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Based on a review of documentation, based on interviews with hospital staff members, and based on a review of hospital policies and procedures, it was determined that the hospital failed to adequately control the distribution of drugs in accordance with applicable standards of practice in order to assure the safety of the patients of this hospital.

Findings include:

In an interview with I1 on 06/06/11 at 0945 hours in the office of the Chief Nursing Executive, I1 stated that the hospital had employed a nurse who had been terminated in January of 2011 over concerns regarding his/her "mental well-being," and described concerns regarding the employee's own safety and the perceived risk for suicide. I1 stated that behavioral issues were on-going over a long period of time, and that no new behavior was present at the time of the employee's termination. Further, I1 stated that hospital staff members had no indication that the terminated employee would consider harming another person. I1 stated that the terminated employee turned in his/her identification badge and "keys" at the time of his/her termination, but that there was no documentation contained in a personnel file to confirm that this relinquishment had taken place.

I1 described an incident that took place on March 15, 2011, in which a pain pump on a postoperative patient had presumably malfunctioned on the evening shift at about 7 p.m., shift change on the unit, and was immediately removed from service. The electronic pain pump, which contained a pre-measured vial of a narcotic medication, indicated that only a small amount of the medication had been delivered, and yet the medication vial inside the locked pain pump was empty. Fearful that the patient receiving medication through the pain pump had been delivered an overdose of the narcotic, emergency actions were taken. Emergency care providers allegedly noticed that patient did not demonstrate signs or symptoms of a medication overdose, and appeared to have suffered no ill effects from the medication. The pain pump was immediately removed from service, and was later determined by the facility's biomedical engineers to be functioning properly.

Two weeks later, on March 30, 2011, at around 7 p.m., a second incident occurred. I1 stated that March 30, 2011, was a Wednesday, historically a busy day on the medical/surgical unit. Wednesdays were typically the days that orthopedic procedures had been performed, procedures that would have been likely to require the use of a pain pump for the relief of a patient's pain. I1 stated that on a typical Wednesday on the medical/surgical unit, three to five pain pumps could have been in use by postoperative patients. On March 30, 2011, a second pain pump appeared to have malfunctioned, with the electronic calculation of medication delivered dramatically differing from how much of the narcotic remained in the locked pain pump. This pain pump had also been unplugged. In this incident, the patient affected was alert and oriented, and reported that a (person) in a white lab coat had been in his/her room recently and had worked on his/her pain medication pump. Staff members on duty were interrogated at approximately 2300 hours, and a Certified Nursing Assistant (CNA) stated that s/he thought s/he had seen the terminated employee--though the CNA had not yet been aware of the termination of the former employee--leaving the patient's room. The CNA stated that it was difficult to recognize the former employee, as s/he had gained weight, and s/he had been wearing a blonde wig, but the CNA was not especially concerned at the time, as the patient had a pain pump, and the former employee had been an IV (intravenous) therapy nurse in the hospital. A "pump interrogation" was performed, which revealed that the door to the pain pump had been unlocked, and that the vial of narcotic medication had been removed, and that, after several recorded attempts the plunger and empty vial could not be properly seated back into the machine, and the pain pump had been manually turned off. A printed version of this pump interrogation was reviewed at the time of this investigation, which validated the verbal information given. The police were immediately notified of the theft of medication, as were management team members of the hospital, both of whom met at the hospital the following morning at approximately 7 a.m. An action plan was formulated, a photograph of the former employee was distributed to security staff, and employees were informed of the situation. I1 stated that, as it had been two weeks between the last incidents, they felt they should be prepared for a potential problem within the next couple of weeks. The former employee returned to the medical/surgical unit on the evening shift of March 31, 2011, and despite wearing a white lab jacket, a brown wig and red-framed glasses, was recognized by hospital staff members. The former employee was apprehended by the police while still in the hospital, and was found to be carrying an empty syringe as well as an unknown amount of the oral narcotic "Vicodin" in the pocket of his/her lab jacket. The former employee confessed to the March 30, 2011, theft of the narcotic Dilaudid.

I1 stated that a disclosure to the patient and his/her spouse who, on March 30, 2011, had been affected by the actions of the former employee, was made immediately by the hospital, which included the offer and acceptance of testing to determine risks associated with a potential break in aseptic technique. I1 also stated that although there were no policy changes that had come about as a result of these incidents, there were a number of procedural changes, which included the following:

The hospital planned a change to a "secured badge" system within 12 to 14 weeks of the date of this investigation.
There had been an increase in the number of security people assigned to monitor people coming and going from the facility.
Doors leading in and out of the hospital had previously been locked at 2200 hours, but this routine had been changed to 2100 hours, one hour earlier, since the incidents occurred.
Cameras had been installed in the ceiling of the medical surgical unit, with plans to place them "everywhere" in the future.
In the future, employees would promptly be notified of who had become a former employee.
Pain pump keys would be locked in the electronic pyxis carts, and a nurse would need to sign them out in order to use them in the future, in the same manner that a narcotic medication would be signed out from a pyxis cart.
Extra sets of keys would be removed or secured within the hospital.

I2 was present during this entire interview, and verbally agreed with the report of the sequence of events.

In an interview with I2 at 1030 on 06/06/11 in the board room, I2 stated that a review of the situation by the quality improvement program had determined that there had been no inventorying of pain pump keys prior to the first event on March 15, 2011, and that the hospital realized that this was a problem, as there had been "no process for keeping the keys checked out to the right people at the right time." I2 stated that previously the keys were "readily available to IV nurses," but that now a nurse must "check into pyxis" to obtain a set of keys. I2 stated that "PCA keys," clarified to mean Patient Controlled Anesthesia, also referred to in this report as 'pain pumps,' "could be found anywhere." I2 stated that prior to this series of events, there had been no written policy and procedure in the hospital which would have defined the expectation for security or determined the the line of custody of the pain pump keys. I2 read aloud hand-written notes from "ad hoc" management meetings held from March 15, 2011, through and beyond March 31, 2011, which addressed a root cause, immediate mitigation of the breach, as well as long-term solutions to prevent similar incidents from occurring in the future. The hand-written notes also supported the procedural changes articulated by I1 during the 0945 hours interview.

In an interview with I3 at 1045 hours in the board room, I3 clarified that the former employee "quit in a telephone call, because (s/he) knew (s/he) was going to get fired," and that there had been a long history of problems associated with the former employee's attendance, as well as "performance issues" reported by patients and co-workers alike. The former employee allegedly stated at the time that s/he resigned that s/he was "tired of all the suspicion." I3 stated that a grave concern with the former employee was that s/he "kept falling outside the red line." I3 described a "Pandora" system, in which the use of all narcotics within the hospital was tracked. The system tracked the number of hours the nurse worked, the number of patients the nurse worked with, and the usage of narcotics. This nurse's statistics consistently fell "outside the red line" of what would normally have been expected. A "Pandora" report was generated by the pharmacy manager "before December" of 2010, which caused the pharmacy manager to audit the records of patients cared for by the former employee, wherein a significant irregularity, the removal of the narcotic Dilaudid from the pyxis system for a patient, but no physician order for the Dilaudid, and no documentation that the Dilaudid had been administered to the patient, nor to any patient the former nurse cared for on that day, could be located. The pharmacy manager notified I3 of the discrepancy. I3 reported that it was during the telephone call to the former employee to schedule a time to talk about the newly-discovered irregularity that the former employee resigned from his/her position.

I3 also clarified that the former IV nurse had never been "issued" keys, but that there were several sets of keys, each containing a pain pump key, available for the IV nurses' use while working inside the hospital.

At 1100 hours on 06/06/11 in the board room, I4 was interviewed. I4 stated the hospital used pain pumps manufactured by Hospira, that each Hospira pain pump came with two keys, and that in the Portland service area, all keys were identical, "from pump-to-pump and from hospital-to-hospital." I1 confirmed this information. I4 revealed a pain pump key, small and silver, and with a barrel-shaped, irregularly "toothed" end. I4 stated that the hospital had a "bag of keys" which were all identical and which were not inventoried or monitored. I4 stated the s/he didn't know "if there were twenty keys or thirty-five keys in that bag." S/he also stated that there were three sets of keys in a locked room "in the department." I4 stated that prior to these incidents it had been the procedure to obtain a set of keys from the department at the start of a nurse's shift, and then to return the keys at the end of his/her shift. I4 stated that "a couple of months" before the former employee left his/her position within the hospital, "a (pain pump) key turned up missing, but we just thought it was a broken link," clarified to mean that the ring/device holding multiple keys together had failed, causing the loss of a key, and that "we didn't put much thought into it." I4 stated that the missing key had been replaced with one of the spare keys. I4 demonstrated the access and use of a Hospira pain pump with a key.

In an interview with I5 on 06/06/11 at 1115 hours in the board room, I5 confirmed the "red line" information from the 1045 hours interview with I3, and acknowledged concerns regarding the pattern of medication administration by the former employee for "a couple of months" before s/he left his/her position in the hospital. I5 presented an undated hospital policy titled: "PCA Key Management," which s/he said had gone into effect immediately after the apprehension of the former employee, and would be implemented within all Oregon hospitals within the Providence system by July 1, 2011. I5 presented a printed read-out of a pyxis cart dated 06/05/11, demonstrating the check-out and check-in process of pain pump keys by Registered Nurses, which s/he stated had become the new procedure as a result of this series of events.

Based on a review of documentation, based on interviews with hospital staff members, and based on a review of hospital policies and procedures, it was determined that the hospital failed to adequately control the distribution of drugs in accordance with applicable standards of practice in order to assure the safety of the patients of this hospital.

Findings include:

In an interview with I1 on 06/06/11 at 0945 hours in the office of the Chief Nursing Executive, I1 stated that the hospital had employed a nurse who had been terminated in January of 2011 over concerns regarding his/her "mental well-being," and described concerns regarding the employee's own safety and the perceived risk for suicide. I1 stated that behavioral issues were on-going over a long period of time, and that no new behavior was present at the time of the employee's termination. Further, I1 stated that hospital staff members had no indication that the terminated employee would consider harming another person. I1 stated that the terminated employee turned in his/her identification badge and "keys" at the time of his/her termination, but that there was no documentation contained in a personnel file to confirm that this relinquishment had taken place.

I1 described an incident that took place on March 15, 2011, in which a pain pump on a postoperative patient had presumably malfunctioned on the evening shift at about 7 p.m., shift change on the unit, and was immediately removed from service. The electronic pain pump, which contained a pre-measured vial of a narcotic medication, indicated that only a small amount of the medication had been delivered, and yet the medication vial inside the locked pain pump was empty. Fearful that the patient receiving medication through the pain pump had been delivered an overdose of the narcotic, emergency actions were taken. Emergency care providers allegedly noticed that patient did not demonstrate signs or symptoms of a medication overdose, and appeared to have suffered no ill effects from the medication. The pain pump was immediately removed from service, and was later determined by the facility's biomedical engineers to be functioning properly.

Two weeks later, on March 30, 2011, at around 7 p.m., a second incident occurred. I1 stated that March 30, 2011, was a Wednesday, historically a busy day on the medical/surgical unit. Wednesdays were typically the days that orthopedic procedures had been performed, procedures that would have been likely to require the use of a pain pump for the relief of a patient's pain. I1 stated that on a typical Wednesday on the medical/surgical unit, three to five pain pumps could have been in use by postoperative patients. On March 30, 2011, a second pain pump appeared to have malfunctioned, with the electronic calculation of medication delivered dramatically differing from how much of the narcotic remained in the locked pain pump. This pain pump had also been unplugged. In this incident, the patient affected was alert and oriented, and reported that a (person) in a white lab coat had been in his/her room recently and had worked on his/her pain medication pump. Staff members on duty were interrogated at approximately 2300 hours, and a Certified Nursing Assistant (CNA) stated that s/he thought s/he had seen the terminated employee--though the CNA had not yet been aware of the termination of the former employee--leaving the patient's room. The CNA stated that it was difficult to recognize the former employee, as s/he had gained weight, and s/he had been wearing a blonde wig, but the CNA was not especially concerned at the time, as the patient had a pain pump, and the former employee had been an IV (intravenous) therapy nurse in the hospital. A "pump interrogation" was performed, which revealed that the door to the pain pump had been unlocked, and that the vial of narcotic medication had been removed, and that, after several recorded attempts the plunger and empty vial could not be properly seated back into the machine, and the pain pump had been manually turned off. A printed version of this pump interrogation was reviewed at the time of this investigation, which validated the verbal information given. The police were immediately notified of the theft of medication, as were management team members of the hospital, both of whom met at the hospital the following morning at approximately 7 a.m. An action plan was formulated, a photograph of the former employee was distributed to security staff, and employees were informed of the situation. I1 stated that, as it had been two weeks between the last incidents, they felt they should be prepared for a potential problem within the next couple of weeks. The former employee returned to the medical/surgical unit on the evening shift of March 31, 2011, and despite wearing a white lab jacket, a brown wig and red-framed glasses, was recognized by hospital staff members. The former employee was apprehended by the police while still in the hospital, and was found to be carrying an empty syringe as well as an unknown amount of the oral narcotic "Vicodin" in the pocket of his/her lab jacket. The former employee confessed to the March 30, 2011, theft of the narcotic Dilaudid.

I1 stated that a disclosure to the patient and his/her spouse who, on March 30, 2011, had been affected by the actions of the former employee, was made immediately by the hospital, which included the offer and acceptance of testing to determine risks associated with a potential break in aseptic technique. I1 also stated that although there were no policy changes that had come about as a result of these incidents, there were a number of procedural changes, which included the following:

The hospital planned a change to a "secured badge" system within 12 to 14 weeks of the date of this investigation.
There had been an increase in the number of security people assigned to monitor people coming and going from the facility.
Doors leading in and out of the hospital had previously been locked at 2200 hours, but this routine had been changed to 2100 hours, one hour earlier, since the incidents occurred.
Cameras had been installed in the ceiling of the medical surgical unit, with plans to place them "everywhere" in the future.
In the future, employees would promptly be notified of who had become a former employee.
Pain pump keys would be locked in the electronic pyxis carts, and a nurse would need to sign them out in order to use them in the future, in the same manner that a narcotic medication would be signed out from a pyxis cart.
Extra sets of keys would be removed or secured within the hospital.

I2 was present during this entire interview, and verbally agreed with the report of the sequence of events.

In an interview with I2 at 1030 on 06/06/11 in the board room, I2 stated that a review of the situation by the quality improvement program had determined that there had been no inventorying of pain pump keys prior to the first event on March 15, 2011, and that the hospital realized that this was a problem, as there had been "no process for keeping the keys checked out to the right people at the right time." I2 stated that previously the keys were "readily available to IV nurses," but that now a nurse must "check into pyxis" to obtain a set of keys. I2 stated that "PCA keys," clarified to mean Patient Controlled Anesthesia, also referred to in this report as 'pain pumps,' "could be found anywhere." I2 stated that prior to this series of events, there had been no written policy and procedure in the hospital which would have defined the expectation for security or determined the the line of custody of the pain pump keys. I2 read aloud hand-written notes from "ad hoc" management meetings held from March 15, 2011, through and beyond March 31, 2011, which addressed a root cause, immediate mitigation of the breach, as well as long-term solutions to prevent similar incidents from occurring in the future. The hand-written notes also supported the procedural changes articulated by I1 during the 0945 hours interview.

In an interview with I3 at 1045 hours in the board room, I3 clarified that t