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Based on review of facility documents, staff interviews, and observations, 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 482.28 Food and Dietetic Services
CFR 482.41 Physical Environment
CFR 482.42 Infection Control

Based on review of three facility quality improvement projects, it was determined that the facility failed to aggregate all data for each improvement project, in one out of the three projects reviewed.

Findings include:

On 5/14/15 at 9:35 AM, the facility's Reprocessing Quality Improvement project was reviewed in the presence of Staff #20 and Staff #36. There was no evidence that the data collected was aggregated. This was confirmed by Staff #36.

A. Based on observation, review of facility policy, and staff interview, it was determined that the facility failed to implement its policy for seizure precautions.

Findings include:

Reference: Facility policy titled Seizure Protocol states, "... III. Special Precautions: ... [4th bullet] Seizure & Aspiration Precaution signs, [5th bullet] Suction machine at bedside ..."

1. On 5/12/15 at 2:30 PM, Unit 3 Main was toured in the presence of Staff #21. A patient was observed in Room #326-1 with a sign above his/her bed indicating seizure precautions.

a. Upon interview at 3:00 PM, Staff #40 stated that for seizure precaution patients, fall precautions are implemented, oxygen is at the bedside, the patient is placed on aspiration precautions, and portable suction equipment is at the bedside.

2. There was no portable suction equipment at this patient's bedside or a sign above his/her bed indicating aspirations precautions, as indicated in facility policy and Staff #40's interview regarding a patient on seizure precautions.


B. Based on observation and review of facility policy and procedure, it was determined that the facility failed to implement its policy for Intravenous Therapy.

Findings include:

Reference: Facility's policy Code No: DV: HR: 007, titled Intravenous Therapy states, "... B. Peripheral Intravenous [IV] Access ... [2nd bullet] Peripheral site dressings are to be changed every 96 hours or as necessary if dressing becomes wet or soiled. IV insertion sites must be left visible for site inspections. The site must be dated, with time, site, catheter size and initials of the RN or LPN performing the insertion. [second bullet] Peripheral IV sites are to be changed every 96 hours or sooner if site becomes inflamed using the IV securement device. ..."

1. On 5/12/15 at 10:30 AM, a tour of the 5th Floor Telemetry Unit was conducted in the presence of Staff #21, Staff #33, and Staff #27. Patient #1, in Room #581-2, was observed with an IV in his/her left hand that was dated 5/7/15. Patient #1's IV site was not changed after 96 hours as indicated in facility policy.

2. On 5/12/15 at 2:30 PM, Unit 3 Main was toured in the presence of Staff # 21.

a. Patient #9 was observed with an IV in his/her left antecubital. The site failed to include the following: date, time, site, catheter size and initials of the RN or LPN performing the insertion, in accordance with facility policy.

b. Patient #8 was observed with an IV in his/her left forearm that was wrapped with Kling dressing. The IV site was not visible for site inspection with the Kling covering, and the site failed to include the following: date, time, site, catheter size and initials of the RN or LPN performing the insertion.

c. Patient #10 was observed with an IV site that failed to include the following: date, time, site, catheter size and initials of the RN or LPN performing the insertion.

3. The above findings were reviewed with Staff #21.




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4. On 5/13/15 at 11:30 AM, a tour of the Intensive Care Unit was conducted in the presence of Staff #19 and Staff #44.

a. Patient #12 was observed with two IV catheters in his/her right upper extremity; one in the right hand and one in the right forearm. The IV sites did not have dressings that included documentation of the date, time, site, catheter size and initials of the RN or LPN that performed the insertions.

b. The above was confirmed by Staff #19.

Based on observation, staff interview, and review of facility policy and procedure, it was determined that the facility failed to ensure that all medications are administered per policy.

Findings include:

Reference: Facility policy Title: Administration: General, Code No.: 13-01, Section Pharmacy- Administration of Medications, states, "... Non-Time Critical Scheduled Medications Non Time critical schedule medications (anything that is not determined as time critical) must be administered one (1) hour before or after the scheduled time. ..."

1. On 5/12/15 at 2:30 PM Unit 3 Main was toured in the presence of Staff #21. Patient #8 was observed sitting in a chair with a sitter at his/her bedside. An IV pole with a medication of Meropenem 1 gram IV solution in 100 cubic centimeters of .9 normal saline, prepped with IV tubing, was observed hanging on the pole. The medication label on the IV bag indicated the medication was due at 10:00 AM.

a. Staff #38 stated upon interview, at 2:38 PM, that he/she did not administer this medication to Patient #8 yet because he/she was eating lunch, and he/she went for a test in the morning.

b. Staff #40 confirmed the unit maintains a daily log of patient movement on and off the unit. Per Staff #40, Patient #8 left the unit for an echocardiogram test at 11:00 AM and returned to the unit at 12:20 PM.

2. Staff #38 failed to administer Patient #8's scheduled 10:00 AM dose of Meropenem IV one hour before or after its scheduled time as indicated in facility policy.

A. Based on document review and staff interview conducted on 5/12/15, it was determined that the facility failed to ensure implementation of policies and procedures addressing destruction of partial doses of a controlled dangerous substance (CDS).

Findings include:

1. One of four medical records (Medical Record #24) reviewed for accountability of CDS lacked evidence of destruction of a partial dose of fentanyl.

a. The administration of a total of 75 mcg. (micrograms) of fentanyl, a Schedule II CDS, was recorded on the Anesthesia Record, dated 5/12/15, in Medical Record #24.

b. The removal of 2 vials of fentanyl 100mcg/2ml and the return of one vial of fentanyl 100mcg/2ml for Patient #24 by the Certified Registered Nurse Anesthetist (CRNA), on 5/12/15, was recorded on the Pyxis MedStation System report.

c. Staff #37 confirmed that facility policy was to waste partial doses of CDS in the presence of a witness and record the event through the Pyxis drug dispensing system. He/she confirmed that there was no evidence of an entry for the wastage of the remaining 25mcg of fentanyl that was not administered to Patient #24.

B. Based on observation and staff interview conducted on 5/12/15, it was determined that the facility failed to ensure the development of policies and procedures addressing the use of the Pyxis drug dispensing devices for medication administration.

Findings include:

1. Staff #37 confirmed that the facility does not utilize a unit dose drug distribution system with individual cassettes or containers that includes scheduled cart exchanges at least every 24 hours.

a. Staff #37 stated that the majority of medications are removed by nursing staff from a unit dose drug dispensing device.

2. Staff #73 stated that he/she removes medications from the drug dispensing device for all his/her patients prior to doing a medication pass. He/she places each medication in the patient's medication cassette.

3. Staff #37 was unable to provide a policy and procedure addressing the "filling" of cassettes by nursing staff from the drug dispensing device prior to each medication pass.

Based on observations, staff interview, and document review, it was determined that the facility failed to ensure that the food and dietetic services is an organized dietary service that is directed and staffed by qualified personnel. In addition, the facility failed to ensure that the nutritional needs of the patients are met in accordance with practitioners' orders and acceptable standards of practice.

Findings include:

1. The facility failed to ensure that the Director of Food & Nutrition provides effective daily management of the Food Service Department. Refer to Tag A0620.

2. The facility facility failed to ensure that physicians order patient specific therapeutic diets. Refer to Tag A0630.

Based on document review, staff interview and observation, it was determined that the facility failed to ensure that the director of food services provides effective daily management of the Food and Nutrition Services Department in accordance with the "Food Service Manager/Clinical Nutrition Manager" job description.

Findings include:

Reference #1: The Food Service Manager/Clinical Nutrition Manager job description states, "Manages the nutrition care, support, and education for patients and outpatients. Serves as liaison between medical/nursing/food and nutrition disciplines ... Maintains policies, procedures and credentials ... Overseeing the department's food production operations stressing the highest quality and customer satisfaction ... Assure that food production employees are properly trained and direct them to properly accomplish their jobs ... Maintain standards of sanitation under regulatory and HACCP guidelines."

Reference #2: N.J.A.C. 8:24-6.5(b) states, "The physical facilities shall be cleaned as often as necessary to keep them clean."

Reference #3: N.J.A.C. 8:24-6.5(a) states, "The physical facilities shall be maintained in good repair."

Reference #4: N.J.A.C. 8:24-4.7 (a) states, "Equipment food-contact surfaces and utensils shall be sanitized." 8:24-4.7 (b) states, "Utensils and food-contact surfaces of equipment shall be sanitized before use after cleaning."

Reference #5: N.J.A.C. 8:24-4.9 (h) states, "The warewashing machine ... shall be operated in accordance with the machines dataplate and other manufacturer's instructions."

Reference #6: N.J.A.C. 8:24-4.9 (i) states, "The temperature of the wash solution in spray type warewashers that use hot water to sanitize shall not be less than: ... For multi-tank, conveyor, multitemperature machine, 150 degrees Fahrenheit. N.J.A.C. 8:24-4.9 (k) states, "In mechanical operation, the temperature of the fresh hot water sanitizing rinse as it enters the manifold may not be more than 194 degrees Fahrenheit, or less than ... 180 degrees Fahrenheit."

Reference #7: The facility Machine Warewashing temperature monitoring form states Power wash tank temperature: 150 - 165 degrees Fahrenheit; the dual rinse tank and final rinse tank temperature: 180 - 200 degrees Fahrenheit.

Reference #8: N.J.A.C. 8:24-6.2(i) states, "Light bulbs shall be shielded, coated or otherwise shatter resistant."

Reference #9: The Patient Tray Assessment policy states, "A minimum of 20 tray assessments per month will be completed by all subunit area management ... Tray assessment results will be summarized on a monthly basis by the patient services manager or designee to provide ongoing continuous performance improvement."

Reference #10: The Food Sanitation Checklist policy states, "The Sanitation Supervisor is responsible for completing the Monthly Sanitation Checklist ... If necessary, the Sanitation Supervisor will develop an action plan to supplement the daily cleaning schedule. ... A copy of the inspection must be given to the Food Services Director/Food Service Manager."

1. On 4/12/15, Staff #10 stated that facility staff are trained and maintain sanitation in the food services department as required in 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 N.J.A.C. 8:24 and facility policies and procedures.

a. Staff #10 could not provide for review, evidence of ongoing food service staff training, as required in Reference #1.

2. On 4/12/15, in the presence of Staff #10, the following deficient practices were observed:

a. The kitchen, bake shop and warewashing area walls and ceilings were not maintained clean. The walls had an accumulation of dried brown, red, and yellow food splatter residue on them. The ceiling tiles had brown stains on them. Refer to Reference #2 and Reference #3.

b. The artificial plants/trees located in the cafeteria salad bar area had a heavy accumulation of dust on them. Refer to Reference #2 and Reference #3.

c. The light fixture located above the cafeteria coffee station had a heavy accumulation of dust on it. Refer to Reference #2 and Reference #3.

d. The cook was observed measuring food temperatures without sanitizing the thermometer first. Staff #14 took the thermometer out of his/her pocket, placed it directly in the baked chicken, then removed the thermometer, rinsed it in water, dried it with a paper towel and placed it back in his/her pocket. Refer to Reference #4.

(i) Staff #14 stated that the correct procedure is to wipe the thermometer with an alcohol wipe before measuring food temperatures and after measuring food temperatures. He/She stated that he/she did not have an alcohol wipe available at the time of taking the chicken temperature.

e. On 4/12/15 at 11:20 AM, prior to the start of the lunch meal tray line, the patient trays, plates and dome covers were observed wet and ready for lunch use. Staff #13 stated that this is how they come from the dishwasher.

(i) On 4/12/15 at 11:30 AM, the dishes, pans and trays were observed going through the kitchen warewashing machine with the following temperatures: wash at 118 degrees Fahrenheit, dual rinse at 159 degrees Fahrenheit and final rinse at 174 degrees Fahrenheit. The warewashing machine failed to wash at the required 150 degrees Fahrenheit and rinse at the required 180 degrees Fahrenheit, in accordance with Reference #6 and Reference #7.

f. Upon review of the Breakfast, Lunch and Dinner Machine Warewashing Temperature monitoring forms for March to date of survey, it was noted that 456 out of 630 entries were below the required warewashing temperatures. The out of range warewashing temperature concerns and action plans were not reported and documented in accordance with Reference #6 and Reference #7.

g. The hood filters located over the stoves and steam kettles were observed with a heavy accumulation of brown and white substances. Staff #10 was unable to comment on when the filters were cleaned last. Refer to Reference #2 and Reference #3.

h. The main kitchen bake shop lights lacked light covers/shields. Refer to Reference #8.

i. Twelve cutting boards were observed in poor and worn condition. Refer to Reference #2 and Reference #3.

j. The main kitchen ice machine had dust and rust on it. The ice scoop was located on a tray with plastic wrap on it. Refer to Reference #2 and Reference #3.

k. The ICU, 5W, 4M, Emergency Department, 3M, and 3 Forensics unit pantries were not maintained clean. The cabinet shelves and drawers had a heavy build up of dust and food particles on the interior and exterior. The microwave interiors had red and brown tacky substances and stains. The refrigerators had brown, purple and red stains. The refrigerator gaskets were frayed and in disrepair. The ice machines had white stains and tacky substances on the faucet and drains. Refer to Reference #2 and Reference #3.

3. On 4/13/15, Staff #10 was not able to provide the tray assessment reports from 1/1/15 to 4/13/15. Refer to Reference #9.

4. On 4/13/15, Staff #10 provided the 1/15/15, 2/15/15, 3/15/15 and 4/14/15 Food Safety checklists for review. The checklists contained the following documentation: "Exhaust hood is clean and log is maintained." "No" is checked on the form, followed by a note dated 2/15/15, 3/15/15 and 4/14/15 that no log is maintained. Staff #10 was unable to provide for review, the action plan for this deficient practice. Refer to Reference #10.

5. The above findings were confirmed by Staff #10 on 4/12/15 at 11:55 AM.

Based on document review, staff interview and observation, it was determined that the facility failed to ensure that physicians order patient specific therapeutic diets.

Findings include:

1. On 4/12/15, two of two medical records contained incomplete tube feeding orders. The tube feeding orders failed to specify the route of administration, duration of feeding and/or water flush requirements.

a. Medical Record #7 contained the following incomplete diet order dated/timed 5/10/15 at 4:30 PM: "Cont. on tube feeding Isosource 1.5 cal @ 60 ml."

b. Medical Record #11 contained this incomplete diet order, "Continue nepro @ 40cc/hr, dated on 5/3/15 at 12:10 AM via GT."

Based on observation, staff interview, and document review between 5/11/15 and 5/14/15, it was determined that the facility failed to ensure compliance with the 2000 edition of the National Fire Protections Association's 101, Life Safety Code.

Findings include:

1. The facility failed to develop and implement policies and procedures to ensure the safe handling and storage of medical gases. Refer to Tag A0710.

2. The facility failed to ensure that patient sleeping rooms greater than one thousand square feet are equipped with two remote means of egresses. Refer to Tag A0710.

3. The facility failed to ensure that corridors resist the passage of smoke. Refer to Tag A0710.

4. The facility failed to ensure that the means of egress is continually maintained free of all obstructions or impediments to full instant use in the case of a fire or other emergency. Refer to Tag A0710.

5. The facility failed to ensure that access controlled locks are installed in accordance with the National Fire Protection Association's 101, Life Safety Code. Refer to Tag A0710.

6. The facility failed to ensure that medical gas systems are properly installed and maintained. Refer to Tag A0710.

7. The facility failed to develop and implement policies and procedures to ensure that the fire alarm system is properly maintained. Refer to Tag A0710.

8. The facility failed to develop and implement policies and procedures to ensure that the fire standpipe systems are maintained. Refer to Tag A0710.

9. The facility failed to develop and implement policies and procedures to ensure that fire doors are maintained. Refer to Tag A0710.

10. The facility failed to develop and implement policies and procedures to ensure hazardous areas are properly protected. Refer to Tag A0710.

11. The facility failed to develop and implement policies and procedures to ensure that flammable liquid cabinets are properly maintained. Refer to Tag A0710.

12. The facility failed to develop and implement policies and procedures to ensure that emergency showers are available for immediate use. Refer to Tag A0710.

13. The facility failed to develop and implement policies and procedures to ensure the proper use of electrical extension cords. Refer to Tag A0710.

14. The facility failed to develop and implement policies and procedures to ensure that equipment is maintained for the safety of patients. Refer to Tag A0724.

Based on observation, staff interview and document review, it was determined that the facility failed to meet the applicable provisions of the 2000 edition of the Life Safety Code of the National Fire Protection Association.

Findings include:

Reference #1: National Fire Protection Association's 2000 edition of the Life Safety Code, 101:19.3.2.1, Hazardous areas. Any Hazardous areas shall be safe-guarded by a fire barrier having a 1-hour fire resistance rating or shall be provided with an automatic extinguishing system in accordance with 8.4.1. The automatic extinguishing shall be permitted to be in accordance with 19.3.5.4. Where the sprinkler option is used, the area shall be separated from other spaces by smoke-resisting partitions and doors. The doors shall be self-closing or automatic-closing. ...

Reference #2: National Fire Protection Association's 1999 edition of the Standard for Health Care Facilities, 99:10-6, Emergency Shower, Where the eyes or body of any person can be exposed to injurious corrosive materials, suitable fixed facilities for quick drenching or flushing of the eyes and body shall be provided within the work area for immediate emergency use.

Reference #3: National Fire Protection Association's 1999 edition of the Standard for Health Care Facilities, 99:10-7.2.1, Flammable and combustible liquids shall be used and stored in approved containers in accordance with National Fire Protection Association's Flammable and Combustible Liquids Code (NFPA 30).

Reference #4: National Fire Protection Association's 2000 edition of the Life Safety Code, 101:19.3.6.2.1, Corridor Walls shall be continuous from the floor to the underside of the floor or roof deck above. ...

Reference #5: National Fire Protection Association's 2000 edition of the Life Safety Code, 101:7.1.10.1, Means of egress shall be continually maintained free of all obstructions or impediments to full instant use in the case of a fire or other emergency.

Reference #6: East Orange General Hospital Architectural Plan NK Project Number 1782.013 dated 10/17/13.

Reference #7: National Fire Protection Association's 2000 edition of the Life Safety Code, 101:19.2.5.2, Any patient room for sleeping or any suite that includes patient sleeping rooms, of more then 1000 square feet shall have not less then two exit access doors remotely located from each other.

Reference #8: Fire Sprinkler and Standpipe Test Report dated 4/23/15, ... Device failed 8/29/2013 ... Device failed 10/30/14 ...

Reference #9: National Fire Protection Association's 1999 edition of the Standard for Health Care Facilities, 99:4-3.1.1.1, Cylinder Management, Cylinders in service and in storage shall be individually secured and located to prevent falling or being knocked over.

Reference #10: National Fire Protection Association's 1999 edition of the Standard for Health Care Facilities, 99:4-1.2.3(m) A shutoff valve shall be located immediately outside each vital life-support or critical care area in each medical gas line, and located as to be readily accessible in an emergency.

1. On 5/14/15 at 11:10 AM, in the presence of Staff #8, an accordion style gate with a padlock was secured to the wall within the means of egress from the East Pavilion 6th Floor Physical Therapy Treatment area.

2. On 5/14/15 at 11:20 AM, in the presence of Staff #8, two (2) smoke detectors located over the Physical Therapy Gym floor were missing their outer covers.

3. On 5/14/15 at 11:20 AM, in the presence of Staff #8, in the stairwell of the East Pavilion, the Exit door from the stair tower exposure to the outside, was electronically locked with magnets and required the activation of the buildings fire alarm system or a special key to release the door.

4. On 5/14/15 at 11:50 AM, in the presence of Staff #8, the Lobby Exit door facing the street, was electronically locked with magnets and required the activation of the buildings fire alarm system or a special key to release the door.

5. On 5/14/15 at 10:35 AM, in the presence of Staff #8, several electrical extension cords were being used to power computers in CAPS Room #106 in the East Pavilion.

6. On 5/11/15 at 2:45 PM, in the presence of Staff #8, the following doors separating the Laboratory from the corridor were not self-closing:

a. The door near Phlebotomy

b. The main entrance door to the Laboratory

7. On 5/11/15 at 2:20 PM, in the presence of Staff #8, the DRS-601 Sakura Diversified Slide Strainer machine in the Laboratory, located under the XPert Balance Fume Hood prevented the protective door from closing.

8. On 5/11/15 at 2:30 PM, in the presence of Staff #8, the emergency shower in the Laboratory Histology Room was blocked by a cart, a chair, and work counters.

a. The door handle to the room is capable of being locked and would require a key to access.

9. On 5/11/15 at 2:35 PM, in the presence of Staff #8, the flammable liquid cabinet in the Histology Department within the Laboratory, did not self-close and latch.

10. On 5/11/15 at 12:20 PM, in the presence of Staff #8, the corridor wall behind Treatment Station's #1 and #2 within the Dialysis suite, was not secured to the floor to resist the passage of smoke.

11. On 5/12/15 at 11:00 AM, in the presence of Staff #8, the use of eight (8) patient rooms on the Second Floor North Wing were changed into storage rooms greater then fifty (50) square feet and did not have the required one hour fire resistance rating based on the following:

a. The doors were not marked as fire rated doors by an approved testing laboratory.

b. A review of facility plans did not provide evidence that the ceilings and wall assemblies are constructed to meet the one-hour fire resistance requirement.

c. The doors to these rooms were not self-closing or automatic-closing.

12. On 5/12/15 at 11:45 AM, in the presence of Staff #8, the Soiled Utility Room door in Radiology did not close fully and latch.

13. On 5/12/15 at 2:30 PM, in the presence of Staff #8, the door to the Fire Pump Room was held open by a wooden wedge.

14. On 5/12/15 at 2:35 PM, in the presence of Staff #8, fire door #AB01, in the basement, was held open by storage.

15. On 5/12/15 at 2:40 PM, in the presence of Staff #8, the door to the Elevator Machine Room was held open by a wooden wedge.

16. On 5/12/15 at 2:45 PM, in the presence of Staff #8, two (2) fire doors were held open with wire outside the Elevator Machine Room.

17. On 5/12/15 at 11:50 AM, in the MRI Suite, two (2) wheel chairs were stored side-by-side in the exit access corridor, blocking one hundred percent (100%) of the exit.

a. A curtain was also drawn across one hundred percent (100%) of the exit access corridor.

b. Staff #8 confirmed these findings.

18. On 5/11/15 at 11:05 AM, in the presence of Staff #8, the Intensive Care Unit (ICU) on the 5th floor contained a room at the end of the unit, which contained eight (8) inpatient bays and a Nurse's Station.

a. A review of the facility document referenced above (Reference #6), indicates that the unit is one thousand five hundred and ninety five (1,595) square feet in area.

(i) The Intensive Care Unit has a single exit.

b. Staff #8 confirmed this finding.

19. On 5/14/15 at 1:00 PM, in the presence of Staff #8, a manual pull station for the fire alarm system, located in the corridor outside the Cafe was blocked by a wooden cabinet.

20. On 5/14/15, a review of the facility Fire Sprinkler and Standpipe Inspection Reports, dated 4/23/15, provided evidence that the following hose station devices failed testing on 8/29/13 and 10/30/14 and were still not repaired:

a. The Basement Device #13, located in Stair #3.

b. The Ground Floor Device #19, located in Stair #3.

21. On 5/11/15 at 10:45 AM, in the presence of Staff #8, an "E" size compressed gas cylinder containing oxygen was located in an alcove next to the crash cart outside of Room #569.

22. On 5/14/15, a review of the facilities medical gas service report provided evidence that shutoff valves serving the Surgical Suite Post Anesthesia Care Unit (PACU) are located within the PACU.

23. On 5/14/15, a review of the facilities medical gas service report provided evidence that shutoff valves serving the Holding Area are located within the Holding Area and not outside of the unit.

24. On 5/12/15, in the presence of Staff #8, in the Crisis Management Unit, the emergency exit door, complete with a lighted Exit sign, leading directly to the outside, was electronically locked by a magnet hold device with no other means of releasing the door.

a. During an interview, Staff #8 confirmed that the door would release upon loss of power or by operating the manual pull stations for the building's fire alarm system.

b. Staff #8 confirmed that no other means are available to unlock this door.

Based on observation and interview, it was determined that the facility failed to ensure that facilities and equipment are maintained at an acceptable level of safety and quality.

Findings include:

1. During a tour of the East Pavilion conducted on 5/14/15 at approximately 10:00 AM, in the presence of Staff #8, the automated external defibrillator (AED) in the lobby was noted to have pads on the machine that were expired as of 1/24/14.

a. The extra set of pads provided for this AED were expired as of 3/12/13.

b. These findings were confirmed by Staff #8.


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2. On 5/12/15 at 11:40 AM, in the presence of Staff #6 and Staff #8, the nurse call bell in the Radiology patient waiting room did not function.

a. During interview, Staff #6 confirmed that he/she did not know where the nurse call bell alerts to or how long it has not functioned.

Based on observation, staff interview, and document review between 5/11/15 and 5/14/15, it was determined that the facility failed to ensure that a sanitary environment was provided to avoid sources and transmission of infections

Findings include:

1. The facility failed to develop and implement policies and procedures to ensure the proper disinfection of medical equipment. Refer to Tag A0748.

2. The facility failed to develop and implement policies and procedures to prevent the spread of germs though proper hand hygiene. Refer to Tag A0748.

3. The facility failed to develop and implement policies and procedures to ensure the proper handling of soiled surgical instruments. Refer to Tag A0748.
4. The facility failed to develop and implement a system to ensure the safety of patients requiring dialysis treatments. Refer to Tag A0749.

5. The facility failed to develop and implement a system to ensure the safety of patients requiring treatment in a negative pressure room. Refer to Tag A0749.

A. Based on observation, staff interview and document review conducted on 5/14/15, it was determined that the facility failed to ensure that its Environmental Sanitation policy is implemented.
Findings include:
Reference #1: Facility policy titled Environmental Sanitation and Terminal Cleaning OR/ Interventional Radiology states, "... VI. Procedure: ... 2. The c-arm and table should be cleaned following the Instructions for Use (IFU) of the manufacturer."
Reference #2: OEC C-arm Operations Manual states on page 11 Safety, "1.4.9 Cleaning Instructions ... Use only soap and lukewarm water to clean the surfaces of the system. Do not use detergents or organic solvents to clean the system. ... Do not wet surfaces that are not closed or sealed. ..."
1. At 12:30 PM, at the end of a surgical procedure in Operating Room #2, Staff #55 was observed cleaning the C-arm [piece of x-ray equipment].
a. He/she was observed spraying copious amounts of disinfectant spray on the entire C-arm, including the back of the monitor which was not completely sealed.
b. Upon interview, Staff #55 stated that he/she was using "Virex disinfectant spray."
c. The facility failed to ensure that the OEC C-arm manufacturer's instructions for cleaning were followed.
B. Based on observation, staff interview and document review conducted on 5/12/15, it was determined that the facility failed to ensure that soiled instruments are transported in accordance with the nationally-recognized guidelines that it has selected for its Infection Control program.
Findings include:
Reference #1: AORN (Association of periOperative Registered Nurses) Perioperative Standards and Recommended Practices 2013 edition, RP [Recommended Practices]: Care of Instruments section V states, "V.b. All Instruments opened in the operating or procedure room should be decontaminated whether or not they have been used. All instruments opened during a surgical procedure are considered contaminated."
Reference #2: OSHA (Occupational Safety and Health Administration) 29 CFR part 1910.1030(d)(2)(xiii) states, "Specimens of blood or other potentially infectious materials shall be placed in a container which prevents leakage during collection, handling, processing, storage, transport, or shipping."
1. Upon interview with Staff #19 on 5/12/15 at 10:30 AM, he/she stated that the facility follows CDC (Centers for Disease Control and Prevention), AAMI (Association for the Advancement of Medical Instrumentation), AORN and OSHA guidelines for its Infection Control program.
2. During an observation at the end of a surgical procedure in Operating Room #2, Staff #66 was observed preparing soiled instruments for transport to the Sterile Processing Department.
3. Staff #66 stated that he/she separates the instruments. The "used" instruments are kept in the top tier bin and the "unused" instruments are kept in the bottom tier bin.
a. The facility failed to ensure that all instruments opened during a surgical procedure are considered contaminated, in accordance with AORN standards.
4. The instruments were observed to be wrapped in red bags marked "biohazard" that were left open, and the bins were observed to be transported without lids.
a. The facility failed to ensure that potentially infectious materials are placed in a container which prevents leakage during transport.
5. These findings were confirmed by Staff #19 and Staff #36.
C. Based on observation, staff interview and document review conducted on 5/14/15, it was determined that the facility failed to ensure that its policies regarding Hand Hygiene is implemented.
Findings include:
Reference: Facility's policy #A:SR:011, titled Hand Hygiene states, "... III. Indications: A. Hands should be decontaminated: ... 2. Before donning gloves and when performing a sterile procedure ... 5. Before and after contact with a patient. 6. After contact with inanimate objects (including medical equipment) in the immediate vicinity of the patient. 7. Before donning and after removing gloves. 8. Before preparing/administering medications."
1. During a tour of Operating Room (OR) #2 at 12:30 PM on 5/14/15, Staff #55 was observed removing his/her soiled gloves without sanitizing his/her hands.


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2. Prior to the start of the surgical procedure on 5/12/15 at 12:00 PM, Staff #29 inserted a Foley catheter in Patient #6. After the Foley catheter insertion, Staff #29 removed his/her gloves, placed his/her hands on his/her hips, and continued to have further contact with the patient without sanitizing his/her hands.

3. Prior to the start of the surgical procedure on 5/12/15 at 12:00 PM, Staff #33 failed to properly sanitize his/her hands throughout the care of Patient #6 during a surgical procedure as follows:

a. After airway intubation

b. Before and after medication administrations into the intravenous (IV) tubing ports

c. After documenting on a clipboard

A. Based on observation, document review, review of two of three Medical Records (#25 and #27) of acute care patients dialyzed in the facility chronic outpatient hemodialysis unit and staff interview on 5/15/15, it was determined that the facility infection control officer failed to develop and implement infection control policies.
Findings include:
Reference #1: The facility New Jersey License states, "... General Acute Care Hospital ... Service Types ... 7 Chronic Hemodialysis Stations ..."
Reference #2: Facility policy titled Infection Control Prevention Policy states, "... There are a variety of pathogenic organisms that are hazardous for patients and staff in the dialysis setting. The Hepatitis type B virus can remain viable for at least a week in a dried state of (sic) surfaces ... All patients (sic) Hepatitis status will be known PRIOR to admission to the facility and will be tested per unit protocol ..."
Reference #3: CDC (Centers for Disease Control) MMWR April 27, 2001 titled, Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients states, "... Routine Serologic Testing ... The HBV serologic status (i.e., HBsAg, total anti-HBc, and anti-HBs) of all patients should be known before admission to the hemodialysis unit ... Schedule for Routine Testing for Hepatitis B Virus ... All patients ... On Admission ..."
1. The facility provided hemodialysis to acute hospitalized patients in the seven (7) station chronic hemodialysis unit on 3 West, when those patients' Hepatitis B antigen status was unknown.
a. Staff #68 confirmed at 9:05 AM that the seven (7) station chronic hemodialysis unit on 3 West is used to provide hemodialysis to acute hospitalized patients in renal failure as well as chronic ESRD (end stage renal disease) patients that are transferred from Long Term Care Facilities. Staff #2 confirmed that the facility follows CDC guidelines for infection control.
b. Medical Record #25 contained Acute Hemodialysis Physician's Orders dated 4/27/15 which stated, "... HBsAG ... Unknown ..."
(i) The Hospital Services Flowsheets dated 4/27/15, 4/28/15, 4/30/15, 5/2/15, 5/4/15 and 5/6/15 contained documentation that Patient #25 was provided hemodialysis treatments in the chronic hemodialysis unit on those dates. Upon request for the Hepatitis B antigen (HBsAG) test result for Patient #25, Staff #2 provided documentation of a negative HBsAG test dated May 12, 2015. Thus, Patient #25 was dialyzed in the chronic outpatient hemodialysis unit on 4/27/15, 4/28/15, 4/30/15, 5/2/15, 5/4/15 and 5/6/15, when the HBsAG was unknown.
(ii) The facility staffing sheet dated 4/27/15 contained documentation that when Patient #25 was receiving hemodialysis on 4/27/15, there were three additional patients receiving hemodialysis on the chronic hemodialysis unit at the same time.
c. Medical Record #27 contained Acute Hemodialysis Physician's Orders dated 5/12/15 which stated, "... HBsAG ... Unknown ..."
(i) The Hospital Services Flowsheet dated 5/12/15 contained documentation that Patient #27 was provided a hemodialysis treatment in the chronic hemodialysis unit on 5/12/15 from 5:00 PM to 7:30 PM.
(ii) Upon request for the Hepatitis B antigen (HBsAG) test result for Patient #27, Staff #2 provided documentation of a negative HBsAG test dated 5/12/15 at 19:10 or 7:10 PM. Thus, Patient #27 was dialyzed in the chronic outpatient hemodialysis unit on 5/12/15, when the HBsAG was unknown.
d. These findings were confirmed by Staff #2.
Reference #4: Facility policy titled "1% Bleach Solution" states, "...This solution expires in 24 hours and the container must be dated with the expiration date."
1. The facility failed to ensure that bleach solution containers are labeled, in accordance with policy.
a. At 9:15 AM, in the presence of Staff #70, a container filled with a clear liquid had a label stating, "1% Bleach Solution." Staff #70 confirmed that this bleach solution is used to disinfect equipment in the dialysis facility. This container did not have a label with the expiration date.
Reference #5: Facility policy titled, "Infection Control: Aseptic Technique" states, "...Properly clean and disinfect equipment..."
Reference #6: CDC (Centers for Disease Control) MMWR April 27, 2001 titled Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients states, "... Any item taken to a patient's dialysis station could become contaminated with blood and other body fluids and serve as a vehicle of transmission to other patients either directly or by contamination of the hands of personnel. Therefore, items taken to a patient's dialysis station, including those placed on top of dialysis machines, should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being returned to a common clean area or used for other patients ..."
1. The facility failed to ensure that items taken into the hemodialysis station are disinfected prior to being taken to a clean area and failed to have a policy, in accordance with CDC guidelines.
a. Upon request for the facility policy regarding cleaning of equipment in the hemodialysis station, Staff #2 provided the policy in Reference #5 above.
b. At 10:25 AM, Staff #70 brought a Phoenix meter into Station #2 and checked the pH and conductivity of the dialysate. Staff #70, without the benefit of disinfecting the Phoenix meter, returned the meter to the clean storage area.
c. Facility policy titled Infection Control: Aseptic Technique failed to contain a procedure for cleaning equipment taken into the dialysis station.
Reference #7: Facility policy titled Catheter Site Care and Dressing Change states, "... Close curtains ... Wash hands ... Put on gloves ... Carefully remove all dressings from the exit site ... Discard contaminated gloves. Wash hands. Put on a new set of gloves ... Clean the skin around the exit site as follows: Using alcohol and povidone iodine, starting at the exit site and moving outward ... Allow povidone iodine to dry completely. Using Chlorhexidine, scrub the area with a back and forth motion for 30 seconds ..."
1. Staff failed to close curtains, remove gloves and wash hands while providing catheter care, in accordance with facility policy.
a. While wearing gloves, at 10:30 AM, Staff #70, at Station #2, removed the catheter insertion site dressing and the catheter limb dressings for Patient #27, without the benefit of closing the curtains. Staff #70, without the benefit of removing the gloves and washing his/her hands, then cleansed the catheter insertion site with Chlorhexidine.
2. Although the facility policy titled Catheter Site Care and Dressing Change states that alcohol, povidone iodine and Chlorhexidine are to be used to cleanse the catheter exit site, Staff #70 used Chlorhexidine alone.
a. When asked why Staff #70 did not cleanse the catheter exit site with alcohol and povidone iodine as well as the Chlorhexidine, Staff #2 stated that the policy should state that either alcohol and povidone iodine or Chlorhexidine can be used, however, the policy does not state that.
Reference #8: Facility policy titled Central Venous Catheter (CVC) Post Dialysis Care states, "... Wash hands ... Don PPE ... Disconnect blood lines from catheter aseptically ..."
1. Staff failed to provide post treatment catheter care, in accordance with policy.
a. While wearing gloves, at 1:30 PM, Staff #70, after providing catheter care to Patient #27 post treatment, wearing the same gloves, touched the hemodialysis machine monitor, then proceeded to continue with catheter care, without the benefit of removing the gloves and performing hand hygiene.
Reference #9: Facility policy titled, "Hand Washing: Alcohol Based Disinfection" states, "... Hand washing is done when ... After removing gloves ..."
1. Staff failed to wash hands after glove removal, in accordance with policy.
a. At 10:33 AM, Staff #70, after providing catheter care for Patient #27, removed his/her gloves and without the benefit of washing his/her hands, documented on the paper medical record.
b. At 1:30 PM, Staff #70, after providing catheter care to Patient #27, post treatment, removed his/her gloves and without the benefit of washing his/her hands, documented on the paper medical record.


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B. Based on document review and staff interview, it was determined that the facility failed to ensure a system for identifying and evaluating measures that control infections and communicable diseases of patients and personnel that require negative pressure airflow ventilation.
Findings include:
1. On 5/12/15, Staff #3 confirmed the the facility has three (3) negative pressure rooms. Two of the three rooms(Room #314 and Room #316) are on 3 Main, a medical/surgical unit. The other is the Orthopedic Room within the Emergency Department.
a. On 5/12/15, the ED/Orthopedic Room (also a negative pressure room), did not have a working gauge that provided visual communication to confirm that negative pressure was working properly for the room.
(i) Staff #47 could not confirm that the negative pressure airflow was properly working or activated when the switch is in the "ON" position.
(ii) On 5/13/15, Staff #24 confirmed that the system is tested weekly and was in working condition on the last date of testing, 5/8/15. The gauge was checked and the internal components of the vacuum line were found to be disconnected.
(iii) Weekly testing of the negative pressure rooms by building services, cannot ensure proper daily working conditions by the unit staff at the time the room is needed for specific airflow utilization. Medical staff cannot identify if the negative pressure airflow is properly working once the airflow switch is turned on without the indicating gauges working properly.
2. The above was confirmed by Staff #3, Staff #24, and Staff #47.

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 for high risk criteria for patient discharge planning in two (2) of four (4) medical records reviewed for discharge planning (Medical Records #1 and #8).

Findings include:

Reference #1: Facility policy Code No.: CC:UR:03:002, Interdisciplinary Rounds states, "... II. Purpose: To provide an opportunity for a collaborative effort between multiple disciplines to assess and/or reassess the discharge needs of the patient. To identify any resources the patient may require and establish a plan of care. ... III. Procedure: 1. Interdisciplinary rounds are held daily on all patient care units at a pre arranged time. 2. The core participants in the interdisciplinary rounds include but are not limited to the nurse assigned to each patient, physician advisor, case manager, social worker, unit clinical coordinator and or/manager, dietician, and other ancillary care providers ..."

Reference #2: Facility policy Code No.: CC: DPP:02:11, High Risk Screening states, "I. Policy: It is the policy of the Department of Continuing Care Services that High Risk Screening or Assessment is completed upon admission for all patients who requires (sic) Case Management and Social Services. ... III. Procedure: 1. the Case Manger's and Social Worker's (sic) will review the unit census for newly admitted patients that need screening to identify patients that are high risk for discharge needs. 2. All admission assessments is (sic) screened using the High Risk Screening Criteria See Below: [1st bullet] Above 65 years old ... [7th bullet] Dementia/Alzheimer's ... [9th bullet] Social Barriers (financial issues, no insurance, ...) ... [11th bullet] Chronic Kidney disease ... 2. Identified patients will receive a visit from the Case Manager and/or Social Worker assigned to the unit within 24 hours of admission. ..."

1. On 5/12/15, review of Medical Record #1 in the presence of Staff #21 and Staff #27 on Unit 5 West, indicated the following:

a. The patient was admitted to the facility on 5/7/15.

b. Per the physician's History and Physical (H&P) dictated on 5/8/15, the patient presented to the Emergency Department with shortness of breath, and admitted that he/she has not taken any of his/her medications for a five (5) week period, for medical problems which include diabetes mellitus, hypertension, and asthma. The patient reported he/she was unable to obtain the medications due to lack of insurance. The patient was known to have chronic kidney disease (CKD) 3 and now has worse CKD 4. The plan of care section of the H&P indicated that hemodialysis was discussed with the patient and hemodialysis would be instituted if needed.

c. Review of the Nursing Admission Assessment indicated that the patient had financial concerns, and has no transportation home.

2. Staff #62 stated during interview that the Case Managers (CM) work with the Social Workers (SW) and ideally they see/screen patients for discharge needs within 24 hours. Staff #62 stated the CM and SW screen every patient and do not wait for a physician or nurse referral. They print out the patient census list each day and determine who the new patients are that need to be screened. Staff #62 states the interdisciplinary team also meets each day to discuss patients.

a. 5 West's Interdisciplinary Rounds sign in sheet for Friday 5/8/15 was reviewed and indicated two CMs, a SW, the unit's nurses, a physician advisor, and the Director of Continuing Care attended the Interdisciplinary Rounds.

3. Further review of Medical Record #1 indicated the patient was not seen or screened until 5/11/15 at 2:30 PM, per a SW assessment note.

a. The assessment note did not identify the patient as a high risk screen or as having financial concerns in the check mark boxes provided. This SW attended the interdisciplinary rounds on 5/8/15. Without the identification of this patient as having financial concerns, as identified by the physician in the H&P and a nurse on the nursing admission assessment, it could not be determined that this information was communicated to the interdisciplinary team.

b. The facility failed to screen a patient with high risk criteria of financial concerns and CKD within 24 hours per their high risk screening criteria policy.

4. On 5/12/15 during tour of Unit Main 3 in the presence of Staff #21, Patient #8 was observed to have a sitter at his/her bedside. The sitter reported the patient is hard of hearing and resides in a nursing home. Review of Medical Record #8 indicated per the face sheet that this 94 year old patient was admitted on 5/9/15, and has a diagnosis of dementia.

a. Review of the Case Manager Initial Assessment and Discharge Form indicated the patient was not screened for discharge needs until 5/12/15 at 9:00 AM.

b. The facility failed to screen a patient with high risk criteria of dementia and an age above 65 years old, 24 hours per their high risk screening criteria policy.