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Based on review of medical record (MR), hospital policy and staff interviews, it was determined the hospital staff failed to follow their own policy for informed consent. This affected MR # 1, 1 of 10 sampled records reviewed and had the potential to negatively affect all patients treated at the facility.

Findings include:

Policy Title: Informed Consent
Approval Date: 11/08/2016

Purpose:
To establish guidelines that ensures a uniform approach to obtaining patient consent for treatment...

Policy:

Absent emergency or extraordinary circumstances, no medical or surgical procedure will be performed upon an patient unless the patient has had the opportunity to confer with a physician...Emergency or extraordinary circumstances shall be considered...the physician shall document the emergency or extraordinary circumstances in the patient's medical record.

Circumstance that require a consent shall be, but not limited to:
6. Endoscopy...cystoscopy...bronchoscopy...Any doubts concerning the necessity for obtaining informed consent shall be resolved in favor of obtaining informed consent...
Obtaining Informed Consent
The attending physician performing or supervising the surgical or medical procedure, or...designee, shall be responsible for obtaining informed consent.
Special situations
...two members of the medical staff must indicate in writing...the medical services are necessary...that a delay...would increase the risk to the patient's life or health...
When The Patient Is Unable to Provide Consent...consent shall be obtained from the patient's legal next-of-kin...
Consent by Telephone...When a patient lacks medical decision capacity making and the next-of-kin not physically present...may be contacted by telephone, verbal consent may be obtained...a witness is required...when telephone consent is obtained...at least one other person witnessing the conversation shall sign the consent form...

1. MR # 1 was admitted to the hospital on 10/27/16 with diagnoses including Sepsis due to unspecified organism, Nausea and Vomiting, Acute Renal Failure, Paroxysmal Atrial Fibrillation with rapid ventricular response (RVR) and Hypertension.

Record review was performed on 10/23/17 with Employee Identifier (EI) # 1, Registered Nurse, Telemetry Director assisting.

Medical record documentation included 2 procedures performed while in the medical intensive care unit (MICU), cystoscopic placement of a foley catheter on 12/2/16 and bronchoscopy on 12/3/16. There was a consent for bronchoscopy but no consent for the cystoscopic placement of a foley catheter.

The 12/2/16 urological consult documentation revealed a history of nodular prostate disease and prior unsuccessful catheterization attempts by nursing staff.

Further review of the urology consult documentation revealed the patient suffered cardiopulmonary arrest on 12/2/16, was intubated/sedated and no family at bedside. The urologist documented an unsuccessful attempt to pass an angle tip guide wire through the urethra into the bladder resulted in a false passage in the posterior urethra and "...at this point I decided to proceed with cystoscopy placement of a foley catheter..."

The urologist documentation revealed successful placement of foley catheter under cystoscopic guidance.

The medical record did not include consent documentation for placement of foley catheter under cystoscopic guidance. There was no documentation of an attempt to contact the next of kin or two medical staff signatures indicting the risk to health with delay of the procedure.

In an interview conducted on 10/24/17 at 3:10 PM, EI # 1, confirmed there was no consent documentation for cystoscopic placement of the foley catheter.

In a phone interview conducted on 10/24/17 at 3:21 PM, the MICU, Nurse Manager, EI # 5 reported the normal process is for consent to be completed. No consent documentation was found.

During the survey attempts to interview the consulting urologist were unsuccessful. An interview was conducted on 10/26/17 at 10:10 AM with Physician Identifier (PI) # 3, Medical Doctor, Physician Advisor. PI # 3 reviewed the urology consult documentation and confirmed the foley catheter was placed using the fiberoptic light as a guide from a cystoscope.

The facility staff failed to follow the hospital policy for informed consent.

Based on review of medical records (MR), policy and procedure and interviews with facility staff, it was determined the staff failed to:

1) notify the Physician or Certified Registered Nurse Practitioner (CRNP) with results of abnormal/critical laboratory results.

2) complete and document accurate patient intake and output results in the medical record.

This affected MR # 1, 1 of 10 records reviewed and had the potential to negatively affect all patients treated at the facility.

Findings include:

Policy Title: Critical Results Notification
Approved Date: 04/14/2017

Purpose: To ensure physician notification when critical results indicate the need for prompt attention to the patient.

Policy: Mobile Infirmary has established a sixty minute turnaround time for contacting a physician or licensed independent practitioner regarding a critical result.

...Procedure: Any critical results should be called to the physician or LIP (Licensed Independent Practitioner) by the testing department following the release of the result to the person reporting the result.

If the testing department does not notify the physician/LIP within 30 minutes, the manager, director of nursing supervisor should be notified. The nurse will document the date, time, critical result and the manager, director or House Supervisor he/she notified.

After critical result notification is made, documentation is made in the patient's medical record in doc (document) flow sheets under provider notification with the date, time, who was notified, what results were given and any orders received. If no new orders are received, note that in the medical record also.

Definitions:
A critical result is a test that is beyond the normal variation and suggests a serious medical condition that may require immediate medical attention for the patient.
Read Back: The individual accepting the critical result must document the result and then read back the critical result, in its entirety, to the reporter at the time the result is given.

1. MR # 1 was admitted to the hospital surgical intensive care unit on 10/27/16 with diagnoses including Sepsis due to unspecified organism, Nausea and Vomiting, Acute Renal Failure, Paroxysmal Atrial Fibrillation with rapid ventricular response and Hypertension.

Record review revealed a physician's order dated 11/27/16 at 2:10 PM for routine intake and output every shift and at 2:30 PM, 0.9 % NaCl (sodium chloride or normal saline-NS) solution 100 milliliter/hour (ml/hr) per intravenous (IV) route was ordered. The patient was NPO, nothing by mouth.

Review of the nurse documentation dated 11/27/16 from 7:01 AM to 7:00 PM revealed no urine output amount. The documentation area was blank. Staff failed to document the amount of urine output or the absence of urine output.

On 11/28/16 from 7:00 PM to 11/29/16 at 7:00 AM, there was no documentation of the amount of I.V. fluid intake.

On 11/29/16 from 7:00 AM to 7:00 PM, there was no documentation of the amount of I.V. fluid intake.

On 11/30/16 from 7:00 AM to 12/1/16 at 7:00 AM, there was no documentation of the amount of urine output.

On 12/1/16 from 7:00 AM to 7:00 PM, staff failed to document I.V. fluid intake amount. The I.V. fluids were discontinued on 12/1/16 at 12:53 PM.

Medical record review revealed the following nurse assessment documentation while on 3 Northeast (3 NE) medical surgical unit on 12/1/16:

At 3:44 PM, BP (blood pressure) 139/78, pulse 110, Temperature (T) 99.3, respiration rate (RR) 22 per minute, and SPO2 (saturated oxygen level) 94 %.

At 7:15 PM, BP 139/78, pulse 115, RR 26 minute, and SPO2 92 %. Nurse assessment documentation by Employee Identifier (EI) # 2, Registered Nurse (RN), 3 NE revealed respirations were dyspneic with exertion, tachypnea (rapid breathing), unlabored (breathing), diminished breath sounds with rhonchi to right upper lobe. There was no documentation the RN contacted the physician or CRNP of the tachypnea and rhonchi.

At 11:58 PM, EI # 2 documented the patient's RR had increased to 40 times a minute. EI # 2 documented physician notification of the on call Pulmonologist, Physician Identifier (PI) # 1. On 12/2/16 at 12:15 AM, PI # 2, the CRNP on call for the pulmonology group, ordered STAT (perform immediately) chest x-ray and ABG's (arterial blood gases). Orders were written by EI # 2 on 12/2/16 at 12:18 AM for STAT ABG's and a chest xray.

The chest x ray was completed on 12/2/16 at 12:45 AM. The x ray report findings, compared to the 12/1/16 result revealed interstitial and airspace disease seen, right (side) greater than left, slightly decreased since prior study. Impression slightly decreased cardiac failure/volume overload.

The STAT ABG's were performed by the respiratory technician on 12/2/16 at 2:11 AM, resulted at 2:11 AM, which was 1 hour and 53 minutes after ordered STAT. The results revealed the following abnormal:
pH (acid base balance) 7.5 (H) [high], reference normal range 7.35-7.45
pCO2 (carbon dioxide level) 30.60 (L) [low], reference normal range 35.00-45.00
pO2 (saturated oxygen) 49.00 (LL) [low low], reference normal range 80.00-105.00
% O2 Hgb (percentage oxygenated hemoglobin) 88.00 (L)

There was no documentation the STAT ABG's and chest xray results were reported by EI # 2 or the testing department staff to the CRNP or physician.

Record review revealed on 12/2/16 at 10:32 AM the patient experienced respiratory failure, lost pulse and respirations, a code blue was called. The patient required endotracheal intubation, was placed on a respirator for breathing assistance and transferred to the ICU (intensive care unit).

In an interview on 10/25/17 at 10:34 AM, EI # 2, RN, 3 NE reported she/he had no recall of the events and confirmed there was no documentation the CRNP or physician was notified of the abnormal STAT ABG's and chest xray results.

An interview was conducted on 10/25/17 at 1:00 PM with PI # 2, the CRNP who ordered the STAT tests. PI # 2 reported she/he had no recollection of the case and confirmed there was no documentation follow up orders were given for the abnormal STAT ABG's and chest xray. The surveyor asked PI # 2 what would have been done for MR # 1 had the results been called? PI # 2 reported " the patient was hypoxic and orders would have been given to transfer the the unit (ICU)."

Based on medical record (MR) review, review of policies and procedures and staff interviews, it was determined the respiratory therapy staff failed to:

1) perform and document pre and post patient assessment findings per the hospital policy and procedure.

2) perform and document the administration of all respiratory treatments as ordered by the physician.

3) perform STAT (immediate) arterial blood gas (ABG) test per hospital policy.

This affected MR # 1, one of ten sampled patients and had the potential to affect all patients receiving respiratory (pulmonary) care services at the hospital.

Findings include:

Policy Title: Aerosol Therapy via Hand-held Nebulizer (HHN)
Approval Date: 5/16

Policy:
Hand-held small volume nebulizers are utilized to administer aerosols to the upper and lower airways...
Procedure:
1. Verify physician's order.
5. Patient shall be monitored before and after therapy:
a. heart rate
b. respiratory rate
c. auscultation
d. patient's subjective response to therapy
e. physiological (clinical) response to therapy
f. sputum production: quantity, color, and consistency...
Documentation of therapy...on the EMR (electronic medical record-RT (respiratory therapy) Assess and Treat flowsheet...

Policy Title: Metered Dose Inhaler
Approval Date: 6/16
...Procedure:
...5. Monitor patient before, during, and after therapy:
a. heart rate
b. respiratory rate
c. auscultation
d. patient's subjective response to therapy
e. physiological (clinical) response to therapy
f. sputum production: quantity, color, and consistency...
Documentation of therapy shall be provided on the Pulmonary Service therapy flowsheet in the medical record and include:
8). Effectiveness of therapy: subjective, objective , and clinical...

Policy Title: Request Response Time
Approval Date: 5/16

Purpose: To provide a guideline for Pulmonary Service Department personnel for target response times to physician requests.

Policy: Personnel of the Pulmonary Service Department should respond to physician requests at the appropriate time, based on the priority (routine vs.[versus] vs. STAT). Appropriate response times are...
STAT: target response time is within 10 minutes. A STAT request shall take priority over other types of request.
...If a delay in responding to a request is anticipated, the therapist or technician should contact the Team Leader of the shift for appropriate direction...

1. MR # 1 was admitted to the hospital on 11/27/16 with diagnoses including including Sepsis, due to unspecified organism, Nausea and Vomiting, Acute Renal Failure and Paroxysmal Atrial Fibrillation with rapid ventricular response and Hypertension.

Record review revealed a multi-Disciplinary Problem care plan with problem identified "Patient requires aerosol/inhaler procedure, start 11/30/16. The goal, to promote bronchodialation/decrease inflammation/deliver medications.

Further review revealed physician orders dated 11/30/16, start at 11:00 AM for Tiotopium (Spiriva) inhalation capsule 18 mcg (microgram) daily and Ipratropium-Albuterol (DUO-NEB) 0.5 milligram (mg)-3 mg/3 ml (milliliter) nebulizer solution every 4 hours, start 11/30/16 at 11:00 AM.

Review of the Medication Administration Record (MAR) documentation revealed the Spiriva ordered for 11/30/16 for 11:00 AM administration was not given until 5:08 PM on 11/30/16. The Respiratory Therapist (RT) documented "RT not aware of the new tx (treatment)."

There was no documentation the 11/30/16 11:00 AM dose of DUO-NEB and the 3:00 PM dose was administered as ordered. The RT documented DUO-NEB administered at 5:08 PM and again at 7:07 PM, which was 2 hours 59 minutes after the last dose, not every 4 hours. There was no documentation DUO-NEB ordered for 11:00 PM on 11/30/16 was administered.

Review of the 12/1/16 MAR documentation revealed the 3:00 AM dose of DUO-NEB was administered at 4:20 AM, which was 1 hour and 20 minutes late. There was no documentation the 12/1/16 7:00 AM DUO-NEB dose was administered.

There was no documentation the 12/1/16 daily Spiriva daily dose was administered, respiratory staff documented at 10:06 AM, "not given". On 12/1/16 at 3:00 PM, staff documented DUO-NEB "not given".

On 12/1/16 at 11:58 PM, Employee Identifier (EI) # 2, Registered Nurse (RN), documented patient's respiratory rate had increased to 40 a minute. On 12/2/16 at 12:18 AM, the medical record revealed a physician's order was written for STAT ABG's (arterial blood gases) and chest xray.

The record documentation revealed STAT ABG's were obtained by the RT (respiratory technician) on 12/2/16 at 2:11 AM and resulted at 2:11 AM, which was 1 hour 53 minutes after STAT ABG's were ordered. The STAT results revealed the following abnormal findings:
pH (acid base balance 7.5 (H) [high], reference normal range 7.35-7.45
pCO2 (partial pressure of carbon dioxide) 30.60 (L) [low], reference normal range 35.00-45.00
pO2 (partial pressure of oxygen) 49.00 (LL) [low low], reference normal range 80.00-105.00
% O2 Hgb (oxygenated hemoglobin proportion) 88.00 (L)

There was no documentation the abnormal ABG's were reported to the RN, physician or ordering practitioner by the respiratory department staff.

There was no record documentation the reason STAT ABG's were not performed within the respiratory staff target response time of 10 minutes and no documentation the department Team Leader was notified of the delay.

Review of the respiratory therapy pre and post patient assessments for aerosol and metered dose treatments failed to include documentation of post treatment breath sounds and pulse rate on 12/1/16 at 8:59 PM.

There were no pre treatment breath sounds documented on 12/2/16 at 12:40 PM.

There were no post treatment breath sounds documented on 12/5/16 at 2:54 AM, 7:29 PM and 11:40 PM.

There were no post treatment breath sounds documented on 12/6/16 at 7:30 PM.

There were no post treatment breath sounds documented on 12/7/16 at 3:35 AM, 7:40 AM and 11:22 AM. At 11:22 AM on 12/7/16, there were no pre and post pulse and respirations documented.

In an interview on 10/25/17 at 11:30 AM, EI # 3, Respiratory Therapy Manager, confirmed the above findings and was unable to provide additional documentation regarding the missed, late treatments and delayed STAT ABG response time.

In an interview on 10/26/17 at 9:52 AM, EI # 4, Certified Respiratory Therapist reported there were times respiratory treatments and procedures have not been completed as ordered due to "time constraints". EI # 4 reported she/he was not sure of the STAT response time and would find out.