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.

TRINITAS REGIONAL MEDICAL CENTER 225 WILLIAMSON STREET ELIZABETH, NJ 07207 July 16, 2014
VIOLATION: GOVERNING BODY Tag No: A0043
Based on document review, staff 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 Condition of Participation:

CFR 482.42 Infection Control
VIOLATION: INFECTION CONTROL Tag No: A0747
Based on observation, staff interview, and review of documentation, it was determined that the facility failed to maintain an ongoing program designed to prevent, control, and investigate infections and communicable diseases.

Findings include:

1. The facility failed to ensure implementation of its hand hygiene policy and CDC guidelines for handwashing. (Refer to Tag A-0748).

2. The facility failed to provide and maintain a sanitary environment to avoid sources and transmission of infections and communicable diseases, and failed to implement the Association for the Advancement of Medical Instrumentation (AAMI) standards and the CDC Guidelines for Prevention of Infections. (Refer to Tag A-0749).

a. These findings were cause for an Immediate Jeopardy to be identified on 7/16/14. The Immediate Jeopardy was abated on the afternoon of 7/16/14 after receiving an acceptable plan of correction.
VIOLATION: INFECTION CONTROL OFFICER(S) Tag No: A0748
A. Based on observation, staff interview and review of policies and procedures, it was determined that the facility failed to ensure that hand hygiene is performed in a manner consistent with hospital policy and nationally recognized guidelines.

Findings include:

Reference #1: Facility policy titled "Hand Hygiene" states, " ... Procedure: 1. Hand hygiene must be performed before and after patient or patient-care equipment contact ... after removing gloves ... f. Wash each hand and wrist thoroughly as follows: 1. Apply liquid soap to hands and scrub using friction for at least fifteen seconds ... Turn faucets off with the paper towel. 8. Discard paper towel ..."

Reference #2: CDC Guideline for Hand Hygiene in Health Care Settings Recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force (2002) states on page 32, "Recommendations: 1. Indications for hand washing and hand antisepsis ... (I) Decontaminate hands after contact with inanimate objects (including medical equipment) in the immediate vicinity of patient (J) Decontaminate hands after removing gloves ... 2. Hand-hygiene technique ... (B) When washing hands with soap and water, wet hands first with water, apply an amount of product recommended by the manufacturer to hands, and rub hands together vigorously for at least 15 seconds covering all surfaces of the hands and fingers."

1. During a tour of the Emergency Department on 7/15/14 at 10:20 AM, Staff #71, a Medical Doctor (MD), was observed washing his/her hands with soap and water at the handwashing sink in Room 15 for 5 seconds, which is not in accordance with facility policy.

2. On 7/15/14 at 11:00 AM, Staff #47 was observed washing his/her hands with soap and water for 5 seconds at the handwashing sink in room 6214 on nursing unit 6 South (6S). Staff #47 then closed the hot water faucet with his/her left hand and then dried his/her hands with a paper towel. He/she wiped the excess water from the sink top with the same paper towel used to dry his/her hands, and then discarded the paper towel in the trash receptacle.

3. On 7/15/14 at 11:10 AM, on nursing unit 6S, Staff #48 was observed cleaning the glucose monitor without wearing gloves. Staff #48 did not wash his/her hands after cleaning the monitor.

4. On 7/15/14 at 12:05 PM, in Room #6222 on nursing unit 6S, Staff #59 was observed removing a pair of "dirty" gloves and then donning a new pair of clean gloves without performing hand hygiene. At 12:35 PM, he/she removed his/her gloves and, without performing hand hygiene, picked up the receiver of the facility wall-mounted telephone, which was located in the hallway outside of Room #6222.

5. On 7/16/14 at 11:45 AM, Staff #55, a CRNA (Certified Registered Nurse Anesthetist), was observed in the Same Day Surgery Operating Room #1. He/she prepared intravenous medications for administration to Patient #9. At 11:55 AM, without changing gloves, Staff #55 intubated Patient #9. Post intubation, without changing gloves, he/she then inserted a nasogastric tube. Staff #55 then removed his/her gloves, performed hand hygiene with an alcohol based gel, and then donned a new pair of clean gloves. At 11:58 AM, Staff #55 removed the "dirty" gloves and donned a clean pair of gloves without performing hand hygiene.

6. On July 16, 2014 at 2:10 PM, Staff #58, an MD, was observed removing a pair of non-sterile gloves, and then donning a pair of sterile gloves without performing hand hygiene.

7. On July 16, 2014 at 2:12 PM, Staff #54, an MD, was observed donning a pair of sterile gloves without first performing hand hygiene.






8. On 7/15/14 at 11:10 AM, in the Endoscopy Department outside Endo Procedure Room #1, Staff #27 was observed removing a soiled pair of gloves after cleaning the floor.

a. He/she did not sanitize his/her hands after glove removal.

9. On 7/15/14 at 11:00 AM, in the Endoscopy Soiled Workroom, Staff #30 was observed removing soiled gloves after instrument care and donning a new pair of gloves without sanitizing his/her hands. This practice was observed three times.

a. There was no hand washing sink in the Endoscopy Soiled Workroom.

b. There was an alcohol based hand rub (ABHR) dispenser installed at the far end of the room, away from the reprocessing sink and counter space.

c. This finding was confirmed with Staff #3, Staff #28, Staff #29, Staff #30 and Staff #31.

Reference #3: CDC Guideline for Hand Hygiene in Health Care Settings Recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force (2002) states on page 32,
"Recommendations: 1. Indications for hand washing and hand antisepsis ... B. If hands are not visibly soiled, use an alcohol based hand rub for routinely decontaminating hands in all other clinical situations ... G. Decontaminate hands after contact with body fluids or excretions, mucous membranes ... "

10. On 7/16/14 at 2:54 PM, in the Central Sterile Processing Department (CSPD) Decontamination Room, Staff #42 was observed cleaning soiled and bloody instruments.

a. The phone rang and he/she proceeded to pick up the telephone handset with his/her soiled gloves.

b. The soiled telephone handset was then handed over to Staff #25.

c. Staff #25 did not sanitize his/her hands after the handset was hung up.

d. Staff #25 and Staff #42 did not clean the soiled telephone handset.

e. These findings were confirmed by Staff #25 and Staff #42.

B. Based on observation, document review, and staff interview it was determined that the facility failed to ensure a functional environment for the provision of surgical services in the Endoscopy Department.

Reference #1: SGNA (Society of Gastroenterology Nurses and Associates) Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes, 2012 edition, states on page 9 of 22, "Reprocessing Room ... Reprocessing of contaminated patient equipment must be done in an area designated and dedicated for this function."

1. On 7/15/14 at 11:17 AM, it was observed that the room functioning as the Endoscopy Clean room had a sign that read "Decontamination Room", and the room functioning as the Endoscopy Soiled Workroom had a sign that read "Clean Workroom".

a. Staff #32 stated that the rooms have been switched.

b. This finding was confirmed by Staff #3, Staff #28, Staff #31 and Staff #32.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
A. Based on observation and document review it was determined that the facility failed to implement its policy for Infusion Therapy.

Findings include:

Reference #1: Facility policy titled 'Policy: Infusion Therapy: Initiation, routine Care and Maintenance of Peripheral and Specialized Vascular Devices' states, "Policy: ... 6. Continuous IV tubing is changed and labeled every 96 hours. 7. Intermittent IV tubing, for infusion through an intermittent infusion device (IID), is changed and labeled every 24 hours. ... II Basic Procedures: Peripheral Lines ... F. Date, time and initial the dressing."

1. On 7/14/14 at 11:00 AM Unit 6 South was toured in the presence of Staff #4 and Staff #7. Patient #1 in Room 6218-2 was interviewed, and stated he/she was admitted on Saturday, 7/12/14. Patient #1 had a pink peripheral intravenous (IV) catheter in his/her left antecubital. The intravenous pole adjacent to his/her bed had a primary/continuous IV fluid tubing connected to a bag of normal saline, and an intermittent/secondary IV tubing for an antibiotic, that was connected to the primary saline tubing.

a. The Continuous IV tubing and the Intermittent IV tubing was not labeled as to the date and time of original use as per policy.

i. Without dating and timing the IV tubing, it could not be determined if the intermittent tubing was within or had exceeded its 24 hour time of use as per policy.

b. The IV site dressing in Patient #1's left antecubital was not dated and timed as per policy, to indicate the date and time of insertion.






2. During a tour of the Medical ICU (Intensive Care Unit) on 7/14/14 at 1:45 PM, in the presence of Staff #18 and #21, it was observed that in Room #2017, the Continuous IV tubing and the Intermittent IV tubing was not labeled as to the date and time of original use as per policy.

a. Without dating and timing the IV tubing, it could not be determined if the intermittent tubing was within or had exceeded its 24 hour time of use as per policy.

B. Based on direct observation, staff interview, and review of policies and procedures, it was determined that the facility failed to implement infection control measures to ensure a sanitary environment was maintained during medication preparation.

Findings include:

Reference #1: Facility policy titled "Safe Injection Practices" states, " ... Aseptic technique will be used to avoid contamination of sterile injection equipment ... "

Reference #2: CDC [Center for Disease Control] guidelines for Medication preparation state, " ... Parenteral medications should be accessed in an aseptic manner ... Hand hygiene should be performed before handling medications and the rubber septum should be disinfected with alcohol prior to piercing it ..."

Reference #3: Clinical Nursing Skills & Techniques, 7th Edition, Perry and Potter, Chapter 22, pg 580, states, "An ampule is made of glass ... Aspiration of medication from the ampule is achieved with a filter needle and syringe ..."

1. On 7/15/14 at 10:10 AM, Staff #44 was observed preparing a parenteral injection of Morphine for Patient #7 on the counter space in Emergency Department (ED) Room #14. The counter, which was being used as the immediate medication preparation area, also contained 4 loose vials of blood and a specimen container partially filled with urine.

2. On 7/16/14 at 11:25 AM, Staff #55 was observed preparing medications for parenteral injection. Staff #55 did not disinfect the rubber septum of the medication vial with alcohol prior to piercing it with a needle. Staff #55 did not disinfect the neck of the glass ampule with alcohol prior to breaking it off. Staff #55 did not use a filter needle to aspirate medication from the ampule.

3. On 7/16/14 at 1:45 PM, Staff #58 was observed preparing medications for parenteral injection. Staff #58 did not disinfect the rubber septum of the medication vial with alcohol prior to piercing it with a needle. Staff #58 did not disinfect the neck of the glass ampule with alcohol prior to breaking it off. Staff #58 did not use a filter needle to aspirate medication from the ampule.

4. On 7/16/14 at 3:30 PM, Staff #21 stated that the facility uses "Perry and Potter" as its reference for nursing procedures. Staff #21 confirmed that a filter needle must be used when medication is aspirated from a glass ampule into a syringe.

C. Based on direct observation and review of policies and procedures, it was determined that the facility failed to implement infection control measures to ensure a sanitary environment during blood glucose point of care testing.

Reference: Facility policy titled, "Capillary Blood Glucose Testing using the Abbott Precision Xceed Pro (Blood Glucose Monitor)", states, " ... Wipe the monitor off with the approved germicidal cleaner. Remove gloves and wash hands ..."

1. On 7/15/14 at 11:00 AM, Staff #47 was observed to clean only the front side of the blood glucose monitor with a germicidal wipe prior to performing a finger stick glucose monitoring test on Patient #8. Staff #47 did not adhere to the above referenced facility policy.

2. On 7/15/14 at 11:10 AM, Staff #48 was observed wiping the glucose monitor off with the approved germicidal cleaner without wearing gloves. Staff #48 did not wash his/her hands after cleaning the monitor. Staff #48 did not adhere to the above referenced facility policy.

D. Based on direct observation, staff interview and review of facility documentation, it was determined that the facility failed to implement infection control measures to ensure a sanitary environment was maintained.

Reference #1: The Manufacturer's Instructions for Use for "Dispatch Hospital Cleaner Disinfectant with Bleach" states, " ... Ready-to-Use 1:10 Dilution of Bleach and Detergent ... "

1. On 7/15/14 at 11:40 AM, Staff #59 was observed performing a post-discharge terminal cleaning of Room #6222-1. Staff #59 stated that the objects in the room are cleaned with a 1:10 bleach solution disinfecting wipe.

a. Staff #59 stated that these wipes were prepared, as needed, by the Environmental Services personnel by "eye-balling the amount of Dispatch bleach solution poured into the tub container. Cold water is added to the rim of the tub, and then a roll of dry wipes are added. The cover to the tub is replaced, and a label with the name, ingredients, and contact time of the bleach disinfectant is placed on the outside of the tub." Staff #59 stated "All the housekeepers do it this way."

2. On 7/15/14 at 2:30 PM, Staff #24 stated that according to the manufacturer's instructions for use, the Dispatch bleach solution is ready to use and should not be diluted. Staff #24 stated that the proper technique to prepare a tub of Dispatch wipes is to "Pour the ready to use bleach solution into the base of the tub, and then add the dry wipes. The bleach solution will "wick up" to moisten the wipes."

3. Staff #59 did not prepare the Dispatch disinfecting wipes according to the Manufacturer's Instructions for Use, creating a solution that was less than a 1:10 bleach solution.

Reference #2: Facility policy titled "Cleaning of Special Procedure Rooms and Same Day Surgery" states, " ... Terminal Cleaning: Spot Clean all fixtures attached to the ceiling, walls doors [sic] ... fixtures attached to the walls ... with a hospital approved disinfectant ..."

4. On 7/16/14 at 1:45 PM, the following observations were made in Labor and Delivery Operating Room #1:

a. The ventilation slats located on the wall to the right of the door, and the wall near the anesthesiology equipment and the baby bassinet, had visible black colored stains and thick dust.

b. Two removable armboards had adhesive tape on multiple places on each armboard. Tape is not a cleanable surface.

c. The legs of 3 silver colored portable equipment tables had rust.

d. There was an approximately 2 inch long chip in the enamel of the overhead operative spot light.

e. There were 2 holes in the wall to the left of the main door, near the anesthesiology equipment, exposing a porous surface that cannot be properly cleaned.

Reference #3: The Manufacturer's Instructions for Use for the Bemis Quick-Drain states, " ... Daily cleaning with 3 liters water and a pH neutral enzymatic cleaner ..."

5. During a tour of the Medical ICU (Intensive Care Unit) on 7/14/14 at 1:55 PM, Staff #18 confirmed that the Bemis Quick-Drain device was used daily, but he/she did not know if it was cleaned daily, as per manufacturer's instructions for use. Staff #18 stated, "It's done by someone from maintenance."

a. On 7/15/14 at 9:35 AM, Staff #3 stated that he/she had spoken to the environmental services manager who is responsible for cleaning the Bemis Quick-Drain device in the ICU. Staff #3 confirmed, that according to the environmental services manager, the Bemis Quick-Drain device was not cleaned daily, but only a few times a week.

b. On 7/15/14 at 9:45 AM, Staff #24 confirmed that the facility has 5 Bemis Quick-Drain devices, and maintenance personnel cleans them daily, as per manufacturer's instructions for use. Staff #24 stated that the facility does not maintain a log of the dates and times these devices are cleaned.

c. On 7/16/14 at 10:35 AM, Staff #5 stated that the Bemis Quick-Drain device located in the Same Day Surgery dirty utility room is cleaned daily by someone from maintenance. Staff #5 confirmed that a daily cleaning log is not maintained.

i. At 10:37 AM, in the presence of Staff #5, it was observed that the collar of the Bemis Quick-Drain metal canister, and the handle of the canister cover had evidence of several irregularly shaped red color stains.

6. Staff #24 confirmed that the facility does not maintain a log of the dates and times the Bemis Quick-Drain devices are cleaned. Therefore, it could not be determined if the Bemis Quick-Drain devices were cleaned according to the manufacturer's instructions for use.

7. On 7/15/14 at 10:30 AM during tour of Unit 6 South in the presence of Staff #4 and Staff #7, silk tape was observed along the laminate counter top edge next to the computer. Silk tape is not a cleanable surface.






E. Based on observation, staff interview, and review of facility documentation, it was determined that the facility failed to ensure that an ongoing Infection Control program is maintained. The infection control and prevention program has not adequately implemented the Association for the Advancement of Medical Instrumentation (AAMI) standards and the CDC Guidelines for Prevention of Surgical Site Infection.

Findings include:

Reference #1: AAMI (Association for the Advancement of Medical Instrumentation) Sterilization in Health Care Facilities, 2014 edition section 7.2.2, Manufacturer's instructions states, "The written instructions of the device manufacturer should always be followed."

Reference #2: CDC Guideline For Prevention Of Surgical Site Infection, 1999 states on page 268, "d.1. Sterilize all surgical equipment according to published guidelines."

Reference #3: Facility Infection Control policy titled, "Isolation Precautions" states, "... Procedure: ... G. Patient Care Equipment ... 2. Ensure that reusable equipment is not used for the care of another patient until it has been cleaned and reprocessed appropriately."

1. On 7/15/14 and on 7/16/14, after observation in the CSPD (Central Sterile Processing Department), review of the sterilization records and manufacturer's IFUs (instructions for use), it was determined that the facility failed to ensure that manufacturer's IFUs are followed.

a. The manufacturer IFU for the Microaire drill state, "Do not use IUSS (immediate use steam sterilization)."

i. Review of IUSS logs for May and June 2014 reveal that this item was routinely sterilized using an IUSS cycle.

b. The manufacturer IFU for the Green laryngoscope states, "... Steam sterilization only ... Prevac: 4 minutes exposure; 20 minutes drying time at 270 degrees F [Fahrenheit]"

i. Review of sterilization records reveal that the Green laryngoscope was routinely sterilized using Sterrad.

c. The manufacturer IFU for the Wolf microlaryngoscope instrument states to steam sterilize "at 272 degrees F, 3 minute exposure time. Do not sterilize items using IUSS cycle."

i. Review of sterilization records reveal that the Wolf microlaryngoscope instrument was sterilized using IUSS.

d. The manufacturer IFU for the Pilling microlaryngoscopy instruments stated, "Steam sterilize at 273 degrees F, 5 minutes exposure time."

i. Review of sterilization records reveal that the Pilling microlaryngoscopy instruments were sterilized at 270 degrees F, 11 minutes exposure time.

e. The manufacturer IFU for the V. Mueller microlaryngoscopy instruments stated, "Steam sterilize at 270 degrees, 4 minute exposure time, 30 minute drying time."

i. Review of sterilization records reveal that the V. Mueller microlaryngoscopy instruments were sterilized at 270 degrees F, 11 minutes exposure time, 8 minutes drying time.

g. The manufacturer IFU for the Medline fabric towels stated, "Prevac Steam Sterilization... Temperature: 270 degrees F... Sterilization Time: 4 minutes ... Dry Time: 15 minutes ... Warning DO NOT use extended dry or sterilization times. DO NOT put surgical textiles and sterilization containers in the same load."

i. Review of sterilization records reveal that the Medline fabric towels were sterilized at 270 degrees F, 4 minutes exposure, and 30 minutes drying time and with sterilization containers within the loads.

ii. Staff #25 stated that they extended the drying time because the packs were becoming wet.

iii. Staff #25 confirmed that the Medline IFUs were not followed.

Reference #4: CDC Guideline For Prevention Of Surgical Site Infection, 1999 states on page 261, "... (5) Flash sterilization of surgical instruments ... During operation the need for emergency sterilization of equipment may arise ... However, flash sterilization is not intended to be used for either reasons of convenience or as an alternative to purchasing additional instrument sets or to save time."

1. On 7/14/14, during a tour of the CSPD, in the presence of Staff #3 and Staff #16, Staff #25 stated that "they flash sterilize instruments in the OR (Operating Room) routinely."

a. The facility failed to ensure that it had the volume of surgical equipment to support the volume of surgical cases it performs.

b. A review of the sterilization records, CSPD logs, the OR (Operating Room) schedules, and the Infection logs confirms that surgical equipment is routinely sterilized using an immediate use steam sterilization (IUSS) or flash method.

i. In May 2014, there were a total of 17 items that were sterilized using IUSS.

ii. In June 2014, there were a total of 17 items that were sterilized using IUSS.

c. There was one case of post-op infection reported in May 2014.

i. The instruments used were sterilized using IUSS.

d. These findings were confirmed by Staff #3 and Staff #25.

F. Based on observation, document review, and staff interview, it was determined that the facility failed to ensure that intravascular diagnostic contrast media was prepared and administered in accordance with manufacturer's directions and the Centers for Disease Control and Prevention (CDC) guidelines.
Findings include:
Reference #1: The manufacturer's package instructions (Revised September 2013) for Isovue Multipack-370 (NDC #0270-1316-41) states, "... Directions for Proper Use of Isovue Multipack ... 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 syringes and administered using sterile technique. Unused portions of the drug must be discarded ... a. The transferring Isovue (lopamidol injection) from the Pharmacy Bulk Package should be performed in a suitable work area, such as a laminar flow hood, utilizing aseptic technique. "

Reference #2: Centers for Disease Control and Prevention (CDC) website: <http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf>, titled "2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings" states, "... IV. Standard Precautions ... Assume that every person is potentially infected or colonized with an organism that could be transmitted in the healthcare setting and apply the following infection control practices during the delivery of health care. ... IV.H.3. Use fluid infusion and administration sets (i.e., intravenous bags, tubing and connectors) for one patient only and dispose appropriately after use. Consider a syringe or needle/cannula contaminated once it has been used to enter or connect to a patient's intravenous infusion bag or administration set 453. Category IB."

1. On 7/16/14, during a tour of the Cardiac Catheterization procedure room at 1:55 PM, one opened Isovue Multipack-370 200 ml (milliliter) contrast media bottle labeled "7/16 12:45 PM" was found hanging on an IV (intravenous) pole spiked with an anti-reflux valve and tubing.
a. Upon interview, Staff #62 confirmed that the Isovue bottle was used for multiple patients earlier that day. Staff #62 stated that it was the practice of the facility to use the Isovue Multipack-370 200 ml bottles for multiple patients.
b. Staff #62 stated that it was the practice of the facility to spike the Isovue Multipack bottle with an anti-reflux valve and tubing extension, which is then connected to each patient's contrast intravenous catheter tubing. Staff #62 stated that the anti-reflux valve and tubing are routinely kept until the Isovue Multipack bottle is discarded.
c. Staff #62 stated that when the patient's procedure is complete, usually using 80 cc (cubic centimeter) of contrast per procedure, the tubing is re-capped for the next patient.
d. This finding was confirmed by Staff #62 and Staff #61, in the presence of Staff #3 and Staff #16.
2. Review of the manufacturer's package instructions for the proper use of Isovue Multipack-370 revealed that the facility failed to transfer Isovue from the 200 ml Pharmacy Bulk Package into sterile syringes in a suitable work area, such as a laminar flow hood, utilizing aseptic technique in accordance with manufacturer instructions. (Reference #1)
3. The facility did not dispose of a fluid infusion set and connector after each single patient's use, in accordance with CDC guidelines. (Reference #2)