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Based on interview and document review, the facility did not have an effective governing body that carried out the functions required of a governing body as evidenced by the following:

1. Failed to ensure the policy and procedure related to nurse staffing was implemented in the Intensive Care Unit (ICU), Behavioral health Unit (BHU) and medical/surgical unit to ensure the safe and effective care of patients at all times. (A Tag 392)

2. Failed to ensure the policy and procedure and protocol related to the administration of a high risk medication, Propofol, was consistently implemented by Medical and Nursing staff at all times. (A Tag 405 #1, #2)

3. Failed to ensure a root cause analysis was conducted after a sentinel event occurred in the ICU regarding the inappropriate administration of the high risk medication Propofol. (A Tag 267)

4. Failed to ensure the adequate oversight by pharmacy and nursing leadership pertaining to the administration of the high risk medication Propofol. (A Tag 492 #1, #2, #3, #4 and A Tag 386)

5. Failed to ensure the sentinel event regarding the administration of the high risk medication Propofol was reported as a medication error. (A Tag 266)

6. Failed to ensure an occurrence report was completed after a sentinel event occurred in the ICU.
(A Tag 266)

7. Failed to ensure the Annual Competencies for ICU Nurses were obtained regarding the administration of high risk medications. (A Tag 397 #3)

8. Failed to ensure a Registered Nurse in the ICU, on orientation, was not independently administering high risk medications when she was not deemed competent to do so. (A Tag 397 #2)

9. Failed to ensure the rapid response team documentation was complete and per hospital policy for multiple patients. (A Tag 289)

10. Failed to ensure documented follow up concerning a variance in process after a variance occurred during a rapid response team/code blue event. (A Tag 288)

11. Failed to ensure that ICU level patients were assigned to nurses competent to care for ICU level patients. (A Tag 397 #1)

12. Failed to ensure the facility's previous plan of correction was implemented concerning the education of 100% of its nursing, respiratory and laboratory staff for code blue /rapid response team process and procedure. (A Tag 289)


An interview with members of the Governing Body was conducted on 3/2/12 at 11:30 A.M. The governing body stated that they were not aware of these deficient practices.

The cumulative effect of these systemic problems resulted in the facility's failure to deliver care in compliance with the Condition of Participation for Governing Body and failure to provide care to their patients in a safe environment.

Based on interview, record and document review, the hospital failed to ensure that an effective quality assessment and performance improvement program (QAPI) was implemented, when the hospital:

1. Failed to ensure that root cause analysis and investigation was conducted on a sentinel event involving the administration of the high risk medication, Propofol.
(A-tag 267)

2. Failed to ensure that Medication errors were reported.
(A-tag 266 and A tag 285 )

3. Failed to ensure that a previous plan of correction that pertained to emergency response procedures was fully implemented, and the hospital continued to experience variances in that process.
(A-tag 289)

4. Failed to analyze a variance in it's Code Blue process in an effort to identify opportunities for performance improvement. This was a repeat deficient practice for the hospital.
(A tag 288)

5. Nursing and Pharmacy Leadership failed to maintain oversight of the adminstration of the high risk medication Propofol following a Sentinel Event involving that medication.
(A-tag 386 and A-tag 492)

The cumulative effect of these systemic practices and issues resulted in the failure of the hospital to deliver statutorily mandated compliance with the Condition of Participation for Quality Assessment and Performance Improvement.

Based on observation, interview, record and document review, Nursing Leadership did not provide adequate oversight to establish and maintain safe and effective care of patients, when Nursing Leadership:

1. Failed to ensure that nursing practice pertaining to the administration of the high risk medication Propofol was safe and administered per the hospital protocol.
(A tag 405 # 1, 2, 3, 4 and A tag 385)

2. Failed to ensure that nurse-to-patient ratios were implemented per hospital policy.
(A tag 392 #1, 2 )

3. Failed to ensure that medications were administered per physician orders.
(A tag 405 # 5, 6)

4. Failed to ensure that Registered Nurses assigned to administer high risk medications to patients, and monitor those patients were competent to perform those duties.
(A tag 397 # 1, 2 )

5. Failed to ensure that medication errors were reported.
( A tags 266 and 385)

6. Failed to ensure that variances in Code Blue and Rapid Response Team responses were analyzed and addressed.
(A tag 288 and A tag 289)

7. Failed to ensure that patient care plans were developed and implemented.
( A tag 395 # 2, 3 and A tag 396 # 1)

8. Failed to ensure that accurate patient intake and outputs were monitored and recorded.
(A tag 396 # 2)

9. Failed to ensure that an emergency crash cart in the ICU was maintained per policy.
(A tag 505)

10. Failed to ensure that restraint orders were implemented.
(A tag 168 #1, 2)

The cumulative effect of these systemic practices and issues resulted in the failure of the hospital to deliver statutorily mandated compliance with the Condition of Participation for Nursing Services.

2. On 2/29/12 at 8:00 A.M., a tour of the Intensive Care Unit (ICU) was conducted with the Director of Nurses (DON).

Following the tour of the ICU on 2/29/12, record review was conducted of Patient 3's medical record. According to the record, Patient 3 was admitted to the ICU on 1/11/12, with respiratory failure and was dependent on a breathing machine. Other diagnoses included seizures, encephalitis (brain inflammation), severe dyskinesia (a movement disorder with involuntary movements) and acute psychosis, per a History and Physical dated 1/11/12.

A review of the clinical record revealed that Patient 3's father had signed a document entitled, "Advance Directive Acknowledgement," on 1/11/12. Patient 3's father indicated that Patient 3 had not executed any Advance Directives, but the father, on the patient's behalf, had requested information about Advance Directives from the facility.

Per a Psychosocial Assessment form completed on 1/13/12, Social Worker (SW) 1 acknowledged that Patient 3 did not have an Advance Directive and that the family desired further information.

There was no further documentation in the record to indicate that Patient 3's family had received the requested information concerning Advance Directives. There was no additional documentation by SW 1, or any other SW, since the initial psychosocial assessment conducted on the patient's day of admission, 1/11/12. As of 2/29/12, Patient 3 had been hospitalized for 50 days.

On 2/29/12 at 8:40 A.M., an interview was conducted with SW 1. SW 1 was unable to present any documentation or verbalize as to whether the family had received the requested information concerning an Advance Directive.

A review of the "Advance Healthcare Directive" policy, dated 12/10 was conducted on 2/29/12. Per the policy, "Social Services shall provide the patient with information on Advance Health Care Directives."

On 2/29/12 at 9:00 A.M., SW 1 and the DON acknowledged that the family should have been provided with the requested information and documentation should have been in the record to attest to that.

3. On 2/29/12 at 8:00 A.M. a tour of the Intensive Care Unit (ICU) was conducted with the Director of Nurses (DON).

A record review of Patient 4's record was conducted following the tour of the ICU. Patient 4 was admitted to the facility on 2/24/12, for malnutrition and acute kidney failure, per the facesheet. Patient 4 had a history of a heart arrythmia, high blood pressure, and experienced a cardiac arrest on 2/26/12, after her admission to the facility, per a consult dated 2/27/12. Per a History and Physical dated 2/24/12, the patient's daughter was her Durable Power of Attorney (DPOA-able to act on another person's behalf for legal matters).

A review of the clinical record revealed a document entitled, "Authorization to Release Patient Records," dated 2/24/12, and signed by Patient 4's daughter. Per the document, the daughter authorized the hospital to obtain Patient 4's Advance Directive from another facility.

On 2/29/12 at 10:00 A.M., an interview was conducted with Registered Nurse (RN) 3. Per RN 3, she spoke with the patient's daughter on 2/26/12, concerning the Advance Directive request. The patient's daughter told RN 3 that she wanted the hospital to get a copy of the Advance Directive so that the hospital would know her mother's wishes. RN 3 told the patient's physician. Per RN 3, the physician talked with the daughter and reported back to RN 3 that, "everything was ok," and "no Advance Directive."

Another document entitled "Resuscitation Status Orders" dated 2/26/12, and signed by Patient 4's daughter and Patient 4's physician, indicated that Patient 4 was a "full resuscitation" status.

As of 2/29/12, there was no Advance Directive found in Patient 4's record.

A review of Social Worker (SW) 2's initial psychosocial assessment conducted on 2/27/12, revealed no documentation pertaining to any follow up or any attempt to obtain the patient's Advance Directive.

A review of the Social Worker's job description was conducted on 2/29/12. Per the job description, one of the SW's primary job duties included completing activities pertaining to advance directives, POA (power of attorney), and patient rights.

On 2/29/12 at 10:30 A.M., an interview was conducted with the Director of Social Services who acknowledged that SW 2 should have followed up to determine if Patient 4's daughter was the actual DPOA for healthcare, and to obtain a copy of the patient's Advance Directive.



26660

Based on interview and record review, the hospital failed to implement its policy and procedure related to Advance Directives, for 11 of 34 (3, 4, 51, 52, 53, 54, 55, 56, 57, 58, 59) sampled patients.
Findings:
1. Record review of 9 (51, 52, 53, 54, 55, 56, 57, 58, 59) outpatient medical records of patients undergoing medical procedures requiring general anesthesia, was conducted on 2/29/12, at 2:00 P.M. The records revealed no documentation in 9 (51, 52, 53, 54, 55, 56, 57, 58, 59) of 9 outpatient records, regarding Advance Directive notices or that Advance Directive information was provided to these patients. A form titled, Pre-operative checklist and Post Anesthesia care unit record, indicated to place a check box next to a statement, "Advance Directive. If patient has one, it must be in the chart." In 9 out of 9 outpatients medical records reviewed the checkbox was left blank.
An interview with the Admitting Manager was conducted on 2/28/12 at 12:15 P.M. She stated that the facility used a form titled, Advance Directive acknowledgement, "for inpatients only." She stated that the facility did not use this form for outpatients. The admitting manager further stated that, when an outpatient is admitted for a procedure they are asked if they have an Advance Directive and if they have an Advance Directive, the facility will attempt to have a copy of it placed in the medical record. She stated that there was no documentation that a notice of Advance Directive information provided to the outpatients was documented in the outpatient records.
On 2/29/12 at 10 A.M., a review of the hospital's policy and procedure (P&P) titled "Advance Health Care Directive," specified that, "Every adult or emancipated minor will be provided written information at the time of admission concerning an individual's right under state law to make decisions regarding his or her medical care. This includes the right to accept or refuse treatment and the right to formulate Advance Directives." The P&P did not specify that this policy applied to inpatients only.

Based on interview and record review, the hospital failed to ensure that restraint orders were complete, for 2 of 34 sampled patients (11,12), when the orders did not indicate to which extremity or extremities the restraints would be applied. In addition, the facility failed to ensure that a restraint was applied as ordered, for 1 of 34 sampled patients (11).

Findings:

1. A review of Patient 11's medical record was conducted on 2/28/12, at 2:10 P.M. Patient 11 was admitted to the hospital on 2/7/12, with diagnoses that included severe Alzheimer dementia (deterioration of intellectual faculties), per the History and Physical, dated 2/7/12. Per the same report, Patient 11 had an unwitnessed fall which resulted in pelvic and sacroiliac joint fractures.

A review of Patient 11's Physical Restraint Orders, dated 2/20/12 at 10:05 P.M., indicated that the reasons for the use of restraints included: At risk for injury to self (removing invasive lines/tubes and/or other); Cognitive impairment resulting in the patient's inability to follow instructions regarding safety measures; Attempting to get out of bed without calling for assistance after alternative measures have failed risking harm to self. Per the same record, under the section "Type of Restraint," a check mark indicated that the restraint ordered was for the wrist. However, the order did not indicate whether the wrist restraint was to be applied onto the right or left or to the bilateral wrists.

A review of the nursing documentation for 2/20/12 and 2/21/12, indicated that Patient 11 had restraints applied to both left and right wrists. However, there was no documented evidence that the incomplete restraint order was clarified with the ordering physician.

Further review of Patient 11's Physical Restraint Orders, dated 2/26/12 at 10:15 P.M., indicated an order for bilateral wrist, and right ankle restraints. However, a review of the nursing documentation from 2/27/12 at 8:00 A.M. through 2/28/12 at 6:00 A.M., revealed that bilateral wrist restraints and a left ankle restraint, were applied to the patient instead of a right ankle restraint, as ordered by the physician.

A joint record review and interview with the Intensive Care Unit/Medical-Surgical Nurse Manager (ICU/MSNM) was conducted on 2/28/12 at 3:35 P.M. The ICU/MSNM acknowledged that Patient 11's restraint order was incomplete. The ICU/MSNM also acknowledged that the restraint order should have been clarified with the ordering physician. The ICU/MSNM also acknowledged that the order to apply a right ankle restraint was not followed as ordered.

2. A review of Patient 12's medical record was conducted on 3/1/12 at 9:20 A.M. Patient 12 was admitted to the hospital on 1/26/12, with diagnoses that included mitral valve endocarditis (an infection of the heart valve) with right lower lobe pneumonia, per the History and Physical, dated 1/27/12.

A review of Patient 12's Physical Restraint Orders, dated 2/11/12 at 10:55 P.M., indicated that the reasons for the use of restraints included: At risk for injury to self; Cognitive impairment resulting in the patient's inability to follow instructions regarding safety measures. Per the same record, under the section "Type of Restraint," a check mark indicated that the restraint ordered was for the wrist. However, the order did not indicate whether the wrist restraint was to be applied onto the right or left or bilateral wrists.

A review of the nursing documentation for 2/11/12 and 2/12/12, indicated that Patient 12 had restraints applied to both left and right wrists. However, there was no documented evidence that the incomplete restraint order was clarified with the ordering physician.

A joint record review and interview with the Intensive Care Unit/ Medical-Surgical Nurse Manager (ICU/MSNM) was conducted on 3/1/12 at 10:25 A.M. The ICU/MSNM acknowledged that Patient 12's restraint order was incomplete. The ICU/MSNM also acknowledged that the restraint order should have been clarified with the ordering physician.

Based on interview and record review, following a Sentinel Event, (SE-an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof) in the Intensive Care Unit (ICU), related to the administration of the high risk drug, Propofol (a general anesthetic drug that depresses the central nervous system and used in the ICU setting to manage patients on breathing machines), the hospital failed to ensure that nursing leadership provided ongoing oversight pertaining to the administration of Propofol in the ICU.

Findings:

On 2/28/12, the hospital's Propofol policy and procedure, dated 12/20/11, was reviewed. Per the policy, propofol infusions were initiated at a rate of 5 micrograms (mcg)/kilogram (kg)/ minute. The infusion rates were to be increased in increments of 5 mcg/kg/min every 5 minutes until the desired level of sedation was achieved using the lowest possible dose.

A review of the hospital's policy entitled, "High Risk High Alert Medications," dated 12/20/12, defined high-alert medications as "drugs that bear a heightened risk of causing significant patient harm when they are used in error." The policy identified Propofol as a high risk/high alert drug.

On 2/29/12 at 1:05 P.M., a joint interview was conducted with the following staff: The Chief Operating Officer (COO), the Chief Administrative Officer/Risk Manager (CAO/RM), the Director of Nursing (DON), the ICU/MSU Nurse Manager (NM), and the Director of Pharmacy (DP). The above team was asked if the hospital had experienced any adverse events pertaining to the drug Propofol. The ICU/MSU NM stated that in October or November of 2011, Patient 1 mistakenly received an infusion of Propofol (1000 mg/100 ml, or the entire bottle) in a 30 minute period. The ICU/MSU NM stated that she was at the bedside because she was part of the Rapid Response Team. Per the ICU/MSU NM, she checked the IV bottle of Propofol and saw that it was hung at 4:00 P.M. She stated that she checked the time when she entered the room and it was 4:30 P.M, and the bottle of Propofol was empty. The ICU/MSU NM acknowledged that a mistake had occurred in the administration of the high risk drug, Propofol. The team was unclear how the mistake occurred, but held RN 1 accountable for the error. The team acknowledged that the error should have been considered an SE by hospital.

On 2/28/12 at 11:15 A.M., a tour was conducted of the ICU with the ICU/MSU Nurse Manager (NM). The ICU was comprised of 5 beds and all beds were occupied. Patients 3 and 4 were ventilated via breathing machines and were receiving intravenous infusions of Propofol.

Following the ICU tour and record review, the following observations were shared with the COO, the CAO/RM, the DON, the DP, and the ICU/MSU NM:

A record review was initiated on 2/29/12 at 9:25 A.M. Patient 4 was admitted to the hospital on 2/24/12, for malnutrition and kidney failure, per the facesheet. Per physician progress notes of 2/25/12, a Code Blue was called because the patient was lethargic with a blood pressure of 56/43. Emergent intervention was initiated, a breathing tube was inserted, and the patient was transferred to the ICU.

Per RN 10's Nursing Progress note, dated 2/26/12 at 8:00 P.M., Patient 4 was agitated and reached for her breathing tube. RN 10 documented that Patient 4 "started on Propofol at 40 mcg. as patient was agitated." The patient's blood pressure prior to the infusion was 160/80. At 8:30 P.M., RN 10 documented that the patient's blood pressure dropped to 83 and the Propofol was titrated down to 5 mcg. RN 10 documented that she initiated the infusion at 40 mcg. when the protocol instructed Propofol to be initiated at 5 mcg. RN 10 documented that she titrated the infusion down to 5 mcg. and then increased it back to 10 mcg/kg/min. at 9:45 P.M. There was no documentation on the MAR to indicate that the increment changes were doublechecked with another RN.

A record review was inititated on 2/29/12 at 10:00 A.M. Patient 3 was admitted to the ICU on 1/11/12 with respiratory failure and was dependent on a breathing machine, per the facesheet.

On 2/21/12 at 7:55 P.M., RN 10 documented in the progress notes that Patient 3 was "really agitated" and "keeps trying to get out of bed."

On 2/21/12 at 8:00 P.M., a physician gave a telephone order to "re-start on Propofol drip."

On 2/21/12 at 8:10 P.M., RN 10 documented "Propofol restarted at 50 mcg., titrated down to 20 mcg., when patient fell asleep." RN 10 documented that she started the infusion at the highest dose/rate possible, rather than start at 5 mcg./kg/min and increase in increments of 5 mcg., per the hospital protocol. In addition, there was no documentation on the Medication Administration Record (MAR) to indicate that the increment changes in Propofol were double checked by another RN.

A review of the ICU flowsheet for 2/24/12 revealed the following discrepancies regarding the Propofol infusion: At 12:00 P.M., the patient was off Propofol. RN 1 documented that she restarted the Propofol at a rate/dose of 10 mcg/kg/min., rather than 5 mcg, per the protocol. At 7:00 P.M., RN 31 documented that the Propofol was decreased to 3 mcg/kg/min, rather than decrease the infusion by an increment of 5 mcg per the protocol. At 2:00 A.M., Patient 3's the infusion was at 5 mcg. At 3:00 A.M, RN 31 documented that he increased the infusion to 30 mcg. At 4:00 A.M., RN 31 documented that Propofol was increased to 50 mcg/kg/min for continued agitation. There was no documented evidence of RN doublechecks regarding the dose/rate changes, and no evidence that Propofol was adjusted in incremental increases of 5 mcg/kg/min per hospital protocol.

Additional ICU flowsheets for the dates 2/25/12, 2/26/12, 2/27/12 and 2/18/12, revealed similar practices by the ICU RN staff concerning the administration of the Propofol infusion to Patient 3. RNs did not consistently increase or decrease the infusion by increments of 5 mcg/kg/min. RNs did not consistently restart the Propofol infusion at the lowest rate 5mcg/kg/min. RNs did not document double checks of the adjustments on the MAR. There was no documented evidence that the ICU RN staff consistently implemented the Propofol "vacations" or awakenings that were to occur on a daily basis, per the hospital protocol.

On 2/29/12 at 1:20 P.M., the ICU/MSU NM was asked how she maintained oversight of the administration of Propofol by the ICU RNs since the SE. The ICU/MSU NM stated that she "rounded every morning in the ICU." She stated that she double checked the physican's Propofol orders with the infusion rates. She stated that she checked to ensure that Propofol titration was done correctly by the RN staff. The ICU/MSU NM stated that she checked the charts and flowsheet documentation. The ICU/MSU NM was asked to verbalize or explain the hospital's Propofol policy and procedure and protocol. The ICU/MSU NM could not verbalize the protocol. The ICU/MSU NM was asked how, if she truly performed those functions on a daily basis, could the ICU nursing staff continue to demonstrate a lack of adherence to the hospital's policy and procedure pertaining to the administration of Propofol. The ICU/MSU NM had no response.

3. A tour of the north unit in the Behavioral Health Unit (BHU) was conducted on 2/28/12 at 11:30 A.M. A review of the assignment sheet, dated 2/28/12, indicated that there were 2 licensed nurses working that day, a registered nurse (RN) and a licensed vocational nurse (LVN). According to the assignment sheet, the RN had 6 patients and the LVN also had 6 patients. There was no documentation to show break relief assignments on the BHU.

An interview with RN 12 was conducted on 2/28/12 at 11:35 A.M. RN 12 stated that if she needed to take a break and her partner for the day was an LVN, she would call the "Call Center" at the BHU, so they could send a BHU competent RN to relieve her. However, RN 12 stated that if she wanted to take a break and her partner for the day was an RN, RN 12 stated that she could take her break without calling for relief because her partner was an RN. RN 12 stated that the other RN will then be in-charge of 12 patients while RN 12 was on her break.

A review of the hospital policy and procedure titled Nurse Staffing Guidelines for the Behavioral Health Unit, was conducted on 2/28/12, at 4:00 P.M. The policy indicated that, "The licensed nurse-to-patient ratio for the inpatient Behavioral Health Unit shall be 1:6 or fewer at all times."



21053

Based on observation, interview and document review, the hospital failed to implement it's policies and procedures pertaining to nurse staffing for the Intensive Care Unit (ICU), the Medical Surgical Unit (MSU), or the Behavior Health Unit (BHU). The hospital failed to ensure that adequate numbers of licensed nursing staff were maintained at all times, to ensure that patient care needs were met and that "quality effective patient care" was delivered, as per the hospital's own policies and procedures.

Findings:

1. On 2/28/12 at 11:15 A.M., a tour was conducted of the ICU with the ICU/MSU Nurse Manager (NM). The ICU was comprised of 5 beds and all beds were occupied.

The ICU daily assignment sheet was reviewed with Registered Nurse (RN) 4. Three RNs were assigned to care for 5 patients. RN 4 was assigned to one patient on 2/28/12. The other 2 RNs had 2 patients each. RN 4 stated that there was no RN assigned to a "charge nurse" role, and that there was not an assigned resource nurse to cover nurses during breaks and meals. RN 4 was asked how breaks and meal breaks were covered in the ICU. RN 4 stated that a Respiratory Therapist would come to the ICU when an RN took a break, and the other 2 RNs would cover 5 patients. RN 4 acknowledged that an RT is not equivalent to an RN. RN 4 acknowledged that during those time periods the required nurse-to-patient staff ratios were not met, as 1 nurse would cover 3 or possibly 4 patients, depending on the acuity levels of the patients. RN 4 stated that on that morning (2/28/12) she relieved RN 2 for a coffee break. RN 4 stated that RN 2 was assigned to 2 patients, which meant that RN 4 watched her own patient plus 2 others, for a total of 3 patients during that time period.

On 2/28/12 at 11:30 A.M., an interview was conducted with ICU RN 2. RN 2 stated, "we usually cover each other when we take our breaks and meal breaks."

A review of the hospital's policy entitled, "Unit Staffing and Acuity Guidelines for the Intensive Care Unit (ICU)," dated 12/21/09, was reviewed on 2/28/12. Per the policy, "The ICU Staffing Plan shall have guidelines to ensure adequate staffing of the unit, to provide quality patient care and telemetry observation." "The ICU Staffing Plan shall reflect compliance to the mandatory nurse staffing ratios." Per the policy, "the licensed Nurse-to-patient ratio in the ICU shall be 1:2 or less at all times according to the acuity."

2. On 2/28/12 at 11:45 A.M., a tour of the MSU was conducted with the ICU/MSU NM and Assistant ICU/MSU NM. The MSU break/lunch log was reviewed with both NMs and the Charge Nurse, RN 6. On 2/28/12, the MSU had a Charge Nurse and a resource nurse assigned to the unit. However, the break/lunch log for 2/28/12, revealed that RNs relieved each other for all breaks and meal breaks. Per the sheet, RN 7 and 8 were assigned to relieve each other. The Charge Nurse, RN 6, stated that RN 7 and RN 8 each were assigned 4 patients that day. RN 6 stated that when the RNs relieved each other for breaks, each would be covering 8 patients during that time period. RN 6 was unable to verbalize what the mandated nurse-to-patient staffing ratio was for the MSU, per hospital policy. RN 6 stated that she had been a Charge Nurse for 6 months, and "that was the way" she was instructed to assign break coverage for the RNs.

On 2/28/12, the hospital's policy entitled, "Nurse Staffing Guidelines for the Medical Surgical Units," dated 12/20/10, was reviewed. Per the policy, staffing guidelines for the MSU were in place to ensure sufficient number of assigned qualified, competent staff with the goal of providing safe and quality patient care. Per the policy, "The licensed nurse-to-patient ratio for the inpatient MSU will be 1:5 or fewer at all times." "The 1:5 maximum nurse-to-patient ratio represents the maximum number of patients that will be assigned to one licensed nurse at any one time."

The MSU break/lunch logs and patient assignment sheets were reviewed for both the A.M. and P.M shifts during the month of 2/12. Multiple logs and patient assignment sheets for both shifts (12-hour shifts) were reviewed and demonstrated that RNs relieved each other for breaks, rendering the unit out of compliance with the hospital's nurse-to-patient staffing ratios, to ensure safe and effective care of patients at all times, per the hospital's policy.

On 2/28/12 at 11:55 A.M., the ICU/MSU NM and ICU/MSU Assistant NMs were interviewed. Per the ICU/MSU NM, the hospital's mandated nurse-to-patient ratio was a maximum of 1:5. She acknowledged that the unit was not in compliance with the nurse-to-patient staffing ratios at all times in the ICU and MSU care units, asper hospital policy. The ICU/MSU NM stated that she was, "under constraint of budgetary requirements." The Assistant/MSU NM stated, "I understand its not the right thing to do, but it's the staff that we have."

On 2/28/12 at 12:15 P.M., an interview was conducted with the Director of Nursing (DON). The DON stated that she was unaware that the nurse-to-patient staffing ratios were not upheld in the ICU and MSU, per hospital policy.

On 3/2/12 at 11:30 A.M. a joint interview was conducted with 6 members of the Governing Body to include the Chief of Staff, Medical Doctor (MD) 32. Per MD 32, the "most important" thing to him as Chief of Staff was having competent staff and mandated nurse-to-patient staffing ratios in place. MD 32 stated he was unaware that the hospital was not following it's own staffing policy and procedure and did not have the required nurse-to-patient staffing ratios in place. MD 32 stated that he was "shocked."

Based on interview and record review, the hospital failed to ensure that 1 of 34 sampled patient's (13) dialysis access sites, was assessed consistently. In addition, the hospital failed to ensure that physician's orders were implemented as ordered, for 2 of 34 sampled patients (12,13).

Findings:

1. Patient 13's medical record was reviewed on 2/29/12 at 9:35 A.M. Patient 13 was admitted to the hospital on 2/18/12, with diagnoses that included end stage renal disease (kidney failure), per the patient's History and Physical, dated 2/19/12.

A review of Patient 13's Nursing Assessment record, dated 2/19/12 at 7:00 P.M., indicated that Patient 13 had a dialysis access site on the left upper extremity. The documentation indicated that the dialysis access site had a thrill (a distinct "buzzing" feeling when blood flows rapidly through the fistula - when an artery and vein is joined together) and bruit (a sound heard through a stethoscope of blood "whooshing" through the fistula). However, further review of the Nursing Assessment Records indicated that assessments of the patient's dialysis access site were not consistently done.

A review of Patient 13's Nursing Assessment record, dated 2/18/12 and 2/26/12, showed no documented evidence that the patient's dialysis access site was assessed on both shifts (7:00 A.M.-7:00 P.M.) and (7:00 P.M.-7:00 A.M.). A review of the patient's Nursing Assessment record, dated 2/27/12, indicated that the dialysis access site was assessed at 7:20 A.M. However, at 7:45 P.M., that same day, the documentation indicated that the patient did not have a dialysis access site, which was inaccurate.

An interview with registered nurse (RN) 8 was conducted on 2/29/12, at 10:05 A.M. RN 8 stated that Patient 13 had a fistula on the left arm for dialysis access. RN 8 stated that the dialysis access site should be assessed every shift.

A joint record review and interview with the Intensive Care Unit/ Medical-Surgical Nurse Manager (ICU/MSNM) was conducted on 2/29/12 at 10:30 A.M. The ICU/MSNM acknowledged that, Patient 13's dialysis access site was not consistently assessed. The ICU/MSNM acknowledged that the dialysis access site should have been assessed every shift.

2. Patient 12's medical record was reviewed on 3/1/12 at 9:20 A.M. Patient 12 was admitted to the hospital on 1/26/12, with diagnoses that included end stage renal disease (kidney failure), per the History and Physical, dated 1/27/12.

A review of the Physician's Order sheet, dated 2/7/12 at 10:30 P.M., indicated an order to weigh Patient 12 every other day and record the weight.

A review of Patient 12's 24 Hour Care Record dated 2/8/12, indicated that the patient's weight that day was 113.2 kg (kilograms). However, there were no documented weights for Patient 12 on 2/10/12, 2/11/12, and 2/12/12.

Further review of Patient 12's Physician's Order sheets, dated 2/8/12 at 10:40 A.M., indicated an order for a fluid restriction of 1000 cc (cubic centimeter) per day. However, a review of the patient's 24 Hour Care Records, dated 2/10/12, 2/11/12, and 2/12/12, indicated that the patient's total intake during the above dates were: 1750 cc (2/10/12), 1265 cc (2/11/12), and 1852 cc (2/12/12). The total fluid intake for Patient 12 on 2/10/12, 2/11/12, and 2/12/12, were not within the fluid restriction orders that the physician had written.

A joint record review and interview with the Intensive Care Unit/ Medical-Surgical Nurse Manager (ICU/MSNM), was conducted on 3/1/12 at 11:30 A.M. The ICU/MSNM acknowledged that the physician's orders pertaining to Patient 12's weight and fluid restriction were not followed as ordered.

3. Patient 13's medical record was reviewed on 2/29/12 at 9:35 A.M. Patient 13 was admitted to the hospital on 2/18/12, with diagnoses that included end stage renal disease (kidney failure), per the History and Physical, dated 2/19/12.

A review of Patient 13's Dietary Recommendation sheet and nutritional physician's order sheet, dated 2/20/11 at 10:30 A.M., indicated an order to give Nephro (dietary supplement) 1 can as needed if the patient refuses her meals.

A review of the Physician's Progress Notes, dated 2/25/12 at 10:30 A.M., indicated that Patient 13 had "+ (positive) cachexia (weakness and wasting of the body due to severe chronic illness).

A review of Patient 13's 24 Hour Care Record, dated 2/24/12, indicated that the patient refused lunch. However, there was no documented evidence that the patient was given 1 can of Nephro as ordered by the physician. A review of the patient's 24 Hour Care Record, dated 2/26/12, showed no documentation whether the patient ate dinner or not. However, there was no documented evidence that the patient was given Nephro as ordered. According to the patient's 24 Hour Care Record, dated 2/27/12, the patient refused dinner. However, there was no documented evidence that the patient was given Nephro as ordered by the physician.

A joint record review and interview with the Intensive Care Unit/ Medical-Surgical Nurse Manager (ICU/MSNM), was conducted on 2/29/12 at 10:30 A.M. The ICU/MSNM acknowledged that the order pertaining to Nephro was not implemented as ordered by the physician.

Based on interview and record review, the hospital failed to ensure that a written care plan related to dialysis, was developed for 1 of 34 sampled patients (13). In addition, the hospital failed to ensure that 1 of 34 sampled patients (28) care plans was implemented, to accurately record the patient's fluid intake and output.

Findings:

1. A review of Patient 13's medical record was conducted on 2/29/12, at 9:35 A.M. Patient 13 was admitted to the hospital on 2/18/12, with diagnoses that included end stage renal disease (kidney failure), per the History and Physical, dated 2/19/12. Per the same record, the patient was on hemodialysis (a method for removing waste products, as well as free water from the blood when the kidneys are in renal failure).

There was no documented evidence that a written care plan related to Patient 13's hemodialysis was developed.

A joint record review and interview with registered nurse (RN) 8 was conducted on 2/29/12 at 10:05 A.M. RN 8 acknowledged that a written care plan related to Patient 13's hemodialysis was not developed.

A joint record review and interview with the Intensive Care Unit/ Medical Surgical Nurse Manager (ICU/MSNM) was conducted on 2/29/12 at 10:30 A.M. The ICU/MSNM acknowledged that a written care plan related to Patient 13's hemodialysis should have been developed.


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2. Patient 28 was admitted to the hospital on 8/5/11, with diagnoses that included septic shock, recurrent ventilator (a respirator or breathing machine) assisted pneumonia, chronic ventilatory dependent respiratory failure, chronic malnutrition, anemia and failure to thrive, according to the admission History and Physical. A review of Patient 28's medical record and concurrent interview with Registered Nurse (RN 1), was conducted on 3/1/12 at 3:40 P.M. RN 1 stated that she remembered Patient 28, and had been assigned to care for her in the Intensive Care Unit (ICU) a couple of times. RN 1 recognized her own handwriting on the ICU Nursing Flowsheet, dated 11/5/11. Under the category of "Output Urine," RN 1 had charted that every hour from 8:00 A.M. to 5:00 P.M., Patient 28's urinary output was 66 cc (cubic centimeters). RN 1 was asked how she calculated that Patient 28's urine output was the exact same amount for 10 hours. RN 1 replied that she read the amount of urine in the micrometer of the urinary drainage bag the first hour of her shift and recorded that amount on the Nursing Flowsheet. RN 1 had recorded 16 cc for the first hour of her shift. Then, RN 1 explained that, at the end of her shift, she emptied the urinary drainage bag and divided the amount, minus the 16 ccs, by the number of hours after the first hour.

A nursing intervention documented on Patient 28's care plan was to, "Monitor and record I & O (fluid intake and output). The purpose of the hospital's policy and procedure entitled "Intake and Output," dated 12/20/10, was "To keep an accurate record of total fluid intake and output to assure the best medical therapy."

An interview was conducted with the Point (equal to Charge) RN of ICU (RN 4), on 3/2/12 at 8:25 A.M. RN 4 stated that all patients in the ICU have hourly urinary outputs recorded on the Nursing Flowsheet. She stated that this is done by recording the urinary output every hour and then draining the urinary drainage bag. RN 4 further stated that it is never acceptable to empty the drainage bag at the end of a 12 hour shift and divide the total amount of urine by 12, because you would only be guessing at the patient's hourly urine output. RN 4 also stated that it is very important to document the patient's urinary output every hour to determine if the patient is developing renal problems.

On 3/2/12 at 8:35 A.M., an interview was conducted with the hospital's Director of Nursing (DON). The DON also stated that it is not acceptable to determine an ICU patient's urinary output by emptying the urinary drainage bag at the end of a shift and dividing by the number of hours in the shift, because the nurse would not be able to determine the patient's renal function each hour.

Based on interview and record review, the hospital failed to ensure that an ICU (intensive care unit) level patient, was assigned to a nurse with critical care competency. In addition, an RN (Registered Nurse) in the ICU was independently administering high risk medications when she was not deemed competent to do so. And, the hospital failed to ensure that annual competencies were conducted for the ICU Registered Nurses who administered high risk medications.

Findings:

1. A random interview with RN 13, a Medical/Surgical (Med/Surg) nurse, was conducted on 3/1/12 at 1:58 P.M. RN 13 stated that she had been assigned a patient in the past who was on Neosynephrine (a potent vasopressor - an agent that causes constriction of blood vessels) drip.

An interview with the Intensive Care Unit/ Medical-Surgical Nurse Manager (ICU/MSNM) was conducted on 3/1/12 at 2:15 P.M. The ICU/MSNM confirmed that RN 13 was assigned a patient who was on a Neosynephrine drip, because there was no available bed in the Intensive Care Unit (ICU). The ICU/MSNM stated that RN 13 ensured that the patient was stable while she, (the ICU/MSNM), cared for the patient and charted on the patient's medical record. The patient's chart was requested for review.

Patient 14's medical record was reviewed on 3/2/12 at 9:02 A.M. Patient 14 was admitted to the hospital on 1/24/12, per the facesheet. A review of the Physician's Order Sheet, dated 1/24/12 at 4:40 P.M., indicated orders that included, "Admit to ICU" and "Neosynephrine drip: 10 mcg/min (micrograms/minute) Titrate to keep SBP (systolic blood pressure) > 90 mmHg (millimeters of mercury - unit of pressure measurement)."

The Nursing Progress Note written by RN 14 (a Med/Surg nurse), dated 1/24/12 at 8:00 P.M., indicated that Patient 14 was admitted to the east wing (Med/Surg Unit) after a bronchoscopy (a technique of visualizing the inside of the airways for diagnostic and therapeutic purposes) procedure. According to the progress note, Patient 14 was connected to a ventilator, had a nasogastric tube for suction, and was on a Neosynephrine drip. Per the same record, at 8:05 P.M. that same day, the patient's blood pressure went down to "60's/35." RN 14 documented that the physician was informed and an ICU nurse increased the Neosynephrine drip. Per the same record, a late entry for 8:05 P.M. (no time indicating when the late entry was written) was documentated by an ICU nurse. The documentation indicated that, "Called in to check on pt. (patient) c (with) ? (decrease) BP (blood pressure). Neo (Neosynephrine) drip @ (at) 10 mcg (micrograms).....M.D. already notified Neo titrated ? (increase). The ICU nurse further documented that at 8:25 P.M., "BP better, Neo titrated ? 20 mcg.....Primary RN @ bedside." The primary RN assigned to monitor Patient 14, and who documented the majority of the nursing care provided to Patient 14 except for the titration of the Neosynephrine drip, was RN 14 a Med/Surg nurse.

A group interview with the Governing Body, represented by the hospital's Chief Executive Officer (CEO), Chief Operating Officer (COO), Medical Director, Chief of Staff, two other physicians, and the Director of Admission and Marketing, was conducted on 3/2/12 at 11:30 A.M. The physicians were asked what their expectations were related to patient care, when they ordered patients to be admitted to the ICU. Physician 11 stated that it was his expectation that the patient would be cared for by a nurse trained in the ICU setting. Physician 11 also stated that the hospital's practice of assigning Medical/Surgical nurses who were not competent in caring for ICU patients should stop immediately. The Medical Director stated that in Patient 14's case, an ICU nurse was partially involved with the patient's care. However, the Medical Director also stated that an ICU nurse should be caring for an ICU patient at all times. The Medical Director acknowledged that this did not happen in Patient 14's case. The Chief of Staff stated that he was shocked to find out that a Med/Surg nurse was assigned an ICU patient.

RN 14's employee file was reviewed on 3/2/12 at 11:55 A.M. The was no documented evidence that RN 14 had competency in critical care.

An interview with the Chief Operating Officer (COO) was conducted on 3/2/12 at 12:30 P.M. The COO stated that the hospital did not have a written policy and procedure related to managing ICU overflow or when ICU beds were not available for ICU patient admission.


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2. On 2/29/12 at 1:05 P.M., a joint interview was conducted with the following staff: the Chief Operating Officer (COO), the Chief Administrative Officer/Risk Manager (CAO/RM), the Director of Nursing (DON), the ICU/MSU Nurse Manager (NM), and the Director of Pharmacy (DP). The team was asked if the hospital had experienced any adverse events pertaining to the drug Propofol. The ICU/MSU NM stated that in October or November of 2011, Patient 1 mistakenly received an infusion of Propofol (1000 mg/100 ml, or the entire bottle) in a 30 minute period. The ICU/MSU NM stated that she was at the bedside because she was part of the Rapid Response Team. Per the ICU/MSU NM she checked the IV bottle of Propofol and saw that it was hung at 4:00 P.M. She stated that she checked the time when she entered the room and it was 4:30 P.M., and the bottle of Propofol was empty. The ICU/MSU NM acknowledged that a mistake had occurred in the administration of the high risk drug, Propofol. The team was unclear how the mistake occurred, but held RN 1 accountable for the error.

An interview was conducted with the hospital's Intensive Care Unit (ICU)/Medical Surgical Unit (MSU) Clinical Educator (CE), on 3/2/12 at 10:10 A.M., to discuss the orientation of new Registered Nurses (RN) to the ICU. The CE explained that after four days of general hospital orientation the new ICU RN meets with his/her Preceptor and the CE. When an RN is transferred within the hospital from the Medical/Surgical Unit to the ICU, a minimum of six weeks working/orientation with a Preceptor in the ICU is required. The CE further explained that the Preceptor is to complete a weekly written evaluation of the newly hired ICU RN's performance. During the six week orientation period the Preceptor can "sign off" the RN as being competent in any particular clinical area until competency has been demonstrated in all clinical areas of ICU nursing. The CE was asked for all the weekly Preceptor evaluations for RN 1, a new ICU RN that had transferred from the Med/Surg unit on 8/1/11. The CE was unable to provide any written evaluations by the Preceptor of RN 1's clinical performance in ICU between 8/1/11 and 9/9/11 (RN 1's six week orientation period in ICU).

A review of RN 1's personnel file was conducted with the CE on 3/2/12 at 11:00 A.M. A document entitled Competency Assessment / Essential Responsibilities was reviewed with the CE. The Reviewer Instructions portion of the Competency Assessment indicated that "An Initial Competency Assessment is due by the end of each employee's Provisional Period for all new hires, change in position or promotion, and transfer from another department." There was a section in the Competency Assessment for the administration of high risk medications. There were 20 high risk medications listed along with Emergency Standing Orders. An RN needed to demonstrate competency in the administration of those twenty medications as well as competency with Emergency Standing Orders for eight different life threatening cardiac diagnoses to be deemed competent to work independently to administer high risk medications in ICU. On RN 1's orientation Competency Assessment sheet, along side each of the 20 high risk medications and the Emergency Standing Orders, was handwritten, "needs more exposure, more experience and verification with another RN."

A review of the hospital's policy and procedure entitled "Competency Assessment," dated 12/20/10, indicated that, "Those employees who work in high risk, problem prone patient care settings must have a competency assessment of unit/department specific skills documented prior to performing the procedure or task independently."

During the interview with the CE on 3/2/12, the CE acknowledged that on 10/14/11, when the Propofol medication error occurred in ICU, RN 1 had independently administered high risk medications to Patient 1, when she had not been deemed competent to be performing the task independently.

3. An interview was conducted with the Intensive Care Unit (ICU) /Medical Surgical Unit (MSU) Nurse Manager (NM) on 3/1/12 at 10:00 A.M. The NM stated that the annual competencies for the ICU Registered Nurses (RN) did not include the RNs having to demonstrate competency in the administration of high risk medications. The NM further stated that, no inservices are conducted regarding the administration of high risk medications after an RN has completed orientation to the ICU.

On 3/1/12 at 10:10 A.M., an interview was conducted with RN 3 who was a full time ICU staff nurse for the past four years. RN 3 stated that she is not expected to demonstrate competency for the administration of high risk medications on an annual basis.

On 3/1/12 at 1:50 P.M., an interview was conducted with the hospital's ICU/MSU Clinical Educator (CE). The CE stated that he and the NM oversee the annual competencies for the RNs in the ICU. The CE further stated that he has never seen anything in any of the ICU RNs files to indicate that the administration of high risk medications is part of their annual competencies. The CE was unable to provide any documentation that the RNs in ICU demonstrated competency in the administration of high risk medications on an annual basis.

4. Patient 12's medical record was reviewed on 3/1/12 at 9:20 A.M. Patient 12 was admitted to the hospital on 1/26/12, with diagnoses that included end stage renal disease (kidney failure), per the History and Physical, dated 1/27/12.

A review of the Physician's Order Sheet, dated 2/12/12 at 8:30 P.M., indicated an order for "Propofol (used to induce or maintain anesthesia during certain surgeries, tests, or procedures) drip for sedation." The physician's order did not indicate to use the hospital's Propofol protocol. The order did not indicate the desired RASS score (Richmond Agitation/Sedation Scale - used for quantifying the patient's sedation level) to be achieved with the Propofol. The order was not signed, dated, and timed by the nurse who received the order.

A review of the nursing flowsheet, dated 2/12/12, indicated that Propofol was started between 8:00 P.M. and 9:00 P.M. at 10 mcg (micrograms). According to the record, Patient 12's RASS score was -3 (moderate sedation - movement or eye opening to voice but no eye contact) and remained at -3 until 6:00 A.M. on 2/13/12. Per the same record, the patient's Propofol was titrated down to 5 mcg between 2:00 A.M. and 3:00 A.M. on 2/13/12. However, there was no documentation to explain why the patient's Propofol was decreased between 2:00 A.M. and 3:00 A.M.

The hospital's policy and procedure titled "Propofol Protocol," was reviewed on 3/1/12 at 10:15 A.M. The policy indicated that, "The Propofol protocol will be initialed by the physician with the order 'Propofol drip per protocol'." This was not followed when the order did not indicate to follow the Propofol protocol. The policy also indicated to initiate Propofol infusion at 5 mcg/kg/min. This was not followed when the registered nurse initiated Propofol at 10 mcg. The policy also indicated to "decrease Propofol infusion rate by increments of 5 mcg/kg/min at 5 minute intervals until a RASS score of -2 (briefly awakens with eye contact to voice less than 10 seconds) is achieved." This policy was not followed when the patient's RASS score remained at -3 from 2/12/12 between 8:00 P.M. and 9:00 P.M. until 2/13/12 at 6:00 A.M. and yet the patient's Propofol infusion rate was not decreased until 2/13/12 between 2:00 A.M. and 3:00 A.M.

A joint record review and interview with Registered Nurse (RN) 10 was conducted on 3/2/12 at 7:10 A.M. After reviewing Patient 12's medical record, RN 10 acknowledged that the Propofol order was incomplete and should have been clarified with the ordering physician. RN 10 stated that she started the Propofol infusion rate at 10 mcg/kg/min and acknowledged that she did not follow the Propofol protocol which was to start the infusion rate at 5 mcg/kg/min. RN 10 stated that the target RASS score per the protocol was -2. However, when asked why the Propofol infusion rate remained at 10 mcg/kg/min for 6 straight hours when the patient's RASS score remained at -3, RN 10 could not explain why she did not titrate or adjust the drip to meet the target RASS score per the protocol.


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Based on observation, interview and record review, the hospital failed to ensure that medications were administered per the physican's order and/or in accordance with established procedures and protocols, for 6 of 34 sampled patients (1,3,4,12,21,28). A high risk medication was not consistently administered per an established protocol, by Registered Nurse (RN) staff in the Intensive Care Unit (ICU). Patient 1 became markedly hypotensive (low blood pressure) and required emergent intervention, when a high risk medication (Propofol) was not administered correctly by RN 1. Patient 4 became hypotensive when the same high risk medication was not initiated per protocol by an RN.

Findings:

1. On 2/28/12, the hospital's Propofol (a general anesthetic drug that depresses the central nervous system, used in the ICU setting to assist in managing patients on breathing machines) policy and procedure, dated 12/20/11, was reviewed. Per the policy, propofol infusions were initiated at a rate of 5 micrograms (mcg)/kilogram (kg)/ minute. The infusion rates were to be increased in increments of 5 mcg/kg/min every 5 minutes until the desired level of sedation was achieved using the lowest possible dose.

A review of the hospital's policy entitled "High Risk High Alert Medications," dated 12/20/12, defined high-alert medications as drugs that "bear a heightened risk of causing significant patient harm when they are used in error." The policy identified Propofol as a high risk/high alert drug.

A record review was initiated on 2/29/12 at 11:20 A.M. Patient 1 was admitted to the hospital's ICU on 10/11/11, with diagnoses that included an above the knee amputation, shortness of breath, and pain per the patient registration form. Per a History and Physical dated 10/11/11, other diagnoses included end stage kidney disease and hemodialysis, diabetes, pulmonary hypertension, and status post heart transplant.

Per a physician order dated 10/13/11, a Propofol intravenous infusion (drip) was ordered. The order specified that Propofol 10 milligrams(mg)/milliliter (ml), 100 ml bag, infuse at a rate of 3.6 ml/hr (weight based dosing) and that the infusion be titrated (adjusted) to a RASS scale (Richmond Agitation Sedation Scale: a scale used to assess the applicable degree of sedation required for a patient to avoid under or over sedating a patient) of -2 (negative 2).

A review of an ICU flowsheet dated 10/14/11, revealed that at 4:30 P.M., RN 1 initiated a Propofol infusion at 5 mcg/kg/min. At 4:45 P.M., RN 1 documented that Patient 1's blood pressure had dropped to 53/48, the Rapid Response Team (RRT: a team whose purpose is to provide early intervention and stabilization to prevent clinical deterioration to a patient prior to an adverse health event) was called; 250 ml. Normal Saline was infused, and the Propofol infusion was stopped. Per RN 1's notes a Neosynephrine (medication to increase blood pressure) infusion was started. At 5:00 P.M., RN 1 documented that the patient's blood pressure was stable at 153/68.

On 2/29/12 at 1:05 P.M. a joint interview was conducted with the following staff: the Chief Operating Officer (COO), the Chief Administrative Officer/Risk Manager (CAO/RM), the Director of Nursing (DON), the ICU/MSU Nurse Manager (NM), and the Director of Pharmacy (DP). The team was asked if the hospital had experienced any adverse events pertaining to the drug Propofol. The ICU/MSU NM stated that in October or November of 2011, Patient 1 mistakenly received an infusion of Propofol (1000 mg/100 ml, or the entire bottle) in a 30 minute period. The ICU/MSU NM stated that she was at the bedside because she was part of the Rapid Response Team. Per the ICU/MSU NM she checked the IV bottle of Propofol and saw that it was hung at 4:00 P.M. She stated that she checked the time when she entered the room and it was 4:30 P.M, and the bottle of Propofol was empty. The ICU/MSU NM acknowledged that an error had occurred in the administration of the high risk drug, Propofol. The team was unclear how the error occurred, but held RN 1 accountable for the error.

On 2/29/12 at 1:00 P.M. an interview was conducted with the Director of Pharmacy (DP) who acknowledged that the side effects of Propofol include decreased respirations, blood pressure, and heart rate.

2. On 2/28/12 at 11:15 A.M. a tour was conducted of the ICU with the ICU/MSU Nurse Manager (NM). The ICU was comprised of 5 beds and all beds were occupied. Patient 4 was ventilated via a breathing machine and was receiving an intravenous infusion of Propofol (a general anesthetic drug that depresses the central nervous system, used in the ICU setting to assist in managing patients on breathing machines).

On 2/28/12 a review of the hospital's policy and procedure entitled "Propofol Protocol," dated 12/20/11 was conducted. Per the protocol, Propofol infusions were initiated at 5 mcg/kg/min. The infusion rate was to be titrated (adjusted) by increments of 5mg/kg/min every 5 minutes until the desired level of sedation was achieved using the lowest possible dose.

A review of the hospital's policy entitled "High Risk High Alert Medications," dated 12/20/12, defined high-alert medications as drugs that bear a heightened risk of causing significant patient harm when they are used in error. The policy identified Propofol as a high risk/high alert drug.

On 2/28/12 at 3:10 P.M., an interview was conducted with RN 9. RN 9 stated that RNs titrated (adjusted) the dose/rate of a Propofol infusion based on the level of sedation required for a patient, per physican order. RN 9 stated there was a hospital protocol for Propofol administration RN 9 stated that those incremental changes in the infusion were to be double checked by another RN, and then both RNs were required to document that double check on the Medication Administration Record (MAR). RN 9 stated that RNs also documented those changes in the progress notes of the ICU flowsheet.

On 2/29/12 at 9:15 A.M., an interview was conducted with RN 3. Per RN 3, with a physician's order RNs could initiate a Propofol infusion at a low dose/rate. RN 3 stated, "5 micrograms (mcg.)/kilogram (kg)/minute (min) was a low dose, but the RN could initiate the infusion at 1-2 mcg., per their own clinical judgement. RN 3 stated RNs titrated the infusion rate in increments, and used own clinical judgement to determine how much those incremental adjustments should be, in order to achieve a certain level of sedation. RN 3 stated that the upper limit for the infusion was 50 mcg./kg/min, and RNs could not exceed that. RN 3 stated that Propofol "vacations" were implemented for patients once a shift to assess a patient's response, and to determine the lowest dose of propofol required.

A record review was initiated on 2/29/12 at 9:25 A.M. Patient 4 was admitted to the hospital on 2/24/12, for malnutrition and kidney failure, per the facesheet. Per physician progress notes on 2/25/12, a Code Blue was called because the patient was lethargic with a blood pressure of 56/43. Emergent intervention was initiated, a breathing tube was inserted, and the patient was transferred to the ICU.

Per a physician order dated 2/26/12, a Propofol intravenous "drip" (infusion) was ordered to achieve a RASS scale (Richmond Agitation Sedation Scale: a scale used to assess the applicable degree of sedation required for a patient to avoid under or over sedating a patient) of -2 (negative 2).

Per RN 10's Nursing Progress note, dated 2/26/12 at 8:00 P.M., Patient 4 was agitated and reached for her breathing tube. RN 10 documented that she "started on Propofol at 40 mcg. as patient was agitated." The patient's blood pressure prior to the infusion was 160/80. At 8:30 P.M., RN 10 documented that the patient's blood pressure dropped to 83 and the Propofol was titrated down to 5 mcg. RN 10 documented that she initiated the infusion at 40 mcg. when the protocol instructed Propofol to be initiated at 5 mcg. RN 10 documented that she titrated the infusion down to 5 mcg. and then increased it back to 10 mcg/kg/min. at 9:45 P.M. There was no documentation on the MAR to indicate that the increment changes were doublechecked with another RN.

Per RN 2's Nursing Progress note, dated 2/28/12 at 3:00 P.M, Patient 4 was on Propofol at 20 mcg/kg/min. RN 2 documented in the progress notes at 4:45 P.M. that she decreased the infusion to 10 mcg/kg/min. Per the hospital protocol, Propofol was to be decreased in increments of 5 mcg/kg/min, not 10mcg/kg/min, as RN 2 did.

On 2/29/12 at 1:00 P.M., an interview was conducted with the Director of Pharmacy (DP) who acknowledged that the side effects of Propofol include decreased respirations, blood pressure, and heart rate. The DP acknowledged that the Propofol protocol had not been followed by the RNs.

3. On 2/28/12 at 11:15 A.M., a tour was conducted of the ICU with the ICU/MSU Nurse Manager (NM). The ICU was comprised of 5 beds and all beds were occupied. Patient 3 was ventilated via a breathing machine and was receiving an intravenous infusion of Propofol (a general anesthetic drug that depresses the central nervous system, used in the ICU setting to assist in managing patients on breathing machines).

On 2/28/12 a review of the hospital's policy and procedure entitled "Propofol Protocol," dated 12/20/11 was conducted. Per the protocol, Propofol infusions were initiated at 5 mcg/kg/min. The infusion rate was to be titrated (adjusted) by increments of 5mg/kg/min every 5 minutes, until the desired level of sedation was achieved using the lowest possible dose.

A review of the hospital's policy entitled "High Risk High Alert Medications," dated 12/20/12, defined high-alert medications as drugs that "bear a heightened risk of causing significant patient harm when they are used in error." The policy identified Propofol as a high risk/high alert drug.

On 2/28/12 at 3:10 P.M., an interview was conducted with RN 9. RN 9 stated that RNs titrated (adjusted)the dose/rate of a Propofol infusion based on the level of sedation required for a patient, per physican order. RN 9 stated there was a hospital protocol for Propofol administration RN 9 stated that those incremental changes in the infusion were to be double checked by another RN, and then both RNs were required to document that double check on the Medication Administration Record (MAR). RN 9 stated that RNs also documented those changes in the progress notes of the ICU flowsheet.

On 2/29/12 at 9:15 A.M. an interview was conducted with RN 3. Per RN 3, with a physician's order, RNs could initiate a Propofol infusion at a low dose/rate. RN 3 stated "5 micrograms (mcg.)/kilogram (kg)/minute (min) was a low dose, but the RN could initiate the infusion at 1-2 mcg, per their own clinical judgement. RN 3 stated RNs titrated the infusion rate in increments, and used own clinical judgement to determine how much those incremental adjustments should be, in order to achieve a certain level of sedation. RN 3 stated that the upper limit for the infusion was 50 mcg./kg/min, and RNs could not exceed that. RN 3 stated that Propofol "vacations" were implemented for patients once a shift to assess a patient's response, and to determine the lowest dose of propofol required.

A record review was inititated on 2/29/12 at 10:00 A.M. Patient 3 was admitted to the ICU on 1/11/12, with respiratory failure and was dependent on a breathing machine. Other diagnoses included seizures, encephalitis (brain inflammation), severe dyskinesia (a movement disorder with involuntary movements) and acute psychosis, per a History and Physical dated 1/11/12.

On 2/21/12 at 7:55 P.M., RN 10 documented in the progress notes that Patient 3 was "really agitated" and "keeps trying to get out of bed."

On 2/21/12 at 8:00 P.M., a physician gave a telephone order to "re-start on Propofol drip."

On 2/21/12 at 8:10 P.M., RN 10 documented "Propofol restarted at 50 mcg., titrated down to 20 mcg., when patient fell asleep." RN 10 documented that she started the infusion at the highest dose/rate possible, rather than start at 5 mcg./kg/min and increase in increments of 5 mcg., per the hospital protocol. In addition, there was no documentation on the Medication Administration Record (MAR) to indicate that the increment changes in Propofol were double checked by another RN.

A review of the ICU flowsheet for 2/24/12 revealed the following discrepancies regarding the Propofol infusion: At 12:00 P.M., the patient was off Propofol. RN 1 documented that she restarted the Propofol at a rate/dose of 10 mcg/kg/min., rather than 5 mcg, per the protocol. At 7:00 P.M., RN 31 documented that the Propofol was decreased to 3 mcg/kg/min, rather than decrease the infusion by an increment of 5 mcg per the protocol. At 2:00 A.M., Patient 3's the infusion was at 5 mcg. At 3:00 A.M, RN 31 documented that he increased the infusion to 30 mcg. At 4:00 A.M., RN 31 documented that Propofol was increased to 50 mcg/kg/min for continued agitation. There was no documented evidence of RN doublechecks regarding the dose/rate changes, and no evidence that Propofol was adjusted in incremental increases of 5 mcg/kg/min per hospital protocol.

Additional ICU flowsheets for the dates 2/25/12, 2/26/12, 2/27/12 and 2/18/12 revealed similar practices by the ICU RN staff concerning the administration of the Propofol infusion to Patient 3. RNs did not consistently increase or decrease the infusion by increments of 5 mcg/kg/min. RNs did not consistently restart the Propofol infusion at the lowest rate 5mcg/kg/min. RNs did not document double checks of the adjustments on the MAR. There was no documented evidence that the ICU RN staff consistently implemented the Propofol "vacations" or awakenings that were to occur on a daily basis per the hospital protocol.



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5. Patient 21 was admitted to the hospital on 2/7/12, with a diagnosis of chronic paranoid schizophrenia, decompensated, according to the patient's History and Physical. A review of Patient 21's chart was conducted on 2/28/12 at 3:00 P.M. According to a physician's order, dated 2/28/12 and timed at 12:04 P.M., Patient 21 was to receive "Miralax (a drug for the treatment of constipation) 17 mg. (milligrams) in juice or water po (by mouth) now." At the time of the record review (3:00 P.M.), there was no notation by a Registered Nurse (RN) that the medication order had been noted or the medication administered.

An interview was conducted with RN 21, on 2/28/12 at 3:15 P.M. RN 21 stated that he "did not see the physician's order." RN 21 proceeded to note the physician's order by signing, dating and timing the physician's order and then administered the medication to Patient 21 at 3:20 P.M.

A review of the hospital's policy and procedure entitled "Ordering Prescription Medications" indicated that, "Now" means, "within one (1) hour."

On 2/28/12, an interview was conducted with the Manager of the Behavioral Health Unit at 3.25 P.M. The Manager stated that, the hospital's policy and procedure was not being followed when RN 21 did not administer a drug ordered to be given "now," until 3 hours and 20 minutes after the physician wrote the order for the medication.

A review of the hospital's policy and procedure entitled, "Medication Administration," indicated that, "Drugs shall be prepared and administered in accordance with orders of the prescriber or practitioner responsible for the patient's care and accepted standards of practice."

6. Patient 28 was admitted to the hospital on 8/5/11, with diagnoses that included septic shock, recurrent ventilator (a respirator or breathing machine) assisted pneumonia, chronic ventilatory dependent respiratory failure, chronic malnutrition, anemia and failure to thrive, according to the admission History and Physical. A review of Patient 28's medical record and concurrent interview with Registered Nurse (RN) 1, was conducted on 3/1/12 at 3:40 P.M. RN 1 stated that she remembered Patient 28 and had been assigned to care for her in the Intensive Care Unit (ICU) a couple of times. RN 1 acknowledged that her own hand writing was on the Medication Administration Record (MAR) dated 11/4/11. RN 1 stated that she had circled the 9:00 A.M. medication administration time for Atenolol (medication for high blood pressure), and the 2:00 P.M. medication administration time for Cardizem (medication for high blood pressure and heart failure) on the MAR, because she did not administrator those two medications at the prescribed time. RN 1 had also written on the MAR next to Cardizem, "150/70 Vasopressin (a medication that increases blood pressure and decrease urine flow)" and next to the Atenolol she had written, "Vasopressin Drip." RN 1 further stated that she held the administration of the Atenolol and Cardizem because Patient 28 was on a Vasopressin Drip. The physician ordered the Cardizem to be held if Patient 28's systolic (blood pressure within the arteries when the heart is contracting) blood pressure was less than 100. RN 1 stated that at 2:00 P.M., Patient 28's blood pressure was 150/70 (systolic over diastolic: the blood pressure of the heart after contraction). RN 1 stated that she had not called Patient 28's physician prior to holding the administration of the two heart medications.

On 3/2/12 at 8:25 A.M., an interview was conducted with the ICU "Point RN" (equal to a Charge Nurse) of the day, RN 4. RN 4 stated that it was very common to have patients in ICU on a Vasopressin drip and receiving Atenolol and Cardizem. RN 4 further stated that RN 1 should not have held the administration of the two heart medications if the patient's blood pressure was 150/70. If RN 1 was uncertain, RN 4 said she should have called the physician. RN 4 also stated that RNs must call an MD prior to holding the administration of any medication.

An interview was conducted with the hospital's Director of Nursing (DON) on 3/2/12 at 8:35 A.M. The DON stated that it is not acceptable nursing practice to hold the administration of a patient's medication without a physician's order.

Based on interview and record review, the facility failed to ensure that a physician documented a significant event in an ICU patient's medical record.
Findings:
A review of Patient 1's medical record, conducted on 2/29/12 at 2:00 P.M., indicated that on 10/14/11 at 4:00 P.M., RN 2 documented that physician 1 was at the bedside questioning about Propofol (a medication used for anesthesia). At 5:00 P.M., RN 2 documented that Patient 1's blood pressure was 53/48 and the Rapid Response Team (RRT) was called. A bolus of 250 ml (milliliters) of normal saline was administered to the patient, and the Propofol was stopped per Physician 1's order.
A review of Physician 1's progress notes for 10/14/11, conducted on 2/29/12 at 2:30 P.M., indicated that there was no physician documentation regarding Patient 1's drop in blood pressure and/or of the RRT's arrival, and of Physician 1's actions to treat Patient 1.
An interview with Physician 1 was conducted on 2/29/12 at 4:30 P.M. Physician 1 stated that he did not recall if he was told by nursing staff that the Propofol was administered incorrectly. He did acknowledge that he should have documented in the progress notes about Patient 1's drop in blood pressure, his treatment of Patient 1, and the Rapid Response Team's arrival and actions to treat Patient 1's low blood pressure.
An interview with the Medical Director was conducted on 2/29/12 at 4:00 P.M. He stated that it was his expectation that Physician 1 should have documented Patient 1's drop in blood pressure and his treatment of Patient 1.

Based on observation, interview, record and document review, the hospital did not provide pharmaceutical services and care that met the needs of the patients when pharmaceutical services:

1. Failed to ensure that the high risk medication Propofol was administered in a safe manner and administered per the hospital protocol.
(A tag 405 # 1, 2, 3, 4)

2. Failed to ensure that medications were administered per physician orders.
(A tag 405 # 5, 6)

4. Failed to ensure that high risk medications were administered by Registered Nurses deemed competent to administer those medications.
(A tag 397 # 1, 2 )

5. Failed to ensure that medication errors were reported.
( A tags 266 and 285)

6. Failed to ensure that pharmacists provided adequate oversight regarding the administration of the high risk medication, Propofol.
(A tag 492)

7. Failed to ensure that pharmacists checked for all outdated medications on emergency crash carts.
(A tag 505)

The cumulative effects of these systemic problems resulted in the pharmacy's inability to provide pharmaceutical services and care in a safe and effective manner in accordance with the statutorily-mandated Conditions of Participation for Pharmaceutical Services.

Based on observation, interview, and record review the hospital failed to ensure that the Director of Pharmacy (DP) supervised and provided oversight of the use of Propofol in the hospital Intensive Care Unit (ICU). The DP failed to ensure a process was in place to detect that nursing staff were not administering Propofol in accordance with physician's orders and/or in accordance with the hospital approved Propofol protocol. As a result, two out of three reviewed patients (Patient 1 and 4) who had received or were currently receiving Propofol became hypotensive. Patient 1 became markedly hypotensive and required emergent intervention when a nurse administered a bottle of Propofol over one-half hour in error. Patient 4 became hypotensive when nursing staff initiated Propofol at a much faster rate (40 mcg/kg/min versus 5 mcg/kg/min) than stipulated by the protocol. Nursing staff restarted Propofol on a third patient (Patient 3) at a much faster rate (50 mcg/min versus 5 mcg/kg/min) than stipulated by the hospital Propofol protocol. While Patient 3 did not have any apparent adverse outcome there was a risk for potential adverse outcome. The hospital's Propofol protocol was not consistently followed for the administration of a Propofol drip to Patient 12, and the hospital's pharmacists did not identify the inconsistencies.

Findings:

Propofol is an injectable medication that is infused via an intravenous (IV) line into a vein. It has an FDA (Food and Drug Administration which is the institution that regulates the approval, labeling, and all regulatory issues regarding medications in the United States) approved indication for the induction and maintenance of general anesthesia. It also has an FDA approved indication for the sedation of intubated (an airway has been placed in the patient's trachea or windpipe) mechanically ventilated (a machine "breathes" for the patient) adult patients in the Intensive Care Unit (ICU) setting. The sedation can be required because the state of intubation and mechanical ventilation can be unpleasant causing patients to become agitated, to fight the ventilation machine by trying to breathe on their own, and in some case by attempting to pull the tube out of their trachea.

The Propofol product labeling (package insert) documents that decreased heart rate (bradycardia) and decreased blood pressure (hypotension) are side effects of Propofol. The product labeling documents that heart and breathing (cardiorespiratory) depression is "...likely to occur at higher blood concentrations which result from bolus dosing or rapid increases in the infusion rate." The product labeling documents: " When indicated, initiation of sedation should begin at 5 mcg/kg/min (micrograms/kilogram/minute) ...(and) should be increased by increments of 5 to 10 mcg/kg/min until the desired level of sedation is achieved."

On 2/29/12 a review of the policy and procedure entitled "Propofol Protocol" indicated that the physician could initiate the protocol by ordering "Propofol drip per protocol." It stipulated that Propofol should be initiated at 5 mcg/kg/min and increased in increments of 5 mcg/kg/min every five minutes until the desired level of sedation was achieved. The protocol documented that the Richmond Agitation and Sedation Scale (RASS) would be used to assess sedation levels. The policy did not indicate what a desired level of sedation was but it did stipulate that sedation to a RASS score greater than -2 (negative 2: defined in the protocol as light sedation: briefly awakens with eye contact to voice of less than 10 seconds) required a physician's order.

1. A review of Patient 1's clinical record conducted on 2/29/12 at 11:20 A.M., indicated Patient 1 was admitted to the hospital ICU on 10/11/11. Per a physician order, dated 10/13/11, a Propofol intravenous infusion (drip) was ordered. The order specified that Propofol 10 milligrams(mg)/milliliter (ml), 100 ml bag, infuse at a rate of 3.6 ml/hr (weight based dosing) and that the infusion be titrated (adjusted) to a RASS scale (Richmond Agitation Sedation Scale: a scale used to assess the applicable degree of sedation required for a patient to avoid under or over sedating a patient) of -2 (negative 2).

A review of an ICU flowsheet dated 10/14/11, revealed that at 4:30 P.M., RN 1 initiated a Propofol infusion at 5 mcg/kg/min. At 4:45 P.M., RN 1 documented that Patient 1's blood pressure had dropped to 53/48, the Rapid Response Team (a team whose purpose is to provide early intervention and stabilization to prevent clinical deterioration to a patient prior to an adverse health event) was called; 250 ml. Normal Saline was infused, and the Propofol infusion was stopped. Per RN 1's notes a Neosynephrine (medication to increase blood pressure) infusion was started. At 5:00 P.M., RN 1 documented that the patient's blood pressure was stable at 153/68.

On 2/29/12 at 1:05 P.M. a joint interview was conducted with the following staff: The Chief Operating Officer (COO), the Chief Administrative Officer/Risk Manager (CAO/RM), the Director of Nursing (DON), the ICU/MSU Nurse Manager (NM), and the Director of Pharmacy (DP). The team was asked if the hospital had experienced any adverse events pertaining to the drug Propofol. The ICU/MSU NM stated that in October or November of 2011 a patient (Patient 1) mistakenly received an infusion of Propofol (1000 mg/100 ml, or the entire bottle) in a 30 minute period. The ICU/MSU NM stated that she was at the bedside because she was part of the Rapid Response Team. Per the ICU/MSU NM she checked the IV bottle of Propofol and saw that it was hung at 4:00 P.M. She stated that she checked the time when she entered the room and it was 4:30 P.M., and the bottle of Propofol was empty. The ICU/MSU NM acknowledged that an error had occurred in the administration of the high risk drug, Propofol. The team was unclear how the error occurred, but held RN 1 accountable for the error.

2. On 2/28/12 at 11:15 A.M. a tour was conducted of the ICU with the ICU/MSU Nurse Manager (NM). The ICU was comprised of 5 beds and all beds were occupied. Patient 4 was ventilated via a breathing machine and was receiving an intravenous infusion of Propofol.

On 2/28/12 at 3:10 P.M., an interview was conducted with RN 9. RN 9 stated that RNs titrated (adjusted) the dose/rate of a Propofol infusion based on the level of sedation required for a patient, per physician order. RN 9 stated there was a hospital protocol for Propofol administration RN 9 stated that those incremental changes in the infusion were to be double checked by another RN, and then both RNs were required to document that double check on the Medication Administration Record (MAR). RN 9 stated that RNs also documented those changes in the progress notes of the ICU flowsheet.

On 2/29/12 at 9:15 A.M. an interview was conducted with RN 3. Per RN 3, with a physician's order, RNs could initiate a Propofol infusion at a low dose/rate. RN 3 stated"5 micrograms (mcg.)/kilogram (kg)/minute (min) was a low dose, but the RN could initiate the infusion at 1-2 mcg., per their own clinical judgement. RN 3 stated RNs titrated the infusion rate in increments, and used own clinical judgement to determine how much those incremental adjustments should be, in order to achieve a certain level of sedation. RN 3 stated that the upper limit for the infusion was 50 mcg./kg/min., and RNs could not exceed that. RN 3 stated that Propofol"vacations"were implemented for patients once a shift to assess a patient's response and to determine the lowest dose of Propofol required.

On 2/29/12 at 9:25 A.M., a review of Patient 4's clinical record indicated that Patient 4 was admitted to the hospital on 2/24/12. Per physician progress notes on 2/25/12, a Code Blue was called because the patient was lethargic with a blood pressure of 56/43. Emergent intervention was initiated, a breathing tube was inserted, and the patient was transferred to the ICU.

Per a physician order, dated 2/26/12, a Propofol intravenous "drip" (infusion) was ordered to achieve a RASS scale (Richmond Agitation Sedation Scale: a scale used to assess the applicable degree of sedation required for a patient to avoid under or over sedating a patient) of -2 (negative 2).

Per RN 10's Nursing Progress note, dated 2/26/12 at 8:00 P.M., Patient 4 was agitated and reached for her breathing tube. RN 10 documented that she "started on Propofol at 40 mcg. as patient was agitated." The patient's blood pressure prior to the infusion was 160/80. At 8:30 P.M., RN 10 documented that the patient's blood pressure dropped to 83 and the Propofol was titrated down to 5 mcg. RN 10 documented that she initiated the infusion at 40 mcg. when the protocol instructed Propofol to be initiated at 5 mcg. RN 10 documented that she titrated the infusion down to 5 mcg. and then increased it back to 10 mcg/kg/min. at 9:45 P.M. There was no documentation on the MAR to indicate that the increment changes were double checked with another RN.

Per RN 2's Nursing Progress note, dated 2/28/12 at 3:00 P.M., Patient 4 was on Propofol at 20 mcg/kg/min. RN 2 documented in the progress notes at 4:45 P.M. that she decreased the infusion to 10 mcg/kg/min. Per the hospital protocol, Propofol was to be decreased in increments of 5 mcg/kg/min, not 10 mcg/kg/min, as RN 2 did.

On 2/29/12 at 1:00 P.M. an interview was conducted with the Director of Pharmacy (DP) who acknowledged that the side effects of Propofol include decreased respirations, blood pressure, and heart rate. The DP acknowledged that the Propofol protocol had not been followed by the RNs.

3. On 2/28/12 at 11:15 A.M. a tour was conducted of the ICU with the ICU/MSU Nurse Manager (NM). The ICU was comprised of 5 beds and all beds were occupied. Patient 3 was ventilated via a breathing machine and was receiving an intravenous infusion of Propofol.

On 2/28/12 at 3:10 P.M., an interview was conducted with RN 9. RN 9 stated that RNs titrated (adjusted)the dose/rate of a Propofol infusion based on the level of sedation required for a patient, per physician order. RN 9 stated there was a hospital protocol for Propofol administration RN 9 stated that those incremental changes in the infusion were to be double checked by another RN, and then both RNs were required to document that double check on the Medication Administration Record (MAR). RN 9 stated that RNs also documented those changes in the progress notes of the ICU flowsheet.

On 2/29/12 at 9:15 A.M. an interview was conducted with RN 3. Per RN 3, with a physician's order, RNs could initiate a Propofol infusion at a low dose/rate. RN 3 stated "5 micrograms (mcg.)/kilogram (kg)/minute (min) was a low dose, but the RN could initiate the infusion at 1-2 mcg., per their own clinical judgement. RN 3 stated RNs titrated the infusion rate in increments, and used own clinical judgement to determine how much those incremental adjustments should be, in order to achieve a certain level of sedation. RN 3 stated that the upper limit for the infusion was 50 mcg./kg/min., and RNs could not exceed that. RN 3 stated that Propofol "vacations" were implemented for patients once a shift to assess a patient's response, and to determine the lowest dose of Propofol required.

On 2/29/12 at 10:00 A.M. a review of Patient 3's clinical record indicated that Patient 3 was admitted to the ICU on 1/11/12 with respiratory failure and was dependent on a breathing machine.

On 2/21/12 at 7:55 P.M., RN 10 documented in the progress notes that Patient 3 was "really agitated" and "keeps trying to get out of bed."

On 2/21/12 at 8:00 P.M., a physician gave a telephone order to "re-start on Propofol drip."

On 2/21/12 at 8:10 P.M., RN 10 documented "Propofol restarted at 50 mcg., titrated down to 20 mcg., when patient fell asleep." RN 10 documented that she started the infusion at the highest dose/rate possible, rather than start at 5 mcg./kg/min and increase in increments of 5 mcg., per the hospital protocol. In addition, there was no documentation on the Medication Administration Record (MAR) to indicate that the increment changes in Propofol were double checked by another RN.

A review of the ICU flowsheet for 2/24/12 revealed the following discrepancies regarding the Propofol infusion: At 12:00 P.M., the patient was off Propofol. RN 1 documented that she restarted the Propofol at a rate/dose of 10 mcg/kg/min., rather than 5 mcg, per the protocol. At 7:00 P.M., RN 31 documented that the Propofol was decreased to 3 mcg/kg/min, rather than decrease the infusion by an increment of 5 mcg per the protocol. At 2:00 A.M., Patient 3's the infusion was at 5 mcg. At 3:00 A.M., RN 31 documented that he increased the infusion to 30 mcg. At 4:00 A.M., RN 31 documented that Propofol was increased to 50 mcg/kg/min for continued agitation. There was no documented evidence of RN double checks regarding the dose/rate changes, and no evidence that Propofol was adjusted in incremental increases of 5 mcg/kg/min per hospital protocol.

Additional ICU flowsheets for the dates 2/25/12, 2/26/12, 2/27/12 and 2/18/12 revealed similar practices by the ICU RN staff concerning the administration of the Propofol infusion to Patient 3. RNs did not consistently increase or decrease the infusion by increments of 5 mcg/kg/min. RNs did not consistently restart the Propofol infusion at the lowest rate 5 mcg/kg/min. RNs did not document double checks of the adjustments on the MAR. There was no documented evidence that the ICU RN staff consistently implemented the Propofol "vacations" or awakenings that were to occur on a daily basis per the hospital protocol.

On 2/29/12 at 1:05 p.m. during an interview with the Director of Pharmacy (DP) in the board room he stated his oversight consisted of the following:

He made sure staff had placed a Propofol "procedure sheet" into the clinical records of patients receiving Propofol.

He made daily rounds to check which patients were on Propofol.

During those rounds, he would check to see if a bottle of Propofol was hanging on a given patient. He would check to see how fast the pump was running and he would check with the nurse if he had any concerns. But, he did not document any of his interventions. All interventions were all verbal.

During the interview he stated that there was no written procedure stipulating how to monitor Propofol drips that other pharmacist could use if they went on rounds.

He stated he had the following understanding of the Propofol protocol:

a. Nursing staff members were to assess the RASS.

b. If a patient had not reached the goal RASS, one would titrate the drip every five minutes in increments of 5 mcg/kg/hour (not minutes as in the protocol).

c. He was not sure what the initial rate was (the protocol documented one should initiate the Propofol drip at 5 mcg/kg/min).

d. He stated that the "sedation vacation" would occur once daily, that the patient was taken off the Propofol drip and the patient would wake up.

A review of the protocol on 2/29/12 ,under "Awakening", indicated that the drip rate was to be reduced by 5 mcg/kg/min until the patient reached an RASS of zero "awake and alert" which meant the Propofol could still be running when the patient reached that level of consciousness. The DP stated he did not check the chart to see if the awakening process took place as required.

The DP was unable to demonstrate that he supervised and provided oversight of the use of Propofol in the hospital's ICU.


21052

4. Patient 12's medical record was reviewed on 3/1/12 at 9:20 A.M. Patient 12 was admitted to the hospital on 1/26/12, with diagnoses that included end stage renal disease (kidney failure), per the History and Physical, dated 1/27/12.

A review of the Physician's Order Sheet, dated 2/12/12 at 8:30 P.M., indicated an order for "Propofol drip for sedation." The physician's order did not indicate to use the hospital's Propofol protocol. The order did not indicate the desired RASS score (Richmond Agitation/Sedation Scale - used for quantifying the patient's sedation level) to be achieved with the Propofol. The order was not signed, dated, and timed by the nurse who received the order.

A review of the nursing flowsheet, dated 2/12/12, indicated that Propofol was started between 8:00 P.M. and 9:00 P.M. at 10 mcg (micrograms). According to the record, Patient 12's RASS score was -3 (moderate sedation - movement or eye opening to voice but no eye contact) and remained at -3 until 6:00 A.M. on 2/13/12. Per the same record, the patient's propofol was titrated down to 5 mcg between 2:00 A.M. and 3:00 A.M. on 2/13/12. However, there was no documentation to explain why the patient's propofol was decreased between 2:00 A.M. and 3:00 A.M.

The hospital's policy and procedure titled Propofol Protocol was reviewed on 3/1/12 at 10:15 A.M. The policy indicated that, "The Propofol protocol will be initialed by the physician with the order 'Propofol drip per protocol.' This was not followed when the order did not indicate to follow the Propofol protocol. The policy also indicated that to initiate Propofol infusion at 5 mcg/kg/min. This was not followed when the registered nurse initiated Propofol at 10 mcg. The policy also indicated to "decrease Propofol infusion rate by increments of 5 mcg/kg/min at 5 minute intervals until a RASS score of -2 (briefly awakens with eye contact to voice less than 10 seconds) is achieved." This policy was not followed when the patient's RASS score remained at -3 from 2/12/12 between 8:00 P.M. and 9:00 P.M. until 2/13/12 at 6:00 A.M. and yet the patient's Propofol infusion rate was not decreased until 2/13/12 between 2:00 A.M. and 3:00 A.M.

A joint record review and interview with the Director of Pharmacy (DP) was conducted on 3/1/12 at 1:15 P.M. The DP stated that since Propofol was a high risk medication, a pharmacist should have been involved with following up with the physician regarding the incomplete Propofol order. The DP also stated that a pharmacist should have reviewed Patient 12's medical record the day Propofol was ordered or the following day. The DP acknowledged that the Propofol protocol was not consistently followed for Patient 12 and should have been identified by pharmacy.

Based on observation of two nurses passing medications to two patients (41, 42)on the Medical Surgical Nursing Unit, clinical record review, document review, and staff interview, the hospital failed to ensure that a process was in place to ensure that cholestyramine (brand name is Questran: a bile absorbing agent used to lower cholestrol levels), was administered separately from other medications to prevent possible binding of these medications by the cholestyramine and subsequent poor absorption (see #1).

The hospital failed to ensure that a process was in place that would prevent a patient from getting a crushed patoprazole tablet (used to decrease stomach acid and treat or prevent ulcers) which could be degraded, and hence not available for absorption, in the acid environment of the stomach. This failure took place even though the hospital had a pantoprazole suspension product in stock that could be given to patients who could not swallow tablets (see #2).

Findings:

1. On 2/29/12 at 8:36 A.M. Nurse 44 administered a cup containing a powder to Patient 42 via a percutaneous gastric (PEG) tube after mixing it with water. He identified the powder as Questran. A review of Patient 42's clinical record on that date at 11:28 A.M. indicated that a physician had ordered Questran 4 gm, aminodarone 200 mg (used to treat abnormal heart rhythms), PhosLo (lowers high phophate levels in the blood), levatriacetam (an antiseizure medication), metoprolol 100 mg (used to lower high blood pressure), losartan 50 mg (used to lower high blood pressure), and ursodiol 300 mg (used to dissolve gallstones) to be given to Patient 42. A review of the medication administration record (MAR: used by nurses to accurately medicate their patients and to document the date and time a dose of medication was administered) indicated that Patient 42 should have received these medications during the morning medication pass with the Questran. During an interview with Nurse 44 on 2/29/12 at 12:21 P.M. when asked why he had not given these medications during the medication pass, he stated that he had crushed and added them to the Questran.

Questran (generic name is cholestyramine) is a resin that binds bile acid. By doing this, Questran reduces cholesterol levels. On 3/2/12 a review of the product labeling obtained in the hospital pharmacy indicated it documented that "SINCE CHOLESTYRAMINE RESIN MAY BIND OTHER DRUGS GIVEN CONCURRENTLY, IT IS RECOMMENDED THAT PATIENTS TAKE OTHER DRUGS AT LEAST 1 HOUR BEFORE OR 4 TO 6 HOURS AFTER CHOLESTYRAMINE RESIN (OR AS AT GREAT AN INTERVAL AS POSSIBLE) TO AVOID IMPEDING THEIR ABSORPTION" (capitol letters and underlined words in product labeling). A drug interaction program available with Lexi Comp, a nationally recognized data base, listed amiodarone and ursodiol as two specific drugs that may interact with Questran in a significant manner such that an intervention should occur to maximize the benefit or to minimize any toxicity (toxicity would not have been an issue in this case).

On 3/2/12 at 9:28 A.M. the DP added Questran as a "new" medication to Patient 42's medication profile to see what the computer would flag. It flagged Questran as a duplicate medication (as Patient 42 already had this medication entered into his profile) but it provided no warning about the possible interaction with any of the medications in Patient 42's profile. A review of the Lexi Comp 2009-2010 DRUG INFORMATION HANDBOOK provided by the DP at that time indicated it listed amiodarone as a potential interaction. When asked why one would give Questran at the same time as the other 9 A.M. medications to Patient 42 in light of the above, the DP said "I don't know."

On 3/2/12 at 1:18 P.M. during an interview with Pharmacist 45 (who had entered a previous Questran order into the computer which preceded the current order) he stated that Questran could bind other medications. He stated he depended on the computer to cue him.

On 3/2/12 a review of Policy and Procedure MM6.10-01 entitled "Medication Management" (Effective 11/1/04 and Reviewed 12/20/10), indicated it stipulated that pharmacists were to review a patient's medication regimen prior to dispensing a new medication and that pharmacist was to review the medication regimen for interactions and incompatibilities.

2. On 2/29/12 at 9:31 A.M. Nurse 43 administered one 40 mg tablet of pantoprazole (reduces stomach acid) to Patient 41 after she crushed it. The manufacturer's product labeling documents that pantoprazole is enteric coated (a coat that will not dissolve in the acid environment of the stomach). It documents that the stability of pantoprazole is pH dependant with degradation increasing with decreasing (more acid) pH. The pH of a solution is a measure of the solution acidity with a pH of 7 (found in pure water) being neutral and with decreasing pH values representing a more acidic condition; stomach acid has pH of 1 to 3). The product labeling documents that the half life (the time in which 50% of the medication is degraded) of protonix is 220 hours at a pH of 7.8 (slightly basic) and 2.8 hours at a pH of 5. At a pH of 1 to 3 the stomach pH is 100 to 10,000 times as acid as a solution with a pH of 5. Therefore, by crushing the tablet, the pantoprazole would potentially be destroyed by the acid state of the stomach with the potential for therapeutic failure. The product labeling documents there is a suspension of pantoprazole available that can be given in apple juice or with apple sauce to patients who cannot swallow the tablets.

On 2/29/12 at 3:39 P.M. during an interview with Pharmacist 46, she said pantoprazole tablets should not be crushed. She said the pharmacy had a suspension available that could be used for patients that could not swallow tablets and she produced a unit of use (unit dose) package of the pantoprazole suspension during the interview.

Based on observation, interview and document review, the hospital failed to implement its policy and procedure for emergency crash cart maintenence. The emergency crash cart in the Intensive Care Unit (ICU) contained an inventory check list of medications, to include intravenous solutions, with mislabeled expiration dates. In addition, the inventory checklist contained a mislabeled expiration date for suction tubing.

Findings:

On 2/28/12 at 2:15 P.M., a tour of the ICU was conducted. The ICU had one emergency crash cart. The crash cart was opened and inventoried with the Director of Nurses (DON). The following discrepancies were observed:

One 250 milliliter (ml.) dextrose with water intravenous (IV) solution was noted to have an expiration date of 6/13. The inventory checklist of the crash cart documented that the expiration date of the 250 ml. dextrose with water IV was 3/13.

A 1000 ml. bottle of normal saline solution was noted to have an expiration date of 12/13. The inventory checklist documented that the expiration date of the bottled normal saline was 3/12.

A sterile package of suction tubing was noted to have an expiration date of 11/16. The inventory checklist documented that the expiration date of the tubing was 1/15.

On 2/28/12 the "Emergency Cart Maintenance" policy and procedure was reviewed. Per the policy, "each month the Director of Pharmacy will assign a pharmacist to open each Emergency Cart....to inventory and replace expired medications. The inventory will be documented on the current Emergency Cart Daily Checklist."

On 2/28/12 at 2:30 P.M., an interview was conducted with the Director of Pharmacy (DP). The DP stated that the pharmacists only checked the emergency medication tray on the cart and did not open the rest of the cart to check the IV or bottled solutions. The DP stated that the nursing staff checked the rest of the crash cart inventory. The DP acknowledged that all medications on the cart, including the the IV solutions and bottled normal saline solutions should be checked by the pharmacist to ensure accuracy of labeling and expiration dates.

Based on observation and interview, the hospital failed to ensure that expired food was discarded.

Findings:

A tour of the kitchen was conducted with the Director of Dietary (DOD) on 2/28/12 at 11:00 A.M. According to the DOD, a food that was opened in the past 30 days should be discarded.

During an inspection of the kitchen's refrigerator, the following food items were observed:

A jar of cherries opened on 11/11/2011

A can of cranberry sauce opened on 12/28/11

A container of discolored tofu opened on 1/18/11

The DOD acknowledged that the above noted food items found in the refrigerator should have been discarded afer 30 days from the date they were labeled.

Based on observation, interview and document review, the facility failed to ensure that a Registered Nurse (RN) in the Intensive Care Unit (ICU), could locate the ICU's fire extinguisher and fire pull station. Staff who were unaware of the location of emergency equipment had the potential to cause a delay in response to an emergency situation and increase the risk to patients, visitors and other staff.

Findings:

On 2/28/12 at 11:15 A.M., a tour was conducted of the ICU with the ICU Nurse Manager (NM). The ICU was comprised of 5 beds and all 5 beds were occupied.

An interview was conducted with RN 2, on 2/28/12 at 11:20 A.M. RN 2 stated that she had worked in the ICU for about 7 months. RN 2 was unable to verbalize the location of the ICU's fire extinguisher and fire pull station. She made attempts to guess at the possible location of the items.

A review of the facility's Fire Plan (no date) was conducted on 2/28/12. Per the plan, staff response to a fire included pulling the nearest manual fire alarm pull station. The fire pull station activated the alarm and indicated the location of the fire automatically. The fire pull station also activated the audiovisual notification (chimes/horns/bells and strobes) to enable other staff to know the alarm was activated. The plan also instructed staff to extinguish the fire if it was reasonably safe to do so. Per the plan, in many cases a fire could be extinguished quickly by a fire extinguisher with little risk.

On 3/2/12 at 3:10 P.M., an interview was conducted with the Director of Facilities (DF). The DF acknowledged that RN 2 should have known the location of the emergency fire equipment.

Based on observation and interview, the hospital failed to ensure that a Registered Nurse (RN) in the Intensive Care Unit (ICU), implemented the hospital's wound dressing change policy and procedure. A wound dressing applied to a peripherally inserted central intravenous catheter (PICC line, a long catheter typically inserted in the arm and ending in a large vein near the heart) was not dated, timed or initialed, to indicate when the dressing had last been changed and would be due for a new dressing. Lack of a timely treatment and dressing change to a intravenous catheter site could increase a patient's risk of infection to that site or systemically.

Findings:

On 2/28/12 at 11:15 A.M., a tour was conducted of the ICU with the ICU Nurse Manager (NM).

On 2/28/12 at 11:20 A.M., an observation of Patient 2 was conducted. Patient 2 was in the ICU due to respiratory failure. Per the ICU census sheet, Patient 2 had other diagnoses that included endocarditis (heart infection), pneumonia (lung infection), and congestive heart failure. A thin transparent dressing was observed on the lower part of the patient's right inner arm. There were no markings noted on the dressing such as a date, time, or initials of the person who last changed the dressing.

An interview was conducted with RN 2 on 2/28/12 at 11:20 A.M. RN 2 was assigned to Patient 2. Per RN 2, the unmarked dressing was applied to the patient's PICC line. RN 2 stated that PICC line dressings were to be changed every 7 days. RN 2 stated that she had completed her morning patient assessment but had not noticed that the dressing was not dated or timed. RN 2 stated that the policy was to date and time all dressings.

On 2/28/12, the Wound Dressing Change/Applications policy, dated 12/10, was reviewed. Per the policy, wound dressings were to be annotated with a date, time and initials of the person who changed the dressing.

On 2/28/12 at 11:30 A.M., the ICU NM acknowledged that staff had not implemented the hospital's wound dressing policy, which could increase the patient's risk for infection.

Based on interview and record review, the hospital failed to ensure that it's policy and procedure pertaining to documentation standards for Social Workers (SW), was implemented by SW 1 for Patient 3. SW 1 failed to document updated and ongoing progress reports and assessments in the patient's interdisciplinary plan of care, to ensure that adequate discharge planning efforts and interventions were implemented.

Findings:

On 2/29/12 at 8:00 A.M., a tour of the Intensive Care Unit (ICU) was conducted with the Director of Nurses (DON).

Patient 3 was admitted to the ICU on 1/11/12, with respiratory failure and was dependent on a breathing machine. Other diagnoses included seizures, encephalitis (brain inflammation), severe dyskinesia (a movement disorder with involuntary movements) and acute psychosis, per a History and Physical dated 1/11/12.

A review of the clinical record revealed that Patient 3's father had signed a document entitled, "Advance Directive Acknowledgement," on 1/11/12. Patient 3's father indicated that Patient 2 had not executed any Advance Directives, but the father on the patient's behalf, had requested information about Advance Directives from the facility.

Per an initial Psychosocial Assessment form completed on 1/13/12, Social Worker (SW) 1 acknowledged that Patient 3 did not have an Advance Directive, and that the family desired further information. SW 1 documented that any needed resources for the patient were "TBD" (to be determined). SW 1 documented in the initial assessment that he was unable to assess the patient's fears, anxieties, concerns or what helped the patient cope with stress or problems.

There was no further documentation in the record to indicate that Patient 3's family had received the requested information concerning Advance Directives. There was no further documentation in the record concerning any follow up that SW 1 had conducted with the patient's family, concerning the "to be determined" issues, identified in the initial assessment. There was no additional documentation by SW 1, or any other SW, since the initial psychosocial assessment conducted on the patient's day of admission, 1/11/12. As of 2/29/12, the patient had been hospitalized for 50 days.

On 2/29/12 at 8:40 A.M., an interview was conducted with SW 1. SW 1 was unable to present any documentation or verbalize as to whether the family had received the requested information concerning an Advance Directive. SW 1 acknowleged that there was no documented evidence that he had followed up with the patient or family to ensure that the patient and/or family's needs were addressed.

A review of the "Advance Healthcare Directive" policy, dated 12/10, was conducted on 2/29/12. Per the policy, "Social Services shall provide the patient with information on Advance Health Care Directives."

A review of the hospital's Documentation Standards for Social Services policy, dated 12/10, was reviewed on 2/29/12. Per the policy, "patient care plans will be updated weekly or more often as patient needs indicate, reflecting progress, discharge planning efforts, counseling, and services provided." Documentation in the progress notes were to adequately reflect the "proposed plan of social services intervention and discharge plan needs."

On 2/29/12 at 9:00 A.M., the DON acknowledged that the family should have been provided with the requested information pertaining to Advance Directives. The DON acknowledged that the lack of documentation in the progress notes did not reflect that ongoing assessments and interventions had been performed by Social Services.

Based on interview, record and document review, the hospital failed to implement its Medication Error Reporting policy and procedure, and its Occurrence Report process. The hospital failed to ensure that a Sentinel Event (SE- an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof) pertaining to the administration of the high risk drug, Propofol (a general anesthetic drug that depresses the central nervous system) was reported as a medication error, in an effort to identify opportunities for improvement in the administration and management of a high risk medication.

Findings:

A record review was initiated on 2/29/12 at 11:20 A.M. Patient 1 was admitted to the hospital's Intensive Care Unit (ICU) on 10/11/11, with diagnoses that included an above the knee amputation, shortness of breath, and pain, per the patient registration form. Per a History and Physical dated 10/11/11, other diagnoses included end stage kidney disease and hemodialysis, diabetes, pulmonary hypertension, and status post heart transplant.

Per a physician's order, dated 10/13/11, a Propofol intravenous infusion (drip) was ordered. The order specified that Propofol 10 milligrams(mg)/milliliter (ml), 100 ml bag, infuse at a rate of 3.6 ml/hr (weight based dosing) and that the infusion be titrated (adjusted) to a RASS scale (Richmond Agitation Sedation Scale: a scale used to assess the applicable degree of sedation required for a patient to avoid under or over sedating a patient) of -2 (negative 2).

A review of an ICU flowsheet dated 10/14/11, revealed that at 4:30 P.M., RN 1 initiated a Propofol infusion at 5 mcg/kg/min. At 4:45 P.M., RN 1 documented that Patient 1's blood pressure had dropped to 53/48, the Rapid Response Team (a team whose purpose is to provide early intervention and stabilization to prevent clinical deterioration to a patient prior to an adverse health event) was called; 250 ml. Normal Saline was infused, and the Propofol infusion was stopped. Per RN 1's notes, a Neosynephrine (medication to increase blood pressure) infusion was started. At 5:00 P.M., RN 1 documented that the patient's blood pressure was stable at 153/68.

A review of the hospital's policy entitled, "High Risk High Alert Medications," and dated 12/20/12, defined high-alert medications as, "drugs that bear a heightened risk of causing significant patient harm when they are used in error." The policy identified Propofol as a high risk/high alert drug.

On 2/29/12 at 1:05 P.M. a joint interview was conducted with the following staff: The Chief Operating Officer (COO), the Chief Administrative Officer/Risk Manager (CAO/RM), the Director of Nursing (DON), the ICU/MSU Nurse Manager (NM), and the Director of Pharmacy (DP). The team was asked if the hospital had experienced any adverse events pertaining to the drug Propofol. The ICU/MSU NM stated that, in October or November of 2011, Patient 1 mistakenly received an infusion of Propofol (1000 mg/100 ml, or the entire bottle) in a 30 minute period. The ICU/MSU NM stated that she was at the bedside because she was part of the Rapid Response Team. Per the ICU/MSU NM she checked the IV bottle of Propofol and saw that it was hung at 4:00 P.M. She stated that she checked the time when she entered the room and it was 4:30 P.M, and the bottle of Propofol was empty. The ICU/MSU NM acknowledged that a mistake had occurred in the administration of the high risk drug, Propofol, and that the entire 1000 mg/100 ml bottle should never have been infused in 1/2 hour. The team was unclear how the mistake occurred, but held RN 1 responsible for the error.

The team was asked if the Propofol event was reported as a medication error. The DP replied "No."

The ICU/MSU NM stated that, if she found Propofol not being administered per protocol, she would not consider that a medication error. She stated she would not complete an occurrence report.

The DP acknowledged that Propofol was a high risk/high alert medication. The DP acknowledged that the Propofol medication error met the definition of a Sentinel Event, and that the recurrence of such an event would carry a significant chance of a serious adverse outcome.

A review of the hospital's policy entitled "Medication Error Reporting," dated 12/20/10, was reviewed on 3/1/12. One of the purposes of the policy was to "facilitate improvement of all aspects of medication administration." The policy defined a medication error as "any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient or consumer." Per the policy, all medication errors shall be reported on the Occurrence Report Form by the staff involved in the medication error.

On 3/1/12 at 2:35 P.M., an interview was conducted with the hospital's Risk Manager (RM). Per the RM, an occurrence report form was never completed by the staff concerning the Propofol medication error. The RM confirmed that an occurrence report form should have been completed by the involved staff, and that, the event should have been reported as a medication error.

Based on interview, record and document review, the hospital failed to ensure that its Sentinel Event policy and procedure was implemented, when a Sentinel Event (SE- an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof) occurred surrounding the inappropriate administration of a high risk medication, Propofol (a general anesthetic drug that depresses the central nervous system). A Root Cause Analysis (a method used to investigate and determine the causes of a Sentinel Event) was not conducted by the hospital in an attempt to identify systemic issues and problems, to improve safe and effective patient care. This resulted in a situation of Immediate Jeopardy.

Findings:

On 2/28/12, the hospital's Propofol policy and procedure, dated 12/20/11, was reviewed. Per the policy, Propofol infusions were initiated at a rate of 5 micrograms (mcg)/kilogram (kg)/ minute (min). The infusion rates were to be increased in increments of 5 mcg/kg/min every 5 minutes, until the desired level of sedation was achieved using the lowest possible dose.

A record review was initiated on 2/29/12 at 11:20 A.M. Patient 1 was admitted to the hospital's ICU on 10/11/11, with diagnoses that included an above the knee amputation, shortness of breath, and pain per the patient registration form. Per a History and Physical dated 10/11/11, other diagnoses included end stage kidney disease and hemodialysis, diabetes, pulmonary hypertension, and status post heart transplant.

Per a physician's order dated 10/13/11, a Propofol intravenous infusion (drip) was ordered. The order specified that Propofol 10 milligrams(mg)/milliliter (ml), 100 ml bag, infuse at a rate of 3.6 ml/hr (weight based dosing) and that the infusion be titrated (adjusted) to a RASS scale (Richmond Agitation Sedation Scale: a scale used to assess the applicable degree of sedation required for a patient to avoid under or over sedating a patient) of -2 (negative 2).

A review of an ICU flowsheet dated 10/14/11, revealed that at 4:30 P.M., RN 1 initiated a Propofol infusion at 5 mcg/kg/min. At 4:45 P.M., RN 1 documented that Patient 1's blood pressure had dropped to 53/48, the Rapid Response Team (a team whose purpose is to provide early intervention and stabilization to prevent clinical deterioration to a patient prior to an adverse health event) was called; 250 ml. Normal Saline was infused, and the Propofol infusion was stopped. Per RN 1's notes a Neosynephrine (medication to increase blood pressure) infusion was started. At 5:00 P.M., RN 1 documented that the patient's blood pressure was stable at 153/68.

A review of the hospital's policy entitled "High Risk High Alert Medications," dated 12/20/12, defined high-alert medications as drugs that bear a heightened risk of causing significant patient harm when they are used in error. The policy identified Propofol as a high risk/high alert drug.

On 2/29/12 at 1:05 P.M., a joint interview was conducted with the following staff: The Chief Operating Officer (COO), the Chief Administrative Officer/Risk Manager (CAO/RM), the Director of Nursing (DON), the ICU/MSU Nurse Manager (NM), and the Director of Pharmacy (DP). The team was asked if the hospital had experienced any adverse events pertaining to the drug Propofol. The ICU/MSU NM stated that in October or November of 2011 Patient 1 mistakenly received an infusion of Propofol (1000 mg/100 ml, or the entire bottle) in a 30 minute period. The ICU/MSU NM stated that she was at the bedside because she was part of the Rapid Response Team. Per the ICU/MSU NM she checked the IV bottle of Propofol and saw that it was hung at 4:00 P.M. She stated that she checked the time when she entered the room and it was 4:30 P.M, and the bottle of Propofol was empty. The ICU/MSU NM acknowledged that a mistake had occurred in the administration of the high risk drug, Propofol. The team was unclear how the mistake occurred, but held RN 1 accountable for the error.

The hospital management team was asked if an RCA was performed following the event. The COO stated that, a "mini RCA" had been conducted. Per the COO, the hospital considered it to be an employee performance issue and there was not a focus on systemic issues or concerns concerning the administration or management of Propofol. The team had not identified the error as a Sentinel Event.

On 2/29/12, a review of the hospital's policy and procedure entitled "Sentinel Event Response-Root Cause Analysis," dated 12/20/10, was conducted. Per the policy, the phrase "or the risk thereof," in the definition of an SE includes, "any process variation for which a recurrence would carry a significant chance of a serious adverse outcome." Per the policy and procedure, "An RCA is used to investigate and determine causes of the SE. The analysis also directs follow up actions to improve systems and processes to prevent further occurrences of a similar nature. The analysis focuses primarily on systems and processes, not individual performance." In addition, there was no reference in the policy concerning the definition of a "mini RCA."

The hospital's management team acknowledged that an RCA should have been performed as a result of the Propofol event. The management team acknowledged that, a recurrence of the Propofol medication error had the potential to cause a significant chance of a serious adverse outcome. The managment team was informed that, there were 2 patients currently in the ICU on Propofol infusions, and that, the ICU RNs were not following the hospital's policy, procedure and protocol for Propofol infusions.

On 2/29/12 at 3:10 P.M., a situation of Immediate Jeopardy was determined to be present. A meeting was held with the Chief Executive Officer (CEO), the COO, the CAO/RM, the DON, the Director of Admissions and Marketing, the DP, and the Director of Laboratory, to inform them of the immediate jeopardy. After receipt of an acceptable corrective action plan, the immediate jeopardy was abated on 3/1/12 at 12:55 P.M.

Based on observation, interview and record review, the hospital failed to ensure that the nursing staff reported medication errors, in accordance with the hospital policy on medication errors, regarding the use of Propofol in the hospital Intensive Care Unit (ICU). Three patients (1, 3, 4) received Propofol at a much faster rate than stipulated by the hospital approved protocol and as a result, 2 of 3 patients (1, 4) became hypotensive (low blood pressure--an adverse effect of Propofol). The failure of the hospital to report these errors resulted in the hospital's ability to prevent these errors in the future, as evidenced by the fact that the errors occurred over a period of months (Nov 2011 through Feb 2012). Furthermore, the Pharmacy Department could not provide evidence that it did any quality data gathering for analysis, for the high risk drugs of heparin (a blood thinner that can result in severe bleeding if not properly controlled) administered as an intravenous (IV) infusion, and insulin (lowers high blood sugar levels and can result in a severe fall in blood sugar levels which can result in coma and/or death if not properly controlled) as an IV infusion.

Findings:

1a. Propofol is an injectable medication that is infused via an intravenous (IV) line into a vein. It has an FDA (Food and Drug Administration which is the institution that regulates the approval, labeling, and all regulatory issues regarding medications in the United States) approved indication for the induction and maintenance of general anesthesia. It also has an FDA approved indication for the sedation of intubated (an airway has been placed in the patient's trachea or windpipe) mechanically ventilated (a machine "breathes" for the patient) adult patients in the Intensive Care Unit (ICU) setting. The sedation can be required because the state of intubation and mechanical ventilation can be unpleasant, causing patients to become agitated and to fight the ventilation machine, by trying to breathe on their own, and in some cases, by attempting to pull the tube out of their trachea.

The Propofol product labeling (package insert) documents that decreased heart rate (bradycardia) and decreased blood pressure (hypotension) are side effects of Propofol. The product labeling documents that heart and breathing (cardiorespiratory) depression is "...likely to occur at higher blood concentrations which result from bolus dosing or rapid increases in the infusion rate." The product labeling documents: "When indicated, initiation of sedation should begin at 5 mcg/kg/min (micrograms/kilogram/minute) ...(and) should be increased by increments of 5 to 10 mcg/kg/min until the desired level of sedation is achieved."

On 2/29/12, a review of the policy and procedure entitled "Propofol Protocol," indicated that the physician could initiate the protocol by ordering "Propofol drip per protocol." It stipulated that Propofol should be initiated at 5 mcg/kg/min and increased in increments of 5 mcg/kg/min every five minutes until the desired level of sedation was achieved. The protocol documented that the Richmond Agitation and Sedation Scale (RASS) would be used to assess sedation levels. The policy did not indicate what a desired level of sedation was, but it did stipulate that sedation to a RASS score greater than -2 (negative 2: defined in the protocol as light sedation: briefly awakens with eye contact to voice of less than 10 seconds) required a physician's order.

1b. A review of Patient 1's clinical record was conducted on 2/29/12 at 11:20 A.M., and indicated that Patient 1 was admitted to the hospital ICU on 10/11/11.

Per a physician's order, dated 10/13/11, a Propofol intravenous infusion (drip) was ordered. The order specified that Propofol 10 milligrams(mg)/milliliter (ml), 100 ml bottle, infuse at a rate of 3.6 ml/hr (weight based dosing) and that the infusion be titrated (adjusted) to a RASS scale of -2 (negative 2).

A review of an ICU flowsheet dated 10/14/11, revealed that at 4:30 P.M., RN 1 initiated a Propofol infusion at 5 mcg/kg/min. At 4:45 P.M., RN 1 documented that Patient 1's blood pressure had dropped to 53/48. The Rapid Response Team (a team whose purpose is to provide early intervention and stabilization to prevent clinical deterioration to a patient prior to an adverse health event) was called; 250 ml. Normal Saline was infused, and the Propofol infusion was stopped. Per RN 1's notes a Neosynephrine (medication to increase blood pressure) infusion was started. At 5:00 P.M., RN 1 documented that the patient's blood pressure was stable at 153/68.

On 2/29/12 at 1:05 P.M., a joint interview was conducted with the following staff: The Chief Operating Officer (COO), the Chief Administrative Officer/Risk Manager (CAO/RM), the Director of Nursing (DON), the ICU/MSU Nurse Manager (NM), and the Director of Pharmacy (DP). During this interview ICU/MSU NM stated that in October or November of 2011 a patient, Patient 1, had received an infusion of Propofol (1000 mg/100 ml, or the entire bottle) in a 30 minute period.

1c. On 2/28/12 at 11:15 A.M. a tour was conducted of the ICU with the ICU/MSU Nurse Manager (NM). The ICU was comprised of 5 beds and all beds were occupied. Patient 4 was ventilated via a breathing machine and was receiving an intravenous infusion of Propofol.

On 2/28/12 at 3:10 P.M., an interview was conducted with RN 9. RN 9 stated that RNs titrated (adjusted) the dose/rate of a Propofol infusion based on the level of sedation required for a patient, per the physician's order. RN 9 stated there was a hospital protocol for Propofol administration. RN 9 stated that those incremental changes in the infusion were to be double checked by another RN, and then both RNs were required to document the double check on the Medication Administration Record (MAR). RN 9 stated that RNs also documented those changes in the progress notes of the ICU flowsheet.

On 2/29/12 at 9:15 A.M. an interview was conducted with RN 3. Per RN 3, with a physician's order, RNs could initiate a Propofol infusion at a low dose/rate. RN 3 stated, "5 micrograms (mcg.)/kilogram (kg)/minute (min) was a low dose, but the RN could initiate the infusion at 1-2 mcg., per their own clinical judgement. RN 3 stated RNs titrated the infusion rate in increments, and used their own clinical judgement, to determine how much those incremental adjustments should be, in order to achieve a certain level of sedation. RN 3 stated that the upper limit for the infusion was 50 mcg./kg/min., and RNs could not exceed that. RN 3 stated that Propofol "vacations" were implemented for patients once a shift, to assess a patient's response and to determine the lowest dose of Propofol required.

On 2/29/12 at 9:25 A.M., a review of Patient 4's clinical record was conducted and indicated that, Patient 4 was admitted to the hospital on 2/24/12. Per the physician progress notes dated, 2/25/12, a Code Blue was called because Patient 4 was lethargic and had a blood pressure of 56/43. Emergent intervention was initiated, a breathing tube was inserted, and the patient was transferred to the ICU.

Per a physician's order dated 2/26/12, a Propofol intravenous "drip"(infusion) was ordered, to achieve a RASS scale (Richmond Agitation Sedation Scale: a scale used to assess the applicable degree of sedation required for a patient to avoid under or over sedating a patient) of -2 (negative 2).

Per RN 10's Nursing Progress note, dated 2/26/12 at 8:00 P.M., Patient 4 was agitated and reached for her breathing tube. RN 10 documented the following: "started on Propofol at 40 mcg. as patient was agitated." The patient's blood pressure prior to the infusion was 160/80. At 8:30 P.M., RN 10 documented that the patient's blood pressure dropped to 83 and the Propofol was titrated down to 5 mcg. RN 10 documented that she initiated the infusion at 40 mcg, when the protocol instructed Propofol to be initiated at 5 mcg. RN 10 documented that she titrated the infusion down to 5 mcg and then increased it back to 10 mcg/kg/min at 9:45 P.M. There was no documentation on the MAR to indicate that the incremental changes were double checked with another RN.

Per RN 2's Nursing Progress note, dated 2/28/12 at 3:00 P.M., Patient 4 was on Propofol at 20 mcg/kg/min. RN 2 documented in the progress notes at 4:45 P.M. that she decreased the infusion to 10 mcg/kg/min. Per the hospital protocol, Propofol was to be decreased in increments of 5 mcg/kg/min, not 10 mcg/kg/min, as RN 2 did.

On 2/29/12 at 1:00 P.M. an interview was conducted with the Director of Pharmacy (DP) who acknowledged that the side effects of Propofol included decreased respirations, decreased blood pressure, and decreased heart rate. The DP acknowledged that the hospital's Propofol protocol had not been followed by the RNs.

1d. On 2/28/12 at 11:15 A.M. a tour was conducted of the ICU with the ICU/MSU Nurse Manager (NM). The ICU was comprised of 5 beds and all beds were occupied. Patient 3 was ventilated via a breathing machine and was receiving an intravenous infusion of Propofol.

On 2/28/12 at 3:10 P.M., an interview was conducted with RN 9. RN 9 stated that RNs titrated (adjusted) the dose/rate of a Propofol infusion based on the level of sedation required for a patient, per a physician's order. RN 9 stated there was a hospital protocol for Propofol administration. RN 9 stated that incremental changes in propofol infusion were to be double checked by another RN, and then both RNs were required to document that double check on the Medication Administration Record (MAR). RN 9 stated that RNs also documented those changes in the progress notes of the ICU flowsheet.

On 2/29/12 at 9:15 A.M., an interview was conducted with RN 3. Per RN 3, with a physician's order, RNs could initiate a Propofol infusion at a low dose/rate. RN 3 stated, "5 micrograms (mcg.)/kilogram (kg)/minute (min) was a low dose, but the RN could initiate the infusion at 1-2 mcg., per their own clinical judgement. RN 3 stated RNs titrated the infusion rate in increments, and used own clinical judgement to determine how much those incremental adjustments should be, in order to achieve a certain level of sedation. RN 3 stated that the upper limit for the infusion was 50 mcg./kg/min., and RNs could not exceed that. RN 3 stated that Propofol "vacations" were implemented for patients once a shift, to assess a patient's response, and to determine the lowest dose of Propofol required.

On 2/29/12 at 10:00 A.M., a review of Patient 3's clinical record indicated that, Patient 3 was admitted to the ICU on 1/11/12, with respiratory failure and was dependent on a breathing machine.

On 2/21/12 at 7:55 P.M., RN 10 documented in the progress notes that, Patient 3 was "really agitated" and "keeps trying to get out of bed."

On 2/21/12 at 8:00 P.M., a physician gave a telephone order to "re-start on Propofol drip."

On 2/21/12 at 8:10 P.M., RN 10 documented "Propofol restarted at 50 mcg., titrated down to 20 mcg., when patient fell asleep." RN 10 documented that she started the infusion at the highest dose/rate possible, rather than start at 5 mcg./kg/min and increase in increments of 5 mcg., per the hospital protocol. In addition, there was no documentation on the Medication Administration Record (MAR) to indicate that the incremental changes in Propofol were double checked by another RN.

A review of the ICU flowsheet for 2/24/12, revealed the following discrepancies regarding the Propofol infusion: At 12:00 P.M., the patient was off Propofol. RN 1 documented that she restarted the Propofol at a rate/dose of 10 mcg/kg/min., rather than 5 mcg, per the protocol. At 7:00 P.M., RN 31 documented that the Propofol was decreased to 3 mcg/kg/min, rather than decrease the infusion by an increment of 5 mcg per the protocol. At 2:00 A.M., Patient 3's infusion was at 5 mcg. At 3:00 A.M., RN 31 documented that he increased the infusion to 30 mcg. At 4:00 A.M., RN 31 documented that Propofol was increased to 50 mcg/kg/min for continued agitation. There was no documented evidence of RN double checks regarding the dose/rate changes, and no evidence that Propofol was adjusted in incremental increases of 5 mcg/kg/min per hospital protocol.

Additional ICU flowsheets for the dates 2/25/12, 2/26/12, 2/27/12 and 2/28/12, revealed similar practices by the ICU RN staff for the administration of the Propofol infusion to Patient 3. The ICU RNs did not consistently increase or decrease the infusion by increments of 5 mcg/kg/min. The ICU RNs did not consistently restart the Propofol infusion at the lowest rate 5 mcg/kg/min. The ICU RNs did not document double checks of the adjustments on the MAR. There was no documented evidence that the ICU RN staff consistently implemented the Propofol "vacations" or awakenings that were to occur on a daily basis, per the hospital protocol.

During the joint interview 2/29/12 at 1:05 P.M. conducted with the Chief Operating Officer (COO), the Chief Administrative Officer/Risk Manager (CAO/RM), the Director of Nursing (DON), the ICU/MSU Nurse Manager (NM), and the Director of Pharmacy (DP) the ICU/MSU NM acknowledged that, an error had occurred in the administration of the high risk drug, Propofol to Patient 1. The team was unclear how the error occurred, but held RN 1 accountable for the error. Furthermore, the survey team shared data from Patient 3 and 4's clinical records regarding Propofol infusion irregularities, with the hospital staff during this meeting. During an interview of the ICU/MSU NM conducted at that time, the ICU/MSU NM stated that, when she found "outliers" she would speak with nurses but she did not fill out Occurrence Reports, when she found those errors. Also, during the joint interview, the CAO/RM and the DP stated that it was the hospital's policy to fill out an Occurrence Report when staff discovered that a medication error had occurred.

A review of the policy and procedure entitled, "Medication Error Reporting Policy" (effective 10/06 and Revised 12/20/10), and conducted on 3/1/12, indicated the following:

The policy was to: "Facilitate improvement of all aspects of medication administration."

The policy defined a medication error as: "Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health professional ..."

It stipulated that: "All medication errors shall be reported on the Occurrence Report Form by the staff involved in the medication error ..."

2. During an interview conducted with the Director of Pharmacy (DP) on 3/2/12 at 11:39 A.M., he stated the Pharmacy Department tracked high volume and high risk medications. The DP stated the Pharmacy Department tracked Coumadin (a blood thinner the use of which could result in severe bleeding if not controlled properly), total parenteral nutrition (TPN: the provision of highly concentrated solutions of nutrients via a central venous route that could result in metabolic problems if not controlled properly), heparin drips (a blood thinner that could result in severe bleeding if not properly controlled), and insulin drips (lowers high blood sugar levels and can result in a severe fall in the blood sugar level which could result in coma and/or death if not properly controlled).
He stated that the results of the Coumadin surveillance were reported to the hopsital's Performance Improvement system, and there was a written record of the TPN surveillance. With regard to the heparin infusions, the DP stated the pharmacy staff checked to see if the rate adjustment was appropriate but there was no written record of this process. With regard to the Insulin Drips, the DP stated the pharmacy staff would go out and check the blood sugar levels but he said there was no written record of this process.

During an interview conducted with the COO on 3/1/12 at 1 P.M., the COO stated that the DP had done a study on high risk drugs. He stated that the DP monitored heparin drips but he did not make written reports or report results of his findings to the hospital quality assurance system. He stated the DP made verbal recommendations.

Based on interview and document review, the facility failed to analyze a significant variation in it's Code Blue (hospital code used to indicate that a patient required emergent resuscitation) process, in an effort to identify opportunities for improvement and to implement preventive actions and learning. When staff did not know how to enable a defibrillator machine (a machine used to send electrical energy to the heart in life threatening heart arrythmia emergencies) to shock a patient, via gel pads placed on a patient's chest, there was no evidence of follow up or staff education by the Clinical Educator. This was a repeat deficient practice by the hospital.

Findings:

On 3/2/12 at 9:05 A.M., a joint interview was conducted with the Intensive Care Unit (ICU) and Medical Surgical Clinical Educator (CE), the Director of Nursing (DON), the Chief Administrative Officer (CAO)/Risk Manager (RM), and the Chief Operating Officer (COO), concerning the hospital's Quality Assurance and Performance Improvement (QAPI) efforts. The hospital was cited in a previous survey in October of 2011, for failure to analyze significant variations in their emergency processes and procedures.

The Code Blue/Rapid Response Team (RRT: a hospital team that provides early intervention and stabilization of a patient to prevent clinical deterioration) Committee Agenda for 1/9/12, was reviewed with the above staff members. The agenda included data review from 12/11 Code Blue/RRT responses. The agenda noted that, "there was one situation where the staff need education on how to 'pads' button on the debrillator." Under the section for "action/follow-up/recommendations," there was no documentation pertaining to any education that was performed to address the staff's inability to operate the defibrillator.

Per the COO, during a Code Blue, staff were unsure how to switch the defibrillator control switch from "paddle mode" to "pads." The heart can be defibrillated via paddles that are placed directly on a patient's chest or through gel pads that are placed on the patient's chest.

The Clinical Educator was unable to verbalize any actions that were taken as a result of the process variance.

Based on interview, record and document review, the hospital failed to implement an action for a performance improvement plan. When the hospital demonstrated significant variances in it's Code Blue (hospital code used to indicate that a patient requires emergent resuscitation) and Rapid Response Team (RRT a hospital team that provides early intervention and stabilization of a patient to prevent clinical deterioration) responses, it failed to provide education to all clinical staff per it's own performance improvement and action plan. The hospital continued to demonstrate process variations in RRT events specific to patient assessments and documentation, during those emergency responses.

Findings:

1. During a Federal Complaint Validation Survey conducted on 11/1/11, the hospital was cited for a deficient practice pertaining to the analysis of their Code Blue and RRT process variations. The hospital's corrective plan of action stated that, "100 % of the clinical staff to include nursing, respiratory, and laboratory were re-educated to the purpose and procedure of the Code Blue and RRT events." The completion date for that action item was, 11/15/11.

On 3/1/12 at 2:10 P.M., an interview was conducted with the Intensive Care Unit (ICU) and Medical Surgical Unit (MSU) Clinical Educator (CE). The CE stated that he had not educated 100 % of the clinical staff as of 3/1/12. The CE stated that he was unaware that the education of the staff was to be completed by 11/15/11, per the hospital's own corrective plan of action. Per the CE, some of the nursing and respiratory staff had received education. None of the laboratory clinical staff had been educated in accordance with the plan.

On 3/2/12 at at 9:05 A.M., an interview was conducted with the COO. The COO was unable to verbalize why the clinical educator was unaware of the requirement to educate 100% of the clinical staff by 11/15/11.

2. On 3/1/12 at approximately 9:05 A.M., an overhead call was heard for the Rapid Response Team (RRT) to go to the east wing of the Medical Surgical Unit (MSU), room 4A. Various staff members were observed running down the hallway to the MSU.

On 3/1/12 at 12:50 P.M., a review of Patient 34's clinical record and Code Blue/Rapid Response Team Event Record for the above event, was conducted with the Assistant ICU/MSU NM (intensive care unit/medical surgical nurse manager).

Patient 34 was admitted to the hospital on 2/2/12, with a significant history of chronic respiratory failure and oxygen dependence. The patient had multiple hospitalizations secondary to chronic obstructive lung disease and pneumonia, per a History and Physical, dated 2/3/12.

Per the RRT event record, dated 3/1/12, Patient 34 complained that she couldn't breathe. She was "restless and used her accessory muscles to breathe." She was "gasping for breath." The RRT was called at 9:05 A.M. The event record form contained a section to document vital signs and the time. At 9:05 A.M., a blood pressure of 133/77 and an oxygen saturation level of 99% were recorded. There were no other documented vital signs on the record. There was no evidence that the patient's heart or respiratory rates were assessed or recorded when the patient had complained of significant breathing problems. There was no documentation that the patient's lung sounds had been auscultated (listened to with a stethoscope). There was no documented pain assessment. The record indicated that the patient's response "seemed more related to discomfort and pain in her spine." Patient 34 was administered oxygen at a higher rate, and 1 milligram (mg.)of Morphine (pain medicine), but there was no assessment of the patient's vital signs or response to those interventions. The RRT was cleared at 9:15 A.M.

On 3/1/12 at 1:05 P.M., an interview was conducted with Respiratory Therapist (RT) 1. RT 1 had worked at the hospital for 3 weeks. RT 1 responded to the RRT event on 3/1/12. Per RT 1 he listened to Patient 34's lungs and she had rhonchi (abnormal lung sounds). He thought the patient may have aspirated. RT 1 stated that he had not been informed to document his assessments during RRT events.

An interview was conducted with the Assistant ICU/MSU Nurse Manager on 3/1/12 at 1:10 P.M. The Assistant ICU/MSU Nurse Manager acknowledged that the lack of documented vital signs and thorough patient assessment was unacceptable.

3. On 3/1/12 at 2:35 P.M. a review of 4 Rapid Response Team (RRT) event records from November and December of 2011, was conducted with the Chief Administrative Officer/Risk Manager (RM). The following discrepancies were identified:

a. On 11/2/11, a patient's oxygen saturation level dropped to 80 and when the patient did not respond to interventions, the RRT was called at 7:20 P.M. The patient required emergency intubation (placement of a breathing tube) by an anesthesiologist. No time was recorded for when the patient was intubated. There were no recorded assessments of the patient's respiratory rate or lung sounds prior to the emergency intubation.

b. On 11/26/11 at 8:45 P.M., an RRT was called for a patient who had a "high heart rate" and complained of chest pain. There was no documented assessment pertaining to the patient's respiratory rates or airway status noted on the record. The RRT event record was not completed.

c. On 12/7/11, a patient was found "unresponsive." The patient's pulse was "barely palpable." The RRT was called at 4:50 P.M. A non rebreather oxygen mask was applied to the patient at 4:50 P.M. There was no documented assessment of the patient's respiratory rates or lung sounds found on the record.

d. On 12/16/11 a patient arrived to the hospital via an ambulance with her tracheostomy tube partially out. The patient's oxygen saturation level was 83%. The patient was "blue in the face" and the RRT was called. There were no documented assessments on the event record of the patient's respiratory rates or lung sounds.

The RM acknowledged that the RRT event code records were incomplete. The RM acknowledged that the records did not contain complete and thorough patient assessments. The RM acknowledged that in the review of the RRT code event records, the discrepancies and missing documentation pertaining to patient assessments had not been identified by the hospital.

Based on observation of two nurses passing medications to two patients on the Medical Surgical Nursing Unit, the hospital failed to ensure medications were administered to one of these two patients (Patient 41) as ordered by the physician. Three errors were made out of a total of 20 opportunities for error for a final error rate of 15%. Furthermore, the hospital failed to ensure that nursing staff implemented the hospital procedure for checking the accuracy of the medication administration record (MAR: used by nurses to accurately medicate their patients and to document the date and time a dose of medication was administered) for Patient 41 which resulted in the administration of a multiple vitamin tablet to Patient 41 for fourteen days after it had been discontinued.

Findings:

1. Observation conducted on 2/29/12 at 9:31 A.M., on the medical/surgical unit, Nurse 43 administered one 81 mg tablet of enteric coated aspirin, one plain multiple vitamin tablet, and one tablet of Domiciling 875 mg/Clavulinate 125 mg (generic Augmentin: an extended spectrum antibiotic) to Patient 41. On 2/29/12, a review of Patient 41's clinical record was conducted and indicated that on 2/10/12, a physician had ordered that Patient 41 receive two tablets, not one, of the 81 mg enteric coated aspirin, and that on 2/10/12, a physician had ordered that Patient 41 receive one 500 mg tablet of Augmentin each day, not an 875 mg tablet, and that, on 2/11/12, a dietician had recommended that the multivitamin be discontinued and replaced with Nephro-Vite (a vitamin given to patients with renal problems). A physician had signed the recommendation but had not timed and dated the order. Patient 41 should not have gotten the multiple vitamin tablet. A nurse had noted the order at 10 A.M. on 2/15/12.

2. On 2/29/12 at 9:31 A.M. Nurse 43 administered one plain multiple vitamin tablet to Patient 41. On 2/29/12, a review of Patient 41's clinical record indicated that on 2/11/12, a dietician had recommended that the multivitamin be discontinued and replaced with Nephro-Vite (a vitamin given to patients with renal problems). A physician had signed the recommendation but had not timed and dated the order, so Patient 41 should not have gotten that tablet. A nurse had noted the order at 10 A.M. on 2/15/12.

During an interview conducted with the COO on 3/2/12 at 9:36 A.M., the COO stated that the chart check process failed to pick up the fact that the multivitamin had been discontinued. He stated that the nursing staff was supposed to update the MAR with order changes at the time they noted the order, and that there was a 12 hour chart check process to ensure that this happened. He stated that if this process was missed the error could go on undetected.

During an interview conducted with Administrative Nurse 47 on 3/2/12 at 1:51 P.M., on the Medical Surgical Nursing Unit, Nurse 47 stated that there was no policy and procedure for the chart check process, but there was an established process for this check which took place as follows:

a. The chart checks took place every 12 hours

b. At the change of shift the ongoing and the offgoing respective staff members would go over all the medications that were ordered that shift as well as any follow-up that needed to be done.

c. Both the oncoming and offgoing staff members would initial and date the orders.

d. The oncoming and offgoing staff members would go over the MARs at the same time and would check the MARs against the orders at that time.

e. If a discrepancy was noted at the shift change, staff would fax the order to the pharmacy and call the pharmacy.

Administrative Nurse 47 stated that the Registered Dietician's Recommendations that were signed by the physicians were part of the chart check.

A review of the 2/15/12, MAR at the time of this interview, indicated that the multivitamin order had been crossed off by nursing staff. A review of the 2/16/12, MAR indicated that the MVI order was still being printed out on the printed MARs which meant the pharmacy had not discontinued it.

During an interview conducted with the Director of Pharmacy (DP) on 3/2/12 at 9:28 A.M., the DP stated that the multivitamin order should have been discontinued by the pharmacy staff based on the approval, by signature, of the dietician's recommendation by the physician. He stated it was a medication error and it occurred because the Medical Surgical Unit secretary failed to make a copy of the signed dietician's recommendation and send it to the pharmacy.