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Based on observation, interview and record review, the facility failed to ensure a sanitary environment by ensuring staff removed all sources of contamination from surgical instruments during the pre-wash phase of sterilization, and failed to monitor sterilized instruments after processing was completed to ensure there is no residue on the instruments prior to performing surgical procedures on patient in the operating room resulting in non-compliance with the Condition of Participation for Infection Control and an Immediate Jeopardy situation with the potential to affect any patient receiving a surgical procedure at the facility. The facility does approximately 400 surgical procedures per month and on 3/18/2013 there were 31 surgical procedures scheduled.

Findings:

During an observation on 3/18/2013 at 2 p.m., central sterile technician staff #L was cleaning instruments in the sink and preparing them for placement, in trays, in the instrument washer. One tray was observed to have some instruments with some red colored and other unknown materials still on the instruments. She was asked if she ensures the instruments are free of materials from the surgical procedures before she places in the instrument washing machine and she responded, "No, not always." She said she soaks the instruments, and then the instrument washer should take care of the rest, and if anything was left, it would be identified prior to the wrapping. This observation and interview was witness by the assistant chief nursing officer (ACNO).

During a tour on 3/18/2013 at 2:20 p.m., the sterile instrument storage area was observed with multiple sterilized surgical trays and other sterile items stored on shelving units.
On 3/18/2013 at 2:30 p.m., a sterile tray was requested to be opened to inspect the instruments. The sterile processing department (SPD) supervisor was asked to select a tray that would not be needed immediately. She selected one tray labeled as a minor tray, and labeled as last processed on 3/18/2013. She stated the tray was either used today or over the weekend. She selected a Mayo Hegar 7 ? inch (") and 6 ?" (both instruments designed to hold a suture and needle during procedures) and both were wiped with a white cloth and both had a gray substance of an unknown origin. The gray residue was not visible to the eye on either instrument.

She then selected another tray labeled as a major hysterectomy tray, processed last on 3/15/2013, opened it and selected a Mayo Hegar 9", 7 1/4", and a Heaney needle holder. She wiped all of the instruments with a white cloth and all three instruments had a grey unknown residue found on the white cloth. Again, this gray residue was not visible to inspection.

During an interview on 3/18/2013 at 2:20 p.m., the SPD supervisor, employed at the hospital for the past 2 months, said currently there was no system in place to determine what patient, case, or doctor the instruments were used on last. When asked where she thinks the residue came from, she said it could be from the detergent concentration, the way the instruments were pre-cleaned, or it could be from the age of the instruments, they could be at their end of life cycle. She also said the needle holders have grooves and really require scrubbing when cleaned.

On 3/18/2013 at 3:10 p.m. during an observation of the instrument wrapping area, an interview was conducted with central sterile technician, staff #F who said he routinely wipes all plastic coated type handles and cords. However, he does not routinely wipe or check for any gray residue or any compromise on any of the metal instruments.

On 3/19/2013 at 4 p.m., the risk manager provided an email from the operating room educator dated 3/19/2013 at 1:02 p.m. from the repair agency for the instruments communicating the following information: "The repair agency person stated that often the tungsten carbide inserts in the needle holders has to be replaced due to a) wear and tear; b) the water or detergents used; and c) the larger needles used can cause the softer tungsten carbide to shed small grey-black particles. Most often, it is found that it is the wear of the instrument since steel is harder composite than the tungsten carbide that grips the needle. The scored tungsten carbide in the inserts can after much use shed the fine grey-black particles found after being processed in SPD."

During an interview on 3/21/2013 at 1:40 p.m., operating room technician staff #N said she has been with the hospital for about 2 years. She said she has witness the gray residue on instruments during the past 2 years. She said on one occasion, she thought was last year, during a kidney/prostate case, she observed the surgeon's glove get wet, and the gray residue was visible on his gloves. When asked if the surgeon discarded the instrument, she responded "no". She also said she had observed small bits of bone on Kerrison bone biting instruments used during spinal cases. She said she has always discarded these instruments and obtained others prior to patient contact. She said she would report these occurrences to the operating room manager and the charge nurse.

During an interview on 3/21/2013 at 1:50 p.m., the operating room manager, employed at the hospital for the past 11 years, confirmed there have been reports of dirty instruments in the past. She said when this happens, the instruments are discarded from the patient cases and re-processed.

During an interview on 3/21/2013 at 1:55 p.m., the operating room technician staff #M said he has been at the hospital for about 2 years. He said that he has never seen the gray residue but about 2 years ago when he first started, he was in the process of opening up the sterile instrument for a case and found tissue in a biopsy forceps instrument. He said he immediately removed all of the instruments and obtained all new sterile instruments for the case. He said about 1 year ago, he found bone fragments on a Tap 5.0 instrument and had to return it for re-processing. Yesterday (3/20/13), when opening the instruments for a surgical procedure, he inspected one of the cannulated (tube-like) instruments and visually saw debris. He wiped it with a Q-tip and found a reddish colored substance that he thought was possibly blood. He said he discarded all of these instruments and obtained others prior to patient contact. He said he reports these type incidents to the operating room manager or the charge nurse.

Both the operating room manager and the operating room technician staff #M said they felt there has been an improvement in the quality of instrument sterilization since a new sterile processing supervisor was hired about 2 months ago.

Review of the policy "Decontamination of Instruments", dated as reviewed last 2/2012, states the policy purpose is:
"To assure safe and efficient handling of used/contaminated instruments.
The policy is-All instruments removed from the sterile packaging will be cleaned and decontaminated as soon as possible after use.
The procedure states-d) All instruments need to be inspected before entering the automated washer for its need to be manually cleaned."

During an interview on 3/18/2013 at 3:15 p.m., the SPD supervisor said the Association for the Advancement of Medical Instrumentation is used for standards of practice related to instruments (ANSI/AAMI). Review of page 55, dated 2010 provided by the supervisor of SPD, showed the following rationale in the 7.5.1-General Considerations as follows: "The purpose of cleaning and rinsing is to remove all visible debris from an item and to reduce the number of particulates, microorganisms, and potential pyrogens. The accepted standard for the degree for cleanliness is 'visibly clean.' Thorough cleaning and rinsing are vital to the effectiveness for subsequent microbicidal process used for decontamination, disinfection, and/or sterilization. The amount of residue that remains will vary depending on the conditions of use of the cleaning agents, the specific component materials of the reprocessed devices, and the methods used to reduce residuals before reuse. Any organic material or residual cleaning agents remaining on an item can inactivate chemical disinfectants or sterilants as well as protect microorganisms from destruction....Adequate cleaning and rinsing should result in low bioburden, which is essential to the effectiveness of terminal sterilization and to the protection of patients form pyrogens."

During an interview on 3/18/2013 at 2:30 p.m., the sterile processing department (SPD) supervisor said that currently there was no routine preventative maintenance program in place related to surgical instruments.

During an interview on 3/19/2013 at 3:45 p.m., the chief nursing officer said she believes the last time the instrument maintenance company was at the facility was November of 2012.

Based on observation, interview and record review, the facility failed to ensure policies and procedures related to ensuring a sanitary environment within the operating rooms were enforced.

Findings:

1. During an observation on 3/18/2013 at 2 p.m., central sterile technician staff #L was cleaning instruments in the sink and preparing them for placement, in trays, in the instrument washer. One tray had some instruments with some red colored and other unknown material still on the instruments. She was asked if she ensures the instruments are free of materials from the surgical procedures before she places in the instrument washing machine and she responded, "No, not always." She said she soaks the instruments, and then the instrument washer should take care of the rest, and if anything was left, it would be identified prior to the wrapping. This observation and interview was witness by the assistant chief nursing officer (ACNO).

During a tour on 3/18/2013 at 2:20 p.m., the sterile instrument storage area was observed with multiple sterilized surgical trays and other sterile items stored on shelving units.
On 3/18/2013 at 2:30 p.m., a sterile tray was requested to be opened to inspect the instruments. The sterile processing department (SPD) supervisor was asked to select a tray that would not be needed immediately. She selected one tray labeled as a minor tray, and labeled as last processed on 3/18/2013. She stated the tray was either used today or over the weekend. She selected a Mayo Hegar 7 ? inch (") and 6 ?" (both instruments designed to hold a suture and needle during procedures) and both were wiped with a white cloth and both had a gray substance of an unknown origin. The gray residue was not visible to the eye on either instrument.

She then selected another tray labeled as a major hysterectomy tray, processed last on 3/15/2013, opened it and selected a Mayo Hegar 9", 7 1/4", and a Heaney needle holder and wiped all of the instruments with a white cloth and all three instruments had a grey unknown residue found on the white cloth. Again, this gray residue is not visible to inspection.

During an interview on 3/18/2013 at 2:20 p.m., the SPD supervisor, employed for the past 2 months, said that currently there was no system in place to determine what patient, case, or doctor the instruments were used on last. When asked where she thinks the residue came from, she said it could be from the detergent concentration, the way the instruments were pre-cleaned, or it could be from the age of the instruments, they could be at their end of life cycle. She also said the needle holders have grooves and really require scrubbing when cleaned.

On 3/18/2013 at 3:10 p.m. during an observation of the instrument wrapping area, an interview was conducted with central sterile technician #F who said he routinely wipes all plastic coated type handles and cords. However, he does not routinely wipe or check for any gray residue or any compromise on any of the metal instruments.

During an interview on 3/21/2013 at 1:40 p.m., operating room technician #N said she has been with the hospital for about 2 years. She said she has witness the gray residue on instruments during the past 2 years. She said on one occasion, she thought it was last year, during a kidney/prostate case, she observed the surgeon's glove get wet, and the gray residue was visible on his gloves. When asked if the surgeon discarded the instrument, she responded "no". She also said, she had observed small bits of bone on Kerrison bone biting instruments used during spinal cases. She said she has always discarded these instruments and obtained others prior to patient contact. She said she would report these occurrences to the operating room manager and the charge nurse.

During an interview on 3/21/2013 at 1:50 p.m., the operating room manager for the past 11 years, confirmed there have been reports of dirty instruments in the past. She said, when this happens, the instruments are discarded from the patient cases and re-processed.

During an interview on 3/21/2013 at 1:55 p.m., operating room technician #M said he has been at the hospital for about 2 years. He said he has never seen the gray residue, but about 2 years ago when he first started, he was in the process of opening up the sterile instrument for a case and found tissue in a biopsy forceps instrument. He said he immediately removed all of the instruments and obtained all new sterile instruments for the case. He said about 1 year ago, he found bone fragments on a Tap 5.0 instrument and had to return it for re-processing. Yesterday, when opening the instruments for a surgical procedure, he inspected one of the cannulated (tube-like) instruments and visually saw debris. He wiped it with a Q-tip and found a reddish colored substance, he thought was possibly blood. He said he discarded all of these instruments and obtained others prior to patient contact. He said he reports these type incidents to the operating room manager or the charge nurse.

Both the operating room manager and operating room technician #M said they felt there was an improvement in the quality of instrument sterilization since a new sterile processing supervisor was hired about 2 months ago.

Review of the policy "Decontamination of Instruments" dated as reviewed last 2/2012, states the policy purpose is: "To assure safe and efficient handling of used/contaminated instruments." The policy is, "All instruments removed from the sterile packaging will be cleaned and decontaminated as soon as possible after use." It read, "All instruments need to be inspected before entering the automated washer for its need to be manually cleaned."

During an interview on 3/18/2013 at 3:15 p.m., the SPD supervisor said the Association for the Advancement of Medical Instrumentation is used for standards of practice related to instruments (ANSI/AAMI). Review of page 55, dated 2010 provided by the supervisor of SPD showed the following rationale in the 7.5.1-General Considerations as follows: "The purpose of cleaning and rinsing is to remove all visible debris from an item and to reduce the number of particulates, microorganisms, and potential pyrogens. The accepted standard for the degree for cleanliness is 'visibly clean'. Thorough cleaning and rinsing are vital to the effectiveness for subsequent microbicidal process used for decontamination, disinfection, and/or sterilization. The amount of residue that remains will vary depending on the conditions of use of the cleaning agents, the specific component materials of the reprocessed devices, and the methods used to reduce residuals before reuse. Any organic material or residual cleaning agents remaining on an item can inactivate chemical disinfectants or sterilants as well as protect microorganisms from destruction....Adequate cleaning and rinsing should result in low bioburden, which is essential to the effectiveness of terminal sterilization and to the protection of patients form pyrogens."

2. During an observation on 3/18/2013 at 3 p.m. in operating room (OR) #6, the anesthesia locked cart top drawer was found to have 1 opened single dose 10 milliliter (ml) vial of normal saline, opened, unlabeled, and undated with an unknown amount remaining. Also 1 opened glycopyrrolate 5 milliliters (ml.) multi-dose vial opened, unlabeled, and undated with an unknown amount remaining. The anesthesia machine unlocked cart top drawer was found to have 1 bottle of Forane 100 ml. and 1 bottle of Sevoflurane 250 ml. Both were opened, unlabeled, and undated with an unknown amount remaining.

During an interview on 3/18/2013 at 3 p.m. the anesthesiologist said the vials should have been discarded after the surgical case was completed. During an interview on 3/18/2013 at 3:05 p.m., the supervisor of SPD confirmed operating room #6 was last used and the surgical case completed today at 10:30 a.m.

3. During an observation on 3/18/2013 at 3:20 p.m. in operating room (OR) #1, the anesthesia locked medication cart top drawer was found to have:

1 Atropine Sulfate 1 milligrams (mg.)/ml. abbojet (a pre-filled system of medications) available for immediate patient use with and expiration date of 2/01/2013 opened, unlabeled, and undated with an unknown amount remaining

The anesthesia machine unlocked cart top drawer had one bottle of Forane 100 ml. opened, unlabeled, and undated with an unknown amount remaining

One bottle of Suprane 240 ml., both , 2 bottles of Sevoflurane 250 ml., one was unopened and one was opened, unlabeled, and undated with an unknown amount remaining.

One 50 ml. vial of 8.4 % Sodium Bicarbonate and 1-50 ml IV bag of Potassium Chloride both opened, unlabeled, and undated with an unknown amount remaining.

On 3/18/2013 at 3:20 p.m., the supervisor of SPD said that the operating room #6 was last used and the surgical case completed today at 2:08 p.m.

4. During an observation on 3/18/2013 at 3:35 p.m. in OR #9 which is used for heart surgical cases, the anesthesia machine top drawer was found to be unlocked, accessible to unauthorized personnel

One expired abbojet Epinephrine 1:10,000/10 ml. available for immediate patient use with an expiration date of 3/01/2013

One bottle of Sevoflurane 250 ml.

Two bottles of Suprane 240 ml. (1 opened and 1-unopened)

Two Lidocaine 5 ml. 2% abbojets 2%

Three 10 ml. epinephrine 10 ml. unopened vials

One bottle of Nitroglycerin 50 mg.

None of the opened medications were labeled, dated, or timed.

5. Observation of the anesthesia medication cart on 3/18/2013 at 3:35 p.m. in OR #9 found it unlocked and unattended, leaving it available for access by unauthorized personnel.

The top drawer had one opened 20 ounce bottle of diet Pepsi

One 100 ml. bag of expired Epinephrine mix (1 mg./100 ml.) labeled available for immediate patient use with an expiration date of 3/07/2013 at 11 p.m.

One opened and engaged Epinephrine 1 mg. abbojet was found, and it was unknown if it was used for a patient. The operating room manager was asked if she could make a determination if the medication had been used on a patient, and she said no she would not know if it was used or when it was opened, since it was not labeled with a date and time.

A total of 3 opened, unlabeled abbojets were found in this drawer.

One 10 ml. syringe was found with a label identifying the medication as Epinephrine, but there was no strength, and it was undated and untimed.

One 100 ml. intravenous (IV) bag was found with a label of Phenylephrine but there was no strength or amount of additive, and it was undated and untimed.

The unlocked drawer also had the following medications available to unauthorized personnel:

Five vials of Heparin 10 ml.

One Esmolol 10 ml. vial

One Neostigmine 10 ml. vial

Two Phyenylephrine 1 mg. single dose vials

One Glycopyrate 5 ml. vial

One Lidocaine 5 ml. vial

One Succinylcholine 10 ml. vial

One Aminocaprocic Acid 20 ml. vial

During an interview on 3/18/2013 at 3:30 p.m., the supervisor of SPD confirmed operating room #9 was last used and the surgical case completed today at 1:30 p.m.

During an interview on 3/18/2013 at 3:30 p.m., the OR manager said the housekeeping staff have access to the operating rooms after cases are completed to terminally clean all rooms and would have access to the unlocked medication items in the anesthesia machine drawers.

During the above observations and interviews, the assistant chief nursing officer, infection control nurse, and operating room manager were all present to confirm the findings.

Review of the policy "Single/Multi-Dose Vials and Containers" (excludes anesthesia gases), dated as last revised on 1/2012 showed the scope of the policy. It read, "This document is intended for all health care professionals in patient care areas, including procedural and operating rooms....Products labeled as multi-dose vials, i.e., glycopyrrolate, lidocaine, etc. and as multi-use containers, i.e. inhalers, ointments/creams, and drops, etc. are to be limited to use for a single patient and then discarded. These items should NOT accompany the patient upon transfer outside of the procedural or operating room areas and must be discarded. As with multiple dose vials, single dose vials, i.e. esmolol, ephedrine, metroprolol, etc. are to be limited for a single patient and then discarded. Use on a second or subsequent patient is not permissible."

During an interview on 3/21/2013 at 2 p.m., the infection control nurse confirmed the facility's current policy showed all multi-dose vials (except insulin) are to be treated as single-dose vials.

Review of the policy "Medication management", dated as reviewed last on 1/2011, read for "Storage of Medications, Inpatient Medications" that "All patient care areas are equipped with automatic dispensing medication (ADM), locked medication room, or locked medication cabinet for medication storage....Monthly inspections are performed by pharmacy personnel who will check for outdated and improperly stored medication, facility-wide. Outdated or unusable medications are stored in bins marked for this class of medication and are properly disposed of by the facility's disposal contractor.... Multiple dose vials are labeled with the date, time, and initials when opened. Shelf life shall be according to the manufacturer's recommendation."

Review of the policy "Medication Safety", dated as last reviewed on 5/2012, read, "Any solution/medication found in the invasive procedure area without a label shall be discarded. If there is any doubt as to the strength or identity of a medication/solution, it shall be discarded....Anesthesia providers shall follow the same procedure of labeling all medications drawn up for use...."

During an interview on 3/21/2013 at 1:20 p.m., the OR manager said the anesthesia medication carts should not have any medications left in them. After the completion of the procedure, the medications are to be returned to the pharmacy or to the Pxyis machine.

During an interview on 3/19/2013 at 12:50 p.m., staff H, a cardiac surgeon, was asked if he allows beverages in the operating room during procedures, responded "no" and was disappointed to find out about the Pepsi found in the anesthesia medication cart.

Review of the policy "Food Consumption", dated as revised last on 1/2013 read that "Food consumption shall be allowed only in designated areas....No eating or drinking allowed in the work place, on nursing units, or in any area where there are patients, in any areas where pharmaceuticals are prepared, or in any area where laboratory tests are performed."