The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.
|STANFORD HEALTH CARE||300 PASTEUR DRIVE STANFORD, CA 94305||March 15, 2012|
|VIOLATION: GOVERNING BODY||Tag No: A0043|
|Based on documentation and interview, the governing body failed to effectively provide oversight in regards to transfusion and nursing services. This lack of oversight resulted in the transfusion service staff not implementing policies and procedures for the distribution of blood products (see 482.27). In addition, nursing failed to implement policies and procedures for administering blood products (see 482.23(c)(3)).
The cumulative effect of these systemic problems resulted in the hospital's failure to deliver quality health care in a safe environment.
|VIOLATION: NURSING SERVICES||Tag No: A0385|
|Based on interview and record review, the hospital's nursing service failed to provide the nursing staff with necessary supervision to ensure safe administration of blood and blood products to one of thirteen sampled patients (2).
An immediate jeopardy situation was identified on 2/7/12 at 3:16 p.m. Hospital administrative staff were informed of the immediate jeopardy during a conference and a plan of correction was requested. An acceptable plan of correction was received in the CDPH office by a facsimile report on 2/7/12 at 6:20 p.m. The hospital's immediate corrections included staff inservice regarding blood administration policies and procedures, patient and blood match verification, verification of patient identification for blood pickup labels, and immediate discontinued use of "cubbies" for storage of patient identification labels.
1. The nursing staff failed to administer blood to Patient 2 in accordance with the hospital's policies and procedures for blood component administration. Patient 2, with A positive blood type, received three units of AB type blood that were labeled with another patient's (Patient 1) name.
2. Nurses failed to implement nursing policies and procedures to verify and document blood and blood products matched the patient's identity prior to administration.
3. The emergency department (ED) nursing staff failed to implement the hospital's guidelines for urgent massive blood transfusions in a safe manner.
The cumulative effect of the nursing deficiencies resulted in the nursing services failure to prevent a blood transfusion error in the emergency department (see 423.23(c)(3)).
|VIOLATION: BLOOD TRANSFUSIONS AND IV MEDICATIONS||Tag No: A0409|
|**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**
Based on interview and record review, the nursing staff failed to administer blood to one of thirteen sampled patients (2) in accordance with the hospital's policies and procedures (P&Ps) for blood component administration as follows:
1. Patient 2, with A positive blood type, received three units of incompatible AB type blood that were labeled with Patient 1's name.
2. Nurses failed to implement nursing policies and procedures to identify the patients, and verify and document the blood matched the patient's identity prior to administration of blood and blood products.
3. The emergency department (ED) nursing staff failed to implement the hospital's guidelines for urgent massive blood transfusions in a safe manner.
1. Record review on 2/7/12 indicated Patient 2 arrived in the emergency department (ED) on 1/31/12 at 1:55 p.m. alert and oriented, complaining of pain in the upper abdomen and right shoulder, vomiting, weakness, and difficulty breathing. Patient 2 was [AGE] years old and had a history of heart disease and stroke. According to the ED Transfer Summary received from Administrative Staff A on 2/7/12, Patient 2's blood type was recorded in the medical record on 1/31/12 as A positive.
According to an ED nurse progress note dated 1/31/12 at 6:44 p.m. the hospital massive transfusion guideline (hospital protocol for the urgent delivery of blood and blood compounds to patients) was activated for Patient 2. This occurred around 6:34 p.m. according to the Blood Transfusion RCA 1/31/12 Timeline received by Administrative Staff B on 3/7/12.
The ED physician's note, dated 1/31/12 in the ED Transfer Summary, indicated Patient 2 had a cardiac arrest (heart stopped) and cardiopulmonary resuscitation (CPR, chest compressions to establish a heart rate) was started at 6:28 p.m. The patient received three units of blood at around 6:49 p.m. Patient 2's condition continued to deteriorate, and she expired at 6:59 p.m.
The nursing department policy and procedure for blood and blood component administration (B.50, dated 11/10), reviewed on 2/7/12, instructed the nurse administering the blood product to check the "Medication and Blood Products Transfusion Record" (a transfusion service form which accompanies each unit of blood) against the label on the bag containing the blood product with a second nurse (RN, LVN, NP, PA, or physician) to verify it was the correct unit. The same two nurses would then verify that the patient's identification on the wristband matched the information on the transfusion services product chart copy (same as "Medication and Blood Products Transfusion Record" form), and the blood product. The RN administering the blood product, and the person checking the identification of the patient and the blood product, must both sign the Medication and Blood Products Transfusion Record for each blood product before each transfusion. The hospital laboratory services, also referred to as transfusion services (TS), processed the physician orders for all blood and blood products.
On 2/7/12, review of the transfusion service record dated 1/31/12 indicated the transfusion service issued three units of red blood cells with another patient's (Patient 1) blood type instead of Patient 2's blood type. The hospital records listed Patient 2's blood type as A Positive and Patient 1's was AB. The wrong patient identification label was used to process the request for the massive blood transfusion. A patient identification label included the patient's name, date of birth and medical record number. The transfusion service filled the massive transfusion blood container with blood and blood components incompatible with Patient 2's blood type.
On 2/7/12, registered nurse A (RN A) stated he pulled the patient label from the "cubby hole" (row of slots to store patient labels) designated for Room 1 and brought it to the transfusion service (TS) for processing. He obtained, and transported the massive transfusion container (a TS container used to transport multiple bags of blood) to Patient 2's bedside at about 6:44 p.m. Registered nurse B, at the bedside, failed to perform the required patient and blood type identification check with another nurse before administering the three units of incompatible blood. The verification process would have ensured Patient 2 received the correct blood transfusions and thereby received care under safe conditions.
The assistant nurse manager of the hospital's emergency department (ED) stated on 2/7/12 at 2 p.m. the blood transfusion error occurred because the wrong patient label was used to obtain the blood products, and the nurse administering the blood did not follow the hospital policy and procedures regarding verification of the patient with the blood product prior to administration.
2. On 2/7/12, the medication and blood products transfusion records that accompanied the blood administered to Patient 2 on 1/31/12 were reviewed. The medication and blood products transfusion records lacked the required signatures to indicate the RN administering the blood products, and a second person, checked the identification of the patient with the blood products, before each transfusion.
Review of Patient 1's electronic record on 2/7/12 determined it contained medication and blood products transfusion records for the three blood transfusions that were actually administered to Patient 2. Patient 1 did not have physician orders for blood transfusions on 1/31/12 and did not receive blood transfusions as documented in Patient 1's medical record.
Patient 2's electronic record, reviewed on 2/7/12, indicated Patient 2 received four blood transfusions on 1/31/12 before administration of an additional three blood transfusions of the wrong blood type. Patient 2's record contained copies of the medication and blood products transfusion record for only two of the four initial transfusions. The initial blood transfusion medication and blood products records also lacked the required RN signatures as evidence of patient verification for a match with the blood. The hospital was unable to provide the missing medication and blood products transfusion records for the other two initial transfusions, one unit of blood and one unit of plasma.
The ED nursing staff failed to document the administration of blood products in accordance with the hospital policy and procedure for blood and blood component administration.
3. The massive transfusion guideline (MTG), a protocol for the urgent delivery of blood and blood components to patients was reviewed on 2/7/12. According to the protocol, the MTG was implemented when an attending physician called the transfusion service's licensed medical technologist (charge technologist) with a telephone order for a massive transfusion for a specific patient.
An interview with RN A on 2/7/12 indicated the ED physician did not call in the MTG order, by telephone, to a licensed medical technologist (charge technologist) in the transfusion service laboratory, in accordance with the MTG procedures. Instead, the physician verbally called out the order for MTG in the ER, thereby requesting emergency blood for Patient 2. RN A stated he responded to the physician's verbal order for MTG for Patient 2 by obtaining a patient label from Patient 2's cubby hole [Room 1] and delivered the label to the TS. The patient identification label RN A used belonged to a different patient, but was in the Room 1 cubby hole.
RN A did not accurately identify Patient 2, and failed to follow the MTG protocol when he did not use the call slip (form identified in the P&Ps) which should have been used for blood pick up.
|VIOLATION: LABORATORY SERVICES||Tag No: A0576|
|Based on documentation and interview, the hospital laboratory service failed to meet the needs of its patients by not ensuring policies and procedures, developed to protect patients from transfusion errors, were implemented for 6 of 9 sampled patients (1, 4, 6, 8, 9, and 10). Failure to implement this policy and accompanying procedures limits the efficacy of delivering blood products in a safe manner.
On 3/14/12, transfusion service administrative staff (transfusion service manager and quality manager, Transfusion Service) were interviewed regarding an error in dispensing blood products. According to the hospital's investigation, at approximately 6:34 p.m. on 1/31/12, a Transfusion Service (TS) tech received a telephone call from the emergency room regarding the need for a massive transfusion guide (MTG), a protocol for the urgent delivery of blood and blood components (MTG package) to patients. Simultaneously, a nurse from the emergency department approached the transfusion service door requesting the MTG blood. The Charge TS met the nurse (RN A), and serviced his request for MTG blood without using a telephone order from the requesting physician to verify the patient's information. The TS who took the telephone call, saw the Charge TS with RN A, and terminated the emergency room telephone call, without referring it to the Charge TS.
It was later determined RN A had provided an incorrect patient label (wrong patient) when requesting the MTG blood. The label was given to the Charge TS who began processing the blood with the wrong patient name. RN A brought the MTG package back to the emergency room , and the emergency room nurse (RN B) administered to Patient 2, the blood that had been prepared in error with another patient's name (Patient 1).
On 3/15/12 the hospital's transfusion service policy and procedures were reviewed. The Massive Transfusion Guide (MTG) policy and procedure (SOP POL 7.01) direct staff as follows:
1. The attending physician/MTG leader caring for the patient to notify the Transfusion Service (TS) Charge Tech by phone, identifying the patient being placed on MTG by name, medical record number, date of birth and gender. This verbal order will be documented on the Emergency Phone/Verbal Order Log.
2. Verbal notification will be followed by sending a courier with a SHC OR call slip and/or call slip with physician signature to the TS requesting MTG package. The procedure also referenced the delivery of the MTG package. The procedure indicated that for emergency department only, the TS would deliver the MTG package.
The form titled "emergency transfusion service phone/verbal order log" (ETSP/VOL) was a single patient form that recorded the patient name, medical record number, date of birth, location, ordering physician, contact person, call slip request, contact number, read back (to validate order), product information and TS check list. The form also indicated in bold letters, that all calls must be routed to the Charge Tech with a date and time.
On 3/15/12 nine patient MTG transfusion records were reviewed. Six of the nine records were not complete in accordance with transfusion service policy and procedure.
1. Patient 1, ETSP/VOL dated 1/31/12, was not complete as the correct patient name was not entered, date of birth, contact person, read back and Charge TS check list was not complete. In addition, the Charge TS did not take a telephone call to verify the requested information to obtain the blood.
2. Patient 4, ETSP/VOL dated 2/23/12, had no read back entered.
3. Patient 6, ETSP/VOL dated 1/7/12, no contact number or person entered, no read back, TS checklist incomplete, and MTG was picked up by ED, not delivered by TS.
4. Patient 8, ETSP/VOL dated 2/5/12 and 2/6/12, Charge TS check list not completed
5. Patient 9, ETSP/VOL dated 2/1/12, no date of birth, ordering physician, contact numbers, call slip request, read back, pickup, and Charge TS check list not completed.
6. Patient 10, ETSP/VOL dated 2/12/12, the MTG was picked up by the ED nurse and not delivered by the TS as directed by policy.
Further review of the patient transfusion records indicated that in all ten charts, a "call slip" as referenced in the procedure (SOP PRO 7.01) was not used when obtaining the MTG. There were various forms used as substitutes for call slips, for example, plain paper with a patient sticker attached, and without all of the required call slip entries.
The MTG policy statement indicated, the "purpose of the following guidelines is to provide a guide for efficient and effective procurement and delivery of blood products for trauma and other patients who meet criteria for massive transfusion." "The MTG also serves to standardize laboratory monitoring to aid clinicians in crisis situations."