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Tag No.: A0122
Based on a review of the hospital policies and procedures, medical records, and staff interviews, it was determined the facility failed follow their grievance process with in the time frame stated in the hospital policy and procedure in 1 of 1 patients (Patient# 39).
Findings include:
A review of the Public Relations correspondence between the complainant and the facility revealed the patient's spouse first spoke with the facliity on 06/03/10, regarding the patient being admitted against the patient's will.
A response letter dated 06/11/10 was sent to the complainant.
The complainant, unsatisfied with the facility's response, contacted the facility a second, third, and fourth time, in writing, on the following dates: 06/16/10, 06/28/10, and 08/20/10.
On 6/24/10, the complainant was called by the Public Relations Manager who urged the complainant to contact the Grievance Committee. The Grievance Committee sent a letter to the complainant on 07/07/10, stating the committee would investigate the allegations and would contact the complainant in approximately 30 days.
On 8/24/10, the grievance committee responded with an apology, stating the review was still not completed.
Review of the hospital policy/procedure # 2865 titled "Patient Complaint, Discrimination and Grievance" requires: "...Grievances...verbal or written. The Complaint Coordinator will conduct or oversee...within a reasonable time frame...process starts when Complaint cannot be resolved...Within seven (7) days of receipt...
Level Two Grievance...Acknowledge receipt...within 5 days...Review...provide..in person or by telephone...to the Committee within 60 days...Respond to the complainant within ten (10) business days...Where the grievance cannot be investigated within...notify...the investigation remains ongoing...."
The Public Relations Manager confirmed during an interview conducted on 09/13/10 at 1030, that a final correspondence letter dated 9/13/10, was written by the Grievance Committee and will be sent to the complainant.
The facility failed to respond timely, per policy, to the complainant.
Tag No.: A0168
Based on review of hospital policy and procedure, medical records and interview, it was determined the hospital failed to require that the use of restraint is in accordance with the order of a physician or other licensed independent practitioner who is responsible for the care of the patient, for 1 of 3 patients who were restrained for the management of violent behavior (Pt #36).
Findings include:
Review of hospital policy/procedure titled: Restraint use in Violent Situations revealed: "...Initiation of restraint or seclusion...2. Obtain a written or documented verbal order prior to initiation of restraint or seclusion. If the need for restraint or seclusion occurs so quickly that an order cannot be obtained prior to the application of the restraint or seclusion, the order must be obtained either during the emergency application of the restraint or seclusion or immediately after...."
Pt #36 arrived at the Emergency Department (ED) on 4/27/10, at 0437. At 0557, a nurse documented: "...pt arrives with EMS (Emergency Medical Services) and PD (Police Department) in restraints. pt is combative and confused. possible h/o (history of) alzheimers. pt initially called 911 to report that he had killed his brother with a frying pan. (per PD, no such event took place)...."
At 0508, a nurse documented administration of Haldol 5mg IV Push and Ativan 1mg IV Push
At 0621, a nurse documented: "...pt released from restraints, pt quiet, sleepy and cooperative at this time, md aware...."
At 0622, a physician documented a physical examination.
At 1448, a physician documented: "...pt altered, extremely aggressive, harmful to staff on arrival. chem & physical restraints. pt more awake now, but still confused, unsure baseline as pt confused & unable to locate any family...."
At 1940, a nurse documented administration of Ativan 1mg IV Push.
Pt was transferred to a geriatric behavioral unit. Medical record contained no documentation to indicate that the patient was in police custody.
The medical record did not contain an order for restraints.
The Sr. Clinical Manager, ED, confirmed during interview on 9/15/10, that the medical record did not contain a physician's order for restraint. S/he confirmed that nursing staff was required to get the order.
Tag No.: A0171
Based on review of policy/procedure, medical records, and interview, it was determined that the hospital failed to require that an order for restraint used for the management of violent patient behavior must be time limited per hospital policy for 2 of 3 (Pt's #35 & 36).
Findings include:
Review of hospital policy/procedure titled: Restraint use in Violent Situations revealed: "...Each order for restraint or seclusion in violent situations must state the maximum duration of the restraint or seclusion...."
Pt #35 arrived at the ED on 5/15/10 at 1720.
At 1743, a nurse documented: "...Patient restrained at 1735...Time of Original Order: 1735...."
At 1843, a physician documented: "...family came in room and he became physically aggressive, threat of harm to staff and self and was restrained...awake now but intoxicated.
At 1859, a nurse documented: "...pt sleeping intermittently, restraints released pt understands to remain in bed...."
At 1917, the physician documented: "...he is less combative and agreed to come out of restraints if he acted appropriate...."
The medical record contained a Restraint Order Form. A physician indicated that the order was for "...Emergent, Violent or Self-destructive Behavior Restraint...Reason for restraint: Suicidal...Self-Injury...Danger to others. The section of the form to indicate the type of restraint was blank. The section to indicate duration of restraint was blank.
Cross reference Tag (0168) for information regarding Pt #36.
Pt #36's medical record contained no order for restraints, including any time limit.
The Sr. Clinical Manager, ED, confirmed during interview on 9/15/10, that restraint order for Pt #35 was not time-limited and Pt #36's medical record did not contain a physician's order for restraint.
Tag No.: A0175
Based on review of hospital policy/procedure, medical records, and interview, it was determined the hospital failed to require that the condition of a patient who is restrained for the management of violent behavior is monitored a minimum of every 15 minutes per hospital policy for 2 of 3 patients (Pt's #35 & 36).
Findings include:
Review of hospital policy/procedure titled: Restraint use in Violent Situations revealed: "...5. Monitor the patient for appropriateness and necessity of restraints or seclusion, restraint safely applied, risks associated with the intervention, level of distress or agitation, cognitive status and vital signs...Restraint or Seclusion: Minimum of every 15 minutes, more frequent or continuous depending on assessment of patient...."
Cross reference Tag (0171) for information regarding Pt #35.
Pt #35's medical record contained a form titled Restraint Flow Sheet which contained a statement: "...Frequency of assessment documentation = every 15 minutes...." The form contained entries at 1735, 1800, and 1830.
Cross reference Tag (0168) for information regarding Pt #36.
Pt #36's medical record did not contain documentation of monitoring of the patient every 15" during restraint.
The Sr. Clinical Manager ED, confirmed during interview on 9/15/10, that the medical records of Pt's #35 & 36 did not contain documentation of the required monitoring of the patients.
Tag No.: A0178
Based on review of hospital policy/procedure, medical records, and interviews, it was determined the hospital failed to require that a patient be seen face-to-face by a physician or other licensed independent practitioner or a trained registered nurse within 1 hour after the initiation of restraint to manage violent behavior per hospital policy for 2 of 3 patients (Pt's #36 & 37).
Findings include:
Review of the hospital policy/procedure titled Restraint Use in Violent Situiations revealed: "...Perform a face-to-face evaluation of the patient as soon as possible, but no later than 1 hour after the initiation of violent restraint or seclusion...(Physician, LIP, or Trained RN)...."
Cross reference Tag (0168) for information regarding Pt #36.
Pt #36's medical record did not contain documentation of a face-to-face evaluation within 1 hr. of the initiation of restraint.
The Sr. Clinical Manager ED, confirmed during interview on 9/15/10, that Pt #36's medical record did not contain documentation of a face-to-face evaluation within 1 hr. of the initiation of the restraint.
Cross reference Tad (178) for information regarding Pt #37.
Pt #37 was placed in lockable bilateral wrist and leg restraints on 8/2/10 at 1215 due to violent behavior which included hitting staff. The patient was also attempting to pull out his foley catheter.
The medical record did not contain documentation of the one hour face-to-face evaluation of the patient after this restraint.
On 9/13/10, the RN Clinical Informatics Facility Director confirmed that Pt #37's medical record did not contain documentation of the one hour face-to-face evaluation of the patient after the restraint on 8/2/10.
Tag No.: A0267
Based on review of hospital policy/procedure, hospital documents, medical record, and interview, it was determined that the hospital failed to measure and track quality indicators relating to adverse patient events per hospital policy as evidenced by:
1. failure to require documentation via a factual account of an incident in the patient's medical record, per policy; and
2. failure to require review of an incident within 72 hours of the initial entry of the incident in the computerized system per policy.
3. failure to require that all episodes of restraint are documented on a restraint log/audit tool per hospital policy;
Findings include:
Review of the hospital policy/procedure titled Incident Reporting, Serious and Sentinel Event Reporting revealed: "...Procedure/Interventions: ...Immediate Response to Incident with actual/potential impact on patient: (Health Care Staff)...6. Document factual account of the incident in the medical record...Report Incident (Health Care Staff)...Assign incident to appropriate departments for investigarion. (QM)...Investigation and Closing Case (Director/Designee)...1. Review the incident within 72 hours from date of initial entry...."
1. On 9/8/10, Director Quality Management provided a timeline and peer review worksheet regarding the hospital's internal investigation regarding Pt #37's care and subsequent death. He stated that the hospital was treating the case as a potential root cause analysis. He stated during interview on 9/15/10, that at this point, the case was being categorized as an "Incident" with regard to the hospital's procedures.The CMO described, on 9/15/10, how the hospital has facilitated numerous meetings and discussions regarding the patient's care
An incident report was initially entered on 8/4/10 into the hospital's Softmed system. The incident was described as a delay in treatment, referencing the initial order for the patient to be transferred to ICU on 8/1/10.
Cross reference Tag (0392) for additional information regarding Pt #37.
Pt #37's medical record contained no documentation by hospital personnel regarding the circumstances surrounding the reason that the patient was not transferred to ICU when the physician initially ordered the transfer. Nursing leadership did not document rationale for requesting the cancellation of the order to transfer the patient to ICU, or provisions for the patient's nursing care needs in Telemetry. The medical record contained no documentation regarding any discussion between physician an House Supervisor, other than the physician's progress note the following day.
The Director of Quality Management stated, during interview on 9/15/10 that the physician had documented the circumstances in progress notes on the following day. However, the physician is not a staff member of the hospital.
2. The first review of the incident was documented in the system on 8/16/10. A manager also documented review on 8/16/10.
The Director of Quality Management confirmed during interview on 9/15/10, that the review did not occur within the 72 hours from date of initial entry as required by policy/procedure.
The QAPI (Quality Assessment and Performance Improvement) program has not ensured that the policy/procedure regarding analysis and tracking of adverse patient events is followed.
3. Review of hospital policy/procedure titled Restraint Use in Violent Situations revealed: "...Quality improvement activities related to the use of restraint or seclusion:...Document all episodes of restraint on a restraint log/audit tool...."
Review of hospital document Restraint Committee Meeting Minutes, August 10, 2010 revealed: "...There were five restraints that were not reported during the month...One restraint on 7/31/10 was on 3D and continued when patient was transferred to 3A...Correction made on July Log...."
Review of the meeting minutes revealed that patient restraint data are not consistently being logged/ monitored as required by policy/procedure.
Tag No.: A0392
Based on review of policy/procedure, medical record, and interview, it was determined that the hospital failed to have adequate numbers of staff personnel for the Intensive Care Unit to ensure that a registered nurse was available for bedside care of 1 of 1 patient (Pt #37).
Findings include:
Pt #37 was admitted to the hospital on 7/31/10 at 0610, via the ED. His admitting diagnosis was Pancreatitis (acute); with abdominal pain. After admission, a physician determined that the patient had Recurrent Pancreatitis, Alcoholism, and Hyperlipidemia. The patient's lipase and amylase levels were significantly elevated. The patient was initially admitted to a Medical Unit (4D), and an RN completed the "Medicine/Surgical Routine Orders," recording the ordering physician's name.
On 8/1/10, at 1115, Physician #2 wrote an order: "...Transfer to ICU...." The physician documented in the progress note: "...Recurrent Pancreatitis...Alcohol withdrawal-moderate...ARF (Acute Renal Failure)...Alcoholism...."
The medical record contained three pages of "Critical Care Routine Admission Orders" dated 8/1/10 and signed by Physician #2 at 1100, 1115, and 1130. At 1257, an RN recorded a telephone order from Physician #2: "...Cancel transfer to ICU...Transfer pt to Telemetry with companion and orders...."
At 1400, an RN documented: "...2 sitters in room + wife and mother. Pt scooted off bed & stood up attempting to leave room. This RN & other staff in room to get pt back to bed pt uncooperative. Security called, pt placed back in bed. Pt confused...."
Documentation indicated that the patient was transported to 3D Telemetry at 1436.
The medical record contained no "Progressive Care Telemetry Orders."
On 9/10/10, the RN Director Critical Care and Clinical Care Operations confirmed that the medical record contained no "Progressive Care Telemetry Orders;" that the patient was being transferred from the medical unit to the Telemetry Unit; and that the "Progressive Care Telemetry Ordrs" were required.
Review of the patient's arterial blood gases revealed the following oxygen levels. (PO2 = partial pressure of oxygen in arterial blood; normal range: 69.0-116.0; O2 sat = percentage of available hemoglobin that is saturated with oxygen; normal range: 90-100%.):
On 8/1/10 at 1915, his PO2 was 67.0 and O2 sat 95.8. On 8/2/10, at 0700, the patient was started on Bipap and his PO2 was 37.0. & O2Sat was 91.4. At 1023, the PO2 was 72.0 and O2 sat 96.8. At 1500, the PO2 was 57 and O2 sat was 73.9; at 1510, the PO2 was 41 and O2 sat was 55.7 on a ventilator. At 1518, the PO2 was 99 and O2 sat 96.2. At 1955, PO2 was 54 and O2 sat 85.2. At 2050, PO2 was 50 and O2 sat 84.8. At 2234 PO2 was 45 and O2 sat was 84.4 on a ventilator.
On 8/2/10, at 0730, Physician #2 documented: "...Pt sedated today. No restraints needed but having fluctuations of P02=37. VS (Vital signs) stable today but remains pale & clammy...Pt was ordered to go to ICU yesterday but was transferred to telemetry instead w/1:1 nurse because...charge nurse & House Supervisor said that there's no bed available & cannot provide nurse & concerned that transfer is inappropriate & will not be paid. Explained to them that pt has worsening pancreatitis, episodes of hypoxia, ARF (Acute Renal Failure) & in full alc.(alcohol) withdrawal. however, they keep on insisting on reasoning. They told me that they will just call rapid response if pt will have resp. distress. Since this discussion was delaying care of my pt, he was transferred for telemetry to implement nursing care ASAP...."
Physician #2 stated during interview conducted on 9/9/10, at 1203, that the patient was a very large man and became uncontrollable at times. The physician wanted to give the patient more Ativan but when the patient became sedated, his oxygen saturation dropped. The physician feared that the patient would go into respiratory arrest and s/he wanted the patient in ICU if he required intubation. S/he wanted everything in place and readily available should the patient require intubation (rather than to wait for rapid response team). He stated that he had written the order for the patient to be transferred to ICU during his morning rounds on 8/1/10. However, s/he received a call from the House Supervisor on his way home. The House Supervisor informed the physician that there was no ICU bed available and that the patient could be transferred to telemetry with a 1:1 nurse. Physician #2 stated that he thought the patient was with a 1:1 nurse; not a companion. S/he stated that he agreed for the patient to go to telemetry because he believed that the patient would have the same care that he would receive in ICU.
Physician #2 confirmed during interview conducted on 9/10/10, at 1130, that s/he had hurriedly authenticated the telephone order to cancel the transfer to ICU and for the patient to transfer to telemetry with a companion. He didn't read the telephone order carefully before authenticating it. S/he stated that he did not realize that the pt. was with a 1:1 companion and not a nurse. The nurse that recorded the telephone order was unavailable during survey.
Review of the hospital policy/procedure titled Companion Expectations revealed: "...Definition...Companion...for the purposes of this policy is an unlicensed caregiver assigned to a patient(s) to provide supportive supervision, complete activities of daily living and assist in maintaining patient safety for a non-suicidal patient...."
Review of the 3D Nursing Assignment Sheets for 8/1/10, revealed that the nurse assigned to the patient on the 0700-1900 shift was responsible for 3 additional patients. The nurse assigned to the patient on the 1900-0700 shift (ending on 8/2/10) was assigned to one other patient.
Review of the ICU staffing documents for 8/1/10 day shift and night shift revealed that the 2A ICU unit was "closed." During interview on 9/10/10, at 1140, the RN Director Critical Care & Clinical Care Operations confirmed that the patient could have been transferred to the 2A ICU unit and the unit could have been opened and staffed with the Charge Nurse and the "SWAT" nurse. S/he also referred to the hospital policy/procedure titled: Admission, Transfers, Discharges, and Triage: Critical Care Services: "...Criteria for admission to ICU...6. Patients who require frequent assessment or interventions more than every two hours for more than four hours duration or whose assessments/interventions are complex requiring intensive time to complete...." S/he stated that the patient would have met this criteria for ICU admission and that he could have been accomodated.
The policy/procedure described above contained: "... Review Date: 5/18/10...Original Date: 6/1/10...Effective date: 8/13/10...." The RN Director Critical Care & Clinical Care Operations stated on 9/15/10, that the policy was in use on 8/1/10.
On 8/2/10, at 0810, Physician #2 wrote an order: "...Transfer to ICU...."
The physician documented in the progress notes: "...Pt had 2 'code gray' because of combativeness and agitation. Pt was given several doses of Ativan & Valium & was put in leather restraints & sedated on Bipap...Imp (Impression): Alcohol withdrawal...Hypoxia...Acute Pancreatitis...ARF improving...Transfer to ICU...."
At 0850, a physician wrote a progress note: "...Pancreatitis, likely secondary to ETOH. Now in severe agitation...Being transferred to ICU...Respiratory Failure-likely ARDS (Adult Respiratory Distress Syndrome)/effusions/Pneumonia/atelectasis...Pancreatitis-severe...Severe Alcohol withdrawal...decreased platelets/increased BS(Blood Sugar)/ARF likely secondary to severe Pancreatitis...Start Ativan gtt. may need Diprovan gtt...May need Intubation...."
Documentation in the medical record indicated that the patient arrived in ICU on 8/2/10, at 0950. He was admitted to the 3A ICU Unit.
Tag No.: A0395
Based on review of hospital policies/procedures, medical record, and interview, it was determined that the hospital failed to require that a registered nurse supervise and evaluate the nursing care of the patient as evidenced by:
1. failing to provide ICU care to a patient who was assessed by the physician as requiring ICU care and who met criteria for admission/transfer to ICU for 1 of 1 patient (Pt #37); and
2. failing to assess the patient at the required intervals, administer the required medication, and/or administer medication at the required intervals for 3 of 3 patients who were placed on the Alcohol Withdrawal Management Protocol and were assessed with scores of 5 or higher (Pt/s #33, 34 & 37).
Findings include:
1. Cross reference Tag (0392).
2. Review of the hospital policy/procedure titled Alcohol Withdrawal Management Protocol revealed: "...When a physician orders 'Alcohol Withdrawal Protocol'...the Alcohol Withdrawal Management Protocol and Preliminary Treatment Plan and the CIWA-AR (Clinical Institute Withdrawal Assessment from Alcohol-Revised) scale will be initiated...All items on the protocol are applicable unless otherwise indicated by the physician...The physician will be notified of a CIWA-AR scale score of greater than 11 after a successive total of 60mg Diazepam (Valium) or 6 mg Lorazepam (Ativan) has been administered to the patient...Procedure/Interventions: ...Verify order for protocol by physician...Perform patient assessments as scheduled on the protocol and as needed based on the patient's status...Administer medication as per protocol orders...Continuously monitor oxygen saturation and notify physician if saturation drops below 92%...Forms: ...Alcohol Withdrawal Management Physician Orders...Diazepam (Valium) 5 mg PO (by mouth) q 4 hours PRN if CIWA score is 5-7, 12 doses...Diazepam (Valium) 10 mg PO q 2 hours PRN if CIWA score is 8-11, 6 doses...Diazepam (Valium) 20 mg PO q 1 hour PRN if CIWA score is > 11, 3 doses...If CIWA score 5-7, repeat assessment Q4H and medicate according to CIWA-AR scale...If CIWA score 8-11, repeat assessment Q2H and medicate according to CIWA-AR scale...If CIWA score >11, repeat assessment Q1H and medicate according to CIWA-AR scale...If NPO (nothing by mouth), use Lorazepam (Ativan): ...Lorazepam (Ativan) 2mg IV, Q4H PRN if NPO and CIWA score 5-7, 3 dose(s)...Lorazepam (Ativan) 2mg IV, Q2H PRN if NPO and CIWA score 8-11, 3 dose(s)...Lorazepam (Ativan) 2 mg IV, Q1H PRN if NPO and CIWA score >11, 3 doses...."
Pt #33 was admitted on 7/12/10. A physician ordered the CIWA-AR protocol on 7/12/10. The patient was taking oral medication. This patient's lowest score was "2" and highest score was "11." On 7/12/10, at 2207, the nurse documented a score of 7 and administered no medication. According to the protocol, the nurse should have administered 5mg of Valium. On 7/13/10, at 1028, the nurse documented a score of 8. S/he administered the correct dose of Valium, but did not reassess in 2 hours per protocol. On 7/13/10, at 1728, the nurse documented a score of 5. S/he administered the correct dose of Valium, but did not reassess in 4 hours per protocol. The nurse documented the patient's score of 5 on 7/14/10 at 0549, and assessed the patient again at 1036 (greater than the required 4 hours). The patient's score at 1036 was 11. The nurse documented the next assessment at 1305 (greater than the required 2 hours). The patient was discharged on 7/15/10.
The findings from this medical record indicated that the nurse assessed at incorrect intervals and failed to administer one dose of medication.
Pt #34 was admitted on 7/30/10. A physician wrote an order on 7/31/10 at 1130: "...Ativan prn as per CIWA scale...." The patient was taking oral medication.
The patient's highest CIWA-AR score was 5. The nurse documented the score "5" on 7/31/10 at 1852 and reassessed at 2301 (greater than the 4 hrs required).
Cross reference Tag (0392) for information regarding Pt #37.
Review of Pt #37's medical record revealed:
At 0900, an RN completed the "Medicine/Surgical Routine Orders," recording the ordering physician's name. The orders included: "...Additional Orders: ...Alcohol withdraw CIWA (Clinical Institute Withdrawal Alcohol) 2x day (two times per day); Protocol if CIWA >8...."
The medical record did not contain the "protocol" or Alcohol Withdrawal Prevention Orders for the 7/31/10 orders.
Pt #37's medical record contained documentation that he was NPO.
An RN recorded the following alcohol withdrawal assessment totals and administered the following
medication:
7/31/10
1000 CIWA score 9; pt. received Ativan 2mg IV at 1030.
1200 CIWA score 0; pt. received no medication.
1430 CIWA score 7; pt. received Ativan 2mg IV at 1437.
1830 CIWA score 7; pt. received Ativan 2mg IV at 1828.
2030 CIWA score 17; pt. received Ativan 2mg IV at 2059.
2200 RN documented notification of physician: "...the patient has been given 2 doses of Ativan 2 mg per CIWA protocol, but the patient is still agitated. New order received...." The nurse documented a telephone order by the physician: "...Zyprexa 10mg now for agitation..."
2230 CIWA score 21; pt. received Ativan 2mg IV at 2334 (The pt should have been assessed at 2130 and given Ativan according to score. Nurse delayed giving Ativan with no clarification to do so. (Zyprexa is not part of the CIWA protocol).
8/1/10
0030 CIWA score 20; pt. received no medication. Pt. should have been assessed at 2330 and should have received 2 mg Ativan.
0230 CIWA score 13; pt. received no medication. Pt. should have been assessed at 0130 and received medication.
0430 CIWA score 19; pt. should have been assessed at 0330 and received medication. Pt. received Ativan 2mg IV at 0449.
Note: The medical record contained documentation at 0519, that the patient was restless, agitated and refusing to comply with the NPO order.
0619 CIWA score 4. Pt received no medication. Pt should have been assessed at 0530.
Note: The medical record contained documentation at 0651 that the patient was agitated and pulling at lines, tubes and drains.
During interview on 9/13/10, hospital pharmacist confirmed that it would be very unusual for a patient's CIWA-AR score to decrease from 19 to 4 within 2 hours, when the patient's scores had been so high previously.
0903 CIWA score 8; pt. received Ativan 2mg IV at 0900.
1100 CIWA score 5; pt. received Ativan 2mg IVat 1122
1500 CIWA score 20; pt. received Ativan 2mg IV at 1515
1600 CIWA score 7; pt. received no medication. Pt should have received 2mg Ativan.
1625 Nurse recorded telephone order for restraints.
1652 Nurse recorded a physician's telephone order for Valium 10mg IV "now." Pt received Valium 10mg IV. Pt placed in restraints at 1730.
1700 CIWA score 22; pt. received Ativan 2mg IV at 1705.
1800 CIWA score 22; pt. received Ativan 2mg IV at 1815.
1958 CIWA score 24; pt. should have been assessed at 1900 and received medication. Pt received Ativan 2mg IV at 2030.
No documentation of notification of physician as required by protocol.
2111 CIWA score 23; patient received Ativan 2mg IV at 2128.
2130 Nurse recorded physician's telephone order for Valium 10mg q4hr prn agitation. (No clarification regarding how to administer it in conjunction with Ativan.)
2132 Nurse notified physician of critical lab results: ammonia level 29 (normal range 9-35); Arterial Blood Gases (ABG): P02 67 (normal range 69-116); HCO3 (Bicarb)20.4 (normal range 22-26);and Base Excess, ABG: -4.2 (normal range-2.4-- -2.3).
2225 CIWA score 15; patient received Ativan 2mg IV at 2230.
2325 Documentation of notification of physician of pt's lab results. (No new lab results are on medical record. Notification was to a different physician than the one notified at 2132.)
2342 CIWA score 11; patient received Ativan 2mg IV at 2330
8/2/10
0132 CIWA score 13; patient received Ativan 2mg IV at 0132.
No documentation of notification of physician as required by protocol.
At 0145, patient received Valium 10mg IV
At 0230 patient received Ativan 2mg IV; no CIWA assessment documented. Pt. should have been assessed at 0232.
0315 CIWA score 9; patient received Ativan 2mg IV at 0330.
0500 CIWA score 9; patient received Valium 10 mg IV at 0541 and Ativan at 0542. Pt should have received Ativan at 0500 per protocol.
0545 RN documented telephone order from physician: "...Stat ABG (Arterial Blook Gases) x1 now...."
0630 Documentation of notification of physician of critical lab results. "...New orders received...." (P02 37)
0630 RN documented telephone order from physician: "...Place pt on Bipap stat...Repeat ABG on 2 hrs Post Bipap...Consult. Dr.______ Re Hypoxia...."
0650 Documentation of notification of physician for consult. "...Called several times to the answering service without success...."
0700 /CIWA score 13; Ativan 2mg was pulled from the automated medication system at 0752, but not charted as administered.
0815 Physician ordered: "...Transfer to ICU...."
0815 Physician ordered : "...Portable chest X-ray now...."
0900 CIWA score 13. Pt should have been assessed at 0800. Pt received Ativan 2mg IV at 0913.
1022 CIWA score 16. Pt should have been assessed at 1000. Pt received Valium 10mg IV at 1045. Pt. should have received Ativan 2mg. No documentation on chart for order to use Valium in place of Ativan for CIWA. (Valium ordered for agitation.)
1030 a nurse noted: "...Physician call back/On-site visit...Dr. notified of CXR (Chest X-Ray) results and ABGs. Orders given...."Documentation of Chest X-ray results 0936: "... Bilateral lower lobe infiltrates...Atelectasis persist...."
1035 a nurse noted: "...Physician call back/On-site visit...."
1100 Patient was started on an Ativan IV infusion at 2mg/hr.
At 1415, pt received Valium 10mg IV.
During interview on 9/13/10, the pharmacist and RN Clinical Informatics Facility Director confirmed that the nurses had not followed the CIWA-AR Protocol regarding frequency of assessments, administration of medication, and utilizing Valium in place of Ativan for CIWA-AR scores without clarifying with the physician.
During interview on 9/13/10, the Director of Quality Management confirmed that the nursing staff on any unit other than Behavioral Health had not received training in the use of the CIWA-AR Scale or Protocol.
Nursing did not implement the Alcohol Withdrawal Prevention Orders when recording the initial physician orders for the Medicine/Surgical Routine Orders. Nursing did not assess the patient at the correct intervals per CIWA-AR scale or administer medication at the correct intervals. Nursing administered the Ativan and the Valium at close intervals without obtaining a clarification order from a physician. Nursing administered Valium in place of Ativan without obtaining a physician's clarification order. Nursing did not notify physician when the CIWA-AR scale score was greater than 11 after a successive total of 6 mg Ativan was administered to the patient per protocol.
Tag No.: A0404
Based on a review of the hospital policies/procedures, documents, medical records, and staff interviews, it was determined that the hospital failed to require that a nurse administer medications in accordance with the orders of the practitioner/s responsible for the patient's care as evidenced by:
1. failing to require that a copy of a protocol referenced in a telephone order be placed on the patient's medical record and scanned to pharmacy per hospital directive for 1 of 1 patient (Pt #37);
2. failing to administer the required medication, and/or administer medication at the required intervals for 2 of 3 patients who were placed on the Alcohol Withdrawal Management Protocol and were assessed with scores of 5 or higher (Pt/s #33 & 37);
3. failing to clarify an incomplete medication order prior to administering medication, per hospital policy for 1 of 1 patient (Pt#37);
4. failing to clarify an unclear medication order for 1 of 3 patients who were placed on the Alcohol Withdrawal Management Protocol and were assessed with scores of 5 or higher (Pt. #34);
5. failing to obtain and document a verbal order for titration of an IV medication per hospital policy; for 1 of 1 patient (Pt#37); and
6. failing to administer and titrate the intravenous (IV) medications as ordered per the physician for 3 of 5 ICU (intensive care unit) patients (Patients #14, #27, and #28 ).
Findings include:
Review of a Memorandum, provided by the hospital, To the Nursing Directors, Sr. RN Managers, and RN Managers from the CNO dated July 27, 2010, revealed: "...RE: Medication Order Management--Workflow Change...The RN caring for the patient will review physician medication orders for completeness and will note orders with date, time, and his/her signature prior to the orders being scanned to Pharmacy. Please refer to BH policy # 3656, titled Medication Orders...Orders referencing a protocol must include the title of the protocol and a copy of the protocol must accompany the order when scanning to the pharmacy...If a medication order requires clarification...a new order will be written...Verbal and telephone orders need to be read back to the physician (physicians are being educated to ask) and should be reflected when noting orders. Please refer to BH policy #3656, titled Medication Orders.
Review of hospital policy/procedure titled: Medication Orders revealed: "...The medication order will include...Medication name...Dose...Dosage form...Strength or concentration...Frequency of administration...Route...Directions for use...Date and time...The nurse or pharmacist will promptly review orders with the prescriber whenever there is a question concerning the order's...completeness, clarity, dosage...or need for other clarification...."
1. Cross reference Tag (0395), item #2.
2. Cross reference Tag (0395), item #2.
3.Cross reference Tag (0395) for information regarding Pt#37.
Review of Pt #37's medical record revealed:
On 8/2/10, at 0850, a physician wrote a progress note: "...Pancreatitis, likely secondary to ETOH. Now in severe agitation...Being transferred to ICU...Respiratory Failure-likely ARDS (Adult Respiratory Distress Syndrome)/effusions/Pneumonia/atelectasis...Pancreatitis-severe...Severe Alcohol withdrawal...decreased platelets/increased BS(Blood Sugar)/ARF likely secondary to severe Pancreatitis...Start Ativan gtt. may need Diprovan gtt...May need Intubation...."
At 0930, a physician completed Critical Care Routine Admission Orders, which included: "...Additional Orders...Start on Ativan gtt (drip), titrate to agitation...."
On 9/14/10, the Pharmacy Senior Manager confirmed during interview that the above order was incomplete. According to pharmacy documentation, the pharmacy sent the ICU Sedation and Pain Management order set to the ICU at 1219 on 8/2/10, for the physician to clarify the order.
A physician completed the order set by marking: "...Sedation...3...Calm and cooperative (not external stimuli required to elicit movement AND patient is purposeful/follows commands)...Lorazepam (Ativan Infusion). Start infusion at 1mg/hr, IV. Sum the PRN use over the first (sic) 6 hour period, divide by 6 and add to current infusion rate as the new rate. Max dose 10mg/hr. Call MD for any further needed increases. IV solution 40mg/40ml=D5W Bag volume...." The order set was dated 8/2/10, but not timed.
Documentation in the medical record indicated that the patient arrived in ICU on 8/2/10, at 0950. He was admitted to the 3A ICU Unit.
The RN started the Ativan infusion at 1100, prior to the time that pharmacy sent the ICU Sedation and Pain Management order set to the ICU for the physician to clarify the order.
4. Pt #34 was admitted on 7/30/10. A physician wrote an order on 7/31/10 at 1130: "...Ativan prn as per CIWA scale...." The patient was taking oral medication.
Review of the hospital policy/procedure titled Alcohol Withdrawal Management Protocol revealed: "...Diazepam (Valium)...PO (by mouth)...If NPO (Nothing by mouth), use Lorazepam (Ativan). The nurse documented that s/he pulled Valium 5mg ( from the automated medication dispensing machine) when the patient's CIWA-AR score was 5 and the patient refused the medication. The medical record contained no clarification of the Ativan order (to administer Valium instead of Ativan).
5. Review of the hospital policy/procedure titled Practitioner Orders: Accepting, Transcribing, and Signing-Off revealed: "...verbal orders whall be countersigned by the responsible physician...Telephone and verbal orders are read back to the physician/practitioner for verification prior to implementation...Telephone and Verbal orders will be documented in the medical record to verify read back of the physician's order with the indication...'VOV' for 'Verbal Orders Verified' during downtime. Verbal orders will be documented in the EMR (Electronic Medical Record) as 'Verbal with Readback'...."
Review of Pt #37's medical record revealed:
An RN documented the Ativan infusion started on 8/2/10 at 1100, running at 2mg/hr.
At 1130, the RN increased the infusion rate to 3mg/hr.
At 1145, the RN increased the infusion rate to 4mg/hr.
At 1200, the RN increased the infusion rate to 5mg/hr.
At 1215, the RN increased the infusion rate to 6mg/hr.
The medical record did not contain a physician's order to increase the infusion rate after the initial calculation contained in the order set.
RN #16 stated during interview on 9/14/10, that s/he had informed the physician that the 2mg wasn't effective in calming the patient and the physician had given the RN a verbal order to continue increasing the Ativan until the patient was comfortable. The RN stated that the patient was agitated and was removing his Bipap. The RN recalled that one of the physicians had asked what the dosage was and instructed the RN to increase the infusion from 5mg to 6mg. A physician told the RN to increase the infusion to either 5mg or 6mg. The RN confirmed that the medical record did not contain documentation of the verbal order and that the physician did not specify the time interval between increases of dosage. The RN also stated the s/he believed that the initial order (which was incomplete) "covered" the RN to titrate the Ativan. S/he confirmed that there were no parameters in the initial order.
6. Review of hospital policy/procedure titled " Medication...Taper/Titrate Orders, requires: "...adjust dose and/or flow rate to achieve desired parameters specified by the physician or LIP (licensed independent practitioner)...."
A review of the Physician's Orders for Patient #27, revealed: the order for Norepinephrine (Levophed)8 mg (milligrams)/250 mL (milliliters) 0.9%NaCl (sodium chloride)(0.032 mg/mL;32 mcg (micrograms)/mL. Initiate fusion at 2 mcg/min (minute) and titrate every one minute by increments of 5 mcg/min (Max rate=50 mcg/minute) to maintain: MAP (mean arterial pressure) greater than 65 mmHg (millimeters of mercury).
Review of the MAR (medication administration record) dated 09/11/10, at 1145 revealed: the nurse documented the Levophed IV medication was initiated at 2mcg/min and was titrated every 15 minutes by incriments of 2 mcg/min. rather than titrated every one minute by incriments of 5 mcg/min.as ordered.
The Senior Clinical Manager of ICU confirmed the findings of incorrect medication dosing and titration, during an interview conducted on 09/13/10 at 1545.
A review of the Physician's Orders for Patient #28, revealed: the order for Esmolol 2500 mg/250mL 0.9% NaCL (10mg/mL) (Max same as standard)
Loading dose of 500 mcg/kg over 1 minute then initiate infusion at 50mcg/kg/min. Titrate infusion every 5 minutes by incriments of 50mcg/kg/min (Max rate = 300 mcg/kg/min) to maintain: HR (heart rate) less than 100 bpm (beats per minute).
Review of the MAR dated 9/13/10 at 1215 revealed the Esmolol was started at 50 mcg and the patient's HR was 115. The documentation further revealed the medication was titrated every 15 minutes rather than the every 5 minutes as ordered. There was no documented heart rate after 1300 or before 1400 while the titration infusion rate contiued to be increased. There was no documentation of the Esmolol loading dose.
A review of the Physician's Orders for Patient #14, revealed: the order dated 9/12/10 at 1300 hours for Dobutamine IV start at 2.5 mcg (micrograms)//kg (kilogram)/min(minute). Increase to 5 mcg/kg/min in 1 hour if no significant arrhythmia - ventricular, supraventricular rhythms.
Review of the MAR (medication administration record) dated 09/12/10 at 1630 hours revealed Dobutamine initiated at 2.5 mcg/kg/min: the nurse documented the Dobutamine IV medication continued at 2.5 mcg/kg/min then titrated up to 5 mcg/kg/min at 1830 hours on 9/12/10. At 2000 hours on 9/12/10, Dobutamine was titrated down to 4 mcg/kg/min with chart indicating patient in normal sinus rhythm. Dobutamine remained at 4 mcg/kg/min from 9/12/10 at 2000 hours until 9/13/10 at 0400 hours. there was no documentation of arrhthymias in the nurses notes.
The Clinical Manager of ICU confirmed the findings of incorrect medication dosing and titration, during an interview conducted on 09/14/10 at 1145.