HospitalInspections.org

Based on observation and staff interview, it was determined that the facility failed to ensure that the patient's privacy is considered during their hospital stay.

Findings include:

1. On 5/14/19 at 10:15 AM, a tour of the Intensive Care Unit (ICU) was conducted in the presence of Staff #22. The unit has two central electronic telemetry monitors which contain patient information.

a. The telemetry monitors were hanging on the wall in the hallway across from both sides of the nurse's station. Six (6) out of 6 ICU patient's first and last names were identified next to their room numbers on the central telemetry monitor screens.

(i) The telemetry monitors in the ICU were readily visible to the visitors from the hallway between the patients' rooms and the nurse's station.

2. The above findings were confirmed by Staff #22 and Staff #24.

A. Based on medical record review and staff interview, it was determined that the facility failed ensure that the patient's plan of care, developed by the registered nurse, includes interventions, goals, and expected outcomes related to hemodialysis for one (1) out of one (1) hemodialysis patient (Medical Record #8).

Findings include:

1. Medical Record #8 contained documented evidence that the patient was a chronic hemodialysis patient.

2. Patient #8's care plan, dated 5/7/19, did not include evidence that the registered nurse developed interventions, goals, and expected outcomes that were related to hemodialysis.

3. On 5/14/19 at 12:15 PM, an interview with Staff #21, the hemodialysis nurse, stated that he/she does not develop a plan of care related to hemodialysis for patients. Staff #21 stated that the only plan of care that is developed for a patient, is the one that the floor nurse completes and he/she was not sure if it includes goals and expected outcomes for hemodialysis.

4. An interview with Staff #1 on 5/14/19 at 12:15 PM, confirmed that the care plan should reflect goals and expected outcomes related to hemodialysis.

B. Based on medical record review and staff interview, it was determined that the facility failed to ensure that staff adhere to the physician ordered plan of care.

Findings include:

Reference: "The Nursing Practice Act for the State of New Jersey" states: "The practice of nursing as a registered professional nurse (RN) is defined as diagnosing and treating human responses to actual or potential physical and emotional health problems, through such services as case finding, health teaching, health counseling, and provision of care supportive to or restorative of life and wellbeing, and executing medical regimens as prescribed by a licensed or otherwise legally authorized physician or dentist."

1. A review of Medical Record #8 revealed the following:

a. A physician's order, dated 5/7/19, for Patient #8's hemodialysis treatment states, "... BFR [blood flow rate] As tolerated to a maximum 300 ml/min ..."

(i) The hemodialysis treatment record, dated 5/7/19, revealed that the BFR was set at 350 ml/min (milliliter per minute) from 2:30 PM until 4:30 PM. This was not in accordance with the physician's order.

2. During interview on 5/15/19 at 2:10 PM, Staff #1 confirmed the above findings and stated that the medical record did not have evidence of why the BFR was increased.

a. Staff #1 confirmed that Medical Record #8 did not have a physician's order for the BFR to be increased to 350 ml/min.

b. Staff #1 stated that the registered nurse should have followed the physician's order or obtained a physician's order before increasing the BFR.

A. Based on observation and staff interview, it was determined that the facility failed to ensure the development of policies and procedures that irrigation solutions are stored in accordance with manufacturer's recommendations.

Findings include:

1. During an observation on 5/15/19 at 2:00 PM, three (3) unopened 500 ml (milliliter) bottles of 0.9% Sodium Chloride for Irrigation, dated "5/28" were found in the warming cabinet in the substerile room of the surgical suite.

a. Upon request, Staff #74 was not able to provide evidence of the manufacturer's recommendation for storing the irrigation solutions above the room temperature.

2. Upon interview, Staff #74 stated that the facility did not have a policy addressing the irrigation solutions stored in warming cabinet.

3. The above was confirmed by Staff #1 and Staff #6.

B. Based on observation, staff interview, and document review, it was determined that the facility failed to ensure the development and implementation of policies and procedures addressing medications brought into the hospital by patients.

Findings include:

Reference: Facility policy titled "Medications Brought into the Hospital by Patients and/or Physicians" states, " ... III. Procedure: ... The medication will be returned to the patient upon discharge from the hospital unless the physician responsible for the patient deems it necessary to not return the medications and follows the process listed below. If a Patient has to use a Home Medication while in hospital, receipt of medication and daily dispenses will be recorded on Med form Home Daily Dispense Log. A log will be completed for each medication and will be stored in the bag with the medication. ..."

1. On 5/15/19 at 11:33 AM, in the main pharmacy department, the following was identified:

a. Two (2) Alprazolam 0.25 mg (milligram) tablets, contained in a clear zip lock bag labeled, "Patient Supplied Medication, [name of Patient #37], Alprazolam 0.25 mg, date 3/31" were found in the narcotic cabinet.

(i) Review of the corresponding documentation provided by Staff #74, titled, "Medication From Home" indicated that on 4/2/19, Patient #37 was discharged.

b. Nine (9) Belsomra 20 mg tablets, contained in a clear zip lock bag labeled, "Patient Supplied Medication, [name of Patient #38], Belsomra 20 mg, date 1/6" were found in the narcotic cabinet.

(i) Review of the corresponding documentation provided by Staff #74, titled, "Medication From Home" indicated that on 1/7/19, Patient #38 was discharged.

c. One (1) Suboxone 2.0 mg/0.5 mg film, contained in a clear zip lock bag labeled, "Patient Supplied Medication, [name of Patient #39], Suboxone 2.0 mg/0.5 mg film" was found in the narcotic cabinet.

(i) Review of the corresponding documentation provided by Staff #74, titled, "Medication From Home" indicated on 1/8/19, Suboxone 2 mg /0.5 mg film was returned to Patient #39. However, on 1/21/19, it was documented on "Medication From Home log" that one (1) Suboxone 2.0/0.5 mg film was found in the nursing station, not returned to patient.

2. Upon interview, Staff #74 confirmed that when patients are discharged, medications brought into the hospital should be returned. If the patients fails to pick up their own medications brought into the hospital, the medications should then be destroyed.

a. The policy referenced above does not address procedures for the destruction of medication not returned to patients upon discharge.

3. Staff #74 confirmed the above findings.

Based on document review and staff interview conducted on 5/14/19, it was determined that the facility failed to ensure implementation of policies and procedures addressing the accountability of controlled dangerous substances (CDS).

Findings include:

Reference: Facility policy titled, "Automated Dispensing Cabinets-Wasting Medications" states, "... III. Procedure for wasting a Controlled Substance: All or part of a controlled medication may be wasted. Controlled medications are for one time use; partial doses may not be saved to administer at a later point in time. The exception to this rule is if the medication is being given in rapid succession. Areas approved for rapid succession administration are Anesthesia, PACU, and the Emergency department. Wasting of the medication must take place before administration. Medication used for rapid succession dosing may be wasted after administration. These medications must be wasted within 10 minutes of the last dose. ..."

1. The removal of one (1) Hydromorphone (Dilaudid) 2 mg (milligram)/1 ml (milliliter) vial, a Schedule II Controlled Dangerous Substance (CDS), was recorded on AcuDose report, on 3/4/19, for Patient #36. The administration of "Hydromorphone 0.4 ml," on 3/4/19 at 5:32 PM and 5:37 PM, was recorded on the medication administration summary in Medical Record #36. There was no evidence of wastage of the remaining 0.2 ml of Hydromorphone.

2. Review of AcuDose report for Fentanyl 100 mcg (microgram) / 2 ml in the Intensive Care Unit (ICU), a Schedule II CDS, for Patient #10 revealed that the wastage of the medication did not take place before the administration for the following occurrences:

a. On 5/11/19 at 2:11 PM, one (1) vial of Fentanyl 100 mcg/2 ml was removed. At 2:13 PM, 50 mcg was administered and at 2:14 PM, the remaining 50 mcg was wasted.

b. On 5/13/19 at 9:36 AM, one (1) vial of Fentanyl 100 mcg/ 2 ml was removed. At 9:42 AM, 50 mcg was administered and at 9:44 AM, the remaining 50 mcg was wasted.

c. On 5/13/19 at 11:25 PM, one (1) vial of Fentanyl 100 mcg/ 2 ml was removed. At 11:26 PM, 50 mcg was administered and at 11:39 PM, the remaining 50 mcg was wasted.

2. Upon interview, Staff #74 stated that the wastage of Fentanyl for Patient #10 should have been done prior to administration.

3. The above findings were confirmed by Staff #74.

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

Findings include:

Reference: United States Pharmacopoeia Chapter 797 (USP 797) states, "Opened or needle-punctured single-dose containers, such as bags, bottles, syringes, and vials of sterile products and CSPs [compounded sterile products] shall be used within 1 hour if opened in worse than ISO [International Organization for Standardization] Class 5 air quality and any remaining contents must be discarded."

1. During an observation at 2:03 PM on 5/15/19, the following pre-drawn syringes and one (1) opened single-dose bag, containing medication, were found past the beyond-use time of 1 hour from the time of preparation in the anesthesia cart in Operating Room (OR) #3:

a. One (1) 2 ml (milliliter) pre-drawn syringe, containing a clear liquid, labeled "Midazolam 2 mg (milligram) / 2 ml ...Use By: 5/16/19 ...Time: 12:43 PM and [initials of preparer]."

b. One (1) pre-drawn syringe, containing a clear liquid, labeled "Fentanyl ...Use By: 5/16/19... 12:42 PM and [initials of preparer]."

c. One (1) 5 ml pre-drawn syringe, containing a clear liquid, labeled "Lidocaine 1 % Use By: 5/16/19... 12:43 PM and [initials of preparer]."

d. One (1) pre-drawn syringe, containing a clear liquid, labeled "Propofol ...Use By: 5/15/19 ... 6:43 PM and [initials of preparer]."

e. One (1) pre-drawn syringe, containing a clear liquid, labeled "Glycopyrrolate ...Use By: 5/16/19 ... 7:06 AM and [initials of preparer]."

f. One (1) pre-drawn syringe, containing a clear liquid, labeled "Phenylephrine ...Use By: 5/16/19 ... 8:59 AM and [initials of preparer]."

g. One (1) pre-drawn syringe, containing a clear liquid, labeled "Ephedrine 5 mg/ ml Use By: 5/15/19 ... 6:39 AM and [initials of preparer]."

h. One (1) pre-drawn syringe, containing a clear liquid, labeled "Phenylephrine... Use By: 5/15/19 ... 6:39 AM and [initials of preparer]."

i. One (1) pre-spiked Sodium Chloride 0.9% solution, 100 ml IV (intravenous) bag labeled "Phenylephrine ... Use By: 5/16/19 ... 7:06 AM and [initials of preparer]."

j. One (1) pre-drawn syringe, containing a clear liquid, labeled "Phenylephrine ...Use By: 5/16/19 ...10:49 AM and [initials of preparer]."

(i) Upon interview, Staff #76 stated that the practice of beyond use time is 24 hours from time of preparation.

(ii) Upon request, Staff #74 was not able to provide policies and procedures addressing the beyond use time specific to the operating room.

2. During an observation on 5/14/19 at 2:50 PM, two (2) pre-spiked Sodium Chloride 0.9% solution, 100 ml bags were found hanging in the infusion room.

a. Upon interview, Staff #77 stated that the practice of the facility is to pre-spike the single dose bags of Sodium Chloride 0.9 % solution in the morning, use them throughout the day, and then discard at the end of the day.

3. The above findings were confirmed by Staff #74.

Based on observation, document review, review of the the New Jersey State Sanitary Code, Sanitation in Retail Food Establishments and Food and Beverage Vending Machines (N.J.A.C. 8:24), and staff interviews, conducted on 5/13/19 and 5/14/19, it was determined that the facility failed to ensure that the Food Service Director conducts daily management of the Food Services Department.

Findings include:

Reference #1: Chapter 24, 8:24-4.6(c) states: "Non-contact surfaces of equipment shall be kept free of an accumulation of dust, dirt, food residue and other debris."

Reference #2: Chapter 24, 8:24-4.6(j) states: "Non-contact surfaces of equipment shall be cleaned at a frequency necessary to preclude accumulation of residues."

Reference #3: Chapter 24, 8:24-6.5(a) states: "The physical facilities shall be maintained in good repair."

Reference #4: Chapter 24, 8:24-6.5(b) states: "The physical facilities shall be cleaned as often as necessary to keep them clean."

Reference #5: Facility document titled, " Patient Tray Assessment" states, "...Standard of Food on Tray 20 minutes out..Soup 150 degrees Fahrenheit, Entree 135 degrees Fahrenheit, Starch 135 degrees Fahrenheit, Vegetable 135 degrees Fahrenheit, Hot Beverage 150 degrees Fahrenheit, Dessert 50 degrees Fahrenheit, Milk 45 degrees Fahrenheit..."

Reference #6: Facility policy and procedure titled, "SLK PP Anatomic Wash for raw Fruits and Vegetables" states, "...PROCEDURE 5. Test strips are used to determine the proper anatomic concentration. ..."

Reference #7: Facility policy and procedure titled, "SLK PP Dishwashing/Pot washing Policy" states, "...Procedure 5. For pot washing, a 3 compartment sink is utilized. Quaternary sanitizer solution is utilized at 200 parts per million minimum."

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

Reference #9: Facility policy and procedure titled, "SLK PP Labeling and dating of Food Items" states, "...III. Procedure 1. All food items must be covered when opened and stored either in its original container when acceptable or placed into an NSF approved container. ...3. Properly labeling of food items includes: Refrigerated foods, Frozen foods, Shelf stable products...3. Food items need to be monitored constantly for expiration dates and food quality...All food service employees are responsible to monitor food items for expiration dates and food quality...Shelf Stable Foods (Dry Storage)...3. Shelf stable non-refrigerated food items shall be discarded one (1) year from the opened date. (i.e. spices, pasta, sugar, rice, etc). ..."

1. On 5/13/19 at 11:05 AM, a tour of the kitchen was conducted in the presence of Staff #7 and Staff #8. The following observations were made:

a. Walk-in refrigerator #90 D and # 91 D were visibly covered with a gray-brown crusted substance. There was a grayish-black substance on the gaskets, preventing the refrigerator doors from having a tight seal.

b. Walk-in refrigerator #92 D had ceiling fans which were heavily covered with dust and debris. (Refer to References #1, #2, #3 and #4)

2. On 5/13/19 at 11:25 AM, a tour of the kitchen ware-washing area was conducted in the presence of Staff # 7, Staff #8, and Staff #12. The following observations were made:

a. Staff #10 was using an Oasis 146 sanitizing solution with 146 Multi Quat Sanitizer strips to check the sanitizer concentration. The sanitizer testing strips had expired 3/10/2019. (Refer to References #7 and #8)

(i) Staff #10 checked the sanitizing solution concentration before the water was at the fill line in the sink. The water was still running into the sink along with the sanitizing solution as Staff #10 checked the sanitizing concentration. (Refer to References #7 and #8)

b. There was a standing upright fan in use placed next to the clean pots and pan rack. The upright standing fan was heavily covered with dust and debris. The air from the fan was blowing towards the clean pot and pan rack. (Refer to References #1 and #2)

c. There was a hand washing sink next to the pot wash area, that contained brown stains and debris. (Refer to Reference #4)

d. Flour, pasta, and sugar containers failed to have a label indicating the date they were filled. (Refer to Reference #9)

3. On 5/13/19 at 12:30 PM, a tour of the kitchen dry storage area was conducted in the presence of Staff # 7, Staff #8, and Staff #12. The following observations were made:

a. Two (2) twelve (12) ounce bottles of malt vinegar, one expired on 12/31/2018 and the other, opened bottle, was expired on 12/21/2017. (Refer to Reference #9)

b. Ten (10) ready-to-hang, one (1) liter enteral feeding Vital 1.5 Calorie formula bottles, expired on 4/1/2019. (Refer to Reference #9)

c. Two (2) ready-to-hang, one (1) liter enteral feeding 2 Cal HN formula bottles, expired on 5/1/2019. (Refer to Reference #9)

d. Eighteen (18) 10.75 grams of Banatrol Plus packets, expired July, 2018.
(Refer to Reference #9)

e. The insulation around the ceiling pipes in the storage area was exposed. (Refer to Reference #3)

(i) Two (2) ceiling tiles had orange-brown discoloration. (Refer to Reference #3)

4. The vegetable wash station failed to have test strips used to determine the proper anatomic concentration. (Refer to Reference #6)

5. On 5/14/2019 at 12:15 AM, in the presence of Staff #9, a meal test tray was checked. The following was noted:

a. Five (5) out of eight (8) food items failed to be within acceptable food temperature range. (Refer to Reference #5)

(i) Vanilla pudding- 60 degrees Fahrenheit

(ii) Carrots - 138 degrees Fahrenheit

(iii) Chicken noodle Soup - 100 degrees Fahrenheit

(iv) Apple juice - 60 degrees Fahrenheit

(v) Fat free Milk - 50 degrees Fahrenheit

6. The above findings were confirmed by Staff #7, Staff #8, and Staff #12.

Based on observation and staff interview on 5/15/19, it was determined the facility failed to ensure that a safe and sanitary environment is maintained for patients, staff, and the general public.

Findings include:

1. During a tour of the on-campus Ambulatory Surgery Center conducted at 1:30 PM, in the presence of Staff #19, the seams on the surface of the monolithic flooring installed within Operating Room (OR) #2 and OR #3 were found open and parted which would preclude cleaning.

2. This finding was confirmed by Staff #19.

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

Findings include:

1. The facility failed to provide and maintain a sanitary environment to avoid sources and transmission of infections and communicable diseases, and failed to implement nationally recognized infection control guidelines. (Refer to Tag A 749)

A. Based on observation, staff interview, review of facility documents, and nationally recognized guidelines, it was determined that the facility failed to adhere to acceptable standards of practice for the reprocessing of all surgical instruments.

Findings include:

Reference: Association for the Advancement of Medical Instrumentation (ANSI/AAMI) ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities, section 7 Cleaning, disinfection (microbial processes) and other decontamination steps, ... 7.3 Manufacturer's written IFU [instructions for use]. The device manufacturer's current written IFU should be accessible, reviewed and followed. If there is no specific written IFU in the labeling, then the manufacturer should be contacted and requested to provide a documented method of cleaning. ... 7.4.1 General consideration for all devices and utensils - To help ensure effective decontamination of devices, sterile processing personnel should a) follow the device manufacturer's written IFU to ensure proper decontamination and disinfection of the device; ..."

1. Upon interview, Staff #12 and Staff #65 confirmed that AAMI guidelines were followed in the SPD (Sterile Processing Department).

2. On 5/14/19 at 11:25 AM, a tour of the of the SPD was conducted in the presence of Staff #12 and Staff #65. The following was observed:

a. In the Decontamination Room, Staff #66 was observed manually cleaning surgical instruments from a "W HDC Dental Tray A1." The count sheet for the tray was requested.

b. At 11:35 AM, a request was made to Staff #65, the SPD supervisor, for the manufacturer's instructions for use (IFU) for three (3) of the instruments from the count sheet.

(i) Universal Tofflemire Type RE - Jarit 838-210

(ii) Heidbrink Root Tip Pick #2 - Jarit 835-551

(iii) Gracey (Hufriedy) (SG11/12)

c. At 11:40 AM, two (2) out of the three (3) surgical instruments' IFUs (Heidbrink Root Tip Pick #2- Jarit 835-551 and Gracey (Hufriedy) (SG11/12), could not be obtained and therefore, were not available to review and/or refer to for accurate reprocessing.

d. At 11:45 AM, interview with Staff #65 confirmed the facility does not have written IFUs for all surgical instrumentation. The SPD uses the "One-Source" computerized program as their primary reference to obtain the manufacturer's IFUs for the surgical instruments.

e. At 1:00 PM, in the SPD, in the presence of Staff #12, a request was made to Staff #65, the SPD supervisor, for the manufacturer's IFUs for three (3) of the instruments from the "W RSC Athroscopy Set" surgical tray count sheet.

(i) Probe-Smith & Neph 7204869

(ii) #3 Safety Knife Handle - Bard-Parker 374030

(iii) Metzenbaum SCS 7 CVD - Jarit 100-262

f. One (1) out of three (3) surgical instruments' IFU's (#3 Safety Knife Handle - Bard-Parker 374030), could not be obtained and therefore, was not available to review and/or refer to for accurate reprocessing.

g. A total of three (3) out of six (6) surgical instrumentation IFU's requested were not received and/or available to verify that sterile reprocessing was performed in accordance with manufacturer's instructions.

3. The above findings were confirmed by Staff #12, Staff #65, Staff #67 and Staff #68.

On May 14, 2019 at 2:50 PM, Staff #1, Staff #6, Staff #5 and Staff #12, were notified that the above findings resulted in an Immediate Jeopardy (IJ). A copy of the completed IJ template was provided and a removal plan was requested. The removal plan was received and accepted on May 15, 2019. An onsite visit was conducted on May 24, 2019 to monitor compliance with the accepted IJ removal plan. The facility was found to be out of compliance and the IJ could not be removed. A second IJ template was provided and a removal plan was requested and accepted on May 24, 2019.

4. The following findings were noted on the May 24, 2019 visit:

a. Review of the sterilization log dated, 5/16/19, indicated that "seven (7) RSC GI Tubings and four (4) RSC RF Probes" were sterilized.

(i) Upon request, Staff #78 was not able to provide evidence of the corresponding IFUs.

b. Review of the sterilization logs dated, 5/17/19, indicated that "one (1) Dental Unidose gun and seven (7) RSC eye preps" were sterilized.

(i) Upon request, Staff #78 was not able to provide evidence of the corresponding IFUs.

c. In the presence of Staff #6, Staff #27, and Staff #78, Staff #79 provided a peel-pouched package containing a "RSC eye prep."

(i) Inside the peel-pouch, a surgical eye cup with a white colored gauze was found.

(ii) Upon interview, Staff #79 stated that the facility practice was to sterilize the surgical eye cup together with the Covidien gauze.

(iii) Review of the corresponding Covidien cotton products IFU states, " ...But because Covidien has no knowledge of the sterilization hardware or the cycle parameters used by customers, Covidien cannot comment on the effect of the customer cycle on the sterility ... ."

d. Review of the sterilization log dated, 5/16/19, indicated that one (1) cystoscopy tray was sterilized at the temperature of 270 degrees Fahrenheit with 5 minutes exposure time. The following was identified:

(i) In the cystoscopy tray, four (4) blue silicone nipples were sterilized with the temperature of 270 degrees Fahrenheit and exposure time of 5 minutes. The corresponding instructions for use states, " ...3. Sterilize in ...temperature: 273 degrees Fahrenheit and exposure time: 4 minutes."

(ii) In the cystoscopy tray, Karl Storz surgical instruments were sterilized with the exposure time of 5 minutes. The corresponding manufacturer's instructions for use states, " ...exposure time: 4 minutes."

(iii) Staff stated that the practice of the facility is to sterilize the all surgical instruments with the same temperature of 270 degrees Fahrenheit and same exposure time of 5 minutes, instead of the manufacturer's instructions for use of the devices and instruments.

5. The above findings were confirmed by Staff #6 and Staff #27.

On May 24, 2019 at 3:45 PM, Staff #6 was notified that the above finding resulted in an Immediate Jeopardy (IJ) and a copy of the completed IJ template was provided. The removal plan was received and accepted on May 24, 2019. On May 31, 2019, an onsite revisit was conducted and revealed that the removal plan for the IJ was implemented and the IJ was removed.

B. Based on observation, staff interview and review of Occupational Safety and Health Administration (OSHA) regulations, it was determined that the facility failed to ensure implementation of OSHA regulations in the transport of soiled items.

Findings include:

Reference: 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. ..."

1. On 5/15/19 at 1:15 PM, an observation of a room turnover, cleaning, and disinfection in Operating Room (OR) #3 was conducted and the following was revealed:

a. A table-top cart, covered with a blue surgical disposable drape, contained soiled instrumentation being transported to the Decontamination Room.

(i) A laproscopic clip, laproscopic bag and probes were being transported without being contained.

2. The above findings were confirmed by Staff #12 and Staff #72.

C. Based on staff interview, review of facility policies and procedures and nationally recognized guidelines, it was determined that the facility failed to ensure the referenced AAMI guidelines the facility adopted for their SPD policies and procedures for sterile processing, are the most current available.

Findings include:

1. On 5/14/19, Staff #12 and Staff #65 confirmed the sterile processing department (SPD) follows AAMI guidelines for decontamination and sterile processing of surgical instrumentation.

a. A request was made for the policies the facility follows for decontamination and sterilization/reprocessing of surgical instrumentation. Two (2) policies were received: "Sterilization General Policy" and "Decontamination." The following was identified:

(i) The facility policies titled, "Sterilization General Policy" and "Decontamination" were both revised in 8/2017 and reviewed in 1/2019.

(ii) The "References" utilized for the policies were documented as follows: ANSI/AAMI ST79: 2010 A1:2010 & A2:2011 & A3:2012 & A4:2013.

2. The Advancement of Medical Instrumentation (AAMI) guidelines most current edition ST79, is "ANSI/AAMI ST79: 2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities," therefore, both policies were not using the most current guidelines as references.

D. Based on observation, staff interviews, and review of facility documents, it was determined that the facility failed to ensure the overall hospital environment is maintained to control infections and communicable diseases of patients and personnel.

Findings include:

1. On 5/14/19 at 10:10 AM, and on 5/15/19 at 11:15 AM, in the presence of Staff #12, while touring the areas of the Sterile Processing Department (SPD), the floors in the hallways of the SPD and kitchen departments had a visible dark build-up of debris.

2. Staff #12 confirmed the above findings.

3. During a tour of the Emergency Department (ED) on 5/13/19 at 11:25 AM, the following was observed:

a. Triage Room #1:

(i) A sharps container was secured to the wall, the opening was obstructed with paper towels.

(ii) The floor was visibly dirty.

b. Triage Room #2:

(i) The paint was visibly chipped on the walls.

(ii) The floor was visibly dirty.

(iii) The cabinets were marked with tape and tape residue.

c. Utility Room:

(i) The paint was visibly chipped on the walls.

(ii) The floor was visibly dirty.

(ii) The cabinets' surface was visibly dirty.

d. Soiled Utility Room:

(i) The paint was visibly chipped on the walls.

(ii) The floor was visibly dirty.

(iii) The cabinets were marked with tape and tape residue.

e. Exam Rooms #9, #10 #12 and #15:

(i) The paint was visibly chipped on the walls.

(ii) The floor was visibly dirty.

(iii) A dental box contained dust and the contents were crushed and had expired sterile packages within the box.

f. Staff #29 confirmed the above findings.

4. During a tour of the 2 South Unit on 5/14/19 at 11:05 AM, the following was observed:

a. The Family Nourishment area:

(i) The floor was visibly dirty.

(ii) The cabinets were marked with residue.

b. The floor was visibly dirty in Room #221

c. The trash receptacle in Room #221 was overflowing.

d. The floor was visibly dirty in Room #217.

e. Staff #20 and Staff #32 confirmed the above findings.

5. During a tour of the 3 North Unit on 5/14/19 at 12:55 PM, the following was observed:

a. Twenty (20) out of twenty (20) Patient Room doors were marked with tape and/or tape residue.

b. Staff #20 and Staff #32 confirmed the above findings.

6. An onsite visit of the Washington Township Outpatient Facility was conducted on 5/15/19. The following was noted:

a. During a tour of the Ultrasound room conducted on 5/15/19 at 9:55 AM, there was a small table that had surface damage and exposed uncleanable wood-like base material.

b. During a tour of the Ultrasound room conducted on 5/15/19 at 9:55 AM, the wall behind the Ultrasound machine had damage and scratched areas making it an uncleanable surface.

c. During a tour of the Bone Density Scan room conducted on 5/15/19 at 10:00 AM, the wall with the chair and patient scale and the wall behind the exam bed had surface damage making it an uncleanable surface.

d. On 5/15/19, the above findings were confirmed by Staff #55 during the tour.



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E. Based on observation, document review, and staff interview, it was determined that the facility failed to ensure the development and implementation of policies and procedures addressing the use of multi-dose medication vials in an immediate patient care area.

Findings include:

Reference #1: Centers for Disease Control (CDC) website https://www.cdc.gov/injectionsafety/providers/provider_faqs_multivials.html, Questions about Multi-dose vials, states, "...2. Can multi-dose vials be used for more than one patient? How? Multi-dose vials should be dedicated to a single patient whenever possible. If multi-dose vials must be used for more than one patient, they should only be kept and accessed in a dedicated medication preparation area (e.g., nurses station), away from immediate patient treatment areas. This is to prevent inadvertent contamination of the vial through direct or indirect contact with potentially contaminated surfaces or equipment that could then lead to infections in subsequent patients. If a multi-dose vial enters an immediate patient treatment area, it should be dedicated for single-patient use only. 3. What are examples of the "immediate patient treatment area"? Examples of immediate patient treatment areas include operating and procedure rooms, anesthesia and procedure carts, and patient rooms or bays."

Reference #2: Facility policy titled, "Medication Management" states, "... III. Procedure: ... 2. Multidose vials must have expiration date written when opened. Date should be 28 days after vial was opened. Discard multidose vials after single use... ."

1. During an observation of a post-procedure room turnover in Operating Room (OR) #3 at 2:03 PM on 5/15/19, one (1) opened and needle-punctured multi-dose vial of Neostigme 10 mg (milligram)/ 10 ml (milliliter), was found in the anesthesia cart.

a. Upon interview, Staff #76 confirmed that the multi-dose vial of Neostigme was accessed for multiple patients in the OR and not in a clean medication preparation area. Staff #76 stated that she/he administered the multi-dose vial of Neostigme for two patients.

2. Facility policy (Reference #2) does not address multi-dose vials used in an immediate patient care area.

3. The above findings were confirmed by Staff #6, Staff #73, and Staff #76.

On May 15, 2019 at 3:45 PM, Staff #6 and Staff #73 were notified that the above findings resulted in an Immediate Jeopardy (IJ) and a copy of the completed IJ template was provided. A removal plan was received and accepted on May 17, 2019. On May 24, 2019, an onsite revisit was conducted and revealed that the removal plan for the IJ was implemented and the IJ was removed.

F. Based on observation, document review, and staff interviews, it was determined that the facility failed to ensure that medications are prepared in a sanitary environment in accordance with the Centers for Disease Control (CDC) guidelines.

Findings include:

Reference: Centers for Disease Control (CDC) website http://www.cdc.gov/injection safety/providers/provider_faqs_med-prep.html, Medication Preparation Questions, states, "Where should I draw up medications? Medications should be drawn up in a designated clean medication area that is not adjacent to areas where potentially contaminated items are placed. Examples of contaminated items that should not be placed in or near the medication preparation area include: used equipment such as syringes, needles, IV tubing, blood collection tubes, needle holders (e.g., Vacutainer® holder), or other soiled equipment or materials that have been used in a procedure. In general, any item that could have come in contact with blood or body fluids should not be in the medication preparation area."

1. During an observation in Operating Room (OR) #3 on 5/15/19 at 2:03 PM, the following pre-drawn syringes, containing medications, were found in the anesthesia cart:

a. One (1) 2 ml (milliliter) pre-drawn syringe, containing a clear liquid, labeled "Midazolam 2 mg (milligram) / 2 ml ...Use By: 5/16/19 ...Time: 12:43 PM and [initials of preparer]."

b. One (1) pre-drawn syringe, containing a clear liquid, labeled "Fentanyl ...Use By: 5/16/19... 12:42 PM and [initials of preparer]."

c. One (1) 5 ml pre-drawn syringe, containing a clear liquid, labeled "Lidocaine 1 % Use By: 5/16/19... 12:43 PM and [initials of preparer]."

d. One (1) pre-drawn syringe, containing a clear liquid, labeled "Phenylephrine ...Use By: 5/16/19 ... 8:59 AM and [initials of preparer]."

e. One (1) pre-drawn syringe, containing a clear liquid, labeled "Rocuronium ...Use By 5/16/19 ...12:43 and [initials of preparer.]"

2. Upon interview, Staff #76 stated that she/he had prepared the syringes at the end of the case, while a patient was present, in preparation for the next surgical cases.

3. The above finding was confirmed by Staff #6, Staff #73, and Staff #76.

On May 15, 2019 at 3:45 PM, Staff #6 and Staff #73 were notified that the above finding resulted in an Immediate Jeopardy (IJ) and a copy of the completed IJ template was provided. An IJ removal plan was received and accepted on May 17, 2019. On May 24, 2019, an onsite revisit was conducted and revealed that the removal plan for the IJ was implemented and the IJ removed.

G. Based on observation and staff interview, it was determined that the facility failed to ensure that single dose vials are discarded immediately after a single patient use.

Findings include:

1. During an observation in Operating Room (OR) #3 on 5/15/19 at 2:03 PM, one (1) opened and needle-punctured single dose vial of Furosemide 40 mg/4 ml, was found in the anesthesia cart.

a. Upon interview, Staff #76 stated that the opened single dose vial of medication had been stored in the anesthesia cart, prior to his/her working shift.

2. The above finding was confirmed with Staff #6, Staff #73, and Staff #76.

On May 15, 2019 at 3:45 PM, Staff #6 and Staff #73 were notified that the above finding resulted in an Immediate Jeopardy (IJ) and a copy of the completed IJ template was provided. An IJ removal plan was received and accepted on May 17, 2019. On May 24, 2019, an onsite revisit was conducted and revealed that the removal plan for the IJ was implemented and the IJ removed.


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H. Based on observation, staff interview, review of facility policy, and review of Center for Disease Control guidelines, it was determined that the facility failed to adhere to professionally acceptable standards of practice for hand hygiene.

Findings include:

Reference #1: Facility policy, "Standard Precautions", states, "... Hand Hygiene Wash hands with an [sic] hospital approved hand soap and water after touching blood, ... and contaminated items. Wash hands immediately after gloves are removed, ... Gloves Wear gloves ... when touching ... contaminated items and surfaces. ..."

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... I. Decontaminate hands after contact with inanimate objects...in the immediate vicinity of the patient. ... J. Decontaminate hands after removing gloves. ... 2. Hand Hygiene Technique... B. When washing hands with soap and water,... rub hands together vigorously for at least 15 seconds, covering all surfaces of the hands and fingers. ..."

1. On 5/14/19, Staff #21 was observed, in the presence of Staff #1, providing care to a patient receiving hemodialysis. The following was identified:

a. At 12:00 PM, Staff #21 was observed touching the contaminated hemodialysis machine with his/her bare hands while a patient was receiving hemodialysis. Staff #21 did not wear gloves when touching the contaminated hemodialysis machine.

b. At 12:03 PM, after touching the contaminated hemodialysis machine with his/her bare hands, Staff #21 scrubbed his/her hands with soap for four (4) seconds and then rinsed with water. This is not in accordance with CDC recommendations.

c. At 12:04 PM, while Patient #8 was dialyzing, Staff #21 touched the hemodialysis machine with his/her bare hands to turn off a machine alarm.

d. At 12:10 PM, Staff #21 touched the contaminated hemodialysis machine with his/her bare hands and then entered the clean glove box without the benefit of hand hygiene.

e. At 12:14 PM, Staff #21, while wearing gloves, disconnected the extracorporeal circuit from Patient #8's fistula needle. Staff #21 removed his/her gloves and without performing hand hygiene, entered the clean glove box and retrieved a new pair of gloves.

f. At 12:17 PM, Staff #21, while wearing gloves, removed the contaminated extracorporeal circuit from the hemodialysis machine and disposed of it in a red hazardous waste bag. Staff removed his/her gloves and without the benefit of hand hygiene, entered the clean glove box and retrieved a new pair of gloves.

g. At 12:28 PM, Staff #21, while wearing gloves, removed Patient #8's fistula needles from his/her right arteriovenous fistula (AVF). Staff #21 removed his/her gloves and without performing hand hygiene, entered the clean glove box and retrieved a new pair of gloves.

h. At 12:42 PM, after completing the cleaning and disinfection of Patient #8's hemodialysis machine, Staff #21 removed his/her gloves and without performing hand hygiene, entered the clean glove box and retrieved a pair of gloves.

i. At 12:43 PM, Staff #21, while wearing gloves, removed the fistula clamp from Patient #8's right upper AVF.

(i) While holding the contaminated fistula clamp, Staff #21 removed his/her gloves and held the contaminated fistula clamp in his/her bare hands and placed it on the hemodialysis machine. Staff #21 did not wear gloves while holding the contaminated fistula clamp and did not perform hand hygiene prior to entering a clean glove box.

2. On 5/15/19 at 1:35 PM, Staff #1 stated that staff should be wearing gloves whenever they touch equipment that is used during the hemodialysis treatment. Staff #1 confirmed the above findings and stated that he/she observed Staff #21 not performing hand hygiene after removing his/her gloves and that hand hygiene should be performed after the removal of gloves and after touching the hemodialysis machine.

I. Based on observation and review of accepted national guidelines, it was determined that the facility failed to adhere to professionally acceptable standards of practice for surgical attire.

Findings include:

Reference #1: AORN "Perioperative Standards and Recommended Practices; RP: Surgical Attire" states, "V1.a. The mask should cover the mouth and nose and be secured in a manner to prevent venting. ... VI.b. A fresh, clean surgical mask should be worn for every procedure. The mask should be discarded whenever it becomes wet or soiled. ... VI.b.1. Masks should not be worn hanging from the neck. The filter portion of a surgical mask harbors bacteria collected from the nasopharyngeal airway. The contaminated mask may cross-contaminate the surgical attire top. ... VI.c. Surgical masks should be discarded after each procedure. Masks should be removed carefully by handling only the mask ties. Hand hygiene should be performed after removal of masks. Removing masks by the ties prevents possible contamination of the hands. The filter portion of the mask harbors bacteria collected from the nasopharyngeal airway."

Reference #2: AORN FAQs https://www.aorn.org/clinicalfaqs/attire states, "Wearing surgical masks and face and eye protection is recommended by the Centers for Disease Control and Prevention (CDC) and is a regulatory requirement. ...
Surgical masks worn in the perioperative setting serve two purposes. First, they help protect the patient and environment from microbial contamination by organisms carried in the provider's mouth or nose. Second, they provide protection for the wearer from exposure to blood, body fluids, or other potentially infectious materials."

1. A tour of the Intensive Care Unit (ICU) was conducted on 5/14/19 and the following was observed:

a. At 1:56 PM, Staff #40 was observed wearing a surgical mask and entering ICU Room #9, to administer treatment to a contact isolation patient.

(i) Staff #40 donned (the practice of putting on) Personal Protective Equipment (PPE), however, never changed the surgical mask.

(ii) Upon completion of the treatment, Staff #40 doffed (the practice of taking off) the PPE, kept the surgical mask on and proceeded to enter ICU Room #11 to administer a treatment to the patient in that room.

b. At 2:15 PM, Staff #41 was observed exiting ICU Room #11 wearing a surgical mask, and then walked across the unit, around the bend, and then behind the nursing station to converse with other staff members.

(i) At 2:18 PM, Staff #41 re-entered ICU Room #11, wearing the same mask.

J. Based on observation, staff interview, and a review of facility policy, it was determined that the facility failed to adhere to the acceptable standards of practice for the cleaning and disinfection of contaminated surfaces, medical devices, and equipment after each patient use.

Findings include:

Reference #1: The CDC's publication, "Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients, MMWR, Vol. 50, No. RR-5, April 27, 2001", states, "... Infection Control Precautions for All Patients ... Any item taken to a patient's dialysis station could become contaminated with blood and other body fluids and serve as a vehicle of transmission to other patients either directly or by contamination of the hands of personnel. Therefore, items taken to a patient's dialysis station, ... should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being returned to a common clean area or used for other patients. Unused medications or supplies (e.g., syringes, alcohol swabs) taken to the patient's station should not be returned to a common clean area or used on other patients. ... Hemodialysis in Acute-Care Settings. ... when chronic hemodialysis patients receive maintenance hemodialysis while hospitalized, infection control precautions specifically designed for chronic hemodialysis units (see Recommended Practices at a Glance) should be applied to these patients. "

Reference #2: Facility policy, "Standard Precautions" states, "... Patient Care Equipment Handle used patient care equipment soiled with blood, body fluids, secretions, and excretions in a manner that prevents skin and mucous membrane exposures, contamination of clothing, and transfer of microorganisms to patients and environments. Ensure that reusable equipment is not used for the care of another patient until it has been cleaned and disinfected appropriately ..."

1. On 5/14/19 at 12:32 PM, Staff #21 cleaned and disinfected a blue clamp and then hung it on the intravenous (IV) pole attached to the hemodialysis machine, prior to the IV pole being cleaned and disinfected, therefore, contaminating the blue clamp.

a. Staff #21 stated that the clamp will stay with the hemodialysis machine and will be used on the next patient receiving hemodialysis.

b. At 12:45 PM, Staff #21 completed the cleaning and disinfection of the hemodialysis machine and the portable reverse osmosis (RO) machine, and stated that the machines were to be returned to storage until needed for another patient treatment.

c. Staff #21 did not clean the IV pole that was attached to the hemodialysis machine.

d. There were two (2) packaged blood pressure cuffs located on the basket of the hemodialysis machine and were present during the dialysis treatment. Staff #21 did not clean and disinfect or dispose of the blood pressure cuffs.

(i) At 12:55 PM, Staff #21 stated that the blood pressure cuffs are extras that stay with the machine in case they are needed to be used for other patients.

(ii) Staff #21 stated that the blood pressure cuff packages do not need to be cleaned and disinfected because they are wrapped in a plastic packaging. Staff #21 confirmed that the blood pressure packages were not cleaned and disinfected and could be used on another patient.

2. On 5/15/19 at 12:33 PM, Staff #21 pushed the contaminated hemodialysis machine and portable RO machine into the common hallway and returned to Patient #8's room.

a. At 12:35 PM, a hospital employee was observed walking between the contaminated hemodialysis machine and the RO machine in the hallway carrying a food tray to be delivered to a patient.

b. At 12:38 PM, Patient #8's family member was observed squeezing through the doorway between the hemodialysis machine and the door jam. Patient #8's family members clothing rubbed up against the contaminated hemodialysis machine while Staff #21 was cleaning and disinfecting the machine.

3. On 5/15/19 at 1:45 PM, an interview with Staff #1 indicated that the contaminated hemodialysis machine and the portable RO machine should be cleaned and disinfected prior to being placed in the common hallway.

4. On 5/15/19 at 1:50 PM, an interview with Staff #21 revealed that he/she usually cleans and disinfects the hemodialysis machine and the portable RO machine while it is in the patient's room and then pushes it into the hallway.


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K. Based on observation, document review, and staff interview, it was determined that the facility failed to ensure that the manufacturer's instructions for cleaning are followed by employees.

Findings include:

Reference: The PDI Sani-Cloth Germicidal Disposable wipes states, "Agent for Professional Disposables International, Inc. (PDI) ..... Open lid. Pull out wipe. Close lid tightly. Bucket [or pail or container.... When not in use keep center cap of lid closed to prevent moisture loss."


1. Staff #40 was observed in Room #9, administering a respiratory treatment to a patient on contact isolation.

a. Prior to starting the respiratory treatment, Staff #40 pulled a PDI Sani-Cloth Germicidal Disposable wipe out of the container and used it to wipe equipment. Staff #40 then placed the used wipe on the handle of the medication cart.

(i) Staff #40 stated the wipe was pulled out of the container so that he/she can use it to wipe down equipment after the treatment.

b. Staff #40 administered the respiratory treatment, when it was completed, he/she pulled the wipe off the medication cart handle and used it to disinfect equipment.

L. Based on observation, interviews, and medical record review, it was determined that the facility failed to ensure that infection control education is provided to patients and family.

Findings include:

Reference: CDC website page titled, "Frequently Asked Questions about Clostridium Difficile for Healthcare Providers" (https://www.cdc.gov/hai/organisms/cdiff/cdiff_faqs_hcp.html) states, "Prevent the Spread of C. diff. Information for Patients. If someone with C. diff (or caring for someone with C. diff) doesn't clean their hands with soap and water after using the bathroom, they can spread the germs to everything they touch. And if someone with C. diff can't take a shower with soap and water, they can end up with C. diff germs on their skin. Then, when someone else touches the skin of that person, or the surfaces that person touched, they can pick up the germs on their hands. C. diff germs are so small relative to our size that if you were the size of the state of California, a germ would be the size of a baseball home plate. There's no way you can see C. diff germs on your hands, but that doesn't mean they're not there. Washing with soap and water is the only way to prevent the spread from person to person."

1. During a tour of the 3 North Unit on 5/14/19 at 11:30 AM, the following was observed:

a. Patient #23, in Room #329, was on contact isolation.

(i) Staff #35 stated that Patient #23 was on contact isolation for Clostridium Difficile

b. Personal Protective Equipment (PPE) was hanging on an over the door organizer outside patient Room #329.

(i) On top of the clean PPE was a used PPE gown.

(ii) Interview with Patient #23's family member revealed that he/she had placed the used gown over the clean gowns so that it can be reused upon entry to the room.

c. When interviewing Patient #23's family member, he/she stated education on hand hygiene was given, and stated that he/she was instructed to use the hand sanitizer that was on the wall.

d. Review of the medical record of Patient#23, failed to show any documentation that the patient