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1100 BLYTHE BOULEVARD

CHARLOTTE, NC null

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on hospital policy and procedure review, medical record review, manufacturer's recommendations, hospital Guidelines for Disinfection and Sterilization in Healthcare Facilities, observations, and staff interviews, the hospital's Infection Control program failed to monitor and provide oversight of infection control practices to ensure blood glucose meters were cleaned between patients to prevent availability and use of contaminated equipment for 3 of 6 meters; failed to label control solutions for 8 of 12 samples audited; failed to ensure multi-dose vials did not enter the patient treatment area for 1 of 1 multidose vial medication administration observations; failed to ensure therapy table mats were cleaned between 4 of 5 patients; and failed to ensure Fiberoptic Endoscope Evaluation of Swallow (FEES) scope was hung vertically following high-level disinfection per manufacturer's instructions for use for 1 of 1 scopes.

The findings include:

1. Review on 06/08/2016 of the hospital's "Blood Glucose Monitoring" policy, reviewed 04/2016 revealed, "...The Centers for Disease Control and Prevention recommend that, whenever possible, patients shouldn't share blood glucose meters. If you must share a device, you should clean and disinfect it after every use...to prevent carryover of blood and infectious agents ...Contaminated blood glucose monitoring equipment increases the risk of infection by such bloodborne pathogens as hepatitis B, hepatitis C, and human immunodeficiency virus."

Review on 06/08/2016 of the hospital's "Cleaning noncritical equipment and device (Nursing)" policy, revised 02/2014 revealed, "The purpose of this policy is to clarify procedures for cleaning of equipment that remains in the department ...Item ...Accucheck machine ...Frequency ...Between patients and PRN visibly soiled ..."

Observation on 06/08/2016 at 1515 during tour of Unit #1 revealed four (4) blood glucose meters in total, two (2) docked at nursing station number one (1) and two (2) docked in nursing station number two (2). Observation of monitors docked at nursing station number one (1) revealed monitor number one (1) had a smeared brownish-red substance located on the back of the meter. Observation of monitors docked in nursing station two (2) revealed monitor numbers three (3) and four (4) had two smeared spots of a brownish-red substance on each meter.

Observations during the survey revealed eight (8) control solutions (used to ensure the meter and test strips are working properly) without labels. Observation revealed there was no available documentation for review that indicated the date the control solutions were opened or the expiration date.

Interview on 06/08/2016 at 1515 with the Staff #2 during the unit tour revealed the brownish-red substance on the blood glucose monitors, "Looks like blood to me." Interview revealed blood glucose monitors should be cleaned and disinfected after each use per policy. Interview further revealed nursing staff should label control solutions with the date each was opened and an expiration date of 90 days after initial use. Interview confirmed observation findings during unit tour.

2. Review on 06/08/2016 of the hospital's "Multi-Dose Vial Entry" policy, revised 08/2014 revealed, "...PROCEDURE: ...3. Multidose vials should be stored and manipulated in the identified common medication preparation area in the specific unit or patient care area ..."

Observation on 06/08/2016 at 1240 revealed Staff #1 entered the patient treatment area with a pre-used, Multidose vial of Humalog (insulin) on the portable work station on wheels (WOW). Observation revealed the vial had multiple labels attached that read, "Insulin Lispro (Humalog) 100 UNITS/ML (milliliter) HIGH RISK MEDICATION." Observation revealed the Multidose vial was placed back in the medication room for future use.

Interview on 06/08/2016 at 1255 with Staff #4 revealed Multidose vials are not routinely taken into the patient treatment area. Interview revealed Multidose vials are housed in the Medication Room where medication preparation should take place. Interview revealed once the required dose of medication is drawn from a Multidose vial, a label is attached to the syringe with the medication name and dose. Interview revealed the insulin was not prepared per policy because this surveyor was observing the medication administration process and the intent was to help facilitate the observation. Interview revealed the Multidose vial should not have been taken into the patient treatment area. Interview confirmed findings of the medication pass observations.

3. Review on 06/08/2016 of the hospital's "Cleaning noncritical equipment and devices (Therapies)" policy, revised 07/2015 revealed, "The purpose of this policy is to clarify procedures for cleaning of equipment used by the Therapy Department ...Item ...Mats/Therapy tables ...Frequency* When equipment is used for patients on Contact/Contact Enteric precautions, clean before use on another patient ...Daily and PRN (as needed) visibly soiled ...Comment ...therapy tables will be disinfected after use by patient on Contact or Enteric precautions ... "

Observation on 06/07/2016 at 1350 of the hospital's Physical Therapy/Rehabilitation (PTR) department revealed 11 therapy tables with mats. Observation revealed five (5) tables (#s 2-5) were actively being used for therapy. Observation revealed four (4) therapy table mats were not disinfected between patients.

Interview on 06/07/2016 at 1350 with Staff #5 during the department tour revealed therapy table mats are cleaned between patients if he or she is on contact precautions. Interview revealed the PTR staff use their judgment to determine whether the table needs to be cleaned or not, "So if they see it's dirty, they will clean it." Interview revealed the department, "Has a high volume of patients and do not consider patients with intact skin an infection risk." Interview revealed, "Cleaning takes away from our time with the patient. If we were to clean them (therapy tables) between each patient, we won't be able to get all the scheduled therapy in." Interview revealed risk for infection or transmission of disease were not a concern for patients with intact skin. Interview confirmed findings of the observations during the PTR department tour.

Concurrent interviews on 06/08/2016 at 0850 Staff #6 and #7 revealed the hospital Infection Prevention rounds are conducted on the patient care units twice weekly in addition to an environment of care round that is conducted on a weekly basis. Interview revealed Staff #6 does not conduct rounds of the PTR department. Interview revealed, "I should be making rounds in that area after what I saw yesterday during your tour." Interview revealed Staff #6 and #7 were not aware therapy table mats in the PTR were not disinfected after each patient. Interview revealed PTR staff should disinfect the therapy tables between patients. Interview confirmed findings of the PTR department observations.

4. Review on 06/08/2016 of the "Pentax Naso-Pharyngo-Laryngoscopes" manufacturer's recommendations revealed, "...4.2. Post Reprocessing ...5) The endoscope should be hung in a clean, dry, well-ventilated storage cabinet at room temperature. The insertion tube and light guide cable should be hung and kept as straight as possible during storage. "

Review on 06/08/2016 of the hospital's, "Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008" revealed, "Disinfection of Healthcare Equipment ...Published recommendations for cleaning and disinfecting endoscopic equipment should be strictly followed. Unfortunately, audits have shown that personnel do not consistently adhere to guidelines on reprocessing and outbreaks of infection continue to occur ...Store: store the endoscope in a way that prevents recontamination and promotes drying (e.g., hung vertically)
... "

Closed record review on 06/08/2016 revealed a 52 year old female (Patient #11) was transferred to (named hospital) on 04/20/2016 following a prolonged hospitalization at (other hospital) stroke and subsequent mitral valve replacement (MVR: heart valve that allows blood flow between parts of the heart) on 03/24/2016. Review revealed the patient's diagnoses included: MRSA (Methicillin-resistant Staphylococcus Aureus: common infection resistant to many antibiotics), Endocarditis (enlarged heart) following MVR, Embolic (blood clot) stroke, Recurrent acute hypoxic respiratory failure (loss of oxygen), Pneumonitis (inflammation of the walls of the air sacs in the lung), Tracheostomy (cut in the windpipe to help with breathing) placement, and percutaneous endoscopic gastrostomy (PEG) tube placement (feeding tube). Review revealed Patient #11 had a history of MRSA (Methicillin-resistant Staphylococcus Aureus: bacteria) and Endocarditis CRE (Carbapenem-resistant Enterobacteriaceae: bacteria), and was placed on Contact Precautions (used to decrease risks of transmission of disease to others) on 04/20/2016. Review revealed a speech assessment was performed on 04/20/2016, including a Fiberoptic endoscopic examination of swallow (FEES: tube passed through the nose used to look at the voice box and esophagus) scope to assess her swallowing ability. Review revealed the patient was discharged 05/08/2016.

Observation on 06/07/2016 at 1100 of the hospital's Sterile Processing area revealed FEES scopes were stored in a locked box, inside a closed plastic tote. Observation revealed the FEES scopes were not "hung and kept as straight as possible during storage" per manufacturer's recommendations or hospital guidelines for disinfection.

Interview on 06/07/2016 at 1110 with Staff #8 revealed when a FEES scope is used, it is placed in a tote and transported to the processing area. Interview revealed the dirty tote is cleaned and disinfected with HB Quat (disinfecting spray) and the FEES scope is placed back into the clean tote. Interview revealed the FEES scopes did not have to be hung "because there are no lumens (measures amount of light)." Interview revealed historically, FEES scopes have not been stored vertically for that reason. Interview revealed scopes with lumens are hung vertically. Interview revealed manufacture recommendations are that, "The endoscope should be hung and kept as straight as possible during storage." Interview revealed the interpretation of the recommendations were for scopes with lumens, which would not include the FEES scope. Interview revealed the manufacture instructions for use were specified for "Naso-Pharynogo-Laryngoscopes, model #'s FNL-7RP3, FNL-10RP3, and FNL-15RP3." Interview revealed the FEES scope model number used at (named hospital) was "FNL-10RP3" and the recommendations were that the scope should be hung following cleaning. Interview revealed the manufactures instruction for use were misinterpreted. Interview confirmed findings of the FEES scope storage observation.

Interview on 06/09/2016 at 1430 with Staff #9 revealed one FEES scope is stored in the Physical Therapy Rehabilitation (PTR) department, in a locked box, inside a closed plastic tote. Interview revealed other FEES scopes are stored in the equipment processing area (EPA). Interview revealed when the dirty scope is taken to the (EPA), and another tote with a clean scope is obtained. Interview revealed the hospital has a total of five scopes available for use. Interview revealed a total of 10 FEES scopes were performed April 2016 to present. Interview revealed 5 of 9 patients scoped, one patient was scoped twice, were on Contact Precautions when the study was conducted. Interview confirmed findings of the FEES scope storage observation.

5. Review on 06/08/2016 of the "Pentax Naso-Pharyngo-Laryngoscopes" manufacturer's recommendations revealed, "...4.2. Post Reprocessing ...5) The endoscope should be hung in a clean, dry, well-ventilated storage cabinet at room temperature. The insertion tube and light guide cable should be hung and kept as straight as possible during storage. "

Review on 06/08/2016 of the hospital's, "Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008" revealed, "Disinfection of Healthcare Equipment ...Published recommendations for cleaning and disinfecting endoscopic equipment should be strictly followed. Unfortunately, audits have shown that personnel do not consistently adhere to guidelines on reprocessing and outbreaks of infection continue to occur ...Store: store the endoscope in a way that prevents recontamination and promotes drying (e.g., hung vertically)
... "

Closed record review revealed a 53 year old male (Patient #12) was transferred to (named hospital) on 03/24/2016 for continued treatment and stabilization following prolonged hospitalization at (other acute care hospital). Review revealed the patient's diagnoses included, Traumatic brain injury secondary to gunshot wound with L SDH (left subdural hematoma: blood clot of the brain) and hygroma (body of spinal fluid); Acute respiratory failure secondary to altered mental status/encephalopathy (deterioration of the brain) in the setting of sepsis (system-wide infection); Escherichia coli (bacteria) urinary tract infection; Methicillin-sensitive Staphylococcus aureus (MRSA) in the sputum; and Dysphagia (difficulty swallowing). Review revealed the patient was placed on Contact Precautions on 03/24/2016. Review revealed a speech assessment was performed on 03/25/2016, including a Fiberoptic endoscopic examination of swallow (FEES: tube passed through the nose used to look at the voice box and esophagus) to assess her swallowing ability. Review revealed the patient was discharged on 04/08/2016.

Observation on 06/07/2016 at 1100 of the hospital's Sterile Processing area revealed FEES scopes were stored in a locked box, inside a closed plastic tote. Observation revealed the FEES scopes were not "hung and kept as straight as possible during storage" per manufacturer's recommendations or hospital guidelines for disinfection.

Interview on 06/07/2016 at 1110 with Staff #8 revealed when a FEES scope is used, it is placed in a tote and transported to the processing area. Interview revealed the dirty tote is cleaned and disinfected with HB Quat (disinfecting spray) and the FEES scope is placed back into the clean tote. Interview revealed the FEES scopes did not have to be hung "because there are no lumens (measures amount of light)." Interview revealed historically, FEES scopes have not been stored vertically for that reason. Interview revealed scopes with lumens are hung vertically. Interview revealed manufacture recommendations are that, "The endoscope should be hung and kept as straight as possible during storage." Interview revealed the interpretation of the recommendations were for scopes with lumens, which would not include the FEES scope. Interview revealed the manufacture instructions for use were specified for "Naso-Pharynogo-Laryngoscopes, model #'s FNL-7RP3, FNL-10RP3, and FNL-15RP3." Interview revealed the FEES scope model number used at (named hospital) was "FNL-10RP3" and the recommendations were that the scope should be hung following cleaning. Interview revealed the manufactures instruction for use were misinterpreted. Interview confirmed findings of the FEES scope storage observation.

Interview on 06/09/2016 at 1430 with Staff #9 revealed one FEES scope is stored in the Physical Therapy Rehabilitation (PTR) department, in a locked box, inside a closed plastic tote. Interview revealed other FEES scopes are stored in the equipment processing area (EPA). Interview revealed when the dirty scope is taken to the (EPA), and another tote with a clean scope is obtained. Interview revealed the hospital has a total of five scopes available for use. Interview revealed a total of 10 FEES scopes were performed April 2016 to present. Interview revealed 5 of 9 patients (one patient was scoped twice) scoped were on Contact Precautions when the study was conducted. Interview confirmed findings of the FEES scope storage observation.

6. Review on 06/08/2016 of the "Pentax Naso-Pharyngo-Laryngoscopes" manufacturer's recommendations revealed, "...4.2. Post Reprocessing ...5) The endoscope should be hung in a clean, dry, well-ventilated storage cabinet at room temperature. The insertion tube and light guide cable should be hung and kept as straight as possible during storage. "

Review on 06/08/2016 of the hospital's, "Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008" revealed, "Disinfection of Healthcare Equipment ...Published recommendations for cleaning and disinfecting endoscopic equipment should be strictly followed. Unfortunately, audits have shown that personnel do not consistently adhere to guidelines on reprocessing and outbreaks of infection continue to occur ...Store: store the endoscope in a way that prevents recontamination and promotes drying (e.g., hung vertically)
... "
Closed record Review on 06/08/2016 of revealed a 49 year old male (Patient #13) was transferred to (named hospital) on 03/28/2016 following prolonged hospitalization at (other acute care hospital). Review revealed the patient's diagnoses included, "Debility secondary to septic shock from a urinary tract infection with culture growing pansensitive Escherichia coli (bacteria the is resistant to all antibiotics tested)," Vocal cord paralysis, and Dysphagia (difficulty swallowing). Review revealed Patient #13 was placed on Contact Precautions on 03/28/2016. Review revealed a speech assessment was performed on 03/29/2016, including a Fiberoptic endoscopic examination of swallow (FEES: tube passed through the nose used to look at the voice box and esophagus) scope to assess his swallowing ability. Review revealed the patient was discharged on 05/02/2016.
Observation on 06/07/2016 at 1100 of the hospital's Sterile Processing area revealed FEES scopes were stored in a locked box, inside a closed plastic tote. Observation revealed the FEES scopes were not "hung and kept as straight as possible during storage" per manufacturer's recommendations or hospital guidelines for disinfection.

Interview on 06/07/2016 at 1110 with Staff #8 revealed when a FEES scope is used, it is placed in a tote and transported to the processing area. Interview revealed the dirty tote is cleaned and disinfected with HB Quat (disinfecting spray) and the FEES scope is placed back into the clean tote. Interview revealed the FEES scopes did not have to be hung "because there are no lumens (measures amount of light)." Interview revealed historically, FEES scopes have not been stored vertically for that reason. Interview revealed scopes with lumens are hung vertically. Interview revealed manufacture recommendations are that, "The endoscope should be hung and kept as straight as possible during storage." Interview revealed the interpretation of the recommendations were for scopes with lumens, which would not include the FEES scope. Interview revealed the manufacture instructions for use were specified for "Naso-Pharynogo-Laryngoscopes, model #'s FNL-7RP3, FNL-10RP3, and FNL-15RP3." Interview revealed the FEES scope model number used at (named hospital) was "FNL-10RP3" and the recommendations were that the scope should be hung following cleaning. Interview revealed the manufactures instruction for use were misinterpreted. Interview confirmed findings of the FEES scope storage observation.

Interview on 06/09/2016 at 1430 with Staff #9 revealed one FEES scope is stored in the Physical Therapy Rehabilitation (PTR) department, in a locked box, inside a closed plastic tote. Interview revealed other FEES scopes are stored in the equipment processing area (EPA). Interview revealed when the dirty scope is taken to the (EPA), and another tote with a clean scope is obtained. Interview revealed the hospital has a total of five scopes available for use. Interview revealed a total of 10 FEES scopes were performed April 2016 to present. Interview revealed 5 of 9 patients (one patient was scoped twice) scoped were on Contact Precautions when the study was conducted. Interview confirmed findings of the FEES scope storage observation.

7. Review on 06/08/2016 of the "Pentax Naso-Pharyngo-Laryngoscopes" manufacturer's recommendations revealed, " ...4.2. Post Reprocessing ...5) The endoscope should be hung in a clean, dry, well-ventilated storage cabinet at room temperature. The insertion tube and light guide cable should be hung and kept as straight as possible during storage. "

Review on 06/08/2016 of the hospital's, "Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008" revealed, "Disinfection of Healthcare Equipment ...Published recommendations for cleaning and disinfecting endoscopic equipment should be strictly followed. Unfortunately, audits have shown that personnel do not consistently adhere to guidelines on reprocessing and outbreaks of infection continue to occur ...Store: store the endoscope in a way that prevents recontamination and promotes drying (e.g., hung vertically)
... "

Open record review on 06/08/2016 revealed a 25 year old, pregnant female (Patient #14) was transferred to (named hospital) on 04/20/2016 following a prolonged hospitalization at (other acute care hospital). Review revealed the patient's diagnoses included, Aneurism rupture, dysphagia (difficulty swallowing), and respiratory failure after tracheotomy (cut in wind pipe to help with breathing) placement. Review revealed Patient #14's urine was positive for Escherichia coli and she was placed on Contact Precautions on 03/28/2016. Review revealed a speech assessment was performed on 04/20/2016, including a Fiberoptic endoscopic examination of swallow (FEES: tube passed through the nose used to look at the voice box and esophagus) scope to assess her swallowing ability.
Observation on 06/07/2016 at 1100 of the hospital's Sterile Processing area revealed FEES scopes were stored in a locked box, inside a closed plastic tote. Observation revealed the FEES scopes were not "hung and kept as straight as possible during storage" per manufacturer's recommendations or hospital guidelines for disinfection.

Interview on 06/07/2016 at 1110 with Staff #8 revealed when a FEES scope is used, it is placed in a tote and transported to the processing area. Interview revealed the dirty tote is cleaned and disinfected with HB Quat (disinfecting spray) and the FEES scope is placed back into the clean tote. Interview revealed the FEES scopes did not have to be hung "because there are no lumens (measures amount of light)." Interview revealed historically, FEES scopes have not been stored vertically for that reason. Interview revealed scopes with lumens are hung vertically. Interview revealed manufacture recommendations are that, "The endoscope should be hung and kept as straight as possible during storage." Interview revealed the interpretation of the recommendations were for scopes with lumens, which would not include the FEES scope. Interview revealed the manufacture instructions for use were specified for "Naso-Pharynogo-Laryngoscopes, model #'s FNL-7RP3, FNL-10RP3, and FNL-15RP3." Interview revealed the FEES scope model number used at (named hospital) was "FNL-10RP3" and the recommendations were that the scope should be hung following cleaning. Interview revealed the manufactures instruction for use were misinterpreted. Interview confirmed findings of the FEES scope storage observation.

Interview on 06/09/2016 at 1430 with Staff #9 revealed one FEES scope is stored in the Physical Therapy Rehabilitation (PTR) department, in a locked box, inside a closed plastic tote. Interview revealed other FEES scopes are stored in the equipment processing area (EPA). Interview revealed when the dirty scope is taken to the (EPA), and another tote with a clean scope is obtained. Interview revealed the hospital has a total of five scopes available for use. Interview revealed a total of 10 FEES scopes were performed April 2016 to present. Interview revealed 5 of 9 patients (one patient was scoped twice) scoped were on Contact Precautions when the study was conducted. Interview confirmed findings of the FEES scope storage observation.

8. Review on 06/08/2016 of the "Pentax Naso-Pharyngo-Laryngoscopes" manufacturer's recommendations revealed, " ...4.2. Post Reprocessing ...5) The endoscope should be hung in a clean, dry, well-ventilated storage cabinet at room temperature. The insertion tube and light guide cable should be hung and kept as straight as possible during storage. "

Review on 06/08/2016 of the hospital's, "Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008" revealed, "Disinfection of Healthcare Equipment ...Published recommendations for cleaning and disinfecting endoscopic equipment should be strictly followed. Unfortunately, audits have shown that personnel do not consistently adhere to guidelines on reprocessing and outbreaks of infection continue to occur ...Store: store the endoscope in a way that prevents recontamination and promotes drying (e.g., hung vertically)
... "

Open record review on 06/08/2016 revealed a 44 year old male (Patient #15) was transferred to (named hospital) on 05/17/2016 following a traumatic brain injury. Review revealed the patient's diagnoses included, Traumatic brain injury with right subdural hematoma (accumulation of blood outside the brain); Status-post (S/P) Left skull fracture repair; S/P left fibula and tibia fracture repair; S/P Pelvis fracture repair; left rib fractures; and dysphagia (difficulty swallowing), among others. Review revealed a culture taken from his craniectomy on May 2nd was positive for Enterococcus (bacteria) and he was placed on Contact Precautions on 05/17/2016. Review revealed a speech assessment was performed on 05/17/2016, including Fiberoptic endoscopic examination of swallow (FEES: tube passed through the nose used to look at the voice box and esophagus) to assess her swallowing ability
Observation on 06/07/2016 at 1100 of the hospital's Sterile Processing area revealed FEES scopes were stored in a locked box, inside a closed plastic tote. Observation revealed the FEES scopes were not "hung and kept as straight as possible during storage" per manufacturer's recommendations or hospital guidelines for disinfection.

Interview on 06/07/2016 at 1110 with Staff #8 revealed when a FEES scope is used, it is placed in a tote and transported to the processing area. Interview revealed the dirty tote is cleaned and disinfected with HB Quat (disinfecting spray) and the FEES scope is placed back into the clean tote. Interview revealed the FEES scopes did not have to be hung "because there are no lumens (measures amount of light)." Interview revealed historically, FEES scopes have not been stored vertically for that reason. Interview revealed scopes with lumens are hung vertically. Interview revealed manufacture recommendations are that, "The endoscope should be hung and kept as straight as possible during storage." Interview revealed the interpretation of the recommendations were for scopes with lumens, which would not include the FEES scope. Interview revealed the manufacture instructions for use were specified for "Naso-Pharynogo-Laryngoscopes, model #'s FNL-7RP3, FNL-10RP3, and FNL-15RP3." Interview revealed the FEES scope model number used at (named hospital) was "FNL-10RP3" and the recommendations were that the scope should be hung following cleaning. Interview revealed the manufactures instruction for use were misinterpreted. Interview confirmed findings of the FEES scope storage observation.

Interview on 06/09/2016 at 1430 with Staff #9 revealed one FEES scope is stored in the Physical Therapy Rehabilitation (PTR) department, in a locked box, inside a closed plastic tote. Interview revealed other FEES scopes are stored in the equipment processing area (EPA). Interview revealed when the dirty scope is taken to the (EPA), and another tote with a clean scope is obtained. Interview revealed the hospital has a total of five scopes available for use. Interview revealed a total of 10 FEES scopes were performed April 2016 to present. Interview revealed 5 of 9 patients (one patient was scoped twice) scoped were on Contact Precautions when the study was conducted. Interview confirmed findings of the FEES scope storage observation.

9. Review on 06/08/2016 of the "Pentax Naso-Pharyngo-Laryngoscopes" manufacturer's recommendations revealed, " ...4.2. Post Reprocessing ...5) The endoscope should be hung in a clean, dry, well-ventilated storage cabinet at room temperature. The insertion tube and light guide cable should be hung and kept as straight as possible during storage. "

Review on 06/08/2016 of the hospital's, "Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008" revealed, "Disinfection of Healthcare Equipment ...Published recommendations for cleaning and disinfecting endoscopic equipment should be strictly followed. Unfortunately, audits have shown that personnel do not consistently adhere to guidelines on reprocessing and outbreaks of infection continue to occur ...Store: store the endoscope in a way that prevents recontamination and promotes drying (e.g., hung vertically)
... "

Open medical record review on 06/08/2016 revealed a 63 year old female (Patient #16) was transferred to (named hospital) on 05/07/2016 following a prolonged hospitalization at (other acute care hospital) for multiple acute infarcts (blockage of oxygen to the brain) and an ejection fraction (EF) (amount of blood that leaves the heart when it pumps) of 55-60% (Reference range 100%). Review revealed the patient's diagnoses included, Left hemiparesis (paralysis), Dysmetria (lack of coordination), Dysdiadochokinesia (inability to perform rapid, repetitive movements). Review revealed a speech assessment was performed on 05/09/2016, including a Fiberoptic endoscopic examination of swallow (FEES: tube passed through the nose used to look at the voice box and esophagus) to assess her swallowing ability.

Observation on 06/07/2016 at 1100 of the hospital's Sterile Processing area revealed FEES scopes were stored in a locked box, inside a closed plastic tote. Observation revealed the FEES scopes were not "hung and kept as straight as possible during storage" per manufacturer's recommendations or hospital guidelines for disinfection.

Interview on 06/07/2016 at 1110 with Staff #8 revealed when a FEES scope is used, it is placed in a tote and transported to the processing area. Interview revealed the dirty tote is cleaned and disinfected with HB Quat (disinfecting spray) and the FEES scope is placed back into the clean tote. Interview revealed the FEES scopes did not have to be hung "because there are no lumens (measures amount of light)." Interview revealed historically, FEES scopes have not been stored vertically for that reason. Interview revealed scopes with lumens are hung vertically. Interview revealed manufacture recommendations are that, "The endoscope should be hung and kept as straight as possible during storage." Interview revealed the interpretation of the recommendations were for scopes with lumens, which would not include the FEES scope. Interview revealed the manufacture instructions for use were specified for "Naso-Pharynogo-Laryngoscopes, model #'s FNL-7RP3, FNL-10RP3, and FNL-15RP3." Interview revealed the FEES scope model number used at (named hospital) was "FNL-10RP3" and the recommendations were that the scope should be hung following cleaning. Interview revealed the manufactures instruction for use were misinterpreted. Interview confirmed findings of the FEES scope storage observation.

Interview on 06/09/2016 at 1430 with Staff #9 revealed one FEES scope is stored in the Physical Therapy Rehabilitation (PTR) department, in a locked box, inside a closed plastic tote. Interview revealed other FEES scopes are stored in the equipment processing area (EPA). Interview revealed when the dirty scope is taken to the (EPA), and another tote with a clean scope is obtained. Interview revealed the hospital has a total of five scopes available for use. Interview revealed a total of 10 FEES scopes were performed April 2016 to present. Interview revealed 5 of 9 patients (one patient was scoped twice) scoped were on Contact Precautions when the study was conducted. Interview confirmed findings of the FEES scope storage observation.

10. Review on 06/08/2016 of the "Pentax Naso-Pharyngo-Laryngoscopes" manufacturer's recommendations revealed, " ...4.2. Post Reprocessing ...5) The endoscope should be hung in a clean, dry, well-ventilated sto