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.

INSPIRA MEDICAL CENTER ELMER 501 WEST FRONT STREET ELMER, NJ 08318 Aug. 26, 2015
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
A. Based on observation it was determined that the facility failed to implement its policy and procedure for disposal of needles, syringes, and other sharps.

Findings include:

Reference: Facility policy and procedure Subject: Disposal of Needles/Syringes and Other Sharps INF.9.B states, "I. POLICY A. To provide the user a safe handling technique and disposal procedure for needles/syringes and other sharps. B. To properly dispose of contaminated needles/syringes and other sharps after use with minimal risk of injury. II. RESPONSIBILITY A. All hospital staff including but not limited to physicians employed by the hospital or who have staff privileges, --[facility's healthcare system title]-- employees and all contracted staff handling needles/syringes and other sharps will handle and dispose of them in accordance with this policy and procedure. ... C. All departments handling needles /syringes and other sharps are responsible to notify environmental services for replacement of filled containers and other problems. ... III. PROCEDURE A. Sharps containers will be routinely collected by a contracted collection agency. If sharps containers are noted by staff to be full between pickups or if any other problems or concerns occur, staff is responsible to notify environmental services. B. Sharps containers are locked and mounted on brackets in designated areas on all units/departments. ... E. Exercise extreme caution in the handling of needles/syringes and other sharps during and after use. After use of needles/syringes and other sharps, observe the following precautions. (sic) 1. Initiate the safety device when present. ... 4. Dispose of as soon as possible after use by placing in the nearest rigid, puncture-resistant, leak-proof container designated specifically for this purpose, in accordance with the New Jersey state regulations. ... F. Any department using other types of sharps containers will be responsible for the safe use, handling, and replacement of filled containers. Notify environmental services to properly dispose of filled containers. ..."

1. On 8/24/15 Unit 2 South was toured in the presence of Staff #21. The Medication Room was observed at 10:50 AM.

a. An IV (intravenous) cart located within the Medication Room had a small red sharps disposal container that was filled past the fill line with IV needles and syringes. The IV needles and syringes were also protruding out thru the top of the container's opening.

b. An unsecured small red sharps disposal container was observed on the counter top by the sink, behind several 450 milliliter bottles of Readi-Cat.

2. On 8/24/15, during a tour of the Hyperbaric Unit at 11:03 AM, in the presence of Staff #4, Staff #12 and Staff #13, a large red sharps container was observed to be stored on the floor between the handwashing sink and a counter, unsecured.

a. This finding was confirmed with Staff #12 and Staff #13.

3. On 8/25/15, during a tour of O.R. #2 at 11:20 AM, in the presence of Staff #5, Staff #6 and Staff #44, a sterile 60 ml syringe was observed to be on top of the anesthesia cart.

a. Staff #44 stated that the syringe was used during a previous case (i.e., surgical procedure) in the room.

b. This finding was confirmed with Staff #5 and Staff #6.

4. On 8/25/15, during a tour of O.R. #3 in the presence of Staff #5, Staff #6, Staff #31, and Staff #35, a vial of Bacitracin injectable solution containing approximately 4 mls of solution, was observed in Staff #34's front pocket, with a needle and 10 ml syringe injected into the vial.

a. The needle of the syringe was observed to be punctured through the septum of the medication vial.

b. Staff #34 stated, "I already injected the Bacitracin into the (irrigation) bag. I keep the bottle to show the surgeon what's in the bag."

c. This finding was confirmed with Staff #5, Staff #6 and Staff #31.

5. The facility failed to ensure that its policy on the disposal of needles/syringes and other sharps is implemented in the O.R.

B. Based on observation it was determined that the facility failed to store all multi-dose vials appropriately.

Findings include:

Reference: Facility policy and procedure Mixing drugs in a syringe using two multidose vials states, "... Special Considerations ... [10th bullet] Keep multidose vials away from the immediate patient environment where they can be contaminated. ... References ... 2. Dolan, S.A. et al. (2010). APIC position paper: Safe injection, infusion and medication vial practices in healthcare. American Journal of Infection Control, 38, 167-172. ..."

1. On 8/24/15 at 12:15 PM Staff # 24 was observed administering an insulin injection to a patient in Room 209-1. Staff #24 placed the humalog insulin vial in his/her pocket after preparing the insulin injection for administration to the patient.

a. By placing the vial in his/her pocket, and proceeding to give patient care, the nurse did not keep the multi-dose vial away from the immediate patient care environment.

b. The referenced journal article in the above referenced policy and procedure states, "... Vials ... [8th bullet] Keep multi-dose vials away from the immediate patient environment. [9th bullet] Never store or transport vials in clothing or pockets. ..."





C. Based on observation and review of facility policy and procedure, it was determined that the facility failed to implement its hand hygiene policy.

Findings include:

Reference #1: Facility policy and procedure Subject: Hand Hygiene/Hand Washing and Hand Antisepsis INF.6 states, "I. POLICY All personnel will perform hand hygiene before and after care of the patient. Hand hygiene is the most important method of preventing the spread of infection. ... III. PROCEDURE ... 3. Indications for hand hygiene and hand antisepsis: ... B. Before touching clean items, equipment, or linen C. Before invasive and non-invasive procedures D. Before handling medication or food E. Before and after touching a patient, their belongings, or their environment F. Before donning gloves and after glove removal (non-sterile as well as sterile) ... K. After touching contaminated items, equipment, linen ... 4. Surgical hand antisepsis: ... C. Surgical hand antisepsis using either an antimicrobial soap or an alcohol based had rub with persistent activity is recommended before donning sterile gloves when performing surgical procedures. ... "

Reference #2: Guideline for Hand Hygiene in Health Care Settings: Recommendation of the Healthcare Infection Control Practices Advisory Committee [HICPAC] and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force, published in the CDC (Centers for Disease Control and Prevention) Morbidity and Mortality Weekly Report at MMWR 2002; 51 (No. RR-16) page 32 states, "Recommendations: 1. Indications for Handwashing and Hand antisepsis ... C. Decontaminate hands before having direct contact with patients. ... E. Decontaminate hands before inserting ... peripheral vascular catheters, or other invasive devices ... F. Decontaminate hands after contact with a patient's intact skin ... G. Decontaminate hands after contact with ... a patient's nonintact skin ... I. Decontaminate hands after contact with inanimate objects ... in the immediate vicinity of the patient. J. Decontaminate hands after removing gloves."

1. On 8/24/15 at 11:00 AM during tour of Unit 2 South in the presence of Staff #21, a housekeeper, was observed with gloves on, taking soiled linen from a patient in Room 212. He/she brought the soiled linen to the Soiled Utility Room, then proceeded back to the housekeeping cart and continued working. The housekeeper did not remove his/her gloves and perform hand hygiene after touching contaminated linen.

2. On 8/24/15 at 12:15 PM Staff # 24 was observed administering an insulin injection to a patient in Room 209-1. Staff #24 administered the insulin injection, discarded the needle in a sharps disposal container, and removed his/her gloves. Staff #24 then proceeded to open the patient's oral medications into a medication cup, administer the medications to the patient, then assisted the patient up in bed and adjust his/her pillows. Staff #24 did not perform hand hygiene after he/she removed her gloves following the injection, and prior to administering the patient's oral medication.

3. On 8/24/15 at 10:58 AM, during a tour of the Hyperbaric Unit, an empty alcohol based hand rub (ABHR) dispenser was observed to be installed on a wall outside of the unit.

a. Staff #13 stated, "We have to buy our (bottle dispenser) sanitizer. The hospital does not provide them."

4. On 8/24/15 at 11:50 AM during observation of a procedure in the Wound Care Center Procedure Room, Staff #14 was observed to change his/her soiled gloves without sanitizing his/her hands.

a. Staff #14 stated, "Our sanitizer (bottle) ran out and I haven't had a chance to replace it."

b. A hand washing sink was observed in the room.

i. Staff #14 did not use the hand washing sink to sanitize his/her hands.

c. This finding was confirmed with Staff #14.

5. On 8/25/15, during a tour of the O.R. at 11:55 AM, in the presence of Staff #5, Staff #6, and Staff #31, the ABHR dispenser in O.R. #3 did not dispense the ABHR when activated.

a. This finding was confirmed with Staff #5, Staff #6, and Staff #31.

6. On 8/25/15, during a tour of the Endoscopy Department at 2:05 PM, the ABHR dispenser did not dispense the ABHR when activated.

a. These findings were confirmed with Staff #6, Staff #31, and Staff #46.

7. On 8/25/15 in Operating Room (O.R.) #2, Staff #42 and Staff #43 were observed performing multiple glove changes without sanitizing their hands.

a. This finding was confirmed with Staff #5 and Staff #31.

D. Based on observation, staff interview and review of facility policy conducted on 8/24/15 and 8/25/15, it was determined that the facility failed to ensure that its soiled reprocessed instruments are transported in accordance with OSHA regulation and its Infection Control policy.

Findings include:

Reference #1: Facility policy titled Decontamination Process states, "... I. Soiled items should be contained during transport from the point of use to the decontamination/ preparation area. ... Containment may be accomplished by any means that adequately prevents inadvertent personnel contact with or exposure to the soiled items during transfer. These means include covered carts, plastic container with lids or other methods appropriate to the specific situation and/or environment."

Reference #2: OSHA (Occupational Safety and Health Administration) 29 CFR part 1910.1030(d)(2)(xiii) states, "Specimens of blood or other potentially infectious materials shall be placed in a container which prevents leakage during collection, handling, processing, storage, transport, or shipping."

Reference #3: OSHA 29 CFR part 1910.1030(g)(1)(i)(A) states, "Warning labels shall be affixed to containers of regulated waste, refrigerators and freezers containing blood or other potentially infectious material; and other containers used to store, transport or ship blood or other potentially infectious materials ..."

1. On 8/24/15 at 11:55 AM during observation of a wound care procedure in the Wound Care Center Procedure Room, soiled reprocessed instruments were observed to be placed in a covered white plastic bucket.

a. According to Staff #14, the bucket is used to transport the soiled instruments to the Sterile Processing Department for reprocessing.

b. The bucket did not contain a biohazard warning label, in accordance with OSHA regulation.

c. This finding was confirmed with Staff #4.

2. On 8/25/15, during a tour of the O.R. #1 immediately after a surgical procedure at 11:30 AM, trays of soiled instruments were observed to be transported without a leak-proof container and a biohazard warning label, in accordance with OSHA regulations and facility policy.

a. Soiled surgical scopes and cables were observed to be contained in a basin, covered with a disposable blue wrapper.

i. The soiled scopes and cables were not contained in a leak-proof container and were transported without a biohazard warning label, in accordance with OSHA regulations and facility policy.

b. These findings were confirmed with Staff #5, Staff #31, and Staff #33.

Reference #4: AORN (Association of Perioperative Registered Nurses) Perioperative Standards and Recommended Practices 2013 edition, RP [Recommended Practices]: Care of Instruments section V states, "V.b. All Instruments opened in the operating or procedure room should be decontaminated whether or not they have been used. All instruments opened during a surgical procedure are considered contaminated."

1. During an interview with Staff #30 on 8/25/15, he/she stated that the facility follows AAMI, AORN, SGNA and OSHA guidelines.

a. A review of the facility's policy titled, 'Decontamination' referenced to AAMI, AORN and OSHA guidelines.

2. On 8/25/15, during a tour of the O.R. #1 immediately after a surgical procedure at 11:30 AM, in the presence of Staff #5, Staff #31, and Staff #33, Staff #32 stated, "I separate the unused instruments and keep them on the tray at the bottom of the cart."

a. The practice of separating "unused" instruments that have been opened in the operating room does not conform with the AORN guidelines.

b. This finding was confirmed with Staff #5, Staff #31, and Staff #33.


E. Based on observation, facility document review and staff interviews conducted on 8/24/15 and 8/25/15, it was determined that the facility failed to ensure that manufacturers' instructions are followed.

Findings include:

Reference #1: CDC [Centers for Disease Control and Prevention] Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 page 84 states, "Disinfect noncritical medical devices (e.g., blood pressure cuff) with an EPA-registered hospital disinfectant using the label's safety precautions and use directions. ... By law, all applicable label instructions on EPA-registered products must be followed. If the user selects exposure conditions that differ from those on the EPA-registered product label, the user assumes liability from any injuries resulting from the off-label use and is potentially subject to enforcement action under FIFRA [Federal Insecticide, Fungicide, and Rodenticide Act]."

Reference #2: Facility policy titled Infection Control-Chamber Disinfection states, "... 5.5 In the event of contamination within the chamber ... The chamber should then be disinfected using an approved cleaning agent."

Reference #3: Perry Baromedical manufacturer's Instructions for Use (IFU) for the Perry Sigma 36 Hyperbaric Chamber states, "... Commercial Products approved for cleaning and disinfecting are:
Tor HB
Coverage HB
Hibitane
Ascend
Asepti HB
Do not use any cleaners or disinfectants containing alcohol. They initiate crazing of the acrylic cylinder."

1. During an interview with Staff #6 on 8/24/15 at 12:05 PM, he/she stated that the facility follows CDC, AAMI, AORN, NJ-DOH and OSHA guidelines.

2. During a tour of the Hyperbaric Unit on 8/24/15 at 11:05 AM, the unit was observed to have two Perry Sigma 36 Hyperbaric Chambers.

a. Staff #13 stated that he/she uses Clorox hydrogen peroxide wipes to clean the Perry Sigma 36 Hyperbaric Chambers.

b. The facility failed to ensure that its hyperbaric chambers are cleaned with approved cleaning and disinfecting agents, in accordance with the manufacturer's cleaning instructions.

3. Staff #13 was asked to demonstrate how he/she cleans with the wipes.

a. Staff #13 stated, "I wipe with hydrogen peroxide and then wipe it off before it dries."

b. The manufacturer's label instructions for the Clorox Hydrogen Peroxide wipes states, "Bacteria [listed] ... : 30 second contact time ... Bacteria [listed]... : 1 minute contact time ... Viruses: 1 minute contact time"

i. Staff #13 stated he/she does not know what contact time is.

ii. Staff #13 was observed to demonstrate that he/she wipes the disinfectant off immediately after application with a dry towel.

c. The facility failed to ensure that the manufacturer's instructions for use (IFUs) for the Clorox Hydrogen Peroxide Wipes are followed.

Reference #4: AAMI Sterilization in Health Care Facilities, 2014 edition, section 7.2.2 states, "Manufacturers' written IFU [Instructions for Use]: The written instructions of the device manufacturer should always be followed. ... The device labeling should identify specific methods of cleaning and sterilization that have been validated by the manufacturer."

Reference #5: General Electric Healthcare pulse oximeter sensor IFU states, "... Cleaning 1. Clean the lenses and the sensor before and after each patient use with 60% isopropyl or 90% ethyl alcohol."

1. During a tour of O.R. #2 at 11:20 AM, in the presence of Staff #5, Staff #6 and Staff #31, Staff #44 was asked how he/she cleans the General Electric Healthcare pulse oximeter sensors.

a. Staff #44 stated that he/she uses Clorox hydrogen peroxide wipes to clean the pulse oximeter sensors.

2. The facility failed to ensure that the manufacturer's IFU for the pulse oximeter sensors are followed.

3. This finding was confirmed with Staff #5, Staff #6 and Staff #31.

Reference #6: Riley Medical FlashPak manufacturer's IFU states, "... 6. The residual water condensate should be removed before using the container again. Dry the container by blotting with a soft absorbent cloth or towel."

1. On 8/25/15 at 11:56 AM, in the presence of Staff #5, Staff #6, and Staff #31 in Substerile Area A of the Operating Room, a Riley FlashPak was observed to be stored on a storage rack.

2. The FlashPak was observed to be moist with condensate and stored with the lid secured, preventing the condensate from air drying.

3. Staff #31 stated that the FlashPak is "cleaned every week."

4. The facility failed to ensure that the FlashPaks are cleaned prior to use, in accordance with its manufacturer's IFU.






F. Based on observation and staff interview it was determined that the facility failed to ensure that a sanitary environment to prevent and control infectious and communicable diseases is provided.

Findings include:

1. On 8/25/15 at 10:50 AM, in the presence of Staff #5 and Staff #6 in O.R. #2 (Cystoscopy Room), the following was observed:

a. The floor near the storage cabinet was soiled with brownish stains.

b. The floor around the O.R. table was soiled with brownish residues.

c. The floor under the O.R. table was soiled with brownish stains.

d. Staff # 31 stated that the room had been terminally cleaned.

e. These findings were confirmed with Staff # 5 and Staff #6.

2. On 8/25/15 at 2:55 PM, during a tour of the Clean Linen Room, in the presence of Staff #6 and Staff #36, the following was observed:

a. The door to the Clean Linen Room was propped open.

i. Staff #36 stated at 3:00 PM, "The door shouldn't be open."

b. A wooden ladder was stored leaning directly on a stack of clean patient gowns.

c. The floor beneath the linen cart was soiled with brownish-gray residues.

d. The floors were soiled with dirt and dust.

e. Staff #36 stated that the room had been cleaned "this morning".

3. During an observation in OR #2 on 8/25/15, the following was observed:

a. Staff #44 lifted an armrest from the floor and placed it under Patient #7's left arm.

b. An open purse was on the floor next to the anesthesia cart.

c. These findings were confirmed with Staff #5 and Staff #31.

4. During an observation on 2 South on 8/26/15, the following was observed:

a. Staff #39 listened to Patient #8's lungs using a stethoscope.

i. Staff #39 did not clean the stethoscope after use.

b. Staff #39 checked Patient #8's oxygen level with a pulse oximeter.

i. Staff #39 did not clean the pulse oximeter after use.

c. These findings were confirmed with Staff #6.