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Based on observation, interview and record review, the Governing Body failed to:

A. ensure a patient care/surgical equipment used for invasive surgical procedures was properly sanitized. They failed to ensure there was a sanitary environment for the sterile processing of surgical instruments. They failed to ensure sanitary practices were used in care of the environment and patient care equipment on 7 of 7 units (Surgery, Radiology, Respiratory, Kitchen, Medical/surgical, Emergency Department and Intensive care unit).

Refer to A0144, A0749 and A0951 for additional information.



B. ensure staff followed their policy and procedure for providing informed consent by anesthesia to patient before having patients sign the consent for anesthesia.

Refer to A0131 and A0955 for additional information.


C. ensure surgical patients received post anesthesia evaluations before patients were discharged from the hospital. Anesthesia personnel were not evaluating patients post anesthesia before being discharged from the day surgery care area, nor were they evaluating patients that were admitted to the hospital within the required 48 hours.

Refer to A1005 for additional information.

Based on observation, document review and interview the facility failed to:

A. 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.

Refer to tag A0131 for additional information.


B. provide evidence of discharge teaching 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.

Refer to tag A0144 for additional information.



C.1. provide a sanitary environment for the sterile processing of surgical instruments.


C.2. provide evidence of the required quality control testing done on the Cidex OPA Solution Test Strips. Without the quality control testing of the strips the facility could not ensure the endoscopes, vaginal probes or any other equipment processed in the Cidex were properly disinfected.

C.3. provide evidence of the preventive maintenance 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.

C.4. 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.

C.5. 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.)

C.6. The air exchange at the decontamination area was not being checked as required. The area was not being checked to ensure there was a negative air flow to ensure that air exchange and air flow of contaminated air is leaching into the surgical area.

C.7. Biological Testing- Form.
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.)

Refer to tag A0144 and A0195 for additional information.

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 pre-admitted 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 that 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.

Based on observation, document review and interview the facility failed to:

A. ensure there was evidence of discharge teaching one. 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 it now. The patient signed the paper. No family was with the patient.

An interview on with staff #36 revealed that 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 that the sterile processing area are dirty and in need of cleaning and maintenance. The floors were stained, dull and had no finish. A cloth was taken and used to wipe on the floor in the corner of the room. The cloth was covered with lint and dirt. Staff #4 and #15 were in agreement that 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. Staff #2, #3, #4 and #15 agreed with the surveyors 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 faucets in the only sink in the Sterile Processing area 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 that the bottom of the cabinet was covered in rust. Areas caked on dust was found throughout the sterile processing area. As the surveyor whipped a finger across the top of the autoclave machine, 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. The unsanitary practices in the surgical department were determined to create an environment that placed patient safety in an Immediate Jeopardy situation, resulting in the likelihood of harm, serious injury, and subsequent death to patients.

Refer to tag A0951 for additional information.

Based on interview and record review, the facility failed to ensure accurate nursing assessments were done and interventions were implemented on patients who were at risk for suicide, receiving anesthetic agents and presenting to the Emergency Department (ED) with pain. This was found in 5 of 5 patients (Patient #s' 18, 19, 23, 24, and 25).
This deficient practice had the likelihood to cause harm in all patients.

Findings include:

Review of the clinical record of Patient #19 revealed she was a 32 year old, female, who presented to the emergency department on 09/18/2015, at 3:02 p.m., with a chief complaint of suicide ideation. Patient #19 was taken to the seclusion room.

Review of the triage assessment revealed Patient #19 had a history of bipolar and schizophrenia disorder, was sent over from the mental health mental retardation center and given a classification of ESI3 (meaning urgent). Patient #19 also had a pain level of 10 (0 being no pain and 10 being worst possible). According to nurses notes, Patient #19 revealed she wanted to hurt herself at 3:02 p.m.. The first documentation of a complete suicide assessment was at 6:47 p.m. (3 hours and 45 minutes after presenting to the ED). There was documentation at 6:47 p.m. that Patient #19 was placed on suicide precautions. At 6:47 p.m. the pain level was also documented as being 8.

According to nursing documentation at 8:31p.m., Patient #19 was at the desk acting very hostile toward staff, stating that she was having pain and needed something for it. Patient #19 was hesitant to answer the RN assessment questions of pain. Patient #19 states she was having pain all over and always does. Patient #19 then states her pain was in her left eye and ear due to a bad tooth ... RN states will communicate Patient #19 pain to the doctor and see what order he was able to give for pain medication ....Ultram and Tylenol ordered for pain. At 8:33 p.m., Patient #19 was given Ultram and Tylenol (over 5 hours after first complaining of pain).

During an interview on 09/30/2015, after 10:30 a.m., Staff #22 confirmed the acuity assessment was incorrect and should have been at a ESI 2 (Emergent ) level. Staff #22 confirmed a complete suicide assessment was not performed and the pain medication was not administered timely.

Review of the clinical record of Patient #23 revealed he was a 69 year old, male, who presented to the ED on 09/18/2015 at 10:40 a.m. in respiratory arrest. Patient #23 was intubated on admission and at 10:45 a.m., he was given two anesthetic agents Etomidate and Rocuranium (neuromuscular blocker used for anesthesia).

The first documentation of a RASS (Richmond Agitation Sedation Scale) assessment was 45 minutes after medication administration.


Review of the clinical record of Patient #18 revealed, she was a 82 year old, female, who presented to the Emergency department (ED) on 09/19/2015 at 10:06 p.m. Patient #18 was described as being combative and had assaulted a police officer. Patient #18 was seen earlier today in ED for a fall and a laceration repair. Patient #18 was assessed at 10:06 p.m. as having a pain level of 10 (0 being no pain and 10 being worst possible). The initial screening revealed Patient #18 replied "no" to having thoughts of suicide or harming herself. According to nursing documentation at 10:10 p.m., Patient #18 hit police officer multiple times. Patient #18 complained of left wrist pain and was in loose handcuffs at the time. There was no documentation of what was done about the pain.

At 11:31 p.m. (over an hour later), the anti-inflammatory agent Motrin was given for a headache. There was no documentation of what the pain level was at this time. There was no documentation of an assessment or intervention of what was done about the wrist pain.

According to documentation on 09/20/2015, at 01:04 a.m., (almost 3 hours after presenting), Patient #18 came out to the nurses station and stated "I'm going home and I'm going to kill myself". There was no documentation of a suicide assessment being performed at this time or after this.

On 09/20/2015, at 12:10 p.m., Patient #18 was transferred out to a psych hospital.

During an interview on 09/29/2015, after 3:30 p.m., Staff #32 and 33 confirmed the missing assessments.


Review of the clinical record of Patient #24 revealed he was a 45 year old, male, who presented to the ED on 09/20/2015 at 1:54 p.m. with complaints of left shoulder pain (dislocation).

At 2:16 p.m., consents were received for sedation and the reason was for a reduction of the left shoulder.

At 2:18 p.m., the pain agent Dilaudid 0.5 milligrams (mg)intravenous (IV) and antiemetic Zofran 4 milligrams IV was given.

At 2:30 p.m., there was documentation that the procedure started. Nursing documented to "SEE SEDATION FLOW SHEET".

At 2:33 p.m., the anesthetic agent Propofol intravenous push was given.
There was no nursing pre-anesthesia assessment on the chart.

At 3:14 p.m., Patient #24 was discharged from the hospital.

During an interview on 09/30/2015, after 10:30 a.m., Staff #22 confirmed the RASS (Richmond Agitation Sedation Scale) assessment should have been performed, but it was not on the chart.

Review of the clinical record of Patient #25 revealed he was a 31 year old, male, who presented to the ED on 09/23/2015, at 12:30 p.m., with complaints of dyspnea (difficulty breathing), numbness to arms and legs, complaints of neck and shoulder pain for 1 month. The pain level was assessed on admission at the level of 4. Patient #25 was given an anxiety agent during his stay and a diagnosis of Panic disorder. Patient #25 was discharged at 2:45 p.m. and there was no documentation of a reassessment of the pain level prior to discharge.

Review of the facility policy named "ASSESSMENT/REASSESSMENT" dated 08/2015 revealed the following:

III. PROCEDURE

B.1. The RN collects comprehensive data pertinent to the patient's health and/or situation in a systematic and on-going process

2. Patients's in the ER are to reassessed on basis of acuity and or any change in status.

IV. SPECIAL CONSIDERATION

A. Assessments are to include physical, psychosocial, environmental, spiritual, and educations needs assessments.

D.The nurse assessment it to be documented in Meditech. The trauma flow sheet is to be completed on major trauma victims.

Review of the facility policy named "Emergency Adult Deep Sedation" dated 08/2015 revealed the following:

RN responsibilities are to:
a. Perform the pre- procedural patient assessment.

b. G. Continuous monitoring of the patient:

2) LOC, pain rating/scoring and RASS Scale are to be recorded pre-procedure as baseline, immediately pre-induction with MD notification of values, as initial procedure assessment, every 5 minutes intra-procedure and every 10 minutes post-procedure.

Post-procedure: Physician and RN

d)The patient must have the following parameters monitored and documented until the pre-procedural level of consciousness and vital signs have returned to pre-procedure level of consciousness and vital signs have returned to pre-procedural baseline per the RASS system.

Review of the Ventilation & Sedation Orders set revealed the following :

Richmond Agitation Sedation Scale (RASS)

Procedure for RASS Assessment. The basis of the RASS assessment is to see what amount of stimulation is necessary to evoke a response and evaluate sedation.

Review of a facility process named "RASS Assessment" revealed the following:

The nurse will conduct and document a RASS in Meditech using the "Complete RASS Sedation Assessment" intervention:

Prior to initial administration of medication
Prior to any dose change
15 minutes after a dose change; and
Every two hours.

Based on observation and interview the facility failed to ensure medical records were stored in a manner to protect them from fire and rodents in 1 of 1 storage buildings.

Findings include:

During an observation on 09/28/2015, after 11:55 a.m., the medical record storage barn was found to be a metal building. Inside was three separate areas which were separated by wood or metal fencing. You had to go through the first two areas to get to the medical records. Inside the first area was a large plastic container of gasoline on the floor placed in front of a cabinet which was identified as flammables. When the door of the cabinet was opened, cans of paint were found in inside. There were cans of paint observed along with other yard equipment throughout the room.

Inside the second room was a stack of wood, furniture and debris piled up in the middle of the floor. Spider webs were noted in the room.

Inside the third room was medical records. Rows of pediatric records were stored inside corrugated boxes. Twenty plus boxes of patient records were stored directly on the floor and some of the records had spilled onto the floor. The floor of the room was covered with dirt and debris. The room had a buildup of spider webs.

There were no water sprinklers in the area in the event of a fire.

Staff #32 confirmed the observations.

Based on observation and interview, the facility failed to ensure emergency medications and other patient medications were stored in a locked area in 1 of 1 unit (ICU).

Findings include:

During an observation on 09/29/2015, after 11:00 a.m., the following was found in the Intensive care unit (ICU):

A patient supply room had a door that was propped open. Inside the room was two trays of Emergency drugs in an unlocked cabinet. The trays included some of the following drugs: Lidocaine, Epinephrine, Atropine, Amiodarone, SoluMedrol, Benadryl, Narcan, Calcium Gluconate and Calcium Chloride.

When you exited the supply room door it led to the nurses station which was open. Just outside the door was an open area called the medication room which could be entered by anyone passing in the hallway. Patient medications were stored in unlocked bins in this medication area. There were bags of antibiotics hanging on a wall in this area which were not locked up.

Staff #28 confirmed the observation and reported the door nor the cabinet had a lock.

Review of a facility policy from the Medication Management -Storage named "Storage:General" dated 10/2013 revealed the following:

All drugs and biologicals must be stored in a manner to prevent access by non-authorized personnel. Persons without legal access to drugs and biologicals cannot have unmonitored access to drugs or biologicals, and cannot have keys to medication storage rooms, carts, cabinets or containers.

Based on observation, document review and interview failed to:

A. ensure a sanitary environment for the sterile processing of surgical instruments.

A tour of the facility was conducted on 09/28/2015, with the infection control practitioner, staff #4, and the director of surgery, staff #15. The tour revealed the sterile processors are dirty and in need of cleaning and maintenance. The floors were stained, dull and had no finish. A cloth was taken and used to wipe the floor in the corner of the room. The cloth was covered with lint and dirt. Staffs #4 and #15 were in agreement that the floors were not clean. The dirt that was whipped up on the cloth was from 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 to verify the findings. Staff #2, #3, #4 and #15 confirmed 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 webs and dust covered the boxes. One of the boxes 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 faucets of the only sink in the Sterile Processing area, were observed to be 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 that 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.

Interviews with staff #2, #3, #4 and #15 confirmed the findings at the time of the tour of Sterile Processing.


B. ensure infection control processes were in place to identify and report unsafe practices that caused increased risk for infections to patients, visitors and employees.

Refer to tag A0749 for additional information.



C. ensure staff followed established policies in the surgical department.

Refer to tag A0951 for additional information.

Based on observation, interview and record review the facility failed to ensure:


A. safe and sanitary practices were used during sterile processing of patient equipment in 3 of 3 departments (Surgery, Radiology and Respiratory).


B. sanitary practices were used in care of the environment and patient care equipment on 4 of 4 units (Kitchen, Medical/surgical, Emergency Department and Intensive care unit).


C. infection control processes were in place to identify and report unsafe practices that caused increased risk for infections to patients, visitors and employees.


This deficient practice posed an Immediate Jeopardy to patient health and safety. This deficient practice placed all patients at risk for the likelihood of harm, serious injury, impairment and or subsequent death.


Findings include:


Surgery Department


A tour of the facility was conducted on 09/28/2015, with the infection control practitioner, staff #4, and the director of surgery, staff #15. The tour revealed the sterile processors were dirty and in need of cleaning and maintenance. The floors were stained, dull and had no finish. A cloth was taken and used to wipe the floor in the corner of the room. The cloth was covered with lint and dirt. Staff #4 and #15 agreed that the floors were not clean. The dirt that was whipped up on the cloth was from 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 verified the findings. Staff #2, #3, #4 and #15 agreed with the surveyors 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 webs and dust covered the boxes. One of the boxes 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 faucets of the only sink in the Sterile Processing area were corroded and pitted, and cannot be cleaned or disinfected adequately. 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, 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.

Interviews with staff #2, #3, #4 and #15 confirmed the findings at the time of the tour of Sterile Processing.

The facility failed to ensure staff followed established policies and participated in unsanitary practices in the surgical department that were determined to create an environment that placed patient safety in an Immediate Jeopardy situation, resulting in the likelihood of harm, serious injury, and subsequent death to patients.
Refer to tag A0951 for additional findings for surgery and sterile processing..




28659


Kitchen

On 9/26/2015, in the a.m., a tour of the walk in freezer revealed 4 stalagmites of ice rising from the floor of the walk-in freezer, at the back wall. There were lesser amounts of ice observed on the floor. The suspected source of ice accumulation was a small leak in the ceiling of the walk-in freezer forming condensation.


Further observations during the tour revealed a water leak in the walk-in cooler. A large rectangular plastic tub was observed placed on a top shelf below the cooling system. The tub was collecting water that was dripping from the vent. This was confirmed by the Department Manager who was giving the tour. She confirmed the leak had been there long enough to report it to the maintenance department for repair. Also during the tour of the walk-in cooler, two (2) large clear plastic bags of meat (one frozen chicken and the other thawed hamburger) was observed not sealed. The mouth of both bags was open to the air. The meat product inside each bag was exposed to the outside air.


On 9/27/2015, at 9:00 a.m., an interview with the Maintenance Director indicated he was not aware of any water leaks in the kitchen coolers or freezers.



Radiology

On 9/28/2015, a tour of the Radiology Department revealed the use of Cidex OPA (a high level disinfectant). The tour was being given by the Department Director, staff #5. He was asked, to explain the process for the safe use of the Cidex OPA. He referred the question to a department radiology tech, staff #39, who was responsible for mixing and testing the Cidex OPA. Staff #39 used it to sanitize specific instruments (vaginal probes) used in the Radiology department.


The following explanation was given by Radiology tech #39. She explained that she was one (1) of two (2) staff who were responsible for the use of the product. She indicated straight Cidex OPA was poured into a container and the container was dated for 14 days. Instruments that were sanitized in the Cidex OPA were then rinsed under running tap water for 90 seconds. Staff #39 was asked if she used a timer for her 90 second tap water rinse. She stated 'No," she usually just counted it out. She and the department director were asked to provide the policy for the use of Cidex OPA. Both staff indicated there was no policy. The staff used the manufacturer's product insert to mix and test the product. The radiology tech indicated they used the manufacturer's form and kept a log of the Cidex OPA mixture.


A review of the manufacturer's product insert revealed the temperature parameters being recorded by the department staff for open Cidex OPA was not correct.


The facility Cidex OPA logs revealed that the staff had recorded temperatures intended for the safe storage of unopened Cidex OPA (59-86 degrees Fahrenheit) instead of opened Cidex. According to the product insert once the Cidex OPA bottle was opened the safe use temperature changed to a more restricted temperature range (67.6 degrees Fahrenheit or higher and a 12 minute soak was recommended). The product insert indicated a temperature should be recorded prior to each days use. Instruments that were sanitized in Cidex OPA were to be rinsed in potable water (Tap water) by submersion for 90 seconds in three separate water baths with each water bath being emptied and refilled in clean water if the same water container was being used. The product insert included instruction and explanation for use, as well as a staff competency check off to be used prior to implementation of the uses of the Cidex OPA. The Department Manager confirmed manufacturer's competency check off was not being used and his staff had not participated in competency training prior to using Cidex OPA.


Further review of the Cidex OPA product insert indicated that Cidex OPA should only be used in a well ventilated room and personal protective equipment should be worn during its use. The insert information indicated both a positive and negative dip stick test was required using specialized test strips indicating an adequate concentration of the product remained in the mixture, however even with a positive test strip the product should not be used past fourteen (14) days.


Review of the facility daily log sheets for the Cidex OPA revealed the temperature was taken one time from April 22, 2015 until September 28, 2015, five (5) months. Review of the August 2015 log sheets indicated a test strip had been done on the 16th day after the Cidex OPA was mixed. A signature appeared on the log on the sixteenth (16) day. Two (2) days after the mixture had expired. Staff #39 did not know what the test strip and signature indicated.


The facility had no policy for safely and consistently using the Cidex OPA. The facility had no competency in use indicating the staff were trained and competent to safely use the Cidex OPA. The facility could not insure instruments (vaginal probes) sanitized using Cidex OPA were properly sanitized or rinsed and the risk of infection from cross contamination could not be ruled out. The Infection Control officer confirmed during an interview on 9/28/2015 she was unaware of the improper use of Cidex OPA within the Radiology department.





10135

During observations on 09/28-29/2015 the following was found:

Medical/Surgical unit
A caddy was found in a cabinet in the medication room which contained two arterial blood sampler packets which expired 03/2013; one syringe of sterile saline expired 11/2012, two needles expired 11/2013 and three blood tubes expired (12/2011,02/2012 and 04/2012). There also an unbagged oxygen mask stored in the caddy which was covered with dust.

Inside the clean equipment room, patient care supplies were stored on a bottom shelf which had no splash guard.

A basin was found with patient bed alarms stored inside it which were identified as being clean. The alarms had white cloth cords attached to them that were now turning yellow and brown. The cloth cord attachments could not be sanitized between patients.

Staff #21 confirmed the observations.


Emergency Department
Minimum care room was identified as being clean by Staff #22. A linen container in the room was found with soiled linen in it.

Another ED bay was identified as being clean by Staff #22. The biohazard container in the room had used intravenous tubing, dressings and paper in it. The linen container had soiled linen in it.

Inside a supply cabinet in Trauma Room #1, a tray which was wrapped in sterile draping was marked as being a chest tube tray. The tray was not dated as to when it was sterilized.

There was also a Trauma kit inside the supply cabinet which expired 05/2015.

The patient clean/sterile supply room and patient nutritional area were housed together. There was no separation between the two areas. Patient sterile suctioning supplies were stored on an open shelf next to the ice machine, and refrigerator. A coffee pot was also on the shelf in the nutritional area. Four floor tiles underneath the shelf were cracked and in need of repairing.

Staff #22 confirmed the observations and reported the trash and linen stays in the rooms and are picked up twice a day.


Intensive care unit
Packets of suctioning supplies were stored in a basket which was covered with dust. Patient positioning pads were stored in close proximity to the floor on the bottom shelf of a piece of equipment. The equipment and the floor were covered in dust. The top covering of the positioning pads were worn and missing the top layer making them unable to be sanitized.
Staff #28 confirmed the observations.

Based on observation, interview and record review the facility failed to:


A. provide evidence that 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 endoscopes, vaginal probes or any other equipment processed in the Cidex were properly disinfected.

B. provide evidence that 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.

C. 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.

D. 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.)

E. provide required air exchange checks for the Decontamination Area. The area was not being checked to ensure there was a negative air flow. Air exchanges and air flows ensure that contaminated air is not leaching into the surgical area.

F. 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.)

Refer to A0951 for additional information.




G. 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.


Refer to A0955 for additional information.

Based on observation, interview and record review the facility failed to:

A. provide evidence that 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 endoscoopes, vaginal probes or any other equipment processes in the Cidex were properly disinfected.

B. provide evidence that 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.

C. 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.

D. 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.)

E. provide required air exchange checks for the Decontamination Area. The area was not being checked to ensure there was a negative air flow. Air exchanges and air flows ensure that contaminated air is not leaching into the surgical area.

F. 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.)


Findings include:

A. An observation on 9/29/2015, was made of the endoscope 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.

B. 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 unkempt. 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".

C. 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
No accounting for cycles713-732

In month of July 89 loads were Flashed and not accounted for. The facility flashed 211loads in the month of July.


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
No accounting for cycles 897-924

In month of August approximately 148 loads were Flashed and not accounted for. The facility flashed 183 loads in the month of August.


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 12030

6/11/2015- 5mm Olympus Scope-Cycle 12031

6/11/2015- batteries- cycle 12032
No accounting for cycles 12033- 12038

6/13/2015- Bicep Tendon Tray- cycle12039

6/13/2015- Batteries- cycle12040

6/13/2015- Bone Tray- cycle 12041

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.


D. 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 ....."


E. 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 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. 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.


F. 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

Based on observations, interviews 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 to all patients.

Findings include:


Patient #29 was observed on 09/28/2015, being pre admitted 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.

Based on observations, interviews and record review, the facility failed to follow their policy and procedure for providing a post aesthesia evaluation before the patient were discharged from the hospital. Anesthesia was signing off on patients in Phase 1 PACU (post anesthesia care unit) while patient were still sedated. Anesthesia personnel were not evaluating patients post anesthesia before being discharged from the day surgery care area, nor were they evaluating patients that were admitted to the hospital within the required 48 hours.

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


Findings include:


Anesthesia personnel were observed bringing patients to Phase 1 PACU (post anesthesia care unit) 09/28/2015, and signing the Anesthesia paper work discharging the patient from anesthesia care. The two patients (patients #29 and 30) observed were asleep and not responsive enough to participate in a post anesthesia evaluation.

A review of the document titled "Post-Operative Anesthesia Care" revealed,

"A post anesthesia evaluation prior to discharge for outpatients and within 48 hours for inpatients shall be recorded by the person who administers the anesthesia. ...Responsibilities: The attending anesthetist is responsible for post anesthesia care of all patients who have received anesthesia (general, spinal, regional, local anesthesia with standby). This includes documentation of all post anesthesia visits.

An interview on 9/28/2015, with staff #15 and #36 revealed anesthesia staff were not evaluating patients prior to discharge. The interview confirmed the facility was not following their policy.

An interview on 09/30/2015, with the lead CRNA (certified registered nurse anesthestist) confirmed the anesthesia providers were not evaluating patients prior to them being discharged.