HospitalInspections.org

Based on review of facility policies, interview and review of data gathered as part of a quality measurement for safe procedure review for expected behaviors it was determined the facility failed to provide over sight to staff, document observations and gather information for patient safety reporting. This has the potential to affect all patients served at this facility.

Findings include:


Policy Title: Safe Procedure Review Policy
Audience: All Employees
Original effective date: 10/1/2013 Revision date: 6/1/2015

" II. Policy:
All patients having an operative, invasive or bedside procedure shall have steps taken from the pre-procedure period through the entire procedure to assure verification of the correct person, procedure and site. The tools used will involve active participation and communication from all procedural team members.

III. Procedure: Safe Procedure Review Form

This form is not a part of the Medical Record, but the checklist needs to be followed for every patient who has an invasive procedure that occurs in a procedure room in which anesthesia is involved.

Topics on the checklist included:

A. Before sedation or induction of anesthesia...
B. Site marking...
D. Time out process...
F. Briefing...
G. Before patient leaves the room and debriefing..."


In an interview 10/8/15 at 1:30 PM with Employee Identifier (EI) # 12, Director of OR (Operating Room) stated that EI # 13, the Education Director of OR, was doing direct observations in the OR to observe OR staff related to the safe procedure review for expected behaviors.

Employee Identifier # 12 provided the surveyors with an audit tool related to the safe procedure review process that the hospital was suppose to use to evaluate staff. The tool was to be used during live observations of the OR staff. A review of the information provided from EI # 12 revealed that EI # 13 observed 48 surgical procedures to audit for the safe procedure review. EI # 13 failed to document what specific observations were made, dates of the observations or areas where staff followed or failed to follow the safe procedure review process. The live observation form for the audit tool had three sections titled:

1. Before Induction or Sedation
2. Before the Procedure Start
3. Before Patient and Surgeon Leaves the Room.

Under each section items to observe as being completed by the staff as part of the safe procedure review were listed with yes or no options to select. EI # 13 documented medical record numbers, surgical procedure performed, initials of staff in the OR and the physician's name. There was no other data documented to support staff were following the safe procedure review process and if problems or trends were identified.

In a telephone interview 10/8/15 at 1:44 PM with EI # 13, the Education Director of OR, stated, "I only observed the staff in OR and when they missed a step, I would ask them if that step was covered, I only have documented what's on the form in my book. No documentation of when they didn't follow the process." EI # 13 stated that the observations were completed on different days, but this was not documented on the live observation forms.

The data collected on the Safe Procedure Review failed to indicate problems with staff following the process as written and failed to identify potential areas which could affect patient safety in the OR.

Based on review of facility policies, job descriptions and interview it was determined the facility failed to follow policies related to sterilization of surgical instruments and failed to educate the staff (Scrub Technicians and Circulating Nurses) in the correct process for assuring sterility of instruments prior to use in a surgical setting where a Caesarean Section was performed on Patient Identifier (PI) # 1 on 9/28/15. This has the potential to affect all patients served and did affect PI # 1.


Findings include:

Refer to A - 749 for findings.

Based on review of facility policies, job descriptions and interview it was determined the facility failed to follow policies related to sterilization of surgical instruments and failed to educate the staff (Scrub Technicians and Circulating Nurses) in the correct process for assuring sterility of instruments prior to use in a surgical setting where a Caesarean Section was performed on Patient Identifier (PI) # 1 on 9/28/15. This has the potential to affect all patients served and did affect PI # 1.

Findings include:

Policy Title: Guidelines for Cleaning, Disinfection & Sterilization of Patient Care Items

II. Policy

" A. Classification of Items:
Determining the appropriate category under which a patient item is to be cleaned, disinfected or sterilized depends upon the intended use of that particular item...

1. Critical Items (Class I):
Critical items include any instruments that will be introduced into the patient's bloodstream, through the patient's skin, or into other normally sterile areas.
Examples...surgical instruments...
Meticulous physical cleaning followed by sterilization is required for all critical items...

B. Definitions
Sterilization: Sterilization is the complete elimination or destruction of all forms of microbial life. It may be accomplished by the following physical and chemical methods: steam under pressure; dry heat; hydrogen peroxide, paracetic acid and ethylene oxide...

Patient -Care Objects:
Critical
Sterilized in the hospital- Surgical instruments and devices; trays and sets..."

Policy Title: Sterilization of Instruments and Supplies Policy

I. Policy:

" A. All sterilizers are checked with biological test packs with each load.
B. Articles to be steam sterilized must be decontaminated, cleaned and inspected before wrapping.
C. All items used within a sterile field must be rendered sterile...
F. Articles to be steam sterilized must be wrapped (except where peel-packs are used) as well as a Sterilization Process (steri gauge) Integrator placed inside each package...

II. Procedure:
E. A Sterilization Process (Steri Gauge) Integrator is placed inside the package or open tray, as well as the outside of every package sterilized i.e. steam tape.
F. Instrument set trays will have a listing of all contents placed inside prior to processing and the tray is labeled appropriately.
G. Items for Sterile Processing will be labeled as follows:
1. Name of item or set; and
2. Initials of person assembling the item and the person double checking the completeness of the item or tray."

Policy Title: Instrument Cleaning/Processing

I. Policy:
" B. All instruments, equipment and supplies used for patient care and procedures must be appropriately processed to ensure they are free from infectious bacteria...

II. Procedure:
E. Instruments from instrument sets are counted, re-racked and placed in the instrument tray for sterilization...An instrument count sheet with signature of assembling technician is included in each instrument set..."

Policy Title: Aseptic Technique Policy
Audience: OR (Operating Room) and OB (Obstetrics) Staff

I. Policy:

" A. Basic principles of asepsis and aseptic techniques shall be strictly adhered to in creating and maintaining a sterile field for every surgical procedure...

II. Procedure:
A. Before opening sterile packages, it is the responsibility of the person opening the package to check the:
1. Integrity of the package;
2. Appearance of the sterilization integrator;
3. Chemical integrator on and inside each package to ensure that the item has been subjected to the sterilization process; and ...
B. It is the responsibility of the scrub person to check the sterilization integrator within the sterile pack, in addition to the circulator...
M. When there is any doubt as to the sterility of an item or surface, it is considered contaminated:
3. The following situations should raise doubt about the sterility of an item:
e. Absence of sterility integrated within package."


Policy Title: OSHA Bloodborne Pathogens Exposure Control Plan
Infection Control:

I. Introduction:
" The Occupational Safety and Health Administration (OSHA) has promulgated its occupational exposure to bloodborne pathogens standard to promote the safety of workers who routinely work with and come in contact with materials which may contain infectious agents such as Human Immunodeficiency Virus (HIV), the Hepatitis B Virus (HBV) and the Hepatitis C Virus (HCV)...

III. Policy:
This exposure plan covers all individuals who have potential exposure to blood and other potential infectious materials while at South Baldwin Regional Medical Center. This includes all South Baldwin Regional Medical Center personnel, all contracted employees, all physicians with privileges, all volunteers and all individuals in training (students) for healthcare professions..."

OB Technician (tech) Position Descriptions:
" Position Purpose:
The OB Tech is responsible for assisting in the care of patients under the direction of the RN (Registered Nurse). She is responsible for scrubbing and assisting in cesarean deliveries and maintaining integrity is (in) all surgical procedures...
General Duties:
4. Performs Surgical Scrub duties, maintain OR standards, participates in time outs; performs surgical counts and assists the physician..."

During an investigation into a complaint on 10/6/15 at 3:30 PM, Employee Identifier (EI) # 10, the Chief Nursing Officer (CNO) confirmed a Caesarean Section was performed 9/28/15 on Patient Identifier # 1 with instruments that were not identified as sterile by the biologic indicator in the pack.

An interview was conducted 10/8/15 at 9:55 AM with EI # 4, OB/Scrub Tech who assisted with the surgical procedure 9/28/15. EI # 4 stated that she was trained on the job by another tech who was not a certified OR scrub tech. EI # 4 states since the incident 9/28/15 they are now doing the Safe Procedure Review and the nurses were educated to verify sterility with the indicator with the techs which they were not doing prior to this incident.

EI # 4 states that she was aware of the indicator on the outside of the packet lock changing and the indicator inside but had not been told of the sticker on the outside of the container until this incident.

An interview was conducted 10/8/15 at 10:30 AM with EI # 5, OB Tech. EI # 5 stated that she had been scrubbing for about a year, that it was new to her.

EI # 5 stated that prior to the incident 9/28/15 they were not following Safe Procedure Review timeout and not verifying the sterility indicators with the nurses.

In an interview with EI # 6, Infection Control on 10/8/15 at 11:15 AM she confirmed they had no exposure plan/policy for patient exposure. EI # 6 stated she would follow up with the physician for follow up care and tests post discharge.

In an interview with EI # 7, the Physician Hospitalist on 10/8/15 at 12 noon, he verified he did follow up with an Infection Control Specialist after the incident. EI # 7 stated that after the patient's discharge he would no longer be involved with the follow up post exposure since his role was as the Hospitalist.

In an interview with EI # 8 the Obstetrician, on 10/8/15 at 1:00 PM, she confirmed she was notified 9/29/15 by EI # 1, the Director of Specialty Services that the indicator in the pack had not turned indicating sterility. EI # 8 consulted with EI # 7 the hospitalist regarding treatment for the possible exposure and explained to the patient the incident.

The surveyor asked EI # 8 what the follow up plans were for the patient and further lab studies. EI # 8 stated she would see the patient at a routine 2 week check up and then again in 6 weeks. As for the follow up to the exposure she planned to get with the Infection Control person, EI # 6 for follow up.

A telephone interview was conducted 10/14/15 at 7:50 AM with EI # 9, RN. EI # 9, who served as the circulator during the 9/28/15 surgical case stated that she started working in the OB department in February 2015. She stated that her orientation was completed by several different nurses, that she did have experience in Labor and Delivery but not surgery, had not participated in Caesarean Sections prior to this job. EI # 9 stated that she was not trained to look for sterilization indicators with the techs.

The lack of training for the staff who participated in the C-Section, the failure to follow policies and their job descriptions, resulted in a patient exposure on 9/28/15. During this incident surgical instruments were used that had not been exposed to steam sterilization. Since the 9/28/15 incident hospital staff have been in-serviced on all safety procedures to assure only sterile instruments are used. Survey staff confirmed hospital staff were now aware of the safe procedure review process, following this process and maintaining documentation related to the sterility of the surgical packs used on all C-Sections.

Based on medical record review, hospital policy, interviews and observations the hospital failed to assure sterile surgical instruments were used to perform a Cesarean Section (C-Section) on Patient Identifier (PI) # 1 and that Employee Identifier (EI) # 9, Registered Nurse (RN), and EI # 4, Scrub Tech, were properly trained to check for sterile indicators on surgical packs. This affected PI # 1 and had the potential to affect all patients served.

Findings include:

Refer to A - 944 and A - 951 for findings.

Based on medical record review, observation, hospital policy and interviews the hospital failed to assure the Registered Nurse (RN) performing circulating duties in the Obstetrics (OB) Cesarean Section (C-Section) operating room was properly trained and fully performed her duties related to the Safe Procedure Review process. This affected Patient Identifier (PI) # 1 and had the potential to affect all patients served.

Findings include:

Patient Identifier (PI) # 1 was admitted to the hospital on 9/27/15 at 40 weeks gestation of pregnancy. On 9/28/15 at 7:41 PM, PI # 1 was taken to the Obstetrics (OB) Cesarean Section (C-Section) operating room to deliver her baby. A review of the operative report dated 9/28/15 at 8:25 PM documented "Procedure briefing was performed before incision/puncture/insertion including time out." A review of the anesthesia record revealed documentation a "time out performed" was completed by hospital staff. A review of the delivery summary for this c-section revealed Employee Identifier (EI) # 9, a Registered Nurse (RN), served as the circulator during this procedure and EI # 4, a Scrub Tech, assisted with the procedure. The anesthesia record revealed the surgery ended at 8:37 PM and PI # 1 was taken to the Post Anesthesia Care Unit (PACU).

A review of the postpartum flowsheet dated 9/29/15 at 9:15 AM, documented EI # 1, Director of Speciality Services, was on the OB floor and spoke with EI # 8, the Obstetrician that performed PI # 1's C-Section.

The OB Provider Postpartum Progress Note completed by EI # 8, dated 9/29/15 at 9:26 AM, documented, "notified per surgery director that instruments used in surgery last pm (night) were not processed completely and may pose infection risk will consult medicine for adequate antibiotic coverage, full investigation implemented, pt (patient) informed and questions addressed also infection control to consult with pt regarding screening, expectations, concerns."

A review of the Medical Record (MR) revealed a consultation note dated 9/29/15 at 1:30 PM, documented by EI # 7, a Physician Hospitalist at South Baldwin Regional Medical Center. The consultation note documented PI # 1 underwent a C-Section and "...the patient may have been contaminated with incompletely sterilized surgical instruments." EI # 7 documented he spoke with EI # 8, the Obstetrician that performed PI # 1's C-Section, and also an infectious disease physician. EI # 7 documented PI # 1 agreed to prophylactic therapy and to receive Rocephin and Vancomycin.

Hospital Policy:

Policy Title: Safe Procedure Review Policy
Audience: All Employees
Original effective date: 10/1/2013 Revision date: 6/1/2015

II. Policy:
All patients having an operative, invasive or bedside procedure shall have steps taken from the pre-procedure period through the entire procedure to assure verification of the correct person, procedure and site. The tools used will involve active participation and communication from all procedural team members.

III. Procedure: Safe Procedure Review Form

This form is not a part of the Medical Record, but the checklist needs to be followed for every patient who has an invasive procedure that occurs in a procedure room in which anesthesia is involved.

Topics on the checklist included:

A. Before sedation or induction of anesthesia...
B. Site marking...
D. Time out process...
F. Briefing...
G. Before patient leaves the room and debriefing...

The policy for Safe Procedure Review failed to include documentation under the Briefing section to read with the same information as on the poster in the Operating Room (OR) and OB which reads:
" Nurse and Technologist share:
Sterility including indicator results..."

Policy Title: Aseptic Technique Policy
Audience: OR (Operating Room) and OB (Obstetrics) Staff

I. Policy:

A. Basic principles of asepsis and aseptic techniques shall be strictly adhered to in creating and maintaining a sterile field for every surgical procedure...

II. Procedure:
A. Before opening sterile packages, it is the responsibility of the person opening the package to check the:
1. Integrity of the package;
2. Appearance of the sterilization integrator;
3. Chemical integrator on and inside each package to ensure that the item has been subjected to the sterilization process; and ...
B. It is the responsibility of the scrub person to check the sterilization integrator within the sterile pack, in addition to the circulator...
M. When there is any doubt as to the sterility of an item or surface, it is considered contaminated:
3. The following situations should raise doubt about the sterility of an item:
e. Absence of sterility integrated within package.

During an interview on 10/6/15 at 3:30 PM, Employee Identifier (EI) # 10, the Chief Nursing Officer (CNO) confirmed a Caesarean Section (C-Section) was performed 9/28/15 with instruments that were not identified as sterile by the biologic indicator in the pack.

On 10/06/15 at 4:37 PM, surveyors conducted a tour of the C-Section Operating Room (OR) with hospital staff. During the tour surveyors observed a wall poster in the OR titled, "Safe Procedure Review." On the "Safe Procedure Review" poster it was documented the nurse and technologist shared the responsibility for sterility, including indicator results. During this tour it was confirmed the hospital had a total of 5 C-Section surgical trays. The C-Section surgical trays were observed and all 5 had an outside indicator to show the trays had been exposed to steam sterilization. One of the 5 trays was opened by hospital staff and surveyors observed the biological indicators inside the tray and confirmed the indicators had changed to show the contents of the tray had been sterilized.

A telephone interview was conducted 10/14/15 at 7:50 AM with EI # 9, RN that was the circulating nurse during PI # 1's C-Section on 9/28/15. EI # 9 stated that she started working in the OB department in February 2015. She stated that her orientation was completed by several different nurses and that she did have experience in Labor and Delivery, but not surgery. EI # 9 had not participated in Caesarean Sections prior to working at South Baldwin Regional Medical Center. EI # 9 stated that she was not trained to look for sterilization indicators with the techs prior to the 9/28/15 incident.

Following the 9/28/15 incident South Baldwin Regional Medical Center inserviced Central Sterile and OB Labor and Delivery staff related to the safe procedure review process, checking the sterility of instruments trays and the steam chemical integrator.

An interview was conducted 10/8/15 at 9:55 AM with EI # 4, OB Tech who assisted in PI # 1's C-Section procedure on 9/28/15. EI # 4 stated since the incident on 9/28/15 staff are now following the Safe Procedure Review and the nurses have been educated to verify sterility of the indicator with the techs, which they were not doing prior to this incident.

An interview was conducted 10/8/15 at 10:30 AM with EI # 5, OB Tech. EI # 5 stated that prior to the incident on 9/28/15 staff were not following the Safe Procedure Review timeout and not verifying the sterility indicators with the nurses.

Survey staff confirmed following the 9/28/15 incident the OR and OB staff were aware of the safe procedure review process, following this process and maintaining documentation related to the sterility of the surgical packs used on all C-Sections.

Based on medical record review, hospital policies, observation and interviews it was determined the facility failed to:

1. Follow policies related to sterilization of surgical instruments.

2. Educate the staff (Scrub Technicians and Circulating Nurses) in the correct process for Safe Procedure Review in the Operating Room and Obstetrics when Caesarean Sections are performed.

3. Ensure the sterilization process was followed for surgical instruments used in a Caesarean Section.

This has the potential to affect all patients served and did affect Patient Identifier (PI) # 1.

Findings include:

Patient Identifier (PI) # 1 was admitted to the hospital on 9/27/15 at 40 weeks gestation of pregnancy. On 9/28/15 at 7:41 PM, PI # 1 was taken to the Obstetrics (OB) Cesarean Section (C-Section) operating room to deliver her baby. A review of the operative report dated 9/28/15 at 8:25 PM documented "Procedure briefing was performed before incision/puncture/insertion including time out." A review of the anesthesia record revealed documentation a "time out performed" was completed by hospital staff. A review of the delivery summary for this c-section revealed Employee Identifier (EI) # 9, a Registered Nurse (RN), served as the circulator during this procedure and EI # 4, a Scrub Tech, assisted with the procedure. The anesthesia record revealed the surgery ended at 8:37 PM and PI # 1 was taken to the Post Anesthesia Care Unit (PACU).

A review of the postpartum flowsheet dated 9/29/15 at 9:15 AM, documented EI # 1, Director of Speciality Services, was on the OB floor and spoke with EI # 8, the Obstetrician that performed PI # 1's C-Section.

The OB Provider Postpartum Progress Note completed by EI # 8, dated 9/29/15 at 9:26 AM, documented, "notified per surgery director that instruments used in surgery last pm (night) were not processed completely and may pose infection risk will consult medicine for adequate antibiotic coverage, full investigation implemented, pt (patient) informed and questions addressed also infection control to consult with pt regarding screening, expectations, concerns."

At 10:45 AM the postpartum flowsheet documented EI # 8 was called blood work results and nursing staff documented EI # 8 had consulted EI # 7, a Physician Hospitalist at South Baldwin Regional Medical Center, for antibiotic orders. At 2:00 PM the postpartum flowsheet documented EI # 7 saw PI # 1 and ordered Vancomycin and Rocephin. At 3:00 PM the postpartum flowsheet documented Vancomycin was infusing intravenously as ordered.

A review of the Medical Record (MR) revealed a consultation note dated 9/29/15 at 1:30 PM, documented by EI # 7, a Physician Hospitalist at South Baldwin Regional Medical Center. The consultation note documented PI # 1 underwent a C-Section and "...the patient may have been contaminated with incompletely sterilized surgical instruments." EI # 7 documented he spoke with EI # 8, the Obstetrician that performed PI # 1's C-Section, and also an infectious disease physician. EI # 7 documented PI # 1 agreed to prophylactic therapy and to receive Rocephin and Vancomycin.

Policy Title: Guidelines for Cleaning, Disinfection & Sterilization of Patient Care Items

II. Policy

" A. Classification of Items:
Determining the appropriate category under which a patient item is to be cleaned, disinfected or sterilized depends upon the intended use of that particular item...

1. Critical Items (Class I):
Critical items include any instruments that will be introduced into the patient's bloodstream, through the patient's skin, or into other normally sterile areas.
Examples...surgical instruments...
Meticulous physical cleaning followed by sterilization is required for all critical items...

B. Definitions
Sterilization: Sterilization is the complete elimination or destruction of all forms of microbial life. It may be accomplished by the following physical and chemical methods: steam under pressure; dry heat; hydrogen peroxide, paracetic acid and ethylene oxide...

Patient-Care Objects:
Critical
Sterilized in the hospital- Surgical instruments and devices; trays and sets..."

Policy Title: Sterilization of Instruments and Supplies Policy

I. Policy:

" A. All sterilizers are checked with biological test packs with each load.
B. Articles to be steam sterilized must be decontaminated, cleaned and inspected before wrapping.
C. All items used within a sterile field must be rendered sterile...
F. Articles to be steam sterilized must be wrapped (except where peel-packs are used) as well as a Sterilization Process (steri gauge) Integrator placed inside each package...

II. Procedure:
E. A Sterilization Process (Steri Gauge) Integrator is placed inside the package or open tray, as well as the outside of every package sterilized i.e. steam tape.
F. Instrument set trays will have a listing of all contents placed inside prior to processing and the tray is labeled appropriately.
G. Items for Sterile Processing will be labeled as follows:
1. Name of item or set; and
2. Initials of person assembling the item and the person double checking the completeness of the item or tray."

Policy Title: Instrument Cleaning/Processing

I. Policy:
" B. All instruments, equipment and supplies used for patient care and procedures must be appropriately processed to ensure they are free from infectious bacteria...

II. Procedure:
E. Instruments from instrument sets are counted, re-racked and placed in the instrument tray for sterilization...An instrument count sheet with signature of assembling technician is included in each instrument set..."

Policy Title: Aseptic Technique Policy
Audience: OR (Operating Room) and OB (Obstetrics) Staff

I. Policy:

" A. Basic principles of asepsis and aseptic techniques shall be strictly adhered to in creating and maintaining a sterile field for every surgical procedure...

II. Procedure:
A. Before opening sterile packages, it is the responsibility of the person opening the package to check the:
1. Integrity of the package;
2. Appearance of the sterilization integrator;
3. Chemical integrator on and inside each package to ensure that the item has been subjected to the sterilization process; and ...
B. It is the responsibility of the scrub person to check the sterilization integrator within the sterile pack, in addition to the circulator...
M. When there is any doubt as to the sterility of an item or surface, it is considered contaminated:
3. The following situations should raise doubt about the sterility of an item:
e. Absence of sterility integrated within package."


18259


Policy Title: Safe Procedure Review Policy
Audience: All Employees
Original effective date: 10/1/2013 Revision date: 6/1/2015

II. Policy:
" All patients having an operative, invasive or bedside procedure shall have steps taken from the pre-procedure period through the entire procedure to assure verification of the correct person, procedure and site. The tools used will involve active participation and communication from all procedural team members.

III. Procedure: Safe Procedure Review Form
This form is not a part of the Medical Record, but the checklist needs to be followed for every patient who has an invasive procedure that occurs in a procedure room in which anesthesia is involved.

A. Before sedation or induction of anesthesia...
B. Site marking...
D. Time out process...
F. Briefing...
G. Before patient leaves the room and debriefing..."

The policy for Safe Procedure Review failed to include documentation under the Briefing section to read with the same information as on the poster in the OR and OB which reads:
" Nurse and Technologist share:
Sterility including integrator results..."


During an interview on 10/6/15 at 3:30 PM, Employee Identifier (EI) # 10, the Chief Nursing Officer (CNO) confirmed a Caesarean Section was performed 9/28/15 with instruments that were not identified as sterile by the biologic indicator in the pack.

On 10/06/15 at 4:37 PM, surveyors conducted a tour of the C-Section OR with hospital staff. During the tour surveyors observed a wall poster in the OR titled, "Safe Procedure Review." On the "Safe Procedure Review" poster it was documented the nurse and technologist shared the responsibility for sterility, including indicator results. During this tour it was confirmed the hospital had a total of 5 C-Section surgical trays. The C-Section surgical trays were observed and all 5 had an outside indicator to show the trays had been exposed to steam sterilization. One of the 5 trays was opened by hospital staff and surveyors observed the biological indicators inside the tray and confirmed the indicators had changed to show the contents of the tray had been sterilized.

An interview was conducted 10/8/15 at 9:55 AM with EI # 4, OB Tech who assisted in PI # 1's C-Section procedure on 9/28/15. EI # 4 stated that she was trained on the job by another tech who was not a certified OR scrub tech. EI # 4 states since the incident 9/28/15 staff are now following the Safe Procedure Review and the nurses have been educated to verify sterility of the indicator with the techs, which they were not doing prior to this incident.

An interview was conducted 10/8/15 at 10:30 AM with EI # 5, OB Tech. EI # 5 stated that she had been scrubbing for about a year, that it was new to her. EI # 5 stated that prior to the incident on 9/28/15 staff were not following the Safe Procedure Review timeout and not verifying the sterility indicators with the nurses.

A telephone interview was conducted 10/14/15 at 7:50 AM with EI # 9, RN that was the circulating nurse during PI # 1's C-Section on 9/28/15. EI # 9 stated that she started working in the OB department in February 2015. She stated that her orientation was completed by several different nurses and that she did have experience in Labor and Delivery, but not surgery. EI # 9 had not participated in Caesarean Sections prior to working at South Baldwin Regional Medical Center. EI # 9 stated that she was not trained to look for sterilization indicators with the techs prior to the 9/28/15 incident.

The hospital policy failed to include the pertinent information requiring the Nurse and technologists share: Sterility including integrator results.

Since the 9/28/15 incident hospital staff have been in-serviced on all safety procedures to assure only sterile instruments are used. Survey staff confirmed hospital staff were now aware of the safe procedure review process, following this process and maintaining documentation related to the sterility of the surgical packs used on all C-Sections.

Based on review of facility policies, interview and review of data gathered as part of a quality measurement for safe procedure review for expected behaviors it was determined the facility failed to provide over sight to staff, document observations and gather information for patient safety reporting. This has the potential to affect all patients served at this facility.

Findings include:


Policy Title: Safe Procedure Review Policy
Audience: All Employees
Original effective date: 10/1/2013 Revision date: 6/1/2015

" II. Policy:
All patients having an operative, invasive or bedside procedure shall have steps taken from the pre-procedure period through the entire procedure to assure verification of the correct person, procedure and site. The tools used will involve active participation and communication from all procedural team members.

III. Procedure: Safe Procedure Review Form

This form is not a part of the Medical Record, but the checklist needs to be followed for every patient who has an invasive procedure that occurs in a procedure room in which anesthesia is involved.

Topics on the checklist included:

A. Before sedation or induction of anesthesia...
B. Site marking...
D. Time out process...
F. Briefing...
G. Before patient leaves the room and debriefing..."


In an interview 10/8/15 at 1:30 PM with Employee Identifier (EI) # 12, Director of OR (Operating Room) stated that EI # 13, the Education Director of OR, was doing direct observations in the OR to observe OR staff related to the safe procedure review for expected behaviors.

Employee Identifier # 12 provided the surveyors with an audit tool related to the safe procedure review process that the hospital was suppose to use to evaluate staff. The tool was to be used during live observations of the OR staff. A review of the information provided from EI # 12 revealed that EI # 13 observed 48 surgical procedures to audit for the safe procedure review. EI # 13 failed to document what specific observations were made, dates of the observations or areas where staff followed or failed to follow the safe procedure review process. The live observation form for the audit tool had three sections titled:

1. Before Induction or Sedation
2. Before the Procedure Start
3. Before Patient and Surgeon Leaves the Room.

Under each section items to observe as being completed by the staff as part of the safe procedure review were listed with yes or no options to select. EI # 13 documented medical record numbers, surgical procedure performed, initials of staff in the OR and the physician's name. There was no other data documented to support staff were following the safe procedure review process and if problems or trends were identified.

In a telephone interview 10/8/15 at 1:44 PM with EI # 13, the Education Director of OR, stated, "I only observed the staff in OR and when they missed a step, I would ask them if that step was covered, I only have documented what's on the form in my book. No documentation of when they didn't follow the process." EI # 13 stated that the observations were completed on different days, but this was not documented on the live observation forms.

The data collected on the Safe Procedure Review failed to indicate problems with staff following the process as written and failed to identify potential areas which could affect patient safety in the OR.

Based on review of facility policies, job descriptions and interview it was determined the facility failed to follow policies related to sterilization of surgical instruments and failed to educate the staff (Scrub Technicians and Circulating Nurses) in the correct process for assuring sterility of instruments prior to use in a surgical setting where a Caesarean Section was performed on Patient Identifier (PI) # 1 on 9/28/15. This has the potential to affect all patients served and did affect PI # 1.


Findings include:

Refer to A - 749 for findings.

Based on review of facility policies, job descriptions and interview it was determined the facility failed to follow policies related to sterilization of surgical instruments and failed to educate the staff (Scrub Technicians and Circulating Nurses) in the correct process for assuring sterility of instruments prior to use in a surgical setting where a Caesarean Section was performed on Patient Identifier (PI) # 1 on 9/28/15. This has the potential to affect all patients served and did affect PI # 1.

Findings include:

Policy Title: Guidelines for Cleaning, Disinfection & Sterilization of Patient Care Items

II. Policy

" A. Classification of Items:
Determining the appropriate category under which a patient item is to be cleaned, disinfected or sterilized depends upon the intended use of that particular item...

1. Critical Items (Class I):
Critical items include any instruments that will be introduced into the patient's bloodstream, through the patient's skin, or into other normally sterile areas.
Examples...surgical instruments...
Meticulous physical cleaning followed by sterilization is required for all critical items...

B. Definitions
Sterilization: Sterilization is the complete elimination or destruction of all forms of microbial life. It may be accomplished by the following physical and chemical methods: steam under pressure; dry heat; hydrogen peroxide, paracetic acid and ethylene oxide...

Patient -Care Objects:
Critical
Sterilized in the hospital- Surgical instruments and devices; trays and sets..."

Policy Title: Sterilization of Instruments and Supplies Policy

I. Policy:

" A. All sterilizers are checked with biological test packs with each load.
B. Articles to be steam sterilized must be decontaminated, cleaned and inspected before wrapping.
C. All items used within a sterile field must be rendered sterile...
F. Articles to be steam sterilized must be wrapped (except where peel-packs are used) as well as a Sterilization Process (steri gauge) Integrator placed inside each package...

II. Procedure:
E. A Sterilization Process (Steri Gauge) Integrator is placed inside the package or open tray, as well as the outside of every package sterilized i.e. steam tape.
F. Instrument set trays will have a listing of all contents placed inside prior to processing and the tray is labeled appropriately.
G. Items for Sterile Processing will be labeled as follows:
1. Name of item or set; and
2. Initials of person assembling the item and the person double checking the completeness of the item or tray."

Policy Title: Instrument Cleaning/Processing

I. Policy:
" B. All instruments, equipment and supplies used for patient care and procedures must be appropriately processed to ensure they are free from infectious bacteria...

II. Procedure:
E. Instruments from instrument sets are counted, re-racked and placed in the instrument tray for sterilization...An instrument count sheet with signature of assembling technician is included in each instrument set..."

Policy Title: Aseptic Technique Policy
Audience: OR (Operating Room) and OB (Obstetrics) Staff

I. Policy:

" A. Basic principles of asepsis and aseptic techniques shall be strictly adhered to in creating and maintaining a sterile field for every surgical procedure...

II. Procedure:
A. Before opening sterile packages, it is the responsibility of the person opening the package to check the:
1. Integrity of the package;
2. Appearance of the sterilization integrator;
3. Chemical integrator on and inside each package to ensure that the item has been subjected to the sterilization process; and ...
B. It is the responsibility of the scrub person to check the sterilization integrator within the sterile pack, in addition to the circulator...
M. When there is any doubt as to the sterility of an item or surface, it is considered contaminated:
3. The following situations should raise doubt about the sterility of an item:
e. Absence of sterility integrated within package."


Policy Title: OSHA Bloodborne Pathogens Exposure Control Plan
Infection Control:

I. Introduction:
" The Occupational Safety and Health Administration (OSHA) has promulgated its occupational exposure to bloodborne pathogens standard to promote the safety of workers who routinely work with and come in contact with materials which may contain infectious agents such as Human Immunodeficiency Virus (HIV), the Hepatitis B Virus (HBV) and the Hepatitis C Virus (HCV)...

III. Policy:
This exposure plan covers all individuals who have potential exposure to blood and other potential infectious materials while at South Baldwin Regional Medical Center. This includes all South Baldwin Regional Medical Center personnel, all contracted employees, all physicians with privileges, all volunteers and all individuals in training (students) for healthcare professions..."

OB Technician (tech) Position Descriptions:
" Position Purpose:
The OB Tech is responsible for assisting in the care of patients under the direction of the RN (Registered Nurse). She is responsible for scrubbing and assisting in cesarean deliveries and maintaining integrity is (in) all surgical procedures...
General Duties:
4. Performs Surgical Scrub duties, maintain OR standards, participates in time outs; performs surgical counts and assists the physician..."

During an investigation into a complaint on 10/6/15 at 3:30 PM, Employee Identifier (EI) # 10, the Chief Nursing Officer (CNO) confirmed a Caesarean Section was performed 9/28/15 on Patient Identifier # 1 with instruments that were not identified as sterile by the biologic indicator in the pack.

An interview was conducted 10/8/15 at 9:55 AM with EI # 4, OB/Scrub Tech who assisted with the surgical procedure 9/28/15. EI # 4 stated that she was trained on the job by another tech who was not a certified OR scrub tech. EI # 4 states since the incident 9/28/15 they are now doing the Safe Procedure Review and the nurses were educated to verify sterility with the indicator with the techs which they were not doing prior to this incident.

EI # 4 states that she was aware of the indicator on the outside of the packet lock changing and the indicator inside but had not been told of the sticker on the outside of the container until this incident.

An interview was conducted 10/8/15 at 10:30 AM with EI # 5, OB Tech. EI # 5 stated that she had been scrubbing for about a year, that it was new to her.

EI # 5 stated that prior to the incident 9/28/15 they were not following Safe Procedure Review timeout and not verifying the sterility indicators with the nurses.

In an interview with EI # 6, Infection Control on 10/8/15 at 11:15 AM she confirmed they had no exposure plan/policy for patient exposure. EI # 6 stated she would follow up with the physician for follow up care and tests post discharge.

In an interview with EI # 7, the Physician Hospitalist on 10/8/15 at 12 noon, he verified he did follow up with an Infection Control Specialist after the incident. EI # 7 stated that after the patient's discharge he would no longer be involved with the follow up post exposure since his role was as the Hospitalist.

In an interview with EI # 8 the Obstetrician, on 10/8/15 at 1:00 PM, she confirmed she was notified 9/29/15 by EI # 1, the Director of Specialty Services that the indicator in the pack had not turned indicating sterility. EI # 8 consulted with EI # 7 the hospitalist regarding treatment for the possible exposure and explained to the patient the incident.

The surveyor asked EI # 8 what the follow up plans were for the patient and further lab studies. EI # 8 stated she would see the patient at a routine 2 week check up and then again in 6 weeks. As for the follow up to the exposure she planned to get with the Infection Control person, EI # 6 for follow up.

A telephone interview was conducted 10/14/15 at 7:50 AM with EI # 9, RN. EI # 9, who served as the circulator during the 9/28/15 surgical case stated that she started working in the OB department in February 2015. She stated that her orientation was completed by several different nurses, that she did have experience in Labor and Delivery but not surgery, had not participated in Caesarean Sections prior to this job. EI # 9 stated that she was not trained to look for sterilization indicators with the techs.

The lack of training for the staff who participated in the C-Section, the failure to follow policies and their job descriptions, resulted in a patient exposure on 9/28/15. During this incident surgical instruments were used that had not been exposed to steam sterilization. Since the 9/28/15 incident hospital staff have been in-serviced on all safety procedures to assure only sterile instruments are used. Survey staff confirmed hospital staff were now aware of the safe procedure review process, following this process and maintaining documentation related to the sterility of the surgical packs used on all C-Sections.

Based on medical record review, hospital policy, interviews and observations the hospital failed to assure sterile surgical instruments were used to perform a Cesarean Section (C-Section) on Patient Identifier (PI) # 1 and that Employee Identifier (EI) # 9, Registered Nurse (RN), and EI # 4, Scrub Tech, were properly trained to check for sterile indicators on surgical packs. This affected PI # 1 and had the potential to affect all patients served.

Findings include:

Refer to A - 944 and A - 951 for findings.

Based on medical record review, observation, hospital policy and interviews the hospital failed to assure the Registered Nurse (RN) performing circulating duties in the Obstetrics (OB) Cesarean Section (C-Section) operating room was properly trained and fully performed her duties related to the Safe Procedure Review process. This affected Patient Identifier (PI) # 1 and had the potential to affect all patients served.

Findings include:

Patient Identifier (PI) # 1 was admitted to the hospital on 9/27/15 at 40 weeks gestation of pregnancy. On 9/28/15 at 7:41 PM, PI # 1 was taken to the Obstetrics (OB) Cesarean Section (C-Section) operating room to deliver her baby. A review of the operative report dated 9/28/15 at 8:25 PM documented "Procedure briefing was performed before incision/puncture/insertion including time out." A review of the anesthesia record revealed documentation a "time out performed" was completed by hospital staff. A review of the delivery summary for this c-section revealed Employee Identifier (EI) # 9, a Registered Nurse (RN), served as the circulator during this procedure and EI # 4, a Scrub Tech, assisted with the procedure. The anesthesia record revealed the surgery ended at 8:37 PM and PI # 1 was taken to the Post Anesthesia Care Unit (PACU).

A review of the postpartum flowsheet dated 9/29/15 at 9:15 AM, documented EI # 1, Director of Speciality Services, was on the OB floor and spoke with EI # 8, the Obstetrician that performed PI # 1's C-Section.

The OB Provider Postpartum Progress Note completed by EI # 8, dated 9/29/15 at 9:26 AM, documented, "notified per surgery director that instruments used in surgery last pm (night) were not processed completely and may pose infection risk will consult medicine for adequate antibiotic coverage, full investigation implemented, pt (patient) informed and questions addressed also infection control to consult with pt regarding screening, expectations, concerns."

A review of the Medical Record (MR) revealed a consultation note dated 9/29/15 at 1:30 PM, documented by EI # 7, a Physician Hospitalist at South Baldwin Regional Medical Center. The consultation note documented PI # 1 underwent a C-Section and "...the patient may have been contaminated with incompletely sterilized surgical instruments." EI # 7 documented he spoke with EI # 8, the Obstetrician that performed PI # 1's C-Section, and also an infectious disease physician. EI # 7 documented PI # 1 agreed to prophylactic therapy and to receive Rocephin and Vancomycin.

Hospital Policy:

Policy Title: Safe Procedure Review Policy
Audience: All Employees
Original effective date: 10/1/2013 Revision date: 6/1/2015

II. Policy:
All patients having an operative, invasive or bedside procedure shall have steps taken from the pre-procedure period through the entire procedure to assure verification of the correct person, procedure and site. The tools used will involve active participation and communication from all procedural team members.

III. Procedure: Safe Procedure Review Form

This form is not a part of the Medical Record, but the checklist needs to be followed for every patient who has an invasive procedure that occurs in a procedure room in which anesthesia is involved.

Topics on the checklist included:

A. Before sedation or induction of anesthesia...
B. Site marking...
D. Time out process...
F. Briefing...
G. Before patient leaves the room and debriefing...

The policy for Safe Procedure Review failed to include documentation under the Briefing section to read with the same information as on the poster in the Operating Room (OR) and OB which reads:
" Nurse and Technologist share:
Sterility including indicator results..."

Policy Title: Aseptic Technique Policy
Audience: OR (Operating Room) and OB (Obstetrics) Staff

I. Policy:

A. Basic principles of asepsis and aseptic techniques shall be strictly adhered to in creating and maintaining a sterile field for every surgical procedure...

II. Procedure:
A. Before opening sterile packages, it is the responsibility of the person opening the package to check the:
1. Integrity of the package;
2. Appearance of the sterilization integrator;
3. Chemical integrator on and inside each package to ensure that the item has been subjected to the sterilization process; and ...
B. It is the responsibility of the scrub person to check the sterilization integrator within the sterile pack, in addition to the circulator...
M. When there is any doubt as to the sterility of an item or surface, it is considered contaminated:
3. The following situations should raise doubt about the sterility of an item:
e. Absence of sterility integrated within package.

During an interview on 10/6/15 at 3:30 PM, Employee Identifier (EI) # 10, the Chief Nursing Officer (CNO) confirmed a Caesarean Section (C-Section) was performed 9/28/15 with instruments that were not identified as sterile by the biologic indicator in the pack.

On 10/06/15 at 4:37 PM, surveyors conducted a tour of the C-Section Operating Room (OR) with hospital staff. During the tour surveyors observed a wall poster in the OR titled, "Safe Procedure Review." On the "Safe Procedure Review" poster it was documented the nurse and technologist shared the responsibility for sterility, including indicator results. During this tour it was confirmed the hospital had a total of 5 C-Section surgical trays. The C-Section surgical trays were observed and all 5 had an outside indicator to show the trays had been exposed to steam sterilization. One of the 5 trays was opened by hospital staff and surveyors observed the biological indicators inside the tray and confirmed the indicators had changed to show the contents of the tray had been sterilized.

A telephone interview was conducted 10/14/15 at 7:50 AM with EI # 9, RN that was the circulating nurse during PI # 1's C-Section on 9/28/15. EI # 9 stated that she started working in the OB department in February 2015. She stated that her orientation was completed by several different nurses and that she did have experience in Labor and Delivery, but not surgery. EI # 9 had not participated in Caesarean Sections prior to working at South Baldwin Regional Medical Center. EI # 9 stated that she was not trained to look for sterilization indicators with the techs prior to the 9/28/15 incident.

Following the 9/28/15 incident South Baldwin Regional Medical Center inserviced Central Sterile and OB Labor and Delivery staff related to the safe procedure review process, checking the sterility of instruments trays and the steam chemical integrator.

An interview was conducted 10/8/15 at 9:55 AM with EI # 4, OB Tech who assisted in PI # 1's C-Section procedure on 9/28/15. EI # 4 stated since the incident on 9/28/15 staff are now following the Safe Procedure Review and the nurses have been educated to verify sterility of the indicator with the techs, which they were not doing prior to this incident.

An interview was conducted 10/8/15 at 10:30 AM with EI # 5, OB Tech. EI # 5 stated that prior to the incident on 9/28/15 staff were not following the Safe Procedure Review timeout and not verifying the sterility indicators with the nurses.

Survey staff confirmed following the 9/28/15 incident the OR and OB staff were aware of the safe procedure review process, following this process and maintaining documentation related to the sterility of the surgical packs used on all C-Sections.

Based on medical record review, hospital policies, observation and interviews it was determined the facility failed to:

1. Follow policies related to sterilization of surgical instruments.

2. Educate the staff (Scrub Technicians and Circulating Nurses) in the correct process for Safe Procedure Review in the Operating Room and Obstetrics when Caesarean Sections are performed.

3. Ensure the sterilization process was followed for surgical instruments used in a Caesarean Section.

This has the potential to affect all patients served and did affect Patient Identifier (PI) # 1.

Findings include:

Patient Identifier (PI) # 1 was admitted to the hospital on 9/27/15 at 40 weeks gestation of pregnancy. On 9/28/15 at 7:41 PM, PI # 1 was taken to the Obstetrics (OB) Cesarean Section (C-Section) operating room to deliver her baby. A review of the operative report dated 9/28/15 at 8:25 PM documented "Procedure briefing was performed before incision/puncture/insertion including time out." A review of the anesthesia record revealed documentation a "time out performed" was completed by hospital staff. A review of the delivery summary for this c-section revealed Employee Identifier (EI) # 9, a Registered Nurse (RN), served as the circulator during this procedure and EI # 4, a Scrub Tech, assisted with the procedure. The anesthesia record revealed the surgery ended at 8:37 PM and PI # 1 was taken to the Post Anesthesia Care Unit (PACU).

A review of the postpartum flowsheet dated 9/29/15 at 9:15 AM, documented EI # 1, Director of Speciality Services, was on the OB floor and spoke with EI # 8, the Obstetrician that performed PI # 1's C-Section.

The OB Provider Postpartum Progress Note completed by EI # 8, dated 9/29/15 at 9:26 AM, documented, "notified per surgery director that instruments used in surgery last pm (night) were not processed completely and may pose infection risk will consult medicine for adequate antibiotic coverage, full investigation implemented, pt (patient) informed and questions addressed also infection control to consult with pt regarding screening, expectations, concerns."

At 10:45 AM the postpartum flowsheet documented EI # 8 was called blood work results and nursing staff documented EI # 8 had consulted EI # 7, a Physician Hospitalist at South Baldwin Regional Medical Center, for antibiotic orders. At 2:00 PM the postpartum flowsheet documented EI # 7 saw PI # 1 and ordered Vancomycin and Rocephin. At 3:00 PM the postpartum flowsheet documented Vancomycin was infusing intravenously as ordered.

A review of the Medical Record (MR) revealed a consultation note dated 9/29/15 at 1:30 PM, documented by EI # 7, a Physician Hospitalist at South Baldwin Regional Medical Center. The consultation note documented PI # 1 underwent a C-Section and "...the patient may have been contaminated with incompletely sterilized surgical instruments." EI # 7 documented he spoke with EI # 8, the Obstetrician that performed PI # 1's C-Section, and also an infectious disease physician. EI # 7 documented PI # 1 agreed to prophylactic therapy and to receive Rocephin and Vancomycin.

Policy Title: Guidelines for Cleaning, Disinfection & Sterilization of Patient Care Items

II. Policy

" A. Classification of Items:
Determining the appropriate category under which a patient item is to be cleaned, disinfected or sterilized depends upon the intended use of that particular item...

1. Critical Items (Class I):
Critical items include any instruments that will be introduced into the patient's bloodstream, through the patient's skin, or into other normally sterile areas.
Examples...surgical instruments...
Meticulous physical cleaning followed by sterilization is required for all critical items...

B. Definitions
Sterilization: Sterilization is the complete elimination or destruction of all forms of microbial life. It may be accomplished by the following physical and chemical methods: steam under pressure; dry heat; hydrogen peroxide, paracetic acid and ethylene oxide...

Patient-Care Objects:
Critical
Sterilized in the hospital- Surgical instruments and devices; trays and sets..."

Policy Title: Sterilization of Instruments and Supplies Policy

I. Policy:

" A. All sterilizers are checked with biological test packs with each load.
B. Articles to be steam sterilized must be decontaminated, cleaned and inspected before wrapping.
C. All items used within a sterile field must be rendered sterile...
F. Articles to be steam sterilized must be wrapped (except where peel-packs are used) as well as a Sterilization Process (steri gauge) Integrator placed inside each package...

II. Procedure:
E. A Sterilization Process (Steri Gauge) Integrator is placed inside the package or open tray, as well as the outside of every package sterilized i.e. steam tape.
F. Instrument set trays will have a listing of all contents placed inside prior to processing and the tray is labeled appropriately.
G. Items for Sterile Processing will be labeled as follows:
1. Name of item or set; and
2. Initials of person assembling the item and the person double checking the completeness of the item or tray."

Policy Title: Instrument Cleaning/Processing

I. Policy:
" B. All instruments, equipment and supplies used for patient care and procedures must be appropriately processed to ensure they are free from infectious bacteria...

II. Procedure:
E. Instruments from instrument sets are counted, re-racked and placed in the instrument tray for sterilization...An instrument count sheet with signature of assembling technician is included in each instrument set..."

Policy Title: Aseptic Technique Policy
Audience: OR (Operating Room) and OB (Obstetrics) Staff

I. Policy:

" A. Basic principles of asepsis and aseptic techniques shall be strictly adhered to in creating and maintaining a sterile field for every surgical procedure...

II. Procedure:
A. Before opening sterile packages, it is the responsibility of the person opening the package to check the:
1. Integrity of the package;
2. Appearance of the sterilization integrator;
3. Chemical integrator on and inside each package to ensure that the item has been subjected to the sterilization process; and ...
B. It is the responsibility of the scrub person to check the sterilization integrator within the sterile pack, in addition to the circulator...
M. When there is any doubt as to the sterility of an item or surface, it is considered contaminated:
3. The following situations should raise doubt about the sterility of an item:
e. Absence of sterility integrated within package."


18259


Policy Title: Safe Procedure Review Policy
Audience: All Employees
Original effective date: 10/1/2013 Revision date: 6/1/2015

II. Policy:
" All patients having an operative, invasive or bedside procedure shall have steps taken from the pre-procedure period through the entire procedure to assure verification of the correct person, procedure and site. The tools used will involve active participation and communication from all procedural team members.

III. Procedure: Safe Procedure Review Form
This form is not a part of the Medical Record, but the checklist needs to be followed for every patient who has an invasive procedure that occurs in a procedure room in which anesthesia is involved.

A. Before sedation or induction of anesthesia...
B. Site marking...
D. Time out process...
F. Briefing...
G. Before patient leaves the room and debriefing..."

The policy for Safe Procedure Review failed to include documentation under the Briefing section to read with the same information as on the poster in the OR and OB which reads:
" Nurse and Technologist share:
Sterility including integrator results..."


During an interview on 10/6/15 at 3:30 PM, Employee Identifier (EI) # 10, the Chief Nursing Officer (CNO) confirmed a Caesarean Section was performed 9/28/15 with instruments that were not identified as sterile by the biologic indicator in the pack.

On 10/06/15 at 4:37 PM, surveyors conducted a tour of the C-Section OR with hospital staff. During the tour surveyors observed a wall poster in the OR titled, "Safe Procedure Review." On the "Safe Procedure Review" poster it was documented the nurse and technologist shared the responsibility for sterility, including indicator results. During this tour it was confirmed the hospital had a total of 5 C-Section surgical trays. The C-Section surgical trays were observed and all 5 had an outside indicator to show the trays had been exposed to steam sterilization. One of the 5 trays was opened by hospital staff and surveyors observed the biological indicators inside the tray and confirmed the indicators had changed to show the contents of the tray had been sterilized.

An interview was conducted 10/8/15 at 9:55 AM with EI # 4, OB Tech who assisted in PI # 1's C-Section procedure on 9/28/15. EI # 4 stated that she was trained on the job by another tech who was not a certified OR scrub tech. EI # 4 states since the incident 9/28/15 staff are now following the Safe Procedure Review and the nurses have been educated to verify sterility of the indicator with the techs, which they were not doing prior to this incident.

An interview was conducted 10/8/15 at 10:30 AM with EI # 5, OB Tech. EI # 5 stated that she had been scrubbing for about a year, that it was new to her. EI # 5 stated that prior to the incident on 9/28/15 staff were not following the Safe Procedure Review timeout and not verifying the sterility indicators with the nurses.

A telephone interview was conducted 10/14/15 at 7:50 AM with EI # 9, RN that was the circulating nurse during PI # 1's C-Section on 9/28/15. EI # 9 stated that she started working in the OB department in February 2015. She stated that her orientation was completed by several different nurses and that she did have experience in Labor and Delivery, but not surgery. EI # 9 had not participated in Caesarean Sections prior to working at South Baldwin Regional Medical Center. EI # 9 stated that she was not trained to look for sterilization indicators with the techs prior to the 9/28/15 incident.

The hospital policy failed to include the pertinent information requiring the Nurse and technologists share: Sterility including integrator results.

Since the 9/28/15 incident hospital staff have been in-serviced on all safety procedures to assure only sterile instruments are used. Survey staff confirmed hospital staff were now aware of the safe procedure review process, following this process and maintaining documentation related to the sterility of the surgical packs used on all C-Sections.