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.

CHRISTUS MOTHER FRANCES HOSPITAL SULPHUR SPRINGS 115 AIRPORT RD SULPHUR SPRINGS, TX 75482 Sept. 30, 2015
VIOLATION: PATIENT RIGHTS: INFORMED CONSENT Tag No: A0131
Based on observation, interview and record review, the facility failed to follow their policy and procedure for providing informed consent by anesthesia to patient before having patients sign the consent for anesthesia. The facility was having patients sign the anesthesia consent at the time of pre-registration before seeing and being evaluated by anesthesia.

This deficient practice had the likelihood to cause harm in all patients.

Findings include:


Patient #29 was observed on 09/28/2015 being preadmitted for a surgical procedure by staff #36. Staff #36 placed the Anesthesia Consent in front of the patient and stated, "This is your consent for anesthesia". Patient #29 signed the consent without question.

A review of the document titled INFORMED CONSENT: Anesthesia revealed
PROCEDURE:

Concept of Informed Consent:
Must consist of:
The risks, drawbacks, complications and expected benefits or effects of anesthesia
Alternate choices of and to anesthesia
The nature of the treatment
The risks, drawbacks, complications and expected benefits or effects of such treatment
Potential problems related to recuperation
Any alternatives to the procedure and their risks and benefits
The likelihood of success
Possible result of non-treatment
That the patient understands the information
That the patient has been verbally informed about the anesthesia or procedure
That the patient has had the opportunity to ask questions
Is needed for procedures designated by Texas Medical Disclosure list and is needed for any procedure where anesthesia is planned.

Obtaining Informed Consent:
It is the attending physician's and/or surgeon's responsibility to discuss the need for a procedure requiring anesthesia with the patient and/or surrogate decision maker.
The anesthesia provider is responsible for providing the discussion with the patient regarding anesthesia.
The anesthesia informed consent form is prepared by the anesthesia provider or nurse and is supplemented through written additions that give further information relevant to the patient's condition ........

An interview on 9/28/2015 with staff #35 and staff #36 revealed it was the practice of the facility to have all Anesthesia Consent sign by the patient prior to Anesthesia seeing the patient. Staff confirmed they were not following the facility's policy for informed consent.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
Based on observation, document review and interview the facility failed to:

A. ensure there was evidence discharge teaching was being done. It was the practice of the facility to have patients' sign their discharge instructions in the pre-operative area when the patient was being made ready for surgery.
While observing patient #29 on 9/28/2015 being made ready for surgery staff #36 placed a paper in front of the patient and said this is your discharge paper work and we're going to get you to sign in now. The patient signed the paper. No family was with the patient.
An interview on with staff #36 revealed it was the practice of the facility to have the discharge teaching paper work signed before the patient went to surgery.
An interview 9/29/2015 with staff #15 and staff #37 in the endoscopy area both staff confirmed the patient signed their discharge teaching papers before the procedure.
B. ensure a sanitary environment for the sterile processing of surgical instruments.
A tour of the facility was conducted on 09/28/2015 with the infraction control practitioner, staff #4 and the director of surgery, staff #15. The tour revealed the sterile processing are dirty and in need of cleaning and maintenance. The floors were stained, dull and had no finish. A cloth was taken and wiped on the floor in the corner of the room. The cloth was covered with lint and dirt. Staff #4 and #15 were in agreement the floors were not clean. The dirt that was wiped up on the cloth was from the lack of cleaning and not from days use.
A floor to ceiling cabinet was inspected and found to be overflowing with equipment and supplies. Each of the packaged supplies that were removed was found to be expired with dates from 2008. There were large bundles of red rubber catheters out of their sterile packages and then taped together. These expired supplies were available to be used for patient care. Staffs #2 and #4 were asked to join the tour and verify the findings. An agreement with the surveyor, staff #2, #3, #4 and #15 that the expired supplies found in the floor to ceiling cabinet were too numerous to count. The sterile processing tech was asked why these expired items were being kept and she stated I can just re-sterilize them.
On inspection of a closet in the Sterile Processing Area two small cardboard boxes were inspected. The two boxes were sticky boxes left by the exterminator. (The sticky boxes are used by the exterminator on the next visit to the facility you inspect what type of insect the facility has and treat according to the findings.) The sticky boxes had the appearance of being there for a long time. Cob weds and dust covered the boxes. One of the box had the entire bottom (sticky area) covered in dead bugs. The second box was so full you could not see through it because of dead bugs.
The only sink in the Sterile Processing area faucets were corroded and pitted and not able to be cleaned or disinfected. The drain in the sink was found to be in the same condition (corroded and pitted). In the cabinet under the sink the drain pipes were corroded and pitted with water leaking from them. The cabinet's bottom had a foam rubber mat covering it. When the mat was peeled back it revealed the bottom of the cabinet was covered in rust. High caked on dust was found throughout the sterile processing area. As the surveyor whipped a finger across the top of the autoclave it returned a large volume of dust that was caked to the finger. Clumps of dirt fell straight to the floor.


C. ensure staff followed established policies and participated in unsanitary practices in the surgical department by failing to:

1. provide evidence the required quality control testing was being done on the Cidex OPA Solution Test Strips. Without the quality control testing of the strips the facility could not ensure the endoscopy scope, vaginal probes or any other equipment processes in the Cidex were properly disinfected.
2. provide evidence the preventive maintenance was being done on the autoclaves(steam sterilizer used to sterilize surgical instrument) located in the sterile processing department and the two autoclaves located in the Surgical Department.
3. provide appropriate sterile processing of surgical instruments. The facility was using flash sterilization routinely to process surgical instruments for the convenience of a quick turnaround for surgical sets. Flash sterilization shall be avoided whenever possible.
4. provide quality control for flash sterilization. Flash Sterilization: Quality Control Program required the biologicals to be sent to the sterile processing area. The staff responsible for sterile processing did not know how to incubate the biologicals. (Biologicals are filled with bacteria spores. They are a test used to ensure a steam sterilizer reaches the required temperature to kill the bacteria.)
5. provide required air exchange checks for the Decontamination Area. The area was not being checked to ensure there was a negative air flow. Air exchange and air flow ensures contaminated air is not leaking into the surgical area.
6. provided biological testing according to manufactures recommendations.
The staff responsible for sterile processing did not know the appropriate time to incubate the biologicals. (Biologicals are filled with bacteria spores. They are a test used to ensure a steam sterilizer reaches the required temperature to kill the bacteria.)

An observation on 9/29/2015 was made of the endoscopy scope processing area. The staff was observed as they walked through the process of handling and cleaning a scope. Staff skipped the procedure for running the quality control testing of the Cidex Test Strips,
An interview on 09/29/2015 with staff #15, #37 and #38 in the scope processing room when asked how the quality controls were run on the Cidex OPA Solution Test Strips,staff #37 and #38 stated they used drops. Staff #37 and #38 stated they had moved the drops and they could not be located at this time. Staff #15 was asked, they use drops, the response yes, I guess.
An interview on 09/30/2015 with staff #1, #2, #3, #15 and #19 were asked to provide evidence the Cidex OPA Solution Test Strips were having the required quality control test prior to being used. No evidence was provided.
During the review of the Use of Cidex OPA Solution Test Strips policy it was determined the facility was not following their policy. The personnel in the Respiratory Department, Surgical Department and the Endoscopy Department were not following the policy and running the required controls on the cidex solution test strips.
A review of the facility's policy titled "Use of Cidex OPA Solution Test Strips" revealed
"III. PROCEDURE
Nursing Actins: Rationale:
1. Don personal protective equipment Gloves. Fluid-Repellent gown. Eye protection
2. Check the date on the test strip bottle
3. Record the date that the bottle of Cidex OPA Test Strips was opened on the Container label.
4. Prepare the control solutions to perform the quality Control (QC) test: Verify the expiration date on the Cidex OPA Solution

Full strength Cidex OPA Solution may be
Used as the positive control

Prepare a negative control by diluting 1
Part full strength Cidex
Label each solution
5. Following the Instruction for Use, Dip 3 Test strips into each of the prepared solutions One at a time for 1 full second
6. Check for the following test results. Positive control solution strips should appear completely purple.
Negative control solution strips should either remain blue or exhibit an incomplete change to purple.
7. If the results of the QC test indicate that the test strip is not functioning properly, discard the remaining strips.
8. Cidex OPA Solution will be tested for the MEC prior to each use.
9. Dip entire pad at the end of the test strip into the container. Hold in the test strip solution for 1 full second before removing.
10. Remove excess solution from the indicating pad by standing the strip upright on a paper towel.
11. Read the results of the color reaction on the indicating pad exactly 90 seconds after the test strip was removed from the solution.
12. The indicating pad will be completely turn purple to indicate that the MEC is present..
13. Discard Cidex OPA Solution after 14 days
Even is the test strips indicate a concentration above the MEC.

The manufacturer's recommendation for quality control of Cidex OPA Test Strips are:
"Implementing routine use of control solutions will increase user proficiency, minimize procedural errors and protect against the inadvertent use of outdated product or product that is deteriorated due to improper storage or handling. Each facility should establish its own Quality Control procedures. Perform quality control testing by following DIRECTIONS FOR USE for the appropriate OPA Solution. Preparation of Control Solutions: Verify the OPA Solution is within the expiration date printed on the label.
Positive Control Solution: Use full-strength CIDEX OPA or MetriCide OPA Plus Solution as the positive control. The indicator pad of the strip dipped into the positive control should develop a green color (see PASS color blocks on bottle label).
Negative Control Solution: For CIDEX OPA - Dilute one part of the Positive Control Solution with one part water (1:1). Mix thoroughly. For MetriCide OPA Plus - Dilute one part of the Positive Control Solution with two parts water (1:2). Mix thoroughly. The indicator pad of the strip dipped into the negative control should display a blue color (see FAIL color blocks on bottle label).
If the results from the control solutions are not as expected, do not use the remaining strips for testing disinfectant solutions. Retain the bottle of test strips and contact Serim Research Corporation at 1-800-542-4670 or your local Serim distributor to request technical support.

Multiple request were made of the facility's representative's, staff #1, #2, #3, #15 and #19 for documents revealing when the autoclaves were last cleaned and serviced. No records were made available to the surveyor for review. The facility had three autoclaves. One was in the basement in sterile processing area and two were located in the hallway of the surgical department.
An interview 9/30/2015 with staff #19 revealed staff #12 has scheduled a company to come into the facility to clean and check/service of the Autoclave machine located in the Sterile processing department and the two autoclaves located in the Surgical Department.
During the review of the policy titled "Sterilizer: Preventive Maintenance" the policy revealed:
"II. GUIDELINES
A. Daily, the sterilizer is cleaned and inspected by the trained sterile supply personnel. This includes washing and rinsing all surfaces of the sterilizer and racks with hospital approved disinfectant cloth.
3. The strainer is removed and cleaned daily.
C. The time, temperature documentation devices and temperature pressure gauges are calibrated after any repair affecting sterilizer performance and according to the Biomed routine.
D. Preventative maintenance is performed according to Biomed ' s routine. The
Maintenance record is maintained in the Biomed office.
An observation of the sterile processing room on 09/28/2015 with the CNO, Director of Surgical Services, Risk/Quality, Infection Control Preventionist and the sterile processing technician present, the surveyor whipped a finger across the top of the Autoclave Sterilizer and a large amount of dark grey/brown fibrous material, with the appearance of caked up dust and dirt, balled up and fell to the floor. The Sterilizer had the appearance of being dirty and un-kept. All that were present was asked if they agreed the Autoclave Sterilizer was dirty and all agreed with a "Yes". Staff #3 replied "I don't need to see any more, we need to get housekeeping in here to clean this place".

An observation was made on 9/28/2015 in the Surgical Department with the Director of Surgery present. In the hallway there were two autoclaves (steam sterilizer used to sterilize surgical equipment) and both were being used at the time of the observation. The autoclave with the name 433/533 HCMC was flashing a surgical set to be used on patient #29.

A request was made of staff #15 to review the Immediate Use Steam Sterilization (IUSS) Flash) logs. Staff revealed a log was not kept. We place the strips on a piece of paper with the patient's name and place them in a drawer. Staff #15 was asked if he knew what his usage was and staff #15 replied "it's high. We flash a lot." Asked if you report the usage/percent to Quality staff #15 replied "no".
An interview 09/28/2015 with staff #4 revealed Infection Control was unaware of the high usage of Immediate-Use Steam Sterilization (flash sterilization).
An interview 09/29/2015 with staff #2 revealed Quality was unaware of the high usage of Immediate-Use Steam Sterilization (flash sterilization). The Surgical Department has never been asked to report the usage.
An interview 09/29/2015 with staff #3 revealed Nursing Administration was unaware of the high usage of Immediate-Use Steam Sterilization (flash sterilization).
Staff #15 provided the surveyor a handful of papers in disarray, titled Surgery QI Worksheet, to review the facility's Immediate Use Steam Sterilization usage. The documents revealed the machine being reviewed was named 433/533 HCMC the dates reviewed were:
7/02/2015- Laparotomy Tray and camera -Cycle Number of the sterilizer 501
No accounting for cycle #502
7/02/2015- Batteries- cycle 503
No accounting for cycles 504-514
7/06/2015- Cysto Set- cycle 515
7/06/2015- Cysto Set- cycle 516
No accounting for cycles 517
7/06/2015- Lap Appy tray and camera- cycle 518
No accounting for cycles 519- 561
7/14/2015- Lap Appy tray- cycle 562
No accounting for cycles 563-571
7/15/2015- unable to read- cycle 572
No accounting for cycles 573-599
7/20/2015-Cysto Set- cycle 600
7/20/2015- Cysto Set- cycle 601
7/20/2015- Cysto Set- cycle 602
7/20/2015- Cysto Set- cycle 603
No accounting for cycles 604-609
7/21/2015- Batteries- cycle 610
No accounting for cycles 611-612
7/21/2015- Batteries- cycle 613
7/21/2015- Bone Tray- cycle 614
No accounting for cycles 615
7/21/2015- Batteries- cycle 616
7/21/2015- bone Tray- cycle 617
7/21/2015- unable to read- cycle 618
No accounting for cycles 619-637
7-23-2015-Bone Tray- cycle 638
7/23/2015- Batteries- cycle 639
No accounting for cycles 640-648
7/24/2015- unable to read- cycle 649
No accounting for cycles 650
7/24/2015- Batteries- 651
7/24/2015- Tray O'connor, suction tip-cycle 652
No accounting for cycles 653-654
7/24/2015- Omni- cycle 655
No accounting for cycles 656-660
7/27/2015- Cysto Set- cycle 661
No accounting for cycles 662-677
7/28/2015- alignment piece- cycle 678
7/28/2015- Bone Tray- cycle 679
7/28/2015- batteries- cycle 680
7/28/2015- batteries- 681
No accounting for cycles 682-683
7/29/2015-Cysto Set- cycle 684
No accounting for cycles 685- 698
7/30/2015- Arthroscopy tray- cycle 699
No accounting for cycles 700-711
7/31/2015- Pincher- cycle 712
In month of July 89 loads were Flashed and not accounted for. The facility flashed 211loads in the month of July.

No accounting for cycles713-732
8/04/2015-Batteries- cycle 733
8/04/2015- Lap Chole Tray, Scopes- cycle 734
8/04/2015- Batteries- cycle 735
No accounting for cycles736
8/04/2015- Power, weitlanders, homans- cycle 737
8/04/2015- Batteries- cycle 738
No accounting for cycles739-741
8/05/2015- O'Conner O'Sullivan, Hyst Clamps- cycle 742
No accounting for cycles743-752
8/06/2015- Arthroscopy Tray, light cord- cycle753
8/06/2015- Suction tips X 2-cycle 754
8/06/2015- Arthroscopy Tray, light cord-cycle 755
No accounting for cycles756-762
8/07/2015- Miner Vascular Tray- cycle 763
No accounting for cycles764-773
8/10/2015- Blunt Weitlanders- cycle 774
8/10/2015- Cysto Set- cycle 775
No accounting for cycles776-785
8/11/2015-unable to read- cycle 786
No accounting for cycles787-800
8/12/2015- Batteries- cycle 801
8/13/2015- Batteries- cycle 802
No accounting for cycles 803-819
8/17/2015- 5mm Scope- cycle 820
No accounting for cycles821- 832
8/18/2015- Batteries- cycle 833
No accounting for cycles834-835
8/18/2015- Batteries- cycle 836
8/18/2015- Ankle Trauma Set- cycle 837
No accounting for cycles 838-848
8/20/2015- Batteries- cycle 849
8/20/2015- Bone Set- cycle 850
No accounting for cycles 851- 859
8/21/2015- Cyber Wand- cycle 860
No accounting for cycles 861-877
8/25/2015- Batteries- cycle 878
No accounting for cycles 879-895
8/27/2015- Arthroscopy Tray, Shoulder Tray- Cycle 896
In month of August approximately 148 loads were Flashed and not accounted for. The facility flashed 183 loads in the month of August.

No accounting for cycles 897-924
9/1/2015- Batteries- cycle 925
No accounting for cycles 926- 970
9/06/2015- unable to read- cycle 971
No accounting for cycles 972
9/08/2015- Lap Appy Tray- cycle 973
9/8/2015- Foot Tray, Cordless Driver- cycle 974
No accounting for cycles 975-977
9/08/2015- unable to read- cycle 978
No accounting for cycles 979- 985
9/09/2015- unable to read- cycle 986
No accounting for cycles 987- 1001
9/10/2015- F.S. Inst.- cycle 1002
No accounting for cycles 1003- 1036
9/15/2015- Batteries- cycle 1037
9/15/2015- Hip Ret. Tray- cycle 1038
No accounting for cycles 1039
No Date- Retractor Tray X 2 Power X 1- cycle 1040
No accounting for cycles 1041-1060
9/17/2015- Batteries X 2- cycle 1061
9/17/2015- Shoulder Tray X 2- cycle 1062
No accounting for cycles 1063-1070
9/18/2015- Pincher, suction tip- cycle 1071
9/18/2015- Scopes X 2, grasper X 3, Cautery cord, light cord, camera head- cycle1072
9/18/2015- Lap Chole, Appy Tray- cycle 1073
No accounting for cycles 1074- 1090
9/22/2015- Batteries- cycle 1091
9/22/2015- unable to read- cycle 1092
9/22/2015- Batteries- cycle 1093
No accounting for cycles 1094
9/22/2015- Bone Tray- cycle 1095
For the month of September 1 until Sept.22, 2015 approximately 179 loads were Flashed and not accounted for. The facility flashed 198 loads in the month from September 1 until Sept.22, 2015.

Staff #15 provided the surveyor a handful of papers in disarray, titled Surgery QI Worksheet, to review the facility's Immediate Use Steam Sterilization usage. The second machine being review was also located in the surgical hallway. This machine did not have an identifying number or name. The dates reviewed were:
6/11/2015- Bone Tray- cycle
6/11/2015- 5mm Olympus Scope-Cycle
6/11/2015- batteries- cycle
No accounting for cycles -
6/13/2015- Bicep Tendon Tray- cycle
6/13/2015- Batteries- cycle
6/13/2015- Bone Tray- cycle
No other current documents were made available for review by the surveyor after multiple requests of staff #1, #2, #3, #15 and staff #19. This autoclave machine was observed being used on 9/28/2015 and 9/29/2015.

During the review of the policy titled "Sterilization: Flash" the policy revealed:
"GUIDELINE STATEMENT
A. This policy outlines the procedure for providing adequate sterilization of surgical instrumentation and equipment using a flash autoclave. Flash sterilization shall be avoided whenever possible. Flash sterilization may be utilized only in the following instances:
I. Manufacturer ' s recommendation
2. Emergency situations when no replacement instruments are available."
A review of the 2014 edition of the book titled Perioperative Standards and Recommended Practices (AORN) revealed immediate use steam sterilization (IUSS) should be kept to a minimum and should be used only in selected clinical situations and in a controlled manner. Immediate use steam sterilization should be used only when there is insufficient time to process the preferred wrapped or container method intended for terminal sterilization.
Immediate use steam sterilization should be performed only if all of the following conditions are met:
The device manufacturer's written instructions he device manufacturer's written instructions included instructions for IUSS.
The device manufacturer's written instructions for cleaning , cycle type, exposure times, temperature settings, and drying times (if recommended) are available and followed.
Items are placed in a containment device that has been validated for IUSS and cleared by the FDA for this purpose and in a manner that allows steam to contact all instrument surfaces.
The containment device manufacturer's written instructions for use are followed.
Measures are taken to prevent contamination during transfer to the sterile field.
Items subject to IUSS are used immediately and not stored for later use or held from one procedure to another.

The review of document authored jointly by AAMI, AORN, APIC titled "Immediate-Use Steam Sterilization" revealed "Today, however, "flash sterilization" is an antiquated term that does not fully describe the various steam sterilization cycles now used to process items not intended to be stored for later use. Current guidelines may require longer exposure times and/or the use of single wrappers or containers designed to allow for aseptic transfer of an item to the point of use. The term "immediate-use steam sterilization" more accurately reflects the current use of these processes.

An observation was made on 9/28/2015 in the Sterilization Processing Area with the Director of Surgery and the Infection Control Practitioner present. The sterile processing tech was asked to talk the surveyor through process of sterilizing surgical instruments. After going through the process the surgical tech was not able to the answer the question, what was the time for incubating the biological.

An interview on 9/28/2015 with the sterile processing tech with staff #4 and #15 present revealed the tech did not know the manufacturer's recommendation for incubating the biological test. The Sterile processing Tech was asked how long were the biologicals incubated for. The Sterile processing Tech's response was, "I was taught for about 3 or 4 hours, just until it turns color, then I throw it out. If I process a lode later in the day I place the biological in the incubator and read it the next morning. The tech was asked do you know what the manufacturer's recommendation for incubating the biological test. The response was no, I just do what I was taught.

The question was asked of staff #15, as the surgical director, do you know what the manufacturer's recommendation for incubating the biological test. Staff #15 replied, "No".

The question was asked of staff #4, as the Director of Infection Control do you know what the incubation time is. Staff #4 responded "No".

With all above mentioned staff present the manufacture's recommendation for incubating the biological was reviewed. The manufacture's recommendation's revealed Interpretation:
3. Biological growth from the sterilization failure may be detected in as soon as 3-5 hours .....
4. Act on a positive test as soon as it is observed ....
5. The recommended incubation time is 10 hours ...

A review of the document titled "Flash Sterilization: Quality Control Program" revealed:

"POLICY STATEMENT:
The purpose is to ensure that materials processed through the steam sterilizer by flash sterilization method have been exposed to the prescribed sterilization process.
GUIDELINES
A. Policies and procedures should be followed and consistent:
1. Should be consistent for the quality of patient care
2. Should enhance the performance of new personnel
B. Records should be kept and documented for each sterilize load as follows:
1. General contents;
2. Duration and temperature of the exposure phase of the cycle (on computer print);
3. Initials of the operator;
4. The identification number of the sterilizer (on computer print).
5. The date and time (on computer print).
C. If flash sterilization for implantable devices is unavoidable
1. Maintain full trace ability to the patient. (refer to tract ability of patient policy and procedure).
2. Run a biological indicator with the load and provide;
a. General contents of implantable devices load on a card with patients' name or hospital number
b. Send biological indicator with device contents card to Sterile
Supply and is read 24 hours later by the Sterile Supply technician.
1. A negative pass response to the biological indicator denotes a sterilize malfunction. (See Policy and Procedure for sterilizer malfunctions).

A review of the 2014 edition of the book titled "Perioperative Standards and Recommended Practices" (AORN) revealed:

"VII.f. Immediate use steam sterilization should not be used for implantable devices except in cases of defined emergency when no other option is available .....
VII.g. Documentation of cycle information monitoring results should be maintained in a log ....
VII.g.2. A record describing what could have been done to prevent IUSS of the implant should be completed and used as part of a quality monitoring system ....."


During an observation of the surgical instrument decontamination area with the Director of Surgery and the Infection Control Practitioner present. Staff f #15 was asked if the room had had the airflow checked. Staff #15 stated maintenance would have that information.

Staff #4 was asked if infection control monitored if airflow in critical areas of the hospital were being monitored. Staff #4 stated that would be maintenance.

An interview with staff #15 was not aware if the decontamination area had a negative air flow. Staff #15 was not aware if there were any vent filters or if the vent filters were being changes.

An interview with staff #12 revealed he was not aware of the decontamination area in the OR department. Staff #12 had not checked the Decontamination area for a negative or positive airflow. Staff #12 had not checked the Decontamination area for air exchange. The Decontamination area should be no fewer than 10 air exchanges per hour.

During the review of the policy titled "Decontamination Area" revealed

"IV. Guideline G. Ventilation System:
1. Should be negative pressure.
2. Is exhausted to a filtered partial re- circulating system.
3. There should be no fewer than 10 air exchanges per hour (monitored by Safety Officer.)

A review of the 2014 edition of the book titled Perioperative Standards and Recommended Practices (AORN) revealed:

"Physical separation aids in achieving environmental and microbial control. Suring manual cleaning of instruments, particulates, aerosolized matter, dust and microbial counts are elevated. Physical separation and vented airflow to the outside minimizes potential contamination of processed items".

A review of a document titled Air Exchange Report revealed an outside contracted company was contracted to enter the facility and check the air exchange in 21 areas of the hospital. The decontamination area was not on the list to be checked.


An observation was made on 9/28/2015 in the Sterilization Processing Area with the Director of Surgery and the Infection Control Practitioner present. The sterile processing tech was asked to talk the surveyor through process of sterilizing surgical instruments. After going through the process the surgical tech was not able to the answer the question, what was the time for incubating the biological.


An interview on 9/28/2015 with the sterile processing tech with staff #4 and #15 present revealed the tech did not know the manufacturer's recommendation for incubating the biological test. The Sterile processing Tech was asked how long were the biologicals incubated for. The Sterile processing Tech's response was, "I was taught for about 3 or 4 hours, just until it turns color, then I throw it out. If I process a lode later in the day I place the biological in the incubator and read it the next morning. The tech was asked do you know what the manufacturer's recommendation for incubating the biological test. The response was no, I just do what I was taught.

The question was asked of staff #15, as the surgical director, do you know what the manufacturer's recommendation for incubating the biological test. Staff #15 replied, No.

The question was asked of staff #4, as the Director of Infection Control, do you know what the incubation time is. Staff #4 responded, No.

With all above mentioned staff present the manufacture's recommendation for incubating the biological was reviewed. The manufacture's recommendation's revealed Interpretation:
3. Biological growth from the sterilization failure may be detected in as soon as 3-5 hours .....
4. Act on a positive test as soon as it is observed ....
5. The recommended incubation time is 10 hours ...


A review of the document titled "Biological Testing" revealed

"1. GUIDELINE STATEMENT
A record of Biological Testing in Surgery is maintained for the purpose of tracking.
II. RESPONSIBILITY
Surgery staff competent in running the Flash Sterilizer.
III. PROCEDURE
A. Both sterilizers will have a biological test run the first load on each Monday or first day of the week in case of the Monday being a holiday.
B. A biological test is run on all major repairs and all implantable devices.
C. Follow the instructions on the form and send to Sterile Supply as soon as possible.

A review of the 2014 edition of the book titled "Perioperative Standards and Recommended Practices" (AORN) revealed:

VIII.e.4. Biological indicators should be used to monitor sterilizer efficacy. Efficacy monitoring should be performed at least weekly and preferably daily.

XX.c. All physical, chemical, and biological monitoring results, including result from controls, should be interpreted by qualified personnel in the time frame specified by the manufacturer or the monitor and should be included in the sterilization record.


It was determined that these deficient practices of not following these policies created an environment that place patient safety in an Immediate Jeopardy situation, resulting in the likelihood of harm, serious injury, and subsequent death to patients