HospitalInspections.org

Based on observation, staff interview and review of facility documents, it was determined that the facility failed to ensure that specific State law requirements were met.

Findings include:

Reference #1: ANSI/AAMI RD52:2004 titled Dialysate for Hemodialysis section 5.4.4.1 states, "In addition to container labeling, there should be permanent records of batches produced. These records should include the concentrate formula produced, the volume of the batch, the lot numbers of powdered concentrate packages, the manufacturer of the powdered concentrate, the date and time of mixing, any test results, the person performing the mixing, the person verifying mixing and test results, and the expiration date (if applicable)."

1. During an interview, Staff #26 and #27 stated that bicarbonate concentrate formula mixing process is currently not being documented. Facility policy and procedures were not available regarding preparation of bicarbonate concentrate formula.

Reference #2: N.J.A.C. Title 8 Chapter 43G Hospital Licensing Standards section 30.5 (g)2
states, "Separate clean and soiled work or utility rooms shall be available within a reasonable distance."

1. The Phoenix meter station (which measures the pH and conductivity of the Dialysate) was located inside the soiled utility room of the Inpatient Dialysis Unit. The Soiled Utility room can only be accessed through the isolation room.

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

CFR 482.11 Compliance With Laws

Based on observation on the days of the survey, 5/4/2010 and 5/5/2010, it was determined that the facility failed to ensure that the condition of the physical plant and the overall hospital environment was maintained in such a manner that the safety and well-being of patients was assured.

Findings include:

1. On the day of the survey, 5/4/2010 at 10:30 AM in the presence of Staff #34, #35, and #36, it was confirmed that in the 6th floor Housekeeping Closet, next to Room 6186, there was dirt and dust on the floor and in the sink receptor.

2. On the day of the survey, 5/4/2010 at 11:15 AM in the presence of Staff #34, #35, and #36, it was confirmed that there was dirt and rust under the Staff Locker Room sink, in Room 6171.

3. On the day of the survey, 5/4/2010 at 12:45 PM in the presence of Staff #34, #35, and #36, it was confirmed that there was rust and dirt on the floor of the 5th floor Electrical Closet, by the Elevator Lobby.

4. On the day of the survey, 5/4/2010 at 1:00 PM in the presence of Staff #34, #35, and #36, it was confirmed that there was dirt, grime, debris and cups behind the ice machine in the 'Staff Only Area' of the 5th floor, near Room 526.

5. On the day of the survey, 5/4/2010 at 3:15 PM in the presence of Staff #34, #35, and #36, it was confirmed that there was rust on the flushing rim sink and blackish dirt under the sink lip in Soiled Utility Room 4155.

6. On the day of the survey, 5/5/2010 at 11:45 AM in the presence of Staff #34, #35, and #36, it was confirmed that there was dust on the exhaust register of the 3rd floor East Wing closet across from Stair #15.

7. On the day of the survey, 5/4/2010 at 10:45 AM in the presence of Staff #34, #35, and #36, it was confirmed that in Soiled Utility Room 6188, the bed pan spray did not function.

8. On the day of the survey, 5/4/2010 at 11:00 AM in the presence of Staff #34, #35, and #36, it was confirmed that there was a leak in the 6th floor Gym roof. Also in this room, at the ceiling, the wallcovering was peeling.

9. On the day of the survey, 5/4/2010 at 11:30 AM in the presence of Staff #34, #35, and #36, it was confirmed that there were stained ceiling tiles outside Room 620 and Electrical Closet 6166.

10. On the day of the survey, 5/4/2010 at 1:15 PM in the presence of Staff #34, #35, and #36, it was confirmed that the 5th floor Physical Therapy Room had a stained ceiling tile.

11. On the day of the survey, 5/4/2010 at 1:45 PM in the presence of Staff #34, #35, and #36, it was confirmed that there was a damaged ceiling tile in Janitors Closet 5181.

12. On the day of the survey, 5/4/2010 at 2:45 PM in the presence of Staff #34, #35, and #37, it was confirmed that there was a stained ceiling tile in Soiled Utility Room 4180.

13. On the day of the survey, 5/5/2010 at 10:30 AM in the presence of Staff #34, #35, and
#37, it was confirmed that there was a stained ceiling tile in the 4th floor Schuman Building Clean Utility Room.

14. On the day of the survey, 5/5/2010 at 11:15 AM in the presence of Staff #34, #35, and
#37, it was confirmed that there were holes through to the wall cavity in the ceramic tile facing of the 3rd floor East Wing storage area, across from Stair #8.

15. On the days of the survey, 5/5/2010 at 12:00 PM in the presence of Staff #34, #35, and
#37, it was confirmed that there was a stained ceiling tile in the corridor near Room 394 of the 3rd floor East Wing.

16. On the day of the survey, 5/5/2010 12:30 PM in the presence of Staff #34, #35, and #37, it was confirmed that there were missing and/or stained ceiling tiles in the basement Environmental Services Locker Room.

17. On the day of the survey, 5/5/2010 at 1:00 PM in the presence of Staff #34, #35, and
#37, it was confirmed that the exterior wall of the Basement Caged Enclosure for RMW sharps containers was broken through with large openings to a crawl space enclosure.

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

Findings include:

Reference #1: LaMotte, the manufacturer of DPD Chlorine Test Kit states, "Use of the Octet Comparator: The octet comparator contains eight permanent color standards. A test sample is inserted into the openings in the top of the comparator. The sample can then be compared to four color standards at once and the value read off the comparator."

1. On 5/5/10 at 11:00 AM, Staff #25 was requested to perform the free and total residual chlorine testing in the water treatment room. Instead of comparing the test sample with the color standards of the octet comparator, Staff #25 was observed comparing the color to a hardness test bottle color standards.

Reference #2: Facility policy and procedure titled, "Chlorine/Chloramine Testings," states, "PROCEDURE: 1. Rinse test tube with sample water. Fill to 10mL mark with sample water. 2. Add one Chlorine DPD #1R Tablet. Cap and shake until tablet disintegrates. 3. Immediately insert test tube into Chlorine DPD Comparator. Match sample color to a color standard. Record as ppm Free Available chlorine. 4. Add one Chlorine DPD #3 Tablet. Cap and shake until tablet disintegrates. 5. Insert test tube into chlorine DPD Comparator. Match sample color to a color standard. Record as ppm Total Residual Chlorine."

1. On 5/5/10 at 11:10 AM, Staff #25 was observed testing for Total Residual Chlorine. Although the Total Residual Chlorine test results are obtained by adding Chlorine DPD #3 into the DPD #1 sample water, Staff #25 was observed testing for Total Residual Chlorine with another clean sample water.

a. Staff #25 stated that he/she had not received any training on chlorine and chloramine testing procedure since he/she became a per diem employee at the facility.

Reference #3: Manufacturer of 'Naturalyte 4000' states, "1: To mix the Naturalyte 4000 dry pack, add purified water to the container provided with the dialysis machine. Fill to the 7.7 liter mark. Container must be free of bacterial and chemical contamination. NOTE: This bicarbonate base concentration should be used on the same day it is mixed."

1. On 5/5/10 at 12:00 PM, Staff #25 was asked to demonstrate mixing of Naturalyte. Staff
#25 stated that the bicarbonate jugs are rinsed with tap water located at the hand sink in the treatment room and filled with RO water from the RO permeate port located in the water treatment room.

a. Although all the bicarbonate jugs were of same volume capacity, each jug was marked with a slightly different fill line. When Staff #27 was questioned about the accuracy of the fill line marks, Staff #27 insisted that all the line marks have been measured at 7.7 liter.

b. Staff #26 and #27 stated that the Inpatient Dialysis Unit currently does not have any policies and procedures on rinsing and disinfection of bicarbonate concentrate jugs. Staff #25 stated that the jugs are being rinsed with tap water located at the hand sink and inverted to dry on the bicarbonate jug drying rack overnight. Daily rinsing, and/or disinfection of the bicarbonate jugs have not been documented.

Reference #4: Facility policy on 'RO Machine' states, "The facility will have on file a copy of the Manufacturer's Manual, available to technical and patient care staff, to provide means of operation and standards set forth by the Manufacturer."

1. The manufacturer instruction manual for the 'Millipore Reverse Osmosis Unit,' located in the water treatment room, was not available onsite for review.

A. Based on observation and document review, it was determined that the facility failed to ensure the proper separation of clean and soiled processes.

Findings include:

Reference: State regulation, "Society of Gastroenterology Nurses and Associates, Inc. Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes (2000) Section (9)," states, "reprocessing of contaminated patient equipment should be done in an area designated and dedicated for this function. This should be a room separate from where endoscopic procedures are performed."

1. On 5/4/10 at 11:00 AM, Staff #13 was observed pre-cleaning a soiled endoscope in the same room he/she conducted a high disinfection procedure of a clean scope.


B. Based on observation, staff interview and document review, it was determined that the facility failed to ensure that endoscopes were stored properly in the designated cabinet at the conclusion of the high level disinfection procedure.

Findings include:

Reference: Facility policy #10 titled, "Guideline For Infection Prevention and Control in Flexible Endoscopy" states, "Endoscopes should be stored in the designated scope cabinet that will protect the endoscope and minimize the potential for accumulation of residual moisture and allow continual circulation of air. They should not be stored coiled in cases that cannot be properly cleaned. Endoscopes should be hung in a vertical position to facilitate drying."

1. On 5/4/10, Staff #13, stated at 11:05 AM that endoscopes are hung on a hook in the reprocessing room as an extra drying procedure until the end of the day. The processed endoscopes are then placed into a bin and wheeled into the designated storage cabinet.


C. Based on observation and document review, it was determined that the facility failed to ensure that manufacturer recommendations regarding testing of the efficacy of the OPA Cidex solution was followed.

Findings include:

Reference: Manufacturer recommendations for 'Cidex OPA Test Strips' state, "Cidex OPA solution should be tested before each usage with Cidex OPA Solution test strips in order to guard against solution below its minimum effective concentration."

1. On 5/4/10, Staff #13, stated at 11:10 AM that the efficacy of the Cidex OPA solution is tested twice daily.


D. Based on observation, staff interview and document review, it was determined that the facility failed to ensure that instruments are properly packaged in peel packages to ensure proper sterilization.

Findings include:

Reference: State regulation (AAMI) guideline, "Comprehensive guide to steam sterilization and sterility assurance in health care facilities AAMI ST79:2006, section (8.3.4)" states, "if the item is to be double-packaged, two sequentially sized pouches should be used (i.e., the sealed inner pouch should fit inside the other pouch without folding)."

1. On 5/5/10 at 11:06 AM, four (4) peel packs containing weatlander retractors were observed in the Center Core sterile storage area located in the Operating Room (OR) with the inner peel pouch folded.


E. Based on observation, staff interview and document review, it was determined that the facility failed to ensure that a sanitary environment was provided.

Findings include:

Reference: Facility policy, "Surgical Suite Clean-up" states, "to establish protocol and procedures to be followed for cleaning the operating room in order to control and reduce the possibility of cross infection of the surgical patient. The area in which the surgical team can be contained is the area that must be cleaned between cases. The perimeter of the room need only be terminally cleaned daily."

1. There was evidence of lint and staining from Betadine solution on the Velcro strip on the OR table in OR #2.

2. The vent in OR #2 had evidence of dust accumulation.

Based on observation, staff interview and review of facility documents, it was determined that the facility failed to ensure that specific State law requirements were met.

Findings include:

Reference #1: ANSI/AAMI RD52:2004 titled Dialysate for Hemodialysis section 5.4.4.1 states, "In addition to container labeling, there should be permanent records of batches produced. These records should include the concentrate formula produced, the volume of the batch, the lot numbers of powdered concentrate packages, the manufacturer of the powdered concentrate, the date and time of mixing, any test results, the person performing the mixing, the person verifying mixing and test results, and the expiration date (if applicable)."

1. During an interview, Staff #26 and #27 stated that bicarbonate concentrate formula mixing process is currently not being documented. Facility policy and procedures were not available regarding preparation of bicarbonate concentrate formula.

Reference #2: N.J.A.C. Title 8 Chapter 43G Hospital Licensing Standards section 30.5 (g)2
states, "Separate clean and soiled work or utility rooms shall be available within a reasonable distance."

1. The Phoenix meter station (which measures the pH and conductivity of the Dialysate) was located inside the soiled utility room of the Inpatient Dialysis Unit. The Soiled Utility room can only be accessed through the isolation room.

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

CFR 482.11 Compliance With Laws

Based on observation on the days of the survey, 5/4/2010 and 5/5/2010, it was determined that the facility failed to ensure that the condition of the physical plant and the overall hospital environment was maintained in such a manner that the safety and well-being of patients was assured.

Findings include:

1. On the day of the survey, 5/4/2010 at 10:30 AM in the presence of Staff #34, #35, and #36, it was confirmed that in the 6th floor Housekeeping Closet, next to Room 6186, there was dirt and dust on the floor and in the sink receptor.

2. On the day of the survey, 5/4/2010 at 11:15 AM in the presence of Staff #34, #35, and #36, it was confirmed that there was dirt and rust under the Staff Locker Room sink, in Room 6171.

3. On the day of the survey, 5/4/2010 at 12:45 PM in the presence of Staff #34, #35, and #36, it was confirmed that there was rust and dirt on the floor of the 5th floor Electrical Closet, by the Elevator Lobby.

4. On the day of the survey, 5/4/2010 at 1:00 PM in the presence of Staff #34, #35, and #36, it was confirmed that there was dirt, grime, debris and cups behind the ice machine in the 'Staff Only Area' of the 5th floor, near Room 526.

5. On the day of the survey, 5/4/2010 at 3:15 PM in the presence of Staff #34, #35, and #36, it was confirmed that there was rust on the flushing rim sink and blackish dirt under the sink lip in Soiled Utility Room 4155.

6. On the day of the survey, 5/5/2010 at 11:45 AM in the presence of Staff #34, #35, and #36, it was confirmed that there was dust on the exhaust register of the 3rd floor East Wing closet across from Stair #15.

7. On the day of the survey, 5/4/2010 at 10:45 AM in the presence of Staff #34, #35, and #36, it was confirmed that in Soiled Utility Room 6188, the bed pan spray did not function.

8. On the day of the survey, 5/4/2010 at 11:00 AM in the presence of Staff #34, #35, and #36, it was confirmed that there was a leak in the 6th floor Gym roof. Also in this room, at the ceiling, the wallcovering was peeling.

9. On the day of the survey, 5/4/2010 at 11:30 AM in the presence of Staff #34, #35, and #36, it was confirmed that there were stained ceiling tiles outside Room 620 and Electrical Closet 6166.

10. On the day of the survey, 5/4/2010 at 1:15 PM in the presence of Staff #34, #35, and #36, it was confirmed that the 5th floor Physical Therapy Room had a stained ceiling tile.

11. On the day of the survey, 5/4/2010 at 1:45 PM in the presence of Staff #34, #35, and #36, it was confirmed that there was a damaged ceiling tile in Janitors Closet 5181.

12. On the day of the survey, 5/4/2010 at 2:45 PM in the presence of Staff #34, #35, and #37, it was confirmed that there was a stained ceiling tile in Soiled Utility Room 4180.

13. On the day of the survey, 5/5/2010 at 10:30 AM in the presence of Staff #34, #35, and
#37, it was confirmed that there was a stained ceiling tile in the 4th floor Schuman Building Clean Utility Room.

14. On the day of the survey, 5/5/2010 at 11:15 AM in the presence of Staff #34, #35, and
#37, it was confirmed that there were holes through to the wall cavity in the ceramic tile facing of the 3rd floor East Wing storage area, across from Stair #8.

15. On the days of the survey, 5/5/2010 at 12:00 PM in the presence of Staff #34, #35, and
#37, it was confirmed that there was a stained ceiling tile in the corridor near Room 394 of the 3rd floor East Wing.

16. On the day of the survey, 5/5/2010 12:30 PM in the presence of Staff #34, #35, and #37, it was confirmed that there were missing and/or stained ceiling tiles in the basement Environmental Services Locker Room.

17. On the day of the survey, 5/5/2010 at 1:00 PM in the presence of Staff #34, #35, and
#37, it was confirmed that the exterior wall of the Basement Caged Enclosure for RMW sharps containers was broken through with large openings to a crawl space enclosure.

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

Findings include:

Reference #1: LaMotte, the manufacturer of DPD Chlorine Test Kit states, "Use of the Octet Comparator: The octet comparator contains eight permanent color standards. A test sample is inserted into the openings in the top of the comparator. The sample can then be compared to four color standards at once and the value read off the comparator."

1. On 5/5/10 at 11:00 AM, Staff #25 was requested to perform the free and total residual chlorine testing in the water treatment room. Instead of comparing the test sample with the color standards of the octet comparator, Staff #25 was observed comparing the color to a hardness test bottle color standards.

Reference #2: Facility policy and procedure titled, "Chlorine/Chloramine Testings," states, "PROCEDURE: 1. Rinse test tube with sample water. Fill to 10mL mark with sample water. 2. Add one Chlorine DPD #1R Tablet. Cap and shake until tablet disintegrates. 3. Immediately insert test tube into Chlorine DPD Comparator. Match sample color to a color standard. Record as ppm Free Available chlorine. 4. Add one Chlorine DPD #3 Tablet. Cap and shake until tablet disintegrates. 5. Insert test tube into chlorine DPD Comparator. Match sample color to a color standard. Record as ppm Total Residual Chlorine."

1. On 5/5/10 at 11:10 AM, Staff #25 was observed testing for Total Residual Chlorine. Although the Total Residual Chlorine test results are obtained by adding Chlorine DPD #3 into the DPD #1 sample water, Staff #25 was observed testing for Total Residual Chlorine with another clean sample water.

a. Staff #25 stated that he/she had not received any training on chlorine and chloramine testing procedure since he/she became a per diem employee at the facility.

Reference #3: Manufacturer of 'Naturalyte 4000' states, "1: To mix the Naturalyte 4000 dry pack, add purified water to the container provided with the dialysis machine. Fill to the 7.7 liter mark. Container must be free of bacterial and chemical contamination. NOTE: This bicarbonate base concentration should be used on the same day it is mixed."

1. On 5/5/10 at 12:00 PM, Staff #25 was asked to demonstrate mixing of Naturalyte. Staff
#25 stated that the bicarbonate jugs are rinsed with tap water located at the hand sink in the treatment room and filled with RO water from the RO permeate port located in the water treatment room.

a. Although all the bicarbonate jugs were of same volume capacity, each jug was marked with a slightly different fill line. When Staff #27 was questioned about the accuracy of the fill line marks, Staff #27 insisted that all the line marks have been measured at 7.7 liter.

b. Staff #26 and #27 stated that the Inpatient Dialysis Unit currently does not have any policies and procedures on rinsing and disinfection of bicarbonate concentrate jugs. Staff #25 stated that the jugs are being rinsed with tap water located at the hand sink and inverted to dry on the bicarbonate jug drying rack overnight. Daily rinsing, and/or disinfection of the bicarbonate jugs have not been documented.

Reference #4: Facility policy on 'RO Machine' states, "The facility will have on file a copy of the Manufacturer's Manual, available to technical and patient care staff, to provide means of operation and standards set forth by the Manufacturer."

1. The manufacturer instruction manual for the 'Millipore Reverse Osmosis Unit,' located in the water treatment room, was not available onsite for review.

A. Based on observation and document review, it was determined that the facility failed to ensure the proper separation of clean and soiled processes.

Findings include:

Reference: State regulation, "Society of Gastroenterology Nurses and Associates, Inc. Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes (2000) Section (9)," states, "reprocessing of contaminated patient equipment should be done in an area designated and dedicated for this function. This should be a room separate from where endoscopic procedures are performed."

1. On 5/4/10 at 11:00 AM, Staff #13 was observed pre-cleaning a soiled endoscope in the same room he/she conducted a high disinfection procedure of a clean scope.


B. Based on observation, staff interview and document review, it was determined that the facility failed to ensure that endoscopes were stored properly in the designated cabinet at the conclusion of the high level disinfection procedure.

Findings include:

Reference: Facility policy #10 titled, "Guideline For Infection Prevention and Control in Flexible Endoscopy" states, "Endoscopes should be stored in the designated scope cabinet that will protect the endoscope and minimize the potential for accumulation of residual moisture and allow continual circulation of air. They should not be stored coiled in cases that cannot be properly cleaned. Endoscopes should be hung in a vertical position to facilitate drying."

1. On 5/4/10, Staff #13, stated at 11:05 AM that endoscopes are hung on a hook in the reprocessing room as an extra drying procedure until the end of the day. The processed endoscopes are then placed into a bin and wheeled into the designated storage cabinet.


C. Based on observation and document review, it was determined that the facility failed to ensure that manufacturer recommendations regarding testing of the efficacy of the OPA Cidex solution was followed.

Findings include:

Reference: Manufacturer recommendations for 'Cidex OPA Test Strips' state, "Cidex OPA solution should be tested before each usage with Cidex OPA Solution test strips in order to guard against solution below its minimum effective concentration."

1. On 5/4/10, Staff #13, stated at 11:10 AM that the efficacy of the Cidex OPA solution is tested twice daily.


D. Based on observation, staff interview and document review, it was determined that the facility failed to ensure that instruments are properly packaged in peel packages to ensure proper sterilization.

Findings include:

Reference: State regulation (AAMI) guideline, "Comprehensive guide to steam sterilization and sterility assurance in health care facilities AAMI ST79:2006, section (8.3.4)" states, "if the item is to be double-packaged, two sequentially sized pouches should be used (i.e., the sealed inner pouch should fit inside the other pouch without folding)."

1. On 5/5/10 at 11:06 AM, four (4) peel packs containing weatlander retractors were observed in the Center Core sterile storage area located in the Operating Room (OR) with the inner peel pouch folded.


E. Based on observation, staff interview and document review, it was determined that the facility failed to ensure that a sanitary environment was provided.

Findings include:

Reference: Facility policy, "Surgical Suite Clean-up" states, "to establish protocol and procedures to be followed for cleaning the operating room in order to control and reduce the possibility of cross infection of the surgical patient. The area in which the surgical team can be contained is the area that must be cleaned between cases. The perimeter of the room need only be terminally cleaned daily."

1. There was evidence of lint and staining from Betadine solution on the Velcro strip on the OR table in OR #2.

2. The vent in OR #2 had evidence of dust accumulation.