
Standards
Roles &
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.03.01.01
Joint Commission Standards
The Hospital Uses Standardized
Procedures for Managing Tissue
19
The Hospital Uses Standardized Procedures for
Managing Tissue
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
-----------------------------------------------------------------------------------------------------------------------------------------------------------
New FSA CMS MOS CR DOC SC ESP
-----------------------------------------------------------------------------------------------------------------------------------------------------------
Transplant A ESP-1
Services
BMH Applicable Roles
Scheduler, Materials Management, and Materials Management Information Systems Coordinator
20
The Hospital Uses Standardized Procedures for
Managing Tissue
Transplant Safety: TS.03.01.01
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
-----------------------------------------------------------------------------------------------------------------------------------------------------------
New FSA CMS MOS CR DOC SC ESP
-----------------------------------------------------------------------------------------------------------------------------------------------------------
Transplant D A ESP-1
Services
BMH Applicable Roles
Scheduler, Materials Management, and Materials Management Information Systems Coordinator
21
The Hospital Uses Standardized Procedures for
Managing Tissue
Transplant Safety: TS.03.01.01
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
-----------------------------------------------------------------------------------------------------------------------------------------------------------
New FSA CMS MOS CR DOC SC ESP
-----------------------------------------------------------------------------------------------------------------------------------------------------------
Transplant A ESP-1
Services
BMH Applicable Roles
Materials Management, Materials Management Information Systems Coordinator
22
The Hospital Uses Standardized Procedures for
Managing Tissue
Transplant Safety: TS.03.01.01
TS.03.01.01, EP 4
The hospital coordinates its acquisition, receipt, storage, and issuance of tissues throughout the
hospital.
EP Attributes
-----------------------------------------------------------------------------------------------------------------------------------------------------------
New FSA CMS MOS CR DOC SC ESP
-----------------------------------------------------------------------------------------------------------------------------------------------------------
Transplant A
Services
BMH Applicable Roles
Materials Management Information Systems Coordinator
23
The Hospital Uses Standardized Procedures for
Managing Tissue
Transplant Safety: TS.03.01.01
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
-----------------------------------------------------------------------------------------------------------------------------------------------------------
New FSA CMS MOS CR DOC SC ESP
-----------------------------------------------------------------------------------------------------------------------------------------------------------
Transplant A
Services
BMH Applicable Roles
Materials Management Information Systems Coordinator
3
24
The Hospital Uses Standardized Procedures for
Managing Tissue
Transplant Safety: TS.03.01.01
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
-----------------------------------------------------------------------------------------------------------------------------------------------------------
New FSA CMS MOS CR DOC SC ESP
-----------------------------------------------------------------------------------------------------------------------------------------------------------
Transplant M D C
Services
BMH Applicable Roles
Materials Management Information Systems Coordinator
25
The Hospital Uses Standardized Procedures for
Managing Tissue
Transplant Safety: TS.03.01.01
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
-----------------------------------------------------------------------------------------------------------------------------------------------------------
New FSA CMS MOS CR DOC SC ESP
-----------------------------------------------------------------------------------------------------------------------------------------------------------
Transplant M D C
Services
BMH Applicable Roles
Materials Management
26
The Hospital Uses Standardized Procedures for
Managing Tissue
Transplant Safety: TS.03.01.01
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
-----------------------------------------------------------------------------------------------------------------------------------------------------------
New FSA CMS MOS CR DOC SC ESP
-----------------------------------------------------------------------------------------------------------------------------------------------------------
Transplant M D C
Services
BMH Applicable Roles
Materials Management Information Systems Coordinator
27
The Hospital Uses Standardized Procedures for
Managing Tissue
Transplant Safety: TS.03.01.01
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
-----------------------------------------------------------------------------------------------------------------------------------------------------------
New FSA CMS MOS CR DOC SC ESP
-----------------------------------------------------------------------------------------------------------------------------------------------------------
Transplant A
Services
BMH Applicable Roles
CPD, Center Core
28
The Hospital Uses Standardized Procedures for
Managing Tissue
Transplant Safety: TS.03.01.01
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
-----------------------------------------------------------------------------------------------------------------------------------------------------------
New FSA CMS MOS CR DOC SC ESP
-----------------------------------------------------------------------------------------------------------------------------------------------------------
Transplant 3 A ESP-1
Services
BMH Applicable Roles
CPD, Center Core
29
The Hospital Uses Standardized Procedures for
Managing Tissue
Transplant Safety: TS.03.01.01
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
-----------------------------------------------------------------------------------------------------------------------------------------------------------
New FSA CMS MOS CR DOC SC ESP
-----------------------------------------------------------------------------------------------------------------------------------------------------------
Transplant A
Services
BMH Applicable Roles
Laboratory, Director
30
Transplant Safety: TS.03.02.01
Joint Commission Standards
The Hospital Traces All
Tissues Bi-directionally
31
The Hospital Traces All Tissues Bi-directionally
Transplant Safety: TS.03.02.01
TS.03.02.01, EP 1
Elements of Performance:
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
-----------------------------------------------------------------------------------------------------------------------------------------------------------
New FSA CMS MOS CR DOC SC ESP
-----------------------------------------------------------------------------------------------------------------------------------------------------------
Transplant 3 D A
Services
BMH Applicable Roles
Materials Management Information Systems Coordinator
32
The Hospital Traces All Tissues Bi-directionally
Transplant Safety: TS.03.02.01
TS.03.02.01, EP 2
Elements of Performance:
The hospital identifies, in writing, the materials and related instructions used to prepare or process
tissues.
EP Attributes
-----------------------------------------------------------------------------------------------------------------------------------------------------------
New FSA CMS MOS CR DOC SC ESP
-----------------------------------------------------------------------------------------------------------------------------------------------------------
Transplant M D C ESP-1
Services
BMH Applicable Roles
Materials Management Information Systems Coordinator
33
The Hospital Traces All Tissues Bi-directionally
Transplant Safety: TS.03.02.01
TS.03.02.01, EP 3
Elements of Performance:
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
-----------------------------------------------------------------------------------------------------------------------------------------------------------
New FSA CMS MOS CR DOC SC ESP
-----------------------------------------------------------------------------------------------------------------------------------------------------------
Transplant M D C
Services
BMH Applicable Roles
Materials Management, Materials Management Information Systems Coordinator, Front Desk, RNs
34
The Hospital Traces All Tissues Bi-directionally
Transplant Safety: TS.03.02.01
TS.03.02.01, EP 4
Elements of Performance:
The hospital documents in the recipient’s medical record the tissue type and its unique identifier
EP Attributes
-----------------------------------------------------------------------------------------------------------------------------------------------------------
New FSA CMS MOS CR DOC SC ESP
-----------------------------------------------------------------------------------------------------------------------------------------------------------
Transplant A
Services
BMH Applicable Roles
RNs, Materials Management Information Systems Coordinator
35
The Hospital Traces All Tissues Bi-directionally
Transplant Safety: TS.03.02.01
TS.03.02.01, EP 5
Elements of Performance:
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
-----------------------------------------------------------------------------------------------------------------------------------------------------------
New FSA CMS MOS CR DOC SC ESP
-----------------------------------------------------------------------------------------------------------------------------------------------------------
Transplant A
Services
BMH Applicable Roles
Materials Management Information Systems Coordinator, Peri-Operative Services Coordinator, Director
36
The Hospital Traces All Tissues Bi-directionally
Transplant Safety: TS.03.02.01
TS.03.02.01, EP 6
Elements of Performance:
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
-----------------------------------------------------------------------------------------------------------------------------------------------------------
New FSA CMS MOS CR DOC SC ESP
-----------------------------------------------------------------------------------------------------------------------------------------------------------
Transplant A
Services
BMH Applicable Roles
Materials Management Information Systems Coordinator, Peri-Operative Services Coordinator, Director
37
Transplant Safety: TS.03.03.01
Joint Commission Standards
The Hospital Investigates Adverse Events Related
to Tissue Use or Donor Infections
38
The Hospital Investigates Adverse Events Related to
Tissue Use or Donor Infections
Transplant Safety: TS.03.03.01
TS.03.03.01, EP 1
Elements of Performance:
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
-----------------------------------------------------------------------------------------------------------------------------------------------------------
New FSA CMS MOS CR DOC SC ESP
-----------------------------------------------------------------------------------------------------------------------------------------------------------
Transplant D A ESP-1
Services
BMH Applicable Roles
Surgeons, Materials Management Information Systems Coordinator
39
The Hospital Investigates Adverse Events Related to
Tissue Use or Donor Infections
Transplant Safety: TS.03.03.01
TS.03.03.01, EP 2
Elements of Performance:
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
-----------------------------------------------------------------------------------------------------------------------------------------------------------
New FSA CMS MOS CR DOC SC ESP
-----------------------------------------------------------------------------------------------------------------------------------------------------------
Transplant D A ESP-1
Services
BMH Applicable Roles
Surgeons
40
The Hospital Investigates Adverse Events Related to
Tissue Use or Donor Infections
Transplant Safety: TS.03.03.01
TS.03.03.01, EP 3
Elements of Performance:
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
-----------------------------------------------------------------------------------------------------------------------------------------------------------
New FSA CMS MOS CR DOC SC ESP
-----------------------------------------------------------------------------------------------------------------------------------------------------------
Transplant 3 A
Services
BMH Applicable Roles
Surgeons, Materials Management Information Systems Coordinator, Materials Management
41
The Hospital Investigates Adverse Events Related to
Tissue Use or Donor Infections
Transplant Safety: TS.03.03.01
TS.03.03.01, EP 4
Elements of Performance:
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
-----------------------------------------------------------------------------------------------------------------------------------------------------------
New FSA CMS MOS CR DOC SC ESP
-----------------------------------------------------------------------------------------------------------------------------------------------------------
Transplant 3 A
Services
BMH Applicable Roles
Materials Management, Materials Management Information Systems Coordinator
42
The Hospital Investigates Adverse Events Related to
Tissue Use or Donor Infections
Transplant Safety: TS.03.03.01
TS.03.03.01, EP 5
Elements of Performance:
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
-----------------------------------------------------------------------------------------------------------------------------------------------------------
New FSA CMS MOS CR DOC SC ESP
-----------------------------------------------------------------------------------------------------------------------------------------------------------
Transplant 3 A
Services
BMH Applicable Roles
Surgeons, Medical Director, Peri-Op Director, Infection Control, Risk Management, Blood Bank
43
The Hospital Investigates Adverse Events Related to
Tissue Use or Donor Infections
Transplant Safety: TS.03.03.01
TS.03.03.01, EP 6
Elements of Performance:
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
-----------------------------------------------------------------------------------------------------------------------------------------------------------
New FSA CMS MOS CR DOC SC ESP
-----------------------------------------------------------------------------------------------------------------------------------------------------------
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 Logs
Tissue 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
Scheduling
Materials
Management
RN Doctor CPD Engineering Lab
MMIS
Coordinator
OR 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 Responsibilities
Roles
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
Complete the template
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
Personnel for solution building
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
Personnel for solution building
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
– 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
Complete the template
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
Personnel for solution building
Key questions Key success factors
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 Responsibilities2
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
Personnel for solution building
Key questions Key success factors
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
Standards
Roles &
Responsibilities
Education &
Coaching

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FINAL Tissue Toolkit

  • 1. Tissue Management Tool Kit Lead authors: Todd Henderson Jessica Vasquez
  • 2. 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.
  • 3. 2 How to Use this Took Kit Identify Solve Sustain
  • 4. 3 Identify Standards • Identify the Problem Areas that are contributing to non- compliance • Identify areas where compliance can be improved
  • 5. 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
  • 6. 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
  • 7. 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: Standards Roles and Responsibilities Education and Coaching Communication 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
  • 8. 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
  • 9. 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 Communicate with OR team, physicians, facility leadership team Week 2 Checklist
  • 10. 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 Communicate with OR team, physicians, facility leadership team Week 3 Checklist
  • 11. 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 Communicate with OR team, physicians, facility leadership team Week 4 Checklist
  • 12. 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 Communicate with OR team, physicians, facility leadership team 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.
  • 13. 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 Communicate with OR team, physicians, facility leadership team 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.
  • 14. 13 Tissue Management Tools Standards Roles & Responsibilities Education & Coaching
  • 15. 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
  • 17. 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.
  • 18. 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
  • 19. 18 Transplant Safety: TS.03.01.01 Joint Commission Standards The Hospital Uses Standardized Procedures for Managing Tissue
  • 20. 19 The Hospital Uses Standardized Procedures for Managing Tissue 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 ----------------------------------------------------------------------------------------------------------------------------------------------------------- New FSA CMS MOS CR DOC SC ESP ----------------------------------------------------------------------------------------------------------------------------------------------------------- Transplant A ESP-1 Services BMH Applicable Roles Scheduler, Materials Management, and Materials Management Information Systems Coordinator
  • 21. 20 The Hospital Uses Standardized Procedures for Managing Tissue Transplant Safety: TS.03.01.01 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 ----------------------------------------------------------------------------------------------------------------------------------------------------------- New FSA CMS MOS CR DOC SC ESP ----------------------------------------------------------------------------------------------------------------------------------------------------------- Transplant D A ESP-1 Services BMH Applicable Roles Scheduler, Materials Management, and Materials Management Information Systems Coordinator
  • 22. 21 The Hospital Uses Standardized Procedures for Managing Tissue Transplant Safety: TS.03.01.01 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 ----------------------------------------------------------------------------------------------------------------------------------------------------------- New FSA CMS MOS CR DOC SC ESP ----------------------------------------------------------------------------------------------------------------------------------------------------------- Transplant A ESP-1 Services BMH Applicable Roles Materials Management, Materials Management Information Systems Coordinator
  • 23. 22 The Hospital Uses Standardized Procedures for Managing Tissue Transplant Safety: TS.03.01.01 TS.03.01.01, EP 4 The hospital coordinates its acquisition, receipt, storage, and issuance of tissues throughout the hospital. EP Attributes ----------------------------------------------------------------------------------------------------------------------------------------------------------- New FSA CMS MOS CR DOC SC ESP ----------------------------------------------------------------------------------------------------------------------------------------------------------- Transplant A Services BMH Applicable Roles Materials Management Information Systems Coordinator
  • 24. 23 The Hospital Uses Standardized Procedures for Managing Tissue Transplant Safety: TS.03.01.01 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 ----------------------------------------------------------------------------------------------------------------------------------------------------------- New FSA CMS MOS CR DOC SC ESP ----------------------------------------------------------------------------------------------------------------------------------------------------------- Transplant A Services BMH Applicable Roles Materials Management Information Systems Coordinator 3
  • 25. 24 The Hospital Uses Standardized Procedures for Managing Tissue Transplant Safety: TS.03.01.01 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 ----------------------------------------------------------------------------------------------------------------------------------------------------------- New FSA CMS MOS CR DOC SC ESP ----------------------------------------------------------------------------------------------------------------------------------------------------------- Transplant M D C Services BMH Applicable Roles Materials Management Information Systems Coordinator
  • 26. 25 The Hospital Uses Standardized Procedures for Managing Tissue Transplant Safety: TS.03.01.01 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 ----------------------------------------------------------------------------------------------------------------------------------------------------------- New FSA CMS MOS CR DOC SC ESP ----------------------------------------------------------------------------------------------------------------------------------------------------------- Transplant M D C Services BMH Applicable Roles Materials Management
  • 27. 26 The Hospital Uses Standardized Procedures for Managing Tissue Transplant Safety: TS.03.01.01 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 ----------------------------------------------------------------------------------------------------------------------------------------------------------- New FSA CMS MOS CR DOC SC ESP ----------------------------------------------------------------------------------------------------------------------------------------------------------- Transplant M D C Services BMH Applicable Roles Materials Management Information Systems Coordinator
  • 28. 27 The Hospital Uses Standardized Procedures for Managing Tissue Transplant Safety: TS.03.01.01 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 ----------------------------------------------------------------------------------------------------------------------------------------------------------- New FSA CMS MOS CR DOC SC ESP ----------------------------------------------------------------------------------------------------------------------------------------------------------- Transplant A Services BMH Applicable Roles CPD, Center Core
  • 29. 28 The Hospital Uses Standardized Procedures for Managing Tissue Transplant Safety: TS.03.01.01 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 ----------------------------------------------------------------------------------------------------------------------------------------------------------- New FSA CMS MOS CR DOC SC ESP ----------------------------------------------------------------------------------------------------------------------------------------------------------- Transplant 3 A ESP-1 Services BMH Applicable Roles CPD, Center Core
  • 30. 29 The Hospital Uses Standardized Procedures for Managing Tissue Transplant Safety: TS.03.01.01 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 ----------------------------------------------------------------------------------------------------------------------------------------------------------- New FSA CMS MOS CR DOC SC ESP ----------------------------------------------------------------------------------------------------------------------------------------------------------- Transplant A Services BMH Applicable Roles Laboratory, Director
  • 31. 30 Transplant Safety: TS.03.02.01 Joint Commission Standards The Hospital Traces All Tissues Bi-directionally
  • 32. 31 The Hospital Traces All Tissues Bi-directionally Transplant Safety: TS.03.02.01 TS.03.02.01, EP 1 Elements of Performance: 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 ----------------------------------------------------------------------------------------------------------------------------------------------------------- New FSA CMS MOS CR DOC SC ESP ----------------------------------------------------------------------------------------------------------------------------------------------------------- Transplant 3 D A Services BMH Applicable Roles Materials Management Information Systems Coordinator
  • 33. 32 The Hospital Traces All Tissues Bi-directionally Transplant Safety: TS.03.02.01 TS.03.02.01, EP 2 Elements of Performance: The hospital identifies, in writing, the materials and related instructions used to prepare or process tissues. EP Attributes ----------------------------------------------------------------------------------------------------------------------------------------------------------- New FSA CMS MOS CR DOC SC ESP ----------------------------------------------------------------------------------------------------------------------------------------------------------- Transplant M D C ESP-1 Services BMH Applicable Roles Materials Management Information Systems Coordinator
  • 34. 33 The Hospital Traces All Tissues Bi-directionally Transplant Safety: TS.03.02.01 TS.03.02.01, EP 3 Elements of Performance: 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 ----------------------------------------------------------------------------------------------------------------------------------------------------------- New FSA CMS MOS CR DOC SC ESP ----------------------------------------------------------------------------------------------------------------------------------------------------------- Transplant M D C Services BMH Applicable Roles Materials Management, Materials Management Information Systems Coordinator, Front Desk, RNs
  • 35. 34 The Hospital Traces All Tissues Bi-directionally Transplant Safety: TS.03.02.01 TS.03.02.01, EP 4 Elements of Performance: The hospital documents in the recipient’s medical record the tissue type and its unique identifier EP Attributes ----------------------------------------------------------------------------------------------------------------------------------------------------------- New FSA CMS MOS CR DOC SC ESP ----------------------------------------------------------------------------------------------------------------------------------------------------------- Transplant A Services BMH Applicable Roles RNs, Materials Management Information Systems Coordinator
  • 36. 35 The Hospital Traces All Tissues Bi-directionally Transplant Safety: TS.03.02.01 TS.03.02.01, EP 5 Elements of Performance: 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 ----------------------------------------------------------------------------------------------------------------------------------------------------------- New FSA CMS MOS CR DOC SC ESP ----------------------------------------------------------------------------------------------------------------------------------------------------------- Transplant A Services BMH Applicable Roles Materials Management Information Systems Coordinator, Peri-Operative Services Coordinator, Director
  • 37. 36 The Hospital Traces All Tissues Bi-directionally Transplant Safety: TS.03.02.01 TS.03.02.01, EP 6 Elements of Performance: 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 ----------------------------------------------------------------------------------------------------------------------------------------------------------- New FSA CMS MOS CR DOC SC ESP ----------------------------------------------------------------------------------------------------------------------------------------------------------- Transplant A Services BMH Applicable Roles Materials Management Information Systems Coordinator, Peri-Operative Services Coordinator, Director
  • 38. 37 Transplant Safety: TS.03.03.01 Joint Commission Standards The Hospital Investigates Adverse Events Related to Tissue Use or Donor Infections
  • 39. 38 The Hospital Investigates Adverse Events Related to Tissue Use or Donor Infections Transplant Safety: TS.03.03.01 TS.03.03.01, EP 1 Elements of Performance: 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 ----------------------------------------------------------------------------------------------------------------------------------------------------------- New FSA CMS MOS CR DOC SC ESP ----------------------------------------------------------------------------------------------------------------------------------------------------------- Transplant D A ESP-1 Services BMH Applicable Roles Surgeons, Materials Management Information Systems Coordinator
  • 40. 39 The Hospital Investigates Adverse Events Related to Tissue Use or Donor Infections Transplant Safety: TS.03.03.01 TS.03.03.01, EP 2 Elements of Performance: 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 ----------------------------------------------------------------------------------------------------------------------------------------------------------- New FSA CMS MOS CR DOC SC ESP ----------------------------------------------------------------------------------------------------------------------------------------------------------- Transplant D A ESP-1 Services BMH Applicable Roles Surgeons
  • 41. 40 The Hospital Investigates Adverse Events Related to Tissue Use or Donor Infections Transplant Safety: TS.03.03.01 TS.03.03.01, EP 3 Elements of Performance: 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 ----------------------------------------------------------------------------------------------------------------------------------------------------------- New FSA CMS MOS CR DOC SC ESP ----------------------------------------------------------------------------------------------------------------------------------------------------------- Transplant 3 A Services BMH Applicable Roles Surgeons, Materials Management Information Systems Coordinator, Materials Management
  • 42. 41 The Hospital Investigates Adverse Events Related to Tissue Use or Donor Infections Transplant Safety: TS.03.03.01 TS.03.03.01, EP 4 Elements of Performance: 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 ----------------------------------------------------------------------------------------------------------------------------------------------------------- New FSA CMS MOS CR DOC SC ESP ----------------------------------------------------------------------------------------------------------------------------------------------------------- Transplant 3 A Services BMH Applicable Roles Materials Management, Materials Management Information Systems Coordinator
  • 43. 42 The Hospital Investigates Adverse Events Related to Tissue Use or Donor Infections Transplant Safety: TS.03.03.01 TS.03.03.01, EP 5 Elements of Performance: 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 ----------------------------------------------------------------------------------------------------------------------------------------------------------- New FSA CMS MOS CR DOC SC ESP ----------------------------------------------------------------------------------------------------------------------------------------------------------- Transplant 3 A Services BMH Applicable Roles Surgeons, Medical Director, Peri-Op Director, Infection Control, Risk Management, Blood Bank
  • 44. 43 The Hospital Investigates Adverse Events Related to Tissue Use or Donor Infections Transplant Safety: TS.03.03.01 TS.03.03.01, EP 6 Elements of Performance: 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 ----------------------------------------------------------------------------------------------------------------------------------------------------------- New FSA CMS MOS CR DOC SC ESP ----------------------------------------------------------------------------------------------------------------------------------------------------------- Transplant 3 A Services BMH Applicable Roles Surgeons, Medical Director, Peri-Op Director, Infection Control, Risk Management, Blood Bank
  • 45. 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
  • 46. 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
  • 47. 46 Temperature Recording Logs Tissue 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%
  • 50. 49 Scheduling Materials Management RN Doctor CPD Engineering Lab MMIS Coordinator OR 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 Responsibilities Roles
  • 51. 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 Complete the template KEY
  • 52. 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 Personnel for solution building 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
  • 53. 52 Policy Education2 Description: Refresher competencies of policies & procedures Objective: Knowledge of policies Roles Personnel for solution building 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 – 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
  • 55. 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 Complete the template No template necessary, however this area was raised as a concern, address locally as needed KEY
  • 56. Education of staff 55 Lack of Staff Education1 Description: Lack of knowledge on Standards & Policies Objective: Education Personnel for solution building Key questions Key success factors 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?
  • 57. 56 Minimal Education on Roles and Responsibilities2 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 Personnel for solution building Key questions Key success factors 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..
  • 58. 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
  • 59. 58 Tissue Management Tools Standards Roles & Responsibilities Education & Coaching