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Based on document review, interview and observation, it was determined that the Governing Body failed to demonstrate it is effective in carrying out the responsibilities for the operation and management of the hospital. The Governing Body failed to provide necessary oversight and leadership as evidenced by the lack of compliance with the following Conditions of Participation:

CFR 482.25 Pharmaceutical Services

Based on review of 3 closed medical records and staff interview, it was determined that the facility failed to ensure that the "Important Message from Medicare" notification was provided to patients within 48 hours of discharge.

Findings include:

1. Closed electronic medical records #46, #47, and #48 lacked evidence that the "Important Message from Medicare" notification was provided to the patients within 48 hours of discharge.

2. The above was confirmed by Staff #37 and Staff #92.

Based on medical record review, staff interviews, and review of facility policies and procedures, it was determined that the facility failed to ensure that the attending physician was notified as soon as possible after restraints were ordered.

Findings include:

Reference #1: Facility policy titled, "Management of the Non-Behavioral Health Patient Requiring Restraints", states, "...Procedure:...6. The licensed physician, APN (Advanced Practice Nurse) with prescriptive privileges or PA (Physician Assistant) will be notified immediately of the need for the restraint and the order obtained within an hour...If this physician, APN with prescriptive privileges, PA is not the patient's treating physician he/she must notify the treating physician as soon as possible..."

Reference #2: Facility policy titled, "Management of the Behavioral Health Patient Requiring Restraints", states, "...Procedure:...21) ...If this licensed independent practitioner/PA is not the patient's attending physician, the attending physician must be notified as soon as possible..."

1. On 1/30/14, 2 of 2 medical records (#40 and #42) did not have evidence that the attending physician was notified, as soon as possible after the initial order for restraints was written by the physician or LIP [Licensed Independent Practitioner].

a. Staff #65 stated the SICU (Surgical Intensive Care Unit) is a closed unit. Staff #65 stated this means that the surgeon is the attending physician and the Intensivist is a consultant physician. However, only the Intensivist and assigned medical/surgical resident physicians and APNs manage the care and write orders for patients in the SICU. Staff #65 stated there is always an Intensivist in the facility. Staff #65 stated, that when there is a change in a patient's condition, including the need to apply restraints, the medical/surgical resident physician or APN notifies the Intensivist immediately by phone or by text.

b. There was no documented evidence in the above medical records that the Intensivist was notified as soon as possible after the initial restraint orders were written.

c. This was confirmed by Staff #63.

2. On 1/31/14, 2 of 3 medical records (#64 and #67) did not have evidence that the attending physician was notified, as soon as possible after the initial order for restraints was written by the physician or LIP.

a. The above was confirmed by Staff #2 and Staff #5.

Based on staff interview and review of facility documents, it was determined that the facility failed to ensure that quality indicators for the contracted Renal Dialysis service were measured, analyzed, and tracked.

Findings include:

1. The "--- [contracted dialysis service] Hospital Services Acute Quality Improvement Facility Management Meeting Minutes" dated 9/30/2013, lists 20 Acute Clinical Outcome Indicators (ACOI). Nine (9) of 20 ACOI items listed, document that the current month's "% (percent) compliance" was below the goal percent compliance. However, the assessments of compliance for six items that do not meet the % compliance goal are marked with "Yes" beside the goal. Staff # 75 stated on 1/31/14, the "Yes" indicates that the ACOI item met goal but stated that the assessment is inaccurate according to documented data.

2. The ACOI items not meeting goal, documented in the 9/30/2013 meeting minutes, include:

a. "2. If access problems, physician was notified": 78% current month compliance with 95% goal (assessment: "Yes").

b. "3. Unauthorized use of access by non-dialysis personnel": 1% current month compliance, 17% previous month, and 82% previous previous with 90% goal; (assessment "No").

c. "5. Ordered time = Run time": 97% current month compliance, 82% previous month, and 32% previous previous with 100% goal (assessment "Yes").

d. "6. Ultrafiltration Goal = Ordered Goal": 87% current month compliance with 90% goal (assessment "Yes").

e. "9. Hypotensive episode during tx requiring intervention": 82% current month compliance, 69% previous month, 26% previous previous with 90% goal (assessment "No").

f. "13. IV Maintenance Anticoagulant delivered per pump": 83% current month compliance, 83% previous month, 34% previous previous with 90% goal (assessment "Yes").

g. "14. Renal Disease education provided to patient and/or family": 62% current month compliance with 85% goal (assessment "Yes").

h. "16. Physician notified of critical lab results received during tx": 89% current month compliance with 95% goal (assessment "Yes").

i. "17. Hemoglobin <9.0 gm/dl": 60% current month compliance, 64% previous month, 59% previous previous with 90% goal (assessment "No").

3. The "--- [contracted dialysis service] Hospital Services Acute Quality Improvement Facility Management Meeting Minutes" dated 1/16/2014, document that 9 of the 20 listed Acute Clinical Outcome Indicators do not meet goal compliance for "Previous" and "Previous Month" and all of the ACOI for "Current Month" are listed as "N/A". Six (6) of the items that do not meet the % compliance goal for are marked with "Yes," meaning the ACOI met goal.

4. ACOI items not meeting goal documented on 1/16/2014 meeting minutes include:

a. "2. If access problems, physician was notified":" N/A" for current month compliance, 56% previous month, 63% previous previous with 95% goal (assessment: "Yes").

b. "3. Unauthorized use of access by non-dialysis personnel": N/A for current month compliance, 1% previous month, and 2% previous previous with 90% goal; (assessment "No").

c. "5. Ordered time = Run time": N/A for current month compliance, 94% previous month, and 98% previous previous with 100% goal (assessment "Yes").

d. "6. Ultrafiltration Goal = Ordered Goal": N/A for current month compliance, 86% previous month with 90% goal (assessment "Yes").

e. "9. Hypotensive episode during tx requiring intervention": N/A for current month compliance, 69% previous month, 76% previous previous with 90% goal (assessment "No").

f. "13. IV Maintenance Anticoagulant delivered per pump": N/A for current month compliance, 46% previous month, 54% previous previous with 90% goal (assessment "Yes").

g. "14. Renal Disease education provided to patient and/or family": N/A for current month compliance, 69% previous month, and 73% previous previous with 85% goal (assessment "Yes").

h. "16. Physician notified of critical lab results received during tx": N/A for current month compliance, 60% previous month, and 68% previous previous with 95% goal (assessment "Yes").

i. "17. Hemoglobin <9.0 gm/dl": N/A for current month compliance, 67% previous month, 65% previous previous with 90% goal (assessment "No").

Based on staff interview and review of facility documents, it was determined that the facility failed to ensure that collected data of Acute Clinical Outcome Indicators for the contracted Renal Dialysis Service was used to identify opportunities for improvement and make changes that would lead to improvements.

Findings include:

1. The "--- [contracted dialysis service] Hospital Services Acute Quality Improvement Facility Management Meeting Minutes" dated 9/30/2013, lists 9 of 20 Acute Clinical Outcome Indicators that were below goal for the month. In addition, the meeting minutes state, "Provide more education to new teammates on how the questions are worded and how to answer correctly" in "Plan of Action" for ACOI items.

2. During interview on 1/31/14, Staff #75 stated that the way the questions are worded on the tracking program for the ACOI was not well understood by staff entering data and led to inaccurate information in percentage [%] compliance tallies recorded in the 9/30/13 Quality Improvement Meeting Minutes. Staff #75 could not provide additional information or documentation regarding staff education or other action taken to improve uniform and accurate reporting of compliance with Acute Clinical Outcome Indicators.

3. The "--- [contracted dialysis service] Hospital Services Acute Quality Improvement Facility Management Meeting Minutes" dated 1/16/2014, shows no improvements in Acute Clinical Outcome Indicators compliance, again, documenting 9 of the 20 listed ACOI that do not meet goal compliance for "Previous Previous" and "Previous Month" and all of the ACOI for "Current Month" are listed as "N/A". There was no Plan of Action listed in the 1/16/14 meeting minutes for improvement in compliance with documented tracking of ACOI.

Based on medical record review, staff interview, and review of facility policy and procedure, it was determined that the facility failed to ensure that all initial nursing assessments are completed in accordance with facility policy, in 2 of 3 medical records reviewed (Medical Records #34 and #35).

Findings include:

Reference: Facility policy and procedure titled, 'Assessment/Reassessment: Multidisciplinary' states "... Procedure: A) Initial nursing Assessment: 1) The initial nursing assessment is completed by a Registered Nurse in collaboration with the patient and family using a service-specific health assessment form. 2) The inpatient health history assists the Registered Nurse in triggering referrals to other members of the health care team. ... C) Time Frames: Initial assessments/reassessments shall be completed within the following timeframes: ... Discipline/Department: Med/Surg [Medical/Surgical]Units Initial Assessment /Screen: 8 hours from admission."

1. On 1/30/14 at 2:00 PM, the Ante-Partum High Risk Unit was toured in the presence of Staff #5. Medical Record review was conducted in the presence of Staff #5 and Staff #55, and indicated that the nursing admission assessments for Patients' #34 and #35 were not completed by a Registered Nurse within 8 hours of admission, as per facility policy.

a. During interview on 1/30/14, Staff #5 stated that the Ante-Partum High Risk Unit is a Medical-Surgical unit.

2. Patient #34 was admitted to the Ante-Partum High Risk Unit on 1/16/14. According to Staff #55, Patient #34 was transferred from the Triage area on 1/16/14 at 4:45 PM. The 'Admission Record' was blank or indicated "no data in this time range" in the following areas of the 'Admission Record':

a. 'Cultural/Spiritual Practices' was blank.

b. 'Living Situation/ Discharge Planning' was blank.

c. 'Advance Directive' indicated "no data in this time range."

d. 'Patient Rights' indicated "no data in this time range."

e. 'Personal Belongings' indicated "no data in this time range."

f. 'Learning Assessment for Current Hospitalization' indicated "no data in this time range."

g. 'Screenings' [which includes domestic violence, nutritional, and functional screenings] indicated "no data in this time range."

h. 'Physician Notification' indicated "no data in this time range."

3. Patient #35 was admitted to the Ante-Partum High Risk Unit on 1/20/14. The 'Admission Record' was blank or indicated "no opportunity to talk privately" in the following areas of the 'Admission Record':

a. 'Learning Assessment for Current Hospitalization' was blank.

b. The 'Domestic Violence' part of the 'Screenings section indicated "no opportunity to talk privately."

Based on observation, document review and staff interview conducted on 1/28/14, it was determined that the facility failed to ensure implementation of policies and procedures addressing patient identity confirmation prior to medication administration.

Findings include:

Reference: Facility policy titled "Medication Administration: Nursing Responsibilities" states, "Medication Administration - 1. Two patient identifiers must be checked prior to medication administration. The patient name and date of birth from the medication order must be compared against the patient identification band. The patients' allergies must be compared against the patient allergy band prior to medication administration..."

1. During one of two medication pass observations conducted, Staff #93 failed to verify Patient #68's identification or allergy band prior to administering medication on 1/28/14 at 10:20 AM.

2. Upon interview, Staff #93 confirmed that he/she had failed to check 2 patient identifiers or allergy band. He/she stated that he/she was aware of the need to check but had forgotten to do so.

Based on medical record review and review of facility policy and procedure, it was determined that the facility failed to ensure that the informed consent form was dated and timed according to facility policy.

Findings include:

Reference: Facility policy titled, "Informed Consent" states, "...II. INFORMED CONSENT:...4. A properly executed informed consent must contain at least the following:...g) Signature of patient or Surrogate Decision Maker (with relationship);
h) Date and time the consent is obtained from the patient or Surrogate Decision Maker; and i) Date, time and signature of the professional person witnessing the consent..."

1. On 1/31/14, 4 of 8 informed consent forms reviewed, in Medical Records #45, #60,
#61, #62, were not executed as required in the above referenced policy.

a. Medical Record #45 (consent dated 1/23/14), Medical Record #60 (consent dated 1/28/14) and Medical Record #61 (consent dated 1/16/14), did not have evidence of the time the consent was obtained from the patient, or the time the physician certified the discussion of the elements of the informed consent with the patient.

b. Medical Record #62 did not have evidence of the date or time consent for blood products transfusion was obtained from the patient, or the time the physician certified the discussion of the elements of the informed consent with the patient.

c. Medical Record #45 did not have evidence the patient gave his/her consent for a bone marrow biopsy.

i. The physician hand wrote the following note at the bottom of the consent form: "___ agrees with biopsy. Has blurry vision. Unable to sign for himself." This note was signed by the responsible physician.

ii. There was no witness to the patient's verbal consent.

2. There was no evidence in the above referenced policy titled "Informed Consent" what procedure is to be followed if an informed consent is obtained verbally for operative, procedural intervention, or blood products transfusion.

Based on observation, document review and staff interview, it was determined that the facility failed to ensure that pharmaceutical services promoted safe medication use.

Findings include:

1. The facility failed to ensure that single dose vials are used for just one patient and discarded. Refer to Tag A491.

2. The facility failed to ensure that multidose vials accessed in an immediate patient care area are used for one patient and discarded. Refer to Tag A500.

3. The facility failed to ensure that spiked and/or compounded intravenous solutions that are not prepared in the pharmacy are discarded if not immediately administered. Referred to Tag A500.

Based on observation, document review and staff interview conducted on 1/30/14, it was determined that the facility failed to ensure implementation of policies and procedures addressing the use of single-dose injectable vials.

Findings include:

Reference: Facility policy titled "Expiration Dating- Sterile Single and Multiple-dose injectable vials, Topical Solutions, Oral Bulk Solutions, and Topical Solid Preparations" states, "Policy:...Single Dose Injectable Vials Injectable drugs procured in containers designated as "single-use" shall be discarded immediately after use."

1. Review of Anesthesia Controlled Substance Record Cards, utilized by Anesthesia Services to record CDS usage, revealed that single dose vials of Fentanyl 250mcg/5ml were used for multiple patients. Examples include but are not limited to:

a. The use of 2 vials for the administration of Fentanyl to a total of 4 patients was recorded on the Anesthesia Controlled Substance Record Card for Pack #75, dated 1/27/14.

b. The use of 1 vial for the administration of Fentanyl to a total of 2 patients was recorded on the Anesthesia Controlled Substance Record Card for Pack #91, dated 1/29/14.

c. The use of 1 vial for the administration of Fentanyl to a total of 2 patients was recorded on the Anesthesia Controlled Substance Record Card for Pack #101. The date the pack was used was not recorded.

d. The use of 1 vial for the administration of Fentanyl to a total of 2 patients was recorded on the Anesthesia Controlled Substance Record Card for Pack #72, dated 1/29/14.

e. The use of 1 vial for the administration of Fentanyl to a total of 2 patients was recorded on the Anesthesia Controlled Substance Record Card for Pack #91, dated 1/29/14.

f. The use of 3 vials for the administration of Fentanyl to a total of 6 patients was recorded on the Anesthesia Controlled Substance Record Card for Pack #102, dated 1/28/14.

2. These findings were confirmed by Staff #6 and Staff #98.


These findings resulted in an Immediate Jeopardy which immediately curtailed this practice. The Immediate Jeopardy was abated on 1/30/14, day of survey, upon receipt of an acceptable plan of correction.

A. Based on observation, document review and staff interview, it was determined that the facility failed to ensure implementation of policies and procedures addressing the preparation of IV [intravenous] solutions outside the Pharmacy.

Findings include:

Reference: Facility Policy M-1-3, titled "Subject: Expiration Dating- Sterile Single and Multiple-dose injectable vials, Prepared IV Solutions and Syringes, Topical Solutions, Oral Bulk Solutions, and Topical Solid Preparations" states, POLICY: ... "Preparation of IV Solutions - Preparation of any IV solution, including piggybacks, and medicated infusions, outside of the Pharmacy, must be administered to the patient within 1 hour of preparation. - Spiking of any IV infusion, including piggybacks and medicated infusions, must be administered to the patient within 1 hour of preparation."

1. On 1/28/14, at 10:30 AM, a spiked back of Magnesium Sulfate was found in the medication bin for Patient #69, located in Tower 9. It was not known when the bag had been spiked. Review of records indicated that the medication had been removed from the drug dispensing device on 1/27/14 at 8:29 AM.

2. On 1/29/14, at 11:05 AM, a spiked 500ml bag of Lactated Ringers for Injection was found in the anesthesia cart in Pediatric Operating Room (OR) #6. The time the bag had been spiked was unknown.

3. On 1/29/14, at 11:30 AM, three 1000ml bags of 0.9% Sodium Chloride for Injection had a label affixed to them stating that Heparin 30,000 Units had been added on 1/28/14 at 8:00 AM.

a. Upon interview, Staff #94 stated that the compounded parenteral solution would usually be stored "overnight."

These findings resulted in an Immediate Jeopardy which immediately curtailed this practice. The Immediate Jeopardy was abated on 1/29/14, day of survey, upon receipt of an acceptable plan of correction.

B. Based on observation, document review, and staff interview, it was determined that the facility failed to ensure development and implementation of policies and procedures addressing the use and storage of multiple dose medication vials in immediate patient treatment areas.

Findings include:

Reference #1: Centers for Disease Control and Prevention (CDC) FAQ [frequently asked questions] regarding Safe Practices for Medical Injections states, "...Questions about Multi-dose vials...2. Can multi-dose vials be used for more than one patient? How?...Multi-dose vials should be dedicated to a single patient whenever possible. If multi-dose vials must be used for more than one patient, they should not be kept or accessed in the immediate patient treatment area. This is to prevent inadvertent contamination of the vial through direct or indirect contact with potentially contaminated surfaces or equipment that could then lead to infections in subsequent patients. If a multi-dose vial enters the immediate patient treatment area, it should be dedicated to that patient only and discarded after use...3. What are examples of the " immediate patient treatment area " ? ...Examples of the immediate patient treatment area include patient rooms or bays, and operating rooms."

1. On 1/29/14 at 11:05 AM, an opened 10ml multi-dose vial of Rocuronium 10mg/ml was found in the anesthesia cart in Pediatric OR #6.

2. Upon interview with OR staff members #95, #96, and #97, it was noted that all staff stated that multi-dose vials used in an immediate patient care area, such as an OR, were to be used for a single patient.

3. Upon request, Staff #6 was unable to provide a policy and procedure addressing this.

These findings resulted in an Immediate Jeopardy which immediately curtailed this practice. The Immediate Jeopardy was abated on 1/29/14, day of survey, upon receipt of an acceptable plan of correction.

A. Based on observation and review of facility policies and procedures, it was determined that facility failed to ensure implementation of Infection Control policies and procedures of the contracted Renal Dialysis service.

Findings include:

Reference #1: --- [contracted dialysis service] HealthCare Partners Inc. Acute Services Policy & Procedure Manual #1, Policy: 7-03-01 titled, "Infection Control in the Hospital Dialysis Setting" states, "2. Teammates will thoroughly wipe down all non-disposable items and equipment such as the blood pressure cuff, the inside and outside of the prime container, clamps, the dialysis delivery systems, and electronic devices with 1:100 bleach solution after every treatment."

1. On 1/30/14 at 11:40 AM, Staff #77 was observed cleaning the dialysis machine and the surrounding treatment station following patient treatment at Station #4. Staff #77 failed to clean all non-disposable items and equipment in the treatment station, as indicated in Reference #1.

a. Staff #77 was observed wiping down the blood pressure cuff but failed to clean the blood pressure cord that had been draped across the top of the patient bed.

b. Staff # 77 failed to clean the prime bucket attached to the side of the dialysis machine.

Reference #2: --- [contracted dialysis service] Inc. Acute Services Policy & Procedure Manual #2, Policy: 7-12-34 titled, "Bicarbonate Concentrate" states under "Commercial Liquid Bicarbonate" section, "4. When commercial liquid bicarb solution is used, the manufacturer's container should be labeled with date, time and initials of teammate when opened and any unused liquid is discarded at the end of the treatment day."

Reference #3: --- [contracted dialysis service] Inc. Acute Services Policy & Procedure Manual #2, Policy: 7-12-36 titled, "Acid Concentrates" states, "4. Open, unused solution in acid concentrate containers are to be capped, stored in a secure location and used within 30 days of date opened."

1. On 1/30/14 at 11:40 AM, Staff #77 was observed cleaning the dialysis machine and the surrounding treatment station following patient treatment at Station #4. Staff #77 failed to clean the exterior of the commercial concentrate containers used in patient treatment and that could be used, according to policy, for more than one patient through the treatment day for bicarbonate and up to 30 days for acid.

a. Staff #77 removed the commercial jugs of acid and bicarbonate concentrates from the bottom ledge of the dialysis machine to the floor to gain access to clean the bottom ledge of the machine, but failed to clean the exterior of the jugs before returning the un-cleaned jugs used in previous patient treatment, to the clean ledge at the bottom of the dialysis machine.

Reference #4: --- [contracted dialysis service] Inc. Acute Services Policy & Procedure Manual #1, Policy: 7-03-01 titled, "Infection Control in the Hospital Dialysis Setting" states, "25. The outside surfaces of all equipment will be wiped with a bleach solution prior to removal from treatment area."

1. On 1/30/14 at 11:40 AM, Staff # 77 was observed cleaning the dialysis machine and the surrounding treatment station following patient treatment at Station #4. Staff #77 failed to clean a removable item that was used in patient Station #4 prior to removing it to a clean patient area.

a. Staff #77 removed the fiber board clipboard from the top of the dialysis machine that was used during patient treatment at Station #4 and placed it on top of the clean dialysis machine in the next patient Station #5 without wiping or cleaning the clipboard.

B. Based on staff interview and review of facility policies and procedures, it was determined that the facility failed to ensure the policy for Infection Prevention Practices in Central Sterile Processing (CSP) Department is implemented.

Findings include:

Reference: Central Sterile Processing: Infection Prevention Practices in CSP policy, reviewed 03/2011 states, "Environmental Services: 1). All work surfaces, shelves and fixtures shall be cleaned each shift with approved germicidal cleaner."

1. On 1/29/14, Staff #78 and Staff #89 were interviewed in the CSP Decontamination Room. When questioned how often and by whom, the keyboard used to input soiled instrument barcodes as they are received into the decontamination room is cleaned, Staff #89, who works in the decontamination room, stated, the keyboard is cleaned by the housekeeping department once a day. Staff #78, the Manager of CSP, stated that the keyboard should be cleaned each shift by CSP staff.




08373

C. Based on observation, staff interview, and review of documentation on January 29, 30, and 31, 2014, it was determined that the facility failed to ensure that an ongoing program designed to prevent, control, and investigate infections and communicable diseases is maintained. The infection control and prevention program has not adequately implemented the Association for the Advancement of Medical Instrumentation (AAMI) standards and the CDC Guideline for Prevention of Surgical Site Infection, 1999, that was selected by the hospital.

Findings include:

Reference #1: ST 79, section 6.3, Care and handling of contaminated reusable items at the point of use states, "Contaminated reusable items should be handled as little as possible at the point of use. Soiled items should be immediately contained and transported to the decontamination area or soiled utility area, where cleaning procedures can be accomplished away from patient care. Soil should be removed by a method that does not promote cross contamination; for example, personnel should avoid splashing water and thereby contaminating the area near the sink, and other surfaces in the environment."

1. On 1/31/14, Staff #85 indicated that soiled instruments (scissors, tissue nippers, blades, curettes, and handles) from patient procedures at the offsite Wound Care Center, are soaked in Empower foam detergent in a covered basin in patient procedure rooms.

a. Staff #85 indicated that the soaking soiled instruments are emptied into the hand wash sinks in the patient procedure rooms at the end of the day. The soiled instruments are then transported to a clean utility room and placed in red plastic containers with covers awaiting transport to the main hospital Sterile Processing department for sterilization. A potential for cross contamination to environmental surfaces and staff in patient procedure areas is possible.

Reference #2: ST 79, section 7.2.2, Manufacturer's instructions states, "The written instructions of the device manufacturer should always be followed."

1. Staff #99, at the offsite Sleep Center on Plum Street indicated that reusable sleep center equipment (tubing and masks) are placed directly in a basin of Quaternary disinfectant after patient use.

a. The manufacturer of the Quaternary disinfectant and sleep center equipment indicates that equipment should be washed with a neutral detergent prior to disinfection. The manufacturer instructions were not followed.

Reference #3: Central Sterile Processing policy titled "Immediate Use Sterilization" states, "All items to be sterilized for immediate use must be cleaned and sterilized following manufacturers instructions."

1. The manufacturer's instructions pertaining to the recommended sterilization cycle was not followed for the Immediate Use Sterilization cycle used in the Operating Room (OR).

a. On January 30, 2014 Staff #8 stated that all autoclaves used in the Main OR operate on gravity cycles only.

b. The facility's Immediate Use Sterilization policy does not provide instructions for the use of the Riley FlashPaks. Staff #8 stated that all instrumentations are placed into FlashPaks before sterilization in the OR.

Reference #4: The Zimmer brand Air Dermatome II manufacturer instructions state under sterilization recommendations (page 10 of instruction manual), "Cycle Type Gravity/Gravity Displacement Not Recommended due to excessively long sterilization cycles which are not practical. "

1. A review of the "Immediate Use Sterilization Log" revealed that on 1/10/14, a Zimmer Dermatone II was processed for 10 minutes (gravity cycle), which is not a sterilization cycle recommended by the device manufacturer.

Reference #5: The Olympus brand Working Element manufacturer instructions states under sterilization (page 86 of system guide book), "Use only prevacuum autoclave cycles to ensure that steam fills all lumens."

1. A review of the "Immediate Use Sterilization Log" revealed that on 1/9/2014, autoclave for OR 16 cycle #73173 had a Working Element autoclaved at 270-275 for 10 minutes (gravity cycle), rather than a prevaccum cycle recommended by the manufacturer.

Reference #6: The Aesculap brand instruments with box-locks manufacturer instruction states under Sterilization for the US market, "Aesculap advises against sterilizing the device by flash Sterilization." The manufacturer instructions further state, "Other sterilization cycles may also be suitable, however individuals or hospitals not using the recommended method are advised to validate any alternative method using appropriate laboratory techniques."

Reference #7: The V.Muellar brand general surgical instruments manufacturer instructions state under Sterilization, "Gravity steam sterilization parameters - Minimum Temperature: 132 C (270F) Minimum exposure time: 15 minutes."

1. A review of the "Immediate Use Sterilization Log" revealed that on 1/3/14, autoclave A cycle 22877 had an ENT instrument set processed at 270-275 Fahrenheit (F) for 10 minutes. Staff #8 provided a list, of which Aesculap and V.Muellar brand instrumentation were included. The manufacturer instructions for both brands do not provide a recommendation for a 270 F for 10 minutes gravity cycle. Staff #88 stated that the facility has not validated any alternative sterilization method as stated by Aesculap brand instruments for the above ENT instrument set.

Reference #8: The Riley brand FlashPak instructions for use states, " 1. Clean and inspect the container. The container should be washed with a surgical instrument detergent, rinsed with tap water and dried with a soft absorbent towel."

1. On 1/30/14, five (5) Flashpaks were observed stored on a stainless steel cart in the sterile corridor. There were water droplets on the interior surfaces of the cases from inadequate drying before storage.

Based on medical record review and patient interview, it was determined that the facility failed to ensure that discharge planning evaluations are discussed with the patient or the patient's representative.

Findings include:

1. Patient #27 was admitted to the facility on 1/23/14 with the diagnosis of a fractured ankle. A physician order, dated 1/24/14 at 15:09 stated, "Consult Social Services Priority: Routine, Reason for Consult: Home Care and Rehab."

a. The initial social worker note in Medical Record #27, dated 1/27/14, stated the discussion with the physician indicated the patient would need sub-acute rehabilitation services post discharge. In addition, the social worker was to review the option list with the patient. On 1/28/14, a social worker note indicated the options would be discussed with patient on 1/29/14, and that the anticipated plan for discharge would be on 1/29/14 or 1/30/14.

b. There was no evidence in the medical record the patient or patient's representative were informed of the discharge plan prior to 1/29/14.

2. Patient #24 was admitted to the facility on 1/23/14 with the diagnosis of a fractured hip. A physician order, dated 1/25/14 at 15:25 stated, "Consult Social Services Priority: Routine, Reason for Consult: Home Care and Rehab." An initial social worker note, dated 1/27/14, evaluated the patient's options for discharge planning.

a. There was no evidence in the medical record that the patient, prior to 1/29/14, was made aware of his/her discharge plan.

b. Interview with Patient #24 on 1/29/14 confirmed the lack of awareness of his/her discharge plan post hospitalization.

3. The above was confirmed by Staff #50 and Staff #81.

Based on medical record review, it was determined that the facility failed to ensure documentation in the patient medical record that the patient or individual acting on the patient's behalf, received a list of post acute care providers to choose from for post hospital care.

Findings include:

1. Medical Record #25 contained a social worker note dated 1/27/14, in which a discussion of rehabilitation was discussed with the family. There was no evidence in the medical record, the patient or individual acting on behalf of the patient was provided a list of facilities to choose from for post hospital care.

2. Medical Record #29 contained a social worker note dated 1/27/14, in which a discussion of subacute rehabilitation was discussed with the patient. There was no evidence that the patient was provided a list of facilities to choose from for post hospital care.

3. The above was confirmed by Staff #37 and Staff #47.

Based on observation, staff interview, and review of facility policy and procedure, it was determined that the facility failed to ensure that a radioactive emergency spill policy that guides the current practice of the radiology staff is provided.

Findings include:

Facility policy and procedure titled "Nuclear Medicine- Radioactive Material Emergency Procedure" states, "Purpose: To ensure that an emergency involving radioactive materials is handled in a safe manner. ...Procedure: ...Other Hazards: e.g., spills or suspected spills of radioactive materials where material does not become airborne. ... 3- Decontaminate: a) Obtain the spill kit. ... b) If the spill can not be decontaminated within reasonable time and means close the area and notify the RSO [Radiation Safety Officer] and security."

1. On 1/29/14 at 10:30 AM, the Nuclear Medicine Department was toured in the presence of Staff #5 and Staff #23. During interview, Staff #23 stated that if there was a spillage of radioactive material/pharmaceuticals, he/she would use the Radiation Spill Wash on the area and clean up with an absorbent towel. Staff #5 stated a "Hazmat Code" would also be called.

2. On 1/29/14 at 11:35 AM, the Cardiac Stress Test Lab on the second floor was toured in the presence of Staff #5 and Staff #23. Staff #23 was initially unable to locate the spill kit. The spill kit was located in a lower cabinet next to the sink, behind and underneath a stack of patient sheets, not readily available if needed in an emergency.

a. Staff #23 was unable to locate the Radiation Spill Wash and confirmed there was not a bottle/can present in the Cardiac Stress Test Lab.

3. Review of the above referenced policy and procedure lacked inclusion of the use of the Radiation Spill Wash and calling a "Hazmat Code" when there is a radioactive spillage, as per staff interviews above.