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Based on policy review, record review, observation and interview, the Governing Body failed to assume responsibility and provide oversight of the hospital's Quality Assessment and Performance Improvement Program, Pharmaceutical Services and Infection Control Program.

The findings included:

1. The Governing Body failed to ensure the Chief Executive Officer assumed responsibility and appropriately managed the Quality Assessment and Performance Improvement Program, Pharmaceutical Services and Infection Control Program.
Refer to A 0057

2. The Governing Body failed to ensure the Quality Assessment and Performance Improvement program reflected all the hospital's services, and tracked, trended and analyzed data to improve health outcomes and the reduction of incidents.
Refer to A 0263

3. The Governing Body failed to ensure the provision of pharmaceutical services by promoting a safe medication use process.
Refer to A 0490

4. The Governing Body failed to ensure the hospital developed, implemented and maintained an active hospital - wide Infection Control Program for the prevention and control of infections.
Refer to A 0747

Based on policy review, record review and interview, the Chief Executive Officer (CEO) failed to assume responsibility and appropriately manage the Quality Assessment and Performance Improvement Program, Pharmaceutical Services and Infection Control Program.

The findings included:

1. Review of the hospital's "Quality and Safety Plan" revealed, "...The Quality Council's members include the Chief Executive Officer (CEO)...The Quality Council is responsible for the establishment of Performance and Process Improvement activities based on input from internal and external sources...The Quality and Safety Committee is under the direction of the Quality Council. The committee members include the CEO...The Quality and Safety Committee is responsible for reviewing the Performance Improvement activities of the facility..."

2. Review of the Facility - wide Environment of Care/Safety Indicators dated 2011 - 2012 revealed, "...Hospital Acquired Conditions (HACS) Pressure Ulcers...Sept. [September] 2012 (1), Nov. [November] 2012 (2), Dec. [December] 2012 (1)..." There was no documentation of a threshold/goal, analysis of the data or action plan developed to prevent the development of hospital acquired pressure ulcers.

Record review of the Environment of Care meeting minutes dated 9/12/12, 11/14/12, 1/9/13 and the Performance Improvement/Quality Council meeting minutes dated 9/20/12, 10/19/12, 11/18/12, 12/19/12, 1/17/13 revealed no documentation the Hospital Acquired Conditions (HACS) Pressure Ulcers had been analyzed or action plans developed for the prevention of hospital acquired pressure ulcers.

There was no documentation the CEO had provided input to ensure action plans were developed for the hospital acquired pressure ulcers.

During an interview in the board room on 5/22/13 at 11:10 AM, the Director of Nursing (DON) was questioned about the HACS of Pressure Ulcers and stated, "...There is no analysis of data or action plan...just numbers acquired...having one decubitus is one too many..."

3. Observations in the surgery department on 5/20/13 and 5/21/13 revealed staff performing disinfection of scopes and surgical instruments and were not following manufacturer's guidelines of the proper dilution amounts to ensure efficacy of the disinfecting products.
Refer to A 0749

Observations in the surgery department on 5/20/13 revealed staff performing Flash sterilization on a routine basis when Flash sterilization was only to be used in an emergency.
Refer to A 0951 and A 0756

Record review of the Environment of Care meeting minutes dated 9/12/12, 11/14/12, 1/9/13, Performance Improvement/Quality Council meeting minutes dated 9/20/12, 10/19/12, 11/18/12, 12/19/12, 1/17/13 and Facility - wide Environment of Care/Safety Indicators dated 2011 - 2012 revealed no documentation of disinfection and sterilization procedures being monitored or reported.

There was no documentation the CEO had provided input to ensure the oversight of the disinfection and sterilization processes.

During an interview in the board room on 5/22/13 at 11:10 AM, the Director of Nursing was asked about disinfection and sterilization procedures being monitored or reported to the Performance Improvement committee. She stated, "...No, surgery disinfection and sterilization procedures are not mentioned in the quality council minutes..."

4. Observation in the surgery department on 5/20/13 revealed medications were not kept in a secure area and were not locked in the anesthesia cart in Operating Room (OR) #3, the medication cart stored in the hallway outside the OR suites and the anesthesia cart in the Endoscope room.
Refer to A 0502

Observation in OR #3 on 5/20/13 revealed the anesthesia cart in OR #3 contained Schedule II drugs that were opened and unsecured.
Refer to A 0503

During an interview in OR #3 on 5/20/13 at 11:55 PM, the Surgery Department Unit Manager confirmed the unlocked, unattended anesthesia cart and the Morphine vials in the top drawer of the cart. The Surgery Department Unit Manager stated, "...Yes, the cart is open and unattended...There are two vials of Morphine..."

5. Observation in OR #3, Annex and Telemetry Care Unit (TLC) on 5/20/13 and the Endoscope room on 5/21/13 revealed medications were opened, not dated, labeled and stored properly.
Refer to A 0505

Observation in OR #3 and the Endoscope room on 5/20/13 and 5/21/13 revealed medication safety practices were not being followed in all anesthetizing areas.
Refer to A 1002

During an interview in the surgery department hallway on 5/20/13 at 2:00 PM, the Certified Registered Nurse Anesthetist (CRNA) confirmed the unlocked unattended anesthesia cart in OR #3 suite. The CRNA confirmed the multi dose vials of medications were opened with no labeled dates of expiration.

During an interview in the Endoscope Room on 5/21/13 at 2:10 PM, the CRNA shook his head no and stated, "...That is not good, those syringes [Diprivan]...that [Neosynephrine] are not suppose to be in there...the CRNA working this room is gone for the day...this should have been cleaned up..."

6. Record review of OR #1 and 3's "Humidity and Temperature Monitoring Log" revealed, April and May humidity readings were above 60%.
Refer to A 0726

There was no documentation of input from the CEO to ensure the humidity levels were within acceptable limits in the ORs.

During an interview in the Autoclave #1 room on 5/20/13 at 12:00 PM, the Surgery Department unit manager stated, "...We do not have a current policy for measuring humidity and temperature in the OR..."

During an interview in the Autoclave #1 room on 5/20/13 at 12:00 PM, Staff #3 was asked what was the process if the humidity or temperature is out of range. Staff #3 stated, "...If not in range I notify maintenance and that is all I do..."

7. Observation in OR #1, 2 and 3 on 5/20/13 at 11:30 AM revealed an unsanitary environment of dust, dirt and debris.
Refer to A 0749

There was no documentation the CEO had monitored the environment in the OR suites.

During an interview in OR #1 on 5/20/13 at 11:30 AM, The Surgery Department unit manager confirmed all the findings in OR #1. She stated, "...Yes, we use this room for surgery...that dust bunny has hair in it...Yes, I see all the dust...that white chalky substance in the floor is from where they patched the ceiling because we had a leak...I don't know how long ago that leak was..."

During an interview in the board room on 5/21/13 at 1:51 PM, the Director of Nursing was asked when are the OR suites to be cleaned. She stated, "...I know after each case they are supposed to clean..."

8. Observation in the Annex dirty utility room and the TLC dirty utility room on 5/21/13 at 9:20 AM, revealed 2 red Biohazard barrels stacked on top of each other. The top barrel's lid was unsecured and red bags were exposed.
Refer to A 0749

During an interview in the Annex dirty utility room on 5/21/13 at 9:20 AM, the Annex unit manager was asked about the Biohazard barrels being stacked on top of each other and the lid unsecured on the top barrel. She stated, "...Yeah, being stacked is very tall...Yes, the top barrel could tip off, I have not thought of that...It could tip over and the contents spill..."

Based on policy review, record review, observation and interview, the hospital failed to develop, implement and maintain an effective Quality Assessment and Performance Improvement Program to include analyzing, tracking, monitoring, developing action plans and evaluating those plans for Hospital Acquired Conditions (HACS) of Pressure Ulcers, and for disinfection and sterilization procedures on a routine basis in the surgery department.

The findings included:

1. The hospital failed to ensure the development of an active hospital - wide performance improvement program that analyzed and tracked quality indicators related to Hospital Acquired Conditions (HACS) of Pressure Ulcers, and for disinfection and sterilization procedures on a routine basis in the surgery department.
Refer to A 0273

2. The hospital failed to develop and implement action plans for Hospital Acquired Conditions (HACS) Pressure Ulcers and measure its success.
Refer to A 0283

3. The governing body failed to provide oversight of the Quality Assessment and Performance Improvement Program for patient safety and the reduction of Hospital Acquired Conditions (HACS) of Pressure Ulcers and monitor the effectiveness and safety of disinfection and sterilization procedures on a routine basis in the surgery department.
Refer to A 0309

Based on policy review, record review and interview, the hospital failed to develop an active hospital - wide performance improvement program which analyzed and tracked quality indicators related to Hospital Acquired Conditions (HACS) of Pressure Ulcers, and monitor disinfection and sterilization procedures in the surgery department.

The findings included:

1. Review of the hospital's "Quality and Safety Plan" revealed, "...Performance indicators are set, monitored, and reported monthly as a means to reach goals set by the organization. Action plans address how to accomplish goals. Corrective actions are expected when goals have not been met..."

2. Review of the Environment of Care meeting minutes dated 9/12/12, 11/14/12, 1/9/13, Performance Improvement/Quality Council meeting minutes dated 9/20/12, 10/19/12, 11/18/12, 12/19/12, 1/17/13 and the Facility - wide Environment of Care/Safety Indicators dated 2011 - 2012 revealed no documentation of disinfection and sterilization procedures being monitored or reported.

During an interview in the board room on 5/22/13 at 11:10 AM, the Director of Nursing was asked about disinfection and sterilization procedures being monitored or reported in Performance Improvement. She stated, "...No, surgery disinfection and sterilization procedures are not mentioned in the quality council minutes..."

3. Review of the Facility - wide Environment of Care/Safety Indicators dated 2011 - 2012 revealed, "...Hospital Acquired Conditions Pressure Ulcers...Sept. 2012 (1), Nov. 2012 (2), Dec. 2012 (1)..." There was no documentation of threshold/goal, analysis of the data or action plan developed for the prevention of HACS Pressure Ulcers.

Review of the Environment of Care meeting minutes dated 9/12/12, 11/14/12, 1/9/13 and Performance Improvement/Quality Council meeting minutes dated 9/20/12, 10/19/12, 11/18/12, 12/19/12, 1/17/13 revealed no documentation of Hospital Acquired Conditions (HAC) Pressure Ulcers being analyzed.

During an interview on 5/22/13 at 11:10 AM the DON was questioned about the HACS of Pressure Ulcers and stated, "...There is no analysis of data or action plan...just numbers acquired...having one decubitus is one too many..."

Based on policy review, record review and interview, the hospital failed to develop and implement action plans for Hospital Acquired Conditions (HACS) Pressure Ulcers and measure its success.

The findings included:

1. Review of the hospital's "Quality and Safety Plan" revealed, "...Performance indicators are set, monitored, and reported monthly as a means to reach goals set by the organization. Action plans address how to accomplish goals. Corrective actions are expected when goals have not been met..."

2. Review of the Facility - wide Environment of Care/Safety Indicators dated 2011 - 2012 revealed, "...Hospital Acquired Conditions (HACS) Pressure Ulcers...Sept. 2012 (1), Nov. 2012 (2), Dec. 2012 (1)..." There was no documentation of threshold/goal, analysis of the data or action plan developed for the HACS Pressure Ulcers.

Review of the Environment of Care meeting minutes dated 9/12/12, 11/14/12, 1/9/13 and Performance Improvement/Quality Council meeting minutes dated 9/20/12, 10/19/12, 11/18/12, 12/19/12, 1/17/13 revealed no documentation of Hospital Acquired Conditions (HACS) Pressure Ulcers being analyzed or action plans developed for the prevention of HACS Pressure Ulcers.

3. During an interview in the board room on 5/22/13 at 11:10 AM, the Director of Nursing was asked about about the HACS of Pressure Ulcers, she stated, "...There is no analysis of data or action plan...just numbers acquired...having one decubitus is one too many..."

Based on policy review, record review and interview, the governing body failed to provide oversight of the Quality Assessment and Performance Improvement Program to ensure patient safety and the reduction of Hospital Acquired Conditions (HACS) of Pressure Ulcers, and failed to monitor the effectiveness and safety of the disinfection and sterilization procedures in the surgery department.

The findings included:

1. Review of the hospital's "Quality and Safety Plan" revealed, "...The "SPICE [Safety, Process Improvement, Customer Excellence]," with support and approval from the Board of Commissioners, has the responsibility for monitoring every aspect of patient care from admission through diagnosis, treatment, recovery, and discharge to identify and resolve any breakdowns while striving for continuous improvement in the services we provide...The Board of Commissioners is ultimately responsible for the quality of care provided...The Board has a responsibility to evaluate the effectiveness of the Quality and Safety activities performed throughout the facility and the "SPICE" Program as a whole..."

2. Review of the Facility - wide Environment of Care/Safety Indicators dated 2011 - 2012 revealed, "...Hospital Acquired Conditions (HACS) Pressure Ulcers...Sept. 2012 (1), Nov. 2012 (2), Dec. 2012 (1)..." There was no documentation of threshold/goal, analysis of the data or action plan developed for the HACS Pressure Ulcers.

Review of the Environment of Care meeting minutes dated 9/12/12, 11/14/12, 1/9/13 and Performance Improvement/Quality Council meeting minutes dated 9/20/12, 10/19/12, 11/18/12, 12/19/12, 1/17/13 revealed no documentation the Hospital Acquired Conditions (HACS) Pressure Ulcers had been analyzed or action plans developed for the prevention of the HACS Pressure Ulcers.

There was no documentation of the governing body's intervention to ensure HACS Pressure Ulcers were analyzed and action plans developed in order to prevent HACS Pressure Ulcers.

During an interview on 5/22/13 at 11:10 AM the DON was questioned about the HACS of Pressure Ulcers and stated, "...There is no analysis of data or action plan...just numbers acquired...having one decubitus is one too many..."

3. Observations in the surgery department on 5/20/13 and 5/21/13 revealed, staff performing disinfection of scopes and surgical instruments were not following manufacturer's guidelines of the proper dilution amounts to ensure efficacy of the disinfecting products.

Observations in the surgery department on 5/20/13 revealed, staff performing Flash sterilization on a routine basis when Flash sterilization is only to be used in an emergency.

Record review of the Environment of Care meeting minutes dated 9/12/12, 11/14/12, 1/9/13, Performance Improvement/Quality Council meeting minutes dated 9/20/12, 10/19/12, 11/18/12, 12/19/12, 1/17/13 and Facility - wide Environment of Care/Safety Indicators dated 2011 - 2012 revealed no documentation of disinfection and sterilization procedures being monitored or reported.

There was no documentation the governing body had monitored the sterilization and disinfecting procedures in order to ensure the safety and effectiveness of the processes.

4. During an interview in the board room on 5/22/13 at 11:10 AM, the Director of Nursing was asked about disinfection and sterilization procedures being monitored or reported in Performance Improvement. She stated, "...No, surgery disinfection and sterilization procedures are not mentioned in the quality council minutes..."

Based on policy review, observation and interview, the hospital failed to ensure pharmaceutical services were provided in a safe and effective manner, medications were stored in a secure and locked area, schedule II drugs were stored in a secure and locked manner, outdated, unlabeled, unusable drugs and biologicals were unavailable for patient use, and medication safety was practiced in all anesthetizing areas.

The findings included:

1. The hospital failed to ensure drugs and biologicals were kept in a secure area and locked in the surgery department.
Refer to A 0502

2. The hospital failed to ensure Scheduled II drugs were kept in a secure area and locked in the surgery department.
Refer to A 0503

3. The hospital failed to ensure opened medications were dated, labeled and stored properly.
Refer to A 0505

4. The hospital failed to ensure medication safety was practiced in all anesthetizing areas.
Refer to A 1002

Based on policy review, observation and interview, the hospital failed to ensure drugs and biologicals were kept in a secure area and locked in all areas of the surgery department for 4 of 5 (Anesthesia medication refrigerator, Nurses medication cart, Anesthesia cart Operating Room Suite #3, Anesthesia cart Endoscope room) medication storage areas on 2 of 2 (5/20/13 and 5/21/13) survey observation days.

The findings included:

1. Review of the hospital's "Medication storage, handling and security" policy revealed, "...The carts and medication room are to be locked when not in use...Access to med rooms, and locked storage cabinets is restricted by job description and units worked..."

Review of the hospital's "Medications, Refrigerated storage of" policy revealed, "...Refrigerators identified as medication storage refrigerators will be labeled as such..."

Review of the hospital's "Medications" policy revealed, "...Do not leave any medication at the patient's bedside...Medications from home that the patient brings to the hospital will be disposed of in one of two ways: Sent home with an immediate relative, Sent to the hospital pharmacy to be stored until the patient is discharged...Medication carts will be locked when left unattended..."

Review of the hospital's "Medication, Patient's Own - Storage" policy revealed, "...Drugs that are not to be used during the patient's hospitalization will be given to the patient's family to take home..."

2. Observation in the Autoclave #1 room on 5/20/13 at 10:45 AM revealed a large refrigerator with no lock on it. Inside the refrigerator were the following anesthesia medications:
Diprivan 10mg (milligrams)/ml (milliliters).
Rocuronium Bromide 10mg/ml.
Methergonovine Maleate 25mg/5ml.
Bacitracin 50,000 units.
Succinylcholine 200mg 20mg/ml.
There were three doors that accessed the room. One from the main hallway in the surgery department, one from the OR suites hallway and one from not in use recovery room.

During an interview in the Autoclave #1 room on 5/20/13 at 10:45 AM, the Surgery Department Unit Manager stated, "...There is no lock on the refrigerator, it is full of medications used for anesthesia...Yes, anyone can come in this room that has access to the surgery department main hall...Maintenance, housekeeping, techs, nurses, doctors and materials management because they bring supplies into this room and drops them on the floor..."

During an interview in the board room on 5/21/13 at 1:45 PM the Director of Nursing (DON) stated, "...So, we need a lock on that (anesthesia medication refrigerator)..."

3. Observation in the hallway outside the Operating Room (OR) suites on 5/20/13 at 11:15 AM revealed a medication cart with no lock on it and unsecured medications in the cart.

During an interview in the hallway outside the OR suites on 5/20/13 at 11:15 AM, the Surgery Department Unit Manager confirmed the unlocked and unsecured medication cart. She stated, "...Yes, we don't have a lock on this cart...Yes, anyone walking by could access all the medications...Yes, we have housekeeping, techs, nurses, doctors and maintenance that come back here and walk by this cart in the hallway..."

During an interview in the board room on 5/21/13 at 1:45 PM the Director of Nursing (DON) stated, "...We need a lock on that (OR suite nursing medication cart)..."

4. Observation in the OR #3 suite on 5/20/13 at 11:55 AM revealed an anesthesia cart unlocked and unattended with the following medications on top of the cart:
Ondansetron 4mg/2ml.
2% (percent) Lidocaine.
Propofol 1% 20ml.
Phenylephrine 1% 10mg/ml.

In the unlocked drawer of the anesthesia cart were the following medications:
Rocuronium 50mg/5ml (2 vials).
Succinylcholine 200mg 20mg/ml vial.
Atropine .4mg/ml 20 ml vial (2 vials).
Naloxone .4mg/ml 10ml vial.
Neostigmine 1:1000 10mg/10ml 20ml vial.
Lidocaine 2% 20mg/ml 50 ml vial.
Hydralazine 20mg/ml (3 vials).
Labetalol 100mg/20ml 5mg/ml vial.
Nalbuphine 20mg/ml 10ml vial.
Morphine 10mg/10ml (2 vials).
Two 100ml bag .9% NS (normal saline) bag with a blue label with the word Ultiva.
One bag of .9% NS with the blue label Ultiva spiked and primed with 100ml of solution in the bag. Second bag of .9% NS with the blue label Ultiva spiked and primed with less than 1/2 of the solution in the bag.

During an interview in OR #3 suite on 5/20/13 at 11:55 AM, the Surgery Department Unit Manager confirmed the unlocked unattended anesthesia cart. She stated, "...Cases are through for the day and anesthesia is not back here..."

During an interview in the surgery department hallway on 5/20/13 at 2:00 PM, the Certified Registered Nurse Anesthesist (CRNA) confirmed the unlocked unattended anesthesia cart in OR #3 suite. The CRNA was asked about the spiked bag of Ultiva with one of the bags partially used. The CRNA stated, "...Yes, they were used last week on a foot case, they should have been discarded...Yes, the anesthesia cart in OR #3 has been used today on other cases with the Ultiva like that...it should have been discarded last week..."

5. Observation in the Endoscope Room on 5/21/13 at 2:10 PM revealed an anesthesia cart unlocked with two 50ml (milliliters) vials of Diprivan 10mg (milligrams)/ml opened with two syringes laying beside them. These medications were on top of the cart. Inside the opened tool box was a 100 ml bag of .9% Normal Saline with the word written in black marker "Neosynephrine".

During an interview in the Endoscope Room on 5/21/13 at 2:10 PM, the CRNA confirmed there were no more cases scheduled for this room. The CRNA stated, "...Yes, these medications are unsecured and the CRNA working this room is gone for the day..."

6. Observation in the Short Stay area labeled #6 bay on 5/20/13 at 9:10 AM revealed a bottle of Hydrocodone with Patient #3's name on it. The bottle of Hydrocodone was sitting on top of the overbed table. The curtain to bay #6 was pulled completely back revealing the medication and room content. There were no family members or patient in the room. Located beside bay #6 were other bays with patients and family members. Observed walking around bay #6 and the short stay area were housekeeping, nurses, unit secretary and techs.

During an interview in bay #6 on 5/20/13 at 9:10 AM, the Surgery Department Unit Manager confirmed the patient's unsecured narcotic medication. She stated, "...That belongs to named patient (Patient #3) that should not be out like that..."

Observation in the bay #6 on 5/20/13 at 9:40 AM revealed the bottle of Hydrocodone gone. There were no family members or patient present in bay #6. There were family present in the bay #5 next to bay #6.

During an interview in bay #6 on 5/20/13 at 9:40 AM, Staff #6 was questioned what happened to bay #6 patient's bottle of Hydrocodone. Staff #6 stated, "...I saw the bottle sitting out, unattended so I put it in the patient's belonging bag..."

Based on policy review, observation and interview, the hospital failed to ensure Scheduled II drugs were kept in a secure area and locked for 1 of 4 (Operating Room #3) medication storage areas observed in surgery.

The findings included:

1. Review of the hospital's "Pharmaceutical Services" policy revealed, "...Controlled drugs are received and stored by the Anesthesia Department, who maintains accurate usage and waste records..."

Review of the hospital's "Medication storage, handling and security" policy revealed, "...The carts and medication [med] room are to be locked when not in use. Access to med rooms, and locked storage cabinets is restricted by job description and units worked..."

Review of the hospital's "Medications" policy revealed, "...Medication carts will be locked when left unattended..."

2. Observation in OR #3 on 5/20/13 at 11:55 PM revealed the anesthesia cart unlocked, unattended and two multidose vials of Morphine 10 mg (milligrams)/10 ml (milliliters) open in the top drawer of the cart.

3. During an interview in OR #3 on 5/20/13 at 11:55 PM, the Surgery Department Unit Manager confirmed the unlocked, unattended anesthesia cart and the Morphine vials in the top drawer of the cart. The Surgery Department Unit Manager stated, "...Yes, the cart is open and unattended...There are two vials of Morphine..."

Based on policy review, observation and interview, the hospital failed to ensure opened medications were dated, labeled and stored properly in areas for 4 of 7 (The Anesthesia med cart in Operating Room #3, Anesthesia cart Endoscope Room, Annex and the Telemetry Care Unit) medication storage areas.

The findings included:

1. Review of the hospital's "Medications - Multiple Use Containers" policy revealed, "...Discard multi-dose vials 28 days after first use unless the manufacturer specifies otherwise...Label multi-dose vials with the revised expiration date once the vial is opened or punctured (i.e., determine date to expire; usually 28 days later)..."

2. Observation in the Operating Room (OR) #3 on 5/20/13 at 11:55 AM revealed an anesthesia cart unlocked and unattended with the following medications opened and not dated medications on top of the cart:
Ondansetron 4mg (milligrams)/2ml (milliliters).
2% (percent) Lidocaine.
Propofol 1% 20ml.
Phenylephrine 1% 10mg/ml.

In the unlocked anesthesia cart drawer were the following opened and not dated medications:
Rocuronium 50mg/5ml (2 vials).
Succinylcholine 200mg 20mg/ml vial.
Atropine .4mg/ml 20 ml vial (2 vials).
Naloxone .4mg/ml 10ml vial.
Neostigmine 1:1000 10mg/10ml 20ml vial.
Lidocaine 2% 20mg/ml 50 ml vial.
Hydralazine 20mg/ml (3 vials).
Labetalol 100mg/20ml 5mg/ml vial.
Nalbuphine 20mg/ml 10 ml vial.
Morphine 10mg/10ml (2 vials).

During an interview in OR #3 suite on 5/20/13 at 11:55 AM, the Surgery Department Unit Manager confirmed the unlocked unattended anesthesia cart. She stated, "...Cases are through for the day and anesthesia is not back here..."

During an interview in the surgery department hallway on 5/20/13 at 2:00 PM, the Certified Registered Nurse Anesthesist (CRNA) confirmed the unlocked unattended anesthesia cart in OR #3 suite. The CRNA confirmed the multi dose vials of medications were opened with no labeled dates of expiration.

3. Observation in the Annex medication room on 5/21/13 at 9:20 AM revealed an opened multi dose vial of Novolog insulin.

During an interview in the Annex medication room on 5/21/13 at 9:20 AM, the Annex Unit Manager confirmed the opened not dated vial of insulin. She stated, "...It should have a label documenting the expiration date..."

4. Observation in the Telemetry Care Unit (TLC) medication area on 5/21/13 at 9:50 AM revealed an opened multi dose vial of Novolin R insulin.

During an interview in the TLC medication area on 5/21/13 at 9:50 AM, Staff #2 confirmed the opened not dated vial of insulin. She stated, "...Yes, there is no date and it should be..."

5. Observation in the Endoscope Room on 5/21/13 at 2:10 PM revealed a multi dose vial of Lidocaine 1% 10mg/ml 50ml opened with no labeled date of expiration sitting on a table.

During an interview in the Endoscope Room on 5/21/13 at 2:10 PM, the Surgery Department Unit Manager stated, "...That is my nurses fault, we should have dated..."

6. Observation in the Endoscope Room on 5/21/13 at 2:10 PM revealed an anesthesia cart unlocked with two 50ml (milliliters) vials of Diprivan 10mg (milligrams)/ml opened with two syringes laying beside them. These medications were on top of the cart. Inside the opened tool box was a 100 ml bag of .9% Normal Saline with the word written in black marker "Neosynephrine".

During an interview in the Endoscope Room on 5/21/13 at 2:10 PM, the CRNA stated, "...That is not suppose to be in there, and it is not labeled, should have the dose, date, time, initials..."

Based on policy review, observation and interview, the hospital failed to maintain a sanitary environment to avoid sources and transmissions of infection, store supplies properly, follow manufacturer's guidelines for disinfecting surgical instruments and scopes, follow proper techniques for storage of regulated waste, ensure the Chief Executive Officer, Medical Staff and Director of Nursing fulfilled its responsibility of ensuring the hospital - wide quality assurance program monitored sterilization procedures on a routine basis, flash sterilization was used for emergency sterilization only, and proper ventilation, humidity and temperature controls were maintained in the surgery department.

The findings included:

1. The hospital failed to ensure proper ventilation, humidity and temperature controls were maintained in the Surgery Department.
Refer to A 0951

2. The Infection Control Officer failed to maintain a system to ensure a sanitary hospital environment.
Refer to A 0749

3. The hospital failed to ensure the Chief Executive Officer, Medical Staff and Director of Nursing fulfilled its responsibility of ensuring the hospital - wide quality assurance program monitored sterilization procedures on a routine basis.
Refer to A 0756

4. The hospital failed to ensure flash sterilization was used for emergency sterilization only.
Refer to A 0951

Based on policy review, observation and interview, the Infection Control Officer failed to maintain a system to ensure the hospital provided care in a sanitary environment in order to avoid sources and transmissions of infection, supplies were stored appropriately, manufacturer's guidelines were followed for disinfecting surgical instruments and scopes, and proper storage of regulated waste on 2 of 2 (5/20/13 and 5/21/13) observation days.

The findings included:

1. Review of the Intercept Detergent manufacturer's guidelines revealed, "...Unique non-enzymatic formula specifically developed for manual or automated cleaning of endoscopes and accessories prior to reprocessing...At the dilution rate of 1/3 oz. [ounce] per gallon of water..."

Observation in the Endoscope cleaning room on 5/20/13 at 9:20 AM revealed Staff #1 squirted one pump (3 oz.) of Intercept Detergent in a sink with water. There was no water fill line in the sink. Staff #1 cleaned a dirty endoscope. After cleaning the scope the sink was emptied. Staff #1 was asked by the surveyor to fill the sink to the proper dilution amount of water as per manufacturer's guidelines. The dilution amount of water per the manufacturer's guidelines was not the same as the amount the staff had used to clean the dirty endoscope.

During an interview in the Endoscope cleaning room on 5/20/13 at 9:20 AM, Staff #1 was asked was the water in the sink measured to the manufacturer's dilution guidelines. Staff #1 stated, "...No, I just eyeball it to the level I think..."

During an interview in the Endoscope cleaning room on 5/20/13 at 9:20 AM, the Surgery Department unit manager confirmed the water was not the proper dilution rate for 1 oz. of Intercept. She stated, "...We will measure correctly the amount of water to put in each time until we get a sink fill line permanently..."

2. Review of the Rapicide manufacturer's guidelines revealed, "...Indications for Use as a high level disinfectant when used or reused at 35 degrees C [centigrade]..."

Observation in the Endoscope cleaning room on 5/20/13 at 9:20 AM revealed the temperature reading on the Rapicide high level disinfectant and sterilant storage tank at 37 degrees Centigrade.

During an interview in the Endoscope cleaning room on 5/20/13 at 9:20 AM, Staff #1 confirmed the Rapicide temperature of 37 degrees Centigrade. She stated, "...It is 37 degrees..."

During an interview in the Endoscope cleaning room on 5/20/13 at 9:20 AM, the Surgery Department Unit Manager confirmed the Rapicide temperature of 37 degrees Centigrade. She stated, "...I could not find anywhere in the literature of a range of what I thought. All the literature says maintain at 35 degrees..."

3. Review of the Haemo-Sol manufacturer's guidelines revealed, "...one scoop per tub and soak 10 minutes...1/2 oz. to 1 gallon..."

Observation in the surgical suite dirty utility room on 5/20/13 at 10:00 AM revealed Staff #5 placed one scoop of Haemo-Sol in a pan, placed surgical instruments in the pan and filled the pan with water. There was no water fill line on the pan. There was no observation the staff had measured the water to equal 1 gallon per manufacturer's guidelines. Staff #5 cleaned the instruments and placed them in a rack, then emptied the pan.

During an interview in the surgical suite dirty room on 5/20/13 at 10:00 AM, Staff #5 was asked what was the process for cleaning dirty surgical instruments. Staff #5 stated, "...I put the scoop of cleaner in the bowl, then put my stuff [instruments] in, then add water, but not to much water so it won't overflow...No, I don't know how much water my pan holds...No idea, the sink doesn't hold water well that is why I use the pan..."

During an interview in the surgical suite dirty room on 5/20/13 at 10:00 AM, the Surgery Department Unit Manager confirmed there was no water fill line in the pan. She stated, "...I will measure out the correct water amount and put a fill line...what is being used is not correct, we will start measuring..."

4. Observation in the Autoclave #1 room on 5/20/13 at 10:45 AM, revealed two large boxes of syringes on the floor near the anesthesia refrigerator.

During an interview in the Autoclave #1 room on 5/20/13 at 10:45 AM, the Surgery Department Unit Manager stated, "...Materials Management brings supplies to this room and drops them on the floor..."

5. Review of the hospital's "Infection Control/Confine and Contain" policy revealed, "...Phase III - Completion of Surgery: Surgery Personnel Using appropriate cleaning solution, clean the OR [operating room] lights, beds, all furniture and equipment, trash receptacles, and spots on walls. The entire floor should be cleaned if there is any possibility that contaminants were aerosolized or that body fluid have dripped anywhere on the floor surface..."

Review of the hospital's "Operating Room Sanitation" policy revealed, "...Prior to the first scheduled procedure of the day, horizontal surfaces will be damp dusted. Horizontal surfaces include tables, equipment, and overhead lights. Damp-dusting will be done with clean cloth moistened with Clorox and water mixture...Terminal Cleaning - at the End of the Day's Schedule: The entire floor of the OR will be mopped with Sanimaster III...Regular cleaning: Walls and ceiling of the Operating Rooms will be washed with Sanimaster phenolic monthly..."

Observation in OR #1 on 5/20/13 at 11:30 AM revealed the following:
White chalky powder like substance on the floor between the OR stretcher and equipment.
A red vial top, white zip tie and paper backing from a label in the floor.
Debris on the bottom shelf of a piece of equipment used for scopes.
A large gray dust ball with black hair mixed in the ball located beside the OR stretcher.
Too numerous to count moderate size gray dust balls along all four wall edges of the room and behind the equipment.
A large amount of dust particles on the equipment in the OR suite.

During an interview in OR #1 on 5/20/13 at 11:30 AM, the Surgery Department Unit Manager confirmed all the findings in OR #1. She stated, "...Yes, we use this room for surgery...that dust bunny has hair in it...Yes, I see all the dust...that white chalky substance in the floor is from where they patched the ceiling because we had a leak...I don't know how long ago that leak was..."

Observation in OR #2 on 5/20/13 at 11:40 AM revealed the following:
A large amount of gray dust balls along all four wall edges of the room and behind the equipment.
A paper cover from a suction catheter in the floor.
A black knob off a foot stool in the floor.
A suction canister connector, a needle cover and an intravenous port cover in the floor.
The Surgery Department unit manager took her hand and wiped across the top of a piece of equipment and a large amount of dust particles flew in the air.

During an interview in OR #2 on 5/20/13 at 11:40 AM, the Surgery Department Unit Manager confirmed all the findings. She stated, "...Yes, OR 2 has been used for surgery today and it has been cleaned..."

Observation in OR #3 on 5/20/13 at 11:50 AM revealed the following:
A 1 gallon jug of Betadine solution opened sitting on top of a foot stool in the corner of the room.
A nickel size spot of brown substance and moderate size of brown smears on the floor beside the OR stretcher.
An opened anesthesia cart with partially used medications, supplies and supply papers on top.

During an interview in OR #3 on 5/20/13 at 11:50 AM, the Surgery Department Unit Manager confirmed all the findings. She stated, "...Yes, OR 3 has been used for surgery today and it has been cleaned..." When asked how often is the OR terminally cleaned the unit manager stated, "...Monthly..."

During an interview in the board room on 5/21/13 at 1:51 PM, the Director of Nursing was asked when are the OR suites to be cleaned. She stated, "...I know after each case they are supposed to clean..."

6. Review of the hospital's "Infectious Waste Management" policy revealed, "...Infectious waste should be placed in impervious red bags...stored in a leakproof, fully enclosed container..."

Observation in the Annex dirty utility room on 5/21/13 at 9:20 AM revealed 2 red Biohazard barrels stacked on top of each other. The top barrel's lid was unsecured and red bags were exposed.

During an interview in the Annex dirty utility room on 5/21/13 at 9:20 AM, the Annex unit manager was asked about the Biohazard barrels being stacked on top of each other and the lid unsecured on the top barrel. She stated, "...Yeah, being stacked is very tall...Yes, the top barrel could tip off, I have not thought of that...It could tip over and the contents spill..."

7. Observation in the Telemetry Care Unit (TLC) dirty utility room on 5/21/13 at 9:50 AM revealed 2 red Biohazard barrels stacked on top of each other. The top barrel's lid was unsecured.

During an interview in the TLC dirty utility room on 5/21/13 at 9:50 AM, Staff #2 confirmed the stacked Biohazard barrels and the top lid unsecured.

Based on policy review, record review, observation and interview, the hospital failed to ensure the Chief Executive Officer, Medical Staff and Director of Nursing fulfilled its responsibility of ensuring the hospital - wide quality assurance program monitored sterilization procedures on a routine basis.

The findings included:

1. Review of the hospital's "Sterilization and Disinfection" policy revealed, "...Flash sterilization will only be used for emergency sterilization of clean, unwrapped instruments, and porous items only...Flash sterilization should be used only when time does not permit sterilization by the preferred wrapped procedure because speed reduces the margin of safety..."

2. Record review of the Environment of Care meeting minutes dated 9/12/12, 11/14/12, 1/9/13 and Performance Improvement/Quality Council meeting minutes dated 9/20/12, 10/19/12, 11/18/12, 12/19/12, 1/17/13 revealed no documentation of sterilization procedures being monitored.

3. Observation of the Autoclave #1 room on 5/20/13 at 10:30 AM revealed no documentation of monitoring of flash sterilization and no tracking or trending of the use of flash sterilization.

4. During an interview in Autoclave #1 room on 5/20/13 at 10:30 AM, Staff #5 stated, "...We use Autoclave #1, we call it little autoclave for flash and everything else...Yes, we flash instruments all the time...We flash all the time and only use our big Autoclave #2 for the big stuff it is not quick, so we flash...No, I didn't realize flash was not a good thing...We flash a lot..."

During an interview on 5/20/13 at 10:35 AM, Surgery Department Unit Manager stated, "...No, we don't track or trend how much or what we are flashing...We just document the load on a card and place in an envelope then file in a cabinet...No, I don't look at it or report it to anyone..."


During an interview on 5/20/13 at 1:41 PM, the Director of Nursing (DON) was asked what was herr understanding for flash sterilization and was it tracked and trended. The DON stated, "...Flash is something they do when they need it in an emergency...No, we don't track or trend it..."

Based on policy review, record review, observation and interview, the hospital failed to provide surgical services in a manner to ensure the health and safety of patients.

The findings included:

1. The hospital failed to maintain a sanitary environment in the surgery department.
Refer to A 0749

2. The hospital failed to ensure the Chief Executive Officer, Medical Staff and Director of Nursing fulfilled its responsibility of ensuring the hospital - wide quality assurance program monitored sterilization procedures on a routine basis.
Refer to A 0756

3. The hospital failed to ensure proper ventilation and humidity controls were maintained in the Surgery Department and to ensure flash sterilization was used for emergency sterilization only.
Refer to A 0951

4. The hospital failed to ensure safety practices in all anesthetizing areas.
Refer to 1002

Based on policy review, observation and interview, the hospital failed to ensure surgical services were provided in a safe environment by achieving and maintaining proper humidity controls in the operating rooms (OR) and proper ventilation controls in the use of Cidex solution and ensure flash sterilization was used for emergency sterilization only in 3 of 5 (Operating Room #1, 3, and Autoclave #1 room) areas observed.

The findings included:

1. Review of the hospital's "Humidity and Temperature Monitoring Log" revealed, "...Humidity acceptable range is 30% to 60%..."

2. Review of the Operating Room (OR) #1's "Humidity and Temperature Monitoring Log" revealed the following Humidity readings in April and May:
4/16/13 humidity 64.
4/17/13 - 4/20/13 humidity 65.
4/21/13, 4/22/13 humidity 64.
4/23/13 humidity 66.
4/24/13 humidity 68.
4/25/13, 4/26/13 humidity 66.
4/27/13 humidity 62.
5/4/13 - 5/9/13 humidity 68.
5/10/13 - 5/12/13 humidity 65.
5/13/13 - 5/15/13 humidity 64.
5/16/13 - 5/20/13 humidity 62.

3. Review of the OR #3's "Humidity and Temperature Monitoring Log" revealed the following Humidity readings in April and May:
4/10/13 - 4/16/13 humidity 64.
4/17/13 humidity 67.
4/18/13 humidity 64.
4/19/13 humidity 62.
4/25/13, 4/26/13 humidity 62.
4/27/13, 4/28/13 humidity 64.
4/29/13 humidity 66.
4/30/13 humidity 68.
5/1/13 - 5/7/13 humidity 68.
5/8/13 humidity 72.
5/9/13 humidity 74.
5/10/13 - 5/20/13 humidity 72.

4. During an interview in the Autoclave #1 room on 5/20/13 at 12:00 PM, the Surgery Department Unit Manager stated, "...We do not have a current policy for measuring humidity and temperature in the OR..."

During an interview in the Autoclave #1 room on 5/20/13 at 12:00 PM, Staff #3 was asked what was the process if the humidity or temperature were out of range. Staff #3 stated, "...If not in range I notify maintenance and that is all I do..."

5. Review of the hospital's "Sterilization and Disinfection" policy revealed, "...Flash sterilization will only be used for emergency sterilization of clean, unwrapped instruments, and porous items only...Flash sterilization should be used only when time does not permit sterilization by the preferred wrapped procedure because speed reduces the margin of safety..."

Observation in the Autoclave #1 room on 5/20/13 at 10:30 AM revealed no visible log or documentation in an organized manner of instruments that had been flashed.

During an interview in the Autoclave #1 room on 5/20/13 at 10:30 AM, Staff #5 stated, "...We use Autoclave #1, we call it little autoclave for flash and everything else...Yes, we flash instruments all the time...I didn't realize flash was not a good thing...We flash a lot...We flash all the time and only use our big Autoclave #2 for the big stuff it is not quick, so we flash..."

6. Review of the Cidex OPA manufacturer's guidelines revealed, "...Cidex OPA solution should be stored in the original container at controlled room temperature 15 - 30 degrees C [Centigrade] in a well - ventilated, low - traffic area..."

Review of the hospital's "ENV [environmental) Services Laboratory Safety Report" dated 8/21/12 documented analysis for OB (obstetrical) 2, OR 2, OR 3, OR 1 and ER (emergency room) 2. The report did not analyze the Autoclave #1 room where the Glutaraldehyde is used.

During an interview in the Autoclave #1 room on 5/20/13 at 12:00 PM, the Surgery unit manager stated, "...We keep the Cidex in this room [Autoclave #1] and the staff come in here to use it...Yes, this room is open to all staff that have a badge to get into the surgery department and materials management drops supplies in here, housekeeping, anesthesia, maintenance and surgical staff come in here..."

Based on policy review, observation and interview, the hospital failed to ensure the anesthesia services were organized to ensure safety practices in all anesthetizing areas for 2 of 4 (Operating Room #3 and Endoscope Room) anesthesia medication areas.

The findings included:

1. Review of the hospital's "Medication: labeling of syringes used in anesthesia" policy revealed, "...Medications drawn up in syringes that are not immediately used will have attached identification allowing immediate visual documentation of contents. The labeling process should note drug name, strength and amount (if not apparent). The following processes may be used to identify syringe contents: The vial from which the medication is drawn is taped to the syringe. A label is affixed to the syringe noting the above information. Syringe contents (including above information) are labeled directly with a permanent marker. All prepared syringes will be discarded at the end of each case..."

Review of the hospital's "Pharmaceutical Services" policy revealed, "...All drugs must be properly labeled..."

2. Observation in the Endoscope Room on 5/21/13 at 2:10 PM revealed an anesthesia cart with two 50ml (milliliters) vials of Diprivan 10mg (milligrams)/ml opened with two syringes laying beside them. One syringe contained a white liquid with a capped needle attached. There was no label on the syringe. A second syringe contained a white liquid with an intravenous extension tubing primed with the liquid. The primed extension tubing was draped along the top of the med cart with the end hanging in a sharps box filled with used needles and vials. There was no label on the syringe.

In the tool box on top of the medication cart was a 100 ml bag of .9% Normal Saline with the word written in black marker "Neosynephrine".

During an interview in the Endoscope Room on 5/21/13 at 2:10 PM, the Certified Registered Nurse Anesthetist (CRNA) shook his head no and stated, "...That is not good, those syringes [Diprivan]...that [Neosynephrine] is not suppose to be in there...the CRNA working this room is gone for the day...this should have been cleaned up..."

4. Observation in the OR #3 suite on 5/20/13 at 11:55 AM revealed an anesthesia cart unlocked and unattended with the following medications on top of the cart:
Ondansetron 4mg/2ml.
2% (percent) Lidocaine.
Propofol 1% 20ml.
Phenylephrine 1% 10mg/ml.

In the unlocked drawer of the anesthesia cart were the following medications:
Rocuronium 50mg/5ml (2 vials).
Succinylcholine 200mg 20mg/ml vial.
Atropine .4mg/ml 20 ml vial (2 vials).
Naloxone .4mg/ml 10ml vial.
Neostigmine 1:1000 10mg/10ml 20ml vial.
Lidocaine 2% 20mg/ml 50 ml vial.
Hydralazine 20mg/ml (3 vials).
Labetalol 100mg/20ml 5mg/ml vial.
Nalbuphine 20mg/ml 10ml vial.
Morphine 10mg/10ml (2 vials).
Two 100ml bag .9% NS (normal saline) bag with a blue label with the word Ultiva.
One bag of .9% NS with the blue label Ultiva spiked and primed with 100ml of solution in the bag. Second bag of .9% NS with the blue label Ultiva spiked and primed with less than 1/2 of the solution in the bag.

During an interview in OR #3 suite on 5/20/13 at 11:55 AM, the Surgery Department Unit Manager confirmed the unlocked unattended anesthesia cart. She stated, "...Cases are through for the day and anesthesia is not back here..."

During an interview in the surgery department hallway on 5/20/13 at 2:00 PM, the Certified Registered Nurse Anesthesist (CRNA) confirmed the unlocked unattended anesthesia cart in OR #3 suite. The CRNA was asked about the spiked bag of Ultiva with one of the bags partially used. The CRNA stated, "...Yes, they were used last week on a foot case, they should have been discarded...Yes, the anesthesia cart in OR #3 has been used today on other cases with the Ultiva like that...it should have been discarded last week..."

Based on facility policy, employees certification record and interview it was determined the facility failed to ensure all Emergency Department nurses were competent in Advanced Cardiovascular Life Support (ACLS) and Pediatric Advanced Life Support (PALS) for 3 of 23 (Nurse #1, 2, and 3) Emergency Department (ED) nurses.

The findings included:

1. Review of the facility's "Cardio-Pulmonary Arrest/Code Blue/Code Purple" policy revealed, "...All...nurses within the Emergency Department are required to be ACLS and PALS certified..."

2. Review of the employees certification documentation revealed Nurse # 1, 2, and 3 were not certified at the time of these findings.

3. During an interview in the Emergency Department on 5/22/13 at 9:30 AM, the ED Director verified PALS and ACLS were not up to date for these three nurses.