HospitalInspections.org

Based on medical record review and staff interview the hospital's respiratory staff failed to assess patients according to the mechanical ventilator weaning policy and procedure for 4 of 4 sampled ventilator patients (#3, 5, 1 and 6).

Findings include:

Review of the "Ventilator Weaning Protocol Orders" (undated) revealed ...
"Inclusion criteria:
1. Hemodynamically stable, no on vasopressors
2. Awake, able to open eyes on verbal command, follow simple commands.
3. Reason of respiratory failure improving or stabilizing
4. Acceptable oxygenation and ventilation documented by saturation above 88% on FIO2 (Oxygen delivered) 50% or below, pH 7.35 or more
5. Chest radiology stable or improving
Exclusion criteria:
1. Hemodynamically unstable requiring vasopressors
2. FIO2 above 0.5 or P/F ratio below 200
3. PEEP (Peak END Expiratory Pressure) above 10
4. Minute ventilation above 15 L (liters)
5. Respiratory rate (RR) above 30 per minute
6. Heart rate (HR) above 120
7. New fevers above 101 F (Farenheit)
8. Ongoing sepsis
9. Neuromuscular disease (relative)
10. Conscious sedation or general anesthesia in the last 12 hours...

...Tracheostomy collar trail (TCT).
1. Once the patient is stable on PSV (Pressure Support Ventilation) 15 or less for 12 hours, check and document weaning parameters as below.
a. Minute ventilation VE (Minute Volumn) below 12
b. Respiratory rate below 30
c. NIF (Negative Inspiratory Force) below 24
d. Rapid Shallow Breathing Index (RR/Tv (Respiratory Rate/Tidal Volumn) in liters) below 105
2. If patient meets the above criteria, then proceed with TCT. If not, then discuss with the pulmonologist and ask for further orders.
3. Patient will be placed on TCT at 8 am initially with continuous oxygen flow with FIO2 above 0.1 from the last ventilator setting. Target FIO2 (Oxygen delivered) is to maintain SaO2 (oxygen saturation) 90 or more. Explain to the patient about the procedure and alleviate any concerns. Suction and position the patient with elevated head at above 30 degrees and as comfortable as appropriate.
4. Initiate TCT for 1 hour on first day. Observe at bedside initially for 5 minutes and the every 15 minutes. Abort TCT if patient develops any of the features as documented in Weaning Discontinuation.
5. If patient tolerates the TCT, then increase the TCT by 1 hour next day.
6. Once TCT is tolerated for 2 hours, proceed with TCT for 12 hours and rest in nighttime on the previous stable ventilator settings. Then next day, proceed with TCT for 24 hours. Once patient has completed 24 hours on TCT, then inform pulmonologist and discontinue ventilator...
...8. Weaning discontinuation: Stop further weaning if patient develops any of following signs:
a. Any of the exclusion criteria
b. Increased respiratory rate above 30 for more than 4 minutes with perspiration, paradoxical breathing.
c. If patient develops any of above signs, switch the patient back to the last stable setting or increase the support until patient is stabilized. Hold weaning for 24 hours then re-initiate as described above."

1. Closed medical record review on 03/12/2011 and 03/13/2011 of patient #3 revealed a 71 year old female admitted 03/01/2011 at 1453 with respiratory failure. Review of the record revealed the patient transferred from another acute hospital with a tracheostomy and ventilator support. Admission orders indicated the patient was to be a Full Code and the ventilator was to be in an Assist/Control Mode. Review of the Cardiology consult conducted on 03/02/2011 revealed..."ASSESSMENT AND PLAN:..The patient does have a history of deep venous thrombosis and congestive heart failure and prior history of weakness and deconditioning... She did have an episode of bradycardia where she became unresponsive. The patient may have underlying sick sinus or tachybrady syndrome...Her bradycardia episode may be due to her underlying sick sinus with tachybrady syndrome for which she may eventually require permanent pacemaker once she is aseptic."

Review of the Pulmonary consult conducted 03/09/2011, dictated at 1745 revealed..."ASSESSMENT AND PLAN...Respiratory failure: Severe chronic obstructive pulmonary disease with breath stacking whenever she gets anxious. Anxiety issues have to be managed; otherwise, the patient will never be able to come off the ventilator. Once her anxiety is under better control, then we should be able to have her wean from the ventilator, but in the meantime we will maintain her pressure support ventilation (CPAP/PSV) with intermittent assist control as needed. We will continue to follow along with you."
Review of the respiratory therapy Mechanical Ventilator Log shows the patient was in the AC (Assist Control) mode from 03/01/2011 at 1540 through 03/02/2011 at 1230 when she was put on CPAP until 03/02/2011 at 1420 where the patient was back on AC until 03/05/2011 at 0005 when she was placed on CPAP. The patient remained on CPAP until 03/06/2011 at 0000, when she was put back on AC. At 1150 on 03/06/2011 she was again on CPAP, then placed back on AC at 1210, remaining on AC until 03/09/2011 at 0725, where she was placed on CPAP until 1745. At 1745 the patient was placed on the TC (Trach Collar) per the pulmonary physician consultant order on 03/09/2011 at 1735, "TC as tolerated 88% Sats, ABG (arterial blood gas) in AM. Review of the respiratory therapy notes indicated the FIO2 (oxygen concentration) being delivered was adjusted from 30% to 40 % per TC trail protocol. The patients O2 Saturation was 91% with RR of 24, a heart rate of 97. Continued review of the respiratory therapy noted show no evidence of assessment of the patient's condition during the five minutes after the patient was changed to the T-collar and 15 minutes while on the T-collar as per protocol. At 1850 on 03/09/2011 the nurse documents "condition unchanged. SPO2 (oxygen saturation) 91%, No discomfort noted. At 1950 the nurse documents "Assessment complete. pt alert and able to make needs known. confusion noted at times. Denies pain #8 trach on TC 40% with O2 sat 94%"... The respiratory therapist documents at 2020 FIO2 at 40%, saturation at 95%, RR of 22, HR at 102. At 2155 the nurse documents "Anxiety noted. Resp becoming labored. O2 sat 94%. Klonipin VT given for anxiety" "2252 asleep with resp even, unlabored. No S/S of anxiety. At 2334 the respiratory therapist documents RR 20, O2 sat. 99, HR 92 and at 0015 on 03/10/2011 the nurse again documents "Vitals stable, Resp unlabored. Alert with eyes open. Denies pain or SOB. O2 sat 94%"...at 0140 "asleep with resp unlabored . O2 sat 94%. At 0310 on 03/10/2011 the respiratory therapist documents RR 21, O2 sat 95% and HR 86. At 0315 the nurse documents..."Denies pain. Resp even, unlabored, Suctioned for comfort.." On 03/10/2011 at 0530 the nurse documents (this nurse note is dated 03/09/2011 but should have been 03/10/2011 per nurse interview) "anxiety noted. Klonipin 0.5 mg VT given..." The respiratory therapist documents on 03/10/2011 at 0551 RR 20, O2 sat 99 and HR 100. At 0700 (shift change) the nurse oncoming nurse documents the patient is lethargic, skin warm, dry, poor turgor, and pale, mucous membranes dry. The nurse also documents "assumed care of pt. pt lethargic on TC 40% difficulty breathing. RT (respiratory therapy) made aware pt responded to stimuli assessment completed per flow sheet pt with HOB (head of bed) elevated ...changed bed in low position..."Laboratory reports revealed an ABG (arterial blood gas) had been drawn/run at 0715 per previous order with pH 7.12, PCO2 105, PO2 112, FIO2 of 60%. The Nurse note and the respiratory therapy note both indicate the patient was placed back on the Ventilator at 0742 on 03/10/2011 on the AC mode due to the ABG results and the attending Physician had been notified. At 0744 the nurse documents the "telemetry nurse called this nurse...HR 44 rapid response...called MD at bedside. (This MD was the hospitalist on Call for that day). The respiratory therapist also documented at 0745 "rapid response called Pt coded. The "Hospital Code Report Flowsheet" indicates the code was called at 0745 on 03/10/2011 and the patient was pronounced at 0802, by the Hospitalist on call.

Review of the telemetry EKG strips show the HR dropped to 44 at 0743, 36 at 0744, and 38 at 0747. Further review of the "All ASCOM" phone alarms which the O2 sat. monitor was being monitor from (this does not give the actual O2 sat., only indicated the time the alarm went off) showed on 03/10/2011 the alarm went off once at 0250, 0417, 0419, 0534 the approximate time anxiety medication had been given and from 0747 through 0755 during which time the code was being performed.

Phone interview with the Hospitalist on 04/13/2011 at 1610 and again a face to face interview on 04/14/2011 at 1245 revealed he had initially came to the patient's room to check on some bleeding around the PEG tube insertion that had been reported to him three times during the night. He also indicated there had been no reports of the patient having breathing difficulties during the night. When he first noticed the patient in the AM he felt the patient was having some labored breathing, but was not cyanotic and color was normal and the patient was arousable. He stated he did not have the impression the pt. was crashing. After checking the PEG tube site he left the room to go see another patient. He returned to the room when the code was called. He also stated "what ever happened it happened very fast". The Hospitalist documented in Physician's Progress Notes "03/10/2011 at 0815 called to bedside for brady cardia Pt pulseless electrical activity Arrest. ACLS chest compressions and meds epi x 3, atropine x 2 Bicarb x1 needle decompression performed +air Pt difficult to ventilate no pulse. Pt pronounced deceased at 0802 AM.

A Certificate of Death states immediate cause of death Cardiac Arrest resulting from Acute Respiratory Failure and Chronic Respiratory Failure. Other significant conditions contributing to death include Deep Vein Thrombosis.

Interview with the pulmonologist on 04/13/2011 at 1340 indicated he had written the order to have the patient put on the TC, without following the Ventilator weaning protocol, because the patient was exhibiting what he called stacking breathing while on the ventilator, which meant she was fighting the ventilator. The pulmonologist indicated there was two ways to treat this, one by sedating the patient or two take the patient off the ventilator. He did indicate he expected the staff to monitor the patient's condition during the five minutes after the patient was changed to the T-collar and 15 minutes while on the T-collar as per protocol. The pulmonologist indicated he had explained this to a family member, however a phone interview with the family member on 04/14/2011 at 1155 indicated she does not remember a physician explaining this to her.

Interview on 04/13/2011 at 1330 with the Director of Respiratory Services revealed she was unable to find documentation of the patient's condition for the first 5 minutes and every 15 minutes after the patient was changed to a T- collar on 3/9/2011 at 1545. Interview confirmed the Ventilator Weaning protocol was not followed.

2. Open medical record review on 04/14/2011 of patient #5 revealed a 68 year old female admitted on 03/09/2011 at 1805 with ventilator - dependent respiratory failure from another acute hospital, with a tracheostomy. The admitting orders were to put patient on the Ventilator with the AC (assiste control) mode. The pulmonologist also signed the Weaning from Ventilator protocol on 03/09/2011 at 1815, to start 03/10/2011. Review of the respiratory therapy notes showed the patient was on AC mode starting on 03/9/2011 at 1810 until 03/10/2011 at 1400 when she was put on CPAP (PSV) weaning through 03/13/2011 at 1415 when she was put on ATC (trach collar) for 1 hour, then put back on CPAP at 1520. Record review revealed no documentation of the patient's condition for the first five minutes after the patient was changed to the T- collar or every fifteen minutes after as per protocol. The patient remained on CPAP until 03/15/2011 at 1020 when she was again put on the TC until 2150, 11.5 hours, when she was put back on CPAP. Again there was no documentation of the patient's condition for the first five minutes after the patient was changed to the T - collar or every fifteen minutes after as per protocol. The patient remained on CPAP from 03/15/2011 at 2150 until 03/16/2011 at 0750 when she was again put on the TC until she was returned to CPAP on 03/17/2011 at 0830. Again there was no documentation of the patient's condition for the first five minutes after the patient was changed to the T - collar or every fifteen minutes after as per protocol. The patient remained on CPAP from 03/17/2011 at 0830 until 03/19/2011 at 1350 when she was put back on the T - collar. She remained on the T- collar until 2130 on 03/19/2011, with no documentation of the patient's condition for the first five minutes after the patient was changed to the T-collar or every fifteen minutes after as per protocol. From 03/19/2011 at 2130 she was on CPAP until 03/20/2011 at 1410 when she was put back on the T-collar. No documentation of the patient's condition for the first five minutes after the patient was changed to the T-collar or every fifteen minutes after as per protocol. The patient again remained on the T-collar from 03/20/2011 at 1410 until 04/03/2011 at 1650 when she was put back on the ventilator in AC mode. Record review revealed no documentation of the patient's condition for the first five minutes after the patient was changed to the T-collar or every fifteen minutes after as per protocol. Review showed on 04/06/2011 at 0710 the patient was put on CPAP and remained there until 04/13/2011 at 0950 when she was placed on the TC until 1220, approximately 2.5 hours, then went back on CPAP, with no indication the patient's condition was assessed for the first five minutes after the patient was changed to the T-collar or every fifteen minutes after as per protocol.

Interview on 04/13/2011 at 1330 with the Director of Respiratory Services revealed she was unable to find documentation of the patient's condition for the first 5 minutes and every 15 minutes after the patient was changed to a T- collar on each attempt to wean the patient from the ventilator. Interview confirmed the weaning ventilator protocols were no followed.



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3. Open record review on 04/13/2011 of Patient #1 revealed a 48 year-old male admitted 04/01/2011 with respiratory failure. Review of the record revealed the patient transferred from another acute hospital with a tracheostomy and mechanical ventilator initiated on 12/15/2010. Review of respiratory therapy notes dated 04/01/2011 revealed the patient arrived on a ventilator mode of "CPAP" (continuous positive airway pressure). Review of a pulmonary physician's consultation note dated as dictated 04/04/2011 revealed the patient had been "on and off pressure support for the last several days prior to admission. He has periods of fatigue when he is on pressure support for prolonged periods .... Impression/Plan: Respiratory Failure: The patient does seem to be slowly improving currently tolerating pressure support ventilation in a reasonable fashion. He is on protocol and hope to progress as tolerated. We will have to maintain his secretions, as I believe this is the primary inhibitor of ventilator weaning. I suspect that with slow support ventilator weaning, we should be able to get him off the ventilator. He has failed all other attempts previously for spontaneous breathing trial attempts trying to get him off the ventilator because of the debilitation and neurological deficits ... " Review of physician's orders dated 04/04/2011 at 1000 revealed an order for "T-collar (tracheostomy collar) as tolerated." Further review of physician's orders revealed "Ventilator Weaning Protocol Orders" that were signed by the physician on 04/06/2011 at 1530. Review of the Ventilator Weaning Protocol Orders revealed "Tracheostomy collar trial (TCT) ...4. Initiate TCT for 1 hour on first day. Observe at bedside initially for 5 minutes and then every 15 minutes.... " Review of a "Mechanical Ventilator Log" dated 04/04/2011 revealed the patient was on CPAP mode at 0400 and 0700 and then changed to a tracheostomy collar at 1020. Review of the log revealed a respiratory rate (RR) of 20, Heart Rate (HR) of 97 and oxygen saturation (SAO2) of 98% at 1020. Review of respiratory therapy (RT) notes at 1150 recorded "patient remains prn (as needed) for assessment. No restraints, no pulling on trach." Further review revealed the patient remained on the tracheostomy collar at 1245 with a RR of 20, HR was not documented and SAO2 was not documented. Review of the log revealed the patient was changed back to CPAP mode at 1400. Log review revealed no documentation of RR, HR or SAO2 at 1400. Review of RT notes at 1400 recorded "patient placed back on CPAP 10/5/4% (settings). Nurse called RT to room. Patient was diaphoretic and desated to 88% (SAO2). Less receptive to verbal command. Patient very lethargic. PT (physical therapy) working with patient." Review revealed a RR of 33, HR of 97 and SAO2 of 96% recorded at 1515. Review revealed respiratory rate (RR), HR and SAO2 were recorded at 1020 when the T-collar was placed, RR at 1245 (no HR or SAO2), then RR, HR and SAO2 at 1515 (4 hours and 55 minutes after the T-collar was placed). Record review revealed no documentation of the patient's condition for the first five minutes after the patient was changed to the T-collar or every fifteen minutes after as per protocol. Record review revealed the patient was placed on the T-collar from 1020 until 1400 (3 hours and 40 minutes), not consistent with the one hour as per protocol. Further review of the mechanical ventilator log revealed the patient remained on the ventilator through 04/13/2011 at 1000 when the T-collar was reapplied. Review revealed a RR of 26, HR of 88 and SAO2 100% at 1000. Review of the notes revealed the patient was changed back to CPAP mode at 1307 (3 hours and 7 minutes after the T-collar was applied). Review revealed a RR of 22, HR of 90 and SAO2 of 100% recorded at 1307 (3 hours and 7 minutes after the T-collar was applied). Record review revealed no evidence of assessment of the patient's condition during the five minutes after the patient was changed to the T-collar and 15 minutes while on the T-collar as per protocol.

Interview on 04/14/2011 at 1130 with the Director of Respiratory Services revealed she was unable to find documentation of the patient's condition for the first 5 minutes and every 15 minutes after the patient was changed to a T-collar on 04/04/2011 and 04/13/2011. Interview confirmed the patient was placed on the T-collar for 3 hours and 40 minutes on 04/04/2011 and 3 hours and 7 minutes on 04/13/2011. Interview confirmed the Ventilator Weaning protocol directed staff to place the patient on the T-collar for 1 hour initially. Interview confirmed the Ventilator Weaning protocol was not followed.

4. Open record review on 04/14/2011 of Patient #6 revealed a 69 year-old female admitted 04/05/2011 with respiratory failure, ventilator dependant and trachestomy. Review of the record revealed the patient transferred from another acute hospital with a tracheostomy and mechanical ventilator initiated on 03/31/2011. Review of respiratory therapy notes dated 04/05/2011 revealed the patient arrived on a ventilator mode of "CPAP" (continuous positive airway pressure). Review of physician's orders revealed "Ventilator Weaning Protocol Orders" that were signed by the physician on 04/06/2011 at 1530. Review of the Ventilator Weaning Protocol Orders revealed "Tracheostomy collar trial (TCT) ...4. Initiate TCT for 1 hour on first day. Observe at bedside initially for 5 minutes and then every 15 minutes...." Further review of physician's orders dated 04/11/2011 at 1155 revealed an order for "T-collar (tracheostomy collar) trial x (times) 2 hours as tolerated on 35%. Wean O2 (oxygen) to maintain sats (SAO2) > (greater than) 90%." Review of a "Mechanical Ventilator Log" dated 04/11/2011 revealed the patient was on CPAP mode at 0850 and then changed to a tracheostomy collar at 1100. Review of the log revealed a respiratory rate (RR) of 18, Heart Rate (HR) of 85 and oxygen saturation (SAO2) of 97% at 1100. Review of the log revealed the patient was changed back to CPAP mode at 1330 (2 hours and 30 minutes after T-collar placed). Review revealed a RR of 18, HR of 89 and SAO2 98% at 1330. Record review revealed no documentation of the patient's condition for the first five minutes after the patient was changed to the T-collar or every fifteen minutes after as per protocol. Record review revealed the patient was placed on the T-collar from 1100 until 1330 (2 hours and 30 minutes), not consistent with the physician's order for 2 hours. Further review of the mechanical ventilator log revealed the patient remained on the ventilator through 04/12/2011 at 1515 when the T-collar was reapplied. Review revealed a RR of 18, HR of 82 and SAO2 98% at 1515. Review of the notes revealed the patient was changed back to CPAP mode at 1815 (3 hours after the T-collar was applied). Review revealed a RR of 17, HR of 76 and SAO2 of 96% recorded at 1815 (3 hours after the T-collar was applied). Record review revealed no evidence of assessment of the patient's condition during the five minutes after the patient was changed to the T-collar and 15 minutes while on the T-collar as per protocol. Further review of the mechanical ventilator log revealed the patient remained on the ventilator through 04/13/2011 at 1025 when the T-collar was reapplied. Review revealed a RR of 24, HR of 92 and SAO2 98% at 1025. Review of the notes revealed the patient was changed back to CPAP mode at 1230 (2 hours and 5 minutes after the T-collar was applied). Review revealed a RR of 29, HR of 109 and SAO2 of 98% recorded at 1230 (2 hours and 5 minutes after the T-collar was applied). Record review revealed no evidence of assessment of the patient's condition during the five minutes after the patient was changed to the T-collar and 15 minutes while on the T-collar as per protocol.

Interview on 04/14/2011 at 1200 with the Director of Respiratory Services revealed she was unable to find documentation of the patient's condition for the first 5 minutes and every 15 minutes after the patient was changed to a T-collar on 04/11/2011, 04/12/2011 and 04/13/2011. Interview confirmed the patient was placed on the T-collar for 2 hours and 30 minutes on 04/11/2011, 3 hours on 04/12/2011 and 2 hours and 5 minutes on 04/13/2011. Interview confirmed the physician's order directed staff to place the patient on the T-collar for two hours initially. Interview revealed the protocol for ventilator weaning should be followed regarding times for T-collar trials. Interview confirmed the Ventilator Weaning protocol and physician's orders were not followed.