The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

JEFFERSON STRATFORD HOSPITAL 18 EAST LAUREL ROAD STRATFORD, NJ 08084 April 25, 2019
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
STRATFORD CAMPUS

A. Based on observation, staff interviews, and document review, it was determined that the facility failed to ensure that written manufacturers' instructions for use for instruments and devices are followed.

Findings include:

Reference: The Association for the Advancement of Medical Instrumentation (AAMI) Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities, 2017 edition, section 7.3 states, "Manufacturers' written IFU [Instructions for Use]: The device manufacturer's current written IFU should be accessible, reviewed, and followed."

1. Upon review of the Sterilization Record log for Sterilizer #3, dated 4/16/19, the following was noted on load #5:

a. A sigmoidoscope was sterilized at an exposure time of 15 minutes at 270 degrees Fahrenheit.

i. The corresponding manufacturer's instructions for use for Sigmoidoscope states, "...Sterilization ...2. Perform one autoclave cycle that includes 6 minutes at 270 degrees Fahrenheit. ..."

2. Upon review of the Sterilization Record log for Sterilizer #3, dated 4/18/19, the following was noted on load #6:

a. A Piezo Dental Tray was sterilized at the temperature of 275 degrees Fahrenheit.

i. The corresponding manufacturer's instructions for use for Piezo Dental Tray states, "...After use, always sterilize the above components in the autoclave at 273 degrees Fahrenheit. ..."

3. The above findings were confirmed with Staff #13, Staff #14, and Staff #15 on 4/25/19 at 2:00 PM.

B. Based on observation, staff interview, and document review, it was determined that the facility failed to ensure implementation of policies and procedures addressing the transport of sterile items.

Findings include:

Reference: Facility policy titled "Transport of Sterile Items" states, "Procedure: ...1. b. Sterile items are to be positioned in such a manner as to prevent compression. c. Packaging is inspected for integrity and proper labeling prior to distribution."

1. During an observation on 4/24/19 at 11:33 AM in the Sterile Supply Room of the surgical suite, the following was observed:

a. Seven (7) peel-pouched sterilized surgical scissors and forceps were found in a compressed position in a small, narrow bin.

i. The peel-pouched packages had visible curled, crushed, and bent packaging, which can compromise the package integrity.

b. Sixteen (16) peel-pouched sterilized surgical sutures were found in a compressed position in a small, narrow bin.

i. The peel-pouched packages had visible curled, crushed, and bent packaging, which can compromise the package integrity.

ii. The tubes that contained sterilized surgical sutures had an adhesive label with curled edges and adhesive residue.

2. The above findings were confirmed with Staff #4 and Staff #15 at 11:45 AM on 4/24/19.

C. Based on observation, staff interview, and document review, it was determined that the facility failed to ensure the implementation of policies and procedures addressing environmental cleaning of the surgical suite.

Findings include:

Reference: Facility policy titled "Practices for Environmental Cleaning in the Surgical Suite" states, "... Policy: Cleaning will be done in such a manner to minimize exposure of health care workers and patients to bio-hazardous substances and prevent cross contamination. ...Procedure: ...3. After each surgical case a safe, clean environment should be established. A. Operating room equipment and furniture that are visibly soiled should be cleaned with a EPA-registered hospital approved germicidal agent at the end of each surgical procedure. Equipment and furniture used for the surgical procedures are considered contaminated ... d. Disposable items contaminated with blood and/or tissue that would release blood or other infection materials in a liquid or semi liquid state if compressed or items that are caked with dried blood or OPIM (other potentially infectious materials) must be placed in closable, leak proof container or bags. The bags are color coded and labeled, or tagged for easy identification of biohazardous waste."

1. During an observation of post-procedure room turnover on 4/24/19, the following was observed:

a. At 10:49 AM in Operating Room (OR) #4, Staff #9 was observed transporting a cart containing a suction canister with reddish fluid, covered with a white bed linen. Upon interview, Staff #4 confirmed that the suction canister contained blood and other bodily fluid.

i. The suction canister was not placed in a closed, leak-proof, color coded container or a labeled or tagged bag.

b. At 11:00 AM in OR #4, Staff #9 was observed picking up garbage from the floor with gloved hands. With the soiled gloves on, Staff #9 touched the door knob and exited the room.

i. At 11:01 AM, Staff #10 exited the room, touching the contaminated door knob with clean hands.

ii. Staff #9 and Staff #10 failed to prevent cross contamination.

c. At 11:26 AM in OR #2, Staff #15 stated that the room had been turned over for the next patient and the room was patient ready.

i. The surfaces of the mayo table had not been cleaned and disinfected during post-procedure room turnover.

ii. In the anesthesia medication drawer, yellowish sticky residue was noted.

2. The above findings were confirmed with Staff #15, Staff #6, and Staff #4.

D. Based on observation, staff interviews and document review, it was determined that the facility failed to ensure implementation of policies and procedures addressing hand hygiene.

Findings include:

Reference: Facility policy titled "Hand Hygiene" states, "... Responsibility: All associates, physicians, students, contacted workers and volunteers must cleanse their hands: ...6. After contact with any blood or body fluids 7. Before donning and after removing gloves ...11. Before and after handling medications..."

1. On 4/24/19 at 11:26 AM in OR #2, Staff #12 was observed donning gloves and preparing a medication. Staff #12 did not perform hand hygiene before donning gloves.

2. The above finding was confirmed with Staff #15 and Staff #4 on 4/24/19 at 11:30 AM.

E. Based on observation, staff interview, and document review, it was determined that the facility failed to ensure implementation of infection control overview policies and procedures related to environment of care, in accordance with acceptable standards of practice.

Reference #1: Facility policy titled "Infection Control Overview" states, " ...Responsibilities: Environmental Services General Manager shall : Supervise activities in the department, Assess skills of staff in the department ...Infection Practitioners shall: Assist Environmental Services General Manager in evaluation of sanitation practices ...Controls of the System: There shall be a formula for every mixture used in the department. Bottles and containers shall be properly labeled as to content and mix date and the intended purpose or use."

Reference #2: Association of periOperative Registered Nurses (AORN), Guidelines for Perioperative Practice, 2017 edition, pg. 17 states, "...Recommendation V. V.a.1. Areas and items that should be cleaned on a schedule include ...clean and soiled storage areas ...environmental services closets."

1. During an observation of post-procedure room turnover on 4/24/19 at 10:50 AM in OR #4, Staff #10 was observed mopping the floor.

a. Upon interview, Staff #10 stated that the cleaning solution utilized for the mop heads, came from the storage closet, but was unable to verbalize the product she/he was using to mop the floor.

2. On 4/24/19, in the environmental services storage closet, in the surgical suite the following was observed:

a. The floor was visibly dirty with dust particles and numerous stains.

b. Two (2) unlabeled yellow buckets, containing mop heads and liquid, were found.

i. Upon interview, Staff #9 stated that one of the unlabeled yellow buckets contained the cleaning solution, Ecolab Performance Ultra Cleaner, for the mop heads. When questioned about the preparation of the cleaning solution, Staff #9 stated that the solution was diluted automatically and dispensed from the dispensing system.

ii. Upon interview, Staff #15 stated that Ecolab Performance Ultra Cleaner was no longer the cleaning solution the facility utilized.

iii. Upon request, Staff #6 was not able to provide evidence of monitoring for environmental cleaning of post-procedure room turnover.

3. The above findings were confirmed with Staff #4, Staff #6, and Staff #15.

F. Based on document review and staff interview conducted on 4/25/19, it was determined that the facility failed to ensure the development of policies and procedures, regarding a tracking mechanism, for all items reprocessed in accordance with the Association for the Advancement of Medical Instrumentation (AAMI) guidelines.

Findings include:

Reference: The Association for the Advancement of Medical Instrumentation (AAMI) ST 79: 2017, Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities, pg. 72 states, "... 13.3.2 ... Each item or package intended for use as a sterile product should be labeled with a lot control identifier prior to sterilization. The lot control identifier should identity ...b) a detailed list of the contents (e.g., identification of multiple sets and the contents of paper-plastic pouches)."

1. Review of the Sterilization Record log, dated 4/18/19 for Sterilizer #2, indicated that on Load #3, "4-FHS" were sterilized.

2. Upon interview, Staff #14 stated that on 4/18/19, four (4) surgical instruments from the Family Health Center, an offsite location, had been sterilized.

3. Upon interview on 4/24/19 at 2:00 PM, Staff #13, Staff #14, and Staff #15 confirmed that recording "4-FHS" on the sterilization log, did not provide a tracking mechanism for all items reprocessed for retrieval, in the event the sterilizer malfunctions.

G. Based on staff interview and document review conducted on 4/24/19, it was determined that the facility failed to ensure implementation of policies and procedures addressing autoclave care and maintenance.

Findings include:

Reference: Facility policy titled "Autoclave Care & Maintenance" states, "Policy: ...Running a process challenge device with a biological daily for all cycle types being used in each sterilizer for the 1st load of the day ..."

1. Upon interview, Staff #14 stated that the facility has the ability to either run a pre-vacuum cycle or a gravity displacement cycle.

2. When questioned about running a process challenge device (PCD) with a biological indicator in a gravity displacement cycle, Staff #14 stated that he/she runs a PCD monthly, not daily, as indicated in the policy.

3. The above finding was confirmed with Staff #13, Staff #14, and Staff #15.






CHERRY HILL CAMPUS

A. Based on observation, review of nationally recognized guidelines, and staff interviews, it was determined that the facility failed to ensure that hinged instruments are sterilized in accordance with AAMI guidelines.

Findings include:

Reference: ANSI/AAMI ST 79: 2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, pg. 50 states, "... 8.2 Instruments... b) Instruments should be positioned to allow the sterilant to come into contact with all surfaces. ... ."

1. Upon interview on 4/24/19 at 10:00 AM, Staff #4 confirmed that the facility follows AAMI and AORN guidelines for infection control.

2. During a tour of Sterile Storage Room A on 4/24/19, in the Operating Room (OR) suite, six (6) surgical scissors in peel-packs were sterilized in the closed position. The closed position prevents the sterilant from coming in contact with all surfaces.

3. Staff #1, Staff #4, and Staff #7 confirmed the above findings.

B. Based on observation, review of manufacturer's instructions for use (MIFUs), and staff interviews, it was determined that the facility failed to ensure that MIFUs for surface disinfectants are followed.

Findings include:

Reference: Manufacturer's Instructions for Use for Oxivir 1 Wipes states, "... Use Directions... Wipe hard, non-porous environmental surfaces with towelette. Allow surface to remain wet for 1 minute... Allow to air dry or rinse with potable water if necessary. ... ."

1. During an observation of post-procedure room turnover cleaning in OR #5, on 4/24/19 at 12:24 PM, the following was observed:

a. Staff #14 used an Oxivir wipe to clean a pillow, then immediately placed the pillow on top of a metal cart. Staff #14 then used a second wipe to clean a second pillow. After cleaning, he/she immediately placed the second pillow on top of the first pillow.

b. Staff #14 did not allow the surface of the pillows to remain wet for one minute, as referenced above.

2. Upon interview at 1:00 PM, Staff #14 was asked the contact time for Oxivir. He/she stated, "One minute." Staff #14 was asked what contact time means and what needs to occur for one minute. He/she stated, "I'm not sure."

3. Staff #1, Staff #7, and Staff #15 confirmed the above finding.

C. Based on observation, review of facility policy and procedure, and staff interviews, it was determined that the facility failed to ensure that policies and procedures regarding environmental cleaning of operating rooms are implemented.

Findings include:

Reference: Facility policy titled, Practices for Environmental Cleaning in the Surgical Suite states, "... 3. After Each Surgical Case a safe, clean environment should be established... Equipment and furniture used for the surgical procedures are considered contaminated through contact with patients and OPIM (other potentially infectious material), including blood. ... ."

1. During an observation of post-procedure room turnover cleaning in OR #5, on 4/24/19 at 12:24 PM, the following was observed:

a. Staff #12 and Staff #14 entered OR #5 and began cleaning the room in preparation for the next case.

i. A large table was located in the back of the room with four (4) unopened packets of Vicryl sutures located on top of the table.

ii. Droplets of blood were visible on the floor inches away from the table.

b. At 1:10 PM, Staff #14 stated, "OK, the room is now clean." Staff #14 was asked if the room was patient ready and he/she replied, "yes."

i. Staff #12 or Staff #14 did not clean the back table prior to Staff #14's indication that OR #5 was clean. Staff #14 was asked why he/she did not clean the back table. He/she stated, "I was just about to go over there to clean it now."

2. Staff #1, Staff #7, and Staff #15 confirmed the above findings.

D. Based on observation, review of nationally recognized guidelines, and staff interviews, it was determined that the facility failed to ensure that endoscopes are reprocessed in accordance with acceptable standards of practice.

Findings include:

Reference #1: The Centers for Disease Control and Prevention (CDC) Essential Elements of a Reprocessing Program for Flexible Endoscopes-Recommendations of the Healthcare Infection Control Practices Advisory Committee, Last update: June 28, 2017 Page 5 of 12 states, "Documentation: ... 4. Maintain documentation of the effectiveness of the products used for cleaning and disinfection (e.g., document the results of testing for effective concentrations of the chemical disinfectant, expiration dates for test strips and chemical disinfectants). ..."

Reference #2: Manufacturer's Instructions for Use, Rapicide PA High-Level Disinfectant states, "... Do not use after expiration date. The product may be used for twenty-one (21) days after the containers are opened. DO NOT use after that time has expired. ... ."

Reference #3: Manufacturer's Instruction for Use, Advantage Plus Medivator, Endoscope Reprocessor states, "... Test Strips - used to test the concentration of the HLD (high-level disinfectant) after each cycle. ... ."

1. During a tour of the Endoscopy Suite on 4/25/19 at 11:26 AM, the following was identified:

a. Upon interview on 4/25/19 at 11:35 AM, Staff #20 confirmed that the facility used Rapicide PA high-level disinfectant to reprocess endoscopes. He/she stated that the Rapicide PA disinfectant is changed "approximately every three (3) days."

i. Upon request, Staff #20 was unable to provide evidence of the dates the Rapicide PA disinfectant had been changed.

b. Upon interview on 4/25/19 at 11:40 AM, Staff #20 stated that minimum recommended concentration (MRC) checks, to test the concentration of the disinfectant, are conducted after every load, according to the endoscope reprocessor's manufacturer's instructions.

i. Upon request, Staff #20 was unable to provide evidence of the MRC checks conducted after every load.

2. Staff #7, Staff #19, and Staff #20 confirmed the above findings.





WASHINGTON TOWNSHIP

Based on observation, staff interview, review of facility policies and procedures, and nationally recognized guidelines, it was determined that the facility failed to ensure implementation of policies and procedures addressing dress code in the Central Processing Department (CPD).

Findings include:

Reference: Facility policy titled "Dress Code" states, "...Procedure: Central Processing Personnel...7. Jewelry should not be worn, including wrist watches and bracelets in the sterilization, prep and pack, and decontamination. Exemptions are wedding rings. ..."

1. On 4/24/19 at 10:57 AM, in the CPD Prep and Pack area, in the presence of Staff #2, Staff #10, and Staff #13, Staff #11 was observed inspecting a Dual Mobility General 2 Instrument Kit, while wearing a silver colored ring on his/her left thumb.

2. Upon interview, Staff #13 stated that facility policy states no jewelry, with the exception of wedding rings.