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- 1. 1 Hospital Tissue Services – Can You Hear Us? Joint Commission Standards Review ©Copyright,TheJointCommission March 28, 2011 American Association of Tissue Banks Annual Spring Meeting Megan E. Sawchuk, MT(ASCP) Associate Director Standards Interpretation Group Tissue Standards – Background Why did The Joint Commission add tissue standards to other accreditation programs? – Prior to July 2005, the Joint Commission only AATB March 2011 Meeting – Pg. 2 ©Copyright,TheJointCommission y , y surveyed these standards in organizations where the laboratory was Joint Commission accredited. – The potential for tissue-borne infections and other adverse outcomes in recipients of donor tissues is a significant quality and safety concern. AATB March 2011 Meeting – Pg. 3 ©Copyright,TheJointCommission Which healthcare organizations? Same standards for tissue – Hospitals – Critical Access Hospitals – Ambulatory AATB March 2011 Meeting – Pg. 4 ©Copyright,TheJointCommission – Ambulatory – Office Based Surgery – Laboratories Solid organ standards subsequently added to all except laboratories What is tissue? The Joint Commission includes any product that is cellular-based at the time of use for the patient, whether human or non-human Products derived from tissue that are not AATB March 2011 Meeting – Pg. 5 ©Copyright,TheJointCommission cellular-based at the time of use are not included (even if animal derived), e.g. collagen What is tissue? FDA manages these products under the Center for Biologics, Evaluation and Research (CBER), but may classify as: – Tissue Medical device AATB March 2011 Meeting – Pg. 6 ©Copyright,TheJointCommission – Medical device – Medication/Drug – Blood product – Combination product
- 2. 2 Why is there confusion over the applicability of the Tissue Standards? FDA regulations apply to (not inclusive list): – Food – Cosmetics AATB March 2011 Meeting – Pg. 7 ©Copyright,TheJointCommission – Drugs – Medical devices – Vaccines, blood and biologics – Cellular-based products – Tissue – Blood derivatives (Albumin, Rhogam, Factor concentrates, Tisseel, FloSeal) Which standards apply to blood derivatives? Joint Commission surveys based on which department is managing them – Immunohematology (Blood Bank) – Stringent tracking requirements by lot number S L b t t d d QSA 05 01 01 d AABB AATB March 2011 Meeting – Pg. 8 ©Copyright,TheJointCommission – See Laboratory standards QSA.05.01.01 and AABB standards 5.1.6 & 6.2.3 – Medication Management (Pharmacy) – Sufficient tracking to determine who may be impacted in the event of a recall – Could be through inventory management records rather than patient specific lot number identification records. – See Hospital standard MM.05.01.17 Blood derivatives managed by OR If a blood derivative is managed by the OR (e.g. FloSeal) and neither the laboratory or pharmacy have taken responsibility, then standards default to AATB March 2011 Meeting – Pg. 9 ©Copyright,TheJointCommission responsibility, then standards default to Immunohematology as the most applicable to blood derivatives. Combination Products AATB March 2011 Meeting – Pg. 10 ©Copyright,TheJointCommission2010 Tissue Storage & Issuance Standards Three overarching themes – Standardized procedures – Bi-directional traceability – Adverse event investigation AATB March 2011 Meeting – Pg. 11 ©Copyright,TheJointCommission Standardized procedures - TS.03.01.01 Assign responsibility for overseeing the tissue program throughout the organization. Implement procedures to standardize AATB March 2011 Meeting – Pg. 12 ©Copyright,TheJointCommission p p systems and processes related to: – Acquiring – Receiving – Storing – Issuing
- 3. 3 Standardized procedures - TS.03.01.01 Confirm suppliers are FDA registered as a tissue establishment – Not required for autologous or cellular- based medical devices AATB March 2011 Meeting – Pg. 13 ©Copyright,TheJointCommission – Registration updated annually – Available on FDA’s website – http://www.fda.gov/cber/tissue/tissregdata.htm Confirm state license when required Standardized procedures - TS.03.01.01 Follow manufacturer instructions Document receipt of all tissues Verify package integrity Verify transport temperature AATB March 2011 Meeting – Pg. 14 ©Copyright,TheJointCommission Verify transport temperature – Validated shipping containers acceptable – Document received undamaged and within stated timeframe – Other methods include actually measuring the temperature, monitoring devices, documenting the presence of dry ice, etc. Standardized procedures - TS.03.01.01 Maintain daily storage temperature records – Room temperature – Refrigerated – Frozen, including deep freeze & liquid nitrogen AATB March 2011 Meeting – Pg. 15 ©Copyright,TheJointCommission Ambient vs. Room temperature – Storage temperature stated in package insert – Room temperature = specific temperature range – Ambient = general temperature of surroundings – Temperature documentation is not required for ambient products (upon receipt or daily storage) Standardized procedures - TS.03.01.01 Have alarm systems and an emergency storage back-up plan. – Not required for room temperature/ambient AATB March 2011 Meeting – Pg. 16 ©Copyright,TheJointCommission Comply with state and/or federal regulations when acting as a supplier. – Routinely shipping tissue to another facility is “distribution”; requires FDA registration. – Returning unused tissue to the supplier is not considered distribution Bi-directional traceability - TS.03.02.01 The organization’s record keeping ensures traceability This is a critical process in investigating adverse events AATB March 2011 Meeting – Pg. 17 ©Copyright,TheJointCommission adverse events The who, what, when, where (and sometimes why…) of what happened to the tissue Bi-directional traceability - TS.03.02.01 Records permit traceability – From donor or supplier to recipient/disposition – From the recipient/disposition to the donor or supplier Document unique identifier(s) in the recipient’s AATB March 2011 Meeting – Pg. 18 ©Copyright,TheJointCommission q ( ) p medical record Documents identify (by log for example) – Tissue product type – Dates, times, and staff at receipt, preparation and issuance – Materials used to prepare tissue, e.g. saline lot for reconstitution
- 4. 4 Bi-directional traceability - TS.03.02.01 Retain records for at least 10 years – Storage temperatures – Procedures, manuals, package inserts, related instructions Retain records for at least 10 years beyond d t f di t ib ti t l t ti AATB March 2011 Meeting – Pg. 19 ©Copyright,TheJointCommission date of distribution, transplantation, disposition, or expiration (whichever is latest). – Tissue supplier (or manufacturer for medical devices) – Original numeric or alphanumeric donor and lot identification – Recipient name or final disposition – Tissue expiration date Bi-directional traceability - TS.03.02.01 Return Tissue Utilization Record (TUR) cards to the supplier Disclosure permitted by Health Insurance Portability and Accountability Act (HIPAA) at 45 CFR 164.512(b)(iii)(B) and (C) AATB March 2011 Meeting – Pg. 20 ©Copyright,TheJointCommission Adverse Event Investigation - TS.03.03.01 The organization has systems to investigate adverse events. Critical because…. – Prompt investigation provides response AATB March 2011 Meeting – Pg. 21 ©Copyright,TheJointCommission p g p p and treatment to affected recipients – Effective communication helps to prevent spread of infection from infected donor Used to be…Consistently in the Top 10 most frequently cited laboratory standards Adverse Event Investigation - TS.03.03.01 Use written procedures to investigate tissue adverse events Report adverse event to supplier as soon as aware AATB March 2011 Meeting – Pg. 22 ©Copyright,TheJointCommission Sequester tissue reported as a suspected cause of infection Identify and inform recipients of risk when donors subsequently found to have HIV, hepatitis, etc. Adverse Event Investigation - TS.03.03.01 What do you do when you learn from the source facility that a tissue is suspected of carrying an infectious disease? – What is the process for identifying and informing the recipient(s)? AATB March 2011 Meeting – Pg. 23 ©Copyright,TheJointCommission informing the recipient(s)? What do you do when you learn from the patient (via physician, nurse, ICP, etc.) that tissue is a possible cause of infection or adverse event? – How would you report these to the source facility (active vs. passive reporting systems)? Tissue Standards Frequently Asked Questions What is expected for temperature alarms and emergency back-up? – Temperatures documented at least once per day – Continuous temperature monitoring (not necessarily recording) for refrigerators and AATB March 2011 Meeting – Pg. 24 ©Copyright,TheJointCommission y g) g freezers – Alarms activated by the continuous temperature monitoring device – Alarms responded to 24/7 – Emergency back-up refers to storage – Room temp or ambient storage does not require continuous temperature monitoring or alarms
- 5. 5 Tissue Standards Frequently Asked Questions What is the Joint Commission looking for in regards to tissue suppliers? – Evidence of the source facility’s FDA registration (website printout, check off list) St t li if li bl ( h t li # AATB March 2011 Meeting – Pg. 25 ©Copyright,TheJointCommission – State license if applicable (photocopy, license #, etc.) Our organization does not “store” tissues (implanted same day received); do these standards still apply? – Yes, as applicable. Contact the Standards Interpretation Group – Phone: 630-792-5900, Option 6 – Online: http://www.jointcommission.org/Standards/OnlineQuestionForm/ Check out the Frequently Asked Questions G t j i t i i More information? AATB March 2011 Meeting – Pg. 26 ©Copyright,TheJointCommission – Go to www.jointcommission.org – Hover over the “Standards” tab – Click on Standards FAQs – Select your program manual, e.g. Hospital – Select link to individual FAQs Comment on current standards anytime! 1. Visit www.jointcommission.org 2. Hover over the word “Standards” 3. Select “Comment on a Standard” ©Copyright,TheJointCommission Thank you! ©Copyright,TheJointCommission Thank you!