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Based on observation and interview, the provider failed to ensure all drugs and biologicals in three of four emergency rooms were stored in a locked room, monitored location, or secured location to prevent access by unauthorized individuals. Findings include:

1. Random observations throughout the survey from 5/16/11 through 5/18/11 revealed the following unsecured drugs and biologicals:

Emergency room 1:
*14 - 10 milliliter (ml) sodium chloride prefilled syringes.
*2 - 10 ml sterile water prefilled syringes.
*4 - 5 ml heparin flush prefilled syringes.
*29 - 1000 ml intervenous (IV) bags of sterile water.

Examination room 5:
*3 - 4 ounce bottles of povidone Iodine.
*1 - bottle of Hibiclens scrub.
*1 - bottle hydrogen peroxide.
*3 - 10 ml sodium chloride prefilled syringes.
*4 - 5 ml heparin flush prefilled syringes.

Emergency room 2:
*1 - tube of lidocaine external use cream.
*4 - 5 ml sodium chloride prefilled syringes.
*4 - 5 ml heparin flush prefilled syringes.
*3 - 1000 ml IV bags of lactated ringers solution.
*1 - 500 ml IV bag of 5 % dextrose solution.
*1 - 1000 ml IV bag of dextrose/sodium chloride solution.

Interview on 5/17/11 at 4:30 p.m. with the director of patient services (DPS) and the infection control coordinator confirmed the above listed drugs and biologicals were not in secured areas. They further confirmed anyone who entered those areas would have access to the above listed items. The DPS informed the surveyor the provider did not have a policy in regards to the security of drugs and biologicals.

Based on observation, interview, record review, and policy reviews the provider failed to ensure:
*Flash sterilization was not the primary method of sterilization for ophthalmic instruments.
*One of one procedure medication tray was maintained in sanitary and hygenic manner.
*Two of two multiple dose vials of 1 percent (%) lidocaine on the intravenous cart were disposed of after being opened greater than 28 days.
Findings include:

1. Observation on 5/17/11 at 8:35 a.m. of the intravenous cart going to patient 21's room revealed two 20 milliliter vials of 1% lidocaine were on top of the cart:
-One vial was 3/4 empty and had an opened date of 3/6/11 on it.
-One vial was 1/2 empty and had an opened date of 3/28/11 on it.

Interview on 5/17/11 at 8:38 a.m. with the director of patient services who was going to start patient 21 intravenous catheter revealed:
*The 1% lidocaine had been used to numb the area of the intravenous catheter sites of patients.
*Opened multiple dose vials were to be disposed of 28 days after they were opened.

2. Observation and interview on 5/17/11 at 10:50 a.m. of the operating room manager transporting patient 21's back to his room after his colonoscopy revealed:
*A medication tray that was used from procedure-to-procedure was placed on top of the patient's lap during transportation.
*Without cleansing the exterior of the medication tray the operating room manager placed that tray back into the provider's main medication room.
*The medication tray was normally transported in that manner during procedure days to ensure medication security.

3. Interview, record review, and policy review on 5/17/11 at 1:50 a.m. with surgical technician A and the operating room manager revealed:
*Ophthalmic procedures were preformed one day every two months in the provider's operating room. Six through nineteen ophthalmic procedures were performed during that one day of procedures.
*The provider did not have any ophthalmic instruments. The physician who preformed the procedures brought two sets of instruments with him.
*They used a 270 degree Fahrenheit (F),10 minute unwrapped flash sterilization on the ophthalmic instruments prior to starting the procedures as well as in-between and after procedures.
*The reason the ophthalmic instruments were flashed sterilized in th above manner was related to lack of time between cases and because the physician had told them it was okay.
*The provider's infection control coordinator did not review the use of flash sterilization.
*Ophthalmic instrument manufacturer's instructions provided by surgical technician A stated:
-Flash sterilization was to be used only in emergencies.
-The cycles recommended required the instruments to be wrapped,
-"High Speed (flash) autoclave: 270 F (132 C) for 10 minutes; unwrapped. This method should be reserved for emergencies only."
*They were not aware if the provider had a policy for initial sterilization of surgical instruments that came to the facility from an outside source.
*The provider had a reviewed and revised February 2011 policy on flash sterilization that stated: "Flash sterilization should be used only in urgent situations such as a dropped instrument during a procedure, when time does not allow doing a whole cycle and when indicated by the manufacturer."
*Both agreed the manufacturer's instructions and the provider's policy were not being followed for the proper sterilization of ophthalmic instruments.

Review of the Centers for Disease Control, Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 manual, page 58 through 59, pertaining to flash sterilization revealed:
*The time required for flash sterilization depended on the type of sterilizer and the type of items sterilized. The wrapped method of sterilization was the preferred method for sterilization.
*Performed correctly flash sterilization was an effective process for the sterilization of critical medical devices.
*Flash sterilization was a modification of conventional steam sterilization in which the items were placed in an open tray or placed in a specially designed, covered, rigid container to allow for rapid penetration of steam.
*"Historically, it is not recommended as a routine sterilization method because of the lack of timely biological indicators to monitor performance, absence of protective packaging following sterilization, possibility for contamination of processed items during transportation to the operating rooms, and the sterilization cycle parameters (i.e., time, temperature, pressure) are minimal."
*To address some of those concerns healthcare facilities had: "Placed equipment for flash sterilization in close proximity to the operating room to facilitate aseptic delivery to the point of use, extended the exposure time to ensure lethality comparable to sterilized wrapped items, used biological indicators that provide results in 1 hour for flash-sterilized items, and used protective packaging that permits steam penetration."
*"When sterile items are open to air, they will eventually become contaminated, the longer a sterile item is exposed to air, the greater the number of microorganisms that will settle on it."
*Flash sterilization was acceptable for processing cleaned patient-care items that could not be packaged, sterilized, and stored before use.
*Flash sterilization should not have been used for reasons of convenience as an alternative to purchasing additional instrument sets or to save time.

Review of the Association of periOperative Registered Nurses, Perioperative Standards and Recommended Practices, 2010 Edition, Denver, CO, pages 460-463, revealed:
*"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."
*Flash sterilization should have been performed only if all of the following conditions were met:
-The device manufacturer's written instructions on cycle type, exposure times, temperature setting, and dry times (if recommended) were available.
-Measures were taken to prevent contamination during transfer to the sterile field.
-Flash sterilized items were to be used immediately and not stored for later use.

Interview on 5/17/11 at 3:00 p.m. with the infection control coordinator and the director of patient services revealed:
*Both agreed the manufacturer's instructions and the provider's policy were not being followed for the proper sterilization of ophthalmic instruments.
*They were not aware if the provider had a policy for initial sterilization of surgical instruments that came to the facility from an outside source.
*They both agreed all of the above findings were breaches in proper infection control.

Based on interview and policy review, the provider failed to annually review and revise nursing policies and procedures. Findings include:

1. Interview and policy review on 5/17/11 at 3:00 p.m. with the director of patient services revealed:
*She had oversight of all of nursing services.
*Multiple nursing policies and procedures had not been updated for several years.
*She was in the process of reviewing and revising some of the polices and procedures but did not have them finished.
*She was not sure if the provider had a policy that required all policies and procedures to be annually reviewed and revised.
*She agreed the Centers for Medicare and Medicaid Services regulations called for annual review of all of the provider's policies and procedures.
*She agreed the nursing services policies and procedures were not appropriately reviewed and revised annually as required.