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Based on review of hospital policy, blood administration annual education documentation, closed medical record review, credentialing file review, quality performance documentation review and staff and physician interviews, the hospital's governing body failed to provide leadership oversight to ensure the needs of patients were met by failing to ensure systems were in place to ensure the safe administration of blood.

The findings include:

1. Nursing staff failed to have an effective nursing service providing oversight of day to day operations to ensure registered nursing staff provided monitoring, supervision and responded to signs and symptoms of potential blood transfusion reactions to patients receiving blood products.

~cross refer to 482.23 Nursing Services Condition: Tag A0385

2. The hospital's governing body failed to ensure contracted services provided by the laboratory medical director were evaluated for provision of effective and safe administration of blood products.

~cross refer to 482.12(e)(1) Governing Body Standard: Tag A0084

Based on credentialing file review, laboratory policy and procedure review, physician and staff interviews, closed medical record review and quality performance documentation review, the hospital's governing body failed to ensure contracted services provided by the laboratory medical director were evaluated for the provision of effective and safe administration of blood products.

The findings include:

Review of the Laboratory Medical Director's credentialing file revealed the medical director was a pathologist who provided services under contract.

Review of the laboratory "Document Control Policy" adopted 01/05/2004 revealed ... "B. All policies and procedures will be approved and authorized by the Laboratory Director, Technical Director and/or Medical Director before implementation. Hard copy approval signatures and/or documentation will be maintained by persons as designated in Part A of this procedure. All policies and procedures will be reviewed annually by the Laboratory Director, Technical Director, Medical Director and/or designee. Documentation of review will be noted for each procedure."
Review of the laboratory policy "Transfusion of Rh Positive Products to Rh Negative Recipients" adopted 12/04/2006 revealed "Policy A. Red Cell Transfusion 1. Rh negative patients should receive Rh negative red cells whenever possible (see BB 1.04 [Blood Bank policy]) except in emergency situations or as directed by available inventory. ...3. Transfusion of Rh incompatible red cells may be required in times of blood product shortages, massive transfusion, or when only Rh positive (antigen negative) red cells for clinically significant antibodies are available.... Further review of the policy "Historical Record" recorded a revision date of 05/15/2009 and revision description of "Removed need to contact Pathologist before switching patient to Rh positive as long as SOP 1.04 (Standard Operating Procedure) is followed (selection of blood products)...." Review revealed the revision was signed by the laboratory manager on 2/01/10 and medical director on 2/4/10.

Review of the Blood Bank policy SOP 1.04 "Selection of Blood and Blood Products" effective 08/01/2004 revealed "...Rh positive patients may receive Rh negative blood, but not vice versa, unless deemed necessary in emergency situation, refer to 'ISSUING BLOOD IN AN EMERGENCY (1.11).' Notify the physician if such action is taken. ...If a different ABO type is used, it should be crossmatch compatible. Rh positive blood should not be used for Rh negative individuals (for exceptions, see SOP 1.11, part A Massive Transfusion Requests)." Review revealed the policy was signed by the laboratory medical director on 07/25/2007. Further review revealed the handwritten statement, "Refer to Blood Conservation Policy for Rh negative patients." Review revealed the statement was initialed by the laboratory manager and dated July 2008.

Review of the laboratory "Blood Conservation Policy" revealed no effective date and no signature of approval by the medical director. Review revealed "Purpose: Rh negative blood is a limited life saving resource. It is the policy of this laboratory and the medical director to reserve Rh negative blood for the population that would be at greatest risk during a life threatening event. Therefore, Rh negative red blood cells are not available to the general population but are reserved for neonates and female patients of child bearing age (<51y/o). Procedure: 1-notify the pathologist in house or on call that you have a non-qualifying Rh negative patient for transfusion. 2-the pathologist will notify the ordering physician...."

Interview on 03/30/2010 at 1310 with the laboratory medical director revealed the "Blood Conservation Policy" was in effect July 2008 through February 4, 2010. Interview revealed the policy was revised due to the lack of supply of Rh negative blood in the hospital's blood bank and the need to administer Rh positive donor blood to Rh negative recipients. Interview revealed the policy change consisted of notification to the pathologist prior to administration of a donor Rh type that was different than the recipients Rh type. The physician stated the pathologist would contact the ordering provider to discuss any concerns prior to administration. The physician stated the reason for the change was because physicians and nursing staff had concerns with blood compatibility. Interview revealed the physician / pathologist had conducted a "lunch and learn" educational session in December 2009 related to "TRALI" (Transfusion Related Acute Lung Injury) to increase nursing staff knowledge related to blood type incompatibility. Interview revealed a policy change was made in February 2010 after the training that eliminated the need to notify the pathologist prior to administration of different Rh types and eliminated the need for the pathologist to contact the ordering physician prior to blood administration of different Rh type. Interview revealed the laboratory maintains 2 units of O negative blood as minimum inventory in the lab blood bank.

Closed medical record review of Patient #1 revealed an 82 year-old female admitted 06/01/2009 for a left knee arthroplasty. Record review revealed the patient expired on 06/20/2009. Record review revealed the patient received 5 units of packed red blood cells, with 3 units administered on 06/02/2009, 1 unit administered on 06/03/2009 and 1 unit administered on 06/05/2009. Review of the lab slip revealed the recipient (patient) was blood type O negative and the donor blood type was O positive for all 5 units of the packed red blood cells. Record review revealed no evidence the pathologist was notified prior to administration of O positive blood type to the O negative patient as indicated in the "Blood Conservation Policy." Record review revealed no evidence the pathologist discussed the blood type with the ordering physician prior to administration of the blood.

Interview on 03/30/2010 at 1310 with the laboratory medical director (pathologist) confirmed the "Blood Conservation Policy" was in effect in June 2009 and he should have been notified by lab staff that the patient was receiving O positive blood. Interview revealed the physician did not recall being notified or contacting the ordering physician about this patient prior to the administration of the blood. The physician stated he could not remember if this had happened or not.

Review of quality performance tracking revealed no evidence of monitoring compliance with this policy change (to notify the pathologist and ordering physician of different donor and recipient Rh types). Review of the quality performance documentation revealed no monitoring related to historical review of availability of O negative blood inventory during June 2009.

Interview on 03/31/2010 at 0930. with the laboratory manager revealed O negative blood type inventory is reviewed daily, but no tracking of inventory is kept for historical review. Interview on 03/31/2010 revealed the Blood Bank current inventory of O negative was 8 units, with 2 units being the minimum number of units available daily. This inventory would support the administration of 6 units of O negative blood to any O negative patient that needed blood. Following the administration of 6 units, 2 units of O negative blood would remain and meet the minimal inventory standard set by the laboratory. Interview revealed there was no system in place to monitor this process for compliance. Interview revealed the lab manager was unable to provide the number of units of O negative blood that was available in inventory on 06/02/2010, 06/03/2010 and 06/05/2010 when Patient #1 received O positive blood.

Based on review of hospital policies and procedures, complaint/grievance files, opened and closed medical records, and staff interviews the facility failed to initiate the grievance process and provide a written response to 1 of 1 complaints/grievance files reviewed (patient #1).

The findings include:

Review on March 29, 2010 of hospital policy titled, Service Recovery (PR 130.02, revised 10/08), revealed "This policy sets forth the procedure for employees to implement service recovery when a customer (a patient and his/her family members, a visitor) presents an unmet need." Policy review revealed "D. 3. Tier Three: Issues... are managed at an Administrative level." Policy review revealed "Medical error" as an example of a tier three issue. Further policy review revealed no clear process of how "unmet needs" transition to "grievances."

Review of hospital policy, Patient Grievance Management Policy (PR 130.01, revised 05/09), revealed, "DEFINITIONS "Patient Grievance" is a written or verbal complaint (when the verbal complaint is about patient care and is not resolved at the time of the complaint by staff present or who can quickly be at the patient's location) by a patient, or the patient's representative... " Policy review revealed "PROCEDURE...7. In the resolution of the patient grievance, the facility administrator will provide the patient with written notice of the decision, the name of the appropriate contact person, the steps taken to investigate, the results of the grievance process, and the date of completion."

Review on March 29, 2010 of hospital document titled, "(name of hospital) Customer Care Report", revealed a complaint issued by the husband of patient #1 regarding events on 06/02/2009 entered in Section I-General Information. Review of the Customer Care Report revealed, "Husband states he feels his wife received the wrong blood for her transfusion on Tuesday, June 2, 2009," entered in Section II-Complaint Information. Further review of the document revealed no reference to written correspondence with the complainant.

Review on March 30, 2010 of the medical record of patient #1 revealed an 82 year-old female admitted on June 1, 2009 for a scheduled left knee arthroplasty (total knee replacement). Patient #1 had a medical history of Rheumatoid Arthritis, Atrial Fibrillation, Carotid Artery Stenosis, Hypertension and Hyperlipidemia. Medical record review revealed the patient, initially stable after knee surgery on 06/01/2009, became hypotensive on 06/02/2009 at 0230 and experienced a respiratory arrest on 06/04/2009 at 2355. Medical record review revealed physician orders dated 06/02/2009 at 0735 to transfuse with 2 units of packed red blood cells. Medical record review revealed Unit #1 started infusing on 06/02/2009 at 1000 and Unit # 2 started infusing on 06/02/2009 at 1410. Medical record review revealed patient's blood type was O Negative and donor blood type of Unit 1 and 2 was O Positive. Medical record revealed physician documentation on 06/05/2009 at 1230 "Addendum: s/w (spoke with) family. They are upset about 1) Blood transfusion of 2 days ago Pt (patient) O - (negative) got O+ blood."

Interview on March 29, 2010 at 0830 with administrative staff revealed a "service recovery report" was filed for patient #1 but was not processed as a grievance. Interview revealed complaint " should have " been handled as a grievance and a written response should have been prepared for the family of patient #1.

Telephone interview on March 31, 2010 at 1600 with family of patient #1 revealed no written communication received from the facility.

Based on review of hospital policy, blood administration annual education documentation, closed medical record review and staff and physician interviews, the hospital's nursing staff failed to have an effective nursing service providing oversight of day to day operations to ensure registered nursing staff provided monitoring, supervision and responded to signs and symptoms of potential blood transfusion reactions to patients receiving blood products.

The findings include:

1. Registered nursing staff failed to administer blood according to the hospital's policy for 6 of 8 sampled patients that received blood transfusions (#1, #2, #5, #7, #6 and #4).

~cross refer to 482.23(c)(3) Nursing Services: Blood Transfusion, Tag A0409

2. Registered nursing staff failed to identify signs and symptoms of a potential blood transfusion reaction and respond according to hospital policy for 2 of 8 sampled patients that received blood transfusions (#1 and #2).

~cross refer to 482.23(c)(3) Nursing Services: Blood Transfusion, Tag A0409

Based on review of hospital policy, blood administration annual education documentation, closed medical record review and staff and physician interviews, the hospital's nursing staff failed to administer blood according to the hospital's policy for 6 of 8 sampled patients that received blood transfusions (#1, #2, #5, #7, #6 and #4); and failed to identify signs and symptoms of a potential blood transfusion reaction and respond according to hospital policy for 2 of 8 sampled patients that received blood transfusions (#1 and #2).

The findings include:

Review of the hospital's "Blood Product Administration" policy revised May 2009 revealed "F.1. Take vital signs in the following sequence: a. 15 minutes before transfusion is initiated as baseline. Licensed person to remain with patient for 15 minutes following initiation of the transfusion. b. Then 15 minutes after starting the transfusion. Observe the patient periodically during the transfusion. c. One hour into the transfusion. d. Then every hour. e. At the end of the transfusion. f. 30 minutes after the transfusion. NOTE: The sequence of vital signs is used for each unit. .... 2.m. If any signs/symptoms of a reaction occur, stop blood product immediately, notify the physician, and complete the form "Investigation of Suspected Blood Transfusion Reaction" and forward to the laboratory. Signs and symptoms include: chills, fever, headache, nausea, nonproductive cough, hypotension, chest pain, dyspnea, vomiting, asthma symptoms, facial swelling, cyanosis, pulmonary edema, diarrhea, diffuse bleeding, urticaria, itching, shock, renal failure, hemoglobinuria. n. Each unit of blood shall be infused within four hours."

Review of the "Blood Product Transfusion Reactions" policy reviewed/revised October 2008 revealed "I. Known or suspected blood transfusion reactions shall be reported. ...IV. NOTE POSSIBLE SYMPTOMS OF BLOOD TRANSFUSION REACTIONS (not all inclusive:) ...Febrile, non-hemolytic Temperature elevation (equal to or greater than) 1.8 degrees F (Farenheit) during the transfusion and up to one hour post transfusion. ...VI. Intervention A. Stop the transfusion and inform the physician that a transfusion reaction is suspected. B. Obtain order to either continue or discontinue the blood transfusion. 1. Transfusion may be continued if the only symptom is hives. 2. If the transfusion is discontinued, obtain order for transfusion reaction workup. C. Complete Investigation of Suspected Transfusion Reaction Form any time a transfusion reaction is suspected. D. Inform Blood Bank of reaction/suspected reaction. E. Collect specimens as indicated on Transfusion Reaction Form. F. Send blood bag, blood requisition, IV (intravenous) set and fluids to Blood Bank with the completed Transfusion Reaction Form. VII. Documentation A. Time of reaction. B. Whether or not transfusion was discontinued. C. Patient's vital signs before and after transfusion. E. Lab work obtained. F. MD notified."

Review of annual nursing education related to blood administration provided 2009 revealed "Take TPR and BP (temperature, pulse, respirations and blood pressure) in the following sequence: 1. 15 minutes before transfusion is initiated as baseline: 2. Then 15 minutes after starting the transfusion: 3. One hour into the transfusion: 4. Then every hour: 5. At the end of the transfusion: 6. 30 minutes after the transfusion."

1. Review of the closed medical record of patient #1 revealed an 82 year-old female admitted on June 1, 2009 for a scheduled left knee arthroplasty (total knee replacement). Medical record review revealed a medical history of Rheumatoid Arthritis, Atrial Fibrillation, Carotid Artery Stenosis, Hypertension and Hyperlipidemia. Medical record review revealed the patient, initially stable after knee surgery on 6/1/09, became hypotensive on 06/02/2009 at 0230. Medical record review revealed physician orders dated 06/02/2009 at 0735 to transfuse with two units of packed red blood cells (PRBC). Medical record review revealed infusion of Unit #1 on 06/02/2009 from 1000-1255 with vital signs monitored according to policy and no transfusion reaction noted. Medical record review revealed physician orders dated 06/02/2009 at 1415 to discontinue PCA (Patient Controlled Analgesia) Pump, hold hypertension medications and diuretics, give additional IV (Intravenous) fluid, and "okay to give 2nd unit of PRBC." Medical record review revealed infusion of Unit #2 on 06/02/2009 from 1410-1715. Medical record review revealed vital signs (temperature, pulse, respirations and blood pressure) were monitored. Medical record review revealed patient's temperatures were 98.2?F (degrees Fahrenheit) at 1420, 97.6?F at 1520, 99.8?F at 1620, 99.3?F at 1720, and 100.3 ?F at 1750. Medical record review revealed a 2.1?F (98.2 - 100.3) increase in temperature 35 minutes after completion of Unit #2. Medical record review revealed physician documented on 6/2/2009 at 1540 "Notified by RN of low BP." Medical record review revealed no documentation of physician notification of patient's temperature increase to 100.3 ?F after completion of second unit of blood. Medical record review revealed no documentation of a transfusion reaction and no notification of blood bank staff of potential transfusion reaction.

Medical record review revealed the patient received two additional transfusions of PRBC as ordered by the physician on 06/02/2009 at 1945, Units #3 & #4. Medical record review revealed transfusion of Unit #3 began on 06/02/2009 at 2245 and ended on 06/03/2009 at 0230. Medical record review revealed no documented temperatures on 06/03/09 at 0100, 0200 or 0230 or 0300, hourly during the transfusion, at end and 30 minutes after completion. Medical record review revealed transfusion of Unit #4 began on 06/03/10 at 0400 and ended at 0605. Medical record review revealed no documented temperatures on 06/03/2010 at 0400, 0415, 0600 or 0735, prior to starting, 15 minutes after start, hourly during the transfusion, at end, and 30 minutes after completion .

Consequently, medical record review revealed a temperature elevation greater than 1.8 ?F, during the transfusion of Unit #2, was not reported to the physician and documentation of temperatures were not recorded hourly during, at end, and 30 minutes after completion of transfusion for Units #3 and #4 according to policy and procedures.

Interview on 03/31/2010 at 1250 with nurse monitoring patient #1 during infusion of Unit #2 revealed "main focus" was patient's low blood pressure and "...this was a very ill patient on a general floor." Interview revealed that nurse communicated vital signs to the physician at 1354 and 1945 but not at the time of the temperature increase to 100.3?F. Interview revealed that for temperature elevations equal to or greater than 1.8 ?F, 30 minutes after completion of transfusion, the bag and tubing should be sent to the blood bank, a blood reaction form completed, and the physician notified. The interview confirmed a transfusion reaction work-up was not completed.

Telephone interview on 03/31/2010 at 1515 with the physician caring for patient #1 during the transfusion of Unit #2 revealed the physician did not remember if the nurse notified her/him of the patient's temperature increase to 100.3?F.









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2. Closed medical record review of Patient #2 revealed a 54 year-old female admitted 05/28/2009 with worsening shortness of breath and a chronic cough. Record review revealed the patient was discharged on 06/09/2009. Record review revealed the patient received 2 units of packed red blood cells (PRBC) on 06/03/2009. Review of lab blood slip documentation revealed the first unit of blood was started at 1140 and ended at 1430. Review of vital sign (VS) documentation revealed temperature, pulse, respirations and blood pressure (TPR and BP) were done at 0600 with the next VS recorded at 1140 (time of start of blood administration). Record review revealed no documentation of TPR and BP (baseline VS) 15 minutes prior to the start of the transfusion. Review of the patient's VS at 1140 (start of transfusion) revealed a temperature of 98 degrees Farenheit and a blood pressure of 124/67. Further review revealed the next VS were documented at 1200 (20 minutes after the blood was started). VS were recorded hourly through 1415. Review of the patient's VS at 1415 revealed a temperature of 99.8 degrees Farenheit (increased 1.8 degrees since start of blood transfusion) and a blood pressure of 142/75 (change in BP from start of blood transfusion). Review of the record revealed no evidence of a response to these changes. Review revealed no notification to the physician of a possible transfusion reaction. Record review revealed the first unit of blood ended at 1430 and the second unit of blood was started at 1430. Record review revealed the next set of VS were recorded at 1530 (1 hour and 15 minutes after the last VS were recorded). Review revealed no VS were documented at the end of the first unit of blood or 30 minutes after the first unit was completed. Review revealed no evidence VS were monitored 15 minutes after the start of the second unit of blood. Review of the VS at 1530 revealed the patient had a temperature of 99 degrees Farenheit and blood pressure of 187/109 (significant increase in BP). Record review revealed no recheck of the patient's BP was recorded and no evidence that the physician was notified of the changes in the patient's VS. Record review revealed the next VS were recorded at 1615 and 1704. Review of the record revealed a temperature at 1704 of 100 degrees Farenheit (2 degree increase since start of blood administration). Review of the record revealed no evidence of a response to the increase in temperature. Review revealed no notification to the physician of a possible transfusion reaction. Record review revealed the second unit of blood was completed and ended at 1725 with the next set of VS recorded at 2140 (4 hours and 36 minutes after the transfusion ended). Review revealed no evidence VS were monitored at the end of the second transfusion and 30 minutes after the completion.

Interview with nursing administrative staff on 03/31/2010 at 1740 confirmed the findings. Interview revealed the patient's vital signs were not monitored according to the hospital's policy and there were gaps in the monitoring. Interview revealed the hospital's blood administration policy did not define parameters for blood pressure changes, but that changes in the patient's blood pressure should be considered as a potential transfusion reaction. Interview confirmed that the patient's temperature increased 1.8 to 2 degrees after the baseline temperature at the start of the transfusion and that the policy states that a 1.8 degrees or greater increase would be considered a potential transfusion reaction. The interview revealed that there was no evidence of a response to the changes in the patient's VS. The interview confirmed there was no evidence the physician was notified or the blood was stopped. Interview confirmed no transfusion reaction workup was done.

Consequently, nursing staff failed to follow the hospital's blood administration and transfusion reaction policies by failing to monitor the patient's VS according to the policy and failing to identify a potential transfusion reaction. Nursing staff failed to stop the blood administration at the time of an increase in temperature and failed to notify the physician of a potential reaction.

3. Closed medical record review of Patient #5 revealed a 71 year-old female admitted 08/15/2009 with urinary retention and hematuria (blood in the urine). Record review revealed the patient was discharged 08/24/2009. Record review revealed the patient received four units of packed red blood cells (PRBC) with the first unit started on 08/16/2009 at 1435 and ended at 1845 (infusing 4 hours and 10 minutes). Record review revealed the VS were recorded at 1400 (35 minutes prior to starting the blood), 15 minutes after starting the blood and hourly during the administration with a set of VS recorded at 1750. Record review revealed the transfusion ended at 1845 with the next set of VS recorded at 1918. Record review revealed no VS recorded at the completion of the first unit of blood. Record review revealed the second unit of blood was started at 2040 with no VS taken since 1918 (1 hour and 22 minutes prior to the start of the transfusion). Record review revealed VS were recorded at 15 minutes after the transfusion and hourly. Review of nursing notes revealed the patient had an increased respiratory rate of 26 and increased BP of 168/100 at 2210. Review revealed the physician was notified and the transfusion was stopped at 2220. Review revealed a transfusion reaction workup was completed. Further review revealed a third unit of blood was started on 08/18/2009 at 2130. Record review revealed a baseline temperature at 2115 of 99.4 degrees Farenheit. Review revealed TPR and BP were recorded at 2145. Record review revealed no temperature recorded at 2200 (hourly VS). Review revealed the third unit of blood ended on 08/19/2009 at 0015 and the fourth unit of blood was started at 1505. Record review revealed a temperature of 100.1 Farenheit was recorded at 0800 (7 hours and 5 minutes before the blood was started) and pulse, respirations and blood pressure were recorded at 1400 (1 hour and 5 minutes prior to starting the blood). Record review revealed VS were taken at 1505 when the blood was started, 15 minutes after the blood was started and hourly during the administration. Record review revealed the blood was completed at 1725 with VS recorded at 1730. Record review revealed the next VS were recorded at 1900 (1 hour and 30 minutes after the blood ended). Record review revealed no VS recorded 30 minutes after the blood ended.

Interview with nursing administrative staff on 03/31/2010 at 1740 revealed the patient's vital signs were not monitored according to the hospital's policy and there were gaps in the monitoring. Interview confirmed the first unit of blood should have been discarded four hours after removal from the blood bank and was not. Interview confirmed nursing staff failed to follow the hospital's blood administration policy.

4. Closed medical record review of Patient #7 revealed a 71 year-old female admitted 09/13/2009 with acute blood loss anemia, etiology not known. Record review revealed the patient had a upper endoscopy and colonoscopy and was discharged on 09/17/2009. Record review revealed the patient received a unit of packed red blood cells (PRBC) on 09/13/2009 that started at 1625 and ended at 2100 (4 hours and 35 minutes after starting). Review of documentation of the patient's vital signs revealed TPR (temperature, pulse and respirations) and BP (blood pressure) were recorded at 1530 (55 minutes before the transfusion started), 1629 (4 minutes after the transfusion started) and BP only (no temperature, pulse or respirations) at 1646 (21 minutes after the transfusion started). Record review revealed the first recording of temperature after the blood was started was at 1816 (1 hour and 51 minutes after start and 1 hour and 30 minutes since prior temperature done). Further review revealed a blood pressure recorded at 1900 with no hourly temperature recorded. The next TPR and BP were recorded at 2000 (1 hour and 44 minutes since prior temperature check done), 2100 and 2130. Record review revealed a second unit of PRBC was started on 09/13/2009 at 2215 and ended on 09/14/2009 at 0000. Record review revealed no TPR and BP were recorded at 0000 when the unit was stopped. Review revealed a fourth unit of PRBC was started on 09/15/2009 at 1330 and ended at 1630. Record review revealed VS were recorded at 1230 (1 hour prior to the start of the fourth unit) and at 1330 when the unit was started. Review of the hourly VS revealed VS were recorded at 1429 with the next VS at 1545 (1 hour and 46 minutes since prior VS). Record review revealed the fourth unit of blood ended at 1630. The next VS were recorded at 1900 (3 hours and 15 minutes after the unit ended). Record review revealed no temperature, pulse, respirations or blood pressure were recorded at 1630 when the unit ended or 30 minutes after the completion of the blood.

Interview on 03/31/2010 at 1730 with nursing administrative staff revealed blood should not be allowed to continue to hang after four hours and should be discarded if the unit has not been completed. Interview with the staff member confirmed Patient#7's first unit of blood was allowed to continue infusing greater than four hours conflicting with the hospital's policy. Interview further revealed the patient's vital signs were not monitored according to the hospital's policy. The staff member confirmed there was no evidence that temperature, pulse, respirations and blood pressure were taken 15 minutes before the first unit of blood was started, 15 minutes after the first unit of blood was started, hourly during the first and fourth units of blood, at the conclusion of the second and fourth units of blood and 30 minutes after the conclusion of the fourth unit of blood. Interview confirmed nursing staff failed to monitor the patient according to the hospital's policy.



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5. Closed medical record review of Patient #4 revealed a 46 year-old female admitted 12/25/2009 with acute pancreatitis / DKA (diabetic ketoacidosis), agitation, confusion, vomiting and abdominal pain. Record review revealed the patient had an upper endoscopy and was discharged on 01/02/2010. Record review revealed the patient received a unit of packed red blood cells (PRBC) on 01/01/2010 that started at 1450 and ended at 1710. Review of documentation of the patient's vital signs revealed TPR (temperature, pulse and respirations) and BP (blood pressure) were recorded at 1446 (4 minutes before the transfusion started), 1505 (15 minutes after the transfusion started), 1650 (60 minutes after the transfusion started), 1710 (when the transfusion was stopped), 1729 (18 minutes after the transfusion was stopped), and 1750 (40 minutes after the transfusion was stopped). Record review revealed no documentation of vital signs 15 minutes before the blood transfusion was started, 1 hour after the blood was started and 30 minutes after the blood transfusion was completed. Record review revealed a second unit of PRBC was started on 01/01/2010 at 1735 and ended on 01/01/2010 at 1953. Review of documentation of the patient's vital signs revealed TPR (temperature, pulse and respirations) and BP (blood pressure) were recorded at 1729 (6 minutes before the transfusion started), 1750 (15 minutes after the transfusion started), 1835 (60 minutes after the transfusion started), 1850 (15 minutes after the previous reading of vitals signs), and then 2303 (4 hours 10 minutes after the transfusion was stopped). Record review revealed no documentation of vital signs 15 minutes before the blood transfusion was started, at the end of the transfusion and 30 minutes after the blood transfusion was completed.

Interview on 03/31/2010 at 1730 with nursing administrative staff confirmed there was no evidence that the patient's vital signs were monitored 15 minutes prior to starting the blood transfusions, 1 hour after starting the blood transfusion for Unit #1, at the end of the transfusion of Unit #2 and 30 minutes after the completion of the transfusions for Unit #1 and #2. Interview confirmed nursing staff failed to monitor the patient according to the hospital's policy.

6. Review of the closed medical record of patient #6 revealed a 66 year-old male admitted on 09/21/09 - 09/23/09 with a diagnosis of diverticulitis of colon with hemorrhage. Medical record review revealed the patient received a transfusion of 1 Unit of Fresh Frozen Plasma (FFP) as the physician ordered. Medical record review of the blood bank lab slip revealed the transfusion started on 09/22/09 at 2120 and was completed on 9/22/09 at 2240. Medical record review revealed no documentation of patient's temperature 30 minutes after the transfusion was complete.

Interview on 03/30/2009 at 1420 with nursing staff, during computer charting review, revealed that for patient #6 the temperature 30 minutes after transfusions end was not recorded. Interview confirmed nursing staff failed to monitor the patient according to the hospital's blood administration policy.