HospitalInspections.org

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Based on interview and record review, the hospital failed to ensure that all staff are appropriately trained and credentialed for tasks being performed as required by State law for 4 of 8 files reviewed (Staff #607, #608, #609, and #610).

Failure to ensure that staff have the proper training and credentials to perform their assigned job duties places patients at risk of inconsistent or inadequate care.

References: Washington Administrative Code (WAC) 246-320-156 Management of human resources;

WAC 246-827-0330 Medical assistant-registered - Collection of specimens;

WAC 246-841-400 Standards of practice and competencies for nursing assistants.

Findings included:

1. Record review of the personnel files for 4 staff members showed:

a. Two nursing assistants (Staff #607 & Staff #608), who performed blood glucose monitoring, did not have the Medical Assistant-Registered (MA-R) credential required to collect a blood specimen by finger or heel stick.

b. Files for two staff members, an Emergency Department Scribe (Staff #609), and an Electroencephalography Technician (Staff #610), did not have documented orientation to their assigned work environments.

2. On 09/04/19 at 10:50 AM, Surveyor #5 asked a Certified Nursing Assistant (CNA) (Staff #503) about his credentials for performing blood glucose checks. Staff #503 stated that he performs blood glucose checks but does not have an MA-R credential. Staff #503 stated that he did not know an MA-R credential was required. At the time of the interview, Surveyor #5 asked the hospital's Interim Chief Nursing Officer (Staff #502) about MA-R credentials for CNA's who perform blood glucose monitoring. Staff #502 stated he did not know whether an MA-R was required.

3. On 09/04/19 at 2:00 PM, Surveyor #5 asked a CNA (Staff #505) about her credentials for performing blood glucose checks. Staff #505 confirmed that she performs blood glucose checks but does not have an MA-R credential. Staff #505 stated she did not know whether the hospital required an MA-R for CNA's who perform blood glucose checks.

4. On 09/05/19 at 4:00 PM, Staff #502 and the Accreditation and Clinical Compliance Consultant (Staff #504) confirmed that the CNA staff performing blood glucose monitoring do not have MA-R credentials. Staff #502 and Staff #504 stated that they were unable to locate a regulation requiring a CNA to have an MA-R in order to perform blood glucose monitoring. They asked Surveyor #5 to email the regulatory code reference.

5. On 09/06/19 between 8:30 AM and 12:30 PM, Surveyor #6 interviewed the Human Resource Consultant (Staff #611) about hospital and unit orientation for Staff #609 and Staff #610. Staff #611 stated that Staff #609 was contracted staff and may not have completed hospital or unit orientation. Staff #611 stated that orientation was not a formal process when Staff #610 was hired by Legacy Health System in 2011 and that orientation was missed when Staff #610 transferred to Legacy Salmon Creek Medical Center in 2015.
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Based on observation, interview, document review, and review of Governing Body documents, the Governing Body failed to develop and maintain an effective system for policy review and approval (Item #1) and failed to meet the requirements for the Condition of Participation for Governing Body (Item #2).

Failure to ensure patients are provided with care that meets acceptable standard of practice and meets the patient's healthcare needs in a safe environment risks poor health care outcomes, injury, and death.

Findings included:

Item #1 Governing Body Policy Approval

1. From 09/03/19 through 09/06/19, Surveyor #5 and Surveyor #6 reviewed 34 policies provided by the hospital including:

a. "Pain Management for Hospitalized Adult Inpatients," policy number 900.5359, revised 06/19,

b. "Inpatient Tubing Change Routine," policy number 900.4248, revised 12/18,

c. "Patient Screening, Assessment, and Reassessment," policy number 900.3224, reviewed 11/18,

d. "Interdisciplinary Plan of Care," policy number 900.5000, reviewed 05/17,

e. "Restraint and Seclusion for Patient Safety," policy number 900.5274, reviewed 11/18,

f. "Storage and Handling of Medications and Pharmaceutical Supplies in Patient Care Areas and Pharmacy," policy number 900.3243, revised 06/19,

g. "Medications: Administration," policy number 900.3102, revised 04/18,

h. "Patient Identification Verification and Banding," policy number 900.4297, revised 10/17,

i. "Checking Expiration Dates," policy number LHS.835.012, revised 07/06,

j. "Inpatient Assessment, Reassessment, and Screening by the Clinical Dietician," policy number 900.3157, reviewed 05/18,

k. "Sterile Compounding Quality Assurance," policy number 916.3403, reviewed 11/18,

l. "Performance Improvement and Patient Safety Program Plan," policy number 100.48, reviewed 04/18,

m. "Adverse Drug Event," policy number 900.3342, revised 12/18,

n. "Managing Patient Complaints and Grievances," policy number 100.38, revised 07/17,

o. "Pain, Agitation, and Delirium (PAD) Protocol for Mechanically Ventilated Patients," policy number 901.6008, reviewed 06/18,

p. "Alcohol Withdrawal Protocol," policy number 900.5609, reviewed 04/19,

q. "Automated Medication Dispensing System (AMDA)," policy number 900.3070, reviewed 06/19,

r. "Adult ICU Insulin Infusion Protocol," policy number 901.6024, reviewed 07/19,

s. "Management of Artificial Airways, with or without Mechanical Ventilation for *Adult Patients," policy number 900.1146, reviewed 08/16,

t. "Universal Protocol Time-Out and Verification Process for Surgical and Nonsurgical Invasive Procedure," policy number 900.3380, revised 07/19,

u. "Newborn Identification," policy number 911.4141, reviewed 06/17,

v. "Standard Development, Approval, and Maintenance," policy number 100.02, reviewed 07/18,

w. "Patient, Visitor, and Employee Incident Reporting," policy number 100.28, revised 07/17,

x. "Contracted Clinical Service Providers," policy number 100.83, revised 03/17,

y. "Whirlpool Tub Disinfecting/Birthing Pool Cleaning," policy number 125.5000, revised 03/18.

z. "Infection Prevention & Control Program Description and Plan," policy number 600.15, revised 01/17,

aa. "Hand Hygiene," policy number 600.35, revised 08/19,

bb. "Surgical Hand Scrub," policy number 909.4827, revised 01/19,

cc. "Basic Ten Steps of Discharge Cleaning," policy number 125.4001, revised 01/17,

dd. "Occupied Room Cleaning," policy number 125.4300, revised 04/17,

ee. "Operating Room and Procedural Areas: Environmental Cleaning and Terminal Cleaning," policy number 909.4005, revised 10/18,

ff. Airborne Hazard Respiratory Protection Program, Use of Respirator," policy number 600.37, revised 08/18,

gg. "Sanitation-Food Utensil Handling & Serving," policy number 150.309, revised 04/17,

The surveyors observed that each policy was titled as a Legacy Health Policy. Surveyor #5 and Surveyor #6 were unable to determine that the policies applied to, and were approved for use at Legacy Salmon Creek Medical Center.

2. On 09/06/19, Surveyor #5 reviewed the Governing Board minutes dated 05/31/19. Surveyor #5 observed in the section of the minutes dedicated to policy review that the Legacy System Hospital names were listed across the top of the minutes and adjacent to each hospital name was an "X." The minutes showed that an "X" placed next to the hospital name showed that the policy had been reviewed and approved by that specific hospital's committees. For Salmon Creek Medical Center, policies marked with an "X" included:

a. "Transplant Program QAPI Program," policy number 918.3004,

b. "Kidney Transplant and Recipient Center," policy number 918.3005,

c. "Waitlist Management," policy number 918.6001,

d. "Maintenance of ACT," policy number 922.4236,

e. "Anticoagulation Management of ECMO," policy number 922.5063,

f. "LTS Adverse Event and Unanticipated Outcome Response," policy number 918.3001,

g. "Protocol A 2 B and A 2 O," policy number 918.3002,

h. "Transplant Nurse Initiated Order Set," policy number 918.3003,

i. "ECMO in Adults," policy number 922.5064.

Surveyor #5 observed that these policies were for services that the hospital did not provide including Organ Transplant and Extracorporeal Membrane Oxygenation (ECMO).

3. On 09/06/19 at 3:00 PM, Surveyor #5 interviewed the Interim President (the Chief Executive Officer to Legacy Salmon Creek Hospital) (Staff #519), the Manager of Accreditation and Clinical Compliance (Staff #522), the Accreditation and Clinical Compliance Consultant (Staff #504), the Vice President of Quality and Corporate Compliance (Staff #520), and the Board President (Staff #521). Surveyor #5 asked the Governing Board how System Level Policies were reviewed and approved for the individual hospitals within the Hospital System. Staff #521 stated that policy review was part of the consent agenda and that when reviewing the items in the consent agenda an "X" next to the hospital name meant that the hospital committees had approved the policy. At this time, Surveyor #5 questioned the Board's policy approval process as the policies listed in the Board Minutes dated 05/31/19 were approved for implementation for services Salmon Creek Medical Center did not provide, and the policies provided to the surveyor did not reflect that they were approved specifically for use at Legacy Salmon Creek Medical Center and appeared to be system level policies. Staff #521 confirmed the observation and stated that the policy review and approval process would need to be reviewed.

Item #2 Governing Body Oversight

Findings included:

Due to the scope and severity of deficiencies detailed under 42 CFR 482.12 Conditions of Participation for Governing Body, the Condition of Participation for Governing Body was NOT MET.

The hospital failed to develop and maintain an effective system for policy review and approval.

Cross Reference: A043 - Item #1

The hospital failed to approve and appoint a Chief Executive Officer to provide effective oversight to ensure patients are provided with care that meets acceptable standard of practice and meets the patient's healthcare needs in a safe environment.

Cross Reference: A057

The hospital failed to determine whether patient care contractors meet all Medicare Conditions of Participation and standards.

Cross Reference: A083

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Based on interview and document review, the Governing Body failed to appoint a Chief Executive Officer who is responsible for managing the hospital.

Failure to approve and appoint a Chief Executive Officer to provide effective oversight to ensure patients are provided with care that meets acceptable standard of practice and meets the patient's healthcare needs in a safe environment risks poor health care outcomes, injury, and death.

Findings included:

1. On 09/06/19, Surveyor #5 reviewed the Governing Board minutes dated 07/26/18, 09/27/18, 11/29/18, 01/24/19, 03/28/19, 05/31/19, and 07/26/19. Surveyor #5 found no evidence the new Interim Chief Administrative Officer (Staff #519) had been approved and appointed by the Board of Directors.

2. On 09/06/19 at 3:00 PM, Surveyor #5 interviewed the Interim President (the Chief Executive Officer to Legacy Salmon Creek Hospital) (Staff #519), the Manager of Accreditation and Clinical Compliance (Staff #522), the Accreditation and Clinical Compliance Consultant (Staff #504), the Vice President of Quality and Corporate Compliance (Staff #520), and the Board President (Staff #521). Staff #522, #520, and #521, were unable to verify if the Board of Directors had approved and appointed Staff #519 as Chief Executive Officer for Legacy Salmon Creek Hospital.

3. On 09/06/19 at 5:00 PM, Staff #504 stated that the hospital was unable to locate the Board of Director approval in the minutes, but that the minutes had been redacted and the hospital was trying to determine if the information was contained in a non-redacted format. Staff #504 asked if the hospital could submit the information if they were able to locate it. Surveyor #5 did not receive any additional information.

4. Document review of the hospital's Governing Body Bylaws titled, "2018 Amended and Restated Bylaws of Legacy Health," amended 11/29/18, showed no information about the Board of Directors responsibilities to appoint a Chief Medical Officer for the hospital.
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Based on interview, document review, review of the hospital's quality and performance improvement program, and review of Governing Body documents, the Governing Body failed to ensure that the hospital had an effective system in place to evaluate the quality of care provided by contracted services for 3 of 3 contracts reviewed.

Failure to determine whether patient care contractors meet all Medicare Conditions of Participation and standards risks provision of ineffective and unsafe healthcare to patients.

Findings included:

1. Document review of the hospital's policy titled, "Contracted Clinical Service Providers," policy number 100.83, revised 03/17, showed that on a quarterly basis, the Legacy Manager overseeing the contracted service will collect and review information on each of the established performance measures, determine whether the vendor was involved in any patient safety alerts or complaints, and collect feedback from staff that directly observed the vendor's provision of care and service to determine whether service expectations have been met. If concerns (i.e. vendor did not meet a performance measure or staff has reported quality concerns) arise from the evaluation, the Legacy manager will collaborate with the vendor to develop a performance improvement plan. The Legacy Manager will oversee the implementation of the process improvement plan and report on the progress in the following quarter.

2. On 09/05/19, Surveyor #5 reviewed 3 clinical contract annual evaluations. The review showed:

a. 2 of the 3 contracts reviewed were evaluated by staff at another hospital in the hospital's system. Surveyor #5 found no evidence that the hospital evaluated the clinical contracts.

b. 1 of the 3 contracts reviewed showed the contracted service was approved for continuation, but the documentation showed that there were issues identified including oral hygiene of the contracted staff, double booking, long wait times, last minute communications, interpreters arriving late, interpreters leaving early, interpreters not interpreting everything or interpreting incorrectly, and delays for onsite interpreters to arrive. Surveyor #5 found no evidence that a process improvement plan was developed or implemented related to the quality care concerns documented in the annual contract evaluation.

3. On 09/06/19, Surveyor #5 reviewed the hospital's 2019 Quality Committee meeting minutes. Surveyor #5 found no evidence that every contracted service was evaluated as part of a quality assessment and performance improvement (QAPI) program.

4. Surveyor #5 found no evidence in the Board of Director minutes dated 07/26/19, 09/27/18, 11/29/18, 01/24/19, 03/28/19, 05/31/19, and 05/31/19 that the Governing Body implemented an effective process to ensure the hospital assessed the services furnished under contract, identified quality and performance problems, implemented appropriate corrective or improvement activities, and ensured the monitoring and sustainability of those corrective or improvement activities.

5. On 09/06/19 at 1:00 PM, the Accreditation and Clinical Compliance Consultant (Staff #504) stated that she called and talked with the Legacy System Contract Manager about the contract that showed deficiencies in quality of care provided and that the Contract Manager stated that the quality concerns were not identified by Legacy Salmon Creek Medical Center, but rather another hospital in the system.
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Based on record review, interview, and review of hospital policies and procedures, the hospital failed to ensure that a licensed provider wrote an order for seclusion for 2 of 4 seclusion records reviewed (Patient #501, and #505).

Failure to ensure that a provider writes an appropriate order for seclusion risks psychological harm, loss of dignity, and personal freedom.

Findings included:

1. Document review of the hospital's policy and procedure titled, "Restraint and Seclusion for Patient Safety," policy number 900.5274, reviewed 11/18, showed that each episode of restraint is initiated on the order of the licensed Independent Practitioner responsible for the patient. The order includes the indication for the use of restraint, the type, and number of restraint devices and method to be utilized, and the length of time the order is applicable.

2. On 09/03/19 at 3:15 PM, Surveyor #5, a Registered Nurse (RN) (Staff #506) and the Assistant Unit Manager (Staff #507) reviewed the medical record for Patient #501 who was admitted on 08/23/19 for the treatment of cellulitis, chest pain, dyspnea, and alcohol withdrawal. The review showed:

a. On 08/26/19 at 2:00 PM, hospital staff placed the patient in 4-point restraint. Surveyor #5 found no evidence a provider wrote an order for the restraint episode.

b. On 09/02/19 at 8:00 AM, hospital staff placed the patient in 4-point restraint. Surveyor #5 found no evidence a provider wrote an order for the restraint episode.

2. On 09/06/19 at 11:00 AM, Surveyor #5 and a Registered Nurse (RN) (Staff #514) reviewed the discharged medical records for Patient #505 who was admitted on 05/22/19, for the treatment of attempted suicide. The review showed:

a. On 05/22/19, hospital staff placed the patient in 4-point soft restraints from 11:20 PM until 2:52 AM. The provider ordered specified hard locking restraint.

b. On 05/23/19, hospital staff placed the patient in 4-point restraints from 3:17 AM until 4:30 AM. The provider order specified only for right wrist restraint.

3. At the time of the observation, Staff #503 confirmed the finding and stated that she was not clear why the orders were not applied as ordered.
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Based on interview, record review, and review of hospital policies and procedures, the hospital failed to ensure that patients restrained for violent, self-destructive behavior were monitored as directed by hospital policy, as demonstrated by 3 of 3 patients reviewed (Patient #503, #504, and #505).

Failure to follow approved policies and procedures for restraint use risks physical and psychological harm, loss of dignity, and violation of patient rights.

Findings included:

1. Document review of the hospital's policy and procedure titled, "Restraint and Seclusion for Patient Safety," policy number 900.5274, reviewed 11/18, showed for patients placed in violent restraint, a Registered Nurse (RN) must reassess the patient every 2 hours for:

a. Behavior exhibited by the patient indicating the need for restraint,

b. Device type and number of restraints,

c. Signs of any injury,

d. Address nutrition and hydration needs,

e. Circulation and skin condition,

f. Range of motion and repositioning,

g. Elimination needs,

h. Hygiene needs,

i. Psychological status,

j. Communicate with the patient regarding the restraint intervention,

k. Assess readiness for discontinuing the restraint.

The RN will delegate the every 15 minute monitoring of safety and signs of injury, psychological and emotional status, and physical comfort to a Certified Nursing Assistant.

2. On 09/06/19 at 11:00 AM, Surveyor #5 and a Registered Nurse (RN) (Staff #514) reviewed the discharged medical records for 3 patients placed in violent restraints (Patient #503, #504, and #505). The review showed:

a. On 06/04/19, Patient #503 was admitted for the treatment of methamphetamine intoxication. On 06/04/19 at 6:39 PM, hospital staff placed the patient in 4-point violent restraints. Surveyor #5 found no evidence staff monitored the patent every 15 minutes.

b. On 04/29/19, Patient #504 was admitted for the treatment of Acute Blood Loss, Hemoptysis, Rectal Bleeding, and Alcohol Use disorder. On 04/30/19 at 1:07 AM, hospital staff placed the patient in 4-point violent restraints. Surveyor #5 found no evidence staff monitored the patient every 15 minutes.

c. On 05/22/19, Patient #505 was admitted for the treatment of attempted suicide. On 05/22/19 at 11:20 PM, hospital staff placed the patient in 4-point restraints from 11:20 PM until 2:52 AM. Surveyor #5 found no evidence a Registered Nurse (RN) assessed the patient every 2 hours or that staff monitored the patent every 15 minutes.

3. At the time of the observations, Staff #503 confirmed the finding and stated that the patients should have been monitored every 15 minutes.
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Based on interview, record review, and review of the policies and procedures, the hospital failed to ensure that patients placed in restraints or seclusion received a face-to-face assessment within one hour by a physician or licensed independent practitioner as directed by hospital policy for 4 of 4 patients reviewed (Patients #502, #503, #504, and #505).

Failure to perform the required face-to-face evaluation to determine whether the patient actually meets the specific criteria for restraint or seclusion places patients at risk of harm, injury, or other decline in status.

Findings included:

1. Document review of the hospital's policy and procedure titled, "Restraint and Seclusion for Patient Safety," policy number 900.5274, reviewed 11/18, showed that a responsible licensed independent practitioner or trained Registered Nurse (RN) shall perform and document a face-to-face assessment of the patient's physical and psychological status within one hour of the initiation of restraint. Only a Behavioral Health RN with documented education, training, and competency may complete the one-hour face-to-face in lieu of the responsible provider.

2. On 09/05/19 at 11:35 AM, Surveyor #5 and the Assistant Nurse Manager of the Emergency Department (Staff #510) reviewed the medical record for Patient #502 who was admitted on 09/02/19 for a psychiatric evaluation related to escalating violent behavior and autism. The review showed on 09/03/18 at 12:16 PM, staff placed the patient in 4-point violent restraints. Surveyor #5 found no evidence a provider performed a 1-hour face-to-face assessment.

3. At the time of the observation, Staff #510 confirmed the finding.

4. On 09/05/19 at 4:00 PM, the Accreditation and Clinical Competence Consultant (Staff #504) stated that in the Emergency Department it was the Physicians responsibility to perform the 1-hour face-to-face evaluation.

5. On 09/06/19 at 11:00 AM, Surveyor #5 and a Registered Nurse (RN) (Staff #514) reviewed the discharged medical records for 3 patients placed in violent restraints (Patient #503, #504, and #505). The review showed:

a. On 06/04/19, Patient #503 was admitted for the treatment of methamphetamine intoxication. On 06/04/19 at 6:39 PM, hospital staff placed the patient in 4-point violent restraints. Surveyor #5 found no evidence a provider performed a 1-hour face-to-face assessment.

b. On 04/29/19, Patient #504 was admitted for the treatment of Acute Blood Loss, Hemoptysis, Rectal Bleeding, and Alcohol Use disorder. On 04/30/19 at 1:07 AM, hospital staff placed the patient in 4-point violent restraints. Surveyor #5 found no evidence a provider performed a 1-hour face-to-face assessment.

c. On 05/22/19, Patient #505 was admitted for the treatment of attempted suicide. On 05/22/19 at 11:20 PM, hospital staff placed the patient in 4-point restraints from 11:20 PM until 2:52 AM and again on 05/23/19 from 3:17 AM until 4:30 AM. Surveyor #5 found no evidence a provider performed a 1-hour face-to-face assessment for either episode of restraint.

6. At the time of the observation, Staff #503 confirmed the finding and stated that she was not aware of the 1-hour face-to-face assessment requirement.
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Based on interview, document review, and review of quality data, the hospital failed to develop and implement performance improvement activities and action plans that supported hospital quality indicators related to patient safety and quality of care.

Failure to develop projects and action plans based on results of data collection aimed at improving patient outcomes puts patients at risk from harm due to substandard care.

Findings included:

1. Document review of the hospital's policy titled, "Performance Improvement and Patient Safety Program Plan," policy number 100.48, reviewed 04/18, showed that the goal of the Performance Improvement and Patient Safety Committee is to aggregate and use quality data across the system by leaders to set expectations, develop plans, manage process design, measure, assess, improve, and maintain performance of clinical management and support activities.

2. On 09/06/19, Surveyor #5 and members of the hospital's Quality Committee reviewed the hospital's Quality and Process Improvement Program. Surveyor #5 observed the hospital was not meeting its established targets for surgery site infections, catheter associated blood stream infections, heart failure readmissions, and catheter associated urinary tract infections.

Surveyor #5 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 Improvement Consultant (Staff #522) and the Chief Nursing Officer (Staff #504) stated that the hospital had implemented decentralized workgroups and that the quality program meeting minutes did not reflect the process improvement activities of the hospital.
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Based on record review, interview, and review of policy and procedure, the hospital failed to ensure staff members completed and documented pain reassessments after each pain management intervention for 5 of 7 pain management interventions reviewed (Patient #509) (Item #1), and failed to provide pain intervention for 2 of 2 pain levels requiring pain management intervention (Patient #501) (Item #2).

Failure to treat and reassess a patient's pain risks inconsistent, inadequate, or delayed relief of pain.

Findings included:

Item #1 Pain Reassessment

1. Document review of the hospital's policy titled, "Pain Management for Hospitalized Adult Patients," policy number 900.5359, revised 06/19, showed that within approximately 60 minutes of every as needed (PRN) opioid administration the nurse must assess the patients:

a. respiratory rate,

b. respiratory pattern,

c. oxygen saturation,

d. response to PRN interventions,

e. sedation scale.

The nurse should establish therapeutic goals with the patient prior to initiating pain management plan. Usual therapeutic goals may be a pain rating of 3 or less on a 0-10 scale.

2. On 09/04/19 at 4:12 PM, Surveyor #5 and the Accreditation and Clinical Compliance Consultant (Staff #504) reviewed the medical record for Patient #509 who was admitted on 08/12/19 for premature labor and childbirth. The review showed:

a. On 09/01/19 at 2:07 PM, nursing staff medicated the patient with Ibuprofen 800 mg by mouth for a pain score of 8/10. Surveyor #5 found no evidence the patient's pain was reassessed.

b. On 09/01/19 at 4:03 PM, nursing staff medicated the patient with Hydromorphone (an opioid medication used to treat pain) 2 mg intravenously (IV) for a pain score of 4/10. Surveyor #5 found no evidence the patient's pain was reassessed.

c. On 09/02/19 at 12:13 AM, nursing staff medicated the patient with Hydromorphone 4 mg IV for a pain score of 9/10. Surveyor #5 found no evidence the patient's pain was reassessed.

d. On 09/02/19 at 5:57 AM, nursing staff medicated the patient with Ibuprofen 800 mg by mouth for a pain score of 6/10. Surveyor #5 found no evidence the patient's pain was reassessed.

e. On 09/02/19 at 8:01 AM, nursing staff medicated the patient with Hydromorphone 4 mg IV for a pain score of 6/10. Surveyor #5 found no evidence the patient's pain was reassessed.

3. At the time of the observation, Staff #504 confirmed the finding and stated the hospitals policy was to reassess in an hour.

Item #2 Pain Intervention

1. Document review of the hospital's policy titled, "Pain Management for Hospitalized Adult Patients, " policy number 900.5359, revised 06/19, showed the Critical Care Pain Observation Tool (CPOT) is a validated tool for behavioral pain assessment in adult patients that are unable to rate their pain. Pain should be suspected in the presence of known painful pathology or procedures including mechanical ventilation, care procedures, immobilization ...

2. On 09/03/19 at 3:15 PM, Surveyor #5, a Registered Nurse (RN) (Staff #506), and the Assistant Unit Manager (Staff #507) reviewed the medical record for Patient #501 who was admitted on 08/23/19 for the treatment of cellulitis, chest pain, dyspnea, and alcohol withdrawal. The review showed that the patient had CPOT scores greater than 3 on 08/28/19 at 4:00 AM and at 11:55 PM. Surveyor #5 found no evidence of a pharmacological or non-pharmacological intervention for the CPOT score.

3. At the time of the observation, Staff #506 confirmed the finding and stated that they treat pain for a CPOT greater than 3.
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Based on interview, record review, and review of policies and procedures, the hospital failed to develop an individualized plan for patient care for 3 of 6 patients reviewed (Patient #501, #507, and #508).

Failure to develop an individualized plan of care can result in the inappropriate, inconsistent, or delayed treatment of patient's needs and may lead to patient harm and lack of appropriate treatment for a medical condition.

Findings included:

1. Document review of the hospital's policy and procedure titled, "Interdisciplinary Plan of Care," policy number 900.5000, reviewed 05/17, showed that a Registered Nurse (RN) will develop an individualized care plan of each patient admitted as an inpatient, or placed in observation status on an inpatient unit. Care plans are individualized by the RN through selection of only those interventions and goals in each template that is appropriate to the specific needs of each patient. Care plans may also be individualized by selecting an individual problem, and then selecting appropriate interventions and goals from the Epic Care Plan database of goals and interventions. The care plan should be modified through the addition of new problems, goals, or interventions or resolutions of problems and goals. The care plan includes problems, interventions, and Patient Goals including a goal date.

2. On 09/03/19 at 3:15 PM, Surveyor #5, a Registered Nurse (RN) (Staff #506), and the Assistant Unit Manager (Staff #507) reviewed the medical record for Patient #501 who was admitted on 08/23/19 for the treatment of cellulitis, chest pain, dyspnea, and alcohol withdrawal. The review showed:

The patent had a history of diabetes. During the course of the hospitalization the patient developed pain and was receiving pain medication, developed hematuria and an indwelling catheter was placed, experienced respiratory failure and was intubated, and was assessed as a high fall risk. Additionally, the patient developed a pressure ulcer on her coccyx that was treated with a Mepilex placed on the patient's coccyx. Surveyor #5 found no evidence the care plan was individualized to include problems, interventions, or patient goals with goal dates for the acute pain, impaired gas exchange, infection/risk of infection, risk for unstable blood glucose, or impaired skin integrity.

3. At the time of the finding, Staff #507 confirmed the lack of individualization of the care plan.

4. On 09/04/19 at 8:30 AM, Surveyor #5, a Registered Nurse (Staff #515), and the Assistant Manager (Staff #507) reviewed the medical Record for Patient #507. The Patient was admitted on 08/29/19 for the treatment of Cirrhosis, Gastro-Intestinal bleeding, and Encephalopathy. The patient had a history of diabetes. During the hospitalization, the patient developed a red area with delayed blanching on the coccyx, and experienced respiratory failure and was intubated. Surveyor #5 found no evidence the care plan was individualized to include problems, interventions or patient goals with goal dates for the, impaired gas exchange, risk for unstable blood glucose, or impaired skin integrity.

5. On 09/04/19 at 11:15 AM, Surveyor #5, a Registered Nurse (RN) (Staff #517), and the Assistant Nurse Manager (Staff #518) reviewed the medical record for Patient #508 who was admitted on 09/03/19 for the treatment suicide attempt. The review showed that the patient had a history of Parkinson's disease with recent progression of the disease, Dementia, and Arthritis. During the hospitalization, the patient began experiencing swallowing difficulties, and decreased mobility. Surveyor #5 found no evidence the care plan was individualized to include problems, interventions, or patient goals with goal dates for the impaired swallowing, impaired mobility, or self-care deficit.

6. At the time of the finding, Surveyor #5 asked Staff #517 if she could modify or individualize the care plan. Staff #517 stated she "was not sure" how to individualize the care plan. Staff #517 spent time clicking through screens within the computerized system and was eventually able to find where the care plan could be modified and individualized.

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Based on interview and record review, the hospital failed to ensure that the director of nursing service conducted evaluation activities of non-employee nursing personnel.

Failure to ensure that the director of nursing services provides for the performance evaluation of non-employee nursing personnel places patients at risk for inconsistent or inadequate care.

Reference: Washington Administrative Code (WAC) 246-320-156 Management of human resources.

Findings included:

1. Record review of the personnel and training files for a non-employee nurse (Staff #605) showed that the most recent performance review was conducted on 07/22/19.

2. On 09/04/19, during an interview with Surveyor #5, the Interim Chief Nursing Officer (Staff #502) stated that the Nursing Float Pool was operated at the Legacy Health System Level. Staff #502 stated that each day staff at Legacy Health System determines which of their hospitals needed float pool staff and dispatched them accordingly. At the time of the interview, the Nursing Supervisor (Staff #501) confirmed the statement.

3. On 09/06/19 between 8:30 AM and 12:30 PM, during the Human Resources meeting, Surveyor #5 asked the hospital's Interim President (Staff #606) about the performance review for non-employee nursing staff. Staff #606 stated that non-employee nursing staff were trained and evaluated by the Legacy System Resource Pool Manager, who is not the director of nursing services at the hospital.
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Based on interview and document review, the hospital failed to ensure nursing staff implemented safe medication administration practices prior to medication administration (Item #1) and failed to ensure that all providers used aseptic technique during medication administration as observed in 2 of 2 surgical procedures (Patients #803 and #804) (Item #2).

Failure to practice safe medication administration practices risks medication error, patient infections, patient injury, and patient death.

Findings included:

Item #1 Medication orders

1. Document review of the hospital's policy titled, "Medications: Administration," policy number 900.3102, revision date 04/18, showed that medications are administered in accordance with the orders of a prescriber who is responsible for the patient's care and in accordance with law, regulation, and hospital standards. Nurses will scan the patient's medications and the patient's wristband immediately prior to medication administration. If the barcode is unreadable, the nurse will verify the 6 rights of correct medication administration (right patient, right drug, right dose, right time, right route, and right documentation).

2. On 09/03/19 at 3:15 PM, Surveyor #5, a Registered Nurse (RN) (Staff #506), and the Assistant Unit Manager (Staff #507) reviewed the medical record for Patient #501 who was admitted on 08/23/19 for the treatment of cellulitis, chest pain, dyspnea, and alcohol withdrawal. The review showed:

a. On 08/24/19 at 9:40 PM, Patient #501 scored a 12 on the CIWA Assessment (Clinical Institute Withdrawal Assessment) and nursing staff medicated the patient with 2 mg Ativan (a benzodiazepines used to treat anxiety) intravenously (IV). A physician order showed the patient should receive Ativan 2 mg IV for a CIWA score greater than or equal to 13 or greater or equal to 9 if the patient was not taking food by mouth (NPO). Surveyor #5 found no evidence the patient was NPO.

b. On 08/31/19 at 12:55 AM, Patient #501 had a glucose level of 155 mg/dl and nursing staff administered 3 units of NovoLog insulin subcutaneously. A physician order for a sliding scale insulin protocol showed that for a blood sugar of 140-180 mg/dl the patient was not to be administered any additional insulin.

c. On 09/01/19 at 12:37 AM, Patient #501 had a blood glucose level of 223 mg/dl and nursing staff administered 9 units of Novolog Insulin. A physician order for a sliding scale insulin protocol showed that for a blood sugar of 221-260 mg/dl the patient was to be administered only 5 units of NovoLog Insulin Subcutaneous.

3. At the time of the finding, #Staff 507 confirmed the medication errors. She stated that the specific insulin protocol was not normally used in the medical intensive care unit.
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Item #2 Aseptic Technique

Reference:
AORN 2019 The rubber septum on all vials should be disinfected with alcohol and allowed to dry before each entry. [3: Moderate Evidence]

1. Document review of the hospital's policy titled, "Medication Administration," policy #900.3102, revision date 04/18, showed that each time medications are administered, aseptic technique is used including cleansing the accessed rubber septum.

2. On 09/04/19 at 11:40 AM, Surveyor #8 observed the procedure for Patient #803. During the procedure the following observations were made:

a. The Registered Nurse (RN) (Staff #803) removed the non-sterile cap off the verapamil injection bottle and presented the medication bottle to the Surgical Technologist (ST) (Staff #807) without sanitizing the rubber septum.

b. Registered Nurse (RN) (Staff #803) removed the non-sterile cap off the Nitroglycerin bottle and presented the medication bottle for the Surgical Technologist (ST) (Staff #807) without sanitizing the rubber septum.

3. On 09/04/19 at 1:10 PM, Surveyor #8 observed the procedure for Patient #804. During the procedure the Surgical Tech (Staff #808) removed the non-sterile cap from a contrast dye bottle and failed to sanitize the rubber septum prior to inserting the intravenous (IV) spike of the IV tubing.

4. At the time of the observations, the Nurse Manager (Staff #806) confirmed the findins and reported she was not aware that the cap that is removed was not a sterile cover.
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Based on interview and document review, the hospital failed to ensure that medications were kept secure from unauthorized use.

Failure to secure medications risks unauthorized use, medication errors, and patient harm.

Findings included:

1. Document review of the hospital's policy titled, "Storage and Handling of Medications and Pharmaceutical Supplies in Patient Care Areas," policy number 900.3243, revised 06/19, showed that all medications must be kept in a secure area, and/or locked at all times. All non-controlled medications must be visibly observable in a staffed area or locked when in a patient care area that is not staffed.

2. On 09/06/19 at 10:25 AM, Surveyor #5, the Outpatient Rehab Supervisor (Staff #512), and the Rehabilitation Manager (Staff #513) inspected the Outpatient Physical Therapy Rehabilitation Center located in the hospital's Medical Office Building. During the inspection, Surveyor #5 asked Staff #512 and #513 if medications were stored in the Center. Staff #512 confirmed there were medications and opened an unlocked cupboard in the patient care area and retrieved a key to a locked cupboard adjacent to the unlocked cupboard in the patient care area. Surveyor #5 observed medications including 15 vials of dexamethasone 20 mg/5 mL (a corticosteroid medication used in the treatment of many conditions, including rheumatic problems, a number of skin diseases, severe allergies, asthma, chronic obstructive lung disease, croup, brain swelling, and along with antibiotics in tuberculosis).

3. At the time of the finding, Staff #513 confirmed the key to unlock the medication cupboard was stored in an unlocked cupboard in a patient care area.
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Based on observation, interview, and document review, the hospital failed to ensure that dietary staff members implemented procedures for food safety consistent with the 2009 Federal Drug Administration Food Code.

Failure to implement food safety requirements puts patients, staff, and visitors at risk for development of food borne illness.

Findings included:

Item #1 - Hand Hygiene

1. Document review of the Legacy Health System's "Hand Hygiene Policy," Policy #600.35, revised 08/19, showed that staff are to perform hand hygiene before putting on gloves, and wash hands with soap and water before serving food or drink. Policy #600.35 does not reference Legacy Salmon Creek Medical Center (LSCMC).

Document review of the Legacy Health System's "Sanitation-Food Utensil Handling & Serving," policy #150.309, revised 04/17, showed that staff are to keep hand contact to a minimum and use utensils and/or disposable gloves when handling raw ingredients. Food safety regulations for hospitals in Washington state, the 2009 Federal Drug Administration Food Code, requires that food employees may not contact exposed, ready-to-eat food with their bare hands. Policy #150.309 does not reference Legacy Salmon Creek Medical Center, but refers to Silverton Medical Center (an Oregon hospital).

2. On 09/05/19 between 12:30 PM and 2:00 PM, Surveyor #6 toured the Food & Nutrition department with LSCMC Clinical Nutrition Supervisor (Staff #601), and the LSCMC Executive Chef (Staff #602). The observation showed a food employee (Staff #604) don and doff food service gloves 3 times without washing her hands or performing any hand hygiene.

3. On 09/05/19 at 1:55 PM, Surveyor #6 interviewed Staff #604 about the hospital's policy and expectation regarding food service glove use. Staff #604 stated that gloves are to be changed to avoid cross contamination between different types of food. She stated that glove use is required when working at the grill. Staff #604 did not include hand washing in her description of required glove use.

4. On 09/05/19 at 2:00 PM, the surveyor interviewed the LSCMC dietary afternoon supervisor (Staff #603) about the hospital's policy and expectation regarding handwashing in relation to food service glove use. Staff #603 stated that gloves are to be changed between tasks, food employees are to wash hands frequently. She stated that hand washing is not required for every glove change.

Reference: 2009 FDA Food Code 2-301.14 (8); 3-301.11 (2)

Item #2 - Handwashing Sink Available for Use

1. On 09/05/19 at 2:30 PM, during a tour of the food service at the Creekside Café (an espresso/coffee bar), Surveyor #6 observed that the handwashing sink was filled with ice, making the sink inaccessible for handwashing.

2. At the time of the observation, the surveyor asked the LSCMC Executive Chef (Staff #602) about the hospital's policy and expectation regarding use of food service handwashing sinks. Staff #602 stated that food employees at LSCMC are trained to keep handwashing sinks available for handwashing at all times.

Reference: 2009 FDA Food Code 5-205.11 (2)

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Based on observation and interview, the hospital failed to ensure that patient care supplies were maintained with intact, non-absorbent, cleanable surfaces.

Failure to ensure patient care equipment and supplies have non-absorbent, cleanable surfaces places patients, staff, and visitors at increased risk of exposure to harmful microorganisms.

Findings included:

1. On 09/04/19, between 6:40 PM and 9:00 PM, Surveyor #6, the Accreditation & Clinical Compliance Consultant (Staff #614), and the Environmental Services (EVS) Evening Supervisor (Staff #615) observed the terminal cleaning of Operating Room #10 by an EVS staff member (Staff #616). Surveyor #6 observed cellophane tape securing the end cap on the boom arm of the ceiling mounted procedure lights.

2. At 9:00 PM, Surveyor #6 interviewed Staff #616 about the procedure for reporting damaged equipment. Staff #616 stated that she would report to her supervisor or complete an electronic work request. Staff #616 stated that the damaged boom arm had been reported but she was unsure of the date.

3. On 09/05/19 between 7:25 AM and 9:00 AM, Surveyor #6 and a Labor & Delivery Nurse (Staff #617) observed the between cases cleaning of Birthing Room #4E10b by an EVS staff member (Staff #618). The observation showed:

a. A wood-laminate covered drop-leaf cart had areas of exposed plywood. Plywood is an absorbent material and is not cleanable.

b. The surface of the computer-mouse pad on the anesthesia cart was peeling around the circumference, exposing unfinished rubber foam.

c. Two informational signs posted on the wall were constructed of paper, not protected by a cleanable surface or cover.

d. Foam bumpers on a ceiling mounted shelving unit had split areas and showed worn texture.

e. An arm cushion on the procedure bed had an area of exposed foam from a tear in the vinyl cover.

4 On 09/05/19 at 9:00 AM, Surveyor #6 interviewed Staff #618 about the procedure for reporting damaged equipment. Staff #618 stated that she would report to her supervisor or complete an electronic work request.
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Based on observation, document review, and interview, the hospital failed to ensure that hospital staff performed hand hygiene (HH) according to hospital procedure and accepted standards of practice (Item #1), failed to ensure that staff followed disinfectant manufacturer instructions (Item #2), failed to use effective disinfection methods during environmental cleaning procedures (Item #3), and failed to develop and implement a quality control system to prevent the use of patient care supplies that exceeded the manufacturer's expiration date (Item #4).

Failure to ensure staff members perform effective hand hygiene, protect patient care supplies and equipment from sources of contamination, and prevent the use of expired supplies risks ineffective patient care and increased exposure to harmful microorganisms.

Findings included:

Item #1 Hand Hygiene

1. Document review of the Legacy Health System's policy titled, "Hand Hygiene," Policy #600.35, revised 08/19, showed that hospital staff are to perform hand hygiene before putting on gloves and after removing gloves. The hand hygiene procedure for use of alcohol-based hand rub is to apply an appropriate amount, rub hands together until dry. Policy #600.35 does not reference Legacy Salmon Creek Medical Center (LSCMC).

2. On 09/03/19 between 1:10 PM and 2:50 PM, Surveyor #8 observed a knee-replacement surgery for patient #801. The observation showed that a Stryker manufacturer's Representative (Staff #801) dropped 4 implant boxes (storage box for implants and surgical components in their original, sterile packaging) on the floor (a contaminated surface). Staff #801 picked up the implant boxes and opened them without sanitizing the boxes or performing hand hygiene. The Nurse Circulator (Staff #803) then removed the implant from its box without performing hand hygiene or sanitizing the box.

3. On 09/03/18 at 3:00 PM, Surveyor #8 asked the OR Manager (Staff #809) and the Surgical Services Director (Staff #806) whether the hospital had a policy that allowed the use of surgical supplies that had come in contact with the floor. They reported the hospital did not have such a policy. Staff #809 and Staff #806 stated that hospital staff follow AORN standards.

4. On 09/04/19 between 1:20 PM to 2:45 PM, Surveyor #6 and the Environmental Services (EVS) Manager (Staff #612) observed the discharge cleaning of patient room 527B by a member of the EVS staff (Staff #613). The observation showed that Staff #613 did not perform hand hygiene in 8 of 11 glove changes observed. Staff #613 used an alcohol based hand rub prior to 3 of 11 glove changes observed, however she re-contaminated her hands by blowing on them prior to donning gloves in two of those observations.

Item #2 Disinfectant Use

1. Review of the manufacturer's product label for 3M Disinfectant Cleaner RCT Concentrate 40A and 40L states that surfaces treated with appropriately diluted disinfectant must remain wet for 3 minutes to ensure disinfection in healthcare settings.

Document review of the Legacy Health System's policy titled, "Basic Ten Steps of Discharge Cleaning," Policy #125.4001, revised 01/17, showed that staff are to disinfect surfaces and follow manufacturer recommended dwell time [the time a disinfectant is required to remain on a surface to effectively kill pathogens]. Policy #125.4001 does not reference Legacy Salmon Creek Medical Center (LSCMC).

2. On 09/04/19, between 1:20 PM to 2:45 PM, Surveyor #6 and the Environmental Services (EVS) Manager (Staff #612) observed the discharge cleaning of patient room 527B by a member of the EVS staff (Staff #613). The observation showed that Staff #613 used a disinfectant cloth to wipe glass surfaces, television and computer monitors, and the communication white board. Staff #613 followed the disinfectant cloth immediately with a dry cloth without allowing the 3 minute dwell time required by the manufacturer.

3. At the time of the observation, Surveyor #6 interviewed Staff #613 about disinfectant use. Staff #613 stated that was Number 40, it should remain wet for a few minutes, and it should air dry.

Item #3 Environmental Cleaning

1. Document review of the GlideScope Video Laryngoscopes User's Manual showed that the exterior of the monitor and scope cradle should be cleaned with IPA (Isopropyl Alcohol 70% Solution) wipes.

Document review of the Legacy Health System's procedure titled, "Operating Room and Procedural Areas: Environmental Cleaning and Terminal Cleaning," procedure #909.4005, reviewed 10/18, showed that environmental services and perioperative team members must disinfect anesthesia carts and equipment after each procedure, during Room Turnover, and between cases. Equipment identified in the anesthesia area include laryngoscope handles, cart tops, and the pyxis machine. Procedure #909.4004 does not reference Legacy Salmon Creek Medical Center (LSCMC).

2. On 09/04/19, between 6:40 PM and 9:00 PM, Surveyor #6, the Accreditation & Clinical Compliance Consultant (Staff #614), and the EVS Evening Supervisor (Staff #615) observed the terminal cleaning of Operating Room #10 by an EVS staff member (Staff #616). The observation showed:

a. Staff #616 used a long handled mop to disinfect the upper surfaces of ceiling mounted booms at 7:30 PM. At 8:20 PM Staff #615 used a long handled dust mop to "high dust" the upper surfaces of the booms. She did not re-disinfect those surfaces.

b. Staff #616 used a desk telephone during the terminal cleaning but failed to disinfect the telephone surfaces after use.

3. At 9:00 PM, Surveyor #6 interviewed Staff #616 about the hospital's expectation for disinfection during a terminal cleaning procedure. Staff #616 stated that all surfaces should be disinfected after every procedure, and during terminal cleaning. She stated that the booms and the telephone should have been disinfected again.

4. On 09/05/19 between 7:25 AM and 9:00 AM, Surveyor #6 and a Labor & Delivery Nurse (Staff #617) observed the between cases cleaning of Birthing Room #4E10b by an EVS staff member (Staff #618). The observation showed:

a. Staff #618 used a long handled dust mop to "high dust" surfaces around the room, including the ceiling mounted booms directly over the anesthesia cart and pyxis (automated medication dispensing system). Staff #618 did not disinfect the surfaces before completing the between case cleaning.

b. Staff #618 used a disinfectant cloth to wipe the top surface of a stainless steel tray and the support post of a Mayo stand (small, portable, surgical instrument stand), she did not disinfect the bottom of the tray or the wire tray support.

c. Surveyor #6 observed an accumulation of dust and dried debris on a GlideScope system. A label on the monitor stated, "Do not wipe with anything - damp water only."

5. At 9:00 AM Surveyor #6 interviewed Staff #618 about the hospital's expectation for disinfection during a between case cleaning procedure. Staff #618 stated that the booms should be positioned so that they are not directly above other equipment before being dusted or disinfected, and that all surfaces should be disinfected. Staff #618 stated that she doesn't clean the GlideScope and she did not know who does.

Item #4 Expired Supplies

1. Document review of the hospital's policy and procedure titled, "Checking Expiration Dates," policy number L.H.S.835.012, revised 07/06, showed that all items stocked in the perpetual inventory location are checked for expiration and all expired items are removed from service.

2. On 09/04/19 at 1:30 PM, Surveyor #5, the Family Birth Center Manager (Staff #508), and a Clinical Nurse Educator (Staff #509) inspected the neonatal resuscitation room. Surveyor #5 observed the following:

a. 1 bottle of alcohol hand gel with a manufacturers expiration of 08/16;

b. 1 bottle of alcohol hand gel with a manufacturers expiration of 09/17;

c. 1 blood tube with an expiration date of 07/18.

3. At the time of the observation, Staff #508 confirmed the finding and removed the expired supplies.

4. On 09/05/19 at 10:10 AM, Surveyor #5 and the Emergency Department Assistant Nurse Manager (Staff #510) inspected the hospital's Emergency Department. Surveyor #5 observed the following:

a. 1 Arrow Central Line Introducer Kit with a manufacturer's expiration date of 11/18;

b. 1 CathGuard 9 French Central Line with a manufacturer's expiration date of 04/30/19;

c. 4 Culture Swabs with a manufacturer's expiration date of 05/31/19;

d. 1 Arterial Line Kit with a manufacturer's expiration date of 08/31/19.

5. At the time of the observation, Staff #510 confirmed the findings and removed the expired supplies.
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Based on observation, interview and review of hospital's policies and procedures, the hospital failed to ensure that surgical staff and joint manufacturers' representatives followed standard infection control practices for traffic control (Item #1), surgical attire (Item #2), and aseptic technique (Item #3).

Failure to ensure staff members follow accepted aseptic procedures in surgery, hospital policy for surgical attire, and traffic control places patients and staff at risk for developing infections.

Item #1 Traffic Control

Reference: Association of periOperative Registered Nurses (AORN) Guideline for Sterile Technique (2019) - "Recommendations VII. Personnel should move within or around a sterile field in a manner that prevents contamination of the sterile field. Airborne contaminants and microbial levels in the surgical environment are directly proportional to the amount of movement and the number of people in the OR or other procedure room. VII. Doors to the operative or invasive procedure room should be kept closed as much as possible except during the entry and exit of patients, required personnel, and necessary equipment."

Findings included:

1. Document review of the hospital's policy titled, "Surgical Services-Operating Room & Interventional Suites Traffic Patterns in the Operating Room Suites, Cath Lab, Endo Suites, and Family Birth Operating Rooms," policy number 909.3107, reviewed 12/2018, showed traffic control in the restricted areas where sterile procedures are performed will be maintained to minimize the potential for cross contamination and to define appropriate environmental controls.

2. On 09/03/19 between 1:10 PM and 2:50 PM, Surveyor #8 and the Operating Room (OR) Manager (Staff #809) observed the knee surgery for Patient #801. During the procedure, the surveyor noted continual movements of staff leaving the Operating Room and re-entering with supplies.

3. At this time, Surveyor #8 asked the Operating Room Manager (Staff #809) if he was aware of the number of times the staff were entering and exiting through the OR door, he said "no". Surveyor #8 asked how they monitored the traffic flow in and out of the OR and if so, what were their findings or benchmark. Staff #809 reported they do not monitor traffic patterns in the operating rooms.

4. On 09/06/18 at 4:10 PM during the infection control meeting, Surveyor #3 and Surveyor #8 asked the IP regarding the monitoring of traffic patternsfor the operating rooms. The IP reported she was not aware of monitoring movements in the OR.

Item #2 Surgical Attire

Findings included:

1. Document review of the hospital's policy titled, "Restricted and Semi Restricted Area Attire and Peri-Operative Attire," Policy #909.3604, revised 08/18, showed that masks will be worn when there are open sterile supplies and if sterile instruments or scrubbed personnel are present in an OR/procedural room. The mask will be tied and securely fit to the face to prevent venting, The mask should also cover the mouth and nose. All head hair will be contained within a disposable surgical head covering. Beards, sideburns and other facial hair will be contained within a disposable covering.

2. On 09/03/19 between 1:10 PM and 2:00 PM, Surveyor #8 and the OR Manager (Staff #809) observed the knee replacement surgery for Patient #801. The observation showed:

a. The Physician's Assistant (PA) (Staff #805) working in the sterile field, wore a surgical mask that did not encompass his facial hair.

b. The Physician's Assistant (PA) (Staff #805) working in the sterile field, wore a surgical cap that partially covered his head hair.

c. The Surgeon (Staff #804) working in the sterile field, wore a surgical cap that did not cover his head hair at the nape of his neck, nor his side-burns.

d. The Circulating Nurse (Staff #803) wore a surgical mask that did not encompass his facial hair

e. At 1:40 PM, the Anesthesia Provider (Staff #802) removed his mask and blew his nose during the surgical procedure.

f. The Stryker Representative (Stryker Rep) (Staff #801) wore a surgical cap that did not cover her hair during the surgical procedure.

3. On 09/03/19 at 2:19 PM, Surveyor #8 and the OR Manager (Staff #809) observed the procedure for Patient #802. The observation showed:

a. The X-ray technician (Staff #810) in the OR was not wearing a surgical mask while sterile instruments were open to the sterile field.

b. Surgeon (Staff #811) wore a surgical mask that did not cover his beard.

4. On 09/03/18 at 3:00 PM, Surveyor #8 interviewed the Director of Surgical Services (Staff #806) and the OR Manager (Staff #809). The manager confirmed that the surgery department follows AORN guidelines and that staff have a hard time adhering to the attire policies.

Item #3 Aseptic Technique

Reference: Association of periOperative Registered Nurses (AORN) Guideline for Environmental Cleaning (2019) - "Recommendations II. The patient should be provided with a clean, safe environment. II.e. Floors in the perioperative practice setting should be considered contaminated at all times. II.e.1. Items that contact the floor for any amount of time should be considered contaminated.

(AORN) Guideline for Hand Hygiene (2019) -"Recommendations II. Decontaminate hands after contact with inanimate objects (including medical equipment) in the vicinity of the patient. III. Perioperative team members should perform hand hygiene. III. a. Personnel should perform hand hygiene: 2. Before performing a clean or sterile task (opening sterile supplies); 4. After contact with patient surroundings (inanimate surfaces and objects, including medical equipment, in the immediate vicinity of the patient; the floor or items that have come in contact with the floor)."

Findings included:

1. On 09/03/19 between 1:10 PM and 2:50 PM, Surveyor #8 and the OR Manager (Staff #809) observed a knee replacement surgery for Patient #801. The observation showed that during the procedure, a Stryker Representative (Staff #801) entered the operating room carrying sterile knee implants in 4 cellophane wrapped boxes. After entering the OR, Staff #801 dropped the sterile implant boxes on to the floor. The boxes were labeled:

a. Triathion Cruciate Retaining Left Femur;

b. Primary Tibial Case Plate #3;

c. Triathion Symmetric Patellar S31mm;

d. Tibial Bearing set #3.

2. The Stryker Rep (Staff #801) picked up the boxes from the floor and proceeded to open them one at a time to the Circulating RN (Staff #813). The sterile knee implant boxes that had just been contaminated by contact with the floor were not disinfected prior to being opened.

3. On 09/03/18 at 3:00 PM, Surveyor #8 interviewed the OR Manager (Staff #809) and the Surgical Services Director (Staff #806) about the hospital's OR policies and procedures. Staff #809 and Staff #806 confirmed that the hospital follows AORN standards. When asked if they had a hospital policy that allowed dropped sterile implants and sterile supplies to be picked up and opened to a sterile table, they reported they did not have a policy. Surveyor #8 asked about the lack of hand hygiene observed, Staff #806 and #809 did not provide a verbal response.