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Based on review of the medical record it was determined that an opiate naive patient received a fentanyl patch in error over 4 days, which (1) was twice the initial dose recommendation for opiate tolerant patients, (2) was not identified by pharmacy, physicians, or nursing, and (3) resulted in a narcotic overdose. This regulation is not met as evidenced by:

Patient #1 is a 56-year-old male who lives in a psychiatric group home, and receives oversight services from a psychiatric day program. Patient #1 came to the emergency department (ED) on 2/20/2010 at 6:14 pm with increasing abdominal pain and one episode of vomiting. Patient #1 ' s history is significant for congenital, bilateral deafness, Schizoaffective disorder, hypertension, and severe constipation. Patient #1 uses American Sign Language (ASL), and is his own healthcare decision-maker. The ED obtained an interpreter. Patient #1 ' s history indicates that he is not opioid tolerant, and was therefore, " Opioid naive. "

Opioid tolerance is defined as patients who have been taking daily, for a week or longer, at least 60 mg of morphine, 30 mg of oral oxycodone, or at least 8 mg of oral hydromorphone or an equianalgesic dose of another opioid. Opioids are high alert medications due to the potential for respiratory depression leading to death. Fentanyl is a synthetic opioid. According to recommendations, Fentanyl patches are only to be used in opioid tolerant individuals, with a starting dose of 25 mcg/hour.

Examination, computed tomography (CT), and x-ray revealed a distended, tense, severely painful abdomen, with a sigmoid volvulus. A surgical consult recommended a conscious colonoscopy for decompression. While attempting to gain consent through an interpreter, it was unclear to the physician if patient #1 actually understood all the risks and benefits as described. Patient #1 appeared eager for the procedure, but a call placed to the group home and day program inquired about a guardian, or power of attorney. As none were found, the gastroenterologist (GE) performed the procedure with " Double physician consent. "

The hospital has a new hospital-wide information technology (IT) called " Epic, " installed December 2009. Part of the medication ordering system, called " Order and hold " is a function (appearing as a screen on the computer) allowing surgeons in particular, to order medications, which are given following surgery as part of post-op treatment. These orders are in addition to admitting physician orders.

Administrative staff reports that when the GE was in process of ordering IV fentanyl for the procedure, the GE remembers that a fentanyl patch continually and inappropriately came to the ordering screen. This necessitated the GE cancel the fentanyl patch several times. When the desired fentanyl IV appeared to be the only fentanyl ordered, the GE proceeded. Unknown to the GE, the fentanyl patch was not cancelled, but became part of the " Order and hold " function. Review of the electronic record reveals both fentanyl patch and fentanyl injection orders of 2/21 at 12:20 am.

Around the time of working with the new IT system, the " Order and hold " screen had to be manually brought to the screen for physician viewing. Therefore, the GE did not realize he had inadvertently ordered a fentanyl patch for patient #1 that went to the Order and Hold function. In fact, the GE ' s follow-up plan included a recommendation to "Avoid narcotics or any medications which cause colonic inertia."

It should be noted that Hospital Administration found no like medication errors, were not able to reproduce the error, and have since modified the IT system to show all medication screens to any physician viewing each patient record.

The pharmacy Medication Orders, policy dated 6/2004 states "All medication orders are reviewed and verified by a registered pharmacist prior to printing a label and dispensing the medication to the nursing unit." A pharmacist verified the order, failing to question patient #1's tolerance for opiates. Consequently, the pharmacist did not identify patient #1 as opioid naive, and did not consult the ordering physician (GE).

Patient #1 had a successful colonoscopy procedure on 2/21 at 1:50 am to decompress the volvulus, after which, he reported no pain at 4:38 am and 8:00 am. Plans were to admit and follow-up with a colectomy. Patient #1 admitted post-op, to the medical surgical unit. There, nursing " Released " his orders, including the " Order and Hold " fentanyl patch 50 mcg/hr every 72 hours. Patient #1 ' s regular psychiatric medications were on hold. An RN placed the fentanyl patch on patient #1 at 8:49 am. No RN documentation revealed the patch placement location, however, the patch was placed on patient #1 ' s back. The nurse failed to question patient #1 ' s tolerance for opiates, and failed to note two negative pain assessments. Consequently, the nurse did not identify that patient #1 was opioid naive, was having no pain, and did not contact the physician.

On 2/22 at 11:27, the medicine hospitalist wrote "Patient reports abdominal pain and distension to have improved significantly, denies chest pain." The medicine list included the ordered fentanyl patch for placement every 72 hours, and the note, " ...well controlled with current analgesic regimen. " The plan was to continue the current management, pain medications and that patient #1 would undergo sigmoid resection (colectomy).

On 2/23 at 7:36 pm, patient #1 was noted to have periods of confusion and agitation. The interpreter found patient #1 to be using signs, which were not part of ASL, and not understood. The physician questioned patient #1 ' s ability to sign consent for surgery. Multiple calls were placed to the contact RN at his placement. Administrative staff at the patient #1 ' s placement informed the hospital for the second time, that patient #1 is capable of making his own decisions, and can sign consents. An RN progress note states, " Patient with intermittent confusion and agitation throughout the day, less so with interpreter at bedside. Patient easier to redirect with interpreter present. Patient to transfer to SCU (Special Care Unit), Tracy given report and patient transferred ... " (The SCU is a hospital unit with a greater nurse to patient ratio (4:1), serving patients with special needs.)

The surgeon decided against performing the sigmoid resection based on his belief that patient #1 was not competent to sign consent for surgery at that time. The physician wrote, " From the surgical standpoint, Dr.___ suggested that further intervention can be done as an outpatient electively. For this, patient is referred to follow up with Dr. ___as an outpatient in 2-4 weeks. "

On 2/24, at 5:38 am per erroneous order, an RN placed a second fentanyl transdermal patch. No specific site placement is noted, no removal or waste of the previous 2/21 patch is recorded.

At 12:32 pm, patient #1 discharged to his placement without a list of medications.
The hospital explains that although a list of discharging medications could be seen on the monitor screen, the station printer was down due to work on the new IT system. The discharging PA (physician ' s assistant) wrote in part, " Continue all previous home medications, " and, " No new medication needed." "Avoid narcotic medications or any agents that may cause constipation." These instructions suggest that the PA did not know of the fentanyl patch which was not discontinues until after discharge. Consequently, the group home RN/interpreter who came for patient #1 was not informed of, or aware that patient #1 had a fentanyl patch on his back.

Group home staff brought patient #1 back to the hospital by 4 pm after they found him in and obtunded state at the group home. During ED diagnostics, a radiologist found a fentanyl patch on his back. Patient #1 required intervention with narcan, and recovered.

Following an initial medication error, in which patient #1 was ordered a fentanyl patch no physician, pharmacist or nurse (over the course of 4 days), questioned or identified that (1) patient #1 was opiate naive, yet received a transdermal opiate, (2) patient #1 had no pain during two assessments following the procedure, yet was given a fentanyl patch, (3) a relative contraindication of opiates for patient #1 ' s condition, (4) the opiate dosage was twice the recommended starting dose for an opiate tolerant patient, (5) patient #1 ' s sudden change in mental status impacting his ability to make healthcare decisions, may have been due to the opiate he was receiving, and (6) patient #1 was discharged with a fentanyl patch in contrast to discharging documents recommending no narcotic medications.

Based on the review of the medical record of patient #1 it was determined that nursing staff failed to utilize safe standards of practice for the use of opiates through assessment, administration, and handling and documentation of a fentanyl patch as evidenced by:

Patient #1 is a 56-year-old male who lives in a psychiatric group home, and receives oversight services from a psychiatric day program. Patient #1 came to the emergency department (ED) on 2/20/2010 at 6:14 pm with increasing abdominal pain and one episode of vomiting. Patient #1's history is significant for congenital, bilateral deafness, Schizoaffective disorder, hypertension, and severe constipation. Patient #1 uses American Sign Language (ASL), and is his own healthcare decision-maker. The ED obtained an interpreter. Patient #1's history indicates that he is not opioid tolerant, and was therefore, "Opioid naive."

Opioid tolerance is defined as patients who have been taking daily, for a week or longer, at least 60 mg of morphine, 30 mg of oral oxycodone, or at least 8 mg of oral hydromorphone or an equianalgesic dose of another opioid. Opioids are high alert medications due to the potential for respiratory depression leading to death. Fentanyl is a synthetic opioid. According to recommendations, Fentanyl patches are only to be used in opioid tolerant individuals, with a starting dose of 25 mcg/hour.

Examination, computed tomography (CT), and x-ray revealed a distended, tense, severely painful abdomen, with a sigmoid volvulus. A surgical consult recommended a conscious colonoscopy for decompression. While attempting to gain consent through an interpreter, it was unclear to the physician if patient #1 actually understood all the risks and benefits as described. Patient #1 appeared eager for the procedure, but a call placed to the group home and day program inquired about a guardian, or power of attorney. As none were found, the gastroenterologist (GE) performed the procedure with "Double physician consent."

The hospital has a new hospital-wide information technology (IT) system called "Epic," installed December 2009. Part of the medication ordering system, called " Order and hold" is a function (appearing as a screen on the computer) allowing surgeons in particular, to order medications, which are given following surgery as part of post-op treatment. These orders are in addition to admitting physician orders.

Administrative staff reports that when the GE was in process of ordering IV fentanyl for the procedure, the GE remembers that a fentanyl patch continually, and inappropriately came to the ordering screen. This necessitated the GE cancel the fentanyl patch several times. When the desired fentanyl IV appeared to be the only fentanyl ordered, the GE proceeded. Unknown to the GE, the fentanyl patch was not cancelled, but became part of the "Order and hold" function. Review of the electronic record reveals both fentanyl patch and fentanyl injection orders of 2/21 at 12:20 am.

Despite patient self-reports of no pain at 4:38 am and 8:00 am, an RN placed a fentanyl patch on patient #1 at 8:49 am. No RN documentation revealed the patch placement site, however, the patch was placed on patient #1's back. The RN failed to speak with the physician regarding patient #1's status of no pain. The RN failed to question or identify patient #1's tolerance for opiates. Consequently, neither did the RN identify that patient #1 was opioid naive.

On 2/24, at 5:38 am per the erroneous order, an RN placed a second fentanyl transdermal patch. No specific placement site is noted. However, the RN states she placed the patch on patient #1's back. No documentation of the removal or wasting of the 2/21 patch is found.

On 2/24 at 12:32 pm, patient #1 discharged to his placement without a list of medications. The hospital explains that although a list of discharging medications could be seen on the monitor screen, the station printer was down due to work on the IT system. The discharging PA (physician's assistant) wrote in part, "Continue all previous home medications," and "No new medication needed." "Avoid narcotic medications or any agents that may cause constipation." These instructions suggest that the PA did not know of the fentanyl patch which was not discontinued until 2/24 at 1:57 pm. Consequently, the group home RN/interpreter who came for patient #1 was not informed of, or aware that patient #1 had a fentanyl patch on his back.

Group home staff brought patient #1 back to the hospital by 4 pm after they found him in an obtunded state at the group home. During ED diagnostics, a radiologist found the fentanyl patch dated on his back. Patient #1 required intervention with Narcan, and recovered.

The fentanyl patch found on patient #1's back, had a hand-written date of 2/21. The patch, documented to have been placed on 2/24 was not found. Based on all information, the RNs did not meet standards of care for safe medication administration in the care of patient #1 by (1) using pain assessment information to guide pain medication use, (2) reconciling ordered medications with previous patient medications, (3) removal of the fentanyl patch placed on 2/21, (4) wasting of the fentanyl patch placed on 2/21, (5) reconciling the fentanyl patch prior to discharge, per discharging instructions for no narcotics.

Based on review of the medical records it was determined that a deaf, schizophrenic, group home patient was discharged with a fentanyl patch on his back, and (1) no medication list to inform his caregivers, (2) no verbal notification to caregivers of the fentanyl patch, (3) instructions not to use narcotics. The fentanyl patch resulted in a medical emergency when 4 hours later, he was found in an obtunded state, and required emergency intervention. This regulation is not as evidenced by:

Patient #1 is a 56-year-old male who lives in a psychiatric group home, and receives oversight services from a psychiatric day program. Patient #1 came to the emergency department (ED) on 2/20/2010 at 6:14 pm with increasing abdominal pain and one episode of vomiting. Patient #1 ' s history is significant for congenital, bilateral deafness, Schizoaffective disorder, hypertension, and severe constipation. Patient #1 uses American Sign Language (ASL), and is his own healthcare decision-maker. The ED obtained an interpreter. Patient #1 ' s history indicates that he is not opioid tolerant, and was therefore, "Opioid naive."

Opioid tolerance is defined as patients who have been taking daily, for a week or longer, at least 60 mg of morphine, 30 mg of oral oxycodone, or at least 8 mg of oral hydromorphone or an equianalgesic dose of another opioid. Opioids are high alert medications due to the potential for respiratory depression leading to death. Fentanyl is a synthetic opioid. According to recommendations, Fentanyl patches are only to be used in opioid tolerant individuals, with a starting dose of 25 mcg/hour.

Examination, computed tomography (CT), and x-ray revealed a distended, tense, severely painful abdomen, with a sigmoid volvulus. A surgical consult recommended a conscious colonoscopy for decompression. Patient #1 had a successful colonoscopy procedure on 2/21 at 1:50 am to decompress the volvulus, after which, he reported no pain. Plans were to admit and follow-up with a colectomy.

The hospital has a new hospital-wide information technology (IT) system called "Epic" installed December 2009. Part of the medication ordering system, called "Order and hold" is a function (appearing as a screen on the computer) allowing surgeons in particular, to order medications, which are given following surgery as part of post-op treatment. These orders are in addition to admitting physician orders.

Administrative staff reports that when the GE was in process of ordering IV fentanyl for the procedure, the GE remembers that a fentanyl patch continually, and inappropriately came to the ordering screen. This necessitated the GE cancel the fentanyl patch several times. When the desired fentanyl IV appeared to be the only fentanyl ordered, the GE proceeded. Unknown to the GE, the fentanyl patch was not cancelled, but became part of the "Order and hold" function. Review of the electronic record reveals both fentanyl patch and fentanyl injection orders of 2/21 at 12:20 am.

Around this time of working with the new IT system, the "Order and hold" screen was manually brought to the screen for physician viewing. Therefore, the GE did not realize he had inadvertently ordered a fentanyl patch for patient #1 that went to the Order and Hold function. In fact, the GE's follow-up plan included a recommendation to "Avoid narcotics or any medications which cause colonic inertia."

On 2/22 at 11:27, the medicine hospitalist wrote "Patient reports abdominal pain and distension to have improved significantly, denies chest pain." The medicine list in the note reveals the ordered fentanyl patch for placement every 72 hours, and the note, " ...well controlled with current analgesic regimen." The plan was to continue the current management, pain medications and that patient #1 would undergo sigmoid resection.

Due to growing confusion demonstrated by patient #1, the surgeon decided against performing the sigmoid resection based on his belief that patient #1 was not competent to sign consent for surgery at that time. The physician wrote "From the surgical standpoint, Dr.___ suggested that further intervention can be done as an outpatient electively. For this, patient is referred to follow up with Dr. ___as an outpatient in 2-4 weeks."

On 2/24, at 5:38 am per erroneous order, an RN placed a second fentanyl transdermal patch. No specific site placement is noted, no removal or waste of the previous 2/21 patch is recorded.

At 12:32 pm, patient #1 discharged to his placement without a list of medications.
The hospital explains that although a list of discharging medications could be seen on the monitor screen, the station printer was down due to work on the IT system. The discharging PA (physician ' s assistant) wrote in part, "Continue all previous home medications, " and, "No new medication needed." "Avoid narcotic medications or any agents that may cause constipation." These instructions suggest that the PA did not know of the fentanyl patch which appeared on patient #1's list of medications. Consequently, the group home RN/interpreter who came for patient #1 was not informed of, or aware that patient #1 had a fentanyl patch on his back.

Group home staff brought patient #1 back to the hospital by 4 pm after they found him in an obtunded state at the group home. During ED diagnostics, a radiologist found the fentanyl patch on his back. Patient #1 required intervention with Narcan, and recovered.

In summary, the hospital states that at the time of discharge, the discharge medication list was viewable, but not printable. However, the PA did not write a list of discharging medications, which would have been cause for review of the fentanyl patch. The discharging PA did not appear to know that patient #1 had a fentanyl patch on his back at discharge, as he wrote recommendations for no narcotics. Consequently, neither patient #1 nor the group home RN received any information regarding the fentanyl patch on patient #1's back, which had an impact on continuing care, and which created a medical emergency.