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Based on document review and staff interview, the acute care hospital's administrative staff failed to:

1. Ensure 1 of 1 Contracted Laboratory Service (CLS) provided blood to Patient #1 in a safe and effective manner. Please refer to A-0084.

2. Ensure 1 of 1 CLS incorporated all of their internal, hospital specific performance improvement data into the hospital wide performance improvement program. Please refer to A-0084.

3. Ensure the hospital wide performance improvement program included an adverse patient event where an outside company's paramedic hung a unit of the incorrect type of blood, connected the tubing, started the blood infusing through the tubing, and the staff stopped the infusion shortly prior to the blood reaching the patient after the laboratory staff identified they issued the incorrect type of blood. Please refer to A-0286.

4. Ensure the hospital wide performance improvement program included all of the internal performance improvement information from 1 of 1 contracted laboratory services. Please refer to A-0308.

5. Ensure the hospital wide performance improvement program included all of the internal incident reports from 1 of 1 contracted laboratory services. Please refer to A-0309.

6. Ensure the nursing staff followed the hospital's policies and procedures for administering blood to 1 of 5 patients reviewed who received a blood transfusion. Please refer to A-0409.

7. Ensure the nursing staff followed the hospital's policies and procedures for reporting adverse patient events to the hospital's performance improvement program. Please refer to A-0409.

8. Ensure the laboratory staff issued the correct type of blood for a transfusion in 1 of 5 patients reviewed who received a blood transfusion. Please see A-0576.

9. Ensure 1 of 1 CLS reported the incident where a patient almost received the incorrect type of blood to the hospital wide performance improvement program. Please see A-0576.

The cumulative effect of these failures and deficient practices resulted in the hospital's inability to effectively carry out the responsibilities of the hospital. The CLS' administrative staff identified an average of 144 units of blood transfused at the hospital per month and an average of 8 internal incident reports generated per month.

II. During the investigation of incident 65113-C, the on-site survey team identified an Immediate Jeopardy (IJ) situation (a crisis situation that placed the health and safety of patients at risk) related to the Condition of Participation for Laboratory Services (42 CFR 482.27) and the Condition of Participation for Nursing Services (42 CFR 482.23). The hospital staff failed to ensure a patient received the correct type of blood for a transfusion.

1. The administrative staff failed to initially develop and implement a corrective action plan to ensure the laboratory staff entered the correct blood type into the computer for patients and to ensure the nursing staff performed a 2 RN verification prior to transfusing blood to a patient.

2. While on-site, the survey team identified an Immediate Jeopardy (IJ) situation and notified the administrative staff on 1/19/17. The administrative staff promptly took action to abate the immediacy of the situation. The hospital staff removed the immediacy prior to the survey team exiting the complaint investigation when the administrative staff took the following actions:

a. The hospital administrative staff developed and/or updated policies and procedures for the transfusion of blood, including addressing situations where the patient will receive the blood during the transfer to another facility.

b. The laboratory administrative staff developed and/or updated policies and procedures, including 2 person verification, during entry of a patient's blood type into the computer.

c. The laboratory staff will use the hospital wide incident reporting system to report incidents in the laboratory to the hospital wide performance improvement program.

d. The administrative staff began educating the nursing staff on the new blood transfusion policy changes and new procedures on 1/19/17. The nursing staff received the education prior to the start of their next shift.

e. The hospital educational staff incorporated the policy changes into the new hire nursing orientation.

f. The hospital administrative staff implemented a system to monitor ongoing compliance. The Vice President of Patient Care Services and Laboratory Manager are responsible for monitoring the ongoing compliance.

Based on document review and staff interview, the hospital's governing body failed to ensure 1 of 1 Contracted Laboratory Service (CLS) provided services in a safe and effective manner. The contracted laboratory service's administrative staff identified an average of 144 units of blood transfused each month at the hospital and approximately 8 internal laboratory incident reports per month.

Failure to ensure the CLS provided services in a safe and effective manner resulted in the CLS staff issuing a unit of blood from the wrong blood type of a patient, and the CLS failing to include their internal performance improvement data into the hospital wide performance improvement program.


Findings included:

1. Review of the policy "Oversight of Care Provided Through Contractual Agreement," revised 10/2015, revealed in part, "The process to ensure that contracted services for patient care are safe and effective is as follows: ... A description of the performance expectations associated with each contracted service is included in the written agreement for that service."

2. Review of the "Memorandum of Agreement Between Mercy Medical Center ... and [Contracted Laboratory Service's name]," signed 5/13/13, revealed in part, "Additional performance measures: ... Review of incidences of ... other unexpected occurrences."

3. Review of Patient #1's medical record revealed Patient #1 presented to the hospital's Emergency Department (ED) on 12/26/16, complaining of difficulty breathing. ED Physician A ordered the hospital staff to perform laboratory testing on Patient #1. ED Physician A determined Patient #1 required a blood transfusion. ED Physician A ordered the hospital staff to transfuse 1 unit of blood to Patient #1 on 12/26/16 at 3:35 PM.

4. During an interview on 1/19/17 at 2:20 PM, Laboratory Technician D stated she received an order to prepare a unit of blood so the nursing staff could transfuse it to Patient #1. She started by determining Patient #1's blood type. She looked at the test equipment and entered Patient #1's blood type in the computer as "B Positive."

Laboratory Technician D obtained a unit of "B Positive" blood from the laboratory refrigerator and quickly checked to determine if the donor's blood would cause Patient #1's blood to clump (a potentially fatal reaction). The donor's blood did not cause Patient #1's blood to clump, so Laboratory Technician D contacted the ED staff and told them to pick up the blood for Patient #1.

Laboratory Technician D used the computer to verify she released the correct unit of blood to the ED staff member who picked up the blood. After the ED staff member left the laboratory, Laboratory Technician D was cleaning up her work station and looked at the blood type testing equipment and saw Patient #1 actually had "B Negative" blood.

Laboratory Technician D notified her supervisor, who instructed her to inform the ED staff not to administer the incorrect unit of "B Positive" blood to Patient #1. When Laboratory Technician D contacted the ED, the ED staff stated they had already started the transfusion for Patient #1 using the incorrect "B Positive" blood. Laboratory Technician D told the ED staff to stop the transfusion and return the "B Positive" blood to the laboratory.

5. Review of the laboratory specific "Erroneous Reported Result Log" from 12/26/16 revealed Laboratory Technician D incorrectly identified Patient #1's blood type as "B Positive" instead of the correct type, "B Negative."

6. Review of an untitled document from the CLS revealed the laboratory staff identified 48 errors reported internally to the CLS from 7/1/16 to 1/17/17. The CLS identified 7 incidents that occurred during 7/2016, 12 incidents that occurred during 8/2016, 5 incidents that occurred during 9/2016, 4 incidents that occurred during 10/2016, 4 incidents that occurred during 11/206, 11 incidents that occurred during 12/2016, and 5 incidents that occurred between 1/1/17 and 1/17/17.

7. Review of the document, "CLINICAL SAFETY COMMITTEE REPORTING MATRIX January-December 2017..." revealed the Laboratory Manager reported information about the laboratory's patient safety measures to the Clinical Safety Committee on January 10, 2017.

8. Review of the Clinical Safety Committee minutes, dated 7/12/16, revealed the CLS staff failed to report the 7 incidents that occurred in the CLS during 7/2016.

9. Review of the Clinical Safety Committee minutes, dated 8/9/16, revealed the CLS staff failed to report the 12 incidents that occurred in the CLS during 8/2016.

10. Review of the Clinical Safety Committee minutes, dated 11/8/16, revealed the CLS staff failed to report the 5 incidents that occurred in the CLS during 9/2016, the 4 incidents that occurred in the CLS during 10/2016, and the 4 incidents that occurred in the CLS during 11/2016.

11. Review of the Clinical Safety Committee minutes, dated 1/10/17, revealed the CLS staff failed to report the 11 incidents that occurred in the CLS during 12/2016 and the 5 incidents that occurred in the CLS between 1/1/17 and 1/17/17.

12. Review of the "Mercy Medical Center - Dubuque Joint Quality Oversight Committee Charter and Goals 2017," dated 10/5/16, revealed in part, "Charter. Govern quality services at Mercy Medical Center by providing policy oversight and coordination of efforts in performance improvement, including areas of clinical quality ... blood and procedure review ..."

13. Review of the "Mercy Medical Center Joint Quality Oversight Committee" meeting minutes, dated 1/7/15, revealed the governing body's quality committee discussed the utilization of blood products, but did not discuss any laboratory quality improvement topics beyond blood transfusion utilization.

14. Review of the CLS' policy "Performance (Process) Improvement (PI) Plan," revised 11/3/16, revealed the policy lacked a requirement to report errors that occurred in the laboratory to the hospital.

15. Review of an undated document revealed the Risk Manager attested the Laboratory Manager did not inform the Clinical Safety Committee on 1/10/17 about the incident where Laboratory Technician D issued an unit of the incorrect blood type for transfusion to Patient #1.

16. During an interview on 1/19/17 at 2:40 PM, the Laboratory Manager stated the CLS failed to report information from CLS' Quality Council to the hospital's performance improvement program.

17. During an interview on 1/19/17 at 11:40 AM, the hospital's Director of Performance Improvement and the Risk Manager stated the CLS failed to provide the hospital's performance improvement committees with any information from the CLS' internal performance improvement program.

18. During an interview on 1/19/17 at 2:40 PM, the Laboratory Manager stated the laboratory was a contracted service at the hospital. The laboratory staff viewed the error as only affecting the laboratory staff. The Laboratory Manager did not report the incident to the hospital's PI committee, the Clinical Safety Committee, or the Joint Quality Oversight Committee. Instead, the Laboratory Manager only addressed the issue in the CLS' internal performance improvement program.

19. During an interview on 1/19/17 at 1:00 PM, Pathologist E (also the president of the medical staff) stated the CLS' internal Quality Council discussed the incidents during Patient #1's care. While there was a mechanism for the medical staff (all of the doctors and mid-level practitioners who can provide care to patients at the hospital) to review an incident similar to what happened to Patient #1, the medical staff did not review the incident. Since the hospital's medical staff and Joint Quality Committee did not review the incidents during Patient #1's care, the hospital's governing body was not aware of what happened to Patient #1.

Based on document review and staff interview, the acute care hospital's administrative staff failed to:

1. Ensure the hospital wide performance improvement program included an adverse patient event where an outside company's paramedic hung a unit of the incorrect type of blood, connected the tubing, started the blood infusing through the tubing, and the staff stopped the infusion shortly prior to the blood reaching the patient after the laboratory staff identified they issued the incorrect type of blood. Please refer to A-0286.

2. Ensure the hospital wide performance improvement program included all of the internal performance improvement information from 1 of 1 contracted laboratory services (CLS). Please refer to A-0308.

3. Ensure the hospital wide performance improvement program included all of the internal incident reports from 1 of 1 CLS. Please refer to A-0309.

The cumulative effect of these failures and deficient practices resulted in the hospital's inability to maintain an effective, hospital wide performance improvement program. The CLS' administrative staff identified an average of 144 units of blood transfused at the hospital per month and an average of 8 internal incident reports per month.

Based on document review and staff interview, the hospital's administrative staff failed to ensure 1 of 1 contracted laboratory service (CLS) reported a situation where the laboratory staff issued an unit of blood with the incorrect blood type for the nursing staff to transfuse to Patient #1 to the hospital wide performance improvement committee, the Clinical Safety Committee. The hospital's administrative staff also failed to ensure the hospital's nursing staff reported 2 of 2 instances where the nursing staff failed to verify 2 of 2 units of blood for Patient #1 prior to starting the transfusion to Patient #1. The hospital administrative staff stated the nursing staff transfused approximately 144 units of blood per month to patients.

Failure to ensure the CLS and nursing staff reported all patient safety events resulted in the Clinical Quality Committee's inability to track the hospital's performance to monitor the safety of the patient care provided at the hospital.


Findings Included:

1. Review of Patient #1's medical record revealed Patient #1 presented to the hospital's Emergency Department (ED) on 12/26/16, complaining of difficulty breathing. ED Physician A ordered the hospital staff to perform laboratory testing on Patient #1. ED Physician A determined Patient #1 required a blood transfusion. ED Physician A ordered the hospital staff to transfuse 1 unit of blood to Patient #1 on 12/26/16 at 3:35 PM.

2. During an interview on 1/19/17 at 2:20 PM, Laboratory Technician D stated she received an order to prepare a unit of blood so the nursing staff could transfuse it to Patient #1. She started by determining Patient #1's blood type. She looked at the test equipment and entered Patient #1's blood type in the computer as "B Positive."

Laboratory Technician D obtained a unit of "B Positive" blood from the laboratory refrigerator and quickly checked to determine if the donor's blood would cause Patient #1's blood to clump (a potentially fatal reaction). The donor's blood did not cause Patient #1's blood to clump, so Laboratory Technician D contacted the ED staff and told them to pick up the blood for Patient #1.

Laboratory Technician D used the computer to verify she released the correct unit of blood to the ED staff member who picked up the blood. After the ED staff member left the laboratory, Laboratory Technician D was cleaning up her work station and looked at the blood type testing equipment and saw Patient #1 actually had "B Negative" blood.

Laboratory Technician D notified her supervisor, who instructed her to inform the ED staff not to administer the incorrect unit of "B Positive" blood to Patient #1. When Laboratory Technician D contacted the ED, the ED staff stated they had already started the transfusion for Patient #1 using the incorrect "B Positive" blood. Laboratory Technician D told the ED staff to stop the transfusion and return the "B Positive" blood to the laboratory.

3. Review of the policy "Blood Products," last reviewed 2/2015, revealed in part, "Proper identification of the blood ... must again be verified by two [Registered Nurses] ... Verify that the unit number, blood type, and expiration date on the product ID sheet matches the unit number, blood type, and expiration date on the blood bag.... The transfusing nurse and the witness nurse stand apart and do not read from the same documents. If correct, then both are to sign the pre-transfusion verification section of the product ID, as well as the date and time the blood transfusion is started."

4. Review of Patient #1's medical record revealed the nursing staff failed to create any documentation indicating they verified the identification of the blood prior to administering the blood to Patient #1 or any documentation they administered the blood to Patient #1.

5. During an interview on 1/18/17 at 10:00 AM, Registered Nurse (RN) C stated acknowledged she did not verify the units of blood with another nurse both times she handed the units of blood to Outside Company Paramedic B, as required by the hospital's policy.

6. Review of Clinical Safety Committee Minutes, dated 1/10/17, revealed the meeting minutes lacked evidence the Laboratory Manager informed the Clinical Safety Committee about the incidents involving laboratory staff issuing the wrong type of blood for the nursing staff to transfuse to Patient #1. The meeting minutes also lacked evidence the nursing staff reported they failed to verify the 2 units of blood prior to administering the blood to Patient #1.

7. Review of an undated document revealed the Risk Manager attested the Laboratory Manager failed to inform the Clinical Safety Committee on January 10, 2017 about the incident where Laboratory Technician D issued an unit of the incorrect blood type for transfusion to Patient #1.

8. Review of the policy "Reporting of Unusual Occurrences Involving Patients," Current Revision: July 2016, revealed in part, "Any occurrence that either did or could directly result in an injury to a patient shall be submitted through the organization patient incident reporting system.... The patient incident reports are to be initiated by the employee involved in or responding to the unusual occurrence."

9. During an interview on 1/18/17 at 10:00 AM, RN C stated she did not complete an incident report on the events that occurred during Patient #1's care, as she felt the laboratory staff should report the incident to the hospital's performance improvement program.

10. During an interview on 1/19/17 at 2:40 PM, the Laboratory Manager stated the laboratory was a contracted service at the hospital. The laboratory staff viewed the error as only affecting the laboratory staff. The Laboratory Manager did not report the incident to the hospital's PI committee, the Clinical Safety Committee. Instead, the Laboratory Manager only addressed the issue in the contracted laboratory's internal PI program.

11. During an interview on 1/18/17 at 11:40 AM, the Director of Performance Improvement and Risk Manager stated they did not know about the incidents during Patient #1's care on 12/26/16 (24 days later). The Risk Manager stated she reviewed the incident reports every working day. If the staff had submitted an incident report, she would have seen an incident report about the incidents during Patient #1's care on 12/26/16.

The Director of Performance Improvement stated if she was aware of the incidents during Patient #1's care on 12/26/16, she would have directed the Risk Manager to perform an in-depth analysis of what happened. Risk Manager would attempt to identify how the errors occurred and what steps the hospital staff could take to prevent a similar error from occurring with another patient.

The Director of Performance Improvement and the Risk Manager both acknowledged that since the nursing staff did not create an incident report addressing the failure to verify the 2 units of blood prior to administration to Patient #1 and the contracted laboratory staff failed to inform the Clinical Quality Committee that the laboratory staff issued an unit of blood to the nursing staff to transfuse for Patient #1, the Clinical Quality Committee could not analyze or track the adverse patient events involved in Patient #1's care. The lack of reporting prevented the hospital's Performance Improvement program from identifying the causes of the errors and implementing actions to prevent the errors from recurring.

Based on document review and staff interview, the hospital's administrative staff failed to ensure 1 of 1 contracted laboratory service (CLS) included their internal performance improvement program into the hospital's performance improvement program. The CLS' administrative staff identified an average of 8 internal laboratory incident reports generated per month.

Failure to include the contracted laboratory's performance improvement program into the hospital's performance improvement program resulted in the hospital's performance improvement's inability to identify trends in the contracted laboratory's performance and implement corrective action in response to identified concerns.

Findings included:

1. Review of the policy "Oversight of Care Provided Through Contractual Agreement," revised 10/2015, revealed in part, "The process to ensure that contracted services for patient care are safe and effective is as follows: ... A description of the performance expectations associated with each contracted service is included in the written agreement for that service."

2. Review of the "Memorandum of Agreement Between Mercy Medical Center ... and [Contracted Laboratory Service F's name]," signed 5/13/13, revealed in part, "Additional performance measures: ... Review of incidences of ... other unexpected occurrences."

3. Review of the Clinical Safety Committee minutes, dated: 1/10/17; 11/8/16; 8/9/16; and 7/12/16, revealed all the documents lacked evidence the contracted laboratory service reported data from their internal performance improvement program to the hospital's performance improvement committee.

4. Review of the "Mercy Medical Center - Dubuque Joint Quality Oversight Committee Charter and Goals 2017," dated 10/5/16, revealed in part, "Charter. Govern quality services at Mercy Medical Center by providing policy oversight and coordination of efforts in performance improvement, including areas of clinical quality ..."

5. Review of the "Mercy Medical Center Joint Quality Oversight Committee" meeting minutes, dated 1/7/15, revealed the governing body's quality committee discussed the utilization of blood products, but did not discuss any laboratory quality improvement topics beyond blood transfusion utilization.

6. Review of the documents "[Contracted Laboratory Service's name] Quality Council Agenda," dated: 12/15/16; 11/17/16; 10/27/16; 9/15/16; and 8/18/16, revealed the CLS's Quality Council discussed performance improvement topics specific to each hospital where they provided services. The Quality Council members discussed how to improve concerns the committee identified at each hospital.

7. Review of the CLS' policy "Performance (Process) Improvement (PI) Plan," revised 11/3/16, revealed the policy lacked a requirement to provide hospital specific performance improvement data to each hospital.

8. During an interview on 1/19/17 at 2:40 PM, the Laboratory Manager stated the CLS failed to report information from the CLS's Quality Council to the hospital's performance improvement program.

9. During an interview on 1/19/17 at 11:40, the hospital's Director of Performance Improvement and the Risk Manager stated the CLS failed to provide the hospital's performance improvement committees with any information from the contracted laboratory service's internal performance improvement program.

Based on document review and staff interview, the hospital's administrative staff failed to ensure 1 of 1 contracted laboratory service (CLS) reported all adverse patient events to the hospital's performance improvement program. The CLS' administrative staff identified an average of 8 laboratory incident reports per month.

Failure to report all adverse patient events to the hospital's performance improvement program resulted in the performance improvement program's inability to identify trends in the CLS' incident reports and develop corrective action.

Findings included:

1. Review of an untitled document from the CLS revealed the laboratory staff identified 48 errors reported internally to the CLS from 7/1/16 to 1/17/17.

2. Review of the Clinical Safety Committee minutes, dated: 1/10/17; 11/8/16; 8/9/16; and 7/12/16, revealed all the documents lacked evidence the contracted laboratory service reported the errors to the hospital's performance improvement committee.

3. Review of the "Mercy Medical Center - Dubuque Joint Quality Oversight Committee Charter and Goals 2017," dated 10/5/16, revealed in part, "Charter. Govern quality services at Mercy Medical Center by providing policy oversight and coordination of efforts in performance improvement, including areas of clinical quality ... blood and procedure review ..."

4. Review of the "Mercy Medical Center Joint Quality Oversight Committee" meeting minutes, dated 1/7/15, revealed the governing body's quality committee discussed the utilization of blood products, but did not discuss any laboratory quality improvement topics beyond blood transfusion utilization.

5. Review of the "Memorandum of Agreement Between Mercy Medical Center ... and [the CLS' name]," signed 5/13/13, revealed in part, "Additional performance measures: ... Review of incidences of ... other unexpected occurrences."

6. Review of the CLS' policy "Performance (Process) Improvement (PI) Plan," revised 11/3/16, revealed the policy lacked a requirement to report errors that occurred in the laboratory to the hospital.

7. During an interview on 1/19/17 at 2:40 PM, the Laboratory Manager stated the CLS failed to report internal incident reports or adverse events to the hospital quality system. Instead, the CLS reviewed the reports internally and failed to provide information on the incident reports or adverse events to the hospital's performance improvement program.

8. During an interview on 1/19/17 at 11:40, the hospital's Director of Performance Improvement and the Risk Manager stated the CLS failed to provide any internal incident reports or adverse event data to the hospital.

I. Based on document review and staff interview, the acute care hospital's administrative staff failed to:

1. Ensure the nursing staff followed the hospital's policies and procedures for transfusing blood to 1 of 5 patients reviewed who received a blood transfusion. Please refer to A-0409.

2. Ensure the nursing staff followed the hospital's policies and procedures for reporting adverse patient events to the hospital's performance improvement program. Please refer to A-0409.

The cumulative effect of these failures and deficient practices resulted in the hospital's inability to ensure the nursing staff safely performed blood transfusions. The contracted laboratory service's administrative staff identified an average of 144 units of blood transfused at the hospital per month.

II. During the investigation of incident 65113-C, the on-site survey team identified an Immediate Jeopardy (IJ) situation (a crisis situation that placed the health and safety of patients at risk) related to the Condition of Participation for Laboratory Services (42 CFR 482.27) and the Condition of Participation for Nursing Services (42 CFR 482.23). The hospital staff failed to ensure a patient received the correct type of blood for a transfusion.

1. The administrative staff failed to initially develop and implement a corrective action plan to ensure the laboratory staff entered the correct blood type into the computer for patients and to ensure the nursing staff performed a 2 RN verification prior to transfusing blood to a patient.

2. While on-site, the survey team identified an Immediate Jeopardy (IJ) situation and notified the administrative staff on 1/19/17. The administrative staff promptly took action to abate the immediacy of the situation. The hospital staff removed the immediacy prior to the survey team exiting the complaint investigation when the administrative staff took the following actions:

a. The hospital administrative staff developed and/or updated policies and procedures for the transfusion of blood, including addressing situations where the patient will receive the blood during the transfer to another facility.

b. The laboratory administrative staff developed and/or updated policies and procedures, including 2 person verification, during entry of a patient's blood type into the computer.

c. The laboratory staff will use the hospital wide incident reporting system to report incidents in the laboratory to the hospital wide performance improvement program.

d. The administrative staff began educating the nursing staff on the new blood transfusion policy changes and new procedures on 1/19/17. The nursing staff received the education prior to the start of their next shift.

e. The hospital educational staff incorporated the policy changes into the new hire nursing orientation.

f. The hospital administrative staff implemented a system to monitor ongoing compliance. The Vice President of Patient Care Services and Laboratory Manager are responsible for monitoring the ongoing compliance.

The following Condition level deficiency remained for the Condition of Participation in Nursing Services (A-0385).

Based on document review and staff interview, the hospital's administrative staff failed to ensure the nursing staff followed the facility's policies for blood transfusion and incident reporting in 1 of 5 closed medical records (Patient #1) where the patient received a blood transfusion. The hospital administrative staff identified an average of 144 units of blood transfused per month at the hospital.

Failure to follow facility policies and procedures resulted in a patient receiving 2 units of blood without 2 nurses ensuring the patient received the correct unit of blood prior to transfusing the blood. The failure could potentially result in the patient receiving an incorrect unit of blood and potentially leading to a fatal reaction. Failure to follow the facility's policies on incident reporting resulted in the hospital's quality improvement staff not knowing about the incident, preventing them from implementing corrective actions to prevent another patient from experiencing a similar error.


Findings included:

1. Review of Patient #1's medical record revealed she presented to the hospital's Emergency Department (ED) on 12/26/16. The medical record revealed ED Physician A ordered Patient #1 to receive a blood transfusion.

2. Review of the policy "Blood Products," last reviewed 2/2015, revealed in part, "Proper identification of the blood ... must again be verified by two [Registered Nurses] ... Verify that the unit number, blood type, and expiration date on the product ID sheet matches the unit number, blood type, and expiration date on the blood bag.... The transfusing nurse and the witness nurse stand apart and do not read from the same documents. If correct, then both are to sign the pre-transfusion verification section of the product ID, as well as the date and time the blood transfusion is started."

3. Review of Patient #1's medical record revealed the nursing staff did not create any documentation indicating they verified the units of blood prior to transfusing the blood to Patient #1 or any documentation Patient #1 received blood products.

Outside Company Paramedic B documented they arrived to transfer Patient #1 to another hospital. "The [hospital] nurse noted that [Patient #1's] hemoglobin (oxygen carrying part of the blood) was critical[ly low] and that [Patient #1] would be getting a blood transfusion during transport.... Crew had to wait for several minutes for the unit of blood to come. Crew assisted the patient in sliding from the bed to the [ambulance] cot.... The unit of blood showed up and was started by Crew and nursing staff. Just after starting the infusion, the nurse came back into the room and told the crew to stop the infusion per the lab and that the unit needed to go back [to the lab]. Crew waited for a new unit of blood to [arrive]. Once [the new unit of blood] arrived, it was started in the ambulance."

4. During an interview on 1/18/17 at 10:00 AM, Registered Nurse (RN) C stated that Patient #1 arrived at the hospital complaining of difficulty breathing. ED Physician A had the laboratory staff perform tests on Patient #1's blood and decided Patient #1 needed to transfer to another hospital for access to care not available at Mercy Hospital. ED Physician A ordered Patient #1 to receive a blood transfusion prior to or at the time of the transfer.

The ambulance personnel arrived while RN C was waiting for the laboratory staff to prepare the blood for transfusion. Once the blood was ready, RN C gave the unit of blood to Outside Company Paramedic B to initiate in the ED room. Approximately 5 minutes after Outside Company Paramedic B started the blood transfusion, the laboratory staff called RN C and told RN C to stop the blood transfusion and they needed the unit of blood back. RN C told Outside Company Paramedic B to stop the infusion and return the blood to the laboratory. The blood from the incorrect unit was in the bag, connected to the tubing, and the staff intervened before the incorrect type of blood reached Patient #1. The ED staff returned the incorrect unit of blood to the laboratory. The new unit of blood arrived and RN C handed the unit of blood to Outside Company Paramedic B to start in the ambulance.

RN C stated Patient #1 was still in RN C's care at the time she handed the units of blood to Outside Company Paramedic B. RN C correctly recited how to perform a 2 nurse verification of blood prior to transfusion, according to the hospital's policy. RN C acknowledged she did not verify the units of blood with another nurse both times she handed the units of blood to Outside Company Paramedic B, as required by the hospital's policy.

5. During an interview on 1/20/17 at 12:30 PM, the Accreditation Coordinator acknowledged the hospital's policy required RN C to verify the units of blood with another nurse prior to handing the units of blood to Outside Company Paramedic B. The Accreditation Coordinator acknowledged the hospital's policy on blood administration lacked guidance to the nursing staff on how to handle situations where the hospital's nursing staff members did not initiate the blood transfusion prior to transferring the patient to another hospital. The Accreditation Coordinator acknowledged RN C's failure to verify the unit of blood with a second nurse prior to administering the blood to Patient #1 could have resulted in RN C transfusing blood intended for another patient to Patient #1, and potentially result in a fatal transfusion reaction.

6. Review of the policy "Reporting of Unusual Occurrences Involving Patients," Current Revision: July 2016, revealed in part, "Any occurrence that either did or could directly result in an injury to a patient shall be submitted through the organization patient incident reporting system.... The patient incident reports are to be initiated by the employee involved in or responding to the unusual occurrence."

7. During an interview on 1/18/17 at 10:00 AM, RN C stated she failed to complete an incident report on the events that occurred during Patient #1's care.

8. During an interview on 1/18/17 at 11:40 AM, the Director of Performance Improvement and Risk Manager stated RN C should have completed an incident report on the events that occurred during Patient #1's care.

I. Based on document review and staff interview, the acute care hospital's administrative staff failed to:

1. Ensure 1 of 5 patients reviewed who received a blood transfusion received the correct type of blood. Please refer to A-0576.

2. Ensure 1 of 1 contracted laboratory service (CLS) reported the incident where a patient received the incorrect type of blood to the hospital wide performance improvement program. Please refer to A-0576.

The cumulative effect of these failures and deficient practices resulted in the hospital's inability to ensure patients who required a blood transfusion received the correct type of blood. The CLS' administrative staff identified an average of 144 units of blood transfused at the hospital per month.

II. During the investigation of incident 65113-C, the on-site survey team identified an Immediate Jeopardy (IJ) situation (a crisis situation that placed the health and safety of patients at risk) related to the Condition of Participation for Laboratory Services (42 CFR 482.27) and the Condition of Participation for Nursing Services (42 CFR 482.23). The hospital staff failed to ensure a patient received the correct type of blood for a transfusion.

1. The administrative staff failed to initially develop and implement a corrective action plan to ensure the laboratory staff entered the correct blood type into the computer for patients and to ensure the nursing staff performed a 2 RN verification prior to transfusing blood to a patient.

2. While on-site, the survey team identified an Immediate Jeopardy (IJ) situation and notified the administrative staff on 1/19/17. The administrative staff promptly took action to abate the immediacy of the situation. The hospital staff removed the immediacy prior to the survey team exiting the complaint investigation when the administrative staff took the following actions:

a. The hospital administrative staff developed and/or updated policies and procedures for the transfusion of blood, including addressing situations where the patient will receive the blood during the transfer to another facility.

b. The laboratory administrative staff developed and/or updated policies and procedures, including 2 person verification, during entry of a patient's blood type into the computer.

c. The laboratory staff will use the hospital wide incident reporting system to report incidents in the laboratory to the hospital wide performance improvement program.

d. The administrative staff began educating the nursing staff on the new blood transfusion policy changes and new procedures on 1/19/17. The nursing staff received the education prior to the start of their next shift.

e. The hospital educational staff incorporated the policy changes into the new hire nursing orientation.

f. The hospital administrative staff implemented a system to monitor ongoing compliance. The Vice President of Patient Care Services and Laboratory Manager are responsible for monitoring the ongoing compliance.

The following Condition level deficiency remained for the Condition of Participation in Laboratory Services (A-0576).



III. Based on document review and staff interview, the hospital's administrative staff failed to ensure the hospital's CLS issued the correct type of blood to 1 of 5 closed medical records (Patient #1) when the patient received a blood transfusion. The hospital administrative staff identified an average of 144 units of blood transfused per month at the hospital.

Failure to ensure the staff issued the correct type of blood resulted in the laboratory staff issuing a unit of blood for a patient that was not fully compatible with the patient's blood type. Transfusing blood not fully compatible to a patient could result in life threatening or fatal reactions.


Findings Included:

1. Review of Patient #1's medical record revealed Patient #1 presented to the hospital's Emergency Department (ED) on 12/26/16, complaining of difficulty breathing. ED Physician A ordered the hospital staff to perform laboratory testing on Patient #1. ED Physician A determined Patient #1 required a blood transfusion. ED Physician A ordered the hospital staff to transfuse 1 unit of blood to Patient #1 on 12/26/16 at 3:35 PM.

2. During an interview on 1/19/17 at 2:20 PM, Laboratory Technician D stated she received an order to prepare a unit of blood so the nursing staff could transfuse it to Patient #1. She started by determining Patient #1's blood type. She looked at the test equipment and entered Patient #1's blood type in the computer as "B Positive."

Laboratory Technician D obtained a unit of "B Positive" blood from the laboratory refrigerator and quickly checked to determine if the donor's blood would cause Patient #1's blood to clump (a potentially fatal reaction). The donor's blood did not cause Patient #1's blood to clump, so Laboratory Technician D contacted the ED staff and told them to pick up the blood for Patient #1's transfusion.

Laboratory Technician D used the computer to verify she released the correct unit of blood to the ED staff member who picked up the blood. After the ED staff member left the laboratory, Laboratory Technician D was cleaning up her work station and looked at the blood type testing equipment and saw Patient #1 actually had "B Negative" blood.

Laboratory Technician D notified her supervisor, who instructed her to inform the ED staff to not transfuse the incorrect unit of "B Positive" blood for Patient #1. When Laboratory Technician D contacted the ED, the ED staff stated they already started the transfusion for Patient #1 using the incorrect "B Positive" blood. Laboratory Technician D told the ED staff to stop the transfusion and return the "B Positive" blood to the laboratory.

While waiting for the ED staff to return the incorrect "B Positive" unit of blood, Laboratory Technician B began processing a unit of "B Negative" blood for the nursing staff to administer to Patient #1. When the ED staff returned to the laboratory with the incorrect "B Positive" unit of blood, Laboratory Technician D issued the correct "B Negative" unit of blood to the ED staff for Patient #1's transfusion.

3. During an interview on 1/19/17 at 1:00 PM, Pathologist E (a physician who specialized in interpretation of laboratory tests and provided oversight to the laboratory staff) acknowledged Laboratory Technician D issued the ED staff a unit of "B Positive" blood for Patient #1 instead of the correct "B Negative" blood. Pathologist E stated the error occurred because Laboratory Technician D read the test results from the blood type testing equipment and entered incorrect information into the computer. The computer did not alert the laboratory staff they issued an incorrect unit of blood for Patient #1 because Laboratory Technician D entered the incorrect information into the computer.

Pathologist E instructed the laboratory staff to write the interpretation of the blood type test results on the testing equipment to prevent a recurrence of the error.

4. During an interview on 1/18/17 at 4:00 PM, the Laboratory Manager stated if the laboratory staff only wrote the results of the blood type test on the testing equipment, the laboratory staff could still enter incorrect information about a patient's blood type and potentially not realize the error, allowing another patient to receive an incorrect type of blood.



IV. Based on document review and staff interview, the hospital administrative staff failed to ensure the laboratory staff reported 1 of 1 instance where the laboratory staff issued an unit of blood from the incorrect blood type donor to a patient (Patient #1) into the hospital wide Performance Improvement (PI) program. The hospital administrative staff stated the nursing staff transfused 144 units of blood per month.

Failure to ensure the laboratory staff include all instances of patient safety events into the hospital wide PI program resulted in the PI program not ensuring the laboratory staff took corrective action to prevent another patient from receiving an unit of the incorrect blood type.


Findings Included:

1. Review of the laboratory specific "Erroneous Reported Result Log" from 12/26/16 revealed Laboratory Technician D incorrectly identified Patient #1's blood type as "B Positive" instead of the correct type, "B Negative."

2. Review of the document, "CLINICAL SAFETY COMMITTEE REPORTING MATRIX January-December 2017..." revealed the Laboratory Manager reported information about the laboratory's patient safety measures to the Clinical Safety Committee on January 10, 2017.

3. Review of an undated document revealed the Risk Manager attested the Laboratory Manager failed to inform the Clinical Safety Committee on January 10, 2017 about the incident where Laboratory Technician D issued an unit of the incorrect blood type to Patient #1 for transfusion.

4. During an interview on 1/19/17 at 2:40 PM, the Laboratory Manager stated the laboratory was a contracted service at the hospital. The laboratory staff viewed the error as only affecting the laboratory staff. The Laboratory Manager failed to report the incident to the hospital's PI committee, the Clinical Safety Committee. Instead, the Laboratory Manager only addressed the issue in the contracted laboratory's internal PI program.