The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

IROQUOIS MEMORIAL HOSPITAL 200 FAIRMAN STREET WATSEKA, IL 60970 Dec. 14, 2012
VIOLATION: STAFFING AND DELIVERY OF CARE Tag No: A0392
Based on a review of Hospital policy, a review of CNA job description, a review of CNA personnel files, and staff interview, it was determined in 1 of 4 (E1) CNA personnel files reviewed, the Hospital failed to ensure documentation of CNA certification, in accordance with Hospital policy.
Findings include:

1. The Hospital policy titled "Licenses/ Certifications" (effective 10/1/05) was reviewed 12/14/12. It indicated "Employees must have the licenses and certifications required for their position. By their first day of work, employees must provide documentation to verify the required license/ certification is forthcoming..."

2. The CNA job description was reviewed on 12/14/12. It indicated "Experience/ Education: ... completion of CNA program with certification...

3. The CNA personnel file of E1 was reviewed on 12/13/12. E1 was hired by the Hospital as a CNA on 11/13/12. There was no documentation to indicate proof of completion of a CNA program or certification.

4. During an interview with the Human Resource Manager on 12/12/12 at 2:00 PM it was confirmed that the record did not contain proof of certification.
VIOLATION: PATIENT CARE ASSIGMENTS Tag No: A0397
Based on review of Hospital policy, a review of ED and OR RN personnel files, and staff interview, it was determined in 2 of 2 (E5, E6) OR RN personnel files and 3 of 3 (E7, E8, E9) ED RN personnel files reviewed, in which the RN could administer IV Conscious Sedation, the Hospital failed to ensure RNs who administer IV Conscious Sedation were trained and competent in the provision of IV Conscious Sedation.
Findings include:

1. The Hospital policy titled "CONSCIOUS SEDATION" (reviewed 3/09) was reviewed. It indicated "Medication for the purpose of conscious sedation is permitted in the OR, ED, ICU, Cardiac Testing Unit and Radiology... 4. Physician must be immediately available when IV push medication is administered, except when administered by an anesthesiologist or CRNA."

2. The personnel file of E5 was reviewed on 12/12/12. E5 was hired by the Hospital as an OR RN on 7/11/11. There was no documentation to indicate E5 had been trained and/or demonstrated competency in the provision of IV Conscious Sedation.

3. The personnel file of E6 was reviewed on 12/12/12. E6 was hired by the Hospital as an OR RN on 5/20/96. There was no documentation to indicate E6 had been trained and/or demonstrated competency in the provision of IV Conscious Sedation.

4. The personnel file of E7 was reviewed on 12/12/12. E7 was hired by the Hospital as an ED RN on 7/12/99. There was no documentation to indicate E7 had been trained and/or demonstrated competency in the provision of IV Conscious Sedation.

5. The personnel file of E8 was reviewed on 12/12/12. E8 was hired by the Hospital as an ED RN on 3/26/07. There was no documentation to indicate E8 had been trained and/or demonstrated competency in the provision of IV Conscious Sedation.

6. The personnel file of E9 was reviewed on 12/12/12. E9 was hired by the Hospital as an ED RN on 6/10/99. There was no documentation to indicate E9 had been trained and/or demonstrated competency in the provision of IV Conscious Sedation.

7. During staff interviews, conducted with the Surgery Manager, the ED Manager, and the VP of Nursing throughout the survey tours 12/11/12 thru 12/13/12, it was verbalized by all that ED and OR RNs are trained and demonstrated competence in the provision of IV Conscious Sedation.

8. During a staff interview, conducted on 12/13/12 at 12:00 PM with the VP of QAPI, it was confirmed that all ED RNs and OR RNs were expected to complete IV Conscious Sedation training and competency. It was further confirmed that there was no proof of IV Conscious Sedation training and/or competency in any of the personnel files.
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

A. Based on medical record review and staff interview, it was determined in 2 of 6 (Pts #2, #6) medical records reviewed, in which the patient presented to the ED, the Hospital failed to ensure care was provided in accordance with physician orders.
Findings include:

1. The medical record of Pt #2 was reviewed on 12/12/12. Pt #2 was (MDS) dated [DATE] with the Chief Complaint of Altered Mental Status. ED physician orders indicated Levaquin IV was to be administered. There was no documentation to indicate this was administered. ED nursing documentation indicated Pt #2 was given Ativan 1mg IV at 9:40 AM, Ativan 1mg IV at 9:49 AM, and Atropine 1 mg IV at 11:00 AM. There was no physician order. Pt #2 was admitted to inpatient status with the diagnosis of [DIAGNOSES REDACTED]

2. The medical record of Pt #6 was reviewed on 12/13/12. Pt #6 was admitted on [DATE] with the diagnosis Dyspnea. ED documentation indicated O2 at 3L/NC was applied at 3:12 PM, was increased to 4 L/NC at 3:15 PM, a nebulizer treatment was given at 3:18 PM, and the O2 was increased to venturi at 50% at 5:45 PM. There were no physician orders.

3. During a staff interview, conducted with the VP of Nursing on 12/13/12 at 3:00 PM, it was confirmed that all care provided was expected to have corresponding physician orders. It was confirmed that the above charts did not have orders for the care provided.

B. Based on a review of Hospital policies, medical record review, and staff interview, it was determined 3 of 3 (Pts #16, #18, #19) medical records reviewed, in which the patient received PCA pain management, the Hospital failed to ensure that the physician PCA orders are completed and contain pertinent information needed to treat the patients receiving narcotics via PCA Infuser Plus pump.
Findings include:

1. The Hospital policy titled "Medication Orders Complete" (revised 12/05) states under "Procedure: 3. Standing orders are allowed when they are pre-defined and written into the patient record as either a read-back verify order or a document is added to the permanent record. The use of "standing order" or equivalent without the exact parameters of a proper order (drug name, dose, route, frequency, etc.) will be clarified with the prescriber." The Hospital policy titled "GENERAL NURSING POLICY AND PROCEDURE PATIENT CONTROLLED ANALGESIA INFUSER PLUS II (PCA PLUS II)" (revised 8/12) states under "POLICY; Patient Controlled Analgesia Infuser may be used upon physician order. PHYSICIAN RESPONSIBILITIES: 1. The physician will write the orders for the patient regarding controlled analgesia that includes all of the following or will write per protocol: (PCA dose guidelines attached): a. Mode of administration b. The medication to be utilized and strength c. Loading dose if desired d. The incremental dose e. The lockout interval f. The four-hour dose limit g. Primary IV line fluids and rate h. The continuous infusion parameters (if applicable)"

2. The medical record of Pt #16 was reviewed on 12/13/12. Pt #16 was admitted on [DATE] with the diagnosis [DIAGNOSES REDACTED] Right Transverse Colon. On 11/19/12, the post operative orders indicated "Morphine PCA per protocol." There were no parameters regarding mode of administration, dose, etc. There was no copy of the PCA protocol on the medical record in neither paper nor electronic form.

3. The medical record of Pt #18 was reviewed on 12/14/12. Pt #18 was admitted on [DATE] with the diagnosis Fracture Right Hip. On 11/27/12, there was a physician order "3. Morphine PCA continuous infusion protocol..." There was no copy of the PCA protocol on the medical record in neither paper nor electronic form.

4. The medical record of Pt #19 was reviewed on 12/14/12. Pt #19 was admitted on [DATE] with the diagnosis Post Bowel Resection. On 11/18/12 at 2:50 AM, there was a physician order "Morphine PCA per protocol." There were no parameters regarding mode of administration, dose, etc. There was no copy of the PCA protocol on the medical record in neither paper nor electronic form.

5. During a staff interview on 12/14/12 at 1:00 PM with the Medical Record Analyst, it was confirmed that the PCA Dosage Guidelines are not being utilized by the physicians or being placed on the chart.
VIOLATION: INTEGRATION OF EMERGENCY SERVICES Tag No: A1103
Based on observation and staff interview, it was determined the Hospital failed to ensure emergency equipment was maintained in safe operating condition in the Cardiac/ Pulmonary Rehabilitation Department. This has the potential to affect 100% of the patients who utilize the Cardiac/ Pulmonary Rehabilitation Department.
Findings include:

1. During a tour of the Cardiac/Pulmonary Rehabilitation Department on 12/12/12, at 12:45 PM, the following items were observed in the crash cart: 1- Laryngoscope handle was covered with what appeared to be corrosive material, not functioning and batteries were not available for use.

2. During a staff interview conducted with the Cardiac/Pulmonary Rehabilitation Department Nurse Manager on 12/12/12, at 1:00 PM, it was confirmed that the laryngoscope was not functioning and should have been replaced.
VIOLATION: RADIOACTIVE MATERIALS Tag No: A1035
Based on a review of Hospital policy and procedure, observation and staff interview, it was determined that on 1 of 2 Nuc Med staff observed, the Hospital failed to ensure all Nuc Med staff properly utilized mandated safety badges.
Findings include:

1. The Hospital policy and procedure titled, "Radiation Safety" (with a revised date of 3/09) was reviewed. It indicated under "Procedure: 7. All radiologic technologists are required to wear a film badge at all times while on duty...." The policy and procedure titled, "Personnel Exposure Monitoring Program" (with no revised/reviewed/implemented dates) was reviewed. It indicated under "Procedure: External Exposure Program 2) All individuals who handle radioactive materials that emit ionizing radiation will be issue (sic) a TLD finger badge to be worn during working hours."

2. During a tour of the Radiology Department, conducted on 12/11/12 at 1:29 PM, it was observed that 1 of 2 Nuclear Med technologists that were on duty was not wearing a ring badge as required.

3. During an interview with the Director of Radiology, conducted on 12/11/12 at 1:30 PM, it was verbalized that the Nuc Med technologist should have had their assigned ring badge on as the Nuc Med technologist was currently on duty.
VIOLATION: QUALIFIED EMERGENCY SERVICES PERSONNEL Tag No: A1112
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on a review of ED RN job descriptions, ED personnel files, and staff interview, it was determined in 1 of 3 (E9) ED RN personnel files reviewed, the Hospital failed to ensure all ED RNs were certified in PALS, in accordance with their job description.
Findings include:

1. The Hospital job description titled "POSITION DESCRIPTION/PERFORMANCE EVALUATION: Job Title: RN, Department: Emergency" indicated "LICENSE OR CERTIFICATE REQUIRED:... Pediatric Advanced Life Support (PALS) & ... within 1 year."

2. The personnel file of E9 was reviewed on 12/12/12. E9 was hired by the hospital on [DATE]. There was no documentation to indicate E9 had completed PALS certification.

3. During a staff interview, conducted on 12/12/12 at 2:00 PM with the Human Resource Manager, it was verbalized that there was no documentation to indicate E9 had completed PALS certification and that this was an expectation for that position. On 12/13/12 at 3:30 PM, it was also confirmed with the Educator that there was no proof of PALS certification for E9.
VIOLATION: NURSING SERVICES Tag No: A0385
Based on a review of Hospital policies, CNA job description, CNA personnel files, ED and OR RN personnel files, medical record review, and staff interview it was determined that the Hospital failed to ensure services were provided in a safe environment in accordance with physician orders, policies, and job descriptions, by staff trained in the provision of their respective services. The cumulative effect of these systemic practices has the potential to affect 100% of the patients who receive services at the Hospital.
Findings include:

1. The Hospital failed to ensure documentation of CNA certification, in accordance with Hospital policy. Please see deficiency cited at A-0392.

2. The Hospital failed to ensure RNs who administer IV Conscious Sedation were trained and competent in the provision of IV Conscious Sedation. Please see deficiency cited at A-0397.

3. The Hospital failed to ensure care was provided in accordance with physician orders. Please see deficiency cited at A-0405A.

4. The Hospital failed to ensure that the physician PCA orders are completed and contain pertinent information needed to treat the patients receiving narcotics via PCA Infuser Plus pump. Please see deficiency cited at A-0405B.
VIOLATION: MEDICAL RECORD SERVICES Tag No: A0431
Based on a review of Hospital policies, medical record review, and staff interview it was determined the Hospital failed to ensure that policies and processes were followed, documentation was authenticated, dated, and timed, and VTE Risk Assessments were completed as per policy. The cumulative effect of these practices resulted in the Hospital's inability to ensure clinical records were maintained to ensure patients care and treatment was provided under the orders of a physician and according to hospital policy. This has the potential to affect 100% of the patients who receive services at the Hospital.
Findings include:

1. The Hospital failed to ensure its process for use of Standing and/or Clinical Pathways/ Care Maps policies were followed. Please see deficiency cited at A-0450.

2. The Hospital failed to ensure verbal/telephone orders were authenticated, dated, and timed. Please see deficiency cited at A-0454A.

3. The Hospital failed to ensure MSE ' s were timed to reflect whether it had been completed within 24 hours of admission or registration. Please see deficiency cited at A-454B.

4. The Hospital failed to ensure verbal/ telephone orders were signed within 24 hours, in accordance with its policy. Please see deficiency cited at A-0457.

5. The Hospital failed to ensure its VTE Risk Assessment was completed in accordance with its policy. Please see deficiency cited at A-0467.
VIOLATION: MEDICAL RECORD SERVICES Tag No: A0450
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on a review of Hospital policy, medical record review, and staff interview, it was determined in 1 of 20 (Pt #2) medical records reviewed, the Hospital failed to ensure its process for use of Standing and/or Clinical Pathways/ Care Maps policies were followed.
Findings include:

1. The Hospital policy titled "Clinical Pathways/ Care Maps" (revised 4/08) was reviewed on 12/13/12. It indicated "Physician initiates the pathway... 1. Upon admission write the order on Physician's Order Form, "Use Pathway/ Map." The clinical pathway/ map form will become the physician order sheet. It does require ordering physician's signature within 24 hours..."

2. The medical record of Pt #2 was reviewed on 12/12/12. Pt #2 was admitted on [DATE] with the diagnosis Sepsis. There was a "Pneumonia Care Map" filled out by the RN; however, there was no order to implement the care map. Pt #2 expired and physician documentation indicated arrival after this time. There was a "R/O MI and MI Care Maps" which were marked; however, there was no documentation to indicate the physician had implemented this Care Map, no documentation to indicate the date, time, or who filled out the Care Map and there was no physician signature, date, or time.

3. During a staff interview, conducted with the VP of Nursing on 12/14/12 at 11:00 AM, it was confirmed that the Clinical Pathways/ Care Maps are to be ordered by the physician and that a copy of the Clinical Pathway/ Care Map is to be placed on the medical record and the physician is suppose to date, time, and sign it.
VIOLATION: ORDERS DATED AND SIGNED Tag No: A0454
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

A. Based on medical record review and staff interview, it was determined in 3 of 20 (Pts #2, #5, #6) medical records reviewed, the Hospital failed to ensure verbal/telephone orders were authenticated, dated, and timed.
Findings include:

1. The medical record of Pt #2 was reviewed on 12/12/12. Pt #2 was admitted on [DATE] with the diagnosis Sepsis. On 11/29/12 at 12:45 PM, there was a verbal order "Do not resuscitate." There was no documentation to indicate the date or time of the physician signature.

2. The medical record of Pt #5 was reviewed on 12/12/12. Pt #5 was admitted on [DATE] for wound care. On 12/2/12 at noon, there was a telephone order "May consult...." There was no date or time to indicate when the order was signed by the physician. It further contained a stamped uterine cytology entry which had no date or time as to when the order was stamped and as of 12/12/12 at 3:00 PM, there was no date or time as to when the physician signed it.

3. The medical record of Pt #6 was reviewed on 12/13/12. Pt #6 was admitted on [DATE] with the diagnosis Dyspnea. On 11/16/12 at 5:45 AM, there was a telephone order "Hook patient up to pleurovac at..." and on 11/16/12 at 7:00 PM, there was a verbal order "May remove ..." There was no documentation to indicate the date or time as to when the physician signed these orders.

4. During a staff interview, conducted with the VP of Nursing on 12/14/12 at 11:00 AM, it was confirmed that all entries into the medical record were expected to be dated, timed, and signed, including signing of verbal and/or telephone orders.

B. Based on medical record review and staff interview, it was determined in 1 of 20 (Pt #2) medical records reviewed, the Hospital failed to ensure MSE ' s were timed to reflect whether it had been completed within 24 hours of admission or registration.
Findings include:

1. The medical record of Pt #2 was reviewed on 12/12/12. Pt #2 was admitted on [DATE] with the diagnosis Sepsis. There was no documentation to indicate the time as to when the MSE was completed.

2. During a staff interview, conducted with the VP of Nursing on 12/14/12 at 11:00 AM, it was confirmed that all entries into the medical record were expected to be dated, timed, and signed.
VIOLATION: VERBAL ORDERS AUTHENTICATED BASED ON LAW Tag No: A0457
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on a review of Hospital policies, medical record review, and staff interview, it was determined in 1 of 20 (Pts #5) medical records reviewed, the Hospital failed to ensure verbal/ telephone orders were signed within 24 hours, in accordance with its policy.
Findings include:

1. The Hospital policy titled "Medication Administration- Preparation and Precautions" (reviewed 8/12) was reviewed on 12/13/12. It indicated "8. Verbal/ Telephone Orders: E. The order is to be signed by the prescriber within 24 hours. The Hospital policy titled "Communication: Verbal and Telephone Orders: Critical Test Results Communication" (revised 4/08) was reviewed on 12/13/12. It indicated "Telephone/ Verbal orders... The Licensed Independent Practitioner must authenticate the order with a date, time, and signature within 24 hours."

2. The medical record of Pt #5 was reviewed on 12/12/12. Pt #5 was admitted on [DATE] for wound care. On 12/3/12 at 7:10 AM, there was a telephone order "PT/ PTT for a PICC line insertion today at 1300" and on 12/3/12 at 7:30 AM, there was a verbal/ telephone order "May have PICC line inserted." As of 12/12/12 at 4:00 PM, neither of the orders had been signed by the physician, in accordance with Hospital policy.

3. During a staff interview, conducted with the VP of Nursing on 12/13/12 at 3:00 PM, it was confirmed that verbal/ telephone orders were to be signed, dated, and timed by the practitioner within 24 hours of receipt.
VIOLATION: CONTENT OF RECORD - OTHER INFORMATION Tag No: A0467
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on a review of Hospital policy and procedures, medical record review, and staff interview, it was determined that in 2 of 20 (Pts #3, #17) medical records reviewed, the Hospital failed to ensure its VTE Risk Assessment was completed in accordance with its policy.
Findings include:

1. The Hospital policy and procedure titled, "General Nursing Policy and Procedure Manual Anticoagulant Therapy" (revised 01/12). The policy indicated under, "PROCEDURE: 1. Nurse completes the nurse portion of the VTE Risk Assessment and Physician Orders on inpatient admissions who are 18 years and older... b. The physician completes the doctor's portion of the form...."

2. The medical record of Pt #3 was reviewed on 12/13/12. It indicated Pt #3 was admitted on [DATE] with a diagnosis of Cesarean Delivery. There was no documentation in the medical record that indicated the "VTE Risk Assessment and Physician Orders" was completed.

3. The medical record of Pt #17 was reviewed on 12/13/12. It indicated Pt #17 was admitted on [DATE] with a diagnosis of Abnormal Ultrasound. The VTE risk assessment indicated a total of 4. The physician portion of the assessment indicated "total points 3-4: ... Prophylaxis Regimen Orders: Lovenox 40 mg subq every 24 hours, Heparin 5000 units subq every 8 hours... "There was no documentation to indicate the physician reviewed the VTE Risk Assessment and/or addressed whether VTE orders were to be invoked or not.

4. During an interview with a staff nurse, conducted on 12/13/12 at 2:10 PM with the VP of Nursing, it was verbalized that the patients should have been assessed for thrombosis risk and that the "VTE Risk Assessment and Physician Orders" should be in the medical record and should be signed by the physician indicating whether or not there was a need to invoke them.
VIOLATION: PHARMACEUTICAL SERVICES Tag No: A0490
Based on observation, review of Hospital policies, and staff interview it was determined the Hospital failed to ensure medications were prepared in a manner to prevent cross contamination, stored in a secure manner to prevent risk of diversion and potential changes in medication efficacy, and labeled per policy to ensure safety of use. The cumulative effect of these systemic practices has the potential to affect 100% of the patients who receive services at the Hospital.
Findings include:

1. The Hospital failed to prevent the risk of contamination of medications being prepared for patient use by failing to ensure a safe environment for storage, handling and preparation of drugs in the pharmacy on the work/drug preparation table. Please see deficiency cited at A-0501.

2. The Hospital failed to ensure its narcotic medications were properly safeguarded. Please see deficiency cited at A-0503.

3. The Hospital failed to ensure outdated drugs and/or biologicals were not available for use in patient care areas. Please
see deficiency cited at A-0505A.

4. The Hospital failed to ensure its policy for multidose vials was followed and that pre-drawn medications were identified. Please see deficiency cited at A-505B.
VIOLATION: PHARMACIST SUPERVISION OF SERVICES Tag No: A0501
Based on observation, review of policy and procedure and staff interview, it was determined that the Hospital failed to prevent the risk of contamination of medications being prepared for patient use by failing to ensure a safe environment for storage, handling and preparation of drugs in the pharmacy on the work/drug preparation table. This systemic practice has the potential to affect 100% of the patients receiving medications at the Hospital.
Findings include:

1. During a tour of the Pharmacy on 12/11/12 at 2:00 PM, it was observed that the work/drug preparation table had 2 open coke bottles, 1 glass and 1 cup of ice water, as well as medication vials being prepared for patient use.

2. The Hospital policy "PHARMACY" (policy #1) issued 1/06, was reviewed on 12/11/12. Under "Policy: All medications are prepared in a safe manner. PROCEDURE: In preparing medications, Pharmacy staff will use appropriate technique to avoid contamination during medication preparation, which includes... Maintaining clean, uncluttered and functionally separate areas for product preparation to minimize the possible (sic) of contamination."

3. During a staff interview conducted with the Pharmacist on 12/11/12 at 2:00PM, it was verbalized that the bottles, glass, and cup were not to be on the drug preparation table.

4. During a staff interview conducted with VP Quality and Performance Improvement on 12/11/12 at 2:00 PM, during the tour of the Pharmacy Department, the VP Quality and Performance Improvement witnessed the opened drinks and verbally confirmed that this area is used as a lunch table by the staff, therefore not functionally separate from other activities that could present risk of contamination.
VIOLATION: CONTROLLED DRUGS KEPT LOCKED Tag No: A0503
Based on a review of Hospital policies, observation, and staff interview, it was determined that the Hospital failed to ensure its narcotic medications were properly safeguarded. This has the potential to affect 100% of the patients serviced by the Hospital.
Findings include:

1. The Hospital policy titled, "Pharmacy Manual" (with an issued date of 1/06) was reviewed. On page 28 it indicated under "Security: All controlled drugs in schedules II, III, IV, and V will be stored in double locked security...." and on Page 31 it indicated under "Pharmacy Storage: All Schedule II drugs are stored in a double locked narcotics cabinet."
The Hospital policy titled "Medication Administration- Preparation and Precautions" (reviewed 8/12) was reviewed on 12/13/12. It indicated "18. Controlled Drugs: A. Stored under double lock."

2. During a tour of the locked Pharmacy department, conducted on 12/11/12 at 2:40 PM, a cabinet was observed within the pharmacy department that contained the Hospital ' s narcotics. The cabinet was observed to be unlocked. The narcotics were accessed by a pharmacy technician without a key.

3. During an interview with the Pharmacist, conducted on 12/11/12 at 2:45 PM, it was verbalized that the cabinet was not locked to make it easier for staff to access the narcotics during Pharmacy hours.
VIOLATION: UNUSABLE DRUGS NOT USED Tag No: A0505
A. Based on observation, a review of Hospital policy, and staff interview, it was determined the Hospital failed to ensure outdated drugs and/or biologicals were not available for use in patient care areas. This has the potential to affect 100% of the patients serviced by the Hospital, both inpatient and outpatient.
Findings include:

1. During a tour of the Hospital, conducted throughout the survey dates 12/11/12 thru 12/13/12, with the respective department Managers, the following outdated drugs and/or biologicals were observed to be expired:

In the Surgical Department:
OR #4: on the Anesthesia cart: 2 Lidocaine 2% with Epinephrine expired 6/1/12, and one 1 ml Naloxone 0.4 mg/ ml expired 10/1/12.
In the OR Medication Room: one 10 ml Vecuronium Bromide expired 11/12, one 2 ml Droperidol expired 11/1/12, four 20 ml Xylocaine Methylparaben Free 1.5% expired 3/12, three 50 ml 8.4% Sodium Bicarbonate expired 11/1/12, one 45 gram Metronidazole Topical Gel 0.75% expired 6/12, and one 50 ml vial 8.4% Sodium Bicarbonate expired 10/1/12.
In Procedure Room #2, Medication Cart: 1- Atropine Sulfate injectable, 0.4 mg/ml, 20 ml, expired 12/8/12, and 1- Methapred, 40 mg vial, expired 11/12.

In the offsite outpatient Rehabilitation Department on 12/12/12, at 8:00 AM, 4- BIOFREEZE, 32 oz, containers expired 2008.

In the Pharmacy on 12/11/12 at 2:00 PM, a 250 ml IV solution bag with an expiration date of 11/12 was found on the sink ledge in the drug preparation room.

2. The Hospital policy "PHARMACY" (policy #2) issued 1/06, was reviewed on 12/11/12. Under "Policy: All drug storage areas within this hospital will be inspected at least monthly by the Pharmacy Technician. The purpose is to ensure proper storage of medications PROCEDURE: ... Drugs shall not be kept in stock after the expiration date... Outdated and unusable drugs and IV solutions will be returned to the Pharmacy for quarantine and return to manufacturer for credit."

3. During staff interviews, conducted throughout the survey with the respective department managers of whom conducted the survey of their respective departments, the outdated drugs and/or biologicals that were available for patient use were verified by each respective department manager and it was also verbalized by each that outdated drugs and/or biologicals were to be checked monthly for outdates and disposed of.

4. During the pharmacy tour on 12/11/12 the pharmacy technician stated that a Home Health Care agency staff member brought the solution back to the pharmacy due to it being expired and set it on the sink. The Pharmacist and the pharmacy technician confirmed a storage closet in the back of pharmacy is used to store expired or unusable medications, although no process is in place to assure returned medications are quarantined from usable medications until placed in closet assigned for storage of unusable medications.

B. Based on observation, a review of Hospital policy, and staff interview, it was determined the Hospital failed to ensure its policy for multidose vials was followed and that pre-drawn medications were identified. This has the potential to affect 100% of both the inpatient and outpatients serviced by the Hospital.
Findings include:

1. During a tour of the Hospital, conducted 12/11/12 thru 12/13/12, the following were observed:
In the Surgery Department, OR #4 on the Anesthesia Cart: one 10 ml syringe of Succinycholine was observed in the top drawer. There was no documentation to indicate when it was drawn up, who drew it up, what the dose was, or when it expired. One open 20 ml vial of Glycopyrrolate, one open 20 ml Atropine Sulfate; one open 10 ml Neostigmine Methylsulfate, and two open 5 ml Flumazenil, all observed with no date to indicate when each was opened.
In the Outpatient Surgery Department on 12/11/12, at 2:20 PM, it was observed that 1- Lidocaine HCL injectable, 10 mg/ml, 20 ml multi dose vial was opened but no date as to when opened.

2. The Hospital policy titled "Medication Administration- Preparation and Precautions" (reviewed 8/12) was reviewed on 12/13/12. It indicated "12. Multidose Vials: C. Label the vial with date opened and initials... F. Once a multidose vial is opened or punctured, it must be relabeled with a revised expiration date of 28 days..."

3. During a staff interview, conducted on 12/12/12 at 3:00 PM with the VP of Nursing, it was confirmed that multidose vials were to be labeled when opened with the date of opening, initials, and expected to be disposed of 28 days after opening if not used.
VIOLATION: ORGANIZATION Tag No: A0619
A. Based on a review of Hospital policy, a review of refrigerator and freezer temperature logs, and staff interview, it was determined the Hospital failed to ensure dietary refrigerator and freezer temperatures were monitored and outlying results were followed up on in accordance with its policy. This has the potential to affect 100% of the patients and visitors serviced by the Hospital Dietary department.
Findings include:

1. The Hospital policy titled "Food and Non Food Item Storage" (revised 11/12) was reviewed. It indicated "Procedure: 3. Temperatures are taken every two hours.... Any malfunctions are reported to Maintenance..."

2. The Hospital refrigerator and freezer temperature logs for Nov. 2012 were reviewed on 12/12/12. The log indicates the freezer temperatures are to be 0 degrees or below. The following are examples of temperatures not being taken every 2 hours and/or outlying temperatures which were not followed up on, in accordance with its policy. Examples: Hobart Freezer #1: 22 out of 30 days indicated temperatures > 0 degrees and no documentation of follow up. 4 out of 30 days failed to indicate a temperature was taken every 2 hours. Hobart Freezer #2: 24 out of 30 days indicated temperatures > 0 degrees and no documentation of follow up. 4 out of 30 days failed to indicate a temperature was taken every 2 hours, in accordance with its policy.

3. During a staff interview, conducted with the Dietary Manager on 12/12/12 at 9:30 AM, it was verbalized that a new policy was implemented in October and was officially passed by the Board of Directors effective 11/12. It is the expectation that temperatures are taken every 2 hours around the clock. Food Service personnel are to take the temperatures between 5 AM and 7 PM. Maintenance is to take the temperatures between 9 PM and 3 AM. Any outlying temperatures are to be reported to Maintenance for follow up and correction of any problems.

B. Based on a review of Hospital policy, a review of dishwasher logs, a review of manual dishwasher chemical sanitizer instruction sheet, observation, and staff interview, it was determined the Hospital failed to ensure dishwashing systems were monitored for temperature, chlorine (for manual dishwasher), and PPM, in accordance with its policies to ensure proper sanitation of dietary items to prevent the spread of communicable diseases. This has the potential to affect 100% of the patients and visitors serviced by the Hospital Dietary department.
Findings include:

1. The Hospital policy titled "Dish Machine Temperatures" (Implemented 10/12) was reviewed on 12/12/12. It indicated "Policy: Dish machine temperatures will be monitored and recorded... Procedure: 1. e. Complete this procedure twice daily... 2. b. With a chemical sanitizing agent..."

2. The automated dishwasher logs for November thru December 12, 2012 were reviewed. There was no documentation to indicate the temperature or chlorine were checked on 11/19/12 AM and PM, 11/20/12 AM and PM, 11/22/12 AM and PM, 12/3/12 AM, and 12/4/12 PM.

3. The Chemical Sanitizer instruction sheet, observed hanging over the manual dishwashing area, was reviewed. It indicated "4. To test the water read the instructions on the chlorine test strip container. 5. It should read 50 PPM. 8. Please record this chlorine levels 2 times a day..."

4. A 3 sink dishwashing area was observed during a tour of the Dietary Department on 12/12/12 at 9:30 AM. It was verbalized by the Dietary Manager that the expectation is that the staff will check the chlorine level twice a day and the results should be 50 PPM for the manual 3 sink dishwashing area and the automated dishwasher is to be at 200PPM. There was no documentation to indicate these levels had been monitored and recorded as per the instruction sheet.

5. During a staff interview, conducted with the Dietary Manager on 12/12/12 at 9:30 AM, it was verbalized that the expectation is that the staff will check the water temperature and the chlorine levels twice a day on the manual dishwashing area and document these results on the flowsheet in which there was no flowsheet that existed. It was further confirmed that there was no documentation of checking of the temperature and chlorine levels for the automated dishwasher for the above listed dates.

C. Based on observation, a review of Hospital policy, and staff interview, it was determined the Hospital failed to ensure poultry products and dry goods were dated when received or opened and that food was stored in accordance with its FIFO policy to ensure the quality and safety of food storage and prevention of food borne illnesses. This has the potential to affect 100% of the patients and/or visitors serviced by the Dietary Department.
Findings include:

1. During a tour of the Hospital, conducted on 12/12/12 at 9:00 AM with the Dietary Manager, the following items were observed to be stored without regard to the date of receiving and/or date of opening: 10 Resource Thicken Up observed with the expiration dates of 8/13, 10/13, and 12/13. These were observed mixed up on the storage shelf with 10/13 up front and 8/13 in the back and 12/13 in the middle and 10 Beneprotein with the expiration dates of 2/14 and 1/14 were observed on the storage shelf with 2/14 in front and 1/14 in the back, instead of vice versa. All dry goods and open bags of chicken patties, chicken wings, and chicken legs were observed without dates to indicate when they were received and/or when they were opened.

2. The policy titled "Storage and Thawing of Meats, Fish, and Poultry Products" (revised 11/12) was reviewed. It indicated "8. Meat products are dated when received. They are to be used in "First in, First Out" basis."

3. During a staff interview, conducted with the Dietary Manager on 12/12/12 at 9:30 AM, it was verbalized that all food items were to be dated and stored in FIFO order, including dried goods. It was confirmed that food items were to be dated when opened.
VIOLATION: PHYSICAL ENVIRONMENT Tag No: A0700
Based on observation during the survey walk-through, staff interview, and document review during the Life Safety portion of a critical access initial survey conducted on December 14, 2012 the surveyors find that the facility failed to provide and maintain a safe environment for patients and staff.

This is evidenced by the number, severity, and variety of Life Safety Code deficiencies that were found. Also see A710
VIOLATION: LIFE SAFETY FROM FIRE Tag No: A0710
Based on observation during the survey walk-through, staff interview, and document review during the Life Safety portion of a critical access initial survey conducted on December 14, 2012, the surveyors find that the facility does not comply with the applicable provisions of the 2000 Edition of the NFPA 101 Life Safety Code.

See the Life Safety Code deficiencies identified with K-Tags on the CMS Form 2567, dated December 14, 2012
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
A. Based on observation, review of policy and procedure and staff interview, it was determined that the Hospital failed to ensure a safe environment by controlling infections and communicable diseases of patients and personnel in the medical imaging department by ensuring that staff performed hand hygiene after patient contact. This has the potential to affect 100% of the patients receiving medical imaging services at the Hospital.
Findings include:

1. During observation of an angiography procedure in the medical imaging department on 12/11/12 from 1:00-1:30 PM, it was observed that staff was exiting the angiography room after removing PPE and after patient contact without performing hand hygiene. Hand sanitizer was available in the angiography room, but was observed to not be easily accessible.

2. The Hospital policy "Hand Washing Procedure For Non-Surgical Personnel" revised 1/04, was reviewed on 12/11/12. Under "Policy: Personnel shall wash using the procedures outlined below under any of the following conditions:.... 2. Before and after patient or resident contact." The policy "Removing PPE" page 135 was reviewed 12/11/12. Under "Hand Hygiene: Perform hand hygiene immediately after removing PPE!"

3. During a staff interview, conducted on 12/11/12 between 1:00 PM-1:30 PM with the Director of Radiology, it was confirmed that staff members were exiting the angiography room after having patient contact and that they did not perform hand hygiene immediately after removing PPE. It was also confirmed that the hand sanitizer dispensers were inaccessible for use prior to exiting angiography room.

B. Based on observation and staff interview, it was determined the Hospital failed to ensure items used in the Surgery Department were maintained to prevent the shedding of particles and cross contamination throughout the Surgery Department. This has the potential to affect 100% of the patients, both inpatient and outpatient, who receive surgical services at the Hospital.
Findings include:

1. During a tour of the Surgery Department Sterile Supply Room, conducted on 12/11/12 at 2:45PM, a metal cart was observed with green Christmas garland draped around the cart. It was verbalized by the Surgery Manager that the cart was decorated with garland "for the Season" and was used to transport patient care items throughout the OR.

2. During a staff interview, conducted with the Surgery Manager on 12/11/12 at 2:45 PM, it was confirmed that the OR cart should not have garland as it has the potential to spread infection.

C . Based on observation, a review of Hospital policy, and staff interview, it was determined the Hospital failed to ensure compounded items were labeled with date, strength, initials, and expiration date. This has the potential to effect 100% of the patients, both inpatient and outpatient, serviced by the Hospital.
Findings include:

1. During a tour of the Hospital, conducted 12/11/12 thru 12/13/12, the following were observed. In the Surgery Department Medication Room, one bottle Acetic Acid was observed. In the Endoscopy Room, approximately 40 containers of Formalin were observed on the procedure cart. There was no documentation to indicate when these were prepared, what the strength was, who prepared them, or when they expired. In the Lab Department on 12/12/12, at 10:00 AM, it was observed 50 - 20 fl oz containers of Formaldehyde, did not contain strength, reagent lot number, expiration date and initials of person who prepared the containers.

2. The Hospital policy titled "Reagent Labeling" (revised 5/18/07) indicated "1) At the time of preparation or receipt, all reagents, solid or liquid should include the following information. A. Identity B. Strength of Concentration C. Date of preparation... D. Date of expiration... F. Initials of the person preparing the reagent..."

3. During a staff interview, conducted with the Surgery Manager on 12/11/12 at 2:00 PM, it was verbalized that the Surgery Manager spoke with the Pharmacist per telephone and it was confirmed that the Acetic Acid should have had the strength, date compounded, who compounded it, and when it would expire.

4. An interview with the Lab Manager on 12/12/12, at 10:10 AM confirmed that all containers of Formaldehyde should be labeled with proper labeling prior to being used and dispensed to other areas of the hospital.

5. During a staff interview, conducted with the VP of Nursing on 12/13/12 at 9:00 AM, it was confirmed that the Laboratory prepares the Formalin specimen containers and that these were to be labeled with the date of preparation, who prepared it, the strength, and the expiration date.

D. Based on observation and staff interview, it was determined the Hospital failed to ensure outdated supplies were not available for use in patient care areas. This has the potential to affect 100% of the patients serviced by the Hospital, both inpatient and outpatient.
Findings include:

1. During a tour of the Hospital, conducted throughout the survey dates 12/11/12 thru 12/13/12, with the respective department Managers, the following outdated supplies were observed to be expired:

In the Surgical Department: Sterile Supply Room- 2 Alcare OR expired 1/12, 3 Nova Sure Carbon dioxide cartridges expired 11/12,
and 1 box of 5 Suture Anchor 5.5 expired 11/12.
OR #4: one 24 ounce CaviCide expired 1/12. On the Anesthesia cart: three 3.5 inch 22 gauge needles expired 8/11, one 3 1/2 inch 25 gauge Spinal needle expired 12/08, two 4 11/16 inch 25 gauge Spinal needles (one expired 8/05 and one expired 8/10).
In the Sterile Storage area of Central Sterilizing: four 8 ounce 1 Step Skin Care Lotion Cavilon all expired 5/06.
Two of two scrub sinks were observed to have Alcare OR expired 1/12.
In the OR Medication Room: five BD Continuous Epidural Trays expired 9/12, six Portex Continuous Epidural Trays expired 9/11, one Spinocan Spinal needle tray expired 1/12.
In Procedure Room #2, 32 Hemoccult slides expired 10/12, Medication Cart: 2 - LMA UNIQUE, disposable, Size 1, expired 12/2006, 4- LMA, size 3, expired 12/28/11, and 4- LMA, size 2, expired 3/2008.
In the Recovery Room Crash Cart: 2- E-Z Lubricating Jelly, 4 oz, expired 11/12.

In the Dietary Department: 16 Resource 2.0 expired 7/11/12.

In the M/S Dirty Utility: one box of approximately 40 Sani-Cloth Bleach Wipes, expired 4/11 and 5/11. On the M/S Chest Tube Cart: one Kendall Vasoline Gauze expired 6/12.

In the ED ear cart: 3 Rapid Rhino 5.5cm (Nasal Packing) expired 9/11, 9 Rhino Nasal Pac 7.5 expired 4/11, 2 Rhino Nasal Pac 7.5 expired 11/10, and 1 Rhino Nasal Pac 7.5 expired 1/11.

In the Cardiac/Pulmonary Rehabilitation Department on 12/12/12, at 12:45 PM, in the crash cart: 1- Intubating Stylet, 14 Fr, expired 7/2012, 1- Tracheal Tube, size 8, expired 7/2011, 1- Tracheal Tube, size 8.5, expired 10/2011, 1- Tracheal Tube, size 7, expired 4/2011, 1- EZ Lubricating Jelly, 4 oz, expired 2/2011,

In the Lab Department on 12/12/12, at 10:00 AM, 6- Avant Hand Sanitizer, 2.75 fl oz bottles, expired 9/2012.

2. During staff interviews, conducted throughout the survey with the respective department managers of whom conducted the survey of their respective departments, the outdated supplies that were available for patient use were verified by each respective department manager and it was also verbalized by each that outdated supplies were to be checked monthly for outdates and disposed of.
VIOLATION: LEADERSHIP RESPONSIBILITIES Tag No: A0756
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on a review of Hospital policies, a review of the HAI report for 2011, a review of Case Review Form, and staff interview, it was determined the Hospital failed to ensure its QAPI program effectively enforced and monitored its IC program processes in a timely manner. This has the potential to affect 100% of the patients, both inpatient and outpatient, serviced by the Hospital.
Findings include:

1. The Hospital policy titled "Authority of Infection Control" (revised 4/4/12) was reviewed on 12/14/12. It indicated "The Clinical Performance Improvement Committee has the authority to institute appropriate infection control measures when a possible danger exists to patients, personnel, and/or visitors. The ICN contacts the Clinical Performance Improvement Committee Chairman or a medical member of the Committee on any possible dangers that exist..."

2. The Hospital policy titled "Infection Control Reporting" (revised 2/07) was reviewed on 12/14/12. It indicated "1. Nurses identifying the possibility of a surgical site infection... report findings to the ICN in writing..."

3. The HAI report for 2011 was reviewed. It indicated Pt #21 was admitted on [DATE] with the diagnosis Incarcerated Femoral Hernia with Small Bowel Obstruction, underwent an Exploratory Laparotomy with Hernia Repair and Small Bowel Resection on 2/10/11, and was discharged [DATE]. Pt #21 was readmitted [DATE] thru 3/11/11. It indicated "Culture/ Xray results: MRSA, Pseudomonas Aerugnosa". There was no documentation to indicate when the culture was done. It indicated the Hospital was notified of the infection on 3/1/11. Notification was sent to the surgeon on 3/16/11 for follow up. The surgeon response was received on 4/10/12, was sent to the Committee member for review on 7/02/12, and as of 12/14/12, has the "Reviewer Findings" are listed as "pending". This is 21 months post notification of the initial infection occurring with no final response.

4. The HAI report for 2011 indicated Pt #22 was admitted on [DATE] thru 9/3/10 with the diagnosis Right Osteoarthritis of the Knee and underwent Right Total Knee Prosthesis on 8/31/10. Pt #22 was readmitted on [DATE] thru 4/19/11. It indicated "Culture/ Xray results: Staph epidermis and with 2nd admission 4/14/11, Vancomycin intramuscular was given every 12 hours." It indicated the Hospital was notified of the infection on 3/8/11. Notification was sent to the surgeon on 5/12/11, was sent to Committee member on 5/20/11, returned to the surgeon for further information on 5/27/11, and went to the Committee member on 5/27/11. It further indicated follow up on 10/11/11 and 6/14/12. As of 12/14/12, it has the "Reviewer Findings" listed as "pending". This is 20 months post notification of the initial infection occurring with no final response.

5. The HAI report for 2011 indicated Pt #23 was admitted on [DATE] with the diagnosis Uterine Adnexa and underwent Total Abdominal Hysterectomy on 4/12/11. It further indicated Pt #23 developed "wound culture status post outpatient... MRSA positive." It indicated the Hospital was notified of the infection on 4/18/11. Notification was sent to the surgeon on 6/15/11. It did not indicate when the response was received. It indicated it went to the Committee member on 8/2/11 and 7/2/12. As of 12/14/12, has the "Reviewer Findings" are listed as "pending". This is 21 months post notification of the initial infection occurring with no final response.

6. The Hospital policy titled "Infection Control Committee (revised 5/02) was reviewed. It indicated "III. Functions of the Infection Control Committee: A. A review is made on all patients who possibly have a nosocomial infection. The ICN is responsible for gathering data on patients who may have a hospital acquired infection... The ICN gathers data for the committee and receives a form containing all pertinent information on any patient that has an infection from the nursing units... The IC Committee will study all data gathered on these patients, determine if the infection is indeed hospital acquired... T. Pertinent findings and recommendations are submitted to the Medical Staff..."

7. The form titled "Case Review Form" was reviewed. It indicated "The case below has been selected for peer review for the reason indicated. Please submit your reply in the "Practitioner's Response" section and return this form to the Medical Staff Office as soon as possible..."

8. During a staff interview, conducted with the Chair of Surgery, the ICN, and the VP of Nursing on 12/14/12 at 10:30 AM, the following was verbalized. When asked how infections are followed post discharge, the Chair verbalized "In the past I received a list of my patients monthly from the ICN and had to fill it out as to whether any infections had occurred." The Chair was uncertain as to how the process was done at this Hospital. The ICN verbalized that the ICN "contacts the physician offices monthly to follow up on surgical cases and whether any infections have occurred." It was confirmed by the ICN and the VP of Nursing that there "is difficulty getting the forms completed and returned." It was confirmed that the above reports had not been brought to completion to ascertain whether an HAI had occurred or not.
VIOLATION: SURGICAL SERVICES Tag No: A0940
Based on observation, a review of Hospital policy, a review of Hospital policy manual, a review of AORN 2012 Book, a review of CDC "Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008," a review of Flash Sterilization logs, a review of the list of number of sterilized instruments, a review of OR General Surgery Report, a review of Rules and Regulations of the Medical Staff, a review of medical record, and staff interview, it was determined the Hospital failed to ensure sterilization was performed in a safe manner in accordance with acceptable standards of practice and informed consents for procedures were properly executed. The cumulative result of the failed practices has the potential to affect 100% of the surgical patients, both inpatient and outpatient, serviced by the Hospital. As a result of failure to comply with acceptable standards of practice and facility policy, patients are at risk of not being informed or understanding procedures that are to be performed and of developing potential infections due to failure of the Hospital to keep the use of Flash sterilized surgical instruments to a minimum.
Findings include:

1. The Hospital failed to ensure sterilization was performed in a safe manner in accordance with acceptable standards of practice by keeping Flash sterilization to a minimum. Please see deficiency cited atA-0951.

2. The Hospital failed to ensure all patients were informed or had an understanding of procedures by properly executing an informed consent prior to performing the procedure. Please see deficiency cited atA-0955.
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
Based on observation, a review of Hospital policy, a review of Hospital policy manual, a review of AORN 2012 Book, a review of CDC "Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008," a review of Flash Sterilization logs, a review of the list of number of sterilized instruments, a review of OR General Surgery Report, and staff interview, it was determined the Hospital failed to ensure sterilization was performed in a safe manner in accordance with acceptable standards of practice by keeping Flash sterilization to a minimum. This has the potential to affect 100% of the surgical patients, both inpatient and outpatient, serviced by the Hospital.
Findings include:

1. During a tour of the Surgery Department, conducted on 12/11/12 at 3:00 PM with the Surgery Manager, it was observed that Flash sterilization documentation indicated the use of Flash sterilization on instruments being used in surgical services. When asked what they used Flash sterilization for, the Surgery Manager verbalized that "we have 6 eye trays and if we have more than 6 eyes scheduled, we have to Flash them. We use Flash for blades (laryngoscope) also. That's the majority of the log."

2. The Hospital policy manual was reviewed. The policy titled "Infection Control Resources" (issued April 2010) was reviewed on 12/14/12. It indicated "The following resources can provide infection prevention and control guidelines: CDC, APIC..." It was further verbalized by the Surgery Manager that they follow AORN also. This was confirmed by the ICN. The AORN 2012 Book was reviewed on 12/14/12. It indicated "Recommendation IV: 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... IV a. 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 CDC "Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008" was reviewed on 12/14/12. It indicated "Flash Sterilization: Overview... Historically, it is not recommended as a routine sterilization method... Flash sterilization should not be used for reasons of convenience, as an alternative to purchasing instrument sets, or to save time."

3. The Hospital policy titled "Flash Sterilizer" (revised 10/11) was reviewed 12/13/12. It indicated "Policy: A flash sterilizer shall be available in between rooms in the Operating Suite. Purpose: To provide sterilizing facilities of items before or during surgical procedures when necessary..."

4. The Flash Sterilization logs were reviewed on 12/13/12 at 2:25 PM with the Surgery Manager. Documentation indicated that Arthroscopy, Laparoscopy, and Vendor supplies were also being Flashed and had patient names listed next to them. It was verbalized by the Surgery Manager that the Hospital has 3 Arthroscope trays, "so when we schedule more than 3, we flash them." When asked about the Laparoscopes, used for Laparoscopic Cholecystectomies, Laparoscopic Appendectomies, and Laparoscopic Hernias, it was verbalized "We Flash ALL of the Laparoscopic equipment. We don't Central Sterilize any of them. They are not wrapped at all. We just Flash them. We have 3- 10 mm and 2-5 mm Laparoscopic instruments." When asked why they Flash instead of doing Central Sterilizing, it was verbalized "Probably because they never have. Some scopes require Cydex to be used. Some require the Central Sterilizing. We (referring to Administration and Surgeons) decided to keep them all unwrapped and Flash them." When asked about Vendor who bring in equipment and/or supplies, it was verbalized "this is mainly orthopedic and we don't have time to do the Central Sterilizing process so we Flash them."

5. The list of the number of Central Sterilized loads/ number of instruments and the number of Flash Sterilized load/ number of instruments was reviewed on 12/14/12. It indicated the following extensive use of Flash sterilization:
September 2012 - 5.3% of the loads / 2.3% of the instruments sterilized were flashed
October 2012 - 8.8% of the loads / 3.4% of the instruments sterilized were flashed
November 2012 - 14% of the loads / 6.5% of the instruments sterilized were flashed
As of December 14, 2012 at 10:30 AM, the Hospital had utilized Flash sterilization for 11 loads with 27 instruments for the following procedures: 1 Laparoscopic tubal; 2 Laparoscopic Appendectomies; 6 Laparoscopic Cholecystectomies; 5 Eye surgeries; and 1 Arthroscope.

6. A staff interview was conducted with the Chair of Surgery on 12/14/12 at 10:00 AM. When asked if the Chair was aware of the use of Flash Sterilization for Laparoscopic instruments, the Chair verbalized "Yes." When asked if the Chair realized this was being used for Arthroscopy equipment, eye equipment, and Vendors, the Chair verbalized "I knew in my past experience that Flash wasn't used much but when I came here, they used it and said they always had so I didn't question it any further."
VIOLATION: INFORMED CONSENT Tag No: A0955
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on a review of Rules and Regulations of the Medical Staff, a review of Hospital policy, medical record review, and staff interview, it was determined in 1 of 2 (Pt #4) medical records reviewed, in which the patient required informed consent for wound debridement, the Hospital failed to ensure that the patient was informed or had an understanding of the procedure by properly executing an informed consent prior to performing the procedure.
Findings include:

1. The Rules and Regulations of the Medical Staff were reviewed on 12/14/12. It indicated "Part 8.2 Informed Consents: ... All invasive procedures shall have an Informed Consent obtained by the attending physician or surgeon..."

2. The Hospital policy titled "OPERATING ROOM POLICY AND PROCEDURE MANUAL: INFORMED CONSENTS" states that "Surgicals (sic) shall have a signed Permission for Operation or Procedure, prior to surgery."

3. The medical record of Pt #4 was reviewed on 12/12/12. Pt #4 was admitted on [DATE] for wound care. On 12/4/12, a consultation note dictated by the wound care specialist physician under "PROCEDURE: The patient underwent debridement of the left buttock ulcer... Subcutaneous debridement less than 20 cm, right distal dorsal toe ulcer debridement down to the bone..." There was no documentation to indicate Pt #4 was informed of the treatment prior to the procedure or that an informed consent was obtained.

4. During a staff interview on 12/14/12 at 12:00 PM with the VP of QAPI, it was confirmed that there should be an informed consent obtained on all invasive procedures and that no informed consent was on Pt #4's medical record.