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Based on interview and record review the facility governing body (Board of Trustees) failed to ensure direct patient care services provided under contract agreements were provided in a safe, effective manner that was systematically evaluated and integrated into the facility quality assessment and performance improvement (QAPI) program. The facility census was 177.

Findings included:

1. Review of the facility's undated policy titled, "Negotiation, Review, Approval and Evaluation of Patient Care Contracts" showed the following direction:
-1. A. All contracts must be approved by the Board of Trustees.
-II. B. Direct Patient Care was defined as non-employees (contract staff) with access to high risk and patient care areas whose services provide direct patient care.
-II. C. Contractors were subject to yearly evaluation.
-II. I. Evaluation of the quality of contracted services was based on written expectations.

Further review of the policy showed the facility failed to direct contractors to develop and maintain QAPI studies and projects to report and integrate into the facility QAPI program.

2. Review of the facility's list of contractors (twenty one single spaced pages) showed direct care services including nurse staffing, diagnostic imaging, cardiovascular anesthesia, water used in hemodialysis machines, home health, hospice services, emergency room physicians and other physicians in specialized areas of medical care.

3. During an interview on 10/18/12 at 10:58 AM Staff GG, Director of Risk Management stated that the contractors who provided direct patient care were not included in the facility QAPI program and confirmed the integration of the contractors into the facility QAPI program was an area that needed improvement.

4. During an interview on 10/18/12 11:00 AM, Staff GGG, Director of Pharmacy stated that the quality assurance monitoring received from three contracted services are not reported to the hospital wide quality assurance council. The three contracted services are:
-Two separate services that provide sterile compounding (mixing), preparation of and repackaging of patient medications;
-One service that provides environmental and equipment testing for the pharmacy clean room (a distinct room within the pharmacy, which contains all the essential equipment to ensure sterility of all medications, delivered through the blood stream).


17863

Based on interview, record review and policy review, the facility failed to ensure that pre-printed medication orders sets (group of orders that are used for multiple patients) defined specific parameters for use in the pre and post (before and after) surgical areas. This had the potential to cause under medication or over medication in patients receiving pain or sedation medications. The facility performs an average of 558 cases per month. The facility census was 177.

Findings included:

1. Record review of the facility's policy titled "Physician Orders for Medications" revised 01/12, showed that range orders include a dose and dosing interval of which either may vary over a prescribed range and that the variable dose of frequency allow for change in patient situation or status.

2. Record review of pre-printed Day of Surgery Adult Surgical Services Physician's Order set, dated 10/17/12, for Patient #23 showed range orders for Versed (a sedative) 0.5-2 milligrams (mg - unit of measure) Intravenous (IV - in the vein) push every five minutes to a total of 2 mg for anxiety.

3. Record review of pre-printed Laparoscopic Surgery, Post-op Physician's Order set, dated 10/17/12, for Patient #23 showed range orders for:
-Morphine (pain medication) 2-5 mg IV every two hours as needed for severe pain;
-Vicodin (pain medication) 1-2 tablet orally (by mouth) every four hours as needed for moderate pain;
-Norco (pain medication) 1-2 tablet orally every six hours as needed for moderate pain.

4. Record review of pre-printed Post Anesthesia Care Unit (PACU) Adult Physician's Order set, dated 10/17/12, for Patient #23 showed range orders for Morphine 1-5 mg IV push every 10 minutes as needed for breakthrough pain greater than 6/10 (pain measurement on a 1-10 scale).

5. Record review of Patient #23's medication administration record showed the following medications were administered to her at the maximum range dose allowed per physician order, each time a medication was given on 10/17/12:
-At 8:49 AM, Versed 2 mg IV push;
-At 10:58 AM, Morphine 5 mg IV push;
-At 11:06 AM, Morphine 5 mg IV push.

6. During an interview on 10/171/12 at 12:30 PM, Staff JJ, Registered Nurse stated that we give 5 mg (maximum range dose order) of Morphine to everyone, because "any less than that won't touch them", and added that dosage administration was based on nursing judgment.

7. Review of an email reply dated 10/18/12 at 8:38 AM, showed that Staff K, Director of Surgical Services, wrote, "A range order ... needs to be defined. I will be working ...to take away the ability to enter a range order without clarification".

8. During an interview on 10/17/12 at 2:15 PM Staff GGG, the Director of Pharmacy, stated that she was aware of the problem with the current utilization of physician orders that include the medication dosage ranges, and that it was a bad practice.


17863

Based on observation, interview and record review the facility failed to ensure the confidentiality of paper patient medical records (protected health information or PHI) stored on-site in a building annex of the facility. The facility census was 177.

Findings included:

1. Review of the facility's policy titled, "Confidentiality", dated 04/08/01 showed the following direction:
-Guideline: Patient information and records are confidential and should never be discussed with anyone.
-Procedure: Managers will instruct staff on confidentiality matters and will discipline employees who are in violation of this guideline.

The policy failed to address protection of the confidentiality of the multiple paper medical records or PHI created and maintained in multiple facility departments.

2. During an interview on 10/16/12 at 9:20 AM Staff A, Interim Manager, Health Information Management (HIM) stated that:
-The facility maintained a mixture of paper and electronic patient medical records.
-The paper portion of the patient medical records were scanned into the electronic record after discharge.
-The scanned paper records were kept for three months after scanning (in case it was discovered a document was not scanned/missed it could be recovered and scanned).
-Most clinics (such and Pain Clinic and Wound Clinic) maintained all paper patient medical records.

3. Observation on 10/16/12 at approximately 10:30 AM in the Pain Clinic showed clinic staff stored discharged patient medical records in the clinic office ready for "pick up" and transport to the building annex.

4. During an interview on 10/16/12 at approximately 10:32 AM Staff T, Unit Registrar stated that Pain Clinic staff maintained the discharged patient medical records until there was enough to box up and send to the building annex. When Pain Clinic staff had enough medical records to send to storage, they would call Staff S to transport the boxes to the building annex.

5. During an interview on 10/16/12 at 10:45 AM Staff S confirmed that:
-He was a housekeeper.
-He had been transporting boxes of paper records from many facility departments to the building annex for storage over the last ten years.
-When he initially started placing boxes in the building annex he noticed there was no method of identification of the department that sent the boxes and there was no method of identifying what was in the boxes so, he started dating each box (the dates from the records in the boxes) and he labeled, separated and segregated boxes as he brought them from the main building.
-He had access to all records because he had the key to the building.
-Boxes that he transported were not sealed.
-He was sometimes called to take boxes of records from the building annex to the main facility (back to the sending department).
-His supervisor had access to the building annex (had another key).

6. Observation on 10/16/12 at 10:49 AM in the building annex showed:
-A large "butler building" separated from the main building.
-A large unfinished interior with multiple rows of shelving each stacked with cardboard storage boxes labeled with dates (as long ago as 2003).
-None of the boxes were sealed.
-Near the access door, on the floor were construction supplies (Staff S stated he thought Plant Operations had allowed contractors to place building supplies in the annex).
-Some of the boxes contained surgical records with patient names, dates and times of surgical procedure and patient diagnoses; other boxes contained blood bank records; other boxes contained delivery room records with the mother's names, physicians, gestation period, presentation, fetal monitoring, medications, names of the pediatricians, nurses and anesthesiologists.
-Stacks of boxes and other shelving were separated by space for ease of access.

7. During an interview on 10/16/12 at 11:00 AM Staff S stated that:
-He maintained a log of the number of boxes and department that sent the box.
-He was not aware of any facility policy regarding maintaining confidentiality of patient medical records in storage.
-He also stated there was another "downstairs" section of the building annex.

8. Observation on 10/16/12 at 11:02 AM in the downstairs section of the building annex showed a smaller area of three rooms. Two of the rooms were pad locked.

9. During an interview on 10/16/12 at 11:05 AM Staff S stated the pad locked rooms contained boxes from the Human Resources department and the other was boxes from Administration. The third room was unlocked and contained boxes from the Breast Clinic.

10. Observation on 10/16/12 at 11:05 AM showed staff stored Breast Clinic patient information; radiology films and printed information including name of the patient and date of birth.

11. During an interview on 10/17/12 at 9:23 Staff N Privacy Officer and Security Specialist stated the following:
-She had no input into the use of the building.
-She knew Plant Operations departments had oversight of the building annex.
-She was concerned because she had to verify who had keys or access to keys and she was concerned because there was no traffic control (access and traffic into the building).
-She had looked at limiting the access to the building annex and knew there were six keys (Staff S, Staff S's supervisor, security, Plant Operations plus two other unstated key holders).
-There was no inventory of the boxes (content).
-As Privacy Officer and Security Specialist, she was concerned that there were a number of keys and traffic into the area.
-She knew that as an organization, the facility should have one consolidated medical record and not fragmented sections from various departments.
-She would review the use of the building and the protection of PHI.

The facility failed to have policies in place that govern the use of the building and the protection of PHI stored in the building.

Based on observation, interview, record review, and policy review, the facility failed to ensure informed consent was properly executed for patient procedures for two (Patients #6 and #19) of 14 current patients and for one (Patient #14) of one discharged patient reviewed. The facility census was 177.

Findings included:

1. Review of the facility's Plan for Provision of Patient Care, Section XI Administrative Implication for Selected Clinical Issues, paragraph F. Organization-Wide Statement on Blood/Blood Products Administration, dated 10/12/10 showed direction for facility physicians to discuss blood transfusion with the patient and have the patient sign the Blood Component Transfusion Consent before any blood or blood product was infused.

2. Review of an undated copy of the facility's Medical Staff Rules and Regulations provided by Staff III, Manager of Performance Improvement showed direction for staff to provide evidence of informed consent in each patient medical record where informed consent was required by facility policy

3. Record review of the facility's policy titled, "Informed Consent/General Treatment Consent" revised on 10/11, showed that it is the physician's duty to inform the patient of the risks, benefits and any alternatives available to them, and that the informed consent is valid only if the patient understands the nature of the procedure, why it is being recommended, its benefits, the significant risks involved, and any alternative treatments that exist.

4. Record review of Patient #6's medical record showed a consent form for dialysis, which was signed and dated by Patient #6 and a witness on 10/16/12 at 2:00 PM. The bottom of the consent form, which included the reason for the procedure, risks, benefits, alternatives, etc, as explained to the patient by the physician, did not contain a physician's signature.

5. Record review of Patient #19's medical record showed a consent form for Endoscopy (to look inside the body with a scope) was dated 10/15/12 and signed by the patient's family member, but did not contain a physician's signature indicating that he had explained the reason for the procedure, risks, benefits, alternatives, etc.

6. During an interview on 10/16/12 at 10:46 AM, Staff H, Registered Nurse (RN), stated that a consent form must include a physician's signature, after the physician has reviewed the risks and benefits with the patient.

7. Record review of Patient #14's Permanent Transfusion Record form dated 09/13/12 at 1:28 PM showed staff transfused one unit of single donor (SD) platelets.

Review of the patient's Permanent Transfusion Record form dated 09/14/12 at 10:27 AM (a second form) showed staff infused a second unit of SD platelets.

8. Further review of Patient #14's medical record and consent forms showed no consent forms for the two units of SD platelets transfused on 09/13/12 or on 09/14/12.

9. During an interview on 10/17/12 at 2:49 PM Staff A, Interim Manager of Health Information Management (HIM) stated that:
-Any patient who received blood or blood products should have a signed consent for those blood/blood products completed and on the medical record.
-Patient #14's medical record did not show evidence of signed consents for the blood/blood products on the medical record.




16215

Based on observation, interview, and policy review, the facility failed to ensure the safety and integrity of intravenous medications and the tubing necessary for delivering the solutions to two (Patient #30, Patient #31) of four patients reviewed. The facility census was 177.

Findings included:

1. Review of the facility's policy titled "Intravenous Therapy Overview", dated 03/11 showed that the intravenous (IV) solutions (medications or nutrients in controlled prescribed amounts administered through tubing inserted into a person's circulatory system (blood stream) through an intravenous catheter placed into a vein administered by the venous (through the vein) route should not be hanging longer than 24 hours (once administration begins, bags of IV solutions hang from infusion pumps and poles while being administered).

Review of the facility's policy titled, "Medication Administration" dated 08/12 showed:
-Labeling of all medications outside of pharmacy (on nursing units) are required to be labeled with the time and date the medications are prepared.
-At a minimum, the label should contain the patient name, patient location, directions for use, the drug name, drug strength, and expiration date (medications not intended for immediate administration in one single dose);
-All medications found unlabeled should be discarded immediately.

2. Observation on 10/16/12 at 10:13 AM on the surgical unit showed Patient #31 with unlabeled IV fluids and unlabeled IV tubing. The IV fluids infusing were:
-One-500 milliliter bag of Potassium Chloride 0.45% 20 milliequivillent (mEq/l, a fluid administered to replace serum potassium);
-One-1000 milliliter bag of Sodium chloride 0.9% (a fluid to replace serum sodium).

Observation on 10/16/12 at 10:17 AM on the surgical unit showed Patient #31 with two intravenous medications infusing per IV catheter. Both IV medication bags and attached tubing were unlabeled. The IV fluids that were infusing were:
-One-1000 millilieter bag of Sodium Chloride 0.45% with 20 mEq/l of potassium chloride added (a fluid replacement with potassium added to replace serum potassium;
-Ceftriaxone one gram (an antibiotic administered to treat infections).

3. Observation on 10/16/12 at 1:45 PM on the orthopedic unit showed Staff LLL administer per intravenous infusion pump an unlabeled one-liter bag of Sodium Chloride 0.9% per unlabeled IV tubing to Patient #30.

4. During an interview on 10/16/12 at 1:45 PM while initiating a one-liter bag of Sodium Chloride 0.9% per unlabeled IV tubing per IV infusion pump to Patient #30, Staff LLL stated that the bag came pre-printed with the contents of the solution and that the tubing should have been labeled. Staff LLL did not recognize the need to label the IV solution.

5. During an interview on 10/17/12 at 2:00 PM with the Director of Pharmacy, Staff GGG stated that all intravenous solutions, whether mixed from the pharmacy or taken from the stock on the nursing units, are required to be labeled with the patients name, room number, dose, the time it was administered, and the expiration date. She also stated that labeling is required for all IV tubing. Staff GGG verified that IV solutions and IV tubing that are not labeled have the potential to have altered integrity and safety of the IV solution and IV tubing and should be discarded when found unlabeled.

6. During an interview on 10/18/12 at 3:40 PM, the Infection Prevention Practitioner, Staff HHH stated that she was aware of problems with unlabeled IV fluids, IV fluids not discontinued after twenty-four hours (hanging for more than twenty- four hours) and IV tubing not being labeled. Staff GG stated that nursing staff education was provided in October 2011, during the fourth quarter of 2011 and April 2012.

Based on observation, interview and record review, the facility failed to:
-Continuously monitor temperature and humidity (moisture in the air) in the Sterile Processing Department (SPD);
-Ensure that humidity in the SPD was maintained within normal limits, potentially affecting the sterility of instruments used in surgical procedures, and
-Failed to maintain a sanitary environment with easily cleanable wall surfaces in the blood drawing area of the laboratory. The facility performs an average of 558 surgical cases per month. The facility census was 177.

Findings included:

1. During an interview on 10/18/12 at approximately 5:00 PM, Staff AA, Vice President of Quality, stated that the facility did not have a policy related to monitoring temperature and humidity in the Sterile Processing Department (SPD).

2. Record review of the SPD temperature and humidity log documentation showed that between 05/09/12 and 10/18/12 SPD staff failed to monitor temperature and humidity for:
-178 out of 495 opportunities in the SPD Assembly area (area where surgical instruments are placed in packaging or trays prior to sterilization);
-177 out of 495 opportunities in the SPD Sterile Storage area (area where surgical instruments are stored after they have been sterilized);
-179 out of 495 opportunities in the SPD Decontamination area (area where dirty instruments are brought into the SPD).

3. During an interview on 10/18/12 at 9:15 AM, Staff NN, SPD Supervisor, stated SPD staff are expected to document the temperature and humidity of the Assembly, Sterile Storage and Decontamination area every shift, every day (three times a day, seven days a week).

4. Observation on 10/18/12 at 9:15 AM showed the SPD humidity was 16% (normal range was 30-60%) in the Sterile Storage area.

5. Record review of the SPD temperature and humidity log documentation showed the humidity in the SPD was below the normal range for the following:
-Assembly area (in September) for six out of 33 shifts documented (an additional seven shifts showed no humidity documentation) between 09/18/12 and 09/30/12;
-Assembly area (in October) on 10/05/12 (24-28%), 10/06/12 (16-25%), 10/07/12 (16%), 10/08/12 (16-21%), 10/09/12 (25%), 10/10/12 (16%), 10/11/12 (21%), 10/12/12 (21%) and 10/18/12 (16%);
-Sterile Storage area (in September) for three out of 33 shifts documented (an additional seven shifts showed no humidity documentation) between 09/18/12 and 09/30/12);
-Sterile Storage area (in October) on 10/05/12 (26% to normal range), 10/06/12 (16-25%), 10/07/12 (16-21%), 10/08/12 (21-25%), 10/09/12 (27%), 10/10/12 (21-23%), 10/11/12 (23%), 10/12/12 (25-29%) and 10/18/12 (21%);
-Decontamination area (in September) for three out of 33 shifts (an additional seven shifts showed no humidity documentation) between 09/18/12 and 09/30/12;
-Decontamination area (in October) on 10/06/12 (16-22%), 10/07/12 (16%), 10/08/12 (16-25%), 10/09/12 (29%), 10/10/12 (21-22%), 10/11/12 (25%), 10/12/12 (22-29%) and 10/18/12 (16%).

6. During an interview on 10/18/12 at 9:15 AM, Staff NN, SPD Supervisor, stated that lower than normal humidity affects the integrity of the sterile instrument packaging, thus affecting the sterility of the surgical instruments. Staff NN stated that SPD staff do not notify Plant Services when the humidity is low, because Plant Services staff stated there was nothing they could do to bring the humidity back within normal range. Staff NN added that the hospital was in the process of installing a humidity monitor because they recognized that the humidity was frequently outside of expected limits.. .

7. Record review of a work request dated 06/14/12 showed a request to install a humidifier (increases moisture in the air) for the SPD.

8. During an interview on 10/18/12 at 3:30 PM, Staff Y, Plant Operations Manager, stated that the lower than normal humidity in the SPD areas were identified at the beginning of 2012, but the installation of the humidifier was delayed because the lower than normal humidity was considered a cold weather issue.

9. Observation of the laboratory on 10/17/12 at 2:00 PM showed severe gouges, scrapes and chipped plaster on both sides a doorway to a room in the laboratory where blood is drawn from patients. The doorway was not equipped with any protective strips or bumpers and the missing chips and gouges created rough wall surfaces that were no longer easily cleanable.

10. During an interview on 10/17/12 at 2:00 PM, Staff UU, Director of Laboratory Services, stated that the door gets repeated damage from wide wheelchairs being wheeled through the door. She stated that they might have to widen the door but that she had not submitted a work order for widening the door.



04467

Based on observation, interview, and policy review, the facility failed to remove expired supplies from the crash cart in the Outpatient Pain Clinic and Progressive Care Unit, and failed to establish a program of preventive maintenance for Ultrasound liquid gel warmers in Diagnostic Imaging. The facility census was 177.

The facility census was 177.

Findings included:

1. Record review of the facility's policy titled "Crash Cart" dated 06/12, showed the following:
-CSR (Central Supply and Receiving) will restock the missing supplies on cart and check for expired supplies. An expiration tag noting the first CSR item in cart to expire will be noted on the outside of the third drawer of the cart.
-CSR will check any carts not exchanged during a quarter for outdated CSR supplies.

2. Observation on 10/16/12 at 2:50 PM, of the Outpatient Pain Clinic showed the following expired supplies in the clinic's crash cart:
-Nine 10 millimeter (ml) saline flushes (used to clear intravenous (IV) lines of medicine and ensure the IV line is useable), seven with expiration date 05/2012, one with expiration date 12/2010 and one with expiration date 06/2012.
-Five arterial blood gas sampling kits (used to measure gas exchange and oxygenation), two with expiration date 06/2012, one with expiration date 07/2012, and one with expiration date 12/2011.
-One cricothyrotomy catheter set (used to establish an airway) with expiration date 08/2012.
-Four 16 gauge jelco stylet (needle placed in the vein so fluids and medication can be administered directly in the vein) with expiration date 12/2011.
-Four 18 gauge jelco stylet with expiration date 07/2012.
-Two antiseptic solutions (used to reduce the risk of infection) with expiration date 04/2012.
-One multi lumen central venous catheter (a catheter placed into a large vein in the neck to administer fluids, medications and/or obtain blood for tests) kit with expiration date 09/2011.
-One pressure monitoring line with expiration date 03/2011.
-One central line dressing (used to cover a central venous catheter) kit with expiration date 02/2012.

3. During an interview on 10/16/12 at 3:10 PM, Staff KKK, Registered Nurse (RN) stated that CSR checked the clinic's crash cart but she did not know who checked the supplies in it. Staff KKK stated that when the crash cart is opened staff call pharmacy but she did not know for sure what the process is after pharmacy is called.

4. During a telephone interview on 10/19/12 at 10:15 AM, Staff MM, Director of CSR stated that any crash cart not exchanged during a quarter, CSR staff perform a check for expired supplies. Staff MM stated after staff has performed a check of supplies, they place an expiration tag on the outside of the crash cart to alert when an item is going to expire first. Staff MM stated that it is a joint effort between CSR staff and nursing staff to monitor for expired supplies in crash carts. Staff MM stated that the Outpatient Pain Clinic had not always participated in the exchange program and had recently joined the program. Staff MM stated there had been a misunderstanding with CSR staff because they did not realize the Outpatient Pain Clinic had recently joined the exchange program. Staff MM stated that staff had been reminded the Outpatient Pain Clinic is participating in the exchange program.

5. Observation on 10/16/12 at 1:50 PM of the Progressive Care Unit (PCU), showed five outdated groin dressings - Lot #554170, which expired 08/12.

6. During an interview on 10/16/12 at 1:50 PM, Staff L, PCU Director, stated that although the unit did not have a routine for checking for expired supplies, it was the responsibility of the nursing staff to ensure outdated supplies were removed.

7. Observation in the ultrasound room of the Diagnostic Imaging department on 10/17/12 at 11:15 AM showed two bottles of ultrasound gel (a type of conductive medium that is used in ultrasound diagnostic techniques and treatment therapies) in a warmer. A second pair of bottles was in a warmer located in an adjacent ultrasound room. No Biomed sticker (medical engineers who inspect, test and repair analytical medical equipment such as warmers, defibrillators, and blood pressure monitors) was on the warmers to indicate that Maintenance or Biomed departments were monitoring the units temperature ranges to ensure patient safety.

8. During an interview on 10/12/12 at 11:20 AM, Staff X, Director of Diagnostic Imaging and Staff Y, Director of Plant Operations stated that the gel warmers were not currently on any type of a tracking log to monitor temperatures. They stated that as far as they knew, there was no policy or established methodology for checking the temperatures of the warmers.


29047





04467

Based on observation, interview, and policy review the facility failed to take immediate steps to prevent potential transmission of infections through the use of pharmacy bulk package (PBP) intravenous radiographic contrast media (a material used to improve the visibility of internal bodily structures in an X ray image), used throughout the day for multiple patients in a non-sterile open environment and exposing patients to the risk of developing a potentially life-threatening infection. The facility census was 177.

Findings included:

1. Observation on 10/17/12 at 11:00 AM showed a pharmacy bulk package container of radiographic contrast media hung in the radiology suite.

2. Review of an ISMP (Institute for Safe Medication Practices) Medication Safety Alert dated 09/21/12 stated that inappropriate use of pharmacy bulk packages of intravenous contrast media increases risk of infections. The Medication Safety Alert states that the contents of PBPs are intended for use in a pharmacy admixture program and use is to be restricted to a "suitable work area" such as a laminar flow hood (a piece of equipment that provides an aseptic work area while allowing the containment of infectious splashes or aerosols and consists of a coarse pre-filter, a blower and a very fine filter to protect the operator, process or both) or equivalent clean air compounding area. The article stated that some staff erroneously believe the use of a sterile transfer set is all that is required, and hang a PBP of intravenous contrast media with a sterile transfer set attached for the entire day in a radiology suite or other unsuitable environment, and use it on multiple patients. The article stated that this is not consistent with the requirements of the US Food and Drug Administration, (FDA), the Centers for Medicare and Medicaid Services (CMS) Conditions of Participation for Hospitals, Center for Disease Control (CDC) Injection Safety Guidelines and the Joint Commission standards.

The article cited a report published in the Morbidity and Mortality Weekly Report (MMWR) dated July 13, 2012, which stated that no less than three serious and possibly one fatal infection from methicillin-resistant Staphylococcus aureus (MRSA) contaminated media had been linked to same container use for multiple patients.

3. During an interview on 10/17/12 at 2:00 PM, Staff X, Director of Diagnostic Imaging stated that they use multiple dose containers of a pharmacy bulk packaged (PBP) product used for administering doses to multiple patients throughout the day. She stated that her department does not have a specific policy for use of PBP's and they usually received notification of medication safety alerts through email or word of mouth from Pharmacy. She stated that a new bottle of contrast media is spiked and hung daily and changed every eight hours. She stated that the lower portion of the intravenous tube (from the in-line valve connection to the infusion site on the patient's arm) is changed with each patient, but the portion of tubing between the spiked bottle and the valve is not changed until a new bottle is introduced.

4. During a telephone interview on 11/06/12, at 11:00 AM, Staff HHH, Infection Control Preventionist, stated that she had not personally seen the alert. She stated that Pharmacy usually pushes pharmaceutical recall alerts and Purchasing usually follows up on FDA alerts. She stated that someone from Nuclear Medicine had called their department regarding the use of multi-dose bottles of contrast media and were told it was not recommended. She said Infection Control was apparently not aware of the email communication between Materials Management, Pharmacy and Diagnostic Imaging departments.

Based on interview, record review, policy review and review of the Association of Perioperative Registered Nurses recommended practice, the facility failed to ensure that immediate use sterilization (flash) was not used as a substitute for sufficient instrument inventory. The facility performs an average of 558 surgical cases per month. The facility census was 177.

Findings included:

1. Review of 2012 Association of Perioperative Registered Nurses (AORN) recommended practices for sterilization in the perioperative practice setting showed the following:
- Use of flash sterilization should be kept to a minimum.
- Flash sterilization should be used only in selected clinical situations and in a controlled manner.
- 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.

2. Record review of the facility's policy titled "Immediate Use Sterilization" revised on 02/12, showed that immediate use sterilization should not be used as an alternative to purchasing additional instrument sets.

3. Record review of the Operating Room (OR) Immediate Use Sterilization log showed the following surgical instruments were processed through immediate use sterilization for:
-Wolf ureteroscopes (thin, viewing instrument), once on 09/14/12 because "we have only one set of these scopes, opened on previous case";
-Small Dyonics Suction Punch (used for surgical cutting), once on 09/27/12 because it was "one of a kind, used on previous case";
-(Surgeon) Specialties (specific instruments requested frequently by a surgeon), three separate times on 10/01/12 because there were "not enough trays for all (six) scheduled cases ";
-Zimmer cable ready system (used for orthopedic surgeries), once on 10/01/12 because it was "opened on first case needed to run as available for second case";
-Biomed General Tray #2 (tray made up of specific surgical instruments), once on 10/01/12 because it was "opened on first case need available for second case".

4. During an interview on 10/17/12 at 11:10 AM, Staff II, Case Pull Technician, stated that it takes approximately four hours to complete a standard sterilization cycle and that there aren't enough of (Surgeon's) Specialties instruments to cover scheduled cases.

5. During an interview on 10/17/12 at 11:17 AM, Staff K, Director of Surgical Services, stated she was aware the immediate use sterilization was used due to a lack of inventory and has requested an increase in the instrument supply that is frequently flashed for this reason. Staff K added that she was aware of the standard that immediate use sterilization should not occur because inventory supply does not meet the surgical case load.