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Based on observation, interview, and record review, the GB failed to assume full responsibility for determining, implementing, and monitoring policies governing all hospital functions to ensure compliance with COPs under 482.21 (QAPI), 482.42 (Infection Control), and 482.51 (Surgical Services) as evidenced by:

1. Failure to ensure the contracted EVS provider complied with all applicable standards and Conditions of Participation by allowing the contractor to evaluate their services independently. Cross reference to A083.

2. Failure to provide the comprehensive oversight of the contracted EVS provider. Cross reference to A084.

Failure to ensure the QAPI program was implemented and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. Cross reference to A263.

4. Failure to ensure the sanitary environment was maintained and the active IC program was developed and implemented to prevent the spread of infections in accordance with the hospital's P&Ps and nationally recognized infection control practices and guidelines. Cross reference to A747.

5. Failure to ensure surgical services were well organized and provided in accordance with the hospital's P&Ps and acceptable standards of practice to ensure the health and safety of the patients. Cross reference to A940.

The cumulative effect of these systemic failures resulted in the hospital's inability to provide quality healthcare to the patients in a safe environment.

Based on interview and record review, the GB failed to ensure the contracted EVS provider complied with all applicable standards and Conditions of Participation by allowing the contractor to evaluate their services independently. This failure resulted in the potential for an unsanitary environment for the patients, staff, and visitors.

Findings:

Review of the hospital's P&P titled Contract Programs dated 9/14/12, showed in part, "...The contract monitoring process ensures the following: Contractor provides all contracted services, Improved program performance, Identify potential problems ..."

Review of the hospital's Quality and Patient Safety program dated 3/28/17, showed in part, "...The purpose of the Quality and Patient Safety Program is to continuously, objectively, and systematically monitor and evaluate the quality of patient care and administrative services...Provide an objective system for evaluating delivery of services ..."

Review of the hospital's documents titled Office of Governing Body Affairs, Guidelines and Procedures dated 1990 showed in part, "...The governing body is legally and morally responsible for all hospital activities. It is valid then to expect that a structure and process exists to demonstrate governing body involvement in financial, planning, quality and management oversight activities...The governing body strives to assure quality patient care by requiring and supporting the establishment and maintenance of an effective hospital-wide quality assurance program...Such reports should include the activities and mechanisms for monitoring and evaluating the quality of patient care, for identifying and resolving problems, and for identifying opportunities to improve patient care..."

1. On 8/15/17 at 1335 hours, an interview with the Medical Director, Infection Control was conducted. The Medical Director stated the RN staff consisted of one full time ICP who was on vacation at this time. The Medical Director stated there was one ICP position vacant and one position recently filled with a trainee. ICP 1 was a former member of the staff who worked part time as a relief ICP nurse. The Medical Director, Infection Control stated she reported to the Chief of Infection Control and Medical Executive Committee. The Director stated the full time ICP reported to the CNO.

The Medical Director, Infection Control stated the EVS performed their own audits using Blacklight testing in various areas to ensure thorough cleaning and disinfecting of the patient care areas. The findings were presented to the quality committee on a bi-monthly basis.

Review of the GB meeting minutes dated 8/26 and 11/18/16, 2/24 and 6/23/17, failed to show documented evidence the GB had reviewed or evaluated the contracted EVS for safety and quality.

During an interview with the Director of Quality/PI on 8/16/17 at 1030 hours, the Director of Quality/PI stated, "Quality does not oversee environmental services. Infection control monitors cleaning and does not report to QA" and "We don't have a good system to assess the Quality of contracted services."

2. The Housekeeping Services Agreement assessment tool for the fiscal year 2015-16 was provided for review on 8/17/17, by the Director, Accreditation & Licensing. The Director stated the assessment for this fiscal year had not yet been completed.

Assistant Hospital Administrator 1 was interviewed on 8/18/17 at 0830 hours, and stated she completed the last year's assessment of the EVS during the week of 5/23/16, for the previous fiscal year. When asked if she had a clinical background or received training to assess the EVS service, she stated no.

Review of the form showed the assessment was completed for only three patient care areas: respiratory therapy, blood gas lab, and sleep lab. Ten items were audited, including clean ash trays and clean sand jars (the hospital is non-smoking), dust on curtains and furniture, walls, sinks, and clean beds. The responses documented were all in compliance and verified by either observation or inquiry. When asked to explain "inquiry," the Administrator stated she asked either hospital staff or EVS staff to verify. When asked why these three areas were chosen to represent an overall review of the EVS performance instead of the patient rooms on the nursing units or other high risk areas such as procedural areas, the Administrator stated she was unable to say why and was new to the hospital at that time. The Administrator stated, "She could see this now, it makes sense."

The additional areas reviewed included the exterior of the hospital and parking lots. A review of biohazard waste and waste removal was completed by the Patient Safety team of the same three patient areas listed above.

Based on observation, interview, and record review, the hospital failed to ensure the GB provided comprehensive oversight of the contracted EVS provider. There was no documented evidence to show consistent, comprehensive, and accurate direct observation, supervision, and evaluation of the cleaning services performed in the hospital. This failure had the potential for negative effects in maintaining a clean and sanitary environment for the patients.

Findings:

Review of the hospital's P&P titled Contract Programs dated 9/14/12, showed in part, "...The contract monitoring process ensures the following: Contractor provides all contracted services, Improved program performance, Identify potential problems ..."

Review of the hospital's Quality and Patient Safety program dated 3/28/17, showed in part, "...The purpose of the Quality and Patient Safety Program is to continuously, objectively, and systematically monitor and evaluate the quality of patient care and administrative services...Provide an objective system for evaluating delivery of services ..."
The facility's document titled Infection Control Plan dated 2/18/17, showed in part, "...Maintain regular contact with all departments to develop, implement and monitor compliance with Infection Control policies throughout Olive View Medical Center...Review, evaluate and approve all aseptic, isolation and sanitation techniques. Make environmental rounds to evaluate and correct, if necessary, employee practices related to aseptic technique, isolation, cleaning, sterilization, disinfection and sanitation ..."

The facility's document titled Office of Governing Body Affairs, Guidelines and Procedures dated 1990 showed in part, "...The governing body is legally and morally responsible for all hospital activities. It is valid then to expect that a structure and process exists to demonstrate governing body involvement in financial, planning, quality and management oversight activities ...The governing body strives to assure quality patient care by requiring and supporting the establishment and maintenance of an effective hospital-wide quality assurance program ...Such reports should include the activities and mechanisms for monitoring and evaluating the quality of patient care, for identifying and resolving problems, and for identifying opportunities to improve patient care...Required Reporting Categories. Approval / Reporting Requirements...Quality Assurance: Activity Report (Quarterly), Evaluation Report (Annually), Critical issues / incidents (As needed)..."

Review of the GB meeting minutes dated 8/26, 11/18/16, 2/24 and 6/23/17, failed to show documented evidence the GB reviewed or evaluated the contracted EVS for safety and quality.

During an interview with Director of Quality/PI on 8/16/17 at 1030 hours, the Director stated, "Quality does not oversee environmental services. Infection control monitors cleaning and does not report to QA" and "We don't have a good system to assess the Quality of contracted services."

1. Multiple observations from 8/14 to 8/18/17, showed the EVS staff failed to follow the AORN's guidelines and hospital's P&P for the cleaning process in the ORs and GI lab. In addition, the EVS staff and direct supervising EVS staff did not receive accurate information and comprehensive training as to when the new cleaning products including QC Peroxide were introduced into use, resulting in the OR and GI lab floors not being cleaned with a disinfectant cleaner. The wet time for the cleaning wipes used to clean surfaces was not followed. Cross reference to A749, example #1.

2. On 8/15/17 at 1445 hours, an interview was conducted with the Director of EVS. The Director of EVS stated the EVS worked with the IC Committee regarding all cleaning products used in the hospital. When asked how the EVS staff was supervised, he stated the EVS supervisors made direct observations of the EVS staff utilizing the checklists with targeted areas of focus for cleaning and sanitizing the patient care areas. These direct observations were conducted on all EVS staff at least once per month and collated in the unit for validation of yearly competencies.

On 8/16/17 at 1115 hours, an interview was conducted with the EVS Supervisor to discuss the use of QC Peroxide in the ORs. The EVS Supervisor stated when the new product was introduced in June 2017, for which she received the instructions from her managers that the QC Peroxide floor cleaner was a disinfectant product. The EVS Supervisor stated she understood the QC Peroxide floor cleaner was to be used in the ORs, especially if the floor had a heavy spillage of blood products. Otherwise, the EVS staff could use the Oxivir Tb wipes (disinfectant).

When asked how the EVS staff was supervised for quality, the EVS Supervisor stated she validated the EVS staff on the thoroughness of cleaning using the direct observation checklist tool at a minimum of once a month. The EVS Supervisor stated the checklists were for the occupied patient rooms, terminals, and between case cleaning in the ORs.

During a follow-up interview and concurrent facility document review with the Director of EVS on 8/17/17 at 1116 hours, he stated the QC Peroxide floor cleaner was the new product used in the hospital beginning 6/8/17; however, the EVS staff did not receive additional training on the proper use of the QC Peroxide floor cleaner since it was similar to the product that the hospital had used previously. The Director of EVS verified the inservices provided to the EVS staff did not include where (floors or surfaces) to use the products. When asked if the IC Committee or ICP reviewed the training material provided to the EVS staff, the Director of EVS stated he did not think so and verified the ICP was not aware of specific training for the use of QC Peroxide.

During an interview with ICP 1 on 8/17/17 at 1300 hours, she verified the IC program did not have oversight of the curriculum provided to the EVS staff for in-service training. ICP 1 stated the contracted EVS service provided their own curriculum, which did not need approval from the IC committee. ICP 1 also stated the EVS contracted service was responsible for the ordering of cleaning and disinfectant supplies needed for each department.

3. On 8/16/17 at 1415 hours, an interview and concurrent facility document review was conducted with the Director of EVS.

The 7 Step Cleaning Evaluation Competency for the Annual Assessment for EVS 4 dated 1/24/17, was reviewed. However, the column to show the competency method validated by "V=Verbal," "T=Test," or "O=Observed" was not completed. The bottom of the form showed the area for "Overall Competency (1-5 Rating)" was left blank. The Director of EVS verified the annual competency evaluation was incomplete for EVS 4 as it did not show the method of validation and overall level of competency.

Review of the Environmental Checklist (last revised 6/7/13), for cleaning of airborne isolation room for EVS 1 dated 7/9/17, and the Occupied Patient Room for EVS 5 dated 8/12/17, completed by an EVS Supervisor, showed the section titled "Appropriate Contact Time" with a "yes," "no," or "NA" (not applicable) check box next to the following items:

- "A-456 disinfection: 10 minutes"
- "Bleach 1:10 dilution: 5 minutes"
- "Lemon Lift with Bleach"

Review of the Environmental Checklist/Operating Room (last revised 1/21/11) for cleaning observation of EVS 1 for OR 8 dated 8/13/17, (one day prior to the surveyor's observation of EVS 1 in OR 8) showed the tool did not specify the type of cleaning solution used on the equipment or floors, only the appropriate contact time for disinfection.

The Director of EVS stated the tools were not updated to reflect the use of Oxivir Tb wipes or QC Peroxide introduced into use in June, 2017. He stated the tools should be changed to validate the use QC Peroxide and Oxivir Tb wipes to ensure the EVS staff was consistently observed for the correct use and disinfection contact times of surfaces with the current products.

The Terminal cleaning logs for July 2017, were reviewed with the Director of EVS. The logs showed ORs 1-6 and 8 were inspected daily. There were areas for the initials of the EVS staff that cleaned the room and the EVS supervisor who inspected the cleaning. Further review of the form showed for 10 of 20 days, the form was completed with the initials for EVS 13 and EVS Supervisor 2 in what appeared to be the same handwriting.

The Director of EVS confirmed the finding. The Director of EVS further stated the form was in English and he was not sure the non-English speaking EVS staff understood how to use the form. The Director of EVS stated he did not review the completed forms.

Based on interview and record review, the hospital failed to ensure the advance directive information was provided to the patient as requested for one of 33 sampled patients (Patient 3). This failure posed the potential for not honoring the patient's wishes.

Findings:

Review of the hospital's P&P titled Advance Directives dated 4/11 showed social work staff will respond to patient referrals within 72 hours of requesting information about the advance directive.

Patient 3's medical record review was initiated on 8/14/17. The medical record showed Patient 3 was admitted to the hospital on 8/9/17.

Review of the advance directive tab in the ORCHID (hospital electronic health care program) showed Patient 3 did not have the advance directive and wished to receive further information about the advance directive. A referral was made to the social worker.

Further medical record review failed to show Patient 3 received any information about the advance directive.

During an interview and concurrent medical record review with the Medical Case Worker and Supervisor Staff Nurse 3 on 8/15/17 at 1357 hours, the Case Worker stated she focused on the discharge planning for Patient 3 and did not address the advance directive. Supervising Staff Nurse 3 verified Patient 3 did not receive any further information about the advance directive.

Based on observation, interview, and record review, the hospital failed to ensure the QAPI program was implemented and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program as evidenced by:

1. Failure to ensure their QAPI program's quality processes related to EVS provider and IC program were designed and implemented to ensure the quality and safety of patient care provided. Cross reference to A273.

2. Failure to ensure the QAPI Program identified and prioritized opportunities for improvement to patient care including care provided in high volume, high risk, and problem prone areas such as the ORs and procedural areas. Cross reference to A283.

3. Failure of the GB to ensure the QAPI program reflected the complexity of the hospital's organization and services including IC, EVS contracted services, and infrastructure for quality and effectiveness. Cross reference to A308.

The cumulative effect of these systemic failures resulted in the hospital's inability to implement and maintain a QAPI program designed to maximize the quality healthcare in a safe environment.

Based on observation, interview, and record review, the hospital failed to ensure their QAPI program's quality processes related to EVS provider and IC program were designed and implemented to ensure the quality and safety of patient care provided. This practice increased the risk of poor patient health outcomes.

Findings:

Review of the hospital's document titled Infection Control Plan dated 2/18/17, showed in part, "...Maintain regular contact with all departments to develop, implement and monitor compliance with Infection Control policies throughout Olive View Medical Center...Review, evaluate and approve all aseptic, isolation and sanitation techniques. Make environmental rounds to evaluate and correct, if necessary, employee practices related to aseptic technique, isolation, cleaning, sterilization, disinfection and sanitation
..."

Review of the hospital's P&P titled Contract Programs dated 9/14/12, showed in part, "...The contract monitoring process ensures the following: Contractor provides all contracted services, Improved program performance, Identify potential problems ..."

Review of the hospital's Quality and Patient Safety program dated 3/28/17, showed in part, "...The purpose of the Quality and Patient Safety Program is to continuously, objectively, and systematically monitor and evaluate the quality of patient care and administrative services...Provide an objective system for evaluating delivery of services ..."

Review of the hospital's document titled Office of Governing Body Affairs, Guidelines and Procedures dated 1990 showed in part, "...The governing body is legally and morally responsible for all hospital activities. It is valid then to expect that a structure and process exists to demonstrate governing body involvement in financial, planning, quality and management oversight activities...The governing body strives to assure quality patient care by requiring and supporting the establishment and maintenance of an effective hospital-wide quality assurance program...Such reports should include the activities and mechanisms for monitoring and evaluating the quality of patient care, for identifying and resolving problems, and for identifying opportunities to improve patient care..."

During an interview with Director of Quality/PI on 8/16/17 at 1030 hours, the Director of Quality/PI stated, "Quality does not oversee environmental services. Infection control monitors cleaning and does not report to QA." and "We don't have a good system to assess the Quality of contracted services."

1. On 8/15/17 at 1335 hours, an interview with the Medical Director, Infection Control was conducted. The Medical Director, Infection Control stated the hospital surveillance of infections included conducting EOC rounds twice monthly with the multidisciplinary core of Administrators, Safety Officer, Environmental Services, and Supervising Administrator for the specific area. Some areas were visited more frequently based on the risk assessment, infection rates, and findings. The Medical Director, Infection Control stated the findings from the EOC rounds were followed up by the IC department. The scheduled and findings of the hospital's EOC rounds were requested for 2017.

However, the EOC rounds were not conducted as scheduled as 26 scheduled EOC rounds were not completed. The EOC rounds for the high risk areas such as the ORs, NICU, L&D, Cardiology, GI lab, and special procedures were scheduled twice a year, not more often than the regular patient care area. Findings from the EOC rounds for ORs 3A, 3B, and 3C were not addressed as the sections for corrective action plan and completion date were blank. Cross reference to A748, example #2.

During an interview with the QAPI committee on 8/17/17 at 0900 hours, the QAPI committee was asked how high risk areas such as ORs, NICU and procedural areas were evaluated for quality and how the QAPI committee overseeing the IC data. The QAPI staff stated the IC data was not reported to the quality and the ICP reported to the MEC.

The EVS staff failed to follow the AORN's guidelines and the hospital's P&P for the cleaning process in the ORs and GI lab. The EVS staff were not trained regarding the new products used in the hospital. The terminal cleaning log completed by the EVS staff was inaccurate and not reviewed by the supervising staff. The EVS competency and evaluation forms were not specific and reflect the cleaning solutions used in the hospital. Cross reference to A084.

Based on interview and medical record review, the hospital failed to ensure the QAPI Program identified and prioritized opportunities for improvement to patient care including care provided in high volume, high risk, and problem prone areas such as the ORs and procedural areas. This failure created the risk for the hospital to not be able to improve patient care and safety.

Findings:

Review of the hospital's Quality and Patient Safety program dated 3/28/17, showed in part, "...The purpose of the Quality and Patient Safety Program is to continuously, objectively, and systematically monitor and evaluate the quality of patient care and administrative services...Provide an objective system for evaluating delivery of services ..."

Review of the hospital's document titled Office of Governing Body Affairs, Guidelines and Procedures dated 1990 showed in part, "...The governing body is legally and morally responsible for all hospital activities. It is valid then to expect that a structure and process exists to demonstrate governing body involvement in financial, planning, quality and management oversight activities...The governing body strives to assure quality patient care by requiring and supporting the establishment and maintenance of an effective hospital-wide quality assurance program...Such reports should include the activities and mechanisms for monitoring and evaluating the quality of patient care, for identifying and resolving problems, and for identifying opportunities to improve patient care..."
Review of the GB meeting minutes dated 8/26, 11/18/16, 2/24, and 6/23/17, failed to show documented evidence the GB reviewed or evaluated the hospital contracted EVS for safety and quality.

During an interview with Director of Quality/PI, on 8/16/17 at 1030 hours, the Director stated "Quality does not oversee environmental services. Infection control monitors cleaning and does not report to QA." and "We don't have a good system to assess the Quality of contracted services."

On 8/15/17 at 1335 hours, an interview with the Medical Director, Infection Control was conducted. The Medical Director, Infection Control stated hospital surveillance of infections included conducting EOC rounds twice monthly with the multidisciplinary core of Administrators, Safety Officer, Environmental Services, and Supervising Administrator for the specific area . Some areas were visited more frequently based on the risk assessment, infection rates, and findings. The Medical Director, Infection Control stated the findings during the EOC rounds were followed up by the IC department. The scheduled and findings of the hospital's EOC rounds were requested and reviewed for 2017.

The EOC rounds were not conducted as scheduled as 26 scheduled EOC rounds were not completed due to shortage of staff. The EOC rounds for the high risk areas such as the ORs, NICU, L&D, Cardiology, GI lab, and special procedures were scheduled twice a year, not more often than the regular patient care area.
Findings from the EOC rounds for ORs 3A, 3B, and 3C were not addressed as the sections for corrective action plan and completion date were blank. Cross reference to A748, example #2.

During an interview with the QAPI committee on 8/17/17 at 0900 hours, the QAPI committee was asked how high risk areas such as ORs, NICU and procedural areas were evaluated for quality and how the QAPI committee overseeing the IC data. The staff stated the IC data was not reported to QAPI. The ICP reported to the MEC.

Based on interview and medical record review, the GB failed to ensure the QAPI program reflected the complexity of the hospital's organization and services to include IC, EVS contracted services, and infrastructure for quality and effectiveness. These failures created the risk of the patients receiving poor quality medical care in an unsanitary and unsafe environment.

Findings:

1. The hospital failed to ensure their QAPI program's quality processes related to EVS provider and IC program were designed and implemented to ensure the quality and safety of patient care provided. Cross reference to A273.

2. The QAPI Program failed to identify and prioritize opportunities for improvement to patient care including care provided in high volume, high risk, and problem prone areas such as the ORs and procedural areas. Cross reference to A283.



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3. Multiple observations in the Main OR, PACU, SDSU and L&D OR 8 of accumulations showed dust and poorly maintained surfaces of equipment and structure. Cross reference to A951, example #10.

Patient rooms and nursing stations on the Medical-Surgical Units (4A and 4D) were not maintained. Cross reference to A724, example
#5.

During the interview with Chief of Surgery on 8/16/17 at 1849 hours, he stated the hospital was more than 30 years old building and had many areas of wear and tear that required the repairs and replacement. For example, the OR floors were replaced about seven years ago, but due to the high frequency of use and the heavy machines being moved in and out of the ORs, the OR floor had cracks and black stains around the OR table.

During an interview with the QAPI Committee on 8/17/17 at 0900 hours, the aging infrastructure was discussed. The QAPI staff stated there were daily huddle meetings on all units and the findings discussed in the emails. When asked to provide information about a project identified during the EOC rounds or daily huddles such as the need for OR floor repair, the QAPI staff stated the administration had the list of projects and their priorities.

Based on observation, interview, and record review, the hospital failed to ensure the nursing staff provided necessary care and services to meet the care needs for three of 33 sampled sampled patients (Patients 3, 13, and 31) as evidenced by:

1. The nursing staff failed to accurately monitor the weights for Patients 3 and 31.

2. The nursing staff failed to obtain the physician's order to discontinue the bedside sitter when the sitter was no longer needed for Patient 3.

3. The nursing staff failed to notify the physician of the patient's refusal of the antibiotic medication for Patient 13.

These failures created the risk of substandard healthcare outcomes to these patients.

Findings:

1a. During a tour of the Step-Down Unit on 8/14/17 at 1101 hours, Patient 3 was observed receiving a hemodialysis treatment at the bedside.
Medical record review for Patient 3 was initiated on 8/14/17. The medical record review showed Patient 3 was admitted to the hospital on 8/9/17.

Review of the Dialysis Management showed Patient 3 received hemodialysis treatment on the following dates:

- 8/10/17 from 1100 to 1400 hours.
- 8/11/17 from 1800 to 2000 hours.
- 8/14/17 from 1000 to 1300 hours.

Review of the Flowsheet showed Patient 3's weight as follows:

* 8/9/17 at 1735 hours, 75.3 kg measured by a bed scale (upon admission)
* 8/10/17 at 0015 hours, 74.2 kg measured by a bed scale
* 8/11/17 at 0433 hours, 70.7 kg measured by a bed scale (after hemodialysis treatment on 8/10/17)
* 8/14/17 at 0430 hours, 71 kg measured before the dialysis treatment at 1000 hours (no identified scale type)
* 8/14/17 at 1219 hours, 82.8 kg measured by a standing scale, 11.8 kg of weight gain from the pre-hemodialysis weight.

During an interview and concurrent medical record review with RN 31 on 8/17/17 at 1350 hours, RN 31 verified the above finding and stated the patient's weight was not accurately measured and documented.

b. During a review of the medical record for Patient 31, the medical record showed the patient was admitted to the hospital on 7/25/17, with diagnoses, including perforated diverticulitis (a hole in an infected area of the intestines that can lead to a larger infection in the abdomen) and phlegmon (pus) around the area of perforation.

Review of the nutrition assessment note dated 7/29/17, showed Patient 31's nutrition problem was "Inadequate protein-energy intake related to bowel rest for perforated diverticulitis with new phlegmon as evidenced by Clear liquid Diet meets < (less than) 50% of estimated kcal (calorie) and protein needs."

Review of the physician orders showed an order dated 7/30/17, for "Adult Parenteral Nutrition." This physician order included an order for "Weight - daily."

Further review of the medical record showed Patient 31 was weighed only one time during the admission instead of daily as ordered.

A follow-up nutrition progress note dated 8/3/17, showed the patient continued to receive the parenteral nutrition. There was no documented evidence of the follow-up weight to monitor the fluid status.

During an interview with RN 35 on 8/17/17 at 1330, she stated Patient 31's medical record for this hospitalization only showed one weight was recorded on 7/26/17. RN 35 verified the patient had an order for daily weights and those weights were not recorded in the medical record.

2. Review of the Physician's Order dated 8/12/17 at 1005 hours, showed to place a sitter at bedside for Patient 3.
Review of the Psychiatry Consult Initial Evaluation dated 8/12/17 at 1604 hours, showed Patient 3 attempted to strangle self by wrapping the medical device cords around her neck earlier today. The Evaluation showed the incident was from being confused/delirious/uncomfortable rather than in the context of a suicide attempt.

Review of the 24 Hours Assignment Sheets showed a sitter was provided inconsistently for Patient 3. For example, the sitter was assigned only on the following dates and times:

* On 8/13/17, from 1500 to 2330 hours
* On 8/14/17, from 0700 to 1530 hours and 8/14/17 at 2300 hours to 8/15/17 at 0730 hours.

An interview and concurrent record review with Supervisor Staff Nurse 3 was conducted on 8/15/17 at 1308 hours. Supervisor Staff Nurse 3 stated the close observation by the unit staff was utilized in place of the bedside sitter due to being short of staff. When asked who determined to provide the close observation instead of the bedside sitter, the Supervisor Staff Nurse 3 stated it was made by the nursing judgment.

An interview was conducted with Nurse Manager 7 on 8/16/17 at 1055 hours. Nurse Manager 7 verified the order for sitter was not consistently carried out for Patient 3. The Manager stated the nursing staff should have obtained a physician's order to discontinue a sitter when the psychiatric consultation showed the incident was a misunderstanding.

3. On 8/14/17 at 1340 hours, a review of Patient 13's medical record was initiated.
Review of the ED Note dated 8/10/17 at 2053 hours, showed Patient 13 presented to the Psychiatric ED with an indwelling catheter for neurogenic bladder (dysfunction of the urinary bladder). The urine collection bag was "very dirty" and the inside of the tube was "caked" with a white material. The plan was to send a urine culture.

Review of Patient 13's Urine Culture result dated 8/12/17 at 1048 hours, showed Patient 13 was infected with Klebsiella pneumoniae (bacteria) in the urine.

Review of the EMR Order screen dated 8/11/17 at 1414 hours, showed Patient 13 was prescribed with Levaquin (antibiotic) 500 mg by mouth Q 24 hours for 10 days for UTI.

Review of the EMAR showed Patient 13 refused one dose of Levaquin on 8/13/17 at 1400 hours.

However, review of the EMR Provider Notification screen showed the RN did not notify the physician of the patient's refusal of Levaquin.

On 8/14/17 at 1452 hours, an interview and concurrent medical record review was conducted with MD 9 concerning Patient 13. MD 9 stated the physician should have been notified when the patient refused the dose of antibiotic as he was being treated for UTI.




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3. On 8/14/17 at 1340 hours, a review of Patient 13's medical record was initiated.

Review of Patient 13's ED Note dated 8/10/17 at 2053 hours, showed Patient 13 presented to the Psychiatric ED with an indwelling catheter for neurogenic bladder (dysfunction of the urinary bladder). The urine collection bag was "very dirty" and the inside of the tube was "caked" with a white material. The plan was to send a urine culture (identifies bacteria growing in the urine).

Review of Patient 13's Urine Culture resulted on 8/12/17 at 1048 hours, showed Patient 13 was infected with Klebsiella pneumoniae (bacteria) in the urine.

Review of the EMR Order screen dated 8/11/17 at 1414 hours, showed Patient 13 was prescribed to take Levaquin (antibiotic) 500 mg by mouth every 24 hours for 10 days for the treatment of the UTI.

Review of the EMAR showed Patient 13 refused one dose of Levaquin on 8/13/17 at 1400 hours.

However, review of the EMR Provider Notification screen showed the RN had not notified the physician that Patient 13 had refused a dose of Levaquin.

On 8/14/17 at 1452 hours, an interview and concurrent medical record review was conducted with MD 9 concerning Patient 13. MD 9 stated the physician should have been notified when the patient refused the dose of antibiotic as he was being treated for a UTI.

Based on interview and record review, the hospital failed to ensure an individualized care plan problem was developed to address the care needs for one of 33 sampled patients (Patient 3), creating the risk of not providing necessary care and services to meet the care needs for this patient.

Findings:

Patient 3's medical record review was initiated on 8/14/17. The medical record showed Patient 3 was admitted to the hospital on 8/9/17.

Review of the medical record dated 8/10/17, showed Patient 3 was placed in contact isolation precaution for MRSA to nares. However, review of Patient 3's Interdisciplinary Plans of Care failed to show a care plan problem was developed to address the contact isolation precaution.

During an interview and concurrent medical record review with Supervisor Staff Nurse 3 on 8/15/17 at 1405 hours, she verified the above finding.

Based on observation, interview, and record review, the hospital failed to ensure the medications were administered as ordered as per the hospital's P&P for three of 33 patients (Patients 18, 29, and 30) as evidenced by:

1. Patient 29 received 0.9% sodium chloride (type of IV solution) via IV to KVO without the medication order.

2. The mental status and pain level assessments were not completed as per the hospital's P&P for Patient 30 who received the narcotic pain medication via the PCA.

3. The insulin medications were not administered before meals as ordered for Patient 18.

These failures created the risk of medication errors and poor health outcomes for these patients.

Findings:

1. Review of the hospital's P&P titled "Intravenous Administration - Adult" dated 12/13 showed in part, "...Review physician's order for type of solution, name of medication, dosage, route, rate or titration parameter, frequency and purpose of infusion. Prior to initiation of therapy, any "To Keep Open" (TKO) or "Keep Vein Open" (KVO) order need to require a specific infusion rate by the physician..."

On 8/15/17 at 0855 hours, during the medication administration observation, 0.9% sodium chloride IV bag was observed infusing at the KVO rate to Patient 29. During a comparison of Patient 29's medication orders and the medications that the patient received showed no medication order for the 0.9% sodium chloride to keep vein open. RN 2 acknowledged there was no physician's order for the IV solution.

During an interview on 8/15/17 at 0955 hours, Supervising Staff Nurse 2 and Nurse Manager 7 acknowledged the medication order was required for IV solution to keep vein open.

2. Review of the hospital's P&P titled "Patient Controlled Analgesia and Narcotic Infusions: Peripheral and Central Venous Administration" dated 9/16 showed in part, "...Patient Monitoring and Documentation ... Vital signs, mental status (level of consciousness and orientation), pain level assessment and intervention initially Q 15 minutes x 1, Q 30 minutes x 1, Q 2 hours x 1, and every 4 hours thereafter if adequate pain management achieved and vital signs stable..."

On 8/15/17 at 1345 hours, review of Patient 30's medical record was initiated in the presence of the Inpatient Pharmacy Supervisor, RPh 1, and RN 10.

Patient 30 was admitted to the hospital on 7/23/17. Patient 30 received morphine (a narcotic medication to treat moderate to severe pain) through the PCA which was initiated on 7/24/17 at 1328 hours.

Further review of the medical record showed the assessment for mental status was completed five hours 30 minutes after the initiation of PCA. The assessment for pain level was completed seven hours after the initiation of PCA. There were no documented evidence of the assessments for mental status and pain levels at 15 minutes, 30 minutes and 2 hours after the initiation of PCA as required by the hospital's P&P. In addition, the assessments for mental status and pain levels were not consistently done Q four hours thereafter as per the hospital's P&P.

The Inpatient Pharmacy Supervisor, RPh 1, and RN 10 acknowledged above finding.



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3. On 8/15/17 at 0925 hours, the medication pass observation was conducted in the presence of Supervising Staff Nurse 6. RN 21 was observed entering Patient 18's room with two insulin (antidiabetic) syringes with no label. RN 21 first scanned the patient's wrist band and then scanned one of the labels from RN 21's identification badge. Four labels that contained a barcode were observed on the back of RN 21's identification badge. RN 21 stated she kept the labels of four different insulin medications on her identification badge. Patient 18's family member asked if it was okay to receive insulin after breakfast. RN 21 stated yes. RN 21 was observed injecting two insulin syringes to the patient's left upper arm.

At 1000 hours, an interview was conducted with Supervising Staff Nurse 3. When asked the hospital's practice to prepare the insulin, Supervising Staff Nurse 3 stated the nurse labeled the syringe with a sticker after drawing the insulin from the vial. The sticker was prepared by the pharmacy and stored in the same bin with the insulin vial in the Pyxis (automated medication dispensing system).

At 1011 hours, two labels of Lispro (a fast-acting form of insulin) were observed being stored with the Lispro vial in the Pyxis.

Patient 18's medical record review was initiated on 8/15/17. The medical record showed Patient 18 was admitted to the hospital on 8/10/17.

Review of the physician's order dated 8/10/17, showed to administer 30 units of Glargine (a long-acting insulin) and 5 units of Lispro every
morning before meals, within 30 minutes of blood glucose being checked.

Review of the Blood Glucose Point of Care dated 8/15/17 at 0815 hours, showed Patient 18's blood sugar level was 146 mg/dl.

On 8/15/17 at 1030 hours, Supervising Staff Nurse 3 acknowledged the above finding.

Based on interview and record review, the hospital failed to ensure blood transfusions were administered as per the hospital's P&P for two of 33 sampled patients (Patients 3 and 17) as evidenced by:

1. Nursing staff failed to timely obtain the VSs as per the hospital's P&P for Patient 17 who received blood transfusion.

2. Patient 3 did not receive the instructions and education materials regarding blood transfusion.

These failures created the risk of poor health outcomes to these patients.

Findings:

1. Review of the hospital's P&P titled Blood/Blood Component Transfusion-Adult revised 12/15 showed the VS should be taken at a minimum:

- Within 30 minutes prior to initiating transfusion.
- 15 minutes after starting transfusion or after 50 ml transfused, whichever comes first (remain with the patient and observe close. Most severe transfusion reactions occur within the first 15 minutes of transfusion).
- Hourly during transfusion and at completion.
With any sign/symptoms of adverse reaction.
Patient 17's medical record review was initiated on 8/15/17. The medical record showed Patient 17 was admitted to the hospital on 7/14/17.

Review of the Transfusion Record and VS showed the following:

* The blood transfusion was started on 7/15/17 at 1130 hours. The VS prior to the transfusion was taken on 7/15/17 at 0712 hours, which was four hours and 18 minutes instead of within 30 minutes prior to the initiation of transfusion.

* The blood transfusion was started on 7/18/17 at 0454 hours. The VS was taken on 7/18/17 at 0420 hours. However, the second VS was taken at 0530 hours, which was 36 minutes instead of 15 minutes after starting transfusion.

* Another blood transfusion was started on 7/18/17 at 1117 hours. The VS was taken on 7/18/17 at 1108 hours. However, the second VS was taken at 1145 hours, which was 28 minutes instead of 15 minutes after starting transfusion.

* The blood transfusion was started on 7/21/17 at 0830 hours and ended at 1055 hours. The VS was taken on 7/21/17 at 1130 hours, which was 35 minutes after the completion instead of at the time of completion.

The blood transfusion was started on 7/25/17 at 0835 hours and ended at 1030 hours. The VS prior to the transfusion was taken on 7/25/17 at 0715 hours, which was one hour and 20 minutes instead of within 30 minutes of the initiation of transfusion. The next VS was taken at 1120 hours. There was no documented evidence of the VS being obtained 15 minutes after starting and upon completion of the transfusion.

* The blood transfusion was started on 7/25/17 at 1140 hours and ended at 1440 hours. The VS was taken at 1530 hours, which was 50 minutes after the completion instead of at the completion of the transfusion.

* Another blood transfusion was started on 7/25/17 at 1445 hours and ended at 1600 hours. The VSs were taken at 1240 hours which was two hours and five minutes instead of within 30 minutes prior to the transfusion, 1530 hours which was 45 minutes instead of 15 minutes after starting transfusion, and 1930 hours which was three hours and 30 minutes after the completion instead of at the completion of the transfusion.

* The blood transfusion was started on 8/15/17 at 0730 hours. The VS was taken at 0757 hours which was 27 minutes instead of 15 minutes after starting the transfusion.

During an interview and concurrent medical record review with RN 32 on 8/15/17 at 1011 hours, the RN verified the patient's VSs were not taken as per the hospital's P&P.

2. According to the Health and Safety Code, Division 2, Licensing Provisions, Section 1645 (The Paul Gann Blood Safety Act), whenever there is a reasonable possibility, as determined by a physician and surgeon or doctor of podiatric medicine, that a blood transfusion may be necessary as a result of a medical or surgical procedure, the physician and surgeon or doctor of podiatric medicine, by means of a standardized written summary as most recently developed or shall inform, either directly or through a nurse practitioner, certified nurse midwife, or a physician assistant, who is licensed in autologous blood and directed and nondirected homologous blood from volunteers. The Act also showed the person who provided the patient with the standardized written summary shall note on the patient's medical record that the standardized written summary was given to the patient.

Review of the hospital's P&P titled Blood/Blood Component Transfusion-Adult revised 12/15 showed the RN will document instruction and education provided to the patient/family in the EHR.

During an interview and concurrent medical record review with RN 32 on 8/15/17 at 1011 hours, the RN demonstrated how to retrieve the education material from the ORCHID. The Educator showed the instruction titled "A Patient's Guide to Blood Transfusion" was available from the ORCHID. Review of the "A Patient's Guide to Blood Transfusion" showed the contents of Paul Gann Blood Safety Act were included.

Patient 3's medical record review was initiated on 8/14/17. The medical record showed Patient 3 was admitted to the hospital on 8/9/17.

Review of the Blood Production Administration dated 8/9/17, showed two units of red blood cells were administered to Patient 3. However, under the section for Patient's Guide to Blood Transfusion, there was no documented evidence to show the brochure was given to the patient.

Review of the list of instruction/education given to Patient 3 showed no educational materials were provided.

During an interview and concurrent medical record review with RN 33 on 8/15/17 at 1410 hours, the RN verified Patient 3 did not receive the blood transfusion instruction which included Paul Gann Blood Safety Act.

Based on observation, interview, and record review, the hospital failed to ensure the medical records were accurate for two of 33 sampled patients (Patients 9 and 10), creating the increased risk of providing incorrect information to other healthcare providers who involved with the care for these patients.

Findings:

1. Review of the hospital's P&P titled Sedation Policy revised 6/11, showed the practitioner shall perform an appropriate patient assessment and documentation prior to the administration of moderate/deep sedation which must include over all physical assessment of major organ system including cardiac (heart) and pulmonary (lungs).

During an observation of Patient 9's procedure on 8/14/17 at 1530, MD 8 was observed not performing the heart and lung examinations as per the hospital's P&P.

However, on 8/15/17, review of Patient 9's medical record showed the Physical Exam section of the Pre-procedure/Sedation Note dated 8/14/17 at 1540 hours, showed Patient 9's heart and lungs were examined.

On 8/17/17 at 0830 hours, the Supervising Staff Nurse II for Procedural Nursing was informed and acknowledged Patient 9's medical record was inaccurate.



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2. On 8/14/17 at 1348 hours, Patient 10's surgical procedure was observed in OR1. The patient was in the supine position during the procedure. The surgical team included the medical student who was assisting with the procedure.

On 8/15/17, Patient 10's medical record review was conducted. The Main OR Intraoperative Record dated 8/14/17, showed RN 7 documented that the patient's body position was "Low Lithotomy." In addition, the document for the surgical team did not include the name of the medical student.

On 8/15/17 at 1422 hours, the Supervising Staff Nurse II for Procedural Nursing confirmed the finding.

Based on observation, interview, and record review, the hospital failed to ensure the consents for blood transfusion and pericardiocenstesis were accurate and complete for two of 33 sampled patients (Patients 3 and 4). This failure had the potential for the patients to not receive appropriate care as the medical information was not accurate and complete.

Findings:

1. Patient 3's medical record review was initiated on 8/14/17. The medical record showed Patient 3 was admitted to the hospital on 8/9/17.

The Transfusion Record showed the blood transfusion for Patient 3 was started on 8/9/17 at 1605 hours and ended at 1705 hours.

The Consent for Blood Transfusion form dated 8/9/17, showed Patient 3's family member had signed the consent. However, the section for time was left blank.

During an interview and concurrent medical record review with RN 34 on 8/15/17 at 1308 hours, the RN verified the finding.



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2. On 8/14/17 at 1048 hours, during the tour of the Step-Down Unit, Patient 4 stated, "no English" in respond to the greeting. The RN was observed coming in to translate for the patient.

Medical record review showed Patient 4 had a pericardiocenstesis procedure on 8/3/17.
However, review of the informed consent for this procedure showed no documented evidence of the interpreter used to translate for the patient.

On 8/14/17 at 1052 hours, during an interview, RN 29 stated Patient 4's physician who obtained the consent stated he had one RN from the catheterization laboratory translate for the patient while obtaining the consent but did not document it.

On 8/15/17 at 1525 hours, the Clinical Nursing Director, Medical/ICU provided the name of the catheterization laboratory RN who translated for Patient 4 on 8/3/17, and acknowledged the finding.

Based on interview and record review, the hospital failed to ensure the verbal order for restraints was authenticated by the physician as per the hospital's P&P for one of 33 sampled patients (Patient 12). This failure created the potential of the physician not being aware of Patient 12's hospital course and current status.

Findings:

Review of the hospital's P&P titled Verbal/Telephone Orders revised 7/7/17, showed verbal and telephone orders must be limited to urgent and emergent situations where immediate written communication is not feasible. The entire telephone/verbal order must be read back to the prescriber after it is documented in the EMR. A provider who is a member of the patient care team will sign the orders in the EMR as soon as possible and no later than 48 hours after the order is written.

On 8/14/17 at 1340 hours, review of Patient 12's medical record was initiated.

Patient 12's Record of Denial of Patient's Rights dated 8/10/17 at 1826 hours, showed Patient 12 was restrained for aggressive outbursts and throwing things at the staff on 8/10/17, from 1826 to 2220 hours.

Review of the EMR showed Patient 12 was ordered to have the restraint applied to all four limbs and the waist for up to four hours for physical abuse to others on 8/10/17 at 1826 hours. However, review of the physician's order failed to show documented evidence the physician had authenticated the order.

An interview and concurrent medical record review was conducted with Psychiatrist 3 on 8/15/17 at 0950 hours. Psychiatrist 3 verified the order was never authenticated by the physician. He demonstrated on the EMR how the order was placed so the physician was alerted to authenticate the order entered by an RN. He stated the physician would be notified via the EMR when the RN placed the order under the communication type of "Verbal with Read Back" in the EMR. However, Psychiatrist 3 stated this order was not entered in this manner.

During an interview with Nurse Manager 2 on 8/18/17 at 0820 hours, she stated the RN had incorrectly placed the order in the EMR and the physician was never alerted to authenticate the order. Nurse Manager 2 stated the ordering physician was not on the unit at the time of the incident and had given the order to the RN over the telephone. However, the physician was able to perform a face-to-face evaluation of Patient 12 within the hour.

Based on interview and record review, the hospital failed to ensure the executed informed consent was accurate for one of 33 sampled patients (Patient 24), creating the increased risk of the patient to not receive the accurate information about the treatment plan.

Findings:

Review of Patient 24's medical record was initiated on 8/15/17 at 1415 hours. The medical record showed Patient 24 came to the hospital on 8/15/17, for a procedure.

The Preprocedure/Sedation Note dated 8/15/17 at 0920 hours, showed the planned procedure was paracentesis.

The Procedure Note dated 8/15/17 at 1045 hours, showed the paracentesis procedure was performed on Patient 24.

However, review of the Authorization form and Informed Consent to Surgery or Special Diagnostic or Therapeutic Procedure signed by Patient 24 on 8/15/17 at 0945 hours, showed the patient had signed for "Thoracentesis" and "abdomen" procedure.

During an interview and concurrent review of Patient 24's medical record with the Director, Accreditation & Licensing on 8/18/17 at 0845 hours, the Director confirmed the above informed consent signed by Patient 24 did not reflect the procedure performed on the patient.

Based on observation, interview, and record review, the hospital failed to ensure the hazardous sterile compounding room had a comfortable temperature for the compounding personnel. This failure had the potential for contamination of the compounded sterile products.

Findings:

Review of the hospital's P&P titled "Sterile Room Operating Procedures and Environmental Control" dated 12/16 showed the required garbing includes "... a non-shedding coverall gown...a chemo gown is required in addition to the coverall when compounding hazardous drugs...The sterile compounding area is to be well-lit and include a temperature 20 - 24 degrees (C) Celsius (68-75 degrees F) or cooler to maintain comfortable conditions for compounding personnel when attired in the required compounding garb ..."

The USP is a scientific, non-profit organization that sets the standards for the quality, purity, identity, and strength for medications manufactured and consumed worldwide. The USP is federally recognized as an authoritative source regarding minimum standards of safe practice applicable to both sterile and non-sterile compounding. The USP <797> (USP chapter 797) establishes the minimum standards of practice applicable when preparing, storing, and transporting CSPs to be followed by all health care personnel in any setting.

According to the USP <797>, compounding facilities shall provide a comfortable and
well-lighted working environment, which typically includes a temperature of 20 degrees C or cooler (68 degrees F), to maintain comfortable conditions for compounding personnel to perform flawlessly when attired in the required aseptic compounding garb.

According to the CMS, USP <797> is the minimum applicable standards of practice for safe sterile compounding. Hospitals must ensure that they meet all currently accepted standards for safe preparation and administration of compounded sterile products.

On 8/15/17 at 1340 hours, during an observation in the pharmacy, the hazardous clean room felt warm and very uncomfortable. The wall thermometer showed the room temperature was at 76.6 degrees F. Pharmacy Technicians 1 and 2 who were working in the room acknowledged it had been warm and very uncomfortable. They also stated it had been uncomfortable in the hazardous clean room for a while. The Inpatient Pharmacy Supervisor also acknowledged the room temperature was uncomfortable.

Review of the hazardous clean room temperature log showed the room temperature had been consistently high over 70 degrees F since the beginning of June 2017. The Inpatient Pharmacy Supervisor acknowledged the finding.

Based on observation, interview, and document review, the hospital failed to ensure only authorized personnel had access to the area where the medications being stored. This failure had the potential for accessing the pharmaceuticals by the unauthorized personnel.

Findings:

Review of the hospital's P&P titled "Storage, Handling, Security, and Disposition of Medications" dated 7/17 showed in part, "... Environmental Services, Central Services, and other non-licensed unauthorized personnel may have access as needed with supervision by authorized personnel ..."

On 8/15/17 at 1005 hours, during an observation of the Step-Down Unit, EVS 6 was observed cleaning the medication room without the supervision of the authorized personnel. The Inpatient Pharmacy Supervisor and RN 10 acknowledged the EVS staff should be supervised by the authorized personnel when cleaning the medication room.

Based on observation, interview, and record review, the hospital failed to ensure the mislabeled, outdated, and unusable medications and biologicals were removed from the patient care areas as evidenced by:

1. Four opened eye drop medications were not labeled properly with the expiration date which was 28 days after it was opened.

2. Two bottles of sterile water were kept in the warmer without the labels.

3. Four expired vacutainers were kept in the SDSU Pediatric Crash Cart.

Two expired bottles of Balanced Salt Solution (irrigating solution) and four expired packets of sterile droppers were stored in the sterile compounding clean room. The partially used bottle of sterile water for injection 10 ml and partially used bag of Dextrose 10% in water 250 ml (type of IV solution) found on the IV compounding bench were undated.

5. Multi-lumen CVC (Central Venous Catheter) kit with the expiration date of 6/17 was observed in the medication room on the Step-Down Unit.

These failures had the potential for the patients to receive the outdated and unusable medications and biologicals.

Findings:

1. On 8/14/17 0940 hours, during the tour of the SDSU medication room, four eye medications were observed with the orange stickers showing the written opened and expiration dates as follows:

* atropine sulfate (mydriatic) 1% multidose solution bottle with the opened date of 7/25/17, and expiration date of 12/17.

* plenylephine hydrochloride (mydriatic) 2.5% multidose solution bottle with the opened date of 8/6/17, and expiration date of 8/5/18.

* cyclopentolate (anticholinergic) 1% multidose solution bottle with the opened date of 8/11/17, and expiration date of 8/10/18.

* tropicamide (mydriatic) 1% with the opened date of 8/8/17, and expiration date of 3/18.

On 8/16/17 at 0930 hours, during an interview, the Inpatient Pharmacy Supervisor stated the expired date for the opened eye drop solution was 28 days after it was opened.

2. On 8/14/17 0940 hours, the substerile room (a sterile room between ORs 1 and 2) was observed to have the warmer for warming the blanket and solution. Two sterile water plastic bottles were kept in the warmer with no label showing the stored date. The Supervising Staff Nurse II Surgical Services confirmed the finding.

Review of the manufacturer's warming recommendations dated 11/10 showed to warm the irrigation solutions in plastic pour bottles, the solution can be warmed for not exceeding 50 degrees Celsius (122 degrees Fahrenheit) for a period no longer than 60 days, or 66 degrees Celsius (150 degrees Fahrenheit) for a period no longer than 72 hours.

3. The hospital's P&P tiled Resuscitation: Adult Medical Emergency (Code Blue), Pediatric Medical Emergency (Code White), Neonatal resuscitation-NICU, Emergency Cart Location, Content and Maintenance/Exchange revised 7/17 showed on daily maintenance, each hospital unit location with an emergency cart is responsible for checking contents of the cart.

On 8/15/17 at 1011 hours, the pediatric crash cart located at the SDSU was inspected with RN 14. The following was observed:

* Two blue vacutainers with the expiration date of 4/17.
* Two green vacutainers with the expiration date of 7/17.

RN 14 stated the SDSU staff checked the crash cart plastic lock number daily but did not open the cart to check the content. The Central Services was responsible for checking the expired items.



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4. Review of the hospital's P&P titled Single and Multi-dose Parenteral Medication Vials dated 7/16 showed in part, " ...Used single-dose vials must not be stored for later use, no matter what the size of the vial ..."

On 8/14/17 at 1315 hours, during an observation in the hospital's pharmacy non-hazardous clean room, two bottles of Balanced Salt Solution and four packets of sterile droppers were observed with the expiration date of 6/17. The partially used bottle of sterile water 10 ml and partially used bag of Dextrose 10% in water 250 ml were also undated on the IV compounding bench.

The Inpatient Pharmacy Supervisor acknowledged the outdated pharmaceuticals. She also stated the single use containers should be discarded after initial use.

5. On 8/15/17 at 1010 hours, during an observation of the medication room on the Step-Down Unit, the multi-lumen CVC kit with the expiration date of 6/17 was observed on the shelf with the unexpired kits. The Inpatient Pharmacy Supervisor and RN 10 acknowledged the outdated CVC kit.

Based on observation, interview, and record review, the hospital failed to ensure the annual safety evaluation was performed for two thyroid shields found in OR 1, creating the increased risk of staff being exposed to the radiation.

Findings:

On 8/14/17 at 1435 hours, two protective thyroid shields were observed in OR 1. During the concurrent interview with Supervising Staff Nurse II Surgical Services, he stated thyroid shields were currently use by the OR staff and the annual safety check was completed by the radiology department. The radiology department would have the record for review.

On 8/15/17, review of the log for the protective gears showed no documented evidence the annual check was performed on these thyroid shields.

Based on interview and record review, the hospital failed to ensure the effective process for monitoring and identifying hazard related to the use of lead aprons and radiation exposure badges. This failure had the potential to expose the patients and staff to excessive radiation.

Findings:

During a tour of the radiology department and concurrent interview on 8/14/17 at 0950 hours, when asked about lead apron tracking, MD 1 stated, "Policy requires annual X-ray and tracking."

During an interview and concurrent document review with Radiology Technician on 8/14/17 at 1045 hours, he stated, "It's a problem...sometimes we have to track them (aprons) down...some physicians keep them in their office or in their car."

Review of the hospital's Lead Shielding Annual Report, Main Radiology dated 7/17 showed the listing of 414 lead aprons with varying types and multiple locations. However, 163 of the lead aprons listed were not found. There was no notation of the due date or last date inspected. The Radiology Technician stated, "We need to update our spreadsheet....I'm trying to track them down."

Review of the hospital's Occupational Radiation Exposure Report dated 7/26/17, showed no documented evidence of the tracking for the overdue or expired radiation exposure badges.

Based on record review and interview, the hospital failed to ensure the Utilization Review Plan addressed the required notifications in the event of determination of the admission or continued stay was not medically necessary.
This failure created the risk of not informing the patient and other parties involving with patient care of the admission or continued stay determination.

Findings:

On 8/16/17 at 0937 hours, during the review of the hospital's Utilization Review Plan for Admission Review and Continued Stay with RN 27, the plan did not include the requirement that if the physician review showed the patient's stay was not medically necessary or appropriate, the written notification of this decision must be sent to the attending physician, patient (or next of kin), facility administrator and the single State Agency (in the case of Medicaid) no later than 2 days after such final decision and in no event later than 3 working days after the end of the assigned extended stay period.

This finding was acknowledged by RN 27.

Based on observation, interview, and record review, the hospital failed to ensure the detailed description of the location of the disaster or emergency bottled water supply. The water supply was necessary to ensure adequate hydration and hygiene of the patients and staff during a disaster that would require shelter in place with no resources coming into the hospital. This failure had the potential for staff confusion during a disaster and not meeting the fluid needs for both patients and staff during a disaster .

Findings:

During a review of the hospital's document titled "Critical Incident Planning: Water Supplies for Olive View" (undated), the document showed the plan is to provide water for 1500 staff and 355 patients (1855 total persons) for four days. The plan is based on providing one gallon per person per day for four days. The document also showed 6724 gallons of water are stored in various locations on the hospital grounds, 200 five gallon bottles of water are stored at various locations throughout the hospital, and 30 five gallon bottles of water are in the Supply Chain Warehouse.

During an observation and concurrent interview with the DFANS and DF on 8/5/17 between 1000 and 1050 hours, the five gallon bottles of water listed in the above document as "Location: Various throughout the hospital; 30 in Supply Chain Warehouse" were inventoried. The Supply Chain Warehouse had 27 five gallon bottles of water. The Utilization Review office on the sixth floor had 7 five gallon bottles and the kitchen had 4 bottles. Multiple other offices throughout the hospital were asked if they had any of the five gallon bottles and they did not. During the concurrent interview, both of them did not know where the various locations were for the five gallon bottles of water required as per the hospital's document.

During an interview with the Emergency Management Clerk on 8/17/17 at 1040 hours, he stated that the five gallon bottles of water were stored in multiple locations throughout the hospital campus. He had performed the inventory of the bottles on 8/16/17, that showed 12 locations within the hospital where varying numbers of bottles were being stored. There were also 39 locations outside of the hospital building but on the premises, which each location stored anywhere from 1 to 28 bottles. He was unable to state how the hospital staff would be able to determine the location of all the bottled water during a disaster when there were no details on the locations where the water bottles being stored in the disaster plan.

Based on observation, interview, and record review, the hospital failed to ensure the hospital's environment and equipment were maintained in a safe and sanitary manner as evidenced by:

1. Accumulations of dust and poorly maintained surfaces of equipment and structure were observed in the Main OR, PACU, SDSU, and L&D OR 8.

2. The OR table in OR 1 was malfunctioned.

3. The medication refrigerators were not cleaned and maintained.

4. Three reusable LMAs were not discarded after the warranty limit as per the manufacturer's instructions.

5. Patient rooms and nursing stations on the Medical-Surgical Units (4A and 4D) were not maintained.

6. Three dialysis machines had rust on the base at the back of the machines. One portable RO machine had missing paint exposing the metal underneath, and dirt buildup on the structure attaching the portable RO tanks to the back of the machine.

8. Multiple pieces of equipment were not maintained in the IR, GI, and cath lab areas. Expired devices were found in the GI lab storage room.

9. Emergency supplies were not stored in the emergency crash cast as per the hospital' s Adult Emergency Cart Contents.

10. The tile flooring with grout in the shower room located in the Psychiatric ED was not maintained.

These failures could create the increased risk of unsafe environment and safety for patients, staff, and visitors.

Findings:

1. Multiple observations in the Main OR, PACU, SDSU, and L&D OR 8 showed accumulations of dust and poorly maintained surfaces of equipment and structure. Cross reference to A951, example #10.

2. The OR table in OR 1 was observed to be malfunctioned during an ongoing procedure. Cross reference to A951, example #3.

3. On 8/16/17 at 1355 hours, the medication refrigerators in the SDSU, Main OR, and PACU; and the MH cart were inspected. Trash was found inside each refrigerator. In addition, the MH medication refrigerator had accumulated ice in the freezer compartment. During a concurrent interview with EVS 11, she stated she cleaned this area on a daily basis.

The OR Pharmacist was interviewed on 8/15/17 at 1355 hours regarding cleaning of the MH medication refrigerator. The OR Pharmacist stated the EVS staff was responsible for cleaning the refrigerator, but he was aware of the refrigerator being locked by the pharmacy and the EVS staff would not have access to it.

4. Three reusable LMAs were not discarded after one year warranty as per the manufacturer's instructions. Cross reference to A1002, example #1.

5. Review of the hospital's P&P titled Shine-7 Step Cleaning Process for non-patient care areas showed to damp mop all appropriate areas and to mop out corners to prevent the buildup.

The website for Health Facilities Magazine, American Hospital Association Publication, showed textured surfaces, seams, and porous material support biofilm by providing a perfect place to attach and harbor where they cannot be reached during the disinfection process.

On 8/14/17 at 1015 hours, during a tour of the medical surgical units (4A and 4D) with Supervising Staff Nurse 8, the following was observed:

* The metal handwashing sink at the 4A nursing station had a black substance on the edges of the sink. The tile floors in the area had a buildup of black substance in the corners and on the floor at the base of the floor/wall molding. The section of the floor/wall molding was missing. The formica covered the shelves on the wall near the sink had missing areas of the formica exposing the porous wood underneath.

In the patient room #A107, the wall next to the sink had water damage to the wall above the floor/wall molding. The wall next to the closet by the sink had a large dark stain. The entry door and door frame had large area of missing paint exposing the porous wood underneath.

* The floor of the nourishment room was covered with the small 1 inch white ceramic tiles.
However, there were missing and chipped tiles with a black buildup in the areas of the missing tiles. There was a rusty and dirty doorstop attached to the floor. One side of the refrigerator had a metal plate which secured the refrigerator to the floor. The plate was rusted. The door to the dietary room also had areas of missing paint exposing the porous wood.

* The metal handwashing sink at the 4D nursing station had a white crusty buildup around the edge of the sink. Also, the buildup of black substance were observed in the corners and on the floor at the base of the floor/wall molding.

* The doors for the patient rooms and non-patient rooms had areas of missing paint along the edges and on the front of the doors and door frames exposing the porous wood underneath.

On 8/17/17 at 1415 hours, during an interview with the EVS Manager, he verified the staff were aware of the black buildup in the corners and on the floors of the nursing stations and patient rooms, and they were working with the maintenance staff to replace the broken floor/wall moldings.

* When asked, the hospital could not provide any Environment of Care Round Reports for these identify areas since January 2017.
In a concurrent interview with Supervising Staff Nurse 8, she acknowledged the findings.

6. On 8/14/17 at 1510 hours, during an observation of the storage room for the contracted dialysis services with RN 28, the following was identified:

* Three dialysis machines had rusted areas on the base at the back of the machines.

* One portable RO machine had a large area of missing paint exposing the metal underneath. There was a buildup of dirt on the structure attaching the portable RO tanks to the back of the machine.

In a concurrent interview, these findings were acknowledged by RN 28.

7. During the observations of the IR, GI, and cath lab areas on 8/14, 8/15, 8/16, and 8/17/17, multiple pieces of equipment were not maintained. Cross reference to A749, example
#5.

8. On 8/14/17 at 1305 hours, during an observation accompanied by the Supervising Staff Nurse II for Procedural Nursing, COO, RNs 2, 3, and 4, two packages of Fusion Wire Guide Locking Device (a device used to secure wire guide during the procedure) found in the GI lab storage room had expired in 1/17.

In a concurrent interview, the Supervising Staff Nurse II for Procedural Nursing confirmed the finding.
Review of the hospital's P&P titled Emergency Cart Location, Contents and Maintenance/Exchange revised 8/14 showed Central Services is responsible for obtaining the opened cart from the unit and returning it to the Central Services designated area for cleaning, restocking, and locking.

Review of the Adult Emergency Cart Contents dated 12/14/10, showed the following items were listed:

- One ETT connector size 3 in Drawer #1.
- Four of 19 gauge 1 ½ inch needles in Drawer #2
- One adult cricothyrotomy tray and one triple lumen catheter in the bottom shelf.

On 8/14/17 at 1110 hours, the emergency crash cart in the 5D Step Down Unit was inspected in the presence of Supervising Staff Nurse 3. However, the above listed items were not found in the emergency crash cart. Supervising Staff Nurse 3 verified the finding.

10. In the Psychiatric Emergency Department, the tile flooring with grout in the shower room was not maintained. Cross reference to A749, example #20.




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5. Review of the hospital's P&P titled Shine-7 Step Cleaning Process for non-patient care areas showed to damp mop all appropriate areas and to mop out corners to prevent the buildup.

The website for Health Facilities Magazine, an American Hospital Association Publication, showed that textured surfaces, seams and porous material support biofilm by providing a perfect place to attach and harbor where they cannot be reached during the disinfection process.

On 8/14/17 at 1015 hours, during tour of the medical surgical units (4A and 4D) with Supervising Staff Nurse 8, the following was observed:

* The metal handwashing sink at the nursing station on 4A had a black substance on the edges of the sink. The tile floors in the area had a buildup of a black substance in the corners and on the floor at the base of the floor/wall moulding, and a section of the floor/wall moulding was missing. The formica covered shelves on the wall near the sink had missing areas of the formica covering, exposing the porous wood underneath.

* In the patient room A107, the wall next to the sink had water damage to the wall above the floor/wall moulding. The wall next to the closet by the sink had a large dark stain. The entry door into the room and the door frame had large areas of missing paint and exposed porous wood underneath.

* The floor of the nourishment room was covered with small 1 inch white ceramic tiles. There were missing and chipped tiles with a black buildup in the areas of the missing tiles. There was a doorstop attached to the floor which was rusty and dirty. On one side of the refrigerator was a metal plate which was used to secure the refrigerator to the floor. The plate was rusted. The door to the dietary room also had areas of missing paint and exposed porous wood.

* The metal handwashing sink at the nursing station on 4D had a white crusty buildup around the edge of the sink. Also, a buildup of a black substance in the corners and on the floor at the base of the floor/wall moulding.

On 8/17/17 at 1415 hours, during an interview with the EVS Manager, he acknowledged the staff were aware of the black buildup in the corners and on the floors of the nursing stations and patient rooms, and they were working with the maintenance staff to replace the broken floor/wall mouldings.

When asked, the hospital could not provide any Environment of Care Round Reports for these areas since January 2017.

Further observation of both areas showed the doors to patient rooms and non-patient rooms had areas of missing paint on the edges and fronts of the doors, and the door frames exposed the porous wood underneath.

In a concurrent interview, Supervising Staff Nurse 8 acknowledged the findings.

6. On 8/14/17 at 1510 hours, during an observation of the storage room for the contracted dialysis service with RN 28, the following was identified:

* Three dialysis machines had rusted areas on the base at the back of the machines,
* One portable RO machine had a large area of missing paint exposing the metal underneath. There was a buildup of dirt on the structure attaching the portable RO tanks to the back of the machines.

In a concurrent interview, these findings were acknowledged by RN 28.



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7. During the observation of the IR, GI, and cath lab areas on 8/14, 8/15, 8/16, and 8/17/17, items with crack, rust, dust or substablce build up were identified in the IR, GI and cath lab areas. Cross Reference to A749, example #5.

8. On 8/14/17 at 1305 hours, during an observation accompanied by the Supervising Staff Nurse II for Procedural Nursing, RN 2, COO, RN 3, and RN 4, two packages of Fusion Wire Guide Locking Device (a device used to secure wire guide during the procedure) found in the GI lab storage room were expired in 1/17.

In a concurrent interview, the Supervising Staff Nurse II for Procedural Nursing confirmed the finding.




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9. Review of the hospital's P&P titled Emergency Cart Location, Contents and Maintenance/Exchange revised 8/14 showed Central Services is responsible for obtaining the opened cart from the unit and returning it to the Central Services designated area for cleaning, restocking, and locking.

Review of the Adult Emergency Cart Contents dated 12/14/10, showed the following:

* One size 3 ETT connector in the Drawer #1.
* Four of 19 gauge 1 ½ inch needles were supposed to be stocked in the Drawer #2.
* One adult cricothyrotomy tray and one triple lumen catheter were supposed to be stocked in the bottom shelf.

On 8/14/17 at 1110 hours, an emergency crash cart in the Step Down Unit was inspected in the presence of Supervising Staff Nurse 3. The following was identified:

* There was no size 3 ETT connector in the Drawer #1.
* Four of 18 gauge 1 ½ inch needles were found in the Drawer # 2 instead of 19 gauge 1 ½ inch needles in the Drawer #2.
* There was no adult cricothyrotomy tray and triple lumen catheter in the bottom shelf.

Supervising Staff Nurse 3 verified the above findings.



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10. In the ED Psychiatric unit, the tile grouting of the shower room was eroded and brown. Cross reference to A0749 example #20.

Based on observation, interview, and record review, the hospital failed to ensure the temperature and humidity levels were monitored in the IR and GI procedural areas as per the AORN's guidelines. This failure created an increased risk of infections. In addition, the hospital failed to ensure adequate and proper lighting in the clean utility room on the Medical Surgical Unit where the IV solutions being stored, creating the potential for the patients to receive the wrong IV solutions.

Findings:

According to the AORN's Guidelines for Perioperative Practice, 2017 edition, Guideline for a Safe Environment of Care, Part 2, restricted areas include the operating and other rooms in which operative or other invasive procedures are performed. The restricted areas are intended to be the cleanest; therefore, the HVAC requirements for the restricted areas are the most stringent. The HVAC system reduces the amount of environmental contamination by carrying airborne contaminates away from the sterile field and removing these contaminants through the return duct vents located at the periphery of the room. The temperature should be less than 75 degrees Fahrenheit for the sterile storage area, between 70 to 75 degrees Fahrenheit for the procedure room, and between 68 to 73 degrees Fahrenheit for the endoscopy procedure rooms and clean workroom. The humidity levels should be less than 60% for the sterile storage area and clean workroom, and should be maintained between 20% to 60% for the procedure rooms and the endoscopy procedure room.

1. Observation of the hospital's GI procedural area was conducted with the Supervising Staff Nurse II for Procedural Nursing, COO, RNs 2, 3, and 4 on 8/14/17 at 1305 hours. The GI procedural area had two GI procedure rooms, one sterile supply storage room, one scope processing room, and one scope storage room. The thermostat in the sterile supply storage room showed the room temperature was 75.4 degrees F. When asked, RN 4 stated the temperature and humidity levels were not monitored for the sterile supple storage room.

A follow-up interview was conducted with the Supervising Staff Nurse II for Procedural Nursing on 8/14/17 at 1440 hours. When asked, she stated the temperature and humidity levels were not monitored in the GI procedural area including the two GI procedure rooms.

2. Observation of the hospital's IR procedural area was conducted with the Supervising Staff Nurse II for Procedural Nursing, Supervisor Radiology Tech, RNs 16, 18, and 19 on 8/15/17 at 1325 hours. The IR procedural area had one IR procedure room, one work station area, and one room connecting to the work station area. Sterile packages were observed being stored in the work station area and the room connected to the work station area. There was a thermostat in the IR procedure room.

RN 19 stated the IR procedure room was considered as a restricted area because the sterile procedures were performed in that room. When asked, the Supervisor Radiology Tech stated the temperature and humidity levels were not monitored for six or seven months.

When asked, the Supervising Staff Nurse II for Procedural Nursing stated the hospital utilized the AORN's guidelines as the hospital's standard of practice. She confirmed the temperature and humidity levels were not monitored for the IR and GI procedural areas as per the AORN's guidelines.



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3. Review of the hospital's P&P titled Storage, Handling, Security, and Disposition of Medications dated 7/17 showed in part, "...All medications are stored under the proper conditions of sanitation, light, moisture, ventilation, segregation, security, and temperature ..."

On 8/15/17 at 1050 hours, during an observation on the Medical Surgical Unit, the clean utility room where the IV solutions being stored did not have adequate lighting. The Inpatient Pharmacy Supervisor, RNs 10 and 11 acknowledged the finding.

Based on observation, interview, and record review, the hospital failed to ensure the sanitary environment was maintained and the active IC program was developed and implemented to prevent the spread of infections in accordance with the hospital's P&Ps and nationally recognized infection control practices and guidelines as evidenced by:

1. Failure to ensure the hospital's IC committee developed and implemented their IC P&Ps throughout the hospital. The IC staff failed to consistently conduct and document active surveillance of the high risk, high volume, and problem prone areas of the hospital such as the peri-operative areas in order to identify the risks for infections; and failed to oversee the activities of the contracted EVS. Cross reference to A748.

2. Failure to ensure the IC officers developed an effective system to implement P&Ps and professional standards and evaluate measures for identification, investigation, reporting, and preventing infections within the hospital. Cross reference to A749.

3. Failure to ensure the contracted EVS provider complied with all applicable standards and Conditions of Participation. Cross reference to A083.

4. Failure to provide comprehensive oversight of the contracted EVS provider. Cross reference to A084.

The cumulative effect of these systemic failures resulted in the hospital's inability to minimize the risk of spread of infections in the hospital.

Based on observation, interview, and record review, the hospital failed to ensure the hospital's IC committee developed and implemented their IC P&Ps throughout the hospital. In addition, the IC staff failed to consistently conduct and document active surveillance of the high risk, high volume, and problem prone areas of the hospital, such as the peri-operative areas in order to identify the risks for infections and failed to oversee the activities of the contracted EVS. These failures created an increased risk of the spread of infections throughout the hospital.

Findings:

Review of the hospital's "Infection Control Plan" dated 2/18/2017, showed in part, "...Maintain regular contact with all departments to develop, implement and monitor compliance with Infection Control policies throughout Olive View Medical Center...Review, evaluate and approve all aseptic, isolation and sanitation techniques. Make environmental rounds to evaluate and correct, if necessary, employee practices related to aseptic technique, isolation, cleaning, sterilization, disinfection and sanitation ..."

On 8/15/17 at 1335 hours, an interview with the Medical Director, Infection Control was conducted. The Medical Director stated the RN staff consisted of one full time ICP who was on vacation at this time. She stated there was one ICP position vacant and one position recently filled with a trainee. ICP 1 was a former member of the staff who worked part time as a relief ICP nurse. The Medical Director, Infection Control stated she reported to the Chief of Infection Control and the Medical Executive Committee. The Director stated the full time ICP reported to the CNO.

The Medical Director, Infection Control stated the hospital surveillance for infections included conducting the EOC rounds twice monthly with the multidisciplinary core of Administrators, Safety Officer, Environmental Services, and Supervising Administrator for the specific area. Some areas were visited more frequently based on the risk assessments, infection rates, and findings. The Medical Director stated the findings from the EOC rounds were followed up by the IC department. The scheduled and findings of the hospital's EOC rounds for 2017 were requested.

The Infection Prevention Officer stated the EVS performed their own audits using the Blacklight testing in various areas to ensure thorough cleaning and disinfecting of the patient care areas. The findings were presented to the quality committee on a bi-monthly basis. The Infection Prevention Officer also stated all new cleaning products were reviewed by the IC committee.

1. The observations of the use of QC Peroxide cleaner on the OR floors were shared with Infection Prevention Officer. The Infection Prevention Officer confirmed the manufacturer's product specifications showed the Ecolab Peroxide Glass and Surface Cleaner was a multi-purpose cleaner with no sanitizing or disinfecting properties. Cross reference to A0749, example #1.

The Infection Prevention Officer stated it was not the practice of the hospital to use the QC Peroxide cleaner in the ORs. Infection Control approved the product for use as a neutral floor cleaner for the regular patient care areas.

On 8/15/17 at 1445 hours, an interview was conducted with the Director of EVS. The Director stated EVS worked with the IC Committee regarding all cleaning products used in the hospital. When asked how EVS staff was supervised, he stated the EVS supervisors made direct observations of the EVS staff utilizing checklists with targeted areas of focus for cleaning and sanitizing the patient care areas.
These direct observations were conducted on all EVS staff at least once per month and collated in the unit for validation of yearly competencies.
When asked, the Director stated he was not aware of the QC peroxide cleaner being used for cleaning of the OR floors, and it was intended for use in the regular patient care areas only. The Director of EVS stated Oxivir Tb wipes should be used on the OR floors as well as surfaces. The Director of EVS stated the IC Committee decided on a contact time of 10 minutes for the surfaces to stay wet with Oxivir Tb wipes as that was the time it took to kill fungus.

On 8/16/17 at 1115 hours, an interview was conducted with the EVS Supervisor to discuss the use of QC Peroxide in the ORs. The EVS Supervisor stated when the new product was introduced in June; she received the instructions from her managers that the QC Peroxide floor cleaner was a disinfectant product. The EVS Supervisor stated she understood the QC Peroxide floor cleaner was to be used in the ORs, especially if the floor had a heavy spillage of blood products. Otherwise, the EVS staff could use the Oxiver Tb wipes.

When asked how the EVS staff was supervised for quality, the EVS Supervisor stated she validated the EVS staff on the thoroughness of cleaning by using a direct observation checklist tool at a minimum of once a month. The Supervisor stated the checklists were for the occupied patient rooms, terminals, and between case cleaning in the ORs.

During a follow-up interview and concurrent facility document review with the Director of EVS on 8/17/17 at 1116 hours, he stated the QC Peroxide floor cleaner was a new product used in the hospital beginning 6/8/17, however, the EVS staff did not receive additional training on the proper use of the QC Peroxide floor cleaner since it was similar to the product that the hospital had used previously. The Director of EVS verified the inservices provided to EVS staff did not include where (floors or surfaces) to use the products.
When asked if the IC Committee or ICP reviewed the training material provided to the EVS staff, the Director stated he did not think so and verified the ICP was not aware of specific training for the use of QC Peroxide.

Review of the staff in-service provided for Oxivir Tb wipes on 6/8/17, showed the hospital would be transitioning to use this product on 6/8/17. The inservice outline showed to use Oxivir Tb wipes as a disinfectant wipe. Instructions for the use of Oxivir Tb wipes included pre-cleaning heavily soiled areas, wiping the non-porous environmental surfaces with the Oxivir Tb towel, and allowing it to dry for 10 minutes. The Oxivir Tb must remain visibly wet on the surface for 10 minutes to disinfect. If the product dried before the 10 minutes, it must be reapplied. However, review of the inservice outline did not specify for what types of environments or situations to use the Oxivir Tb wipes.

The Director of EVS stated the EVS staff was trained on how to use the Oxivir Tb wipes using the in-service training on isolation rooms; however, this training was presented on 4/4/17, which was prior to the 6/8/17 inservice of the Oxivir Tb disinfectant.

Review of the Training Sign-in Sheet dated 6/8/17, showed some staff members were on vacation or never signed to confirm the training was received. The Director of EVS stated it was on oversight on his part; training on the use of Oxivir Tb wipes should have been provided to the remaining staff who had not received it.

The Director of EVS was asked about the use of Blacklights to ensure the quality of the cleanliness of the areas cleaned by the EVS staff. The Director of EVS stated only the patient care areas were monitored with the Blacklights due to the large patient volume in these areas. The Blacklights were not used to validate the cleanliness of the ORs or procedural areas. The Director of EVS stated he reported the findings to the QAPI committee quarterly but had not received the recommendations from the committee to use the Blacklights in the ORs or procedural areas.

During an interview with ICP 1 on 8/17/17 at 1300 hours, she verified the Infection Control Program did not have oversight of the curriculum provided to the EVS staff for inservice training. ICP 1 stated the contracted EVS service provided their own curriculum, which did not need approval from the IC committee. ICP 1 also stated the EVS contracted service was responsible for the ordering of cleaning and disinfectant supplies needed for each department.

2. On 8/16/17, the Environmental Tours Schedule-2017 was provided for review. Review of the schedule showed the high risk areas such as the ORs, NICU, L&D, Cardiology, GI lab, and special procedures were scheduled twice a year, not more often than the regular patient care areas. The tools used for rounding and documentation of the findings of the rounds were requested.

Review of the Environmental Tour Checklist and Corrective Action Plan for ORs 3A, 3B, and 3C conducted on 6/8/17, showed the tools were generic and not developed for a specialty area. Environmental concerns were identified in the ORs including dusty and dirty equipment and tape residue on the surgical equipment. Findings documented in the "other" category included incomplete coverage of hair and facial hair and jewelry being worn by the OR staff. However, the boxes to show the "Corrective Action Plan" and "Completion Date" were blank. A random review of EOC rounds documentation for other units showed these boxes were blank as well.

Further review of the Environmental Tours Schedule-2017 showed the EOC rounds were scheduled on 1/26 and 7/24/17 for the second floor radiology/special procedure/CT areas and on 2/7 and 7/20/17 for the cardiology/GI areas.

During an interview and concurrent review of the hospital's documents with the Director, Accreditation & Licensing on 8/16/17 at 1040 hours, she verified the scheduled EOC rounds were not conducted on 7/24/17, for the second floor radiology/special procedure/CT areas including the IR area, and on 7/20/17, for the Cardiology (or the Cath lab area) and GI areas as scheduled. The Director was asked to provide documentation to show the EOC rounds were conducted on 1/26 and 2/7/17 for the above areas.

During a follow-up interview with the Director, Accreditation & Licensing on 8/17/17 at 1115 hours, she stated she was unable to find documentation showing the scheduled EOC rounds were conducted on 1/26 and 2/17/17.

On 8/16/17 at 1020 hours, any additional documentation to show the follow up from the EOC rounds was requested for review.

On 8/16/17 at 1020 hours, an interview with ICP 1 was conducted concerning the EOC rounds. ICP 1 stated the corrective action plans should be completed by the supervisor of the unit which was rounded. However, she stated the corrective action plans were rarely filled out as the usual mode of communication was verbal and through email between the unit staff and IC. ICP 1 stated the follow-up tool was lacking and acknowledged the tool should be utilized to ensure the proper tracking and trending on a hospital-wide level.

ICP 1 stated the Environmental Tours Schedule listed the units to be toured with a multidisciplinary team with the goal being that all units would be toured twice a year regardless of whether the department was considered a high or low risk environment. ICP 1 stated their goal was to conduct all EOC rounds as scheduled; however, they were not able to achieve that goal due to staff shortage.

On 8/16/17 at 1100 hours, the Director, Accreditation & Licensing stated all documentation of the rounds and follow up done for 2017 were already provided to the survey team. The Director confirmed out of 42 scheduled rounds from January 2017 to this date, 26 EOC rounds were not done.

On 8/17/17 at 1407 hours, during an interview, the DHS Appointed Representative for the GB stated she was not aware of the multidisciplinary EOC roundings not being conducted per the Environmental Tours Schedule as the email and verbal communications were not enough to ensure the mitigation of an environmental issue on a unit to unit basis. The DHS Appointed Representative stated the EOC rounds was a tool to track and trend hospital environmental concerns for appropriate oversight and accountability.

3. The AORN's Guidelines for Perioperative Practice, 2017, Guideline for Environmental Cleaning showed the education and competency verification should include topics related to the principles and processes of environmental cleaning. For perioperative areas, environmental services personnel must receive education and complete competency verification activities that address specialized knowledge and skills related to the principles and processes of environmental cleaning. Education and competency verification should include topics related to the principles and processes of environmental cleaning.

On 8/16/17 at 1515 hours, an interview and concurrent facility document review was conducted with the Director of EVS. The following was identified:

* The annual competency and evaluation was incomplete for EVS 4.

The tools used for direct supervision of EVS staff were not updated to reflect the cleaning solutions used during the cleaning and disinfecting the areas.

Cross reference to A084, example #3.

Based on observation, interview, and record review, the hospital failed to ensure the IC officers developed an effective system to implement P&Ps and professional standards and evaluate measures for identification, investigation, reporting, and preventing infections within the hospital as evidenced by:

1. Failure of the EVS staff cleaning the ORs between cases to follow AORN guidelines and the hospital's P&P for the cleaning process in the ORs and GI lab. In addition, EVS staff and direct supervising EVS staff did not receive accurate information and comprehensive training when new cleaning products were introduced into use resulting in the OR and GI lab floors not cleaned with a disinfectant cleaner and the wet time for the cleaning wipes used to clean surfaces was not followed.

2. Failure to ensure HLD was performed in a clean and sanitary area.

3. Failure of the GI staff to perform ATP testing, verify minimum recommended concentration (MRC), and store the disinfected endoscopes as per the hospital's P&P and AORN's guidelines. In addition, the GI staff failed to include the date and time of reprocessing, identifier of the scope reprocessor, the results of process efficacy testing and identify of the person performing the reprocessing when tracking and reviewing for the use of scope.

4. Failure of the GI staff to show documented evidence of daily and weekly maintenance of the scope reprocessors as per the manufacturer's instructions for use.

5. Failure to maintain the procedural areas in a clean and sanitary manner. In addition, multiple pieces of equipment in these procedural areas were rusty.

6. Failure to monitor for temperature and humidity levels in the GI and IR procedural areas as per the AORN's guidelines.

7. Failure to ensure the cooked beans were effectively monitored for safe cooling when stored in the walk-in refrigerator and freezer in the dietary department before serving the patients, which had the potential to result in food borne illnesses and serious complications such as nausea, vomiting, diarrhea, dehydration, and even death in patients who consumed the beans.

8. Failure to ensure one MD prepared the medications for the next surgical procedure in an unsanitary environment and stored the syringe in the pocket of her scrubs.

9. Failure to ensure two RNs and one anesthesiologist disinfected the rubber stopper of a medication vial prior to withdrawing the medication.

10. Failure to ensure the area used to prepare breast milk and formula in the NICU was in a separate designated area out of the patient care area as specified in per the ADA's guidelines.

11. Failure to ensure five RNs and one EVS staff interviewed were knowledgeable of the contact time for disinfecting patient care equipment and care areas.

12. Failure to ensure three MDs, one RN, and one EVS staff performed hand hygiene as per the hospital's P&P.

13. Failure to ensure the staff and visitors followed the hospital's P&P for wearing PPE in isolation rooms.

14. Failure to ensure trash from a previous surgery was cleaned off the OR floor during an ongoing procedure.

15. Failure to ensure the accurate temperature of the nursing station nourishment room refrigerators was monitored when the refrigerator logs consistently did not reflect actual temperatures of the refrigerators.

16. Failure to ensure there was IC consultation prior to the room construction in the Oncology Unit.

17. Failure to ensure a torn seizure pad was not in use for one of 33 sampled patients (Patient 5).

18. Failure to ensure the cardboard boxes were not stored in the radiology storage room next to sterile supplies and non-sterile supplies.

19. Failure to ensure the medication room and clean utility room in the inpatient psychiatric unit were maintained in a clean and sanitary manner.

20. Failure to ensure the shower room flooring in the Psychiatric Emergency Room was not in poor condition, making it difficult to ensure disinfection between patients.

21. Failure to ensure three reusable LMAs were discarded after the warranty limit as per the manufacturer's instructions.

These failures had the potential for spread of infections and negative impacts to the patients' health conditions.

Findings:

1. According to the AORN's Guidelines for Perioperative Practice, 2017 edition, Guidelines for Environmental Cleaning, the patient should be provided with a clean, safe environment. Damp dusting of the OR should be completed before case carts, supplies, and equipment are brought into the room. Damp dusting should be performed methodically, from top to bottom. All floors in the perioperative and sterile processing areas should be disinfected. The floor should be wet with the disinfectant for the dwell time indicated on the manufacturer's instructions for use. Cleaning should progress from the cleanest to dirtiest areas of the floor. Floor surfaces at the perimeter of the room should be disinfected before floor surfaces in the center of the room. The center of the room, where the majority of patient care occurs, is most likely to have higher levels of contamination. The entire floor surface should be disinfected, including areas under the OR bed and mobile equipment.

Review of the hospital's P&P titled Surgical/Invasive Area and Delivery Rooms-Between Cases dated 1/1/13, showed a safe and clean environment should be reestablished after each surgical procedure.

Further review showed the following:

- Prepare germicidal solution as directed.

- Use a solution dampened cloth and damp dust of the light, table, mattress covers, all receptacles, work surfaces and tables.

- Clean all equipment and store in an orderly fashion.

- Return all furniture to its proper location.

- Use a mop dampened with germicidal solution to gather all debris from the floor.

- Wet mop the entire floor around the OR table and adjacent work areas using germicidal solution. Start with the area around and under the operating or delivery table.

"Guidelines" showed to use an EPA-registered germicide.

a. During a tour of the Surgical Services areas in the main OR on 8/14/17 at 1458 hours, accompanied by the Supervising Staff Nurse Surgical Services, OR 1 was observed for cleaning between cases. Three EVS staff was in the room. The following was identified:

* EVS 9 was observed cleaning and disinfecting the back table and trash bag holder, then wiping the Level 1 pump (an IV solution warming pump) located at the lower part of the IV pole (the direst part) and moving up to wipe the top of the IV pole (the cleanest part).

* EVS 8 was observed mopping the floor with a wet mop from one end to the other end of the room, not from the outside to inside of the room. EVS 8 was observed using the Oxivir Tb wipes to clean surfaces and equipment. However, the surfaces appeared to be wet for approximately five minutes. Two other EVS staff, RN 26, and the OR educator were in the room.

When interviewed, the EVS staff stated Oxivir wipes were used to clean surfaces and equipment and QC Peroxide solution was used to clean the floors.

b. The L&D unit was toured on 8/14/17 at 1300 hours, with Supervising Staff Nurse 6. EVS 1 and EVS 2 were just started the cleaning process for OR 8. EVS 1 was observed wiping down the surfaces of the OR table pads and equipment with the Oxyvir Tb wipes. EVS 2 was observed wet mopping the floor at the back corner of the OR. The surfaces of the OR table mattress pads and equipment were visibly wet for approximately four minutes. EVS 1 was also observed walking over the wet areas where EVS 2 was wet mopping several times in order to finish disinfecting the equipment and placing the new plastic bags in the trash and linen hampers.

When asked about the solution used to clean the OR floor, the EVS staff provided the QC Peroxide cleaner bottle. When asked if the floor needed to stay wet for a certain length of time to be disinfected, EVS 1 stated 10 minutes, then stated maybe 5 minutes. When asked if the surfaces wiped with the Oxyvir Tb wipes needed to stay wet for a certain length of time, EVS 1 provided the wipe container which showed one minute contact time. Both of them agreed the floor was walked on immediately after mopping.

c. On 8/14/17 at 1505 hours, the GI procedure room was observed for cleaning between cases, accompanied by the Supervising Staff Nurse II for Procedural Nursing and RN 2. The following was identified:

* EVS 3 was observed mopping the floor with a wet mop starting from the entrance toward the GI tower located at the center of the room, then from the other side of the room back to the center and toward to the entrance. Then EVS 3 was observed using another wet mop to mop the floor again, starting from the side of the room toward the center of the room and from the other side of the room towards the entrance. EVS 3 did not mop and disinfect the perimeter of the room before mopping the center of the room as per the AORN's guidelines.

* EVS 3 was also observed using a wipe to disinfect the OR cart starting from the bottom to the top (from the dirtiest to cleanest area).

* EVS 3 was observed cleaning the surface of the GI tower during the cleaning between cases.
However, EVS 3 did not clean the computer screen and key board on the GI tower.

At 1515 hours, RN 3 brought the disinfected endoscope into the room and prepared the endoscope at the GI tower for the next procedure.

At 1520 hours, the Supervising Staff Nurse II for Procedural Nursing was informed the computer screen and key board were not disinfected by EVS 3 after the last case.

During an interview with EVS 12 on 8/16/17 at 0910 hours, the EVS stated Oxivir Tb wipe was used for all surfaces including the floor when she performed cleaning of the procedural room.

When asked, she stated the surfaces must remain wet for 10 minutes.

Review of the manufacturer's guidelines for QC Peroxide cleaner provided on 8/15/17, showed the cleaner was a glass and multi surface cleaner, "not registered to sanitize or disinfect."

Review of the manufacturer's instructions for use of the Oxivir Tb and Oxivir Tb Wipes showed all surfaces must remain wet for one minute to kill bacteria, five minutes to kill TB, and 10 minutes to kill fungi.

The Medical Director Infection Control was interviewed on 8/15/17 at 1340 hours. The Medical Director was asked about the cleaning product to be used on the OR and procedure room floors. The Medical Director stated Oxyvir Tb wipes. When informed the EVS staff used the QC Peroxide solution to wet mop the OR floor, the Medical Director stated that product was not appropriate as it was not a disinfectant.
On 8/15/17 at 1445 hours, an interview was conducted with the Director of EVS. The Director stated EVS worked with the IC committee regarding all cleaning products used in the hospital. When asked how the EVS staff was supervised, he stated the EVS supervisors made direct observations of the EVS staff utilizing checklists with targeted areas of focus for cleaning and sanitizing the patient care areas.

These direct observations were conducted on all EVS staff at least once per month and collated in the unit for validation of yearly competencies.
When asked, the Director of EVS stated he was not aware of the QC Peroxide cleaner being used for cleaning of the OR floors and it was intended for use in the regular patient care areas only.

The Director of EVS stated Oxivir wipes should be used on the OR floors as well as surfaces. The Director of EVS also stated the IC committee decided on the contact time of 10 minutes for the surfaces to stay wet with the Oxivir Tb as that was the time it took to kill fungus.

On 8/16/17 at 1115 hours, an interview was conducted with the EVS Supervisor to discuss the use of QC Peroxide in the ORs. The EVS Supervisor stated when the new product was introduced in June 2017, she received the instructions from her managers that the QC Peroxide floor cleaner was a disinfectant product. The EVS Supervisor stated she understood the QC Peroxide floor cleaner was to be used in the ORs, especially if the floor had a heavy spillage of blood products. Otherwise, the EVS staff could use the Oxivir Tb wipes.

The EVS Supervisor was interviewed on 8/16/17 at 1115 hours. The EVS Supervisor stated two supervisors worked each shift and directly supervised the EVS staff. When asked about the use of QC Peroxide on the OR and procedure room floors, the EVS Supervisor stated when the new product was introduced in June 2017, she received the instructions from her managers that the QC Peroxide floor cleaner was a disinfectant product. The EVS Supervisor stated she understood the QC Peroxide floor cleaner was to be used in the ORs, especially if the floor had a heavy spillage of blood products. Otherwise, the EVS staff could use the Oxivir Tb wipes.

When asked how the EVS staff was supervised for quality, the EVS Supervisor stated she validated the EVS staff on the thoroughness of cleaning by using a direct observation checklist tool at a minimum of once a month. The EVS Supervisor stated the checklists were for the occupied patient rooms, terminals, and between case cleaning in the ORs.

d. Review of the staff inservice provided for Oxivir Tb on 6/8/17, showed the hospital would be transitioning to use this product on 6/8/17. The inservice outline showed Oxivir Tb wipes were to be used as a disinfectant wipe. Instructions for use included pre-cleaning the heavily soiled areas, wiping the non-porous environmental surfaces with the Oxyvir Tb towel, and allowing it to dry for 10 minutes. The Oxivir Tb must remain visibly wet on the surface for ten minutes to disinfect. If the product dries before the 10 minutes, it must be reapplied. However, review of the inservice outline did not specify for what types of environments or situations to use the Oxivir Tb wipes.

During the follow-up interview and concurrent facility document review with the Director of EVS on 8/17/17 at 1116 hours, he stated the QC Peroxide floor cleaner was the new product used in the hospital beginning 6/8/17; however, the EVS staff did not receive additional training on the proper use of the QC Peroxide floor cleaner since it was similar to the product that the hospital had used previously. The Director of EVS verified the inservices provided to the EVS staff did not include where (floors or surfaces) to use the products. When asked if the IC committee or ICP reviewed the training material provided to the EVS staff, the Director of EVS stated he did not think so and verified the ICP was not aware of specific training for the use of QC Peroxide.

The Director of EVS stated the EVS staff was trained on how to use Oxivir Tb wipes during the inservice training on isolation rooms; however, this training was presented on 4/4/17, which was prior to the 6/8/17 inservice of the Oxivir Tb disinfectant.

Review of the Training Sign-in Sheet dated 6/8/17, showed some staff members were on vacation or never signed to confirm the training was received. The Director of EVS stated it was on oversight on his part; training on the use of Oxivir Tb should have been provided to the remaining staff who had not received it.

On 8/18/17 at 0830 hours, the Supervising Staff Nurse II for Procedural Nursing was informed and acknowledged the EVS staff did not use an Oxivir wipe to mop the floor when cleaning the GI area between cases on 8/14/15 at 1505 hours.

2. On 8/16/17 at 1232 hours, the Central Services area was toured with the Lead Tech. The HLD of two equipment was observed in the decontamination room. During a concurrent interview, the Lead Tech stated in this area, Central Services staff cleaned and disinfected the TEE scopes, cystoscopes, and any other patient care devices used hospital-wide that required HLD.

On 8/16/17 at 1330 hours, during an interview with the ICP, she stated the IC department was aware of the HLD being performed in the decontamination area. The ICP acknowledged this was not an acceptable design due to cross contamination of dirty and clean equipment.

3. Review of the hospital's P&P titled Endoscopy Lab Infection Control dated 1/5/16, showed the five main steps in reprocessing endoscopes are pre-cleaning, leak testing, mechanical cleaning, AER high level disinfection, and storage. Further review of the P&P showed the following:

- ATP testing is to be performed immediately after manual cleaning and prior to disinfection. ATP testing will be performed on all duodenoscopes (ERCP) and linear Endoscopic Ultrasound (EUS) scopes after every procedure. The test swab will be used to test to the suction/instrument channel, above and below the elevator. Scopes that tested positive for ATP, will undergo manual cleaning again. Scopes that fail ATP testing three times will be removed from service and guidance from infection control and the manufacturer will be sought.

- Verify minimum recommended concentration and temperature of solution with Acecide Test Strips prior to each reprocessing.

Ensure that the scope is completely dry before storage; hang the scopes upright in a
well-ventilated cabinet to dry. The distal end should hang freely.

The AORN's Guidelines for Perioperative Practice, 2017 edition, Guideline for Processing Flexible Endoscopes, showed the following:

- Flexible endoscopes that have been mechanically processed should be stored in a cabinet that is either designed or intended by the cabinet manufacturer for horizontal storage of flexible endoscopes or in a cabinet that is sufficient height, width, and depth to allow flexible endoscopes to hang vertically, without coiling and without touching the bottom of the cabinet.

- The hospital should maintain records of flexible endoscope processing and procedures. Records related to flexible endoscope processing should include the date and time; identity of the endoscope and endoscope accessories; method and verification of cleaning and results of cleaning verification testing; number or identifier of the mechanical processor or sterilizer and results of process efficacy testing; and identity of the person(s) performing the processing.

a. Review of the Scope Use History, the reprocessing cycles for AERs A and B, and the ATP Monitoring Log Sheet from 6/1 to 6/18/17, showed the following:

* On 6/2/17, Scopes 2 and 4 were used and reprocessed. However, the ATP Monitoring Log failed to show the ATP testings were performed on both scopes as per the hospital's P&P.

On 6/16/17, Scopes 2, 3, and 4 were used and reprocessed. However, the ATP Monitoring Log failed to show the ATP testings were performed on these scopes as per the hospital's P&P.

During an interview and concurrent review of the hospital's documents with the Supervising Staff Nurse II for Procedural Nursing and RN 17 on 8/17/17 at 1048 hours, RN 17 stated there should be two ATP tests performed on each scope. RN 17 stated the ATP monitoring machine showed seven ATP tests were performed on 6/2/17, and eight ATP tests were performed on 6/16/17.

When asked, RN 17 was unable to provide documented evidence to show which scopes were tested on 6/2 and 6/16/17.

b. Review of the reprocessing cycles for AERs A and B, and the Acecide-C MRC Testing Record dated from 6/1 to 6/16/17 and 8/7 to 8/14/17, showed the Acecide-C MRC testing was not done for each reprocessing as per the hospital's P&P. For example:

* On 6/2/17, 11 loads of the scopes were reprocessed. However, only eight Acecide-C MRC tests were performed for these reprocessed scopes.

* On 6/7/17, 10 loads of the scopes were reprocessed. However, only nine Acecide-C MRC tests were performed for these reprocessed scopes.

* On 6/8/17, 10 loads of the scopes were reprocessed. However, only seven Acecide-C MRC tests were performed for these reprocessed scopes.

On 8/8/17, nine loads of the scopes were reprocessed. However, only six Acecide-C MRC tests were performed for these reprocessed scopes.

* On 8/11/17, 10 loads of the scopes were reprocessed. However, only seven Acecide-C MRC tests were performed for these reprocessed scopes.

* On 8/14/17, 10 loads of the scopes were reprocessed. However, only seven Acecide-C MRC tests were performed for these reprocessed scopes.

During an interview with LVN 1 on 8/15/17 at 0845 hours, LVN 1 stated she performed the Acecide-C MRC testing for each load.

During an interview and concurrent review of the hospital's documents with the Supervising Staff Nurse II for Procedural Nursing on 8/17/17 at 0830 hours, she confirmed the Acecide-C MRC testing was not done for each load as per the hospital's P&P.

c. A tour of the scope storage area was conducted on 8/14/17 at 1440 hours, accompanied by the Supervising Staff Nurse II for Procedural Nursing, COO, RN 2, and LVN 1. Seven disinfected scopes were observed not being hung freely and vertically as per the hospital's P&P and the AORN's guidelines. LVN 1 confirmed the observation.

During an observation, interview, and concurrent review of the hospital's documents with the Supervising Staff Nurse II for Procedural Nursing, RNs 16, 17, and LVN 1 on 8/15/17 at 0845 hours, LVN 1 stated there were two scope reprocessors used for reprocessing the used scopes.

Review of the print-out from the scope reprocessor showed the information from the print-out, including date and time of reprocessing the scope, scope serial number, scope reprocessor serial number, user ID, and wash and disinfection time and temperature.

However, when asked about tracking or tracing for the use of scopes, LVN 1 stated she did not save the print-outs from the scope reprocessor. RN 17 stated she was able to print from the scope reprocessor as needed.

During a follow-up interview and concurrent review of the hospital's document with the Supervising Staff Nurse II for Procedural Nursing, RNs 4 and 16 on 8/15/17 at 1455 hours, RN 4 stated she tracked the use of scopes monthly.
When asked, RN 4 provided the Scope Use History as the tracking record.

Review of the Scope Use History showed the scope model name, scope serial number, examination date, and the patient's name. However, the Scope Use History did not show the date and time of reprocessing, identifier of the scope reprocessor, results of the process efficacy testing, and identification of the person who performed the reprocessing.

When asked, RN 4 stated the print-outs from the scope reprocessor were not kept or reviewed for tracking for the use of scopes.

4. According to the AORN's Guidelines for Perioperative Practice, 2017 edition, Guideline for Processing Flexible Endoscopes, the schedule for preventive maintenance should align with the manufacturer's instruction for use.

Review of the manufacturer's instructions for the use of endoscope reprocessor showed daily maintenance includes cleaning of the mesh filters and fluid level sensor and the weekly maintenance includes cleaning of the alcohol tank.

An interview was conducted with LVN 1 on 8/15/17 at 0845 hours. LVN 1 stated there were two scope reprocessors used for reprocessing the used scopes. When asked about maintenance of the scope processors, LVN 1 stated she changed the air filter and gas filter monthly. LVN 1 did not verbalize the daily cleaning of the mesh filters and fluid level sensor, and weekly cleaning of the alcohol tank. When asked, the LVN was unable to provide documented evidence the scope reprocessors were maintained daily and weekly as per the manufacturer's instructions.

5a. During a tour of the hospital's GI and OPSA area on 8/14/17 beginning at 1305 hours, accompanied by the Supervising Staff Nurse II for Procedural Nursing, COO, RNs 2, 3, and 4 showed the following:

* In the GI area:

- The GI portable cart had an approximately a quarter size of rust on it.

Dust and black substance were noted at the edge and bottom of three scope storage cabinets. * In the OPSA area:

- The paint on a gurney was peeled off.

- Dust was noted on the shelves used to store the normal saline solutions in the Clean Utility Room.

- Dust, black substance, and hair were noted at the corner of the medication room.

- The door of the Clean Utility room was chipped exposing the wood in multiple areas.

- The paint on the wall next to the door of the Clean Utility Room was peeled off.

RN 3 confirmed the above observation and acknowledged the difficulty of cleaning an exposed surface.

b. A tour of the hospital's IR procedure room was conducted on 8/15/17 at 1325 hours, accompanied by the RN Supervisor for Procedures, Supervisor Radiology Tech, RNs 16, 18, and 19. RN 19 stated the EVS staff had cleaned this room and the room was ready to use for another procedure. However, the following was observed:

* The seam of the procedure mattress was worn out and not intact in multiple areas.

* The table shield of the procedure table was worn out and not intact. The base of the procedure table was rusty.

There was approximately four inches gap between the floor and wall where debris could accumulate.

* The power injector had an area of peeled off paint approximately the size of quarter and was rusty.

* Two drawers used to store supplies were chipped exposing the wood areas.

* A piece of paper was found on the floor.

* A drawer used to store clean supplies was dusty.

* Dust was noted at the edge of the floor and wall near the exit door.

The Supervising Staff Nurse II for Procedural Nursing, Supervisor Radiology Tech, and RN 19 confirmed the above observation.

c. During a tour of the hospital's Cardiac Cath lab area on 8/16/17 at 0925 and 1120 hours, accompanied by the Supervising Staff Nurse II for Procedural Nursing, RNs 16 and 20, showed the following:

* In the TEE room:

- The drawers of the sterile storage cabinet were dusty.

- A bin used to store the sterile supplies was dusty.

* In the Cardiac Cath lab procedure room:

- The surface of the leather stool was worn and not intact in multiple areas.

- The table shield had two holes.

- The metal frames of two radiation protection screens were rusty in multiple areas.

- The edge of the wall dividing the procedure and control areas was cracked.

- The procedure table was rusty in multiple areas.

- A vent grill was dusty.

- Dust and black substance build up were noted under the procedure table. When asked the staff was able to clean the dust and removed the black substance.

- The edge of the scrub sink was rusty.

The Supervising Staff Nurse II for Procedural Nursing, RNs 16 and 20 confirmed the observation.

6. According to the AORN's Guidelines for Perioperative Practice, 2017 edition, Guideline for a Safe Environment of Care, Part 2, restricted areas include the operating and other rooms in which operative or other invasive procedures are performed. The restricted areas are intended to be the cleanest; therefore, the HVAC requirements for the restricted areas are the most stringent. The HVAC system reduces the amount of environmental contamination by carrying airborne contaminates away from the sterile field and removing these contaminants through the return duct vents located at the periphery of the room. The temperature should be less than 75 degrees F for the sterile storage area, between 70 to 75 degrees F for the procedure room, and between 68 to 73 degrees F for the endoscopy procedure rooms and clean workroom. The humidity level should be less than 60% for the sterile storage area and clean workroom, and should be maintained between 20% to 60% for the procedure rooms and endoscopy procedure room.

Observation of the hospital's GI and IR procedural areas on 8/14 and 8/15/17, showed the temperatures and humidity levels were not monitored in these areas. Cross reference to A0726, examples #1 and #2.

7. According to the 2013 Food and Drug Administration Food Code, cooked time/temperature control for safety food (food that can cause food borne illness when not properly handled or stored) shall be cooled within 2 hours from 135 to 70 degrees F and within a total of 6 hours from 135 to 41 degrees F or less. Excessive time for cooling of time/temperature control for safety foods has been consistently identified as one of the leading contributing factors to foodborne illness. During slow cooling, time/temperature control for safety foods are subject to the growth of a variety of pathogenic microorganisms (disease causing organism). If the food is not cooled in accordance with this Code requirement, pathogens may grow to sufficient numbers to cause foodborne illness .

Additionally, the food code showed the initial 2-hour cool is a critical element of this cooling process. For example, if cooling from 135 to 41 degrees F or 45 degrees F is achieved in 6 hours, but the initial cooling to 70 degrees F took 3 hours, the food safety hazards may not be adequately controlled.

a. During a tour of the kitchen, in the meat walk-in refrigerator, on 8/14/17 at 1120, a two inch steamtable pan of cooked beans was noted on the shelf dated 8/14/17. During a concurrent interview with FSW 1, she stated the cooked beans was made on Saturday, 8/12/17. Upon further questioning, FSW 1 stated the cooked beans was not labeled with a date when she noticed it in the walk-in refrigerator so she labeled it with the current date. She stated the beans were usually cooked on Saturdays, so she thought these beans had been cooked on 8/12/17 (Saturday). She did not know for sure when the beans were cooked.

During a follow-up interview with the DFANS on 8/14/17 at 1250, he stated the beans had been cooked on 8/11/17. He stated he knew because there were additional pans of beans in the freezer dated 8/11/17. He stated the beans were served in the cafeteria and used for patient food services.

During a concurrent observation in the freezer, six of two inch steamtable pans of cooked beans were noted with the preparation (cooked) date of 8/11/17.

A review of the hospital's "Cooling Log" showed no documented evidence of the cooked beans on 8/11/17. During an interview with the DFANS on 8/14/17 at 1255 hours, he stated the log should have included the cooked beans, but it did not.
He verified there was no documented evidence the pans of beans cooked on 8/11/17, were cooled safely.

Further review of the hospital's "Cooling Log" dated 7/26 and 7/28/17, showed the beans were cooked and cooled on these days. The log showed the following:

* On 7/26/17, the log showed the beans were 190 degrees F at 1230 hours and 80 degrees F at 1430 hours. The beans did not reach 70 degrees F at the two hour temperature check.

* On 7/28/17, the log showed the beans were 192 degrees F at 1300 hours and 83 degrees F at 1500 hours. The beans did not reach 70 degrees F at the two hour temperature check on 7/28/17.

These two entries were initialed by FSW 2.

During an interview with the DFNS on 8/17/17 at 1430, he stated the Cooling Logs were supposed to be reviewed by the supervisors to ensure they were accurately completed. He could not explain why there was no corrective action documented for the improper cooling of the cooked beans on 7/26 and 7/18/17. He stated the two hour temperature for the cooked beans should have been at 70 degrees F or less.

During an interview with FSW 2 on 8/18/17 at 0830, she verified she documented the temperature of the cooked beans on the Cooling Logs. She stated she should have either informed the supervisor that the beans did not reach the safe temperature in two hours or she should have thrown the beans away. She stated that she was too busy and did not notice that they had not reached the safe temperature.

8. According to the AORN's Guidelines for Perioperative Practice, 2017, showed the following:

VIII.e.4. Medications should not be pre-drawn up and stored on the anesthesia cart or elsewhere unless the pre-filled syringes are supplied by the manufacturer or pharmacy.

VIII.e.5. Perioperative team members should not prepare medication products in advance and then store them in clothing or pockets. Preparing medications in advance and storing medications in clothing or pockets increases the risk for contamination and errors.

The L&D unit was toured on 8/14/17 at 1300 hours, with Supervising Staff Nurse 7. The EVS staff was in the process of cleaning of OR 8.

Supervising Staff Nurse 7 sated this OR was used for eye surgeries. While EVS 1 was observed wiping the OR table and EVS 2 was observed dry mopping the floor, MD 1 was observed in the corner of the OR near the computer work station drawing the medications into a syringe. MD 1 then placed the syringe in her pocket and started to exit the room. When asked, MD 1 stated she prepared the medications for the next scheduled patient. MD 1 stated the medications were lidocaine (local a

Based on observation, interview, and record review, the hospital failed to ensure surgical services were well organized and provided in accordance with the hospital's P&Ps and acceptable standards of practice to ensure the health and safety of the patients as evidenced by:

Failure to provide a safe and effective environment and maintain high standards of care for the patients receiving surgical services. Cross reference to A951.

Failure to ensure the anesthesia services were provided in a safe manner. Cross reference to A1002.

The cumulative effect of these systemic practices resulted in the hospital's inability to provide safe and effective surgical services to the patients.

Based on observation, interview, and record review, the hospital failed to provide a safe and effective environment and maintain high standards of care for patients receiving surgical services as evidenced by:

1. Failure to ensure the EVS staff cleaned the ORs between cases as per the AORN's guidelines and hospital's P&P.

2. Failure to ensure the HLD was performed in a clean and sanitary area.

3. Failure to ensure the OR table in OR 1 was functioned during a surgical procedure.

4. Failure to ensure two physicians maintained the sterility of the sterile gowns when changing position during the procedure as per the AORN's guidelines.

5. Failure to ensure the IUSS log was complete.

6. Failure to ensure one MD prepared medications for the next surgical procedure in the sanitary environment and properly stored the prepared medication syringes.

7. Failure to ensure two RNs and one anesthesiologist disinfected the rubber stopper of the medication vials prior to withdrawing the medication.

8. Failure to ensure three MDs performed hand hygiene per the hospital's P&P.

9. Failure to ensure the mock emergency code drills were conducted annually as required per the hospital's P&P and emergency supplies were available in the crash carts as per the hospital's content lists.

10. Failure to ensure the Main OR, PACU, SDSU and L&D OR 8 were free of accumulation of dust and well maintained.

11. Failure to ensure the medication refrigerators in the SDSU, Main OR, and PACU including the MH medication refrigerator were cleaned and maintained.

12. Failure to ensure the EVS terminal cleaning log was properly complete and evaluated by the EVS supervisor.

13. Failure to ensure Patient 10's Operative Report included Medical Student 1 who was assisting with the procedure as the surgical team member.

14. Failure to ensure OR 8 was thoroughly cleaned from the previous surgery.

15. Failure to ensure four eye medications found in the SDSU medication room were properly labeled with the expiration date.

16. Failures to ensure two sterile water bottles in the warmer were labeled with the stored date in the substerile room between ORs 1 and 2.

17. Failure to ensure one solution container found in the unlocked EVS closet in the PACU was properly labeled.

Findings:

1. According to the AORN's Guidelines for Perioperative Practice, 2017 edition, Guidelines for Environmental Cleaning, the patient should be provided with a clean, safe environment. Damp dusting of the OR should be completed before case carts, supplies, and equipment are brought into the room. Damp dusting should be performed methodically, from top to bottom. All floors in the perioperative and sterile processing areas should be disinfected. The floor should be wet with the disinfectant for the dwell time indicated on the manufacturer's instructions for use. Cleaning should progress from the cleanest to dirtiest areas of the floor. Floor surfaces at the perimeter of the room should be disinfected before floor surfaces in the center of the room. The center of the room, where the majority of patient care occurs, is most likely to have higher levels of contamination. The entire floor surface should be disinfected, including areas under the OR bed and mobile equipment.

Review of the hospital's P&P titled Surgical/Invasive Area and Delivery
Rooms-Between Cases dated 1/1/13, showed a safe and clean environment should be reestablished after each surgical procedure.

During the OR cleaning observations in the Main OR and L&D OR 8 on 8/14/17, the EVS staff did not follow the hospital's P&P for the cleaning process. In addition, the EVS staff including the EVS supervising staff did not receive accurate information and comprehensive training when the new cleaning products were introduced into use resulting in the OR floors not being cleaned with a disinfectant cleaner. The wet time for the cleaning wipes used to clean surfaces was not followed the manufacturer's recommendations.
Cross reference to A749, example #1. (2156)

2. The hospital failed to ensure HLD was performed in a clean and sanitary area. Cross reference to A749, example #2. (2156)

3. According to the AORN's Guidelines for Perioperative Practice, 2017 edition, Guideline for Positioning the Patient, the perioperative RN should perform a preoperative assessment of factors related to the procedure that included positioning devices required. The perioperative team members should inspect and ensure the defective positioning equipment are repaired or replaced.

On 8/14/17 at 1320 hours, OR 1 was equipped for a surgical procedure. During the procedure, RN 37 raised the OR table per the surgeon's request. The OR table made a loud noise and did not rise to the position requested. Evaluation of the OR table by engineering showed the OR table hydraulic pump was out of order.

According to the AORN's Guidelines for Perioperative Practice, 2017 edition, Guideline for Sterile Technique, all personnel moving within or around a sterile field should do so in a manner that prevents contamination of the sterile field.

When changing position with each other, scrubbed team members should turn back to back or face to face while maintaining distance from each other, the sterile field, and unsterile areas.

A surgical procedure was observed in OR 1 on 8/14/17 at 1409 hours. Medical Student 1 and MD 4 donned sterile gowns. During changing of the position, they failed to turn back to back or face to face while maintaining distance from each other in front of the sterile field.

5. The hospital's P&P titled Immediate Use Sterilization dated 8/13 showed documentation should be maintained to allow for tractability of every load to the patient for whom the instruments were used.

On 8/14/17 at 0940 hours, four IUSS Daily Operating Room Sterilizer Logs for Sterilizer #1 were reviewed with the Supervising Staff Nurse II Surgical Services. All four logs were incomplete as follows:

* The log dated 7/14/17, showed the documentation of the time to complete the biological test to verify the sterilizer's competency and the result for the daily routine test of the Bowie Dick test (a test of the sterilizer's air removal system. Insufficient air removal can defeat sterilization and result in nonsterile supplies if undetected). However, the results were left blank.

The log dated 7/18/17, showed documentation the indication for the use of IUSS was "batteries." There was no additional information as to why the IUSS was used for the batteries instead of the regular sterilization load.

* The log dated 8/4/17, showed documentation the IUSS load was processed for "Not Enough Tryas." However, the section for specific OR room that required the IUSS instrument was left blank.

* The log dated 8/7/17, showed documentation the battery load was processed by IUSS. Documentation showed the indication for the IUSS load was left blank.

During a concurrent interview, the Supervising Staff Nurse II Surgical Services stated the OR staff were responsible for processing and documenting the IUSS log but did not complete the log.

6. MD 1 prepared the medications for the next surgical procedure in an unsanitary environment and stored the syringe in the pocket of her scrubs. Cross reference to A749, example #8.

7. Two RNs and one anesthesiologist did not disinfect the rubber stopper of the medication vials prior to withdrawing the medication. Cross reference to A749, example #9.

8. Three MDs failed to perform hand hygiene as per the hospital's P&P. Cross reference to A749, example #12.

9. The hospital's P&P titled Resuscitation Adult Medical Emergency (Code Blue), Pediatric Medical Emergency (Code White), Neonatal Resuscitation -NICU, Emergency Cart Location, Contents and Maintenance/Exchange dated 7/17 showed mock codes will be conducted, at a minimum, annually in all patient care areas to ensure competency. Department Managers/Supervisors are responsible for making sure the mock codes are completed.

a. On 8/15/17 at 1011 hours, during an interview with RN 14 and Supervising Staff Nurse II Surgical Services, the staff stated the annual Mock Code was not conducted on the unit for 2016 and 2017.

b. On 8/15/17 at 1011 hours, the SDSU adult and pediatric crash cart was inspected with RN 14. According to the RN, the crash carts came from Central Services with no content list. The licensed staff did not open the cart until needed . The content lists were obtained for both crash carts and reviewed with RN 14. The contents in the carts did not match the content lists as follows:

* The adult crash cart, drawer #1 was missing. One non-rebreather mask, three ETT connectors, one oropharyngeal airway size 2, two suction catheters, and one medium size oxygen mask were found but not listed on the contents list.

* In the bottom slide slot of the adult crash cart, one suction tubing was not found as listed on the contents list. Three packs of surgical gloves size
#8 were found but not listed on the contents list.

* In the bottom drawer of the pediatric crash cart, seven items were found but not listed on the contents list.

10. The Surgical Services area was observed on 8/14-8/16/17. The following was observed:

minimum, annually in all patient care areas to ensure competency. Department Managers/Supervisors are responsible for making sure the mock codes are completed.

c. On 8/15/17 at 1011 hours, during an interview with RN 14 and Supervising Staff Nurse II Surgical Services, the staff stated the annual Mock Code was not conducted on the unit for 2016 and 2017.

d. On 8/15/17 at 1011 hours, the SDSU adult and pediatric crash cart was inspected with RN 14. According to the RN, the crash carts came from Central Services with no content list. The licensed staff did not open the cart until needed. The content lists were obtained for both crash carts and reviewed with RN 14. The contents in the carts did not match the content lists as follows:

* The adult crash cart, drawer #1 was missing. One non-rebreather mask, three ETT connectors, one oropharyngeal airway size 2, two suction catheters, and one medium size oxygen mask were found but not listed on the contents list.


* In the bottom slide slot of the adult crash cart, one suction tubing was not found as listed on the contents list. Three packs of surgical gloves size
#8 were found but not listed on the contents list.

* In the bottom drawer of the pediatric crash cart, seven items were found but not listed on the contents list.

10. The Surgical Services area was observed on 8/14-8/16/17. The following was observed:

a. Observation of OR 1 showed rusty wheels on the wheeled working station cart, nursing cart, and stools. The baseboard metal seal was detached from the wall. There were multiple black stains around the OR table. Tape residue was observed on the bed frame of the OR table.

b. In ORs 1, 2, and 8, multiple black stains, marks, and cracks were observed on the floor.
According to the Surgical Services Supervisor, the ORs were cleaned by the EVS staff, and the OR staff did not provide a supervision or oversee the cleaning.

c. In OR 1 the surface finishing of the entrance door and the door to the substerile room was not intact. On the side of the door, multiple non-intact areas exposing the interior materials were observed. This had the potential of not having a thorough disinfection of due to the porous surface.

d. Dust was observed on the surface of the foot stepper in OR 2.

e. Inspection of the SDSU with RN 14 showed dust on the top surface of the adult crash cart.
In addition, inspection of the medication room showed the floor was dusty and a patient care basin with a heavy accumulates of dust was noted next to the medication cabinet.

In a concurrent interview with EVS 11, she stated she cleaned this area on a daily basis. However, she was not aware the basin stored in the room.

f. OR 8 was observed on 8/15/17 at 1143 hours, with Supervising Staff Nurse 5

* A hole approximately 6" X 2" in size was noted in the wall outside of the OR. Supervising Staff Nurse 5 was unable to state if repairs had been requested.

* A foot stepper was observed stored under the instrument table. The top cover of the stepper was missing leaving the interior metal part exposed to the air.

* Dust was noted on the wall mounted exhaust ventilation vent.

g. The PACU was toured on 8/16/17 at 0849 hours, with RN 14. The following was observed:

* Observation of the isolation room showed the paint was peeling off from the entrance door and surface of the cabinet in the room. In addition, the privacy blind on the window was broken. In a concurrent interview, RN 14 stated the work request was sent for replacement of the window blind. She was unable to say when the repair would occur.

* In the open space near the PACU Bay #11, five emergency patient transfer boards were stored upright on top of a stool. The transfer boards and stool had accumulation of heavy dust. In a concurrent interview with RN 14, the RN stated the transfer boards should be secured to prevent them falling on the patient in Bay #11 or staff during an earthquake.

* Observation of the sink inside the metal cabinet had heavy calcium deposits. When the water was turned on, the water spilled onto the syringe box next to the sink.

11. The medication refrigerators in the SDSU, Main OR, and PACU including the MH medication refrigerator were not cleaned and maintained. Cross reference to A724, example #3. (E2349)

12. According to the AORN's Guidelines for Perioperative Practice, 2017 edition, Guideline for Environmental Cleaning, the education and competency verification should include topics related to the principles and processes of environmental cleaning. For perioperative and environmental services personnel must receive education and complete competency verification activities that address specialized knowledge and skills related to the principles and processes of environmental cleaning. Education and competency verification should include topics related to the principles and processes of environmental cleaning.

The terminal cleaning logs for July 2017 were provided for review by the Director of EVS on 8/16/17 at 1415 hours. The logs showed ORs 1-6 and 8 were inspected daily. There were areas for the initials of the EVS staff that cleaned the room and the EVS supervisor who inspected the cleaning. However, the form showed for 10 of 20 days, the form was completed with the initials for EVS 13 and EVS Supervisor 2 in what appeared to be the same handwriting.

The Director of EVS confirmed the finding. The Director further stated the form is in English and he was not sure the non-English speaking EVS staff understood how to use the form. The Director of EVS stated he did not review the completed forms.

13. On 8/14/17 at 1348 hours, a surgical procedure was observed in OR1. The patient was positioned on supine during the procedure. The surgical team included a medical student who was assisting the procedure.

On 8/15/17, Patient 10's medical record review was conducted. The Main OR Intraoperative Record, dated 8/14/17, RN 7 documented the patient's body position was "Low Lithotomy." The document of surgical team did not include the name of the medical student.

On 8/15/17 at 1422 hours, the Supervising Staff Nurse II confirmed the findings.

14. OR 8 was not thoroughly cleaned from the previous surgery. Cross reference to A749, example #14.

15. Four opened eye drop medications found in the SDSU medication room were not labeled properly with the expiration date which was 28 days after it was opened. Cross reference to A505, example #1.

16. Two bottles of sterile water were kept in the warmer without the labels in the substerile room between ORs 1 and 2). Cross reference to A505, example #2.

17. According to the AORN's Guidelines for Perioperative Practice, 2017 edition, Guideline for Environmental Cleaning, if the cleaning chemical is removed from the original container, the secondary container should be labeled with the chemical name, concentration, and expiration date.

On 8/16/17 at 0849 hours, during a tour of the PACU, a plastic bucket filled with a green colored liquid was stored on the shelf in the unlocked EVS closet. The bucket was labeled "recovery." When interviewed, the EVS staff stated the solution was peroxide (a cleaning product).

However, there was no label of the cleaning solution name, concentration, and expiration date as per the AORN's guidelines.

Based on observation, interview, and record review, the hospital failed to ensure the physician conducted the heart and lungs assessments prior to the procedure for one of 33 sampled patients (Patient 9), creating the increased risk of poor health outcome for this patient.

Findings:

Review of the hospital's P&P titled Sedation Policy revised 6/11 showed the practitioner shall perform an appropriate patient assessment and documentation prior to the administration of moderate/deep sedation which must include an overall physical assessment of major organ systems including cardiac (heart) and pulmonary (lungs).

During an observation of Patient 9's procedure on 8/14/17 at 1530 hours, accompanied by the Supervising Staff Nursing II for Procedural Nursing and RN 2, Patient 9 was brought to the GI procedure room at 1530 hours. MD 8 was observed entering the GI procedure room and examining the patient's abdomen and throat. At 1540 hours, the procedure was started and the fentanyl (general anesthetic) and versed (benzodiazepine) medications were administered to the patient.

However, MD 8 did not perform the heart and lung assessments prior to the administration of the medications to the patient as per the hospital's P&P.

On 8/17/17 at 0830 hours, the Supervising Staff Nursing II for Procedural Nursing was informed and acknowledged the finding.

Based on observation, interview, and record review, the hospital failed to ensure the anesthesia services were provided in a safe manner as evidenced by:

1. The reusable LMAs were used beyond the manufacturer's one year warranty limit.

2. MD Anesthesiologist 7 did not disinfect the rubber stopper of the medication vials prior to withdrawing medication with a syringe during surgical procedures as per the APIC's guidelines.

3. MD Anesthesiologist 5 did not perform hand hygiene after removing gloves during the procedure as per the hospital's P&P.

These failures had the potential for spread of infections in the hospital.

Findings:

1. Review of the manufacturer's warranty for LMAs showed the LMAs are reusable and warranted against the manufacturer's defects for one year from the date of purchase.

On 8/15/17 at 1355 hours, the Anesthesia work room was toured with the Supervising Staff Nurse Surgical Services and Chief of Anesthesia.
Multiple reusable LMAs were observed being stored in this room. According to Anesthesia Tech 1, the hospital kept a tracking sheet for each individual LMA resterilization.

Review of the tracking documents for LMAs #4 (size) showed three LMAs #4 were used since 2012. The Chief of Anesthesia stated he was not aware of the manufacturer's warranty for only one year and the hospital should remove those LMAs from the patient care areas.

2. Review of the APIC Position Paper titled Safe Injection, Infusion, and Medication Vial Practices in Health Care (2016) showed aseptic techniques include disinfecting the rubber stopper of the medication vials with sterile 70% alcohol before inserting a needle.

On 8/15/17 at 1148 hours, during an observation of the general anesthesia induction, MD Anesthesiologist 7 did not disinfect the rubber stopper of the medication vials prior to withdrawing medication with a syringe as per the APIC's guidelines.

3. Review of the hospital's P&P titled Hand Hygiene in Healthcare Setting dated 10/6/16, showed hand hygiene should be performed before and after removing the gloves. Gloves must be changed between each patient contact and care procedure (one task, one pair of gloves).

On 8/14/17 at 1403 hours, the surgical procedure was observed in OR 1. MD Anesthesiologist 5 was observed donning and removing the gloves twice without performing hand hygiene.