Jennifer Collins, RN Quality Liaison Ann & Robert H. Lurie Children's Hospital of Chicago

Transcription

1 Jennifer Collins, RN Quality Liaison Ann & Robert H. Lurie Children's Hospital of Chicago

2 General points of interest Facility Personnel Quality Management Policies & Procedures Donor Evaluation and Management Labeling of Cellular Therapy Products Process Controls Product Storage Product Transportation Documentation and Record Retention

3 Laws/Licensure FDA certifications Logistics Integrated program complete with an organizational chart that links everyone together for the common goal of safe patients, products and recipients Clearly defined responsibilities Documentation of interaction via consults, orders, progress notes Numbers Allogeneic: Average of 10 per year Autologous (auto-only): 5 per year

4 Map showing location of all departments Adequate space to avoid contamination and mixups Designated rooms for harvest Education to avoid infection Cleaning logs ICU Written guidelines for transfer and communication for transplant care Provisions for prompt evaluation and treatment by attending transplant physician available 24- hours Blood bank on premise for blood prime

5 All medical and nursing personnel have current license within their scope of practice personnel have received proper training within their role responsibilities Training is documented Proficiency is evaluated and documented Competency is assessed and documented Continuing education is completed within the area of expertise

6 Stay tuned

7 Standard operating procedures are created by following an SOP that illustrates a standard format with standard headings by which all other SOPs are written. AKA the SOP of SOPs Are numbered Written using evidence based practice and/or within current acceptable guidelines of care Accessible to the personnel who follow and reference them

8 Reporting variances, adverse events or complaints Apheresis procedure for harvesting cells Disasters Everything!

9 There s an SOP for that Donor evaluation and interim assessment Criteria to donate Central line or peripheral intravenous care to avoid infection for donor and recipient Reaction management Who to notify and when What to do Donor follow-up after the harvest procedure

10 There s an SOP for that How to obtain the Unique Product Identifier (UPI) software generated in sequence, print on demand purchased label roll ISBT How, When, Where to label What pen to use when writing on the label (it s been validated)

11 There s an SOP for that To indicate which disposables, reagents and other supplies have been logged/ready for use Ensure the machines are functioning properly Preventative maintenance per service technician And other manufacturers recommendations Equipment is regularly validated

12 There s an SOP for that Where, when and for how long Outer container intended to protect and hold cells (validated for temperature) Conditions for storage: locked, monitored

13 There s an SOP for that Who, How Official lab trained courier Plane, train, automobile Route of transport Traceable With all critical documents and circular of information

14 There might not be a specific SOP for this separate from other SOPs that refer to documentation and records All should be retrievable If computerized, then a system to backup data to prevent loss of records

15 Quality controls Quality assurance audits Verification validation Quality improvement Quality management is putting all of these together

16 This is a common tool can be used to evaluate the collection we discussed earlier Plan: consultation among the transplant and apheresis teams Do the harvest procedure Study the collection efficiency Act or adjust the procedure or the mobilization regimen for the following day

17 You will notice that there is much emphasis on quality throughout all of these standards Common pitfalls Lack of time or got to busy Lack of resources to share the wealth; short-staffed Making it perceived as personal rather than holding each other accountable Started picking up bad habits or short-cuts It s done but not documented Not having a designated person whose responsible for putting it all together If you have strong processes in place to evaluate steps along the way and complete the Controls and the Audits, Verifications and Validations your apheresis program will be successful It is all encompassing