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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

CFR 482.42 Infection Control

Based on observation and staff interview, it was determined that the facility failed to ensure a safe pediatric environment.

Finding include:

1. During a tour of the Pediatric Unit on 4/24/13 at 12:47 PM, in the presence of staff #4, the following was observed in Room #514 on the Pediatric Unit:

a. On the wall opposite the door, on the right-side of the window, the lower panel was hanging off.

b. On the wall opposite the door, on the right and left sides of the window, both access panels to the air conditioner were open, exposing the inner workings of the air conditioner.

2. Staff #3 and Staff #65 confirmed the above findings.

Based on document review and staff interview, it was determined that the governing body failed to ensure that the continuous quality improvement program, for the food operations section of the dietary services department, contained effective corrective actions.

Findings include:

Reference #1: The Quality Improvement Program policy and procedure states: "There is an ongoing quality improvement program designed to objectively and systematically monitor, evaluate, and improve the quality and appropriateness of all aspects of food and clinical nutrition services ... The clinical Nutrition Manager in conjunction with the Director and Assistant Manager is responsible for the process of monitoring and evaluating activities of the QI program ... There is ongoing participation in the hospitals QI program ... Problems identified which require follow up will require the use of corrective action plans. Reassessment will be necessary to determine the effectiveness of the actions and to document improvement in care. The results of monitoring evaluation process will be communicated to pertinent individuals or department services and to the QI committee."

1. On 4/23/13 at 2:15 PM, Staff #52 did not provide for review the requested specific corrective action plans developed and implemented for the nine indicators identified as falling below the established bench marks on the 2012 and 2013 Food and Nutrition Services Performance Monitoring Monthly Trending Profile. Example:

a. The 2012 and 2013 Food and Nutrition Services Performance Monitoring Profiles identified the Food Temperature indicator bench mark as 95%.

b. The 2012 Food and Nutrition Services Performance Monitoring Monthly Trending Profile documented the Food Temperature indicator YTD (Year to Date) average as 61%. The 2012 Food Temperature indicators ranged from a high of 72% in January of 2012 to a low of 48% in December of 2012.

c. The 2013 Food and Nutrition Services Performance Monitoring Monthly Trending Profile Food Temperature indicators documented, are 46.2% in January of 2013; 49.1% in February of 2013 and 43.8% in March of 2013.

d. Staff #51 and Staff #52 did not provide for review, a corrective action plan that was developed and implemented to improve Food Temperature outcomes.

2. On 4/24/13 at 2:30 PM, Staff #52 confirmed the above.

Based on observation, policy review, and staff interview on 4/23/13-4/25/13, it was determined that the facility failed to ensure that pharmaceutical services are provided in a safe manner.

Findings include:

1. The facility failed to implement policies and procedures to ensure that drugs in single dose vials are not available for use on multiple patients.(Refer to Tag A-0491)

2. The facility failed to develop and implement policies and procedures addressing the use of multiple dose vials in immediate patient treatment areas.(Refer to Tag A-0491)

The findings of an opened single dose vial and opened multiple dose vials used in immediate patient treatment areas were cause for an Immediate Jeopardy to be identified on 4/24/13. The Immediate Jeopardy was abated on the afternoon of 4/24/13 after receiving an acceptable plan of correction.

3. The facility failed to ensure implementation of policies and procedures addressing the labeling of pre-drawn medication in syringes.(Refer to Tag A-0491)

4. The facility failed to ensure implementation of policies and procedures addressing the labeling and dispensing of drugs under the supervision of a pharmacist.(Refer to Tag A-0501)

5. The facility failed to implement policies and procedures to ensure that outdated drugs were not available for patient use. (Refer to Tag A-0505)

A. Based on observation and staff interview, it was determined that the facility failed to develop and implement policies and procedures addressing the use of multiple dose vials in immediate patient treatment areas.

Findings include:

Reference: 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. During a tour of the OR (operating room) suite on 4/24/13 at 10:30 AM, the following multi-dose vials were found opened and available for use in the following ORs:

a. OR #2 Anesthesia Pyxis:

i. One opened Humulin R 3 ml (milliliter) vial labeled "Do not use beyond 5/15."

b. OR #14 Anesthesia Pyxis:

i. One opened labetalol hydrochloride 100 mg (milligram)/20 ml vial.

c. OR #14 Pediatric Traveling Cart #5:

i. One opened neostigmine methylsulfate 10 mg/10 ml vial.

d. According to the CDC guidelines referenced above, if a multi-dose vial is used or accessed in the immediate patient treatment area, it should be dedicated to that patient only and discarded after use.

B. Based on observation, policy review, and staff interview, it was determined that the facility failed to implement policies and procedures to ensure medications prepared in syringes were properly labeled.

Findings include:

Reference #1: Facility policy titled "Labeling of Medications On and Off the Sterile Field for Surgical and Invasive Procedures" (Policy #: L-1) states, "... Sterile labels are to be used to label all basins, medication cups and/or syringes containing medications/solutions. At a minimum the label must contain the following information: name of the medication, the dosage and/or the concentration ..."

Reference #2: United States Pharmacopoeia Chapter 797 (USP 797) states, "Opened or needle-punctured single-dose containers, such as bags, bottles, syringes, and vials of sterile products and CSPs [compounded sterile products] shall be used within 1 hour if opened in worse than ISO [International Organization for Standardization] Class 5 air quality and any remaining contents must be discarded."

1. On 4/24/13 at 10:30 AM, one pre-drawn syringe containing 10 ml of a clear solution labeled "cardene" was found in the Anesthesia Pyxis machine in OR #2.

a. The syringe was not labeled with a drug dose or concentration in accordance with facility policy. (Reference #1)

b. The syringe was not labeled with a date or time of when it was prepared. Thus, a beyond-use date and time could not be determined in accordance with USP 797 standards. (Reference #2)

i. Upon interview, when asked how long pre-drawn syringes containing medication are kept before being discarded, Staff #8 stated the practice of the facility was not to pre-draw medications.

c. The syringe was not labeled with the initials of the person who prepared the medication. Staff #59 could not determine who prepared the medication.

C. Based on observation, policy review, and staff interview, it was determined that the facility failed to implement policies and procedures to ensure that drugs in single dose containers are not available for use in multiple patients.

Findings include:

Reference: Facility policy titled "Expiration Dating of Single Use & Multi-Use Medication Containers" (Policy: MM 36) states, "... 2. Expiration Dating...a. Single Use Containers and Sterile Pour Bottles (e.g. water and saline)- All single use containers and sterile pour bottles shall be discarded immediately after use."

1. On 4/24/13 at 11:55 AM, one opened 0.9% sodium chloride 10 ml (milliliter) single dose vial was found in the anesthesia Pyxis machine in OR #14; available for patient administration.

2. The above findings were confirmed by Staff #8, Staff #58 and Staff #59.

Based on observation, policy review, and staff interview, it was determined that the facility failed to implement policies and procedures addressing the labeling and dispensing of drugs under the supervision of a pharmacist.

Findings include:

Reference #1: Facility policy titled "MM4 Medication Labeling Standards" (Policy: MM 4) states, "...Minimum requirements for labeling an intravenous admixture: ... Name and quantity of medication added ... Time/date prepared ... Time/date expired ... Initials of preparer and pharmacist ..."

Reference #2: Facility policy titled "MM 23 Medication Distribution System" states, "... 3. Compounding and preparation, labeling and labeling changes, transferring to different containers and dispensing of all medications from the pharmacy may only be performed by a pharmacist or pharmacy personnel under the direct supervision of a pharmacist ... 4. The pharmacist is responsible for providing any necessary cautionary instructions or ancillary information about medications to the personnel responsible for administering medications ..."

1. On 4/25/13 at 11:30 AM, six 0.9% sodium chloride 100 ml IV (intravenous) bags labeled "Insulin Regular" were found in a bin in the Pharmacy IV Room.

a. Upon interview, Staff #78 stated, "Insulin Regular 100 units was added to the bags, the standard concentration."

b. The labels lacked the quantity of medication added, time/date prepared, time/date of expiration and initials of the preparer and pharmacist in accordance with facility policy. (Reference #1)

2. On 4/25/13 at 1:20 PM, four Levemir 3ml (milliliter) insulin FlexPens were noted in the D-8 Pyxis unit.

a. Upon interview, Staff #59 stated that the FlexPens were stocked in the Pyxis unit. After a pharmacist verifies the physician's order, the nurse would obtain a FlexPen from the Pyxis stock and place a patient demographic label on the FlexPen and proceed to administer the medication to the patient.

i. The practice of a nurse labeling the multi-dose Levemir FlexPen is not in accordance with facility policy. (Reference #2)

3. These findings were confirmed by Staff #58 and Staff #59.

Based on observation and staff interview, it was determined that the facility failed to implement policies and procedures to ensure that outdated medications are not available for patient use.

Findings include:

Reference: Facility policy titled "Medication Storage" (Policy: MM 10) states, "...3. The hospital removes all expired, damaged, and/or contaminated medications and stores them separately from medications available for administration. All medications that are expired, damaged, or recalled must be returned to the Pharmacy and are to be handled in accordance with the institution's outdated and recalled medications policy. These products are segregated from medication available for administration until they are removed from the medical center."

1. On 4/25/13 at 1:20 PM, four Levemir insulin 3 ml (milliliter) FlexPens were noted in the D-8 Pyxis unit. Upon interview, Staff #59 stated that the pharmacy labels the FlexPens with a sticker, indicating the expiration date, once taken out of the refrigerator.

a. Three outdated FlexPens were found in the Pyxis unit labeled "Expiration Date 3/21/13."

b. One FlexPen did not have a pharmacy label indicating the expiration date or when the FlexPen was taken out of the refrigerator. Therefore the expiration date could not be determined.

c. These findings were confirmed by Staff #11, Staff #58, and Staff #59.

A. Based on staff interview, document review, lunch meal observations, and kitchen and pantry tours conducted in the presence of Staff #51, it was determined that the contracted Food Service Director failed to provide daily supervision of the Food and Nutrition Services Department and failed to comply with the New Jersey State Sanitation Code: "Sanitation in Retail Food Establishments and Food and Beverage Vending Machines (Chapter 24)" of the NJ State Sanitary Code NJAC 8:24, as required in the Food Service Director's job description.

Findings include:

Reference #1: NJAC 8:24-3.1 states: "Food shall be safe and unadulterated."

1. On 4/23/13 in the presence of Staff #51, a return cart with juices and milk was observed stored at room temperature against a wall outside of the men's and women's kitchen staff bathrooms. The milk and juice were not refrigerated.

2. On 4/23/13 in the presence of Staff #51, a rack of single serve pizza was observed uncovered and not refrigerated in an out-of-use roll-in cafeteria box.

3. On 4/23/13 at 11:00 AM, Staff #51 confirmed the above.

Reference #2: NJAC 8:24-4.6(c) states: "Non food-contact surfaces of equipment shall be kept free of an accumulation of dust, dirt, food residue and other debris."

1. On 4/23/13 in the presence of Staff #51, dust was observed on the heat lamps, cafeteria signs, and decorations hanging over the hot and cold food service counters throughout the cafeteria.

2. On 4/23/13 in the presence of Staff #51, in the dry storage room, a brown liquid was observed on the floor under the shelving rack.

3. On 4/23/13 in the presence of Staff #51, the main kitchen vegetable cold boxes were observed with food particles and debris on the floors under the shelving.

4. On 4/23/13 in the presence of Staff #51, a heavy dust web-like build up was observed in the opening above the roll-in cafeteria box.

5. On 4/23/13 in the presence of Staff #51 and Staff #52, the B6 pantry microwave, refrigerator and freezer, were observed with a heavy build up of a brown substance on the interior walls and ceiling.

6. On 4/23/13 at 11:30 AM, Staff #51 confirmed the above.

Reference #3: NJAC 8:24-6.2(a) states: "The floors, floor coverings, walls, wall coverings and ceilings shall be designed, constructed and installed so that they are smooth and easily cleanable..."

1. On 4/23/13 in the presence of Staff #51, the dishwashing area ceiling tiles were observed with brownish-red stains.

2. On 4/23/13 at 11:00 AM, Staff #51 confirmed the above.

B. Based on staff interview and document review, it was determined that the contracted Food Service Director failed to provide daily supervision of the Food and Nutrition Services Department and failed to have a continuous quality improvement program for the food operations section of the dietary services department, as required in the Food Service Director's job description.

Findings include:

Reference #1: The Quality Improvement Program policy and procedure states: "There is an ongoing quality improvement program designed to objectively and systematically monitor, evaluate, and improve the quality and appropriateness of all aspects of food and clinical nutrition services...The clinical Nutrition Manager in conjunction with the Director and Assistant Manager is responsible for the process of monitoring and evaluating activities of the QI program...There is ongoing participation in the hospitals QI program...Problems identified which require follow up will require the use of corrective action plans. Reassessment will be necessary to determine the effectiveness of the actions and to document improvement in care. The results of monitoring evaluation process will be communicated to pertinent individuals or department services and to the QI committee."

1. On 4/23/13 at 2:15 PM, Staff #52 did not provide for review, the requested specific corrective action plans developed and implemented for the nine indicators identified as falling below the established bench marks on the 2012 and 2013 Food and Nutrition Services Performance Monitoring Monthly Trending Profile. Example:

a. The 2012 and 2013 Food and Nutrition Services Performance Monitoring Profiles identified the Food Temperature indicator bench mark as 95%.

b. The 2012 Food and Nutrition Services Performance Monitoring Monthly Trending Profile documented the Food Temperature indicator YTD (Year to Date) average as 61%. The 2012 Food Temperature indicators ranged from a high of 72% in January of 2012 to a low of 48% in December of 2012.

c. The 2013 Food and Nutrition Services Performance Monitoring Monthly Trending Profile Food Temperature indicators documented are 46.2% in January of 2013; 49.1% in February of 2013 and 43.8% in March of 2013.

d. Staff #51 and Staff #52 did not provide for review, a corrective action plan that was developed and implemented to improve the Food Temperatures outcomes.

2. On 4/24/13 at 2:30 PM, Staff #52 confirmed the above.

C. Based on staff interview and document review, it was determined that the contracted Food Service Director failed to provide daily supervision of the Food and Nutrition Services Department and failed to implement the Food Safety and Inspection Form policy and procedure, as required in the Food Service Director's job description.

Findings include:

Reference #1: The Food Safety and Inspection Form policy and procedure states: "The Food Safety and Sanitation Inspection must be completed on a monthly basis by the Account Operations Manager...To provide a method of identifying unsafe and unsanitary conditions. To ensure a continual level of Quality Improvement...Develop an action plan to continually improve the level of quality and document in the Monthly Operations Review."

In the Food Safety Audit Rating System form section, the form states:

i. "Total possible points:100."

ii. "Superior 'GOLD' 98 points or above."

iii "Good 'GREEN' 94 to 97.5 points."

iv. "Needs Improvement 'YELLOW' 90 to 93.5."

v. "Unacceptable 'RED' 89.5 points or below."

vi. NOTE: Corrective Action Plan needed for any unsatisfactory items."

1. On 4/23/13 at 2:15 PM, Staff #51 and Staff #52 did not provide for review, specific corrective action plans developed and/or revised to improve the Food Safety Audit scores identified in January, February and March, 2013.

a. The January, 2013 Food Safety Audit Score Achieved documented is 94 points, indicating a GREEN or Good rating. The specific corrective action plan was not provided for review.

b. The February, 2013 Food Safety Audit Score Achieved documented is 90.5 points, indicating a YELLOW or Needs Improvement rating. The specific corrective action plan was not provided for review.

c. The March, 2013 Food Safety Audit Score Achieved is 92.5 points, indicating a YELLOW or Needs Improvement rating. The specific corrective action plan was not provided for review.

2. On 4/24/13 at 2:30 PM, Staff #51 and Staff #52 confirmed the above.

A. Based on observation, staff interview, and review of AAMI guidelines, it was determined that the facility failed to store bulk storage tanks of acid concentrate securely.

Findings include:

Reference: AAMI RD52:2004 section 5.4.3 on 'Bulk storage tanks(acid concentrate)' state, "Procedures should be in place to control the transfer of the acid concentrate from the delivery container to the storage tank to prevent the inadvertent mixing of different concentrate formulations. If possible, the tank and associated plumbing should form an integral system to prevent contamination of the acid concentrate. The storage tanks and inlet and outlet connections, if remote from the tank, should be secure and labeled clearly."

1. On 4/22/13, 3 x 55 gallon drums of acid concentrate, delivered on 4/16/13, were observed being stored unsecured on wooden storage pallets, outside at the loading dock. The acid pumping and transfer port, which is located on the dock, was observed unlocked/unsecured.

a. Staff #22 stated that the lock on the pumping port had been broken and needed to be replaced.

b. A request was made for policies and procedures regarding the transfer of bulk acid, which Staf #22 could not provide.

B. Based on review of the facility's water treatment logs and staff interview, it was determined that the facility failed to complete water hardness testing at the end of each day in accordance with AAMI guidelines.

Findings include:

Reference: AAMI RD52:2004 section 6.2.4 on 'Softeners' state, "The hardness test at the end of each day will indicate the overall effectiveness of the water softener under worst case conditions and will ensure that the softener is sized properly."

1. On 4/23/13, the facility's 'Acute Central Water Treatment Log' reviewed from March 1, 2013 to April 22, 2013 were noted to be missing the 'PM total hardness' results.

2. Staff #22 stated that the facility has only been testing the hardness once a day, in the morning at start up.

C. Based on observation, staff interview, and review of facility documents, it was determined that the facility failed to ensure that all equipment is maintained and operated in accordance with manufacturer's recommendations.

Findings include:

Reference#1: Manufacturer of ' MesaLab Conductivity Standard Solution ' states, "Discard after 30 days after opening."

Reference # 2: Manufacturer of 'Z-Series RO System' states, "Monthly Maintenance: Check the pre-filter at least monthly for core discoloration. If discoloration is observed the pre-filters require more frequent changing or additional pre-filtration. Vent Filter Replacement: This procedure should be followed every 6 months or if the vent filter becomes wetted, whichever occurs first. "

1. On 4/22/13 one opened bottle of conductivity standard solution dated 'open 3/11/13,' and another opened bottle of conductivity standard solution dated, 'exp 6/26/13,' were available for use in the water room. This is not in accordance with Reference #1, which directs an 'open and use' by the time period of 30 days for the conductivity solutions.

2. On 4/22/13, Staff #22 stated that RO pre-filters are replaced monthly, and the vent filters are replaced annually.

a. Upon request, Staf #22 could not provide documentation regarding Filter change.

b. Without documentation of the filter changes, it could not be determined if the pre-filters and vent filters were changed as per manufacturer's guidelines in Reference #2.

Based on observation, staff interview, and review of documentation, it was determined that the facility failed to maintain an ongoing program designed to prevent, control, and investigate infections and communicable diseases.

Findings include:

1. The facility failed to provide and maintain a sanitary environment to avoid sources and transmission of infections and communicable diseases, and failed to implement nationally recognized infection control guidelines. (Refer to Tag A-0749).

A. Based on observation and staff interview on April 23, 2013, it was determined that the facility failed to maintain an ongoing program designed to prevent, control, and investigate infections and communicable diseases. The infection control and prevention program has not adequately implemented facility policies and national guidelines from the Association for the Advancement of Medical Instrumentation (AAMI) that have been selected by the hospital.

Findings include:

Reference #1: The Association for the Advancement of Medical Instrumentation (AAMI) ST 79: 2005. ST 79 replaces and super cedes ST 46 by consolidating with 4 other AAMI standards [ST 33, ST 37, ST 42, and ST 35] approved 7/10/09.
The AAMI document titled " Comprehensive guide to steam sterilization and sterility assurance in health care facilities " states in section 8.9.2, "Storage facilities," "Sterile items should be stored in a manner that reduces the potential for contamination ... Items should be positioned so that packaging is not crushed, bent, compressed or punctured and so that the sterility is not otherwise compromised. Shelving or carts used for sterile storage should be maintained in a clean condition."

Reference #1A: Facility policy entitled, "Event Related Sterility" indicates to store all sterilized items in a manner that will protect the integrity of the package. Department manager or designee will monitor stored sterilized items monthly for integrity of packaging. Event related audit tool is to be used for this purpose.

1. Numerous sterile peel pouches of instruments were observed cramped and crowded into bins in the OR's main sterile storeroom, which may compromise the sterility of the instruments.

2. Several peel pouches of sterile cardiac instruments on the cardiac storage cart, were observed banded together with a plastic tie, and/or a plastic band, which may compromise the sterility of the instruments.

3. One peel pouch containing a sterile Laparoscopic instrument was observed torn.

4. Several peel pouches of sterile instruments were observed folded over, which may compromise the sterility of the instruments.

5. Three sterile trays containing heart valve equipment were observed stored on their vertical sides, which may compromise the sterility of the equipment.

6. Upon interview with Staff #8 and Staff #21, it was determined that a continuous process improvement plan for event related sterility and monthly audits, documenting facility compliance, are not conducted within the OR.

B. Based on observation and staff interview and review of AAMI guidelines on April 23, 2013, it was determined that the facility failed to keep clean instruments separated from decontamination areas.

Findings include:

The AAMI document titled, "Decontamination area", states in section 3.3.7.1,
the area in which instruments and other devices are decontaminated should be physically separate from all other processing areas and from areas in which clean or sterile patient care procedures are carried out.

Findings include:

1. The clean and disinfected Radiology ultrasound probe is stored in the decontamination area, providing a potential for cross contamination.

2. The TEE scope and OB/GYN ultrasound probes are cleaned and disinfected in the room designated as the clean room, as indicated by Staff #41 and Staff #42. The clean and contaminated work activities are not properly segregated, and may provide a potential for cross contamination of equipment.

C. Based on staff interview and review of facility policy and procedure on April 23, 2013, it was determined that the facility failed to clean the ORs according to facility policy and AAMI guidelines.

Findings include:

Reference #1: AAMI document titled "Housekeeping procedures," section 3.4, states, "Housekeeping procedures used to clean operating and delivery rooms should ensure a high level of cleanliness at all times".

Reference #2: Facility policy in the Environmental Services policy and procedure manual, section D, # 1, page 93, titled, "Between case cleaning and end of day cleaning" states, Cleaning and disinfection solutions, mops and accessories will be changed after each case.

1. Upon questioning Staff #38 on the hospital policy and procedure for cleaning the ORs in between patient procedures, it was determined that he/she was not following the hospital policy and procedure titled; "Between case cleaning and end of day cleaning, page 93, section D, #1,"indicating that cleaning/disinfecting solutions, mops, and accessories must be changed after each patient procedure.

2. Staff #38 indicated that if the OR was very bloody from a patient procedure he/she would change the disinfecting solution after each patient case. If the procedure was not very bloody, he/she would change the solution every 2 or 3 rooms.

3. Staff #37 indicated upon interview, that this is not the hospital procedure or policy.

D. Based on observation on April 23, 2013, it was determined that the facility failed to maintain a sanitary environment.

Findings include:

1. The portable white poles in OR #1 are stained, rusted, and not maintained clean.

2. The green chair in OR #1 contains a tear on the seat, making effective cleaning difficult. The chair is soiled and not maintained clean.

3. The black chair in OR #1 contains a tear on the cushion, exposing foam padding, which cannot be maintained clean.

4. The perfusion cart and blue anesthesia cart, padded hand grabs, are torn and in poor repair, exposing the flaking foam padding, which cannot be maintained clean.

5. The waste bin metal frame is rusted and in poor condition.

6. The black Teflon coating along the base of the code cart, adjacent to OR #5, is in very poor repair, with flaking pieces of Teflon, making cleaning difficult.

7. There are three portable metal carts in the soiled utility room that contain dust accumulation.

8. Two metal perforated transport trays for lab specimens are heavily rusted and not easily cleanable.

9. The interior of the cart for the storage of the difficult airway scope contains an accumulation of dust, providing a potential for cross contamination to the scope.

10. The equipment monitor cabinets in OR #9 contain dust accumulation.


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E. Based on observation, staff interview, review of facility documents, and review of equipment manufacturer's recommendations, it was determined that the facility failed to ensure all equipment are maintained to an acceptable level of safety and quality.

Findings include:

Reference #1: AAMI RD52:2004 section Annex E on 'Special considerations for acute hemodialysis' state, "E.3.2 Backflow prevention: "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. Spent dialysate and reject water from a reverse osmosis system unit should be discharged to drain in a manner that minimizes the potential for contamination of the patient care area and the dialysis machine. An appropriate floor drain or standpipe connected to a sink drain should be utilized for this purpose. If such a drain is not available, spent dialysate and reverse osmosis reject water may be discharged into a sink. In that circumstance, the sink should not be used for other purposes during dialysis and care should be taken to properly clean the sink after the treatment. In all cases, there should be an air gap at the point of discharge to prevent backflow into the dialysis machine."

Reference #2: Manufacturer of '2008K Hemodialysis System' operator's manual states, "Starting Point: The machine's drain line is inserted into a drain with an air gap."

1. On 4/22/13 at 1:25PM, approximately 2 inches of spent dialysate and reject water lines were observed submerged in the toilet water located at ICU critical care unit room #822. In the presence of Staff #24, Staff #40 was immediately requested to remove the water lines from the toilet water. Staff #40, pointed to the white rubber glove hanging on the side bar of the dialysis machine and stated that under normal circumstances, she/he ties the lines to the machine with this rubber glove however the glove has loosened during the set up procedure which resulted in water lines to drop into the toilet water.

a. Staff #53 confirmed that the toilets located in each room of the ICU are active and working toilets, available for patient use. Staff #53 also stated that in the past, the water lines were placed in the drain of the handwashing sink available in each room. However, this practice had caused the handwashing sink to overflow on several occasions.

b. Upon review of staff education records, it was determined that Staff #40's most recent 'Annual Water Treatment Training Skill Validation Checklist' which included "Procedure: Able to correctly hook up the water system and turn on(acutes only)" was validated by Staff #22 on 7/28/11.

2. On 4/22/13 at 2:45PM, the facility was notified of an immediate jeopardy condition on improper set up and disposal of spent dialysate and reject water lines during a bedside dialysis treatment. By 4:45PM, an immediate corrective action plan was submitted by the facility and accepted by NJ Department of Health.


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F. Based on observation and review of facility guidelines, it was determined that the facility failed to ensure that prevention of infection among patients and personnel.

Findings include:

Reference: Facility Guideline titled "NICU Hand Hygiene and Cell Phone Guidelines" EVERYONE MUST WASH HANDS BEFORE ENTERING THE NURSERY, This includes ALL VISITORS AND ALL PERSONNEL... On entering the nursery ....roll up sleeves- long sleeves must roll above the elbows. Rub hands vigorously with soap for at least 20 seconds...Upon Re-entering the NICU you must do the following: A 20 second wash or gel."

1. During a tour of the Neonatal Intensive Care Unit (NICU), on 4/24/13 at 12:10 PM, Staff #3 asked the surveyor to remove her long sleeve blazer and wash her hands before entering the NICU. He/she stated this was the practice for infection control in the NICU. The following breech in guidelines were observed:

a. Staff #74 entered the nursery without removing his/her long sleeve lab coat or rolling up long sleeves.

b. No handwashing was performed. Staff #66 prompted Staff #74 to use hand gel by quickly grabbing a bottle and placing it in front for him/her, where upon it was used.

2. Staff #3 was present during this breech and stated this was a staff member that did not frequently enter the NICU and was unaware of the guidelines.

A. Based on medical record review, staff interview, and review of facility policies and procedures, it was determined that the facility failed to ensure implementation of its policy and procedure for ventilator weaning.

Findings include:

Reference: Facility policy and procedure titled, "Vent Management, Weaning and Extubation in the CTICU [CardioThoracic Intensive Care Unit]" states under Procedure: "2. Ventilator Weaning: ... The Respiratory Therapist is authorized to titrate the FiO2 [Fraction of Inspired Oxygen] to maintain an Oxygen Saturation greater than or equal to 92%.
- Adjustments of FiO2 occur no more than every 20 minutes.
- If more than three increases on FiO2 occur within the shift or if a FiO2 greater than 70% is required to maintain a SpO2 [Blood Oxygen Saturation] greater than or equal to 92%, notify the physician..."

1. Medical Record #38 contained "Post-Operative Cardiothoracic Orders" dated 2/26/13 at 6:10 PM, "Pulmonary: Initiate CTICU ventilator management and extubation protocol. Ventilator setting: SMIV [Synchronized Intermittent Mandatory Ventilation] (check mark); Rate: 12/min.; FiO2: 70%; Vt [Tidal Volume]: 750 mL."

2. Review of the "Adult Ventilator Flowsheet" revealed the following:

a. On 2/26 at 1805, the "VT [Tidal Volume]- Set" was documented as "700" and the FiO2 was documented as "70."

i. There was no evidence of an Oximetry reading during this time.

ii. The "VT" was not delivered as ordered.

b. On 2/26 at 1830, the "VT- Set" was documented as "700" and the FiO2 was documented as "50."

i. There was no evidence of an Oximetry reading during this time, even though the FiO2 was decreased from 70% to 50%.

ii. The "VT" was not delivered as ordered.

c. On 2/27 at 1:00 AM, the FiO2 was documented as "40%." There was no evidence of an Oximetry reading during this time, even thought the FiO2 was decreased from 50% to 40%.

d. The above referenced policy was not followed. The FiO2 was titrated but there was no evidence that the Oxygen Saturation was maintained greater than or equal to 92%.

3. The above findings were confirmed by Staff #75 at 1:00 PM on 4/25/13.

4. The above reference policy titled, "Vent Management, Weaning and Extubation in the CTICU" was last reviewed/revised October 1, 2007. During interview at 1:00 PM on 4/25/13, Staff #75 stated that this policy is old and is currently under revision.

B. Based on medical record review and staff interview, it was determined that the facility failed to ensure that services are provided under the orders of a qualified and licensed practitioner.

Findings include:

1. On 4/23/13 at approximately 12:00 noon, the CTICU was toured in the presence of Staff #44 and Staff #47. During this time, Medical Record #11 was reviewed. The medical record contained the following ventilator order, dated 4/21/13 at 22:26: "Vent Mode PRVC, Tidal Volume 650, Pressure Support 10, Peep 5, FiO2 100% and Rate 10."

a. Review of the "Interactive View Print Request" for the following dates/times revealed that the Tidal Volume delivered was documented as 700 and not 650, as ordered:

i. 4/21/13 for the time of 22:00-22:59 EDT

ii. 4/22/13 for the times of 00:00- 00:59 EDT; 04:00- 04:59 EDT; 07:00-07:59 EDT; 12:00-12:59 EDT; 17:00-17:59 EDT; 20:00-20:59 EDT; 23:00-23:59 EDT.

iii. 4/23/13 for the times of 04:00-04:59 EDT and 09:00-09:59 EDT.

2. The above findings were confirmed by Staff #44.

A. Based on observation and staff interview on April 23, 2013, it was determined that the facility failed to maintain an ongoing program designed to prevent, control, and investigate infections and communicable diseases. The infection control and prevention program has not adequately implemented facility policies and national guidelines from the Association for the Advancement of Medical Instrumentation (AAMI) that have been selected by the hospital.

Findings include:

Reference #1: The Association for the Advancement of Medical Instrumentation (AAMI) ST 79: 2005. ST 79 replaces and super cedes ST 46 by consolidating with 4 other AAMI standards [ST 33, ST 37, ST 42, and ST 35] approved 7/10/09.
The AAMI document titled " Comprehensive guide to steam sterilization and sterility assurance in health care facilities " states in section 8.9.2, "Storage facilities," "Sterile items should be stored in a manner that reduces the potential for contamination ... Items should be positioned so that packaging is not crushed, bent, compressed or punctured and so that the sterility is not otherwise compromised. Shelving or carts used for sterile storage should be maintained in a clean condition."

Reference #1A: Facility policy entitled, "Event Related Sterility" indicates to store all sterilized items in a manner that will protect the integrity of the package. Department manager or designee will monitor stored sterilized items monthly for integrity of packaging. Event related audit tool is to be used for this purpose.

1. Numerous sterile peel pouches of instruments were observed cramped and crowded into bins in the OR's main sterile storeroom, which may compromise the sterility of the instruments.

2. Several peel pouches of sterile cardiac instruments on the cardiac storage cart, were observed banded together with a plastic tie, and/or a plastic band, which may compromise the sterility of the instruments.

3. One peel pouch containing a sterile Laparoscopic instrument was observed torn.

4. Several peel pouches of sterile instruments were observed folded over, which may compromise the sterility of the instruments.

5. Three sterile trays containing heart valve equipment were observed stored on their vertical sides, which may compromise the sterility of the equipment.

6. Upon interview with Staff #8 and Staff #21, it was determined that a continuous process improvement plan for event related sterility and monthly audits, documenting facility compliance, are not conducted within the OR.

B. Based on observation and staff interview and review of AAMI guidelines on April 23, 2013, it was determined that the facility failed to keep clean instruments separated from decontamination areas.

Findings include:

The AAMI document titled, "Decontamination area", states in section 3.3.7.1,
the area in which instruments and other devices are decontaminated should be physically separate from all other processing areas and from areas in which clean or sterile patient care procedures are carried out.

Findings include:

1. The clean and disinfected Radiology ultrasound probe is stored in the decontamination area, providing a potential for cross contamination.

2. The TEE scope and OB/GYN ultrasound probes are cleaned and disinfected in the room designated as the clean room, as indicated by Staff #41 and Staff #42. The clean and contaminated work activities are not properly segregated, and may provide a potential for cross contamination of equipment.

C. Based on staff interview and review of facility policy and procedure on April 23, 2013, it was determined that the facility failed to clean the ORs according to facility policy and AAMI guidelines.

Findings include:

Reference #1: AAMI document titled "Housekeeping procedures," section 3.4, states, "Housekeeping procedures used to clean operating and delivery rooms should ensure a high level of cleanliness at all times".

Reference #2: Facility policy in the Environmental Services policy and procedure manual, section D, # 1, page 93, titled, "Between case cleaning and end of day cleaning" states, Cleaning and disinfection solutions, mops and accessories will be changed after each case.

1. Upon questioning Staff #38 on the hospital policy and procedure for cleaning the ORs in between patient procedures, it was determined that he/she was not following the hospital policy and procedure titled; "Between case cleaning and end of day cleaning, page 93, section D, #1,"indicating that cleaning/disinfecting solutions, mops, and accessories must be changed after each patient procedure.

2. Staff #38 indicated that if the OR was very bloody from a patient procedure he/she would change the disinfecting solution after each patient case. If the procedure was not very bloody, he/she would change the solution every 2 or 3 rooms.

3. Staff #37 indicated upon interview, that this is not the hospital procedure or policy.

D. Based on observation on April 23, 2013, it was determined that the facility failed to maintain a sanitary environment.

Findings include:

1. The portable white poles in OR #1 are stained, rusted, and not maintained clean.

2. The green chair in OR #1 contains a tear on the seat, making effective cleaning difficult. The chair is soiled and not maintained clean.

3. The black chair in OR #1 contains a tear on the cushion, exposing foam padding, which cannot be maintained clean.

4. The perfusion cart and blue anesthesia cart, padded hand grabs, are torn and in poor repair, exposing the flaking foam padding, which cannot be maintained clean.

5. The waste bin metal frame is rusted and in poor condition.

6. The black Teflon coating along the base of the code cart, adjacent to OR #5, is in very poor repair, with flaking pieces of Teflon, making cleaning difficult.

7. There are three portable metal carts in the soiled utility room that contain dust accumulation.

8. Two metal perforated transport trays for lab specimens are heavily rusted and not easily cleanable.

9. The interior of the cart for the storage of the difficult airway scope contains an accumulation of dust, providing a potential for cross contamination to the scope.

10. The equipment monitor cabinets in OR #9 contain dust accumulation.


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E. Based on observation, staff interview, review of facility documents, and review of equipment manufacturer's recommendations, it was determined that the facility failed to ensure all equipment are maintained to an acceptable level of safety and quality.

Findings include:

Reference #1: AAMI RD52:2004 section Annex E on 'Special considerations for acute hemodialysis' state, "E.3.2 Backflow prevention: "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. Spent dialysate and reject water from a reverse osmosis system unit should be discharged to drain in a manner that minimizes the potential for contamination of the patient care area and the dialysis machine. An appropriate floor drain or standpipe connected to a sink drain should be utilized for this purpose. If such a drain is not available, spent dialysate and reverse osmosis reject water may be discharged into a sink. In that circumstance, the sink should not be used for other purposes during dialysis and care should be taken to properly clean the sink after the treatment. In all cases, there should be an air gap at the point of discharge to prevent backflow into the dialysis machine."

Reference #2: Manufacturer of '2008K Hemodialysis System' operator's manual states, "Starting Point: The machine's drain line is inserted into a drain with an air gap."

1. On 4/22/13 at 1:25PM, approximately 2 inches of spent dialysate and reject water lines were observed submerged in the toilet water located at ICU critical care unit room #822. In the presence of Staff #24, Staff #40 was immediately requested to remove the water lines from the toilet water. Staff #40, pointed to the white rubber glove hanging on the side bar of the dialysis machine and stated that under normal circumstances, she/he ties the lines to the machine with