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The facility did not meet the Condition of Participation: CFR 482.12 Governing Body when it failed to develop a system, adopt and approve hospital policy and procedure, monitor and evaluate the daily operation of the contracted services, monitor personnel files of all for required immunizations, and for following manufacturer's instructions when disinfecting medical equipment for all patients requiring dialysis services in a universe of 293 patients.

The cumulative effect of these systemic problems had the potential to result in the failure of the hospital to deliver quality care in a safe setting by failing to ensure:

1. The dialysis contracted services were evaluated by the Governing Body for safe, quality of care (Refer to A- 0083).


2. Qualified Registered Nurses, who were assigned to patients receiving contracted dialysis (a medical treatment conducted by a machine that removes waste, salt, and extra water from blood to prevent them from building up in the body) services were competent to perform break relief for the contracted dialysis nurses when providing dialysis services. (Refer to A-0392)

3. Eight of 12 contracted dialysis employee personnel files were kept current with documentation of Influenza vaccine, Hepatitis B (a serious disease caused by a virus that can cause scarring of the liver, liver failure, liver cancer, and even death) immunization, and Tuberculosis (a bacteria called mycobacterium that attacks the lungs) immunizations, and Influenza immunizations (Refer to A-0749).


4. Policies address steps to take when there are discrepancies between a device manufacturer's instructions and automated high-level disinfection equipment manufacturer's instruction for completing high-level disinfection. (Refer to A-0749)

5. Policies address steps to take when there are discrepancies between a device manufacturer's instructions and the sterilizer's manufacturer's instruction for completing sterilization. (Refer to A-0749)

Based on interview and record review, the hospital failed to develop a system, adopt and approve hospital policy and procedure, and monitor the daily operations of the contracted dialysis services to provide safe, quality of care.

These failures had the potential to increase the risk of patient exposure of a contagious disease, such as Hepatitis, (a viral liver disease which can lead to poor health, and possibly liver cancer) for all patients receiving dialysis in the hospital, in a universe of 293 patients.

Findings:

1. During an interview with the Quality Director (QD), on February 1, 2016, at 5:00 PM, she stated she evaluated the dialysis contracted service on December 3, 2015, and was unable to provide documented evidence of any prior evaluations of the service.

During an interview with the contracted dialysis service Biomedical Technical Manager (BTM), on February 2, 2016, at 7:45 AM, he stated the dialysis contracted service has not received a "report-card" type performance evaluation from the facility.

During an interview with the QD, on February 2, 2016, at 8:45 AM, she stated she currently was not sending the dialysis committee meeting minutes to any other committee for review, and did not know what the Governing Body thought of the contracted dialysis service currently in place. The QD was unable to provide documented evidence the dialysis contracted service was reviewed by the Board of Directors (BOD) for the provision of safe, quality care to the hospitalized patients receiving the contracted dialysis services.


During an interview with the QD, on February 2, 2016, at 4:50 PM, she reviewed the "Contract Checklist" dated October 10, 2013, for the contracted dialysis service, noting "N/A (non-applicable)" was indicated next to the sentence "Board of Directors Approval (if greater than or equal to $250,000)." The QD confirmed the BOD did not approve the dialysis contracted service because the contract value was less than $250,000.00.
Therefore the GB did not review the dialysis contracted services due to its internal criteria of only reviewing contracts of $250,000.00, or more.

A review of the GB minutes for the year beginning 2015, to February 4, 2016 (present time,) indicated there was no documented evidence the GB evaluated the quality of the dialysis contracted service. In a concurrent interview with the Director of Medical Staff Services, on February 4, 2016, at 10:13 AM, he confirmed there was no documented evidence the GB had evaluated the contracted dialysis service for all patients receiving the services in the hospital.

During an interview with the hospital Chairman of Medicine (MD 1), on February 4, 2016, at 10:35 AM, he stated he was aware there was a dialysis committee, but "I have never been involved."

During an interview with a Governing Body Member 1 (GB 1), on February 4, 2016, at 11:10 AM, he stated if the subject of an evaluation for the contracted dialysis services came up in a Board meeting "The Board would not discuss it."

During an interview with the Medical Director (MD 2), on February 4, 2016, at 11:30 AM, MD 2 stated the Quality Assessment and Performance Improvement (QAPI-a process that assesses the quality of care provided to patients) for the contracted dialysis service, was discussed in the dialysis committee meetings...and his company has provided acute dialysis services for the hospital patients, since 1994.


During an interview with the Chief Operating Officer/ Chief Nursing Officer (COO/CNO), on February 4, 2016, at 3:20 PM, the COO/CNO stated the hospital's nursing staff complete an evaluation of the contracted dialysis service, but "It's not a formal evaluation." During this interview, she stated the information gathered in the dialysis committee was not shared with the BOD, or other committees... "We haven't been doing that."


The facility document titled "Organizational Quality and Performance Excellence Plan- 2016," indicated "...Authority and Responsibility: The Board of Directors (BOD) has the ultimate authority and responsibility for quality and patient safety for (name of hospital)...The Board of Directors will receive reports at least quarterly from the Medical Executive Committee regarding hospital departments, medical staff and organizational performance excellence activities...Board of Directors: The Board of Directors will oversee the quality and safety of care and service provided to (name of hospital) patients."


A review of the Governing Body Bylaws, titled "Bylaws of (Name of Hospital)," dated October 10, 2013, indicated "...Article II. Purpose...Section 3. Community Benefit. The mission of this Corporation is to provide charitable hospital and other healthcare services of the highest quality to members of the communities which it serves...endeavors to deliver compassionate, high quality affordable health services..."

The facility failed to meet Conditions of Participation: CFR 482.21Quality Assessment and Performance Improvement Program when it failed to develop and maintain an ongoing hospital wide, data-driven quality assessment and performance improvement program of all services furnished under the contract or arrangement which was under the direct oversight of the Governing Body by ensuring:

1. That all contracted dialysis (a medical treatment conducted by a machine that removes waste, salt, and extra water from blood to prevent them from building up in the body services) services were evaluated for Quality and Patient Safety by the Governing Body, and that Policies and Procedures were in place approved by the Governing Body. (Refer to A-0083)

2. That qualified Registered Nurses were competent to perform break relief for contracted dialysis nurses assigned to dialysis patients while providing treatment. (Refer to A-0392)

3. That Infection Control practices were being followed in the Labor and Delivery unit, Neonatal Intensive Care Unit (a unit of the hospital where pre-mature babies are cared for), and Medical-Surgical units (Refer to A-0749).

4. The Neonatal Intensive Care Unit (a unit in the hospital where pre-mature babies are cared for, also know as NICU) freezer and refrigerator (used to store breast milk) temperatures, were monitored and recorded daily (Refer to A-749).


5. Personal protective equipment were worn by a Registered Nurse (RN), a Medical Doctor (MD), and a Environmental Service (EVS) worker, when entering and exiting contact isolation rooms (a room where potential bacteria can be spread by physical contact) without properly wearing isolation gowns and performing hand hygiene before exiting patient room (s). (Refer to A-0749)


6. Eight of 12 contracted dialysis nurses' personnel files, were found to have missing documentation of a pre-employment health exam, current status for Hepatitis B (a serious disease caused by a virus that can cause scarring of the liver, liver failure, liver cancer, and even death), and Influenza immunizations. (Refer to A-0749)


7. The Operating Room (O.R.) disinfectant cleaner was used according to the manufacturer's instructions. (Refer to A-0749)


8. All hinged surgical instruments were sterilized in the open position for effective sterilization. (Refer to A-0749)


11. There was consistent documentation of Dialysis machine cleaning. (Refer to A-0749)


12. Policies were developed to address steps to take when there are discrepancies between a device manufacturer's instructions, and automated high-level disinfection equipment manufacturer's instruction for completing high-level disinfection. (Refer to A-0749)


13. Policies were developed to address steps to take when there are discrepancies between a device manufacturer's instructions and the sterilizer's manufacturer's instruction for completing sterilization. (Refer to A-0749)


The cumulative effect of these systemic problems resulted in the failure of the hospital to deliver care in a safe manner to be in compliance with the Condition of Participation for Quality Assessment and Performance Improvement Program.

Based on interview and record review, the hospital's governing body must ensure that the program reflects the complexity of the hospital's organization and services, including those services furnished under contract. This deficient practice had the potential to affect the health and safety of all inpatients undergoing dialysis services in a universe of 293 patients.

Findings:

During an interview with the Quality Director (QD), on February 1, 2016, at 5:00 PM, she stated she evaluated the dialysis contracted service on December 3, 2015, and was unable to provide documented evidence of any prior evaluations of the contracted dialysis service being provided for the hospital.


During an interview with the contracted dialysis service Biomedical Technical Manager (BTM), on February 2, 2016, at 7:45 AM, he stated the dialysis contracted service has not received a "report-card" type performance evaluation from the facility or from the hospital's quality assurance department.


During an interview with the QD, on February 2, 2016, at 8:45 AM, she stated she didn't know what the GB thought of the contracted dialysis service, and she currently was not sending the dialysis committee meeting minutes to any other committee for review. The QD was unable to provide documented evidence the dialysis contracted service was reviewed by the Board of Directors (BOD) for patient safety, and the quality of service provided by the contracted dialysis service to the hospitalized patients requiring dialysis treatments. There was no documented evidence that the hospital developed policies and procedures regarding the contracted dialysis service being provided for the hospital. There was not evidence that the hospital had oversight of the the services being provided by the contracted dialysis service.


During an interview with the QD, on February 2, 2016, at 4:50 PM, she reviewed the "Contract Checklist" dated October 10, 2013, for the contracted dialysis service, noting "N/A (non-applicable)" was indicated next to the sentence "Board of Directors Approval (if greater than or equal to $250,000)." The QD confirmed the BOD did not approve the dialysis contracted service because the contract value was less than $250,000. (Indicating the hospital does not internally review contracts less than $250, 000.00 in value which was done or not reviewed in this case).


During an interview with the hospital Chairman of Medicine (MD 1), on February 4, 2016, at 10:35 AM, he stated he was aware there was a dialysis committee, but "I have never been involved."


During an interview with the Chief Operating Officer/ Chief Nursing Officer (COO/CNO), on February 4, 2016, at 3:20 PM, the COO/CNO stated the hospital nursing staff do an evaluation of the contracted dialysis service, but "it's not a formal evaluation." Concurrently, she stated the information gathered in the dialysis committee was not shared with the BOD, or other committees... "We haven't been doing that."


During an interview with a Governing Body Member (GB1), on February 4, 2016, at 11:10 AM, he stated if the subject of an evaluation for the contracted dialysis services would come up in a Board meeting " I can't remember The Board discussing it."


The facility document titled "Organizational Quality and Performance Excellence Plan- 2016," indicated "...Authority and Responsibility: The Board of Directors (BOD) has the ultimate authority and responsibility for quality and patient safety for (name of hospital)...The Board of Directors will receive reports at least quarterly from the Medical Executive Committee regarding hospital departments, medical staff and organizational performance excellence activities...Board of Directors: The Board of Directors will oversee the quality and safety of care and service provided to (name of hospital) patients."


A review of the GB minutes for the year beginning 2015, to present time, indicated there was no documented evidence the GB evaluated the quality of the dialysis contracted service, or there was evidence of approved policies and procedures adopted by the hospital of the services provided by the contracted dialysis company. In a concurrent interview with the Director of Medical Staff Services, on February 4, 2016, at 10:13 AM, he confirmed there was no documented evidence the GB had evaluated the contracted dialysis service for all patients receiving dialysis services in the hospital.


A review of the Governing Body Bylaws, titled "Bylaws of (Name of Hospital)," dated October 10, 2013, indicated "...Article II. Purpose...Section 3. Community Benefit. The mission of this Corporation is to provide charitable hospital and other healthcare services of the highest quality to members of the communities which it serves...endeavors to deliver compassionate, high quality affordable health services..."

Based on interview and record review, the facility failed to formulate a process or system to provide break coverage for all contracted dialysis nurses for all facility patients receiving dialysis services in a universe of 293 patients.

This failure had the potential to place the dialysis patients' who are receiving the dialysis contracted service at risk for injury, increased length of stay in the hospital, and possible death.

Findings:

During an interview with the Charge Nurse for 3 Tower (CN3T), on February 2, 2016, at 3:25 PM, she stated the facility nurse provides a break for the contracted dialysis nurse, but they do not have the training and competency to run the dialysis machine. Concurrently, she stated the dialysis nurse must remain at the bedside at all times...they do encourage the dialysis nurse to take breaks before the beginning the treatment, or after the conclusion of the treatment.

During an interview with Registered Nurse 2 (RN 2,) on February 2, 2016, at 3:30 PM, she stated the facility nurses provide break coverage for the contracted dialysis nurse... " A couple of times per week."

During an interview with the Chief Operating Officer/Chief Nursing Officer (COO/CNO), on February 4, 2016, at 2:55 PM, she stated the staff nurses provide break coverage for the contracted dialysis nurse..."But, they do not have competencies to run the dialysis machine."

Concurrently, the COO/CNO stated The Quality Director is responsible for the contracted dialysis services but, "Ultimately, it is reported to me."

A review of the facility document, dated September 2013, titled "Job Description - Title: Chief Operating Officer and Chief Nursing Officer...Position Summary: The COO/CNO provides the leadership, management...to ensure the company has the proper operational controls, administrative and reporting procedures... has authority, responsibility, and accountability for nursing services throughout the organization."

The facility did not meet the Condition of Participation: CFR 482.42 Infection Control when the hosptal failed to deliver care in a sanitary manner when it failed to follow hospital policy and procedure to evade activities that could potentially be a source of transmission of a hospital acquired communicable disease for all patients in a universe of 293 patients


1. A sterile vaginal delivery pack (surgical instruments used by an MD when delivering a baby) was not dated and timed when opened. (Refer to A-0749)

2. An open bottle of Glucola (a sugary drink used to test pregnant patients for diabetes) dated September 15, 2015 was observed in a medication refrigerator on the Labor and Delivery Unit. (Refer to A-0749)

3. On the Neonatal Intensive Care Unit (a unit of the hospital where newly born babies are admitted or care, also called NICU) the temperature logs for the freezer and refrigerator used to store breast milk had several dates without a temperature recorded. (Refer to A-749)

4. A Registered Nurse (RN 1), a Medical Doctor (MD 3), and a Environmental Service worker (EVS 1), were observed entering and exiting contact isolation rooms (a room where potential bacteria can be spread by physical contact) without properly wearing isolation gowns (a form of protective clothing used when entering an isolation room) and were not performing hand hygiene before exiting patient room (s). (Refer to A-0749)

5. Eight of 12 contracted dialysis ( nurses' personnel files, were found to have missing documentation of a pre-employment health exam, and current status for Hepatitis B and Influenza immunizations. (Refer to A-0749)

6. Ensure the Operating Room (OR) disinfectant cleaner was used according to the manufacturer's instructions. (Refer to A-0749)

7. Ensure all hinged surgical instruments were sterilized in the open position for effective sterilization. (Refer to A-0749)

8. Ensure there was consistent documentation of Dialysis machine cleaning. (Refer to A-0749)

9. Develop policies to address steps to take when there are discrepancies between a device manufacturer's instructions and automated high-level disinfection equipment manufacturer's instruction for completing high-level disinfection. (Refer to A-0749)

10. Develop policies to address steps to take when there are discrepancies between a device manufacture's instructions and the sterilizer's manufacturer's instruction for completing sterilization. (Refer to A-0749)

The cumulative effect of these systemic problems resulted in the failure of the hospital to deliver care in a sanitary manner to be in compliance with the Condition of Participation for Infection Control.

Based on observation, interview and record review, the facility failed to follow infection control practices in the Labor and Delivery Department, Neoanatal Intrusive Care Unit, and the Periantal Unit in a universe of 293 patients as manifested by:

1. A sterile vaginal delivery pack was not dated and timed when opened in the Labor and Delivery Unit.

2. An open bottle of Glucola was observed in a medication refrigerator on the Labor and Delivery Unit dated September 15, 2015.

3. In the Neonatal (a newly born baby who usually have a higher need of nursing care) Intensive Care Unit (NICU), the temperature logs for the refrigerator and freezer used to store breast milk, had multiple dates without a temperature recorded.

4. A Registered Nurse (RN 1), Medical Doctor (MD 3), and an Environmental Service (EVS 1) worker were observed entering and exiting contact isolation rooms (rooms where potential contaminates can be spread by contact) without properly wearing isolation gowns, and/or not performing hand hygiene before exiting the patient's rooms.

These deficient findings had the potential to affect the health and safety of all patients requiring obstetrical services in a universe of 293 Pateints. .


Findings:

1. During an observation with the Clinical Director of Labor and Deliver (CDLD), the Quality /Risk Manager (QRM), and the Clinical Director of Pediatrics (CDP), on February 1, 2016, at 2:43 PM, on the Labor and Delivery (L&D) Unit, in an unoccupied patient room, an open vaginal delivery pack (a sterile package containing supplies needed for a vaginal delivery) was observed opened and set up on a table covered by a blue drape. The blue drape was without a date or time to indicated when the sterile vaginal package was opened.

During a concurrent interview with the CDLD, she verified the opened vaginal pack was not dated or timed, and stated the delivery pack should not have been opened until close to delivery (the time a baby is born). The CDLD stated she did not know when the delivery package was opened.

During an interview with the QRM on February 5, 2016 at 9:55 AM, she stated there was no facility policy indicating how long a sterile delivery pack could be opened before the sterility of the contents expired (was no longer safe for use).

2. During an observation on February 1, 2016, at 2:55 PM, accompanied by the CDLD, QRM, and CDP, in the medication room on the L&D Unit, an open bottle of Glucola, (a sugary drink used to test pregnant patients' for diabetes) was half empty, dated September 15, 2015.

During a concurrent interview with CDP, she verified the date on the opened bottle was September 15, 2015 and stated the Glucola should have been discarded in September when it was opened.

During an interview with the QRM on September 5, 2016, at 9:55 AM, the QRM stated the "Glucola was not a medication and should not have been stored in the medication refrigerator. The Glucola is a one time use product provided by the laboratory for Glucose Tolerance Testing."

During an interview with the QRM on February 5, 2016, at 9:40 AM, she stated there was no facility policy or lab policy addressing glucose tolerance testing.

3. During an observation on February 1, 2016 at 3:40 PM, in the Neonatal (newly born baby) Intensive Care Unit (NICU) with the NICU charge Nurse (NCN), the QRM and CDP, the Breast Milk Refrigerator #1 (BMR1), Breast Milk Freezer #1 (BMF1), and Breast Milk Freezer #2 (BMF2) temperature logs were missing daily temperature checks on the following dates;

BMR1:
September 03, 2015
September 26, 2015
September 30, 2015
November 17, 2015
November 19, 2015
November 22, 2015
November 27, 2015
November 29, 2015
December 10, 2015
December 16, 2015
December 17, 2015
December 20, 2015
December 22, 2015
December 23, 2015
December 25, 2015
December 29, 2015
January 26, 2016

BMF1:
November 17, 2015
November 22, 2015
November 27, 2015
November 29, 2015
December 25, 2015
January 27, 2016

BMF2:
November 03, 2015
November 0 4, 2015
November 10, 2015
January 26, 2016

During a review of the facility document titled "Temperature Daily Log," the instructions indicated "Plot daily temp..."

During an interview with the QRM, on February 5, 2016, at 9:37 AM, she stated there was not a facility policy and procedure for daily monitoring of the refrigerator and freezer containing breast milk.

During an interview with the CDP, on February 5, 2016, at 10:30 AM, she stated there was not a facility policy indicating how often the breast milk refrigerator and freezer should be checked.

A review of an undated copy of the NICU daily staff assignment sheet indicated the day (7:00 AM to 7:00 PM) shift should check and record temperatures daily.

4. During an observation on February 2, 2015, at 12:00 PM, in the Critical Intensive Care Unit (CN3T), it was observed in Patient 1's isolation room, that a Registered Nurse (RN 1) was wearing an isolation gown which was not securely closed and tied. The back of the isolation gown was open and the ties were observed to be dragging on the floor.

During a concurrent interview with the Clinical Manager for 3 Tower (CM3T), she confirmed the back of the isolation gown was not securely closed and tied and the ties were dragging on the floor. CN3T stated the back of the gown should be closed and tied at the waist, and the staff were taught to do so.

During an observation on February 2, 2015, at 3:50 PM, with the QRM, Clinical Director 3 Tower (CD3T), and Medical Doctor (MD 3) was observed in Patient 12's contact isolation room to have the isolation gown pulled over his arms and chest, exposing his shoulders. The isolation gown was opened in the back and not tied at the neck or at the waist. No hand hygiene was observed upon exiting the room.

During a concurrent interview with MD 3, he pointed to the nurses station and said he was going to wash his hands at the sink.

During a concurrent interview with the QRM, and CD3T, they verified MD 3 did not wear the isolation gown according to the facility policy, and stated he should have worn the isolation gown over the shoulders, closed at the back of the gown, and should have tied the gown at the waist. The QRM and CD3T verified MD 3 did not wash his hands before leaving Patient 12's room, and stated he always washes his hands at the nurse's station.

During an observation on February 3, 2016, at 10:55 AM, with the Clinical Director of 3 Plaza (CD3P), Environmental Service Worker (EVS 1) was observed entering Patient 3's contact isolation room and preparing to empty trash without wearing an isolation gown.

During a concurrent interview with the CD3P, she verified EVS 1 did not wear an isolation gown when entering Patient 3's room. CD3P then reminded EVS 1 to wear an isolation gown.

During a concurrent observation, EVS 1 was observed exiting Patient 3's room without removing the isolation gown.

During a concurrent interview with EVS 1, she stated she should have removed the gown before leaving the room.

During an interview on February 4, 2016, at 10:45 AM, with the Director of Environmental Services (DEVS), he stated the Environmental Services employees receive training on isolation techniques, they are taught how to put the isolation gown and gloves (known as personal protective equipment -PPE) on prior to entering the isolation room, and they are taught how to remove the gown and gloves prior to leaving the isolation room, regardless if they are touching anything or not.

During an observation on February 3, 2016, at 10:38 AM, a Registered Nurse (RN 3) was observed entering Patient 3's isolation room, opened and placed supplies in a drawer, without putting on the PPE prior to entering the room.

During an interview with RN 3, February 3, 2016, at 10:45 AM, immediately after leaving Patient 3's room, she stated she was just stocking and did not need to wear PPE.

During a concurrent interview with CD3P, on February 3, 2016, at 10:48 AM, she stated RN 3 should have worn PPE because she touched a surface that was potentially contaminated.


The facility policy and procedure titled "Categories of Isolation", dated June, 2014, indicated, "The Infection Control Program shall follow the Center for Disease Control (CDC) guidelines for hospital isolation to promote a safe environment and reduce the risks of transmitting pathogens in the hospital environment...Contact Precautions: Private room is recommended. Gowns are indicated (required) upon entering room...Hand hygiene is performed before clean procedures, patient contact, and after gloves are removed..."


33549

Based on intervew and record review the facility failed to monitor (name of service) contracted dialysis nursing staff employee files, to ensure a pre-employment health exam had been completed, and for evidence of current Hepatitis B immunizations and the annual influenza (or a written declaration of decline) the vaccine(medication injection throught the skin and into the muscle by a needle) for eight of 12 dialysis nursing staff.

This failure had the potential for transmission of a hospital acquired infectious disease for an already immunocompromised (does not have the ability to fight off disease) patient population resulting in an hospital acquired infection, leading toan increased length of hospital stay, and possible death.

5. During a review of (name of service) contracted employee personnel files, (conducted with
the facility Chief Human Resources Officer - CHRO), on February 5, 2016, at 10:00 AM, the following employees were found to be without current documentation:

Employee #1 Current annual influenza vaccine

Employee #2 Current annual influenza vaccine

Employee #3 Pre-employment health exam
Hepatitis B (a serious disease caused by a virus that can cause scarring of the
liver, liver cancer and even death).

Employee #4 Pre-employment health
Current annual influenza vaccine

Employee #5 Pre-employment health exam
Hepatitis B immunization

Employee #9 pre-employment health exam
Expired purified protein derivative (a test to check for the bacteria called mycobacterium tuburculosis-a disease that usually affects the lungs spread by breathing exhaled air from an infected person).
Employee #10 pre-employment health exam
Hepatitis B immunization

Employee #11 Pre-employment health exam
Expired purified protein derivative testing (PPD)
Hepatitis B immunization

During a concurrent interview with the CHRO, she stated she was not aware of the missing employee file documentation, and it was the contracted service's responsibility for maintaining their employee files and providing our department with a copy of any updated license and immunizations.

A review of the hospital policy and procedure (undated) titled "Human Resources and Payroll Records Records...All Employees Enterprise Wide...5. Information regarding employees' health and all related health information will be maintained in a separate file in accordance with the law."


6. During an observation on February 3, 2016, at 11:45 AM, in the Cystoscopy (procedure using a scope to visualize the inside of the bladder) Room, the Surgery Aide (SA) was observed cleaning the cystoscopy bed ( a special bed used during the procedure) with disinfectant. The SA wiped down the bed pad, and after thirty seconds, the bed pad was observed to become dry at all four corners of the pad. The SA did not reapply disinfectant to the dried areas of the pad.

During a concurrent interview, on February 3, 2016, at 11:50 AM, the SA stated the cleaning product was "SaniMaster" and the product wet contact time (amount of time the manufacturer required the disinfectant to have contact with the bed pad in order to kill bacteria) was two minutes.
During a concurrent interview, on February 3, 2016, at 11:55 AM, withThe Administrative Director of Surgical Services confirmed the observation and the SA's statement of the "SaniMaster" contact wet time of two minutes.)

During an interview with the Director of Environmental Services, on February 3, 2016, at 12:10 PM, he stated the product was "SaniMaster" and the wet contact time was ten minutes.

A review of the manufacturer's instructions for the "SaniMaster 4" product indicated "Disinfection: ...Apply solution ...Allow to remain wet for 10 minutes ..."

7. During an observation on February 1, 2016, at 3:45 PM, in the sterile instrument storage area, two Pedicle clamps (locking surgical forceps) were noted to be in the closed position after sterilization. Four towel clamps (a clamp with sharp points used in surgery) were also noted to be in the closed position after sterilization.

During a concurrent interview with the surgical reprossing lead (SRL), she confirmed the pedical and towel clamps were in the closed position and removed them from the area to be sterilized again.

A review of the AORN (Association of perioperative Registered Nurses) Guideline for Cleaning and Care of Surgical Instruments, effective November 15, 2014, indicated "Recommendation IX. Surgical instruments and equipment should be cleaned and decontaminated according to the manufacturer's validated, written instructions for use (IFU) ...IX.a.1. In preparation for manual cleaning, instruments should be disassembled and ports, valves, stop cocks, ratchets, and joints should be opened...Opening and disassembling instruments facilitates contact of the cleaning solution with all surfaces of the instruments ... "

8. During a review of the "Equipment Log Sheet/Acute Dialysis Services" dated January 21, 2016, the log indicated a row of data was missing under the "Post-Dialysis Checklist" portion of the document. The blank areas included "Time, Clean-Wipe Disinfect, Acid Rinse Vinegar, Chemical Disinfect/Bleach Present (+), Chemical Disinfect/Residual Negative (-), Heat Disinfect, RO Machine Disinfect, and RN Team Mate. "

During a review of the "Acute Dialysis Services Daily Patient Log" dated January 21, 2016, the log indicated Patient #1 was treated using Machine Number E451, the start time of the treatment was 20:10 (8:10 PM) and the completed time was 23:10 (11:10 PM)." During a concurrent interview with the Quality Director, on February 1, 2016, 4:05 PM, she confirmed the data and asked that we discuss it further with the Biomedical Technical Manager.

A review of the (contracted dialysis service) policy, section 4, indicated "Machine Set-Up, Maintenance & Disinfection ...That each machine will be cleaned and wiped down with hospital approved disinfectant after each use. At the end of the treatment day each machine will be subject to heat or chemical disinfection. After the disinfection of the machine is complete, the presence of residual bleach will be tested at the drain. If the machine is negative, the machine may be turned off. If the machine is positive then an additional rinse cycle will be completed and the machine retested. "

9. During an interview with the Infection Control Practitioner (ICP) on February 2, 2016, at 7:25 AM, she stated she did not have anything in writing within the facility's Infection Control policies to address what steps to take if the device manufacturer's instructions were inconsistent with the high-level disinfection equipment manufacturer's instructions, for completing high-level disinfection.

10. During a concurrent interview with the ICP, she stated she did not have anything in writing within the facility's Infection Control policies to address what steps to take if the device manufacturer's instructions were inconsistent with the sterilizer's manufacturer's instructions for completing sterilization.

The ICP was asked if the facility had any Infection Control policies that address what steps to take if the device manufacturer ' s instructions were inconsistent with the sterilizer ' s manufacturer ' s instructions for completing sterilization. The ICP stated " No, not in writing. "

Based on observation, interview and record review, the facility failed to follow infection control practices in the Labor and Delivery Department, Neoanatal Intrusive Care Unit, and the Periantal Unit in a universe of 293 patients as manifested by:

1. A sterile vaginal delivery pack was not dated and timed when opened in the Labor and Delivery Unit.

2. An open bottle of Glucola was observed in a medication refrigerator on the Labor and Delivery Unit dated September 15, 2015.

3. In the Neonatal (a newly born baby who usually have a higher need of nursing care) Intensive Care Unit (NICU), the temperature logs for the refrigerator and freezer used to store breast milk, had multiple dates without a temperature recorded.

4. A Registered Nurse (RN 1), Medical Doctor (MD 3), and an Environmental Service (EVS 1) worker were observed entering and exiting contact isolation rooms (rooms where potential contaminates can be spread by contact) without properly wearing isolation gowns, and/or not performing hand hygiene before exiting the patient's rooms.

These deficient findings had the potential to affect the health and safety of all patients requiring obstetrical services in a universe of 293 Pateints. .


Findings:

1. During an observation with the Clinical Director of Labor and Deliver (CDLD), the Quality /Risk Manager (QRM), and the Clinical Director of Pediatrics (CDP), on February 1, 2016, at 2:43 PM, on the Labor and Delivery (L&D) Unit, in an unoccupied patient room, an open vaginal delivery pack (a sterile package containing supplies needed for a vaginal delivery) was observed opened and set up on a table covered by a blue drape. The blue drape was without a date or time to indicated when the sterile vaginal package was opened.

During a concurrent interview with the CDLD, she verified the opened vaginal pack was not dated or timed, and stated the delivery pack should not have been opened until close to delivery (the time a baby is born). The CDLD stated she did not know when the delivery package was opened.

During an interview with the QRM on February 5, 2016 at 9:55 AM, she stated there was no facility policy indicating how long a sterile delivery pack could be opened before the sterility of the contents expired (was no longer safe for use).

2. During an observation on February 1, 2016, at 2:55 PM, accompanied by the CDLD, QRM, and CDP, in the medication room on the L&D Unit, an open bottle of Glucola, (a sugary drink used to test pregnant patients' for diabetes) was half empty, dated September 15, 2015.

During a concurrent interview with CDP, she verified the date on the opened bottle was September 15, 2015 and stated the Glucola should have been discarded in September when it was opened.

During an interview with the QRM on September 5, 2016, at 9:55 AM, the QRM stated the "Glucola was not a medication and should not have been stored in the medication refrigerator. The Glucola is a one time use product provided by the laboratory for Glucose Tolerance Testing."

During an interview with the QRM on February 5, 2016, at 9:40 AM, she stated there was no facility policy or lab policy addressing glucose tolerance testing.

3. During an observation on February 1, 2016 at 3:40 PM, in the Neonatal (newly born baby) Intensive Care Unit (NICU) with the NICU charge Nurse (NCN), the QRM and CDP, the Breast Milk Refrigerator #1 (BMR1), Breast Milk Freezer #1 (BMF1), and Breast Milk Freezer #2 (BMF2) temperature logs were missing daily temperature checks on the following dates;

BMR1:
September 03, 2015
September 26, 2015
September 30, 2015
November 17, 2015
November 19, 2015
November 22, 2015
November 27, 2015
November 29, 2015
December 10, 2015
December 16, 2015
December 17, 2015
December 20, 2015
December 22, 2015
December 23, 2015
December 25, 2015
December 29, 2015
January 26, 2016

BMF1:
November 17, 2015
November 22, 2015
November 27, 2015
November 29, 2015
December 25, 2015
January 27, 2016

BMF2:
November 03, 2015
November 0 4, 2015
November 10, 2015
January 26, 2016

During a review of the facility document titled "Temperature Daily Log," the instructions indicated "Plot daily temp..."

During an interview with the QRM, on February 5, 2016, at 9:37 AM, she stated there was not a facility policy and procedure for daily monitoring of the refrigerator and freezer containing breast milk.

During an interview with the CDP, on February 5, 2016, at 10:30 AM, she stated there was not a facility policy indicating how often the breast milk refrigerator and freezer should be checked.

A review of an undated copy of the NICU daily staff assignment sheet indicated the day (7:00 AM to 7:00 PM) shift should check and record temperatures daily.

4. During an observation on February 2, 2015, at 12:00 PM, in the Critical Intensive Care Unit (CN3T), it was observed in Patient 1's isolation room, that a Registered Nurse (RN 1) was wearing an isolation gown which was not securely closed and tied. The back of the isolation gown was open and the ties were observed to be dragging on the floor.

During a concurrent interview with the Clinical Manager for 3 Tower (CM3T), she confirmed the back of the isolation gown was not securely closed and tied and the ties were dragging on the floor. CN3T stated the back of the gown should be closed and tied at the waist, and the staff were taught to do so.

During an observation on February 2, 2015, at 3:50 PM, with the QRM, Clinical Director 3 Tower (CD3T), and Medical Doctor (MD 3) was observed in Patient 12's contact isolation room to have the isolation gown pulled over his arms and chest, exposing his shoulders. The isolation gown was opened in the back and not tied at the neck or at the waist. No hand hygiene was observed upon exiting the room.

During a concurrent interview with MD 3, he pointed to the nurses station and said he was going to wash his hands at the sink.

During a concurrent interview with the QRM, and CD3T, they verified MD 3 did not wear the isolation gown according to the facility policy, and stated he should have worn the isolation gown over the shoulders, closed at the back of the gown, and should have tied the gown at the waist. The QRM and CD3T verified MD 3 did not wash his hands before leaving Patient 12's room, and stated he always washes his hands at the nurse's station.

During an observation on February 3, 2016, at 10:55 AM, with the Clinical Director of 3 Plaza (CD3P), Environmental Service Worker (EVS 1) was observed entering Patient 3's contact isolation room and preparing to empty trash without wearing an isolation gown.

During a concurrent interview with the CD3P, she verified EVS 1 did not wear an isolation gown when entering Patient 3's room. CD3P then reminded EVS 1 to wear an isolation gown.

During a concurrent observation, EVS 1 was observed exiting Patient 3's room without removing the isolation gown.

During a concurrent interview with EVS 1, she stated she should have removed the gown before leaving the room.

During an interview on February 4, 2016, at 10:45 AM, with the Director of Environmental Services (DEVS), he stated the Environmental Services employees receive training on isolation techniques, they are taught how to put the isolation gown and gloves (known as personal protective equipment -PPE) on prior to entering the isolation room, and they are taught how to remove the gown and gloves prior to leaving the isolation room, regardless if they are touching anything or not.

During an observation on February 3, 2016, at 10:38 AM, a Registered Nurse (RN 3) was observed entering Patient 3's isolation room, opened and placed supplies in a drawer, without putting on the PPE prior to entering the room.

During an interview with RN 3, February 3, 2016, at 10:45 AM, immediately after leaving Patient 3's room, she stated she was just stocking and did not need to wear PPE.

During a concurrent interview with CD3P, on February 3, 2016, at 10:48 AM, she stated RN 3 should have worn PPE because she touched a surface that was potentially contaminated.


The facility policy and procedure titled "Categories of Isolation", dated June, 2014, indicated, "The I