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.

ASCENSION SETON HAYS 6001 KYLE PKWY KYLE, TX 78640 Oct. 28, 2015
VIOLATION: PATIENT RIGHTS Tag No: A0115
The Condition of Participation for Patient's Rights is not met, the hospital failed to protect patient's rights to recieve care in a safe manner.


Findings included:


A facility nurse (Staff #8) did not follow basic infection control policies and standards of practice. Staff #8 re-used single-use Normal Saline Flush syringes on multiple patients throughout Staff #8's 18 months of employment at the facility. This practice exposed over 550 former patients to infectious disease. Cross refer Tag A 144.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
Based on observation, interview, and record review, the facility failed to ensure that patients received care in a safe setting, in that


- Staff #8, a facility nurse, did not follow basic infection control policies and standards of practice. Staff #8 re-used single-use Normal Saline Flush syringes on multiple patients throughout Staff #8's 18 months of employment at the facility. This practice exposed over 550 former patients to infectious disease.


- The environmental services did not clean patient rooms according to the facility policy, placing patients at risk for acquiring an infectious disease or illness.


Findings included:


During an interview with Staff #5, the Chief Nursing Officer (CNO), in an administrative office and review of the written statement on 10/26/15, at 10:30 a.m., Staff #5 stated that a unit nurse noticed Staff #8, RN (Registered Nurse), on 10/10/15, had an opened single-use syringe lying on her computer cart. The unit nurse thought that Staff #8 was being messy and instructed Staff #8 to discard the opened syringe. The unit nurse did not question why Staff #8 had the opened syringe. Later on that day, when the unit nurse noticed there were multiple opened single-use syringes lying on Staff #8's computer cart, the nurse reported the incident to her supervisor. The supervisor immediately notified nursing administration and Staff #8 was removed from providing patient care on 10/10/2015.


The Discovery of Exposure Incident statement written by Staff #5 on October 10, 2015, revealed the following:


"On October 10, 2015, I was notified by Sr. Director of Nursing about an incident where it was discovered that a nurse was using saline flush syringes on multiple patients. Nurse was immediately taken off the schedule the day of the discovery and was scheduled to meet with team of nursing leaders and support to discuss the incident and practice that she was using.


Risk management and infection control were notified that same afternoon of the incident, October 10, 2015.


Nursing leadership and network support met with RN on the Monday, October 12th at 1500.(3:00 p.m.)


RN was asked to explain her practice and process with using saline flush syringes. RN explained that she did not discard the syringe after 1 single use, because she only used 2 ML (milliliter) per flush process. She stated she did not want to waste the unused saline, and would try to keep patient syringes aligned with each patient. She did not label syringes, but did state that she may have used syringes on multiple patients.


When questioning her about types of IV (intravenous) she would flush, she did say that it could be infusing lines, or saline lock devices. (a needless plastic hub attached to a catheter)
She stated that she was carefully to scrub both the hub of the IV/ saline lock and that she would cleans the cap of the saline syringe prior to re-applying.


When asked about her understanding the mis-use of single use of supplies, she was concerned about cost issues. Infection control shared their concerns around this practice and the potential cross contamination that may have occurred with her practice. The RN stated that she had been practicing this technique since her employment here at (the facility), March 2014.


In follow up discussion with nursing practice/ HR,(human resources) this practice was determined violation of nursing practice, requiring disciplinary action and appropriate communication to Texas BON.(Board of Nursing)"


During an interview on 10/26/15, at 11:00 a.m., Staff #1, the Senior Director of Nursing stated that Staff #8 was the nurse in question. She stated Staff #8 was a nurse for over 20 years in other organizations. She stated that due to the nature of the deficient practice the nurse, Staff #8 was no longer an employee of the facility and Staff #8's actions have been reported to the Texas Board of Nursing. The incident was reported throughout the Network by the Health Care that's Safe committee held on 10/16/15.


During an interview on 10/24/15, Staff #4, the Risk Manager stated that the facility had sent out over 550 certified letters to all patients cared for by Staff #8, informing them of the incident and possible risk of exposure. The information was sent in English and in Spanish. The letters instruct some patients to be tested twice or more based on the dates of care at the hospital. She stated that the facility has contracted with an outside laboratory agency to conduct all laboratory testing. The facility set-up a 24/7 direct hot line for former patients to call for information concerning the incident. The facility determined that there were four patients from out of state, and is setting up services with the patient's local health department. The home bound patients will have a contracted home health agency provide the service. Staff #4 stated that the facility is covering the cost of all testing. She stated the facility is closely monitoring patients who were in close proximity to the (5) patients, known or discovered through the Health Department provided records, to have blood borne pathogens at the time of admission.


Observations on 10/26/15, of unoccupied cleaned rooms on the 3rd and 4th floor nursing units in the afternoon revealed:


-Room 330, the patient sink had deteriorated caulk all around the edges, exposing a gap to the underside of the sink, creating an area were bacteria and mold could accumulate.


-Room 305, there was a pink substance on the inside bed rail. The pull out sofa couch had large areas of missing and cracked laminate,creating fissures where disinfection could not be assured.


-Room 318, the pull out sofa couch had a reddish brown smear on the vinyl. The sink had cracked, chipped laminate, creating an unsafe and unsanitary environment.


-Room 41, there was a brown substance on the lower right bed rail. The bathroom had chipped peeling paint by the shower stall and there was hair left in the drain from the previous patient. The wall baseboard was pulling away from the wall, creating an area for bacteria and mold to accumulate.


During an interview on 10/26/15, at 12:00 p.m., in the administrative office, Staff #20, Environmental Services Director, stated the environmental staff conducts a 10 step cleaning process on all rooms. If the environmental staff finds any maintenance issues, they will report it to the unit staffs to put in a maintenance request. If the item is not corrected in a timely manner, the environmental staff will report it to their supervisor for follow up. He stated the environmental supervisors' conduct routine room checks to ensure the rooms are being cleaned properly.



Review of the facility provided Infection Prevention Standard Precautions (last revised 2/2015) on 10/27/15, reflected:


"Associates are responsible and accountable for adherence to infection prevention and control policies and procedures across the Hospital family, as well as those specific to their department/area.

PURPOSE: To reduce the risk of acquisition and transmission of infections among staff, patients, and visitors.

C. Environment:

1. Clean and disinfect patient care equipment according to Facility Cleaning, and Disinfection and Sterilization Policy #8715.05.


G. Safe Injection Practices:

1. Use aseptic technique to avoid contamination of sterile injection equipment.

2. Needles, cannula and syringes are sterile, single-use items and should not be reused for another patient or to access a medication or solution that might be used for a subsequent patient even if the needle or cannula is changed.

4. Consider a syringe or needle/cannula contaminated once it has been used to enter or connect to a patent's intravenous infusion bag or administration set."


Review of the facility provided Network Nursing Orientation content on 10/27/15, reflected:

"Safe Practices

New sterile needle and syringe for each injection
Use single dose vials when possible
Sterile syringe and needle must be used to access multi-dose vials

Pre-filled saline syringes
Only fluid path is sterile
Preservative free
One time use"


Review of the facility provided Infection Prevention Environmental Cleaning and Disinfection (last revised 2/2015) on 10/27/15, reflected:

"PURPOSE:

A. To prevent the transmission of disease in the health care setting through standardized cleaning and disinfection practices

B. To ensure consistency with standards of practice throughout the SETON network in relation to cleaning, disinfection and sterilization.


POLICY:

A. It is the policy of (the hospital) to maintain a clean and sanitary environment ...

Key Points:

A. Surfaces addressing in this policy should be cleanable, i.e. nonporous and or with intact impermeable covers (e.g. mattresses, pillows, padded exam tables). Any damaged surfaces that expose porous material (e.g. mattress foam, unfinished wood must be recovered or refinished.

IV. RESPONSIBILITIES: (The Hospital) Associates are responsible for maintaining a clean and sanitary environment in their areas. Housekeeping personnel are responsible for regular scheduled cleaning as determined by the leaders of each area. Non-housekeeping personnel are responsible for cleaning and disinfecting their work areas when housekeeping is not available."


During an interview on the morning of 10/28/15, in the administrative conference room, the above findings were confirmed by Staff #1, and # 4.
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
Based on record review, and interview, the facility failed to ensure safe administration of drugs and biological's; a facility nurse re-used single-use normal saline flushes on over 550 patients. The facility nurse did not follow accepted standards of practice regarding safe medication administration and did not follow the facility policy on medication administration.


Finding Included:


During an interview on 10/26/15, at 10:30 a.m., with Staff #5, the Chief Nursing Officer (CNO), in an administrative office, and review of subsequent written statement, Staff #5 stated that on 10/10/15, a unit nurse noticed Staff #8, RN (Registered Nurse), had an opened single-use syringe lying on her computer cart. The unit nurse thought Staff #8 was being messy and instructed Staff #8 to discard the opened syringe. The unit nurse did not question why Staff #8 had the opened syringe. Later on that day, when the unit nurse noticed there were multiple opened single-use syringes lying on Staff #8's computer cart, the unit nurse reported the incident to her supervisor. The supervisor immediately notified nursing administration and Staff #8 was removed from providing patient care on 10/10/15.


The Discovery of Exposure Incident statement written by Staff #5 on October 10, 2015, revealed the following:


"On October 10, 2015, I was notified by Sr. Director of Nursing about an incident where it was discovered that a nurse was using saline flush syringes on multiple patients. Nurse was immediately taken off the schedule the day of the discovery, and was scheduled to meet with team of nursing leaders and support to discuss the incident and practice that she was using.
Risk management and infection control were notified the same afternoon of the incident, October 10, 2015.


Nursing leadership and network support met with RN on the Monday, October 12th at 1500.(3:00 p.m.)


RN was asked to explain her practice and process with using saline flush syringes. RN explained that she did not discard the syringe after 1 single use because she only used 2 ML (milliliter) per flush process. She stated, she did not want to waste the unused saline, and would try to keep patient syringes aligned with each patient. She did not label syringes, but did state that she may have used syringes on multiple patients.


When she was questioned about the types of IV (intravenous) she would flush, she did say that it could be infusing lines, or saline lock devices. (a needless plastic hub attached to a catheter). She stated that she was careful to scrub both the hub of the IV/saline lock and that she would clean the cap of the saline syringe prior to re-applying.


When she was asked about her understanding the mis-use of single use supplies, she voiced her concern about cost issues. Infection control staff shared their concerns around this practice and the potential cross contamination that may have occurred with her practice.
The RN stated that she had been practicing this technique since her employment here at (the facility), March 2014.


In follow up discussion with nursing practice/ HR,(human resources), this practice was determined to be a violation of nursing practice, requiring disciplinary action and appropriate communication to Texas BON.(Board of Nursing)"


Review of the facility provided IV (intravenous) and CVC (central venous catheter) Flush Protocol For Adults (dated 4/2009) on 10/27/15, reflected:


"Peripheral IV, PICC (Peripherally Inserted Central Catheter), Subclavian, Jugular, or Femoral Catheter:

In Use: 3 ml 0.9% NaCl (NS) flush before and after each medication
Not in Use: 10 ml 0.9% NaCl (NS) flush every 12 hours"


Review of the facility provided Medications- Administering- Adults Policy (dated July,2014 ) on 10/27/15, reflected:

"Purpose, to establish a procedure for administering medications to adult patients. Competency, all licensed nurses must demonstrate competency in the administration of medications by passing an approved medication exam for their patient care area prior to administering medications. IV Push through a Saline Lock

5. Flush Saline Lock with 1-3 milliliters (ml) 0.9%Normal Saline (NS) and remove the syringe

8. After medication is injected, remove the syringe.

9. Dispose of syringe in trash.

BD PosiFlush Pre-Filled Syringes Usage Guidelines

AFTER USE:

4. Discard used syringe including any unused solution following institution policy. DO NOT REUSE."


During an interview on 10/28/15, in the administrative conference room, in the morning, the above findings were confirmed by Staff #1, and # 4.
VIOLATION: INFECTION CONTROL Tag No: A0747
Based on observation, interview, and record review, the facility failed to maintain an active, hospital-wide program for the prevention and control of infections and communicable diseases. A staff nurse who had completed facility based training and was providing patient care, potentially exposed over 550 patients to infectious diseases by reusing a single-use disposable syringe. The facility implemented a plan to identify those patients that were potentially exposed, however, they had not implemented a systemic plan to ensure that all staff nurses were using single-use syringes appropriately.


Findings included:


- Staff #8 (staff nurse) did not follow infection control policies and standards of practice. Staff #8 re-used, single-use, disposable Normal Saline Flush syringes on multiple patients throughout Staff #8's 18 months of employment at the facility; placing over 550 former patients at risk of having acquired an infectious disease.


- The environmental services did not clean patient rooms according to the facility policy, placing patients at risk for acquiring an infectious disease or illness.


Cross refer Tag A 749.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on observation, interview, and record review, the facility failed to develop, and implement an effective system to control transmission of infections and communicable diseases within the hospital.


- Staff #8, a facility nurse did not follow infection control policies and standards of practice. Staff #8 re-used, single-use, disposable Normal Saline Flush syringes on multiple patients throughout Staff #8's 18 months of employment at the facility; placing over 550 former patients at risk of having acquired an infectious disease.


- The environmental services did not clean patient rooms according to the facility policy, placing patients at risk for acquiring an infectious disease or illness.


Findings included:


During an interview with the Chief Nursing Officer (CNO) on 10/26/15 at 10:30 a.m. and subsequent review of written statement, in an administrative office, Staff #5 stated a unit nurse noticed Staff #8, RN (Registered Nurse), on 10/10/15, had an opened single-use syringe lying on her computer cart. The unit nurse thought Staff #8 was being messy and instructed Staff #8 to discard the opened syringe. The unit nurse did not question why Staff #8 had the opened syringe. Later on that day, when the unit nurse noticed there were multiple opened single-use syringes lying on Staff #8's computer cart, the unit nurse reported the incident to her supervisor. The supervisor immediately notified nursing administration and Staff #8 was removed from providing patient care on 10/10/2015.


The Discovery of Exposure Incident statement written by Staff #5 on October 10, 2015, revealed the following:

"On October 10, 2015, I was notified by Sr. Director of Nursing about an incident where it was discovered that a nurse was using saline flush syringes on multiple patients. Nurse was immediately taken off the schedule the day of the discovery and was scheduled to meet with team of nursing leaders and support to discuss the incident and practice that she was using.
Risk management and infection control were notified the same afternoon of the incident, October 10, 2015.

Nursing leadership and network support met with RN on the Monday, October 12th at 1500.(3:00 p.m.)

RN was asked to explain her practice and process with using saline flush syringes. RN explained that she did not discard the syringe after 1 single use, because she only used 2 ML (milliliter) per flush process. She stated she did not want to waste the unused saline, and would try to keep patient syringes aligned with each patient. She did not label syringes, but did state that she may have used syringes on multiple patients.

When questioning her about types of IV (intravenous) she would flush, she did say that it could be infusing lines, or saline lock devices. (a needless plastic hub attached to a catheter)
She stated that she was carefully to scrub both the hub of the IV/ saline lock and that she would cleans the cap of the saline syringe prior to re-applying.

When asked about her understanding the miss-use of single use of supplies, she was concerned about cost issues. Infection control shared their concerns around this practice and the potential cross contamination that may have occurred with her practice. The RN stated that she had been practicing this technique since her employment here at (the facility), March 2014.

In follow up discussion with nursing practice/ HR,(human resources) this practice was determined violation of nursing practice, requiring disciplinary action and appropriate communication to Texas BON.(Board of Nursing)"


During an interview on 10/26/15, at 11:00 a.m. Staff #1, the Senior Director of Nursing stated that the Staff #8 was the nurse in question. She stated Staff #8 was a nurse for over 20 years in other organizations. She stated that due to the nature of the deficient practice the nurse, Staff #8 was no longer an employee of the facility and Staff #8's actions have been reported to the Texas Board of Nursing. The incident was reported throughout the Network by the Health Care that's Safe committee held on 10/16/15.


During an interview on 10/24/15, Staff #4, the Risk Manager stated the facility had sent out over 550 certified letters to all patients cared for by Staff #8, informing them of the incident and possible risk of exposure. The information was sent in English and in Spanish. The letters instruct some patients to be tested twice or more based on the dates of care at the hospital. She stated the facility has contracted an outside laboratory agency to conduct all lab testing. The facility set-up a 24/7 direct hot line for former patients to call for information concerning the incident. The facility determined there were four out of state patients and is setting up services with the patient's local health department. Home bound patients will have a contracted home health agency provide the service.


Staff #4 stated that the facility is covering the cost of all testing. She stated the facility is closely monitoring patients who were in close proximity to the (5) patients known or discovered, through the Health Department provided records, to have blood borne pathogens at the time of admission.


The Centers for Disease Control and Prevention (CDC) recommended "Safe Injection Practices to Prevent Transmission of Infections to Patients." CDC stated that the primary breaches in infection control practice that contribute to infectious disease outbreaks were 1) reinsertion of used needles into a multiple-dose vial or solution container (e.g., saline bag), and 2) use of a single needle/syringe to administer intravenous medication to multiple patients. Infectious disease outbreaks could be prevented by adherence to basic principles of aseptic technique for the preparation and administration of parenteral medications. These include the use of a sterile, single-use, disposable needle and syringe for each injection given and prevention of contamination of injection equipment and medication.

CDC further stated that infectious disease outbreaks related to unsafe injection practices indicate that some healthcare personnel are unaware of, do not understand, or do not adhere to basic principles of infection control and aseptic technique.

Although the facility had taken steps to identify 550 patients who were potentially exposed to infectious disease, there were 5 patients involved who were identified to have blood borne pathogens according to the Texas Department of Health, the facility have not done anything, at the time of the survey, to re-evaluate its system to ensure safe medication practices and/or re-educate all staff in safe medication practices. Outbreaks related to unsafe injection practices indicate that some healthcare personnel are unaware of, do not understand, or do not adhere to basic principles of infection control and aseptic technique. One of the contributing factors to breaches of infection control practices is the lack of personnel oversight. Other factors are: a) lack of reinforcement in training programs, and b) failure to monitor for adherence of institutional policies on an ongoing basis.

This situation created an immediate jeopardy to the health and safety of patients which has the likelihood of harm.


Observations on 10/26/15, of unoccupied, cleaned rooms on the 3rd and 4th floor nursing units in the afternoon revealed:


-Room 330, the patient sink had deteriorated caulk all around the edges, exposing a gap to the underside of the sink, creating an area were bacteria and mold could accumulate.


-Room 305, there was a pink substance on the inside bed rail. The pull out sofa couch had large areas of missing and cracked laminate,creating fissures where disinfection could not be assured.


-Room 318, the pull out sofa couch had a reddish brown smear on the vinyl. The sink had cracked, chipped laminate, creating an unsafe and unsanitary environment.


-Room 41, there was a brown substance on the lower right bed rail. The bathroom had chipped peeling paint by the shower stall and there was hair left in the drain from the previous patient. The wall baseboard was pulling away from the wall, creating an area for bacteria and mold to accumulate.


During an interview on 10/26/15, at 12:00 p.m., in the administrative office, Staff #20, Environmental Services Director, stated the environmental staff conducts a 10 step cleaning process on all rooms. If the environmental staff finds any maintenance issues they will report it to the unit staffs to put in a maintenance request. If the item is not corrected in a timely manner, the environmental staff will report it to their supervisor for follow up. He stated the environmental supervisors' conduct routine room checks to ensure the rooms are being cleaned properly.


Review of the facility provided Infection Prevention Standard Precautions (last revised 2/2015) on 10/27/15, reflected:


"Associates are responsible and accountable for adherence to infection prevention and control policies and procedures across the Hospital family, as well as those specific to their department/area. PURPOSE: To reduce the risk of acquisition and transmission of infections among staff, patients, and visitors.

C. Environment:

1. Clean and disinfect patient care equipment according to Facility Cleaning, and Disinfection and Sterilization Policy #8715.05.

G. Safe Injection Practices:

1. Use aseptic technique to avoid contamination of sterile injection equipment.

2. Needles, cannula and syringes are sterile, single-use items and should not be reused for another patient or to access a medication or solution that might be used for a subsequent patient even if the needle or cannula is changed.

4. Consider a syringe or needle/cannula contaminated once it has been used to enter or connect to a patent's intravenous infusion bag or administration set."


Review of the facility provided Network Nursing Orientation content on 10/27/15, reflected:

"Safe Practices

New sterile needle and syringe for each injection
Use single dose vials when possible
Sterile syringe and needle must be used to access multi-dose vials

Pre-filled saline syringes

Only fluid path is sterile
Preservative free
One time use"


Review of the facility provided Infection Prevention Environmental Cleaning and Disinfection (last revised 2/2015) on 10/27/15, reflected:

"PURPOSE:

A. To prevent the transmission of disease in the health care setting through standardized cleaning and disinfection practices

B. To ensure consistency with standards of practice throughout the SETON network in relation to cleaning, disinfection and sterilization.


POLICY:

A. It is the policy of (the hospital) to maintain a clean and sanitary environment ...

Key Points:

A. Surfaces addressing in this policy should be cleanable, i.e. nonporous and or with intact impermeable covers (e.g. mattresses, pillows, padded exam tables). Any damaged surfaces that expose porous material (e.g. mattress foam, unfinished wood must be recovered or refinished.
IV. RESPONSIBILITIES: (The Hospital) Associates are responsible for maintaining a clean and sanitary environment in their areas. Housekeeping personnel are responsible for regular scheduled cleaning as determined by the leaders of each area. Non-housekeeping personnel are responsible for cleaning and disinfecting their work areas when housekeeping is not available."



During an interview on the morning of 10/28/15, in the administrative conference room, the above findings were confirmed by Staff #1, and # 4.