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Based on observation, interview, review of manufacturer's product guidelines and facility policy, the facility failed to ensure procedures were in place to monitor length of time intravenous solutions were usable after removal of the external overwrap and expired medications were removed from the crash carts.

Findings include:

On 4/27/11 in the afternoon, an observation was done in the Infusion Center unit of the facility. Review of the crash cart revealed central stores had last checked the drawer on 9/22/09. The drawer contained pediatric electrodes with a manufacturer's expiration date of 9/10 and a tube of Lidocaine jelly with a manufacturer's expiration date of 1/10.

On 4/27/11 in the afternoon, the unit manager of the Infusion Center was interviewed and confirmed the expiration dates of the products. She reported the pharmacy was responsible for checking the medication drawer and central stores was responsible for checking the supplies drawer. The supplies drawer contained the expired pediatric electrodes and Lidocaine jelly.

On 4/27/11 in the afternoon, an observation was done in the Intensive Care Unit (ICU) of the facility. Review of the crash cart revealed the central stores drawer had last been checked on 12/08. The drawer contained three pre-filled syringes containing saline for flushes with a manufacturer's expiration date of 11/01/10.

On 4/27/11 in the afternoon, a registered nurse from the ICU was interviewed and confirmed the expiration dates of the saline flushes. He reported central stores was responsible for checking the supplies drawer which contained the expired saline flushes.

Review of the facility pharmacy policy and procedure, "Expiration Dates: Assignment" with a date of 8/1/03 and a revision date of 5/10 revealed the following:

"Expiration dates for manufactured/bulk products: Expiration dates shall be assigned to all manufactured/bulk products. Expiration dates shall be assigned in accordance with the laws and regulations of this state. In no case shall the assigned date exceed the manufacturer's expiration date for the ingredient having the shortest expiration date."



22046

On 4/25/11 at approximately 10:30 AM, the medication storage room in the emergency room was observed. The following intravenous solutions were observed to have their protective overwraps removed:

- A 1000 cc (cubic centimeter) bag of 0.9% Sodium Chloride Injection
- A 500 cc bag of D5% and 0.45% Sodium Chloride Injection
- Three bags of 25 cc 0.9% Sodium Chloride Injection

None of the intravenous solutions were dated as to when the solutions were removed from their protective overwraps. The product overwrap on the 25 cc bag of Sodium Chloride contained a warning from the manufacturer which read "Do not remove units from the overwrap until ready for use. Use all units promptly when the pouch is opened. The overwrap is a moisture barrier. The inner bag maintains the sterility of the product".

On 4/25/11 at approximately 10:45 AM, a registered nurse (RN) from the emergency room was interviewed and reported she did not know when the intravenous solutions were removed from the protective overwrap.

In an interview with the pharmacist and the pharmacy technician on the afternoon of 4/25/11, both workers reported the intravenous solutions were good for 15 days after the removal of the protective overwrap. The pharmacist and the pharmacy technician reported there was no policy addressing the use of an intravenous solution once the solution was removed from the overwrap. The pharmacist and the pharmacy technician reported there was no system currently in use to identify the date the protective overwraps were removed.

Based on observation, interview, review of facility policy and manufacturer's guidelines the facility failed to follow manufacturer's guidelines for processing of single use items.

Findings include:

On 4/25/11 at 11:00 AM, observations were done in the sterile processing areas and surgical suites. The scope cleaning process was observed in the soiled processing area. The lead processing technician was interviewed and explained the process. The technician explained how the scopes were cleaned with individual cleaning brushes, and that these brushes were processed with the scope in the Steris washer. The technician reported the cleaning brushes were re-processed until the bristles lost their integrity and then a new cleaning brush was used.

The packaging and manufacturer's guidelines for the product was reviewed. The cleaning brush was manufactured by US Endoscopy. The labeling on the package indicated the brush was a 5 millimeter (mm) to 7 mm channel cleaning brush. The labeling indicated the product was non-sterile and had several symbols on the package, including a triangle with an exclamation mark in it and the number 2 with a line through it. The manufacturer's guidelines for the product indicated "these products are intended for single patient use only. Any institution, practitioner, or third party who reprocesses, refurbishes, remanufactures, resterilizes, and/or reuses these disposable devices must bear full responsibility for their safety and effectiveness." Further review of the manufacturer's guidelines revealed a section of the insert explaining all the symbols used on the packaging. The 2 with a line through it meant single use only. The triangle with the exclamation mark meant "read instructions prior to using this product."

On 4/25/11 at 12:30 PM, a customer service representative from US Endoscopy was interviewed by phone and confirmed the product was single use.

On 4/25/11 at 11:30 AM, the surgical manager and the lead processing technician were interviewed. Both indicated they did not know what the symbol of the number 2 with a line through it meant. The lead processing technician reported the facility changed to this cleaning brush about five months ago. Prior to that time the facility had been using single use brushes and were disposing of them after use. The surgical manager reported that since 1/1/11, the facility performed 87 outpatient and 8 inpatient colonoscopies, 49 outpatient and 10 inpatient esophageal gastroduodenoscopies, 1 outpatient and 2 inpatient sigmoidoscopies, and 2 outpatient and 3 inpatient bronchoscopies. The surgical manager reported the facility followed AORN (Association of Perioperative Registered Nurses) and CDC (Centers for Disease Control) standards for infection control in the surgery unit. The surgical manager confirmed the facility did not have a third party re-processing contract. Re-processing of single use devices by a third party involves a Federal Drug Administration approval of re-processing single use devices.

Review of the facility policy, "Cleaning and processing instruments", dated 2/27/07 with the latest revision date of 1/21/11 revealed the following under sterilization process:

"6. Single use packaging materials are used for one sterilization cycle."

Review of the facility policy, "General infection control practices", dated 10/22/03 with the latest revision date of 2/21/11 revealed the following under re-use of single-use items:

"No single-use item shall be reused. This includes syringes, needles, single-use medication vials and any other item labeled for single use."

Review of the facility policy, "Single Use Equipment", dated 08/01/03 with a revision date of 01/11 revealed "Single use equipment (including syringes and vials) shall be used and disposed of in accordance with policy." Under length of use of single use equipment the policy indicated, "Single use equipment shall not be reused."

Based on observation and interview, the facility failed to monitor sterile processing and the cleaning process of the endoscopes for compliance with accepted infection control practices, hospital policies, AORN (Association of Perioperative Registered Nurses) standards, and manufacturer's guidelines.

Findings include:

On 4/25/11 at 11:00 AM, observations were done in the sterile processing areas and surgical suites. The scope cleaning process was observed in the soiled processing area. The lead processing technician was interviewed and explained the process. The technician explained how the scopes were cleaned with individual cleaning brushes, and that these brushes were processed with the scope in the Steris washer. The technician reported the cleaning brushes were re-processed until the bristles lost their integrity and then a new cleaning brush was used.

The packaging and manufacturer's guidelines for the product was reviewed. The cleaning brush was manufactured by US Endoscopy. The labeling on the package indicated the brush was a 5 millimeter (mm) to 7 mm channel cleaning brush. The labeling indicated the product was non-sterile and had several symbols on the package, including a triangle with an exclamation mark in it and the number 2 with a line through it. The manufacturer's guidelines for the product indicated "these products are intended for single patient use only. Any institution, practitioner, or third party who reprocesses, refurbishes, remanufactures, resterilizes, and/or reuses these disposable devices must bear full responsibility for their safety and effectiveness." Further review of the manufacturer's guidelines revealed a section of the insert explaining all the symbols used on the packaging. The 2 with a line through it meant single use only. The triangle with the exclamation mark meant "read instructions prior to using this product."

On 4/25/11 at 11:30 AM, the surgical manager and the lead processing technician were interviewed. Both indicated they did not know what the symbol of the number 2 with a line through it meant. The lead processing technician reported the facility changed to this cleaning brush about five months ago. Prior to that time the facility had been using single use brushes and were disposing of them after use. The surgical manager reported the facility followed AORN (Association of Perioperative Registered Nurses) and CDC (Centers for Disease Control) standards for infection control in the surgery unit. The surgical manager reported that since 1/1/11, the facility performed 87 outpatient and 8 inpatient colonoscopies, 49 outpatient and 10 inpatients esophageal gastroduodenoscopies, 1 outpatient and 2 inpatient sigmoidoscopies, and 2 outpatient and 3 inpatient bronchoscopies.

On 4/25/11 at 12:30 PM, a customer service representative from US Endoscopy was interviewed by phone and confirmed the product was single use.

Review of the facility policy, "Cleaning and processing instruments", dated 2/27/07 with the latest revision date of 1/21/11 revealed the following under sterilization process:

"6. Single use packaging materials are used for one sterilization cycle."

Review of the facility policy, "General infection control practices", dated 10/22/03 with the latest revision date of 2/21/11 revealed the following under re-use of single-use items:

"No single-use item shall be reused. This includes syringes, needles, single-use medication vials and any other item labeled for single use."

On the morning of 4/28/11 at approximately 11:00 AM, the Quality Assurance/Risk Management Coordinator was interviewed. The Coordinator could not provide evidence the sterile processing unit was being monitored by the quality assurance committee. The Coordinator acknowledged procedural problems were identified in the sterile processing area during a state infection control survey in 2010. The Coordinator acknowledged the reprocessing area needed to be monitored due to the history of non compliance with infection control standards and manufacturer's guidelines for reprocessing.

Based on record review and interview, the facility failed to require the results of all abuse investigations be sent to the Bureau of Health Care Quality and Compliance within five days of the incident.

Findings include:

The facility's policy and procedure entitled "Adult Dependant/Elder Abuse Reporting" dated 12/11/03 and last revised on 3/21/11, revealed written reports of incidents of abuse and findings were to be faxed to the Division of Aging. The policy and procedure did not require the investigation be sent to the Bureau of Health Care Quality and Complaince, the State survey and certification agency, within five working days.

In an interview with the social worker on the afternoon of 4/26/11, she confirmed the policy required the written report of the incident and findings to be faxed to the Division of Aging. The social worker was not aware of the requirement to send the report to the Bureau of Health Care Quality and Complaince within a five day period.