QA Investigation Results

Pennsylvania Department of Health
CHILDRENS HOSPITAL OF PHILADELPHIA - TRANSPLANT CENTER
Health Inspection Results
CHILDRENS HOSPITAL OF PHILADELPHIA - TRANSPLANT CENTER
Health Inspection Results For:


There are  2 surveys for this facility. Please select a date to view the survey results.

Surveys don't appear on this website until at least 41 days have elapsed since the exit date of the survey.



Initial Comments:


A re-approval Medicare transplant survey for Pediatric Kidney Only and initial certification Medicare transplant surveys for Pediatric Heart Only, Pediatric Heart/Lung, Pediatric Lung Only and Pediatric Liver Only were conducted onsite from June 11-14, 2012. The entrance conference convened on June 11, 2012, at 9:45 AM with the Transplant Program Staff and Regulatory Staff. The survey team leader introduced the survey team and explained the survey process and purpose, explaining expectations for document requests, interviews and observation needs to complete the survey. The entrance conference attendees gave brief introductions and stated their position responsibilities.

An exit conference was conducted on June 14, 2012, at 1:30 PM and included the Hospital's Administrators, Transplant Program Staff, and Regulatory Staff. Per protocol, the deficiencies found throughout the survey process for the transplant program were identified to the attendees at the exit conference, allowing ample time for questions or discussion. The Transplant Program Staff at the exit conference were given an opportunity to provide evidence of compliance with the requirement of which non-compliance had been found. In these cases of non-compliance noted, no evidence was provided to the surveyors.

The citations were from samples drawn from cases subsequent to the effective date of the Subpart E requirements of June 28, 2007. The deficiency statements include references to the organ program(s) to which the deficient practices apply.

The re-approval Medicare transplant survey included the PKO - Pediatric Kidney Only organ transplant program.

The initial certification Medicare transplant surveys included the following types of organ transplant programs:

PHO - Pediatric Heart Only
PHL - Pediatric Heart/Lung
PLO- Pediatric Lung Only
PLI - Pediatric Liver Only




















Plan of Correction:




482.94(c)(2) ELEMENT
PATIENT NOTIFICATION OF REMOVAL FROM LIST

Name - Component - 00 - Transplant Types: PKO

If a patient on the waiting list is removed from the waiting list for any reason other than death or transplantation, the transplant center must document in the patient's record that the patient (and in the case of a kidney patient, the patient's usual dialysis facility) was notified no later than 10 days after the date the patient was removed from the waiting list.



Observations:

Based on a review of facility policy, medical records (MR) and interview with staff (EMP), it was determined the facility failed to notify each patient's dialysis facility no later than 10 days after the date that the patient was removed from the waiting list for three of five Pediatric Kidney-Only (PKO) medical records reviewed (Sample C - MR1 and MR2. Sample E - MR4).

Findings include:

A review of facility policy, "Job Aid for Transplant Center Notification Management Kidney Transplant Version," dated November 1, 2010, revealed, "Event...Removal from wait list for any reason other than transplantation or death (e.g., no longer a transplant candidate)...Letter Requirement (Certified Mail is recommended)...Written letter to patient with CC to referring provider and pediatrician if different; CC Dialysis Center. Copy of signed letter must be on chart. Include UNOS letter as attachment...Within 10 days of removal date..."

1) A review of Sample C - MR1 revealed the patient was removed from the wait list on April 13, 2012. A further review of Sample C - MR1 revealed there was no documentation, that the dialysis facility was notified that the patient was removed from the wait list.

An interview conducted on June 14, 2012, at 10:30 AM with EMP1 confirmed that Sample C - MR1, contained no documentation, that the dialysis facility was notified that the patient was removed from the wait list.

2) A review of Sample C - MR2 revealed the patient was removed from the wait list on April 13, 2012. A further review of Sample C - MR2 revealed there was no documentation that the dialysis facility was notified, that the patient was removed from the wait list.

An interview conducted on June 14, 2012, at 10:30 AM with EMP1 confirmed that Sample C - MR2 , contained no documentation, that the dialysis facility was notified that the patient was removed from the wait list.

3) A review of Sample E - MR4, revealed the patient was removed from the wait list on March 23, 2012. A further review of Sample E - MR4 revealed there was no documentation that the dialysis facility was notified, that the patient was removed from the wait list.

An interview conducted on June 14, 2012, at 10:30 AM with EMP1 confirmed that Sample E - MR4, contained no documentation, that the dialysis facility was notified that the patient was removed from the wait list.





















Plan of Correction:

In order to ensure communication with all dialysis facilities associated with our waitlisted patients, we have updated our letters templates to include a standing Carbon Copy (CC) to dialysis facility on all letters related to the patient's waitlist status. Letter templates have been updated as of June 22, 2012 by the Transplant Coordinator.

To correct the deficiency related to the three individual findings from the survey, letters will be mailed to the referring dialysis facilities describing the details of removal from the waitlist. Letters will be mailed on June 29, 2012 by the Transplant Coordinator.


In addition, the Transplant Coordinator checklist will be updated to include an item called "Notified Dialysis Unit" as a back-up reminder for Transplant Coordinators.
The Transplant Coordinator checklist has been updated as of June 25, 2012 by the Transplant Compliance Specialist. Transplant Coordinators have been trained on the use of the revised checklist and compliance with the revised policy. This training was conducted by the Transplant Compliance Specialist on July 12th, 2012.

Compliance with dialysis facilities receiving notification on removals from the waitlist will be monitored via chart audit. Beginning in August 2012 through November 2012 all waitlist removals will be reviewed to ensure that the dialysis facility was copied on the patient's removal letter. The audit will be conducted by the Transplant Compliance Specialist.

The results of the monthly audit data will be reviewed at the Transplant Center Quality Council meetings which are held quarterly. Ongoing compliance will be monitored through chart reviews conducted by the Transplant Compliance Specialist quarterly.



482.98(b) STANDARD
TRANSPLANT SURGEON AND PHYSICIAN

Name - Component - 00 - Transplant Types: PHL

The transplant center must identify to the OPTN a primary transplant surgeon and a transplant physician with the appropriate training and experience to provide transplantation services, who are immediately available to provide transplantation services when an organ is offered for transplantation.



Observations:

Based on a review of facility policy and interview with staff (EMP), it was determined the transplant center failed to ensure that a transplant surgeon and transplant physician were immediately available for two separate transplants.

Findings include:

A review of facility policy "TX-7 Notification of Physician and Surgeon Coverage" effective 1/1/10, revealed, "The transplant program coverage plan including physician, surgeons, and our 24/7 coverage will be included in the wait listing letters sent to the patients."

An interview conducted on June 14, 2012, at 10:30 AM with EMP1 confirmed that the facility was notified on two separate occasions of heart/lung availability on September 2, 2010, and January 27, 2012. EMP1 confirmed a transplant surgeon was not available each time and the organs went to a different facility.










Plan of Correction:

Children's Hospital of Philadelphia Heart/Lung Transplant program will send an updated letter to all actively waitlisted patients that states the following:
"The transplant program coverage plan includes physician and surgeon availability for transplantation for 24 hours per day, 7 days per week in most instances. In rare occurrences, events out of the control of the transplant center, such as multiple conflicting emergencies, may necessitate declining an organ offer for you/your child." Letters will be mailed to patients by June 27, 2012 by the Transplant Coordinator.


Our policy (TX-7 Notification of Physician and Surgeon Coverage) has been updated to reflect the new required wording for the wait listing letter that is sent to patients that are waitlisted for the heart and lung program. The policy was updated on June 22, 2012 by the Transplant Compliance Specialist. Transplant Coordinators have been trained on the revisions to the policy by the Transplant Compliance Specialist on July 11, 2012.

Further, in an effort to provide additional support for organ recovery CHOP has arranged for the Hospital of the University of Pennsylvania to provide back-up coverage for organ recoveries. This arrangement is effective July 1, 2012.

Waitlisting letters will be reviewed during quarterly chart audits to ensure that the correct letter template is used for all patients listed during the quarter. The audits will be performed July through November 2012.The audits will be conducted by the Transplant Compliance Specialist.

The results of the monthly audit data will be reviewed at the Transplant Center Quality Council meetings which are held quarterly. Ongoing compliance will be monitored through chart reviews conducted by the Transplant Compliance Specialist quarterly.






482.102(a)(2) ELEMENT
PATIENT INFORMED OF SURGICAL PROCEDURE

Name - Component - 00 - Transplant Types: PKO

Each patient is informed of the surgical procedure.



Observations:

Based on a review of facility policy, medical records (MR), and interview with staff (EMP), it was determined the facility failed to provide evidence that patients were informed regarding the correct surgical procedure for two of five Pediatric Kidney-Only (PKO) medical records reviewed (Sample A - MR3 and Sample E - MR3).

Findings include:

1) A review of facility policy "Recipient Informed Consent to Undergo Evaluation and
Wait Listing For A Kidney Transplant," dated August 2011 revealed, "...Certain conditions in the donor may affect the success of your heart transplant ... "

An interview conducted on June 14, 2012, at 10:15 AM with EMP1 confirmed that the facility's informed consent to undergo evaluation and wait listing for a kidney transplant referenced the "success of your heart transplant."

2) A review of Sample A - MR3 revealed the kidney transplant patient's informed consent to undergo evaluation and wait listing for a kidney transplant referenced "...Certain conditions in the donor may affect the success of your heart transplant...," which was signed by the kidney transplant patient's representative and the physician on November 3, 2011.

An interview conducted on June 14, 2012, at 10:20 AM with EMP1 confirmed that the kidney transplant patient's informed consent to undergo evaluation and wait listing for a kidney transplant referenced, "...Certain conditions in the donor may affect the success of your heart transplant...," which was signed by the kidney transplant patient's representative and the physician on November 3, 2011.

3) A review of Sample E - MR3 revealed the kidney transplant patient's informed consent to undergo evaluation and wait listing for a kidney transplant referenced "...Certain conditions in the donor may affect the success of your heart transplant...," which was signed by the kidney transplant patient's representative and the kidney transplant physician on September 23, 2011.

An interview conducted on June 14, 2012, at 10:20 AM with EMP1 confirmed that the kidney transplant patient's informed consent to undergo evaluation and wait listing for a kidney transplant referenced "...Certain conditions in the donor may affect the success of your heart transplant...," which was signed by the kidney transplant patient's representative and the kidney transplant physician on September 23, 2011.














Plan of Correction:

The kidney transplant informed consent form has been updated and the incorrect version has been eliminated from our forms repository. This correction took place on June 18, 2012.Transplant Coordiantors have been trained on the need to use the correct form by the Transplant Compliance Specialist on July 12, 2012.

A review of all Medical records for currently waitlisted kidney transplant candidates was conducted to identify patient's that may have signed the incorrect form. All patients who have been identified through this chart review will be re-consented using the correct form. The newly signed consent form will be added to the patient's medical record. This will be completed by July 30, 2012.

Ongoing compliance will be maintained through chart reviews conducted by the Transplant Compliance Specialist quarterly.