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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:

42 CFR 482.42 Infection Control

Based on document review and staff interview, it was determined that the facility failed to ensure that the patient is informed when to expect a written response, if the grievance cannot be completed within 7 days.

Findings include:

Reference: Facility policy "Patient Complaint/Grievance" states, "... Definitions: A patient grievance" [sic] is a formal, or informal written or verbal complaint that is made to the hospital by a patient, or the patient's representative, regarding the patient's care (when the complaint is not resolved at the time of the complaint by staff present) ... Procedure: ... 1. Written Complaints ... c. Investigation, appropriate action and a response are to be completed as soon as possible but not exceed 7 business days. If investigation or corrective action cannot be completed within seven business days, then the complainant will be contacted and advised of the status of their concern.
d. Written communication will be issued to the complainant when the investigation is complete. The communication will include a summary of the findings and actions taken by the facility (when applicable) to resolve the grievance. Issuance of this letter will occur within 30 days."

1. The facility policy does not indicate that at the time of the complainant contact (within 7 business days), the complainant will be informed when to expect a written response (within 30 days), as per policy.

2. Three (3) of five (5) complaint files reviewed (Medical Records #36, #37, #38 ) revealed the following:

a. A complaint regarding Patient #36 was received on 10/11/2017. The patient was contacted on 10/18/17. A resolution letter was sent on 10/25/17. At the time of contact on 10/18/17, the complainant was not informed of the time frame, as per policy, of when a written response would be expected.

b. A complaint regarding Patient #37 was received on 10/18/2017. A written response was provided on 10/25/17. A resolution letter was sent on 10/27/17. The written response dated 10/25/17 stated, "You will be notified at the conclusion of our investigation." The letter did not include an expected time frame.

c. A complaint regarding Patient #38 was received on 10/17/2017. A written response was provided on 10/25/17. A resolution letter was sent on 11/27/17. The written response dated 10/25/17 stated, "You will be notified at the conclusion of our investigation." The letter did not include an expected time frame. The resolution letter was issued more than 30 days.

3. The above was confirmed by Staff #2.

Based on observation, review of policies and procedures, and staff interview conducted on 11/29/17, it was determined that the facility failed to implement policies and procedures addressing the beyond-use date of multi-dose vials.

Findings include:

Reference: Facility policy titled "Medication, Administration and Documentation of" states, "...General Standards for Medication Administration: ... 10. Multidose vials must be dated 28 days from the date opened and initialed. The vial may be used for up to 28 days. The vial is discarded after 28 days."

1. At 12:30 PM, an opened, multi-dose vial of Diazepam was found in the Pyxis machine in the Post Anesthesia Care Unit (PACU). There was no indication of when the vial had been opened.

2. The above finding was confirmed by Staff #61, Staff #106 and Staff #108.

Based on observation, staff interview, and document review conducted on 11/29/17, it was determined that the facility failed to ensure that medications are stored in accordance with manufacturer's recommendations.

Findings include:

Reference: The manufacturer's package insert for Anoro Ellipta inhaler states, "ANORO ELLIPTA should be stored inside the unopened moisture-protective foil tray and only
removed from the tray immediately before initial use. Discard ANORO ELLIPTA 6 weeks after opening the foil tray or when the counter reads "0" (after all blisters have been used), whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart."

1. During an observation in the Pharmacy Department, Anoro Ellipta inhalers were found, out of the manufacturer's original packaging, without any indication of when the inhalers had been removed from the original packaging. The beyond use date could not be determined.

2. The above finding was confirmed by Staff #61.

Based on observation, policy review, and staff interview conducted on 11/28/17, it was determined that the facility failed to implement policies and procedures to ensure that drugs are kept in locked storage areas.

Findings include:

Reference: Facility policy titled "Medication Storage and Distribution System" states, "... No medications are to be left unattended at any point so as to compromise their security."

1. During an observation, one pre-drawn syringe labeled, "Rocuromium" was found on top of the anesthesia cart, unlocked and unattended in Operating Room #9.

2. During an observation, one vial of Xylocaine was found in the supply closet in Operating Room #9, unlocked and unattended.

3. The above findings were confirmed by Staff #109 and Staff #111.

Based on observation, staff interview, and document review conducted on 11/29/17, it was determined that the facility failed to ensure that outdated or otherwise unusable drugs are not available for patient use.

Findings include:

Reference: Manufacturer's package insert for Omnipaque-350, 500 ml Pharmacy Bulk Package states, "DIRECTIONS FOR USE: a.The transfer of OMNIPAQUE (Iohexol Injection) from the Pharmacy Bulk Package is restricted to a suitable work area, such as a laminar flow hood.
b. The container closure may be penetrated only one time, utilizing a suitable transfer device and aseptic technique. c. The withdrawal of container contents should be accomplished without delay. However, should this not be possible, a maximum time of 8 hours from initial closure entry is permitted to complete fluid transfer operations. The container should not be removed from the aseptic area during the entire 8 hour period."

1. On 11/29/17 at 10:30 AM, one opened 500 ml (milliliter) bottle of Omnipaque-350, was found in the pharmacy department, labeled "opened 11/7."

2. Upon interview, Staff #61 confirmed that the bottle should have been discarded.

3. The above finding was confirmed by Staff #61.

Based on observation, facility document review and staff interview conducted on 11/28/2017, it was determined that the dietary service 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.

Findings include:

Reference #1: N.J.A.C. 8:24-6.5(a) states, "The physical facilities shall be maintained in good repair."

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(i) states, "Maintenance tools such as brooms, mops, vacuum cleaners, and similar items shall be stored: 1. So that they do not contaminate food, equipment, utensils, linens, and single-service and single-use articles."

References #4: N.J.A.C. 8:24-2.4(c) states, "The following requirements shall apply to hair restraints: 1...employees shall wear hair restraints such as hats, hair coverings or nets, beard restraints, and clothing that covers body hair, that are designed and worn to effectively keep their hair from contacting exposed food, clean equipment, utensils, linens; and unwrapped single-service and single-use articles. ..."

References #5: The facility policy titled, "Personal Hygiene" states, "...13. Wear suitable and effective hair restraints while in the kitchen. ..."

Reference #6: N.J.A.C. 8:24-4.8(k) states, "A test kit or other device that accurately the concentration in mg/L of sanitizing solutions shall be provided. 8:24-4.8(i) states, "Concentration of the sanitizing solution shall be accurately determined by using a test kit or other device."

1. On 11/28/2017, at approximately 9:50 AM, in the presence of Staff #60 and Staff #84, the following deficient practices were observed:

a. A freezer in the receiving area, designated and stocked with Kosher frozen foods, was not plugged in.

(i) The freezer failed to have a thermometer.

(ii) The sliding doors to the freezer had chipped/broken plastic gaskets preventing the doors from closing completely. (Refer to Reference #1 and #2)

b. The Pre-Preparation area floor had visible dirt and debris. There were mops and brooms on the floor. (Refer to Reference #3)

c. In the Pot washing area, Staff #86 used an expired Hydrion QT- 40 strip to check the sanitation solution concentration. (Refer to Reference #4)

d. During a tour of the kitchen tray line and food preparation area, two (2) staff members failed to wear hair restraints for their facial hair. (Refer to Reference #4 and #5)

2. The above findings were confirmed by Staff #60 and Staff #84.

Based on observation and staff interview on 11/28/17, it was determined the facility failed to ensure that a safe and sanitary environment is maintained for patients, staff and the general public.

Findings include:

1. During a tour conducted at 10:30 AM, in the presence of Staff #40, the following were noted:

a. Uncleanable floor surface damage was identified at the base of the wall within Endoscopy Room #2 located in Todd #4.

b. Several stained and discolored ceiling tiles were found located in the boardwalk hallway adjacent to the kitchen area.

c. Areas of wall surface damage adjacent to the window frames were found located within boardwalk hallway.

d. Underneath the receiving warehouse loading dock overhead doors were visible openings to the outside which could allow the entrance of insects or vermin inside the building.

2. These findings were confirmed by Staff #40.

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

Findings include:

Reference #1: Facility policy and procedure "General Cleaning of Laboratory Work Surface" states, "... Purpose: To provide guidelines to be followed by employees on each shift for routine decontamination of laboratory work surfaces. ...Procedure: 1. Clean all work surfaces throughout the day and always at the end of each work shift. ..."

Reference #2: Facility policy and procedure "Cleaning of Washer and Dryer", states, "...Purpose: To prevent the possible spread of infection from one patient to another. Policy: The nursing staff will clean the washer and the dryer daily after use by the patient. ...Point of Emphasis: ...4. Clean around inside washer and dryer. 5. Wash all surfaces with bleach. ...9. Clean interior with bleach and run water through a complete cycle hot water and detergent process if necessary. ..."

1. A tour of the Laboratory (Lab) was conducted on 11/27/17 and revealed the following:

a. In the Hematology Lab, at the hand washing sink, there was a build up of brown/white residue around the facets and the surrounding counter top. In another hand washing sink, there were three (3) used chemistry straws disposed of in the sink.

(i) Upon interview, Staff #17 confirmed the straws were not disposed of correctly.

b. Throughout the Chemistry and Hematology Labs, there was a large accumulation of thick dust on the floors surrounding power cords, behind machines and on surface areas.

c. In the Immunology Lab at the hand washing sink, the wall above the sink had peeling paint, there was brown/white residue around the facets and on the surrounding counter top.

d. In the Microbiology Lab, there were numerous empty plate holders for specimens that had visible brown/black build up of residue. There were numerous metal like plate holders, stacked that contained a brown/orange rust like substance.

(i) The plate holders were ready for use as confirmed by Staff #17. The policy and procedure for cleaning was requested of Staff #17, but was not received.

e. In the Toxicology Lab, the hooded vents (used to extract toxic urine and serums to prevent fumes from entering the rooms), made of a composite material, was peeling and flaking. Surrounding the sink drain under the hood, there was a build up of brown/black residue. The second hood in the Toxicology Lab, used for a water bath, had a build up of thick dust on the back walls under the hood. Surrounding the sink drain under the second hood, there was a build up of brown/black residue.

f. In the Anatomical Pathology Lab, the specimen freezer handle had a thick build up of a brown residue. The flooring throughout the Lab was covered in brown/black marks, that were darker at the edges of the walls and equipment. There was an excessive amount of thick dust on surfaces throughout the Anatomical Pathology Lab.

g. In the Cytology Lab, the large sink used for a water bath contained a white enamel like pan that had an orange/brown rust like substance throughout the surface area.

(i) The cleaning schedule policy and procedure was requested of Staff #17, but was not received.

2. The above policy in Reference #1 was not followed.

3. The above findings were confirmed by Staff #17.

4. A tour of the Adult Psychiatric Unit-AP1 was conducted on 11/28/17 and revealed the following:

a. Above the hardware on hallway doors #A104, #A107, #A134, #A135, #A137 and a physician office door on the West side, there was an approximate one half (1/2) to three quarter (3/4) inch open space.

b. The Tub Room (#A100), had peeling paint and plaster on the shower ceiling. There was a panel door on the ceiling surrounded with a orange/brown residue.

c. The Shower Room (#A113), had a black residue on the shower ceiling, and around the lower emergency call bell. The ceiling vent was surrounded by a orange/brown residue.

d. In the Seclusion Room (#A114), there was dirt on the bed, Styrofoam plates with food wrappers and crumbs, and a plastic water pitcher on the floor. The floor around the walls had a build up of a brown/black residue.

e. The Laundry Room (#A133) inner tub and rims of the washer had a build up of a brown/blue/black residue. In addition, the center agitator and around the rim of the washer was covered with a black residue.

f. The Shower Room (#A126) had peeling paint on the ceiling of the shower. There was a build up of an orange/black residue on the shower molding and the walls adjacent to the shower.

g. In the Activity Area (#A124), the wall behind the door had peeling paint and some wall board exposed.

h. Patient Room (#A123) had an area above the bed with peeling paint on the ceiling.

i. In Tub Room (#A129) there was a build up of a brown/orange residue on the tub molding and the lower call bell panel.

j. The West Seclusion Room floors, around the wall boards, had a brown/black build up of dirt residue. The attached patient bathroom had a brown splattered residue on the tile next to the toilet.

k. The Nurses station had peeling paint and missing wall board around the printer/copier. The corner of the wall next to the medication room door, had missing paint and an area that was exposed down to a silver metal like substance. There were two floor tiles behind the nursing desk that were peeled, exposing the subfloor. The molding surrounding the nursing desk had an accumulation of thick dust.

5. All the above findings were confirmed by Staff #79, Staff #80 and Staff #81.

6. A tour of the unit AP2 was conducted on 11/28/17 and revealed the following:

a. At the end of the East hallway, the wall had spackling that was not painted.

b. Patient Shower (#A213) had a black residue in the seams of the shower wall and on the ceiling. There was orange/black residue surrounding the tiles on the shower floor.

c. The patient bathroom in Room #A211 had spackling on the wall that was unpainted. There was a black residue throughout the wall tiles and some tiles missing grout. The floor had a build up of brown/black residue.

d. Patient Room #A204 had a brown black residue on the wall and floor tiles. There was spackle on the walls that was unpainted.

e. Shower Room (#A206) had peeling paint on the shower ceiling.

f. The hallway between the East and West wings had spackle on the walls that was unpainted.

g. In the West hallway under the window there was spackle without paint.

h. In the patient bathroom (#A238), the tile on the walls had a black residue and caulking missing between some of the tiles.

i. In the Comfort Room (#A232), the carpet had a large amount of dirt like particles. The walls had brown/black scuff like marks throughout.

7. The above were confirmed by Staff #79, Staff #80 and Staff #83.

Based on observation, staff interview, document review and review of nationally recognized guidelines, it was determined that the facility failed to ensure temperature and humidity levels are achieved and maintained.

Findings include:

Reference #1: Association for the Advancement of Medical Instrumentation (AAMI) Sterilization, Part 1: Sterilization in Health Care Facilities Volume 2 2015 Edition, Standards and Recommended Practices, in section ST 79,
.....
section 3.3.6.5 Temperature states, ". "General work areas should have a temperature controlled between 20 degrees Celsius (C) and 23 degrees C (68 degrees Fahrenheit (F) and 73 degrees F). The decontamination area should have a temperature controlled between 16 degrees C and 18 degrees C (60 degrees F and 65 degrees F). The temperature in sterilization equipment access rooms should be controlled between 24 degrees C and 29 degrees C (75 degrees and 85 degrees F) or as recommended by the equipment manufacturer. The temperature in sterile storage and personnel support areas ... may be as high as 24 degrees C (75 degrees F). ... Rationale: ... bacteria thrive at high temperatures; cool temperatures in the decontamination area might help minimize bioburden. ..." In section, 3.3.6.6 Relative Humidity states, "Relative humidity should be controlled between 30% and 60% in all work areas except the sterile storage area, where the relative humidity should not exceed 70%. ..."

Reference #2: Facility temperature and humidity logs for the Decontamination Area " ... (Standard Temperature 60 - 65 degrees Fahrenheit (F)/ Humidity 30 - 60% ..."

Reference #3: Facility temperature and humidity logs for the Sterilization Room Area " ... (Standard Temperature 68 - 78 degrees Fahrenheit (F)/ Humidity 35 - 60% ..."

Reference #4: Facility temperature and humidity logs for the Sterilizer Access Area " ... (Standard Temperature 75 - 85 degrees Fahrenheit (F) ..."

Reference #5: Facility temperature and humidity logs for the Prep and Pack area " ... (Standard Temperature 68 - 73 degrees Fahrenheit (F)/ Humidity 35 - 60% ..."

Reference #6: Facility temperature and humidity logs for the Sterile Storage Room " ... (Standard Temperature 68 - 75 degrees Fahrenheit (F)/ Humidity 35 - 70% ..."

1. On 11/27/17, during the entrance conference, Staff #35 presented the facility's infection control plan/program for 2017 that included the written nationally recognized guidelines and regulations the facility selected as follows: Centers for Disease Control and Prevention (CDC), New Jersey Department of Health (NJDOH), Association for the Advancement of Medical Instrumentation (AAMI), Association of periOperative Nurses (AORN), Joint Commission (TJC), Association for Professionals in Infection Control and Prevention (APIC), Society of Healthcare Epidemiology of America (SHEA), Infectious Diseases Society of America (ISDA), New Jersey Hospital Association (NJHA) and Institute for Healthcare Improvement (IHI).

2. On 11/27/17 at 10:15 AM, during a tour of the Sterile Processing Department (SPD), a review of the department's temperature and humidity logs was conducted and revealed the following:

a. There were various locations within the areas and/or rooms of the SPD that have thermometers that read the area/rooms' temperature and humidity.

(i) Five (5) logs were presented/reviewed for the SPD. Staff #35 and Staff #36 confirmed the SPD follows AAMI guidelines for temperature and humidity ranges.

b. The following SPD locations/areas' logs were requested and received for: 11/1-11/27/2017. Each individual log had temperature and humidity ranges at the top of the recording log as indicated:

-Decontamination room: (Standard Temperature 60-65 degree Fahrenheit (F)/Humidity 30-60%)

-Sterilization room: (Standard Temperature 68-73 degree F/Humidity 35-60%)

-Sterilizer Access area: (Standard Temperature 75-85 degree F)

-Prep and Pack: (Standard Temperature 68-73 degree F/Humidity 35-60%)

- Sterile Storage: (Standard Temperature 68-75 degree F/Humidity 35-70%)

(i) At 11:25 AM, a review of the five (5) logs listed above was conduced and revealed that all temperature and humidity readings for all dates were out of range.

(ii) Staff #36 and Staff #39 confirmed that SPD personnel record the daily readings on the logs and if any out-of-range readings are identified, a work order is submitted documenting the issue to the Facility Department for correction and/or maintenance.

(iii) Copies of multiple work orders that were submitted to the Facilities' Department for the out-of-range readings were provided.

c. At 11:40 AM, Staff #40, personnel from the Facility's Department explained that on 9/11/17, a new HVAC [heating, ventilation and air conditioning] system was installed with a computer sensory program named "One Source." This captures the temperatures and humidity readings for all the designated areas of the facility, including the SPD.

(i) Staff #40 confirmed that the Facility's Department monitors the temperature and humidity from their department.

(ii) There was no documented evidence that the work orders submitted by SPD were addressed by the Facility's Department regarding the out-of-range temperature and humidity readings.

d. On 11/28/17, temperature and humidity logs for the new HVAC system from the SPD, were requested.

(i) On 11/28/17 at 9:50 AM, the logs from the new HVAC were received for the Decontamination Room and the Clean areas. Staff #2 stated because of a computer change they can only provide logs from the Facility's Department new system from 11/21-11/27/2017, for the Decontamination and Clean Room area only.

3. There was no documentation that maintenance or other actions were in place to ensure proper temperature and humidity levels were being maintained, monitored and recorded daily per the guidelines and/or standards the facility chose to follow.

4. Staff #35, #36, #39 and #40 confirmed the above findings.

Based on observation, document review, and staff interview conducted on 11/29/17, it was determined that the facility failed to ensure the provision of a sanitary environment to avoid sources and transmission of infections and communicable diseases, and failed to ensure an adequate Infection Control Program that seeks to minimize infections and communicable diseases.

Findings include:

1. The facility failed to ensure that medications are administered in accordance with manufacturer labeling. (Refer to Tag A 749)

2. The facility failed to ensure that multi-dose vials accessed in an immediate patient care area were used for one patient and immediately discarded. (Refer to Tag A 749)

3. The facility failed to provide a functional and sanitary environment by adhering to professionally acceptable standards. (Refer to Tag A 749)

4. The facility failed to follow and implement nationally recognized infection control guidelines. (Refer to Tag A 749)

A. Based on observation, document review, and staff interview conducted on 11/28/17, it was determined that the facility failed to ensure that medications are administered in accordance with manufacturer labeling.

Findings include:

Reference: Manufacturer's package insert for Isovue-370, 500 ml Pharmacy Bulk Package states, "The pharmacy bulk package is used as a multiple dose container with an appropriate transfer device to fill empty sterile syringes. ISOVUE Multipack injection should be drawn into the syringe and administered using sterile technique. Unused portions of the drug must be discarded. a. The transferring ISOVUE (Iopamidol Injection) from the Pharmacy Bulk Package should be performed in a suitable work area, such as a laminar flow hood, utilizing aseptic technique."

1. On 11/28/17 at 9:51 AM, one (1) 500 ml (milliliter) Isovue 370, Pharmacy Bulk Package bottle, was found spiked and hanging on an IV (intravenous) pole in the CT (Computerized Tomography) Room labeled "11/28 Time: 9 AM."

a. The use of a Pharmacy Bulk Package for multiple doses in the CT Room is not in accordance with manufacturer guidelines as indicated in the above Reference.

2. On 11/28/17 at 9:51 AM, one (1) 1000 ml bag of 0.9% Sodium Chloride for Injection, labeled "11/28 Time: 9 AM" was found attached to the tubing for the Bracco Injeneering Transfer set.

a. Upon interview, Staff #107 stated that the saline bag is used as a flush for multiple patients throughout the day.

b. The bag was labeled "Single Unit Container."

3. The above findings were confirmed by Staff #2, Staff #61, and Staff #107.

These findings resulted in an Immediate Jeopardy which immediately curtailed this practice. The Immediate Jeopardy was removed on 11/28/17, upon receipt of an acceptable plan of correction.

B. Based on observation, document review, and staff interview conducted on 11/29/17, it was determined that the facility failed to ensure that multi-dose vials of medications that are accessed in the immediate patient care area are discarded immediately after use on a single patient.

Findings include:

Reference: CDC guidelines for multidose vials website: http://www.cdc.gov/HAI/setting/outpatient/checklist/outpatient-care-checklist-observations.html>, titled "Infection Prevention Checklist for Outpatient Settings: Minimum Expectations for Safe Care" states, "Multi-dose vials to be used for more than one patient are kept in a centralized medication area and do not enter the immediate patient treatment area (e.g,. operating room, patient room/cubicle) (Note: If multi-dose vials enter the immediate patient treatment area they should be dedicated for single-patient use and discarded immediately after use.)"

1. During an observation at 12:30 PM, one opened needle punctured multi-dose vial of Labetalol 100 mg (milligram)/20 ml (milliliter), labeled as "Date opened 11/24/17 and 1 month exp date 12/21/17," was found in the medication cabinet of the Post Anesthesia Care Unit (PACU).

2. Upon interview, Staff #106 stated that in the PACU medication room, there is no medication preparation area since medication would be drawn up at the patient's bedside. Staff #106 stated that he/she would "carry out the vial, bring the vial to the patient's bedside and scan the barcode on the vial, prepare the medication and bring the vial back to the medication cabinet."

3. Upon request, Staff #61 provided this surveyor with a transaction sheet that revealed that the multi-dose vial of Labetalol 100 mg/ 20 ml was accessed at the patient's bedside for Patient #35 on 11/24/17 at 9:57 AM.

4. The above findings were confirmed by Staff #2 and Staff #61.

This finding resulted in an Immediate Jeopardy which immediately curtailed this practice. The Immediate Jeopardy was removed on 11/29/17, the day of survey, upon receipt of an acceptable plan of correction.





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C. Based on observation, review of facility policies and procedures, and staff interview, it was determined that the facility failed to ensure that infection prevention practices are implemented in accordance with facility policy.

Findings include:

Reference #1: Facility policy "Hand Hygiene" states, "Procedure: I. Handwashing and Hand Antisepsis. A. Indications
1. If hands are visibly soiled or contaminated with blood or body fluids, use liquid soap and water. Also use liquid soap and water: ...
[bullet] When caring for C [clostridium] difficile patients."

Reference #2: Facility policy "Standard and Isolation Precautions for Inpatients and Outpatients" states, "... Procedure: ...
4. Handwashing ...
b) Wash hands after touching blood, body fluids, secretions, excretions, and contaminated items, whether or not gloves are worn. Wash hands
immediately after gloves are removed, between patient contacts, and when otherwise indicated to avoid transfer of microorganisms to other patients or environments. It may be necessary to wash hands between tasks and procedures on the same patient to prevent cross-contamination of different body sites.
c) Used hospital approved soap for routine hand washing if hands are visibly soiled with blood and if patient is diagnosed with C. difficile infection."

1. On 11/27/17 at approximately 12:00 noon, in the presence of Staff #15, a tour of unit B5 was conducted and the following was observed:

a. Patient #25 was on C Difficile Precautions.

b. Staff #92 was observed providing care to Patient #25 while wearing a protective gown and gloves. Staff #92 was observed doing tasks such as taking the patient's bedpan to the bathroom, setting up the patient's meal tray, performing a blood sugar stick and cleaning the glucometer. Staff #92 was wearing gloves during these tasks and changed gloves between tasks, however, he/she did not wash hands between tasks or once he/she exited the patient's room. Staff #92 sanitized his/her hands once he/she exited the patient room.

c. Staff #91 sanitized his/her hands and placed on a gown and gloves prior to entering Patient #25's room to administer medication. Once Staff #91 completed the task, he/she removed the gowns and gloves, sanitized his/her hands and walked away. Upon further interview, Staff #91 indicated that he/she sanitizes his/her the hands and then goes to middle of the unit where the sink is located to wash his/her hands.

2. The above was confirmed by Staff #15.






34120


D. Based on observation, staff interviews, facility document review and review of nationally recognized guidelines, it was determined that the facility failed to implement their recognized infection control guidelines for sterile storage.

Findings include:

Reference: AAMI (Association for the Advancement of Medical Instrumentation) Sterilization in Health Care Facilities, 2015 edition, ST 79, section 8.9.2 Storage facilities states, " ... The items should be positioned so that packaging is not crushed, bent, compressed, or punctured and so that their sterility is not otherwise compromised. ..."

1. On 11/27/17, during the entrance conference, Staff #35 presented the facility's infection control plan/program for 2017 that included the written nationally recognized guidelines and regulations the facility selected as follows: Centers for Disease Control and Prevention (CDC), New Jersey Department of Health (NJDOH), Association for the Advancement of Medical Instrumentation (AAMI), Association of periOperative Nurses (AORN), Joint Commission (TJC), Association for Professionals in Infection Control and Prevention (APIC), Society of Healthcare Epidemiology of America (SHEA), Infectious Diseases Society of America (ISDA), New Jersey Hospital Association (NJHA) and Institute for Healthcare Improvement (IHI).

2. On 11/27/17, during a tour of the Sterile Storage room in the Operating Room (OR) on the fourth floor of the Todd building, the following was observed:

a. Sterile items were being stored on high density shelving and in Pyxis machines. Multiple sterile blue-wrapped packages and peel packs were stored crammed and over-crowded within their designated storage areas/bins.

(i) Multiple sterile wrapped blue-packs had visible ripped chemical indicator tape.

3. The above findings were confirmed by Staff #35 and Staff #45.

E. Based on observation and staff interview, it was determined that the facility failed to maintain a sanitary hospital environment for patient care equipment in the Sterile Processing Department.

Findings include:

1. On 11/27/17, during a tour of the Sterile Processing Department, in the sterilizer access area, the following was observed:

a. There was a stainless steel cart with a top and a bottom shelf.

(i) On the top shelf of the cart, bins that were filled with Cidex OPA, a high-level disinfectant solution, were kept.

(ii) On the bottom shelf, three (3) patient wound vacuum machines, labeled 'clean,' were stored.

b. There was no separation of the supplies to ensure that clean supplies were stored to ensure contamination would not occur near the soiled work station.

2. The above findings were confirmed by Staff #37.


36420


F. Based on observation, review of contractual agreements, policy review, and staff interview, it was determined that the facility failed to ensure that items taken into a dialysis station are disinfected or discarded after use.

Findings include:

Reference #1: Contractual agreement for dialysis services, effective date November 16, 2013, states, "... DUTIES OF PROVIDER. ... 1.04 ... PROVIDER shall provide policies, procedures, and techniques pertaining to the methods by which Services are rendered at HOSPITAL and, if applicable, addressing any metric not meeting pre-established thresholds of performance pursuant to this Agreement. ..."

Reference #2: Fresenius Medical Care policy titled, Infection Control Overview, states, "... Policy: General ... All infection control policies for patient care are consistent with recommendation of the Centers for Disease Control (CDC). ... References ... B. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention (CDC). Recommendations for preventing transmission of infections among chronic hemodialysis patients. Morbidity and Mortality Weekly Report, April 27, 2001/Vol. 50/No. RR-5., www.cdc.gov/mmwr/ ..."

Reference #3: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention (CDC). Recommendations for preventing transmission of infections among chronic hemodialysis patients. Morbidity and Mortality Weekly Report, April 27, 2001/Vol. 50/No. RR-5., www.cdc.gov/mmwr/, 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. Unused medications or supplies (e.g., syringes, alcohol swabs) taken to the patient's station should not be returned to a common clean area or used on other patients. ..."

Reference #4: Fresenius Medical Care policy titled, Cleaning and Disinfection, states, "... General Cleaning ... After use, all equipment and supplies must be considered as potentially blood contaminated, and should be separated, handled with caution and either disinfected or discarded. ..."

1. On 11/29/17, the following observations were made on the Acute Hemodialysis Unit:

a. At 12:57 PM, a patient transporter brought a wheelchair to the bedside of Patient #34 to assist him/her back the nursing unit after the completion of his/her hemodialysis treatment.

(i) The patient transported removed a blanket from the end of the patient's bed and draped it over the wheelchair.

(ii) The patient was then transported off of the hemodialysis unit with the blanket on the wheelchair.

b. At 1:05 PM, Staff #104 was observed cleaning the hemodialysis station.

(i) Staff #104 removed a box of gloves and a container of alcohol based hand sanitizer from the bedside table and placed those items on the counter at the nurse's station.

(ii) The cardboard container of gloves could not be disinfected, and was not disposed of prior to being brought to a common area.

(iii) The container of alcohol based hand sanitizer was not disinfected prior to being brought to a common area.

2. The above observations were confirmed by Staff #100 and Staff #101 on 11/29/17 at 1:10 PM.

G. Based on observation, review of facility policy and procedure, and staff interview, it was determined that the facility failed to ensure that staff perform hand hygiene in accordance with facility policy.

Findings include:

Reference: Facility policy and procedure titled, Hand Hygiene, states, "... I. Handwashing and Hand Antisepsis A. Indications ... 2. If hands are not visibly soiled, use an alcohol-based hand rub or use liquid soap and water for routinely decontaminating hands for the following clinical situations; [bullet] On entering and exiting the patient room or area - 'Clean In/Clean Out' ..."

1. On 11/29/17 at 12:57 PM, the following observations were made on the Acute Hemodialysis Unit:

a. A patient transporter was observed removing a blanket that had been on the end of Patient #34's bed during his/her hemodialysis treatment and placing it onto a wheelchair.

b. The patient transporter then walked to the nurse's station to obtain the patient's chart from the counter without the benefit of performing hand hygiene after leaving the patient's area.

2. The above observations were confirmed by Staff #100 and Staff #101 on 11/29/17 at 1:10 PM.




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H. Based on observation, review of facility documents and staff interview, it was determined that the facility failed to monitor cleaning of equipment for infection control prevention on the Adult Psychiatric Unit.

Findings include:

Reference: Facility policy and procedure " Movable Equipment, Cleaning Of" states, "...Policy: All reusable, movable, equipment will be properly cleaned in between use by each patient. ..."

1. A tour of the Adult Psychiatric Unit-AP1 was conducted on 11/28/17 and revealed the following:

a. In Clean Work Room (#A135), there were two electric razors housed on a charging base. One of the razors had a build up of a brown/black substance, resembling hair, in the blades and on the charging base.

b. Staff #81 confirmed that the electric razors are to be cleaned after each use.

2. The above was confirmed by Staff #79, Staff #80 and Staff #81.


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I. Based on observation, staff interview, and review of facility documents, manufacturer's Instructions For Use (IFU), and nationally recognized guidelines, it was determined that the facility failed to implement their policies, procedures and guidelines for maintaining a sanitary hospital environment to control infections.

Findings include:

1. On 11/27/17, during the entrance conference, Staff #35 presented the facility's infection control plan/program for 2017 that included the written nationally recognized guidelines and regulations the facility selected as follows: Centers for Disease Control and Prevention (CDC), New Jersey Department of Health (NJDoH), Association for the Advancement of Medical Instrumentation (AAMI), Association of periOperative Nurses (AORN), Joint Commission (TJC), Association for Professionals in Infection Control and Prevention (APIC), Society of Healthcare Epidemiology of America (SHEA), Infectious Diseases Society of America (ISDA), New Jersey Hospital Association (NJHA) and Institute for Healthcare Improvement (IHI).

2. On 11/27/17 at 11:47 AM during a tour of the Decontamination Room, the following was observed:

a. There were seven (7) sinks for cleaning and disinfecting soiled instruments.

(i) On the ledge, behind three (3) of the sinks, were three (3) x-ray detectable lap sponges.

(ii) Staff #41 confirmed that he/she uses the lap sponges to wipe out contaminated trays and clean scope lenses. Staff #41 stated that he/she uses the sponge multiple times until it gets "gunky," then it is discarded.

(iii) Staff #36 confirmed that the lap sponges are one time use and should be discarded after one use.

b. There were multiple cleaning brushes exposed and not in their protective packaging, lying on the bottom shelf under the sink.

c. There was white residue stains on the following equipment throughout the room:

(i) the sinks

(ii) the metal-like lid of the trash can located next to the Bradley shower

(iii) the ultrasonic machines

(iv) the tables

(v) the carts

d. There was visible debris observed in the following areas throughout the room:

(i) Biological Indicators (BI) on the sink ledges, on tables, carts, the floor and behind the ultrasonic machines

(ii) pieces of paper were found on a mobile cart and on the floor

e. Staff #41 was observed moving soiled instrument trays, that were soaking in disinfectant, from the sinks to the ultrasonic machines.

(i) During transport from the sink to the ultrasonic machine, contaminated water was being dripped on the floor throughout the room.

3. At 12:00 PM, Staff #36 stated that the Decontamination Room gets cleaned nightly.

Reference #1: Facility policy #916-070-000 titled, "Decontamination of Soiled Instruments and Devices" states, "...Procedure: ...B. Soiled Utility Room-OR (Operating Room): ...8. An enzyme pre-soak, prepared in accordance with the manufacturer's instructions is used to loosen protein soils. 9. Instruments should be manually pre-cleaned if gross soil is present."

Reference #2: Association for the Advancement of Medical Instrumentation (AAMI) ST 79 2017 Edition N.2.2.4 Precleaning states, "Instruments should be precleaned immediately following use. Gross debris should be removed, ...The instruments should be maintained in a moist state before cleaning in order to prevent the drying of surgical debris onto or within them."

1. On 11/27/17 at 12:20 PM, in the Decontamination Room in the presence of Staff #35, Staff #36, and Staff #37, the following was observed:

a. There was a metal-like transport cart that contained a "Mako-Demayo" knee positioner with large amounts of visibly dry tissue on the instrument, as per Staff #36.

(i) Staff #36 confirmed it was tissue remains from a procedure.

(i) Staff #36 and Staff #37 confirmed that the instrument was sprayed with an enzymatic at point of use.

(iii) The instrument appeared dry.

(iv) Staff #36 confirmed that the tissue should be removed from instrument at point of use.

(v) Staff #41 confirmed that the cart containing the soiled knee positioner entered the Decontamination Room at approximately 11:00 AM.

(vi) The dry tissue remained on the knee positioner for 1 hour and 35 minutes, until Staff #41 began cleaning and pre-soaking it at 12:35 PM.

Reference #3: Facility policy #695-004-000 titled, "Accountability For Surgical Instruments/Sets" states, "...Procedure: Surgical Instruments: ...2.0 Sterile Processing Responsibilities 2.1 All surgical instruments shall be properly cleaned per system-wide approved Decontamination policies. At no time are decontamination policies to be circumvented or modified. 2.1.3 The device manufacturer's written instructions must be followed for cleaning, packaging and sterilization."

Reference #4: Association for the Advancement of Medical Instrumentation (AAMI) ST79 : 2017 Edition 7.3 Manufacturer's written IFU states, "The device manufacturer's current written IFU should be accessible, reviewed and followed. ... 7.4.1 General considerations for all devices and utensils To help ensure effective decontamination of devices, sterile processing personnel should a) follow the device manufacturer's written IFU to ensure proper decontamination and disinfection of the device; ..."

Reference #5: Depuy Synthes manufacturer's IFU states, "Cleaning-Mechanical Method: Ultrasonic...Pre-clean method (Pre-clean method must be performed prior to ultrasonic mechanical method ...3. Soak device in a neutral pH enzymatic cleaner or detergent solution for a minimum of ten (10) minutes. ..."

1. On 11/27/17 at 12:30 PM, in the Decontamination Room, Staff #41 was observed pre-soaking several instrument trays in an enzymatic solution.

a. Staff #41 stated that the manufacturer's recommendations for pre-soaking the "Zero-P tray" was 5 minutes.

(i) Staff #41 stated that he/she uses the 5 minute cycle of the ultrasonic machine across the room, as his/her timer for pre-soaking instruments.

(ii) Staff #41 confirmed that he/she pre-soaked the "Zero-P" tray for 5 minutes prior to placing it in the ultrasonic machine.

(iii) The manufacturer's IFU for the "Zero-P" tray was requested.

(iv) Upon review, the IFU indicated to pre-soak the device in an enzymatic solution for a minimum of ten (10) minutes.

(v) Staff #41 failed to follow the manufacturers IFU for the "Zero-P" tray.

Reference #6: PDI Sani-Cloth AF3 Germicidal Disposable Wipe (160 count) pail manufacturer's IFU states, "1. Prepare the bucket. Remove the lid. Next, tear open refill at notch. Always dispense through lid. Wear gloves when dispensing and using this product. Find center of wipe roll, twist corner of wipe into a point and thread through the hole in the pail lid. Pull through about one inch. replace lid. 2. ...When not in use, keep lid closed to prevent moisture loss."

1. On 11/27/17 at 2:15 PM, Staff #44, Staff #47, Staff #48, and Staff #49 were observed cleaning and disinfecting Operating Room (OR) #2 between patients.

a. On a housekeeping cart outside of OR #2, there was a large 160 count refill bag of PDI Sani-Cloth Germicidal Disposable Wipes inside of a PDI Sani-Cloth pail.

(i) The large bag of PDI Sani-Cloth wipes was placed in a pail that did not have a lid.

(ii) The staff donned gloves, removed a wipe from the large bag of PDI Sani-Cloth wipes, and used the wipe to clean and disinfect OR #2.

(iii) The staff were then observed reaching back into the large bag of PDI Sani-Cloth wipes, with their soiled gloves on, to remove more wipes.

(iv) Staff #46 confirmed the pail has a dispensing lid, but it was not on because it is not user friendly.

(v) Staff #44, Staff #47, Staff #48, and Staff #49 failed to remove their soiled gloves and donn clean gloves, prior to reaching back into the large bag of PDI Sani-Cloth Wipes.

(vi) The facility failed to follow the manufacturer's IFU and dispense the wipe through the lid.









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J. Based on observation, review of facility policy and procedures, and staff interview, it was determined that the facility failed to ensure that infection prevention practices are implemented in accordance with facility policy.

Findings include:

Reference #1: Facility policy, Hand Hygiene, states, "Procedure: I. Handwashing and Hand Antisepsis. A. Indications ... If hands are not visibly soiled, use an alcohol-based hand rub ... Before and after donning and removing gloves ... Before donning sterile gloves when inserting a central intravenous catheter ... Decontaminate hands after contact with a patient's intact skin ... Other Aspects of Hand Hygiene ... Remove gloves immediately after caring for a patient."

Reference #2: Facility Policy, Care and Maintenance of Central Venous Access Devices (CVAD) for Adult and Pediatric states, "Guidelines ... 7. All accessing, dressing changes, tubing changes and blood-sampling procedures must be done under strict aseptic technique and as per institutional guidelines... Procedure ...Steps ...2. Don mask, and place second mask on the patient ... 6. Inspect the catheter exit site, surrounding skin and tunnel ... 7. Remove gloves and perform hand hygiene ... 8. Apply sterile gloves ..."

1. During a tour of the Outpatient Infusion and Laboratory Satellite at Vantage Point on 11/28/17, the following was observed:

a. Staff #76 was preparing to access the implanted venous access device of Patient #16.

(i) Staff #76 had a mask hanging around his/her neck. Prior to the procedure, Staff #76 placed the used mask on his/her face.

(ii) Staff #76 did not place a second mask on Patient #16.

(iii) Staff #76 failed to change from clean gloves to sterile gloves before accessing the implanted venous access device.

b. Staff #78 was observed sitting at his/her computer workstation typing with gloves on.

2. During a tour of the outpatient Ocean Laboratory and X-Ray on 11/28/17, the following was observed:

a. Staff #74 was performing a blood draw on Patient #35.

(i) Staff #74 failed to perform hand hygiene after removing gloves.

3. During a tour of the Todd 6 Gym on 11/29/17, the following was observed:

a. Staff #72 failed to perform hand hygiene after having contact with Patient #29.

Based on staff interview, medical record review, and review of facility policy and procedure, it was determined that the facility failed to ensure that a list of home health agencies was available and presented to all patients requiring home health care upon discharge.

Findings include:

Reference: Facility policy, Discharge Planning, states, "Procedure ... 8. A list of home health care agencies and/or post hospital care services will be provided to the patient/patient representative ..."

1. On 11/27/17, review of Medical Record #1 revealed the following:

a. Home Health Services were recommended for Patient #1 on 11/24/17.

b. There is no evidence that Patient #1 was provided with a list of home health agencies.

c. There is no evidence that Patient #1 was provided with a choice of home health agencies.

d. The above findings were confirmed with Staff #8.

2. Upon interview on 11/29/17, Staff #73 revealed the following:

a. A patient that requires home health care is referred to [name of agency].

b. A list of home health agencies are not provided to the patient.

2. Upon interview on 11/29/17, Staff #96 revealed the following:

a. A patient that requires home health care is referred to [name of agency].

b. A list of home health agencies are provided to the patient if requested.

3. The above findings were confirmed by Staff #6.