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Based on observations, staff interviews, and policy review the facility failed to ensure medications were discarded after they had expired. Findings include:

The Labor and Delivery unit within the hospital and at the outpatient Center Sports Medicine and Rehabilitation (CSMR) in Lakeville had medications that were passed there expiration dates.

A tour of the Labor and Delivery unit was conducted on 6/15/11 at 9:00 a.m. with the nurse manager of the unit. During the tour of the unit, 5 pre-filled syringes with Prostaglandin vaginal gel 1 mg/2.5 ml were found in the refrigerator with an expiration date of 5/28/11. A pre-filled syringe of Phenylephrine 0.5 mg per 5 ml was also found in a brown zip lock bag in a drawer that had an expiration date of 6/7/11. The nurse manager confirmed that the pre-filled syringes were outdated and that pharmacy was to have removed outdated medications.

The pharmacy assistant (PA)-B was interviewed on 6/15/11 at approximately 9:45 a.m. and confirmed that it was her job to remove expired medications and had been busy and just had not removed the expired medications. The pharmacy assistant showed this surveyor a print out that indicated the medications had expired. Prostgladin vaginal gel was used for softening of the cervix and Phenylephrine was used for hypotensive emergencies during spinal anesthesia.

During at tour of CSMR at Lakeville on 6/16/11 at approximately 8:20 a.m. with a physical therapist (PT)-A and a physical therapy assistant (PTA)-C there were 6 vials of Dexamethasone 4 mg/1 ml (2 open and 4 sealed vials) all with expiration dates of 4/11. PTA-C confirmed that the 6 vials of Dexamethasone were expired and that it was her job to remove the expired medications which she had not done. Dexamethasone was used for decreasing inflammation.

The facility's pharmacy policy, Omnicell Medication Distribution System on a monthly basis receives a "Medication expire report and then pharmacy removes any medications that will expire according to the list." The pharmacy assistant on 6/15/11 at 9:45 a.m. confirmed that she had the expiration list but had not pulled the expired medications and had not followed the facility's policy on removing expired medications.

Based on record, policy review, and interview, the hospital failed to notify the organ procurement organization (OPO) in a timely matter of patients who had died while in the hospital for 1 of 3 patients (P1). Findings include:

P1's death record dated 3/20/11 lacked documentation that the organ tissue and eye donation program had been contacted after death. The record indicated under "tissue/organ donation" that the OPO was not notified of the patients death.

The organ procurement policy indicated that "the regional procurement agency must be notified after EVERY death and BEFORE mentioning donation to the family. Call as soon after the patient death as possible." LifeSource's definition of Time (Timely Notification) indicated "within one hour after cardiac death."

During interview on 6/16/11 at 2:21 p.m. with the director of surgery who was in charge of the organ tissue and eye donation program verified every death should be reported to the OPO. She reported she was unaware the OPO had not been contacted for P1. She stated she received a report from LifeSource on how many referrals they get quarterly and passes that information onto the Quality Assurance coordinator.

During interview on 6/16/11 at 4:04 p.m. the Quality Assurance Coordinator stated she received the LifeSource reports quarterly and only analyzed them annually. She stated the person in charge of this area was to print off the hospitals death summary and compare to LifeSource referrals to make sure timely reporting was completed. The Quality Assurance coordinator verified this had not been done recently due to staff turn-over in this roll.

Based on interview, record review and policy review, the hospital was found not to be in compliance with the Conditions of Participation for Surgical Services (CFR 482.51) due to failure to ensure proper sterilization of surgical instruments had occurred for 33 of 41 patients that underwent cataract extraction with intraocular lens implant surgeries from 4/06/2011 through 6/08/2011. This potentially could affect most patients provided eye surgery at the hospital. Findings include:

The hospital did not follow their policy/procedures or manufacture's instruction to ensure surgical instruments were sterilized as recommended to prevent the risk of surgical infections.

During the tour of the surgical department on 6/14/11 at 2:40 p.m. the Surgical Services Director (SSD) was interviewed regarding the use of flash sterilization. She stated the microsurgical eye instruments are washed between cases and then placed unwrapped in the flash sterilizer in a tray and are in the autoclave cycle for four minutes. The SSD stated the hospital had three microsurgical eye instruments trays and indicated two physicians were available to perform eye surgeries only on Wednesdays for both physicians. They would use these 3 trays by flash sterilizing them between cases. The SSD reviewed the use of the flash sterilizing record and indicated on 6/8/11 the eye instruments were flash sterilized for four different patients. On 6/1/11 the eye instruments were flash sterilization and used on three different patients. The policy and manufacturer's recommendations for use of flash sterilization on surgical instruments were requested. Three months of the log which recorded the use of the flash sterilization of unwrapped eye instruments were requested.

Review of the hospitals flash sterilization of eye instruments record for 6/8/11 indicated the flashed sterilized instruments were used on 4 of 6 eye surgeries completed that day and on 6/1/11, 3 of 5 eye surgeries completed; on 5/25/11 flash sterilization was used in 10 of 11 eye surgeries; on 5/18/11 flash sterilization was used in 4 of 5 cases; on 5/11/11 flash sterilization was used in 5 of 6 eye surgeries; on 4/27/11 flash sterilization was used in 6 of 7 eye surgeries; on 4/20/11 flash sterilization was used on 4 of the 7 eye surgeries; on 4/6/11 flash sterilization was used for 3 of the 5 eye surgeries.

On review of the manufacturer ' s instructions for flash sterilization provided by the facility stated that that the instruments needed to be wrapped and exposed time of 250 degrees for 30 minutes, this included textile packs and wrapped utensils. It also stated, " Flash sterilization may be associated with increased risk of infection to patients because of pressure on personnel to eliminate one or more steps in the cleaning and sterilization process. " Also, " Flash sterilization should be used only when there is insufficient time to process the preferred wrapped or container method. Flash sterilization should not b use as a substitute for sufficient instrument inventory. "

On 6/17/11 at 9:45 a.m. the SSD provided a copy of the recommendations from 2010 Perioperative Standards and Recommended Practices pertaining to flash sterilization. The recommendations were: "Flash sterilization should be used only when there is insufficient time to process by the preferred wrapped or container method. Flash sterilization should not be used as a substitute for sufficient instrument inventory." The SSD indicated at that time they used the flash sterilization of the unwrapped eye trays when they had more than three eye surgeries on Wednesdays. She confirmed they used the flash sterilization routinely on Wednesdays when the eye surgeries were performed. The facility's policy Sterilization Practices revised January 2011 indicated: Flash sterilization will be kept at a minimum and only utilized when insufficient time to process by preferred methods. The SSD verified the instruments are not wrapped prior to placing in the sterilizer.