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Based on observation, interview, and document review the hospital failed to have a breakable seal to access the emergency malignant hyperthermia medication supply in accordance to hospital policy. This failure could cause inadequate supply of emergency medications because of the potential of medications not being re-supplied.

Findings:

A review on 4/10/18 of the hospital policy entitled Malignant Hyperthermia indicated, "All licensed staff shall be knowledgeable regarding the facility protocol on management of Malignant Hyperthermia and shall abide by the protocol .... The Malignant Hyperthermia Emergency Supply ... kit is sealed by a pharmacist with a plastic numbered seal and the contents of the kit are listed. The earliest medication expiration date is posted on the outside of the kit .... If the seals are broken, the kit is checked and restocked by the pharmacist who then seals the kit and signs the audit form."

During an observation on 04/10/18 at 10:12 AM, in the operating room, there was a malignant hyperthermia (MH) emergency medication supply cart. The cart did not have a plastic numbered breakable seal and it was unknown if the cart had been accessed.

During an interview on 04/10/18 at 10:12 AM, the Pharmacist in Charge (PIC) stated that he was not aware that there was no breakable seal on the MH kit. He also acknowledged that by looking at the cart it was not known if the cart had been accessed or if the cart needed to be re-supplied. He said that he would put a seal on the MH emergency supply.

Based on observation and interview, the facility failed to follow manufacturer preventive maintenance guidelines for one of one facility sterilizers (used for the sterilization of surgical instruments). This resulted in a buildup of debris in the sterilizer, and the potential for avoidable sterilizer malfunction.

Findings:

On 4/10/18 at 11 am, during an initial tour of the Central Supply/Sterilizer Room (CSSR), and a concurrent interview, the Lead Sterilization Tech (LST) explained that the only maintenance he was trained to do for the sterilizer was a monthly thorough cleaning of the inside of the sterilizer. During observation of the inside of the sterilizer, LST confirmed there was a build-up of brownish/rust colored dust and debris. The inside of the door, included a build-up of a black substance. The LST stated he thoroughly cleaned the sterilizer every month, but did not document the procedure, so was not sure the date of the last cleaning. The LST stated facility training, for his position, did not include any other inspection or maintenance procedures for the sterilizer (other than quarterly maintenance by an outside vendor).

On 4/11/18 at 10:30 am, during an interview, the Chief Nursing Officer (CNO) stated facility did not have a policy and procedure for sterilizer cleaning and maintenance procedures.

On 4/11/18 at 11 am, during an interview, and concurrent review of the manufacturer guidelines for inspection and maintenance of the facility's sterilizer, the LST confirmed these guidelines included a schedule of daily, weekly and monthly preventive maintenance procedures that were not being followed.

Daily procedures included:
1. Check record chart or printout for inked record after each cycle;
2. Check the door gasket. Replace it if it has become deformed, brittle, or cracked; and
3. Check that pressure regulator (HI-LO valve) is controlling pressure within acceptable ranges.

Weekly procedures included:
1. Watch the sterilizer as it goes through each phase of a complete cycle and check that all indicating lights are working; 2. Flush chamber drain line as follows:
a. Remove chamber drain screen.
b. Rinse drain with hot solution of trisodium phosphate (two tablespoons to one quart of water). If the use of trisodium phosphate is objectionable, use instead a solution of 1/2 cup of AMSCO Sonic Detergent and one quart of hot water.
c. Wait five minutes.
d. Then flush with one quart of hot water.
e. Place the strainer back in the chamber drain.

Monthly procedures included:
1. Place a few drops of heavy machine oil on door hinge pin. Work oil into hinge by opening and closing the door several times.

After reviewing the guidelines above, LST stated that during each use, he did watch the sterilizer as it went through each phase of a complete cycle and checked that all indicating lights were working, but did not perform any of the other preventive maintenance procedures as described above.

Based on interview, observation and document review the facility failed to maintain a clean and orderly environment when expired supplies were observed available for use in the hospital and at the clinic.

This failure could lead to inaccurate test results and for patients to experience negative clinical outcomes due to ineffective items that were utilized past their expiration dates.

Findings:

During a general tour of the facility starting at 1 pm on 4/9/18, with Registered Nurse (RN) 1, the following was observed in the medical/surgical unit clean utility room and confirmed available for use.

A large plastic bag containing approximately forty (40) individuals antiseptic napkins labeled, "Med Naps," with the expiration date of 12/2017. Med Nap towelettes are used in first aid to help prevent skin infection in minor cuts, scrapes and burns.

Five separate 7.5 ounce bottles of antibacterial hand soap with the expiration date of 6/2016.

RN 1 confirmed that these items were past there expiration dates and removed them from the clean utility room.

During a general tour of the facility's adjacent clinic starting at 2:15 pm on 4/9/18, with Clinic Manager (CM), the following was observed and confirmed available for use.

In Room 8; one bottle of guaiac stool developer (a test reagent that is used to test for the presence of blood in stool), with the expiration date of 3/2018 and one small packet of lubricating jelly with the expiration date of 5/20/17.

In Room 7; one red top blood test tube (a tube used to collect a blood sample) with the expiration date of 5/2017, and one opened bottle of sodium chloride wound irrigation solution, labeled opened 1/31/18.

The CM confirmed that these items were past their expiration dates and removed them from the clinic rooms.

The Center for Disease Control and Prevention (CDC, the leading national public health authority), recommends that all laboratory specimens, test components and controls be monitored to ensure test integrity. Expired test components can degrade test reagents and specimens, and impact reaction times, and affect the overall test results.

The facility's policy titled, "Equipment and Supplies," dated 11/2015, was reviewed and indicated that supplies that are subject to deterioration will be rotated to ensure that expired items will not be available.

Based on interview and record review, the facility failed to ensure care provided to three of 43 patients (Patients 1, 3, and 7) was consistent with the facility's vital signs and transfer policies. This had the potential to result in serious and unrecognized declines in the condition of these patients.

Findings:

The facility policy titled, "Vital Signs Monitoring" and dated 1/2016, was reviewed. It read, "The baseline frequency and vital sign parameters measured will be determined by the physician or (in the absence of orders) by the team leader, and communicated through the physician orders and/or care plan .... Vital signs include temperature, pulse, respirations, blood pressure, oxygen saturation and pain level. Documentation of vital signs will be placed in the electronic medical record (EMR)."

1. A review of Patient 1's record indicated he presented to the Emergency Department (ED), on 3/4/18, with an open fracture (break) of the right ankle and chest pain. Initial vital signs were taken at 8:16 am and Patient 1's pain was 10 (scale 1-10). He was medicated with Morphine (a narcotic pain reliever) 5 milligrams (mg) intravenous (IV) at 8:30 am. At 8:50 am vital signs were rechecked and Patient 1's pain level was 3. Patient 1 was medicated again with Morphine 5 mg IV at 9:10 am. No pain scale assessment was done at that time. Patient 1 was transferred to a higher level of care at 9:30 am.

A review of Patient 1's transfer documents included a "Transfer Assessment" form. Patient 1's last vital signs and assessment was done at 8:50 am and he was transferred out of the ED at 9:30 am.

During an interview on 4/10/18 at 11 am, the Chief Nursing Officer (CNO) stated they follow the California Hospital Association EMTALA (Emergency Medical Treatment and Active Labor Act 2018) in their ED and provided the manual for review. Under the "Hospital Standards for an Appropriate Transfer" section, it read, "It is strongly recommended that hospitals document a patient's vital signs and conduct a medical reassessment of the patient immediately preceding the departure of the patient from the hospital." A copy of the facility's "Transfer Form," last revised 5/2016, was also provided and indicated the assessment should take place within 15 minutes of departure.

During a concurrent interview and record review on 4/10/18 at 11:10 am, the Nursing Supervisor (NS) confirmed the last vital signs and assessment done was at 8:50 am and not within 15 minutes of departure as per their transfer form and practice.

2. A review of Patient 3's record indicated he presented to the ED on 3/9/18 at 2 pm with mental health issues. He was transferred to the medical surgical unit for observation on 3/9/18 at 3:30 pm, where he remained until his discharge on 3/12/18. A review of the vital signs indicated they were taken upon presentation, on 3/9/18 at 2 pm, and not taken again until 3/11/18 at 3:42 am, approximately 36 hours later.

During a concurrent interview and record review on 4/10/18 at 2:30 pm, NS confirmed the above. She stated that the facility's practice and plan for patients on the medical surgical unit was to perform vital signs every four hours. NS confirmed this included mental health patients who were being observed on the medical surgical unit, such as Patient 3.

3. A review of Patient 7's record indicated she was an 8 year old who presented to the ED on 3/16/18 with fever, sore throat, and respiratory distress. She was admitted to the medical surgical unit and vital signs were completed at 3:36 pm. The next vital signs were not done until 3/17/18 at 7 am, more than 15 hours later.

During a concurrent interview and record review on 4/11/18 at 8:30 am, NS confirmed the above. She said Patient 7 should have had her vital signs checked every four hours.

Based on observation, interviews, and document reviews the hospital failed to handle medications in accordance to profession standards of practice as evidence by:

1. The hospital failed to use a residue-free disinfecting agent such as sterile isopropyl alcohol (IPA) to clean the sterile compounding area in accordance to professional standards of practice.

2. The hospital failed to change the pre-filters in the intravenous (IV) hood monthly by maintenance staff in order to maintain sterility in the IV sterile compounding area in accordance to hospital policy.

3. The hospital failed to certify the intravenous (IV) hood every 6 months in accordance to professional standards of practice. The IV hood was certified annually.

4. The hospital failed to ensure safe medication disposal practices for propofol (general anesthetic agent, classified as a controlled substance by the Drug Enforcement Agency) in one of one facility Operating Rooms (OR) when:

Findings:
1. A review on 10/24/17 of the United States Pharmaceopedia 797 Pharmaceutical Compounding (USP 797) Copyright 2008 indicated, "Cleaning and disinfecting shall occur before compounding is performed. Items shall be removed from all areas to be cleaned and surfaces shall be cleaned by removing loose material and residue from spills ... water-soluble solid residues are removed .... This shall be followed by wiping with a residue-free disinfecting agent ... sterile 70% IPA, which is allowed to dry before compounding begins."

During an observation on 04/09/18 at 4:02 PM in the sterile compounding area there was a bottle of non-sterile 70% IPA. The bottle of non-sterile 70% IPA was on top of the intravenous (IV) hood.

During an interview on 04/09/18 at 4:02 PM the Pharmacist In Charge (PIC) stated that staff used the non-sterile 70% IPA to clean the hood before and after mixing IV medications. The PIC acknowledged that sterile 70% IPA should have been used instead of non-sterile 70% IPA.

2. A review on 04/10/18 of the hospital policy entitled IV Compounding and Use of Laminar Flow Hood indicated, "It is the policy of Modoc Medical Center that all licensed staff shall be knowledgeable regarding the facility protocol on IV Compounding and shall abide by the protocol .... Pre-filters will be changed monthly by maintenance staff who will annotate the change on the cleaning log."

A review on 4/10/18 of the 2018 Filter Log indicated that the monthly pre-filters changes did not occur in January and February 2018. The log indicated the filters were not changed.

A review on 4/10/18 of an invoice of the purchase of the pre-filters indicated that the filter did not arrive until approximately 4/26/18. During an interview on 4/10/18 at 10:34 AM with maintenance person 1 he stated that the filters were ordered but did not come in until the end of February and the filter was not replaced until March. He said that in the future he would order the filters earlier to make sure that the pre-filters were changed monthly.

3. A review on 4/10/18 of the United States Pharmaceopedia 797 Pharmaceutical Compounding (USP 797) Copyright 2008 indicated, "Certification and testing of primary ... engineering controls [IV hood] shall be performed by a qualified individual no less than every six months .... Certification procedures such as those outlined in the CETA Certification Guide for Sterile Compounding Facilities ... shall be used."

During an interview on 04/10/18 at 10:31 AM the Pharmacist In Charge stated that the IV hood was certified annually. He also stated that he was not aware that the certification was required every 6 months. He said that he would get the IV hood certified every 6 months.

A review on 4/10/18 of the IV hood certification from 2015-2018 indicated that the IV hood was certified annually.



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4. On 4/9/18 at 2:45 pm, during an initial observation tour of the OR, a pharmaceutical waste bin (similar to a kitchen trash can) contained un-emptied vials of propofol. During a concurrent interview, the Surgical Aide (SA) confirmed the bin's lid was not secure and could easily be removed.

On 4/9/18 at 10:15 am, during an observation, a Environmental Services Aide was observed cleaning the OR (where the unsecured propofol, in the pharmaceutical waste bin, was stored).

On 4/10/18 at 10:15 am, during a concurrent interview, the Director of Pharmacy (DP), stated he was not aware of the process, in the OR, for disposing of medications that were used during surgery. When asked if the vials of propofol were required to be emptied prior to discarding in the pharmaceutical waste bin, the DP stated he was not sure. The DP confirmed the pharmaceutical waste bin was accessible to both licensed and unlicensed staff (housekeeping, sterilization and scrub tech) without accountability (it would not be possible to know if vials were missing from the bin). The DP acknowledged his responsibilities included safe medication practices in the facility, and confirmed the current practice was not safe.

On 4/10/18 at 1:45 pm, during an interview and concurrent review of the job description for the DP, the Chief Nursing Officer (CNO) confirmed the DP's responsibilities included ensuring safe medication disposal practices in the OR. After reviewing the pharmacy policies and procedures, the CNO stated no procedure was found specific to safe medication disposal practices.

On 4/10/18 at 2 pm, during an Interview and concurrent observation of the pharmaceutical waste bin in the OR, the CNO visualized the bin's contents while the bin was turned from side to side and indicated the bin contained approximately 50 vials, in a variety of sizes (more than half of the vials identified as propofol). The CNO confirmed that at least four un-emptied vials of propofol (1000 mg/100 ml) were one-quarter to one-third full (approximately 250 milligrams (mg) - 333 mg), and were accessible to staff without accountability (since it would not be possible to know if vials had been removed from the bin). The CNO explained the facility process for wasting propofol required documentation of the amount wasted, the signature of the person who drew up the propofol and a witness confirming the amount being wasted. The CNO stated staff did not follow required medication disposal procedures since it would not be possible to know how many milligrams of propofol were in the un-emptied vials, without first drawing it up in a syringe, prior to being wasted. The CNO stated vials should be emptied prior to being discarded.

According to the ASHP's (American Society of Health-System Pharmacists) Drug Distribution and Control Guidelines, page 78, "Controlled Substances (CS) diversion in healthcare systems can lead to serious patient safety issues, harm to the diverter, and significant liability risk to the organization. Diversion driven by addiction puts patients at risk of harm, including inadequate relief of pain, inaccurate documentation of their care in the medical record, exposure to infectious diseases from contaminated needles and drugs, and impaired health-care worker (HCW) performance .... These guidelines provide a detailed and comprehensive framework ... in order to protect patients .... (The) Pharmacy reconciles CS in high risk areas, such as surgery and anesthesia areas, by comparing the amount dispensed with the amount documented on the CS administration record, and the amount documented as wasted. The organization identifies specific high risk CS medications ... and procedures include random testing of waste, from all high risk or high volume areas .... Anesthesia and operating rooms are high risk areas for which organizations should consider additional policies and procedures .... To minimize waste, CS are stocked in as ready-to-use form as possible (e.g., avoiding the use of multi-dose vials) and in amounts frequently used ...." The wasting of all CS requires an independent witness and documentation. At least one, but preferably both of the witnesses should be licensed. Procedures should define what constitutes complete and timely documentation of waste. An individual witnessing CS wasting should verify the product label, that the product and amount being wasted matches the documentation, that the drug product being wasted physically matches the drug product in the documentation, and that the wasting occurs per policy for safe disposal and in a manner that makes the drug irretrievable. The entire process for drawing up and wasting from a vial should be witnessed so the individual verifying can be certain that the actual substance is being wasted, and not a substitute or alternative."

According to the Drug Enforcement Administration (DEA), diversion control division, (21 CFR Part 1308) document titled, Schedules of Controlled Substances: Placement of Propofol into Schedule IV; Proposed Rule, dated 10/27/10, "Propofol is the most common intravenous anesthetic in the United States ... documented cases of abuse have been steadily increasing over the past 10 years .... Unfortunately, there is also a very high mortality rate (greater than 33%) associated with this abuse."

According to the American Association of Nurse Anesthetists Journal, dated 12/2017, the article titled Propofol Disposal in the Anesthesia setting indicated, "Propofol accounts for 41% of reported substance abuse cases among anesthesia providers ...." The article's conclusion indicated, "Unique to propofol is its high incidence of fatal outcomes when abused. Ease of access is a primary reason that propofol abuse is increasing, making proper disposal of unused propofol a paramount concern. Tailored interventions to address barriers (to proper disposal) ... (would) significantly decreased the number of un-emptied propofol vials remaining in unsecured bins, in the ORs, thereby decreasing access for diversion."

Based on observation, staff interview, and document review, the facility failed to ensure the implementation of infection control prevention measures when:

1. Infection prevention concerns in the Decontamination Room (area used for washing/brushing/scrubbing contaminated surgical instruments) included:

a. Clean and sterile supplies, that were used in the Operating Room (OR) during surgical procedures, medications, were stored in the Decontamination Room. This had the potential for cross-contamination to patients.

b. The Decontamination Room did not have a door. This had the potential to result in cross-contamination.

c. No lighted magnification was available in the Decontamination Room, where instruments were visually inspected for integrity and for residual visible contamination. This could result in incomplete removal of bioburden from the instruments during the cleaning process and for instruments with compromised integrity to go unidentified.

d. The procedure for surface cleaning in the Decontamination Room, after washing contaminated surgical instruments, did not ensure total saturation of the surface (as required), when a spray bottle was used to dispense the disinfectant.

e. The hopper did not have a splash guard.

2. Infection Prevention concerns in the OR suite included:

a. The air exchanges/ventilation, in the OR, was not tested as required.

b. Two products (lubricant and gas prevention drops) used during a procedure, were then stored in the sterile storage cabinet.

c. The tiled walls had areas of grout with a buildup of blackish brown discoloration.

d. The OR door had a wood surface that had deteriorated so that it was not cleanable.

e. Expired supplies were available for use.

3. The temperature and humidity was not monitored, as required, in areas designated for the storage of sterile supplies (the OR suite and the Central Sterile Supply Room). This had the potential for avoidable risk to the integrity of these supplies.

4. The facility's cleaning procedures for the OR did not ensure adequate "dwell time" (time the cleaning product was required to stay wet, on a surface, to sufficiently kill bacteria and viruses).

These failures had the potential to result in cross-contamination of bacteria and viruses which could lead to patient illness and/or surgical site infections.

Findings:

1.a. On 4/9/18 at 3:35 pm, during observations of the Decontamination Room and concurrent interview, the Surgical Aide (SA) during a concurrent interview confirmed the room had a cabinet that included clean and sterile supplies that were used in the OR during surgical procedures.

During an interview on 4/11/18 at 11:15 am, the Infection Preventionist (IP) confirmed a medication cabinet was located in the decontamination room. The IP stated supplies and medications used for patients during surgery should not be stored in the Decontamination Room due to the potential for cross-contamination. The IP stated the facility used AORN (Association of Peri-Operative Nursing) standards for the surgical services area.

AORN Guideline for Cleaning and Care of Surgical Instruments, effective 11/15/14, was reviewed and indicated, "Recommendation V. Instruments should be cleaned and decontaminated in an area separate from locations where clean items are handled. 10,45,46

Physical separation of decontamination areas from areas where clean items are handled minimizes the risk of cross-contamination. Cross-contamination can result when soiled items are placed in close proximity to clean items or are placed on surfaces upon which clean items are later placed. Droplets and aerosols created during cleaning of soiled instruments can cause cross-contamination of any nearby clean items or surfaces ...."

1.b. On 4/11/18 at 11:15 am, during an observation and interview, the IP confirmed the Decontamination Room, which did not have a door, was immediately adjacent to the scrub sinks, (used for special hand washing prior to surgery), and approximately 10 feet from the OR door. The IP confirmed there was an increased risk for cross-contamination due to the room not having a door.

The AORN Guideline for a Safe Environment of Care, Part 2, effective 5/15/14, was reviewed an indicated, "IV.g.2. The pressure relationship of the semi-restricted area to the adjacent area should be based on the use of the area: ... decontamination room-negative ...."

1.c. On 4/10/18 at 2:45 pm, the process for cleaning endoscopes was observed (in the decontamination room). The Surgical Aide/Scrub Tech (SA) wiped and/or brushed the scope and visually inspected it (for any remaining visible bioburden and for any nicks or other evidence of compromise to the instrument). No magnification was available for use in the decontamination room.

The AORN Guidelines for Processing Flexible Endoscopes, effective 2/1/16, was reviewed an indicated, "VII.c. Lighted magnification should be used to inspect endoscopes and accessories for cleanliness and damage. 12,13,65 [2: High Evidence]

An endoscope that appears clean may harbor debris that cannot be seen without magnification. Lighted magnification may increase the ability to identify residual soil or damage.

VII.c.1. Internal channels of flexible endoscopes may be inspected using an endoscopic camera or borescope. [2: High Evidence]

Endoscopic cameras and borescopes penetrate the lumen and allow for improved visual inspection. 12,58

VII. d. Defective endoscopes, accessories, and equipment should be removed from service and repaired or replaced. 1,13,58 [2: High Evidence]

Identification of defective endoscopes, accessories, and equipment and removal from service reduces the risk of a defective item being used and helps prevent further damage from use."

1.d. On 4/10/18 at 2:45 pm, endoscope cleaning in the decontamination room was observed. After the endoscope had been cleaned and the water had been drained (from the stainless steel basin into the sink), the Surgical Aide/Scrub Tech (SA) sprayed Cavi-spray (chemical disinfectant) on the area (counter-top, stainless steel basin, and sink). The "wet time" requirement of three minutes was confirmed by reading the label on the bottle. The ST confirmed that the entire surface area sprayed was not wet due to the distribution of the sprayed product. The SA stated she had not sprayed as much a usual because the fumes from the spray were irritating (to breathing).

The AORN guidelines for environmental cleaning, effective 11/15/13, was reviewed and included directives for the use of spray chemicals in the peri-operative practice. The guidelines indicated "II.c.6. Spray and misting methods (e.g., a spray bottle) should not be used to apply cleaning chemicals in the perioperative practice setting. 14 Cleaning chemicals that are sprayed produce more aerosols than solutions that are poured or ready to use. 14 If the cleaning solution is contaminated, the spray mechanism may provide a route for airborne transmission of disease. 14 Aerosols generated may ... cause respiratory symptoms (acute or chronic) in personnel and patients."

The Safety Data Sheet (SDS) for the Cavi-spray product (containing cavicide) included precautionary guidelines which directed that cavicide was only to be used outdoors or in well ventilated areas, to avoid breathing vapors, and if inhaled, remove victim to fresh air, and keep at rest in a position comfortable for breathing.

1.e. On 4/11/18 at 11:15 am, during observations in the Decontamination Room, and a concurrent interview, the IP confirmed a hopper (used for discarding contaminated fluids from surgery and for emptying dirty housekeeping buckets) did not have a splash-guard.

2.a. The AORN Guideline for a Safe Environment of Care, Part 1, effective 12/15/12, were reviewed and indicated, "VII.c. Ventilation systems in rooms where anesthesia gases are administered should have an air exchange rate of at least 15 exchanges per hour."

On 4/10/18 at 9:27 am, during an interview, the Director of Plant Operations and Maintenance (DM) stated air exchange tests for the operating room were not done. The DM stated the OR's air handler was a historic (1950's) system. The DM was not aware of current air exchange requirements for the OR.

On 4/11/18 at 8:50 am, during an interview, the CNO stated the facility did not have a policy or any guidelines regarding air exchange requirements for the OR.

2.b. On 4/9/18 at 3 pm, during observations in the OR and a concurrent interview, the Surgical Aide (SA) confirmed that the sterile storage cabinet in the OR contained two items (Simethicone Antigas 1 ounce drops and Lubricating Jelly 4 ounce) that had been opened and used during a procedure. The SA stated the items did not come in contact with the patient and remained on the back table during the endoscopy procedure.

2.c. On 4/10/18 at 10:45 am, during observations in the operating room and a concurrent interview, the Environmental Services Aide (EVSA) confirmed the grout (on the tiled walls) had multiple areas throughout with brownish/black discoloration on the grout lines. The EVSA stated the walls were cleaned before and after surgery days (two to four days per month) and at least every week (if no surgery). EVSA explained the walls were moped with a microfiber mop. When asked how the grout was cleaned, EVSA stated there was not a cleaning schedule specific to the grout. When EVSA was asked if the dark areas of grout were just stained or if there was a buildup of removable debris, EVSA used a rag with cleaning solution, cleaned several areas of grout, and they all came clean.

On 2/10/18 at 11:40 am, the EVS Lead (EVSL) confirmed the above findings and acknowledged there should be a specific grout cleaning process.

2.d. On 4/11/18 at 11:15 am, during observations of the OR suite and a concurrent interview, the IP confirmed the OR door's wood surface had areas that were chipped, gouged, and rough throughout both sides of the door, so that the unsealed wood was exposed. The IP acknowledged it would not be possible to ensure effective cleaning and disinfection of the OR door.

2.e. On 4/9/18 at 2:45 pm, during observations of the operative suite, and a concurrent interview, the SA confirmed that expired items in the OR sterile storage cabinet included three laryngeal masks (device that keeps a patient's airway open during anesthesia) that expired 11/2017, two Megadyne smoke evacuation pencils (removes hazardous fumes of surgical smoke) and one 1000 milliliter bag of normal saline that expired 3/2018.

On 4/11/18 at 11:15 am, during an interview, the IP acknowledged that expired supplies should not be available for use.

3. The AORN Guidelines for a Safe Environment of Care, effective 5/15/14, were reviewed and indicated that sterile storage areas should be monitored and be maintained with humidity of 60 percent or below, and a temperature below 75 degrees Fahrenheit.

On 4/11/18 at 10:30 am, during an interview, the CNO stated the facility did not have a policy and procedure regarding temperature and humidity monitoring for areas designated for storage of sterile supplies.

On 4/11/18 at 11 am, the Central Supply Clerk confirmed no temperature and humidity monitoring was in place for the Central Sterile Supply room (where the majority of the facility's sterile supplies were stored).

On 4/11/18 at 11:15 am, the IP stated the facility followed AORN guidelines and confirmed the circumstances as described above.

4. The Association of Peri-Operative Nurses (AORN) Guideline for Environmental Cleaning, effective 11/13/15, were reviewed and indicated, "II.c.5. Disinfectants should be applied and reap-plied as needed, per manufacturer's instructions, for the dwell time (time surface is required to stay wet) required to kill the targeted microorganisms.

On 4/10/18 at 10:30 am, during an observation of cleaning procedures in the OR with Environmental Services Aide (EVSA), the cleaning product "dwell time" was observed. After EVSA cleaned the surface of monitoring equipment, it was partially dry at one minute and completely dry by two minutes. During a concurrent interview, the EVSA stated she was not sure how long the product was required to be wet on the surface, but thought it was at least three minutes. EVSA got a new wet rag and re-cleaned the same surface. The surface (cleaned with the new wet rag) was partially dry at three minutes and completely dry by four minutes. Concurrent review of the cleaning product label indicated the required dwell time was 10 minutes. The EVSA acknowledged that training for the OR cleaning procedure, had not included observation for dwell time requirements.

On 4/11/18 at 11:15 am, a concurrent interview with the EVS Lead (EVSL, responsible for environmental services training) and the Infection Prevention Nurse (IP) took place. The EVSL and IP confirmed that the cleaning product used for environmental cleaning in the OR had a 10 minute dwell time. The EVSL and IP explained that while EVS audits included swabbing the environment and testing for thorough cleaning with a black light, audits did not include observation for required cleaning product dwell time. The IP acknowledge that it was not possible to ensure elimination of bacteria and viruses if the cleaning product dwell time was not met. The IP stated the facility followed AORN guidelines.

Based on interview and document review, the facility failed to ensure competence of all staff when it failed to complete an annual performance evaluation for one temporary traveling nurse. This had the potential to result in nurses caring for patients who were unqualified.

Findings:

On 4/11/18 at 10:30 am, employee files for seven nursing staff were reviewed with the Human Resources Manager (HRM). During a concurrent interview HRM stated that regular employees receive annual performance evaluations from their managers and she sends out reminders to the managers to ensure they're done on time. A review of Registered Nurse (RN) 1's file indicated she had worked for the hospital since 9/3/12. HRM said RN 1 was a temporary traveler nurse although she had worked for the hospital long term. She said no annual performance evaluation had been done by the hospital for RN 1.

During an interview on 4/11/18 at 11:50 am, the Nursing Supervisor (NS) said they had no policy or practice for completing annual performance evaluations on long term travelers, like they do for regular employees. NS confirmed no formal performance evaluation had been done for RN 1 although she had received orientation and competency checks.

Based on interview and record review, the facility failed to ensure that one of eight sampled patient records had a discharge summary that was signed by the physician in a timely manner. This failure could result in inaccurate medical record and confusion with the coordination of future care of the patient, which could lead to negative clinical outcomes.

Findings:

Patient 14's medical record was reviewed on 4/10/18. Patient 14 was admitted to this facility on 12/2/17, with diagnosis that included left leg cellulitis (a serious skin infection). Patient 14 required several days of intravenous antibiotics and was discharged home on 12/6/17.

During a review of Patient 14's discharge summary, it was noted that this document was dictated by the physician on 12/6/17, it was transcribed on 12/6/17. This discharge summary was then not electronically signed by the physician until 12/22/17 (16-days post discharge).

During a concurrent interview and record review, on 4/10/18 at 3 pm, with the Nursing Supervisor (NS), the above finding was confirmed. The NS stated that this particular physician is out of the country frequently and that could account for the late signature.

The facility's Medical Staff Rules and Regulations, approved 2018, was reviewed and indicated that a patient's medical record will be available for completion in the medical records office for fourteen (14) days after discharge.

Based on interview and document review, the hospital failed to ensure its contracted service for biomedical engineering was adequate when they were unable to evaluate that equipment inspections were done in a timely manner. This had the potential to result in equipment being available for use that was not in proper working condition.

Findings:

On 4/10/18 at 8:25 am, the infant incubator (baby warmer) in the delivery room was observed with the Chief Nursing Officer (CNO). During a concurrent interview the CNO confirmed it had a sticker on it which indicated it had been inspected by biomedical engineering, but the sticker did not include the date. CNO said they had a contract with the biomedical engineer. A list of equipment checks and dates was requested.

The list of equipment which had been inspected, and dates of inspection, was received and reviewed, on 4/11/18. The baby warmer had been inspected approximately six months prior.

On 4/11/18 at 9:30 am, the Director of Maintenance (DM) was asked how often the biomedical engineer inspected the equipment. DM said it varied with the equipment and ranged from quarterly, to every six months, to annually. A list of equipment and how often the equipment was to be inspected was requested but DM said he did not have this list, but their biomedical engineer had this list.

During an interview on 4/11/18 at 11:20 am, the Chief Executive Officer (CEO) said DM had a list of items to be inspected, but did not have the dates they were due to be inspected. CEO confirmed they could not perform a check on the biomedical engineer because they did not have this information.

Based on interview and record review, the hospital failed to maintain a central log in the Emergency Department (ED) in which each patient presenting for emergency care was listed along with all of the information required by regulations and facility policy. The specific information missing from the ED log included the disposition and time of discharge for three patients during 3/2018. This failure had the potential to result in the facility's inability to accurately track the care given to each patient or if care had been refused.

Findings:

During an interview on 4/10/18 at 11 am, the Chief Nursing Officer (CNO) stated they follow the California Hospital Association EMTALA (Emergency Medical Treatment and Active Labor Act 2018) standards in their ED and provided the manual for review. Under the "Maintenance of the Central Log" section it read, "The log must state whether a patient: 4. Was admitted and treated; 5. Was stabilized and transferred; or 6. Was discharged."

On 4/10/18 at 10:50 am, the ED log for 3/2018, was reviewed with the CNO. The disposition, whether a patient was transferred, admitted, or discharged, was not included on 3/5/18 for Patient 44, and on 3/7/18 and 3/9/18 for Patient 3.