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Based on observation, interview and record review the facility's Governing body failed to fulfill its responsibilities for monitoring and implementing policy and procedures. The facility did not meet the condition of participation in governing body by failing to:

1. Maintain a sanitary environment for surgical services, to avoid sources and transmission of infections and communicable disease in the Operating room (OR) by failing to monitor, oversee and assure surgical services were performed in a safe and sanitary environment, including: assuring manufacturer's guideline was followed when using the facility steam sterilizers in Sterile Procedure Department (SPD); assuring OR mattresses did not have tears; assuring single use sterile umbilical clamps were not stored out of the sterile container; assuring the operating room temperature and humidity was monitored and variances recorded, assuring Medical Staff had documented Hepatitis B status or Hepatitis B waiver in order to provide patient care in a safe and sanitary environment (A 0747, A 0749)

2. Have an ongoing Quality Assessment Performance Improvement (QAPI) program that monitored contracted services with Hospital B and assure SPD followed manufacturers guideline when sterilizing instruments. (A 0309)

3. Assure surgical services were provided in a safe and sanitary environment for surgical services, to avoid sources of contamination and transmission of infections and communicable disease and follow manufacturer's guidelines when using the steam sterilizers, and assure the operating room temperature and humidity was monitored and variances recorded. (A 0951)

The cumulative effect of these systemic problems resulted in the Facility's inability to ensure the provision of quality health care in a safe and sanitary environment.

Based on observation, interview, and record review, the hospital failed to provide a
safe setting for a patient who was assessed as a high fall risk, for one of one sampled patient (Patient 1). Patient 1 did not have a wrist band to indicate she was high risk for falls, per hospital policy and nationally accepted guidelines.

Findings:

On 10/25/17 at 9:20 a.m., during a tour of Tower 3 nursing unit with Clinical
Director 1 and other administrative staff, Patient 1, a confused, elderly female, was observed lying in bed with a vest restraint (a type of medical restraint that is used to restrain a patient to a bed or chair), and hand mitts (a hand mitten that is padded in order to prevent a patient from pulling out their IV catheter and tubes). There was no wrist band that identified the patient as being high risk for falls.

On 10/25/17 at 9:20 a.m., during a concurrent interview, Clinical Director 1 confirmed that Patient 1 was considered a high fall risk and should have a Fall Risk wristband.

A review of Patient 1's clinical record indicated the patient was admitted to the Emergency Department (ED) on 10/24/17 with diagnoses that included sepsis (a severe infection of the bloodstream) and delirium (a syndrome, or group of symptoms, caused by a disturbance in the normal functioning of the brain that results in reduced awareness of and responsiveness to the environment). A review of the Adult Assessment/Intervention document, dated 10/25/17 at 3:40 a.m., indicated the patient was identified as needing high fall interventions. One of the interventions included placement of a yellow wristband.

Based on observation, interview,and record review, the facility failed to ensure a patient was not physically restrained when a sitter (a staff member who is in close proximity of a patient at all times in order to monitor for patient's safety) was present. This failure had the potential to result in unnecessary restricted movement and discomfort for the patient.

Findings:

On 10/25/17 at approximately 9:20 a.m., a tour was conducted of Tower 3 with Clinical Director 2, the Quality Management Coordinator, and other administrative staff members. Patient 1 was observed lying in bed on her back, and was incoherent. The patient had a restraint vest (a type of medical restraint that is used to restrain a patient to a bed or chair), and hand mitts (a hand mitten that is padded in order to prevent a patient from pulling out their IV catheter and tubes) were present on each hand. There was a saline lock (an IV catheter that is used for medication administration or fluids) in the patient's upper left arm.

Certified nursing assistant (CNA) 1 was in the room and stated she was the sitter for Patient 1 and her room mate because both patients were confused. When questioned why Patient 1 was restrained, CNA 1 stated she was told by the night shift CNA that Patient 1 had attempted to pull out her IV, and was trying to get out of bed.

When questioned why Patient 1 was still restrained when a sitter was at the bedside, and why there was a mitt restraint on the patient's left hand, as the patient would be unable to remove her IV catheter with her left hand, Clinical Director 2 stated the staff could try removing the vest restraint, then instructed CNA 1 to remove the left hand mitt.

CNA 1 was then asked what she would do if she had to provide care to the other patient and would be unable to keep Patient 1 in sight. CNA 1 replied that it helped that Patient 1 was in restraints so that she (CNA 1) could be behind the curtain caring for the other patient. CNA 1 then stated that she could ask another staff member to watch Patient 1 while she was caring for the other patient.

A review of Patient 1's clinical record indicated the patient was admitted to the Emergency Department (ED) on 10/24/17 with diagnoses that included sepsis (a severe infection of the bloodstream) and delirium (a syndrome, or group of symptoms, caused by a disturbance in the normal functioning of the brain that results in reduced awareness of and responsiveness to the environment).

A review of the hospital's policy, titled, "Restraints: Non-Violent /Non Self-Destructive and Violent, Self-Destructive", dated 9/15, included the following stipulations:

"Restraints may only be imposed to ensure the immediate physical safety of the patient...and must be discontinued at the earliest possible time... The use of restraints occurs only after the alternatives to such use have been considered or attempted as appropriate. Such alternatives may include ...increased observation and monitoring..."

Based on record review and interview, the hospital's Governing Body failed to: monitor and evaluate the facility quality assurance and performance improvement (QAPI) program to assure patient safety: oversee and monitor patient care contracted services with Hospital B, assure Sterile Procedure Department (SPD) followed manufacturers Weight guidelines when sterilizing instruments; assure the operating room temperature and humidity was monitored and variances recorded.

Findings:

During a review of the facility QAPI ongoing studies failed to include: patient care contracted services for Hospital B, operating room temperature and humidity variances recorded. There was no written documentation available for the studies on SPD manufacturer weight guide line for sterilization of instruments and utensils. There was documentation available for the studies that included medical Staff Health screening for Hepatitis B.

A review of a facility document titled "organizational Quality and performance Excellence plan 2017" indicated the Board of Directors has the responsibility for assuring that the hospital services are provided in compliance with regulatory compliance' and Board of Directors "will oversee the quality and safety of services provided" and "improvement plan" dated 1/2017 indicated: the Governing Body has the responsibility for overseeing the monitoring of patient care, in order to identify and resolve any quality of care issues that may result in suboptimal patient care and safety ..."

During an interview with the Infection Preventionist (IP) director, and the Plant Operations Maintenance (POM) director on 10/25/17 at 10:10 a.m., when asked was there any ongoing monitoring or documentation of the temperature and humidity for the operating room (OR) the POM stated there were annual evaluations but there were no documented monitoring available for review.

During an interview with Director of QAPI on 10/25/17 at at 4 p.m. she indicated Hospital B had leased space from the facility and has a current contract. She indicated there were no QAPI studies that included Hospital B. Hospital B had no documentation of a representative that attend or participate in the Governing Body meetings. The facility failed to provide documentation of how the services provided for Hospital B was monitored.

Based on observation, interview, and record review, the facility did not meet the condition of participation in infection control by failing to ensure a sanitary environment as follows:

1. Ensure surgical instrument packs were being weighed, according to manufacturer's specifications for weight limit, prior to being placed in the autoclave (a device used to sterilize instruments and other items). (Refer to A 749)

2. Ensure that an Intensive Care Unit (ICU) patient's urinary catheter drainage bag, and chest tube (a plastic tube that is inserted into the area around the heart, in order to promote lung re-expansion and fluid drainage following surgery) drainage bag, were not in contact with the floor in order to prevent potential contamination and infection. (Refer to A 749)

3. Ensure the ice machine in the Post Partum (period following giving birth) unit was in sanitary condition, and maintained per manufacturer's instructions, in order to prevent bacterial growth. (Refer to A 749)

4. Ensure there was documented evidence that all physicians received the influenza vaccine and Hepatitis vaccine, or signed a declination statement. (Refer to A 749)

5. Ensure the closet for storage of GI endoscopes (nonsurgical procedure used to examine a person's digestive tract) in the Inpatient Gastrointestinal (GI) Procedure Unit was ventilated, in order to prevent bacterial growth and potential cross-contamination between patients. (Refer to A 749)

6. Ensure the Inpatient GI Procedure Unit has a dedicated area for patients who were in isolation due to an infectious organism, in order to prevent cross-contamination between patients and staff. (Refer to A 749)

7. Ensure the faucets in the Main Operating Room (OR) did not contain aerators (a device that is placed on the end of a faucet in order to add air to the water flow), in order to prevent potential harboring of micro-organisms. (Refer to A749)

8. Ensure glucometer units (device that measures the level of sugar in the bloodstream) were disinfected according to hospital policy and manufacturer guidelines, in order to prevent cross- contamination. (Refer to A749)

9. Ensure the surface of a surgical instrument tray for eye surgery, did not contain rust. (Refer to A 749)

10. Ensure surgical marking tape was not worn, and that there was no glue marks on the surgical instruments. Worn marking tape has the potential to contaminate the surgical site. (Refer to A 749)

11. Ensure intravenous (IV) sites indicated the date the IV catheter was inserted, in order to prevent potential infection of the bloodstream. (Refer to A 749)




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12. Ensure temperature and humidity in the Operating room were monitored and variances and corrections documented when operating room (OR) temperature or humidity was out of acceptable range. (Refer to A 749)

13. Ensure sterile umbilical clamps were not stored out of their sterile package inside a drawer with dust and black particles in the infant resuscitation station. (Refer to A 749)

14. Assure operating room (OR) mattresses in the cardiac bypass OR room had no tears. (Refer to A 749)

The cumulative effect of these systemic problems resulted in the hospital's inability to provide an effective hospital wide infection control program in a safe and effective manner.

Based on observation, interview, and record review the facility failed to identify and investigate possible sources of infection by failing to:

a. Ensure surgical instrument packs were being weighed, according to manufacturer's specifications for weight limit, prior to being placed in the autoclave.

b. Ensure that an Intensive Care Unit (ICU) patient's urinary catheter drainage bag, and chest tube drainage bag, were not in contact with the floor.

c. Ensure the ice machine in the Post Partum was in sanitary condition, and maintained per manufacturer's instructions, in order to prevent bacterial growth.

d. Ensure there was documented evidence that all physicians received the influenza vaccine and Hepatitis vaccine, or signed a declination statement.

e. Ensure the closet for storage of GI endoscopes in the Inpatient Gastrointestinal (GI) Procedure Unit was ventilated.

f. Ensure the Inpatient GI Procedure Unit has a dedicated area for patients who were in isolation due to an infectious organism

g. Ensure the faucets in the Main Operating Room (OR) did not contain aerators.

h. Ensure glucometer units were disinfected according to hospital policy and manufacturer guidelines.

i. Ensure the surface of a surgical instrument tray for eye surgery, did not contain rust.

j. Ensure surgical marking tape was not worn, and that there was no glue marks on the surgical instruments.

k. Ensure intravenous (IV) sites indicated the date the IV catheter was inserted.

l. Ensure temperature and humidity in the Operating room were monitored and documented within acceptable range including when variances occurred.

m. Ensure sterile umbilical clamps were not stored out of their sterile package inside a drawer with dust and black particles in the infant resuscitation station.

n. Assure operating room (OR) mattresses in the cardiac bypass OR room had no tears.

These deficient practices had the potential for cross contamination and spread of infection.

Findings:

1. During a tour of the Care Giver Room located in 3 - Pavilion of the facility on October 24, 2017 at 12:25 PM an ice making/dispensing machine was located in the back corner of the room. The ice machine was a "Follett Symphony Series" model. The unit was dripping water from the ice chute located on the front of the machine; there was brown staining on the left interior side of the chute; there was also brown staining and apparent mineral staining in the draining basin on the unit. Opening the top of the machine revealed white water mineral crusting and rust on the left corner.

During a conversation with Clinical Director 5 at that time, she stated that hospital maintenance is responsible for servicing the ice machines. Infection Preventionist 1 asserted that since 2015 the facility had not experienced an outbreak of Legionella infection (bacterium naturally found in water sources that can contribute to respiratory infection; it is usually acquired through droplet inhalation and infection presents itself with flu-like symptoms such as fever, chills, muscle ache).

A review of the manufacturer's instructions for maintaining the ice machine indicated that "cleaning/descaling and sanitizing of the ice machine should be performed by" the "facility's trained maintenance staff" or the manufacturer's authorized service agent. There was no evidence of instruction concerning internal maintenance of the ice machine. The manual also asserts that periodic cleaning/descaling and sanitizing of the ice and water dispenser should be performed as recommended and more so if conditions warrant in order to deliver clean, sanitary ice. The recommended cleaning/descaling and sanitizing intervals are as follows:

Drain Line weekly
Drain Pan/Drip Pan weekly
Exterior as needed
Condenser monthly (air cooled only)
Dispenser and Components semi-annually
Ice machine semi-annually
Transport tube semi-annually
Ice storage area/bin semi-annually

2. Three of the four faucets used for staff hand washing in the main operating room had wire aerator heads attached to them during a tour on October 24, 2017 at 1:00 PM.

At that same time Clinical Director 2 acknowledged there were in fact three faucets with wire aerators attached but asserted that the fourth aerator, that she called a 'flower' head, were within standard infection control guidelines.

According to the California Building Code Section 420A (for OSHPD 1) - Hospitals Section 420A.3 Definitions, Handwashing Fixture - The fixture cannot be equipped with an aerator (device that splits the flow of water out of a faucet and prevents splashing by adding air to its flow), or wrist and elbow blade handles.

Another study presented by Infection Control Today found that microbial volume was up to 10 times greater when aerators were in place than after they had been sterilized. Microorganisms such as Legionella, Acinetobacter, and other gram negative bacteria had significantly higher concentrations in aerators than in the general plumbing system. Low water temperature and low amounts of chlorine in the system water contributed to growth of Legionella bacteria in one particular study. (http://www.infectioncontroltoday.com/news/2014/01/hospital-water-taps-contaminated-with-bacteria.aspx)

3. During a random check of instruments in a 'minor tray' (set of surgical instruments deemed sufficient to repair injuries that are not life threatening) on October 24, 2017 at 1:30 PM in the Sterile Instrument Room, the instrument technician showed that there was plastic tape on handles of several of the instruments. Two of the instruments' tape appeared cracked and worn.

At that time the Reprocessing Supervisor advised that one of the instruments she identified as a vascular dilator had tape on its handle that was "past its prime and should be removed".
When asked what standard of practice the facility followed regarding sterilizing of surgical instruments, she replied that the hospital follows AAMI (Association for the Advance of Medical Instrumentation) and AORN (Association of periOperative Registered Nurses)standards.

According to AORN, as the colored marking tape wears out, pieces of the tape can break off or flake which could result in a foreign body being deposited in the surgical site. Frequent exposure of the tape to autoclave cycles can lead to degradation and shifting of the tape; this can lead to difficulty in removing tape residue. A regular process should be in place to inspect and replacement of marking tape. (Petersen, C. (2010). Marking Instruments With Color-coded Tape, AORN, 92(5), 587-588. www.aorn.org/CE)

The instructions for use for ColorTrack Instrument Identification Sheet Tape indicated that the tape is to be wrapped around the instrument one and a half times; avoid touching the adhesive; cut away excess tape; replace tape when it begins to show signs of wear.

4. During a tour of the Inpatient GI (gastrointestinal) Procedure Unit on October 25, 2017 at 10:50 AM the endoscope (an instrument that can be introduced into the body to give a view of its internal parts by use a flexible tube and small internal camera) storage cabinet was examined. The cabinet contained several scopes hanging from mounts attached to the back of the cabinet; one of the scopes had an attachment lying on the bottom surface of the cabinet. There was no visible ventilation or air filtration system within the cabinet. A subsequent examination of the off campus GI facility revealed up to date storage for endoscopes.

When asked about the frequency of cleaning unused scopes at that time, the GI director noted that they are cleaned weekly and when they seem dirty. The Administrative Director Surgical Services stated concurrently that the hospital is currently updating the endoscopy storage cabinets throughout the facility but the reconfiguration of the GI lab was delaying construction of the new storage cabinets. The Administrative Director GI affirmed that the hospital follows SGNA (Society of Gastroenterology Nurses and Associates, Inc.) infection control standards regarding GI endoscopes.

An examination of the storage standard for endoscopes, according to SGNA, indicated that they should be hung vertically to facilitate drying. This standard does note that detachable components of endoscopes should be removed per the manufacturer's instructions. It also specified that the storage area should be clean, well ventilated, and dust free to discourage microbial contamination. (Society of Gastroenterology Nurses and Associates, inc. (SGNA). (2012). Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes. Chicago, IL)

5. During a tour of the Inpatient GI Procedure Unit Processing Room on October 25, 2017 at 11:00 AM there was red plastic tape marking a certain liquid level in the sink used cleaning instruments.

During a conversation with the GI Director at that time, she specified that red marker indicated 4 gallons of liquid as a reference to the GI Technician when doing initial cleaning of GI instruments.

According to Dolan, a biofilm is an assemblage of microbial cells not easily removed by gentle rinsing that become embedded with a collection of mineral crystals, corrosion particles, clay or silt, or blood components depending upon the environment in which these cells have developed. Most of the investigations into creation of biofilms demonstrate that the microorganisms formed attach more rapidly to water repelling materials such as Teflon or other plastics rather than to water attracting materials like glass or metal. (Donlan, R. (2002). Biofilms: Microbial Life on Surfaces. Emerging Infectious Diseases, 8(9), 881-890.)



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6. On 10/26/17 at 10:05 a.m., during a tour of the Intensive Care Unit (ICU) with Clinical Director 3 and other administrative staff members, Patient 2 was observed sitting up in a chair at the bedside. The patient was alert and oriented. A urinary drainage bag was attached to the side of the chair, and was touching the floor. Another drainage bag on the patient's left side, was observed lying on the floor. Clinical Director 4 stated the bag was attached to a chest tube (a plastic tube that is inserted into the space around the heart, or into the lung, in order to promote lung re-expansion and fluid drainage following surgery), and should not be on the floor, in order to prevent contamination and infection.

A review of the Centers for Disease Control and Prevention (CDC) online article, titled, "Guideline for Prevention of Catheter-Associated Urinary Tract Infection Prevention" included the following:

Appropriate Urinary Catheter Use:

Recommendation III.B.2- Proper Techniques of Urinary Catheter Maintenance-
Keep the collecting bag below the level of the bladder at all times. Do not rest the bag on the floor.

7. a) On 10/24/17 at approximately 1:20 p.m., a tour of the Main Operating Room (OR) was conducted with the OR Administrative Director and RN 1. RN 1 described the sterilization process of the instrument trays. When questioned regarding weighing of the trays prior to placing them in the autoclave (a device used to sterilize instruments and other items), RN 1 stated the trays were not weighed, but the hospital Sterility Assurance Team was considering starting a program for weighing the trays. RN 1 further stated that the OR follows Association of Peri-Operative Nurses (AORN) and Association for the Advancement of Medical Instrumentation (AAMI) guidelines.

A review of the Beli-Med Autoclave users manual provided by the facility, stipulated that the maximum weight of [an instrument tray] must not exceed eight kilograms (17.6 pounds) density factor, and the size must be limited to 250x500x250 millimeters (mm), or 9.8 inches (in) by 19.6 in by 9.8 in.

b) On 10/25/17 at approximately 3 p.m., during a tour of the Outpatient Surgery Center with the Administrative Director of OR, an inspection of a sterile eye tray indicated scattered areas of what appeared to be rust stains on the rubberized bottom surface of the tray. The Administrative Director stated that the tray was old and needed to be replaced.

According to an Infection Control Today online article, dated 10/1/2000,
spotting, staining, and corrosion of surgical instruments can impair their function. Spotting, staining, and corrosion also interfere with sterilization. Spores can be protected from destruction by the layers of iron oxide (rust). (http://www.infectioncontroltoday.com/articles/2000/10/spotting-staining-and-corrosion-of-surgical-instr.aspx)

8. a) On 10/25/17 at 9:20 a.m., during a tour of Tower 3 nursing unit with the Medical-Surgical Administrative Director and Clinical Director 3, Patient 3 was sitting up in bed, and was alert and oriented. A saline lock (an intravenous, or IV catheter that is used as needed for delivery of fluid or medications) was present in the patient's upper right arm. There was no insertion date, or initials of the person who performed the insertion on the catheter dressing.

During a concurrent interview with Clinical Director 3, she stated the site should have been dated and initialed by the staff member.

b) On 10/25/17 at 9:20 a.m., during a tour of Tower 3 nursing unit with the Medical-Surgical Administrative Director and Clinical Director 3, Patient 1 was observed lying in bed, was confused, and had a vest restraint and hand mitts. According to the patient's clinical record, the patient was admitted to the facility's Emergency Department (ED) on 10/24/17 with diagnoses that included sepsis (severe infection of the bloodstream). There was a saline lock present in the patient's right upper arm. There was no date or staff initials on the IV dressing.

During a concurrent interview, Clinical Director 3 stated the dressing should have been dated and initialed at time of insertion, in order to prevent infection.

A review of the facility's policy, titled, "Intravenous Therapy for Adults - Peripheral and Central", revised 7/15, stipulated that all IV sites will be labeled with initiation date/time and nurse initials.

9. On 10/25/17 at 9:15 a.m., during an observation in the presence of the Medical- Surgical Administrative Director, Clinical Director 3, and the Infection Preventionist (IP), RN 3 was asked to demonstrate cleaning of the glucometer unit (device that measures the level of glucose, or sugar, in the blood. RN 3 sanitized her hands, donned a pair of gloves, then wiped the glucometer with a Sani- Cloth Super Wipe disinfectant wipe for a total of 15 seconds. She then stated the glucometer should be allowed to air dry. The IP stated the glucometer was to be continually wiped with the Sani-Cloth so that the glucometer remained wet for a total of 2 minutes.

A review of the online user manual for the Nova Statstrip Blood Glucose Meter stipulated the following:

"Using a new, fresh germicidal bleach wipe, thoroughly wipe the surface of the meter (top, bottom, left and right sides) a minimum of 3 times horizontally, followed by 3 times vertically avoiding the electrical connector. Gently wipe the surface area of the test strip port, making sure no fluid enters the port. Ensure the meter surface stays wet for 1 minute and is allowed to air dry for an additional 1 minute."



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10. On 10/25/17 at 9:20 a.m. during an interview with the Medical Staff credential supervisor and IP director, when asked if medical staff were evaluated for Hepatitis B status, Tuberculosis and influenza, she indicated, the facility currently did not have a policy for Hepatitis B status screening and evaluation for the medical staff. IP director indicated a new policy was developed requiring annual TB testing of Medical Staff effective 12/17.

A review of a facility policy dated effective 12/17, titled: Communicable Disease Surveillance and Vaccination indicated Medical Staff "are required to have annual TB screening and Influenza vaccination".

11. During a Tour of the Outpatient surgery Center Operating Room (OR) on 10/25/17 at 2:40 p.m., with DON#4; DON#2; IP#2 on 10/25/17 at 2:30 p.m. the GI scopes cleaning room endoscopes was observed to have out of range temperature and humidity: Temperature (T) was 81 degree Fahrenheit (F) and Humidity (H) was 27%.

During an interview with the IP director, and the Plant Operations Maintenance (POM) director on 10/25/17 at 10:10 a.m., indicated the temperature and humidity of the various locations in the facility were recorded and evaluated each day at 3 am. Any variances at the 3 am reading were reported to the department and corrected. When asked was there any ongoing monitoring or documentation of the temperature and humidity by the OR and documentation or monitoring for air exchange in the OR, POM#1 indicated there were annual evaluations but no documented monitoring was available. The facility did not have a policy for monitoring air exchanges.

During an interview with the OR director and DON of OR on 10/25/17 at 10: 30 a.m. when asked for the operating room log for temperatures and humidity they indicated there were no logs and no monitoring of temperature and humidity in the OR or any logs or variances and correction time of variances. When asked who checks temperature and humidity, the DON of OR and Director of OR indicated POM monitors and checks temperature and humidity.

A review of the monthly temperature and humidity logs, titled" Plant Operations Maintenance Temperature Humidity HVAC" for 8/2017; 9/2017; and up to 10/25/17 indicated multiple out of range readings each month for both temperature and humidity including in the OR. The Bronchoscopy room did not have any documentation of Humidity readings.

12. During a tour of OR on 10/24/17 at 2:20 p.m. with director of SPD and Director of OR and IP#2, cardiac bypass room the mattress was noted to have tears.

During a tour of the OR sinks two had aerators and two had rose heads. When asked how the rose head and the aerators were cleaned? POM indicated that the rose head was discontinued but no record of cleaning for the aerators or the rose head was provided.

13. On 10/24/17 at 2:40 during an observation of a major tray with director of SPD and Director of OR and IP#2 when asked if trays were weighed for sterilization in the steam sterilizers? She indicated instruments were not weighed before sterilization. IP#2 and director of SPD indicated they followed AORN and manufacturer's guidelines. The facility could not provide documentation as to how to determine the weight limit of instrument trays and utensil trays that were being sterilized.

A review of the manufactures guideline for Sterilizer indicated wrapped instrument set maximum weight must not exceed 10 kg and wrapped utensil is 6 to 8 kg .

14. On 10/24/17 at 11:30 during a Tour of the OB/GYN ward, with Director of OB/GYN, IP#2 and OR director in room 8, in the neonatal warmer bed in the drawer was dust black particles and 8 umbilical clamps.

During an interview with the director of OB/GYN she indicated the umbilical clamps are sterile single use and she did not know why they were in that drawer. A policy and procedure for cleaning of the post-partum rooms was requested and the facility did not have a policy and procedure.

Based on observation, interview and record review, the facility failed to provide surgical services in a safe and sanitary manner. The facility failed to monitor and document variance and corrections when operating room (OR) temperature was out of acceptable range. The facility failed to follow manufacturer guidelines when sterilizing instruments.

Findings:

1. During a tour of the Outpatient Surgery Center Operating Room (OR) on 10/25/17 at 2:40 p.m., with the director of nursing (DON) #4; DON#2; Infection Preventionist #2 on 10/25/17 at 2:30 p.m. the gastrointestinal (GI) scopes cleaning room, the temperature was 81 degree Fahrenheit (F) and Humidity (H) was 27%.

During an interview with the IP director, and the Plant Operations Maintenance (POM) director on 10/25/17 at 10:10 indicated the temperature and humidity of the various locations in the facility were recorded and evaluated each day at 3 a.m. Any variances with the 3 a.m. reading were reported as to the department and corrected. When asked was there any ongoing monitoring or documentation of the temperature and humidity by the OR and documentation or monitoring for air exchange in the OR POM#1 indicated there were annual evaluations but no documented monitoring was available. The facility did not have a policy for monitoring air exchanges.

During an interview with the OR director and DON of OR on 10/25/17 at 10: 30 a.m. when asked for the operating room daily log for temperatures and humidity they indicated there were no logs and no monitoring of temperature and humidity in the OR or any logs of variances and correction time of variances. When asked who checks temperature and humidity, DON of OR and Director of OR indicated POM monitors and checks temperature and humidity.

A review of the monthly temperature and humidity logs, titled" Plant Operations Maintenance Temperature Humidity HVAC " for 8/2017;9/2017; and up to 10/25/17 indicated multiple out of range readings each month for both temperature and humidity including in the OR. Random review of the Temperature(T) and Humidity(H) log for the OR indicated: on 8/31/17 OR#4 T- 68 and H-82%; and OR#5 T- 68 and H-78%. In the action taken section was blank, No variance corrections were documented. On 09/06/2017: OR#4 T- 69; H- 81 and OR#11 T- 69 and H-80%; in the action taken section " Adjusted Humidistat was documented: " Re-Test Temp after action and Re-test Humidity after Action" was blank. On 10/6/2017 OR #4 T- 66.5 and H-61.8% the action taken section was blank and: "Re-Test Temp after action and Re-test Humidity after Action" was blank.

A review of the facility policy and procedure titled titled "Environmental Controls: Temperature and Humidity" dated effective 03/16 revised 10/17 indicated "Temperature and humidity will be monitored and recorded daily and " Humidity in anesthetizing locations shall be between 35% -60%' and: " and for variances from acceptable parameters, the policy indicated "staff will adjust and retest immediately "and if the variance cannot be corrected Clinical leadership would be notified.

A review of the 2010 California Building Code for "Heating, Cooling, and Relative Humidity Requirements for Sensitive Areas or Rooms" indicated the following:

Operating room - the temperature range was 68-75 degrees Fahrenheit (F) and relative humidity was 20-60%.

Gastrointestinal endoscopy procedure room - the temperature range was 68-73 degrees Fahrenheit (F) and relative humidity was 20-60%.

2. During a tour of OR on 10/24/17 at 2:20 p.m. with director of Sterile Procedure Department and Director of OR and IP#2 in the cardiac bypass room, the mattress was noted to have tears.

During a tour of the OR sinks two had aerators and two had rose heads. When asked how the rose head and the aerators were cleaned? POM indicated that the rose head was discontinued but no record of cleaning for the aerators or the rose head was provided.

3. On 10/24/17 at 2:40 during an observation of a major tray with director of SPD and Director of OR and IP#2, when asked if trays were weighed for sterilization in the steam sterilizers? She indicated instruments were not weighed before sterilization. IP#2 and director of SPD indicated they followed Association of periOperative Registered Nurses (AORN) and manufacturers guidelines. The facility could not provide documentation as to how to determine the weight limit of instrument trays and utensil trays that were being sterilized.

A review of the manufactures guideline for Sterilizer indicated wrapped instrument set maximum weight must not exceed 10 kilograms (kg) and wrapped utensil is 6 to 8 kg.