HospitalInspections.org

Based on document review and staff interview, it was determined that the facility failed to ensure surgical services are provided in accordance with acceptable standards of practice of the transplantation process.

Findings include:

1. The facility failed to ensure implementation of policies and procedures addressing the documentation required for performing a "time-out" prior to the start of a surgical procedure. (Cross refer to Tag A 0951, Part A)

2. The facility failed to ensure implementation of their policy and procedure addressing the documentation required for the chain of custody of organ for transplant and organ check in form. (Cross refer to Tag A 0951, Part B)

3. The facility failed to ensure all registered professional nurses provide patient care within their scope of practice, as delineated in the Nurse Practice Act. (Cross refer to Tag A 0951, Part C)

4. The facility failed to ensure proper patient identification before undergoing an invasive procedure. (Cross refer to Tag A 0951, Part D)

A. Based on staff interview on 11/25/19 and 11/26/19 and review of two (2) transplantation medical records for "time-out" procedures, it was determined that the facility failed to ensure implementation of policies and procedures addressing the documentation required for performing a "time-out" prior to the start of a surgical procedure in one (1) out of two (2) medical records.

Findings include:

Reference: The facility policy titled, "Universal Protocol "Time Out" states, " ... The TIME OUT will occur prior to the start of the invasive procedure and involve all members present at that time. ... Documentation of the above verification processes and TIME OUT process will be completed by the Registered Nurse ... in the invasive procedural areas on appropriate pre-procedural and procedural records. ..."

1. On 11/25/19, review of Medical Record #1 revealed on the form titled, "Intra-Operative Record" the section titled, "Final team verification of correct patient, site and procedures are actively verbalized and confirmed by the healthcare team" was not completed.

2. On 11/25/19 at 1:40 PM, it was explained by Staff #10 that when a TIME OUT is conducted, the section titled, "Final team verification of correct patient, site and procedures are actively verbalized and confirmed by the healthcare team" should be checked off in the medical record for the procedure being performed.

3. On 11/26/19, interviews with Staff #25 and Staff #26 confirmed the above finding.

B. Based on staff interview, review of facility policy and procedure, and review of five (5) transplantation medical records, it was determined that the facility failed to ensure implementation of their policy and procedure addressing the documentation required for the chain of custody of organ for transplant and organ check-in form in five (5) out of five (5) medical records.

Findings include:

Reference: Facility policy titled, "Custody of Organ for Transplant and Organ Check In" states, " ... To ensure when an organ for transplant arrives at the Medical Center the process for organ check-in is documented and the chain of custody of the organ is followed and documented in accordance with OPTN (Organ Procurement Transplantation Network) policy. This includes living donor organs recovered outside ... Medical Center. ... Completion of Chain of Custody and Organ Check-In Form Section 1: Receipt of Organ Transport Container ... Section 2: Organ Check-In ... c. Confirm the organ transport container received is the correct organ expected for the recipient. i. Document this organ check in verification was completed ... Section 3: Release of Organ Transport Container for Transplant a.When O.R. or Medical Center associate wishes to take custody of Organ Transport Container for transplantation, he/she must present a completed "Request for Organ Transport Container" issue slip containing the following information: ...vi. Intended recipient name and medical record number... b. Compare type of organ, organ laterality (if kidney) and UNOS (United Network of Organ Sharing) Donor ID number on the Request to Release Organ for Transplant Form to the information on the UNOS label on transport container verbally with medical center associate. If any items do not agree, do not transfer custody of transport container until issue is resolved. c. Record in Section 3 of the chain of custody form intended organ recipient name and signature of associate accepting organ transport container as well as printed name and signature of associate releasing organ transport container on chain of custody form. ..."

1. On 11/25/19 and 11/26/19, a review of Medical Records #1, #2, #7, #8, and #10 was conducted and identified that two different chain of custody forms are being used for transplant patients. One form did not account for a section for organ check-in verification, and the other identified form, that meets the requirements of the facility policy, contained three sections to account for the receipt of the organ transplant container, an organ check-in verification, and a release of the organ transport carrier.

a. The form that was utilized for Patient's #2, #7 and #8, titled, "Chain of Custody for Donor Organ Transport Container" did not include Section 2. This was not in accordance with facility policy. Section 2 of the form requires the receiving department to document that they have verified they have received the correct organ expected for the recipient.

(i) Upon interview on 11/25/19, Staff #10 confirmed that the form that includes all three (3) sections should be the form that is used. He/she also confirmed that there should only be one form in use and was unable to provide a reason why the alternate form would have been utilized.

(ii) Upon interview on 11/25/19, Staff #18 explained that there should only be one form in use and was unable to provide a reason why a different form would have been utilized.

b. The form titled, "Chain of Custody of Organ for Transplant and Organ Check In," that contained all three sections and was indicated by Staff #10 as the form to be used, was identified in Medical Record #1. The section titled, "Section 3: Release of Organ Transport Container (to be completed by Transfusion Medicine Department and O.R. associate at release/issue of organ transport container) ... " was not filled out.

(i) Upon interview on 11/26/19, Staff #25, an operating room (OR) nurse, stated he/she fills out Section 3 of the form in all transplant cases except when the physician delivers the organ to the operating room, then Section 3 would not be completed.

(ii) Staff #10 confirmed that Section 3 should be completed even when a physician is delivering the organ to the OR because it indicates the intended organ recipient name and medical record number (MRN).

c. The form titled, "Chain of Custody of Organ for Transplant and Organ Check In," that contained all three sections as indicated by Staff #10 as the form to be used, was utilized for Medical Record #10. The section titled, "Section 2: Organ for Transplant Check In Verification (to be completed by the receiving Department O.R. or Blood Bank) upon arrival to the Department) ..." was blank.

2. The above findings are not in accordance with facility policy and procedure.

C. Based on observation, staff interview, and review of three (3) pre-operative (pre-op) patients' medical records, it was determined that the facility failed to ensure that registered professional nurses provide patient care in accordance with a physician's order in two (2) out of three (3) medical records of patient's in pre-op.

Findings include:

Reference: The State of New Jersey Nursing Practice Act states: "The practice of nursing as a registered professional nurse RN is defined as diagnosing and treating human responses to actual or potential physical and emotional health problems, through such services as casefinding, health teaching, health counseling, and provision of care supportive to or restorative of life and wellbeing, and executing medical regimens as prescribed by a licensed or otherwise legally authorized physician or dentist."

1. On 11/26/19 during a tour of the pre-operative (pre-op) area, the following was observed:

a. At 10:42 AM, Staff #27 was observed preparing Patient #3 for surgery. Review of Patient #3's medical record at this time identified that the anesthesiologist had not yet seen the patient and did not sign off on any pre-op orders.

(i) At 10:54 AM, it was observed that Patient #3's Intravenous (IV) access had been started and the patient had IV fluids initiated.

(ii) At 10:55 AM, upon review of Patient #3's medical record, the form titled, "Pre-Procedural Orders For SDS (Same Day Surgery)/Endo (Endoscopy) ... " which indicates to obtain IV access and hang 1 Liter of 0.9% normal saline at KVO (Keep Vein Open), was not signed by a physician.

b. At 10:48 AM, Staff #28 had already started Patient #4's IV access and had initiated IV fluids.

(i) At 10:49 AM, upon review of Patient #4's medical record, the form titled, "Pre-Procedural Orders For SDS (Same Day Surgery)/Endo (Endoscopy) ... " which indicates to obtain IV access and hang 1 Liter of 0.9% normal saline at KVO (Keep Vein Open), was not signed by a physician.

(ii) Upon interview, Staff #28 confirmed that he/she should not have started the IV access and the IV fluids without a physician's order.

3. At 10:57 AM, Staff #9 stated that the nursing staff should not be starting patient IV's without a physician's order.


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D. Based on document review, staff interview, and the review of five (5) transplantation medical records, it was determined that the facility failed to ensure proper patient identification before undergoing an invasive procedure in one (1) out of five (5) medical records reviewed.

Findings include:

Reference #1: Policy titled, "Patient Identification" states, "...RELATION TO OPERATION... A system for positive identification of all patients fulfills four basic functions: -Provides a safe process for positive identification of patients... -Improves accuracy of patient identification..... Assessment: ...approved patient identifiers include: Patient's Full Name, Date of Birth, Medical Record Number...".

Reference #2: Policy titled, "Organ Transplant Verification of Donor - Recipient Blood Type" states, "...RELATION TO OPERATION: To ensure the donor (either deceased donor or living donor) blood type and other vital information (blood type, UNOS (United Network of Organ Sharing) ID#, compatibility information) is compatible to the intended recipient and that this is verified by the transplant surgeon and the Circulating RN (registered nurse) in the OR (operating room) prior to transplantation...".

1. Review of the medical record of Patient #1, who received transplantation on 11/18/19, revealed a "Deceased Donor/Recipient Compatibility" form from the OPO (Organ Procurement Organization). This form, dated 11/17/19, was labeled in the top right corner with the full name and social security number of Patient #2.

a. The above form was identified by Staff #18 on 11/26/19 as the compatibility form for Patient #2 which contained Patient #2's specific crossmatch and blood typing information for organ compatibility.

b. Staff #18 and Staff #25 confirmed on 11/26/19 that Patient #2's compatibility form was in Patient #1's chart at the time of Patient #1's transplantation.

2. An interview with Staff #25 indicated that the compatibility form was used for identification purposes, and Staff #25 would check the section called "HLA (Human Leukocyte Antigen) Typing" to look for the patient's name and blood type.

a. Staff #25 indicated that the name sometimes would get cut off in the section "HLA Typing" and confirmed that the middle initial and suffix were missing on this "Deceased Donor/Recipient Compatibility" form dated 11/17/19.

(i) Upon interview on 11/26/19, Staff #25 further confirmed that despite knowing that name could be missing elements in the "HLA Typing" section, he/she would not look to the patient label in the top right corner to confirm the patient identifier of "full name."

(ii) Upon interview on 11/26/19, Staff #18 confirmed the practice is to check the patient identifier of "full name" and blood type by looking at the "HLA Typing" section of the "Deceased Donor/Recipient Compatibility" form, not to check the full name on the patient label located in the top right corner of the form.

b. The blood type listed on Patient #2's compatibility form dated, 11/17/19 and found in Patient #1's chart, was blood type A, the same documented blood type of Patient #1.

3. Staff #18 and Staff #25 confirmed that Patient #2's full name and social security number was indicated in the top right hand corner of the "Deceased Donor/Recipient Compatibility" form, which differed from the name and social security number of the patient's (Patient #1) medical record the form was found in.

a. Upon interview on 11/26/19, Staff #18 confirmed that the name and social security number found in the top right hand corner of the "Deceased Donor/Recipient Compatibility" form was that of Patient #2, and the form was contained in Patient #1's medical record.

4. Patient #1 underwent a kidney transplant on 11/18/19 based on the organ compatibility screen for Patient #2.

a. The facility was unable to provide evidence of an organ compatibility form for Patient #1 completed prior to transplantation on 11/18/19.

b. Once the incident was identified on 11/19/19, the facility performed a Deceased Donor/Recipient Compatibility and crossmatch to ensure that the organ that was intended for Patient #2 was compatible with Patient #1.

(i) The facility provided evidence of a "Deceased Donor/Recipient Compatibility" form, dated 11/19/19, that the organ that was intended for Patient #2 was compatible with Patient #1

5. Upon interview on 11/26/19, Staff #8 and Staff #18 confirmed the above findings.