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Based on clinical record review, policy and procedure review and staff interview, the facility failed to ensure that 1 of 32 sampled patients (25) was free from restraints when haloperidol (a medication used to treat mental disorders) was administered with no documented clinical evidence justifying such use. In addition, there was no documented evidence that less restrictive measures were attempted before its use.

This failure impacted patients' rights to be free from restraints and could result in harm to patients from the medication side effects.

Findings:

A record review revealed that Patient 25 was non - English speaking and refused to use a translation device. The record also included notes indicating that Patient 25 was yelling and agitated.

There was no documented evidence that Patient 25's yelling or agitation was evaluated as an indication of a potential care need. There was no documented evidence that Patient 25's agitation presented a potential risk of harm to self or others.

A review of Patient 25's clinical record revealed an order was received by telephone on 12/10/12 at approximately 10 p.m. for haloperidol to be given to Patient 25 "for agitation." Patient 25 was given the medication that night at approximately 11 p.m.

There was no documentation that less restricting alternatives were attempted before the use of the haloperidol.

Review of the facility's policy "Restraint Policy and Procedure" revised 4/2012 revealed the following: "Using restraint only when alternative interventions have been ineffective to protect patient or others from harm." The policy included directions to "Use alternative measure[s] as preferred interventions ... and use the least restrictive method of restraints whenever possible."

Based on observation, interviews, medical record review and hospital Policy and Procedure review the facility failed to administer a medication to 1 of 32 sampled patients, Patient 2, in accordance with the physician's written medication order.

This failure had the potential to provide inadequate pain control for Patient 2.

Findings:

On 12/12/12 the medical record of Patient 2 was reviewed. At that time the Department noted that, on 12/10/12 at approximately 8:30 a.m., Patient 2's physician had changed the medication range for hydromorhone hydrochloride injectable (a type of narcotic pain reliever) from a range of 1-4 mg to a range of 3-4 mg. IVP (a medication given via an IV line by the nurse injecting it) every 4 hours for breakthrough pain prn (as needed) This change to 3-4 mg was transcribed, in handwriting, onto the Medication Administration Record (MAR) as ordered by the physician.

Review of Pt. 2's MARs dated 12/11 and 12/12/12 showed that Patient 2 received 1 dose of 1 mg. hydromorhone hydrochloride and 5 doses of 2 mg. hydromorhone hydrochloride instead of the 3-4 mg as ordered.

On 12/12/12 at 3:10 p.m. the Director of Inpatient Services (DIS) was interviewed regarding this apparent medication error and the MAR was reviewed with her at the same time. The DIS acknowledged that there were doses given incorrectly. She acknowledged that it appeared that the dose change had been transcribed correctly.

On 12/12/12 at 3:20 p.m. Patient 2 was interviewed about his pain management. He said the pain control was not great. Patient 2 said he was used to taking Kadian (morphine hydrochloride, a different type of narcotic pain reliever) for the last 15 years. Patient 2 stated that his pain was at about an 8 on the 1-10 pain scale and after his medications it would decrease by 10-20 % to maybe 5-6. He stated "I was getting 2 mg and it didn't work but now that I am getting the 4 mg it was a little better."

On 12/12/12 at 3:30 p.m. LN 1 was interviewed about the error and she acknowledged that Patient 2 had received some incorrect doses and the she had given an incorrect dose 12/12/12 at 8:40 a.m.

Review of the hospital Policy & Procedure titled Medication Errors, revised 5/12, identified under the following categories of Medication Errors; 1.b, Wrong dose errors: any dose of a drug that contained the wrong number or measurement of dosage units. Under Medication Errors; Monitoring, Monitoring errors includes failure to review or use a prescribed regimen.

Based on document and policy review and staff interview, the facility failed to ensure accurate accountability of all controlled substance when they failed to have a surveillance plan to detect and identify potential misuse or abuse of medication delivered through specific devices. In addition there was no system in place for ensuring that the policy for surveillance (evaluating discrepancy report) was implemented in all areas of the hospital. Lack of accountability facilitates misuse or abuse of controlled substance, and subsequently put patients at risk of harm.
Findings:

On 12/14/12, approximately at 1 p.m., controlled substance control and accountability was discussed with facility staff, Licensed Pharmacist (LP) 9, LP 10, and LP 11. It was presented that a narcotic discrepancy reports were printed daily for surveillance and evaluation. It was explained that these reports are forwarded to managers of different units or service areas for evaluation and follow up.

There was no clear evidence that these items were always followed up on and returned for trending and tracking.

Evaluation of a random report, dated 12/8/12, showed an unresolved discrepancy for 2 ampules of morphine (5 milligrams each). That deficiency dated back to 11/28/12 and was still unresolved on 12/14/12.

The same report showed an overage of 100 mcg of fentanyl that dated back to 11/21/12, which was unresolved. It was not known where that ampule came from. When asked about these unresolved discrepancies, LP 11 stated that these unresolved discrepancies stay on the report for 30 days, and then they drop off.

Allowing unresolved discrepancies to drop off, without follow up does not ensure accurate accountability for controlled substance, and allows for abuse and misuse. In addition, the such practice was not consistent with the facility's policy.

The policy titled: "Medication Distribution - Pyxis" dated 3/09, included the followings:

"Surveillance of controlled substance dispensing will be performed by the Director of Pharmacy and results reported to the Vice President of Nursing ....

The pharmacy will run a daily resolved and unresolved discrepancy report that will be sent to the Nurse Manager. The Nurse Manger will be responsible for follow up on unresolved discrepancies."

On 12/14/12 at 1 pm, LP 9 confirmed on interview that there was no current system to randomly check accuracy of transactions, for example, the facility was not auditing patients' records to validated accurate administration of medications and accountability of controlled substance.

Based on observation, clinical record review, and staff interview, the facility failed to ensure patient safety for medication administration as follow:

1. Patient 29 was prescribed metformin, a medication used to control blood sugar, even though there were two contraindications for its use in this case. .
2. Patient 28 was administered morphine, pain medication, without monitoring consistent with facility's policy.
3. Surveillance for potential medication errors or adverse drug reactions (ADRs) did not include all patient care areas of the hospital; therefore potential errors and ADRs may have gone undetected in anesthesia (surgery area) and Gastroenterology Laboratory (GI lab).
4. Refrigerated medications were not stored at appropriate temperature. The temperature of the refrigerator used to store medications was below the acceptable range for 8 days.
5. Policy for use of abbreviations and symbols was not implemented, when orders for medications for Patients 27 and 30 did not include a zero before the decimal point.
6. The facility failed to maintain the proper form of sterile water solution for diluting an emergency reversal agent to anesthesia drug, dantrolene, in accordance with accepted standards of practice. Dantrolene is an emergency drug used to treat a life threatening emergency, Malignant Hyperthermia (MH), caused by some general anesthesia inducing agents.

These failures can lead to patient harm and death.

Findings:

1. On 12/13/12 at 6:40 p.m., the clinical record for Patient 29 was reviewed with Licensed Pharmacist (LP) 8. The record revealed an 81 year old with history of diabetes. The patient came to the hospital for worsening of diabetes control. Patient 29 was on multiple medications prior to admission including metformin.

Metformin is used to lower blood sugar in patients with diabetes by decreasing glucose (sugar) production in the liver and by improving insulin sensitivity. This medication is contraindicated in patients with renal (kidney) disease or dysfunction (indicated by a serum creatinine =1.5 mg/dL in males or =1.4 mg/dL in females). A black box warning identified that the risk of accumulation of the drug and lactic acidosis increases with the degree of impairment of renal function. A black box warning, which is strong warning that certain contraindications or serious warnings are involved, particularly those that may lead to death or serious injury.

Lexicomp, a drug resource online, under consideration for geriatric dosing, for metformin, included: "Do not use in patients (80 years or older) =80 years of age unless normal renal function has been established."

Review of Patient 29's laboratory record showed His serum creatinine (scr) on 11/27/12 was 1.7, or slightly elevated indicating a some degree of renal impairment.

There was no evidence that the pharmacist intervened or questioned the order considering the contraindication (scr 1.7), the age of the patient.

2. On 12/12/12 at 10 a.m., review of the clincal record for Patient 28 with LN 4 revealed that the 75 year old man had an order for morphine a potent pain medication. Patient 28 was receiving pain medication via a PCA pump (patient controlled analgesia). Patient controlled analgesia is a method of pain management that permits patients to self-administer medications when needed through intermittent on-demand doses.

The form did not accurately reflect how many times Patient 28 tried to self-administer the pain medication, and how many doses he actually received in order to accurately evaluate the effectiveness of therapy.

By evaluating the number or doses delivered and the number of attempted dosing (number of times the patient pushed the button requesting doses), pain can be better assessed. However, in the absence of such documentation, it was not possible to know if the patient's pain was well controlled or not.

Review of the facility's policy titled: "Patient Controlled Analgesia (PCA) IV infuser pump for pain Management, dated 12/20/11, revealed the following instruction related to monitoring:
"An ongoing respiratory and sedation assessment by the RN (registered nurse) is critical to detection respiratory depression in opioid - sedated patients on PCA. Respiratory rate and quality (depth, ventilation effort, sound) should be included in the respiratory assessment. This cannot be a delegated task."

LP 8 provided a computerized printed document (dated 12/10/12-12/12/12) titled "Vital Signs for Patient" when asked to provide the respiratory and sedation assessments for Patient 28. Review of the document with LP 8 revealed documentation that the monitoring for Patient 28 was not completed by licensed nurses. All documentation on this form was completed by Certified Nursing Aides (CNA). There was no documentation on this document that addressed the quality (depth, ventilation effort, sound) of the patient's respirations. There was no documentation on this document of the sedation level of this patient. There was no documentation provided that a LN completed an respiratory and sedation assessment which includes respiratory rate and quality (depth, ventilation effort, sound) as required by the hospital's policy.

3. Facility Surveillance for potential medication error or adverse drug reaction did not include all patient care areas of the hospital such as anesthesia and GI (gastrointestinal) lab.

a. On 12/13/12, at approximately 3 pm, the clinical record for Patient 33 was reviewed with LP 8. The record revealed that Patient 33 was administered 2 mg of Versed which is a sedative hypnotic used for preoperative sedation. Excessive dosing of such medication could cause oversedation, respiratory depression, and decrease of blood pressure. Flumazenil is a reversal or rescue agent that is used to reverse some of the effects associated with Versed use.

Review of a Clinical Drug Utilization report, generated on 12/11/12, showed that flumazenil was used for Patient 33. Review of the clinical record revealed no documentation that flumazenil was administered to Patient 33 or description of what actually occurred during the procedure to necessitate the use of a rescue agent (flumazenil). Also review of the automated drug dispensing cabinet (Pyxis) transaction records for that patient showed that flumazenil was not returned.

During interview, on 12/13/12, LP 8 stated that reports for rescue agents are run daily and followed up by unit manager to evaluate for the presence of medication errors or adverse drug reaction. When asked for the follow up, LP 8 stated that there was no evidence of follow up related to use of Flumazenil in Patient 33. It was explained that medications removed from the anesthesia Pyxis machine do not show on the triggered report that is run by pharmacy daily.

Due to absence of documentation about the sequence of events in the clinical record and the absence of follow up on rescue medications used by anesthesia, it was not possible to know if the patient was given an overdose of Versed or if he was overly sedated or developed respiratory depression that a rescue agent, flumazenil, had to be used.

b. On 12/13/12 at 6 p.m., review of the clinical record for Patient 27 with LP 8 revealed that the patient underwent a procedure. Review of the anesthesia record revealed that the patient was administered fentanyl, an opioid medication that is used intraoperatively for pain and sedation. If given in excess, fentanyl can lead to oversedation and respiratory depression. Narcan is a rescue agent for opiate/opioid type medication that reverses sedation and respiratory depression.

The intraoperative record, (anesthesia) record showed that 0.8 milligrams of Narcan was administered at the end of the procedure, on 11/2/12 at 2:25 p.m. The record did not have any documentation of what actually happened to the patient to demonstrate the need for using the reversal agent.

There was no evidence that the use of Narcan for Patient 27 was evaluated by pharmacy staff or managers of the unit for the possibility of medication error (excessive dosing) or potential adverse drug reaction. The reason for the absence of follow up was that removal of rescue agents from the anesthesia Pyxis machine did not show on the daily report for pharmacy review according to LP 8.

c. On 12/14/12 at 12 noon, a request to evaluate medication storage in the Gastroenterology Laboratory (GI Lab) where diagnoses and treatment of digestive disorders were performed was attempted. GI lab was closed that day and the door was locked. The VPO (Vice President of Operations) unlocked the door to the lab, but indicated that she did not have access to the medication cabinets. The VPO clarified that pharmacy did not have access to the medication cabinets either, that a GI staff person had to be called to come specifically for that reason.

On 12/14/12 at approximately 12 noon, during interview, LP 9 stated that the pharmacy provides medications to the GI lab based on what they request. When asked about the trigger drug report, LP 9 stated that use of rescue agents in GI lab does not show on the report. Therefore, use of Narcan or flumazenil was not evaluated; consequently, potential medication errors and adverse drug reactions in the GI lab can go detected.

4. On 12/12/12 at approximately 4 pm, review of monthly inspection sheets with LP 10 and LP 9 revealed that some of the areas that the pharmacy has oversight of medication storage included refrigerators that utilize graphing method for monitoring the temperature. In addition, review of the log for medication refrigerators in the ski clinic, revealed documentation that the temperature was below range since opening on 12/7/12 until 12/14/12.

The log showed that the temperature was checked for two refrigerators (#1 and #2) and both of them were below 36 degrees Fahrenheit.

Only on one of the 8 days, 12/12/12, there was documentation of action taken: increasing the temperature. The temp was out of range for 8 days, yet there was no documented evidence demonstrating staff action.

On top of the log, the range was printed as 36-46 degrees Fahrenheit, and instruction to " Call engineering ... if temperature falls out of range. "

5. The facility failed to implement the "Abbreviation and Symbols" policy, dated 6/2012, when orders for Patient 27 and Patient 30 did not include zero before the decimal point when the dose is less than a whole unit with no evidence that these orders were clarified.

a. Review of the record for Patient 30 revealed an order for morphine sulfate, a pain medication. The dose was written as ".8" to be given every 3 hours as needed for pain.

On 12/12/12 at approximately 10 a.m., LP13, stated on interview, that everyone knows about the abbreviation policy and an order should not be written without the zero before the decimal point. LP13 was surprised when he saw the record and how the order was written.

The order clearly showed as 0.8 milligrams, not .8. That was confirmed by hospital staff that read the order, LP 12, LP 13 and LN 3. However, there was no evidence of clarification of the order.

b. On 12/13/12 at 6 p.m., review of the record for Patient 27 with LP 8 revealed that the patient underwent a procedure. Review of the anesthesia record showed an order for Narcan and the dose was written as ".80" units was not clear. Narcan is a rescue agent for opiate/opioid type medication that reverses sedation and respiratory depression.

Narcan comes in 0.4 mg/ml and the usual dose is 0.4 mg to 2 mg. The order was written and reads as ".80". LP 8 confirmed and indicated that such dose is confusing especially when the units (milligrams, or micrograms) were not legible.

There was no evidence that the facility tracked situations of deviation from policy for writing unclear orders for trending, analysis or further action.


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7. During emergency medication storage inspection on 12/13/12 at 5:30 p.m. with the Director of Surgical Services, the required 36 vials of dantrolene (medication used in treatment of Malignant Hyperthermia Crisis, a life threatening emergency condition that may be triggered by general anesthesia medications) was observed in the Malignant Hyperthermia (MH) emergency cart. The sterile water supply found in the MH cart was observed provided in nine 250 milliliter intravenous (IV)-type bags.

Review of the facility Policy titled "Malignant Hyperthermia" (last revised 10/11) showed that the policy was based on the Malignant Hyperthermia Association of the United States (MHAUS) guidelines for preparation and handling of a malignant hyperthermia crisis. The policy indicated that dantrolene was supplied in 20 mg (milligrams) vials and was reconstituted by mixing with 60 (ml) milliliters preservative free sterile water. The policy did not list the specific MH cart content to be maintained.

Malignant Hyperthermia Association of the United States (MHAUS) () is the only association in North America dedicated to the control of malignant hyperthermia (MH) and recommends that, "Sterile water for injection USP (without a bacte¿riostatic agent): Each vial of dantrolene should be reconstituted by adding 60 ml of sterile water for injection USP (without a bacteriostatic agent) and the vial shaken until the solution is clear... This water should be at room temperature or may be pre-warmed to body temperature (38-39°C or 98-99° F). We advise that the sterile water be stored in 100 ml vials, not bags, to avoid accidental IV administration of this hypotonic solution. "

In concurrent interview on 12/13/12 at 5:30 p.m. the Director of Surgical Services stated that 250 ml IV style bags of sterile water were provided for diluting dantrolene instead of the MHAUS recommended 100 ml vials, because the bags were easier to use. The Director of Surgical Services also stated that the 250 ml sterile solution bags were used when preparing and mixing of the medication dantrolene during mock drills for managing MH.

Based on staff interview and document review, the facility failed to ensure that their glucometers (a medical device used to measure patients' blood sugar levels) were appropriately cleaned and sanitized when two of four staff were unable to verbalize the correct procedure related to cleaning and sanitizing glucometers. Such practice placed patients at risk for exposure to bloodborne pathogens.

Findings:

On 12/12/12, four licensed nurses (LN) were interviewed about the frequency of cleaning and sanitizing their unit's glucometer:
1. During an interview at 1:35 p.m., LN 2 stated the glucometer was cleaned every shift.
2. During an interview at 1:48 p.m., LN 3 stated the glucometer was cleaned every 24 hours.

The hospital policy and procedure titled, "(Glucometer) Infection Control," was dated effective on 9/17/12. The policy and procedure determined that after use on each patient the surface should be cleaned with germicidal disposable wipes.

Based on observations, staff interview and document review the hospital failed to ensure that the organization of surgical services was appropriate to the scope of the services offered. The hospital failed to provide defined in writing and approved by the medical staff the scope of surgical services provided by the hospital in all inpatient and outpatient locations of the hospital, including procedures performed in the Radiology Department.

Findings:

On 12/11/12 the hospital administrative staff was asked to provide an organizational chart and the scope of surgical services defined in writing of all surgical services provided in all locations of the hospital. The administrative staff presented Medical Staff Organizational Chart of all Departments by category of services, which included Medicine Department Chair (Chairman, Physician 1) and Surgery Department Chairman (Physician 2). An organizational chart was also presented that included description of surgical services. Interventional Radiology was not part of the surgical services.

In an interview with the Director of Medical Imaging on 12/11/12 at 2:30 p.m. the Director confirmed that Interventional Radiology was under the Medicine Department and did not follow the Surgery Department's policies (for example policies related to surgical attire, environmental cleaning and disinfecting, temperature and humidity monitoring). Invasive surgical procedures performed outside operating rooms were not considered surgeries by the hospital, therefore the Surgery Services oversight was not provided by the Surgery Department. The Director of Medical Imaging presented no departmental policies related to surgical attire, environmental cleaning and disinfecting, temperature and humidity monitoring.

In an interview on 12/11/12 at 4:30 p.m. with the Director of Anesthesia and Surgery, the Director confirmed that his Department provided no oversight of Interventional Radiology (IR) but was not sure if the Chair of Surgery Department (different from surgical services) provided surgical oversight of the surgical procedures performed in the IR Department.

On 12/14/12 at 10:15 a.m. the Physician 1 and the Vice President of Operations (VPO) confirmed that the Medical Imaging, including Interventional Radiology Department, functioned independently from surgical services. Therefore, policies and practices by the surgical departments were not applied in Interventional Radiology. Physician 1 named some of the procedures done in the radiology department which included percutaneous/organ biopsies (lung, liver, thyroid), lumbar punctures, epidural injections and kyphoplasties (procedures on spine bones), among other procedures.

No evidence was presented to show that basic surgical practices in the IR Department were reviewed to identify which processes required standardization and which were Department specific in order to meet the patient safety goals and nationally recognized organizational standards.

Based on observations, staff interview and document review, the hospital failed to ensure that surgical services were consistent with needs and resources. Review of the Medical Imaging departmental and hospital-wide policies related to surgical services and infection control standards and interviews conducted during the survey showed that no appropriate policies or protocols were developed for surgical procedures that were performed in the Interventional Radiology (IR) Department, to ensure aseptic and sterile surveillance and practices were followed and maintained.

These failures had the potential for placing the Interventional Radiology patient(s) at risk for possible exposure to blood-borne pathogen(s) and/or transmission of communicable diseases and/or increased risk for infections related to surgical procedures.

Findings:

Review of surgical logs on 12/11/12 showed that the Medical Imaging Department provided services that included Interventional Radiology.

The on-line medical dictionary defined Interventional Radiology as the branch of radiology concerned with providing diagnosis and treatment of disease by a variety of percutaneous (pertaining to any medical procedure where access to inner organs or other tissue is done via needle-puncture of the skin) procedures performed under the guidance of radiological imaging.

On 12/11/12 starting at 12:50 p.m. Patient 14 was observed having ultrasound guided thyroid biopsy procedure performed in the Interventional Radiology procedure room by a radiologist, Physician 1. A sign posted on the outside of the entry door to the Interventional Radiology room indicated: "required attire." Upon entry to the room, an opened sterile field was observed. The IR registered Nurse (RN 2) confirmed the sterile field was prepared ahead of time, with sterile supplies set-up for Patient 14's procedure.

On 12/11/12 at 12:55 p.m. Patient 14 was observed brought into the procedure room (wearing a patient gown) and assessed by the IR registered nurse (RN 2) prior to the scheduled ultrasound guided thyroid biopsy. The ultrasound technician present in the room and RN 2 were observed wearing surgical scrubs, which per RN 2 were obtained in the surgical department daily and laundered by the facility.

However, at 1:07 p.m. the radiologist (Physician 1) was observed entering the procedure room wearing street clothing (including a dress shirt with sleeves rolled up). Prior to the surgical procedure at 1:10 p.m., Physician 1 was observed explaining to the patient the procedure, which included probing the patient's thyroid gland with several needles under local anesthetics, in order to obtain biopsy specimens. Physician 1 also explained that the procedure was planned as a sterile procedure, with sterile drapes placed over the patient's chest for protecting the sterile field and supplies/instruments.

During the procedure starting at 1:25 p.m. Physician 1 was observed wearing sterile gloves, a hair cover and a mask but no gown to ensure maintenance of the sterile field. The physician was observed reaching with unsterile arms with rolled up sleeves over the sterile field during the procedure.

In an interview on 12/11/12 at 2 p.m. following the procedure, Physician 1, RN 2 and the Director of Risk Management (present during interview) expressed no concerns related to the practices during the procedures, including preparing sterile field 30 minutes or more prior to its use and street clothing worn by the physician in the IR suite. The Director of Risk Management stated that because the environment in the Interventional Radiology room was controlled by the Engineering Department (appropriate air exchanges, temperature and humidity) there was no concern with leaving sterile supplies open for extended time period.

Physician 1 stated that variety of vascular and nonvascular IR procedures were performed in the Medical Imaging Department, mostly in the Interventional Radiology procedure room, but on occasions in other locations of the radiology department. Physician 1 acknowledged that surgical attire practices such as hospital laundered scrubs were not routinely followed during procedures in the IR or the radiology department. The physician stated that although he considered thyroid biopsy as clean procedure requiring sterile supplies, he did not feel that "full-barrier precautions" (precautions including appropriate attire to maintain sterile field) were warranted, unless it was a procedure that required leaving in a device in a patient (such as cardiac catheter or indwelling catheter).

During the survey on 12/11/12 the Director of Medical Imaging presented policy titled "Scope of Services" (last approved 10/10/12) for the Medical Imaging Department. The policy indicated that the Medical Imaging provided a variety of services, which included Vascular/Interventional Radiology. The policy further indicated, that "Interventional procedures will be performed under the guidelines set forth in the invasive procedures document which is attached." The policy had a type-written document attached, titled "Invasive Procedure in Medical Imaging," which was not signed or approved as part of any policy and did not specify procedures performed in Interventional Radiology. During the survey after the above observations, the policy "Scope of Services" was presented again, now with amended section of the attachment titled "Invasive Procedure in Medical Imaging" showing list of procedures in two columns, one for "Procedures requiring full-barrier precautions" and second column with "Procedures not requiring full-barrier precautions." No policies were presented defining full-barrier precautions and practices that would be associated with those precautions.

On 12/14/12 at 10:15 a.m. the Medicine Department Chair (Physician 1) and the Vice President of Operations confirmed that that Medical Imaging including Interventional Radiology Department functioned independently from surgical services. Therefore, policies and practices by the surgical departments were not applied in Interventional Radiology. When asked about the above attachment titled "Invasive Procedure in Medical Imaging," Physician 1 stated he was not familiar with its content. Physician 1 confirmed that the standards of practice for surgical services (such as surgical attire and traffic restrictions) were not followed in the radiology department, because IR procedures were not considered surgical procedures.

The Society for Interventional Radiology, found at http://www.sirweb.org/clinical/cpg/QI35.pdf>): showed the following guidelines; "Sterile technique in the context of medical and surgical procedures refers to the process used to prevent the contamination of wounds and other sites by organisms that can cause infection... The term 'sterile technique' entails a broad range of topics and often overlaps topics with guidelines for the prevention of a surgical site infection (SSI)...

The IR Procedure Classification in Table 1 contained both, Vascular and Nonvascular Interventions under "Clean" categories.

The guidelines further indicated, that: "Clean and clean-contaminated procedures should follow absolute sterile technique. The implications of this recommendation are that the technique and procedures should mirror the operating room setting. This includes at the minimum: Scrub attire that is intended for wear only in the IR suite; Hair coverings to be worn while in the suite and masks when open instruments/trays are present; Sterile gowns and gloves for those participating in the sterile field; The use of sterile drapes in a manner that allows generous coverage of the sterile field; Minimization of traffic in the suite; A semirestricted area to serve as a barrier between the unrestricted area and the fully restricted area (suite) when interventional procedures are being performed. "

The guidelines also indicated, "... The purpose of surgical attire is to promote high-level cleanliness and hygiene within designated environments. The surgical attire is designed to interfere with the passage of microorganisms from personnel to the patient and the IR environment and from the patient to personnel... Hospital-laundered (provided) surgical attire (scrub clothes) should be worn in the IR procedure suite.

The guidelines indicated, that "The CDC and AORN recommend that sterile supplies and sterile fields be prepared immediately before use" and "Sterile items should be handed to an appropriately gowned and gloved individual or placed gently and securely on the sterile field ... Unsterile arms or hands should not pass over the sterile field."

In an interview and document review on 12/13/12 at 11:40 a.m. the Director of Facilities and Administration stated that Radiology Department (including the Interventional Procedure room) was not monitored for temperatures, humidity and/or air exchanges.

Review on 12/14/12 of the Engineering Policy and Procedure titled "Temperature & Humidity" showed it only applied to operating rooms and nurseries but did not include the Radiology Department for monitoring.