1. PHS Increased Risk Requirements for OPO’s and Transplant Centers
Celeste Braly, MSN, RN
Manager, Quality, Kidney Transplant
St. Joseph’s Hospital and Medical Center

2. PHS Increased Risk
BACKGROUND

3. Background Public Health Service (PHS)
Structured under the Public Health Service Act of 1944
Primary division of the US Department of Health & Human Services (HHS)
PHS consists of all agency divisions under HHS including
HRSA
CMS
CDC
(Rogers, Simonds, Lawton, Moseley, & Jones, 1994)
The public health services roots can be traced back to 1798 –but was formalized in 1944 under the Public Health Service Act of 1944.
It is the primary division of the Department of Health and Human Services – The PHS consists of all agency divisions under HHS and includes HRSA, CMS, and the CDC – the primary purpose of the PHS is to protect the health of the country’s population.

4. Background HIV and Transplant
1981 CDC publishes a report describing HIV/AIDS
1985 HIV antibody screening tests available
1991 – investigation into recipient derived HIV from donor organs (4)
Hemodilution (PRBC)
Seroconversion had not occurred (2)
Emergent transplant prior to HIV antibody result known
(Rogers, Simonds, Lawton, Moseley, & Jones, 1994)
In 1981 the CDC publishes a report in Morbidity and Mortality Weekly describing an illness in what would later come to be known as HIV/AIDS
1985 HIV screening tests became available and were utilized which significantly reduced HIV transmission by an organ donor
recipients were found to have contracted HIV – 2 from seroconversion between time of testing to the time of donation, 1 after multiple transfusions given and 1 due to transplant occurring prior to having the antibody test results

5. Background High Risk Designation
PHS Workgroup on Organ and Tissue Transplantation
Donor Screening Guidelines (OPO)
Donor Testing Guidelines (OPO)
Voluntary HIV testing policy (TX. Center)
(Rogers, Simonds, Lawton, Moseley, & Jones, 1994)
As a result of the investigation, a Workgroup was formed which enlisted public and private healthcare professionals, transplant, public health and other organization to come up with a set of guidelines addressing donor screening, testing, and exclusion criteria
Their report to HRSA spurred the request by UNOS to the transplant centers to voluntary test for HIV
And with that request a set of screening and testing guidelines were published

6. Background High Risk Designation
Developed in 1994
Designed to assess for known high risk behaviors that increased the risk for HIV transmission
7 types of risk related to:
High Risk Sexual Behaviors
Drugs Use
Exposure to HIV
Hemophilia
Jail
(Duan, Englesbe, & Volk, 2010)
Known as CDC High Risk, PHS High Risk – there were multiple labels, and it was developed in 1994
And the purpose of the requirement was to assess for behaviors that were known to be associated with an increase risk for HIV transmission
Assessment of donors included were in the area of high risk sexual behaviors, drug use, exposures, hemophiliacs and jail time.

7. Background High/Increased Risk: 1994 – 2013 Comparison
Name change in July 2013
Expanded testing to include HBV and HCV
Purpose to identify recently infected organ donors that would appear negative on serologic testing
Factors known to be associated with increased risk of recent HIV, HBV, or HCV infection
Limited the focus to organ and blood vessels
(Seem, Lee, Umscheid, & Kuehnert, 2013)
Fast forward to 2013, we see a name change from the CDC High Risk or PHS High Risk to the PHS Increased Risk Guidelines
Testing was also expanded to include With the expansion of testing to address potential transmission of Hep B and C in addition to HIV
The focus was to identify factors known to be associated with an increased risk for recent infection with the key word being recent – whereas serologic testing would appear as negative
Limits the focus to organ and vessels and not on tissues/eyes/or cellular products

8. Background High/Increased Risk: 1994 – 2013 Comparison
Time frame reduction
5 years to 12 months
Added to child ≤ 18 months born to a mother with or suspected HIV/HBV/HCV
Added ….breastfed child…..mother is known to be infected with, or at increased risk for, HIV infection
When we compare the 1994 version to the current 2013 version, there are some key differences.
Regarding sexual behaviors we see a reduction in time from 5 years to 12 months
In the child ≤18 months born to a mother either known to have or suspected – originally HIV only, now added HBV and HCV
In the breastfeeding child, they have made a verbiage change to “known to be infected with, or at increased risk for HIV infection
(Seem, Lee, Umscheid, & Kuehnert, 2013)

9. Background High/Increased Risk: 1994 – 2013 Comparison
Correctional system definitions
lockup, jail, prison, juvenile correctional facility
Time frame of incarceration identified:
consecutive 72 hours in the preceding 12 months
Initially incarceration was not defined – verbiage change to “lockup, jail, prison, or a juvenile correctional facility…in addition they outlined the time frame in which the incarceration would have occurred
(Seem, Lee, Umscheid, & Kuehnert, 2013)

10. Background High/Increased Risk: 1994 – 2013 Comparison
STD’s – time frame and specifics
syphillis, gonorrhea, chlamydia, genital ulcers
within past 12 months
New: Persons on HD (preceding 12 months)
New: Lack of medical/behavioral history
Hemodiluted specimen
Prior STD’s guidelines did not identify specifics, nor was there a time limit – now identified as newly diagnosed with, or treated for: syphilis, gonorrhea, chlamydia or genital ulcers within 12 months.
There are 2 new categories in the risk guidelines and that is those patients on HD within 12 months, and the LACK of medical/or behavioral history – both would place the patient in the increased risk category
And lastly, hemodilution – verbiage has been altered from patients who cannot be tested for HIV R/T refusal or inadequate samples or other reason to IF patient blood specimen is hemodiluted, the donor should be considered at an increased risk for HIV, HBV, and HCV infection because the donor’s risk for infection is considered unknown.
(Seem, Lee, Umscheid, & Kuehnert, 2013)

11. Now that we have explored the background and current state of the PHS Increased Risk Guidelines, let’s explore what the OPTN outlines as requirements for the OPO’s.
OPTN POLICY OPO

12. OPTN Policy 2.4 Deceased Donor Medical and Behavioral History
Increased risk screening for disease transmission
Risk Factor Behaviors Address:
Medical
Social
All 3 pathogens reflected within each risk factor
Performed by the OPO with a reliable historian
If no reliable historian, donor considered Increased Risk
(OPTN Policy, 2017)
Increased risk screening is performed by the OPO and a reliable historian – not necessarily a family member. The risk factors address both medical and social behaviors, and address all 3 pathogens; HIV, Hep B and Hep C
A copy of the PHS Increased Risk Categories is on your table for your review

13. OPTN Policy 2.5 Hemodilution Assessment
Serologic testing on hemodiluted blood sample
PHS Increased Risk Designation
Determination of hemodilution
FDA Approved hemodilution calculation
Documentation of all blood products and IV fluid since admission to donor hospital (OPO)
If i.t is determined that the blood sample of the donor is hemodiluted, then the donor is designated as PHS Increased Risk. This determination must be made using an FDA approved hemodilution calculation
(OPTN Policy, 2017)

14. OPTN Policy 2.7.A HIV Screening of Potential Deceased Donors
All deceased donors are to be tested for HIV
Exceptions to screening for all organs other than kidney
Medical judgement of host OPO and recipient transplant hospital or OPO an extreme medical emergency warrants the transplantation of an organ that has not been tested for HIV
Requirements:
Complete medical/social history provided to transplant center (OPO)
PHS Increased Risk Designation assigned (OPO)
Informed Consent obtained and documented (TX Center)
There are extreme circumstances that would warrant a donor to forego HIV testing – this would apply to any organ other than a kidney recipient. As you can see the PHS Increased Risk Designation would be assigned to the donor and requirements/documentation by both the OPO and the transplant center are shown here.
(OPTN Policy, 2017)

15. OPTN Policy 2.9 Required Deceased Donor Infectious Disease Testing
HIV
HIV Ag/Ab combination test OR
HIV RNA OR
NAT
If donor’s ONLY risk factor is having received hemodialysis within the past 12 months – OPO’s may elect to use
HIV antibody (anti-HIV) OR HIV antigen/antibody combination test
The OPTN Policy is very specific as to what tests are to be used in testing for HIV/HepB and C – here you can see that in the case of one risk factor (HD) the OPO may use either the HIV antibody test or the HIV Ag/Ab combination test
(OPTN Policy, 2017)

16. OPTN Policy 2.9 Required Deceased Donor Infectious Disease Testing
Hep B
Hepatitis B surface antigen (HBsAg)
Hepatitis B core antibody (anti-HBc)
Hep C
Hepatitis C antibody (anti-HCV)
Hepatitis C ribonucleic acid (RNA) OR
Diagnostic nucleic acid test (NAT)
Hepatitis B testing is straight forward using the HBsAg AND the Hep B core antibody
Hep C offers a choice between NAT or RNA testing in addition to the Hep C antibody
(OPTN Policy, 2017)

17. PHS Increased Designation – Match Run
Documentation of PHS Increased Risk – Match Run
This is a screen shot of the PHS Increased Risk designation box - this is what is seen within the match run The OPO is required to designate the PHS Increased Risk Designation by answering yes or no at the time of donor registration.

18. OPTN Policy Transplant Centers

19. Prior to Transplant

20. CMS §482.102 (a) (6) – Tag X156 Education prior to listing:
Graft Loss or the health of the recipient
Health Related Risks related to the donor:
Medical history
Social history
Age of the donor
Condition of the organ
Risk of contracting HIV, Hep B, Hep C
CMS requires documented education prior to listing as a candidate in Unet – including all of these elements – read the elements-
At our center we discuss the PHS Increased Risk Designation from the very beginning and use multiple educational tools to help educate the patient and family-we also outline the risks associated with these organs in comparison with waiting on the list, and talk about what will be disclosed at the time of the offer-During our CMS audit in December 2016 and our UNOS audit in Jan of this year, auditors reviewed our education booklet, the evaluation consent form, and the informatio within our power point from our pre transplant classes as source documentation of the education - which there were no findings.

21. OPTN Policy 15.2 Potential Candidate Screening Requirements
All potential transplant candidates must be tested for*
HIV
Hepatitis B
Hepatitis C
Candidates who test positive:
must be offered appropriate counseling.
*unless the testing would violate state or federal laws
OPTN Policy 15 (15.2) designates the required transmissible disease testing for all transplant candidates for HIV, Hep B, and C.
If these patients test positive for any of these disease, documentation that appropriate counseling was offered.
Arizona Administrative Code Requires Providers To: Report Communicable Diseases to the Local Health Department
Submit a report within five working days after a case or suspect case is diagnosed, treated, or detected.
As each state may differ between what is required to be reported - please consult with your states requirements

22. OPTN Policy 15.2 Potential Candidate Screening Requirements
Under OPTN policy, HIV positive Individuals
are permitted as a candidate if permitted by the transplant hospital
Care of HIV test positive organ candidate and recipients must not deviate from general medical practice
I just want to touch briefly that under OPTN Policy 15.2, centers are able to transplant individuals who are HIV +, but deviation from the standard care of these patients from accepted/or general medical practices is not allowed.

23. Prior to Transplant

24. CMS §482.102 (a) (6) Documented disclosure of:
Organ donor risk factors that could affect the success of the graft or the health of the patient, including, but not limited to, the donor’s history, condition or age of the organ used, or the patient’s potential risk of contracting the human immunodeficiency virus and other infectious diseases if the disease cannot be detected in an infected donor.
For CMS the documentation of disclosure to recipients prior to transplant is shown here in (a) (6) in regards to the donor risk factors as it may affect the health of the recipient.

25. CMS § (a) (6) – Tag X156
Education-organ acceptance-prior to transplant
Risks
Health related risks specific to the organ offered:
Medical history
Social history
Condition of the organ
Risk of contracting HIV, Hep B, Hep C
PHS High Risk Designation
Under CMS Tag X156 PRIOR TO TRANSPLANT….CMS requires documented education and consent of the candidate or designee including risk, and health related risks that are specific to the organ.
In December of 2016, our center underwent a CMS audit - the auditor focused on these key elements and reviewed our consents for: the UNOS ID, the reason for the risk and the date/time consent was obtained.

26. OPTN Policy 15.3 Informed Consent of Transmissible Disease Risk
Specific to transmissible disease risk
Required when:
PHS Increase Risk Designation by OPO
Known medical condition of the donor that could be transmitted by the donor
Hemodiluted specimen is used for HIV, Hep B, or Hep C testing
A separate informed consent is required by the recipient or designee prior to transplantation. There are 3 instances this would be required: Designation by the OPO,
a known medical condition that could be transmitted
and/or a hemodiluted specimen is used for HIV/Hep B & C testing-which would automatically list the donor as an increased risk
Under the OPTN evaluation plan, surveyors will request documentation that the potential recipient gave consent when the organ offered met PHS increased risk criteria-some centers utilize a written consent form, while others elect to document in the electronic medical record-
During our UNOS survey in January of this year, the auditors requested the informed consent documentation - which contains recipient name/unos ID#, the nature of the known risk, and the patient or designee’s consent as well as the date/time consent was obtained.
During our CMS audit in December of last year the auditors requested the informed consents – they looked for all 3 elements: UNOS ID, Reason for the risk designation and date (prior to transplant)

27. Conclusion

28. Conclusion Clearly defined criteria that address:
Recent exposures to Hep B & C, and HIV
Not detectable
Insufficient antibodies
False negatives
blood loss
hemodilution
OPO and Transplant Centers
Responsibilities
Accountability
The PHS Increased Risk Guidelines are in place to address known behavioral and medical risks that standard serology testing may not detect due to insufficient antibodies, or in the face of false negatives due to blood loss or hemodilution.
Each of us within the OPO and the transplant centers have a responsibility to our patients and to each other to follow policies and we do that by being held accountable during the survey process.

29. Conclusion Common Goals: Safe transplantations Educated recipients
Clearly defined responsibilities
Communication
Collaboration
The OPO and transplant centers have common goals:
We want to ensure to the best of our ability safe transplantations to educated recipients, with clearly defined responsibilities between the OPO and transplant center, with a way to communicate effectively and to collaborate whenever possible to ensure we reach those goals.

30. “Part of education is learning
“Part of education is learning. And what drives learning is curiosity and collaboration.”
Sir Ken Robinson

31. References
Medicare Program: Hospital Conditions of Participation: Requirements for Approval and Re-approval of Transplant Centers to Perform Organ Transplants; Final Rule, 2007, 42   CFR §§
Duan, K. I., Englesbe, M. J., & Volk, M. L. (2010). Centers for Disease Control "High- Risk" Donors and Kidney Utilization. American Journal of Transplantation, 10, doi: /j x
Organ Procurement and Transplantation Network Policies Retrieved from:

32. Rogers, M. F. , Simonds, R. J. , Lawton, K. E. , Moseley, R. R
Rogers, M. F., Simonds, R. J., Lawton, K. E., Moseley, R. R., & Jones, W. K. (1994). Guidelines for Preventing Transmission of Human Immunodeficiency Virus Through Transplantation of Human Tissue and Organs. Morbidity and Mortality Weekly Report, 43(RR-8), Retrieved from
Seem, D. L., Lee, I., Umscheid, C. A., & Kuehnert, M. J. (2013). PHS Guideline for Reducing Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus Transmission Through Organ Transplantation. Public Health Reports, 128((4)), doi: /

33. Questions?

34. Thank You