HospitalInspections.org

Based on review of clinical records, interviews, review of hospital documentation and review of hospital polices and procedures, the hospital's governing body failed to ensure the quality of care for patient's requiring respiratory support.

1. Please reference A 263, A 347, A 395, A 1151 and A 1163.

2. Review of the Governing Body meeting minutes dated 5/28/08 to 5/26/10 failed to reflect that the Department of Respiratory Care was incorporated into the hospital program.

Based on review of clinical records, interviews, review of facility polices and procedures and review of hospital documentation, the hospital failed to ensure that quality improvement information from the Department of Respiratory Care was provided and/or monitored by the hospital quality/performance improvement department in order to improve patient health outcomes.

Please reference A 1151 and A 1163.

On 6/29/10, Immediate Jeopardy under the Conditions of QAPI and Respiratory Services were identified. The Department requested an Immediate Corrective Action Plan on 6/29/10 to address issues related to ventilator patients and patients who required respiratory supportive therapies. The Plan included educating Respiratory Therapists, implementation of an electronic order entry functionality to facilitate efficiency entering mechanical ventilation orders, education of all nursing staff who care for patients on ventilators or supportive therapies, physician/LIP education regarding orders, and a monitoring plan to ensure that the corrective action plan is implemented. On 6/30/10, an onsite visit was conducted and through review of clinical records, review of facility documentation, and interviews, Immediate Jeopardy was abated.

Based on review of clinical records, interviews, review of hospital polices and procedures and hospital documentation, the hospital failed to ensure that the quality of medical care was provided to patients.

1. Please reference A 263, A 347, A 1151 and A 1163.

2. Interview with the Medical Director of the Pediatric Intensive Care Unit, on 6/28/10, identified that he/she was aware for months that the respiratory therapists had made changes to Patient #6 ' s ventilator without physician orders and MD #23 currently is completing a survey regarding this.

3. Review of the PICU Quality and Safety Committee meeting minutes, for the period of 1/22/09 to 6/18/09 attended by MD #23, identified on 1/22/09 that audits will compare actual ventilator settings to physician ordered settings. On 3/26/09 documentation reflected that MD #23 met with the respiratory therapy department in regards to the Respiratory Therapists changing ventilator settings without physician orders. Interview with the hospital Regulatory Liaison, on 6/30/10, identified that the PICU meeting minutes from 7/09 to present were not available.

4. Review of the Medical Staff meeting minutes, from 6/19/08 to 5/19/10, did not reflect any information from the Department of Respiratory Care.

Based on review of clinical records, interviews and review of hospital policies and procedures for 9 of 18 patients (Patients # 6, 28, 29, 36, 38, 39, 40, 41 and 43) that required respiratory support, the hospital failed to ensure that the physician orders were written and/or complete. The findings include:

1a. Patient #6, a 10 week old, arrived at the Emergency Department (ED) on 1/28/10 at 12:06 A.M. from home with seizure activity and a past medical history that included birth at 35 weeks, trisomy 21 and atrial septal defect. Review of the physician notes, dated 1/28/10, identified that the medical plan included to administer hydrocortisone, intravenous fluids and oxygen, monitor for respiratory support, obtain laboratory tests and to admit the Pediatric Intensive Care Unit (PICU). Review of the clinical record failed to identify any physician orders for the oxygen, intravenous fluids, diagnostic tests and/or the transfer to the PICU. Interview with the Nurse Manager of the ED, on 6/28/10, and review of the clinical record failed to reflect physician orders for the oxygen, intravenous fluids, diagnostic tests and/or the transfer to the PICU and all of these interventions required physician orders.
b. Patient #6 was diagnosed with Respiratory Syncytial Virus (RSV) bronchiolitis and was admitted to the Pediatric Intensive Care Unit (PICU). Review of a physician order, dated 1/28/10 at 8:00 A.M., directed the staff to administer oxygen via nasal cannula to the patient at one to two liters per minute, maintain the patient ' s oxygen saturation although no oxygen saturation range was identified. Interview with the Clinical Manger of the Respiratory, on 6/28/10, and review of the clinical record failed to reflect an oxygen saturation range for Patient #6.
c. Review of the physician progress notes, dated 1/29/10 at 8:45 A.M., identified that the physician was aware that Patient #6 was receiving oxygen at a rate other that the current order, at 2.5 Liters per minute, and there was no further physician orders regarding the level of oxygen to administer to this patient.

Review of the policy and procedure, titled Orders for Patient Care or Research, identified that a physician and/or a licensed practitioner must order oxygen, intravenous fluids, diagnostic tests and transfer from one hospital area to another.

2. Patient #28 arrived at the hospital Emergency Department (ED) on 6/5/10 at 12:00 Midnight from home with persistent seizures. Review of the ED clinical record, from arrival to transfer at 2:45 A.M., identified that Patient #28 was receiving 100 % oxygen via a non re-breather mask and the record did not reflect a physician order. Interview with the Nurse Manager of the ED, on 6/9/10, identified that a physician order is required for the administration of oxygen and there was no physician order for the administration of oxygen to Patient #28. Review of the policy and procedure, titled Orders for Patient Care or Research, identified that a physician and/or a licensed practitioner must order oxygen.

3. Patient #40 was admitted on 5/25/10. Review of physician orders, dated 5/30/10 at 1:05 P.M., directed the staff to place the patient on his/her home BiPAP and the record did not reflect physician orders for inspiratory or expiratory pressures.
Review of the hospital policy and procedure, titled Noninvasive Positive Pressure Ventilation (NPPV or BiPAP), identified that BiPAP requires a physician order; the order includes the supplemental oxygen percentage, the target oxygen saturation level, the frequency and the inspiratory pressure. Review of the hospital policy and procedure, titled Application of Patient Home Ventilator, CPAP or BiPAP Devices, identified that the physician will order the necessary settings.

4. Patient #43 was admitted on 6/4/10 with a history of home BiPAP and review of physician orders, dated 6/4/10 at 11:36 P.M., directed the staff to place the patient on BiPAP and the record did not reflect physician orders for inspiratory and/or expiratory pressures.
Review of the BiPAP computer order, with Information Technology (IT) Staff # 1 on 6/9/10, identified that the fields for this order are pre-populated fields, the fields can be adjusted and include: inspiratory pressure, expiratory pressure, supplemental oxygen percentage, indication, schedule, frequency and additional comments.
Review of the hospital policy and procedure, titled Noninvasive Positive Pressure Ventilation (NPPV or BiPAP), identified that BiPAP requires a physician order; the order includes the supplemental oxygen percentage, the target oxygen saturation level, the frequency and the inspiratory pressure. Review of the hospital policy and procedure, titled Application of Patient Home Ventilator, CPAP or BiPAP Devices, identified that the physician will order the necessary settings.

5. Review of the clinical records of Patients # 28, 29, 36, 38, 39, 40, 41 and 43 failed to identify a physician order that included the target oxygen saturation level while the patient was on BiPAP. Patient #28 was admitted on 6/5/10, Patients #29 and #39 were admitted on 6/6/10, Patients #36 and #38 were admitted on 6/1/10, Patient #41 was admitted on 4/7/10 and Patient #43 was admitted on 6/4/10.

Review of the hospital policy and procedure, titled Noninvasive Positive Pressure Ventilation (NPPV or BiPAP), identified that BiPAP requires a physician order; the order includes the supplemental oxygen percentage, the target oxygen saturation level, the frequency and the inspiratory pressure.

Based on review of the clinical records, interviews and review of hospital policies and procedures for three of eighteen patients (Patients #6, 56 and 68) that required invasive and/or non-invasive ventilation and/or respiratory support, the hospital failed to ensure that the nurse assessed the patient(s) and/or updated the physician regarding the patient's condition.

1a. Patient #6, a 10 week old, arrived at the Emergency Department (ED) on 1/28/10 at 12:06 A.M. from home with seizure activity and a past medical history that included birth at 35 weeks, trisomy 21 and atrial septal defect. Review of the ED documentation did not identify documentation of an assessment of Patient #6 ' s clinical status at the time of discharge from the ED. Interview with the Nurse Manager of the ED and review of the clinical record on 6/28/10, identified that there was no documentation of the patient ' s status at discharge and/or the time that Patient #6 was discharged from the ED. Review of the ED policy and procedure, titled Vital Signs and Problem Focused Nursing Observations, identified that all patients will have a discharge note. A second ED policy and procedure, titled Assessment of Patients, identified that at the time of discharge the nurse completes a patient assessment.
b. Patient #6 was diagnosed with Respiratory Syncytial Virus (RSV) bronchiolitis and was admitted to the Pediatric Intensive Care Unit (PICU). Review of the physician orders, dated 1/31/10 at 8:00 P.M., directed the staff to administer three ounces (90 cubic centimeters (cc)) of formula over three hours via feeding tube. Review of the pediatric nursing flowsheets, dated 2/1/10, at 12:00 Midnight, 3:00 A.M. and 6:00 A.M., reflected that Patient #6 was given 75 cc of formula. Interview with the Nurse Manager of the PICU, on 6/28/10, identified that the staff did not administer the formula according to the physician order. Review of the policy and procedure, titled Orders for Patient Care or Research, identified that the physician orders the patient ' s diet.
c. Review of a physician order, dated 1/28/10 at 8:00 A.M., directed the staff to administer oxygen via nasal cannula to the patient at one to two liters per minute and to notify the physician if greater than two liters was required. Review of the pediatric flowsheets and the clinical record, dated from 1/28/10 at 9:00 P.M. to 1/29/10 at 8:00 A.M., identified that Patient #6 was maintained at two and a half liters per minute and documentation did not reflect that the physician was informed of the patient ' s increased oxygen needs by the nurse. Review of the policy and procedure, titled Orders for Patient Care or Research, identified that the physician must order the oxygen to be administered.
d. Review of the nursing documentation of the patient's ventilator settings on the PICU Patient Care Flowsheets, dated from 2/2/10 at 4:00 P.M. to 2/5/10 at 2:00 P.M., identified fifteen entries that were not consistent with the physician order. Interview with the Nurse Manger of the PICU, on 6/28/10, and review of the clinical record identified that the nurse is responsible for knowing what ventilator settings the physician has ordered for the patient. Review of the hospital policy and procedure, titled Initiating and Monitoring Mechanical Ventilator Support, identified that a physician must order ventilator parameters and/or settings.
In addition, review of the PICU and/or Pediatric General Unit Patient Care Flowsheets, dated 2/5/10 at 4:00 P.M. to 2/7/10 at 8:00 P.M., identified that the nursing staff titrated the nasal oxygen absent a physician order. Interview with the PICU Nurse Manager, on 6/28/10, identified that there were no physician orders to titrate the oxygen for Patient #6. Review of the policy and procedure, titled Orders for Patient Care or Research, identified that a physician and/or a licensed practitioner must order oxygen.

2. Patient #56 was admitted on 6/23/10 and required invasive ventilation. Review of the physician orders, dated 6/29/10 at 1:38 A.M. directed the staff to provide a pressure control mode, SIMV, at a rate of 18 breaths per minute, with PEEP of 5 cm, PS of 5 cm, PIP of 22 cm and supplemental oxygen of 50%. Review of the nursing flow sheets, dated 6/29/10 at 7:37 A.M., identified that Patient #56 received 20 breaths per minute (bpm) instead of 18 bpm that was ordered. The clinical record did not reflect documentation that the physician was informed.

3. Patient #68 was admitted on 6/28/10 and required non-invasive ventilation. Review of the physician order, dated 6/30/10 at 8:58 A.M., directed the staff to provide CPAP inspiratory time of 0.4, PEEP of 4cm and oxygen at 21 %. Review of the nursing flow sheet, dated 6/30/10 at 12:00 Midnight to 12:03 P.M., identified that Patient #68 received oxygen at 25% instead of the ordered 21%. The clinical record did not reflect documentation that the physician was informed.

Review of the hospital policy and procedure, titled Initiating and Monitoring Mechanical Ventilator Support, identified that a physician must order ventilator parameters and/or settings. Review of the hospital policy and procedure, titled Documenting the Nursing Process, identified that the nurse assesses the patient in an ongoing manner.

Based on review of clinical records, interviews and review of facility policies and procedures for 1 patient (Patients # 28) that required respiratory ventilation support, the hospital failed to ensure that a verbal order was documented. The findings include:

Patient #28 arrived at the hospital Emergency Department (ED) on 6/5/10 at 12:00 Midnight from home with persistent seizure, was diagnosed with status epilepticus and admitted to the Pediatric Intensive Care Unit (PICU) on 6/6/10 at approximately 4:00 A.M. Review of the PICU clinical record reflected that at 4:30 A.M. Patient #28 was placed on the non-invasive ventilatory support of Biphasic Positive Airway Pressure (BiPAP) by Respiratory Therapist (RT) #1 and was maintained on that support until 10:15 A.M. The record did not reflect that there was a physician order for the BiPAP. Interview with Assistant Clinical Manager of Respiratory, on 6/9/10, identified that there was no order for the BiPAP for this patient. Interview with RT #1, on 6/10/10, identified that he/she took a verbal order from a physician to initiate the BiPAP for Patient #28 and he/she did not document that verbal order. Review of the policy and procedure, titled Respiratory Care Orders, identified that a respiratory therapist can accept a verbal order and then must write the order.

Review of the hospital policy and procedure, titled Orders for Patient Care or Research, identified that verbal orders are used only in emergencies and in unusual situations and read back to the provider at the time that the order is given.

Based on review of clinical records, interviews and review of facility policies and procedures for 9 of 18 patients (Patients # 28, 40, 43, 63, 64, 65, 66, 67 and 68) that required care and services, the hospital failed to ensure that documentation was complete and/or accurate. The findings include:

1. Patient #28 arrived at the hospital Emergency Department (ED) on 6/5/10 at 12:00 Midnight from home with persistent seizures, was diagnosed with status epilepticus and admitted to the Pediatric Intensive Care Unit (PICU) on 6/6/10 at approximately 4:00 A.M. Review of the PICU clinical record reflected that at 4:30 A.M. Patient #28 was placed on the non-invasive ventilatory support of Biphasic Positive Airway Pressure (BiPAP) by Respiratory Therapist (RT) #1 and was maintained on that support until 10:15 A.M. The record did not reflect that there was a physician order for the BiPAP. Interview with the RT Supervisor, on 6/9/10, identified that there was no order for the BiPAP for this patient. Interview with RT #1, on 6/10/10, identified that he/she took a verbal order from a physician to initiate the BiPAP for Patient #28 and he/she did not document that verbal order. Review of the policy and procedure, titled Respiratory Care Orders, identified that a respiratory therapist can accept a verbal order and then must write the order.

2. Patient #40 was admitted on 5/25/10 and review of physician orders, dated 5/30/10 at 1:05 P.M., directed the staff to place the patient on his/her home BiPAP. Review of the clinical records, dated 5/30/10 to 6/9/10, failed to identify that the hospital staff placed Patient #40 on the BIPAP.

3. Patient #43 was admitted on 6/4/10 with a history of home BiPAP and review of physician orders, dated 6/4/10 at 11:36 P.M., directed the staff to place the patient on BiPAP. Review of the clinical record failed to identify that the hospital staff placed Patient #43 on the BIPAP.

4. Patient #63 was admitted on 6/29/10 and required invasive ventilation. Review of the physician order, dated 6/30/10 at 1:20 A.M., directed the staff to provide volume ventilation via assist control mode (A/C) at a rate of 12 breaths per minute, tidal volume of 500 cc, PEEP of 5 cm, PS of 0cm and supplemental oxygen at 50 %. Review of the nursing flow sheets, dated 6/30/10 at 2:00 A.M. to 10:00 A.M., failed to reflect documentation of the breaths per minute, the tidal volume and the PEEP. Interview with the Information Technology staff #1, on 6/30/10, identified that Patient #63 ' s electronic record did not allow the nursing staff to access the ventilation screen, which was the location to document the ventilation parameters.

5. Patient #64 was admitted on 6/22/10 and required invasive ventilation. Review of the physician orders, dated 6/30/10 at 11:53 A.M., directed the staff to provide volume ventilation via assist control mode (A/C) at rate of 12 breaths per minute, tidal volume of 550 cc, PEEP of 5 cm, PS of 0cm and supplemental oxygen at 40 %. Review of the nursing flow sheets, dated 6/30/10 from 12:00 Midnight to 10:00 A.M., failed to reflect documentation of the mode and/or the tidal volume.

6. Patient #65 was admitted on 6/16/10 and required invasive ventilation. Review of the nursing flow sheets, dated 6/30/10 from 12:00 Midnight to 10:00 A.M., failed to reflect documentation of the mode and/or the tidal volume.

7. Patient #66 was admitted on 6/28/10 and required invasive ventilation. Review of the nursing flow sheets, dated 6/30/10 from 12:00 Midnight to 11:00 A.M., failed to reflect documentation of the mode and/or the tidal volume and/or the oxygen administered.

8. Patient #67 was admitted on 5/8/10 and required non-invasive ventilation. Review of the physician order, dated 6/30/10 at 12:54 A.M., directed the staff to provide CPAP inspiratory time of 0.5, PEEP of 4cm and oxygen at 21 %. Review of the ventilator flow sheet, dated 6/30/10 at 1:12 A.M. to 11:59 A.M., failed to reflect documentation of the inspiratory time.

9. Patient #68 was admitted on 6/28/10 and required non-invasive ventilation. Review of the physician order, dated 6/30/10 at 8:58 A.M., directed the staff to provide CPAP inspiratory time of 0.4, PEEP of 4cm and oxygen at 21 %. Review of the nursing flow sheet, dated 6/30/10 at 12:00 Midnight to 12:03 P.M., failed to reflect documentation of monitoring of the inspiratory time.

Based on review of the clinical record and interview for one patient (Patient #6) that required invasive ventilation, the hospital failed to ensure that the documentation was legible. The findings include:

Patient #6, a 10 week old, arrived at the Emergency Department (ED) on 1/28/10 at 12:06 A.M. from home with seizure activity and a past medical history that included birth at 35 weeks, trisomy 21 and atrial septal defect. The patient was diagnosed with Respiratory Syncytial Virus (RSV) bronchiolitis, required invasive ventilation and was admitted to the Pediatric Intensive Care Unit (PICU). Review of the PICU Patient Care Flowsheets, dated 2/3/10 at 8:00 P.M. and 2/4/10 at 8:00 A.M., identified illegible documentation regarding the ventilator rate and oxygen percentage respectively. Interview with the PICU Nurse Manager, on 6/28/10, identified that the documentation was not legible.

Based on review of clinical records interviews, review of hospital documentation, and interviews, the hospital failed to meet the patient's respiratory needs. The findings include:

1. Please refer to A 1163.

2. Review of the Department of Respiratory Care meeting minutes, from 6/19/09 to 6/25/10, identified that the respiratory therapists failed to ensure that the physician orders for ventilator setting/parameters were consistent with the ventilator setting/parameters delivered. Respiratory Therapists were changing the percentage of oxygen administered without physician orders and a ventilator was set incorrectly. The Respiratory Therapist is responsible to inform the physician when a patient refuses non-invasive ventilation and/or when a ventilator is found with settings other than what was ordered. Documentation further identfiied tha the process of receiving a verbal order from a physician was reviewed. Each Respiratory Therapist must check the active respiratory orders for each patient and the respiratory therapist is accountable to the patient ' s family.
Review of hospital documentation, dated 3/24/09 to 5/24/10, identified that in various patient care areas of the Hospital ventilator settings were not consistent with the physician orders.

3. Review of the Department of Respiratory Care Quality Improvement and Assessment Program identified that there is a monthly meeting of the Quality Improvement Council (QIC) and the activities of the QIC are reported to the Hospital ' s Department of Quality on a regular basis. Review of the Department of Respiratory Care Quality Improvement Council (QIC) meeting minutes dated 1/17/08 to 10/13/09 with the Operational Director of the Department of Respiratory Care and the Clinical Manager of the Department of Respiratory Care, on 6/28/10, identified that there were no QIC meetings for six months in 2008 and there had been no QIC meetings since 11/09. In addition, documentation further identified that in 6/09, ventilator settings for two pediatric patients were identified as not being set according to the physician orders.

4. Review of the job description for the Clinical Manager of the Department of Respiratory Care identified that it is a requirement for the position to report quality improvement information to the Hospital ' s quality program quarterly and annually. Interview with the Clinical Manager of the Department of Respiratory Care, on 6/29/10, identified that he/she has not reported any Department of Respiratory Care quality improvement information to the Hospital ' s quality program.

5. Review of the Hospital Quality Program minutes, dated 6/1/09 to 6/14/10, did not identify that any Department of Respiratory Care quality improvement information was reported to the Hospital ' s quality program. In addition interview with the Medical Director of the Hospital Quality Program, on 6/30/10, identified that there was no process in place for the Department of Respiratory Care to report any quality improvement information to the Hospital ' s quality program.

Based on review of clinical records, interviews and review of facility policies and procedures for 14 of 18 patients (Patients # 6, 29, 36, 38, 39, 40, 41, 43, 46, 48, 56, 57, 61 and #68) that required respiratory ventilation support, the hospital failed to ensure that the Respiratory Therapist adjusted the ventilator settings according to physician order(s). The findings include:

1a. Patient #6, a 10 week old, arrived at the Emergency Department (ED) on 1/28/10 at 12:06 A.M. from home with seizure activity and a past medical history that included birth at 35 weeks, trisomy 21 and atrial septal defect. The patient was diagnosed with Respiratory Syncytial Virus (RSV) bronchiolitis and was admitted to the Pediatric Intensive Care Unit (PICU). Review of the clinical record identified that on 2/2/10 at 3:35 P.M., results of an arterial blood gas reflected a pH of 7.14 (normal 7.35 to 7.45), a pCO2 of 106 (normal of 36 to 44) and pO2 of 62 (normal 80 to 100) and at 4:10 P.M. Patient #6 was intubated and placed on a ventilator. Review of the ventilator flow sheet, dated 2/2/10 at 4:20 P.M., identified Patient #6 was placed on a pressure control ventilation mode, rate of 30 breaths per minute oxygen administered at 100 %, peak inspiratory pressure (PIP) of 30, positive end expiratory pressure (PEEP) of 7 centimeters (cm) and pressure support (PS) of 0 cm, a absent physician order. At 4:30 P.M. review of the patient ' s ventilator flow sheet identified that the ventilator settings were adjusted as follows: PEEP was decreased to 6cm, PIP was decreased to 25 cm, absent a physician order. At 5:40 P.M. the ventilator flow sheet reflected that the ventilator settings were adjusted as follows: PEEP was increased to 8 cm and the oxygen was decreased to 45%, absent a physician order. At 6:40 P.M. the ventilator flow sheet identified that the ventilator settings were adjusted as follows: breaths were decreased to 26 per minute absent physician order. Review of the patient ' s ventilator flow sheet, dated 2/2/10 at 11:00 P.M. the rate was decreased to 24 breaths per minute, absent a physician order.
Documentation was lacking to reflect that physician orders had been obtained for the adjustments in the ventilator settings.
b. On 2/3/10 at 12:40 A.M. a physician order directed the staff to set the ventilator for Patient #6 at pressure control mode, rate of 16 breaths per minute, oxygen administration of 45 %, PIP of 25, PEEP of 8cm, PS of 10cm. Review of the patient ' s ventilator flow sheet, dated 2/3/10 at 12:40 A.M., the rate was set at 18 breaths per minute, oxygen was administered at 30%, absent a physician order. The physician order directed the staff to set the ventilator for Patient #6 at pressure control mode, rate of 16 breaths per minute, oxygen administration of 30 %, PIP of 25, PEEP of 8 cm, PS of 10 cm. Review of the patient ' s clinical record did not reflect that these orders were carried out. At 11:13 A.M. the physician order directed the staff to set the ventilator for Patient #6 at pressure control mode, rate of 16 breaths per minute, oxygen administration of 30 %, PIP of 25, PEEP of 8 cm, and PS of 10 cm. Review of the patient ' s ventilator flow sheet, dated from 2/3/10 at 2:30 P.M., 3:45 P.M, 8:00 P.M. and 2/4/10 at 12:00 Midnight, identified that the rate was set at a rate of 18 breaths per minute, absent a physician order.
Documentation was lacking to reflect that physician orders had been obtained for the adjustments in the ventilator settings.
c. Review of the patient ' s ventilator flow sheet, dated 2/4/10 at 7:55 A.M., identified that the ventilator settings for Patient #6 included pressure control mode, rate of 30 breaths per minute, oxygen administered at 100 %, PIP of 25, PEEP of 8 cm and PS of 10 cm, absent a physician order. At 9:25 A.M., identified that the ventilator settings for Patient #6 included oxygen administered at 50%, absent a physician order. At 11:55 A.M., identified that the ventilator settings for Patient #6 included pressure control mode, rate of 30 breaths per minute, oxygen administered at 30 %, PIP of 25, PEEP of 8 cm and PS of 10 cm, absent a physician order. At 4:30 P.M., identified that the ventilator settings for Patient #6 included pressure control mode, rate of 30 breaths per minute, oxygen administered at 35 %, PIP of 25, PEEP of 8 cm and PS of 10 cm, absent a physician order.
Documentation was lacking to reflect that physician orders had been obtained for the adjustments in the ventilator settings.
d. Review of Patient #6' s ventilator flow sheet, dated from 2/5/10 at 4:30 A.M., identified that the rate was set at 20 breaths per minute absent physician order. At 7:50 A.M., the ventilator settings for Patient #6 included pressure control mode, rate of 20 breaths per minute, oxygen administered at 50 % and PEEP of 5 cm, absent a physician order. At 7:55 A.M., identified that the ventilator settings for Patient #6 included pressure control mode, rate of 20 breaths per minute, oxygen administered at 35 %, PEEP of 5 cm, absent a physician order. Review of the patient ' s ventilator flow sheet, dated from 2/5/10 at 10:20 A.M., identified that the PIP was set at 25 cm, absent a physician order. Review of the patient ' s ventilator flow sheet, dated from 2/5/10 at 10:40 A.M., identified that the PEEP was changed to 6 cm although there was no documentation that the PIP was changed from 25 (at 10:20 A.M.) to the 22. The patient ' s ventilator flow sheet, dated 2/5/10 at 10:45 A.M., identified that the oxygen was increased to 55 %, absent a physician order. The patient ' s ventilator flow sheet, dated 2/5/10 at 11:10 A.M., identified that the oxygen was decreased to 45 %, absent a physician order. Review of the patient ' s ventilator flow sheet, dated from 2/5/10 at 11:30 A.M., identified the settings included that the oxygen was administered at 35% and the PS was 10 cm, absent a physician order.
The physician order, dated 2/5/10 at 12:57 P.M., directed the staff to set the ventilator for Patient #6 at pressure control mode, rate of 10 breaths per minute, oxygen administration of 30 %, PIP of 17, PEEP of 5 cm, PS of 5 cm. Review of the patient ' s ventilator flow sheet, dated from 2/5/10 at 1:20 P.M., identified that the settings included rate of 5 breaths per minute, absent a physician order. In addition review of the patient ' s ventilator flow sheet, dated 2/5/10 at 1:50 P.M., identified that Patient #6 was extubated and placed on a fifteen liter per minute hi-flow nasal cannula, absent a physician order.
Documentation was lacking to reflect that physician orders had been obtained for the adjustments in the ventilator settings.

Interview with the Clinical Manger of the Respiratory and the Assistant Counsel Legal Affairs, on 6/28/10, identified that the identified practices of the Respiratory Therapists were not consistent with physician orders and the hospital is currently addressing this.

Review of hospital policies and procedures, titled Initiating and Monitoring Mechanical Ventilator Support, Policy on Mechanical Ventilator Adjustments and Respiratory Care Orders, identified that ventilator settings/parameters require a physician order, the respiratory therapist must ensure that the ventilator settings are consistent with the physician order(s), the respiratory therapist must ensure that all ventilator changes are guided by written physician order(s), changes to the settings on ventilators are only made by a respiratory therapist except in the case of an emergency (a Physician and/or a Registered Nurse may adjust the oxygen percentage provided that the respiratory therapist is immediately informed) and if the respiratory therapist has any concerns/questions about a physician order (appropriateness and/or completeness) the concern/question will be addressed by the prescribing physician.


2. Patient #29 was admitted to the hospital Pediatric Intensive Care Unit (PICU) on 6/6/10 with the diagnosis of asthma exacerbation. Review of the physician orders, dated 6/6/10 at 8:14 P.M., directed the staff to place the patient on Bi-level Airway Pressure (BiPAP) with supplemental oxygen at 21%. Review of the clinical record, dated 6/6/10 at 9:10 P.M. to 6/9/10 at 8:29 A.M., identified that the patient was on BiPAP with supplemental oxygen at 40 to 70 %, absent a physician order. Interview with the Assistant Clinical Manager of Respiratory, on 6/9/10, identified that if the patient condition required an increase in supplemental oxygen, the physician is informed by the respiratory therapist. Review of the hospital policy and procedure, titled Noninvasive Positive Pressure Ventilation (NPPV or BiPAP), identified that BiPAP requires a physician order; the order includes the supplemental oxygen percentage, the target oxygen saturation level, the frequency and the inspiratory pressure.

On 6/9/10, the Department requested an Action Plan to address patients on invasive ventilation and respiratory support services. On 6/9/10 at 11:20 A.M., the Department requested that the hospital identify all inpatients that have BiPAP orders. Seven (7) patients had BiPAP orders. Clinical record review for 6 of the patients identified on BiPAP revealed the following:

3. Patient #36 was admitted on 6/1/10 and review of the physician order, dated 6/4/10 at 6:55 P.M., directed the staff to place the patient on BiPAP with inspiratory pressure of 10 centimeters (cm), expiratory pressure of 5 cm and with supplemental oxygen of 21 %. Review of the clinical record, dated 6/4/10 at 7:15 P.M. to 6/6/10 at 11:29 P.M., identified that the patient was on BiPAP with inspiratory pressures from 10 to 15 cm and supplemental oxygen between 60 to 70 %, absent a physician order.
In addition, documentation, dated 6/8/10 at 12:07 A.M., identified that Patient #36 refused to be placed on the BiPAP and documentation was lacking to reflect that the physician was informed.

4. Patient #38 was admitted on 6/1/10 and review of the physician orders, dated 6/5/10 at 8:28 A.M., directed the staff to place the patient on BiPAP with inspiratory pressure of 20 cm and expiratory pressure of 8 cm and supplemental oxygen at 40%. Review of the clinical record, dated 6/7/10 at 11:00 P.M. and 6/8/10 at 11:30 P.M., identified that the patient refused to be placed on the BiPAP. Documentation was lacking to reflect that the physician was informed of the patient ' s refusal of BiPAP.

5. Patient #39 was admitted on 6/6/10 and review of the physician orders, dated 6/6/10 at 4:07 A.M., directed the staff to place the patient on BiPAP with inspiratory pressure of 15 cm, expiratory pressure of 5 cm and supplemental oxygen of 21 %. Review of the clinical record, dated 6/7/10 at 12:15 A.M., identified that the inspiratory pressure was 10 cm and the supplemental oxygen was 35 %, absent a physician order
In addition documentation, dated 6/8/10 at 11:58 P.M., identified that the patient refused to be placed on BiPAP. Documentation was lacking to reflect that the physician was informed of the patient ' s refusal of BiPAP.

6. Patient #40 was admitted on 5/25/10 and review of physician orders, dated 5/30/10 at 1:05 P.M., directed the staff to place the patient on his/her home BiPAP at no set inspiratory or expiratory pressures and supplemental oxygen at 21 %. Review of the clinical records, dated 5/30/10 to 6/9/10, did not reflect that Patient #40 was ever placed on the BIPAP and/or that the physician was informed of the patient ' s refusal of BiPAP.

7. Patient #41 was admitted on 4/7/10 and review of the physician orders, dated 5/2/10 at 1:24 P.M., (when the patient was on a ventilator) directed the staff to place the patient on BiPAP at no set inspiratory or expiratory pressures and supplemental oxygen at 50 %. Review of the facility policy and procedure, titled Noninvasive Positive Pressure Ventilation (NPPV or BiPAP), identified that a ventilator in the Continuous Positive Airway Pressure (CPAP) mode can be used for BiPAP as long as the pressure support (PS) and the positive end expiratory pressure (PEEP) are equal to the ordered BiPAP inspiratory pressure. Review of the clinical record, on 5/2/10 at 12:35 P.M., identified that Patient #41 was on a ventilator in a CPAP mode with inspiratory pressure of 5 to 17 cm, absent a physician order.
A second physician order, dated 5/3/10 at 7:01 A.M., directed the staff to place the patient on BiPAP with an inspiratory pressure of 8 cm. Review of documentation, dated 5/3/10 at 7:00 A.M. to 5/6/10 at 5:21 P.M., identified that the patient was on a ventilator in a CPAP mode with inspiratory pressure of 10 cm, absent a physician order.
A physician order dated 5/8/10 at 11:07 P.M., directed the staff to place the patient on BiPAP with inspiratory pressure of 12 cm, expiratory pressure of 5 cm and supplemental oxygen of 21 %. Review of the clinical record did not identify documentation that Patient #41 was placed on the BiPAP with the ordered parameters.
A physician order, on 6/7/10, at 9:03 P.M., directed the staff to place the patient on BiPAP inspiratory pressure of 12 cm. Review of documentation, dated 6/7/10 at 9:11 P.M., identified that the patient was on a ventilator in a CPAP mode with inspiratory pressure of 15 cm, absent a physician order.
On 6/8/10 at 12:43 A.M., a physician order directed the staff to place the patient on BiPAP inspiratory pressure of 12 cm. Review of the clinical record did not identify documentation that Patient #41 was placed on the BiPAP.
On 6/8/10 at 5:25 A.M., a physician order directed the staff to place the patient on BiPAP inspiratory pressure of 15 cm. Review of the clinical record did not identify documentation that Patient #41 was on a ventilator in a CPAP mode and was placed on the BiPAP with the ordered parameters and/or that the physician was informed.
In addition, review of the clinical record, dated 6/9/10 at 1:35 A.M., identified that Patient #41 refused to be placed on the BiPAP and there was no documentation to reflect that the physician was informed of the patient ' s refusal of BiPAP.

8. Patient #43 was admitted on 6/4/10 with a history of home BiPAP and review of physician orders, dated 6/4/10 at 11:36 P.M., directed the staff to place the patient on BiPAP. Review of the clinical record did not reflect documentation that the patient was placed on BiPAP and/or that the physician was informed of the refusal of BiPAP.

Review of the clinical records of Patients # 28, 29, 36, 38, 39, 40, 41 and 43 failed to identify any physician order that included the target oxygen saturation level in accordance with the hospital policy and procedure.

Review of the hospital policy and procedure, titled Noninvasive Positive Pressure Ventilation (NPPV or BiPAP), identified that BiPAP requires a physician order; the order includes the supplemental oxygen percentage, the target oxygen saturation level, the frequency and the inspiratory pressure. In addition, review of the hospital policy and procedure, titled Application of Patient Home Ventilator, CPAP or BiPAP Devices, identified that the physician will order the necessary settings.

9. Patient #46 was admitted on 5/27/10. Review of physician orders, dated 6/1/10 at 6:19 P.M., directed the staff to maintain the patient on the ventilator with a rate of 14 breaths per minute and oxygen of 80%. Review of the ventilator flow sheets, at 6/1/10 at 7:11 P.M., identified that the rate was 10 breaths per minute and the oxygen was 100%, absent a physician order.
A second physician order, dated 6/1/10 at 8:42 P.M., directed the staff to maintain the patient on a ventilator with a rate of 10 breaths per minute and 60 % oxygen. Review of the ventilator flow sheets, from 6/2/10 at 11:25 A.M. to 6/ 10/10 at 1:05 A.M., identified that the oxygen percentage was between 40 to 100%, absent a physician order.

10. Patient #48 was admitted on 5/23/10 and review of the physician orders, dated 5/29/10 at 9:11 A.M., directed the staff to maintain the patient on the ventilator with a rate of 12 breaths per minute and oxygen of 50 %. Review of the ventilator flow sheets, dated 5/29/10 at 2:37 P.M. to 5/30/10 at 12:05 P.M., identified that the rate was at 18 breaths per minute and/or the oxygen was between 50-70%, absent a physician order.
In addition, the ventilator flow sheets, dated 5/30/10 at 9:00 P.M. to 6/2/10 at 8:19 A.M., identified that the oxygen was at 40 %, absent a physician order.
A physician order, dated 6/2/10 at 2:10 P.M., directed the staff to maintain Patient #48 on the ventilator with a rate of 10 breaths per minute, pressure support of 5 cm and oxygen of 40%. Review of the ventilator flow sheets, from 6/2/10 at 4:00 P.M. to 6/3/10 at 8:27 A.M., identified that the pressure support was at 10 cm, absent a physician order.
The ventilator flow sheet, dated 6/5/10 from 10:41 A.M. to 11:45 A.M., identified that the pressure support was 5 cm, absent a physician order.

11. Patient #56 was admitted on 6/23/10 and required invasive ventilation. Review of the physician orders, dated 6/29/10 at 8:14 A.M. directed the staff to provide a pressure control mode, SIMV, at a rate of 20 breaths per minute, with PEEP of 8 cm, PS of 5 cm, PIP of 22 cm and supplemental oxygen of 50%. Review of the ventilator flow sheets, dated 6/29/10 at 8:16 A.M., reflected that the ventilation settings were different that what was ordered including PEEP of 5 cm.
In addition, review of the physician orders, dated 6/29/10 at 9:57 A.M., directed the staff to provided a pressure control mode, SIMV, at a rate of 20 breaths per minute, with PEEP of 8 cm, PS of 5 cm, PIP of 25 cm and supplemental oxygen of 50%. Review of the ventilator flow sheets, dated 6/29/10 at 9:59 A.M., reflected that the ventilation settings were different that what was ordered including a rate of 18 breaths per minute, PEEP of 5 cm and PIP of 22 cm.

12. Patient #57 was admitted on 2/20/10 and required invasive ventilation. Review of the physician order, dated 6/20/10 at 11:25 A.M. and 6/23/10 at 8:57 P.M., directed the staff to provided Continuous Positive Airway Pressure (CPAP) of 6 cm with a Pressure Support (PS) of 6 cm and there was no display of the oxygen to be administered. Review of the ventilator flow sheets, dated 6/20/10 at 12:19 P.M. to 6/29/10 at 9:06 A.M., reflected that the staff provided Patient #57 CPAP of 6 cm, PS of 6 cm and oxygen at 21 % and there was no documentation that the physician was informed of the need for 21% oxygen..

Interview with hospital Information Technology Staff #1, on 6/30/10, identified that on 6/29/10, he/she identified that the oxygen percentage was ordered on 6/23/10 at 8:57 P.M. for Patient #57 although this information could not be displayed on the computer system. In addition, he/she then wrote a verbal order, on 6/29/10 at 9:08 P.M., for Patient #57 CPAP at 6 cm, PS of 6 cm and oxygen at 21 % into the electronic computer system in accordance with the parameters from the physician order on 6/23/10 at 8:57 P.M. Review of the computer system, on 6/30/10, identified that a physician on 6/30/10 signed this order as correct at 9:16 A.M.

13. Patient #61 was admitted on 6/19/10 and required invasive ventilation. Review of the physician order, dated 6/29/10 at 9:20 A.M. directed the staff to place Patient #61 on CPAP trial at 5 cm with PS of 10 cm and oxygen at 21 %. Review of the ventilator flow sheet, dated 6/29/10 from 9:56 A.M. to 10:37 A.M., identified that the staff provided a CPAP trial at 5 cm with PS of 12 cm and 25 % of oxygen, absent a physician order. Interview with RT #7, on 6/29/10, identified that he/she informed MD #19 regarding Patient #61 ' s respiratory needs and received a verbal order to change the ventilator CPAP settings. Interview with MD #19, on 6/29/10, identified that he/she did not speak with any respiratory therapist regarding Patient #61 ' s CPAP trial. A second interview with RT #7, on 6/29/10, identified that he/she did not speak with MD #19 regarding Patient #61.

14. Patient #68 was admitted on 6/28/10 and required non-invasive ventilation. Review of the physician order, dated 6/30/10 at 8:58 A.M., directed the staff to provide CPAP inspiratory time of 0.4, PEEP of 4cm and oxygen at 21 %. Review of the ventilator flow sheets, dated 6/30/10 at 1:14 A.M. to 12:03 P.M., identified that the oxygen was administered between 35 % to 22%, absent a physician order.

Review of hospital policies and procedures, titled Initiating and Monitoring Mechanical Ventilator Support, Policy on Mechanical Ventilator Adjustments and Respiratory Care Orders, identified that ventilator settings/parameters require a physician order, the respiratory therapist must ensure that the ventilator settings are consistent with the physician order(s), the respiratory therapist must ensure that all ventilator changes are guided by written physician order(s), changes to the settings on ventilators are only made by a respiratory therapist except in the case of an emergency (a Physician and/or a Registered Nurse may adjust the oxygen percentage provided that the respiratory therapist is immediately informed) and if the respiratory therapist has any concerns/questions about a physician order (appropriateness and/or completeness) the concern/question will be addressed by the prescribing physician.

On 6/29/10, Immediate Jeopardy under the Conditions of QAPI and Respiratory Services were identified. The Department requested an Immediate Corrective Action Plan on 6/29/10 to address issues related to ventilator patients and patients who required respiratory supportive therapies. The Plan included educating Respiratory Therapists, implementation of an electronic order entry functionality to facilitate efficiency entering mechanical ventilation orders, education of all nursing staff who care for patients on ventilators or supportive therapies, physician/LIP education regarding orders, and a monitoring plan to ensure that the corrective action plan is implemented. On 6/30/10, an onsite visit was conducted and through review of clinical records, review of facility documentation, and interviews, Immediate Jeopardy was abated.