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Based on record review and staff interview,the Hospital failed to ensure that one of one applicable Patients (A) was provided care in a safe setting. The Labor and Delivery staff failed to conduct sponge count according to safe practice and hospital policy in November 2010.

The findings are as follow:

Complaint #10-1532

It was reported eight days following a vaginal delivery, Patient A complained of vaginal odor in November 2010. Patient A was examined by a nurse mid-wife in a clinic, whereby a retained sponge was found in the vaginal cavity. It was reported Nurse Mid-Wife #1 did not inform the Labor & Delivery (L&D)Nurse #1 the sponge had been inserted to control bleeding after the episiotomy repair.

It was reported to the Department, the Labor and Delivery Room was set up by a surgical scrub technician and the initial count of the sponges, instruments and needles were counted by the surgical scrub technician on the day of Patient A's delivery. However, review of the personnel file for the surgical scrub technician, as identified by the Hospital indicated the individual was hired as the unit secretary. The personnel file for the unit secretary lacked any documentation of training and/or credentials to conduct surgical count of sponges, instruments or needles.

The Unit Secretary was interviewed in person on 12/07/10 at 1:36 PM. The Unit Secretary said on the day of the incident, the Unit Secretary did count with a mentor surgical scrub technician. The Unit Secretary said it was the fourth or fifth time the secretary had done sponge count. The Unit Secretary was allowed to cross train without any evidence of employment/hire for the position or appropriate orientation for the position of a labor and delivery room technician. The Unit Secretary said the kit was opened and count was done outside of Patient A's room. The Unit Secretary said the sponges were packed in sets of five. The Unit Secretary said when the kit was set up, then a blanket was placed over the kit and brought into Patient A's room. The Unit Secretary said the count slip was placed on top of the delivery kit. The Unit Secretary signed the count sheet that the initial count was done. The Unit Secretary said there was no contact with the Patient or the Labor & Delivery Room Nurse.

The Hospital's Risk Manager accompanied the Surveyor during the two days of survey. The Hospital's Risk Manager was unaware the Unit Secretary had conducted the intitial count prior to Patient A's delivery. The Hospital's Risk Manager said the Director of Maternal and Child Health and Obstetrical Manager informed the Hospital's Risk Manager the intitial count was done by a surgical scrub technician.

The Director of Maternal and Child Health was interviewed in person on 12/07/10 at 2 PM. The Director of Maternal and Child Health said the Unit Secretary started orientation on the day of the incident. The Director of Maternal and Child Health said on the day of the incident, it was the first time the Unit Secretary had participated in sponge count and setting up the delivery tray. The Director of Maternal and Child Health said there was no specific policy directing the staff in labor and delivery for the specific requirement that count be done by two(qualified) persons.

Review of the Hospital's Policy for Surgical Count indicated all vaginal deliveries, the physician and primary nurse will do the sponge count together and the results will be documented on the delivery flow sheet. The Hospital's Policy did not address the function of mid-level practitioners in the labor and delivery area.

During the course of the survey, the Unit Secretary said a surgical scrub technician was mentoring the Unit Secretary.

Surgical Scrub Technician/Labor & Delivery Technician #2 was interviewed in person on 12/08/10 at 2 PM. Surgical Scrub Technician #2 said it was the first day of training for the Unit Secretary. Surgical Technician #2 said there was no contact with the Patient or the Labor & Delivery Nurse unless the patient was going to have a C-Section. Surgical Scrub Technician #2 said on the day of Patient A's delivery both went into Patient A to request permission to participate in the delivery. Surgical Scrub Technician #2 said the Unit Secretary was supervised in setting up the tray in Patient A' room. Surgical Scrub Technician #2 said the count sheet was not signed because the count was done by the Unit Secretary. Surgical Scrub Technician #2 contradicted the statement of the Unit Secretary.

Labor & Delivery Nurse #1 was interviewed in person on 12/07/10 at 11:50 AM. Labor & Delivery Nurse #1 was assigned to Patient A when Patient A went into active labor. Labor & Delivery Nurse #1 said the table had been previously set up and sponges were usually laid out in sets of ten. Labor & Delivery Nurse #1 said Nurse Mid-Wife #1 reached for the items that were needed. Labor & Delivery Nurse #1said final count was done with Nurse Mid-Wife #1 but count was not always done together. Labor & Delivery Nurse #2 signed the final count was correct.

Nurse Mid-Wife #1 was interviewed in person on 12/07/10 at 10:37 AM. Nurse Mid-Wife #1 said count of the sponges was done in stacks of five prior to delivery. Nurse Mid-Wife #1 said a sponge was placed in the vaginal cavity to control bleeding, after the vaginal repair was done. Nurse Mid-Wife #1 said the sponge should have been removed. Nurse Mid-Wife #1 said count was done independently and not with the Labor & Delivery Nurse (#1).

The Hospital failed to ensure that qualified, trained individuals were assigned to care of the patient. The Hospital failed to ensure that the patient recieved care in a safe setting.

Based on record review and staff interview, the nursing staff failed to ensure appropriate policies and procedures were followed to prevent the infusion of an inccorect blood product to one of one applicable Patients (B) in November 2010.

The findings are as follow:

Complaint #10-1533

Patient B was hospitalized for elective surgery. Patient B had a complicated medical history.

Review of the written Physicians Order dated 11/21/10 at 8 AM indicated a unit of platelets was to be administered to Patient B. Registered Nurse (RN) #1 notified the Blood Bank by telephone. Registered Nurse #1 signed the written Physician's order sheet that the unit of platelets had been transcribed. However, Registered Nurse #1 failed to electronically enter the order for the unit of platelets. Instead, the new order for the transfusion of platelets was entered electronically as a nursing task similar to a nursing care plan intervention for the assigned nurse.

Registered Nurse #1 was interviewed in person on 12/07/10 at 2:34 PM. RN #1 was in charge on the unit where Patient B initially resided. RN #1 said that ordinarily the orders were noted by the unit secretary. RN #1 said there was no unit secretary working on that day. RN #1 called the Blood Bank and requested the unit of platelets for Patient B. RN #1 said ordering platelets may be time consuming because platelets were not stored in the Blood Bank. RN #1 said Patient B's condition had deteriorated. Registered Nurse #1 said Patient B complained of chest pain needed intravenous access. RN #1 said before transferring Patient B to the intermediate care unit (B), a percutaneous intravenous central catheter was inserted by the Intravenous Nurse. RN #1 said Patient B was transferred at approximately 2 PM. RN #1 said the pending platelet transfusion was documented in a nursing progress note and verbally communicated at the time of Patient B's transfer.

Continued review of Patient B's medical record indicated between 2 PM and 2:45 PM, Patient B was transferred to the Intermediate Care Unit for continued management for the complaint of chest pain.

The Director of the Blood Bank and the Blood Bank Supervisor were interviewed in person on 12/08/10 at 9:33 AM and 10:15 AM respectively. Both said a call was received in the Blood Bank at 9:25 AM from inpatient unit A. Both said the request was for a unit of platelets. Both said platelets were requested from the American Red Cross. Both said the platelets arrived for Patient B and were logged into the electronic system at approximately 11:30 AM.

Review of the Hospital's Policy for Procedure for Dispensing, Returning, Transferring and Disposing of Blood and Blood Components indicated it was the responsibility of the issuing technologist and staff person or technician delivering the unit to check all of the necessary information. Using the information from the product pick up slip, the technician was to select the pre-tagged unit from the Blood Bank and check the unit number on the bag with the unit number on the tag. The product had three tags: white, pink and yellow. The pink copy of the unit tag was to be removed and placed into a box on the main desk. The technician was to electronically enter the dispensing and/or the assigned product into the system to record the patients medical record number. The pink slip was to be returned with the unit for pick up. The technician was to check all data for accuracy. The technician was to confirm the patient's name, medical record number, patients blood type, unit number and expiration date and time. The policy indicated if any override prompts (in the electronic system) or additional confirmation was needed a Blood Bank Supervisor was to be called.

The laboratory technicians did not have access to the physicians order either hand written or the electronic physicians order for patients requiring blood or blood product transfusions.

Laboratory Technician #1 was interviewed in person on 12/08/10 at 2:45 PM. Laboratory Technician #1 arrived at work at 3 PM on 11/21/10. Laboratory Technician #1 said it was reported that a unit of platelets had not been picked up by the staff on the intermediate care unit for Patient B. Laboratory Technician #1 said platelets were very fragile and needed to be rotated in a special incubator. Laboratory Technician #1 said there was a time limit for storing platelets. Laboratory Technician #1 placed a call to the unit secretary. Laboratory Technician #1 said there was additionally a call from the unit secretary that a unit of fresh frozen plasma was needed. Laboratory #1 said a staff member came down with a order requisition signed by the unit secretary for a unit of red blood cells. Laboratory Technician #1 said another staff member was to obtain the appropriate order requisition for the plasma. Instead, either the same individual or the nurse returned to the Blood Bank with an order requisition slip for platelets but wanted plasma. Laboratory Technician #1 said a registered nurse returned to the blood bank for the third time. Laboratory Technician #1 had taken a break and did not communicate any verbal concerns for the confusion with the blood products to the other staff. Laboratory Technician #1 said another technician dispensed the plasma product after receiving an order requisition for the plasma.

Laboratory Technician #1 did not notify the Blood Bank Supervisor over the reported confusion with the request for a unit of fresh frozen plasma for which there was no physicians order nor a prepared order requistion which prompted the staff to return to the inpatient unit on three occasions for the order requisition.

Continued review of Patient B's medical record indicated on 11/21/10 at approximately 4:30 PM, the inpatient unit placed a call to the Blood Bank for a unit of fresh frozen plasma. The order requisition for the fresh frozen plasma was discarded by the Blood Bank.

Review of Patient's Transfusion History in the electronic record indicated on 11/21/10 at 4:37 PM, Patient B was transfused a unit of fresh frozen plasma.

Registered Nurse #4 was interviewed in person on 12/08/10 at 8:20 AM. RN #4 co-signed the Transfusion Report which was placed into Patient B's medical record. RN #4 said the written order and consent for the blood product were obtained. RN #4 said the product label was reviewed for the unit number, blood type and expiration of the product. RN #4 said the product name was not reviewed on the blood product.

Review of the Transfusion Report indicated Laboratory Technician #1 prepared/thawed the fresh plasma product and verified the identifying numbers. However the fresh product plasma was dispensed by another technician. Review of the Transfusion Report label indicated the signature (of the two licensed nurses) certified acknowledgment that the nurse identified the intended recipient was Patient B by the Blood Bank Bracelet and compared this unit tag with the bracelet and the blood label. Patient B lacked a blood bank bracelet number on the label. However, the nursing staff were expected to double check the patients personal identification bracelet as outlined in the Hospital Policy.

Continued review of the Transfusion Record dated 11/21/10 indicated RN #3 signed the initiation of the plasma at 5:45 PM which was crossed out with a second written entry of the initial time which read 4:30 PM. The plasma was infused and the transfusion ended at 5:40 PM.

Registered Nurse #3 assigned to Patient B on 11/21/10 did not respond to the Department's investigation of the incident.

Review of Patient B's medical record for the Intervention/Care Procedure for the blood product transfusion indicated on 11/21/10 at 4:55 PM, Patient B's blood product was initiated and completed at 5:40 PM. However, RN #3 failed to document the specific blood product administered.

Review of the Electronic Orders dated 11/21/10 at 6:49 PM, two hours following the administration of the fresh frozen plasma, an order was entered into the system by the unit secretary for a plasma transfusion. The unit secretary indicated the neurosurgeon had ordered the blood product. However, there was no corresponding hand written order by the neurosurgeon as required.

On 11/22/10 at approximately 1 AM, an oncoming Laboratory Technician (#2) noticed the unit of platelets was rotating in a specialized incubator. Laboratory Technician #2 called inpatient unit B/ICC to inform the staff that the platelets had not been picked up by the staff from the Blood Bank.

Laboratory Technician #2 was interviewed in person on 12/08/10 at 1:31 PM. Laboratory Technician #2 said at the change of shift in the Blood Bank report was given that a unit of platelets had not been called for by the inpatient unit. Laboratory Technician #2 said the platelets were rotating in the specialized incubator. Laboratory Technician #2 said the staff on the unit were unable to locate the Transfusion Report for Patient B in the medical record and requested a copy be made from the Blood Bank.

Registered Nurse #5 was interviewed by telephone on 12/08/10. RN #5 said the technician called from the Blood Bank on 11/22/10 at 1 AM. RN #5 filed the safety report for the administration of the incorrect blood product. RN #5 said a nursing supervisor was called and the two of them tried to reconstruct the events which lead to the incorrect transfusion. RN #5 said the Transfusion Report was not in Patient's medical record. RN #5 said the Transfusion Report was found on the floor in the room used by the nursing staff for dictating report. RN #5 said the hospitalist was called and informed of the transfusion error. RN #5 said the hospitalist was informed Patient B had no ill effects from the plasma. RN #5 said the hospitalist said to transfuse Patient B with the platelets.

Based on record review and staff interview, the Hospital failed to ensure that patient care services were provided by qualified and competent nursing staff to one of one applicable Patients (A) in November 2010.

The findings are as follow:

Complaint # 10-1532

It was reported eight days following a vaginal delivery, Patient A complained of vaginal odor in November 2010. Patient A was examined by a nurse mid-wife in a clinic, whereby a retained sponge was found in the vaginal cavity. It was reported Nurse Mid-Wife #1 did not inform the Labor & Delivery (L&D)Nurse #1 the sponge had been inserted to control bleeding after the episiotomy repair.

It was reported to the Department, the Labor and Delivery Room was set up by a surgical scrub technician and the initial count of the sponges, instruments and needles were counted by the surgical scrub technician on the day of Patient A's delivery. However, review of the personnel file for the surgical scrub technician, as identified by the Hospital indicated the individual was hired as the unit secretary. The personnel file for the unit secretary lacked any documentation of training and/or credentials to conduct surgical count of sponges, instruments or needles.

The Unit Secretary was interviewed in person on 12/07/10 at 1:36 PM. The Unit Secretary said on the day of the incident, the Unit Secretary did count with a mentor surgical scrub technician. The Unit Secretary said it was the fourth or fifth time the secretary had done sponge count. The Unit Secretary was allowed to cross train without any evidence of employment/hire for the position or appropriate orientation for the position of a labor and delivery room technician. The Unit Secretary said the kit was opened and count was done outside of Patient A's room. The Unit Secretary said the sponges were packed in sets of five. The Unit Secretary said when the kit was set up, then a blanket was placed over the kit and brought into Patient A's room. The Unit Secretary said the count slip was placed on top of the delivery kit. The Unit Secretary signed the count sheet that the initial count was done. The Unit Secretary said there was no contact with the Patient or the Labor & Delivery Room Nurse.

The Hospital's Risk Manager accompanied the Surveyor during the two days of survey. The Hospital's Risk Manager was unaware the Unit Secretary had conducted the intitial count prior to Patient A's delivery. The Hospital's Risk Manager said the Director of Maternal and Child Health and Obstetrical Manager informed the Hospital's Risk Manager the intitial count was done by a surgical scrub technician.

The Director of Maternal and Child Health was interviewed in person on 12/07/10 at 2 PM. The Director of Maternal and Child Health said the Unit Secretary started orientation on the day of the incident. The Director of Maternal and Child Health said on the day of the incident, it was the first time the Unit Secretary had participated in sponge count and setting up the delivery tray. The Director of Maternal and Child Health said there was no specific policy directing the staff in labor and delivery for the specific requirement that count be done by two(qualified) persons.

Review of the Hospital's Policy for Surgical Count indicated all vaginal deliveries, the physician and primary nurse will do the sponge count together and the results will be documented on the delivery flow sheet. The Hospital's Policy did not address the function of mid-level practitioners in the labor and delivery area.

During the course of the survey, the Unit Secretary said a surgical scrub technician was mentoring the Unit Secretary.

Surgical Scrub Technician/Labor & Delivery Technician #2 was interviewed in person on 12/08/10 at 2 PM. Surgical Scrub Technician #2 said it was the first day of training for the Unit Secretary. Surgical Technician #2 said there was no contact with the Patient or the Labor & Delivery Nurse unless the patient was going to have a C-Section. Surgical Scrub Technician #2 said on the day of Patient A's delivery both went into Patient A to request permission to participate in the delivery. Surgical Scrub Technician #2 said the Unit Secretary was supervised in setting up the tray in Patient A' room. Surgical Scrub Technician #2 said the count sheet was not signed because the count was done by the Unit Secretary. Surgical Scrub Technician #2 contradicted the statement of the Unit Secretary.

Labor & Delivery Nurse #1 was interviewed in person on 12/07/10 at 11:50 AM. Labor & Delivery Nurse #1 was assigned to Patient A when Patient A went into active labor. Labor & Delivery Nurse #1 said the table had been previously set up and sponges were usually laid out in sets of ten. Labor & Delivery Nurse #1 said Nurse Mid-Wife #1 reached for the items that were needed. Labor & Delivery Nurse #1said final count was done with Nurse Mid-Wife #1 but count was not always done together. Labor & Delivery Nurse #2 signed the final count was correct.

Nurse Mid-Wife #1 was interviewed in person on 12/07/10 at 10:37 AM. Nurse Mid-Wife #1 said count of the sponges was done in stacks of five prior to delivery. Nurse Mid-Wife #1 said a sponge was placed in the vaginal cavity to control bleeding, after the vaginal repair was done. Nurse Mid-Wife #1 said the sponge should have been removed. Nurse Mid-Wife #1 said count was done independently and not with the Labor & Delivery Nurse (#1).

The Hospital failed to ensure that qualified, trained individuals were assigned to care of the patient. The Hospital failed to ensure that the patient recieved care in a safe setting.

Based on record review and staff interview, two Registered Nurses #3 and #4 failed to follow appropriate Hospital policies for the safe transfusion of a blood product to one of one applicable Patients (B) in November 2010.

Complaint #10-1533

Patient B was hospitalized for elective surgery. Patient B had a complicated medical history.

Review of the written Physicians Order dated 11/21/10 at 8 AM indicated a unit of platelets was to be administered to the Patient. Registered Nurse (RN) #1 notified the Blood Bank by telephone. Registered Nurse #1 signed the Physician order sheet that the platelet order had been transcribed. However, Registered Nurse #1 failed to electronically enter the order for the platelets. Instead, the new order for the transfusion of platelets was entered electronically as a nursing task similar to a nursing care plan intervention.

Registered Nurse #1 was interviewed in person on 12/07/10 at 2:34 PM. RN #1 was in charge on the unit where Patient B initially resided. RN #1 said that ordinarily the orders were noted by the unit secretary. RN #1 said there was no unit secretary working on that day. RN #1 called the Blood Bank and requested the unit of platelets for Patient B. RN #1 said ordering platelets may be time consuming because platelets were not stored in the Blood Bank. RN #1 said Patient B's condition had deteriorated. Registered Nurse #1 said Patient B complained of chest pain needed intravenous access. RN #1 said before transferring Patient B to the intermediate care unit (B), a percutaneous intravenous central catheter was inserted by the Intravenous Nurse. RN #1 said Patient B was transferred at approximately 2 PM. RN #1 said the pending platelet transfusion was documented in a nursing progress note and verbally communicated at the time of Patient B's transfer.

Continued review of Patient B's medical record indicated between 2 PM and 2:45 PM, Patient B was transferred to the Intermediate Care Unit for continued management for the complaint of chest pain.

The Director of the Blood Bank and the Blood Bank Supervisor were interviewed in person on 12/08/10 at 9:33 AM and 10:15 AM respectively. Both said a call was received in the Blood Bank at 9:25 AM from inpatient unit A. Both said the request was for a unit of platelets. Both said platelets were requested from the American Red Cross. Both said the platelets arrived for Patient B and were logged into the electronic system at approximately 11:30 AM.

Review of the Hospital's Policy for Procedure for Dispensing, Returning, Transferring and Disposing of Blood and Blood Components indicated it was the responsibility of the issuing technologist and staff person or technician delivering the unit to check all of the necessary information. Using the information from the product pick up slip, the technician was to select the pre-tagged unit from the Blood Bank and check the unit number on the bag with the unit number on the tag. The product had three tags: white, pink and yellow. The pink copy of the unit tag was to be removed and placed into a box on the main desk. The technician was to electronically enter the dispensing and/or the assigned product into the system to record the patients medical record number. The pink slip was to be returned with the unit for pick up. The technician was to check all data for accuracy. The technician was to confirm the patient's name, medical record number, patients blood type, unit number and expiration date and time. The policy indicated if any override prompts (in the electronic system) or additional confirmation was needed a Blood Bank Supervisor was to be called.

The laboratory technicians did not have access to the physicians order either hand written or the electronic physicians order for any blood products.

Laboratory Technician #1 was interviewed in person on 12/08/10 at 2:45 PM. Laboratory Technician #1 arrived at work at 3 PM on 11/21/10. Laboratory Technician #1 said it was reported that a unit of platelets had not been picked up by the staff on the intermediate care unit for the Patient. Laboratory Technician #1 said platelets were very fragile and needed to be rotated in a special incubator. Laboratory Technician #1 said there was a time limit for storing the platelets. Laboratory Technician #1 placed a call to the unit secretary. Laboratory Technician #1 said there was additionally a call from the unit secretary that a unit of fresh frozen plasma was needed. Laboratory #1 said a staff member came down with a order requisition signed by the unit secretary for a unit of red blood cells. Laboratory Technician #1 said another staff member was to obtain the appropriate order requisition for the plasma. Instead, returned to the Blood Bank with an order requisition slip for platelets but wanted plasma. Laboratory Technician #1 said a registered nurse returned to the blood bank for the third time. Laboratory Technician #1 had taken a break and did not communicate any verbal concerns for the confusion with the blood products to the other staff. Laboratory Technician #1 said another technician dispensed the plasma product after receiving an order requisition for the plasma.

Laboratory Technician #1 did not notify the Blood Bank Supervisor over the reported confusion with the request for a unit of fresh frozen plasma for which there was no physician order and no prepared order requestion which prompted the staff to return to the inpatient unit on three occasions for the order requisition.

Continued review of Patient B's medical record indicated at approximately 4:30 PM, the inpatient unit placed a call to the Blood Bank for a unit of fresh frozen plasma. The order requisition for the fresh frozen plasma was discarded by the Blood Bank.

Review of Patient's Transfusion History in the electronic record indicated on 11/21/10 at 4:37 PM, Patient B was transfused a unit of fresh frozen plasma.

Registered Nurse #4 was interviewed in person on 12/08/10 at 8:20 AM. RN #4 co-signed the Transfusion Report which was placed into Patient B's medical record. RN #4 said the written order and consent for the blood product were obtained. RN #4 said the product label was reviewed for the unit number, blood type and expiration of the product. RN #4 said the product name was not reviewed on the blood product.


Review of the Transfusion Report indicated Laboratory Technician #1 prepared/thawed the fresh plasma product and verified the identifying numbers. However the fresh product plasma was dispensed by another technician. Review of the Transfusion Report label indicated the signature (of the two licensed nurses) certified acknowledgment that the nurse identified the intended recipient by the Blood Bank Bracelet and compared this unit tag with the bracelet and the blood label. Patient B's lacked a blood bank bracelet number on the label. However, the nursing staff were expected to double check the patients personal identification bracelet.

Continued review of the Transfusion Record dated 11/21/10 indicated RN #3 signed the initiation of the plasma at 5:45 PM which was crossed out with a second written entry of the initial time which read 4:30 PM. The plasma was infused and the transfusion ended at 5:40 PM.

Review of the Intervention/Care Procedure for the blood product transfusion indicated on 11/21/10 at 4:55 PM, Patient B's blood product was initiated and completed at 5:40 PM. However, RN #3 failed to document the specific blood product administered.

Review of the Electronic Orders dated 11/21/10 at 6:49 PM, two hours following the administration of the fresh frozen plasma, an order was entered into the system by the unit secretary for a plasma transfusion. The unit secretary indicated the neurosurgeon had ordered the blood product. However, there was no corresponding hand written order by the neurosurgeon as required.

On 11/22/10 at approximately 1 AM, an oncoming Laboratory Technician (#2) noticed the unit of platelets was rotating in a specialized incubator. Laboratory Technician #2 called inpatient unit B/ICC to inform the staff that the platelets had not been picked up by the staff from the Blood Bank.

Laboratory Technician #2 was interviewed in person on 12/08/10 at 1:31 PM. Laboratory Technician #2 said at the change of shift in the Blood Bank report was given that a unit of platelets had not been called for by the inpatient unit. Laboratory Technician #2 said the platelets were rotating in the specialized incubator. Laboratory Technician #2 said the staff on the unit were unable to locate the Transfusion Report for Patient B in the medical record and requested a copy be made from the Blood Bank.

Registered Nurse #5 was interviewed by telephone on 12/08/10. RN #5 said the technician called from the Blood Bank on 11/22/10 at 1 AM. RN #5 filed the safety report for the administration of the incorrect blood product. RN #5 said a nursing supervisor was called and the two of them tried to reconstruct the events which lead to the incorrect transfusion. RN #5 said the Transfusion Report was not in Patient's medical record. RN #5 said the Transfusion Report was found on the floor in the room used for dictating report. RN #5 said the hospitalist was called and informed of the transfusion error. RN #5 said the hospitalist was informed Patient B had no ill effects from the plasma. RN #5 said the hospitalist said to transfuse Patient B with the platelets.

Based on medical record review and staff interview, the nursing staff obtained and administered a blood product to one of one applicable Patient's (B) without a physician's order. There was no documentation in the medical record the incorrect blood product had been administered nor a physician's order to administer the correct blood product the unit of platelets which had been stored in the Blood Bank . There was no physician documentation that Patient B was administered the incorrect blood product in November 2010.

The findings are as follow:

Complaint # 10-1533.

Review of the Intervention/Care Procedure for the blood product transfusion indicated on 11/21/10 at 4:55 PM, Patient B's blood product was initiated and completed at 5:40 PM. However, RN #3 failed to document the specific blood product administered.

Review of the Electronic Orders dated 11/21/10 at 6:49 PM, two hours following the administration of the fresh frozen plasma, an order was entered into the system by the unit secretary for a plasma transfusion. The unit secretary indicated the neurosurgeon had ordered the blood product. However, there was no corresponding hand written order by the neurosurgeon as required.

On 11/22/10 at approximately 1 AM, an oncoming Laboratory Technician (#2) noticed the unit of platelets was rotating in a specialized incubator. Laboratory Technician #2 called inpatient unit B/ICC to inform the staff that the platelets had not been picked up by the staff from the Blood Bank.

Laboratory Technician #2 was interviewed in person on 12/08/10 at 1:31 PM. Laboratory Technician #2 said at the change of shift in the Blood Bank report was given that a unit of platelets had not been called for by the inpatient unit. Laboratory Technician #2 said the platelets were rotating in the specialized incubator. Laboratory Technician #2 said the staff on the unit were unable to locate the Transfusion Report for Patient B in the medical record and requested a copy be made from the Blood Bank.

Registered Nurse #5 was interviewed by telephone on 12/08/10. RN #5 said the technician called from the Blood Bank on 11/22/10 at 1 AM. RN #5 filed the safety report for the administration of the incorrect blood product. RN #5 said a nursing supervisor was called and the two of them tried to reconstruct the events which lead to the incorrect transfusion. RN #5 said the Transfusion Report was not in Patient's medical record. RN #5 said the Transfusion Report was found on the floor in the room used for dictating report. RN #5 said the hospitalist was called and informed of the transfusion error. RN #5 said the hospitalist was informed Patient B had no ill effects from the plasma. RN #5 said the hospitalist said to transfuse Patient B with the platelets.

There was no written physician's order following the discovering of the incorrect administration of the fresh frozen plasma to administer the unit of platelets which had been stored in the Blood Bank.

There was no physician's progress note Patient B had been administered the wrong blood product ie: plasma instead of a unit of platelets.

Based on record review the Director of Maternal and Child and the OB/GYN Nurse Manager failed to ensure that qualified, trained individuals were providing care to one of one applicable Patients (A) who was later found with a retained sponge in November 2010.

The findings are as follow:

Complaint #10-1532

It was reported eight days following a vaginal delivery, Patient A complained of vaginal odor in November 2010. Patient A was examined by a nurse mid-wife whereby a retained sponge was found in the vaginal cavity. It was reported Nurse Mid-Wife #1 did not inform the Labor & Delivery (L&D)Nurse #1 the sponge had been inserted to control bleeding after the episiotomy repair.

It was reported to the Department, the Labor and Delivery Room was set up by a surgical scrub technician and the initial count of the sponges, instruments and needles were counted by the surgical scrub technician on the day of Patient A's delivery. However, review of the personnel file of the surgical scrub technician as identified by the Hospital indicated the individual was hired as the unit secretary. The personnel file for the unit secretary lacked any documentation of training and/or credentials to conduct surgical count of sponges, instruments or needles.

The Unit Secretary was interviewed in person on 12/07/10 at 1:36 PM. The Unit Secretary said on the day of the incident, the Unit Secretary did count with a mentor surgical scrub technician. The Unit Secretary said it was the fourth or fifth time the secretary had done sponge count. The Unit Secretary was allowed to cross train without any evidence of employment for the position or appropriate orientation for the position of a labor and delivery room technician. The Unit Secretary said the kit was opened and count was done outside of Patient A's room. The Unit Secretary said the sponges were packed in sets of five. The Unit Secretary said when the kit was set up, then a blanket was placed over the kit and brought into Patient A's room. The Unit Secretary said the count slip was placed on top of the delivery kit. The Unit Secretary signed the count sheet that initial count was done. The Unit Secretary said there was no contact with the Patient or the Labor & Delivery Room Nurse.

The Hospital's Risk Manager accompanied the Surveyor during the two days of survey. The Hospital's Risk Manager was unaware the Unit Secretary had conducted the intitial count prior to Patient A's delivery. The Hospital's Risk Manager said the Director of Maternal and Child Health and Obstetrical Manager informed the Hospital's Risk Manager the intitial count was done by a surgical scrub technician.

The Director of Maternal and Child Health was interviewed in person on 12/07/10 at 2 PM. The Director of Maternal and Child Health said the Unit Secretary started orientation on the day of the incident. The Director of Maternal and Child Health said on the day of the incident, it was the first time the Unit Secretary had participated in sponge count and setting up the delivery tray. The Director of Maternal and Child Health said there was no specific policy directing the staff in labor and delivery for the specific requirement that count be done by two persons.

Review of the Hospital's Policy for Surgical Counts indicated all vaginal deliveries, the physician and primary nurse will do the sponge count together and the results will be documented on the delivery flow sheet. The Hospital's Policy did not address the function of mid-level practitioners in the labor and delivery area.

During the course of the survey, the Unit Secretary said a surgical scrub technician was mentoring the Unit Secretary

Surgical Scrub Technician/Labor & Delivery Technician #2 was interviewed in person on 12/08/10 at 2 PM. Surgical Scrub Technician #2 said it was the first day of training for the Unit Secretary. Surgical Technician #2 said there was no contact with the Patient or the Labor & Delivery Nurse unless the patient was going to have a C-Section. Surgical Scrub Technician #2 said on the day of Patient A's delivery both went into Patient A to request permission to participate in the delivery. Surgical Scrub Technician #2 said the Unit Secretary was supervised in setting up the tray. Surgical Scrub Technician #2 said the count sheet was not signed because the count was done by the Unit Secretary. Surgical Scrub Technician #2 contradicted the statement of the Unit Secretary.

Labor & Delivery Nurse #1 was interviewed in person on 12/07/10 at 11:50 AM. Labor & Delivery Nurse #1 was assigned to Patient A when Patient A went into active labor. Labor & Delivery Nurse #1 said the table had been previously set up and sponges were usually laid out in sets of ten. Labor & Delivery Nurse #1 said Nurse Mid-Wife #1 reached for the items that were needed. Labor & Delivery Nurse #1said final count was done with Nurse Mid-Wife #1 but count was not always done together. Labor & Delivery Nurse #2 signed the final count was correct.

Nurse Mid-Wife #1 was interviewed in person on 12/07/10 at 10:37 AM. Nurse Mid-Wife #1 said count of the sponges was done in stacks of five prior to delivery. Nurse Mid-Wife #1 said a sponge was placed in the vaginal cavity to control bleeding after the vaginal repair was done. Nurse Mid-Wife #1 said the sponge should have been removed. Nurse Mid-Wife #1 said count was done independently and not with the Labor & Delivery Nurse (#1).

Based on record review and staff interview,the Hospital failed to ensure that the policies for sponge count were consistently followed by mid-level practitioners and the nursing staff for patients having vaginal deliveries.

The findings are as follow:

Complaint #10-1532

It was reported eight days following a vaginal delivery, Patient A complained of vaginal odor in November 2010. Patient A was examined by a nurse mid-wife whereby a retained sponge was found in the vaginal cavity. It was reported Nurse Mid-Wife #1 did not inform the Labor & Delivery (L&D)Nurse #1 the sponge had been inserted to control bleeding after the episiotomy repair.

It was reported to the Department, the Labor and Delivery Room was set up by a surgical scrub technician and the initial count of the sponges, instruments and needles were counted by the surgical scrub technician on the day of Patient A's delivery. However, review of the personnel file of the surgical scrub technician as identified by the Hospital indicated the individual was hired as the unit secretary. The personnel file for the unit secretary lacked any documentation of training and/or credentials to conduct surgical count of sponges, instruments or needles.

The Unit Secretary was interviewed in person on 12/07/10 at 1:36 PM. The Unit Secretary said on the day of the incident, the Unit Secretary did count with a mentor surgical scrub technician. The Unit Secretary said it was the fourth or fifth time the secretary had done sponge count. The Unit Secretary was allowed to cross train without any evidence of employment for the position or appropriate orientation for the position of a labor and delivery room technician. The Unit Secretary said the kit was opened and count was done outside of Patient A's room. The Unit Secretary said the sponges were packed in sets of five. The Unit Secretary said when the kit was set up, then a blanket was placed over the kit and brought into Patient A's room. The Unit Secretary said the count slip was placed on top of the delivery kit. The Unit Secretary signed the count sheet that initial count was done. The Unit Secretary said there was no contact with the Patient or the Labor & Delivery Room Nurse.
The Hospital's Risk Manager accompanied the Surveyor during the two days of survey. The Hospital's Risk Manager was unaware the Unit Secretary had conducted the intitial count prior to Patient A's delivery. The Hospital's Risk Manager said the Director of Maternal and Child Health and Obstetrical Manager informed the Hospital's Risk Manager the intitial count was done by a surgical scrub technician.

The Director of Maternal and Child Health was interviewed in person on 12/07/10 at 2 PM. The Director of Maternal and Child Health said the Unit Secretary started orientation on the day of the incident. The Director of Maternal and Child Health said on the day of the incident, it was the first time the Unit Secretary had participated in sponge count and setting up the delivery tray. The Director of Maternal and Child Health said there was no specific policy directing the staff in labor and delivery for the specific requirement that count be done by two persons.

Review of the Hospital's Policy for Surgical Counts indicated all vaginal deliveries, the physician and primary nurse will do the sponge count together and the results will be documented on the delivery flow sheet. The Hospital's Policy did not address the function of mid-level practitioners in the labor and delivery area.

During the course of the survey, the Unit Secretary said a surgical scrub technician was mentoring the Unit Secretary.

Surgical Scrub Technician/Labor & Delivery Technician #2 was interviewed in person on 12/08/10 at 2 PM. Surgical Scrub Technician #2 said it was the first day of training for the Unit Secretary. Surgical Technician #2 said there was no contact with the Patient or the Labor & Delivery Nurse unless the patient was going to have a C-Section. Surgical Scrub Technician #2 said on the day of Patient A's delivery both went into Patient A to request permission to participate in the delivery. Surgical Scrub Technician #2 said the Unit Secretary was supervised in setting up the tray. Surgical Scrub Technician #2 said the count sheet was not signed because the count was done by the Unit Secretary. Surgical Scrub Technician #2 contradicted the statement of the Unit Secretary.

Labor & Delivery Nurse #1 was interviewed in person on 12/07/10 at 11:50 AM. Labor & Delivery Nurse #1 was assigned to Patient A when Patient A went into active labor. Labor & Delivery Nurse #1 said the table had been previously set up and sponges were usually laid out in sets of ten. Labor & Delivery Nurse #1 said Nurse Mid-Wife #1 reached for the items that were needed. Labor & Delivery Nurse #1said final count was done with Nurse Mid-Wife #1 but count was not always done together. Labor & Delivery Nurse #2 signed the final count was correct.

Nurse Mid-Wife #1 was interviewed in person on 12/07/10 at 10:37 AM. Nurse Mid-Wife #1 said count of the sponges was done in stacks of five prior to delivery. Nurse Mid-Wife #1 said a sponge was placed in the vaginal cavity to control bleeding after the vaginal repair was done. Nurse Mid-Wife #1 said the sponge should have been removed. Nurse Mid-Wife #1 said count was done independently and not with the Labor & Delivery Nurse (#1).