HospitalInspections.org

Based on observations, staff interview, and facility document review, it was determined the facility staff failed to ensure that medical gases were stored in a way that provided a safe environment.

Findings include:

At 10:30 AM on 4/26/17, during a tour of the CVICU (cardiovascular intensive care unit), the surveyor observed two (2) helium tanks stored in a cabinet above a balloon pump across from room I-2013. Both tanks were full and labeled Rx (prescription only), "contains gas under pressure". May explode if heated. Use and store only outdoors or only in a well-ventilated place. Read and follow SDS (safety data sheet) before use". Staff Member #60 was present when the helium tank was observed in the cabinet, and stated "I'm not exactly sure how it's supposed to be stored, but I will find out and store it as it should be stored".

The SDS for helium states the following in part: "...OSHA/HCS status: This material is considered hazardous by the OSHA Hazard Communication Standard (29 CFR 1910:1200); Classification of the substance or mixture: Gases under pressure-Compressed gas; Hazard statements: Contains gas under pressure may explode if heated. May displace oxygen and cause rapid suffocation". Under the heading "Conditions for safe storage, including any incompatibilities", the MSDS states "Store in accordance with local regulations. Store in a segregated and approved area. Store away from direct sunlight in a dry, cool and well ventilated area, away from incompatible materials (see section 10). Keep container tightly closed and sealed until ready for use. Cylinders should be stored upright, with valve protection cap in place, and firmly secured to prevent falling or being knocked over. Cylinder conditions should not exceed 52 degrees Celsius (125 degrees Fahrenheit). (http://www.airgas.com/msds/001025.pdf;).

The finding was shared with Staff Members# 60 and 22 at the time of discovery, with Staff Members #8 and 16 on 2/26/17 at 5:00 PM.

Based on staff interview and medical record review, it was determined that for one (1) of four (4) patients reviewed for restraint usage restraints, staff failed to ensure that the care plan reflected the use of restraints on the care plan. Patient #10.

Findings include:

Staff Member #18 navigated the EMR (electronic medical record) to facilitate a review of the medical record for Patient #10. The chart review revealed documentation that the patient was restrained with left and right soft limb wrist restraints between 4/19/17 continuing through the time of the record review, due to interference with medical treatment.

Restraints were not documented in Patient #10's plan of care. Staff Member #8 told the surveyor "We have issues with our care plans, we have identified that, and there will be a new style of documenting on care plans effective September 2017".

The finding was discussed with Staff Members #8 and 18 at the time of discovery 4/25/17 at 3:45 PM.

Based on observations, interviews and document review it was determined the facility staff failed to obtain physician orders for the seclusion of one (1) of one (1) patient related to management of violent or self-destructive behavior. (Patient #6)

The findings included:

During the initial entrance conference on 04/24/2017 at 12:30 p.m. with Staff Member #2 the surveyors requested a list of all patients currently in restraints or seclusion.

Observations were conducted on 04/24/2017 from 1:59 p.m. through 2:26 p.m., with Staff Members #9, #10, #11, #12, and #13 on the adult psychiatric unit. The observation occurred in an area adjoining three seclusion rooms. The observation revealed Staff Member #11 was performing the task of monitoring Patient #6 in the locked seclusion room. Staff Member #9 introduced Patient #6 to the surveyor through the locked door. Patient #6 was able to have a limited conversation with the surveyor and began to pace within the seclusion room. A limited review was conducted of Patient #6's electronic record on 04/24/2017 with Staff Member #9. The review revealed Patient #6 had been placed in seclusion twice on 01/23/2017 for assaulting a fellow patient and again on 01/30/2017 for assaulting multiple staff. Patient #6's electronic medical record (EMR) documented the patient had remained in seclusion since 01/30/2017. Staff Member #9 reported keeping Patient #6 in locked seclusion was the least restrictive alternative for maintaining the patient's safety and the safety of other patients.

A review of Patient #6's EMR was conducted on 04/25/2017 from 2:46 p.m. through 4:46 p.m. and continued on 04/26/2017 from 3:45 p.m. through 4:30 p.m., with Staff Member #9. Patient #6's EMR documented the patient was a voluntary admission to the psychiatric unit on 01/10/2017. Patient #6 was admitted to the psychiatric unit after running away and attempting to harm him/herself.

The surveyor performed an in-depth review of seclusion orders from 01/31/2017 through 02/23/2017 and randomly selected days in March (3, 18 and 28) and April (1, 10, and 24) 2017; related to the length of time Patient #6 remained in seclusion from 01/31/2017 continuously through discharge on 04/26/2017.

A review of seclusion orders revealed the physician and/or the licensed independent professional failed to provide the necessary every four hour order for continuation of seclusion on the following dates and times:
02/01/2017 no later than 11:43 a.m.
02/02/2017 no later than 1:45 p.m.
02/03/2017 no later than 1:45 p.m.
02/05/2017 no later than 9:45 a.m. and
02/09/2017 no later than 9:30 a.m.

Staff Member #9 reviewed Patient #9's EMR and paper medical record for down-time paper seclusion orders and to determine whether the patient was off the unit or out of seclusion. Staff Member #9 stated, "I was not able to locate the orders that are missing. [Patient #9's name] was in seclusion for the days and times that were missing. [Patient #6's name] was in seclusion without an order to continue seclusion." The surveyor inquired regarding staff's responsibility to obtain orders to continue seclusion. Staff Member #9 reported it was the responsibility of clinical staff to ensure seclusion orders were obtained within in the timeframe specified of four (4) hours. The surveyor requested the facility's policy for seclusion. Staff Member #9 reported the policy for seclusion utilized the same considerations and guidelines for orders as the restraint policy.

Review of the facility's policy titled "Restraints and Restraint Alternatives" read in part: "B. Orders for Violent and/or Self-Destructive Behavior 1. The use of restraints for violent and/ or self-destructive behavior must be ordered by an [Sic] LIP (Licensed Independent Professional) after an in-person evaluation, unless the patient's RN (Registered Nurse) determines that the need to use restraints and/or seclusion is clinically justified and the LIP is not immediately available ... 3. Each order is time-limited: a. 4 hours for patients 18 years or older ... 4. After the initial order and in-person LIP evaluation, orders for violent and/or self-destructive behavior must be renewed according to the time-limited parameters ..."

An interview was conducted on 04/26/2017 at 4:30 p.m., with Staff Member #9. Staff Member #9 verified staff failed to obtain every four (4) hour seclusion orders while Patient #6 continued in seclusion.

Based on observations, interviews and document review it was determined the facility staff failed to perform every four hour face to face assessments and every two hour general assessment for one (1) of one (1) patient in seclusion for the management of violent or self-destructive behavior. (Patient #6)

The findings included:

During the initial entrance conference on 04/24/2017 at 12:30 p.m. with Staff Member #2 the surveyors requested a list of all patients currently in restraints or seclusion. Patient #6 was included on the list.

Observations were conducted on 04/24/2017 from 1:59 p.m. through 2:26 p.m., with Staff Members #9, #10, #11, #12, and #13 on the adult psychiatric unit. The observation occurred in an area adjoining three seclusion rooms. Staff Member #11 was performing the task of monitoring Patient #6 while the patient was in the locked seclusion room. Staff Member #9 introduced Patient #6 to the surveyor through the locked door. Patient #6 was able to have a limited conversation with the surveyor and began to pace within the seclusion room. A limited review was conducted of Patient #6's electronic record on 04/24/2017 with Staff Member #9. The review revealed Patient #6 had been placed in seclusion twice on 01/23/2017 for assaulting a fellow patient and again on 01/30/2017 for assaulting multiple staff. Patient #6's electronic medical record (EMR) documented the patient had remained in seclusion since 01/30/2017. Staff Member #9 reported keeping Patient #6 in locked seclusion was the least restrictive alternative for maintaining the patient's safety and the safety of other patients.

A review of Patient #6's EMR was conducted on 04/25/2017 from 2:46 p.m. through 4:46 p.m. and continued on 04/26/2017 from 3:45 p.m. through 4:30 p.m., with Staff Member #9. Patient #6's EMR documented the patient had voluntarily admitted him/herself to the psychiatric unit on 01/10/2017. Patient #6 was admitted to the psychiatric unit after running away and attempting to harm him/herself.

The surveyor performed an in-depth review of assessments from 01/31/2017 through 02/23/2017 and randomly selected days in March (3, 18 and 28) and April (1, 10, and 24) 2017; related to the length of time Patient #6 remained in seclusion from 01/31/2017 continuously through discharge on 04/26/2017.

Review of Patient #6's EMR revealed facility staff failed to perform the required every four (4) hour face to face assessments to determine whether the patient met criteria to be released or needed continued seclusion on the following days and times:
02/01/2017- 3:43 a.m., 7:43 a.m. and 8:54 p.m.
02/02/2017- 12:00 a.m., 4:54 a.m., 9:45 a.m., 1:45 p.m., and 5:45 p.m.
02/04/2017- 9:45 a.m. and 9:45 p.m.
02/08/2017- 1:41 p.m., 5:41 p.m. and 9:20 p.m.
02/09/2017- 1:30 p.m. and 9:27 p.m.
02/14/2017- 6:19 a.m.
02/19/2017- 10:19 a.m., 2:34 p.m., and 6:34 p.m.
04/10/2017- 9:55 a.m.

In addition to the every four (4) hour face to face assessments the facility required nursing staff to perform every two hour assessments of patients in restraints or seclusion. Nursing staff failed to perform the required every two (2) hour assessment on the following days and times:
01/31/2017- 1:45 p.m., and 5:45 p.m.
02/01/2017- 1:45 a.m., 3:45 a.m., 3:04 p.m., 7:04 p.m., 9:04 p.m., and 11:04 p.m.
02/02/2017- 2:00 a.m., 4:00 a.m., 7:00 a.m., 12:00 p.m., 3:00 p.m., and 11:00 p.m.
02/09/2017- 10:00 a.m., 2:00 p.m., and 11:00 p.m.
02/12/2017- 2:00 p.m.
02/13/2017- 12:00 p.m.
02/14/2017- 4:00 a.m. and 8:00 a.m.
02/15/2017- 4:00 a.m. and 8:00 a.m.
02/17/2017- 8:00 a.m.
02/18/2017- 5:00 p.m. and 9:00 p.m.
02/19/2017- 12:00 a.m., 3:00 p.m., 9:00 p.m. and 11:00 p.m.
02/20/2017- 1:00 a.m., 3:00 a.m., 3:00 p.m. and 5:00 p.m.
02/21/2017- 8:00 p.m.
02/22/2017- 5:00 a.m., 8:00 a.m. and 8:00 p.m.
02/23/2017- 3:00 a.m.
03/01/2017- 4:00 a.m., 8:00 a.m., 12:00 p.m., and 4:00 p.m.
03/28/2017- 4:00 a.m. and 8:00 p.m.
04/01/2017- 8:00 a.m., 12:00 p.m. and 4:00 p.m.
04/10/2017- 10:00 a.m.

During an interview conducted on 04/26/2017 at 4:44 p.m. Staff Member #9 reported he/she had reviewed Patient #6's paper medical record for downtime forms. Staff Member #9 reported he/she was not able to find additional supporting documentation that facility staff had performed the required face to face assessments for patients in restraints/seclusion or the facility's standard of practice regarding every two hour patient assessments. Staff Member #9 verified the above findings. Staff Member #9 reported without documentation the facility did not have proof the assessments were performed by facility staff. Staff Member #9 verified facility staff failed to follow the organization's policy and procedures for re-evaluating Patient #6.

Review of the facility's policy titled "Restraints and Restraint Alternatives" read in part: "E. Re-evaluation for Violent and/or Self-Destructive Behavior 1. Re-evaluation includes an assessment by RN (Registered Nurse) or LIP (Licensed Independent Professional) to determine the degree to which the restraint and/or seclusion has accomplished the desired outcome. 2. Re-evaluation timeframes (may be done by RN or LIP): a. every 4 hours for patients 18 and older ..."

Based on interview and document review it was determined the facility staff failed to ensure the electronic medical record (EMR) was accurate and complete as evidenced by:

1. Facility staff changed the time of documentation and failed to note the entry was late for one (1) of ten (10) medical records reviewed; (Patient #6) and
2. Facility staff failed to ensure that handoff communication for 1 (one) of 10 patients was complete (Patient #8).

The findings include:

1. A review Patient #6's EMR was conducted on 04/25/2017 from 2:46 p.m. through 4:46 p.m. and continued on 04/26/2017 from 3:45 p.m. through 4:30 p.m., with Staff Member #9. Staff Member #16 was present during the reviews.

During the review of nursing documentation on 04/25/2017; a progress note entry indicated it had been filed (completed) on "02/12/2017 at 7:20 p.m." The progress note was documented as being written at "0230 (2:30 a.m.)" on "02/12/2017." The surveyor inquired if it was usual for a note to have a nearly seventeen (17) hour completion timeframe. Staff Member #9 reviewed the entry which read: "Patient continues to bang on the door, even after receiving green pants, MD (Medical Doctor) called As patient had some probable EPS (extrapyramidal) Symptoms yesterday, as a result of the conversation, pt (patient) medicated with Zyprexa 10 IM (Intramuscular) and Benadryl 50 IM [Sic]." Staff member #9 stated, "This nurse never works night shift, this does not make sense." Staff Member #16 requested to have informatics personnel to review the electronic entry. Staff Member #49 joined the discussion at approximately 4:46 p.m. Staff Member 9 explained the timing of the note. Initially, Staff Member #49 reported if a note was started but "not completed in a timely manner" the EMR system would time the note out. Staff Member #9 informed Staff Member #49 that the nurse who made the entry would never work at 2:30 a.m. or the night shift. Staff Member #49 reported he/she would research the issue.

An interview was conducted on 04/26/2017 at approximately 5:30 p.m., with Staff Members #2, #16, #21, and #49. Staff Member #49 reported the staff had changed the time of his/her progress note. Staff Member #49 shared an email from the provider of the facility's EMR. The email was dated "04/26/2017 450 PM" that read in part: "The nurse manually changed the time, probably intending to enter 2:20 in the afternoon but entered 2:30 in [Name of EMR system]. This is most common when documentation is back-timed, to reflect events that occurred earlier in the day but are being documented late for whatever reason. Of 2:30 is 0230 (AM!). It seems [he/she] didn't notice the "AM" in the time box when [he/she] signed the note." The surveyor asked if it was the facility's policy for staff to change the time of their documentation to have it appear it was performed at a different time. Staff Member #49 reported it was not the facility's policy. Staff Member #21 reported the correct method to chart an earlier event would be to state the time of the event in the note and document the entry as a "late entry." The surveyor requested a copy of the email and the facility's policy for back-timing progress note, late-entry notes and monitoring regarding the changing of note times.

An interview and review of the facility's policy titled "Documentation of Patient Care in the Electronic Health Record" was conducted on 04/27/2017 at 8:46 a.m., with Staff Member #16. Staff Member #16 offered a highlighted section of the policy on page 3, which in part read: "D. Entries [:] ... Late Entries: The medical record is a longitudinal record. As such, documentation in the chart may be amended when corrects or additions to the record are warranted. When the record is amended, both the original note and the corresponding amendment will remain visible ..." The surveyor asked if the facility had another policy for "late entries" since changing the date or time of the original note did not reflect an amendment and a second note or amended note would be visible. Staff Member #16 stated, "No." On further review of the facility's policy tiled "Documentation of Patient Care in the Electronic Health Record" was conducted with Staff Member #16. The policy on page 13 read in part: "L. Progress Notes [:] ...Progress notes for each patient shall be documented at the time of observation and recorded in the patient's medical record."

An interview was conducted on 04/27/2017 at 8:51 a.m., with Staff Member #48 and Staff Member #16 present. The surveyor and Staff Member #48 discussed EMR audits and completion of medical records. Staff Member #48 stated, "Every chart is audited at discharge." Staff member #48 reported the documentation reviewed was related to discharge orders/ instructions, history and physical, Procedure notes, consents and radiology reports. Staff Member #48 reported the healthcare provider responsible for the patient's care was contacted if any information is missing. Staff Member #48 reported the department's goal was to have all information resolved prior to sending data on chart completion to the quality personnel. The surveyor asked if Staff Member #48 and his/her staff monitor the occurrence of staff changing the date and times of their documentation; Staff Member #48 stated, "No, we do not monitor or audit those types of changes." Staff Member #48 reported he/she did not know that staff had the ability to change the time and date of an EMR entry. Staff Member #16 reported "IT security" monitors staff changes in the medical record."

An interview and document review was conducted on 04/27/2017 at 9:20 a.m. with Staff Member #49 and Staff Members #16 and #21 were present. Staff Member #49 reported the facility's IT leaders did not audit surveillance reports, medical record documentation or entries dates and times. Staff member #49 stated, "That type of monitoring is the role of IT Security." Staff Member #49 was able to demonstrate the ability to change the date and time of an entry within a patient's shadow chart. Staff Member #49 stated, "Signing the note will place the actual file time of the entry but there would be no other indication that the note was a late entry. Just changing the time or date would not flag a concern." Staff Member #21 reported even if the staff changed the time or back-timed the note they should place "late-entry," which would reflect the actual time the note was being filed. Staff Member #49 stated, "I have reached out to IT Security, they may be doing something in the background that we do not know about where they flag and monitor changes."

An interview was conducted on 04/27/2017 at 4:20 p.m., with Staff Member #16 and #49. Staff Member #49 reported IT Security had not been surveilling or monitoring whether staff was changing the dates and/or times for EMR entries. The surveyor asked if there was a way to assure the dates and times for progress notes or other entries were accurate; Staff Member #49 stated, "No."



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2. A review of Patient #8's medical record revealed a "ticket to ride" with a drop off time and dated documented 3/31/17 at 10:08 AM; the origin was "North tower 4 East F430 F430.1, and the destination as Fx interventional Rad FXIVR".

The checklist for the sending unit had not been filled out. Information on the checklist included in part, the following information: fall precautions, mental status, whether or not the patient was on oxygen, whether there were special needs, including interpreter, preferred language, difficulty with hearing/speech, and whether or not restraints were required.
The checklist for transport was not filled out.
The checklist for Receiving Unit was not completed, and the verbal review of transport with RN (registered nurse) was not filled out.

An interview was conducted with Staff Member #23 on 4/24/17 at 2:30 PM regarding the use of "ticket to ride", and he/she stated "I'm not sure if they use that since the nurse brings them. That form is used mainly when non-nursing staff take patients. They are used more on the floor".

A review of the facility policy and procedure titled "Handoff Communication" stated in part the following under
"I. Policy
A. Handoff communication shall occur under the following circumstances: "...4. Transfer of patient between departments for test, procedure, or therapy".
"...IV Definition of Terms...."Ticket to Ride-A standardized format printed from the electronic medical record (EMR) that provides accurate and current information about a patient's care, treatment, or service".
"V. Expected Outcomes-Staff will utilize a standardized approach to handoff communication, including an opportunity to ask and respond to questions".

This discovery was discussed with Staff Member #22 at the time of discovery.

Based on staff interview and medical record review, it was determined the facility staff failed to ensure that a consent form was properly executed prior to conducting a procedure for 1 of 10 patients in the survey sample, Patient #7.

Findings include:

A review of Patient #7's medical record revealed a consent for a TEE (Transesophageal echo) in order to evaluate for thrombus (blood clot).

Part II (two) of the consent was titled "Documentation of Informed Consent", and included sections 1, 2, and 3, which were all blank. Those sections were to document the potential benefits, outcomes, risks, complications, and alternatives to the procedure which had been discussed with the patient and/ or his/her representative.

Documentation in Patient #7's medical record indicated that he/she needed an interpreter; however, Section V (five) of the consent titled "Interpreter Information (if applicable), was left blank.

The consent was signed and dated by Patient #7's spouse and the physician/practitioner on 4/5/17 at 1:00 PM.

The findings of the incomplete consent were discussed with Staff Member #22 at the time of discovery at 2:45 PM on 4/24/17.

Based on observations in multiple areas of the facility, interviews and document review it was determined the infection prevention program failed to ensure practices to maintain a sanitary environment and prevent the transmission of infectious agents:

As evidenced by a failure to ensure:

1. The disposal of used supplies and protection of clean linens;

2. Supplies were maintained in a manner to protect them from contamination, used urine and blood collection devices were not left in treatment areas, and the disposal of expired or single used biologicals;

3. The dialysis treatment area was maintained in a sanitary manner, maintaining separation of clean from dirty, and facility audits included the dialysis area;

4. Facility and contracted staff received annual infection prevention training for four (4) of ten (10) facility employees and one (1) of three (3) contracted dialysis staff records reviewed;

5. Facility staff , volunteers, and vendors properly discarded PPE prior to leaving patient care areas and performed glove changes with hand hygiene for eight (8) of eight (8) observations.

6. Dietary staff observed and document the temperatures of the pot sanitizing unit to ensure temperatures were in range to prevent the transmission of food-borne illnesses.

See citation 0749 for further details.

Based on observations, staff interview, and review of the facility's infection prevention and control program policy, it was determined the facility staff failed to ensure that the infection control practices were followed in order to prevent the transmission of communicable diseases within the facility.

As evidenced by a failure to ensure:

1. The disposal of used supplies and protection of clean linens;

2. Supplies were maintained in a manner to protect them from contamination, used urine and blood collection devices were not left in treatment areas, and the disposal of expired or single used biologicals;

3. The dialysis treatment area was maintained in a sanitary manner, maintaining separation of clean from dirty, and facility audits included the dialysis area;

4. Facility and contracted staff received annual infection prevention training for four (4) of ten (10) facility employees and one (1) of three (3) contracted dialysis staff records reviewed;

5. Facility staff , volunteers, and vendors properly discarded PPE prior to leaving patient care areas and performed glove changes with hand hygiene.

6. Dietary staff observed the pot sanitizing unit to ensure temperatures were in range to prevent the transmission of food-borne illnesses.

Findings include:

1. On 4/24/17 between 4:10 PM and 4:30 PM the surveyors observed the following in the Adult Emergency Department (ED):
A. An isolation cart was sitting outside of a negative pressure isolation room at Room #17, which had an "Airborne Precautions" sign posted at the sliding glass doors. There were 2 (two) N-95 masks lying on top of the cart. When asked whether the masks were clean or dirty, Staff Member #18 stated "I'm not sure, but as far as I am concerned, they are dirty". He/she put on gloves and threw away the masks. The patient in Room #17 was in the ED for cough/rule out TB (tuberculosis).

B. A patient lying on a stretcher in the hallway between the adult and pediatric ED's was lying next to an uncovered clean linen cart. The patient, who was waiting to be seen, was wearing street clothes, including shoes, and covered with a blanket. The patient's leg was touching the clean linen. Across from the patient on the stretcher on the other side of the hall was a cart containing loose clean linens. There was a bedside table in front of the cart with 2 knotted blue sheets lying on top of the table. Staff #18 stated "Staff tie the linens in knots then put them onto another cart to use; we tie them in knots so they won't slide off the cart as we get them".

2. The surveyors made the following observations in the Adult ED on 4/26/17 between 8:50 AM and 9:45 AM:

A. A specimen cup containing urine and 2 tubes of blood sitting on top of a supply cart outside of 38 N across from Q2 bed station. The specimen cup and blood tubes were labeled with a patient name and included the date/time 4/25/17 1657 (4:57 PM). Staff Member #18, who was accompanying the surveyors said "that was probably left over from a hall patient".

B. On a shelf of the EKG (electrocardiogram) machine, in the "Station M" equipment storage area, there were packages of open Kendall foam electrodes with the warning "Do not use if package is opened or damaged. Do not open until immediately prior to use". The open packages were not labeled with an open or expiration date. There were loose electrodes not in packaging lying on the shelf outside the manufacturer's packaging.

C. A Dinamap vital sign machine had a used electrode pad attached to a cable lying on the machine.

D. A portable ultrasound machine sitting in the equipment storage area had an unlocked gray box sitting filled with multiple angiocaths sitting under the machine on the cart's shelf. Staff Member #18 stated "We use that for patient's who are hard to stick, that box should be locked, somebody just forgot to lock it back".

E. An open 250 ml (milliliter) bottle of normal saline for irrigation labeled "Single Use for irrigation" was sitting on the counter of Bay 31 and available for use. Bay 31 was unoccupied.

F. A specimen cup containing urine, labeled with a patient name was sitting on the counter of Bay 18; Staff Member #18 stated "This patient was probably just discharged".

G. Four loose electrodes were lying on top of a supply cart outside C4 (four).

H. Staff Member #16 provided the surveyor with correspondence from the manufacturer of the electrodes used by the facility, dated 6/1/16, which included the statement "Do not open until immediately prior to use". The letter stated the following, in part: "This statement is listed within our labeling to ensure that the conductive hydrogel is at the highest degree of freshness during initial use. (Name of manufacturer) has conducted an out of package study for the above listed electrodes. Based on the test results....the above listed electrodes can be used for up to 45 days after the package is opened...".

The open packages of electrodes observed by the surveyors were not labeled with an open date; therefore, it could not be determined when 45 days period had passed.

The facility did not have a policy and procedure related to handling of the electrodes after the package was opened.

3. Surveyors made observations in the area where dialysis was provided to inpatients by contracted staff on 4/27/17 between 3:00 PM and 4:15 PM. Staff Member #40, a contract employee, led the tour. Surveyors made the following observations:

A. 2 (two) open packs of electrode pads with no open date written on the package sitting in a plastic bin on a counter.

B. In the water/supply room there were 2 sinks beside one another which were not labled "clean" or "dirty". Two containers of bleach water were sitting on a towel between the sinks. Lying beside the bleach containers on the towel were plastic hemostats.

The surveyor interviewed Staff Member #40 and asked whether the sinks were designated clean or dirty; he/she stated "One is clean, the other is dirty". The surveyor asked about the hemostats lying on the towel between the sinks, and where staff emptied prime receptacle containers. Staff Member #40 stated "We soak clamps and hemostats in the bleach water then rinse with RO (reverse osmosis) water, then lay them on the towel before hanging them on the IV pole on the machines. We empty prime containers in this sink", pointing to the sink closest to the door. There was no barrier between the sinks, and the clean hemostats and clamps could potentially become contaminated.

C. There were 2 hemodialysis machines turned on but not set up, sitting beside beds which had sheets on them and looked as if they had been used. The surveyor asked Staff Member #40 if the machines were clean or dirty, he/she responded "they are clean", but the beds have not, we are waiting for housekeeping to clean the beds". The surveyor observed that one machine was pushed up against the dirty linens on the bed, contaminating the clean machine. The prime container on the other machine contained approximately 4 (four) inches of fluid. Both the fluid in the prime container and the machine touching the dirty linens were pointed out to Staff Member #40 who stated "that machine hasn't been cleaned yet", and pointing to the machine with the fluid in the prime receptacle.

The surveyor interviewed Staff Member #54, and asked how the dialysis unit and contract employees, were audited for infection control compliance, he/she stated "I don't know how often we get down here to audit dialysis, we do have it on a schedule".

4 A. A review of ten personnel records revealed that four (4) of ten staff had not received annual infection control training.

The facility's policy and procedure "Infection Prevention and Control Program" stated the following in part: "...IPC (infection prevention control) orientation is provided to all new employees of the (facility organization name). Mandatory annual IPC education is also provided for all employees...".

The above findings were shared at the time of discovery with facility staff present, at the end of day discussion on 4/26/17 at approximately 5:00 PM, at the end of day discussion on 4/27/17 at approximately 5:00 PM with Staff Members# 2 and 16.

5 A. An observation on 04/26/2017 beginning at 8:50 a.m.., as the surveyor was leaving the ED, two (2) employees were observed in the hallway, each wearing surgical head covers, scrubs, and surgical masks pulled down under their chins, around their necks. One employee stated he/she worked in the radiology department, the other in the surgical department.


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2 I. An observation was conducted on 04/24/2017 at approximately 4:15 p.m., with Staff Member #19 within the Pediatric Emergency Department. The surveyor and Staff Member #19 passed a warming unit with intravenous (IV) solutions. The surveyor requested the temperature log for the unit. Staff Member #19 stated, "We do not keep a log on the warmer." Staff Member #19 opened the warming unit for the surveyor. The surveyor asked about the four (4) 500 ml (milliliter) bags of 0.9% Sodium Chloride marked "4/20/17." Staff Member #19 stated, "That is the date the bags should have been discarded from the warmer. In fact all of the bags in here (the warming unit) need to be discarded." Staff Member #19 reported the remaining three (3) 500 ml bags of 0.9% Sodium Chloride and the one (1) liter bag of of 0.9% Sodium Chloride was not dated and there was no indication when they should be discarded. Staff Member #19 reported the 0.9% Sodium Chloride IV solution bags could only be kept in the warming unit for up to fourteen (14) days.

2 J. Observations and a second tour of the facility's Emergency Departments were conducted on 04/26/2017 from 8:47 a.m. through 9:40 a.m., with Staff Members #18, #22, #27 and #32. During the tour of the "Triage Area" the surveyor observed a small-sized white vinyl-like blood pressure cuff laying on a desk in "Triage Bay #1". The surveyor asked Staff Member #32 if the facility utilized disposal blood pressure cuffs. Staff Member #27 and Staff Member #32 reported the Emergency departments used disposable blood pressure cuffs. An observation in "Triage Bay #2" revealed a large-sized white vinyl-like blood pressure cuff laying on a counter and the blood pressure unit had an adult size white vinyl-like blood pressure cuff attached. The surveyor inquired if the blood pressure cuffs were clean. Staff Member #27 stated, "There is no way of knowing." Staff Member #27 reported that staff may remove a disposable blood pressure cuff from its package but not use the blood pressure cuff. The surveyor requested the facility's policy for single use disposable items.

An interview was conducted on 04/26/2017 at approximately 6:00 p.m., with Staff Members #16 and #21. The surveyors were informed the policy "Standard Precautions" contained information related single use and disposable items. The policy read in part: "E. Patient-Care Equipment and Instruments/Devices: ... iii. Do not re-use single use or disposable items ..."

4 B. Review of contacted End-Stage Renal Dialysis (ESRD) staff training for infection prevention was conducted on 04/28/2017 at approximately 11:00 a.m., with Staff Members #16 and #21. Staff Member #21 reported that contracted staff had to complete the facility's annual on-line infection prevention training. Review of three (3) ESRD contracted staff employee files revealed one (1) of three (3) had not completed their annual infection prevention training. Initially, Staff member #21 reported all staff has seven (7) months to complete their annual training, which might be beyond the actual annual date. The surveyors requested the facility's policy which allowed for the additional time to complete the on-line training. Prior to exit on 04/28/2017 Staff Member #21 stated, "The facility does not have a policy that documents employees have seven months to complete on-line training." Staff Member #21 reported it was a practice at the facility, however there was no documentation or policy as a foundation.

5 B. An observation was conducted on 04/24/2017 at approximately 1:59 p.m. as Staff Members #12 and #13 escorted the surveyor to a patient care unit. The observation revealed a person walking in the hallway dressed in mint green scrubs wearing hair cover, shoe covers and a used mask around his/her neck. The surveyor inquired if hospital policy allowed for staff to be out of patient care area and wear hair cover, shoe covers and a used mask around their neck. Staff Member #13 stated, "No." Staff Member #13 was able to catch up with the person and requested they remove their used mask, shoe covers and hair covering. Staff Member #13 joined the surveyor and continued the escort to a patient care area. The surveyor requested the facility's policy regarding personal protective equipment (PPE) and surgical attire.

An observation was conducted on 04/24/2017 at approximately 3:59 p.m. in the facility's adult Emergency Department. The surveyor observed a facility staff member with gloved hands remove a package from his/her scrub pocket. The packet contained a cleaning/disinfection cloth. The staff member used the cloth to wipe the surface of a stretcher pad. The staff member did not change gloves prior to taking clean linen from the linen cart. The staff member transported the clean linen to the cleaned stretcher and placed the fitted blue sheet on the stretcher. The staff member did not change gloves and removed a second package from his/her scrub pocket and used the cloth from the package to wipe the surface of another stretcher pad. The staff member using the same gloves obtained another fitted blue sheet from the clean linen cart to make the second stretcher of this observation. The surveyor informed Staff Members #16, #17, and #18 of the observation as the staff member began the process for the third stretcher. Staff Member #18 identified the staff member as a volunteer. Staff Member #18 reported the Emergency Department had volunteers that assisted in ensuring stretcher were ready for patients and other task to assist nursing staff. Staff Member #18 intervened and instructed the volunteer to change gloves and perform hand hygiene. The surveyors requested orientation, infection prevention training for volunteer staff and the facility's policy regarding glove changing/hand hygiene.

On 04/24/2017 at 4:50 p.m. Staff Member #2 offered the facility's policy titled: "Surgical/Procedural Attire." The policy read in part: "B. Masks: ... 5. Mask must be removed (including those hanging around the neck) and discarded when exiting the surgical suite or other procedural areas where mask are worn ...D. Shoes: ... 7. Shoe covers must be removed when exiting the surgical suite or other procedural areas where shoe covers are worn or when visibly soiled ..."

On 04/24/2017 at 4:50 p.m. Staff Member #2 offered a second policy titled "Uniform, Standard Attire for the Department of Nursing." The policy read in part: "Purpose: To provide a standard dress code for the department of nursing ... 4. e. Hats, caps, bandanas and other head coverings are not allowed unless for medical conditions, safety purposes or established religious customs that have been approved by Human Resources [Sic] ..."The policy did not cover the wearing of shoe covers and used masks lowered around the neck.

An interview was conducted on 04/25/2017 at 8:15 a.m. with Staff Member #16. The surveyor explained the policy provided on 04/24/2017 only offered clarity for surgical attire (burgundy scrubs). The surveyor requested the facility's policy and clarification on the color coded attire of facility staff, the use of shoe covers, mask and other PPE worn outside of the patient care areas.

On 04/26/2017 at 8:05 a.m. a policy was made available titled "Standard Precautions." A note attached to the policy read "PPE." The policy read in part: "B. Personal Protective Equipment (PPE) *PPE should be worn as described ... when the nature of the anticipated patient interaction indicates that contact with blood, body fluids, or other potentially infectious material (OPIM) may occur ... Before leaving the patient's room or cubicle, remove and discard PPE in an appropriate waste container ... B. 1 ... e. Change gloves between tasks ... f. Remove gloves promptly after use, before touching non-contaminated items and environmental surfaces and before going to another patient. Perform hand hygiene using soap and water or an alcohol-based hand rub immediately after glove removal to avoid transfer of microorganisms to other persons or environments. g. Gloves are a single-use item ..."

An interview was conducted on 04/26/2017 at approximately 8:35 a.m. with Staff Members #2, #16 and #18. The surveyor informed the facility staff regarding the observed breaches in infection prevention.

An observation was conducted on 04/26/2017 at approximately 5:58 p.m. as Staff Member #16 escorted the surveyors to the facility's exit. A facility staff member approach and entered the elevator. The facility staff member was dressed in medium green scrubs and had a mask lowered and hanging around his/her neck. Staff Member #16 approached the facility staff member and requested that he/she removed the mask.

An observation was conducted on 04/27/2017 at 2:48 p.m., as Staff Members #13, #33, #47, and #52 escorted the surveyor to the kitchen. Prior to reaching the kitchen while walking down the hallway, a staff member passed wearing burgundy scrubs, hair cover and shoe covers. The surveyor stopped and Staff Member #52 approached the staff member in burgundy scrubs, who identified his/herself as an Anesthesia Technician. Staff Member #52 informed him/her that shoe covers could not be worn outside of patient care areas.

An observation was conducted on 04/27/2017 at approximately 2:50 p.m. as Staff Members #13, #33, #47, and #52 escorted the surveyor to the kitchen. Two staff members walked by in burgundy scrubs one staff member had on shoe covers, a mask hanging around his/her neck. Staff Member #13 approached the staff members wearing the mask and shoe covers, who identifies his/herself as the "First Assist in the Main OR (Operating Room)." Staff Member #13 informed both staff related to infection prevention practices shoe covers were not to be worn in hallways or away from patient care areas and masks were to be discarded in the patient care area.

An observation was conducted on 04/27/2017 at 3:23 p.m. as Staff Members #13, #33, and #52 escorted the surveyor from the kitchen to the dialysis area. The surveyor approached Staff Member #59. Staff Member #59 was wearing tan and black scrubs, hair and shoe covers. Staff Member #59 explained he/she was and "Aide" and wore a hair cover to keep the dust and other substance out of his/her hair. Staff Member #59 reported he/she wore the shoe cover to protect his/her shoes. Staff Member #52 informed Staff Member #59 that shoe covers were not to be worn outside of patient care areas. Staff Member #59 stated, "How can I protect my shoes?" Staff Member #53 did not provide Staff Member #59 with an answer.

An observation was conducted on 04/27/2017 at approximately 5:20 p.m. as Staff Member #16 escorted the surveyors to the facility's exit. A staff member in tan scrubs, head cover and shoe covers was walking in the hallway. Staff Member #16 approached the facility staff member and asked which department he/she worked. The staff member reported he/she worked in "housekeeping." The staff member explained he/she wore the hair covering to keep dust and other substances out of his/her hair. The staff member explained he/she wore the shoe covers to protect his/her shoes in order to prevent taking germs into his/her home. Staff Member #16 relayed the facility's policy related to wearing personal protective equipment (PPE) outside of patient care areas.

6. Observations, interviews and document reviews were conducted on 04/27/2017 from 2:49 p.m. through 3:14 p.m., with Staff Members #13, #33, #46, #47, and #52. The observation revealed a pot sanitizing unit at the end of the three (3) compartment sink. The surveyor requested to review the temperature log for the pot sanitizing unit. Staff Member #47 presented the surveyor a form titled "IWICH POTS MACHINE TEMPERATURE LOG." The form contained areas to record the "Breakfast," "Lunch," and "Dinner" "Wash" and "Final Rinse" temperatures. The temperature log for April 2017 did not have entries for April 9, 2017. Staff Member #46 reported the unit was down for repairs. The surveyor asked Staff Member #46 about the back-up process for ensuring all pots were sanitized if the pot sanitizing unit was down/out of order. Staff Member #46 reported the staff would soak the pots in the three (3) compartment sink's sanitizer section for an "additional thirty (30) minutes." The surveyor requested the work order for the pot sanitizing unit and any documentation related to staff's knowledge to soak the pot for an additional thirty (30) minutes. The pot sanitizing unit "IWICH POTS MACHINE TEMPERATURE LOG" for March 2017 did not have document temperatures for the March 9's "Dinner" run.

The surveyor requested to review the "IWICH POTS MACHINE TEMPERATURE LOG" for January 2017 and February 2017. At 3:10 p.m. Staff Member #47 reported the pot sanitizing unit was not down or out of order on April 9, 2017. Staff Member #47 stated, "The person responsible for entering the temperature failed to do [his/her] task." Staff Member #47 stated, "If the unit is out of service; personnel should write that on the log and whatever corrective action was taken in the last column of the log. Staff Member #47 verified the temperatures had not been recorded for March 9, 2017 dinner runs and for all three meal times on April 9, 2017. Staff Member #47 explained the importance of verifying the sanitizing of utensils/dishes/pots as a step to prevent food-borne illness and the spread of food related hazardous microorganisms.

Review of the "IWICH POTS MACHINE TEMPERATURE LOG" for the month of "January 2017" was conducted on 04/28/2017 with Staff Member #16. Staff Member #16 verified dietary personnel failed to enter the "Wash" and "Final Rinse" temperatures for the "Lunch" and "Dinner" on the "IWICH POTS MACHINE TEMPERATURE LOG" for January 18 and 19, 2017. Dietary staff also failed to enter the "Wash" and "Final Rinse" temperatures for the "Dinner" runs on January 27 and 28, 2017.

Review of the "IWICH POTS MACHINE TEMPERATURE LOG" for the month of "FEB (February) 2017" was conducted on 04/28/2017 with Staff Member #16. Staff Member #16 verified dietary personnel failed to enter the "Wash" and "Final Rinse" temperatures for the "Dinner" runs on February 9, 2017. Dietary staff also failed to enter the "Wash" and "Final Rinse" temperatures for the "Lunch" and "Dinner" runs on February 21, 2017.