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Based on facility tours and staff interviews, the facility failed to maintain a safe environment to protect the health and safety of patients.
This failure contributed to the potential use of expired supplies during patient procedures.

FINDINGS:

1. The facility failed to ensure that supplies used during patient procedures were not expired.

a) On 03/26/13 at 3:10 p.m., a tour of the facility's surgical area was conducted with the facility's Regulatory Consultant and Surgical Staff Registered Nurse (RN). The Pre-Operative (Pre-Op) and Post Anesthesia Care Unit (PACU) storage room was viewed and contained 5 ten-milliliter syringes of normal saline with manufacturer's expiration dates ranging from 09/12 to 01/13.
The Operating Room's (OR) storage room was viewed and contained 20 one liter bags of normal saline with manufacturer's expiration dates of 01/13. The facility's malignant hyperthermia kit was viewed and contained 3 ten-milliliter syringes of normal saline with manufacturer's expiration dates of 08/12.
The facility's 2 ORs were viewed and contained the following expired items: 8 twenty-gage intravenous (IV) catheters with manufacturer's expiration dates of 01/13, 2 sixteen-gage IV catheters with manufacturer's expiration dates of 08/11, and 2 eighteen-gage IV catheters with manufacturer's expiration dates ranging from 08/12-09/12.
The facility's Regulatory Consultant and Surgical Staff RN verified the manufacturer's expiration dates and immediately discarded the items.

b) During the tour, an interview was conducted with the facility's Regulatory Consultant and Surgical Staff RN. Both stated it was their expectation that expired items would be removed from the unit and not used during patient procedures.

Based on observations, document review, and interviews, the facility failed to maintain proper storage of drugs and biologicals.

This failure resulted in the potential for expired medications to be used for patient treatment.

FINDINGS:

1. The facility did not follow current standards of practice for multiple dose vials.

a) A position paper from the Association of Professionals in Infection Control and Epidemiology (APIC) titled, "Safe Injection, Infusion and Medication Vial Practices in Healthcare" published July 30th, 2009 stated the following, in pertinent parts:
"The transmission of bloodborne viruses and other microbial pathogens to patients during routine healthcare procedures continues to occur due to unsafe and improper injection, infusion and medication vial practices being used by healthcare professionals within various clinical settings throughout the United States ...
APIC strongly supports adherence to the following safe injection, infusion and medication vial practices ...
Vials
?Always follow the manufacturer's instructions for storage and use...
?Discard single-dose vials after use. Never use them again for another patient.
?If a multidose vial must be used, it should be used for a single patient whenever
possible. The risk of transmission posed by inappropriate handling of multi-dose vials has been clearly demonstrated and mandates a practice of one vial per one patient whenever possible. Infection transmission risk is reduced when multi-dose vials are dedicated to a single patient...
?Dispose of opened multidose medication vials 28 days after opening, unless specified otherwise by the manufacturer, or sooner if sterility is questioned or compromised..."

b) On 03/26/13 at 10:30 a.m., a tour of the facility's Medical Surgical unit was conducted with the facility's Regulatory Consultant and the facility's Medical Surgical Unit Manager. The Medical Surgical Unit Manager stated she was unsure how many days a multidose vial was considered safe for use after being opened. The Medical Surgical Unit Manager was asked to provide the facility's Multi-Dose medication policy to the surveyor, but was unable to locate the online policy despite multiple attempts.

c) On 03/27/13 at 3:30 p.m., a tour of the facility's Emergency Department (ED) was conducted with the facility's Regulatory Consult and ED manager. An opened multiple dose vial of insulin was located in the ED medication room and contained a white label that stated,"Do Not Use 30 Days After Above Date" with a hand-written date written on the label.

During the tour, and ED staff nurse was interviewed. The ED staff nurse stated s/he was unsure how long multi-dose vials of medications, such as insulin, were considered safe for use after being opened and estimated multi-dose medications were good for 30 to 90 days after opening.

d) On 03/27/13 at 4:00 p.m., an interview was conducted with the facility's pharmacist. S/he stated that it was his/her expectation that medications would be discarded 28 days after having been opened. S/he stated s/he was unaware that the current label applied to medications stated 30 days.

e) On 03/27/13, the facility's policy,"Multiple Dose Medication Vials (MDVs)" was reviewed and stated, "The beyond use date after initially entering or opening (e.g. needle-punctured) multiple-dose containers is not to exceed 28 days unless otherwise specified by specified by the manufacturer". The policy further stated,"If the multiple dose vial is insulin, the vial expires 28 days after being dispensed from pharmacy". The facility's pharmacist verified this was the current policy.

The facility failed to implement a system for identifying, reporting, investigating, and controlling infections and communicable diseases that could potentially harm patients and personnel.

Based on observations, document review, and staff interviews, the facility failed to ensure that facility practices were performed in a manner that would prevent communicable diseases.

FINDINGS:

1. The facility did not ensure that cleaning solutions were properly diluted to ensure effective cleaning and disinfection of equipment used during patient procedures.

a) On 03/26/13 at 3:10 p.m., a tour of the facility's surgical area was conducted with the facility's Regulatory Consultant and Surgical Staff Registered Nurse (RN). During the tour, the facility's endoscope and sterile instrument cleaning area was viewed and an interview was conducted with the Surgical Staff RN. The Surgical Staff RN stated that the surgical suite nursing staff had been trained to clean endoscopes and sterile equipment. The Surgical Staff RN stated s/he cleaned the endoscopes and sterile equipment in a cleaning solution that s/he mixed prior to putting them in the endoscope washer or sterile instrument washer. The Surgical Staff RN stated s/he filled the sink with water to cover the scopes and instruments and then added, "one to two squirts" of the cleaning liquid, labeled, "Dual Enzyme". S/he stated there was no marking on the sink to indicate the level of water in the sink or how many gallons it could hold. The manufacturer's instructions on the "Dual Enzyme" cleaner were read by the Surgical Staff RN and stated, "add one to two ounces of cleaner per gallon of water". The facility's Surgical Staff RN was unable to verbalize how s/he was able comply with the manufacturer's instructions without knowing the exact amount of water contained in the sink.

b) On 03/27/13 at 10:30 a.m., the facility's policy, "Endoscopy: Care and Cleaning of Immersible Flexible Endoscopes", was viewed. The policy stated to gather the appropriate supplies including, "Lukewarm water with enzymatic cleaner in amount per manufacturer's guidelines". The facility's Regulatory Consultant verified this was the current policy.

c) On 03/27/13 at 10:30 a.m., the facility's policy, "General Infection Prevention Policy", was viewed. The policy identified sterile instruments as, "critical", and stated, "Federal Law requires all applicable label instructions to be followed. (e.g. use-dilution)". The facility's Regulatory Consultant verified this was the current policy.

2. The facility did not perform required tests to ensure the sterile washer was functioning properly.

a) On 03/26/13 at 3:10 p.m., the facility's sterile washer was viewed with the facility's Regulatory Consultant and Surgical Staff RN. The Surgical Staff RN stated that the surgical suite's nursing staff had been trained to use the sterile washer and that it was procedure to insert a test strip with each washer load to ensure the washer was functioning properly. The Surgical Staff RN was unable to locate the test strips to perform this procedure. The Surgical Services RN stated test strip results were recorded in a log but s/he was unable to state how these results could be documented without the use of test strips.

b) On 03/27/13, the facility's policy, "CSPD: Sterilization Equipment", was viewed. The policy stated, "A. Operate system according to manufacture instructions for use", and to keep a sterilization log containing whether parameters for each load were, "met or not met". The facility's Regulatory Consultant verified this was the current policy.

3. The facility used a broom and a feather duster in patient care areas.

a) On 03/26/13 at 3:10 p.m., a tour of the facility's 2 Operating Rooms (OR) was conducted with the facility's Regulatory Consultant and Surgical Staff RN. The janitor's closet for the OR was viewed and contained a broom and a feather duster.

b) During the tour, an interview was conducted with the facility's housekeeper. The housekeeper stated s/he used the broom and feather duster to dust vents in the ORs and to sweep the floor in the ORs.

c) On 03/27/13 at 10:00 a.m., the facility's policy, "PeriOperative Services: EVS Cleaning the Surgical Procedure Area", was viewed. The policy stated,"High dust entire room using a clean damp mop head to control dust". The policy further stated to, "damp clean with clean cloth dipped in hospital approved detergent", and "damp mop floors". The facility's Regulatory Consultant verified this was the current policy.

4. The facility stored items used for patient procedures on the facility floor.

a) On 03/27/13 at 10:15 a.m., a tour of the facility's Medical Surgical supply room was conducted with the facility's Regulatory Consultant and the facility's Medical Surgical Unit Manager. A hard-paneled box labeled, "Latex Free Kit" and an orange hard-paneled box labeled,"Disaster Kit", were located on the floor of the supply room. The Medical Surgical Unit Manager stated these boxes were kept on the floor and contained patient care items such as latex free foley catheters. The Medical Surgical Unit Manager stated the nursing staff brought these boxes to patient rooms when needed for a procedure.

b) During the same tour, the facility's Regulatory Consultant stated that it was his/her expectation that cardboard boxes would not be kept on the floor, but that the facility did not apply this expectation to other types of boxes.

5. The facility had expired and unlabeled food items for patient consumption.

a) On 03/27/13 at 10:25 a.m., a tour of the facility's Medical Surgical unit was conducted with the facility's Regulatory Consultant and the facility's Medical Surgical Unit Manager. During the tour, the Medical Surgical unit's patient food refrigerator was viewed. The refrigerator contained the following items: a half empty container of ice cream with a manufacturer's expiration date of 09/12, chicken wings wrapped in clear film with no patient label or expiration date, several unlabeled ice cream bars with no expiration date, and a block of sliced cheese contained in plastic wrapping with no patient label or expiration date. The Medical Surgical Unit Manager verified these findings and immediately discarded the items.

b) During the same tour, the facility's Medical Surgical Nurse Manger stated it was his/her expectation that all expired items would be removed from the patient refrigerator. S/he further stated it was his/her expectation that all patient food be labeled when placed in the refrigerator.