HospitalInspections.org

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Based on interview, record review, and review of hospital policies and procedures, the hospital failed to ensure that orders for restraints to manage violent or self-destructive behavior did not exceed four hours for adults and two hours for children and adolescents 9 to 17 years of age, as demonstrated by 3 of 4 patients reviewed (Patients #301, #302, #303, #304).

Failure to follow established procedures for restraints risks physical and psychological harm, loss of dignity, and violation of patient rights.

Findings included:

1. Document review of the hospital policy and procedure titled, "Management of Restraints and Seclusion," policy number PS-012, last revised 03/14/19, showed that implementation and application of restraints or seclusion requires an order from a provider. The order is for a single episode with defined and specific time limits. Restraint orders for emergency behavior management is time limited to four hours for patients greater than 18 years of age. Restraint orders for emergency behavior management is time limited to two hours for patients ages 9 to 17.

2. On 11/05/20 at 12:15 PM, Investigator #3 and the Quality Management clinical abstractor (Staff #301) reviewed the medical records of four patients who were restrained during their hospitalization for violent or self-destructive behavior. The review showed:

a. Patient #301 was a 32-year old patient admitted to the hospital's emergency department (ED) on 10/25/20 for treatment of acute alcohol intoxication. Shortly after arrival to the ED at 1:05 AM, the patient became severely agitated and became a danger to himself and others. A "Code Gray" (behavioral health emergency) was called and the patient was placed in 4-point restraints at 1:15 AM on 10/25/20. A verbal order taken by a Registered Nurse at the time of the Code Gray was written at 4:15 AM on 10/25/20 (3 hours after the patient was placed in restraints).

There were no further orders written for restraints. The patient remained in restraints and was transferred to the Critical Care Unit on 10/25/20 at 1:15 PM. Orders for continuation of restraints were not written as directed by hospital policy.

b. Patient #302 was a 50-year old patient with a past medical history of depression and anxiety admitted to the hospital's ED on 09/08/20 at 3:15 AM for a psychological evaluation by the county designated crisis responder for possible inpatient admission.

On 09/08/20 at 12:00 PM, Patient #302 walked into a neighboring patient's area and became agitated and began yelling. A "Code Gray" was called and Patient #302 was placed in 4-point restraints. No orders were written for restraints. The patient remained in restraints and was transferred to the Critical Care Unit on 09/09/20 at 12:45 AM (a period of 12 hours and 45 minutes). Orders for restraints were not written at least every four hours as directed by hospital policy.

c. Patient #304 was a 15-year old admitted to the hospital's ED on 06/25/20 for psychological evaluation after complaining of suicidal ideation. The patient was placed in 4-point restraints for behavior that was deemed a danger to self and others at 11:15 PM on 06/25/20. The patient remained in restraints until 7:15 AM at 06/26/20. The provider wrote an order for restraints due to self-destructive behavior at 11:29 PM on 06/25/20. The next restraint order was written at 6:00 AM on 06/26/20. The restraint orders were not written at least every two hours as directed by hospital policy.

3. On 11/05/20 at approximately 2:00 PM, during an interview with the investigator, the Quality Management clinical abstractor (Staff #301) confirmed that staff had not followed the hospital's restraint and seclusion policy for continuation or renewal of restraint orders.
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Based on record review, interview, 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 3 of 4 patients reviewed (Patients #301, #302 and #303).

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, "Management of Restraints and Seclusion," policy number PS-018, last revised 03/14/19, showed that when a restraint is ordered for violent or self-destructive behavior, a provider must see and evaluate the need for restraint within one hour after initiation of the intervention. The policy did not include the four elements which need to be evaluated during the face-to-face assessment.

2. On 11/05/20 at 12:15 PM, Investigator #3 and the Quality Management clinical abstractor (Staff #301) reviewed the medical records of four patients who were restrained during their hospitalization for violent or self-destructive behavior. The review showed:

a. On 10/25/20, at 1:15 AM, emergency department (ED) staff placed Patient #301 in 4-point restraints for violent aggressive behavior following a "Code Gray". The investigator found no documentation that a licensed independent practitioner or provider performed a 1-hour face-to-face assessment.

b. On 09/08/20 at 7:30 AM, ED staff placed Patient #302 in 4-point restraints for violent aggressive behavior following an assault on a ED staff. The investigator found no documentation that a licensed independent practitioner or provider performed a 1-hour face-to-face assessment.

c. On 05/16/20 at 6:15 PM, ED staff placed Patient #303 in 2-point restraints for agitated and aggressive behavior. The investigator found no documentation that a licensed independent practitioner or provider performed a 1-hour face-to-face assessment.

3. On 11/05/20 at approximately 2:30 PM, Investigator #3 interviewed the Chief Nursing Officer (Staff #302) about the one-hour face-to-face assessment. Staff #302 confirmed that the initial one-hour face-to-face assessment is to be completed by the credentialed provider staff.
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Based on interview, document review, and review of hospital policies and procedures, the hospital failed to ensure that nursing staff members provided nursing care in accordance with the patient's health care needs.

Failure to follow hospital policy and procedure and recognized standards of care for nursing oversight for patient assessments, reassessment, evaluation, and treatment puts patients at risk for delayed treatment, inappropriate treatment, poor health care outcomes, or patient harm.

Findings included:

1. Failure to perform and document patient's functional status, psychosocial, and educational assessments.

2. Failure to perform and document pain assessments and reassessments.

Cross Reference A0392

3. Failure to develop and implement Emergency Department (ED) policies and procedures that define Standards of Care/Standards of practice to direct ED staff when and how to assess, reassess, and care for patients held for an extended length of time in the ED.

4. Failure to ensure that staff completed required specialized fall risk assessments.

Cross Reference A0395

5. Failure to develop and keep current an individualized plan of care.

Cross Reference A0396

6. Failure to ensure staff follow hospital policy for verbal orders given by a provider.

7. Failure to document medications administered based on those verbal orders.

8. Failure to ensure that nursing staff followed provider orders for medication administration

Cross Reference A0405

9. Failure to ensure nursing staff members performed transfusion services procedures according to hospital policy and procedure.

Cross Reference A0410

Due to the scope and severity of these deficiencies, the Condition of Participation at 42 CFR 482.23, Nursing Services was NOT MET

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Item #1 Functional Assessments

Based on document review and interview, the hospital failed to ensure that staff performed and documented appropriate functional assessments on admission for 3 of 4 inpatient medical records reviewed (Patient #505, #506, and #507).

Failure to assess patient's functional status risks inconsistent, inadequate, or delayed response to patient needs.

Findings included:

1. Document review of the hospital's policy and procedure titled, "Patient Services Policy and Procedure," policy number PS011, revised 08/09/08, showed the following:

-The patient admission assessment occurs upon patient admission and must be initiated by the Registered Nurse (RN) within 2 hours of the admission.

-An admission assessment is used to provide the RN with baseline data to plan the hospitalization period and to identify problems the nursing care plan can solve.

-Essential elements of an admission assessment include physical examination, assessment of pain, safety, psychological, nutritional, social, functional, and self-care capabilities.

Document review of the hospital's policy and procedure titled, "Nursing Admission Assessment and Reassessment," policy number PS-006, reviewed 09/07/20, showed that the essential elements of the admission assessment include a psychological assessment, a social assessment, a functional assessment, and a patient/family education assessment.

2. On 11/04/20 at 11:45 AM, Investigator #5 and a Registered Nurse (Staff #506) reviewed the medical record for Patient #505 who was admitted on 10/27/20 with cellulitis, osteomyelitis, and acute kidney injury. The reviewed showed that the staff did not complete a functional assessment as directed by hospital policy.

3. At the time of the observation, Staff #506 confirmed the finding and stated that staff should have completed the functional assessment.

4. On 11/04/20 at 2:55 PM, Investigator #5 and the Director of Critical Care Unit (CCU) (Staff #501) reviewed the medical record for Patient #506 who was admitted for low blood pressure, dehydration, pancreatic cancer, and colitis. The patient's history showed end stage muscular dystrophy and that he was wheelchair bound. The review showed that staff assessed the patient with increased weakness and as a high risk for fall, but assessed the patient's functional status as normal.

5. At the time of the observation, Staff #501 verified the finding and stated that the patient's functional status should not have been documented as normal.

6. On 11/05/20 at 10:30 AM, Investigator #5 and a Registered Nurse (RN) (Staff #511) reviewed the medical record for Patient #507 who was admitted for a Left Total Knee Replacement. The review showed that the staff did not complete a psychosocial assessment, a functional assessment, or conduct an education screening assessment as directed by hospital policy.

7. At the time of the observation, Staff #511 verified the finding.

Item #2 Psychosocial and Education assessments

Based on document review and interview, the hospital failed to ensure that staff performed and documented psychosocial and education assessments on admission for 2 of 4 inpatient medical records reviewed (Patient #505 and #507).

Failure to assess patients psychosocial and educational status risks inconsistent, inadequate, or delayed response to patient needs.

Findings included:

1. Document review of the hospital's policy and procedure titled, "Patient Services Policy and Procedure," policy number PS011, revised 08/09/08, showed the following:

-The patient admission assessment occurs upon patient admission and must be initiated by the Registered Nurse (RN) within 2 hours of the admission.

-An admission assessment is used to provide the RN with baseline data to plan the hospitalization period and to identify problems the nursing care plan can solve.

-Essential elements of an admission assessment include physical examination, assessment of pain, safety, psychological, nutritional, social, functional, and self-care capabilities.

-The RN who completes the patient admission assessment will assess the patient's educational needs. The assessment of the patient's learning needs is documented on the Patient/Family Education Screen.

Document review of the hospital's policy and procedure titled, "Nursing Admission Assessment and Reassessment," policy number PS-006, reviewed 09/07/20, showed that the essential elements of the admission assessment include a psychological assessment, a social assessment, a functional assessment, and a patient/family education assessment.

2. On 11/04/20 at 11:45 AM, Investigator #5 and a Registered Nurse (Staff #506) reviewed the medical record for Patient #505 who was admitted on 10/27/20 with cellulitis, osteomyelitis, and acute kidney injury. The review showed that the staff did not complete a psychosocial assessment or an education assessment as directed by hospital policy.

3. At the time of the observation, Staff #506 confirmed the finding and stated that staff should have completed the above assessments.

4. On 11/05/20 at 10:30 AM, Investigator #5 and a Registered Nurse (RN) (Staff #511) reviewed the medical record for Patient #507 who was admitted for a Left Total Knee Replacement. The patients had confusion and sundowning (a symptom of Alzheimer's Disease where confusion and agitation get worse in the late afternoon and evening). The review showed that the staff did not complete a psychosocial assessment or conduct an education screening assessment as directed by hospital policy.

5. At the time of the observation, Staff #511 verified the finding.

Item #3 Pain Assessment and Reassessment

Based on interview, record review, and review of policy and procedure, the hospital failed to ensure staff members completed and documented pain assessments and reassessments for each pain management intervention for 6 of 6 patient records reviewed (Patient #505, #506, #507, #508, #509, and #510).

Failure to assess and reassess a patient's pain risks inconsistent, inadequate, or delayed relief of pain and risks patient harm related to delayed recognition of adverse effects of pain medication.

Findings included:

1. Document review of the hospital's policy and procedure titled, "Pain Management," policy number PS-079, reviewed 08/21/18 showed the following:

a. A patient assessment is completed utilizing the admission assessment and shift assessment screens which first address if pain/comfort management is within normal limits. Additional questions address, but are not limited to, ability to communicate degree of pain, assessment behavioral scale, pain goal, current pain rating and location, whether acute or chronic in character, location and specific interventions.

b. A pain assessment is required anytime pain is reported or observed.

c. Mild pain equals a score of 1/10-3/10, Moderate pain equals 3/10-5/10, and severe uncontrolled pain equals 6/10-10/10. The policy requires a review of current pain therapy and interventions to improve pain when the score is greater than 3/10.

d. Pain is reassessed within one hour of pharmacological intervention as appropriate to the medication used.

2. On 11/04/20 at 11:45 AM, Investigator #5 and a Registered Nurse (Staff #506) reviewed the medical record for Patient #505 who was admitted on 10/27/20 with cellulitis, osteomyelitis, and acute kidney injury. The review showed:

a. Staff failed to complete a pain assessment as directed by hospital policy for 2 of 3 episodes of pain with pain medication administration.

b. Staff failed to complete a pain reassessment as directed by hospital policy for 2 of 3 episodes of pain with pain medication administration.

3. At the time of the observation, Staff #506 verified the findings and stated that staff should have documented pain assessment and reassessments.

4. On 11/04/20 at 2:55 PM, Investigator #5 and the Director of Critical Care Unit (CCU) (Staff #501) reviewed the medical record for Patient #506 who was admitted for low blood pressure, dehydration, pancreatic cancer, and colitis. The patient's history showed end stage muscular dystrophy and the patient was wheelchair bound. The review showed that staff failed to complete a pain reassessment for 2 of 2 episodes of pain with pain medication administration.

5. At the time of the observation, Staff #506 verified the findings and stated that staff should have documented pain reassessments.

6. On 11/05/20 at 10:30 AM, Investigator #5 and a Registered Nurse (RN) (Staff #511) reviewed the medical record for Patient #507 who was admitted for a Left Total Knee Replacement. The review showed that staff failed to complete a pain reassessment for 1 of 4 episodes of pain with pain medication administration.

7. At the time of the observation, Staff #511 verified the findings and stated that staff should have documented complete pain reassessments.

8. On 11/06/20 at 11:30 AM, Investigator #5 and the Director of the Critical Care Unit (Staff #501) reviewed the medical record for Patient #508 who was admitted for abdominal pain. The review showed the following:

a. Staff failed to complete a pain assessment as directed by hospital policy for 2 of 5 episodes of pain with pain medication administration.

b. Staff failed to complete a pain reassessment as directed by hospital policy for 1 of 5 episodes of pain with pain medication administration.

9. At the time of the observation, Staff #501 verified the findings and stated that staff should have documented complete pain assessments and reassessments.

10. On 11/06/20 at 2:30 PM, Investigator #5 and the Director of the Critical Care Unit (Staff #501) reviewed the medical record for Patient #509 who was admitted for a stroke. The review showed that staff failed to document a pain reassessment as directed by hospital policy for 1 of 1 episodes of pain with pain medication administration.

11. At the time of the observation, Staff #501 verified the findings and stated that staff should have documented a pain reassessment as directed by hospital policy.

12. On 11/06/20 at 3:00 PM, Investigator #5 and the Director of the Critical Care Unit (Staff #501) reviewed the medical record for Patient #510 who was admitted for chest pain and a urinary tract infection. The review showed that staff failed to document a pain reassessment as directed by hospital policy for 1 of 4 episodes of pain with pain medication administration.

13. At the time of the observation, Staff #501 verified the findings and stated that staff should have documented a pain reassessment as directed by hospital policy.
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Item #1 - Boarding Patients in the Emergency Department

Based on observation, interview, and record review, the hospital failed to develop and implement Emergency Department (ED) policies and procedures that define Standards of Care/Standards of practice to direct ED staff when and how to assess, reassess, and care for patients held for an extended length of time in the ED for 3 of 3 patients reviewed (Patients #308, #309, #310).

Failure to develop and implement policies to direct patient assessment and care puts patients at risk for inconsistent, inadequate, delayed, and unsafe care.

Findings including:

1. Document review of the hospital's policy and procedure titled, "Falls Management," policy number PS-106, last revised 02/15/18 showed that inpatients are assessed for falls upon admission and every shift. Outpatients are assessed, interventions developed, and documented according to the specific patient population, setting, and service. The outpatient fall protocol for the ED showed that all ED patients are considered at risk for falls. The ED module for falls assessment should be used. The policy did not address how often a falls assessment must be completed for patients being cared for in the ED.

2. On 11/04/20 at 11:25 AM, Investigator #3 interviewed an ED Registered Nurse (Staff #308) about patients boarding in the ED. Staff #308 acknowledged that she was unaware of any hospital policy which describe the standards of care for patients boarding in the ED. Staff #308 stated that staff are expected to complete a shift and falls assessment on every patient they cared for in the ED regardless of their length of stay.

3. On 11/05/20 and 11/06/20, Investigator #3 and the Quality Management clinical abstractor (Staff #301) reviewed the medical records of four patients who had extended stays in the ED (beyond 24 hours) prior to admission or transfer to another facility. The review showed:

a. Patient #308 was an 84-year-old who was transferred by ambulance to the ED on 07/10/20 for a mental health evaluation after becoming agitated, assaultive of staff, and attempted to climb out of a window in the nursing care facility where she resided. The patient was evaluated, assessed, and was medically cleared to return to her facility on 07/10/20. The review showed the nursing care facility was unwilling to accept the patient back. Social Services was consulted for placement at a long-term care or geriatric psychiatric facility. The patient remained in the ED until 07/30/20 (a 20-day period) when she was admitted to the hospital for weakness and failure to thrive. During her stay at the ED, the patient suffered a fall on 07/23/20. A review of the ED fall assessments showed that the patient received a falls assessment by the nursing staff every 24 hours instead of every shift (12 hours). Also, the patient was noted for not receiving a falls assessment for two 24-hour periods. A review of the ED shift assessments showed that the patient did not receive an assessment by the nursing staff every 12 hours on 5 separate occasions and did not receive an assessment for one 24-hour period during her stay in the ED.

b. Patient #309 was a 92-year old who was transferred to the ED by ambulance on 07/10/20 for a mental health evaluation after becoming agitated at the nursing home which resulted in the patient kicking out a window screen. The patient was evaluated, assessed, and was medically cleared to return to her facility on 07/11/20. The review showed that the nursing care facility was unwilling to accept the patient back. Social Services was consulted for placement at a long-term care facility. The patient remained in the ED until 07/21/20 (a 10-day period) when she was transferred to a long-term care facility. A review of the ED falls assessment showed that the patient received a falls assessment by the nursing staff every 24 hours instead of every shift (12 hours). Also, the patient was noted for not receiving a falls assessment for one 24-hour period. A review of the ED shift assessments showed that the patient did not receive an assessment by the nursing staff every 12 hours on 5 separate occasions during her stay in the ED.

c. Patient #310 was an 82-year old who transferred to the ED on 11/02/20 for increase in falling and right knee pain. The patient was evaluated, assessed, and was medically cleared on 11/03/20. Social Services was consulted for placement at a long-term care facility as the patient was unable to care for herself. The patient remained in the ED until 11/05/20 (4-day period) when she was transferred to a long-term care facility. A review of the ED falls assessment showed that the patient received a falls assessment by the nursing staff every 24 hours instead of every shift (12 hours). A review of the ED shift assessments showed that the patient did not receive an assessment by the nursing staff for a 29-hour period during her stay in the ED.

d. At the time of the record review, Staff #301 confirmed the missing assessments for falls and shift assessments.

4. On 11/04/20 at 5:04 PM, Investigator #3 interviewed the Director of Hospital Education (Staff #307) about the boarding of patients in the hospital's Emergency Department. Staff #307 stated the hospital did not have a hospital policy which defines the standard of care for patients "boarding in the Emergency Department".

Item #2 - Hourly Rounding following Falls

Based on record review, interview, and review of hospital policies and procedures, the hospital failed to ensure that staff completed required specialized assessments for 4 of 4 patient records reviewed (Patients #704, #705, #706, and #707).

Failure to ensure staff perform hourly rounding following a fall for 48 hours, places patients at greater risk for additional falls and possible bodily injury.

Findings included:

1. Document review of the hospital's policy titled, "Fall Management," policy number PS- 106, last revised 02/15/18, showed that patients will receive hourly rounding for 48 hours following a fall.

2. On 11/06/20 at 8:55 AM, Investigator #7 and a Quality Improvement Specialist (Staff # 702), reviewed the records of four patients who suffered a fall during their hospitalization. The review showed:

a. Patient #704 is a 55-year-old female who was admitted on 05/06/20 for abdominal pain. The patient sustained a fall on 05/09/20 at 3:25 PM. Investigator #7 found no documentation to show that the patient received hourly rounding for the first eight hours following their fall, as required by the hospital policy. The patient then received the required hourly rounding from 3:49 PM on 05/10/20 until 5:30 PM of that same day. The investigator found no documentation that hourly rounding was performed as required for the remainder of the 48-hour period following the fall.

b. Patient #705 is a 64-year old male who was admitted to the medical-surgical unit after undergoing a right below knee amputation. The patient sustained a fall on 05/15/20 at 1:10 PM, while attempting to independently transfer from his bed to a chair. The Investigator found no evidence that hourly rounding was performed or documented from 12:00 AM to 8:00 AM on 05/17/20 (an 8-hour period).

c. Patient #706 is a 64-year old female, who was seen in the Emergency Department (ED) on 05/25/20 at 4:38 for ambulatory dysfunction and urinary tract infection. The patient sustained a fall at 7:25 PM while attempting to ambulate from the lobby to her room in the ED. Investigator #7 found no documentation that hourly rounding was performed after the fall as required by the hospital policy.

d. Patient #707 is a 63-year old male who was admitted on 09/20/20 for shortness of breath. The patient sustained a fall on 09/20/20 at 8:55 PM. Investigator #7 found no documentation that hourly rounding was performed for the first 4 hours after the fall. The patient then received hourly rounding from 09/21/20 at 1:00 AM until 09/21/20 at 8:34 PM. Further review showed that the patient received rounding every 2 hours for the next 24-hour period instead hourly rounding for the full 48 hours, as required by the hospital policy.

3. At the time of the review, Investigator #7 interviewed the Quality Improvement Specialist (Staff #702) about the findings described above. Staff #702 confirmed the findings and acknowledged that hourly rounding was not performed for the required minimum of 48 hours for these patients.
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Based on interview, record review, and review of policies and procedures, the hospital failed to develop and keep current an individualized plan of care for 3 of 4 patients reviewed (Patient #505, #506 and #507).

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, "Patient Services Policy and Procedure," policy number PS011, revised 08/09/08, showed the following:

-The care plan will be individualized to reflect the needs and condition specific to each individual patient. The care plan will be reviewed at least once per shift.

2. On 11/04/20 at 11:45 AM, Investigator #5 and a Registered Nurse (Staff #506) reviewed the medical record for Patient #505 who was admitted on 10/27/20 with cellulitis, osteomyelitis, and acute kidney injury. The review showed that the patient was assessed as a high risk for fall and was experiencing pain that he was receiving pain medication. Investigator #5 found no evidence that high fall risk and pain management were included in the patients plan of care.

3. At the time of the observation, Staff #506 verified the findings and stated that the care plan should have been updated.

4. On 11/04/20 at 2:55 PM, Investigator #5 and the Director of Critical Care Unit (CCU) (Staff #501) reviewed the medical record for Patient #506 who was admitted for hypotension, dehydration, pancreatic cancer, and colitis. The patient's history showed end stage muscular dystrophy and that he was wheelchair bound. Staff assessed the patient with increased weakness and at high risk for falling. Investigator #5 found no evidence that high fall risk was included in the patients plan of care.

5. At the time of the observation, Staff #501 verified the findings and stated that the care plan should have been updated.

6. On 11/05/20 at 10:30 AM, Investigator #5 and a Registered Nurse (RN) (Staff #511) reviewed the medical record for Patient #507 who was admitted for a Left Total Knee Replacement. The review showed that the patient was assessed as a high risk for fall, was experiencing pain that he was receiving pain medication for, was constipated, and that he had a surgical wound. Investigator #5 found no evidence that high fall risk, pain management, alteration in integumentary, or alteration in gastrointestinal function were included in the patients plan of care.

7. At the time of the observation, Staff #511 verified the findings and stated that the care plan should have been updated.
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Item #1 Verbal Orders

Based on record review, interview, and review of hospital policy and procedures, the hospital failed to ensure staff follow its policy for verbal orders given by a provider for 4 of 4 records reviewed (Patients #305, #306, #307, and #308).

Failure to follow the hospital's policy on verbal orders puts patients at risk for medication errors and patient harm.

Findings included:

1. Document review of the hospital's policy and procedure titled, "Verbal and Written Orders," policy number PS141, last reviewed 05/20/19, showed that all orders shall be electronically entered or written into the medical record of the patient. Verbal orders shall be received and entered into the electronic medical record (EMR) by the Registered Nurse. If the EMR is not available, the verbal order will be written on the physician order sheet by the person receiving the order. With the order, there will be an indication that a read back process was conducted. The person receiving the verbal order will sign the written order. The prescribing practitioner must sign the written/electronic record of the verbal order within 48 hours of giving the order.

2. On 11/06/20 at 9:00 AM, Investigator #3 and the Quality Management clinical abstractor (Staff #301) reviewed the medical records of five patients who underwent a clinical procedure in the hospital's cardiac catheterization laboratory. The review showed:

a. Patient #305 is a 65-year old patient admitted to the hospital's cardiac catheterization laboratory on 10/06/20 for a left heart catheterization and coronary artery stent placement. The hospital document titled, "Procedural Medication Report for Cath Lab" listed the 10 medications administered during the procedure. The investigator could find no documentation that showed who (provider) ordered the medications, which clinician (nurse) took the verbal order, and that those verbal orders were authenticated by the ordering physician.

Patient #305 underwent a second procedure in the hospital's cardiac catheterization laboratory on 10/07/20 for acute stent thrombosis (clot). The investigator could find no documentation of the medications that the patient received during this procedure. A pharmacy PYXIS report showed that a medication override withdrawal (indicating no active order was present) was taken for fentanyl (pain medication) and midazaolam (sedating medication) for the patient. The investigator could find no documentation that showed who (provider) ordered the medications, which clinician (nurse) took the verbal order, and that those verbal orders were authenticated by the ordering physician. The hospital medical records department and cardiac catheterization staff were unable to locate those documents when requested.

b. Patient #306 is a 79-year old patient admitted to the hospital's cardiac catheterization laboratory on 10/10/20 for a left heart catheterization. The investigator could find no documentation of the medications that the patient received during this procedure. A pharmacy PYXIS report showed that a medication override withdrawal (indicating no active order was present) was taken for fentanyl (pain medication) and midazaolam (sedating medication) for the patient. The investigator could find no documentation that showed who (provider) ordered the medications, which clinician (nurse) took the verbal order, and that those verbal orders were authenticated by the ordering physician. The hospital medical records department and cardiac catheterization staff were unable to locate those documents when requested.

c. Patient #307 is a 63-year old patient admitted to the hospital's cardiac catheterization laboratory on 10/11/20 following a "Code STEMI" (emergency code for a heart attack) in the hospital. The patient underwent a left heart catheterization and coronary artery stent placement. The hospital document titled, "Procedural Medication Report for Cath Lab" listed the 20 medications administered during the procedure. The investigator could find no documentation that showed who (provider) ordered the medications, which clinician (nurse) took the verbal order, and that those verbal orders were authenticated by the ordering physician.

d. Patient #308 is a 79-year old patient admitted to the hospital's cardiac catheterization laboratory on 10/12/20 for left heart catheterization and coronary artery stent placement. The investigator could find no documentation of the medications that the patient received during this procedure. A pharmacy PYXIS report showed that a medication override withdrawal (indicating no active order was present) was taken for fentanyl (pain medication) and midazaolam (sedating medication) for the patient. The investigator could find no documentation that showed who (provider) ordered the medications, which clinician (nurse) took the verbal order, and that those verbal orders were authenticated by the ordering physician. The hospital medical records department and cardiac catheterization staff were unable to locate those documents when requested.

3. At the time of the review, Investigator #3 interviewed the Quality Management clinical abstractor (Staff #301) about the hospital policy for verbal orders. Staff #301 confirmed that staff had not followed the hospital policy.

4. On 11/06/20 at 11:41 AM, Investigator #3 interviewed a Registered Nurse (Staff #306) who works in the hospital's cardiac catheterization laboratory. Staff #306 stated that she receives verbal orders from the provider for medications given during the procedure. Those medications are recorded on the "Procedural Medication Report for Cathlab" as verbal orders with readback and then sent to the Pharmacy after the case is completed. Staff #306 did not know if the ordering provider signed this form later in medical records.

Item #2 Documenting medications administered

Based on record review, interview, and review of hospital policy and procedures, the hospital failed to document medications administered based on verbal orders given for 3 of 4 records reviewed (Patients #305, #306, and #308).

Failure to document medications administered puts patients at risk for medication errors and patient harm.

Findings included:

1. Document review of the hospital's policy and procedure titled, "Administration of Medications," policy number PS063, last revised 03/06/20, showed that the time the medication was given will be noted on the electronic medication administration record (eMAR). The patient's response to medications must be monitored and documented.

2. On 11/06/20, Investigator #3 and the Quality Management clinical abstractor (Staff #301) reviewed the medical records of five patients who underwent a clinical procedure in the hospital's cardiac catheterization laboratory. The review showed:

a. Patient #305 is a 65-year old who underwent a procedure in the hospital's cardiac catheterization laboratory on 10/07/20 for acute stent thrombosis (clot). The investigator could find no documentation of the medications that the patient received during this procedure including the dosage, route of administration, and time of administration. A pharmacy PYXIS report showed that a medication override withdrawal (indicating no active order was present) was taken for fentanyl (pain medication) and midazaolam (sedating medication) for the patient. The hospital medical records department and cardiac catheterization staff were unable to locate those documents when requested.

b. Patient #306 is a 79-year old patient admitted to the hospital's cardiac catheterization laboratory on 10/10/20 for a left heart catheterization. The investigator could find no documentation of the medications that the patient received during this procedure including the dosage, route of administration, and time of administration. A pharmacy PYXIS report showed that a medication override withdrawal (indicating no active order was present) was taken for fentanyl (pain medication) and midazaolam (sedating medication) for the patient. The hospital medical records department and cardiac catheterization staff were unable to locate those documents when requested.

c. Patient #308 is a 79-year old patient admitted to the hospital's cardiac catheterization laboratory on 10/12/20 for left heart catheterization and coronary artery stent placement. The investigator could find no documentation of the medications that the patient received during this procedure including the dosage, route of administration, and time of administration. A pharmacy PYXIS report showed that a medication override withdrawal (indicating no active order was present) was taken for fentanyl (pain medication) and midazaolam (sedating medication) for the patient. The hospital medical records department and cardiac catheterization staff were unable to locate those documents when requested.

3. At the time of the review, Investigator #3 interviewed the Quality Management clinical abstractor (Staff #301) who confirmed the above findings.

Item #3 Administering Medications per Provider Order

Based on interview and document review, the hospital failed to ensure that nursing staff followed physician's orders for medication administration for 5 of 6 patients reviewed (Patients #506, #507, #508, #509, and #510).

Failure to administer medications according to physician's orders and hospital policies and procedures places patients at risk for harm due to medication errors.

Findings included:

1. Document review of the hospital's job description titled, "Registered Nurse," approved 09/13, showed that an essential duty and responsibility of the Registered Nurse is to administer prescribed medications and treatments in accordance with approved nursing techniques.

Document review of the hospital's policy and procedure titled, "Pain Management," policy number PS-079, reviewed 08/21/18 showed the following:

a. Mild pain equals a score of 1/10-3/10, moderate pain equals 3/10-5/10, severe uncontrolled pain equals 6/10-10/10.

b. Staff are to collaborate with the interdisciplinary team and advocate for pain management options appropriate for the patient, family, caregiver and setting.

c. Staff are to notify the provider when pain management regimen has reached maximum doses ordered with ineffective pain control and when signs/symptoms of adverse reactions occur.

2. On 11/04/20 at 2:55 PM, Investigator #5 and the Director of Critical Care Unit (CCU) (Staff #501) reviewed the medical record for Patient #506 who was admitted for hypotension, dehydration, pancreatic cancer, and colitis. The patient's history showed end stage muscular dystrophy and Type 2 Diabetes Mellitus. The review showed that on 11/03/20 at 8:14 PM, the patient's blood sugar was 248 mg/dl. The provider order stated for the patient to receive 6 units of regular insulin. The document review showed that staff administered only 4 units of regular insulin.

3. At the time of the observation, Staff #501 verified the finding and stated that the patient should have received 6 units of insulin and not the 4 units documented.

4. On 11/05/20 at 10:30 AM, Investigator #5 and a Registered Nurse (RN) (Staff #511) reviewed the medical record for Patient #507 who was admitted for a Left Total Knee Replacement. The review showed that on 11/04/20 at 9:27 PM, the patient received Acetaminophen 650 mg for a pain score of 7/10.

Document review of the provider orders showed the following orders:

a. Acetaminophen 650 mg for a Temperature

b. Hydrocodone (an opioid pain medication) for pain scale of 1/10 to 3/10.

c. Hydromorphone (an opioid pain medication used to treat moderate to severe) for severe pain of 7/10 to 10/10.

5. At the time of the observation, Staff #511 verified that the patient did not have an order for acetaminophen for pain management and stated that staff should have called the provider for an order for Acetaminophen for pain.

6. On 11/06/20 at 11:30 AM, Investigator #5 and the Director of the Critical Care Unit (Staff #501) reviewed the medical record for Patient #508 who was admitted for abdominal pain. The review showed that on 10/30/20 at 3:47 AM the patient received Hydrocodone (an opioid pain medication) for a pain score of 6/10.

Document review of the provider orders showed the following orders:

a. Hydrocodone (an opioid pain medication) for moderate pain.

c. Hydromorphone (an opioid pain medication used to treat moderate to severe) for severe pain.

7. At the time of the observation, Staff #501 verified that staff had not medicated the patient per the parameters of the provider order.

8. On 11/06/20 at 2:30 PM, Investigator #5 and the Director of the Critical Care Unit (Staff #501) reviewed the medical record for Patient #509 who was admitted for a stroke. The review showed that on 10/09/20 at 10:46 AM, the patient received Acetaminophen 650 mg for a pain score of 4/10.

Document review of the provider order showed Acetaminophen 650 mg was ordered for mild pain.

9. On 11/06/20 at 3:00 PM, Investigator #5 and the Director of the Critical Care Unit (Staff #501) reviewed the medical record for Patient #510 who was admitted for chest pain and a urinary tract infection. The review showed the following:

a. On10/17/20 at 9:44 PM, the patient received Acetaminophen 650 mg for a pain score of 5/10. No pain reassessment was documented.

b. On 10/19/20 at 9:10 PM, the patient received Acetaminophen 650 mg for a pain score of 4/10. A reassessment on 10/19/20 at 11:05 PM showed that the patient pain continued to be a 4/10 and the patient was anxious and restless. No further interventions were documented.

c. On 10/20/20 at 8:53 AM, the patient received Acetaminophen 650 mg for a pain score of 4/10. A reassessment on 10/20/20 at 9:28 AM showed that the patient pain continued to be a 4/10 and the patient was anxious and restless. No further interventions were documented.

d. On 10/20/20 at 2:48 PM, the patient received Acetaminophen 650 mg for a pain score of 4/10. A reassessment on 10/20/20 at 4:13 PM showed that the patient pain continued to be a 4/10 and the patient was anxious and restless. No further interventions were documented.

e. Document review of the provider orders showed that Acetaminophen was ordered for mild pain.

10. At the time of the observation, Investigator #5 noted that the only pain medication order was for mild pain and the patient was experiencing moderate pain, and that the patient assessments showed that the patient continued with unrelieved pain and no further interventions were documented in the medical record. Staff #501 verified the patient was not medicated per the parameters of the provider order and stated that the staff should have contacted the provider.
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Based on observation, interview, and document review, the hospital failed to ensure nursing staff members performed transfusion services procedures according to hospital policy and procedure for five of the six patients reviewed (Patients #901, #902, #903, #904, and #906).

Failure to perform transfusion services and procedures according to acceptable standards of practice risks transfusion reactions and complications.

Findings included:

1. Document review of the hospital's Ambulatory Infusion Service's Policy and Procedure titled, "AIS-010 Documentation," reviewed 11/09/2020, showed that all disciplines participating in patient care will document on the progress record, including physicians, nurses, pharmacists, and social workers. Documentation will follow the standards as outlined by the hospital.

Document review of the hospital's Patient Services Policy and Procedure titled, "PS-063 Administration of Medications," reviewed 11/09/2020, stated that PRN medications are to be documented with the actual time the medication was given, and the patient's response to the medication.

Document review of the hospital's Patient Service's Policy and Procedure titled, "PS-023A Blood Transfusion/Blood Products," showed that the documentation requirements include verification signatures at bedside with two licensed staff prior to administration of blood products and documentation of intake and output, administration date, start time, end time, blood product given, infusion rate, two verifier signatures, donor unit number, complete vital signs, and suspected transfusion reaction.

2. On 11/05/2020 at 8:50 AM, Investigator #5, Investigator #9, the Ambulatory Infusion Services Director (Staff #901), and a Staff Nurse (Staff #906), observed Patient #907 receiving a blood transfusion. At the time of the observation, document review of the Transfusion Report Card showed that the blood transfusion had been initiated, but the second verification signature for the blood unit that is required prior to administration of blood products had not been documented.

3. At the time of the observation, Staff #906 verified that staff initiating the blood transfusion had not signed the transfusion card verifying the correct blood unit prior to initiation of the transfusion.

4. On 11/06/2020 from 11:00 AM until 3:10 PM, Investigator #9 reviewed the medical records for six patients receiving transfusions and infusion services through the Ambulatory Infusion Services (AIS) Department. The review showed the following:

Patient #901

a. 03/25/20 - Missing start time on 1 of 2 transfusions reviewed.

b. 08/21/20 - Missing donor unit on 1 of 1 transfusion reviewed.

c. 09/02/20 - Missing administration date on 1 of 2 transfusions reviewed, missing donor unit on 2 of 2 transfusions reviewed, missing start time on 2 of 2 transfusions reviewed.

d. 09/24/20 - Missing type of product infused on 1 of 2 transfusions reviewed, missing donor unit on 1 of 2 transfusions reviewed, missing complete set of vitals on 1 of 2 transfusions reviewed.

e. 09/30/20 - Missing administration date on 1 of 2 transfusions reviewed, missing donor unit on 1 of 2 transfusions reviewed, missing reaction on 1 of 2 transfusions reviewed.

f. 10/07/20 - Missing administration date on 2 of 2 transfusions reviewed, missing start time on 1 of 2 transfusions reviewed, missing medication administration time on 2 of 2 transfusions reviewed, missing donor unit on 1 of 2 transfusions reviewed, missing type of product infused on 1 of 2 transfusions reviewed, missing reaction on 1 of 2 transfusions reviewed, missing complete set of vitals on 1 of 2 transfusions reviewed.

g. 10/08/20 - Missing administration date on 1 of 2 transfusions reviewed, missing medication administration time on 1 of 2 transfusions reviewed, missing reaction on 1 of 2 transfusions reviewed, missing complete set of vitals on 1 of 2 transfusions reviewed.

Patient #902

a. 02/06/20 - Missing time of procedure on 1 of 1 procedure reviewed.

b. 02/20/20 - Missing date of procedure on 1 of 1 procedure reviewed, missing time of procedure on 1 of 1 procedure reviewed.

c. 03/05/20 - Missing time of procedure on 1 of 1 procedure reviewed.

d. 03/19/20 - Missing time of procedure on 1 of 1 procedure reviewed.

e. 04/02/20 - Missing date of procedure on 1 of 1 procedure reviewed, missing time of procedure on 1 of 1 procedure reviewed.

f. 04/16/20 - Missing time of procedure on 1 of 1 procedure reviewed.

g. 04/30/20 - Missing time of procedure on 1 of 1 procedure reviewed.

h. 05/14/20 - Missing time of procedure on 1 of 1 procedure reviewed.

i. 05/29/20 - Missing time of procedure on 1 of 1 procedure reviewed.

j. 06/11/20 - Missing date of procedure on 1 of 1 procedure reviewed, missing time of procedure on 1 of 1 procedure reviewed.

k. 06/25/20 - Missing time of procedure on 1 of 1 procedure reviewed.

l. 07/09/20 - Missing time of procedure on 1 of 1 procedure reviewed.

m. 08/06/20 - Missing time of procedure on 1 of 1 procedure reviewed.

n. 09/03/20 - Missing time of procedure on 1 of 1 procedure reviewed.

o. 09/18/20 - Missing time of procedure on 1 of 1 procedure reviewed.

p. 10/01/20 - Missing time of procedure on 1 of 1 procedure reviewed.

q. 10/15/20 - Missing time of procedure on 1 of 1 procedure reviewed, missing patient reaction to procedure on 1 of 1 procedure reviewed.

r. 10/29/20 - Missing time of procedure on 1 of 1 procedure reviewed.

Patient #903

a. 12/03/19 - Missing time of medication administration on 2 of 2 procedures reviewed.

b. 01/27/20 - Missing time of medication administration on 2 of 2 procedures reviewed, missing patient reaction on 2 of 2 procedures reviewed.

c. 03/20/20 - Missing date of medication administration and time of medication administration on 2 of 2 procedures reviewed.

d. 06/12/20 - Missing time of medication administration on 2 of 2 procedures reviewed, missing patient reaction on 2 of 2 procedures reviewed.

e. 08/20/20 - Missing time of medication administration on 2 of 2 procedures reviewed.

f. 09/22/20 - Missing time of medication administration on 2 of 2 procedures reviewed.

g. 10/28/20 - Missing time of medication administration on 2 of 2 procedures reviewed.

Patient #904

a. 02/29/20 - Missing donor unit on 1 of 2 procedures reviewed.

b. 05/18/20 - Missing start time on 1 of 2 procedures reviewed.

c. 06/22/20 - Missing start time on 1 of 2 procedures reviewed, missing type of product infused on 1 of 2 procedures reviewed.

d. 10/23/20 - Missing volume of infusion on 1 of 2 procedures reviewed, missing start time on 1 of 2 procedures reviewed.

Patient #906

a. 01/07/20 - Missing time of infusion on 1 of 1 procedure reviewed.

b. 01/30/20 - Missing time of infusion on 1 of 1 procedure reviewed.

c. 02/13/20 - Missing date of infusion on 1 of 1 procedure reviewed, missing time of infusion on 1 of 1 procedure reviewed.

d. 02/27/20 - Missing time of infusion on 1 of 1 procedure reviewed.

e. 03/12/20 - Missing date of infusion on 1 of 1 procedure reviewed, missing time of infusion on 1 of 1 procedure reviewed.

f. 09/10/20 - Missing time of infusion on 1 of 1 procedure reviewed.

g. 09/24/20 - Missing time of infusion on 1 of 1 procedure reviewed.

h. 10/08/20 - Missing time of infusion on 1 of 1 procedure reviewed.

i. 10/23/20 - Missing time of infusion on 1 of 1 procedure reviewed.

j. 11/05/20 - Missing time of infusion on 1 of 1 procedure reviewed.

5. On 11/06/20 at 10:25 AM, during interview with Investigator #9, a Staff Nurse (Staff #906) confirmed that the required documentation for administration of blood products/infusions in AIS is the same as the hospital's Transfusion Policies and Procedures.
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Based on observation, interview, and review of hospital policy and procedures, the hospital failed to ensure that medications were kept secure from potential unauthorized access.

Failure to secure medications risks potential diversion, medication errors, and patient safety.

Findings included:

1. Document review of the hospital 's pharmacy policy and procedure titled, "Medication Security," policy number P027, last reviewed 09/25/20, showed that all drugs stored in the hospital shall be accessible only to authorized personnel. All drugs, except those intended for crash cart use, will be stored in a lockable container or areas. All medications at nursing stations shall be in lockable storage at all times. When unattended, medication carts and medication rooms are to be locked. Medications in ancillary departments are to be in locked cabinets or drawers, automated dispensing machine or in areas of immediate supervision of department personnel.

2. On 11/04/20 at 1:30 PM, Investigator #3, the Director of Quality, Risk, & Regulatory Compliance (Staff #303), and a Registered Nurse (Staff #304) inspected the hospital's Cardiac Catheterization Lab suite. During the inspection, Investigator #3 found one 10 ml atropine injectable syringe and one 20 ml vial of 1% lidocaine in an unlocked cart in the procedure suite.

3. On 11/04/20 from 2:00 PM until 4:20 PM, Investigator #5 and Investigator #9, the Critical Care Unit (CCU) Director (Staff #901), Charge Nurse (Staff #902), and Staff Nurse #907, inspected the hospital's Critical Care Unit. Investigator #9 observed an unlocked bronchoscopy cart located near room #10 which contained one ampule of lidocaine 50 mg/5ml, one 20 ml vial of lidocaine 1%, two vials of albuterol sulfate 2.5 mg in 3 ml of normal saline, and one 10 ml vial of muri lube.

4. On 11/04/20 at 2:30 PM, Investigators #5 and #9 interviewed the Critical Care Unit (CCU) Director (Staff #901) who verified that the bronchoscopy cart was left unlocked with unsecured medications. Staff #901 stated that the hospital protocol is for the bronchoscopy cart to be locked/secured when not in use. Monthly cart checks are performed and documented. Staff #901 verified the last documented check for the bronchoscopy cart was completed on 06/04/20 which was the only cart check documented for 2020.

5. On 110/6/20 from 6:59 AM to 8:08 AM, Investigators #5 and #9, and the Surgical Scrub Technician (Staff #903), inspected the Surgical Services Department. During the inspection of Operating Room #1, the investigators observed the hospital staff preparing for an upcoming surgical procedure. During the observation, an Anesthesiologist (Staff #908) entered the operating room at 7:30 AM and left the room at 7:45 AM leaving the anesthesia cart unlocked with unsecured medications.

6. On 11/06/20 at 7:55 AM, during interview with Investigator #5, the Anesthesiologist (Staff #908) was asked about the unlocked anesthesiology cart. Staff #908 stated that he had left the operating room briefly and was returning shortly.
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Based on observation, interview, and document review, the hospital staff failed to ensure that unusable or expired medications were not available for patient administration.

Failure to ensure medication storage areas are devoid of outdated or otherwise unusable medications puts patients at risk for receiving medications with compromised sterility, integrity, or stability.

Reference:

Fresenius Fenwal Blood-Pack Unit Anticoagulant Citrate Phosphate Dextrose Adenine Solution manufacturer instructions, showed the following:

a. The bulk foil pouch contained 12 single units of Anticoagulant Citrate Phosphate Dextrose Adenine Solution.

b. Once the pouch was opened, direct handling of the product surfaces prior to extended storage in the foil pouch, may result in mold growth.

c. Unused units in the foil pouch may be kept up to 60 days by folding and securing open end of the foil pouch to prevent possible loss of moisture provided that:

-The Units are not removed from the foil pouch, or

-Unused units removed from the foil pouch are returned to the foil pouch within 12 hours.

-Units may be removed from the pouch and returned only once.

d. Units removed from the foil pouch (that are not returned within 12 hours) must be used within 4 days (96 hours).

Findings included:

1. Document review of the pharmacy policy and procedure titled, "Unit Inspection," policy number P038, last revised on 12/12/19, showed that all drug storage areas within the hospital will be inspected monthly by appropriate pharmacy personnel. Inspections will ensure that drugs are not kept after their expiration date and that deteriorated medications will not be available for use. The Director of Pharmacy will maintain a record of the monthly unit inspections.

Document review of the hospital's policy titled, "Use of Multidose Vials," reviewed 03/16/20, showed that the expiration date of multidose vials will be at most 28 days from the time the vial is opened or the manufacturer's recommended expiration date listed on the vial, whichever is earliest.

2. On 11/04/20 at 12:00 PM, during inspection of the hospital's Intensive Care Unit medication room, Investigator #5 observed a bottle of Novolog insulin with an expiration date of 11/30/20.

3. At this time, Investigator #5 asked the Registered Nurse (Staff #511) what the hospital process was for dating multiuse vials including when multidose vials expired and what the date written of the vial meant. Staff #511 stated that when the insulin is opened, staff mark an expiration date of 30 days on the bottle.

4. On 11/04/20 at 12:20 PM, during interview with Investigator #5, a Registered Nurse (Staff #510) stated that insulin vials were dated with a 30-day expiration date on opening.

5. On 11/04/20 at 2:40 PM, Investigator #5 inspected a medication room in the hospital's Intensive Care Unit (ICU). Investigator #5 observed 1 multi use vial of Levimir Insulin opened and undated.

6. At the time of the observation, the ICU Director (Staff #501) verified the observation and removed medication.

7. On 11/06/20 at 8:00 AM, during inspection of Operating Room, Investigator #5 and Investigator #7 observed 2 opened, undated multiuse vials of Lidocaine 200mg/20mL (a medication used to treat irregular heart rhythms) and 2 opened, undated multiuse vials of Neostigmine 5mg/10mL (a medication used to reverse the effects of anesthesia medications used during surgery).

8. At the time of the finding, the medications were given to the Charge Nurse (Staff #507) for disposal.

9. On 11/04/20 at 1:30 PM, Investigator #3, the Director of Quality, Risk, & Regulatory Compliance (Staff #303), and a Registered Nurse (Staff #304) inspected the hospital's Cardiac Catheterization Lab suite. Investigator #3 observed 3 glass bottles of intravenous nitroglycerin 25 mg in 250 ml of 5% dextrose in water located in a supply cart. The observation showed that the intravenous medication metal seal had been removed and the rubber diaphragm had been punctured indicating it had been used.

10. At the time of the observation, Staff #304 confirmed the intravenous medication bottle appeared to have previously been used and should have been disposed in the trash upon completion of a case procedure.

11. On 11/05/2020 at 8:40 AM, during inspection of Ambulatory Infusion Services Clinic storage room, Investigator #5 observed the following:

7-Single bags of Anticoagulant Citrate Phosphate Dextrose Adenine Solution laying on a storage shelf not contained in the protective foil manufacturer package. The bags of solution were undated.

12. At the time of the finding, the Ambulatory Infusion Services Registered Nurse (Staff #502) verified the manufacturer instructions for use and storage and stated that they did not store the bags of solution inside the foil packaging.

13. On 11/05/2020 9:00 AM, the Critical Care Unit /Ambulatory Infusion Services (AIS) Director (Staff #501), verified the manufactuer's instructions for use and storage and stated that the bags of solution came in bulk, but that the infusion center performed only about one therapeutic phlebotomy a month.

14. On 11/05/20 at 9:55 AM, Inspectors #3 and #7, the Director of Quality, Risk & Regulatory Compliance (Staff #303) inspected the hospital pharmacy. During the inspection, Investigator #3 reviewed the monthly medication unit inspection reports from January to October 2020 (a 10-month period). The review showed:

a. 5 of 12 clinical areas had no documentation to indicate that pharmacy staff had completed a monthly inspection for the month of July 2020.

b. 3 of 12 clinical areas had no documentation to indicate that pharmacy staff had completed a monthly inspection for the month of August 2020.

c. 6 of 12 clinical areas had no documentation to indicate that pharmacy staff had completed a monthly inspection for the month of September 2020.

d. 6 of 12 clinical areas had no documentation to indicate that pharmacy staff had completed a monthly inspection for the month of October 2020.

15. At the time of the review, Investigator #3 interviewed a pharmacy technician (Staff #305) who confirmed the findings above.

16. On 11/05/20 at 10:00 AM, Investigator #5, Investigator #9, the Director of Intensive Care and Ambulatory Infusion Services (Staff #501), and the Director of the Operating Room and Employee Health (Staff #504) inspected an automated drug dispensing cabinet located in the Ambulatory Infusion Services medication room. Investigator #5 observed 1 vial of meolizumab (a monoclonal antibody that is used in adults to help control symptoms and reduce flares of a rare autoimmune disorder called eosinophilic granulomatosis with polyangiitis (EPGA)). The medication expired in 11/2018.

17. At the time of the observation, Staff #501 and #504 confirmed the finding and removed the medication for return to the pharmacy.

18. On 11/05/20 at 5:00 PM, Investigator #5 reviewed the Ambulatory Infusion Services medication room monthly pharmacy inspection sheets for 02/20, 03/20, 04/20, 05/20, 06/20, and 08/20. The inspection documentation showed that there were no outdated medications present in the automated drug dispensing cabinets.

19. At the time of the observation, a Pharmacy Technician (Staff #509) stated that the pharmacy did not check for this medication as it was a patient own medication.
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Item #1 Sanitizers

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

Findings included:

1. Document review of the hospital's policy titled, "Food Safety and Infection Control," policy number NUT-100, reviewed 11/17, showed that all work surfaces, except the cooking surface and all floors in the Food and Nutrition Services food preparation area will be cleaned daily with the approved disinfectant. All surfaces used for eating will be cleaned with the approved disinfectant after each meal period; all sinks are sanitized after each use.

2. On 11/04/20 at 12:00 PM, during a tour of the West Campus Nutrition Services with the Director of Plant Services (Staff #601), the Nutrition Services Supervisor (Staff #602), and Investigator #8, Investigator #6 observed a container of chlorine sanitizer test strips with an expiration date of 06/2016. Staff #602 stated those were the wrong test strips for their quaternary ammonia sanitizer and brought a container of sanitizer test strips. The second container had an expiration date of 06/15/17.

3. At the time of the observation, Investigator #6 asked Staff #602 about how the sanitizer concentration was accurately determined, as required by food safety regulations. Staff #602 stated that she had not noticed the expiration dates and would order new test strips immediately.

4. On 11/04/20 between 3:30 PM and 4:30 PM, the Director of Plant Services (Staff #601), the Nutrition Services Supervisor (Staff #602), Investigator #8, and Investigator #6 toured the East Campus Nutrition Services. Investigator #6 asked a cook (Staff #603) to check the concentration of a bucket of sanitizer. Staff #603 stated there were no test strips available, that the staff replaces the sanitizer on a schedule.

Reference: 2009 FDA Food Code 4-302.14; 4-501.116

Item #2 Cold Holding

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

Findings included:

1. Document review of the hospital's policy titled, "Food Safety and Infection Control," policy number NUT-100, reviewed 11/17, showed that fruits, vegetables, dairy products, meat, and poultry shall be stored at temperatures between 33 - 41 degrees F; ready-to-eat food that has been prepared for in-house use can be stored for a maximum of seven days at 41 degrees or lower; Cold Table shall keep cold foods at or below 41 F.

2. On 11/04/20 between 3:30 PM and 4:30 PM, the Director of Plant Services (Staff #601), the Nutrition Services Supervisor (Staff #602), Investigator #8, and Investigator #6 toured the East Campus Nutrition Services. During the tour, Investigator #6 used a thin-stemmed thermometer to assess the internal temperature of Potentially Hazardous Food (PHF) in the patient dining room and the kitchen. The temperatures of the following PHFs were above the maximum cold-holding temperature of 41 degrees Fahrenheit:

Patient dining room

a. chicken Caesar salad in a clamshell container nested in ice: 47 degrees Fahrenheit;

b. chef salad with chicken, ham, & boiled egg: 48 degrees Fahrenheit.

Kitchen

c. 4 chicken breasts: 49 degrees Fahrenheit;

d. hamburger patties: 47 degrees Fahrenheit;

e. deli-sliced chicken: 54 degrees Fahrenheit;

f. deli-sliced ham: 55 degrees Fahrenheit.

Reference: 2009 FDA Food Code 3-501.16
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Based on observation, interview, and document review, the hospital failed to have an effective quality control process to ensure that patient care supplies available for use did not exceed their manufacturer's expiration date.

Failure to ensure patient care supplies do not exceed manufacturer's expiration date places patients at risk for inadequate medical treatment and exposure to infectious organisms.

Findings included:

1. Document review of the hospital's policy and procedure titled, "A-811 Unusable and Outdated Medical Supplies," showed that all expired and unusable medical supplies are to be returned to the Supply Chain Department. All general medical supply item storage areas will be inspected on an ongoing basis by the Supply Chain Staff. Areas not accessible to Supply Chain staff will be inspected by end user department staff, according to department specific policies and procedures. Supply Chair and Patient Care departments will collaborate to ensure medical supply areas are managed effectively.

2. On 11/04/2020 from 2:00 PM until 4:20 PM, Investigator #5, Investigator #9, the Critical Care Unit /Ambulatory Infusion Services (AIS) Director (Staff #901), and a Charge Nurse (Staff #902), inspected the hospital's Critical Care Unit. Investigator #5 and Investigator #9 observed the following expired supplies:

a. Bronchoscopy Cart near CCU Room #10:

2 - Blue-top blood tubes with manufacturer's expiration date of 9/30/20.

1 - Gray-top blood tube with manufacturer's expiration date of 10/31/20.

3. At the time of the observation, Staff #901 and #902 confirmed the finding, removed the expired supplies, and stated that hospital staff should be checking for expired supplies monthly.

4. On 11/05/2020 from 8:40 AM to 10:25 AM, Investigator #5, Investigator #9, and the Critical Care Unit /Ambulatory Infusion Services (AIS) Director (Staff #901), inspected the Ambulatory Infusion Services (AIS) Department. The inspection showed the following expired supplies:

a. AIS Supply Room:

1 - Blue-top blood tube with manufacturer's expiration date of 04/30/19.

1 - Blue-top blood tube with manufacturer's expiration date of 10/13/19.

1 - Blue-top blood tube with manufacturer's expiration date of 12/31/19.

1 - Clear-top blood tube with manufacturer's expiration date of 02/29/20.

2 - Blue-top blood tubes with manufacturer's expiration date of 03/31/20.

b. A Wound Cart located in AIS Medication Room:

86 - Tongue depressors with manufacturer's expiration date of 11/2013.

2 - Sorbion Sachet Dressing with manufacturer's expiration date of 10/2015.

1 - Cutimed Siltec Dressing with manufacturer's expiration date of 11/2016.

2 - McKesson ABD Pads with manufacturer's expiration date of 12/2016.

1 - Tegaderm Superabsorber Dressing with manufacturer's expiration date of 01/2017.

1 - VAC Granufoam Bridge Dressing with manufacturer's expiration date of 07/2017.

1 - Biatain Silver Dressing with manufacturer's expiration date of 03/2018.

1 - Colostomy Kit with manufacturer's expiration date of 03/2018.

1 - Tegaderm Foam Adhesive Dressing with manufacturer's expiration date of 02/2019.

2 - Cotton-tipped Applicators with manufacturer's expiration date of 05/2019.

5 - Exuderm Odor Shield with manufacturer's expiration date of 09/2019.

1 - Normal Saline 10 cc syringe with manufacturer's expiration date of 09/01/19.

1 - Normal Saline 10 cc syringe with manufacturer's expiration date of 10/01/19.

1 - VAC Granufoam Bridge Dressing with manufacturer's expiration date of 10/31/19.

1 - Allevyn Adhesive Dressing with manufacturer's expiration date of 11/25/19.

2 - Normal Saline 10 cc syringes with manufacturer's expiration date of 12/01/19.

2 - Allevyn Adhesive Dressing with manufacturer's expiration date of 02/2020.

2 - Cotton-tipped Applicators with manufacturer's expiration date of 03/2020.

2 - Single-Use Sterilization Pack - Bandage scissors with manufacturer's expiration date of 04/2020 and one pack with visible water damage.

1 - Catheter Stabilization Device with manufacturer's expiration date of 05/28/20.

1 - Single-Use Sterilization Pack - Suture removal with manufacturer's expiration date of 06/2020 and visible water damage.

1 - Single-Use Sterilization Pack - Bandage scissors with manufacturer's expiration date of 06/2020.

1 - Tongue depressor with manufacturer's expiration date of 07/2020.

1 - Colostomy bag loose with no date on packaging.

c. Shield Vendor Kits Hanging on Wound Cart in AIS Medication Room

1 - Stoma Powder with manufacturer's expiration date of 10/2013.

1 - Adapt Paste with manufacturer's expiration date of 10/2013.

9 - Coloplast Colostomy Bags with manufacturer's expiration date of 06/2017.

4 - Adapt Lubricating Deodorant with manufacturer's expiration date of 10/06/17.

23 - Adapt Lubricating Deodorant with manufacturer's expiration date of 11/2017.

1 - Stoma Cleaner with manufacturer's expiration date of 09/2019.

1 - Adhesive Remover with manufacturer's expiration date of 04/2020.

2 - Convex 1 ¾" Colostomy Bag Wafers with manufacturer's expiration date of 05/2020.

1 - Adapt Paste with manufacturer's expiration date of 06/2020.

2 - Colostomy Bags with no date on packaging.

d. Cabinets/Drawers next to Wound Cart in AIS Medication Room

1 - Hollister #18176 New Image 2-piece Colostomy Kit with manufacturer's expiration date of 4/2011.

10 - Convatec Duoderm Signal Dressing with manufacturer's expiration date of 08/2011.

1 - Adapt #7906 Stoma Powder with manufacturer's expiration date of 10/2013.

20 - Hollister #18183 2 ¼ Drainable Pouch with manufacturer's expiration date of 11/2013.

20 - Hollister #14603 2 ¼ Ostomy Barrier with manufacturer's expiration date of 02/2014.

2 - Adapt #7906 Stoma Powder with manufacturer's expiration date of 10/2014.

1 - Adapt #7906 Stoma Powder with manufacturer's expiration date of 11/2014.

1 - Adapt #7906 Stoma Powder with manufacturer's expiration date of 01/2015.

3 - RENASYS Adhesive Gel Patch with manufacturer's expiration date of 10/2015.

10 - Hollister #18174 2-piece Drainable Pouch with manufacturer's expiration date of 10/2016.

4 - Hollister 3 ¾ Colostomy Bags with manufacturer's expiration date of 02/2017.

17 - Cavilon No-Sting Barrier Film with manufacturer's expiration date of 12/2017.

75 - Safe N Simple No-Sting Barrier Film with manufacturer's expiration date of 04/16/18.

6 - Safe N Simple Assure Odor Eliminator with manufacturer's expiration date of 09/12/18.

50 - Adapt Protective Skin Wipes with manufacturer's expiration date of 10/13/2018

2 - Safe N Simple Assure Odor Eliminator with manufacturer's expiration date of 10/25/18.

13 - Hollister 4" Colostomy Bags with manufacturer's expiration date of 03/2019.

50 - Unisolve Adhesive Remover with manufacturer's expiration date of 09/2019.

1 - Allevyn Classic Heel Dressing with manufacturer's expiration date of 10/17/19.

1 - Adapt #7906 Stoma Powder with manufacturer's expiration date of 11/2019.

1 - Hollister #19104 2 ¾ New Image Colostomy Kit with manufacturer's expiration date of 01/20.

2 - Safe N Simple Assure Odor Eliminator with manufacturer's expiration date of 05/18/20.

1 - Adapt #7906 Stoma Powder with manufacturer's expiration date of 07/2020.

1 - Kayaya Powder 2.5 ounce with manufacturer's expiration date of 07/2020.

10 - Hollister #18124 2 ¾ Drainable Pouch with manufacturer's expiration date of 09/2020.

5 - Hollister #14604 2 ¾ Ostomy Barrier with manufacturer's expiration date of 10/2020.

1 - McKesson Lubricating Deodorant open with no date noted.

5. On 11/5/20 at 9:40 AM, during interview with Investigator #9, the Ambulatory Infusion Services (AIS) Director (Staff #901) verified the expired medical supplies and stated that hospital staff should be checking for expired supplies monthly per established policies and procedures. The AIS Director stated that the Wound Cart containing the expired supplies was utilized by nursing staff from the Wound Healing Center (East Campus) and that position was eliminated in 2016.

6. On 11/5/2020 from 10:25 AM to 11:15 AM, Investigator #5, Investigator #9, and the Diagnostic Imaging Director (Staff #902), inspected the hospital's Diagnostic Imaging Department. The inspection showed the following expired supplies:

a. Hot Lab Supply Cabinet in Diagnostic Imaging Department

16 - Cotton-tipped Applicators with manufacturer's expiration date of 8/17.

b. Scan Room

1 - Bag of electrodes - opened, not dated.

7. On 11/5/20 at 10:50 AM, during interview with Investigator #9, the Diagnostic Imaging Department Director (Staff #903) verified the expired medical supplies and stated that hospital staff should be checking for expired supplies monthly, but that the expired medical supplies located in the host room supply drawer were not used for patient care.

8. On 11/06/2020 from 6:59 AM to 8:08 AM, Investigator #5, Investigator #9, and a Surgical Scrub Tech (Staff #903), inspected the Surgical Services Department. The inspection showed the following:

a. IV Tray in Glass Cabinet Storage Operating Room #1

1 - BD 24-gauge x 0.7" Instyle Autoguard BC with manufacturer's expiration date of 1/31/20.

5 - Statlock IV Ultra Pediatric with manufacturer's expiration date of 02/2020.

2 - BD 20-gauge x 1.88" Instyle Autoguard BC with manufacturer's expiration date of 4/30/20.

1 - BD 18-gauge x 1.16" Autoguard BC with manufacturer's expiration date of 06/30/20.

5 - BD 20-gauge x 1.1" Instyle Autoguard BC with manufacturer's expiration date of 9/30/20.

12 - BD 18-gauge x 1.16" Autoguard BC with manufacturer's expiration date of 10/31/20.

b. Glass Cabinet Storage Operating Room #3

19 - Tegaderm Film 6 cm x 7 cm #1624W with manufacturer's expiration date of 8/20.

1 - Loose Disposable drape next to IV Tray, unable to verify if clean or dirty.

9. On 11/06/20 at 7:15 AM, during interview with Investigator #9, the Surgical Scrub Tech (Staff #904) verified the expired medical supplies from Operating Room #1 and stated that someone from Central Supply should be checking for expired supplies monthly.

10. On 11/06/20 at 8:05 AM, the Director of the Operating Room and Employee Health (Staff #905) verified the expired medical supplies from Operating Room #3.
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Based on observation and document review, the hospital failed to maintain proper air pressure relationships in clean utility/supply rooms and soiled utility rooms in 2 of 5 observations.

Failure to ensure proper air pressure relationships in clean utility/supply and soiled utility rooms increases the risk of infection to patients and staff.

Reference: Centers for Disease Control and Prevention (CDC): Guidelines for Environmental Infection Control in Healthcare Facilities (2003), updated July 2019. Ventilation Specifications for Health-Care Facilities Table B.2: In Clean workrooms and Clean linen storage air movement relationship to the adjacent area should be out; in soiled or decontamination rooms air movement relationship to the adjacent area should be in.

Findings included:

1. On 11/04/20 between 4:30 PM and 6:00 PM, the Director of Plant Services (Staff #601), Investigator #8 and, Investigator #6 toured the patient care areas of the East Campus. Investigator #6 used a lightweight string to determine the direction of airflow between the 2nd floor clean-linen room and the adjacent corridor. The string was drawn into the clean-linen room, indicating the room had a negative pressure with respect to the corridor. Industry standards require that the air pressure in clean-linen rooms is positive with respect to the corridor.

2. On 11/04/20 at 5:45 PM, during a tour of the patient care areas of the East Campus with Staff #601 and Investigator #8, Investigator #6 used a lightweight string to determine the direction of airflow between the 1st floor clean-linen room and the adjacent corridor. The string was drawn into the clean-linen room, indicating the room had a negative pressure with respect to the corridor. Industry standards require that the air pressure in clean-linen rooms is positive with respect to the corridor.

3. At the time of the observations, Staff #601 confirmed the findings and stated that a work order would be submitted as soon as possible.
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Item #1 - Cross-contamination

Based on observation, document review, and interview, the hospital failed to ensure that staff used effective infection control measures to prevent cross-contamination during terminal cleaning of the Operating Room (OR).

Failure to prevent cross-contamination during cleaning procedures places patients and staff at increased risk of exposure to harmful microorganisms.

References: Association of periOperative Registered Nurses (AORN) Guidelines for Perioperative Practice: Environmental Cleaning, 2020, Recommendation 2. Cleaning Procedures; 2.8.1 Consider items that contact the floor for any amount of time to be contaminated.

Finding included:

1. Document review of the hospital's "Infection Prevention and Control Plan 2020," no document number, showed that the plan includes Centers for Disease Control and Prevention (CDC) and the Association of periOperative Nurses (AORN) as guidelines.

2. On 11/05/20 between 6:45 PM and 8:30 PM, the Director of Plant Services (Staff #601), the EVS Supervisor (Staff #605), Investigator #8, and Investigator #6 observed an EVS staff member (Staff #606) perform a terminal cleaning of Operating Room (OR) #3. The observation showed the following:

a. Staff #606 picked up debris from the floor with gloved hands and continued cleaning without performing hand-hygiene or donning clean gloves;

b. While making up the procedure table, Staff #606 failed to remove his gloves and perform hand-hygiene prior to collecting clean linens. Investigator #6 stopped Staff #606 from using the linens, asked him to remove his gloves, perform hand-hygiene, and collect new linens before making up the procedure table.

3. At 8:30 PM, Investigator #6 interviewed Staff #606 about the observations. Staff #606 stated that he didn't know that he didn't think his gloves touched the floor when he picked up the debris, and that he didn't know that he should perform hand-hygiene before collecting clean linen.

4. On 11/06/20 at 8:25 AM, Investigator #5 and Investigator #9 observed operating room staff prepare the surgical suite and instruments for a surgical procedure. During the observation, Investigator #5 observed a Registered Nurse (Staff # 507) fail to perform hand hygiene prior to donning gloves and fail to perform hand hygiene after doffing gloves.

5. On 11/06/20 at 9:15 AM, the Director of the Operating Room (Staff #504) stated that it was hospital policy to perform hand hygiene before donning and after doffing gloves.

Item #2 - Disinfecting the Operating Room

Based on observation, document review, and interview, the hospital failed to implement effective infection control and sanitation practices during terminal cleaning of the Operating Room (OR).

Failure to effectively clean the OR places patients and staff at risk of exposure to harmful microorganisms.

References: Association of periOperative Registered Nurses (AORN) Guideline for Environmental Cleaning (2020) - "Recommendations 2.8 Always consider floors in the perioperative practice setting to be contaminated."

- Recommendation 4. OR and Procedure Rooms; 4.4 Terminally clean operating and procedure rooms each day the rooms are used. 4.4.1 Clean and disinfect the exposed surfaces of all items, including anesthesia carts; storage cabinets; supply carts; trash and linen receptacles.

Findings included:

1. Document review of the hospital's "Infection Prevention and Control Plan 2020," no document number, showed that the plan includes Centers for Disease Control and Prevention (CDC) and the Association of periOperative Nurses (AORN) as guidelines.

Document review of the hospital's Environmental Services Policy & Procedure titled, "OR Suites," policy number EVS-031, reviewed 10/29/20, showed that EVS staff should clean and disinfect the OR table and all equipment.

2. On 11/05/20 between 6:45 PM and 8:30 PM, the Director of Plant Services (Staff #601), the EVS Supervisor (Staff #605), Investigator #8, and Investigator #6 observed an EVS staff member (Staff #606) perform a terminal cleaning of Operating Room (OR) #3. The observation showed the following:

a. Staff #606 allowed a CaviWipe (disinfectant moistened towelette) to contact the floor while disinfecting the feet of an instrument stand. Staff #606 used the same CaviWipe to disinfect the surfaces of a stainless-steel table;

b. When disinfecting the surgical table, Staff #606 did not remove the attached arm support to disinfect all the table surfaces;

c. Staff #606 did not raise the surgical table to disinfect the pedestal;

d. Staff #606 did not disinfect an open cabinet or any of the contents; gel cones, stainless-steel hardware; or the pillow on top of the cabinet.

Item #3 - Staff knowledge of disinfectant contact time

Based on observation, document review, and interview, the hospital failed to ensure Environmental Services (EVS) staff had knowledge of the contact time (time required to effectively reduce the amount of pathogens) for disinfectant chemicals used in patient care areas.

Failure to allow adequate time for disinfection of surfaces places patients, staff, and visitors at increased risk of exposure to harmful microorganisms.

Reference: Centers for Disease Control and Prevention (CDC) Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (2007), updated 07/19: Recommendations VI. Standard Precautions F. Care of the Environment 3. Use EPA-registered disinfectants in accordance with manufacturer's instructions.

Findings included:

1. Document review of the Virex® II 256 Reference Sheet and the label instructions for use showed that for use as a one-step cleaner/disinfectant, all surfaces must remain wet for 10-minutes.

2. On 11/05/20 at 9:20 AM, the Director of Plant Services (Staff #601), Investigator #8, and Investigator #6 observed an Environmental Services (EVS) staff member (Staff #604) perform a terminal cleaning of Patient Room #212. Investigator #6 asked Staff #604 about the disinfectant in use and the appropriate contact time. Staff #604 stated that the disinfectant in use was Virex and that the contact time depends on what microorganism is targeted.

3. At the time of the observation, Investigator #6 asked Staff #604 and Staff #601 about the hospital use of Virex and the microorganisms they target. Staff #604 stated that when cleaning a COVID-19 rule-out patient room, she uses a 1-minute contact time, when cleaning a COVID-19 positive patient room, she uses a 10-minute contact time. Staff #601 stated that the standard procedure for terminal cleaning of a patient room is to use a 2-minute contact time.

Item #4 - Airborne Transmission Precautions

Based on observation, interview, and document review, the hospital failed to ensure that staff conducted, and documented isolation airflow testing according to national standards and as directed by hospital policy and procedure.

Failure to ensure appropriate airflow for patients isolated with infectious diseases places patients, staff, and visitors at risk of harm from the spread of disease.

Reference: Centers for Disease Control and Prevention (CDC) Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (2007), updated 07/19: Recommendations V. Transmission-Based Precautions D. Airborne Precautions 2. Patient placement (a)(iii) Whenever an AIIR (airborne infection isolation room) is in use for a patient on Airborne Precautions, monitor air pressure daily with visual indicators (e.g., smoke tubes, flutter strips), regardless of the presence of differential pressure sensing devices (e.g., manometers).

Findings included:

1. Document review of the hospital's policy titled, "Installing & Managing Appropriate Pressure," policy number EOC-0049, reviewed 11/15/17, showed that all isolation and reverse isolation rooms are tested at least semi-annually, and checked at least monthly when not in use for proper operation; they are checked daily while in use.

2. On 11/04/20 at 2:30 PM, during inspection of the hospital's Intensive Care Unit (ICU), Investigator #5 interviewed a Registered Nurse (Staff #503) caring for a patient in Airborne Precautions. The Registered Nurse stated that she had forgotten to check the rooms air pressure on that morning.

During further interview related to the hospital's procedure for checking air flow, Staff #503 stated she was unaware of the ball pressure sensor located at the top of the door and she did not know the hospital's policy for confirming negative air pressure for patient's in airborne isolation.

3. At this same time, the Director of the ICU (Staff #501) verified that staff in the ICU do not keep a log book of air pressure checks and that she were unsure of the hospital's policy for checking air pressure flow and that they would provide the policy for the investigator to review.

4. On 11/05/20 at 11:05 AM, during a tour of patient care areas with the Director of Plant Services (Staff #601), Investigator #6 asked about Patient Room #25, an AII/negative air pressure room. Staff #601 stated that engineering does not conduct a daily airflow test when the room is in use by a patient being treated under Airborne Precautions.

5. On 11/06/20 at 12:20 PM, Investigator #6 asked Staff #601 who checks the negative air pressure rooms when a patient is being treated under Airborne Precautions. Staff #601 stated that the nursing staff conducts a tissue test.

Item #5 Fit Testing

Based on observation, interview, and document review, the hospital failed to provide an effective process to ensure that staff who were fit tested to an appropriate N95 respirator mask knew which type and size of mask they were fit tested to use.

Failure to develop and implement effective infection prevention program that ensures staff know what type and size N95 mask to utilize based on their personal fit testing puts patients, staff, and visitors at risk of illness from COVID-19 and other communicable diseases.

Findings included:

1. Document review of the hospital's policy and procedure titled, "N95 Mask Fit Testing," policy number IC-4023, reviewed 10/15/18, showed that all employees who are at reasonable risk of exposure to infectious airborne disease will be evaluated and fit tested to an appropriately fitting N95 respirator mask upon hire, annually during their birth month, in conjunction with required TB surveillance, and upon any event that would alter facial physiology. Following the fit test, the trainer will instruct the employee to sign the fit test log and sign a verification certificate (orange ticket) with the date of the test. Department Managers will provide the necessary resources to carry out the respiratory protection program, enforce the requirements of this program, periodically monitor the use of respirators to ensure they are worn properly and ensure employee compliance in scheduling their fit tests. The fit testing process, development, implementation, and monitoring will be done by the Cardiopulmonary Department with records kept by the Cardiopulmonary Department or its designee.

2. On 11/05/20, at 10:25 AM, during inspection of the hospital's Radiology department, Investigator #5 interviewed a Radiology Technician (Staff #516) about the hospital's procedure for N95 fit testing. At this time, Staff #516 stated that he wore a size regular N95 mask, but he did not know what type of mask he wore and that it could be blue in color.

3. On 11/05/20 at 10:45 AM, during inspection of the hospital's Radiology department, Investigator #5 interviewed a Radiology Technician (Staff #515) about the hospital's procedure for N95 fit testing. At this time, Staff #507 stated that he wore a size regular N95 mask, but he did not know what type of mask he wore.

4. On 11/06/20 at 8:25 AM, Investigator #5 and Investigator #9 observed an Anesthesiologist (Staff #506) prepare a patient for a surgical procedure. During interview with Investigator #5, Staff #506 stated that he had not been fit tested for an N95 mask and stated that the patients were screened for covid symptoms and he felt that he was safe.

5. On 11/06/20 at 8:30 AM, during inspection of the hospital's Operating Room department, Investigator #5 interviewed a Scrub Tech (Staff #514) about the hospital's procedure for N95 fit testing. At this time, Staff #514 stated that he had been fit tested for an N95 mask, but he did not know what type he wore. He stated it was "white."

6. On 11/06/20 at 8:35 AM, during inspection of the hospital's Operating Room department, Investigator #5 interviewed a Registered Nurse (Staff #513) about the hospital's procedure for N95 fit testing. At this time, Staff #513 stated that he wore a size large, but didn't know what type and that it could be blue or white.

7. On 11/06/20 at 9:15 AM, Investigator #5 asked the Director of the Operating Room and Infection Control (Staff #504) about the supplies of N95 in the Operating Room. Staff #504 stated that she kept N95's on her desk and provided for review one box of 3M1860 size regular N95 masks.

8. On 11/09/20 at 11:00 AM, the Director of Respiratory/Cardiopulmonary (Staff #508) verified that Staff #506 was not fit tested for a N95 Respirator and stated that not all the medical providers had been fit tested. She stated that staff should know what size they are fit tested for because they sign a document that lists the type and size of mask the staff is fit tested to. She stated that staff can contact the Cardiopulmonary department for this information.

Item #6 Canister/Filter Changes

Based on observation, interview, and document review, the hospital failed to develop and implement a process to ensure that staff changed respirator mask cartridges/filters as directed by the manufacturer.

Failure to develop and implement effective infection prevention practices puts patients, staff, and visitors at risk of illness from COVID-19 and other communicable diseases.

Findings included:

1. Document review of the manufacturers insert instructions for use titled, "Instruction Sheet for Comfort-Air® Series 100 & 300 Half Mask Respirator," number R-1150At, dated 10/16, stated that the chemical cartridges should be replaced according to the time schedule set by a qualified safety professional. If no schedule is provided, replace daily or a first trace of contaminant odor in the respirator, whichever comes first.

2. On 11/04/20 at 2:00 PM, Investigator #5, the Director of Infection Control/Operating Room (Staff #504), and a Registered Nurse (Staff #512) inspected an industrial respirator used for the care of patients diagnosed with COVID-19 in the hospital's Critical Care Unit. Investigator #5 noted that the cartridges/filters attached to the Dentec 300 half masks were undated. Staff #504 and Staff #512 told the Investigator that the cartridges/filters were used for 3 (12 hour) shifts and then they were discarded.

3. At this time, Investigator #5, Staff #504, and Staff #512 reviewed the manufacturer's instructions for use and noted that the cartridges were to be replaced at minimum of daily. Staff #504 and Staff #512 confirmed the instructions printed in the manufacturer's instructions for use and stated that the hospital had no other time schedule.

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