HospitalInspections.org

Based on interview and record review January 11-12, 2017, the facility failed to ensure that patients were protected in the Intensive Care Unit (ICU) as evidenced by
1. An unsafe setting.
2. Patient neglect.
3. No documentation of training and demonstration of competency in the use of the RotoProne bed.

The identified practices resulted in actual harm to 1 of 3 patients and presented a likelihood for substantial harm to all current and potential patients in the ICU requiring intubation and the RotoProne Therapy System.

Based on interview and record review, the facility failed to ensure the patient's right to a safe setting in the Intensive Care Unit as evidenced by improper positioning and inadequate eye care of 1 of 3 patients in a RotoProne bed. As a result of this failed practice, a patient developed facial sloughing and eschar, and corneal abrasions with reported blindness. Refer to 482.13(c)(2) - [A-0144].

Based on interview and record review, the facility failed to ensure the patient's right to an environment free of neglect in the Intensive Care Unit as evidenced by improper positioning and inadequate eye care of 1 of 3 patients in a RotoProne bed. As a result of this failed practice, a patient developed facial sloughing and eschar, and corneal abrasions with reported blindness. Refer to 482.13(c)(3) - [A-0145].

Based on interview and record review, the facility failed to document training and demonstration of competency by the nursing staff in the use of the RotoProne bed for 6 of 6 registered nurses. Additionally, 4 of 4 registered nurses were inconsistent in the explanation of proper eye care for intubated patients. Refer to 482.13(f)(4) - [A-0208].

Based on interview and record review, the facility failed to ensure the patient's right to a safe setting in the Intensive Care Unit as evidenced by improper positioning and inadequate eye care of 1 of 3 patients (Patient #1) in a RotoProne bed. As a result of this failed practice Patient #1 developed facial sloughing and eschar, and corneal abrasions with reported blindness.

TX00251741

Findings included:

Record review of a complaint received by the Texas Department of State Health Services (received 01/10/2017) revealed Patient #1 was admitted into University General Hospital in November 2016. At the time of discharge, there were "burns all over" his body that were initially thought to be bruises and he was "blind as a result of his burns."

Record review of Admission Note by MD #55 dated 11/04/2016 at 1400 revealed Patient #1 presented to the emergency department (ED) in respiratory distress. He was intubated to protect his airway. There was no trauma to the head. The eyes showed periorbital edema, no proptosis, no eye discharge, and normochromic conjunctiva. Lips, tongue, and gums were intact with endotracheal tube in place. There were multiple abdominal scars. His skin was warm, dry, and intact.

Record review of ICU Admission Orders by MD #56 dated 11/04/2016 at 1200 revealed Patient #1 was ordered propofol [anesthetic administered to intubated, mechanically ventilated adult patients to provide continuous sedation]. "Ocular lubricant ointment to both eyes twice a day as long as patient is sedated" was an option to check. Though Patient #1 was sedated, the eye lubricant was NOT checked off as part of the admission orders.

Record review of Physician's Orders by MD #56 on 11/07/2016 at 0518 revealed Patient #1 was ordered artificial tears 1.4% solution one drop twice a day.

Record review of Progress Note by MD #55 dated 11/08/2016 [no time] revealed: Patient #1 was sedated under propofol drip. His eyes showed external ocular movements were intact with pupils round and reactive to light and accommodation. There was no periorbital edema, proptosis, eye discharge or abnormal scleral coloration.

Record review of Progress Note by MD #56 dated 11/09/2016 at 0800 revealed Patient #1 developed acute respiratory distress syndrome, and was placed on RotoProne bed. He was put in the prone position.

Record Review of Progress Note by MD #56 dated 11/11/2016 at 0910 revealed Patient #1 placed in the RotoProne bed in supine position. His oxygen saturation went down to 88%. Patient #1 was then placed in "prone Trendelenburg" [the body is laid flat abdomen down with the feet higher than the head by 15-30 degrees]. MD #56 went on to write, "This morning I find him in RotoProne bed, in prone Trendelenburg position under sedation with propofol ... intubated on mechanical ventilation ... Plan: ... RotoProne bed supine position - prone again."

Record review of the RotoProne Therapy System User Manual dated December 2014 revealed: Risks and Precautions ... skin breakdown and/or pressure necrosis ... edema and or swelling ... blindness and other consequences of damage to the ocular nerve, corneal abrasions ... increased intra-orbital pressure, central retinal artery occlusion ... Place patient in reverse Trendelenburg position [the body is laid flat with the feet lower than the head by 15-30 degrees] to help minimize facial swelling / edema.

Record review of Cardiology Progress Note by MD #57 dated 11/13/2016 at 1730 revealed: Patient #1 "remains in prone position to be changed to supine this evening."

Record review of Cardiology Progress Note by MD #57 dated 11/14/2016 at 2000 revealed the prone position and RotoProne bed were discontinued for Patient #1.

Record review of Incident Description by RN #58 dated 11/14/2016 at 1916 revealed: Patient #1 was removed from the RotoProne bed on 11/14/2016 by day shift RN #59. RN # 60 discovered during shift change that the patient had a "yellowish film" covering both eyes. RN supervisor #61 was notified.

Record review of Physician's Orders by MD #55 on 11/15/2016 at 0752 revealed artificial tears 1.4% solution one drop four times a day was ordered for Patient #1.

Record review of Progress Note by MD #55 dated 11/16/2016 [no time] revealed Patient #1 had corneal lacerations on both eyes, left globe injury, "both due to RotoProne bed therapy." There were "yellowish secretions" on both eyes.

Record review of Ophthalmology Consult by MD #62 dated 11/16/2016 at 2030 revealed Patient #1 had "bilateral horizontal ulcers about 1/3 corneal height, full thickness with white blood cells in both anterior chambers ... Ulcers secondary to not blinking and not closing eyes." Plan: Continue Bacitracin ophthalmic ointment both eyes four times a day. Tape eyes closed to protect cornea.

In an interview with MD #62, Ophthalmologist, on 01/12/2017 at 1100, he stated:
· Patient #1 was "unconscious" at the time of his ophthalmology consultation on 11/16/2016 and "didn't blink."
· Patient #1 had "ulcers across the center of his eyes because the corneas were exposed."
· Frequently eyes do not close when patients are intubated. This is a "major problem."
· Ointment should be applied to the eyes every four hours.
· Patient #1's eyes were probably left open for "four to five days to a week."
· He ordered bacitracin ophthalmic ointment and tape eyes closed.

In an interview with MD #55 and MD #56 on 01/12/2017 at 0900, both stated they remembered Patient #1. MD #56 stated:
· The protocol for intubated patients is to put Lacri-Lube eye drops in the eyes. The nursing staff should examine the eyes twice a day and the physician, once a day.
· Facial swelling is common with use of the RotoProne bed.
· Being in the prone position is not the best position for supplying the vessels of the eyes with oxygen.
· RE: leaving the eyes open vs. keeping the eyes shut on intubated patients - He was "unsure of the data."

Record review of Progress Note by MD #55 dated 11/17/2016 [no time] revealed Patient #1 was sedated with propofol drip. His presentation suggested decorticated positioning [decorticate posturing - ominous sign of severe brain damage]. Anasarca [or extreme generalized edema, is a medical condition characterized by widespread swelling of the skin due to escape of fluid into the tissues] was noted. He had bilateral corneal lacerations and left globe injury, "both due to prior RotoProne bed therapy." Yellowish secretions were noted on both eyes. The eyes were shut with tape.

Record review of Progress Note by MD #55 dated 11/23/2016 [no time] revealed Patient #1 was unconscious and off sedation. His eyes were covered with dressings. Aanasarca noted. His eyes revealed bilateral corneal laceration and left globe injury, "both due to prior RotoProne bed therapy." The abdomen was "highly distended."

Record review of Patient Assessment Report by RN #63 dated 11/23/2016 at 0800 revealed Patient #1 had edema of right and left foot, ankle, tibia, arm and hand; scrotum; and generalized. Nose - laceration, no drainage. Left lower chest - stage 1 (redness, skin intact). Right eye - unstageable (covered with slough, eschar), scant purulent drainage. Left eye - unstageable (covered with slough, eschar), moderate purulent drainage. Right lower quadrant - bruise, bruising from right flank down to groin, no drainage.

Record review of Patient #1's Assessment Report by RN #60 dated 11/23/2016 at 2000 revealed: Right eye - yellow patch over cornea, unable to visualize the pupil. Left eye - yellow patch over cornea, fair amount of purulent discharge, unable to visualize the pupil. Edema of right and left foot, ankle, arm, and hand; and scrotum. Left lower chest - stage 1 (redness, skin intact), generalized, no drainage. Right eye - unstageable (covered with slough, eschar), scant purulent drainage. Left eye - unstageable (covered with slough, eschar), moderate purulent drainage. Right lower quadrant - bruising from right flank down to groin, no drainage. Nose - wound is dry and intact. Tip of nose with blueness.

Record review of Nursing Note by RN #60 dated 11/23/2016 at 2200 revealed Patient #1 was discharged to another facility.

Record review of Discharge Summary by MD #55 dated 11/30/2016 [no date or time] revealed Patient #1 was discharged on 11/23/2016. Numerous diagnoses were documented including acute respiratory distress syndrome, intubation, lung pseudo tumor, acute hypoxemic respiratory failure, massive hemoptysis, right-sided pleural effusion, chronic obstructive pulmonary disease, malnutrition, congestive heart failure, corneal laceration - chemosis [swelling of the tissue that lines the eyelids and surface of the eye], and left globe injury. Patient #1 was discharged under assisted mechanical ventilation to a long-term acute care facility.

Record review of a Nursing Assessment from the long-term acute care facility by RN #64 dated 11/25/2016 at 1917 revealed Patient #1 had "burns: nose anterior ... present on admission ... thickness obscured by necrosis ... unstageable ... Necrotic tissue type: adherent, soft, black eschar. Necrotic tissue amount: 100%. Exudate: none ... dry wound." Bilateral pressure ulcers on the heels were also documented.

Based on interview and record review, the facility failed to ensure the patient's right to an environment free of neglect in the Intensive Care Unit (ICU) as evidenced by improper positioning and inadequate eye care of 1 of 3 patients (Patient #1) in a RotoProne bed. As a result of this failed practice Patient #1 developed facial sloughing and eschar, and corneal abrasions with reported blindness.

TX00251741

Findings included:

Record review of a complaint received by the Texas Department of State Health Services (received 01/10/2017) revealed Patient #1 was admitted into University General Hospital in November 2016. At the time of discharge, there were "burns all over" his body that were initially thought to be bruises and he was "blind as a result of his burns."

Record review of Admission Note by MD #55 dated 11/04/2016 at 1400 revealed Patient #1 presented to the emergency department (ED) in respiratory distress. He was intubated to protect his airway. There was no trauma to the head. The eyes showed periorbital edema, no proptosis, no eye discharge, and normochromic conjunctiva. Lips, tongue, and gums were intact with endotracheal tube in place. There were multiple abdominal scars. His skin was warm, dry, and intact.

Record review of ICU Admission Orders by MD #56 dated 11/04/2016 at 1200 revealed Patient #1 was ordered propofol [anesthetic administered to intubated, mechanically ventilated adult patients to provide continuous sedation]. "Ocular lubricant ointment to both eyes twice a day as long as patient is sedated" was an option to check. Though Patient #1 was sedated, the eye lubricant was NOT checked off as part of the admission orders.

Record review of Physician's Orders by MD #56 on 11/07/2016 at 0518 revealed Patient #1 was ordered artificial tears 1.4% solution one drop twice a day.

Record review of Progress Note by MD #55 dated 11/08/2016 [no time] revealed: Patient #1 was sedated under propofol drip. His eyes showed external ocular movements were intact with pupils round and reactive to light and accommodation. There was no periorbital edema, proptosis, eye discharge or abnormal scleral coloration.

Record review of Progress Note by MD #56 dated 11/09/2016 at 0800 revealed Patient #1 developed acute respiratory distress syndrome, and was placed on RotoProne bed. He was put in the prone position.

Record Review of Progress Note by MD #56 dated 11/11/2016 at 0910 revealed Patient #1 placed in the RotoProne bed in supine position. His oxygen saturation went down to 88%. Patient #1 was then placed in "prone Trendelenburg" [the body is laid flat abdomen down with the feet higher than the head by 15-30 degrees]. MD #56 went on to write, "This morning I find him in RotoProne bed, in prone Trendelenburg position under sedation with propofol ... intubated on mechanical ventilation ... Plan: ... RotoProne bed supine position - prone again."

Record review of the RotoProne Therapy System User Manual dated December 2014 revealed: Risks and Precautions ... skin breakdown and/or pressure necrosis ... edema and or swelling ... blindness and other consequences of damage to the ocular nerve, corneal abrasions ... increased intra-orbital pressure, central retinal artery occlusion ... Place patient in reverse Trendelenburg position [the body is laid flat with the feet lower than the head by 15-30 degrees] to help minimize facial swelling / edema.

Record review of Progress Note by MD #55 dated 11/16/2016 [no time] revealed Patient #1 had corneal lacerations on both eyes, left globe injury, "both due to RotoProne bed therapy." There were "yellowish secretions" on both eyes.

Record review of Ophthalmology Consult by MD #62 dated 11/16/2016 at 2030 revealed Patient #1 had "bilateral horizontal ulcers about 1/3 corneal height, full thickness with white blood cells in both anterior chambers ... Ulcers secondary to not blinking and not closing eyes." Plan: Continue Bacitracin ophthalmic ointment both eyes four times a day. Tape eyes closed to protect cornea.

In an interview with MD #62, Ophthalmologist, on 01/12/2017 at 1100, he stated:
· Patient #1 was "unconscious" at the time of his ophthalmology consultation on 11/16/2016 and "didn't blink."
· Patient #1 had "ulcers across the center of his eyes because the corneas were exposed."
· Frequently eyes do not close when patients are intubated. This is a "major problem."
· Ointment should be applied to the eyes every four hours.
· Patient #1's eyes were probably left open for "four to five days to a week."
· He ordered bacitracin ophthalmic ointment and tape eyes closed.

Record review of Progress Note by MD #55 dated 11/17/2016 [no time] revealed Patient #1 was sedated with propofol drip. His presentation suggested decorticated positioning [decorticate posturing - ominous sign of severe brain damage]. Anasarca [or extreme generalized edema, is a medical condition characterized by widespread swelling of the skin due to escape of fluid into the tissues] was noted. He had bilateral corneal lacerations and left globe injury, "both due to prior RotoProne bed therapy." Yellowish secretions were noted on both eyes. The eyes were shut with tape.

Record review of Progress Note by MD #55 dated 11/23/2016 [no time] revealed Patient #1 was unconscious and off sedation. His eyes were covered with dressings. Aanasarca noted. His eyes revealed bilateral corneal laceration and left globe injury, "both due to prior RotoProne bed therapy." The abdomen was "highly distended."

Record review of Patient #1's Assessment Report by RN #60 dated 11/23/2016 at 2000 revealed: Right eye - yellow patch over cornea, unable to visualize the pupil. Left eye - yellow patch over cornea, fair amount of purulent discharge, unable to visualize the pupil. Edema of right and left foot, ankle, arm, and hand; and scrotum. Left lower chest - stage 1 (redness, skin intact), generalized, no drainage. Right eye - unstageable (covered with slough, eschar), scant purulent drainage. Left eye - unstageable (covered with slough, eschar), moderate purulent drainage. Right lower quadrant - bruising from right flank down to groin, no drainage. Nose - wound is dry and intact. Tip of nose with blueness.

Record review of Discharge Summary by MD #55 dated 11/30/2016 [no date or time] revealed Patient #1 was discharged on 11/23/2016. Numerous diagnoses were documented including acute respiratory distress syndrome, intubation, lung pseudo tumor, acute hypoxemic respiratory failure, massive hemoptysis, right-sided pleural effusion, chronic obstructive pulmonary disease, malnutrition, congestive heart failure, corneal laceration - chemosis [swelling of the tissue that lines the eyelids and surface of the eye], and left globe injury. Patient #1 was discharged under assisted mechanical ventilation to a long-term acute care facility.

Record review of a Nursing Assessment from the long-term acute care facility by RN #64 dated 11/25/2016 at 1917 revealed Patient #1 had "burns: nose anterior ... present on admission ... thickness obscured by necrosis ... unstageable ... Necrotic tissue type: adherent, soft, black eschar. Necrotic tissue amount: 100%. Exudate: none ... dry wound." Bilateral pressure ulcers on the heels were also documented.

Record review of the facility's policy Patient's Rights Ethics, Rights, and Responsibilities, revised 01/01/2016 revealed: "Patient rights shall include ... The right of the patient to the hospital's response to his or her needs for treatment or services, within the hospital's capacity, its mission, and applicable law and regulation."

Based on interview and record review, the facility failed to ensure that the nursing staff had the specialized qualifications and competence in the use of the RotoProne bed for 6 of 6 registered nurses (Personnel #58, #60, #61, #65, #66, and Personnel #69).

TX00251741

Findings included:

Record review of the personnel files for 6 of 6 registered nurses (Personnel #58, #60, #61, #65, #66, and Personnel #69) revealed no training or orientation for use of the RotoProne bed.

In an interview with RN #66 on 01/11/2017 at 1425, she stated a RotoProne bed representative had provided training on the bed. She also stated that instruction on the RotoProne bed was not part of the annual competency or new hire training.

In an interview with RN #67 (Educator) on 01/12/2016 at 0840, she stated:
· There was no in-services or competencies for the RotoProne bed.
· She attended the first five minutes of the RotoProne bed reps presentation.
· She had plans to develop an in-service and competency for the use of the RotoProne bed but "I have a lot on my plate right now."
· She had no documentation of in-services for the nursing staff on the use of the RotoProne bed.

In an interview with RN #52 (Quality/Risk Management) on 01/12/2017 at 0850, she stated she could not provide evidence of training by the representative on the RotoProne bed.

In an interview with Personnel #68 (RotoProne representative) on 01/12/2017 at 0950, he stated:
· Formal training is required for use of the RotoProne bed.
· The facial pack can cause the skin to shear [gravity pulls underlying tissue in the opposite direction of the skin resulting in tears and restriction of blood to the area]. The facial pack must be removed to adequately assess the facial skin.
· Skin should be checked every two hours.
· It is up to the facility to maintain continued training.
· He had no documentation of past training for staff at the facility.

Record review of the RotoProne Therapy System User Manual dated December 2014 revealed: Risks and Precautions ... skin breakdown and/or pressure necrosis ... edema and or swelling ... blindness and other consequences of damage to the ocular nerve, corneal abrasions ... increased intra-orbital pressure, central retinal artery occlusion ... Place patient in reverse Trendelenburg position [the body is laid flat with the feet lower than the head by 15-30 degrees] to help minimize facial swelling / edema.

Record review of a sign-in sheet for an in-service on the RotoProne bed dated 10/12/2012 [no time] revealed 12 names. The only staff member's name found on the roster that was interviewed during this investigation was that of RN #66.

In an interview with RN #52 (Quality/Risk Management) on 01/12/2017 at 1400, she stated this was the only sign-in sheet that could be found.

Record review of personnel files for RN #58, #60, #61, #65, #66, and RN #69) revealed no documentation of training or annual competencies on the RotoProne bed.

Record review of the facility's policy, Competence of Clinical Staff, revised 01/01/2016 revealed: "Clinical staff members will have their clinical competencies assessed as a part of the initial employment and orientation process and annually thereafter. Demonstration of competence is required prior to independent performance. Competence of clinical staff members is maintained through a combination of ongoing competence assessment and educational activities ... not limited to new patient care equipment/technology ... Registered nurses, including clinical supervisors, nurse managers ..., clinical educators ..., and LVNs have competence assessed as follows: Performance Appraisal annually ... Unit-Specific Skills orientation [and] annually."

Record review of the facility's policy Patient's Rights Ethics, Rights, and Responsibilities, revised 01/01/2016 revealed: "Patient rights shall include ... The right of the patient to the hospital's response to his or her needs for treatment or services, within the hospital's capacity, its mission, and applicable law and regulation."