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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 Condition of Participation:

Cross reference: CFR 482.42 Infection Control

Based on medical record review, staff interview, and review of facility policy and procedure it was determined that the facility failed to implement its policy and procedure for oxytocin administration, and state regulation for administration of Oxytocin, in three of four obstetrical delivery records reviewed (Medical Records #2, #4, and #5).

Reference #1: Facility policy and procedure #: III-3, titled 'Antepartum Use of Oxytocin for Induction or Augmentation', approved in 2006, states "... POLICY: 1. When a physician orders the antepartum use of oxytocin for induction or augmentation of labor, the physician must be readily available to deal with any emergencies that may arise as a result of such use. 2. If the ordering physician is aware that he/she will not be readily available to deal with emergencies/problems which may arise, he/she should arrange for an obstetrician to be readily available to cover such events. ... PROCEDURE: 1. The physician must assess patient in house, including indications for induction, augmentation of labor, within one hour before oxytocin is administered."

Reference #2: N.J.A.C. Title 8 Chapter 43 G Hospital Licensing Standards states at 8:43 G-19.11 (d) "If oxytoxics are administered, the following shall occur within one hour prior to administration: the patient shall be examined vaginally by either a physician with obstetric privileges, a certified nurse midwife or an advanced practice nurse in accordance with hospital bylaws, and electronic fetal heart rate monitoring shall be initiated."

1. On 1/23/12 11:25 AM four medical records were reviewed for obstetrical deliveries, and three of the four patients received Oxytocin intravenously (IV). It was observed in Medical Records #2, #4, and #5 that oxytocin was administered to the patients' without evidence of a completed evaluation by the physician prior to oxytocin administration. The following was observed in each medical record:

a. In Medical Record #2 a telephone physician order dated and timed 1/20/12 at 8:15 AM stated, "start Pitocin 20 units in 0.9 NS [normal saline] 1000 cc @ 1 milliunit & increase q [every] 15-30 min [minutes] q 1 min until cxt [contractions] are strong & q 2-3 minutes apart."

i. Per the second page of the 'IV CARE/HYPERALIMENTATION RECORD AND FLOWSHEET', and the 'LD [Labor & Delivery] Flowsheet', the registered Nurse (RN) started the Pitocin IV on 1/20/12 at 8:30 AM.

ii. There was no evidence in Medical Record #2 of a sterile vaginal examination or assessment by a physician within one hour prior to the initiation of Pitocin as per facility policy and procedure and state regulation. This was confirmed by Staff #7 on 1/23/12 at 12:00 PM.

b. In Medical Record #4 a telephone physician order dated and timed 1/20/12 at 10:15 AM stated "Start Pitocin 20 units in 1000 ml [milliliters] NS at 2 milliunits/minute increase by 2 milliunits/minute every 20/30 minutes until contractions are 2-3 minutes apart lasting 60 seconds IVPB [intravenous piggyback]."

i. Per the second page of the 'IV CARE/HYPERALIMENTATION RECORD AND FLOWSHEET', the registered Nurse (RN) started the Pitocin IV on 1/20/12 at 10:30 AM.

ii. Per the 'LD [Labor & Delivery] Flowsheet' on 1/20/12 at 09:52 AM, the MD performed an exam one hour ago in his/her office. There was no evidence that the physician performed an assessment of the patient on site within one hour prior to the initiation of Pitocin or arranged for an obstetrician to be readily available to cover emergencies/problems which may arise, as per facility policy.

c. In Medical Record #5 a physician order dated and timed 1/22/12 at 8:30 AM stated "Pitocin 20 units in 1 L [liter] NS start at 2 mu [milliunits] & increase per protocol."

i. Per the second page of the 'IV CARE/HYPERALIMENTATION RECORD AND FLOWSHEET' and the 'LD [Labor & Delivery] Flowsheet' the registered Nurse (RN) started the Pitocin IV on 1/22/12 at 8:45 AM.

ii. Per the 'LD [Labor & Delivery] Flowsheet' and per Staff #7, the nurse documented that the physician performed an exam on 1/22/12 at 8:22 AM. There was no evidence in Medical Record #5 of a documented sterile vaginal exam or assessment by the physician within one hour prior to the initiation of Pitocin as per facility policy and procedure and state regulation. This was confirmed by Staff #7 on 1/23/12 at 12:10 PM.

Based on medical record review, staff interview, and review of facility policy and procedure, it was determined that the facility failed to secure a copy of all patients' advance directives when it was documented that an advance directive exists.

Findings include:

Reference #1: Facility policy and procedure #: A-01, titled 'Advanced Directives for Health Care' states "... PROCEDURE: A. inquiry of an Advance Directive Upon Admission 1. An inquiry will be made of each adult patient, at the time of admission, and at other appropriate times, concerning the existence and location of an Advance Directive for Health Care. If the patient is incapable of responding to this inquiry, the medical center will ask the family or person with knowledge of the patient, if available. ... 5. If the patient indicates that an Advance Directive has been executed, but has not made a copy available, personnel documenting admission will document in the patients medical record that follow-up is required. The patient will be encouraged to have the document brought to the medical center. Any member of the health care team who receives the document shall place, or have it placed, in the patient's medical record. ..."

Reference #2: Facility policy and procedure #: A-04, titled 'Admission Assessment' states "... PROCEDURE: ... 12. Obtain Advance Directive data. ... If a patient has an Advance Directive, place copy in the medical record. If a copy is not present, inform patient/family that a copy is necessary. Refer to Social Work as necessary."
A telephone order dated 3/23/11 at 8:40 AM was "e-signed" by the physician on 7/15/11 at 12:33 PM. This was 21 days late.

1. On 1/25/12 at 10:30 AM Medical Records # 30 and #31 were reviewed for the presence of an advance directive. Each medical record indicated that the patient had an existing advance directive. However, the facility did not follow up after the date of admission, on obtaining a copy of the advance directive to be placed in the medical record. The following was observed:

a. In Medical Record #30:

i. The 'Patient Admission Assessment' dated and timed 1/16/12 at 8:40 PM indicated, in the 'Advance Directive' section, that the patient does have an advance directive (AD), it is with the patient's son who is the Power of Attorney (POA), the patient is a DNI (Do Not Intubate), the patient/family was informed to bring in a copy, and a referral was made [checkmark next SW and 'Yes'] to the Social Work Department, as per reference #2 above.

ii. A 'Case management Social Services' note dated and timed 1/17/12 at 2:00 PM indicated that the Social Worker (SW) reviewed the Admission Assessment, but there was no assessment of or discussion regarding the presence and location of an AD.

iii. A 'DNR [Do Not Resuscitate] PROGRESS NOTE,' dated 1/17/12 [not timed], that was signed by the physician indicating the patient was ordered to be a DNI [Do Not Intubate], wants CPR [Cardio-Pulmonary Resuscitation] and that a discussion of the DNR status was held with the patient and family. There was no evidence of an assessment of or discussion regarding the presence and location of an AD.

b. In Medical Record #31:

i. Per the 'GENERAL CONSENT: INPATIENT, OUTPATIENT & EMERGENCY DEPARTMENT' form, 'Yes' was checked next to "I have an Advance Directive/Living Will/Health Care Agent'.

ii. The 'Patient Admission Assessment' dated 1/18/12 [not timed] indicated in the 'Advance Directive' section a '?' mark and "unknown". The last page of the 'Patient Admission Assessment' indicated a referral was made to SW.

iii. A 'Case management Social Services' note dated and timed 1/19/12 at 9:00 AM indicated that the Social Worker (SW) reviewed the Admission Assessment, but there was no assessment of or discussion regarding the presence and location of an AD.

2. In both Medical Records #30 and #31, it was indicated on admission that each patient had an advance directive, but there was no evidence the facility followed up on obtaining a copy of the AD after the date of admission.

Based on medical record review, it was determined that the facility failed to ensure that verbal orders are authenticated within 48 hours.

Findings include:

1. The following telephone orders in Medical Record #50, reviewed on 1/25/12, had not been authenticated within 48 hours:

a. A telephone order dated 11/6/11 at 6:20 PM appears to have been signed by the physician but there was no date and/or time on the entry. There was no evidence that the order was authenticated within 48 hours.

b. A telephone order dated 11/6/11 at 11:40 PM appears to have been signed by the physician but there was no date and/or time on the entry. There was no evidence that the order was authenticated within 48 hours.

2. The following telephone orders in Medical Record #52, reviewed on 1/25/12, had not been authenticated within 48 hours:

a. A telephone order dated 3/23/11 at 8:40 AM was "e-signed" by the physician on 4/15/11 at 12:33 PM, 21 days late.

b. A telephone order dated 3/20/11 at 9:55 PM appears to have been signed by the physician but there was no date and/or time on the entry. There was no evidence that the order was authenticated within 48 hours.

c. A telephone order dated 3/23/11 at 12:00 PM was "e-signed" by the physician on 5/6/11 at 11:14 AM, 42 days late.

d. A telephone order dated 3/23/11 at 9:30 AM was "e-signed" 4/17/11 4:17 PM, 23 days late.


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3. The following telephone orders in Medical Record #27, reviewed on 1/25/12, had not been authenticated within 48 hours:

a. A telephone order dated 10/31/11 at 6:20 PM was "e-signed" by the physician on 11/18/11 at 2:20 PM, 16 days late.

b. A telephone order date 11/1/11 at 9:05 was "e-signed" by the physician on 11/16/11 at 3:30 PM, 13 days late.

c. A telephone order dated 11/1/11 at 3:20 PM was "e-signed" by the physician on 11/11/11 at 11:14 AM, 8 days late.

4. The following telephone orders in Medical Record #28, reviewed on 1/25/12, had not been authenticated within 48 hours:

a. A telephone order dated 10/11/11 at 12:45 PM was"e-signed" by the physician on 11/5/11 at 11:48 AM, 23 days late.

b. A telephone order dated 10/12/11 at 5:30 PM was "e-signed" by the physician on 11/5/11 at 11:48 AM, 22 days late.

c. Telephone orders dated 10/14/11 at 11:00 AM were "e-signed" by the physician on 11/5/11 at 11:48 AM, 20 days late.

d. A telephone order dated 10/14/11 at 4:30 PM was "e-signed" by the physician on 11/5/11 at 11:49 AM, 20 days late.

e. A telephone order dated 10/14/11 at 4:35 PM was "e-signed" by the physician on 11/5/11 at 11:49 AM, 20 days late.

f. A telephone order dated 10/15/11 at 6:15 am was "e-signed" by the physician on 11/3/11 at 5:19 AM, 17 days late.

5. The following telephone orders in Medical Record #29, reviewed on 1/25/12, had not been authenticated within 48 hours:

a. A telephone order dated 11/3/11 at 7:00 PM was "e-signed" by the physician on 11/15/11 at 9:29 PM, 10 days late.

b. A telephone order dated 11/7/11 at 2:00 AM was "e-signed" by the physician on 11/19/11 at 7:51 PM, 10 days late.

c. A telephone order dated 11/7/11 at 3:10 PM was "e-signed" by the physician on 11/17/11 at 8:17 PM, 8 days late.

Based on observation and staff interview conducted on 1/26/12, it was determined that the facility failed to ensure that irrigation solutions were stored in accordance with manufacturer's recommendations.

Findings include:

1. Approximately six 1000 milliliter bottles for 0.9% Sodium Chloride for Irrigation were found in a warmer in the Operating Room Suite at 11:30 AM. The temperature of the warmer was approximately 110 degrees Fahrenheit (the thermometer was graduated in 50 degree increments). The temperature log for the warmer stated to maintain the fluids at 80 to 100 degrees Fahrenheit.

2. Upon interview, Staff #23 was unable to provide the manufacturer's recommendation for storing the irrigation solution above room temperature. Each manufacturer establishes warming guidelines that include temperature ranges and the amount of time the solutions can be stored at these temperatures. The bottles were not dated when placed in the warmer. It could not be determined how long each bottle had been stored in the warmer.

Based on observation, staff interview and document review in the presence of Staff #5, Staff #41, and Staff #42, it was determined that the Director of Food & Nutrition failed to ensure daily supervision of the Food & Nutrition service area in accordance with his/her job description.

Findings include:

Reference #1: Facility job description, "Director Food & Nutrition" stipulates, "SECTION II: SUMMARY OF JOB FUNCTION, This position is responsible for the day to day operations of the Food & Nutrition Services for the Medical Center. ...1. Job Function: Leadership, Ensures the Medical Center is prepared for any regulatory inspection including JCAHO, NJ State, OSHA, etc. with regard to sanitation, nutritional assessment and food preparation. ..."

Reference #2: N.J.A.C. TITLE 8, CHAPTER 43G, HOSPITAL LICENSING STANDARDS, SUBCHAPTER 10. DIETARY, (q) The dietary service shall comply with the requirements of Chapter 24 of the New Jersey State Sanitary Code, "Sanitation in Retail Food Establishments and Food and Beverage Vending
Machines" (N.J.A.C. 8:24).

Reference #3: 8:24-3.3 Protection from contamination after receiving (a) Requirements for preventing contamination (z) Food shall be protected from contamination that may result from a factor or source not specified above.

1. On 1/31/12 at 9:50 AM in the dry storage area, there were 2 boxes of Arginad with an expiration date of "Jan 3 2012;" there were 2 cases of Similac Sensitive 48-2 fluid ounce containers with an expiration date of "Sept 1 2011" and Jan 1 2011;" there was one case of Similac 20 cal/oz 48-2 fluid ounce containers with an expiration date of 1/1/12; and one case of Glucerna 1.5, 6-1000 cc ready to feed containers that had an expiration date of "Jan 1 2012." The storage area contains food items that have exceeded their expiration date.

Reference #4: 8:24-3.3 Protection from contamination after receiving, (j) Food shall only contact surfaces of equipment and utensils that are cleaned and sanitized.

1. On 1/31/12 at 11:10 AM in the Food & Nutrition Department adjacent to the tray line, there was 2 temperature measuring devices that were partially submerged in a container of OASIS 146 MULTI-QUAT SANITIZER on a countertop. Staff #43 took one of the temperature measuring devices and began to take the temperature of the food items in the steam table that were available for lunch meal service. Upon asking how often the OASIS 146 MULTI-QUAT SANITIZER fluid is changed, Staff #43 stated every 3 or 4 days. Upon asking for manufacturer directions for use, Staff #41 provided e-mail documentation dated 1/31/12 from Ecolab that stated, "regarding the oasis 146 the range is 140 to 400 I would recommend testing every couple of days with qt 40 strips and changing when under 200 rpm." Upon asking if the OASIS 146 MULTI-QUAT SANITIZER solution is tested as stated in the e-mail dated 1/31/12 at 1:11 PM, Staff #41 stated, "No."

Reference #5: 8:24-4.2 Design and construction (a) Equipment and utensils shall be designed and constructed to be durable and to retain their characteristic qualities under normal use conditions. (b) Multiuse food-contact surfaces shall be: 1. Smooth; 2. Free of breaks, open seams, cracks, chips, pits, and similar imperfections; 3. Free of sharp internal angles, corners, and crevices; ...

1. On 1/31/12 at 9:45 AM in the Food & Nutrition Department adjacent to the warewashing area, there was a large metal wire whip that had an open seam at the end of the handle exposing sharp metal edges.

Reference #6: 8:24-4.6 Cleaning of equipment & utensils, ...(c) Non food-contact surfaces of equipment shall be kept free of an accumulation of dust, dirt, food residue, and other debris.

1. On 1/31/12 at 10:50 AM in the Food & Nutrition Department, the outside of the cook's reach-in refrigerators had a build-up of food residue at the lower bottom of the refrigerator doors.

Reference #7: 8:24-5.2 Plumbing system (a) A plumbing system shall be:...and 2. Maintained in good repair.

1. On 1/31/12 at 10:10 AM in the Food & Nutrition Department, there was a puddle of water near the large kettle. In an adjacent metal box that housed water pipe junctures, there was water dripping from the water pipe. On 1/31/12, Staff #1 stated that facility staff determined that there was a leak in the water pipe.

2. On 1/31/12 at 10:25 AM in the Food & Nutrition Department, there was a build-up of water at the base of the steam box. On 1/13/12, Staff #1 stated that facility staff determined that there was a leak in the water pipe.

Reference #8: 8:24-6.1 Materials for construction and repair, 8:24-6.1 Materials for construction and repair (a) Indoor surface characteristics shall include the following: 1. Except as specified in (a) 2 below, materials for indoor floor, wall, and ceiling surfaces under conditions of normal use shall be: i. Smooth, durable, and easily cleanable for areas where retail food establishment operations are conducted; ..."

1. On 1/31/12 at 9:45 AM in the Food & Nutrition Department kitchen and adjacent areas, the floor was pitted throughout.

Reference #9: 8:24-6.2 Design, construction, and installation (a) The floors, floor coverings, walls (n) Requirements for the protection of outer openings shall include the following: 1. Except as specified in (n)2 and 3 below, outer openings of a retail food establishment shall be protected against the entry of insects and rodents by: i. Filling or closing holes and other gaps along floors, walls and ceilings; ii. Closed, tight-fitting windows; and iii. Solid self-closing, tight-fitting doors.

1. On 1/31/12 at 10:55 AM in the Food & Nutrition Department at the exit to the loading dock, the doors that lead out to loading dock had a gap in which the light from outside could be seen. This gap could allow the entry of insects and vermin into the Food & Nutrition Department.

Reference #10: 8:24-6.5 Maintenance and operation, (a) The physical facilities shall be maintained in good repair.

1. On 1/31/12 at 10:40 AM in the warewashing area, there was 4 stained ceiling tiles that had pink and brown residue on the surface.

Reference #11: 8:24-6.5 Maintenance and operation, (a) The physical facilities shall be maintained in good repair. ...(b) The physical facilities shall be cleaned as often as necessary to keep them clean. Cleaning shall be done during periods when the least amount of food is exposed such as after closing. This requirement does not apply to cleaning that is necessary due to a spill or other accident.

1. On 1/31/12 at 10:15 AM in the staff locker room the floor had light brown stains and a small build-up of residue at the outer perimeter of the flooring. In the adjacent hallway, the floor had a small build-up of residue at the outer edges of the tile flooring.

Based on observation, it was determined that the facility failed to conform to the applicable provisions of the Life Safety Code concerning width of exit corridors.

Findings include:

1. On 1/26/11 at 10:35 AM, in the presence of Staff #23, the OR exit corridors were restricted to 4'6" by medical equipment.

A. Based on observation, it was determined that the potable water supply to acute dialysis delivery systems is not protected with backflow prevention devices as recommended by industry standard.

Findings include:

Reference:
ANSI/AAMI RD: 52: 2004(R) 2010, Dialysate for Hemodialysis, Annex E, Special considerations for acute hemodialysis E.3.2 Backflow prevention, states, "Unlike central water systems in free-standing dialysis clinics, acute water systems in most cases connect directly to potable water systems. Though it is very unlikely that a portable (acute) water treatment system would back up and contaminate the potable water system, backflow prevention is considered a necessary and safe precaution for these systems. A backflow prevention device, such as a Pressure Principle Backflow Assembly (PPBA) or a vacuum breaker, should be installed at the point of connection to the potable water system."

1. On 1/24/12, the connections from the potable water supply lines to the acute dialysis delivery systems were noted to be lacking backflow preventers.


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B. Based on observation, it was determined that the facility failed to maintain the ice/water machine for its services.

Findings include:

Reference: Follett Ice and water dispenser cleaning, Icemaker cleaning & sanitizing, Periodic cleaning of Follett's icemaker system is required to ensure peak performance and delivery of clean, sanitary ice. The recommended cleaning procedures which follow should be performed at least as frequently as recommended below and more often if environmental conditions dictate. ..."

1. The Follett ice dispenser and water dispenser were not maintained clean.

a. On 2/1/12 at 9:30 AM in the 4 North Food Pantry, the Follett ice dispenser had pink/orange residue at the ice dispenser. The Follett water dispenser had black residue at the spigot. The ICE MACHINE CLEANINGS log indicate that this machine was last cleaned 11/30/11.

b. On 2/1/12 at 11:20 AM in the SICU Food Pantry, the Follett ice dispenser had pink residue at the ice dispenser. The Follett water dispenser had black residue at the spigot. The ICE MACHINE CLEANINGS log indicate that this machine was last cleaned 12/2/11.

c. On 2/1/12 at 12:40 PM in the 3 South Food Pantry, the Follett ice dispenser had black residue at the ice dispenser. The ICE MACHINE CLEANINGS log indicate that this machine was last cleaned 12/1/11.

Based on observations, document reviews, and interviews it was determined that the facility failed to adequately provide an active program for the prevention, control, and investigation of infections and communicable diseases.

Cross reference tag # 0749.

A. Based on observation, staff interview and review of facility documents, it was determined that facility policy, manufacturer's instructions and industry standards were not followed for the hi-level disinfection of transducer probes in the Central Services Department.

Findings include:

Reference #A1a:
Facility policy titled: Processing of Vaginal Ultrasound probes (July 2011) states: Transport to processing room, follow the probes specific IFU (Instructions for Use) for cleaning, all detergents must be diluted according to the manufacturer's instructions, measure the detergent using a measuring cup, measure the water placed into the sink to ensure correct dilution.

Reference #A1b:
Manufacturers (Siemens and Philips) General Cleaning Procedures for all Transducers state: Be sure to use the proper concentration of enzymatic cleaner and rinse thoroughly. ...Use a soft cloth lightly dampened in a mild soap or an enzymatic cleaner to remove any particulate matter or body fluids on the transducer or cable.

Reference #A1c:
AAMI Chemical Sterilization and Hi-Level Disinfection in Health Care Facilities (2005) ST 58- 6.5.4.1., Effective cleaning is a multistep process that relies on several interdependent factors: the quality, type and concentration of detergent or enzymatic cleaner, recommended cleaning method and... operator performance.

1. On 01/23/12 at 11:30 am, Staff # 19 was unable to define cleaning procedures of the transducer prior to hi level disinfection. Staff #19 stated that the procedure for the decontamination of a vaginal probe is receiving the probe in a red biohazard bag through the decontamination area, bringing it into the sterile processing area, taking directly to the pass through window into the sterile side for processing in the hi level disinfectant.

2. Facility policy states after hi level disinfection with Cidex OPA, rinse the probe in a second tote bin, use the sink to dispose of the rinse water.

a. During observation of the hi-level disinfection of transducer probes in the Central Service processing area, on 01/23/12, a second tote bin was not provided for the final rinse.

b. Staff #19 stated that after hi level disinfection the transducer is rinsed with sterile water at the single basin hand washing sink while holding the transducer with one hand and pouring sterile water over it.

B. Based on observation, it was determined that sterilized materials are not stored or monitored in the OR and Endoscopy Department to ensure sterility at the time of use.

Findings include:

1. On 01/25/12, approximately 8-10 single use sterile endotracheal tubes were observed with wrappers opened, inside of the locked anesthesia cart in Endoscopy Room #3.

2. The bottom anesthesia cart drawer in Endoscopy Room #3 contained sterile LMAs (both sterilized and single-use). Two sterile packs containing LMAs (laryngeal mask airways) were compressed and crushed. One sterile LMA (load no. 1 11 06 16) wrapper was punctured on the paper side, compromising the sterility of the contents.

3. Sterile wrapped instruments are stored in a manner that compromises sterility. On 1/25/12 in the bottom anesthesia cart drawer in Endoscopy Room #3, sterile LMAs (laryngeal mask airways) were observed stored in contact with non-sterile items, including three books, packaged cookies and 9 bottles of medications (Propofol and Diprovan).

4. On 1/24/12, a transport cart in the OR prep and pack area containing wrapped instruments to be sent to Central Services for sterile processing was observed to contain 12 soiled, stained and dusty trays on the bottom shelf. On 01/24/12 at 11:30 am, Staff #18 stated that trays are used underneath sterile packs to prevent sterile wrapped items from tears during handling/storage.

5. On 1/24/12 in the OR storeroom, a sterile Syntheses small fragment set, containing implantable items (load no. Jan 05 12 23), was opened for inspection and contained three rusted instruments.
C. Based on observation and document review, it was determined that the facility failed to follow written policy for "Loaner Instrumentation; Borrowed Instruments; Doctors Instruments."

Findings Include:

Reference: # C:
Facility policy titled, 'Loaner Instrumentation; Borrowed Instruments; Doctor's Instruments' states, "The following information should be documented: a) date of the procedure, b) time of the procedure, c) surgeon's name, d) scheduled procedure, e) number of trays arriving, f) when the trays will arrive (date and approximate time) and g) how the trays will arrive (courier, Fed-X, etc..."

On 1/24/12, at 11:30 am a review of the loaner OR instrumentation log records from July 2011 to January 2012 were missing times of the procedure, scheduled procedure and how the trays arrived to the facility.

D. Based on observation, staff interview and document review, it was determined that the facility failed to obtain written manufacturer's instructions for reprocessing of loaner instrumentation.

Findings Include:

Reference: # D:
Facility policy titled, 'Loaner Instrumentation; Borrowed Instruments; Doctor's Instruments.' states, anytime instrumentation is borrowed, rented or provided as loaner from any facility ... The device/set is then processed according to the manufacturer's written instructions. If it is a specialty item, manufacturer's instructions must be obtained and followed before processing.

On 1/24/12 at 11:35 AM, Staff #18 stated that on 1/19/12 a Spineology tray in the OR instrumentation log had been re-processed without the written manufacturer instructions from the vendor.

E. Based on observation, staff interview and document review it was determined that the facility failed to provide written manufacturer recommendations for the use of a non-medical instrument device for a medical procedure.

Finding Include:

Reference # E: "The Association for the Advancement of Medical Instrumentation (AMMI) requirements, Comprehensive guide to steam sterilization and sterility assurance in health care facilities," AAMI ST79, Section (7.2.2), states: the written instructions of the device manufacturer should always be followed. The reusable medical device manufacturer is responsible for ensuring that the device can be effectively cleaned and sterilized. Sterilization qualification of a device requires microbiological, engineering, toxicological, and sometimes clinical evaluations of the device which are well beyond the abilities of the health care facilities. The device labeling should identify specific methods of cleaning and sterilization that have been validated by the manufacturer.


1. On 1/24/12 at 10:50AM, in the OR sterile storage unit, a household spoon was observed in a sterile peel pack. Staff #17 stated that this was being used to scrape out debris from curettes during an OR procedure. No manufacturer specification on using this non-medical device for a medical procedure was available upon request.

F. Based on observation and document review, it was determined that the facility failed to maintain a sanitary environment in the Operating Rooms.

Findings Include:

Reference: # F:
Facility policy Titled: 'Operating Room Suite Cleaning Between Cases.' states, "Clean the operating room table, lights, counters, furniture and all mobile equipment with a hospital approved germicidal solution."

1. On 1/24/12 at 11:00 AM, in OR Room #8 Velcro Strips on the OR table had evidence of lint and what appeared to be old protein residue.

2. On 1/24/12 at 11:15 AM, in OR Room #8 mobile IV equipment had evidence of pitting and what appeared to be blood residue present.

G. Based on observation, staff interview, and review of facility documents, it was determined that facility policy, manufacturer's instructions and industry standards were not followed for the immediate-use sterilization of instruments used for surgical procedures in the Operating Room in the Same Day Surgery Department.

Findings include:

Reference # G1a:
AAMI ST79:2010 "Comprehensive guide to steam sterilization and sterility assurance in health care facilities" states in section 8.6.1
Sterilization parameters for wrapped or containerized items, "The sterilizer manufacturer's written instructions for cycle parameters should be followed. Programmed cycle selections should be used. Any differences between the programmed cycle parameters and the cycle parameters recommended by the medical device manufacturer should be investigated and resolved before the items are sterilized. Procedures for correct cycle selection should be developed and implemented, and process audits should be conducted to ensure compliance."

Reference # G1b:
Facility policy # 9-13 titled "Steam Sterilization for Immediate Use- (SSIU-Flash Sterilization)" states in Procedure section, "2. Only those devices that have written instructions for flash sterilization shall be flashed. 26. Always follow the specific cycle type (gravity or pre-vacuum flash) and the recommended exposure time as directed by the device manufacturer."

Reference # G1c:
Conditioning Manual for BIOM3/BIOM4 and accessories Cleaning, disinfection, sterilization manual provided by Staff # 17 on 1/24/12 states in Packing and sterilization section, "6.2 Steam Sterilization: The sterilization in the steam autoclave was validated with the following minimum parameters: 10 min preheating with three pre-vacuum steps and three steam injections. Sterilizing temperature: 132C. Holding time: 3 min (full time). Drying time: 10 min. The above mentioned parameters are minimum demands which must not fall below. Divergence from these parameters to lower or shorter value have to be validated by the user. Longer duration of exposure time and higher temperature than mentioned above may lead to higher fatigue of material." The document does not include directions for use in Flash Sterilization cycle.

1. The flash sterilization record observed on 1/24/12 in the sub-sterile room between SDS OR 3 & 4 reviewed for January 2012 documents two entries for flash sterilization of "BIOM attachment" on 1/3/12 and on 1/24/12. The sterilization cycles documented were for 270 degrees Farenheit for 10 minutes exposure. The instrument was not sterilized using acceptable cycle parameters according to manufacturer's instructions for steam exposure time or for minimum drying time. Manufacturer's instructions for flash sterilization of the instrument were not obtained prior to the flash sterilization of this instrument as required by facility policy.

H. Based on observation, staff interview, and review of facility documents, it was determined that instrument containers used in the Same Day Surgery Department are not cleaned between uses according to facility policy and industry standards.

Reference # H2a:
AAMI ST79:2010 "Comprehensive guide to steam sterilization and sterility assurance in health care facilities" states in section 7.5.9 Rigid Sterilization container systems, "Rigid sterilization container systems should be cleaned carefully before sterilization even if they are to be returned immediately to use."

Reference # H2b:
Facility policy titled "Packaging Materials and Methods" states, "8. Rigid containers must be completely washed after each use."

1. On 1/24/12 at 2:50pm, Staff #22 was observed cleaning several ophthalmic instrument sets that were returned to the decontamination room in rigid plastic containers with soft plastic inserts to hold the instruments in place. Staff #22 failed to clean the rigid plastic containers or the interior plastic place-holders after removing soiled instruments from the container and before returning the cleaned instruments to the rigid container.

2. Staff #22 was interviewed at 2:50pm on 1/24/12 regarding the cleaning of the instrument containers between uses. Staff #22 stated that "depending on how much time there is," the containers may not be cleaned between uses, or may be wiped down with alcohol on a cloth, or cleaned in the sink.

3. On 1/24/12, a sterile tray observed in storage in the Same Day Surgery instrument packaging room, labeled as "Dr. Harper Instruments," was opened for inspection. The rigid tray container was observed with a red mark on the inside side wall. The red mark was removed with alcohol applied to a cloth by Staff # 22. The soft plastic container insert used to hold the instruments in place was observed soiled with a white residue.

I. Based on observation and review of facility documents, it was determined that workflow patterns in the Same Day Surgery Decontamination Room are not properly set up and staff do not follow facility policy or industry standards to separate clean items from contaminated items.

Reference # I3a:
AAMI ST79:2010 "Comprehensive guide to steam sterilization and sterility assurance in health care facilities" states in section 3.2.3 Functional Workflow Patterns, "Workflow patterns should be designed to ensure that contaminants are contained and employee exposure to blood-borne and other disease-producing organisms is minimized. Workflow patterns should also be designed so that items are moved progressively from being contaminated to being safe to handle."

Reference # I3b:
Facility policy # 4-002 titled, "Flow Patterns in Sterile Processing Department" states, "4. All items must flow from soiled to clean to sterile. At no time is back-tracking permitted."

1. On 1/24/12, the decontamination room in Same Day Surgery Department was observed with the Spectrum eye instrument ultrasonic device located on a metal cart that also contained storage of laboratory specimens on the shelf above and the staging of soiled instruments awaiting manual cleaning.

2. On 1/24/12, Staff #22 was observed cleaning ophthalmic instruments in the Same Day Surgery Department decontamination room. The soiled instruments and containers were placed on the counter on the left side of the sink. The soiled instruments were cleaned and rinsed in a basin in the sink and then placed in the Spectrum ultrasonic device located on the cart containing lab specimen and soiled instrument storage. The instruments taken from the ultrasonic device were then returned to the counter on the left side of the sink that still contained soiled instruments awaiting hand cleaning.

J. Based on observation and review of facility documents, it was determined that the facility failed to observe the activities and review the competency of the staff responsible for reprocessing sterile instruments used in Same Day Surgery Department to ensure compliance with facility policies and industry standards and did not provide complete documentation of competency reviews for staff responsible for reprocessing sterile instruments in the Central Services Department.

Findings include:

Reference # J1:
AAMI ST79:2010 "Comprehensive guide to steam sterilization and sterility assurance in health care facilities" states in section 4.3.1 Sterile Processing personnel states, "There should be a training manual that documents all aspects of training related to the on-site approved protocols. This manual should include checklists to document that training was performed and when competency was achieved. This training manual may reference guidance documents and/or training modules, but it should be based on the facility's policies and procedures, accepted standards of practice, and manufacturers' recommendations."

1. Competency documents for instrument reprocessing staff in Same Day Surgery Department do not demonstrate compliance with facility policies and industry standards.

a. Observed on 1/24/12, it was determined that facility staff failed to implement facility policy and industry standards for the reprocessing of sterile instruments used in the Same Day Surgery Department, including policies regarding the immediate-use sterilization of surgical instruments using written manufacturer recommendations for cycle parameters; cleaning of instrument containers between uses; and maintaining workflow patterns to eliminate back-tracking from clean to soiled areas

b. Requested of Staff #17 on 1/24/12, there was one document provided of competency review of Staff #22 who was observed on 1/24/12, reprocessing sterile instruments used in the Same Day Surgery Department. The one competency document was limited "to identify process when receiving loaner instrumentation," dated 1/21/11. There were no other documents to verify that the Staff #22 was observed for compliance with facility policy and industry standards when reprocessing sterile supplies used in the Same Day Surgery Department.


Reference # J2:
AAMI ST 79:2010, "Comprehensive guide to steam sterilization and sterility assurance in health care facilities", 4.2.2 states "The responsibility for sterile processing should be assigned to qualified individuals who have demonstrated competence in all aspects of sterile processing: decontamination, preparation, packaging, sterilization, sterile storage and distribution.

1. Competencies reviewed did not provide documentation to demonstrate competence. Incomplete results were recorded on annual SPD competency task-specific evaluations for two SPD employees.

a. Staff # 9's annual SPD competency dated 2/16/11 was not a task specific evaluation. Results of tasks observed by the preceptor or evaluator are not marked on the competency as satisfactory or unsatisfactory.

b. Staff # 19's annual SPD competency dated 02/02/11 was not a task specific evaluation. Results (Satisfactory/Unsatisfactory) are not marked or provided by the preceptor.

K. Based on observation, it was determined that non-sterile surgical instruments are stored and available for use in the sub-sterile area between OR #3 & #4 in the Same Day Surgery Department.

Findings include:

1. On 1/24/12, in the sub-sterile room between Same Day Surgery Department OR #3 & #4, loose non-sterile ophthalmic surgical instruments were observed stored in plastic drawers on the counter, in large quantities filling 28 drawers in one plastic bin and 4 drawers in another bin. Staff # 17 stated on 1/24/12 that the instruments are kept "safe" in the sub-sterile room in case a replacement instrument is needed.

2. A metal cabinet attached to the wall in the sub-sterile room between Same Day Surgery Department OR #3 & #4 contained non-sterile trays of instruments and the cabinet was labeled "Unsterile Vitrectomy Old Accessory Instruments." Staff #17 stated on 1/24/12 that the instruments contained in the cabinet are no longer used for surgery at this facility.