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.

ST MARY'S GENERAL HOSPITAL 350 BOULEVARD PASSAIC, NJ 07055 March 27, 2018
VIOLATION: QAPI PERFORMANCE IMPROVEMENT PROJECTS Tag No: A0297
Based on review of facility documentation and staff interview, it was determined that the facility failed to document the reasons for conducting the current quality improvement projects.

Findings include:

1. On 3/27/18, Staff #2 was interviewed regarding performance improvement projects being conducted at the facility.

a. Staff #2 was unable to provide documented evidence of the reasons for conducting the current quality improvement projects.

2. The above finding was confirmed by Staff #1 and Staff #2.
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
Based on staff interview, medical record review, and review of facility documents, it was determined that the facility failed to ensure all medications administered by nursing personnel are administered in accordance with prescriber orders.

Findings include:

1. Medical Record #6 contained an order, dated 12/18/17, for "Hydromorphone 0.5 mg IV (Intravenous) every 10 minutes PRN (as needed) for severe pain (8-10). Stop after 4 doses."

a. The Medication Administration Record (MAR) indicated that Hydromorphone was administered at 6:30 PM, 6:45 PM, 7:05 PM and 8:20 PM.

b. Staff #25 stated that pain assessments were not documented prior to the administration of Hydromorphone.

2. Medical Record #6 contained an order, dated 12/18/17, for "Percocet (Oxycodone/acetaminophen) 5/325 mg PO (by mouth) every 6 hours as needed for moderate pain (4 to 7)."

a. The MAR indicated that one tablet was administered at 11:00 PM. The nursing notes indicated that the patient denied pain.

b. The MAR indicated that one tablet was administered on 12/19/17 at 5:10 AM. The nursing notes indicated that the patient denied pain.

3. Medical Record #7 contained an order, dated 12/19/17, for "Morphine 2 mg IV every 5 minutes, PRN for moderate pain (4-7). Stop after 4 doses."

a. The MAR indicated that Morphine was administered at 2:30 PM, 2:40 PM, 2:50 PM, and 3:00 PM.

b. Staff #25 stated that pain assessments were not documented prior to the administration of Morphine.

4. Medical Record #8 contained an order, dated 12/5/17, for "Hydromorphone 0.25 mg IV (intravenous) every 10 minutes PRN for severe pain (8-10). Stop after 4 doses."

a. The MAR indicated that Hydromorphone 0.25 mg was administered at at 10:33 PM for pain level of 6.

b. The MAR indicated that Hydromorphone 0.25 mg was administered at 10:45 PM for pain level of 6.

5. Medical Record #17 contained an order, dated 3/23/18 for "Morphine 2 mg every 10 minutes PRN for pain (8-10). Stop after 4 doses"

a. The MAR indicated that Morphine was administered at 11:40 AM for pain level of 7.

b. The MAR indicated that Morphine was administered at 11:55 AM for pain level of 4.

c. The MAR indicated that Morphine was administered at 12:10 PM for pain level of 7.

d. The MAR indicated that Morphine was administered at 12:25 PM for pain level of 4.

6. The above findings were confirmed with Staff #25.




7. Review of the Omnicell Report for Patient #1, revealed the following:

a. Staff #11 performed an override on 8/16/17 and removed the following medications from the Omnicell:

i. At 8:08 PM, Magnesium Sulfate 4gm (grams)/100ml (milliliters) IVPB (Intravenous Piggyback)

ii. At 8:09 PM, a Magnesium Sulfate 40gm/1000ml bag

8. Review of the MAR for Patient #1, revealed the following:

a. On 8/16/17, Staff #11 initialed the 20:00 column, indicating he/she administered Magnesium Sulfate 4 grams IVPB 100ml/hr (hour) infused over 60 minutes.

i. On 8/16/17, Staff #11 initialed the 21:00 column, indicating he/she took the Magnesium Sulfate IVPB bag down.

b. There was no documented evidence that Magnesium Sulfate 40gm/1000ml was administered.

9. On 3/22/18 at 10:30 AM, Staff #5 confirmed that Staff #11 entered an order for Magnesium Sulfate 40gm/1000ml in the computer on 8/18/17 at 1:30 AM, two (2) days after the initial administration on 8/16/17 at 8:45 PM.

10. On 3/22/18 at 10:30 AM, Staff #5 confirmed that Staff #11 entered an order for Magnesium Sulfate 4 grams IVPB 100ml/hr (hour) to be infused over 60 minutes.

11. Staff #11 administered Magnesium Sulfate to Patient #1 on 8/16/17 at 8:45 PM without a physician order.
VIOLATION: Condition of Participation: Pharmaceutical Se Tag No: A0489
Based on observation, staff interview, and document review conducted on March 22, 23, and 26, 2018, it was determined that the facility failed to ensure that pharmaceutical services are provided in a safe manner.

1. The facility failed to ensure development of policies and procedures addressing the labeling and beyond-use time of pre-drawn syringes in the operating room. (Cross Refer to Tag A-505).

2. The facility failed to ensure medications are administered according to physician's order (Cross Refer to Tag A-405).

3. The facility failed to ensure adequate accountability of Controlled Dangerous Substances (CDS) (Cross Refer to Tag A-494).
VIOLATION: PHARMACY DRUG RECORDS Tag No: A0494
Based on observation, document review, and staff interview conducted on March 22, 23, and March 26, 2018, it was determined that the facility failed to ensure adequate accountability procedures to ensure control of the distribution, use and disposition of all scheduled drugs as the facility's record system did not adequately track the movement of all scheduled drugs from the point of entry into the hospital to the point of departure in a readily retrievable manner, and thus, failed to minimize the risk for scheduled drug diversion.

Findings include:

Reference #1: Facility policy, Guidelines for the safe Use of Controlled Dangerous Substances (CDS), states, " ...C. Controlled Dangerous Substances (CDS) Non-Floor Stock ...For each non-floor stock CDS ordered for the patient, a supply will be issued by the pharmacy with a corresponding certificate of disposition for recording all doses administered on a diminishing inventory basis. ...7. Each sheet corresponds to a specific drug for a specific patient. 8. All non-floor stock CDS are to be accounted for at each change of shift as are all floor stock CDS."

1. During an observation in the Intensive Care Unit Medication Room, two (2) containers containing a clear liquid, labeled, "Hydromorphone Patient Controlled Analgesia (PCA), Patient name ...direction ...printed 2/25/18 and use by 3/25/18" were found in the narcotic cabinet.

a. Upon interview, Staff #9 stated that medications in the narcotic cabinet were "non floor stock medications" prepared by the pharmacy. Staff #9 stated that this patient's medications should not currently be in the narcotic cabinet.

b. The containers did not have a corresponding certificate.

c. Review of the "Patient Care Area Inspection Report" completed by the pharmacy staff for ICU medication room, dated 3/20/18, indicated that "all controlled substances distribution records are accessible and accounted for and all controlled drugs that are stocked are currently used and there were no discontinued patient medications."

i. Upon interview, Staff #12 stated that Hydromorphone PCA had been discontinued and it should have been taken out of the narcotic cabinet during the pharmacy staff unit inspection.

ii. Upon request, Staff #12 was unable to provide evidence of the "non floor stock medications" being accounted for at each change of shift.

Reference #2: Facility policy, Guidelines for the safe Use of Controlled Dangerous Substances (CDS), states, " ...D. CDS Record Keeping Requirements for Nursing Units/Waste 1. For Controlled drugs in ADC: Witness is required to waste and return CDS to ADC. Narcotic waste must be documented on the ADC with witness. ...Pharmacy is monitoring narcotic waste once a week. Any discrepancy in amount ordered, amount removed, and amount wasted will be addressed to Nurse Manager of each unit."

1. Review of the Omnicell Narcotic Transaction Report for medication, Morphine 4 mg/1 ml, in the Emergency Department revealed the following:

a. On 12/9/17 at 10:31 AM, one (1) vial of Morphine was removed from the Omnicell (an automated dispensing machine) for Patient #11.

i. At 4:27 PM, the report indicated that there was a transaction attributed to Patient #11, a discharged patient. Morphine 2 mg was wasted.

b. On 12/19/17 at 2:27 AM, one (1) vial of Morphine was removed from the Omnicell for Patient #12.

i. At 6:36 AM, the report indicated that there was a transaction attributed to a discharged patient, Patient #12. Morphine 2 mg was wasted.

c. On 12/24/17 at 12:27 PM, the report indicated that there was a transaction attributed to Patient #13, a discharged patient.

i. At 12:27 PM, one (1) vial of Morphine 4 mg/1 ml was removed from the Omnicell for Patient #13 Morphine 2 mg was wasted at 12:27 PM.

d. Upon interview, Staff #12 did not have policies and procedures addressing CDS transactions attributed to discharged patients. Staff #12 confirmed that there should not be CDS taken out for patients who are discharged .

e. On 12/13/17 at 2:07 PM, one (1) vial of Morphine was removed from the Omnicell for Patient #14.

i. Morphine 2 mg was wasted at 6:20 PM. There was a variance of 4 hours and 13 minutes from the time the medication was removed, from the Omnicell, until the time the medication was wasted.

f. On 12/5/17 at 10:13 AM, one vial of Morphine was removed for Patient #15.

i. Morphine 2 mg was wasted at 2:05 PM. There was a variance of 3 hours and 52 minutes from the time the medication was removed, from the Omnicell, until the time the medication was wasted.

g. On 12/1/17 at 1:15 AM, one (1) vial of Morphine was removed from the Omnicell for Patient #16.

i. Morphine 2 mg was wasted at 6:25 AM. There was a variance of 5 hours and 10 minutes from the time the medication was removed, from the Omnicell, until the time the medication was wasted.

ii. Morphine 2 mg was wasted at 6:26 AM. There was a variance of 5 hours and 11 minutes from the time the medication was removed, from the Omnicell, until the time the medication was wasted.

2. Review of the Omnicell Narcotic Transaction Report for the medication, Midazolam 2 mg/2 ml in the Cardiac Catheterization Unit revealed the following:

a. On 1/25/18 at 11:22 AM, one vial of Midazolam was removed from the Omnicell for Patient #18.

i. On 1/26/18 at 10:41 AM, the report indicated that there was a transaction attributed to Patient #18, a discharged patient. Midazolam 1.5 mg was wasted.

3. Review of the Omnicell Narcotic Transaction Report for the medication, Fentanyl 100 mcg (microgram)/2 ml in the Cardiac Catheterization Unit revealed the following:

a. On 1/25/18 at 11:22 AM, one vial of Fentanyl was removed from the Omnicell for Patient #18.

i. On 1/26/18 at 10:41 AM, the report indicated that there was a transaction attributed to Patient #18, a discharged patient. Fentanyl 87.5 mg was wasted.

4. Review of the Narcotic Transaction Record for Patient #7 revealed the following discrepancies when compared with the medical record:

a. On 12/19/17, two (2) vials of Fentanyl 250 mcg/5 ml were removed from the Omnicell.

i. One (1) vial of Fentanyl 250 mcg was returned to the Omnicell.

b. Fentanyl 300 mcg was administered to Patient #7.

i. Fentanyl 200 mcg should have been wasted.

ii. Fentanyl 250 mcg should not have been returned to the Omnicell.

iii. The records do not reconcile.

Reference #3: Facility policy, The Use of Automated Dispensing Cabinet (ADC), states, "6. Discrepancies: ...C. ...If the discrepancy is unresolved then an incident report should be made out and signed by the Charge Nurse, and Pharmacy should be notified ASAP. Also, if a discrepancy stays unresolved for more than 24 hours, then pharmacy will alert the nurse manager for follow up. Daily CDS discrepancies report will be printed via designated printer in the Pharmacy daily to review. Nurse Managers will be notified."

1. Review of the Omnicell Transaction report for Patient #1, on Unit 4 West, revealed the following:

a. On 8/16/17 at 10:16 PM, one (1) vial of Morphine 4 mg/1 ml was removed from the Omnicell.

i. A discrepancy was noted for this transaction.

ii. On 8/20/17 at 6:08 AM, a discrepancy resolution was recorded.

iii. This discrepancy was unresolved for more than 24 hours.

b. Upon interview, Staff #12 was not aware of this discrepancy.

i. The pharmacy was not notified of the discrepancy.

2. The above findings were confirmed with Staff #12 and Staff #13.
VIOLATION: DELIVERY OF DRUGS Tag No: A0500
Based on staff interview, medical record review, and review of facility policies and procedures, it was determined that the facility failed to ensure the effects of high-alert medications on patients are monitored to ensure that medication therapy is appropriate and to minimize the occurrence of toxicity and adverse events.

Findings include:

Reference #1: Facility policy, High Alert Medications, states, "...Purpose: To provide the highest quality pharmaceutical care with the minimum number of medications errors and the lowest patient risk. Medications that the Pharmacy and Therapeutics Committee (P&T) has deemed to be high-alert include the following categories: ...Concentrated electrolyte solutions...iii Magnesium Sulfate..."

Reference#2: Facility policy, Magnesium Sulfate Administration, states, " ...Procedure: ...6. Obtain Baseline readings of the following: ...b) Deep Tendon Reflexes (DTR's) c) Respiratory assessment ... 8. Administer loading dose as ordered by the physician via a secondary piggybacked line and record on the flow sheet. ...12. Complete Magnesium flow sheet to document:
- Breath sounds every 2 hours
- Temperature as per protocol
- Level of consciousness every hour
- Blood Pressure, pulse and respirations every hour ...
- Strict intake and output every hour
- Fetal heart rate (FHR) and contractions every hour if preterm ...
Physician Will Be Notified If A Woman Experiences Any Of The Following Symptoms [sic]: ...
- Double (or blurring of) vision ...
- Respiratory rate < [less than] 14 or > [greater than] 24 ...
- Changes in breath sounds suggestive of pulmonary edema
- Changes in level of consciousness or neurological status
- Absent DTR's
- Urinary output <30 cc/h X [times] 2 consecutive hours ...
Nurse /Patient Ratio When caring for a patient on Magnesium Sulfate: ...Provide 1:1 nursing care during active labor while receiving magnesium Sulfate. ...Magnesium Sulfate As A High-Risk Medication ...Have second nurse check the initial magnesium sulfate IV (Intravenous) bag and pump settings and every magnesium sulfate IV bag that is added and each subsequent rate change. Document in nurse's notes. Documentation: The RN (Registered Nurse) will document in the Magnesium Sulfate Flow Sheet and the Labor & Delivery nurses' motes [sic] if relevant."

1. Review of Medical Record #1 revealed there was no evidence that Staff #11 completed the following:

a. Baseline DTR's and a Respiratory Assessment prior to starting Magnesium Sulfate

b. Documentation of the Magnesium Sulfate Infusion on the "Fluid Administration Record"

c. Documentation of the following elements on the Magnesium Sulfate Flow Sheet:

i. Breath sounds every 2 hours

ii. Temperature as per protocol

iii. Level of consciousness every hour

iv. Strict intake and output every hour

d. Documentation and notification of the physician that Patient #1 was being monitored for the following symptoms:

i. Respiratory Rate less than 14 or greater than 24

ii. Changes in breath sounds suggestive of pulmonary edema

iii. Changes in level of consciousness or neurological status

iv. Absent DTR's

v. Urinary output less than 30cc/hr x two (2) consecutive hours

e. Documentation of the two (2) nurse verification required for the initial Magnesium Sulfate IV bag, pump settings, and any additional Magnesium Sulfate IV bags administered.

2. Staff #5 confirmed that Staff #11 did not document the care of Patient #1 as it was provided.

3. The facility document, Labor and Delivery Report Sheet, indicates that Patient #1 was assigned 1:1 (one-to-one) nursing care.

a. On 3/26/18 at 13:39 PM Staff #5 confirmed the following:

i. Patient #1 was assigned 1:1 nursing care.

ii. If a patient receiving a Magnesium Sulfate Infusion is on 1:1 nursing care, the nurse must remain in the room with the patient.

iii. On 8/16/17, Staff #11 was assigned as the charge nurse for the Labor and Delivery Unit, while also assigned 1:1 nursing care of Patient #1.

iv. Staff #11 was not in Patient #1's room at the time he/she became unresponsive. Patient #1's mother went to the nurses' station to notify staff that Patient #1 was unresponsive.

4. On 3/23/18, review of Patient #1's Magnesium Level collected 8/17/17 at 2:45 AM, was 17.5 mg/dL (milligrams per Deciliter) with a normal range between 1.7-2.5 mg/dL.

5. The above findings were confirmed with Staff #5.
VIOLATION: STAFFING AND DELIVERY OF CARE Tag No: A0392
Based on review of the facility staffing plan, review of facility documents, and staff interview, it was determined that the facility failed to ensure patient acuity levels are used to determine staffing.

Findings include:

Reference: Facility policy, Utilization of Staff and Staffing, states, "... Actual staffing compliment may need to be adjusted upward to meet patient care needs relative to census, acuity, and staff availability ... Actual staffing complement may need to be adjusted downward relative to census and acuity ..."

1. Review of Staffing for the week of 3/18/18 through 3/24/18 on Unit 6E revealed the following:

a. Patient acuity is not documented.

b. This finding was confirmed with Staff #16.

2. Review of Staffing for the week of 3/18/18 through 3/24/18 on Unit 5E and Unit 5W revealed the following:

a. Patient acuity is not documented.

b. These findings were confirmed with Staff #22.
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
Based on staff interview, medical record review, and review of facility policy and procedure, it was determined that the facility failed to ensure that a Registered Nurse (RN) evaluates a patient upon admission.

Findings include:

Reference: Facility policy, Admission and Care of Patient in Labor and Delivery, states, "...Supportive Data: ...2. An admission assessment will be completed by an RN within one (1) hour of admission."

1. Patient #1's electronic flowsheet, Rpt (Report) Standard Info, states, "admitted and Time OB (Obstetrics)" - 8/16/17 at 17:50.

a. There was no documented evidence in Medical Record #1 that an RN performed an initial assessment of the patient upon her admission to Labor and Delivery on 8/16/17 at 17:50.

a. This finding was confirmed with Staff #2 and Staff #5.
VIOLATION: UNUSABLE DRUGS NOT USED Tag No: A0505
Based on observation, staff interview, and document review conducted on March 23, 2018, it was determined that the facility failed to ensure the development of policies and procedures addressing the labeling and beyond-use time of pre-drawn syringes in the operating room, and outdated or otherwise unusable drugs, 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 2:20 PM, the following pre-drawn syringes, containing medication, were found in the anesthesia cart in Operating Room (OR) #7:

a. One (1) pre-drawn syringe, containing a clear liquid, labeled "Rocuronium." '

b. One (1) pre-drawn syringe, containing a clear liquid, labeled "Etomidate."

c. The pre-drawn syringes were not labeled. The contents of the syringes, time of preparation, beyond-use date and time, and the person who prepared the syringes, could not be determined.

i. Upon interview, Staff #26 did not know the exact time the pre-drawn syringes were prepared. Staff #26 was not aware of the beyond use time.

d. Upon request, Staff #12 was not able to provide policies and procedures addressing the labeling of pre-drawn syringes and the beyond use time specific to the operating room.

2. The above findings were confirmed with Staff #12, Staff #26 and Staff #27.
VIOLATION: INFECTION CONTROL Tag No: A0747
Based on observation, staff interview, and document review conducted on March 22, 23, and 26, 2018, 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.

Findings include:

1. The facility failed to ensure that medications are prepared in a sanitary environment in accordance with acceptable standards of practice. (Cross Refer to Tag A-0749).

2. The facility failed to ensure that single dose vials are discarded immediately after single patient use. (Cross Refer to Tag A-0749).
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
A. Based on observation, staff interview, and review of facility documents, it was determined that the facility failed to follow acceptable standards of practice for infection control.

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 on 3/23/18, the following pre-drawn syringes, containing medication were found in the anesthesia cart in OR #7:

a. One (1) pre-drawn syringe, containing a clear liquid, labeled "Rocuronium." '

b. One (1) pre-drawn syringe, containing a clear liquid, labeled "Etomidate."

c. The pre-drawn syringes were not labeled. The contents of the syringes, time of preparation, beyond-use date and time, and the person who prepared the syringes could not be determined.

2. Upon interview, Staff #26 stated that she/he had prepared the pre-drawn syringes in preparation for the next surgical case and placed them in the anesthesia cart. Staff #26 did not know when he/she had prepared the pre-drawn syringes.

a. The syringes were not properly labeled. Therefore, it could not be established that the syringes were prepared in a sanitary environment.

3. The above findings were confirmed by Staff #2, Staff #26 and Staff #27.

This finding resulted in an Immediate Jeopardy which immediately curtailed this practice. The Immediate Jeopardy was removed on 3/22/18, the day of survey, upon receipt of an acceptable plan of correction.

B. Based on observation, document review, and staff interview conducted on March 23, 2018, it was determined that the facility failed to ensure that package integrity of sterile needles and syringes are maintained.

Findings include:

Reference: Apic Position Paper: Safe Injection, Infusion, and Medication Vial Practices in Health Care (2016) states, "Never store needles and syringes unwrapped because sterility cannot be ensured. Keep bulk unwrapped syringes in the original package (e.g., intradermal syringes)... ."

1. Five (5) syringes and needles were found out of their original wrappers and assembled, in the anesthesia cart in Operating Room (OR) #7 at 2:20 PM.

a. Once needles and syringes are removed from their original wrapper, the sterility of the product cannot be maintained.

2. The above finding was confirmed by Staff #26 and Staff #27.

C. Based on observation, staff interview, and document review conducted on March 23, 2018, it was determined that the facility failed to ensure that single dose vials are discarded immediately after single patient use.

Findings include:

1. During an observation in the Endoscopy Room, one (1) opened and needle-punctured single dose vial of Diprovan, was found in the anesthesia cart.

2. Upon interview, Staff #21 stated that single dose vials can be used for multiple patients.

3. The above finding was confirmed with Staff #21.

This finding resulted in an Immediate Jeopardy which immediately curtailed this practice. The Immediate Jeopardy was removed on 3/23/18, the day of survey, upon receipt of an acceptable plan of correction.





D. Based on observation, staff interview, and review of facility documents, it was determined that the facility failed to ensure that the infection Control Program has adequately implemented the Association for Advancement of Medical Instrumentation (AAMI) standards it has selected to follow.

Findings include:

Reference #1: AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities, section 13.5.3 Biological Indicators (BI) 13.5.3.1 General Considerations states, "...All BI's should be used in accordance with the BI manufacturer's written IFU (Instructions For Use)."

1. On 3/23/18 at 11:31 AM Staff #18 and Staff #23 confirmed that the facility's Infection Control program is based on Association of periOperative Registered Nurses (AORN), Center for Disease Control (CDC), Occupational Safety and Health Administration (OSHA),and Association for the Advancement of Medical Instrumentation (AAMI) guidelines and recommendations.

2. On 3/23/18 at 10:30 AM, during a tour of the Sterile Processing Department (SPD), Staff #18 confirmed the Immediate Use Steam Sterilization (IUSS) cycle was only used once in the year 2017 to reprocess instruments and the IUSS cycle has not been used to process instruments since then.

a. On 3/26/18 at 13:00 PM Staff #18 confirmed the facility uses the 3M Attest 1291 Rapid Readout Biological Indicator, for sterilization process monitoring for its Steris Pre-vac Amsco/ Century V-116 IUSS cycle.

i. Although the facility is not using the IUSS cycle to process instruments, the 3M Attest 1291 BI is still used to test the IUSS cycle.

3. The facility document, 3M Attest Rapid Biological Indicator Process Monitor Documentation System, indicates the following:

a. In the box titled, Sterilizer Process Type, the 270 degree F / 132 degree C Vacuum Assisted Steam is marked with a check mark.

i. In the box titled, "Biological Indicator" there is a check mark in front of the Attest 1291 (3 hr rapid/48 hr visual readout) for 250 degree F / 121 degree C Gravity Steam & 270 degree F / 132 degree C Vacuum Assisted Steam.

ii. The BI was performed on Sterilizer #2 at 3:30 AM on 3/20/18.

iii. The BI was performed on Sterilizer #3 at 3:30 AM on 3/20/18.

iv. The BI was performed on Sterilizer #5 at 3:30 AM on 3/20/18.

b. The Mechanical Indicator Strips for the above cycles indicate the following:

i. A flash cycle was run with the BI on Sterilizer #2 at 3:13 AM on 3/20/18 at 270 degrees Fahrenheit (F) for 5 minutes.

ii. A flash cycle was run with the BI on Sterilizer #3 at 2:13 AM on 3/20/18 at 270 degrees F for 5 minutes.

iii. A flash cycle was run with the BI on Sterilizer #5 at 3:26 AM on 3/20/18 at 270 degrees F for 5 minutes.

4. The 3M Attest 1291 manufacturer's IFU states, "...Precautions: Do not use the 3M Attest 1291 Rapid Readout Biological Indicator to monitor sterilization cycles which it is not designed to challenge: 1. 132 degrees C (270 degrees F) or 121 degrees C (250 degrees F) vacuum-assisted steam sterilization cycles. ...".

a. The 1291 BI should not be used to test IUSS 270 degree F vacuum-assisted cycles.

Reference #2: AAMI Sterilization in Health Care Facilities, 2015 edition, ST 79 section 3.3.6.5 "Temperature" states, "General work areas should have a temperature controlled between 20 degrees C and 23 degrees C (68 degrees F and 73 degrees F). The decontamination area should have a temperature controlled between 16 degrees C and 18 degrees C (60 degrees F and 65 degrees F). The temperature in sterilization equipment access rooms should be controlled between 24 degrees C and 29 degrees C (75 degrees F and 85 degrees F) or as recommended by the equipment manufacturer. The temperature in sterile storage and personnel support areas (e.g., toilets, showers, locker rooms) may be as high as 4 degrees C (75 degrees F). Independent monitors should be located in each of the areas where temperature should be controlled; temperature should be recorded daily. Processing personnel in each work area are responsible for monitoring and recording the temperature to ensure that the correct temperature is being achieved."

Reference #3: Facility policy, Temperature and Humidity/Ventilation states, " ...Temperature ranges...Decontamination- 16 degrees C - 18 degrees C (60 degrees F - 65 degrees F). ...Procedure: ...If temperature is not within proper limits, call Engineering Department. ...Reference: AAMI ST79 2010 3.3.6.5 / 3.3.6.6 Comprehensive guide to steam sterilization and sterility Assurance in health care facilities AORN Perioperative Standards and Recommended Practices 2013."

1. On 3/23/18 in the decontamination area, the room temperature reading was 78 degrees F and the humidity was 31%.

a. The temperature and humidity log for the month of March was requested, reviewed, and the following was revealed:

i. The room temperature was out of range in the decontamination area, every day including weekends, from 3/1/18 to 3/23/18. The temperature ranged from 71 degrees F to 81 degrees F.

b. The maintenance work orders were requested and reviewed, and the following was revealed:

i. Work orders were received for 4/12/17, 7/20/17, 9/28/17, 11/6/17, 2/16/18 and 3/23/18.

c. The temperature and humidity logs for the above months were requested, reviewed and the following was revealed:

i. April 2017 - The temperature was out of range in the decontamination area every day including weekends, from 4/1/17 to 4/30/17. The temperature ranged from 72 degrees F to 79 degrees F.

ii. July 2017 - The temperature was out of range in the decontamination area every day including weekends, from 7/1/17 to 7/31/17. The temperature ranged from 72 degrees F to 76 degrees F.

iii. September 2017 - The temperature was out of range in the decontamination area every day including weekends, from 9/1/17 to 9/30/17. The temperature ranged from 74 degrees F to 76 degrees F.

iv. November 2017 - The temperature was out of range in the decontamination area every day including weekends, from 11/1/17 to 11/30/17. The temperature ranged from 72 degrees F to 81 degrees F.

v. February 2018 - The temperature was out of range in the decontamination area every day including weekends, from 2/1/17 to 2/28/17. The temperature ranged from 77 degrees F to 81 degrees F.

d. The work orders indicate the temperature and humidity were checked and adjusted.

e. At 10:40 AM Staff #18 indicated the temperature is recorded mid-afternoon and are out of range due to the heat from the sterilizers.

f. Staff #24 confirmed the following:

i. When the engineering department receives a call for an out of range temperature or humidity, someone from the Engineering Department confirms the temperature and adjusts it accordingly.

ii. The HVAC (Heating, Ventilation, and Air Conditioning) system is from 1985 and is an old unit.

2. On 3/23/18 at 10:52 AM there was a "MovinCool Classic Plus 14" portable air cooled air conditioner in the decontamination area.

a. Staff #18 indicated the "MovinCool" is used to cool the staff down, however it is not used during decontamination of soiled instruments.

i. On 3/26/18 at 10:45 AM, Staff #23 confirmed the "MovinCool" is the corrective measure to control the temperature in the decontamination area.

3. The temperature in the decontamination area is not in accordance with AAMI's recommended temperatures of 60 degrees F to 65 degrees F.

Reference #4: AAMI Sterilization in Health Care Facilities, 2015 edition, ST 79 section 3.4 Housekeeping procedures states, "Housekeeping procedures in areas used for any aspect of decontamination, preparation, or sterilization should be the same as those used to clean operating and delivery rooms and should ensure a high level of cleanliness at all times. ...Rationale: Cleaning removes soil and reduces environmental contaminates, thus reducing the risk of transmission of microorganisms."

1. On 3/23/18 at 10:55 AM in the decontamination area, there were three (3) metal-like sinks next to each other.

a. The sink on the left was dirty and contained a brownish residue, on the inside near the drain, making it an uncleanable surface.

i. The sink on the right contained a white residue on the top surface of the sink.

b. Staff #18 indicated the sinks were used to clean respiratory equipment, however they are no longer used and will be removed.

2. At 12:35 PM in the endoscopy decontamination area, there was a sink with a white cabinet, used to manually clean and disinfect soiled colonoscopes and endoscopes.

a. The white metal-like cabinet contained multiple large brownish residue marks on the front of the cabinet, making it an uncleanable surface.

i. Staff #23 indicated the facility is planning to renovate the endoscopy department and the sink cabinet will be replaced.





E. Based on observation, staff interview, and review of facility documents, it was determined that the facility failed to follow acceptable standards of practice for infection control.

Findings include:

1. On 3/23/18 at 10:55 AM, during a tour of the 6 East unit, in the presence of Staff #2 and #16, the following were observed:

a. Multiple pieces of clear adhesive tape along the laminate counter top edge at the nurses work station.

b. In Room #622, the wall underneath the white board contained an area of peeled paint and an area of peeled, exposed drywall beneath it.

c. In Room #646, which was confirmed as clean and unoccupied at the time of the tour by Staff #16, the following was observed:

i. The portable, metal intravenous (IV) pole, used for hanging IV fluids, contained an uncleanable, chipped brownish residue at the base.

ii. The sharps collection container on the wall had a visible brownish, red-colored remnant of a drip-marking on the side of the container, below the plastic round opening.

d. In Room #648, a room designated by Staff #16 as an area to supply housekeeping carts, the following items were stored directly on the floor.

2. The above findings were confirmed by Staff #1, Staff #2, and Staff #16.

Reference #1: 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. ..."

Reference #2: Facility policy, Hand Hygiene, states, "...1. Policy/Indication: ...B. Hand washing indications 1. Personnel will always perform hand hygiene: ...p. All personnel participating in direct patient care practices perform hand hygiene before and after patient contact regardless of the use of gloves. ..."

1. On 3/23/18 at 11:20 AM, on the 6 East unit, while observing medication administration for Patient #5, the following was revealed:

a. Staff #17 entered Room #616 and administered a medication tablet to the patient.

i. Staff #17 failed to perform hand hygiene prior to direct contact with the patient.

b. The above finding was confirmed by Staff #1 and Staff #2.