Need a copy of TJC QSA.05.01.01

[goodchild]

We're currently tracking Baxter FloSeal in the blood/tissue bank.

FloSeal is considered a blood derivative by the FDA.

We want to transfer oversight of this product to the OR.

The standards interpretation group from TJC indicated that compliance surveys are based on the department which is managing them and if OR was managing this product they would need to follow:

TJC Laboratory standard QSA.05.01.01 and AABB standards 5.1.6 and 6.2.3.

We're not TJC accredited, so I was hoping someone would be willing to share a copy of that particular standard.

 

Thanks!

[Laurie Underwood]

QSA.05.01.01: The laboratory has written policies and procedures for the blood transfusion service.

1. The laboratory has written policies and procedures for the blood transfusion service.

2. The policies and procedures for the blood transfusion service are current and revised whenever standards of practice change.

3. The policies and procedures for the blood transfusion service are available to staff involved in transfusion service.

4. The blood transfusion service director or an individual qualified as a technical supervisor in immunohematology conducts a review of the policies and procedures of the blood transfusion service every two years. The review is documented.

5. The transfusion service director has oversight of policies, processes, and procedures related to the blood transfusion service, including blood administration.

6. The laboratory's writtent policies and procedures for administration of outpatient transfusions include instructions for monitoring adverse patient reactions after release from direct medical observation.

7. The transfusion service obtains written documentation of approval from the medical director when clinical situations warrant an exception to policies, processes, or procedures.

8. The laboratory follows its policies and procedures for the blood transfusion service.

9. The policies and procedures for the blood transfusion service define the staff responsible for the provision of blood, blood components, tissue, derivatives, and services.

[tricore]

The traceability of tissues is the reason our hospital blood banks ended up tracking all bones and tissues except solid organs.

I thought TJC had the tissue regulations under the hospital sections of their regs. I do know TJC inspectors have told hospitals to let the BB track them because the OR was not doing it very well.. This was before there were specific computer programs for tracking tissues that ORs could use.

You might find this helpful. It is from 2010

Transplant Safety (CAMLAB / Laboratory Services)

 

Traceability of Records

Updated | October 01, 2010

Q:  How do we determine if our record keeping permits traceability of implanted tissue?

A:  The organization will need to be able to trace the chain of events or "audit trail" related to implanted tissue for both reporting and investigational purposes.  Records should permit bidirectional tracing of any tissue in order to:

1. Report potential disease transmission to the recipient when notified by the donor source facility
2. Report adverse patient reactions to the donor source facility
3. Investigate the chain of events, e.g. who handled the tissue, how it was transported, stored and processed, dates and times of such activities.

An organization could become aware of the potential for an adverse event from either the donor facility or the recipient.  For example, the donor facility may notify the organization of a suspected infectious disease associated with a particular tissue source.  The organization would need to promptly identify and notify all recipients and quarantine any implicated tissue not yet implanted. Alternatively, the patient's physician might notify the infection control nurse of a post-op infection associated with the tissue implant.  Procedures and records should allow the organization to determine the tissue's unique identifier and enable reporting of the event to the source facility.  In addition, records should facilitate an investigation to determine if the post-op infection could be related to the organization's storage or handling processes, e.g. use of sterile reconstitution supplies, OR procedures, storage temperatures, expiration dates, etc.

Transplant Safety (CAMLAB / Laboratory Services)

 

Tissue Source Facilities - Verification of Licensing & Registration

Updated | October 01, 2010

Q:  What is The Joint Commission looking for in regards to verification of registration and licensing of tissue suppliers?

A:  The source facility should be registered with the US Food and Drug Administration (FDA) and licensed by the state, if the state in which the implanting organization resides requires licensure.

Annual registration is required by the FDA each December for all tissue suppliers who recover, screen, test, process, label, package, or distribute tissues.  Suppliers are expected to be compliant with the FDA regulations that apply to their operations.  Healthcare organizations that only receive and store tissues for implantation or transplantation within their facility are not required to be registered with the FDA. Licensing is state dependent. As of March 2007, five states require licensing, which include New York, Florida, California, Georgia, and Maryland.

The Joint Commission standards can be met by requesting from the source facility copies of their current state license (when applicable) and FDA registration and keeping them on file.  For FDA registration, the supplier's registration status may also be checked annually by using the FDA's online database.

Transplant Safety (CAMLAB / Laboratory Services)

 

Adverse Tissue Reaction Policies

Updated | October 01, 2010

Q:  What is The Joint Commission looking for in adverse tissue reaction policies?

A:  Policies addressing the investigation of adverse tissue reactions should define two essential processes:

1. Reporting potential disease transmission from the donor source facility to the patient, and
2. Reporting adverse patient reactions to the donor source facility.

Reporting: Donor Source Facility to Patient

The Joint Commission encourages facilities to develop reporting policies comparable to the "look back" procedures required for investigation of potential disease transmission in blood products.  For example, this would include receipt of notification from the donor facility, determination of disposition, quarantine of donations in inventory from the indicated source, disposal, and notification of the recipient(s).  The policy should specifically address HIV, HTLV-I/II, HBV and HCV, as well as other transmissible diseases, such as bacteria or fungus.  Policies should define the timeframe for notification, the number of attempts required, and the notification procedure when the patient is deceased.  References for policy development include the Centers for Medicare and Medicaid Services Conditions of Participation for Hospitals [42 CFR 482.27©(4-8)] and theFDA’s Guidance for Industry for blood establishments with regards to patient notification for HIV and HCV, respectively.

Reporting: Patient to Donor Source Facility

Similar to The Joint Commission requirements for suspected transfusion reactions, organizations need to develop policies and procedures for suspected tissue reactions.  The process should be detailed and address criteria for identifying a suspected adverse tissue reaction, initial reporting internally, documented investigation of the complication, and prompt reporting to the donor source facility.  When developing their process, organizations should keep in mind that symptoms of an adverse reaction could present as an acute or chronic condition (ex. fever versus hepatitis).  Other examples of adverse reactions or complications could include, but are not limited to, infection (viral, bacterial, fungal), graft failure, or immune response to the tissue.  Organization's can work with their donor source facilities to establish their reporting policies. Interested organizations may wish to review the FDA regulations for Current Good Tissue Practice or participate inMedWatch, the FDA’s reporting system for adverse events, product use errors and product quality problems associated with medical products.

[goodchild]

Thanks Laurie and Tricore. Luckily for us FloSeal is considered acellular at the time of use so it's not considered a tissue according to TJC.

Edited February 20, 2015 by goodchild