HospitalInspections.org

Based on interview, the Governing Body was not aware, and therefore not responsible, for the conduct of staff members in the Sterile Processing Department SPD. The staff was not following proper procedure in the cleaning and sterilization of surgical instruments. The Governing Body failed to ensure that the Medical Staff was following the bylaws regarding the responsibility of the Medical Staff to ensure quality of medical care was provided to surgical patients. The Governing Body failed to ensure that the Quality Assurance/Performance Improvement (QAPI) department was adequately monitoring and responding to problems in services provided in SPD. The Governing Body failed to ensure that Surgical Services were provided in a way that provided care according to accepted standards of practice. The Governing Body failed to ensure that Infection Control and Prevention Staff were monitoring and responding to problems with surgical instrument processing.

Findings:

1. The Governing Body failed to ensure that Medical Staff Bylaws were adhered to. See tag A-0353

2. The Governing Body failed to ensure that the QAPI program included all medical services. See tag A-0263

3. The Governing Body failed to ensure that surgical services were performed in a manner that would assure the achievement and maintenance of high standards of medical practice and patient care. See tag A-0940

4. The Governing Body failed to ensure that the hospital provided a sanitary environment to avoid sources and transmission of infections and communicable diseases. Surgical instruments were not properly disinfected. See tag A-0747

These deficient practices, together result in the Condition of Participation for Governing Body being NOT MET.

Based on observation, interview and document review, the hospital's QAPI program failed to to monitor critical services in the Sterile Processing, Operating Rooms and Procedural areas to ensure that surgical instruments were properly cleaned and disinfected. This resulted in the possibility of transmission of infectious agents and foreign material from the instruments to patients and staff.

Findings:

1. The Chief of Surgery was not involved in discussions about the issues in the processing of sterile instruments for two days after these issues were discovered. See tag A-0353


2. The hospital failed to ensure the sterile processing department (SPD) followed the manufacturer's IFUs (information for use) for daily and weekly cleaning 9 of 10 autoclaves (machines used to sterilize surgical instruments), 4 of 4 instrument washers, and 2 of 2 ultrasonic machines. (Refer to A-0749 and A-283)

3. Five (5) of 5 trays (2 major, 3 minor) processed (previously sterilized and ready for patient surgical procedures) had more than half of the surgical instruments with brown staining, and multiple instruments were difficult to open (stiffness). (Refer to A-0749 and A-283)

4. No evidence was provided to demonstrate the hospital SPD's (a restricted area where staff must wear proper attire and street clothes are not permitted and is used to clean and disinfect soiled patient equipment and instruments), and the gastrointestinal labs (GI) decontamination areas and the GI procedure room number three (3) were routinely and terminally cleaned (a cleaning method used in healthcare environments to control the spread of infections) or organized in a manner, which prevented the potential for cross contamination. (Refer to A-0749 and A-283)

5. The SPD and the GI department did not have a method for determining the temperature and humidity levels in their decontamination rooms, and Hospital B's SPD decontamination area did not record temperature and humidity levels. (Refer to A-0749 and A-283)

6. Surgical instruments were not cleaned and processed according to nationally recognized infection control standards. (Refer to A-0749 and A-283)

These deficient practices result in the condition for QAPI being NOT MET.

Based on interview, record, and document review, the hospital failed to consistently collect and analyze data related to Nursing documentation of patients pain re-assessments after the administration of pain medications.

In addition, the Infection Control Program failed to consistently observe, collect and analyze data related to the Sterile Processing Units as related to cleaning and sterilization of surgical instruments related to Infection Control.

Findings:

1. During the review of 1 of 86 (42) sampled patient's records, multiple Nurses did not document Patient 42's pain re-assessments. A Member of the Pain Committee stated data collected in regards to incomplete pain re-assessments did not include patients who were discharged or transferred however, Leadership indicated patients who were discharged or transferred were a part of the data. There was a disparity between members of the Pain Committee and Leadership in regards to the types of pain data collected.

The disparity did not ensure consistency in how patients pain data was compiled and analyzed in an effort to improve and sustain efficient re-assessment and pain management assessment in accordance with the hospital's 2017/2018 Performance Improvement and Patient Safety Plan.
Patient 42's medical record was reviewed on 3/13/18.

Patient 42 was admitted to Hospital B on 2/23/18 per the Facesheet.

Physician's orders, dated 3/3/18, indicated Patient 42 received Oxycodone (narcotic pain medication) tablet 10 mg (milligrams) by mouth every four hours as needed for severe pain (pain score 7-10).

Physician's orders, dated 2/28/18, indicated Patient 42 received Tylenol (pain medication) tablet 650 mg by mouth every four hours as needed for moderate pain (pain score 4-6).

A Medication Administration Record (MAR), documented by a Licensed Vocational Nurse (LVN) 43, indicated Patient 42 was administered 10 mg Oxycodone on 3/6/18 at 4:59 P.M. for a severe pain score of seven. There was no documented evidence of Patient 42's pain re-assessment score until 7:21 P.M. on 3/6/18.

A Medication Administration Record (MAR), documented by a Registered Nurse (RN) 44, indicated Patient 42 was administered Tylenol on 3/2/18 at 11:37 A.M. for a severe pain score of eight. There was no documented evidence Patient 42 requested a moderate pain medication for a severe pain score or for communication to Patient 42's physician in regards to the moderate pain medication which was utilized for severe pain. In addition, there was no documented evidence of Patient 42's pain re-assessment score until 8:00 P.M. on 3/2/18.

LVN 43 and RN 44 were not available for interview on 3/13/18.

On 3/15/18 at 9:35 A.M., an interview was conducted with the Inpatient Oncology Nursing Director (IOND) the Surgical Oncology Nurse Manager (SONM), and the Intensive Care Unit Clinical Nurse Specialist (ICU-CNS).

The SONM stated the hospital began pain re-assessment documentation data collection in 2015 and the current threshold for pain re-assessment was at 80 percent because discharged and transferred patients were not factored into the data. The SONM acknowledged LVN 43 and RN 44, as well as other Nurses, had previous non compliance with documentation of patients pain re-assessments however, the data was not analyzed to determine whether the missed re-assessments occurred when patients transferred or discharged unless each patient's medical record was reviewed. The data captured missed opportunities for documentation and did not capture the patient's pain level at the time of discharge or transfer.

The SONM stated the Department Managers reviewed their Nursing pain re-assessment documentation via a weekly generated report. In addition, she stated the report would had to have been reviewed manually to determine whether the missed re-assessments occurred when patients transferred or discharged.

The ICU-CNS stated she was a member of the hospital's Pain Committee.
and the hospital expected Department Managers spoke to Nurses individually on their units and re-educated staff related to any non compliance with documentation of patients medication re-assessments.

On 3/20/18 at 1:00 P.M., a Quality Assurance Performance Improvement (QAPI) meeting was conducted with Leadership. During the interview, the Chief Nursing Officer (CNO) stated the Pain Committee collected Nursing pain re-assessment documentation data via a generated report. In addition, the CNO stated the report was based on the Nurse who administered the pain medication. Furthermore, the Director of Regulatory Affairs (DRA) stated patients who were discharged or transferred were a part of the data.

The hospital's 2017/2018 Performance Improvement and Patient Safety Plan indicated "VIII. Monitoring Performance ...Data is compiled an analyzed...to identify changes that will lead to improvements and determine whether changes have actually improved processes and outcomes."

There was a disparity between a member of the Pain Committee and Leadership in regards to the types of pain data collected. The disparity did not ensure consistency in how patient's pain data was compiled and analyzed in an effort to improve and sustain efficient re-assessment and pain management assessment in accordance with the hospital's 2017/2018 Performance Improvement and Patient Safety Plan.

2. On 3/20/18 at 1 P.M., a QAPI meting was conducted. The Assistant Director of Infection Prevention and Clinical Epidemiology (DIPCE) stated he did not observed, collect and analyze the processes in the Sterile Processing Units at both campus' on a consistent basis.

Based on interview and document review, the Chief (Chair) of Surgery was not aware of issues regarding the processing of surgical instruments for almost two days after immediate jeopardy was called. This resulted in discussion about the problem and the development of an action plan, without the knowledge or contribution of the Chief of Surgery.

Findings:

1. The Chief of Surgery (Chair, Medical Director for Perioperative Services) for both the hospital and the system was interviewed on March 14, 2018 at 10:50 A.M. He stated that he had first been informed of the issues in the Sterile Processing Department (SPD) prior to the interview. He had not been aware that these problems in the SPD area had been identified by the survey team and communicated to administration as an Immediate Jeopardy (IJ) two days prior.

2. A Governing Body meeting was held 3/20/18 at 11:00 A.M. The Chief Medical Officer stated that she should have called the Chief/Chair for Perioperative Services when she was made aware of the findings in Sterile Processing and the declaration of Immediate Jeopardy. The hospital leadership is creating a leadership roster so that the necessary individuals can be quickly contacted for issues regarding their area of responsibility.

3. The Medical Staff Bylaws and the Rules and Regulations were reviewed at 1:35 P.M. on March15, 2018. Section 1.2 of the Bylaws states that The Medical Staff's Purposes are: To assure that all patients ...receive a uniform standard of quality patient care, treatment and efficiency ...A. To provide for a level of professional performance that is consistent with generally accepted standards ..." Page 28 of the Rules and Regulations contains a section entitled "Perioperative Services Committee." It lists the membership of the committee which includes the Chair, the Medical Director for Perioperative Services. The Duties of the committee include "3. To review the effectiveness and efficiency of operating room services ....4. To make recommendations regarding identified issues to the Quality Council and respond to issues of patient care and safety raised by other Medical Staff Committees."

Based on observation, interview and record review the hospital's Nursing Services failed to:

1. Ensure Nursing hand-off communication during nurse to nurse transfer (A-386)

2. Ensure pain re-assessments were documented as performed (A-386);

3. Consistently monitor and re-educate nursing staff pain re-assessments after the administration of pain medication (A-386);

4. Ensure a written plan of care was developed for patients with C-Diff; (A-396)

The Condition of Participation for Nursing Services was NOT MET, due to the cumulative effect of these systemic problems.

Based on interview, record, and document review, the hospital failed to ensure Nursing handoff communication (exchange of information related to a patient's care when the patient's care was transferred from one Nurse to another Nurse) was consistently documented as performed for 1 of 86 sampled patient's (42). In addition, the hospital failed to ensure pain re-assessments were documented as performed for Patient 42, in accordance with the hospital's Pain Management Policy. Furthermore, the hospital failed to consistently monitor and re-educate Nursing staff in regards to the non compliance of patient's pain re-assessments after the administration of pain medications in accordance with the hospital's stated Pain Committee goals.

The lack of documentation, consistent monitoring and re-education to staff, did not ensure an accurate handoff of patient information was exchanged, staff were fully aware of patients pain levels during re-assessment times in an effort to accurately determine the effectiveness of pain management for patients, and sustained employee efficiency in patient's pain re-assessments.

Findings:

1. Patient 42's medical record was reviewed on 3/13/18.

Patient 42 was admitted to Hospital B on 2/23/18 per the Facesheet.

Per Patient 42's Event Summary, the patient was transferred to and from various inpatient units during hospitalization. There was no documented evidence handoff communication occurred from unit to unit by Patient 42's health care providers on 2/24/18, 2/28/18, and 3/1/18.

On 3/13/18 at 8:45 A.M., an interview was conducted with a Registered Nurse (RN) 42, the Medical Surgical Nurse Manager (MSNM), and the Inpatient Oncology Nursing Director (IOND). During the interview, Patient 42's Event Summary of unit to unit transfers was reviewed. RN 42 stated the purpose of patient handoff was to ensure staff understood the patient's plan of care and provided continuity of care. In addition, RN 42 stated, after a handoff communication occurred, both staff documented the occurrence in the patient's medical record.

Per the hospital's policy and procedure etitled, Patient Handoff Communication ,revised 9/20/16, health care providers conducted handoff communication during unit to unit patient transports and "At a minimum, this would include a name and a phone or pager number."

2. Patient 42's medical record was reviewed on 3/13/18.

Physician's orders ,dated 3/3/18, indicated Patient 42 received Oxycodone (narcotic pain medication) tablet 10 mg (milligrams) by mouth every four hours as needed for severe pain (pain score 7-10).

Physician's orders, dated 2/28/18, indicated Patient 42 received Tylenol (pain medication) tablet 650 mg, by mouth every four hours as needed for moderate pain (pain score 4-6).

A Medication Administration Record (MAR), documented by a Licensed Vocational Nurse (LVN) 43, indicated Patient 42 was administered 10 mg Oxycodone on 3/6/18 at 4:59 P.M. for a severe pain score of seven. There was no documented evidence of Patient 42's pain re-assessment score until 7:21 P.M. on 3/6/18.

A Medication Administration Record (MAR), documented by a Registered Nurse (RN) 44, indicated Patient 42 was administered Tylenol on 3/2/18 at 11:37 A.M. for a severe pain score of eight. There was no documented evidence Patient 42 requested a moderate pain medication for a severe pain score or for communication to Patient 42's physician in regards to the moderate pain medication which was utilized for severe pain. In addition, there was no documented evidence of Patient 42's pain re-assessment score until 8:00 P.M. on 3/2/18.

LVN 43 and RN 44 were not available for interview on 3/13/18.

On 3/15/18 at 9:35 A.M., an interview was conducted with the Inpatient Oncology Nursing Director (IOND) the Surgical Oncology Nurse Manager (SON), and the Intensive Care Unit Clinical Nurse Specialist (ICU-CNS). The ICU-CNS stated she was a member of the hospital's Pain Committee and the hospital expected Department Managers spoke to nurses individually on their units and re-educated staff related to any non compliance with patient's medication re-assessment. In addition, during the interview, the SONM stated monthly audits were conducted related to staff compliance with patient medication re-assessments. Furthermore during the interview, the Surgical Oncology Unit's annual pain re-assessment audit's were reviewed. The SONM acknowledged LVN 43 and RN 44 had previous non compliance with patient's pain re-assessments. The SONM stated upon review of the audits, staff were re-educated verbally and it was documented in employee performance evaluations.

Per the hospital's policy and procedure titled, Pain Management revised 10/27/16, "...XI. The healthcare staff will reassess the patient's pain to determine the effectiveness of the pain management strategies. The timing for reassessment is dependent on the intervention and is timed around the peak effect of the treatment... A. PO (by mouth)... approximately 45-75 minutes following administration..."

3. Patient 42's medical record was reviewed on 3/13/18.

Patient 42 was admitted to Hospital B on 2/23/18 per the Facesheet.

Physician's orders, dated 3/3/18, indicated Patient 42 received Oxycodone (narcotic pain medication) tablet 10 mg (milligrams) by mouth every four hours as needed for severe pain (pain score 7-10).

Physician's orders, dated 2/28/18, indicated Patient 42 received Tylenol (pain medication) tablet 650 mg by mouth every four hours as needed for moderate pain (pain score 4-6).

A Medication Administration Record (MAR), documented by a Licensed Vocational Nurse (LVN) 43, indicated Patient 42 was administered 10 mg Oxycodone on 3/6/18 at 4:59 P.M. for a severe pain score of seven. There was no documented evidence of Patient 42's pain re-assessment score until 7:21 P.M. on 3/6/18.

A Medication Administration Record (MAR), documented by a Registered Nurse (RN) 44, indicated Patient 42 was administered Tylenol on 3/2/18 at 11:37 A.M. for a severe pain score of eight. There was no documented evidence Patient 42 requested a moderate pain medication for a severe pain score or for communication to Patient 42's physician in regards to the moderate pain medication which was utilized for severe pain. In addition, there was no documented evidence of Patient 42's pain re-assessment score until 8:00 P.M. on 3/2/18.

LVN 43 and RN 44 were not available for interview on 3/13/18.

On 3/15/18 at 9:35 A.M., an interview was conducted with the Inpatient Oncology Nursing Director (IOND) the Surgical Oncology Nurse Manager (SONM), and the Intensive Care Unit Clinical Nurse Specialist (ICU-CNS). The ICU-CNS stated she was a member of the hospital's Pain Committee and the hospital expected Department Managers spoke to nurses individually on their units and re-educated staff related to any non compliance with patient's medication re-assessment. In addition, during the interview, the SONM stated monthly audits were conducted related to staff compliance with patient medication re-assessments. Furthermore during the interview, the Surgical Oncology Unit's annual pain re-assessment audit's were reviewed. The SONM acknowledged LVN 43 and RN 44 had previous non compliance with patient's pain re-assessments. The SONM stated upon review of the audits, staff were re-educated verbally and it was documented in employee performance evaluations.

On 3/21/18 at 10:00 A.M., LVN 43 and RN 44's annual Performance Evaluations (PE) were reviewed with a Human Resources Licensure Specialist (HRLS), the IOND, and the SONM. LVN 43's PE dated 9/28/17, indicated "Opportunities to improve are in the areas of pain management." RN 44's PE dated 4/18/17 did not contain documented evidence for opportunities to improve in the areas of pain management. The inconsistency in re-education was not in accordance with the hospital's Pain Committee and Surgical Oncology Department Manager stated process.

Based on interview and record review the hospital failed to ensure a written plan of care was developed for 1 of 86 sampled patients (16). Patient 16 was confirmed with Clostridium difficile (Cdiff- A bacteria in the colon which can be transmitted from person to person) and would leave the room. As a result, there was an increase risk for the spread of infection to other patients, visitors and healthcare workers.

Findings:

Patient 16 was admitted to the hospital on 3/8/18 with diagnoses which included sepsis (infection which can cause injury to tissues and organs) per the hospital's Face Sheet.

On 3/15/18 at 9:31 A.M., a review of Patient 16's medical record was conducted with the Nurse Manager of the Emergency Department (NMED). The lab result dated 3/10/18 at 11:41 A.M., indicated Patient 16 had a positive Cdiff result. There was no documented evidence of written care plan for interventions, education and goals related to the Cdiff infection.

On 3/15/18 at 9:53 A.M., a joint interview and record review was conducted with the Nurse Manager (NM 14). NM 14 stated a care plan should have been initiated when the lab results showed positive and would expect the nurse who did the initial assessment upon transfer to the new floor to add the care plan if had been missing. Patient 16 had been transferred to a different floor on 3/14/18.

On 3/15/18 at 10:10 A.M., a joint interview and record review was conducted with RN 15, who was assigned to care for Patient 16. RN 15 stated the patient leaves the floor and stated "thought I charted about the infection yesterday." RN 15 was unable to find any document evidence of a care plan related to the patients Cdiff infection or that he would leave the floor.

On 3/15/18 at 10:27 A.M., an interview was conducted with NM 13. NM 13 stated she would expect a care plan to be developed for the Cdiff infection and Patient 16 leaving the floor. NM 13 further stated she was unaware of the patient leaving the floor and it should have been escalated up to her.

On 3/20/18 at 8:50 A.M., an interview was conducted with the Senior Lab Specialist (SLS) . The SLS stated Patient 15's positive Cdiff lab results were called to RN 17 on 3/10/18 at 11:40 A.M.

RN 17 was not available for an interview.

On 3/20/18 at 10:30 A.M., an interview was conducted with the Director of Infection Prevention (DIP) and the Infection Preventionist (IP). The DIP stated any patient on Cdiff precautions needed to be escorted for observations if they left the room. The DIP was unaware of Patient 15 leaving the floor.

Per the hospital's policy and procedure titled "Contact Precautions/Enhanced Contact Precautions," revised date 06/15, "...Contact precautions will be instituted... Instances in which special organism precautions apply are as follows:... Cdiff...VI Patient Transport/Ambulation...2. Patient may walk in hall wearing clean cover gown if they have been instructed in hand hygiene, are continent, and are able to cooperate with procedures..."

Per the hospital's document titled "Practice Guideline for Documentation," not dated, "...Interdisciplinary Problem-Oriented Patient Care Planning: In-Patient, Assessment/Data... A patient assessment, including patient/family stated goal, is performed once a shift and with changes in patient condition or per Standards of Patient Care... Communication/Documentation... There will be documentation to every identified/assigned Problem every shift..."

Based on interview and record review the hospital failed to ensure nurses reassessed the effectiveness of a pain medication for 4 of 86 sampled patients (14, 15, 16, 63). In addition, interventions were not provided for a patient experiencing pain for 1 of 86 sampled patients (67). As a result, the patients pain may not have been relieved.

The hospital also failed to ensure a medication was administered according to physician's orders to 1 of 86 sampled patients (53). Failure to administer a medication in a timely manner for Patient 53 had the potential for delayed identification of changes in health status and implementation of needed healthcare interventions.

In addition the hospital failed to ensure medications were prepared and administered in accordance with practitioner's orders and hospital policies and procedures when:

-A spiked IV solution bag for Patient 86 was not labeled with required expiration dating. This failure had the potential to increase the patient's risk of infection(s).

-Methadone medication barcodes were not scanned to ensure the correct medication was administered to Patient 87. This failure had the potential to expose the patient to medication errors.

-Patient 88 self-administered nasal spray without an order and specific instructions for self-administration in accordance with policies and procedures. This failure had the potential to expose the patient to medication errors.

-Patient 88 self-administered one spray instead of the ordered two sprays in each nostril of fluticasone nasal spray. This failure resulted in the patient being exposed to a medication error.

-Patients 89, 90, and 91 were administered propofol starting doses not in accordance with the physician's orders.
This failure resulted in the patients being exposed to medication errors.

Findings:

1. Patient 14 was admitted to the hospital on 2/13/18 with diagnoses which included right upper arm burn per the hospital's Face Sheet.

On 3/14/18 at 10:55 A.M., a review of Patient 14's medical record was conducted with the Director of the Emergency Department (DED). The physician order dated 2/19/18, indicated "Oxycodone (pain medication) 15 mg (milligrams) by mouth every 4 hours PRN (as needed) for severe pain (pain scale score 7-10).

The nursing flowsheet for pain on 3/13/18 at 5:39 P.M., indicated Patient 14 had 7 out of 10 pain. The Medication Administration Record (MAR) indicated the patient had received the pain medication on 3/13/18 at 5:39 P.M. There was no documented evidence of a reassessment to check the effectiveness of the pain medication related to Patient 14's pain.

The nursing flowsheet for pain on 3/14/18 at 12:18 A.M., indicated Patient 14 had 7 out of 10 pain. The Medication Administration Record (MAR) indicated the patient had received the pain medication on 3/14/18 at 12:18 A.M. There was no documented evidence of a reassessment to check the effectiveness of the pain medication related to Patient 14's pain

On 3/14/18 at 11:25 A.M., a joint interview and record review was conducted with Registered Nurse (RN 12). RN 12 reviewed the nursing flowsheet and the MAR for 3/13/18 and confirmed he was the RN that assessed and dispensed the pain medication to Patient 14. RN 12 when asked about the reassessment stated he didn't reassess the patients pain but should have.

On 3/20/18 at 8:05 A.M., an interview was conducted with RN 13. RN 13 confirmed she had given Patient 14 the pain medication on 3/14/18 at 12:18 A.M. RN 13 stated the reassessment for medications by mouth was to be done between 45-75 minutes after the administration of the medication and she must have forgot to document it.

On 3/20/18 at 8:10 A.M., an interview was conducted with the Nurse Manager (NM 11). NM 11 stated the expectation was for the RN's was to reassess the patients pain 45-75 minutes after they administered pain medications and to document the reassessment.

2. Patient 15 was admitted to the hospital on 2/28/18 with diagnoses which included burn of the left extremity per the hospital's Face Sheet.

On 3/14/18 at 2:50 P.M., a review of Patient 15's medical record was conducted with the DED. The physician order dated 3/6/18, indicated "Oxycodone (pain medication) 15 mg (milligrams) by mouth every 4 hours PRN (as needed) for severe pain (pain scale score 7-10).

The nursing flowsheet for pain on 3/13/18 at 5:54 P.M., indicated Patient 15 had 8 out of 10 pain. The Medication Administration Record (MAR) indicated the patient had received the pain medication on 3/13/18 at 5:54 P.M. There was no documented evidence of a reassessment to check the effectiveness of the pain medication related to Patient 15's pain

On 3/20/18 at 8:12 A.M., a joint interview and record review was conducted with RN 14. RN 14 confirmed she had given Patient 15 the pain medication on 3/13/18 at 5:54 P.M. RN 14 stated the reassessment for medications by mouth was to be completed between 45-75 minutes after the medicaton was administered, but stated it was the end of her shift and she handed it off to the oncoming shift nurse (RN 16). RN 14 further stated she did not document that she had verbally handed off the information for the reassessment to the oncoming shift.

The RN 16 was not available for an interview.

On 3/20/18 at 8:25 A.M., an interview was conducted with the Nurse Manager (NM 12). NM 12 stated the expectation was for the RN's to reassess the patients pain 45-75 minutes after they administered pain medications. NM 12 further stated if it had been handed off to the oncoming shift nurse it should have documented and the reassessment completed.

3. Patient 16 was admitted to the hospital on 3/8/18 with diagnoses which included sepsis (infection which can cause injury to tissues and organs) per the hospital's Face Sheet.

On 3/15/18 at 9:31 A.M., a review of Patient 16's medical record was conducted with the Nurse Manager of the Emergency Department (NMED). The physician order dated 3/14/18, indicated "Percocet (pain medication) 5-325 mg (milligrams) by mouth every 6 hours PRN (as needed) for moderate pain (pain scale score 4-6).

The nursing flowsheet for pain on 3/14/18 at 8:21 A.M., indicated Patient 16 had moderate pain to the shoulder. The Medication Administration Record (MAR) indicated the patient had received the pain medication on 3/14/18 at 8:21 A.M. There was no documented evidence of a reassessment to check the effectiveness of the pain medication related to Patient 16's pain

On 3/15/18 at 10:10 A.M., a joint interview and record review was conducted with RN 15. RN 15 confirmed she had given Patient 16 the pain medication on 3/14/18 at 8:21 A.M. RN 15 stated she should have done a reassessment one hour after she administered Patient 16 the pain medication.

On 3/15/18 at 10:27 A.M., an interview was conducted with the Nurse Manager (NM 13). NM 13 stated the expectation was for the RN to reassess the patients pain one hour after they administered the pain medication and expected it to be documented.

Per the hospital's policy and procedure titled, Pain Management revised 10/27/16, "...XI. The healthcare staff will reassess the patient's pain to determine the effectiveness of the pain management strategies. The timing for reassessment is dependent on the intervention and is timed around the peak effect of the treatment... A. PO (by mouth)... approximately 45-75 minutes following administration..."


35335

4. On 3/14/18 at 8:39 A.M., during an observation and concurrent interview in Room 1114, a spiked IV normal saline 500 mLs solution bag was observed hanging on Patient 86's IV pole. The spiked IV solution bag was not labeled with an expiration date and/or time. Licensed Nurse 86 (LN 86) acknowledged the above observation of the spiked IV solution bag lacking expiration dating. LN 86 stated the IV solution bag expired 24 hours after being spiked. LN 86 stated she did not know when the bag expired, so she "will hang new bag."

The facility policy and procedure titled, "Medication Preparation, Labeling, and Administration" dated 6/20/17, indicated "Preparer Responsibilities ...4. Label the product correctly. Any time a medication is prepared but not administered immediately, the medication container must be appropriately labeled with the following: expiration date (See Form D2336 for expiration dating)." The facility document "Form 2336 (12-17) Page 1 of 2" indicated for newly spiked (IVs) the required labeling was the "Medication Added" sticker and the maximum infusion hang time was 24 hours.


5. Review of physician's orders dated 2/8/18 for Patient 87 indicated methadone 80 mg daily.

On 3/14/18 at 9:15 A.M., during an observation and concurrent interview in Room 615, LN 87 was observed to handle eight tablets of methadone 10 mg (total 80 mg). The eight methadone 10 mg tablets were observed not all physically connected together. Two methadone 10 mg tablets were observed to be physically separated from the other six methadone 10 mg tablets. LN 87 was observed to repeatedly scan the medication barcodes of the two methadone tablets multiple times. LN 87 was observed not to scan any of the medication barcodes of the remaining six methadone tablets. After the eight methadone tablets were administered to the patient, LN 87 stated she did not scan the medication barcodes on six of the eight methadone tablets.

On 3/14/18 at 9:35 A.M., during an interview, Nurse Manager 87 (NM 87) stated "each medication should be scanned individually."

The facility policy and procedure titled, "Medication Preparation, Labeling, and Administration" dated 6/20/17, indicated "Barcode scan both the patient identification band and medication barcode to ensure the correct medication is being administered to the correct patient."


6. Review of physician's orders dated 3/13/18 for Patient 88 indicated fluticasone nasal spray with an order for two sprays in each naris daily. The fluticasone nasal spray medication order indicated "Self-Administered: No."

On 3/14/18 at 9:58 A.M., during an observation in Room 1001, LN 88 was observed giving the fluticasone nasal spray to Patient 88. Patient 88 was then observed to self-administer the nasal spray to herself.

On 3/14/18 at 10:05 A.M., during an interview, Patient 88 stated she gave herself one spray in each nostril.

On 3/14/18 at 10:05 A.M., during an interview, LN 88 acknowledged Patient 88 self-administered the nasal spray.

On 3/14/18 at 12:07 P.M., during an interview, the Medication Safety Pharmacist acknowledged the fluticasone nasal spray medication order indicated "Self-Administered: No".

The facility policy and procedure titled, "Bedside Medications for Patient Self-Administration" dated 7/5/16, indicated "The medication orders shall specifically state the medication(s) to be placed at the patient's bedside with specific instructions for self-administration."


7. Review of physician's orders dated 3/13/18 for Patient 88 indicated fluticasone nasal spray two sprays in each naris daily.

On 3/14/18 at 9:58 A.M., during an observation in Room 1001, LN 88 was observed handing the fluticasone nasal spray to Patient 88. Patient 88 was then observed to self-administer one spray in each nostril.

On 3/14/18 at 10:05 A.M., during an interview, Patient 88 stated she gave herself one spray in each nostril.

On 3/14/18 at 10:05 A.M., during an interview, LN 88 acknowledged Patient 88 self-administered the nasal spray. She stated the dose was "one in each nose for a total of two" sprays.

On 3/14/18 at 12:20 P.M., during an interview, LN 88 acknowledged the fluticasone nasal spray dose was two sprays in each nostril. She stated Patient 88 needed another dose in each nose today [3/14/18].

The facility policy and procedure titled, "Medication Preparation, Labeling, and Administration" dated 6/20/17, indicated "[The name of the hospital] has adopted the following goals for administration of medication per prescriber order, also known as the "Five Rights" of medication administration ...Right dose." On page 5 of 14, the policy indicated, "Prior to any medication administration: Medication orders will be reviewed on the MAR prior to administration." On page 8 of 14, the policy indicated, "Before administering medications, the caregiver will: Follow the "Five rights" (patient, medication, dose, route, time) for medication administration."


8a. On 3/15/18 at 9:25 A.M., during record review and concurrent interview, a review of Patient 89's medical record was conducted accompanied by Registered Pharmacist 92 (RPh 92) and Clinical Nurse Specialist 93 (CNS 93). The physician's orders dated 1/30/18 at 3:06 A.M. indicated a propofol starting dose of 30 mcg/kg/min. The medical record indicated that LN 89 administered propofol on 1/30/18 at 3:34 A.M. at a starting dose of 10 mcg/kg/min. The RPh 92 acknowledged the above documentation. The CNS 93 stated there were no medication orders clarifying the propofol starting dose.

On 3/20/18 at 9:34 A.M., during record review and concurrent interview, LN 89 stated "I should have asked the physician to put in an order for 10 mcg/kg/min." LN 89 acknowledged she should have obtained a clarification order on the propofol.

The facility policy and procedure titled, "Medication Preparation, Labeling, and Administration" dated 6/20/17, indicated "[The name of the hospital] has adopted the following goals for administration of medication per prescriber order, also known as the "Five Rights" of medication administration ...Right dose." On page 5 of 14, the policy indicated, "Prior to any medication administration: Medication orders will be reviewed on the MAR prior to administration." On page 8 of 14, the policy indicated, "Before administering medications, the caregiver will: Follow the "Five rights" (patient, medication, dose, route, time) for medication administration."

The facility policy and procedure titled, "Patient Treatment and Medication Orders" dated 9/15/17, indicated "Nursing Service Responsibilities ...If a physician/practitioner writes an order on the medical record that is not legible, complete, or clear, the order should be clarified."

8b. On 3/15/18 at 9:54 A.M., during record review and concurrent interview, a review of Patient 90's medical record was conducted accompanied by RPh 92 and CNS 93. The physician's orders dated 2/12/18 at 6:31 P.M. indicated a propofol starting dose of 20 mcg/kg/min. The medical record indicated LN 90 administered propofol on 2/12/18 at 6:39 P.M. at a starting dose of 10 mcg/kg/min. The RPh 92 acknowledged the above documentation. The CNS 93 stated there were no medication orders clarifying the propofol starting dose.

On 3/20/18 at 9:00 A.M., during record review and concurrent interview, a review of Patient 90's medical record was conducted accompanied by Assistant Nurse Manger 90 (ANM 90). The ANM 90 acknowledged LN 90 did not follow the physician's order for the starting dose of propofol on 2/12/18 at 6:39 P.M. according to the medication administration documentation. The ANM 90 stated she would have preferred if there was a clarification order from the physician regarding the starting dose.

LN 90 was not available for interview.

The facility policy and procedure titled, "Medication Preparation, Labeling, and Administration" dated 6/20/17, indicated "[The name of the hospital] has adopted the following goals for administration of medication per prescriber order, also known as the "Five Rights" of medication administration ...Right dose." On page 5 of 14, the policy indicated, "Prior to any medication administration: Medication orders will be reviewed on the MAR prior to administration." On page 8 of 14, the policy indicated, "Before administering medications, the caregiver will: Follow the "Five rights" (patient, medication, dose, route, time) for medication administration."

The facility policy and procedure titled, "Patient Treatment and Medication Orders" dated 9/15/17, indicated, "Nursing Service Responsibilities ...If a physician/practitioner writes an order on the medical record that is not legible, complete, or clear, the order should be clarified."

8c. On 3/15/18 at 10:17 A.M., during record review and concurrent interview, a review of Patient 91's medical record was conducted accompanied by RPh 92 and CNS 93. The physician's orders dated 2/16/18 at 12:11 A.M. indicated a propofol starting dose of 30 mcg/kg/min. The medical record indicated that LN 91 administered propofol on 2/15/18 at 11:18 P.M. at a starting dose of 20 mcg/kg/min. The propofol dose was documented at 20 mcg/kg/min until the propofol dose was changed at 2/16/18 at 4:50 A.M. The RPh 92 acknowledged the above documentation. The CNS 93 stated there were no medication orders clarifying the propofol starting dose.

On 3/20/18 at 9:24 A.M., during an interview, LN 91 acknowledged she should have looked at the physician's orders for propofol.

The facility policy and procedure titled, "Medication Preparation, Labeling, and Administration" dated 6/20/17, indicated "[The name of the hospital] has adopted the following goals for administration of medication per prescriber order, also known as the "Five Rights" of medication administration ...Right dose." On page 5 of 14, the policy indicated, "Prior to any medication administration: Medication orders will be reviewed on the MAR prior to administration." On page 8 of 14, the policy indicated, "Before administering medications, the caregiver will: Follow the "Five rights" (patient, medication, dose, route, time) for medication administration."

The facility policy and procedure titled, "Patient Treatment and Medication Orders" dated 9/15/17, indicated, "Nursing Service Responsibilities ...If a physician/practitioner writes an order on the medical record that is not legible, complete, or clear, the order should be clarified."






35611

9. Patient 63 was admitted to the hospital on 3/12/18 with diagnosis which included delayed delivery after spontaneous rupture of membranes per the hospital Face Sheet.

On 3/13/18 at 2:45 P.M., a record review of Patient 63's nursing flowsheet and medication administration record (MAR) was conducted. The nursing flowsheet indicated on 3/13/18 at 2:43 A.M., Patient 63 had pain five out of ten. The MAR indicated Patient 63 received fentanyl (medication for pain) injection 100 mcg (microgram) via IV (intravenous therapy which delivers medication directly into the vein) for her pain.

On 3/13/18 at 2:50 P.M., a concurrent interview and record review was conducted with RN 63 and assistant nurse manager (ANM). RN 63 and ANM looked through the record and did not find documented evidence that reassessment was done. RN 63 and ANM stated it should have been reassessed 30 minutes after the medication was administered. Both RN 63 and ANM acknowledged it was important to reassess to check the effectiveness of medication. This was not done for Patient 63.

On 3/13/18 at 4:07 P.M., an interview was conducted with nurse manager (NM) 61. NM 61 stated it was important for reassessment to know, "If medication are effective." NM 61 acknowledged this was not done for Patient 63.

A review of the hospital policy and procedure titled, Pain Management, dated 10/16 was conducted. This policy indicated, " ... XI. The health care staff will reassess the patient's pain to determine the effectiveness of the pain management strategies ... B. IV, IM, subcutaneous ... approximately 15-45 minutes following administration ..."... approximately 15-45 minutes following administration ..."


10. Patient 67 was admitted to the hospital on 1/12/18 with diagnoses which included retinopathy of prematurity per the hospital Face Sheet.

A review of Patient 67's nursing flowsheet for 3/18 was conducted. On 3/12/18 Patient 67 had the following pain level:
At 1:20 P.M., 6 out of 10; no documented evidence of intervention
At 1:22 P.M., 5 out of 10; no documented evidence of intervention
At 1:50 P.M., 6 out of 10; no documented evidence of intervention
At 2:04 P.M., 6 out of 10. no documented evidence of intervention

A concurrent interview and record review with assistant nurse manager (ANM) 66 on 3/14/18 at 3:05 P.M., was conducted. ANM reviewed Patient 67's nursing flowsheet and did not find documented evidence that interventions were done. ANM 66 stated pain level of three of more, interventions were required per policy. ANM 66 acknowledged there were no interventions done for patient 67 who experienced pain.

A review of hospital policy and procedure titled, Pain assessment and Management: Infant, revised date 6/17 was conducted. This policy indicated, " ... 4. Treatment/interventions are suggested for scores > (more) 3 ..."


36708

11. Resident 53 was admitted to the hospital on 2/13/18 with diagnoses that included congestive heart failure exacerbation (the heart is unable to maintain an adequate circulation of blood in the bodily tissues or to pump out the venous blood returned to it by the veins) per the hospital's Face sheet.

A record review was conducted on 3/13/18 at 3:05 P.M with nurse manager (NM) 50. The electronic medication administration record (eMAR) indicated, "Potassium chloride (KLOR-CON) ER (extended release) tablet 40 meq (milliequivalent): Dose 40 meq: Oral: PRN: electrolyte replacement if serum potassium 3.5-4.0 mmol/L (millimoles per litre)." In addition, the eMAR indicated, "0955 Given 40 mEq" on 3/13/18.

An interview with the registered nurse (RN) 53 was conducted on 3/13/18 at 3:20 P.M. RN 53 stated she was the primary nurse for Patient 53 on 3/12/18 and had received the potassium level result of 3.6 on 3/12/18 at 5:34 P.M. RN 53 further stated it was during change of shift and had given report to the night shift nurse to replace potassium per PRN orders. RN 53 also stated she had administered the medication today, 3/13/18 at 9:55 A.M. There was no documented evidence to show why the medication was not administered for over 16 hrs.

An interview with the nurse manger (NM) 53 was conducted on 3/13/18 at 3:35 P.M. NM 53 stated it was her expectation of the nurses in her unit to administer medication orders timely, and if there was a delay in administration, a reason of the delay should have been reported and documented.

A review of the hospital's policy and procedure dated 9/15/17, titled Patient Treatment and Medication Orders was conducted. This policy indicated, "Policy: ... VII. Medication and treatments should be administered as ordered by prescribers ..."

Based on observation, interview, and document review, the hospital failed to ensure they had an effective, active system wide infection control program for the prevention, control, and investigation of infections and communicable diseases. The infection control program did not meet the needs of all patients, as evidenced by:

1. The hospital failed to ensure the sterile processing department (SPD) followed the manufacturer's IFUs (information for use) for daily and weekly cleaning 9 of 10 autoclaves (machines used to sterilize surgical instruments), 4 of 4 instrument washers, and 2 of 2 ultrasonic machines.

2. Five (5) of 5 trays (2 major, 3 minor) processed (previously sterilized and ready for patient surgical procedures) had more than half of the surgical instruments with brown staining, and multiple instruments were difficult to open (stiffness).

3. No evidence was provided to demonstrate the hospital SPD's (a restricted area where staff must wear proper attire and street clothes are not permitted and is used to clean and disinfect soiled patient equipment and instruments), the gastrointestinal department (GI) decontamination areas and the GI procedure room number three (3) were routinely and terminally cleaned (a cleaning method used in healthcare environments to control the spread of infections) or organized in a manner, which prevented the potential for cross contamination.

4. The SPD and the GI department did not have a method for determining the temperature and humidity levels in their decontamination rooms, and Hospital B's SPD decontamination area did not record temperature and humidity levels.

5. Surgical instruments were not cleaned and processed according to nationally recognized infection control standards.

6. The hospital's infection control policy regarding proper personal protective equipment (PPE) was not followed.


The cumulative effects of these systemic problems resulted in the hospital's inability to provide an effective hospital wide infection control program resulting in the hospitals inability to provide patient care in a safe and effective manner and in accordance with §482.42 Condition of Participation for Infection Control Services. The seriousness of which, resulted in Immediate Jeopardy, which was identified by the survey team.

Based on observation, interview, and record review, the facility failed to ensure a system was in place for identifying, investigating, and controlling infections and communicable diseases in accordance with internal policies and procedures, as well as nationally recognized infection control practices, guidelines, and regulations.


The facility's infection control program failed to:

1. The hospital failed to ensure the sterile processing department (SPD) followed the manufacturer's IFUs (information for use) for daily and weekly cleaning 9 of 10 autoclaves (machines used to sterilize surgical instruments), 4 of 4 instrument washers, and 2 of 2 ultrasonic machines.
2. Five (5) of 5 trays (2 major, 3 minor) processed (previously sterilized and ready for patient surgical procedures) had more than half of the surgical instruments with brown staining, and multiple instruments were difficult to open (stiffness).

3. No evidence was provided to demonstrate the hospital SPD's (a restricted area where staff must wear proper attire and street clothes are not permitted and is used to clean and disinfect soiled patient equipment and instruments), the gastrointestinal department (GI) decontamination areas and the GI procedure room number three (3) were routinely and terminally cleaned (a cleaning method used in healthcare environments to control the spread of infections) or organized in a manner, which prevented the potential for cross contamination.

4. The SPD and the GI department did not have a method for determining the temperature and humidity levels in their decontamination rooms, and Hospital B's SPD decontamination area did not record daily temperature and humidity levels.

5. Surgical instruments were not cleaned and processed according to nationally recognized infection control standards.

6. Cardiac Catherization Laboratory (Procedural suite equipped with diagnostic imaging used to visualize and treat certain heart abnormalities) staff implemented proper instrument cleaning procedures at point of use (at the patient's operating room/procedure room bed).

7. An Environmental Service Staff (EVS) implemented proper hand hygiene technique when gloves were not removed before exiting a soiled utility room.

8. A Nutrition Service Staff implemented proper patient freezer cleaning techniques in the Transplant unit.

9. Two Surgical Technicians (ST) 1 and 2 followed a standardized approach for the initial decontamination of surgical instruments at the point of use. The lack of properly cleaned and disinfected surgical instruments did not ensure surgical equipments used during procedures were maintained in an effort to prevent cross contamination from patient to patient.

10. One (1) of 86 sampled patients (12) who was on droplet precautions (germs spread by tiny droplets caused by coughing and sneezing). As a result, the visitor was at risk of infection and spreading infection.

11. The staff failed to follow the facility's Policy and Procedure in the use of PPE; and

12. The staff was not knowledgeable in the disinfecting in equipment for patient on contact precautions.

Findings:

During an interview with the Assistant Director of Infection Prevention (ADIP), on March 12, at 11:15 a.m., he stated that the hospital followed nationally recognized infection control guidelines from AAMI (Association for the Advancement of Medical Instrumentation - an organization for advancing the development, and safe and effective use of medical technology), CDC (Centers for Disease Control), APIC (Association for Professionals in Infection Control and Epidemiology) and AORN (Association of perioperative Registered Nurses - leaders in advocating for excellence in perioperative practice and healthcare).

1a. On March 12, 2018, at 11:30 a.m., a tour was conducted, in the presence of the Sterile Processing Supervisor (SPS 1), Lead Sterile Processing Technician (LSPT), and the Director of Infection Prevention (DIP), of Hospital A, "Sterile Processing Prep & Pack Area". The area contained 5 working autoclaves (machines used to sterilize surgical instruments). An observation was made of 5 of 5 autoclaves of the interior floors and walls of the holding chambers (an area where a cart holding surgical instruments is placed for sterilization) had large amount of dark rust color, black, and white staining. The exterior of each autoclave (stainless steel) was covered with large amount of water stains (streaking), and dirt.
During a concurrent interview with the LSPT, he acknowledged the stains in the chamber and on the exterior of each autoclave. LSPT stated the staff does not clean the inside chambers and the staff only wipes down the exterior of the autoclaves.
On March 12, 2018, at 12:50 p.m., an interview was conducted with SPS 1. SPS 1 was asked to provide documentation or logs to show that the manufacturer's information for use (IFU) for routine cleaning and maintenance was done. SPS 1 stated they did not have any documentation to show the autoclaves were cleaned by the users of the machine, as required by the manufacturer. SPS 1 was asked about SPD's quality assurance plan (QA). SPS 1 stated SPD did not have a QA plan.
A review of the manufacturer IFUs was conducted with the SPS 1, and each step of the routine maintenance was discussed. The SPS 1 stated the staff did not perform the following steps described in the manufacturer's IFUs:
- "...Daily Maintenance: "...Regardless of the hardness level of supplied water, the generator must be flushed every day before use to prevent mineral scaling or carryover of debris into the chamber.
- Weekly Maintenance: Flush Chamber Drain...c. Pour a solution of one pint of hot water and 1/4 cup of Steris Liqui-Jet 2 Instrument Detergent or Criti-Klenz Instrument detergent into drain. Solution may puddle in the bottom of the chamber."

Hospital A did not have any documentation or logs to show daily or weekly routine cleaning of autoclaves.

1b. On March 14, 2018, at 8:45 a.m., a tour was conducted, in the presence of the Sterile Processing Supervisor (SPS 2), and the Director of Infection Prevention (DIP), of Hospital B, "Sterile Processing Prep & Pack Area". The area contained 4 working autoclaves (machines used to sterilize surgical instruments).
An observation was made of 4 of 4 autoclaves of the interior floors and walls of the holding chambers (an area where a cart holding surgical instruments is placed for sterilization) had small amount of brown staining. The exterior of each autoclave (stainless steel) was covered with moderate amount of water stains, and dirt.
On March 14, 2018, at 8:55 a.m., an interview was conducted with SPS 2. SPS 2 was asked to provide documentation or logs to show that the manufacturer's IFUs for routine cleaning and maintenance was done. SPS 2 stated the following:
- The autoclaves are wiped down daily by the staff and chamber drains are cleaned.
- Do not have any documentation to show the autoclaves were cleaned by the users of the machine, as required by the manufacturer.
- Acknowledged the water stains, water streaking, and dirt on the exterior of the autoclaves.

A review of the manufacturer IFUs for the autoclave was conducted with the SPS 2, and each step of the routine maintenance was discussed. The SPS 2 stated the staff did not perform the following steps described in the manufacturer's IFUs:
- "...Daily procedures: Clean Chamber...2. Wash the inside of the chamber and shelf assembly (plus any other loading equipment) with a mild detergent such as Liqui-Jet Instrument Detergent or current STERIS equivalent.
- Weekly Maintenance: Flush Chamber Drain...c. Pour a solution of one pint of hot water and 1/4 cup of Steris Liqui-Jet 2 Instrument Detergent or Criti-Klenz Instrument detergent into drain. Solution may puddle in the bottom of the chamber."

1c. On March 14, 2018, at 10:25 a.m., a tour was conducted, in the presence of the Sterile Processing Supervisor (SPS 2), and the Director of Infection Prevention (DIP), of Hospital B, "Decontamination Area". An observation was made of the exterior of the 2 of 2 different ultrasonic cleaners (machine used to clean and disinfect smaller surgical instruments). Each ultrasonic cleaner was covered with significant amount of water streaking, stains, and dirt.
An observation was made of the exterior of the four (4) instrument washers (machine used to clean and disinfect surgical instruments). Each instrument washer was covered with moderate amount of water stains and dirt.
On March 14, 2018, at 10:35 a.m., an interview was conducted with SPS 2. SPS 2 was asked to provide documentation or logs to show that the manufacturer's IFUs for routine cleaning and maintenance was done. SPS 2 stated the following:
- The instrument washers and sonic machines are wiped down daily by the staff and chamber drains are cleaned.
- Do not have any documentation to show the instrument washers and sonic machines were cleaned by the users of the machine, as required by the manufacturer.
- Acknowledged the water stains, water streaking, and dirt on the exterior of the instrument washers and sonic machines.


A review of the manufacturer IFUs for "Routine Maintenance" of the instrument washers indicated the hospital had no evidence to show the following were performed per manufacture instructions:
"Each day" hospital staff, "removed sump debris screen from wash chamber and cleaned" them.
"Rinsed debris screen under running water, each day"
"Removed manifold sliding inlet and inspected for debris" and cleaned it under running water as necessary.
"Weekly cleaned" the exterior surfaces of the washers with a "general cleaner" and "polished" the surfaces.
"Cleaned the wash chamber interior with a moderately alkaline detergent solution. Rinsed with tap water and dried with a lint-free cloth", "weekly".
"Cleaned the wash chamber rotary spray arm assembly and used a fine wire to clean sediment spray jet and rinsed under running water to clean out sediment, "and
"Cleaned door gasket using soapy solution or a mild detergent on a soft cloth", "weekly".

A review of the manufacturer IFUs for the sonic cleaner 1 stipulated, "...4.2 Cleaning Procedures: After last cycle of the day, allow unit to cool down and then clean unit. Use a general purpose cleaner to remove general stains, a stainless-steel stain remover to remove stubborn stains and a stainless-steel polish to keep equipment looking new:
1. Wash cabinet surfaces and chamber interiors with a mild detergent solution. Use a damp cloth or sponge, to apply cleaner in a back-and-forth motion, in same direction as surface grain.
2. Rinse with tap water using a sponge or damp cloth.
3. Dry surfaces with a clean, dry, lint-free cloth.
4. Polish exterior with a clean, dry and lint-free cloth."

A review of the manufacturer IFUs for the ultrasonic cleaner 2 stipulated, "...4-6-1 Daily Cleaning/Decontaminating Procedure: Use a clean cloth or paper towel: 1. Wipe down all internal surfaces above the waterline with your disinfectant, including the inside of the lid and around the seals and hinges, then wipe down all external surfaces, including around the sides of the doors ...3. Towel dry.
"...Weekly Basis: 1. Place 1.2 liters of non-foaming 5% Sodium Hypochlorite based disinfectant into a shallow heat resistant container and place into the tank..."
Hospital B did not have any documentation or logs to show daily or weekly routine cleaning of autoclaves, instrument washers, and ultrasonic machines.

2a. On March 12, 2018 at 12 p.m., Hospital A's SPD, 2 sterilization containers (a major and a minor) filled with multiple previously cleaned and sterilized surgical instruments were inspected, in the presence of the Lead Sterile Processing Technician (LSPT) and the Sterile Processing Technician (SPT 3) and the Director of Infection Prevention (DIP). The following concerns were identified upon observation of the surgical instruments:
In the minor tray 7 of 65 instruments contained the following:
a) One (1) instrument contained chipped and peeled identification tape (ID).
b) Five (5) hinged instruments were difficult to open, and
c) One (1) instrument contained brown staining.

In the major tray, 14 of 85 instruments contained the following:
a) Fourteen (14) hinged instruments were difficult to open.

Immediately following the observations of the instruments, the LSPT and the SPT 3 both stated if the ID tape was peeled, and chipped, contained brown staining, and were difficult to open, the instruments should have been pulled and sent out for replacement.

Hospital A's policy and procedure for inspection of surgical instruments was requested. The LSPT stated the Hospital A did not have a policy for inspection of instruments and follows the manufacturer IFUs and AAMI standards.

2b. On March 14, 2018, at 9:20 a.m., Hospital B's SPD, three (3) sterilization containers (2 majors, and 1 minor) filled with various cleaned and sterilized surgical instruments were inspected, in the presence of the Sterile Processing Supervisor (SPS), the SPT 4, and the Assistant Director of Infection Prevention (ADIP). The following concerns were identified upon observation of the surgical instruments:

In the major tray, 63 of 84 instruments contained the following:
a) Sixty (60) instruments contained brown staining.
b) Two (2) hinged instruments were difficult to open, and
c) One (1) instrument contained ID tape peeling or lifting.

In the minor tray, 13 of 27 instruments contained the following:
a) Eleven (11) instruments contained brown staining, and
b) Two (2) hinged instruments were difficult to open.

In the minor tray, 3 of 34 instruments contained the following:
a) Three hinged instruments were difficult to open.

During the inspection of the instruments, the SPS 2 wiped the brown stains with an eraser which were easily removed. SPT 4 stated the instruments were not cleaned according to AAMI standards which the hospital followed.

Immediately following the observations of the instruments, the SPS 2 and the SPT 4 both acknowledged the brown staining and the instruments were difficult to open and stated the instruments should have been pulled from use. SPS 2 and ADIP both stated they had not open any instrument trays for inspection.

Hospital B's policy and procedure for inspection of surgical instruments was requested. The SPS stated the hospital did not have a policy for inspection of instruments. The ADIP stated the hospital follows AAMI standards.

According to AAMI (Association for the Advancement of Medical Instrumentation - an organization for advancing the development, and safe and effective use of medical technology) - "Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities", CDC (Centers for Disease Control) Guidelines, and AORN (Association of perioperative Registered Nurses - leaders in advocating for excellence in perioperative practice and healthcare) guidelines, their recommendations, stipulated the following:
"Instruments should undergo an inspection for proper function and cleanliness.

1. Instruments should be inspected for a) cleanliness b) proper functioning and alignment, corrosion, pitting, burrs, nick, and cracks, sharpness of cutting edges c) any other defects

2. Instruments in disrepair should be labeled and taken out of service until properly repaired or replaced ..."
A.A.M.I "Standards and Recommended Practice, Safe Handling and Biological Decontamination of Medical Devices in Heath Care Facilities and in Non-Clinical Settings, ANSI/AAMI ST35:2003, keeping in mind this process is in two steps: 1. Complete cleaning and 2. Washing and Sterilization".

During a review of the manufacturer IFUs for ID Tape, it stipulated the following,
"...5. Wrap tape 1.5 times on a stainless steel instrument. Tape should lay flat without gaps...8. Identification tape is not intended as a permanent mark and will discolor, break, chip, or flake over time. Replace as necessary."

3a. On March 12, 2018, at 10 a.m., a tour was conducted of the Sterile Processing Department (SPD) of Hospital A, in the presence of the Sterile Processing Manager (SPM), Lead Sterile Processing Technician (LSPT) and Assistant Director of Infection Prevention (ADIP). The LSPT stated housekeeping cleans the area every day.

A request was made to provide evidence to show terminal cleaning.

An interview was conducted on March 12, 2018, at 4:30 p.m., with the Assistant Director of Environmental Services (ADEVS) and the Environmental Services Manager. The ADEVS stated terminal cleaning is provided in the clean area of SPD, and indicated they had no documentation to show terminal cleaning was performed in the clean area of SPD.

3b. On March 13, 2018, at 1:25 p.m., a tour was conducted of the Gastrointestinal Department (GI) of Hospital A, in the presence of the Assistant Director of Gastrointestinal (ADGI), and the ADIP. The ADGI stated the three procedure rooms were terminally cleaned by EVS.

An interview was conducted on March 13, 2018, at 3:40 p.m., with the ADEVS. The ADEVS stated terminal cleaning performed in the GI procedure rooms and the contamination area, and indicated they had no documentation to show terminal cleaning was performed in the GI decontamination area.

3c. On March 14, 2018, at 8:45 a.m., a tour was conducted of the SPD of Hospital B, in the presence of Sterile Processing Supervisor (SPS 2) and the DIP. The following observations were made:

- Five washer tray tables (approximately 4 feet in length and used as a holding area for cleaned surgical instruments) contained significant amount of black particles, moderate amount of white substance, and large amount of water stains.
- A white cloth laying on the floor under the washer tray table.

A concurrent interview was conducted with SPT 5 and LSPT. SPS stated daily cleaning is done in the clean area of SPD. SPT 5 stated the washer tray tables are washed down at the end of the day. LSPT and SPT 5 both acknowledged the five (5) washer tray tables had significant amount of black particles, white substance, and water stains, and the tables should have been wiped down.
An interview was conducted on March 14, 2018, at 10:06 a.m., with the Environmental Services Manager (EVSM) and the Environmental Services Assistant Manager (EVSAM). The EVSAM stated EVS terminally cleaned both areas of SPD, and indicated they had no documentation to show terminal cleaning of the clean area of SPD.

A review of the Hospital A's "Terminal Cleaning Logs," was conducted on March 12-13, 2018. The following observations were made:
- There were no terminal cleaning logs for SPD (clean and decontamination area).
- There were no terminal cleaning logs for the GI contamination area.
- Two GI procedure rooms (Room 1 & 2) were listed on the GI terminal cleaning log. GI Procedure Room 3 was not listed on the terminal cleaning log.
An interview was conducted with the ADIP on March 13, 2018, at 4 p.m. The ADIP stated, the GI procedure room three (3) was open in November 2017.

An interview was conducted on March 15, at 8:37 a.m. with the EVSM. The EVSM stated his staff terminally cleaned the GI procedure room 3 and indicated they had no terminal cleaning logs to show terminal cleaning of the GI procedure room 3.

A record review was conducted on March 15 at 1 p.m. of an environmental services policy titled, "Sterile Processing", stipulated,"...2. Semi-Restricted Zones: Semi-restricted areas include a clean side and a dirty side. The clean side includes but is not limited to, Sterile Storage, Clean Set-up Wrapping and packing Area. The dirty area consists of the decontamination zone...Environmental Services will complete once-a-day, every 24 hours, and terminal cleaning of both the clean and the dirty sides of the Semi-restricted zones...4. Terminal Clean: Clean Set-up, Wrapping and Packing Area...b. High and low damp dusting of all horizontal surfaces.

AORN, infection control standards the hospital followed, defines terminal cleaning as "thorough environmental cleaning that is performed at the end of each day when the area is being used."
Both AORN and AAMI (Association for the Advancement of Medical Instrumentation) ST79 recommend that sterile processing be terminally cleaned the same as the operating, delivery, and invasive procedure rooms. AAMI ST79 (Section 3.4) states that the best practice is to provide separate housekeeping facilities for the decontamination and clean areas to avoid transferring contaminates from "dirty to clean" areas. AORN recommends that terminal cleaning and disinfection of the sterile processing areas "be performed daily when the areas are not being used."

4. On March 13, 2018, at 1:25 p.m., a tour was conducted of the Hospital A's Gastrointestinal Department (GI), in the presence of the GI manager (GIM) and the Assistant Director of Infection Prevention (ADIP).The following concerns were identified: No method for obtaining temperature and humidity levels in the decontamination room or the storage area for scopes.

During a concurrent interview with GIM, she acknowledged temperature and humidity were not being monitored.

An interview was conducted with the Assistant Facilities Director (AFD) and the Director of Facilities Planning and Management (DFPM) on March 12, 2018, at 4:40 p.m. The AFD stated the SPD and GI decontamination areas were not being monitored for temperature and humidity.

On March 14, 2018, at 8:45 a.m., a tour was conducted of Hospital B's Sterile Processing Department (SPD) in the presence of the Sterile Processing Supervisor (SPS 2) and the ADIP. It was noted daily temperature and humidity levels in the decontamination room were not being recorded.

During a concurrent interview with SPS 2, he acknowledged daily temperature and humidity were not being recorded.

On March 14, 2018, at 11 a.m., a tour was conducted of Hospital B's GI Department, in the presence of the GIM and the ADIP. It was noted temperature and humidity levels in the decontamination room and scope storage area were not being monitored.

During a concurrent interview with GIM, she acknowledged temperature and humidity were not being monitored.

During the survey, requests were made to provide a hospital policy to address temperature and humidity. The document was never produced.

According to AAMI, Sterility Update 2010, relative humidity should be maintained between 30% and 60% in all work areas. "Because of the need to wear PPE, temperature in the decontamination area should be between 60 degrees Fahrenheit and 65 degrees Fahrenheit.
According to AORN, "Flexible Endoscopes: Guidelines at a Glance," stipulates, "Processing rooms or areas maintain relative humidity and temperature within the heating, ventilation, and air conditioning (HVAC) design parameters. Processing flexible endoscopes in an area where temperature, humidity, environmental cleaning, surgical attire, traffic patterns, and security are managed may improve efficiency, help maintain functionality of flexible endoscopes, reduce the risk of cross contamination, and provide a safe work environment."

5. On March 14, 2018, multiple observations and concurrent interviews with SPT 4, were conducted at 10:38 a.m., in the presence of SPS 2 and ADIP, of SPT 4 performing cleaning and disinfecting of dirty surgical instruments that were transported into the decontamination room after a surgical case. The following concerns were identified:
- An observation of SPT 6 inspecting 5 to 6 instruments at one time.
- SPT 6 brushed two instruments with a small brush above the water.
- SPT 6 placed contaminated instruments (8 to 10 at a time) on an instrument stringer in the pre-soaked solution without brushing or rinsing any of the instruments prior to placing the instruments in the tray.
- According to SPT 6, he did not scrub or clean instruments since the instruments were going in the washer.
- According to SPT 6, he did not scrub or clean instruments that are not used during a surgery, even if all the instruments get opened during the surgery case.
- SPT 6 rinsed one instrument under running water.
- SPT 6 did not rinse a tray of instruments prior to placing the tray in the washer.
- SPT 6 placed an entire instrument tray with instruments in the pre-soaked solution.
- SPT 6 left the dispensing hose for the enzymatic solution submerged in the pre-soaked solution with the dirty instruments.
- SPT 6 stated he changed the soiled pre-soaked solution when it's looked dirty.
- SPT 6 did not change the pre-soaked solution between instrument trays.

Immediately following the observations, SPS 2 was asked if the methods used by SPT 6 technique for cleaning and disinfecting the surgical instruments was acceptable practice. SPS 2 stated that it was not the hospital acceptable practice. SPS 2 stated the instruments should be: inspected and cleaned one at a time; submerged under water while brushing; all instruments should be cleaned and rinsed prior to placing the instruments in the washer; and the soiled pre-soaked solution should be changed after every tray. SPS 2 and ADIP both stated they had not observed any of the SPD technicians cleaning and disinfecting instruments. SPS 2 stated SPD follows AAMI standards.

A review of SPT 6 competency file was reviewed on March 15, 2018, at 1:45 p.m., in the presence of the Director of SPD (DSPD), Director of Perioperative Services (DPS), and the Chief Quality Patient Safety Officer. SPT 6 competencies were conducted on March 8, 2018, and it was noted there were no observations and /or return demonstrations of cleaning and disinfecting surgical instruments included in his competencies. DSPD and the DPS both acknowledged there were no observations and/ or return demonstrations of cleaning and disinfecting of surgical instruments in SPT 6 competencies.

A record review was conducted on March 15, 2018, of an Perioperative Services Sterile processing policy titled, " Instrument Cleaning and Decontamination," stipulated, "Purpose: To ensure the safe handling of contaminated items and that proper biological decontamination methods for reusable items between individual patient uses are practiced...The biological process includes thorough cleaning and, whenever necessary for personnel or patient safety, appropriate application of a microbicide process (disinfection or sterilization)...Procedure(s):...B. All instruments are decontaminated as soon as possible in accordance with Manufacturer's instruction for use, after a procedure or delivery from outside consignment loaners from vendor's or physicians. 1. All trays must be carefully checked for sharps and other disposable items. 2. All ringed instruments will be opened and examined for gross debris...3. If instruments contain a large amount of disburden they are cleaned with a nylon brush. Instruments will be immersed in an enzymatic solution while being cleaned...C...1. Decontamination will be completed prior to ultrasonic cleaning."
A record review was conducted on March 15, 2018, of an Perioperative Services Sterile Processing policy titled, "Washer Disinfector," stipulated, "Purpose: To establish a means to initially decontaminate reusable medical devices. Policy: Follow manufacturer's guidelines in the use of this product. Procedure: The washer/disinfector in combination with removing gross debris (handwashing) and the sonic removal of gross debris are the methods used to wash contaminated basins or reusable medical devices."

According to APIC standards and AAMI's Comprehensive guide to steam sterilization and sterility assurance in health care facilities, any instruments that are opened in the OR whether used or not, should be decontaminated. APIC further indicates that sterile processing departments play a significant role in minimizing the risk of surgical site infections.
A.A.M.I "Standards and Recommended Practice, Safe Handling and Biological Decontamination of Medical Devices in Heath Care Facilities and in Non-Clinical Settings, ANSI/AAMI ST35:2003, keeping in mind this process is in two steps: 1. Complete cleaning and 2. Washing and Sterilization".

AORN, one of the nationally recognized infection control guidelines the hospital followed, recommends, "cleaning should be accomplished by submerging the instrument in warm water with an appropriate detergent followed by complete submersion of the instrument in rinse solution to minimize aerosolization of contaminants. Aerosolization of contaminants, splashing of infectious material, and injury from sharp objects are possible when manual cleaning is performed under a stream of running tap water. "

According to AORN recommendations, "The final rinse should be performed with treated (eg, distilled, reverse osmosis, filtered) water of a quality that will not stain or cause damage to instruments or contribute to recontamination of the instrument. Untreated water can contain contaminants, including endotoxins, which can be deposited on instruments during the final rinse. Rinsing with treated water can prevent deposits of impurities or contaminants on instruments. Endotoxins are heat stable and may not be destroyed by subsequent steam sterilization. Tissue contaminated with endotoxins can cause severe inflammation. Treated water can prevent spotting, stains, deposits, and corrosion on the surfaces of instruments", Guidelines for Perioperative Practice. Denver, CO: AORN, Inc. ANSI/AAMI ST79: Comprehensive Guide to Steam Sterilization and Sterility Assurance In Health Care Facilities.

According to APIC and CDC, "Guideline for Disinfection and Sterilization in Healthcare Facilities", if cleaning is done manually, the two essential components are friction and fluidics. Friction (i.e., rubbing/scrubbing the soiled area with a brush) is an old and dependable method. Fluidics (i.e., fluids under pressure) is used to remove soil and debris from internal channels after brushing and when the design does not allow passage of a brush through a channel."

According to IAHCSMM (International Association of Healthcare Central Service Material Management), "The Manual Cleaning Process", use a lint-free cloth and the recommended brush type, all areas of the device should be carefully cleaned, brushed and flushed.


29499

6. On 3/14/18 at 2:00 P.M., a tour of the Cath lab and joint interview was conducted with the Cath Lab Nursing Manager (CLNM) and the Inpatient Oncology Nursing Director (IOND). During the tour, Cath lab core staff were assigned to a procedural case and were not available for interview. The CLNM stated the cleaning of procedural instruments, prior to 3/14/18, in the Cath Lab included the following: After procedures ended, staff placed instruments into a bin, carried the bin to the soiled utility room in the Cath Lab, while inside the soiled utility room, staff sprayed the instruments with an enzymatic cleanser inside the bin and then transported the bin to the Sterile Processing Department.

The hospital's document entitled Requisition for Sterile Processing Services, dated 11/10, did not guide staff related to the proper process for pre-cleaning of instruments at point of use prior to transport to Sterile Processing Department.

7. On 3/12/18 at 11:30 A.M., a tour of the Transplant Unit and joint interview was conducted with the Inpatient Oncology Nursing Director (IOND), the Inpatient Oncology Administrative Assistant, and the Inpatient Oncology Nursing Manager (IONM). During the tour, the unit's patient nourishment room was observed. While in the nourishment room, a Food Service Staff (FSS) 45, scraped pieces of ice away from inside the top portion of the patients freezer. In addition, FSS 45 had a portable bucket with a handle on the sink countertop. Inside the bucket, there were two uncovered and visibly wet, face masks, a pair of gloves, two ink pens, an individual coffee creamer, a plastic spoon and knife, a roll of tape, and an all purpose cleaner spray bottle. During the interview, FSS 45 stated she was removing ice build up inside the freezer because she noticed brown spots throughout the ice. In addition, she stated she carried the utensils in her bucket incase she needed to scrape debris off of the sinks. Furthermore, the FSS 45 stated she had just finished cleaning the nourishment room with the all purpose cleaner, signed the daily cleaning log, did not follow the proper process of ice removal, and should have reported the discolored ice to her Management.

On 3/12/18 at 2:35 P.M., an interview was conducted with the Nutrition Services Assistant Director (ADNS), the IOND, and the IONM. The ADNS stated FSS were trained to

Based on interview, record, and document review, the hospital failed to ensure a Case Management note was documented to reflect an ongoing assessment and a new change of condition for 1 of 86 sampled Patient's (41). The lack of documentation did not ensure staff involved with the patient's care were fully aware of the patient's current condition in an effort to establish and re-evaluate anticipated discharge needs or continuum of care for the patient in accordance with the hospital's Case Management Standards.

Findings:

Patient 41's medical record was reviewed on 3/12/18.

Patient 41 was admitted to Hospital B on 2/28/18 according to the Facesheet.

A Case Manager Initial patient assessment Note, dated 3/1/18, was documented and indicated Case Management would continue to follow the patient.

According to the Medical Record, Patient 41 had low Platelet (cells that circulate in the blood and clot to keep one from bleeding) lab levels between 3/10/18 -3/12/18.

On 3/12/18, there was no additional documentation from Case Management in Patient 41's medical record.

On 3/20/18 at 9:50 A.M., an interview was conducted with a Case Manager (CM) 47, the Director of Case Management (DCM), the Inpatient Oncology Nursing Director (IOND), and the Inpatient Oncology Administrative Assistant (IOAA). During the interview, CM 47 stated CM's visit with patient's during their first 24 hours of hospitalization and conduct and document an initial assessment. In addition, CM 47 stated, CM's then visited and documented the patient's visit on a weekly basis and upon any change in the patient's condition. Furthermore, CM 47 stated she followed the patient initially and then was off work and acknowledged no additional staff visited and documented the visit in lieu of CM's absence. CM 47 and the DCM stated they both were made aware of Patient 41's change of condition related to the Platelet lab results. The DCM stated the hospital expected CM's visited and documented the patient's visit in accordance with the hospital's case Management Standards.

The hospital's document entitled Case Manager Minimum Standards for Review and Documentation in patient's Electronic Medical Record, dated 5/17 indicated "C. The care manager will also document brief substantive notes every 2-3 days... " "...Notes should document our activities to support our patients and their families during their stay and transition."

Based on observation, interview and document review, surgical services were not provided in accordance with acceptable standards of practice. Surgical instruments were not cleaned and disinfected in a manner designed to assure the achievement and maintenance of high standards of medical practice and patient care. This resulted in the possibility of transmission of infectious agents and foreign material from the instruments to patients and staff. The Chief (Chair) of Surgery was not involved in the investigation and action plan for these issues for two days after they were discovered by the survey team.

Findings:

1. Based on observation, interview and document review, the hospital did not provide surgical services in a way that would assure the achievement and maintenance of high standards of medical practice and patient care. See Tag A-0951

2. The Chief (Chair) of Surgery was not involved in the investigation and action plan for these issues for two days after they were discovered by the survey team. See Tag A-0353

These deficient practices resulted in the Condition of Participation for Surgical Services being NOT MET.

Based on observation, interview and document review, the hospital did not provide surgical services in a way that would assure the achievement and maintenance of high standards of medical practice and patient care.

This resulted in the possibility of transmission of infectious agents and foreign material from the instruments to patients and staff.

Findings:

1. The Chief of Surgery (Chair, Medical Director for Perioperative Services) for both the hospital and the system was interviewed on March 14, 2018 at 10:50 A.M. He stated that he had first been informed of the issues in the Sterile Processing Department (SPD) prior to the interview. He had not been aware that some problems in the SPD area had been identified by the survey team and communicated to administration as an Immediate Jeopardy (IJ) two days prior.

2. The Medical Staff Bylaws and the Rules and Regulations were reviewed at 1:35 P.M. on March15, 2018. Section 1.2 of the Bylaws states that The Medical Staff's Purposes are: To assure that all patients ...receive a uniform standard of quality patient care, treatment and efficiency ...A. To provide for a level of professional performance that is consistent with generally accepted standards ..." Page 28 of the Rules and Regulations contains a section entitled "Perioperative Services Committee." It lists the membership of the committee which includes the Chair, Medical Director for Perioperative Services. The Duties of the committee include "3. To review the effectiveness and efficiency of operating room services ....4. To make recommendations regarding identified issues to the Quality Council and respond to issues of patient care and safety raised by other Medical Staff Committees."



29509

During an interview with the Assistant Director of Infection Prevention (ADIP), on March 12, at 11:15 a.m., he stated that the hospital followed nationally recognized infection control guidelines from AAMI (Association for the Advancement of Medical Instrumentation - an organization for advancing the development, and safe and effective use of medical technology), CDC (Centers for Disease Control), APIC (Association for Professionals in Infection Control and Epidemiology) and AORN (Association of perioperative Registered Nurses - leaders in advocating for excellence in perioperative practice and healthcare).

3a. On March 12, 2018, at 11:30 a.m., a tour was conducted, in the presence of the Sterile Processing Supervisor (SPS 1), Lead Sterile Processing Technician (LSPT), and the Director of Infection Prevention (DIP), of Hospital A, "Sterile Processing Prep & Pack Area". The area contained 5 working autoclaves (machines used to sterilize surgical instruments). An observation was made of 5 of 5 autoclaves of the interior floors and walls of the holding chambers (an area where a cart holding surgical instruments is placed for sterilization) had large amount of dark rust color, black, and white staining. The exterior of each autoclave (stainless steel) was covered with large amount of water stains (streaking), and dirt.

During a concurrent interview with the LSPT, he acknowledged the stains in the chamber and on the exterior of each autoclave. LSPT stated the staff does not clean the inside chambers and the staff only wipes down the exterior of the autoclaves.
On March 12, 2018, at 12:50 p.m., an interview was conducted with SPS 1. SPS 1 was asked to provide documentation or logs to show that the manufacturer's information for use (IFU) for routine cleaning and maintenance was done. SPS 1 stated they did not have any documentation to show the autoclaves were cleaned by the users of the machine, as required by the manufacturer. SPS 1 was asked about SPD's quality assurance plan (QA). SPS 1 stated SPD did not have a QA plan.
A review of the manufacturer IFUs was conducted with the SPS 1, and each step of the routine maintenance was discussed. The SPS 1 stated the staff did not perform the following steps described in the manufacturer's IFUs:
- "...Daily Maintenance: "...Regardless of the hardness level of supplied water, the generator must be flushed every day before use to prevent mineral scaling or carryover of debris into the chamber.
- Weekly Maintenance: Flush Chamber Drain...c. Pour a solution of one pint of hot water and 1/4 cup of Steris Liqui-Jet 2 Instrument Detergent or Criti-Klenz Instrument detergent into drain. Solution may puddle in the bottom of the chamber."

Hospital A did not have any documentation or logs to show daily or weekly routine cleaning of autoclaves.

3b. On March 14, 2018, at 8:45 a.m., a tour was conducted, in the presence of the Sterile Processing Supervisor (SPS 2), and the Director of Infection Prevention (DIP), of Hospital B, "Sterile Processing Prep & Pack Area". The area contained 4 working autoclaves (machines used to sterilize surgical instruments).
An observation was made of 4 of 4 autoclaves of the interior floors and walls of the holding chambers (an area where a cart holding surgical instruments is placed for sterilization) had small amount of brown staining. The exterior of each autoclave (stainless steel) was covered with moderate amount of water stains, and dirt.
On March 14, 2018, at 8:55 a.m., an interview was conducted with SPS 2. SPS 2 was asked to provide documentation or logs to show that the manufacturer's IFUs for routine cleaning and maintenance was done. SPS 2 stated the following:
- The autoclaves are wiped down daily by the staff and chamber drains are cleaned.
- Do not have any documentation to show the autoclaves were cleaned by the users of the machine, as required by the manufacturer.
- Acknowledged the water stains, water streaking, and dirt on the exterior of the autoclaves.

A review of the manufacturer IFUs for the autoclave was conducted with the SPS 2, and each step of the routine maintenance was discussed. The SPS 2 stated the staff did not perform the following steps described in the manufacturer's IFUs:
- "...Daily procedures: Clean Chamber...2. Wash the inside of the chamber and shelf assembly (plus any other loading equipment) with a mild detergent such as Liqui-Jet Instrument Detergent or current STERIS equivalent.
- Weekly Maintenance: Flush Chamber Drain...c. Pour a solution of one pint of hot water and 1/4 cup of Steris Liqui-Jet 2 Instrument Detergent or Criti-Klenz Instrument detergent into drain. Solution may puddle in the bottom of the chamber."

3c. On March 14, 2018, at 10:25 a.m., a tour was conducted, in the presence of the Sterile Processing Supervisor (SPS 2), and the Director of Infection Prevention (DIP), of Hospital B, "Decontamination Area". An observation was made of the exterior of the 2 of 2 different ultrasonic cleaners (machine used to clean and disinfect smaller surgical instruments). Each ultrasonic cleaner was covered with significant amount of water streaking, stains, and dirt.
An observation was made of the exterior of the four (4) instrument washers (machine used to clean and disinfect surgical instruments). Each instrument washer was covered with moderate amount of water stains and dirt.
On March 14, 2018, at 10:35 a.m., an interview was conducted with SPS 2. SPS 2 was asked to provide documentation or logs to show that the manufacturer's IFUs for routine cleaning and maintenance was done. SPS 2 stated the following:
- The instrument washers and sonic machines are wiped down daily by the staff and chamber drains are cleaned.
- Do not have any documentation to show the instrument washers and sonic machines were cleaned by the users of the machine, as required by the manufacturer.
- Acknowledged the water stains, water streaking, and dirt on the exterior of the instrument washers and sonic machines.


A review of the manufacturer IFUs for "Routine Maintenance" of the instrument washers indicated the hospital had no evidence to show the following were performed per manufacture instructions:
"Each day" hospital staff, "removed sump debris screen from wash chamber and cleaned" them.
"Rinsed debris screen under running water, each day"
"Removed manifold sliding inlet and inspected for debris" and cleaned it under running water as necessary.
"Weekly cleaned" the exterior surfaces of the washers with a "general cleaner" and "polished" the surfaces.
"Cleaned the wash chamber interior with a moderately alkaline detergent solution. Rinsed with tap water and dried with a lint-free cloth", "weekly".
"Cleaned the wash chamber rotary spray arm assembly and used a fine wire to clean sediment spray jet and rinsed under running water to clean out sediment, "and
"Cleaned door gasket using soapy solution or a mild detergent on a soft cloth", "weekly".

A review of the manufacturer IFUs for the sonic cleaner 1 stipulated, "...4.2 Cleaning Procedures: After last cycle of the day, allow unit to cool down and then clean unit. Use a general purpose cleaner to remove general stains, a stainless-steel stain remover to remove stubborn stains and a stainless-steel polish to keep equipment looking new:
1. Wash cabinet surfaces and chamber interiors with a mild detergent solution. Use a damp cloth or sponge, to apply cleaner in a back-and-forth motion, in same direction as surface grain.
2. Rinse with tap water using a sponge or damp cloth.
3. Dry surfaces with a clean, dry, lint-free cloth.
4. Polish exterior with a clean, dry and lint-free cloth."

A review of the manufacturer IFUs for the ultrasonic cleaner 2 stipulated, "...4-6-1 Daily Cleaning/Decontaminating Procedure: Use a clean cloth or paper towel: 1. Wipe down all internal surfaces above the waterline with your disinfectant, including the inside of the lid and around the seals and hinges, then wipe down all external surfaces, including around the sides of the doors ...3. Towel dry.
"...Weekly Basis: 1. Place 1.2 liters of non-foaming 5% Sodium Hypochlorite based disinfectant into a shallow heat resistant container and place into the tank..."
Hospital B did not have any documentation or logs to show daily or weekly routine cleaning of autoclaves, instrument washers, and ultrasonic machines.

4a. On March 12, 2018 at 12 p.m., Hospital A's SPD, 2 sterilization containers (a major and a minor) filled with multiple previously cleaned and sterilized surgical instruments were inspected, in the presence of the Lead Sterile Processing Technician (LSPT) and the Sterile Processing Technician (SPT 3) and the Director of Infection Prevention (DIP). The following concerns were identified upon observation of the surgical instruments:
In the minor tray 7 of 65 instruments contained the following:
a) One (1) instrument contained chipped and peeled identification tape (ID).
b) Five (5) hinged instruments were difficult to open, and
c) One (1) instrument contained brown staining.

In the major tray, 14 of 85 instruments contained the following:
a) Fourteen (14) hinged instruments were difficult to open.

Immediately following the observations of the instruments, the LSPT and the SPT 3 both stated if the ID tape was peeled, and chipped, contained brown staining, and were difficult to open, the instruments should have been pulled and sent out for replacement.

Hospital A's policy and procedure for inspection of surgical instruments was requested. The LSPT stated the Hospital A did not have a policy for inspection of instruments and follows the manufacturer IFUs and AAMI standards.

4b. On March 14, 2018, at 9:20 a.m., Hospital B's SPD, three (3) sterilization containers (2 majors, and 1 minor) filled with various cleaned and sterilized surgical instruments were inspected, in the presence of the Sterile Processing Supervisor (SPS), the SPT 4, and the Assistant Director of Infection Prevention (ADIP). The following concerns were identified upon observation of the surgical instruments:

In the major tray, 63 of 84 instruments contained the following:
a) Sixty (60) instruments contained brown staining.
b) Two (2) hinged instruments were difficult to open, and
c) One (1) instrument contained ID tape peeling or lifting.

In the minor tray, 13 of 27 instruments contained the following:
a) Eleven (11) instruments contained brown staining, and
b) Two (2) hinged instruments were difficult to open.

In the minor tray, 3 of 34 instruments contained the following:
a) Three hinged instruments were difficult to open.

During the inspection of the instruments, the SPS 2 wiped the brown stains with an eraser which were easily removed. SPT 4 stated the instruments were not cleaned according to AAMI standards which the hospital followed.

Immediately following the observations of the instruments, the SPS 2 and the SPT 4 both acknowledged the brown staining and the instruments were difficult to open and stated the instruments should have been pulled from use. SPS 2 and ADIP both stated they had not open any instrument trays for inspection.

Hospital B's policy and procedure for inspection of surgical instruments was requested. The SPS stated the hospital did not have a policy for inspection of instruments. The ADIP stated the hospital follows AAMI standards.

According to AAMI (Association for the Advancement of Medical Instrumentation - an organization for advancing the development, and safe and effective use of medical technology) - "Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities", CDC (Centers for Disease Control) Guidelines, and AORN (Association of perioperative Registered Nurses - leaders in advocating for excellence in perioperative practice and healthcare) guidelines, their recommendations, stipulated the following:
"Instruments should undergo an inspection for proper function and cleanliness.

1. Instruments should be inspected for a) cleanliness b) proper functioning and alignment, corrosion, pitting, burrs, nick, and cracks, sharpness of cutting edges c) any other defects

2. Instruments in disrepair should be labeled and taken out of service until properly repaired or replaced ..."
A.A.M.I "Standards and Recommended Practice, Safe Handling and Biological Decontamination of Medical Devices in Heath Care Facilities and in Non-Clinical Settings, ANSI/AAMI ST35:2003, keeping in mind this process is in two steps: 1. Complete cleaning and 2. Washing and Sterilization".

During a review of the manufacturer IFUs for ID Tape, it stipulated the following,
"...5. Wrap tape 1.5 times on a stainless steel instrument. Tape should lay flat without gaps...8. Identification tape is not intended as a permanent mark and will discolor, break, chip, or flake over time. Replace as necessary."

5a. On March 12, 2018, at 10 a.m., a tour was conducted of the Sterile Processing Department (SPD) of Hospital A, in the presence of the Sterile Processing Manager (SPM), Lead Sterile Processing Technician (LSPT) and Assistant Director of Infection Prevention (ADIP). The LSPT stated housekeeping cleans the area every day.

A request was made to provide evidence to show terminal cleaning.

An interview was conducted on March 12, 2018, at 4:30 p.m., with the Assistant Director of Environmental Services (ADEVS) and the Environmental Services Manager. The ADEVS stated terminal cleaning is provided in the clean area of SPD, and indicated they had no documentation to show terminal cleaning was performed in the clean area of SPD.

5b. On March 13, 2018, at 1:25 p.m., a tour was conducted of the Gastrointestinal Department (GI) of Hospital A, in the presence of the Assistant Director of Gastrointestinal (ADGI), and the ADIP. The ADGI stated the three procedure rooms were terminally cleaned by EVS.

An interview was conducted on March 13, 2018, at 3:40 p.m., with the ADEVS. The ADEVS stated terminal cleaning performed in the GI procedure rooms and the contamination area, and indicated they had no documentation to show terminal cleaning was performed in the GI decontamination area.

5c. On March 14, 2018, at 8:45 a.m., a tour was conducted of the SPD of Hospital B, in the presence of Sterile Processing Supervisor (SPS 2) and the DIP. The following observations were made:

- Five washer tray tables (approximately 4 feet in length and used as a holding area for cleaned surgical instruments) contained significant amount of black particles, moderate amount of white substance, and large amount of water stains.
- A white cloth laying on the floor under the washer tray table.

A concurrent interview was conducted with SPT 5 and LSPT. SPS stated daily cleaning is done in the clean area of SPD. SPT 5 stated the washer tray tables are washed down at the end of the day. LSPT and SPT 5 both acknowledged the five (5) washer tray tables had significant amount of black particles, white substance, and water stains, and the tables should have been wiped down.
An interview was conducted on March 14, 2018, at 10:06 a.m., with the Environmental Services Manager (EVSM) and the Environmental Services Assistant Manager (EVSAM). The EVSAM stated EVS terminally cleaned both areas of SPD, and indicated they had no documentation to show terminal cleaning of the clean area of SPD.

A review of the Hospital A's "Terminal Cleaning Logs," was conducted on March 12-13, 2018. The following observations were made:
- There were no terminal cleaning logs for SPD (clean and decontamination area).
- There were no terminal cleaning logs for the GI contamination area.
- Two GI procedure rooms (Room 1 & 2) were listed on the GI terminal cleaning log. GI Procedure Room 3 was not listed on the terminal cleaning log.
An interview was conducted with the ADIP on March 13, 2018, at 4 p.m. The ADIP stated, the GI procedure room three (3) was open in November 2017.

An interview was conducted on March 15, at 8:37 a.m. with the EVSM. The EVSM stated his staff terminally cleaned the GI procedure room 3 and indicated they had no terminal cleaning logs to show terminal cleaning of the GI procedure room 3.

A record review was conducted on March 15 at 1 p.m. of an environmental services policy titled, "Sterile Processing", stipulated,"...2. Semi-Restricted Zones: Semi-restricted areas include a clean side and a dirty side. The clean side includes but is not limited to, Sterile Storage, Clean Set-up Wrapping and packing Area. The dirty area consists of the decontamination zone...Environmental Services will complete once-a-day, every 24 hours, and terminal cleaning of both the clean and the dirty sides of the Semi-restricted zones...4. Terminal Clean: Clean Set-up, Wrapping and Packing Area...b. High and low damp dusting of all horizontal surfaces.

AORN, infection control standards the hospital followed, defines terminal cleaning as "thorough environmental cleaning that is performed at the end of each day when the area is being used."
Both AORN and AAMI (Association for the Advancement of Medical Instrumentation) ST79 recommend that sterile processing be terminally cleaned the same as the operating, delivery, and invasive procedure rooms. AAMI ST79 (Section 3.4) states that the best practice is to provide separate housekeeping facilities for the decontamination and clean areas to avoid transferring contaminates from "dirty to clean" areas. AORN recommends that terminal cleaning and disinfection of the sterile processing areas "be performed daily when the areas are not being used."

6. On March 13, 2018, at 1:25 p.m., a tour was conducted of the Hospital A's Gastrointestinal Department (GI), in the presence of the GI manager (GIM) and the Assistant Director of Infection Prevention (ADIP).The following concerns were identified: No method for obtaining temperature and humidity levels in the decontamination room or the storage area for scopes.

During a concurrent interview with GIM, she acknowledged temperature and humidity were not being monitored.

An interview was conducted with the Assistant Facilities Director (AFD) and the Director of Facilities Planning and Management (DFPM) on March 12, 2018, at 4:40 p.m. The AFD stated the SPD and GI decontamination areas were not being monitored for temperature and humidity.

On March 14, 2018, at 8:45 a.m., a tour was conducted of Hospital B's Sterile Processing Department (SPD) in the presence of the Sterile Processing Supervisor (SPS 2) and the ADIP. It was noted daily temperature and humidity levels in the decontamination room were not being recorded.

During a concurrent interview with SPS 2, he acknowledged daily temperature and humidity were not being recorded.

On March 14, 2018, at 11 a.m., a tour was conducted of Hospital B's GI Department, in the presence of the GIM and the ADIP. It was noted temperature and humidity levels in the decontamination room and scope storage area were not being monitored.

During a concurrent interview with GIM, she acknowledged temperature and humidity were not being monitored.

During the survey, requests were made to provide a hospital policy to address temperature and humidity. The document was never produced.

According to AAMI, Sterility Update 2010, relative humidity should be maintained between 30% and 60% in all work areas. "Because of the need to wear PPE, temperature in the decontamination area should be between 60 degrees Fahrenheit and 65 degrees Fahrenheit.
According to AORN, "Flexible Endoscopes: Guidelines at a Glance," stipulates, "Processing rooms or areas maintain relative humidity and temperature within the heating, ventilation, and air conditioning (HVAC) design parameters. Processing flexible endoscopes in an area where temperature, humidity, environmental cleaning, surgical attire, traffic patterns, and security are managed may improve efficiency, help maintain functionality of flexible endoscopes, reduce the risk of cross contamination, and provide a safe work environment."

7. On March 14, 2018, multiple observations and concurrent interviews with SPT 4, were conducted at 10:38 a.m., in the presence of SPS 2 and ADIP, of SPT 4 performing cleaning and disinfecting of dirty surgical instruments that were transported into the decontamination room after a surgical case. The following concerns were identified:
- An observation of SPT 6 inspecting 5 to 6 instruments at one time.
- SPT 6 brushed two instruments with a small brush above the water.
- SPT 6 placed contaminated instruments (8 to 10 at a time) on an instrument stringer in the pre-soaked solution without brushing or rinsing any of the instruments prior to placing the instruments in the tray.
- According to SPT 6, he did not scrub or clean instruments since the instruments were going in the washer.
- According to SPT 6, he did not scrub or clean instruments that are not used during a surgery, even if all the instruments get opened during the surgery case.
- SPT 6 rinsed one instrument under running water.
- SPT 6 did not rinse a tray of instruments prior to placing the tray in the washer.
- SPT 6 placed an entire instrument tray with instruments in the pre-soaked solution.
- SPT 6 left the dispensing hose for the enzymatic solution submerged in the pre-soaked solution with the dirty instruments.
- SPT 6 stated he changed the soiled pre-soaked solution when it's looked dirty.
- SPT 6 did not change the pre-soaked solution between instrument trays.

Immediately following the observations, SPS 2 was asked if the methods used by SPT 6 technique for cleaning and disinfecting the surgical instruments was acceptable practice. SPS 2 stated that it was not the hospital acceptable practice. SPS 2 stated the instruments should be: inspected and cleaned one at a time; submerged under water while brushing; all instruments should be cleaned and rinsed prior to placing the instruments in the washer; and the soiled pre-soaked solution should be changed after every tray. SPS 2 and ADIP both stated they had not observed any of the SPD technicians cleaning and disinfecting instruments. SPS 2 stated SPD follows AAMI standards.

A review of SPT 6 competency file was reviewed on March 15, 2018, at 1:45 p.m., in the presence of the Director of SPD (DSPD), Director of Perioperative Services (DPS), and the Chief Quality Patient Safety Officer. SPT 6 competencies were conducted on March 8, 2018, and it was noted there were no observations and /or return demonstrations of cleaning and disinfecting surgical instruments included in his competencies. DSPD and the DPS both acknowledged there were no observations and/ or return demonstrations of cleaning and disinfecting of surgical instruments in SPT 6 competencies.

A record review was conducted on March 15, 2018, of an Perioperative Services Sterile processing policy titled, " Instrument Cleaning and Decontamination," stipulated, "Purpose: To ensure the safe handling of contaminated items and that proper biological decontamination methods for reusable items between individual patient uses are practiced...The biological process includes thorough cleaning and, whenever necessary for personnel or patient safety, appropriate application of a microbicide process (disinfection or sterilization)...Procedure(s):...B. All instruments are decontaminated as soon as possible in accordance with Manufacturer's instruction for use, after a procedure or delivery from outside consignment loaners from vendor's or physicians. 1. All trays must be carefully checked for sharps and other disposable items. 2. All ringed instruments will be opened and examined for gross debris...3. If instruments contain a large amount of disburden they are cleaned with a nylon brush. Instruments will be immersed in an enzymatic solution while being cleaned...C...1. Decontamination will be completed prior to ultrasonic cleaning."
A record review was conducted on March 15, 2018, of an Perioperative Services Sterile Processing policy titled, "Washer Disinfector," stipulated, "Purpose: To establish a means to initially decontaminate reusable medical devices. Policy: Follow manufacturer's guidelines in the use of this product. Procedure: The washer/disinfector in combination with removing gross debris (handwashing) and the sonic removal of gross debris are the methods used to wash contaminated basins or reusable medical devices."

According to APIC standards and AAMI's Comprehensive guide to steam sterilization and sterility assurance in health care facilities, any instruments that are opened in the OR whether used or not, should be decontaminated. APIC further indicates that sterile processing departments play a significant role in minimizing the risk of surgical site infections.
A.A.M.I "Standards and Recommended Practice, Safe Handling and Biological Decontamination of Medical Devices in Heath Care Facilities and in Non-Clinical Settings, ANSI/AAMI ST35:2003, keeping in mind this process is in two steps: 1. Complete cleaning and 2. Washing and Sterilization".

AORN, one of the nationally recognized infection control guidelines the hospital followed, recommends, "cleaning should be accomplished by submerging the instrument in warm water with an appropriate detergent followed by complete submersion of the instrument in rinse solution to minimize aerosolization of contaminants. Aerosolization of contaminants, splashing of infectious material, and injury from sharp objects are possible when manual cleaning is performed under a stream of running tap water. "

According to AORN recommendations, "The final rinse should be performed with treated (eg, distilled, reverse osmosis, filtered) water of a quality that will not stain or cause damage to instruments or contribute to recontamination of the instrument. Untreated water can contain contaminants, including endotoxins, which can be deposited on instruments during the final rinse. Rinsing with treated water can prevent deposits of impurities or contaminants on instruments. Endotoxins are heat stable and may not be destroyed by subsequent steam sterilization. Tissue contaminated with endotoxins can cause severe inflammation. Treated water can prevent spotting, stains, deposits, and corrosion on the surfaces of instruments", Guidelines for Perioperative Practice. Denver, CO: AORN, Inc. ANSI/AAMI ST79: Comprehensive Guide to Steam Sterilization and Sterility Assurance In Health Care Facilities.

According to APIC and CDC, "Guideline for Disinfection and Sterilization in Healthcare Facilities", if cleaning is done manually, the two essential components are friction and fluidics. Friction (i.e., rubbing/scrubbing the soiled area with a brush) is an old and dependable method. Fluidics (i.e., fluids under pressure) is used to remove soil and debris from internal channels after brushing and when the design does not allow passage of a brush through a channel."

According to IAHCSMM (International Association of Healthcare Central Service Material Management), "The Manual Cleaning Process", use a lint-free cloth and the recommended brush type, all areas of the device should be carefully cleaned, brushed and flushed.

8. On 3/12/18 at 3:25 P.M., an observation of the operating room soiled utility and holding area at Hospital 2 was conducted with the Operating Room Manager (ORM), Sterile Processing Department Supervisor (SPDS) and Sterile Processing Director (SPDD). A cart labeled, Cart 34 with a tray of surgical instruments labeled, Total Hip B set was observed. The instruments were not properly separated and had red stains. The SPDS stated, "If there is still blood on the instruments, someone did not spray as much, when we see the white dots, it is sprayed well." In addition, the SPDD stated, the staff needed to be re-educated on the cleaning of the instruments."

An interview was conducted with the surgical technician (ST) 1 on 3/14/18 at 8:58 A.M. ST 1 stated he had been one of the surgical technicians responsible for cleaning surgical instruments after use before it went to the sterile processing department. ST 1 further stated it has been the practice to spray the instruments with enzymatic (cleaning product) in the soiled utility room and not in the operating room.

An interview was conducted with the surgical technician (ST) 2 on 3/14/18 at 9:05 A.M. ST 2 stated one of his duties was to clean surgical instruments at the operating room before it went to the sterile processing department. ST 2 further stated it has been the practice to spray the instruments with enzymatic (cleaning product) in the soiled utility room and not in the operating room.

An interview with the ORM was conducted on 3/14/18 at 9:10 A.M. The ORM stated that after an OR procedure, the instruments were being cleaned and sprayed with enzymatic in the soiled utility and not in the operating room. The ORM further stated, "Now we have a new process to clean, apply gel to the instruments in the operating room after use."