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Based on the nature of deficiencies, the facility is not in compliance with the Condition of Participation of Patient Rights. The facility also failed to ensure that a safe patient environment was maintained by staff through consistently conducted patient observation rounds.

The facility failed to meet the following Standard under the Condition of Patient Rights:

A 0144 - Care In A Safe Setting: The facility failed to ensure that direct patient care staff performed on-going, consistent, quality, patient safety observations per the facility's policy, per staff training, and per recent staff re-training after the death of Sample Patient #1.

The failure under the Condition of Patient Rights contributed to the determination that an Immediate Jeopardy situation existed in the facility and was not abated at the time of exit.

Based on document review, interviews, and observations, the facility failed to ensure the on-going physical safety of patients admitted to the facility. Patient safety observations were not conducted by facility staff per the facility's policy and expectations.

The failure to perform adequate safety checks placed all patients at risk because of threats to their health and welfare going unidentified by staff.

Findings:

1. Facility staff did not perform patient safety observations (15 minute checks) per the facility's policy. Sample Patient #1 who was found dead and in a condition of rigor mortis (indicating that the patient had died hours prior to being discovered) despite patient observation rounds having been conducted. Despite subsequent staff training and re-education and implementation of additional video monitoring of staff performance of rounds, on 9/27/13, video observation of patient observation rounds conducted on the night shift of 09/23/13 to 09/24/13 on Sample Patient #22, revealed that the patient observations rounds were still not being conducted correctly per policy/procedure.

a) Review on 09/18/13 of the medical record for Sample Patient #1 revealed that the patient was a young adult admitted with history of diagnoses of Episodic Mood Disorder, Multiple Substance Abuses including Opiates, Cocaine and Benzodiazepines, Victim of Sexual Abuse and Insomnia. The patient was treated with high doses of Valium and Vistaril for anxiety, fentanyl patches for pain, and other psychotropic medications. The patient was found at approximately on 7/27/13 at 9:30 a.m. not breathing, no pulse, cyanotic and in full rigor mortis in his/her room, despite documentation of having been checked every 15 minutes throughout the night and morning shifts. The record showed the checks were documented as completed and the patient slept all night from approximately midnight with loud snoring. At least a day prior to the patient being found dead, nurses documented the patient was very sedated and several doses of Valium were withheld because of over-sedation, but no nurse initiated additional vital signs to reassess the patient's condition. During the night prior to the patient being found dead, the record indicated that the patient was "snoring" very loudly after having gone to bed in a condition documented as very sedated even though his/her Valium was withheld due to the symptoms. There was no evidence that the patient was reassessed by nursing during the night with attempts to arouse the patient or to check vital signs.

b) Review on 10/08/13 of the medical reference book, "Stedman's Medical Dictionary, 28th Edition, Lippincott Williams & Wilkins, 2006, page 1699 revealed the following, in part:
"rigor - rigidity, stiffness mortis - Stiffening of the body, 1-7 hours after death, from hardening of the muscular tissues as a consequence of the coagulation of the myosinogen and paramyosinogen; it disappears after 1-6 days or when decomposition begins; cadaveric rigidity, postmortem rigidity."


c) On 09/24/13 at 11:30 a.m., the facility's policy titled, "Patient Observation Policy," revised 03/23/12 was reviewed. The policy stated all patients "are supervised, at a minimum, every 15 minutes," through rounds/observations by staff to ensure patient safety. The policy stated Behavioral Health Associates (BHAs) would observe patients every 15 minutes and specific information regarding the patient would be documented on the patient observation form. The policy stated each patient would have an individual observation form that would be completed and would be become part of the patient's medical record and the patient's identity would be verified, and the location of the patient and patient's behavior would be documented. The policy went on to state required documentation of patient activities when patients were awake during the day. The policy directed when patients were on bed rest or asleep, the BHAs would look for the rise and fall of the patient's chest, count at least 3 respirations, and make sure the patient "moved from his/her previous sleeping position" and document per the policy and the observation form.

d) Review on 09/17/13 of an internal investigative document related to the death of Sample Patient #1, related to the Patient Observation Policy, 2 Behavioral Health Associates (BHAs) stated that they had not conducted patient observation rounds according to policy. In addition, it stated that staff were viewed on camera not conducting patient observation rounds according to policy. Staff were not visualizing the patient and were marking that the patient was asleep in the quiet room.

e) On 09/18/13 at 12:46 p.m., an interview was conducted with the facility's Risk Manager who stated s/he had reviewed camera tapes of the room Sample Patient #1 was in on 07/26/13 and 07/27/13. The Risk Manager stated s/he "focused on the BHAs" to determine if they were conducting patient safety observations per policy. S/he stated the camera tape review reflected the observations were not being conducted per the facility's policy. S/he stated some observations were "fly-by's" meaning BHAs "glanced in the door" of the patient room and did not walk inside the room in order to observe the rise and fall of the patient's chest and to observe at least 3 respirations. The Risk Manager stated s/he reviewed the camera tape of Sample Patient #1's room and did not see the patient change position or move during the night shift and through the morning of 07/27/13. The Risk Manager stated she began reviewing the facility's patient observation policy with nursing staff and BHAs and obtained signatures from staff indicating they understood the policy and expectations for conducting patient observations. The Risk Manager stated expectations for patient safety observations was also conducted with new staff nurses and BHAs and was also part of annual competencies. The Risk Manager stated since the death of Sample Patient #1, staff nurses and BHAs were informed that if it was found that patient safety observations were not conducted per the facility's policy, corrective action would be taken up to and including termination of employment.

The Risk Manager stated since the death of Sample Patient #1, administrative staff increased their morning/daily review of camera tapes from the day/night before. S/he stated each morning s/he reviewed an hour of tape from each of the 3 facility units and documented the review which included the time staff entered a patient's room and when staff exited the room. The Risk Manager stated s/he documented if there were not 4 observations made of each patient room in a 1-hour time frame. S/he stated s/he also documented if staff was in a patient's room for less than 9 seconds as it would take at least this much time to conduct an observation including observing 3 respirations. The Risk Manager stated s/he also reviewed tapes to see that BHAs were documenting on the patient's observation sheets at the time of observation instead of later, which was identified as a problem by the facility. The Risk Manager stated since the death of Sample Patient #1, administrative review of camera tapes had increased and 3 staff members were reviewing tapes including him/herself, the former Chief Executive Officer, and the Plant Operations Director. The Risk Manager stated choosing the videos to review was random and that s/he received documentation of tape reviews from the former CEO and the Plant Operations Manager when their reviews were completed. The Risk Manager stated the facility's patient observation policy and the safety observations document completed for each patient, were not changed since the patients' death.


f) On 09/19/13 at 12:08 p.m., an interview was conducted with the facility's former, interim CEO who confirmed orientation for new staff nurses and BHAs had not changed since the death of Sample Patient #1, and that annual competencies regarding patient safety observations had not changed. The interim CEO stated staff had been re-educated using the same facility policy and documents. The interim CEO stated s/he did conduct some reviews of camera tapes after the death of Sample Patient #1, but as of approximately the first week of September, 2013, s/he no longer had rights to view tapes on facility computers, so s/he was no longer conducting tape reviews.


g) On 09/27/13 at 11:16 a.m., an interview was conducted with the Corporate Clinical Director who stated the expectation after the death of Sample Patient #1 was that administrative staff would increase the review of camera tapes in order to monitor nursing staff and BHAs conducting patient safety observations per facility policy and per recent re-training of staff. The Director stated this had not happened and the daily review of a sample of tapes by the facility Risk Manager was not an increase of administrative monitoring of this issue.


h) On 09/27/13 at 9:36 a.m., view of recent camera tapes was conducted with the facility's Risk Manager, the Corporate Clinical Director, and the facility's Staff Educator and Performance Improvement Specialist. At 10:28 a.m., the Risk Manager completed review of a random sample of tapes from the previous 24 hour period and documented the results of the review. Review of the tape of the Adult Unit 1 showed a BHA in patient room #2108 for 17 seconds on one observation, 9 seconds on the next observation of this patient, and finally only 4 seconds in the patient's room at 3:30 a.m. The Risk Manager stated when s/he reviewed a BHA in a patient room for less than 9 seconds, s/he thinks the patient was probably awake and spoke with the BHA or had some interaction to let staff know the patient was safe. The Risk Manager followed up on this 4 second patient safety observation and stated Staff BHA #1 documented at 3:30 a.m. that the patient in room #2108 was asleep. The Risk Manager stated this patient safety observation was not conducted per facility policy. S/he stated the expectations of staff, and recent retraining of staff, noted the BHAs did not spend enough time in the patient's room to observe 3 respirations.

i) On 09/18/13 a document provided by the Interim Director of Nursing, outlining the actions taking by nursing after the death of Sample Patient #1 was reviewed. The document and accompanying documents detailed meetings held with staff to review expectations for following the Patient Observation Rounds policy/procedure, including having all staff sign an attestation that they would follow the policy. The attestation included the key elements from the policy, including, looking for the rise and fall of the chest, counting at least three respirations and making sure that the patient moved from his/her previous sleep position. There was evidence that all nursing staff had been re-trained regarding conducting patient observation rounds (15 minute checks) according to the policy by the time of the survey.

j) On 09/27/13 at 2:26 p.m., during an interview with the Facility's Risk Manager, the surveyor requested to review tapes of a patient "Quiet Room" to observe staff observations of patients placed in this type of room. The Risk Manager stated s/he did not necessarily look for staff observations of these rooms even though each Quiet Room had a camera inside the room. Quiet Rooms were used in the facility for patients who required closer observation by staff, therefore the camera in the rooms. Tape review revealed that on 09/24/13, in the adolescent unit, a child, Sample Patient #22, was sleeping in a Quiet Room. Review of tapes reflected facility BHA #2 was not conducting patient safety observations per the facility's policy. The tape reflected that on 09/24/13 at 02:29:59, BHA #2 was in the patient's room for 11 seconds but did not shine the flashlight toward the patient in order to ensure observation of the rise and fall of the patient's chest and to observe 3 respirations. At 02:43:35, BHA #2 was observed in the patient's room for 6 seconds with the flashlight shining toward the ceiling not toward the patient. At 02:58:54 BHA #2 was observed in the patient's room for 5 seconds, and at 03:18:02, the BHA was observed in the patient's room for 9 seconds. At 03:44:56, the BHA was observed in the patient's room for 17 seconds but turned away from the patient at one point and looked at the door. At 04:14:37, BHA #2 was observed in the patient's room for 6 seconds. The observation time between 03:44:56 and 04:14:37 was almost 30 minutes, not the required 15 minute interval. At 04:31:47, BHA #2 was observed in the patient's room for 5 seconds holding the flashlight up toward the ceiling. At 04:45:20, the tape showed a green light shining into the room for a few seconds and no staff person entering the room. At 05:08:21, BHA #2 was observed opening the patient's door, which had been left slightly open, but did not step inside the room to observe the patient. Instead, the BHA stood at the threshold of the door and backed out of the room 3 seconds later. At 05:20:37, BHA #2 was observed in the patient's room for 5 seconds. No further review of this tape was conducted by the surveyor and the facility's Risk Manager. The Risk Manager confirmed the findings reflecting lack of correct patient safety observations by BHA #2 for approximately 3 hours while Sample Patient #22 was sleeping. The Risk Manager confirmed the necessity of staff using a flashlight while observing in Quiet Rooms, even though there was dim light provided in these rooms.

k) On 09/27/13 at 3:10 p.m., review of the medical record for Sample Patient #22 was conducted and revealed this was a 9 year old male with a history of seizure disorder who had been moved to the Quiet Room. The Patient Rounds Observation sheets for Sample patient #22 dated 09/24/13 showed all safety observations were conducted by BHA #2 beginning at midnight through 4:30 a.m. and from 05:15 a.m. through 7:15 a.m. Documentation by BHA #2 reflected the patient was sleeping at each observation with the exception of the 3:30 a.m. and 4:00 a.m. observations when the patient was documented as "sleeping in bed." The observation sheet revealed that the observations conducted at 04:45 a.m. and 05:00 a.m. were conducted by other staff whose initial could not be matched with a signature.

l) On 09/27/13, review of the facility's retraining documents for nurses and BHAs regarding patient safety observations was conducted. The documents were titled, "Patient Observation Rounds Expectations Acknowledgement." The documents restated expectations from the facility's patient safety observation policy and included the expectation that staff would look for the rise and fall of a sleeping patient's chest and observe at least 3 respirations for sleeping patients. Staff BHA #1 initialed and signed this document on 8/20/13 and Staff BHA #2 initialed and signed the acknowledgement on 7/30/13.

Based on the nature of deficiencies, the facility failed to be in compliance with the Condition of Participation of Nursing Services. The facility failed to ensure that the Director of Nursing Services ensure that nursing staff complied with policies/procedures related to assessment/reassessment of patients, patient monitoring and medication administration.

The facility failed to meet the following Standards under the Condition of Nursing Services:

Tag A 0386 - Organization of Nursing Services
The facility failed to to ensure that the hospital's director of nursing services ensured that nursing staff adequately documented patient care and complied with all patient care policies and procedures, including those related to patient observations rounds, medication administration and assessment/reassessment of patients.

Tag A 0405 - Administration of Drugs
The facility failed to ensure that facility nursing staff administered a medication, transdermal fentanyl patches, to Sample Patient #1 as ordered by the patient's physician.

The failures under the Condition of Nursing Services contributed to the determination that an Immediate Jeopardy situation existed in the facility and was not abated at the time of exit.

Based on review of medical records and facility documents and staff interviews, the hospital failed to ensure the director of nursing services ensured that nursing staff adequately documented patient care and complied with all patient care policies and procedures. The director of nursing also failed to adequately investigate and correct nursing process errors related to medications administered to Sample Patient #1.

Findings:

1. The director of nursing failed to ensure that all staff were complying with the policy/procedure to conduct patient observation rounds (15 minute checks).

Reference Tag A 144 - Patient Rights - Care in a Safe Setting, for findings related to nursing staff failure to correctly conduct patient observation rounds on Sample Patients #1 and #22.

Reference Tag A 405 - Nursing Services - Administration of Drugs, for findings related to nursing staff failure to correctly administer medications, including fentanyl transdermal patches, according to physician orders and nursing standards of practice.

2. The nursing staff failed to adequately reassess and document the findings for sample patient #1 when there was evidence of a change of condition.

The facility ' s Reassessment Policy read:
" 2. Each Patient is reassessed daily (every 24 hours) and/or as the patient's condition warrant, by an RN. Any condition change noted must be reported to the RN.
3. Reassessment is done to determine the patient's response to treatment or when a change occurs each shift."

a) Review on 09/18/13 of the medical record for Sample Patient #1 revealed that the patient was a young adult admitted on 7/18/13 with history of diagnoses of Episodic Mood Disorder, Multiple Substance Abuses including Opiates, Cocaine and Benzodiazepines, Victim of Sexual Abuse and Insomnia. The patient was treated with Valium and Vistaril for anxiety, fentanyl patches for pain, and the psychoactive medications, Lexapro and Neurontin

The patient was found on 7/27/13 at approximately 9:30 a.m. not breathing, no pulse, cyanotic and in full rigor mortis in his/her room. (Rigor mortis occurs when the limbs of the corpse becomes stiff and difficult to move or manipulate. In humans, it commences after about three to four hours, reaches maximum stiffness after 12 hours, and gradually dissipates until approximately 48 to 60 hours after death). However, the record showed that 15 minute checks were documented and showed the patient slept all night from approximately midnight with loud snoring.
Prior to the patient's being found dead, nurses were documenting that the patient was very sedated and several doses of Valium were withheld because of over-sedation, but no nurse initiated additional vital signs to reassess the patient's condition. During the night prior to the patient being found dead, the record showed that the patient was "snoring" very loudly after having gone to bed in a condition characterized as very sedated. There was no evidence that the patient was assessed by nursing staff during the night with attempts to arouse the patient or check vital signs (including oxygenation status). In addition, earlier in the evening prior to the patient's death, the patient had had at least two episodes of emesis and required medication for that. There was no documentation of a physical assessment when the emesis events happened, and there was no documentation of the nature, amount and contents of emesis in the record.

Further review of the medical record revealed that the patient was receiving Melatonin for sleep, Valium and Vistaril for anxiety, Neurontin and Lexapro for anxiety and depression and Fentanyl transdermal patches for pain.

On the two days prior to the patient being discovered deceased on the morning of 07/27/13, the patient received the following medications that had a central nervous system depressing effect:

07/25/13:
3 mg Melatonin
100 mcg fentany transdermal patches
40 mg Lexapro
Valium 50 mg
Neurontin 1800 mg
Vistaril 75 mg

07/26/13:
100 mcg fentany transdermal patches
40 mg Lexapro
Valium 10 mg
Neurontin 1800 mg
Vistaril 75 mg

b) Review of the "Mosby's 2012 Nursing Drug Reference, 25th Edition," revealed the medications all had central nervous system (CNS) depression effects which can cause drowsiness and vital sign changes and respiratory depression. There were interactions among some of the medications that potentiated the actions of the various CNS depressants as well as extending the half-life of the Valium.
In addition, the half-life (time required for half of the amount of the medication to be secreted from the body) for Valium was 20-50 hours per dose.

Note that the patient had 5 - 10 mg doses on 07/25/13, which was the day the patient began to show significant sedation. By the morning of 07/26/13, the patient was so sedated that s/he only received a 4:05 a.m. PRN dose of Valium. The morning and evening and PRN doses of Valium were held due to the patient ' s level of sedation, but the patient continued to receive the other CNS depressing medications Lexapro, Fentanyl, Neurontin and Vistaril throughout that day. The patient was found to be deceased at about 9:30 a.m. on 07/27/13.

c) Review of, "Taylor's Clinical Skills Nursing," copyright 2008, pages 745 - 751 stated standards of nursing care regarding respiratory assessment and measuring blood oxygenation with the use of a pulse oximeter. The standard states " Many medications affect the function of the respiratory system. Many medications depress the respiratory system. The nurse should monitor patients taking certain medications, such as opioids, for rate and depth of respirations. " The standards state that " a range of 95% to 100% is considered normal, " when assessing blood oxygenation with a pulse oximeter.

Review of the patient ' s vital signs revealed that the patient had pulse oximeter reading on admission on 07/18/13 of 99% oxygen saturation. On 07/20/13 and 07/23/13, the patient ' s oxygen saturation had declined to 94%, which as below the normal range. On 07/26/13, the day prior to the patient ' s death, the patient ' s oxygen saturation level was 93% at 8:30 a.m. and declined to 90%, far below the normal range, by 7:45 p.m. Despite the patient ' s decreased oxygen saturation and extreme sedation, no reassessments of the patient were conducted after the 7:45 p.m. pulse oximeter reading, even though the patient was on multiple medications, including an opioid, that had respiratory and central nervous system depressing effects.


d) On 09/25/13 at 9:20 a.m., BHA #3, was interviewed by telephone about observation rounds conducted for Sample Patient #1 on the night shift (11 p.m. to 7:30 a.m.) on the night of 07/26-27/13. The BHA stated that the patient was snoring loudly, once asleep at approximately 12:00 a.m. S/he stated that s/he was concerned about the loud snoring, which s/he stated was able to be heard " even at the nurses ' station. " The BHA stated that s/he went to the charge nurse (RN #5) and medication nurse (RN #3), who were both at the nurses ' station and notified them of his/her concern about the loud snoring. S/he stated that s/he did not see either of the nurses respond to his/her information and go to check on the patient at that time. S/he stated that the charge nurse (RN #5) took over part of his/her rounds at approximately 1 a.m., including the rounds for Sample Patient #1. S/he stated s/he resumed rounds on Sample patient #1 at approximately 6 a.m., and recalled that at 6 a.m., the patient was no longer snoring loudly. The BHA (#3) stated that s/he continued to make rounds until the end of the shift and did final hand-off rounds with the on-coming shift BHA (#4) as the shift was ending at 7:30 p.m.

e) On 09/26/13 at 1:20 p.m., RN #5, who was no longer an employee of the facility, was interviewed by telephone, about observation rounds conducted for Sample Patient #1 on the night shift (11 p.m. to 7:30 a.m.) on the night of 07/26-27/13. S/he confirmed that Sample Patient #1 was snoring loudly during the night and that the noise could be heard even at the nurses station. S/he had no memory of the BHA (#3) asking him/her to check on the patient. S/he stated that s/he did make rounds on the patient for part of the night. S/he stated that this was his/her first night working on that unit, so s/he was not familiar with the sleeping habits of Sample Patient #1, including whether the snoring was typical or unusual for that patient. S/he recalled that the patient had appeared very drowsy at about 11:45 p.m. when s/he came up to the medication window requesting Valium. S/he stated she refused to give the patient the Valium because of his/her level of sedation, but did not take vital signs or call the provider. S/he confirmed that s/he did not go in to the patient's room to do an assessment or to initiate vital signs for the patient. S/he stated s/he was a newly graduated nurse and that it was his/her first nursing job.


f) On 09/26/13 at 11:55 a. m., during an interview with the president of the medical staff, the care and medical record of sample patient #1 was discussed. The medical director stated that s/he and another provider had conducted an independent review of the case, since they had not cared for the patient. During the interview, the expectations for nurses to initiate additional vital signs or other assessments of this patient, related to over-sedation, loud snoring at night and the documentation of the patients episodes of vomiting was discussed. S/he agreed that nurses should have initiated reassessment of the patient, provided accurate documentation and even contacted the doctor about concerns related to these issues.


g) On 09/19/13 at 11:05 a.m., the Nurse Educator was interviewed and the expectations for documentation of patient symptoms and reassessment of the patient when there was evidence of a possible change of condition was discussed. S/he stated that nurses should have reassessed the patient related to increased sedation symptoms and very noisy snoring during sleep. In addition, s/he stated that the nurses did not adequately document the episodes of emesis, including times, whether witnessed, nature of the emesis and quantity, as s/he would expect as a standard of nursing care and documentation.

3. The facility failed to appropriately review the death event and insure corrections were made to avoid further serious medication errors of a like nature.

a) On 09/19/13 at 4:09 p.m., an interview was conducted with the facility's former Chief Executive Officer (CEO), who also served as the facility's Director of Nursing (DON) and Director of Quality. The CEO was asked to review the medical record for Sample Patient #1 and to explain the administration of fentanyl patches at a 24 hour interval, on 07/25/13 and 07/26/13, instead of the 72 hour interval ordered by the patient's physician. The CEO could find no documented reason that the medication was administered at a 24 hour interval. When asked if this medication error was identified by the facility and reported internally as a medication error, s/he stated it was not reported as an "incident' or "event" and felt it did not constitute a medication error. The CEO stated the administration of the fentanyl patches for Sample Patient #1 had been looked into by the facility and it was his/her opinion that this was not a medication error but a transcription error on the part of nursing staff. The CEO stated when s/he investigated this issue it was not determined which Registered Nurse had made the transcription error because "no one could remember" who did the transcribing of the medication administration record on the date in question. The CEO confirmed that because s/he believed this issue was not a medication error, it was not documented for discussion in Quality Meetings and was not reviewed further by facility staff. The CEO stated s/he had no documentation of this issue being discussed with nursing or other facility staff.

e) On 09/19/13 at 4:25 p.m., the facility's Corporate Clinical Director, who was present when the former CEO was interviewed regarding the administration of Fentanyl patches, stated the administration/changing of the patches on 07/25/13 and 07/26/13 constituted a medication error as the patches were changed out at 24 hours instead of at 72 hours as the patient's physician ordered. The Director stated this incident should have been documented by the facility as a medication error so that it could be reviewed in Quality Meetings and corrections made.

f) On 09/20/13 at 4:30 p.m., the Corporate Clinical Director provided the facility's current policy titled, "Medication Administration," revised 10/21/09, for review. The policy stated it was the responsibility of the night shift nursing staff to ensure that physician orders were transcribed accurately.


g) On 09/20/13 at 10:28 a.m., an interview was conducted with Staff Physician #3 who stated s/he was one of the facility physicians who reviewed the medical record for Sample patient #1 as this patient died in the facility on 07/27/13. Physician #3 reviewed the change of the patches at 24 hours instead of the ordered 72 hour interval and stated s/he would view this as a medication error. Physician #3 stated s/he serves on the facility's medical Executive Committee.

h) Review of Committee of the Whole (COW) Meeting Minutes for January 2013 through August 2013 were reviewed. It was documented that the facility's Risk Manager presented information at these meetings each month regarding facility medication errors. July data regarding medication errors provided by the Risk Manager stated there were 6 medication errors in July with "omissions" as the highest category of errors. Nine medication errors were reported in June 2013 and all 9 errors "reached the patient." The fentanyl patch error was not included in the data presented to the Committee for the month of July.

Based on document review and interviews the facility failed to ensure that staff Registered Nurses administered medications per physician orders. Transdermal Fentanyl patches were administered to Sample Patient #1 at a more frequent time interval than ordered by the patient's physician.

This failure created the potential for serious respiratory depression related to the absorption of the potent narcotic medication through the skin and into the bloodstream.

Findings:

1. Registered nursing staff did not administer Fentanyl per a physician's order. Nursing staff changed a patient's transdermal Fentanyl patch sooner than the 72 hour time interval ordered by the patient's physician.

a) On 09/19/13 at 3:26 p.m., review of the medical record for Sample Patient #1 was conducted. The patient was admitted to the facility on 07/18/13. Upon admission the patient had been prescribed Fentanyl for chronic pain issues. The patient's record revealed a physician order for Fentanyl Patch, 100 micrograms, q 72 hours was received on 07/18/13. The record reflected that this medication was ordered to be discontinued on 07/21/13. The medical record revealed the medication was discontinued on this date (7/21/13) by a physician order as the patient reported s/he "flushed" one of the Fentanyl patches. A new physician order for Fentanyl Patch, 100 micrograms, q 72 hours, was documented in the patient's record on 07/22/13 at 8:45 p.m.

The Medication Administration Record (MAR) for Sample Patient #1, completed by nursing staff, revealed Fentanyl, 100 micrograms, in the form of a transdermal patch, was administered to Sample Patient #1 on 07/19/13 at 10:00 a.m. to the patient's left chest area. Review of the MAR reflected Fentanyl, 100 micrograms was placed "on" the patient on 07/22/13 at 8:45 p.m. The MAR reflected that Fentanyl, 100 micrograms was placed on the patient again on 07/25/13 at 9:00 a.m. and on 07/26/13 at 9:00 a.m. The doses documented on 07/25/13 and 07/26/13 reflected the Fentanyl patches were administered to the patient 24 hours apart, not 72 hours apart as ordered by the patient's physician. No documentation could be found in the patient's medical record indicating that nursing staff had received a new order for Fentanyl from a physician or that nursing staff had contacted a physician to obtain a new/different order for this medication. The same disbursement of Fentanyl patches were confirmed on the Fentanyl 50 mcg Patch Inventory Activity form and the Control II Narcotics form for the same dates.
Further - there was no documented evidence that the used patches were retrieved by nursing staff prior to administration of the new patches.

2. Registered Nursing staff did not use standards of nursing documentation when documenting activities around administration of Fentanyl patches, or " missing " Fentanyl patches, a Schedule II, Controlled Substance. Registered nursing staff did not document skin assessments of Sample Patient #1 prior to the administration of Fentanyl patches.

a) Review of Mosby's 2012 Nursing Drug Reference, 25th edition, stated under dosage and routes, that Fentanyl transdermal patch should be applied to a "flat surface on upper torso and wear for 72 hr; apply new patch on different site for continued relief. "
b) Review of, "Taylor ' s Clinical Skills Nursing, " copyright 2008, pages 236-239, stated standards of practice for nurses when applying transdermal patches to patients. The standard states the patient 's skin should be assessed prior to placing patches and that skin should be clean, dry, and free of hair. The standard states specific medication patches could have specific instructions of where to place patches and that nursing staff should refer to the manufacturer ' s instructions to determine where to place patches. The standard states transdermal patches should not be placed on " irritated or broken skin " and that placement of patches should be rotated. The standard states nurses should write their initials, date, and time of administration on the label side of the patches. The standard states prior to administration of patches, patients should be assessed for " old patches, " which should be removed, folded in half and disposed of per the facility's policy. The standard states, " Document the administration of the medication immediately after administration, including date, time, dose, route of administration, and site of administration on the MAR or record using the required format. " The standard goes on to state, " Ongoing assessment is an important part of nursing care to evaluate patient response to administered medications and early detection of adverse effects. If an adverse effect is suspected, withhold further medication doses and notify the patient ' s primary healthcare provider. Additional intervention is based on type of reaction and patient assessment. "

c) The FDA put out public health alerts in 2005 and again in 2007 stating "the [adverse event] reports indicate that patients are continuing to incorrectly use the fentanyl patch by replacing the patch more frequently than directed in the fentanyl patch instructions, applying more patches than prescribed, or applying a heat source to the patch, all resulting in dangerously high fentanyl levels in the blood.
The fentanyl patch contains fentanyl, a very potent narcotic pain medicine. It is only intended for treating persistent, moderate to severe pain in patients who are opioid-tolerant, meaning those patients who take a regular, daily, around-the-clock narcotic pain medicine. This is extremely important because patients who are opioid-tolerant are more resistant to the dangerous side effects of narcotic pain medicines than patients who only occasionally take these medicines. For patients who are not opioid-tolerant, the amount of fentanyl in one fentanyl patch of the lowest strength is large enough to cause dangerous side effects, such as respiratory depression (severe trouble breathing or very slow or shallow breathing) and death ...Healthcare professionals who prescribe and patients who use the fentanyl patch should be aware of the signs of fentanyl overdose including the following: trouble breathing or slow or shallow breathing; slow heartbeat; severe sleepiness; cold, clammy skin; trouble walking or talking; or feeling faint, dizzy, or confused. If these signs occur, patients or their caregivers should get medical attention right away."

d) Review of the full package insert for Duragesic (fentanyl) patches revealed the following information and instructions for use:
Duragesic (Fentanyl) contains a high concentration of Fentanyl, a Schedule II controlled substance, which is subject to misuse, abuse, addiction, and criminal diversion. Fatal respiratory depression could occur in patients who are not opioid-tolerant and in patients that are opioid-tolerant even if DURAGESIC is not misused or abused. Schedule II opioid substances, including Fentanyl, have the highest potential for abuse and risk of fatal overdose due to respiratory depression. Respiratory depression has been reported with use of DURAGESIC in patients who are opioid-tolerant, even when DURAGESIC has been used as recommended and not misused or abused. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Patients at increased risk may still be appropriately treated with modified-release opioid formulations; however, these patients will require intensive monitoring for signs of misuse, abuse, or addiction.

The patch may be used continuously for 72 hours, and each patch should be applied to a different skin site after removal of the previous transdermal patch. Patches should be applied to intact, non-irritated, and non-irradiated skin on a flat surface such as the chest, back, flank, or upper arm. If the patch falls off before 72 hours, dispose of it by folding in half and flushing down the toilet. A new patch may be applied to a different skin site. Proper disposal of Duragesic is advised in order to prevent adverse reactions, including death, associated with accidental secondary exposure to Duragesic. Dispose of used patches by folding the adhesive side of the patch to itself, then flush the patch down the toilet immediately upon removal.

e) Lab results from a drug screen dated 07/19/13, at the time of admission, showed Sample Patient #1 was positive for benzodiazepines, cocaine, and opiates. In the Discharge Summary for the patient, the physician stated the patient had a history of attention deficit hyperactivity disorder, major depressive disorder, and a history of substance dependence.

f) Review of the medical record for Sample Patient #1 revealed documentation by a Registered Nurse on 07/19/13, that Fentanyl patches were placed on the patient ' s " left chest area." No further documentation was found in the record indicating where subsequent patches were placed, so no evidence was documented that the patches were " rotated " or placed on a different site, per the manufacturer's directions.

g) Review of the initial nursing assessment for Sample Patient #1, dated 07/19/13, revealed a skin assessment was documented by nursing staff. The medical record contained no other documentation of skin assessments by nursing staff, including no assessment of the patient's skin prior to placing fentanyl patches, per the manufacturer and per standards of nursing care.

h) Review of the initial nursing assessment dated 7/19/13 for Sample Patient #1 revealed the patient ' s pain level was 5/10 on the facility 's pain scale upon admission. A nursing note dated 07/23/13 at 2:15 p.m., stated the patient was " groggy and sluggish " was lying down during the day shift " and "complained of pain. " A nursing noted dated, 07/25/13 at 3:30 p.m., documented a quote by the patient during this shift that, " I still have pain, anxiety. " A nursing note dated 07/25/13 at 5:50 a.m., documented the patient complained of " back pain, spasms, took meds, " and returned to bed and fell asleep. No documentation was found in the medical record of the patient's level of pain or further description of pain on these dates. No documentation was found in the medical record on these dates of PRN medications being administered to the patient for pain or other attempts to address patient-reported pain.

i) Review of, " Taylor ' s Clinical Skills Nursing, " copyright 2008, pages 555 - 590 stated standards of nursing care regarding pain. The standards state an accurate assessment of pain is necessary to "guide treatment/relief interventions and evaluate the effectiveness of pain control measures. " The standard states the Registered Nurse should document pain assessment and other significant issues such as pain relief and patient responses. Documentation should include a rating of pain as well as a description of pain provided by the patient.

j) A Nursing note documented on 07/26/13 at 10:40 p.m. stated the patient had emesis x2 and vomited up his/her most recent medications. The note went on to state the patient was " still having difficulties coping and may be withdrawing from excessive amounts of narcotics in system." No further nursing documentation was found to support what "excessive narcotics " meant. The nurse's note further stated the patient would continue to be monitored in a quiet room every 15 minutes and the current treatment plan would stay enforced. No documentation was found in the record that the patient's physician was contacted, even with a suspicion by nursing staff of excessive narcotics in the system nor that they suspected the patient may be in withdrawals.

k) A nursing note dated 07/27/13 at 5:50 a.m., stated the patient was at the medication window at 11:45 p.m., requesting medications s/he had refused earlier at 9:00 p.m., and was falling asleep standing at the med window. The note further stated while the patient was at the medication window drinking Boost, s/he was falling asleep. No documentation by nursing staff was found indicating nursing staff contacted the patient's physician regarding the patient's status.

l) A nursing note dated 07/21/13 at 3:15 p.m., stated the patient "lost " his/her Fentanyl patches (plural) as s/he flushed them down the toilet. The nurse documented the patient then denied flushing Fentanyl patches (plural). The note stated a skin check of the patient and a room check were completed. The nursing note did not state the absence of Fentanyl patches on the patient. The nursing note, as written, indicates both Fentanyl patches were flushed down the toilet by the patient.

m) Review of a physician order dated 07/21/13, stated for nursing staff to apply Fentanyl patches (100 micrograms) and to "date, time, and check each shift for placement." This order was followed by a physician order, from the same physician, to discontinue Fentanyl as the patient was "removing and throwing away" the patches.

n) Review of a nursing note dated 07/26/13 at 3:00 p.m., quoted the patient as stating, "Do I get a patch now? This one fell off. " No further documentation from nursing staff was found regarding a fentanyl patch falling off, if the patch was reapplied to the patient, if the patient's physician was notified of this, or if pharmacy was contacted to aid nursing staff with reapplying the patch or obtaining another patch.

o) There was no documentation by nursing staff in the patient ' s medical record that Fentanyl patches were visualized daily, or at any interval, to ensure patches remained in place, were intact, that patches had not been removed, etc. even with a physician ' s order on 07/21/13 to do so and with evidence of the patient " flushing " patches.

p) Review of the facility ' s medication administration policy stated nothing about the administration of patch medications, labeling of patches, or documentation regarding placement of patches on patients. Section titled, " Administration, " stated licensed nursing staff must know the " correct medication, usual dosing, route of administration, appropriate time, expected effects, contraindications, early signs of untoward effects and toxicity, and possible interactions with other drugs or food of the medication they are administering. " The policy further stated nursing staff would verify the medication matches the physician ' s order, and that the medication is being administered at the " proper time, in the prescribed dose, and by the correct route. " Nothing in the policy addressed how patches were to be administered, skin checks conducted integrity of patient ' s skin who was receiving medication via patches, or rotation of patches administration sites.

q) On 09/20/13 at 12:37 p.m., an interview was conducted with the facility's previous Director of Nursing, who was functioning as the Chief Clinical Officer and Interim Chief Executive Officer (Interim CEO) to discuss issues regarding Fentanyl patches for Sample Patient #1. The Interim CEO stated s/he learned after the patient's death, that the patient reported to staff a missing Fentanyl patch sometime between 07/22/13 and 07/25/13. The Interim CEO stated s/he learned that staff found a medication patch in the courtyard and placed it back on the patient. When asked how staff knew this was a fentanyl patch and that it was the patch missing from Sample Patient #1, s/he stated the patient was the only patient on any kind of medication patch on this date. S/he confirmed the patches were not being labeled by nursing staff at this time. The Interim CEO confirmed there was no documentation of this incident in the medical record for Sample Patient #1, including no documentation that the patient ' s physician was informed of the incident. The Interim CEO confirmed there was no documented communication with pharmacy regarding placing the found patch on the patient. The Interim CEO stated Registered Nurses did not document the presence of medication patches, including fentanyl patches, each day when patients were assessed. S/he stated when removing fentanyl patches; this was not documented as a waste by nursing staff even though the habit was for nurses to discard used fentanyl patches into a red sharps container. The Interim CEO confirmed no documentation that on 07/26/13, when 2 fentanyl patches were placed at 24 hours, the existing 2 patches were documented as removed and discarded. S/he stated the new documentation for RN use regarding fentanyl had not yet gone through the "chain of command for approval," so was not being used by nursing staff.

r) On 09/23/13 at 2:11 p.m., the nurse manager that had retrieved the patch from the outside exercise court sometime between 07/22/13 and 07/25/13 was interviewed. She stated that the patch was not initiated or dated, but s/he was certain that it was the patient's fentanyl patch, because of the appearance and the fact that no other patient was currently on that type of patch (Note: two patches had been applied). When asked if s/he consulted with the physician or the pharmacist before re-applying the patch, s/he stated that s/he only re-applied the patch after consultation with either the CCO/Interim CEO or the Acting DON. She stated that the patch did not appear to be damaged or adulterated in any way that would have put the patient at risk.

s) On 09/23/13 at 3:58 p.m., the Corporate Clinical Director stated that the lack of documentation of the event was unacceptable, the patches should have been initialed and dated. S/he also expressed concern that the patch had been re-applied to the patient. The facility Nurse Educator also stated his/her concerns about the lack of initialing and dating the patches and the lack of documentation of the entire loss/retrieval/re-application of the transdermal fentanyl patch episode. They both state that the new fentanyl policy would specifically address these issues and would be followed up with staff re-education about the use of all patches.

t) Review of the facility ' s document titled, Medical Executive Committee Meeting Minutes dated 09/24/13, revealed a discussion had occurred at this meeting regarding the use of fentanyl patches in the facility. The meeting minutes stated a need for a fentanyl protocol and process to be established for the facility as one did not currently exist. Meeting minutes reflected the medical staff voted unanimously to remove fentanyl from the facility formulary and that while admitted, patients who had been receiving fentanyl would be placed on alternative medications. Prior to this vote, administration had complied a fentanyl patch order form which included instructions to nursing staff on how to apply these patches, to write that date and time of administration and the nurses ' s initials on each new patch, and to dispose of patches by placing them in the red sharps container o the nursing units. No documentation or discussion was found in the meeting minutes of the Medical Executive Committee or the Committee of the Whole regarding placement and documentation required of nursing staff for any other patches used in the facility .
u) On 09/24/13 at 11:23 a.m., an interview was conducted with the facility's contracted pharmacist who stated patches other than fentanyl are used in the facility. No policy or guidance produced that indicated how RNs were to apply, label and document all patches used for patients.

v) Review on 09/25/13 of the autopsy/coroner's report for Sample Patient #1 revealed that the patient's death was caused by complications of acute fentanyl toxicity.