The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

GRAYS HARBOR COMMUNITY HOSPITAL 915 ANDERSON DRIVE ABERDEEN, WA 98520 Aug. 10, 2017
VIOLATION: GOVERNING BODY Tag No: A0043
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Based on observations, interviews, and document reviews, the hospital failed to meet the requirements at 42 CFR 482.12 Conditon of Participation for Governing Body.

Failure to meet infection control and quality program requirements risks an unsafe healthcare environment for patients, visitors, and staff.

Findings:

Due to the scope and severity of condition-level deficiencies detailed under 42 CFR 482.21 Condtion of Participation for Quality Assessment and Performance Improvment and 42 CFR 482.42 Condition for Participation for Infection Control, the Condition of Participation for Governing Body was NOT MET.

Cross-Reference: Tags A0263; A0747
VIOLATION: QAPI Tag No: A0263
Based on observation, interivew, record review, and review of the quality plan, the facility failed to implement a quality program that effectively analyzed data, implmented action plans, and ensure that improvement measures were evaluated. The quality program also failed to effectively analyze data regarding medical errors and potentially adverse events and implement preventative measurements.

Failure to systematically collect and analyze hospital-wide performance data limited the hospital's ability to identify problems and formulate action plans. This reduced the likelihood of sustained improvements in clinical care and patient outcomes.

Findings included:

Condition-level non-compliance was present due to the following:

-Failure to analyze infecton control and negative health outcome data in order implement effective performance improvement measures.

-Failure to assess performance indicators that fell below hospital expectations and develop action plans that lead to sustainable improvement.

-Failure to collect and assess data regarding medical errors and potential adverse events and implement improvement measures.

Cross Reference Tags: A-0273, A-0283, A-286
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
ITEM #1 - INFECTION CONTROL DATA
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Based on interview and review of the hospital's quality program and performance data, the hospital failed to ensure that data regarding hospital infection rates were reported to the hospital's quality program.

Failure to systematically collect, analyze and assess data related to infection rates limits the hospital's ability to improve patient outcomes.

Findings included:

1. The hospital's quality plan titled, "Quality Assurance/Performance Improvement Plan 2017," showed that recommendations from the Pharmacy and Therapeutics/Infection Control Committee were to be presented to the Medical Executive Committee and reported to the Board Quality Committee.

2. On 08/09/17 from 3:00 PM to 4:30 PM, Surveyors #1 and #2 and Quality Director (Staff I), the Quality Consultant (Staff Z), the Quality Assistant (Staff AA) and the Sepsis Coordinator (Staff AB) reviewed the hospital's quality program. At this time, Surveyor #2 reviewed minutes for the Board Quality Committee for the previous 6 months. Surveyor #2 found no evidence the Infection Control Committee reported hospital acquired infection data, or data analysis to the Board Quality Committee. Surveyor #2 found no evidence that performance improvement activities were presented or evaluated by the Board Quality Committee.

3. At the time of the review, the Quality Director (Staff I) told Surveyor #2 that the Infection Control Committee reported to the Medical Executive Committee, not to the Board Quality Committee.

4. At this same time, Surveyor #2 reviewed the prior six months of the Medical Executive Committee minutes. Surveyor #2 found no evidence the Pharmacy and Therapeutic/Infection Control Committee presented hospital acquired infection data, data analysis or improvement plans to the Medical Executive Committee. Surveyor # 2 found no evidence that performance improvement activities were presented or evaluated by Medical Executive Committee meeting minutes.

5. At this same time, the Quality Director (Staff I) confirmed the findings above.
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ITEM #2 - NEGATIVE HEALTH OUTCOMES
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Based on interview and review of quality data, the facility failed to demonstrate that it aggregated and analyzed data related to patient negative health outcomes and incidents injurious to patients.

Failure to systematically collect, aggregate, assess, and implement action plans regarding negative health outcomes and incidents injurious to patient's limits the hospital's ability to improve patient outcomes.

Findings included:

1. On 08/10/17 at 1:00 PM, the hospital's Quality Director (Staff I) was asked to provide quality data pertaining to the collection, assessment, and performance improvement plans related to negative health outcomes and incidents injurious to patients occurring in the hospital over the past year.

2. During the interview, the Quality Director (Staff I) stated that the hospital had no serious reportable events as outlined in Chapter 246-302 WAC and that hospital's analysis and measurement of patient adverse events was not incorporated as part of the quality improvement program because they were a public hospital and subject to record disclosure.

3. Surveyor #2 reviewed individual Root Cause Analysis' (RCA) for three negative health outcomes/incidents injurious to patient events occurring on 05/31/16, 06/07/16, and 06/07/16. The review showed that 1 of 3 RCA's did not include an action plan to correct the deficiencies identified and 2 of 2 RCA's with action plans identified showed no evidence of follow-up monitoring to ensure interventions were effective.

a. The RCA's were presented as individual events. Surveyor #2 found no evidence the data had been analyzed in aggregate. Surveyor #2 found no evidence the aggregate data was reported or reviewed to the Board Quality Committee.
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
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Based on interview and review of the hospital's quality program and performance data, the hospital failed to develop, implement, track, and evaluate performance improvement action plans as directed by its quality improvement plan.

Failure to systematically develop, implement, track, and evaluate action plans limits the hospital's ability to improve patient outcomes.

Findings included:

1. The hospital's quality plan titled, "Quality Assurance/Performance Improvement Plan 2017," showed that actions taken to identify problem/indicators will be conducted by individuals involved with the problem. Monitoring will be initiated by the individuals making the initial investigation. Outcomes of initial evaluations and actions will be taken to the quality committees. Each step in the quality improvement process will be documented by the individuals conducting the assessment. Evaluation and monitoring will be continued to the satisfaction of members involved in the quality committee. A summary of quality improvement documentation will be forwarded to the Board of Quality with supporting data. The Quality Director has the responsibility to track quality improvement activities to ensure timely completion of reviews.

2. On 08/09/17 from 3:00 PM to 4:30 PM, Surveyors #1 and #2 reviewed the hospital's quality program and interviewed the Quality Director (Staff I), the Quality Consultant (Staff Z), the Quality Assistant (Staff AA) and the Sepsis Coordinator (Staff AB).

a. During the review, the surveyors selected quality indicators that were not meeting the hospital's performance goals identified in the hospitals "Quality Assurance/Performance Improvement Plan 2017," including Hospital Acquired Conditions: Patient Falls, Hospital Acquired infections (HAI's), 30 day Sepsis readmissions, Restraints, and Medication Safety/Management.

b. Surveyor #2 found no evidence action plans had been developed, implemented or reevaluated for indicators not meeting the hospital's performance goals.

3. At this same time, interview with the Quality Director (Staff I), showed there was no systematic process for developing, implementing, monitoring, and evaluating action plans to improve hospital performance.
VIOLATION: PATIENT SAFETY Tag No: A0286
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Item #1 Quality Reporting

Based on interview and review of the hospital's quality program, the hospital failed to ensure that aggregated data regarding patient medication errors was reported to the hospital's quality program.

Failure to systematically collect, measure, and assess data regarding medication errors limits the hospital's ability to improve patient outcomes.

Findings included:

1. The hospital's quality plan titled, "Quality Assurance/Performance Improvement Plan 2017," showed that recommendations from the Pharmacy and Therapeutics/Infection Control Committee are presented to the Medical Executive Committee and reported to the Board Quality Committee.

2. On 08/09/17 from 3:00 PM to 4:30 PM, Surveyors #1 and #2 and Quality Director (Staff I), the Quality Consultant (Staff Z), the Quality Assistant (Staff AA) and the Sepsis Coordinator (Staff AB) reviewed the hospital's quality program. At this time, Surveyor #2 reviewed minutes for the Board Quality Committee for the previous 6 months. Surveyor #2 found no evidence the Pharmacy and Therapeutics Committee reported hospital medication error data, or data analysis to the Board Quality Committee.

3. At this same time, Surveyor #2 reviewed the prior six months of the Medical Executive Committee minutes. Surveyor #2 found no evidence the Pharmacy and Therapeutic/Infection Control Committee presented medication error data, data analysis or improvement plans to the Medical Executive Committee.

4. The Quality Director (Staff I) confirmed this findings above at the time of the review.

Item #2 Analyzing Data and Developing Action Plans for Highest Occurring Errors

Based on interview and review of the hospital's quality program, the hospital failed to demonstrate that the grouping of the highest occurring medication errors and error locations were analyzed over time for performance improvement.

Failure to systematically aggregate, analyze, and implement process improvement for errors over time limits the hospital's ability to improve patient outcomes.

Findings included:

1. On 08/08/17 at 1:30 PM, Surveyor #2 inspected the Pharmacy Department and interviewed the Pharmacy Director (Staff AD). At this time, Staff AD provided Surveyor #2 with a Medication Error Report for 1st Quarter 2017. Staff AD told the Surveyor this report is submitted to Pharmacy and Therapeutic/Infection Control Committee for review. The report listed aggregate data for the 1st Quarter 2017 related to error rate, error type, location in the hospital, and type of error.

a. The report showed that 438 of 828 medication errors occurred in the Emergency Department. The surveyor found no evidence in the report this data was further analyzed or action plans were developed for performance improvement.

b. The report showed that 190 of 828 medication errors were related to narcotic discrepancy. The surveyor found no evidence in this report the data was further analyzed or action plans were developed for performance improvement.

2. On 08/09/17 from 3:00 PM to 4:30 PM, at the time of the Quality Program review, Surveyor #2 reviewed the Pharmacy and Therapeutic Committee minutes for 07/28/16, 09/28/16, 01/26/17, and 03/23/17. Surveyor #2 found no evidence the data, data analysis or action plans were discussed or reviewed by the committee.

3. At this same time, Surveyor #2 reviewed the prior six months of the Medical Executive Committee and Board Quality Minutes. Surveyor #2 found no evidence the Pharmacy and Therapeutic/Infection Control Committee presented analyzed data or action plans to these committees as outlined in their quality plan.

4. The Quality Director (Staff I) confirmed the findings above at the time of the review.

Item #3 Near Miss Data

Based on interview and review of the hospital's quality program, the hospital failed to collect, aggregate and analyze data related to near misses.

Failure to systematically collect, aggregate, analyze, and implement process improvement regarding medication errors limits the hospital's ability to improve patient outcomes.

Findings included:

1. On 08/09/17 from 3:00 PM to 4:30 PM, Surveyors #1 and #2 reviewed the hospital's quality program. Surveyor #2 found no evidence "near miss" (an error that happened but did not reach the patient) data or action plans were reported to or reviewed by Medical Executive Committee or Board Quality Committee.

2. At the time of the Quality program review, Surveyor #2 reviewed the Pharmacy and Therapeutic Committee minutes and found no evidence "near miss" data was collected, aggregated, or analyzed or reported to this committee.

3. The Quality Director (Staff I) confirmed the findings above at the time of the review.
VIOLATION: INFECTION CONTROL Tag No: A0747
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Based on observation, interview, and record review, the hospital failed to ensure that staff followed hospital infection control policies and industry standards for sterilization of critical devices, and the administration failed to address problems identified by the infection control program and adequately implement corrective action for previously identified findings.

Failure to properly sterilize critical devices and implement effective corrective action plans for identified infection control issues places patients at risk for infection.

Findings included:

Condition-level non-compliance was present due to the following:

-Failure to properly implement policies designed to control infections.

-Failure to address identified infection control problems and implement effective corrective actions.

Due to the scope and severity of deficiencies cited under 42 CFR 482.42, the Condition of Participation for Infection Control was NOT MET.

Cross Reference: Tags A0749, A0556
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
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ITEM #1 - PERSONAL PROTECTIVE EQUIPMENT
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Based on observation and record review, the hospital failed to ensure that staff members properly donned personal protective equipment (PPE).

Failure to properly don PPE places staff and patients at risk for exposure to pathogens.

Reference: Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the Healthcare Infection Control Practices Advisory Committee, 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings. Pg. 124 "Donning PPE: Gown: Fully cover torso from neck to knees, arms to end of wrist, and wrap around the back. Fasten in back at neck and waist."

Findings included:

1. Record review of the facility's policy titled, "Transmission Based Isolation Precautions," Policy #IC 3004 B, C, and D reviewed 12/15/15, showed that staff are required to wear gowns when entering contact isolation rooms.

2. On 08/07/17 at 11:35 AM, Surveyor #1 observed a physician assistant (Staff A) enter a contact isolation room without properly donning the gown. The staff member draped the gown below the shoulders and did not tie the gown behind the back.

ITEM #2 - HAND HYGIENE
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Based on observation and record review, the hospital failed to ensure that staff members performed hand hygiene as required by hospital policy.

Failure to perform hand hygiene when indicated places patients and staff at risk for infection.

Findings included:

1. Record review of the facility's policy titled, "Hand Hygiene," Policy #IC-3006 revised 07/17/12, showed that staff are to perform hand hygiene following removal of gloves, before patient care, and after contact with body fluids.

2. On 08/07/17 at 11:45 AM, during inspection of the Emergency Department (ED), Surveyor #2 observed Staff J exiting a patient room with gloved hands, carrying a dirty commode and a specimen bag containing a specimen. Staff J carried the dirty commode down the hallway and then set it down in front of the hospitals tube system door. With the same gloved hands, Staff J opened the tube system and placed the specimen in the cartridge and sent it to lab. Staff J picked up the dirty commode and took it to the soiled utility room.

3. On 08/07/17 at 12:12 PM, Surveyor #1 observed a discharge cleaning of a patient room. A housekeeper (Staff B) did not perform hand hygiene following glove removal during glove changes as instructed by hospital policy.

4. On 08/07/17 at 2:20 PM during the observation of a surgical procedure, Surveyor #3 observed Staff Member P. The observation showed that she picked up an item from the floor and failed to perform HH afterward. The same staff member reached down to tie the shoe strings of a surgical technician and did not perform HH afterward.

5. On 08/08/17 at 11:20 AM, Surveyor #2 observed Staff AF prepare and administer intravenous Hydromorphone (pain medication) to Patient #12. The observation showed that Staff AF failed to perform hand hygiene prior to preparing the medication and prior to administering the medication.

6. On 08/08/17 at 2:15 PM, Surveyor #3 observed an Esophagogastroduodenoscopy (EGD) (a procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum). In preparation for the procedure, the endoscopy nurse(Staff U) donned her gloves. The observation showed that the nurse dropped a paper on to the floor and retrieved it with her gloved hands, without changing her gloves and performing hand hygiene. The Infection Control Nurse (Staff M) observing with Surveyor #3 confirmed the finding.

ITEM #3 - IMMEDIATE USE STEAM STERILIZATION
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Based on observation, interview, and record review the facility failed to ensure that staff only used immediate use steam sterilization for emergent need.

Failure to properly sterilize equipment places patients at risk for infection.

Reference: Association of Perioperative Registered Nurses: Guidelines for Perioperative Practice. (2017). Guideline for Sterilization: "Recommendation VII.a. Immediate use steam sterilization should be used only when there is insufficient time to process by the preferred wrapped or container method intended for terminal sterilization. Immediate use steam sterilization should not be used as a substitute for sufficient instrument inventory."

Findings included:

1. Record Review of the facility policy, "Immediate-Use Steam Sterilization," Policy #OR-216, showed that staff are only to perform immediate use steam sterilization in emergent situations and that immediate use steam sterilization is not a substitute for sufficient inventory. The policy also states that the reason for immediate use steam sterilization should be documented.

Record review of sterilization policies showed that the facility did not have a policy regarding vendor supplied instruments. An electronic communication provided to vendors indicated that instruments should be delivered 48 hours prior to the procedure.

2. On 08/08/17 from 8:30 AM to 9:20 AM, Surveyor #1 inspected the sterile processing department of the facility. During the inspection, the surveyor interviewed a surgical technologist (Staff C) regarding immediate use steam sterilization. The staff member indicated that instrument sets for urology cases were often sterilized via immediate use steam sterilization.

3. Record review of immediate use steam sterilization logs for 2017 showed the following:

a. Staff immediate use steam sterilized cystoscopy trays on the following dates: 01/10/17 (3X); 01/17/17 (2X); 01/24/2017; 01/25/17 (2X); 02/14/17; 03/01/17; 03/07/17 (2X); 03/15/17; 03/22/17; 04/25/17 (2X); 05/02/17; 05/03/17; 06/21/17 (2X); 06/22/17; 06/27/17 (2X).

b. Staff immediate use steam sterilized "tur trays" on the following dates: 01/17/17; 01/24/17 (2X); 03/21/17 (2X); 03/28/17; 03/29/17; 05/09/17; 08/08/17.

c. Staff immediate use steam sterilized cryo grids on the following dates: 02/14/17; 03/07/17; 04/11/17; 05/16/17; 08/08/17.

d. Fifty of fifty-seven immediate use steam sterilization recordings from 01/01/17 to 04/03/17 did not have a documented reason as to why immediate use steam sterilization was utilized.

4. On 08/09/17 at 1:42 PM, Surveyor #1 interviewed the lead sterile processing technician (Staff D) regarding urology procedures and immediate use steam sterilization. The interview showed that the facility had three cystoscopy sets and two "tur trays" available for use but more cases could be scheduled than equipment available. The interview also showed that vendors brought the cryo grids prior to scheduled cases and staff immediate use steam sterilized the equipment rather than running it through a full sterilization cycle in the central processing department. The interview also showed that the facility did not maintain a log of vendor supplied items to document when they arrived at the facility.

5. An interview conducted by Surveyor #1 with the lead sterile processing technician (Staff D) on 08/10/17 at 8:45 AM confirmed that the facility did not have a policy regarding sterilization of vendor provided items.

ITEM #4 - FOOD SANITATION
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Based on observation and interview, the hospital failed to implement policies and procedures for food service according to the Washington State Retail Food Code (WAC 246-215).

Failure to follow the Washington State Retail Food Code (WAC 246-215) increases the likelihood of foodborne illness

Findings included:

On 08/08/17 at 9:45 AM, Surveyor #1 inspected the kitchen on the east campus of the facility. The inspection showed the following findings:

A. Sliced tomatoes in a cold holding station measured 45.1 degrees Fahrenheit. The food services supervisor (Staff E) indicated that the items were cut prior to the day the survey took place.

Reference: Washington State Retail Food Code, WAC 246-215- (1) (b)

B. The surveyor observed soup cooling in pans that were deeper than 2 inches. The nutrition director (Staff F) indicated that food was regularly cooled in 4 inch pans. The surveyor asked if the time and temperature were monitored as specified in the retail food code when cooling in pans deeper than 2 inches. The food services supervisor (Staff E) indicated that they were not.

Reference: Washington State Retail Food Code, WAC 246-215- (1)

ITEM #5 - CROSS CONTAMINATION
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Based on observation and interview, the hospital failed to ensure that staff prevented cross-contamination of patient care items.
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Failure to prevent cross contamination places patients, staff and visitors at increased exposure to infectious organisms.
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Findings included:
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On 08/09/17 at 8:55 AM, Surveyor #3 observed a registered nurse (RN) (Staff W) perform care on a patient in Contact Enteric Isolation. The nurse donned appropriate personal protective equipment (PPE) but while in the room she reached underneath her protective gown, with gloved hands and retrieved a pen from her uniform pocket. This action could cause cross contamination of her uniform and other items she touched in the patient care area. The Infection Control Nurse (Staff M) observing the care with Surveyor #3 confirmed the finding.

ITEM #6 - SURGICAL ATTIRE
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Based on observation, review of the hospital's policies and procedures and interview, the surgical staff members failed to follow hospital policy regarding surgical attire.
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Failure to follow hospital policy and practice standards for surgical attire increased the risk for patient infections.
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Findings included:
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1. The hospital policy titled, "Attire of the OR (Operating Room)", Policy # OR-018, revised 02/10/15, showed that surgical hats and hoods should confine the hair as it is a source of bacteria.
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2. On 08/07/17 at 2:10 PM, Surveyor #3 observed a surgical procedure performed on Patient #1. The circulating RN (registered nurse) (Staff P) and the ST (surgical technician) (Staff Q) did not have their hair completely contained in their caps at the sides of the cap, the back and the front forehead. Surveyor #3 discussed the observation with the Director of Surgery (Staff R) who confirmed that all hair should be covered in restricted areas.
VIOLATION: LEADERSHIP RESPONSIBILITIES Tag No: A0756
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Based on observation, interview, and record review, the facility failed to address problems identified by the infection control officer and implement action plans to correct problem areas.

Failure to address infection control problems by implementing effective corrective action plans places patients at risk for infection.

Findings included:

1. Record Review of the hospital policy, "Immediate Use Steam Sterilization," Policy #OR-216, showed that the facility is only to employ immediate use steam sterilization in emergent situations and that the procedure is not a substitute for sufficient inventory.

2. On 08/10/17 at 10:55 AM, Surveyor #1 conducted an interview with the infection control practitioner (Staff M) regarding the infection control program. Surveyor #1 asked the practitioner about immediate use steam sterilization and its apparent overuse in the facility. The practitioner indicated that the issue had been identified as a recurring problem and was cited on the most recent audit of the sterile processing department. The practitioner stated that reports are disseminated to management, the quality department, and the lead surgeon. The practitioner stated that no improvement plan had been developed by the infection control committee or the quality department.

3. Record review of a document titled, "Sterile Processing Best Practices Audit Check List," dated 06/29/17 stated that immediate use steam sterilization as a substitute for sufficient inventory was still an issue.

4. Record review of the past six months of Board Quality Meeting minutes and year of Pharmacy Therapeutic/Infection Control Committee minutes did not show that immediate use steam sterilization issues were discussed.

5. On 08/10/17 at 11:04 AM, Surveyor #1 interviewed the Quality Director (Staff I) and the Chief Nursing Officer (CNO) (Staff N) regarding identified issues with immediate use steam sterilization. The director indicated that the sterile processing audit conducted on 06/29/17 was provided to the quality department by the infection control practitioner (Staff M).

The CNO stated that the administration and the surgical services department periodically review identified problems to determine if new items are needed. A capital budget request for additional instrumentation for urology cases was placed, but was not approved.

6. On 08/10/17 at 1:50 PM, Surveyor #1 interviewed the Chief Operating Officer (COO) (Staff O) regarding the capital budget and approving the purchase of new equipment. The COO stated that the facility was currently in a "break fix" mode, where the hospital approves expenditures for new equipment in order to replace obsolete or damaged equipment. Budgetary constraints prevented the facility from procuring additional equipment for urology cases.

7. Record review of a document titled, "Capital Budget Request - FY 2017," dated 09/20/16, showed that the surgical services department submitted a request for funding for additional urology procedure equipment. The document states the following, "Item Description: Joint Commission continues to monitor the use of "flash sterilization" and we have maintained an audit log since the last 2 visits. It is found during this audit that urology instruments are being flashed on a continuous basis due to not enough for the cases that are booked. With the new urologist here, the number is climbing. We need to be in compliance with the Joint Commission standard of only 5-10% flash sterilization and we are currently at 50% with the urology instruments."

8. On 08/10/17 at 2:17 PM, Surveyor #1 interviewed the CNO (Staff N) a subsequent time regarding identified immediate use steam sterilization issues. The CNO stated that she was the lead of the surgical services department at the time of budgetary requests. The CNO stated that audits are conducted with the infection control practitioner (Staff M) to assess trends or issues with various service lines. Inventory is assessed by the lead technician. This information is collated to develop a capital list for budgetary requests. The board prioritizes which items should be purchased and decided against purchasing additional urological equipment.

The surveyor asked the CNO what other corrective measures were conducted to address the issue. She stated that the surgical services department looks to stagger cases to allow time for proper reprocessing of critical devices, but it is not always possible to stagger cases due to block scheduling of the operating room with surgeons. She also stated that surgeons often request items to be immediate use steam sterilized due to case load and scheduling. The surveyor asked if scheduling issues are addressed with the administration, and the CNO indicated that scheduling is often not addressed outside of the surgical services department.

The surveyor asked the CNO if the quality department or the board provided any oversight of this issue since it had been identified on multiple previous surveys. The CNO indicated that the quality department had not conducted a failure mode and effect analysis (a process for identifying issues and their effects within a system that could contribute to failure) or developed any action plans to reduce the use of immediate use steam sterilization.