HospitalInspections.org

Based on record review and staff interview, the hospital failed to ensure that patients seen at the hospital's offsite outpatient ambulatory clinics were informed of their patient's rights prior to services being provided for 4 of 4 sampled patients seen at these clinics (#39, 40, 41, and 42). This failed practice could lead to patients being seen at outpatient clinics not knowing of their rights. The findings are:

A. Review of the clinical records of Patient #39, 40, 41, and 42 revealed no evidence that they were informed of their patient's rights prior to services rendered to the patients.

B. During the following times, an interview with the different Clinic Directors was completed on 04/25/12 to confirm that the patient's rights document was not being offered to the patients prior to being seen by the providers:
1. At 10:30 am, the Clinic Director at an outpatient facility confirmed that there was no evidence that a patient's rights document was being offered to the patients. When asked, she stated that she did think that patients were being offered the patient's rights document before services were provided to the patients.
2. At 11:30 am, the Clinic Director at another outpatient facility confirmed that there was no evidence that a patient's rights document was being offered to the patients. When asked, she stated that she did think that patients were being offered the patient's rights document before services were provided to the patients.
3. At 12:15 pm, the Clinic Director at a third outpatient facility confirmed that there was no evidence that a patient's rights document was being offered to the patients. When asked, she stated that she did think that patients were being offered patient's rights document before services were provided to the patients.

C. At 12:00 pm, when the Intake Clerk at an outpatient facility was asked to locate the Patient's Rights information form, she was unable to do so.

Based on record review, medical staff policy, contracted laboratory policy and procedures and staff interviews, the hospital failed to ensure that anesthesia and nursing staff personnel completed blood transfusion records in accordance with the facility's policy and procedures for 7 of 10 sampled patients who received blood products in the last six months (Patient #12, 28, 29, 30, 34, 35 and 36). As a result of this deficient practice, the facility may not be able to promptly identify, investigate and report potential blood and blood product transfusion reactions or any other life threatening complications that may occur during and after receiving a blood product. The findings are:

A. Review of Patient #12's medical record revealed that on 11/27/11, Patient #12 presented for routine induction of labor. Due to some fetal heart rate decelerations and given the potential problems with the fetus, the patient was subsequently taken for an urgent cesarean section. The cesarean section went according to plan and the patient was taken to the recovery room, at which time she was noted to have some type of seizure episode. Following the seizure the patient subsequently went into cardiopulmonary arrest requiring resuscitation at that time. The patient was noted to have abnormal lab values consistent with disseminated intravascular coagulopathy (DIC - a condition in which there is a problem with the blood to clot normally). The patient was transferred to the surgical intensive care unit for close observation. The decision was made early in the morning to take her back to the operating room for a total abdominal hysterectomy. Following the hysterectomy, the general surgery/trauma department was consulted to evaluate the patient's intraabdominal bleeding given her significant coagulopathy. The general surgeons performed an exploratory laparotomy, which revealed no significant surgical bleeding, but did reveal medical bleeding which was all consistent with the patient's picture of DIC. During the course of Patient #12's hospitalization, she received 21 units of packed red blood cells (PRBC), 17 units of fresh frozen plasma (FFP), 6 units of cryoprecipitate and 5 units of platelets. The facility's Transfusion Tag documentation revealed the following:
1. For 11 out of 21 units of PRBC given, the required documentation was incomplete. Missing elements included the date the transfusion was given, the start and end times of the transfusion, the printed names of the two licensed personnel (under their signatures, which were illegible), the quantity of the blood product that was given (either being all, 1/4, 1/2 and 3/4 of the units), and a completed "Transfusion Reaction" section.
a. For 5 out of 5 units of PRBC retrieved from the blood storage refrigerator, the required documentation was incomplete. Missing elements included a completed "date of transfusion" section, the start and end times of the transfusion, a completed "transfusion reaction" section, and the quantity of the blood that was given. The printed compatibility label was not attached to the donor unit transfusion form for unit W041211058315 (which includes the first and last name of the patient, medical record number, patient group of blood, donor number, donor group of blood and the date and time the blood was removed from the refrigerator). There was no documentation of the expiration date of the blood for the units that had been retrieved out of the blood storage refrigerator.
2. For 12 out of 17 units of FFP given, the required documentation was incomplete. Missing elements were either the start and end times of the transfusion, or the printed names of the two licensed personnel (under their signatures, which were illegible), the quantity of the blood product that was given (either being all, 1/4, 1/2 or 3/4 of the units), or a notation as to whether the patient had a transfusion reaction.
3. For 2 out of 6 units of cryoprecipitate given, the required documentation was incomplete. Missing elements were either the start and end times of the transfusion, or the printed names of the two licensed personnel (under their signatures, which were illegible), the quantity of the blood product that was given (either being all, 1/4, 1/2 or 3/4 of the units), or a notation as to whether the patient had a transfusion reaction.
4. For 4 out of 5 units of platelets given, the required documentation was incomplete. Missing elements were either the start and end times of the transfusion, or the printed names of the two licensed personnel (under their signatures, which were illegible), the quantity of the blood product that was given (either being all, 1/4, 1/2 or 3/4 of the units), or a notation as to whether the patient had a transfusion reaction.

B. Review of Patient #28's medical record revealed that during the course of his hospital stay, the patient received 7 units of FFP, 4 units of platelets and 1 unit of PRBC. The facility's Transfusion Tag documentation revealed the following:
1. For 1 out of 7 units of FFP given, the required information indicating whether the patient had a blood transfusion reaction was not written on the Transfusion Tag.
2. For 1 out of 4 units of platelets given, the required documentation was incomplete. Either the quantity of blood product that was given was not indicated or a notation was missing on the Transfusion Tag as to whether the patient had a blood transfusion reaction.

C. Review of Patient #29's medical record revealed that during the course of his hospital stay, the patient received 34 units of FFP. The facility's Transfusion Tag documentation revealed the following:
1. For 1 out of 34 units of FFP given, the required documentation was incomplete. Either the quantity of blood product that was given was not indicated or a notation was missing on the Transfusion Tag as to whether the patient had a blood transfusion reaction.

D. Review of Patient #30's medical record revealed that during the course of his hospital stay, the patient received 1 unit of platelets, 10 units of FFP and 20 units of PRBC. The facility's Transfusion Tag documentation revealed the following:
1. For 10 out of 10 units of FFP given, the required documentation was incomplete. Either there was no specific time indicated, or the end time of the transfusion was recorded as "OR" (operating room), or the printed name of one of the licensed personnel was not documented, or the quantity of the blood product that was given was not indicated on the Transfusion Tag.
2. For 20 out of 20 units of PRBC given, the required documentation was incomplete. Either the end time of the transfusion was recorded as "OR" (operating room), or the recorded end time of the transfusion was not indicated. Missing elements of each record included the date of the transfusion, the start and end time of the transfusion, the printed name of one of the licensed personnel, a notation as to whether the patient had a blood transfusion reaction, and an indication on the Transfusion Tag of the quantity of the blood product that was given.

E. Review of Patient #34's medical record revealed that during the course of his hospital stay, the patient received 45 units of FFP, 23 units of platelets and 12 units of PRBC. The facility's Transfusion Tag documentation revealed the following:
1. For 12 out of 45 units of FFP given, the required documentation was incomplete. Missing elements were the date of the transfusion, the start and end time of the transfusion, the amount of blood product that was given, the signatures and printed names of the two licensed personnel, and a notation on the Transfusion Tags as to whether the patient had a blood transfusion reaction.
2. For 8 out of 23 units of platelets given, the required documentation was incomplete. Missing elements were included the date of the transfusion, the quantity of blood product that was given, the signature and printed name of the transfusionist, the completion time of the blood transfusion, and a notation as to whether the patient had a blood transfusion reaction.
3. For 6 out of 12 units of PRBC given, the required documentation was incomplete. Missing elements included the printed compatibility label that should have been attached to the donor unit transfusion form (which includes the first and last name of the patient, medical record number, patient group of blood, donor number, donor group of blood and the date and time the blood was removed from the refrigerator), the quantity of the blood product that was given, the printed name of the transfusionist, the completion time of the blood transfusion, and a notation on the Transfusion Tags as to whether the patient had a transfusion reaction.

F. Review of Patient #35's medical record revealed that during the course of her hospital stay, the patient received 8 units of FFP and 4 units of PRBC. The facility's Transfusion Tag documentation revealed the following:
1. For 1 out of 8 units of FFP given, the required documentation was incomplete. This included the completion time of the blood transfusion.
2. For 1 out of 4 units of PRBC given, the required documentation was incomplete. This unit of blood had been retrieved out of the blood storage refrigerator. There was no indication of the expiration date of the blood. According to the facility policy, this information should have been included on the donor unit. The date that the unit of uncrossmatched blood was signed by the physician was not indicated.

G. Review of Patient #36's medical record revealed that during the course of her hospital stay, the patient received 3 units of PRBC. The facility's Transfusion Tag documentation revealed the following:
1. For 3 out of 3 units of PRBC given, the required documentation was incomplete. Missing elements included the date that the unit of uncrossmatched blood was signed by the physician, the printed name of the second licensed clinician, the quantity of blood that the patient was given, and a notation as to whether the patient had a blood transfusion reaction.
a. For 2 out of 3 units of PRBC that were retrieved out of the blood storage refrigerator, there was no indication of the expiration date of the blood. According to the facility policy, this information should be included on the donor unit.

H. Review of the medical staff policy titled "Transfusion of Blood or Blood Products," effective date 12/20/11, revealed the following:
"Administration...two licensed personnel should then check the blood product against the practitioner's order. Check the name of the blood product, the blood type, blood unit number and expiration date on the blood product container against the same information on the blood product slip. The information must be identical. If it is not, return the blood to the blood bank immediately...Two licensed personnel are required for verification of the patient's name and medical record number on their patient identification bracelet against the name and medical record number of the patient on the blood product slip. The information must be identical...Once all information has been verified, both licensed personnel will sign the blood product slip and the slip should remain on the bag until the blood has been infused...Documentation of blood product administration should at minimum contain the following elements...Patient identification and blood product verification. Date/time the administration began and ended...Type of blood product administered. Amount of blood product administered..Occurrence of transfusion-related complications and interventions taken...
Special Considerations. Blood Transfusion of Uncrossmatched Blood...An attending Licensed Independent Practitioner (LIP) must sign the blood slip form in the section, 'I request the blood be made available before completion of compatibility testing.' The patient's label is placed on all sections of the requisition. The RN, GN, or LIP administering the blood must sign in the transfusionist section with the time started and ended."

I. Review of the contracted laboratory's policy titled "Issuing Products," effective 04/06/12, revealed the following: "If time permits during these [life-threatening] situations, have a 2nd blood bank employee double check to make sure the unit number, component...and expiration date on transfusion tag matches unit number, component and expiration date on component bag. This employee will initial the transfusion tag by the unit number and expiration date."

J. On 04/23/12 at 11:40 am, during interview, the Blood Bank Medical Director confirmed that the Transfusion Tags for Patient #'s 12, 28, 29, 30, 34, 35 and 36 were not completed according to medical staff facility and the contracted laboratory's policy and procedures. The Blood Bank Medical Director stated that sometimes the lab does not even have the Transfusion Tags because they may get soiled with blood, etc. She further stated, "The slips [Transfusion Tags] are dinosaurs. We [the facility staff members] have been using them since the 1980's." She also stated that the expiration dates for the blood units that are kept in the blood storage refrigerator are on the units of blood and are not located on the labels.

K. On 04/25/12 at 3:50 pm, during interview, the Medical Director of the Anesthesia Department reviewed the Transfusion Tags that were issued for the patients in the operating room stated that the illegible signatures of the transfusionists [who are the Anesthesiologists] are "very sloppy and unacceptable. We [the anesthesiologists] are busy hanging the blood. We are guilty of not completing the blood slips. We are pretty good at writing down the start time the blood transfusion began but not good at writing down when the blood is completed. We are writing that information on the anesthesia record." The Medical Director of the Anesthesia Department confirmed that there was no policy or procedure that specifically addresses how the blood is given in the anesthesia department.