FINAL Tissue Toolkit
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This document provides instructions and guidelines for tissue management in the operating room at BMH hospital. It aims to ensure compliance with various standards and regulations regarding proper tissue handling. The toolkit contains sections on roles and responsibilities, education, communication, and common non-compliance issues. It outlines tasks over a 6-week period to identify problem areas, implement solutions by testing them on a small scale, fully implementing the solutions, and creating a sustainability plan to solidify the results long-term. The goal is to establish standardized procedures for acquiring, receiving, storing, and issuing tissues to maintain compliance.
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
- 16. Standards 15
- 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
- 54. Education and Coaching 53 Solution Examples
- 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