HospitalInspections.org

Based on the scope and severity of the deficiencies related to the Quality Assurance and Performance Improvement (QAPI) program, the facility failed to substantially comply with this condition.

Please see the following tags:

A-0273 - Data Collection & Analysis

A-0283 - Quality Improvement Activities

A-0286 - Patient Safety

Based on interviews and document review, the facility failed to utilize data to monitor the effectiveness and safety of services and quality of care.

The findings include:

A review of the facility's adverse event log from 9/1/2020 through 10/18/2021 on 10/20/2021 contained evidence that three (3) of two-hundred fifty (250) adverse event events regarding blood were related to lack of verification of blood products prior to administration as per facility policy.

The documentation contained evidence that on 9/4/2020 "Anesthesia tech brought [two] 2 units of RBCs [red blood cells] to OR [operating room] [ten] 10 instead of OR [seven] 7; one (1) unit was opened in OR [ten] 10 before the provider realized it was for the wrong patient; units were then sent to correct OR and then returned to blood bank; one (1) unit was wasted due to being overtemp."

On 10/1/2020, "...Just after the time of death on 10-1 2144 [9:44 p.m.] after coding the patient for approximately 22 [twenty-two] minutes, the ER [emergency room] nurse arrived to the Door of the IR [interventional radiology] room [two] 2, stating that the patient may have received someone else's blood at some point during [patient's] arrival to the ER to the time of death. [Patient name], was known A positive, and ultimately it was found that [patient] was given B positive cross matched blood that was meant for another patient. We found this after I told the ER nurse I would look through the trash in IR. I dug to the bottom of the trash in IR, to find blood that was B+ matched for [Patient name] that was given...The Fellow [name] explained that while [patient] did get possibly the wrong blood- the outcome would have not changed..."

On 6/12/2021, "A unit of packed red blood cells was infusing as I came on shift. When it finished, I went to chart the completion of the transfusion. Upon entering Bridge, there was no documentation of any blood transfusion being started. I also checked Adhoc [electronic documentation form] for documentation, and there was no record of any transfusion there. There was also no documentation of [fifteen] 15 minute vital sign checks after the transfusion would have been started. Upon finding this, another nurse and I did check the blood, and it was correct. The medicine team and blood bank were notified. No transfusion reactions occurred."

The facility was unable to provide documentation that the adverse event log had been reviewed by the quality program to determine if the lack of verification of blood administered was a recurring issue requiring investigation, review, improvement, and reeducation of staff.

During an interview on 10/20/2021 SM #1 stated that the facility had not completed an investigation of the unsigned/incomplete Transfusion Record Transfusion Tags related to Patient #2 and the incident related to Patient #2 was investigated by the laboratory director and not nursing services.

During the exit conference on 10/20/2021 SM #2 stated the laboratory department had completed an Action Plan because of the incident with Patient #2 that revolved around ensuring blood product verification when there is a handoff of a blood product. SM #2 stated that that there was no quality related investigation related to the lack of verification of blood administered to Patient #2 and that it continues to be an issue.

Based on interviews and document review, the facility failed to take actions aimed at performance improvement related to blood verification of blood prior to administration, due to the potentially fatal result of administering the wrong blood product.

The findings include:

As per Appendix A of the State Operations Manual, "Transfusion reactions can occur during or after a blood transfusion. A patient's immune system recognizes the foreign blood product and attempts to destroy the transfused cells. Incompatible blood products are typically the cause of transfusion reactions. Symptoms may include back pain, bloody urine, hives, chills, fainting, dizziness, fever, flank pain, and skin flushing. More serious complications may include acute kidney failure, anemia, respiratory distress, shock and even death. Transfusion reactions are serious and can be life-threatening. The hospital must have policies and procedures in place for the internal reporting of transfusion reactions."

A review of the facility's adverse event log from 9/1/2020 through 10/18/2021 on 10/20/2021 contained evidence that three (3) of two-hundred fifty (250) adverse event events regarding blood were related to lack of verification of blood products prior to administration as per facility policy.

The documentation contained evidence that on 9/4/2020 "Anesthesia tech brought [two] 2 units of RBCs [red blood cells] to OR [operating room] [ten] 10 instead of OR [seven] 7; one (1) unit was opened in OR [ten] 10 before the provider realized it was for the wrong patient; units were then sent to correct OR and then returned to blood bank; one (1) unit was wasted due to being overtemp."

On 10/1/2020, "...Just after the time of death on 10-1 2144 [9:44 p.m.] after coding the patient for approximately 22 [twenty-two] minutes, the ER [emergency room] nurse arrived to the Door of the IR [interventional radiology] room [two] 2, stating that the patient may have received someone else's blood at some point during [patient's] arrival to the ER to the time of death. [Patient name], was known A positive, and ultimately it was found that [patient] was given B positive cross matched blood that was meant for another patient. We found this after I told the ER nurse I would look through the trash in IR. I dug to the bottom of the trash in IR, to find blood that was B+ matched for [Patient name] that was given...The Fellow [name] explained that while [patient] did get possibly the wrong blood- the outcome would have not changed..."

On 6/12/2021, "A unit of packed red blood cells was infusing as I came on shift. When it finished, I went to chart the completion of the transfusion. Upon entering Bridge, there was no documentation of any blood transfusion being started. I also checked Adhoc [electronic documentation form] for documentation, and there was no record of any transfusion there. There was also no documentation of [fifteen] 15 minute vital sign checks after the transfusion would have been started. Upon finding this, another nurse and I did check the blood, and it was correct. The medicine team and blood bank were notified. No transfusion reactions occurred."

During an interview on 10/20/2021 SM #1 stated that the facility had not completed an investigation of the unsigned/incomplete Transfusion Record Transfusion Tags related to Patient #2 and the incident related to Patient #2 was investigated by the laboratory director and laboratory services and not nursing services.

During the exit conference on 10/20/2021 SM #2 stated the laboratory department had completed an Action Plan because of the incident with Patient #2 that revolved around ensuring blood product verification when there is a handoff of a blood product. SM #2 stated that that there was no quality related investigation related to the lack of verification of blood administered to Patient #2 and that it continues to be an issue.

The facility was unable to provide documentation that the adverse event log had been reviewed by the quality program to determine if the lack of verification of blood administered was a recurring issue requiring investigation, review, improvement, and reeducation of staff. The root cause of the incident related to Patient #2 was not thoroughly investigated by the quality program related to nursing, including review of other related blood product administration errors. The quality program failed to take actions aimed at performance improvement related to nursing verification of blood prior to administration.

Based on interviews and document review the facility failed to analyze the cause and implement preventive actions and mechanisms that include feedback and learning related to lack of verification of administration of blood products.

Then findings include:

A review of the facility's adverse event log from 9/1/2020 through 10/18/2021 on 10/20/2021 contained evidence that three (3) of two-hundred fifty (250) adverse event events regarding blood products were related to lack of verification of blood products prior to administration as per facility policy.

The documentation contained evidence that on 9/4/2020 "Anesthesia tech brought [two] 2 units of RBCs [red blood cells] to OR [operating room] [ten] 10 instead of OR [seven] 7; one (1) unit was opened in OR [ten] 10 before the provider realized it was for the wrong patient; units were then sent to correct OR and then returned to blood bank; one (1) unit was wasted due to being overtemp."

On 10/1/2020, "...Just after the time of death on 10-1 2144 [9:44 p.m.] after coding the patient for approximately 22 [twenty-two] minutes, the ER [emergency room] nurse arrived to the Door of the IR [interventional radiology] room [two] 2, stating that the patient may have received someone else's blood at some point during [patient's] arrival to the ER to the time of death. [Patient name], was known A positive, and ultimately it was found that [patient] was given B positive cross matched blood that was meant for another patient. We found this after I told the ER nurse I would look through the trash in IR. I dug to the bottom of the trash in IR, to find blood that was B+ matched for [Patient name] that was given...The Fellow [name] explained that while [patient] did get possibly the wrong blood- the outcome would have not changed..."

On 6/12/2021, "A unit of packed red blood cells was infusing as I came on shift. When it finished, I went to chart the completion of the transfusion. Upon entering Bridge, there was no documentation of any blood transfusion being started. I also checked Adhoc [electronic documentation form] for documentation, and there was no record of any transfusion there. There was also no documentation of [fifteen] 15 minute vital sign checks after the transfusion would have been started. Upon finding this, another nurse and I did check the blood, and it was correct. The medicine team and blood bank were notified. No transfusion reactions occurred."

A review of the medical record for Patient #2 on 10/19/2021 contained evidence that of eighteen (18) Transfusion Record Transfusion Tags for blood products administered to Patient #2 on 10/1/2021, only one (1) Transfusion Tag was completed as per policy. As per policy and instructions on the Transfusion Tag, documentation should include: signatures of two (2) staff members verifying that "We certify that prior to starting this transfusion we have verified the identity of the patient and unit information and that there are no discrepancies between this unit, the tag attached to this unit and the patient identification," and also the signature of the "infusion started by", "date", and "time". Eleven (11) of eighteen (18) Transfusion Tags were completely blank with no documentation. Two (2) Transfusion Tags did not contain a second verification signature. One (1) Transfusion Tag did not contain the date and time. One (1) Transfusion Tag did not contain a second verification signature, infusion started by signature, date, and time. One (1) Transfusion Tag did not contain infusion started by signature, date, and time. One (1) Transfusion Tag for the B+ blood labeled for a different patient was missing and could not be located by the facility. As per Staff Member (SM) #5, there was no other documentation in the electronic medical record related to blood product administration verification for Patient #2. SM #5 stated that all documentation related to the massive transfusion protocol (MTP) for Patient #2 was documented on the paper hard copy Transfusion Record Transfusion Tags.

A review of the Transfusion Record Transfusion Tags for Patient #12 on 10/20/2021 contained evidence that one (1) of nine (9) Transfusion Tags (for Plasma) did not contain a second verification signature as per facility policy.

A review of the facility's "Fatality Report to the FDA," dated 10/8/2020 contained the documentation, "Corrective Action Plan
MTP Response in [hospital] Emergency Department
General Description: This response is intended for all MTP activations that occur in the Emergency Department regardless of service requesting activation.
Purpose: To provide an additional measure of safety during all MTP activations that prevent the mishandling of blood products and associated documentation.
Process: All MTP activations will now have a Telepage alert activation (MTP Alert). This alert will got to a Nurse and Physician Leadership group. The Nurse Leadership group will consist of the Team Lead, Clinical Coordinator, Assistant Nurse Manager, Nurse Clinician, and Nurse Manager on Call. The Physician group will include the Attending in Charge.
Upon activation of the MTP Alert a member of the leadership team will:
Arrive in person to the location of the MTP
Will assist with documentation and completion of bag tags, ensuring legibility
Will verify products that are delivered are the correct products for that patient
Upon completion of tags will assure they are correctly processed and returned
Will support the bedside RN with documentation
Will lead a debrief prior to the departure of the patient from the ED, the debrief will consist of:
a) The patients ED physician, Nurse leader, and bedside RN
b) Will review and validate all documentation is complete prior to returning to the blood bank."

A review of the facility's incident "Action Plan Implementation Update" contained evidence of the following:
Deviation: Incorrect blood type administered.
Root Cause #2: There lack of standardized MTP processes and use of safety behaviors.
1. Ensure Blood Product Verification when there is a Handoff of a blood product
1.01 Identify areas that do not have barcode scanning or computer access for documentation
1.02 In areas where it's fesable [sic] place Computer on Wheels with Barcode scanning
1.03 Revise, handoff, blood product administration and MTP policy/protocol to specify verification of blood product during handoff/location change
1.04 Evaluate best model for blood product dispensing handoff to include review pharmacy runner model for blood product dispensing
1.05 Implement a blood product dispensing handoff process
2 Standardize team member roles and responsibilities for MTPs across the health system
2.01 Reach out to similar group organizations to gather best practices on the MTP process
2.02 Task the MTP group with reviewing best practices and revising standardized roles
2.03 Implement of revised standardized roles house wide
Root Cause #1: There is not a process to deploy a MTP content expert with defined role and responsibility.
3 Establish a MTP content expert role to assist team members during MTPs
3.01 Identify dedicated team members that are not in staffing to respond to MTP (exclusion of ED and OR)
3.02 Approval of dedicated staffing to fulfill MTP expert role
3.03 ED to establish MTP content expert role to respond to MTP in the ED
3.04 Ensure standard process and expert roles for MTP in the OR
3.05 Create standard education for MTP content experts
3.06 Create a *500 page group for MTP
3.07 Implement MTP content expert roles
3.08 Distribute communication for team members regarding MTP changes

A review of the facility's document titled, "Emergency Department Quality Council (EDQC) Agenda and Minutes, dated 10/12/2020 contained evidence that Patient #2 received "the wrong unit of blood while in IR after departure from ED care, no harm as cause of death due to underlying disease, admin of incorrect unit of blood preventable." This document contained no evidence that Patient #2's bag tags were reviewed for two (2) verification signatures or that lack of blood product verification at bedside per facility policy was not completed, and considered a cause of the error.

During an interview on 10/20/2021 SM #1 stated that the facility had not completed an investigation of the unsigned/incomplete Transfusion Record Transfusion Tags related to Patient #2.

During the exit conference on 10/20/2021 SM #2 stated that there was no quality related investigation of the lack of verification of blood administered to Patient #2 and that it continues to be an issue.

On 10/20/2021 at 11:45 a.m. the above concerns were discussed during the exit conference.

A review of the facility's policy titled, "Blood Products Transfusion," effective date 10/17/2019 states in part,
...D. Patient Identification
D. 1. Verification of the patient's identity is performed prior to the initiation of the transfusion. See PC.PS.001 - Patient Identification.
D.2. Patient identification takes place in the presence of the patient and is conducted by 2 [two] licensed or certified team members utilizing verbal verification and bar code scanning, where applicable.
D.3. Patient identification and product verification is completed using the read- back method. Bag tag information is checked against the patient's armband and unit information is checked against the attached bag tag.
...O. Bag Tags
O.1. Bag tags are to remain attached to the blood products throughout the transfusion process.
O.2. Complete the bag tag is not required when the transfusion is documented in the EMR.
O.3. Complete the back of the bag tag to include the signature of the [two] 2 verifiers is required when EMR is not available. The bag tag is then kept in the patient's chart and scanned into the medical record.
O.4. Uncrossmatched emergency-released blood products require that a [patient's label be placed on each section of the bag tag. The attestation section is completed by the ordering provider (name and signature and returned to Blood Bank. The backs of the other [two] 2 sections are completed and signed by [two] 2 licensed verifiers and kept in the patient's chart as a part of the permanent medical record.
...4. Handling
...4.5. Identify the patient and verify the blood product with another licensed or credentialed team member. Document co-signature in EMR (if available) or by signing the bag tag (if EMR is unavailable).
4.6. Ensure that the bag tag remains attached to the blood product until the transfusion is completed, then discard. Exception is in the case when documentation is completed on the bag tag, then it is kept in the patient's chart as a medical record.
...5. Patient Identification and Blood Products Verification
5.1. Use the 'Read-Back' method below in the process of verification.
1. Once at the patient's bedside, the first verifier reads the patient's name out loud from the patient's identification wristband.
2. The second verifier reads the patient's name out loud from the blood product bag tag.
3. The first verifier reads the unit number out loud from the bag tag.
4. The second verifier read the unit number out loud from the blood product label.
5. The first verifier reads out loud the blood type (ABO/Rh) form the bag tag.
6. The second verifier reads out loud the blood type (ABO/Rh) from the bag tag.
7. Both verifiers check the patient's ABO/Rh in the Blood Bank Quick View and compare to that on the bag tag and product to ensure compatibility.
5.2 Do not proceed to start the infusion if any discrepancy is noted. If anticipating more than 30 minutes delay to resolve the discrepancy, return the product to the Blood Bank.
5.3 Use EMR [electronic medical record] for scanning blood products, where available. Refer to Start Transfusion.
Document the start and end time of transfusion by scanning the product into EMR (where applicable) or on the attached product bag tag (if EMR is unavailable).
...8. Documentation
8.1 Document blood transfusions in EMR by using the transfusion documentation scanning system. If unable to scan blood products (unavailable, issues with scanning), document by completing the AdHoc Form. If both are unavailable, complete documentation on the bag tag and retain in patient's chart.
8.2 Document the start and end time of transfusion by scanning the product in to EMR (where applicable) or on the attached product bag tag (if EMR is unavailable).
8.3 Verify the following mandated documentation in the patient's medical record:
1. A valid consent
2. An order to transfuse
3. The first and last names of the verifiers
4. Vital signs (baseline, 15 minutes, 1 hour after initiation, and end of transfusion)
5. Patient's response to transfusion
6. Patient education provided...

A review of the facility's training document titled, "Initial Competencies for Registered Nurses and New Graduate Nurses," states in part:
...Administration of Blood/Blood Products
...B Administration of Blood/Blood Product:
1. Verify blood/blood product at bedside by two (2) - licensed providers. Sign the blood bag tag on designated line. (NOTE: RN or physician must serve as first verifier.)
...C. Documentation
1. Document in medical record:
a. Time of initiation & completion of infusion.
b. First initial, last name & classification of person starting infusion & two people verifying blood/blood products.
c. The specific product.
d. Donor number of blood/blood products.
e. Amount infused.
f. Vital signs.
g. Patient's response

Based on interviews and document review, it was determined facility staff failed to administer blood transfusions as per policy and procedure for two (2) of twelve (12) patients.

The findings include:

A review of the medical record for Patient #2 on 10/19/2021 contained evidence that of eighteen (18) Transfusion Record Transfusion Tags for blood products administered to Patient #1 on 10/1/2020, only one (1) Transfusion Tag was completed as per policy. As per policy and instructions on the Transfusion Tag, documentation should include: signatures of two (2) staff members verifying that "We certify that prior to starting this transfusion we have verified the identity of the patient and unit information and that there are no discrepancies between this unit, the tag attached to this unit and the patient identification," and also the signature of the "infusion started by", "date", and "time". Eleven (11) of eighteen (18) Transfusion Tags were completely blank. Two (2) Transfusion Tags did not contain a second verification signature. One (1) Transfusion Tag did not contain the date and time. One (1) Transfusion Tag did not contain a second verification signature, infusion started by signature, date, and time. One (1) Transfusion Tag did not contain infusion started by signature, date, and time. One (1) Transfusion Tag for the B+ blood labeled for a different patient was missing and could not be located by the facility. As per Staff Member (SM) #5, there was no other documentation in the electronic medical record related to blood product administration verification for Patient #2. SM #5 stated that all documentation related to the massive transfusion protocol (MTP) for Patient #2 was documented on the paper hard copy Transfusion Record Transfusion Tags.

A review of the facility's adverse event log on 10/20/2021 contained evidence of the documentation that on 10/1/2020, "...Just after the time of death on 10-1 2144 [9:44 p.m.] after coding the patient for approximately 22 [twenty-two] minutes, the ER [emergency room] nurse arrived to the Door of the IR [interventional radiology] room 2 [two], stating that the patient may have received someone else's blood at some point during [patient's] arrival to the ER to the time of death. [Patient name], was known A positive, and ultimately it was found that [patient] was given B positive cross matched blood that was meant for another patient. We found this after I told the ER nurse I would look through the trash in IR. I dug to the bottom of the trash in IR, to find blood that was B+ matched for [Patient name] that was given...The Fellow [name ] explained that while [patient] did get possibly the wrong blood- the outcome would have not changed..."

During an interview on 10/20/2021, SMs #10 and #11 both stated that they recalled the incident with Patient #2 and they did follow the procedure to verify a blood product for this patient and sign the bag tag. SMs #10 and #11 both stated that they did not initiate or administer any blood products for Patient #2 and did not learn about the administration of the incorrect blood product to this patient until their next shift.

A review of the Transfusion Record Transfusion Tags for Patient #12 on 10/20/2021 contained evidence that one (1) of nine (9) Transfusion Tags (for Plasma) did not contain a second verification signature as per facility policy.

During an interview on 10/20/2021, SM #1 stated that the facility had not completed an investigation of the unsigned/incomplete Transfusion Record Transfusion Tags related to Patient #2.

During the exit conference on 10/20/2021 SM #2 stated that there was no quality related investigation of the lack of verification of blood administered to Patient #2 and that it continues to be an issue.

On 10/20/2021 at 11:45 a.m. the above concerns were discussed during the exit conference.

A review of the facility's policy titled, "Blood Products Transfusion," effective date 10/17/2019 states in part,
...D. Patient Identification
D. 1. Verification of the patient's identity is performed prior to the initiation of the transfusion. See PC.PS.001 - Patient Identification.
D.2. Patient identification takes place in the presence of the patient and is conducted by 2 [two] licensed or certified team members utilizing verbal verification and bar code scanning, where applicable.
D.3. Patient identification and product verification is completed using the read- back method. Bag tag information is checked against the patient's armband and unit information is checked against the attached bag tag.
...O. Bag Tags
O.1. Bag tags are to remain attached to the blood products throughout the transfusion process.
O.2. Complete the bag tag is not required when the transfusion is documented in the EMR.
O.3. Complete the back of the bag tag to include the signature of the [two] 2 verifiers is required when EMR is not available. The bag tag is then kept in the patient's chart and scanned into the medical record.
O.4. Uncrossmatched emergency-released blood products require that a [patient's label be placed on each section of the bag tag. The attestation section is completed by the ordering provider (name and signature and returned to Blood Bank. The backs of the other [two] 2 sections are completed and signed by [two] 2 licensed verifiers and kept in the patient's chart as a part of the permanent medical record.
...4. Handling
...4.5. Identify the patient and verify the blood product with another licensed or credentialed team member. Document co-signature in EMR (if available) or by signing the bag tag (if EMR is unavailable).
4.6. Ensure that the bag tag remains attached to the blood product until the transfusion is completed, then discard. Exception is in the case when documentation is completed on the bag tag, then it is kept in the patient's chart as a medical record.
...5. Patient Identification and Blood Products Verification
5.1. Use the 'Read-Back' method below in the process of verification.
1. Once at the patient's bedside, the first verifier reads the patient's name out loud from the patient's identification wristband.
2. The second verifier reads the patient's name out loud from the blood product bag tag.
3. The first verifier reads the unit number out loud from the bag tag.
4. The second verifier read the unit number out loud from the blood product label.
5. The first verifier reads out loud the blood type (ABO/Rh) form the bag tag.
6. The second verifier reads out loud the blood type (ABO/Rh) from the bag tag.
7. Both verifiers check the patient's ABO/Rh in the Blood Bank Quick View and compare to that on the bag tag and product to ensure compatibility.
5.2 Do not proceed to start the infusion if any discrepancy is noted. If anticipating more than 30 minutes delay to resolve the discrepancy, return the product to the Blood Bank.
5.3 Use EMR [electronic medical record] for scanning blood products, where available. Refer to Start Transfusion.
Document the start and end time of transfusion by scanning the product into EMR (where applicable) or on the attached product bag tag (if EMR is unavailable).
...8. Documentation
8.1 Document blood transfusions in EMR by using the transfusion documentation scanning system. If unable to scan blood products (unavailable, issues with scanning), document by completing the AdHoc Form. If both are unavailable, complete documentation on the bag tag and retain in patient's chart.
8.2 Document the start and end time of transfusion by scanning the product in to EMR (where applicable) or on the attached product bag tag (if EMR is unavailable).
8.3 Verify the following mandated documentation in the patient's medical record:
1. A valid consent
2. An order to transfuse
3. The first and last names of the verifiers
4. Vital signs (baseline, 15 minutes, 1 hour after initiation, and end of transfusion)
5. Patient's response to transfusion
6. Patient education provided...

A review of the facility's training document titled, "Initial Competencies for Registered Nurses and New Graduate Nurses," states in part:
...Administration of Blood/Blood Products
...B Administration of Blood/Blood Product:
1. Verify blood/blood product at bedside by two (2) - licensed providers. Sign the blood bag tag on designated line. (NOTE: RN or physician must serve as first verifier.)
...C. Documentation
1. Document in medical record:
a. Time of initiation & completion of infusion.
b. First initial, last name & classification of person starting infusion & two people verifying blood/blood products.
c. The specific product.
d. Donor number of blood/blood products.
e. Amount infused.
f. Vital signs.
g. Patient's response