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Based on a review of the clinical record, staff interviews and a review of the facilities policies and procedures for two of ten patients (Patients' #1 and #2), the facility failed to develop infection control interventions to avoid the potential transmission of infections and communicable diseases. The findings include:
The hospital policy entitled Sterilization/Decontamination and Processing/Storage of Supplies and Instruments failed to identify a procedure in the event of cancelled sterilization and/or failed to identify who would be responsible to ensure the indicators on the instrumentation set identified sterile conditions prior to the transportation of sterilized equipment to each hospital area.
Please refer to A749

Based on a clinical record review, staff interviews and a review of the hospital ' s policies and procedures for two of ten sampled patients (Patients' #1 and #2), the facility failed to develop a system to mitigate the risk of health care associated infections. The finding includes:
Review of the clinical record identified Patient #1 was admitted to the hospital in labor on 10/14/14 at forty weeks gestation. Patient #1 ' s medical and surgical history was unremarkable and the patient ultimately underwent a primary cesarean section on 10/15/14 for failure to progress. Patient #2 was delivered on 10/15/14 at 1:21 PM with an Apgar scores of 8 and 9. Patient #1 tolerated the procedure well and had an uncomplicated post-operative course
On 10/15/14 at 5:30 PM, the Central Sterile Department notified the obstetrical unit that the instrumentation set utilized during Patient #1 ' s surgical procedure did not undergo the sterilization process. MD #1 who was an infectious disease physician consulted with Patient #1 and discussed the risk of contracting an autoimmune disease, Hepatitis B and/or C infection. Hepatitis B Immunoglobulin and Hepatitis B Vaccine were administered to Patient #1. Antiviral therapy was also initiated and administered to Patient #1 with a recommended twenty eight day course of treatment. Patient #1 was directed to discontinue breast feeding as transmission of an autoimmune disease was possible via breast milk. Further review of the clinical record indicated Patient #1 had pumped and discarded her breast milk to protect her supply.
Patient #2 was administered the Hepatitis B virus vaccine and the Hepatitis B immune globulin. Bloodwork was also completed to detect the presence of autoimmune disease; however Patient #1 declined antiviral therapy for Patient #2.
Interview with MD #1 on 11/18/14 at 11:00 AM identified Patient #1 and Patient #2 would need to be tested at one month, two month and at four month intervals, to ensure transmission of viral disease and/or infection was not present. MD #1 further identified Patient #1 would not be able to breastfeed Patient #2 until negative testing was obtained four months postpartum.
Interview with Certified Sterile Processing and Distribution Technician (CSPDT) #1 on 11/18/14 at 1:30 PM indicated on 10/12/14 at approximately 3:10 PM Cesarean Section Instrumentation Set #2 was due to be sterilized however he could not find the set. CSPDT #1 identified he canceled production of Instrumentation Set #2 in the computer system and went home. Further interview with CSPDT #1 indicated he did not communicate to oncoming staff that the instrumentation set could not be found and was not sterilized before he went off duty.
Interview with CSPDT #2 on 11/18/14 at 1:45 PM identified the unsterilized Cesarean Section Instrumentation Set #2 was located on a cart in the Central Sterile Unit with other sterilized sets that she transported to the labor and delivery area on 10/12/14. CSPDT #2 indicated she placed the instrumentation set in the supply area of the operating suite in labor and delivery without checking the indicators on the set to determine their sterility. Further interview with CSPDT #2 identified on 10/15/14 she was working in the decontamination section of the Central Sterile Department and noted when Cesarean Section Instrumentation Set #2 came into the unit the indicator did not identify that it had been sterilized and notified the administrative staff immediately.
On 11/16/14 interview with Scrub Technician #1 and RN #1 who circulated on the case for Patient #1 and #2 on 10/15/14 identified they do not recall if they checked the indicators that were on the inside and outside of Instrumentation Set #2 as they were trained to do.
Interview with the Central Sterile Manager on 11/16/14 at 2:30 PM identified the Central Sterile Department failed to have a system in place that directed what to do and/or who to notify when sterilization was cancelled or not completed.
Subsequent to the event any employee who cancels a sterilization process has to notify management immediately. Instrumentation sets delivered to the obstetrical area have to be signed by the person transporting the instruments and the accepting staff indicating sterility of the equipment. In addition when the time out is conducted during a Cesarean Section sterility of the equipment needs to be confirmed and this step was added to the policy entitled Universal Precautions for Surgical/Invasive Procedures.
The hospital policy entitled Sterilization/Decontamination and Processing/Storage of Supplies and Instruments failed to identify a procedure in the event of cancelled sterilization and/or failed to identify who would be responsible to ensure the indicators on the instrumentation set identified sterile conditions prior to the transportation of sterilized equipment to each hospital area.
The hospital Infection control plan dated 2014 directed the institution would provide a system to include policies and procedures for the surveillance, control and prevention of infections within the hospital. The plan would provide the delivery of safe and efficient care to patients while providing protection from transmission of infections to patients.