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Based on observation, interviews, and record reviews, the hospital failed to provide nursing services in accordance to its policy and procedures, failed to follow phyisican orders, and failed to following accepted standards of nursing practice.

The Condition of Participation for Nursing Services is not met as evidence by the hospital's failure to:

1. Ensure that the policy and procedure for a nursing bedside swallowing evaluation was done, and failed to follow physician orders for a swallow evaluation by a speech therapist for a patient identified with dysphagia (difficulty swallowing). This failure resulted in a patient choking on food, apnea (absence of breathing), cardiac arrest, and subsequent death. (Please refer to A-0395)

2. Ensure that a suction set up was ready for use in a patient's room who was identified as a high risk for aspiration (the taking in of a foreign object, for example food, into the lungs). [Please refer to A 0395].

3. Ensure that the medication lorazepam (anti-anxiety medication) was administered to a patient in accordance with the manufacturers recommendations. (Please refer to A-0405).

Based on observation, interview, and record review the hospital failed to ensure nursing policy and procedures and physician orders were followed, failed to obtain clarification of physician orders, and failed to follow a nursing standard of practice for the care of a patient who required suctioning (the act or process of removing secretions or liquid fluids from hollow or tubular organs or cavitied by means of a tube a a device [such a a suction pump] that operates on negative pressure), for two of thirty sampled patients (Patients 25 and 23).

For Patient 25, who was identified with dysphagia (difficulty swallowing), the nursing staff failed to perform a bedside swallowing evaluation and failed to follow physician's orders regarding a swallow evaluation to be performed by a speech therapist . This failure resulted in Patient 25's choking on food, cardiac arrest, and subsequent death.

For Patient 23, who was identified as high risk for aspiration, nursing failed to follow an accepted standard of nursing practice for the placement and set up of suction device.

Findings:

1. Clinical record review indicated that 71 year old Patient 25 arrived at the hospital's emergency department (ED) on 3/24/13 at 1:46 p.m., via ambulance after a choking episode while eating at a restaurant.

Emergency Medical Services (EMS) record indicated that en route to the ED, Patient A developed a complete airway obstruction (air passages were blocked and the individual could not breath. The EMS paramedic inserted a nasal-pharyngeal airway (rubber tube inserted into the nose which passes into the windpipe; used to bypass possible blockage) and suctioned (insertion of a flexible plastic tubing which is connected to a suction device) in an attempt to clear Patient 25's airway.

After continued suctioning by the paramedic, a large amount of mucus and food was removed. Patient 25's condition was documented as "color improved and level of respiratory (breathing) distress was documented as "decreased."


Review of the ED physician's physical examination of Patient 25 indicated that Patient 25 continued with breathing difficulty and presented with a low oxygen saturation level of 46%, (hypoxia: low level of oxygen circulating in the blood; normal range 95%-100%) , and had a history of a prior stroke which resulted in a right sided weakness of his body.


The ED physician admitted Patient 25 to the medical-surgical Stroke Unit for continued management of diagnoses of choking, hypoxia, and possible aspiration (the taking of a foreign object, for example food, into the lungs). The ED physician ' s admission orders were as follows:
a. NPO (nothing by mouth) except medications.
b. Bed rest and oxygen at 2 liters per minute and monitor oxygen saturation (measurement of oxygen in patient ' s body) continuously.
c. Call Hospitalist for further orders.


Review of the Hospitalist (Hospitalists are physicians whose primary professional focus is the general medical care of hospitalized patients) evaluation and assessment of Patient 25 on 3/24/13 at 7:40 pm indicated the following documentation:

1. Aspiration (event and presumed aspiration pneumonitis [inflammation of lung tissue]). The patient (Patient 25) is being admitted due to his continued need for supplemental oxygen and hypoxia. He (Patient 25) has been placed on Clindamycin (antibiotic medication); we will continue this.
2. Hypoxia secondary to above. Supplemental oxygen will be weaned as needed.
3. Questionable dysphagia (difficulty swallowing), resulting in aspiration event. We will ask for a speech and swallow therapy evaluation.
4. Anticipated length of hospitalization will be approximately 1-2 days. This was explained to the patient upon initial assessment and evaluation. Anticipated discharge date will be 3/26/2013. However if the patient does well he could potentially be discharged tomorrow (3/25/13).


The Hospitalist physician's admission orders for Patient 25 dated 3/24/13 at 7:45 pm were as follows:
1. Admit to Med-Surg Unit
2. Diagnosis: Aspiration with hypoxia
3. Vitals routine
4. Activity: OOB (out of bed) with assistance to chair only.
5. Nursing: Per routine
6. Diet: Cardiac prudent
7. O2 (oxygen) via NC (nasal cannula) at 2 liters; continuous
8. ST (Speech Therapist) evaluation (Screen and Swallowing) Re: R/O (rule out) Aspiration.

There was no documentation noted during review of the nursing progress notes dated 3/24/13 at 9: 45 pm through 3/24/13 at 11 pm, which indicated nursing contacted the ED physician and/or the Hospitalist physician for clarification of orders if Patient 25 should be fed or continued NPO, nor was there documentation the ST screen and swallow evaluation had been scheduled as ordered. In addition, there was no documentation in the nursing progress notes that a nursing swallow screen at the bedside had been performed.

Review of the facility ' s policy and procedure titled, " Swallow Screen by Nursing, Bedside, " dated 12/2003; revised 11/05 indicated the following:

Purpose: To provide a process for identification, assessment, and referral for treatment of patients with difficulty swallowing (dysphagia).

Policy:
1. Registered nurses can perform a bedside swallowing screen with or without physician order.
2. The physician will be notified of signs and symptoms of swallowing difficulties (dysphagia).
3. Based on patient assessment, the nurse will make the appropriate referrals, (e.g. registered dietician (RD) and swallowing evaluation by Speech Therapist (ST) or Occupational Therapist (OT).

Practice:

Bedside swallow screen may be performed by RN based on
physician ' s order or based on patient ' s diagnosis. Certain clinical situation may also warrant bedside nursing swallowing screen ...
Bedside Swallow Screen without physician's order:
1. RN assesses for signs and symptoms of difficulty swallowing. They may include:
a. Patient report of food sticking in throat
b. Difficulty chewing.
c. Pocketing of food (food remaining in the cheeks after a meal).
d. Food remaining in the oral cavity.
e. Change in vocal quality (e.g. wet voice).
f. Symptoms of aspiration
1) Wet, gurgly voice
2) Choking/coughing during or after eating.
i. prior history of dysphagia

2. The RN reports findings to the physician and obtains order for swallowing evaluation and modification of diet and/or nutritional evaluation by the RD (registered dietician).


During an interview on 9/20/13 at 1:30 pm, with the ED RN 1 (registered nurse), assigned to care for Patient 25, RN 1 stated a swallow screen would "automatically" be done in the ED before giving a patient with swallowing problems anything by mouth, but she did not remember if she had done a swallow screen for Patient 25. Review of RN 1's continuous Nursing Progress Notes dated 3/24/15 starting at 1:45pm which listed the chief complaint as SOB (shortness of breath, possible aspiration), ending at 4:18 pm with Patient 25's discharge from the ED at 4:18 pm, failed to show documentation that a bedside swallow screen had been performed.


The Hospitalist was interviewed on 10/2/13 at 11:56 a.m., and stated that he expected the nurse to do a swallow screen, first, and when safe and without problems to allow patient (25) to eat. In addition, the Hospitalist physician stated that Patient 25 "was at risk," and he, (the Hospitalist) should have been contacted for clarification of his orders for a swallowing evaluation to be done by the speech therapist. "


The ED Nurse Manager 1 was interviewed on 10/2/13 at 1:17 pm, and stated the practice in the ED was to do a swallow screen before giving any medications by mouth. During an interview with the ED CN (charge nurse) 1, on 10/2/13 at 1:30 pm, she stated when a stroke patient, with swallowing difficulty is admitted to the ED, the policy and procedure is that a nurse should complete a bedside swallow screen. CN 1 further stated that patients identified with swallowing concerns should be kept NPO (nothing by mouth), until the swallow screen was completed and the physician notified of the result of the evaluation.

Review of Patient 25 ' s medical record indicated RN 2 admitted Patient 25 to the medical -surgical Stroke Unit on 3/24/13 at 8 p.m. RN 2's admission assessment notes listed Patient 25's diagnoses as stroke, right sided body weakness, mild confusion, mildly disorientated, and slurred speech. Patient 25' s Medical-Surgical Telemetry System Review/Plan of Care identified the following problem: " 100% supervision, aspiration precaution. " There were no nursing interventions listed in Patient 25's nursing care plan for the problem of aspiration precaution.

During a telephone interview on 10/8/13 at 2:34 pm with RN 2, he identified himself as a travel nurse (temporary agency staff contracted by the hospital to provide nursing services). RN 2 stated he did not do a bedside swallow screen of Patient 25 and did not remember if he had reported not doing so to the on- coming nurse ,RN 3 during the change of shift report. RN 2 stated the Hospitalist physician had ordered a "regular diet " for Patient 25 but that he did not contact MD 2 to for clarification of the diet order.

Stroke Unit RN 3, assigned to care for Patient 25 on 3/25/13 during the day shift, was interviewed by telephone on 10/4/13 at 8:06 am and stated that she did not "recall " if she did a bedside swallow screen on Patient 25. A review of Patient 25's nursing notes dated 3/25/13 failed to show documentation of a bedside swallow screen by RN 3.

Certified nurse assistant (CNA) 1 was interviewed on 9/20/13 at 2:10 pm, and stated on the morning of 3/25/13, she asked RN 3 if Patient 25 could eat and RN 3 said Patient 25 could have a soft diet but required "100 % supervision while eating. CNA 1 described 100% supervision as, "I have to feed the patient. "

CNA 1 stated that she remembered Patient 25's breakfast consisted of scrambled eggs, a sausage meat patty, cranberry juice, and a cup of coffee, which she fed Patient 25 and that he ate, " quite a bit. "

CNA 1 stated she had to stop feeding Patient 25 because she saw a "bump" on the side of his cheek and Patient 25 began " coughing and spitting " up the food that she was feeding him. CNA 1 stated she did not call for help; instead she stayed in Patient 25's room for about 15- 20 minutes while "suctioning" inside his mouth with a " Yankauer " suction tube.
(Yankauer: is an oral (mouth) tool; typically a firm plastic suction tip with a large opening surrounded, this tool is used to suction mouth secretions in order to prevent aspiration (food going into the lungs).

CNA 1 stated she reported to RN 3 that she had to stop feeding Patient 25 because he was "coughing" to which RN 3 replied, "OK." CNA 1 stated she did not see RN 3 go to Patient 25 ' s room to assess his condition after reporting Patient 25 ' s coughing incident.

The Stroke Unit Nurse Manager 2 was interviewed on 10/2/13 at 9 a.m., regarding CNA 1's suctioning a patient. Nurse Manager 2 stated the scope of practice for CNAs did not include oral suctioning of a patient. " CNA ' s can only check and make sure that a suction machine was set up and ready in the patient's room, "they were not supposed to suction patients. "

During a telephone interview on 9/20/13 at 1:50 pm, CNA 2 stated that she did not recall RN 3 telling the staff during morning report that Patient 25 had passed the swallowing screen but remembered RN 3 reported Patient 25 had a "swallowing problem," and needed 100 % supervision, while being fed.

CNA 2 stated that she cannot recall the time she found Patient 25, but remembers it was between "breakfast and lunch time "on 3/25/13 while she was doing her routine patient check when she found Patient 25 in his room, unresponsive, and that his color was " not right. " CNA 2 stated she tried to wake Patient 25 and when he did not respond, she called for help and a code blue was called. (Code blue: emergency call throughout the hospital for patient assistance; usually for a cardiac arrest or respiratory distress).

Review of the code blue Resuscitation Record dated 3/25/ 13, recorded as 9:47 am, indicated the CPR (cardio-pulmonary resuscitation) started at 9:31 am, and the pre-arrest diagnosis was listed as hypoxia s/p (status/post) choking on food/aspiration. The code is recorded as lasting 18 minutes and Patient 25 was transferred to the ICU (Intensive Care Unit) unresponsive.

The Critical Care Consultant who responded to the code on 3/25/13, documented the following:

Procedure: Endotracheal intubation (endotracheal tube; tube inserted through the mouth into the windpipe [trachea].
1. Indication for procedure: Apnea (temporary cessation of breathing)
and cardiac arrest.
" Patient was found in cardiac arrest ...He was given oxygen via Ambu bad (hand held device use to provide ventilation to patients who are not breathing), and upon layrgngoscopy (procedure used obtain a view of the throat to facilitate tracheal intubation), significant amounts of food material as well as liquid was in the oropharynx (back of the throat). This was suctioned clear ...and an ET (endotracheal tube) inserted via a laryngoscope (device used to facilitate insertion of an ET tube) was placed. "

Review of the Critical Care physician note dated 3/25/13 indicated the following, "...the patient (Patient 25) was in his usual stated of health when he presented with difficulty swallowing and witness choking; he was cyanotic (bluish or purplish discoloration of the skin due to deficient oxygenation of the blood) upon arrival at the hospital. This morning he was being helped with breakfast ..., and did not do very well. At 9:30 am, he was found unresponsive and a code blue was called. When I arrived he was asystolic (no blood pressure) and pulseless (no pulse) and chest compression were taking place. I then intubated (tube inserted through the mouth into the windpipe [trachea] to establish a patent airway) the patient. Currently he, (Patient 25), is unresponsive."

A neurology physician (physician specializing in diseases of nervous system) assessment note dated 3/26/13, indicated that Patient 25 "had cerebral anoxia (brain was deprived of oxygen) and had significant central nervous system injury, and that Patient 25's " prognosis (chances) for making a recovery is poor. "

Patient 25 expired in the Intensive Care Unit on 4/3/13 at 3:50 pm, with a diagnosis of anoxic brain injury with coma.


2. Clinical record review indicated that 62 year old Patient 23 came in to hospital's emergency department on 11/28/13 with altered level of consciousness. She was admitted to Medical-Surgical Stroke Unit on 12/6/13 at 1:03 p.m., for further evaluation, monitoring, and management of her condition.

On 12/7/13 at 11:12 a.m., a swallowing evaluation and assessment was performed by the Speech Therapist which identified Patient 23 as a high risk for aspiration, and required monitored for signs of aspiration, coughing, gurly voice, and throat clearing

During an observation of Patient 23's room on 12/10/13 at 8:30 a.m., a sign on the patient's headboard identicated, "high risk for aspiraation". There was no suction device set up in the room.

The assistant charge nurse of the Medical-Surgical Stroke Unit stated during an interview on 12/10/13 at 9 am, that since Patient 23 was a high risk for aspiration there should have been a suction set up in the room for use.

Based on observation, interview, and record review, the nursing service failed to ensure the administration of an intravenous (IV) medication (lorazepam: used to treat) anti-anxiety medication) according to manufacturer's recommendations for one of 30 sampled residents (Patient 40). This failure had the potential for adverse side effects and medical complications.

Findings:


Record review, on 12/9/13 for Patient 40, indicated he was admitted to the 4 East medical-surgical/renal (kidney) unit of the hospital on 12/6/13 for multiple medical conditions that included alcohol withdrawal.


Physician orders dated 12/7/13, instructed nursing staff to administer lorazapam one milligram (mg) IV, every hour, as needed for symptoms of alcohol withdrawal. Parameters for the specific use and administration of lorazepam, indicated to give the medication if the Patient 40's systolic blood pressure (BP) was between 140-149; heart rate (HR) between 100-109, and temperature between 99 degrees Fahrenheit (F) to 99.9 degrees F. by IV push at a maximum rate of: 2 mg/minute.


(Adverse effects reported with lorazepam are respiratory depression and low BP. IV administration may result in pain or thrombophlebitis (inflammation of the vein in conjunction with a blood clot . Drug reference for the American Pharmacists Association: Lexicomp online.com]



On 12/11/13, at 1:40 p.m., the surveyor observed registered nurse (RN) 2 administer over the period of four seconds, lorazepam 1 mg into the IV access port of Patient 40's right arm for Patient 40's complaints of anxiety. No blood pressure or heart rate was taken prior to, during or after the administration of the lorazepam.



During an interview on 12/11/13, at 2:10 p.m., during an interview and record record review, RN 2 displayed Patient 40's medication administration record for
lorazapam. RN 2 acknowledged she did not obtain vital signs at the time of the lorazepam administration, and said that the injection time is over one or two minutes. When the surveyor informed that she had been timed during the administration of the lorazepam at four seconds, RN 2 stated, "I did?"



The P&P dated 12/'13, "IV: Medications Approved for IV Push Administration," indicated that the RN must be knowledgeable about the administration of the medication, desired therapeutic effects, precautions, and untoward reactions of the drug being administered.


On 12/11/13, at 3:54 p.m., the registered pharmacist (RPh) stated that 2 mg of lorazepam is given over one minute; therefore, one mg is given over 30 seconds. The RPh said she needed to verify this and would let the surveyor know the answer. No further contact was made by the RPh on this matter.


The manufacturer package insert for lorazepam directed the nurse to administer the medication at a rate not to exceed two mg/minute which meant that the injection should be given over 1 minute.

25632

Based on observation, staff interviews, and document reviews, the hospital failed to provide surgical services according to hospital policy and procedures, and accepted standards of practice.


The Condition for Coverage for Surgical Services is not met as evidenced by the hospital's failure to:


1. Ensure the policy and procedure for medication dispensing on to the surgical field and for dispensing to the surgeon was followed. (Please refer to A-0951).

2. Ensure a surgeon followed the policy and procedure for pre-operative skin preparation. (Please refer to A-0951).

3. Ensure that there were sufficient sterile instrumentation for the number of surgical cases scheduled to prevent the practice of "flash sterilization." (Flash sterilization: Is a modification of conventional steam sterilization...it is not recommended as a routine sterilization method because of ...possibility for contamination of processed items during transportation ot the operating roomsm and the sterilization perimeters..." [Please refer to A-0951].

Based on observation, interview, and record review the hospital failed to implement policies and procedures in order to safely provide surgical services to patients during surgical procedures for two (Patient 1, and Patient 84) of six sampled surgical patients. This failure resulted in:
1. The injection of the wrong solution into the left eye of Patient 1 resulting in a corneal transplant and the possible loss of vision in Patient 1's left eye.
2. The allowance of the application of a surgical skin prep of Patient 84 by Surgeon B without the use of sterile surgical gloves which had the potential for contamination of the surgical site and the potential of surgical site infection.
3. The washing of the surgical eye instrumentations set on the back table in the operating room and the flash sterilization of that instrumentation which had the potential for surgical site infection.
Findings:

1. Review of the medical record on 9/9/13 at 9 a.m. showed that Patient 1 was a healthy 71 year old male who was admitted to the hospital on 5/1/2013 for a left eye cataract removal and implantation of an intraocular lens.

During an interview on 9/9/13 at 11 a.m., Surgeon 1 stated that after the patient was anesthetized she made her incision and asked surgical technician (ST) 1 for Vision Blue (trypan blue, a solution used to stain the lens capsule and approved for cataract extractions) in order to inject it into the left eye and to enhance the visualization of the lens capsule. Surgeon 1 was handed a syringe by ST 1 and injected the syringe contents into the left eye.

Surgeon 1 then examined the left eye through the operating scope and found the entire area to be stained an opaque, dense blue. Surgeon 1 asked ST 1, " What did you give me? " " Vision Blue " was the reply from ST 1. Surgeon 1 then asked registered nurse (RN) 1, " What did you give the tech? " to which RN 1 replied, " methylene blue " (a long lasting tissue staining dye not intended for eye injection).

Patient 1's left eye was then repeatedly irrigated with saline (a sterile salt water solution), but the eye remained opaque. Surgeon 1 stated she does not know how methylene blue came into the surgical field, " as it is not in my technique, I never use methylene blue. " Surgeon 1 further stated that since she nearly always has her eye on the operating scope, she asked for the Vision Blue by name, and trusted that the operating room staff would give her the solution she requested. Surgeon 1 stated that she did not observe the solution as it was drawn into the syringe nor did she observe the placement of the label on the syringe.

Patient 1 was later transferred for possible corneal transplant surgery, and despite multiple surgeries, the final outcome for his vision as of 12/9/13, remains uncertain.

A review of the hospital policy and procedure entitled, "Medications on and off the Sterile Field, Verification and Labeling" dated April 2013, indicated, "Medications delivered to the sterile filed in a surgical or procedural setting must be concurrently verbally and visually verified by 2 qualified personnel." , and, "All medication labels are verified both verbally and visually by two qualified individuals when the person preparing the medication is not the person administering the medication. " Further, " In perioperative areas, any medication listed on the physician preference list must be verified with the physician for each procedure prior to delivery to the sterile field and/or administration."

During an interview on 12/10/13 at 10:30 a.m. with ST 1, she stated that she asked RN 1 for Vision Blue and in return received a syringe with a blue substance from RN 1. No vial was displayed. ST 1 transferred the blue material from the syringe carried by RN 1 into a new syringe and put the Vision Blue label on it and placed it on the sterile field table for use in the surgery. Vision Blue is on the surgeon ' s Preference Card, a reference guide for operating room staff regarding the supplies needed for that particular operation. In this case the Preference Card read, " Only uses Viscoat " (a brand of VisonBlue). ST 1 said that while Surgeon 1 was looking through the operating microscope, she asked for Vision Blue, and the syringe labeled Vision Blue was placed in her hand. There was no further verification of the contents of the syringe labeled Vision Blue. ST 1 said, " I asked for Vision Blue and got methylene blue " .

During an interview on 12/10/13 at 3 p.m., RN 1 stated that ST 1 called her and said she needed methylene blue. RN1 came back and showed ST 1 a vial of methylene blue. ST 1 then asked for a syringe in order to transfer it. RN 1 said you only need a drop, pulled a small amount into a syringe and squirted that into a syringe ST 1 was holding. RN 1 did not see the label put on the syringe. RN1 explained that on occasion some surgeons used a drop to mark the location of the incision and all that is needed is a tiny drop, usually dripped into a disposable container on the back table. RN1 again said that all you need is a few drops, then showed ST1 a prefilled syringe of Vision Blue and told ST 1 that she, RN 1, has the Vision Blue if the surgeon requests it. RN 1 did not see the label go on the syringe and did not observe how Surgeon 1 obtained the syringe. RN 1 said that she was charting on the computer at the time. RN 1 stated that she was asked to bring methylene blue to the table; there was never a request for Vision Blue.

In a discussion with the Risk Manager, the Nurse Manager for Surgery and the Director of Perioperative Services on 9/9/12, they agreed, " there was a communication error between the RN and the tech; there was also a labeling error between the RN and the tech. "

2. On 12/10/13 at 7:30 am, an observation of the surgical procedure cataract removal (condition in which the lens of the eye becomes progressively opaque resulting in blurred vision), with an intraocular lens implant (an artificial lens that is implanted into the eye to replace the damaged natural lens as when a cataract is removed) was conducted. Patient 84 was brought to the OR (operating room) on a stretcher accompanied by Anesthesiologist A, and Surgeon B.
Surgeon B positioned Patient 84's head on a headrest and stablized Patient 84's head to the headrest with a strip of tape placed across the forehead. Surgeon B proceeded to the sterile surgical skin preparation table and without putting on sterile gloves, picked up the 10 ml (milliliter) syringe with his bare hands and filled the 10 ml syringe with Betadine solution, and began to irrigate the left eye of Patient 84. Surgeon B then irrigated the area with BSS (balanced salt solution), and then used the sterile sponges provided on the prep table to paint the skin area Patient 84' s left eye. Surgeon B then left the OR to perform a surgical scrub his hands at the outside scrub sink. After completion of the surgical scrub, Surgeon B returned to the OR and the ST (scrub technologist) assisted Surgeon B the sterile application of a sterile surgical gown and and gloves. Surgeon B, using sterile technique, proceeded to drape Patient 84's left eye area with sterile drapes.
A review of the hospital policy and procedure titled, "Practices for Pre-Operative Preparation of the skin," dated12/1994, instructed staff that the purpose of pre-operative skin preparation is to "reduce the risk of post-operative wound infection by removing soil and transient micro-organisms from the skin. "
The policy instructed that "All patients undergoing invasive procedures will undergo pre-operative site preparation according to the guidelines outlined in the policy," and that "All personnel responsible for skin preparation of patients are competent to do so.
The procedure steps included:
1. Equipment needed: " Sterile gloves, prep set, approved antimicrobial is not included in the prep set.
7. Using sterile supplies, and sterile gloves, apply antiseptic agents in a circular motion. "
On 12/10/13 at 7:50a.m., circulating registered nurse (RN) 2 stated that it was Surgeon B "process to prep without glove, he always did it that way."
On 12/10/13 at 8:05a.m., The OR Manager stated that it was Surgeon B's " "practice to prep without gloves; he probably always does that, but that for nursing staff, they must pass a competency evaluation, and gloves are required to prep." The OR Manager stated that Surgeon B should be reported to Medical Staff and they Ithe OR staff) should enforce the policy.

3. An observation was conducted on 12/10/13 at 7:30 am of the surgical procedure cataract (clouding of the lens of the eye) extraction with intraocular lens implantation ( implantation of an artificial lens into the eye to replace the damaged natural lens after cataract is removal). At the end of the surgical pprocedure scrub technician (ST) 2 placed the used surgical eye instruments into the small basin labeled H20 (water) located on the surgical back table. ST 2 added a solution labeled " Prolystica" (a concentrated nutral dtergent used to clean instruments) and proceeded to wash the eye instruments. ST-2 then placed the instruments into the eye instruments into the instrument tray tray and placed the tray into the autoclave located in the OR to be "flash sterilizated" for 10 minutes. This instrument tray of eye instrument were being prepared for use on the following surgical eye procedure to be performed in that OR.

A review of the hospital's policy and procedure titled, "End of Case Cleanup Guidelines," dated 6/2004, instructed staff:
1. Submerge and or /rinse instruments in basin of water to prevent blood and tissue from drying.
2. Place a damp towel over clean instruments
3. Remove all sharps and place in appropriate containers.
4. Remove dirty instruments from basin and flush all lumens and place all contaminated instruments on a towel in the appropriate tray.
5. Place the tray in the rigid container and return to the case cart.
On 12/10/13 at 8a.m., ST2 explained that the hospital only had four sets of eye instruments and typically on Tuesday and Thursday ran two operating rooms of eye cases that usually took 10-15 minutes apiece and that they had to wash the instruments on the back table in the operating room and flash sterilize the eye sets to have the instruments for all the cases.
On 12/10/13 at 9 a.m., the OR Manager stated that she was aware that flash sterilization was not best practice and that they were in the process of ordering enough eye instrument sets to have them properly processed between cases.
On 12/10/13 at 9:30a.m., the Sterile Processing Manager stated that case carts are brought to Central Processing, and the instrument containers are hand washed and rinsed in the decontamination room, then run through the sterilizer washer for 1 hour. The sets are then reassembled, wrapped, and processed through the autoclave and returned to the shelf for use on the next case. But that eye instrumentation sets are processed after the last case of the day.

CDC Guideline for Disinfection and Sterilization in Healthcare Facilities 2008, states that " Flash sterilization should not be used for reasons of convenience, as an alternative to purchasing additional instrument sets, or to save time because of the potential for serious infections. "

Review of the surgical schedule for the dates of the survey showed that on:
12/9/13: Four eye surgery cases were scheduled in OR 6.
12/10/13: Eleven eye surgery cases were scheduled in OR's 6 and 12.
12/11/13: Eight eye surgery cases were scheduled in OR's 6 and 12.
12/12/13: Thirteen eye surgery cases were scheduled in OR's 6 and 12.
12/13/13: Seven eye surgery cases were scheduled in OR's 6 and 12.