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Based observation, interview, and record review, it was determined that the facility did not meet the Condition of Participation for Governing Body by failing to:

1. Provide Contracted Hemodialysis service in a safe manner by failing to: assure nursing staff followed STAT hemodialysis orders; assure nursing staff were trained in responding in an emergency procedure for an incapacitated dialysis nurse during patient hemodialysis. (Refer to A084)

2. Have an ongoing Quality Assessment Performance Improvement (QAPI) program that included: assuring daily biological testing results were completed in the sterile processing department (SPD) on all the loads; monitor and reduce the use of immediate use steam sterilization (IUSS); assuring patient blankets and towels were not used in the decontamination process in SPD; assuring medical staff had documented Hepatitis B status; assuring hemodialysis contracted services were delivered in a safe and effective manner including assuring STAT hemodialysis orders were promptly completed and assure that in an emergency nurses demonstrated ability to turn off a hemodialysis machine if the hemodialysis nurse became incapacitated. (Refer to A 283)

3. Maintain proper compounding records; ensure a pharmacy staff wore their mask properly while participating in the pharmaceutical compounding of sterile (germ-free) medications; assign appropriate Beyond-Use Date (BUD, a date by which the compounded sterile medication must be used before it is at risk for chemical degradation or contamination; similar to an expiration date) to at least one counts of a compounded sterile medication. (Refer to A 501)

4. Ensure medications were kept secure and not left unattended at the patient's bedside. (Refer to A 502)

5. Ensure a single-use injectable medication vial was not available in medication storage area after being used. (Refer to A 505)

6. Ensure that food services employee was competent to prepare and distribute food in sanitary and appetizing manner. The hospital failed to follow food safety standards in labeling and thawing of food. Two of two food service workers were unable to accurately test the chemical concentration of the sanitizing solution. ( Refer to A 622)

7. Ensure that the dysphagia diet provided to patients with swallowing problems were in accordance with recognized dietary practices. (Refer A 629)

8. Ensure that diet manual was approved in accordance with current national standards for dysphagia diets. (Refer A 631)

9. Ensure there was an effective system for identifying and preventing growth of microorganisms that could cause food borne illness in the hospital. Food service staff failed to develop an effective food dating system, failed to maintain the dish washing in a manner that will ensure adequate sanitization of food service utensils and dishware. Staff was incompetent in testing the chemical sanitizer. There was also an improper use of hand gloves. (Refer to A749, A622)

10. Ensure all therapeutic diets was ordered by a practitioner responsible for the care of the patient when patients on the pureed diet were served low sodium diets without a physician order for such diets. This had the potential to result in diminished food intake and longer hospital stays. (Refer to A 630)

11. Coordinate and oversee hospital wide infection control program including: Implement an infection control program that followed acceptable standards of practice in monitoring: Provide and maintain a sanitary environment for surgical services, to avoid sources and transmission of infections and communicable disease by Sterile Processing Department services including assuring daily biological testing was done with each sterilized load and daily controls were completed sterile Operating room environment for the surgical; failed to assure medical staff had documented Hepatitis B status. ( Refer to A 0749)

12. Ensure the Governing Body monitors and oversees Sterile Processing Department services including assuring daily biological testing results and reducing the use of IUSS. (Refer to A 951)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe and sanitary environment.

Based on review of documents and staff interviews, the hospital failed to maintain employee health records for contracted food service workers. The hospital lacked a system to ensure both hired and contracted employees completed required employee health requirements.

Finding:

According to the hospital's policy titled, "Immunization/ Vaccination Program", all individuals shall be screened serologically by the Occupational Health Department (OHD) for ..... Hepatitis B". The policy described that during the hiring process "all candidates shall receive information regarding the infectious process of Hepatitis B ... and the opportunity to elect or decline the hepatitis B vaccine .....All documentation shall be maintained in the employee's medical file that is maintained in OHD".

On May 25, 2018, during review of personnel records for three contracted food service employees, there was no information about Hepatitis B in the employee medical file. In an interview on May 25, 2018 at 2:28 PM, the Nurse Practitioner (NP) for OHD stated the hospital did not maintain information from contract employees. The NP stated the contract services have a requirement to clear its employees of the necessary employee health requirements prior to hire.

In an interview with the Director of Food and Nutrition (DFN) at 2:15 PM on May 25, 2018, DFN indicated that the necessary employee health requirements record was maintained at the headquarters on the East coast. Due to the three- hour time difference, this information was not available to the survey team. The hospital provided the Information regarding the Hepatitis immunization or declination for all three employees after the survey team on May 30, 2018.

The hospital did not know whether these employees met this requirement prior to the survey. The hospital had entered into a contract with food service management company in December 2015.

Based on observation, interview and record review, the hospital's Governing Body failed to ensure that the contracted service performed services in a safe and effective manner by failing to:

1. Assure that dialysis orders were carried out and documented in the medical record as ordered by the physician. The STAT hemodialysis Physician orders for Patient 43 were not carried out promptly.
2. Assure hospital nursing staff could demonstrate how to take over the care of a patient on hemodialysis in case the dialysis nurse was incapacitated.

Findings:

1. During a medical record review of Patient #43 on 5/25/18 at 2:30 p.m., Patient #43 had a STAT hemodialysis order on 4/10/18 at 12:08 a.m. Patient #43 received the emergent hemodialysis 10 hours after the physician ordered STAT on 4/10/18 at 10 am.

A review of the MD 2 note dated 4/10/18 at 5:45 p.m., documented: PRBC (packed red blood cell) given and dialysis was not done, patient was markedly tachypneic (abnormally rapid breathing). The note further documented " 9:45 a.m., when saw the patient discussed with Nurse Manager and Charge Nurse at length and patient was dialyzed today".

During an interview with RMC on 5/24/18 at 3:35 p.m., indicated if MD ordered STAT dialysis orders, they are time sensitive and dialysis service is contacted to provide dialysis within 1 hour. CNO reviews and evaluates all dialysis contracts.

A review of a facility Policy and Procedure undated, titled, "Hemodialysis Patient and Catheter Management" did not include time frame for STAT hemodialysis orders. A review of the Facility Hemodialysis contract titled, Acute hemodialysis Service agreement: dated 11/17/16 indicated "response time for emergency treatment, not to exceed one hour from time of request for service" by the facility.

2. During an observation on the 5th floor on 5/25/18 at 9:40 a.m., with RN10 (dialysis nurse) and RN11 during a hand off for dialysis of Patient #41. RN11 was asked what to do in case RN10 (dialysis nurse) was incapacitated during dialysis including to turn off power and to clamp the lines. RN11 was asked to show how to switch off the power of the hemodialysis machine and how to clamp the catheter. RN 11 pointed to a power off button on the front of the machine; and a second perfusion button on the front of the machine. RN11 did not demonstrate the order on turning off the Dialysis machine per the facility policy and procedure. RN15 was asked if she knew what to do if a dialysis nurse was incapacitated during dialysis. RN15 indicated she was the nurse manager and she oversees the RNs and brought instructions on how to turn off the dialysis machine from the nurses station.

A review of a facility Policy and Procedure undated, titled "Hemodialysis Patient and Catheter Management" indicated document provided by the contracted hemodialysis service titled "Hospital Services Policy and Procedure Emergency procedure for incapacitated Acute dialysis nurse " dated April 2018, indicated " In the event the hemodialysis becomes incapacitated during treatment it is up to the hospital nursing staff to ensure the patient safety" and included instructions to shut the power off and clamping each blood line.

During a review of the "Emergency procedure for incapacitated Acute dialysis nurse training", inservices indicated inservices were done by discussion and evaluated by included return demonstration. There were no QAPI studies available for monitoring emergency services.

Based on observation, interview and record review, the facility failed to ensure privacy for patients' information such as location, patients' full last name, initial of first name, gender, physician, and other information.

Findings:

During a tour of the emergency department (ED) on 5/23/18, at 9:40 a.m., a Status Board which contained patients' information such as the patient's full last name, initial of the first name, location, gender, physician were visible to visitors, other patients and other staff walking down the aisle. The Status Board was mounted on the wall and information on the board was readily available to the public (visitor) and passersby.

During a concurrent interview, the ED Director stated there were four (4) Status Boards in the ED which contained the same information and mounted on the wall by the nurse stations.

According to the facility policy number: MA822 titled, "HIPAA-Safeguards of Protected Health Information" indicated Locator Boards (white Boards) will contain only the room number of the patient, the patient's last name, the name of the attending physician and the nurse assigned to the patient.

Based on observation and interview, the facility failed to close a privacy curtain during provision of care for a patient in the emergency room (ER).

Findings:

On 523/18, at 10 a.m., during the tour of the unit, a patient in Room 6 was observed lying in bed. The patient was wearing a loose boxer short and nothing on the upper torso. A registered nurse and emergency medical staff members were in the room and the privacy curtain was not drawn.

Concurrently during an interview, the ER Director stated the privacy curtain should have been drawn in order for the patient not to be in full view of visitors and other facility staff members and passersby.

Based on observation, interview, and record review, the facility failed to use the appropriate safety mechanisms to protect patients from physical injury.

Findings:

During a visit to the room of Patient 30 on 5/23/2018 at 8:40 AM, the entry way to the room noted this patient was a fall risk. The patient was not wearing a yellow wrist band that indicated the patient was, in fact, at risk of falling without being assisted.

During an interview with the attending registered nurse at that time, RN7, he stated that the fall risk score (tool for measuring fall risk for hospitalized patients so that preventative measures can be taken) for this Patient 30 was 24 and that the patient should have a yellow wrist band to identify a high risk for falling and a bed alarm should be used.

A review of the Fall Score for Patient 30 dated 5/23/18 showed the total score to be 25 and the risk interventions that should be applied are to activate bed alarm, assist with ambulation, use of yellow high fall risk armband, direct supervision of patient.

During an ensuing visit to the room of Patient 31 on 5/23/2018 at 8:45 AM, the entry way to the room also noted that this patient was also at risk of falling. The patient was not wearing a yellow wrist band that indicated the patient was at risk of falling without being assisted.

An examination of the facility's 'Fall Prevention' policy indicated that high fall risk interventions include: placing high fall risk magnet on door of patient's room, use of bed alarm while high fall risk patient is in bed, initiation of Fall Risk Care Plan, provide yellow fall risk armband, direct supervision of patient while on commode or in bathroom, assisting/ supervising all transfers and ambulation with the appropriate equipment.

Based on observation, interview and record review the hospital quality assurance and performance improvement (QAPI) program failed to monitor and assure the daily biological testing results were completed on all loads in the SPD; assure medical staff had documented Hepatitis B status, assure that hospital nurses demonstrated ability to turn off a hemodialysis machine if the hemodialysis nurse became incapacitated and ensure STAT hemodialysis order was promptly completed.

Findings:

1. During a tour of the MIS (minimum invasive suite) OR, on 5/23/18 at 11 a.m., with RN 16 indicated the Immediate Use Steam Sterilization (IUSS) was observed in use, there was no case in the room at the time. A log of the IUSS cases for the month of 2018 was requested but was not provided. A review of a document titled " IMU STATS" included description of trays used after IUSS included logs from 10/2017 to 12/2017 IUSS log with description of surgical instruments prepared in IUSS for next cases included: trays documented with "no info"; total knee trays; hand and foot tray; craniotomy tray; ENT tray and total hip tray.

A review of a facility document titled, "IUSS STATS" indicated the following: the percentage of instruments that underwent flash-sterilization the Main Operating Room for the months of 1/2018; 2/2018; 3/2018 and 4/2018. A description of what instruments and trays were sterilized in the IUSS was not provided for the months of 1/2018 to 4/2018. IUSS for the month of 1/2018 was 72 and cases per month for 1/2018 was 469 cases; IUSS for month of 2/2018 was 49 and cases per month for 2/2018 was 412 cases, IUSS for 3/2018 was 72 and cases per month of 3/2018 was 505 cases, IUSS per month of 4/2018 was 65 and cases per month of 4/2018 was 470 cases. A review of the number or percent of need to follow cases for 1/18 were 36; for 2/2018 were 47 %, for 3/18 were 62%, for 4/18 and 5/18 were not provided. No data was provided for review for 5/18. Overall IUSS STATS for 1/2018 to 4/2018 monthly is documented at 14%.

During an interview with ID RN on 5/25/18 at 8:34 a.m., she indicated the facility followed Centers for Disease Control and Prevention (CDC), Association of periOperative Registered Nurses (AORN) and AIMEE guidelines. A review of the facility undated document titled, "Infection Control Surgical Services: Sterilization practices for the operating room indicated steam sterilization for urgently needed instrumentation only.

2. During a tour of the SPD (sterile processing department) on 5/23/18,at 1:45 p.m., with SPD Director and review of the biological Log "High Temperature Sterilization BI Log (PREVAC), the following information was missing from the log for loads. On 4/26/18 indicator color change was not documented as either Y/N; two loads for 5/3/18 at indicator color change was not documented as either Y/N, on 5/22/18 a control load did not have date out, initial or result of the control documented.

During a tour of SPD decontamination room, patient blankets and patient towels were observed covering the counters adjacent to the decontamination sinks. During an interview with Director of SPD, on 5/23/18 at 2:15 p.m., she indicated the patient blankets and towels were used to dry surgical instruments after being manually decontaminated. The blankets and towels are then sent back to be washed with the facility linen service. A policy and procedure or reference for using patient blankets and patient towels in the decontamination room was requested and not provided.

3. On 5/24/18, at 1:30 p.m., during a review of the medical staff credentialing files, 10 of 10 medical staff did not have Hepatitis B status or waiver on file.

During an interview with the medical staff credential supervisor, she indicated currently did not have a policy for Hepatitis B status screening and evaluation for the medical staff.

4. During an observation on the 5th floor on 5/25/218 at 9:40 a.m., with RN 10 and RN 11 during a hand off for dialysis of Patient 41. RN 11 was asked to do in case RN 10 (dialysis nurse) was incapacitated during dialysis including to turn off power and to clamp the lines. RN 11 was asked to show how to turn the power of the hemodialysis machine and how to clamp the catheter. RN 11 pointed to a power off button on the front of the machine and a second perfusion button on the front of the machine. RN 11 did not demonstrate the order on turning off the dialysis machine per the facility policy and procedure. RN 15 was asked if she knew what to do if a dialysis nurse was incapacitated during dialysis. RN 15 indicated she was the nurse manager and she oversees the RNs and brought instructions on how to turn off the dialysis machine from the nurses station.

A review of an undated facility policy title "Hemodialysis Patient and Catheter Management" indicated document provided by the contracted hemodialysis service titled "Hospital Services Policy and Procedure Emergency Procedure for Incapacitated Acute Dialysis Nurse" dated April 2018, indicated in the event the hemodialysis becomes incapacitated during treatment it is up to the hospital nursing staff to ensure the patient safety and included u=instruction to shut the power off and clamping each blood line.

During review of the "Emergency procedure for incapacitated Acute dialysis nurse training, inservices indicated inservices were done by discussion and evaluated by included return demonstration. There were no QAPI studies available for monitoring emergency inservice.

5. During a medical record review of Patient #43 on 5/25/18 at 2:30 p.m., Patient #43 had a STAT hemodialysis order on 4/10/18 at 12:08 a.m. Patient #43 received the emergent hemodialysis 10 hours after the physician ordered STAT on 4/10/18 at 10 am.

During an interview with RMC on 5/24/18 at 3:35 p.m., indicated if MD ordered STAT dialysis orders, they are time sensitive and dialysis service is contacted to provide dialysis within 1 hour.

A review of an undated facility document titled "Performance Improvement Plan" indicated"The Board of Directors is responsible for maintaining quality patient care....

During a review of the facility QAPI ongoing studies did not include: assuring daily biological testing results were completed in SPD on all the loads; monitor and reduce the use of IUSS; assure patient blankets and towels were not used in the decontamination process in SPD; assuring medical staff had documented Hep B status; hemodialysis contracted services were delivered in a safe and effective manner including assuring STAT hemodialysis orders were promptly completed and assure that in an emergency nurses demonstrated ability to turn off a hemodialysis machine if the hemodialysis nurse became incapacitated.

A review of a facility document titled, "Performance Improvement Plan" undated indicated "The Board of Directors is responsible for maintaining quality patient care" ....

Based on observation, interview and record review, it was determined that the facility did not meet the Condition of Participation (COP) for Nursing Services by failing to:

1. Maintain adequate numbers of staff to provide nursing care to all patients as needed during meal and/or break time. The facility failed to implement the "Plan for Provision of Collaborative Patient Care Services - Description of Scope of Services" policy indicating Staffing plans are designed according to Title 22 staffing ratio requirements. One (1) licensed nurse was taking care of more than 2 patients during meal and or break time in the Critical Care Units. The Medical/Surgical/Telemetry Unit had a buddy break system (relieving each other). (Refer to A 392)

2. Follow Manufacturer's Recommendation to perform quality control test on the glucometer used for patients. (Refer to A 392)

3. Ensure there was a signed job description for the Dialysis Nurse available for review, ensure the Sterile Processing Technician's Competency was accurately filled out (no blanks), a return demonstration by the staff and date/ name of person who conducted competency evaluation. (Refer to A 392)

4. Ensure the patients' pain intensity or level was assessed and documented before administering a pain medication and re-assessed after the medication was administered, to determine the effectiveness. (Refer to A 395)

4. Ensure during pre and post treatment assessment of the hemodialysis, the patient's actual weight was taken, edema was re-assessed, dressing change for access site, physician order for dialyzer to be used and calcium bath was obtained prior to treatment. (Refer to A 395)

5. Ensure the patient who is lying on a special mattress has a single sheet/linen underneath the buttocks to aid in the healing of a pressure sore. (Refer to A 395)

4. Ensure bedside medications such as nystatin powder, normal saline and Desitin when opened should be dated and had a physician order to keep them at bedside. (Refer to A 395)

5. Ensure the registered nurses develop an individualized care plan for patients who were receiving care in the facility. (Refer to A 396)

6. Ensure the nursing staff follow the facility policy and procedure for patients who were on medications for pain management. There was a lack of documented pain assessment and reassessment for the administrations of as needed pain medications and might lead to unnecessary pain suffering, increase risk of adverse/side effects, and/or medication errors. (Refer to A 396, A 405)

The cumulative effect of these systemic problems resulted in the hospital's inability to provide quality health care in a safe environment.

Based on observation, interview and record review, the facility failed to:

1. Maintain adequate numbers of staff to provide nursing care to all patients as needed during meal and/or break time. The facility failed to implement the "Plan for Provision of Collaborative Patient Care Services - Description of Scope of Services" policy indicating Staffing plans are designed according to Title 22 staffing ratio requirements. One (1) licensed nurse was taking care of more than 2 patients during meal and or break time in the Critical Care Units. The Medical/Surgical/Telemetry Unit had a buddy break system (relieving each other).

2. Follow Manufacturer's Recommendation to perform quality control test on the glucometer used for patients.

3. Ensure there was a signed job description for the Dialysis Nurse available for review.

4. Ensure the Sterile Processing Technician's Competency was accurately filled out (no blanks), a return demonstration by the staff and date/ name of person who conducted competency evaluation.

These deficient practices had the potential for not meeting the needs of individual patients.

Findings:

1 (a). On May 24, 2018, at 9:40 a.m., during the initial tour of the unit (critical care unit-surgical) with the Critical Care Director, the unit's census for 7 a.m., to 7 p.m. was 8 patients.

Review of the Daily Roster by Shift dated 5/24/18, day shift indicated CCR (respiratory) had nine (9) patients and there were four (4) registered nurses (RNs) to provide care to the patients. The CCC (cardiac) had 10 patients and two (2) patients requires a 1:1 (nurse patient ratio) and there were 7 RN to provide care. The CCS (surgical) had eight (8) patients and four RN to provide care to the patients.

Further review of the Daily Roster by Shift dated on 5/24/18 did not have documentation to indicate break schedules (30 minutes and two -15 minutes breaks) and who is relieving whom.

On May 24, 2018, at 9:40 a.m., during an interview with RN 8, she stated that each RN is "breaking off" for each other during (30 and 15 minutes) breaks. She further stated before they go on break they endorsed to the other RN who will take care of his/her patients of the patient's condition, code status, allergies, reason the patient was admitted to the unit and any drip that needs to be titrated. In this instance, if the relief RN has her own 2 patients and take care of the other RN's patient who could be a 1:1 nurse to patient ratio or 1:2 nurse to patient ratio, the RN will be taking care of more patients than she/he should was allowed to care for during the shift.

On the same day, at 10 a.m., during an interview, RN 9 stated that at this time she had two (2) patients to care for the morning shift. RN 9 stated in the CCR unit, the RNs are "breaking for each other." For example "if my patient had to go to a procedure, I will stay with my patient however I have to give a short report to the RN who I will endorse my other patient by giving her a review of the systems, diagnosis, code status, allergies and IV drips." RN 9 further stated on occasion the rapid response nurse or charge nurse relieve as well.

Review of the facility policy number: MA1174 titled, "Plan for Provision of Collaborative Patient Care Services - Description of Scope of Services" indicated Staffing plans are designed according to Title 22 staffing ratio requirements. The acuity levels used are the following: Low, Medium 1:2, High 1:1 and Extreme 2:1.

(b) On May 22, 2018, at 11:40 a.m., during the initial tour of the unit (2 Tower-Telemetry, Medical/Surgical) with the Charge Nurse and the unit's census was 24 patients for the 7 a.m. to 7 p.m. shift.

During an interview with RN 10, during the tour, she stated in the unit they have the "Buddy Break" system, which was each RN covers for each other during breaktimes. The RN update each other of the patient's condition before going on break, take each other's hospital provided phone. During break the RN will be taking 8 patients. The CN, who does not have patient load, at times relieves the RN when they go on break.

Review of 2 Tower Staff Assignment dated 5/22/18 for 7 a.m. to 7 p.m., indicated the census was 24 patients and twelve (12) patient were on monitored telemetry distributed to the RN on duty. The assignment also indicated the Break Buddy and time each RN go on break and their corresponding relief RN.

Review of the facility policy number: MA1174 titled, "Plan for Provision of Collaborative Patient Care Services - Description of Scope of Services" indicated Staffing plans for Medical/Surgical/Telemetry Units indicated the staffing plan for all these units is based on and adjusted to meet patient activity and is in compliance with Title 22 and accreditation requirements.

2. On May 23, 2018, at 10 a.m., during observation of the performance of quality control monitoring of the Glucometer machine, RN 11 prepared the glucometer, control solution and control strip. The RN picked up a strip and inserted the strip on the glucometer port. The RN applied a drop of the solution (lo) on to the strip and a reading was shown. The process was repeated for the solution (hi) and reading came out.

Review of the facility policy number: NP1187 titled, "Whole Blood Glucose Testing Using Nova Biomedical StatStrip Glucose Meter - Running Quality Control Solution" indicated, Insert a Test Strip, with the test strip correctly inserted, the apply Sample screen displays. Gently mix the StatStrip Glucose Control Solution before each use. Discard the first drop of control solution from the bottle to avoid contamination. ......

During an interview with RN 11, she was made aware that she failed to follow the facility policy on how to perform the quality control test which was to gently mix the control solution and discard the first drop to prevent cross contamination.

3. On May 25, 2018, at 2 p.m., during review of the personnel and health file of Dialysis Nurse with Education Coordinator indicated there was no job description available for review, the competency evaluation conducted had no date and name of the person who conducted the evaluation. The immunology report dated 9/26/17 indicated the result of the Hepatitis B Surface Antibody was <10 miU/ml should be non-reactive. During a concurrent interview, the Education Coordinator stated there should be an offer of Hepatitis vaccination however, there was no written documentation available to review.

4. Review of the Sterile Processing Technician's Competencies indicated the following:
a. [Brand Name] "Century Medium Sterilizer 26" X 37.5" indicated there was no result of overall competency rating (blank), evaluation method was observation only, no documentation of repeat demonstration, verbalized knowledge and/or written computer test. Under the section for date and initial, the date was not indicated only initial. The date indicated it was completed on January 18 [no year].

b. Competency Checklist - [Brand Name] 24 Biological Indicator indicated there was no staff signature to indicate who performed the competency checklist with SPT.

c. Post Tests on -
1) Protocols for Immediate - Use of Steam Sterilzation indicated the SPT signed but there was no documentation of date, and the result of the Post Test whether SPT Passed/Failed.
2) Reprocessing Flexible Endoscopes
3) Inspecting of Surgical Instruments and Devices

All the above mentioned Post Tests indicated the SPT signed but there was no documentation of date, and the result of the Post Test whether SPT Passed/Failed.

During an interview with Education Coordinator while reviewing the personnel file of SPT, she concurred with the above findings.

Based on interview and record review the facility failed to:

a. Ensure the patients' pain intensity or level was assessed and documented before administering a pain medication and re-assessed after the medication was administered, to determine the effectiveness, for 3 of 46 sampled patients (21, 29 and 32).

b. Ensure during pre and post treatment assessment of the hemodialysis, the patient's actual weight was taken, edema was re-assessed, dressing change for access site, physician order for dialyzer to be used and calcium bath was obtained for Patient 26.

c. Ensure the patient who is lying on a special mattress has a single sheet/linen underneath the buttocks to aid in the healing of a pressure sore for Patient 3.

d. Ensure bedside medications such as nystatin powder, normal saline and Desitin when opened should be dated and had a physician order to keep at bedside for 2 of 46 sampled patients (13 and 29).

These deficient practices had the potential to result in the patients' needs not being met.

Findings:

1. On 5/24/18 at 7:45 a.m., during concurrent interview and record review, registered nurse (RN 3), stated she gave Tylenol to Patient 21, on 5/23/18 because the patient had a headache. The RN stated there was no way of documenting the pain level in the electronic record. RN stated she did not document the pain level in the paper chart either. The RN stated there was no way of knowing if the pain medication was effective, because the pain level was not documented.

Concurrently, CN 1 stated the pain level must be documented in the patients' chart.

Patient 21 was admitted to the facility on 5/22/18 due to pregnancy, admitted to the Post-Partum Unit after delivery.

The medication administration record indicated Patient 21 received Tylenol (acetaminophen, a pain reliever) 650 milligrams (mg) on 5/23/18 at 4:53 p.m., there was no documentation regarding the level or intensity of the pain. At 5:53 p.m., there was documentation that the pain was re-assessed, however, the pain level was not documented.

The facility's policy and procedure titled, "Pain Management of Patients" dated 11/2017, indicated to assess the pain level with each set of routine vital signs and document relief from pain intervention within 60 minutes, and as needed.





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2. On May 22, 2018, at 10:20 a.m., Patient #29 was observed in bed. The patient is alert, oriented and able to communicate her needs. The patient showed her surgical site on the left abdomen covered with a bandage.

Review of the pain documentation dated 5/11/18 at 2005 [8:05 p.m.), the patient complaint of pain on bilateral hip which was assessed as 7 out 10 pain scale. The medication morphine 0.5 mg [milligrams] was administered intravenously (IV). Further review of the clinical record there was no documentation of an assessment of the presence and/or absence of pain after pain medication was administered. On 5/12/18, at 0005 [12:05 a.m.], the patient complaint of left flank pain which was assessed as 5 out 10 pain scale. There was no documentation of offer of pain medication to alleviate the pain.

The facility's policy and procedure number #: MA1312 titled "Pain Management of Patients" dated 11/2017, indicated to assess the pain level with each set of routine vital signs and document relief from pain intervention within 60 minutes, and as needed.

3. On May 23, 2018, at 8:50 a.m., Patient #32 was observed in bed, alert, oriented and able to communicate her needs. She stated she had placement of pacemaker on 5/21/18 and lead revision on 5/22/18.

Review of the Patient Information Sheet Review of the Patient Information Sheet indicated
Patient # 32 was admitted to the facility on May 21, 2018, with diagnosis of bradycardia (a condition wherein an individual has a very slow heart rate, typically defined as a resting heart rate of under 60 beats per minute (BPM) in adults).

Review of the pain documentation dated 5/21/18 at 12:45 p.m., the patient complained of pain which was assessed as 7 out 10 pain scale, The medication Tylenol 650 mg was administered orally (mouth). Further review of the clinical record there was no documentation of the location of pain and reassessment of pain level after pain medication was administered. On 5/22/18, at 1:28 p.m., the patient was administered Tylenol but there was no documentation why it was administered and/or assessment of presence and/or absence of pain.

4. Review of the Patient Information Sheet indicated Patient #26 was admitted to the facility on May 17, 2018, with diagnosis of right hip fracture and insulin dependent.

On May 22, 2018, at 2 p.m., Patient #26 was observed receiving hemodialysis via right Quinton catheter on the right groin area. The patient was dialyzing on 2 K (potassium) and 2.5 Ca (calcium) bath. The blood flow rate (BFR) was 300 and dialysate flow rate (DFR) was 500.

a) The physician hemodialysis order dated 5/23/18 indicated session length: 3 hours, blood flow rate 250-350, dialysate flow rate 500 ml/min, Potassium 1 K, HCO3 35, Calcium 2.5, Sodium 145 Ultrafiltration goal 2-3 Liter, Magnesium 0.75 and Dextrose 200.

Review of the Hemodialysis Record dated 5/23/18 indicated there was no actual post weight taken. The documentation was - 3 pounds (3000 net fluid loss) for the post weight. There was documentation in the record for the Calcium bath used. During Pre-treatment assessment the patient was assessed +1 edema on bilateral lower extremities. However, the Hemodialysis Record did not include the post - treatment assessment. The dressing change for the access site was left blank. The patient was using a F160 dialyzer but there was no dialyzer order. There was no documentation which hemodialysis machine was used during hemodialysis treatment.

b) The physician hemodialysis order dated 5/22/18 indicated session length: 3 hours, blood flow rate 250-350, dialysate flow rate 500 ml/min, Potassium 2 K, HCO3 35, Calcium 2.5, Sodium 145 Ultrafiltration goal 2-3 Liter , Magnesium 0.75 and Dextrose 200.
Review of the Hemodialysis Record dated 5/22/18 indicated there was no actual post weight taken. The documentation was - 3 pounds (3000 net fluid loss) for the post weight. There was documentation in the record for the Calcium bath used. During Pre-treatment assessment the patient was assessed +1 edema on bilateral lower extremities. However, the Hemodialysis Record did not include the post - treatment assessment. The patient was using a F160 dialyzer but there was no dialyzer order.

c) The physician hemodialysis order dated 5/21/18 indicated session length: 3 hours, blood flow rate 250-350, dialysate flow rate 500 ml/min, Potassium 2 K, HCO3 35, Calcium 2.5, Sodium 145 Ultrafiltration goal 2-3 Liter , Magnesium 0.75 and Dextrose 200.
Review of the Hemodialysis Record dated 5/21/18 indicated there was no actual post weight taken. The documentation was - 2 pounds (2000 net fluid loss) for the post weight. There was documentation in the record for the Calcium bath used. During Pre-treatment assessment the patient was assessed +2 general edema. However, the Hemodialysis Record did not include the post - treatment assessment. The patient was using a F160 dialyzer but there was no dialyzer order.

On 5/25/18, at 10:50 a.m., during an interview with RN 18, stated hemodialysis order should be checked prior to starting hemodialysis treatment. At times, there would be a need to clarify orders, if there was none obtain an order. For example a dialyzer, weight.

5. During a tour of the unit on May 22, 2018, at 10 a.m. through 3 p.m., the following was observed:

a. Patient #13 was lying on a special bed. At the bedside were two (2) bottles of opened and undated 0,9 % sodium chloride, a bottle of Nyamyc (nystatin powder) that has no label and 1 tube of Desitin ointment with patient's name.

Review of the Patient Information Sheet indicated the patient was admitted to the facility on May 16, 2018, with diagnosis of unspecified abnormalities of gait.

Review of the Wound Ostomy Nurse Evaluation conducted on 5/17/18 indicated the wound nurse recommended normal saline to cleanse the coccyx/sacrum wounds, apply nystatin powder to bilateral groins and apply Desitin as needed after each peri-care.

During an interview on 5/24/18 at 8 a.m., while reviewing the clinical record with RN 15, there was no documented evidence of a physician order to keep bedside medications and/or documentation an assessment was conducted to keep the medication at bedside.

During wound treatment observation on 5/22/18 at 10:20 a.m., RN 16 was observed to prepare her supplies needed for wound treatment for Patient #13. The patient was lying on special bed with a linen placed on the mattress. Underneath the patient's buttock was a linen folded 2 times (which yielded 4 layers of linen and 2 disposable chux underneath).

The RN removed the soiled dressing which had no label. The wound on the sacral area was exposed. The RN measured the pressure sore as 8 cm (centimeters) by 8 cm by 3 cm and there was undermining at 7 o'clock, 1 o'clock and 12 o clock and deepest was 5.5 cm. The RN irrigated the wound with normal saline, kept dabbing the wound with same gauze, applied hydrogel to wound, apply hydrogel to a gauze and applied to the wound and covered with Alleyvyn dressing and labeled it.

During an interview with the RN at the time of observation RN 16 stated the wound dressing should be labeled, the normal saline, nystatin should be dated when first opened.

b. Patient #29 was lying in bed. At the bedside was a bottle of opened and undated 0.9% sodium chloride and had no label attached.

Review of the Patient Information Sheet indicated Patient #29 was admitted to the facility on May 10, 2018, with diagnosis of rehab non-traumatic C Spine Cord.

During an interview on 5/24/18 at 8 a.m., while reviewing the clinical record with RN 15, there was no documented evidence of a physician order to keep bedside medications and/or documentation an assessment was conducted to keep the medication at bedside.

Based on record review and interview, the facility failed to ensure nursing staff developed, implemented, and kept current nursing care plans for 7 out of 46 sampled patients (13, 18, 26, 29, 32, 33 and 34).

This deficient practice had the potential for not meeting the needs of the patients.

Findings:

1. Review of the Patient Information Sheet indicated Patient #13 was admitted to the facility on May 16, 2018, with diagnosis of unspecified abnormalities of gait. The patient has a colostomy (a surgical operation in which a piece of the colon is diverted to an artificial opening in the abdominal wall so as to by pass a damaged part of the colon).

Review of the Interdisciplinary Care Plan indicated on 5/17/18 the care plan to address the presence of the colostomy was initiated. There was no documented goals/outcomes and interventions were done.

2. Review of the Patient Information Sheet indicated Patient #29 was admitted to the facility on May 10, 2018, with diagnosis of rehab non-traumatic C Spine Cord. On May 9, 2018, the patient had surgery of removal of kidney.

Review of the Interdisciplinary Care Plan initiated on 5/10/18 addressed the presence of a surgical wound. The goal/outcomes and interventions were not documented.

Review of the Interdisciplinary Care Plan initiated on 5/10/18 addressed the pain concern. The goal/outcomes and interventions were not documented.

3. On May 22, 2018, at 11:30 a.m., Patient #33 was observed in bed. The patient was alert, oriented and able to communicate her needs.

Review of the Patient Information Sheet Review of the Patient Information Sheet indicated Patient #33 was admitted to the facility on May 19, 2018, with diagnosis of sepsis and bladder infection. On May 22, 2018, the patient had cystoscopy procedure performed.

Review of the Interdisciplinary Care Plan there was no documentation a care plan was initiated to address the care of patient who recently had a cystoscopy procedure (allows your doctor to examine the lining of your bladder and the tube that carries urine out of your body).

4. On May 23, 2018, at 8:50 a.m., Patient #32 was observed in bed, alert, oriented and able to communicate her needs. She stated she had a lead revision on 5/22/18 and placement of pacemaker on 5/21/18.

Review of the Patient Information Sheet Review of the Patient Information Sheet indicated Patient #32 was admitted to the facility on May 21, 2018, with diagnosis of bradycardia (a condition wherein an individual has a very slow heart rate, typically defined as a resting heart rate of under 60 beats per minute (BPM) in adults).

During an interview with registered nurse (RN 15), while reviewing the patient's medical record she stated there was no specific care plan that addressed care and information regarding the newly placed pacemaker.

5. On May 23, 2018, at 9 a.m., Patient #34 was observed in bed with indwelling catheter draining 56 cc (cubic centimeter ) of cloudy, yellow-colored urine with sediment.

Review of the Patient Information Sheet Review of the Patient Information Sheet indicated Patient #34 was admitted to the facility on May 12, 2018, with diagnosis of respiratory arrest.

Review of the Interdisciplinary Care Plan indicated there was no documentation a care plan was initiated to address the care of patient who had an indwelling catheter in place.

6. Review of the Patient Information Sheet indicated Patient #26 was admitted to the facility on May 17, 2018, with diagnosis of right hip fracture and insulin dependent.

On May 22, 2018, at 2 p.m., Patient #26 was observed receiving hemodialysis via right Quinton catheter on the right groin area. The patient was dialyzing on 2 K (potassium) and 2.5 Ca (calcium) bath. The blood flow rate (BFR) was 300 and dialysate flow rate (DFR) was 500.

Review of the Interdisciplinary Plan indicated hemodialysis was noted on both Problems #6 Fluids -alteration in regulatory/fluids related to hemodialysis and #8 Elimination - alteration in bowel elimination related to hemodialysis, however the goal/outcomes and interventions was not specifically address the hemodialysis access and care, hemodialysis order, etc.


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7. On 5/22/18 at 10:50 a.m., during the tour of the facility with RN 15, Patient 18 was observed in bed, awake and alert. Patient was moving the bed into the desired position. Patient 18 had a urinary collection bag hanging on the bed, the tubing was touching the floor.

During a concurrent interview, Patient 18 stated she had not been instructed on how to care for the urinary collection bag or the tubing.

At 11:48 a.m., the registered nurse RN 2 verified Patient 18 did not have a nursing care plan addressing the alteration of urinary elimination. RN 2 stated if a patient has a urinary drainage collection bag, a care plan should be initiated.

A review of Patient 18's medical record indicated the patient was admitted to the facility on 5/20/18 for small bowel obstruction. A physician's order dated 5/20/18 indicated for Patient to have a urinary catheter insertion STAT (immediately) for urinary retention. The nurses' notes indicated the urinary catheter was inserted on 5/20/18 at 7:47 AM. There was no documented evidence that a care plan addressing the alteration of urinary elimination, including care of bag or tubing. There was no documentation indicating education related to the care of the drainage bag and tubing, was provided to Patient 18.

The facility's policy and procedure titled, "Interdisciplinary Plan of Care" dated 11/2016, indicated a care plan will be initiated within 24 hours of admission. Care Plan will be reviewed and/or updated as needed. RN will initiate care plan. Check all appropriate problems. Check all appropriate goals/outcomes. Check all appropriate interventions. Complete target date, start date and initial. Documentation of patient education will be done by the person doing teaching.

Based on interviews and medical record reviews, the hospital failed to ensure their nursing staff would follow their policy and procedure for patients who were on medications for pain management. There was a lack of documented pain assessment and reassessment for the administrations of as needed pain medications, for two of 46 sampled patients (4, 10). This deficient practice had the potential of inadequate patient monitoring that might lead to unnecessary pain suffering, increase risk of adverse/side effects, and/or medication errors.

Findings:

Review of Patient 4's physician orders indicated Patient 4 had an order dated 5/20/2018 at 12:20 a.m. for morphine (a schedule II controlled substance, an opioid used to treat pain) 2 mg (milligram) intravenously every 5 minutes as needed for severe to unbearable pain (level 8-10).

Review of Patient 4's medication administration record (MAR) indicated the nursing staff had administered two doses of morphine on 5/20/2018 at 12:21 a.m. and 12:27 a.m.

Review of the Post Anesthesia Care Unit (PACU) Record for Patient 4 indicated Patient 4 was in the PACU on 5/20/2018 from 12:14 a.m. to 1:25 a.m. However, the PACU record did not reveal any documented pain level prior to the two aforementioned administrations of the morphine, between 12:15 a.m. to 12:30 a.m.

During a concurrent interview on 5/23/2018 at 4:30 p.m. the clinical informatics nurse confirmed the lack of documented pain assessment for the aforementioned two doses of morphine.

During an interview on 5/24/2018 at 10:45 a.m., the director of pharmacy (DOP) indicated there should be pre- and post- assessment of pain for each as needed pain medication administration.

The hospital policy and procedure, Pain Management of Patients, last reviewed in 11/2017, indicated " ... Pain management of the post-operative patient will begin in the recovery area; pain intensity and quality and response to intervention will be documented ..."

Review of Patient 10's physician orders, MAR, and pain parameter history between the dates 5/22/2018 and 5/24/2018, indicated Patient 10 had an order for hydrocodone / acetaminophen (generic for Norco, also a schedule II controlled substance used to treat pain) 5/325 mg 1 tablet orally every 4 hours as needed (PRN) for moderate to strong pain (level 4-7). Patient 10 received three doses during the course of three days.

In the presence of the clinical pharmacy manager and the risk management nurse manager, the review of Patient 10's nursing assessment reports and parameter history did not reveal a documented pain scale of 4 or above. During a concurrent interview, the DOP indicated Patient 10's documented pain assessments did not meet the criteria for the administrations of the prescribed Norco.

The hospital policy and procedure, Pain Management of Patients, last reviewed in 11/2017, indicated " ... There is a need for assessing and managing pain to help avoid accidental opioid overdose."

Based on observations, interviews and record reviews, the hospital failed to maintain proper compounding records; the hospital failed to ensure a pharmacy staff wore their mask properly while participating in the pharmaceutical compounding of sterile (germ-free) medications; the hospital also failed to assign appropriate Beyond-Use Date (BUD, a date by which the compounded sterile medication must be used before it is at risk for chemical degradation or contamination; similar to an expiration date) to at least one count of a compounded sterile medication for one of 46 sampled patients (Patient 3). These deficient practices had the potential in affecting the safety or health of the patients requiring intravenous medications.

Findings:

1. On 5/22/2018 at 2:45 p.m. during a tour of the pharmacy department, the surveyor requested the sterile intravenous (IV) compounding log. A pharmacist presented a bucket containing several bundles of compounded IV medication labels wrapped with rubber bands.

Review of the top few labels in one bundle of labels did not reveal the lot numbers of the ingredients used, as well as preparation dates and times.

During a concurrent interview, the pharmacy operation manager acknowledged the missing information.

On 5/23/2018 at 1:45 p.m., the pharmacy operation manager (POM) confirmed there were ninety-six (96) IV medication compounding records in the aforementioned bundle. The POM indicated there were sixteen out of 96 records that were compliant to the documentation requirements established by USP 797 (the sterile compounding standards issued by the United States Pharmacopeia, USP; the USP 797 describes the guidelines, procedures and compliance requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded). The POM acknowledged eighty out of 96 compounding records were not in compliance.

2. On 5/22/2018 at 11:10 a.m. during a tour of a medication room on the fifth floor tower, there was a package of cefazolin (an antibiotic for the treatment of certain infections) for injection labeled for Patient 3 inside the IV cabinet (an area to store patients' intravenous medications). The label on the package indicated an expiration date in 30 days. However, an inspection of the packaging information printed on the package indicated "after foil strip removal, product must be used within 7 days."

During a concurrent interview, the director of pharmacy (DOP) acknowledged that the expiration date on the label should reflect the manufacturer recommendation.

Review of the hospital's policy and procedure, Sterile Manufacturing Quality Assurance, Policy number PH 1081 and last reviewed in 5/2017, indicated " ... All expiration dates shall be supported by either the manufacturer's recommendation or supported by reputable data published in the literature."


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3. During a tour of the hospital sterile intravenous (IV) compounding areas, on 5/22/2018 at 11:10 a.m., in the presence of the Director of Pharmacy Services (DOP), a staff pharmacist was standing on the clean side of the demarcation line (a line on the floor that separate the dirty and the clean side) garbed with shoe covers, hair cover, gown, but without a face mask. During a concurrent interview and an inquiry regarding the face mask, the staff pharmacist indicated they should wear a mask.

During another concurrent interview, the DOP stated the pharmacy staff should wear a mask in the sterile IV area.

Review of the hospital's policy, Sterile Manufacturing Quality Assurance Programs and Practices, last reviewed in 11/2017, indicated " ... Prior to each entry into the buffer area (while in the ante area), donning of non-shedding material personal protective equipment (PPE) must be followed in the order described below: ...Don face mask ..."

Based on observation, interviews, and record review, the hospital failed to ensure medications were kept secure and not left unattended at the patient's bedside. This deficient practice had the potential for diversion, tampering, and/or medication errors that may or may not affect the safety or health of the patients.

Findings:

On 5/23/2018, at 9:56 a.m., during a medication pass observation of the Rehabilitation patient care unit on the 3rd Floor Tower, upon entering Patient 6's room together with a registered nurse (RN 17), there was a physical therapist inside the room with Patient 6 and a Medication Mobile Cart (MACS). On top of the MACS, there were five medications for Patient 6, labeled and unsecured.

During a concurrent interview, RN 17 indicated after pulling Patient 6's regular medications from the third floor medication room, the patient complained of pain. RN 17 stated he left those five medications on top of the MACS to get the additional pain medication for Patient 6 from the medication room.

On 5/24/2018 at 8:19 a.m., during an interview with another RN, RN 16 stated medications should always be locked unless under the direct supervision of a nurse.

On 5/24/2018 at 1:25 p.m., during an interview in the presence of RN 16, RN 17 stated that the hospital utilized MACS and the medications should have been locked and stored before leaving Patient 6's room.

A review of the facility's policy and procedure, Medication Administration Process Utilizing MACS/Medication Mobile Cart, policy number NP1191 and last reviewed on 11/2017, indicated, "Medications are not to be left unattended during medication pass."

Based on observation, interviews, and record review, the hospital failed to ensure a single-use injectable medication vial was not available in medication storage area after being used. This deficient practice had the potential to affect the safety or health of the patients.

Findings:

On 5/23/2018, at 9:25 a.m., during an inspection of the medication room located on second floor tower with the director of pharmacy (DOP), there was a medication refrigerator inside the medication room. Inside the medication refrigerator, there was a Ziploc bag containing a vial of diltiazem (a medication to treat high blood pressure and other heart conditions).

During a concurrent interview, the DOP confirmed the vial of diltiazem had been used and it was a single-use vial. The DOP acknowledged the nursing staff should waste the vial after use and it should not be kept in the refrigerator.

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Based on observation, interview and record review, it was determined that the facility did not meet the Condition of Participation (COP) for Food and Dietetic Services by failing to:

1. Ensure that food services employee was competent to prepare and distribute food in sanitary and appetizing manner. The hospital failed to follow food safety standards in labeling and thawing of food. Two of two food service workers were unable to accurately test the chemical concentration of the sanitizing solution. This deficient practice could result in exposure of patients to food borne illness, chemical contamination and poor food intake due to poor presentation and palatability concerns. (Cross refer A 622)

2. Ensure that the dysphagia diet provided to patients with swallowing problems were in accordance with recognized dietary practices. These deficient practice could result in decreased food intake due to poor presentation and increased risk of choking in patients who are unable to form a bolus due to swallowing problems or unable tolerate thin liquids. (Cross refer A 629)

3. Ensure that diet manual was approved in accordance with current national standards for dysphagia diets. (Cross refer A A631)

4. Ensure there was an effective system for identifying and preventing growth of microorganisms that could cause food borne illness in the hospital. Food service staff failed to develop an effective food dating system, failed to maintain the dish washing in a manner that will ensure adequate sanitization of food service utensils and dishware. Staff was incompetent in testing the chemical sanitizer. There was also an improper use of hand gloves. (Cross refer A749, A622)

5. Ensure all therapeutic diets was ordered by a practitioner responsible for the care of the patient when patients on the pureed diet were served low sodium diets without a physician order for such diets. This had the potential to result in diminished food intake and longer hospital stays. (cross refer A630)

The cumulative effect of these systemic problems resulted in the inability of the hospitals' food and nutrition services to direct and staff in such a manner to ensure that the nutritional needs of the patients' were met in accordance with practitioners' orders and acceptable standards of practice.

Based on observation, staff interview and review of facility documents, the hospital failed to ensure that food services employee was competent to prepare and distribute food in sanitary and appetizing manner. The hospital failed to follow food safety standards in labeling and thawing of food. Two of two food service workers were unable to accurately test the chemical concentration of the sanitizing solution. Food service staff failed to follow recipes for patients on pureed diet. This deficient practice could result in exposure of patients to food borne illness, chemical contamination and poor food intake due to poor presentation and palatability concerns.

Finding:

During the tour of the kitchen on May 22, 2018 starting at 9:37 AM, twenty five boxes of chicken breast fillets with hand written dates of "5-14, 5-18 or 5-21" were stored on the shelves in one of the walk -in refrigerators. Six boxes dated "5-14" (May 14, 2018) showed evidence of thawing with the exterior of the boxes visibly wet.

The director of Food and Nutrition (DFN), Operations Manager (OM) were present during the observation. OM stated in the concurrent observation and interview that the items were received frozen. The OM stated in the concurrent interview and observation he was not sure when the items were placed in the refrigerator and that the date on the boxes may not reflect the actual date the items were placed in the refrigerator for thawing. Further investigation revealed that the dates on each of the labels from the food distributor matched the hand written dates on the boxes. The box of chicken from the day before, labeled (5-21) May 21, 2018 which was also stored in the refrigerator demonstrated that items are placed in the refrigerator from when they are delivered to when they are used. Neither the DFN nor the OM provided any evidence that the items were not placed in the refrigerator on the date labeled. The hospital did not have a system in place to monitor when frozen items are thawed and ready for food preparation.

A review of the hospital policy titled "HACCP/ Food Safety program Food Safety Standards and Requirements" with a revision date of 08/17/2016 did not show instructions or guidelines on how long food may be stored in the refrigerator for thawing. A review of the hospital food safety training document titled, "Thawing Food" showed staff were trained on different ways frozen food could be thawed but did not include any information or guidelines on dating or time frames on thawing different kinds of meats in the refrigerator.

According to the United States Department of Agriculture's Food and Food Safety and Inspection Service (FSIS), raw chicken thawed in the refrigerator from its frozen state "can be kept in the refrigerator an additional day or two before cooking". The lack of system to identify and track when chicken is placed in the refrigerator for thawing made it difficult for hospital staff to demonstrate that the thawed chicken pieces had not exceeded the recommended storage times.

The following are some of the bacteria associated with raw chicken: Salmonella enteritiditis, staphylococcus aureus, campylobacter jejuni, listeria monocytogenes, Escherichia coli (E. coli). According to the FSIS, many of these bacteria normally live in the intestines of the animal and can become contaminated during the slaughter, storage, improper handling or poor sanitary practices in food preparation and storage areas. Some of these bacteria cause food borne illness that can result in death.

On May 22, 2018 at 9:54 AM, there were two clear plastic bags with diced pieces of raw meat (stew meat) stored on a stainless steel tray in the refrigerator. The bags contained a dark brown colored liquid called "purge or weep" had also leaked onto the tray. The pool of dark brown colored liquid on the pan. According to the Beef University (a resource program by the Cattlemen's Beef Promotion Board), "Excessive purge in the packaging can be an indication that the product may have been temperature abused at some point".

There was a hand written piece of torn cardboard placed on one of the bags with "beef (sic) 5-19-18" on it. It was not clear it was date of receipt or date of thawing. The rule of thumb (average thawing time) for thawing meat, poultry in the refrigerator is one day for every five pounds. Neither of the bags had over five pounds of meat.

According to the Beef University, stew meat (1 to 1-1/2 inches in thickness) may be thawed in the refrigerator for 24 hours. The OM present did not provide any additional information of the dating or rationale for thawing the meat for about three days.

Food Labeling and dating
There was another pan labeled "diced chicken" with a date of "5/14". In an interview with Cook 1 on May 22, 2018 at 10 AM, Cook 1 indicated that she had pulled the chicken out of the freezer the day before (5/21) for use on 5/22. Cook 1 further explained that the product had originally received on 5/14 but had only used half of the product and refroze the other half. The community standards for dating thawed food is to label it the date it was pulled for thawing and not the date it had been received.

There were other items in the refrigerator that were either not labeled or dated or both. There was an orange colored food that had been vacuum packed that was not labeled or dated by either the manufacturer/ food distributor and hospital staff. The OM who was present during the observation at 10:22 AM on May 22, 2018 that it was butternut squash.

Meal Presentation and Preparation
During lunch trayline observation on May 22, 2018 at 11:40 AM, the tray for one unsampled patient was observed being placed in the food cart for meal distribution. The plate had three individual clear plastic cups each with mashed potatoes, green peas and meatloaf. The mashed potatoes had a mashed potato consistency but the green peas and meatloaf were watery with an applesauce-like consistency.

A review of the tray receipt indicated that the patient was on a Dysphagia House diet with honey-thick liquids. Dysphagia is difficulty or discomfort in swallowing, as a symptom of disease. Cook 2 and the Clinical Nutrition Manager (CNM) explained the food were placed in cups because it would run and not hold shape in a regular plate. No other patient was served his or her entrees in cups. In a 2016 article of the Journal of Clinical Nutrition, the authors found that improvement of meal presentation at a hospital setting increased food intake, reduced waste food substantially and can reduce readmission rate to hospital.

A taste test was conducted on May 22, 2108 at 11: 42 AM. The meatloaf was lumpy, had pieces of meat that needed to be chewed prior to swallowing. Both items lacked flavor. Cook 2 stated in a concurrent interview and observation, the vegetables are prepared without salt because of the diets with low sodium. There was no evidence according to the patient's diet card that a low sodium diet was ordered. The consistency and texture of the food did not comply with current standard of practice and posed a choking hazard. A pureed food needs to be smooth without lumps.

A review of the recipe for the pureed meatloaf revealed that the meatloaf should have pureed in a food processor with hot stock. The hot stock was to be made with low sodium beef and vegetables bases. Cook 2 stated he had used water instead.

On May 23, 2018 at 11:19 AM, a taste test was conducted on the pureed diet. The items were pureed chicken, green beans. The items were flavorful and smooth without lumps but was not the correct consistency. It was so watery; it would be classified as a liquefied pureed diet. Liquefied Pureed diet is designed for patients who have difficulty eating solid food (including puree texture) from spoon or fork .... and liquefied adequately to flow freely".

Cook 2 who prepared the pureed entrée stated in an interview on May 23, 2018 at 11:30 AM had followed the recipe using the broth to puree the items. There were no written instructions on the recipe use of a thickener to achieve the proper consistency. In a concurrent interview with the Executive Chef (EC) stated she had recently purchased a liquid thickener to improve the consistency. The thickener was later added.

On May 22, 2018 at 11:27 AM, surveyor took food temperatures of items for the lunch meal. The temperature of a pink colored liquid labeled "thickened Glucerna" taken out of the refrigerator across from the trayline was 62 degrees Fahrenheit (F). Glucerna is a nutritional supplement for persons with diabetes, a condition where the body does not utilize insulin wee, resulting in high blood sugar. According to community standards, cold foods are served from the trayline at 41 degrees F or below for food safety and palatability.

The temperature of 1 % milk taken from the same refrigerator was 45 degrees F. There were boxes of Glucerna in the same refrigerator. Diet Aide (DA 5) stated in a concurrent observation and interview that she had prepared the Thickened Glucerna with a product stored in the kitchen. DA 5 in response to a question stated she does not know why she had not considered using the cold Glucerna to prepare the thickened drink.

Sanitizer Testing
On May 22, 2018 at 2:30 PM, Diet Aide 2 (DA 2) was asked to demonstrate testing the concentration level of the chemical sanitizer. DA 2 tested the quaternary ammonia (quat) sanitizer three times immersing the test strips for five seconds, six seconds and fifteen seconds. DA 2 did not immerse the test strip according to the manufacturer's recommendation. DA 2 stated he immersed the test strip for 15 seconds because he believed that was the manufacturer's instructions. The test strip concentration varied from between 150 to 300 ppm (parts per million).

On May 22, 2018 at 2: 35 PM, Diet Aide 3 (DA 3) was also asked to demonstrate the testing of the sanitizer. DA 3 tested the quat twice immersing the test strip in the sanitizer for 8 seconds the first time and 15 seconds the second time. The test strip indicated concentration of 200 to 300 parts per million. DA 3 also indicated that she believed the immersion time was 15 seconds. According to the manufacturer's instructions, the test strip should be immersed in the solution for 10 seconds. Neither DA 2 nor DA 3 immersed the test strip as recommended by the manufacturer. In an interview with the DFN and the OM who were present during the observation, both indicated that they were unsure why DA 2 and DA 3 believed the immersion time for the sanitizer was 15 seconds.

A review of the hospital policy and procedure titled, "Sanitizer Solution Monitoring" revised 12/14 showed there was no instruction on the length of time the test strip needed to be immersed in the solution. On May 25, 2018 at 11:30 AM, the DFN indicated that in-service that had the food service staff completed in June 2017 on Pots and Pan Washing and Sanitizer Use did not include test strip immersion time.

Sanitizers are important to eliminate the risks of food-borne illness. Ensuring adequate concentration is important for sanitizing. Without proper sanitation of kitchen surfaces and equipment, microorganisms can be transferred from one food or surface to another leading to food-borne illness.

Glove Use
During kitchen observation on May 23, 2018 at 11:30 AM, the eating surfaces of the silverware being used for tray assembly were exposed. The fork tines and spoon tips were not inverted to prevent eating surfaces to come in contact with hands and ensure silverware is held by the handles. This observation was shared with the DFN and Clinical Nutrition Manager (CNM) who stated during the concurrent interview that staff do have bare hand contact with the food contact areas of the sliver and instead use gloved hands to handle the tips of the silverware.

At approximately 11:32 AM, a Diet aide (DA 4) whose position on trayline was to assemble the tray prior to placement of food plates, walked away from the trayline to one of the office to pick up menu tray slips with gloved hands. DA 4 returned to trayline without removing her gloves, wash hands before proceeding to continue the trayline assembly.

At 11:33 AM, DA 4 walked over to the silverware station next to the trayline and grabbed a handful of forks by the fork tines with the same-gloved hands that she had used to handle the menu slips. The DFN and the CNM, who were present during the observation, asked DA 4 to remove and wash her hands.

Can Opener.
On May 22, 2018 at 10: 35 AM, there was an oily black colored liquid dripping from a can opener in the kitchen. DA 3 stated in a concurrent observation interview that earlier that day, that a degreaser had been added to the can opener and had been sent to the dish machine for cleaning. DA 3 stated it must not have been cleaned well. The presence of the degreaser posed a risk of chemical contamination of food opened with the can opener.

Based on observation, review of hospital documents and staff interviews, the hospital failed to ensure that the dysphagia diet provided to patients with swallowing problems were in accordance with recognized dietary practices. These deficient practice could result in decreased food intake due to poor presentation and increased risk of choking in patients who are unable to form a bolus due to swallowing problems or unable to tolerate thin liquids.

Findings:

During lunch trayline observation on May 22, 2018 at 11:40 AM, the tray for one unsampled patient was observed being placed in the food cart for meal distribution. The plate had three individual clear plastic cups each with mashed potatoes, green peas and meatloaf. The mashed potatoes had a mashed potato consistency but the green peas and meatloaf were watery with an applesauce-like consistency.

A review of the tray receipt indicated that the patient was on a Dysphagia House diet with honey-thick liquids. Dysphagia is difficulty or discomfort in swallowing, as a symptom of disease. Cook 2 and the clinical nutrition manager (CNM) explained the food were placed in cups because it would run and not hold shape in a regular plate. No other patient was served their entrees in cups. In a 2016 article of the Journal Of Clinical Nutrition, the authors found that improvement of meal presentation at a hospital setting can increase food intake, reduce waste food substantially and reduce readmission rate to hospital.

A taste test conducted indicated the pureed peas to be smooth but the meatloaf was lumpy, had pieces of meat that needed to be chewed prior to swallowing. Both items lacked flavor. The consistency and texture of the food did not comply with current standard of practice and posed a choking hazard.

Cook 2 stated in a concurrent interview and observation, the vegetables are prepared without salt because of the diets with low sodium. There was no evidence according to the patient's diet card that a low sodium diet was ordered.

A review of the hospital's diet manual showed it had a Dysphagia Diet (Pureed Texture Solids with Honey- Consistency Liquids). There were no other types of diet for patients with dysphagia or chewing and swallowing problems. The diet manual described the diet principle for the Dysphagia diet as "consisted (sic) of foods that are pureed and liquids thickened to honey-consistency. No coarse textures or lumps of food are allowed." The diet guidelines in the hospital diet manual for Puree diet is "foods are pureed to a smooth consistency unless already in a comparatively smooth form such as mashed potatoes. This texture can be applied to regular or therapeutic diets". The National Dysphagia Diet Pureed Nutrition describes the pureed as "lump-free puree texture."

The clinical nutrition manager (CNM) was interviewed on May 22, 2018 at 11:50 AM regarding the presentation, taste and consistency of the food items served. The CNM stated the house diet for dysphagia was a pureed diet with honey thick liquids. The CNM indicated that the hospital's speech therapist did not have any problems with the consistency of the meals provided. The CNM also stated that the hospital tends to have patients on a low sodium diet in addition to the pureed diet.
An interview was conducted with the Speech Pathologist (SP) on May 24, 2018 at 9:10 AM SP confirmed the house dysphagia diet as pureed food with honey thick liquids. The SP acknowledged the food should be lump-free, not needing to form a bolus.

The hospital's current diet classification is outdated. In 2002, the American Dietetic Association published The National Dysphagia Diet (NDD). The NDD was established to standardize standard terminology and practice applications of dietary texture modification in dysphagia management. The NDD was classified into four levels. NDD Level I (formerly Puree), NDD Level II (formerly Mechanical Soft), NDD Level III (Advanced) and NDD Level IV (regular).
In 2017, both Academy of Nutrition and Dietetics (formerly the American Dietetic Association) and the American Speech and Hearing Association together announced their support of a new global initiative to standardize diets for the treatment of people who suffer from swallowing disorders.

The International Dysphagia Diet Standardization Initiative (IDDSI) created global standardized terminology and definitions for texture-modified foods and thickened liquids to improve the safety and care for individuals with dysphagia. The final dysphagia diet framework consists of a continuum of eight levels (0-7), where drinks are measured from Levels 0 - 4, while foods are measured from Levels 3 - 7.
The hospital diet manual did not reflect either of these two diets for dysphagia management.

Based on observation, review of hospital diet manual and staff interview, the hospital failed to ensure that all therapeutic diets was ordered by a practitioner responsible for the care of the patient when patients on the pureed diet were served low sodium diets without a physician order for such diets. This had the potential to result in diminished food intake and longer hospital stays.

Finding:

A taste test conducted on May 22, 2108 at 11: 42 AM, showed the meatloaf was lumpy. It had pieces of meat that needed chewing prior to swallowing. The vegetables was watery. Both items lacked flavor. Cook 2 stated in a concurrent interview and observation, the vegetables are prepared without salt because of the diets with low sodium. A review of the recipe did not show salt as one of the ingredients. There was no evidence according to the patient's diet card that the patient's physician ordered a low sodium diet in addition to the pureed diet.

The clinical nutrition manager (CNM) was interviewed on May 22, 2018 at 11:50 AM regarding the presentation, taste and consistency of the food items served. The CNM explained that the reason the hospital does not add to the foods served was that the hospital tends to have patients on a low sodium diet in addition to the pureed diet.

An interview was conducted with the Speech Pathologist (SP) on May 24, 2018 at 9:10 AM, SP stated that the pureed diet were served low sodium because a lot of the patients have heart disease.

Review of the hospital's description of the pureed diet did not include the requirement that it was low sodium. The use of the diet as described in the diet manual was for patients with "limited chewing ability, head and neck surgery, dental concerns, anatomical esophageal stricture".

Hospital patients on pureed diets were placed on low sodium diets that their physicians or health practitioners did not order for them.

Based on observation and interview, the condition of the physical plant and the overall hospital environment was not maintained.

Findings:

On 5/22/18 between 10:20 a.m. and 2:40 p.m. the following was observed:

Physical Plant

1. The evaluator observed an eye wash station with both covers off its nozzles in front of a cooling tower at the exterior physical plant area. Closer observation revealed there were three 5 gallon buckets of chemicals on the floor around the eyewash and one barrel of sulfuric acid 93% five feet from the eye wash.

During an interview at the same time as the observation the Supervisor Maintenance Engineer stated that the eye wash station was needed to rinse the eyes in the event that the chemicals used in the area got onto someone's eyes. That chemicals are placed in the sulfuric acid tank to treat the water in the cooling tower to prevent calcium build up.

5th floor North Tower

2. The evaluator observed an accumulation of dust on the floor in a storage room.

During an interview at the same time as the observation registered nurse (RN 1) stated that there was an accumulation of dust on the floor of the storage room because housekeeping did not have access to the storage room because it was an office supply room.

3. The evaluator observed an accumulation of green and white deposits at spout of medication room faucet.

During an interview at the same time as the observation the Director of Environmental Services stated that the faucet should be cleaned every day so there should be no build up.

On 5/23/18 between 9 a.m. and 3:30 p.m. the following was observed:

2nd floor Surgery

4. The evaluator observed in the operating room (OR) restricted area a OR surgical table had a pad with a ½ inch damaged corner exposing the foam padding beneath.

During an interview at the same time as the observation the Manager of Surgical Services stated that the surgical table was in use.

During a second interview at the same time as the observation the Supervisor Maintenance Engineer stated that biomed would be called to replace the surgical table pad.

5. The evaluator observed one of three OR hand wash sinks between OR 3 and 4 did not provide water when push plate was activated.

During an interview at the same time as the observation the Supervisor Maintenance Engineer stated that the water to the sink was turned off, that he didn't know why, and that maintenance was probably being done.

6. The evaluator observed a 4 foot linear area in run room between OR 7 and 8 had a gray color residual on the tile wall.

During an interview at the same time as the observation the Manager of Surgical Services stated that the run room was a restricted area behind the red line and therefore it was a sterile area.

During a second interview at the same time as the observation the Supervisor Maintenance Engineer stated that the gray residual on the wall was not smooth, and that he did not know what it was.

4th floor Berger Tower

7. The evaluator observed a damaged electrical receptacle with jagged edge in room 435.

During an interview at the same time as the observation the Supervisor Maintenance Engineer acknowledged the damaged electrical receptacle.

3rd floor Berger Tower

8. The evaluator observed a call bell cord wrapped around safety grab bar in the bathroom of the rehabilitation gym. When the cord was pulled the wrapped part of the cord prevented activation of the call bell.

During an interview at the same time as the observation the Supervisor Maintenance Engineer acknowledged the wrapped cord prevented activation of the call bell.

Based on observation and interview, facility staff failed to ensure that life safety from fire requirements were met.

Findings:

5th Floor North Tower

1. During the LSC survey on 5/22/18 at 1:50 p.m., the evaluator noted a loose electrical receptacle in the equipment room.

2. At 2 p.m., the evaluator noted a loose electrical receptacle in the corridor by the soiled linen room.

During interviews at the same time as the observations the Supervisor Maintenance Engineering acknowledged the loose receptacles.

4th Floor North Tower

3. During the LSC survey on 5/22/18 at 2:15 p.m., the evaluator noted that the 4th floor corridor door to room N450 could not be held in the closed position.

During an interview at the same time as the observation, the Supervisor Maintenance Engineer stated that the door did not hold in the closed position because the strike plate had moved, and that the strike plate needed to be filed on its side.

2nd Floor Surgery

4. During the LSC survey on 5/23/18 between 9 a.m. and 9:27 a.m., the evaluator noted that there were carbon dioxide extinguishers in operating rooms (ORs).

During an interview at the same time as the observation, the Maintenance Journey Man stated that the CO2 fire extinguishers were checked by weight one time a year during the annual service but that although he conducted monthly inspections of the fire extinguishers, he did not determine fullness of the CO2 extinguishers by weighing or hefting at 30 day intervals.

During an interview on 5/24/18 at 3 p.m., the Supervisor Maintenance Engineer stated that 10 of 10 ORs had CO2 extinguishers.

5. During the LSC survey on 5/23/18 at 9:20 a.m., the evaluator noted that there was a soiled linen cart placed in front of a fire extinguisher cabinet in operating room 6.

During an interview at the same time as the observation, the Supervisor Maintenance Engineer acknowledged the cart obstructing the fire extinguisher in the cabinet.

2nd Floor Berger Tower

6. During the LSC survey on 5/23/18 at 2:14 p.m., the evaluator noted that the 2nd floor corridor door to room 223 could not be held in the closed position.

During an interview at the same time as the observation, the Supervisor Maintenance Engineer stated that staff was on their way to fix it.

1st Floor Perinatal

7. During the LSC survey on 5/23/18 at 2:29 p.m., the evaluator noted that the 1st floor corridor door to room 122 could not be held in the closed position.

Based on observation, interview, and record review, the hospital failed to ensure staff would document temperature monitoring for a warmer installed in the medication room of third floor tower. This deficient practice had a potential affecting the integrity and/or potency of the products stored in the device.

Findings:

During an inspection of the medication room inside the medication room of third floor tower on 5/23/2018 at 9:56 a.m., there was a warmer on the counter. Above the warmer, there was a warmer temperature log. The first page of the log was dated 4/11/2018 and there were two entries on 4/11/2018 and 4/12/2018 respectively. The rest of the dates in the month were left blank. There was no log for the current month of May. In another word, there was no document of temperature monitoring for more than thirty days.

During a concurrent interview, the nursing supervisor of the unit stated the temperature monitoring log should be filled out daily.


.

Based on observation, interview and record review, the hospital failed to meet the Condition of Participation in Infection Control by failing to :

A. Ensure that there was an effective system for identifying and preventing growth of microorganisms that could cause food borne illness in the hospital. Food service staff failed to develop an effective food dating system, failed to maintain the dish washing in a manner that will ensure adequate sanitization of food service utensils and dishware. Staff was incompetent in testing the chemical sanitizer. There was also an improper use of hand gloves. These deficient practices had the potential to affect all admitted patients and staff (Refer to A 749).

B. Reduce the practice of IUSS (Immediate Use Steam Sterilization), monitor and oversee Sterile Processing Department services including assuring daily biological testing was done with each sterilized load and daily controls were completed. Staff failed to follow manufacturer guidelines when sterilizing instruments. The facility also failed ensure Medical Staff had documented Hepatitis B status or Hepatitis B waiver in order to provide medical care in a safe to avoid sources and transmission of infections and communicable disease (Refer to A 749).

C. Ensure soiled linens are not taken out of the patient room and carried along the hallway to be placed in a soiled utility bin in the soiled utility room; Single Patient Use ice bags are not placed by the handwashing sink while awaiting for use; perform hand hygiene after touching the indwelling catheter bag; oxygen tubing was not on the floor while in use and nebulizer/mask in a plastic bag had label in it; faucets in different areas of the hospital/clinics had no aerators and mineral deposit; sterilized instruments such as clamps, forceps, mosquito, and vaginal speculum were opened and the metal tray handle had no colored tape in it; lead aprons were hang properly when not in use; linen cart covers did not have tears; daily High Temperature Sterilization Biological Indicator Log was accurately completed after it was done; the temperature of the Sterile Processing Room was taken daily and reading documented in the log; the handwashing metal sink in the decontamination room had no peeling marker tapes and water temperature reader was working at the time of observation; labeling of the dressing of the IV (intravenous sites) with date and times. (Refer to A 749)

D. Ensure a sterile (germ-free) preparation area (a designated area for preparing sterile intravenous solutions) in a medication room was free of residues or debris; and ensure one of two operating rooms in the labor and delivery department stocked with instruments, clean of residues and packages unopened. (Refer to A 749)

E. Ensure two nurses performed hand hygiene after removing their gloves, during a wound care treatment and dressing change for Patient 13; the tubing connected to a urinary collection bag was kept off the floor for Patient 18; and ensure peripheral intravenous (PIV, used to administer fluids or medication through the vein) sites were labeled with the placement date and time. (Refer to A749)

F. Follow acknowledged sanitary practice during passing of medications; follow recommendations regarding the use of faucets with aerators (devices attached to the end of faucets typically made of metal mesh or other perforated material to add air to the flow of water) throughout the facility; follow recommendations regarding safe use of graduations in sinks intended to clean surgical instruments. (Refer to A 749)

The cumulative effect of these systemic problems resulted in the hospital's inability to provide quality health care in a safe environment.

Based on observation, patient and staff interviews and review of hospital documents the hospital failed to:

A. Ensure that there was an effective system for identifying and preventing growth of microorganisms that could cause food borne illness in the hospital. Food service staff failed to develop an effective food dating system, failed to maintain the dish washing in a manner that will ensure adequate sanitization of food service utensils and dishware. Staff was incompetent in testing the chemical sanitizer. There was also an improper use of hand gloves. These deficient practices had the potential to affect all admitted patients and staff.

B. Reduce the practice of IUSS (Immediate Use Steam Sterilization), monitor and oversee Sterile Processing Department services including assuring daily biological testing was done with each sterilized load and daily controls were completed. Staff failed to follow manufacturer guidelines when sterilizing instruments. The facility also failed ensure Medical Staff had documented Hepatitis B status or Hepatitis B waiver in order to provide medical care in a safe to avoid sources and transmission of infections and communicable disease.

C. Ensure soiled linens are not taken out of the patient room and carried along the hallway to be placed in a soiled utility bin in the soiled utility room; Single Patient Use ice bags are not placed by the handwashing sink while awaiting for use; perform hand hygiene after touching the indwelling catheter bag; oxygen tubing was not on the floor while in use and nebulizer/mask in a plastic bag had label in it; faucets in different areas of the hospital/clinics had no aerators and mineral deposit; sterilized instruments such as clamps, forceps, mosquito, and vaginal speculum were opened and the metal tray handle had no colored tape in it; lead aprons were hang properly when not in use; linen cart covers did not have tears; daily High Temperature Sterilization Biological Indicator Log was accurately completed after it was done; the temperature of the Sterile Processing Room was taken daily and reading documented in the log; the handwashing metal sink in the decontamination room had no peeling marker tapes and water temperature reader was working at the time of observation; labeling of the dressing of the IV (intravenous sites) with date and times

D. Ensure a sterile (germ-free) preparation area (a designated area for preparing sterile intravenous solutions) in a medication room was free of residues or debris; and ensure one of two operating rooms in the labor and delivery department stocked with instruments, clean of residues and packages unopened.

E. Ensure two nurses performed hand hygiene after removing their gloves, during a wound care treatment and dressing change for Patient 13; the tubing connected to a urinary collection bag was kept off the floor for Patient 18; and ensure peripheral intravenous (PIV, used to administer fluids or medication through the vein) sites were labeled with the placement date and time,

F. Follow acknowledged sanitary practice during passing of medications; follow recommendations regarding the use of faucets with aerators (devices attached to the end of faucets typically made of metal mesh or other perforated material to add air to the flow of water) throughout the facility; follow recommendations regarding safe use of graduations in sinks intended to clean surgical instruments.

Findings:

A. Thawing
1. On May 22, 2018 starting at 9:37 am, twenty five boxes of chicken breast fillets with hand written dates of "5-14, 5-18 or 5-21" were stored on the shelves in one of the walk -in refrigerators. Six boxes dated "5-14" (May 14, 2018) showed evidence of thawing with the exterior of the boxes visibly wet.
The director of Food and Nutrition (DFN), Operations Manager (OM) were present during the observation. OM stated in the concurrent observation and interview that the items were received frozen and that the date on the boxes may not reflect the actual date the items were placed in the refrigerator for thawing. There were no other dates on the boxes to indicate the date the item were placed in the refrigerator for thawing.

Further investigation revealed that the dates on each of the labels from the food distributor matched the hand written dates on the boxes. The box of chicken from the day before, labeled (5-21) May 21, 2018 was also stored in the refrigerator
demonstrated that items are placed in the refrigerator from when they are delivered. Neither the DFN nor the OM provided any evidence that the items were not placed in the refrigerator on the date labeled.

The hospital did not have a system in place to monitor when frozen items are thawed and ready for food preparation.

A review of the hospital policy titled, "HACCP/ Food Safety program Food Safety Standards and Requirements" with a revision date of 08/17/2016 did not show instructions or guidelines on how long food may be stored in the refrigerator for thawing. A review of the hospital food safety training document titled "Thawing Food" showed staff were trained on different ways frozen food could be thawed but did not include any information or guidelines on dating or time frames on thawing different kinds of meats in the refrigerator.

According to the United States Department of Agriculture's Food and Food Safety and Inspection Service (FSIS), raw chicken thawed in the refrigerator from its frozen state "can be kept in the refrigerator an additional day or two before cooking". The lack of system to identify and track when chicken is placed in the refrigerator for thawing made it difficult for hospital staff to demonstrate that the thawed chicken pieces had not exceeded the recommended storage times.

The following are some of the bacteria associated with raw chicken: Salmonella enteritiditis, staphylococcus aureus, campylobacter jejuni, listeria monocytogenes, Escherichia coli (E.coli). According to the FSIS, many of these bacteria normally live in the intestines of the animal and can become contaminated during the slaughter, storage, improper handling or poor sanitary practices in food preparation and storage areas. Some of these bacteria cause food borne illness that can result in death.

2. On May 22, 2018 at 9:54 AM, there were two clear plastic bags with diced pieces of raw meat (stew meat) stored on a stainless steel tray in the refrigerator. The bags contained a dark brown colored liquid called "purge or weep" had also leaked onto the tray. The pool of dark brown colored liquid on the pan. According to the Beef University (a resource program by the Cattlemen's Beef Promotion Board), "Excessive purge in the packaging can be an indication that the product may have been temperature abused at some point".

There was a hand written piece of torn cardboard placed on one of the bags with " beeff (sic) 5-19-18" on it. It was not clear it was date of receipt or date of thawing. The rule of thumb (average thawing time) for thawing meat, poultry in the refrigerator is one day for every five pounds. Neither of the bags had over five pounds of meat.

According to the Beef University, stew meat (1 to 1-1/2 inches in thickness) may be thawed in the refrigerator for 24 hours. The OM present did not provide any additional information of the dating.

Food Labeling and dating
There was another pan labeled "diced chicken" with a date of "5/14". In an interview with Cook 1 on May 22, 2018 at 10 AM, Cook 1 indicated that she had pulled the chicken out of the freezer the day before (5/21) for use on 5/22. Cook 1 further explained that the product had originally received on 5/14 but had only used half of the product and refroze the other half. The community standards for dating thawed food is to label it the date it was pulled for thawing and not the date it had been received.

There were other items in the refrigerator that were either not labeled or dated or both. There was an orange colored food that had been vacuum packed that was not labeled or dated by either the manufacturer/ food distributor and hospital staff. The OM who was present during the observation at 10:22 AM on May 22, 2018 that it was butternut squash.

Dish Machine
During observation of the dish washing procedure on May 22, 2018 starting at 2:45 PM, the final rinse temperature of the high temperature dish machine steadily rose from 197 degrees F to 203 degrees F within three minutes. The recommended final rinse water temperature is 180 degrees, with higher limits no greater than 194 degrees F. According to 2017 Food Code Section 4-501.112 " in a mechanical operation, the temperature of the fresh hot water sanitizing rinse as it enters the manifold may not be more than 194oF. The temperature of hot water delivered from a ware washer sanitizing rinse manifold must be maintained according to the equipment manufacturer's specifications and temperature limits specified in this section to ensure surfaces of multiuse utensils such as kitchenware and tableware accumulate enough heat to destroy pathogens that may remain on such surfaces after cleaning.

The surface temperature must reach at least 71ºC (160ºF) as measured by an irreversible registering temperature measuring device to affect sanitization. When the sanitizing rinse temperature exceeds 90ºC (194ºF) at the manifold, the water becomes volatile and begins to vaporize reducing its ability to convey sufficient heat to utensil surfaces. (Food Code Annex).

During the concurrent interview and observation, the DFN indicated that she was not aware of the upper limits of the dish machine water temperatures. A review of the hospital policy and procedure "HACCP/ Food Safety program Food Safety Standards and Requirements" with a revision date of 08/17/2016 did not include an upper limit on the water temperature requirement.

On May 23, 2018 at 10:15 AM, the DFN provided documentation that a mechanical part of the dish washing machine had broken and was replaced.




31993

B. 1. During a Tour of the MIS (minimum invasive suite) Operating Room (OR), on 5/23/18 at 11:00 a.m. with RN16 indicated the Immediate Use Steam Sterilization (IUSS) was observed in use, there was no case in the room at the time. A log of the IUSS cases for the month of May 2018 was requested but not provided. A review of a document titled "IMU STATS" included Description of trays used after IUSS included logs from: 10/2017 to 12/2017 IUSS log with description of surgical instruments prepared in IUSS for next cases included: trays documented with "no info"; Total Knee trays; hand and foot tray; Craniotomy tray; ENT Tray; Total Hip tray.

A review of a facility document titled, "IUSS STATS" indicated the following: The percentage of instruments that underwent flash-sterilization in the Main Operating Room for the Months of 1/2018; 2/2018; 3/2018; 4/2018. A description of what instruments and trays were sterilized in the IUSS was not provided for the months of 1/2018 to 4/2018. "#IUSS per month for 1/2018 was 72 and Cases per month for 1/2018 was 468 cases; " IUSS per month for 2/2018 was 49 and Cases per month for 2/2018 was 412 cases; IUSS per month for 3/2018 was 72 and Cases per month for 3/2018 was 505 cases; IUSS per month for 4/2018 was 65 and Cases per month for 4/2018 was 470 cases. A review of the number or percent of need to follow cases for: 1/18 were 36; for 2/2018 were 47%; for 3/18 were 62%; for 4/18 and 5/18 were not provided. No data was provided for review for 5/18. Overall IUSS STATS for 1/2018 to 4/2018 monthly is documented at 14%.
During an interview with the ID RN on 5/25/18 at 8:35 a.m. she indicated the facility followed: CDC; AORN and AIMMEE guidelines.

A review of a facility document titled: Infection Control Surgical Services: Sterilization practices for the operating Room: undated indicated" Steam Sterilization for urgently needed instrumentation only."

2. During a Tour of the SPD, on 5/23/18 at 1:45 p.m. with SPD director during a review of the Biological Log: titled " High temperature sterilization BI LOG (PREVAC) the following information was missing from the log for loads: on 4/26/18 Indicator Color change was not documented as either Y/N; two loads for 5/3/18 at Indicator Color change was not documented as either Y/N ; On 5/22/18 A Control Load did not have Date out; Time out; initial; or result of the control documented.

During a tour of SPD decontamination room, patient blankets and patient towels were observed covering the counters adjacent to the decontamination sinks.

During an interview with the Dir of SPD, on 5/23/18 at 2:15 p.m. she indicated the patient blankets and towels were used to dry surgical instruments after being manually decontaminated. The blankets and towels are then sent back to the be washed with the facility linen service. A policy and procedure or reference for using patient blankets and patient towels in the decontamination room was requested and not provided.

3. On 6/24/18 at 1:30 p.m., during a review of the medical staff credentialing files 10 out of 10 reviewed medical staff did not have Hepatitis B status or waiver on file.

During an interview with the Medical Staff credential supervisor, When asked for medical staff evaluation for Hepatitis B status evaluation she indicated, the facility currently did not have a policy for Hepatitis B status screening and evaluation for the medical staff.



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C.1. During the tour of the different units on May May 22 through 24, 2018, between the hours of 8 a.m., through 4 p.m., the following was observed:

a. In Room 214, registered nurse (RN 12) was observed coming out of the room, with gloved hands carrying soiled linens and walking by the hallway going to the soiled utility room passing by between 2 to 3 patient rooms along the way. During an interview, RN 5 stated she should have taken a bin by Room 214 to place the soiled linens in order to prevent cross contamination.

b. In Room 229, there were 3 ice bags laying by the sink. The icebags indicated "Single Patient Use".

c. In Room 552, RN 13 was attending to the patient who had an oxygen, a peripheral IV on the right hand and an indwelling catheter. The RN with gloved hands touched the indwelling catheter bag to examine its contents and without removing the soiled gloves turned off the light switch and touched the bed/railings. During an interview at the time of observation, the RN stated the gloves should have been removed prior to performing other task in order not to cross contaminate.

d. In Room 553, the oxygen tubing was on the floor and the nebulizer/mask in the plastic bag had no labels in it.

e. In the Gyne Oncology Clinic -
- There were six (6) examination rooms. The nursing station sinks, laboratory sink, dirty utility room sink, and patient/visitor bathroom sink by the reception area, the faucets had aerators.
- There were 25 sterilized individual blue packages that contained vaginal speculum and one (1) of which was opened and found the tip of the vaginal speculum was closed.


2. On May 23, 2018, at 9:40 a.m., during the tour of the Emergency Room the following was observed:

a. By the reception area, there was a pulse oximeter, vital signs machine, blood pressure cuff and thermometer. The devices/equipments were dusty and had residual types in it.
During an interview with EMT 1, stated that she had not cleaned the equipments as of today. The equipments were utilized when patients needed to be re-checked. There was no cleaning wipes readily available at the time of observation.

b. In Room 10, the faucet /spigot had mineral deposit and exam light was dusty.

c. In the nourishment room, there was a lunch bag labeled with a name inside the nourishment refrigerator mixed with patients' juices and food items.

3. On May 23, 2018, at 11 a.m., during the tour of the Surgery Department the following was observed:

a. In Operating Rooms hallway, there were ten (10) various types of lead apron (apron/skirt/whole gown). The aprons were not suspended freely from the portable round hangers. The aprons were crumpled and folded. One of the gown aprons which was labeled Urology/name of the hospital and was torn by the neck including the lead inside.

During an interview with Radiology Tech on May 25, 2018, at 8 a.m., stated the lead aprons should be hang properly, suspended freely from the shoulder, no folding or creases. If there's a tear it has to be discarded.

b. The linen cart for the recovery room and operating rooms was noted parked in the hallway. The linen cart cover had multiple tears on it. During an interview at the time observation, RN 14 stated the linen cart should not have tears because of the potential for cross contamination.

c. The scrub sink #4 had three faucets which had aerators, the scrub sink #3 had three faucets which had aerators and scrub sink #2 , the faucet had rose spray head on the spout and mineral deposits in it. The Operator Manual indicated to disassemble rose spray head from gooseneck spout assembly. Clean rose spray head then reassemble it. There was no written documentation provided regarding the cleaning of the rose spray head when requested.

4. The Sterile Supply Room -

a. Review of the High Temperature Sterilization BI (Biological) Log (Prevac) on the following dates indicated:
- On May 20, 2018, load numbers 2 and 22 failed to indicate whether color indicator had changed or not.
- On May 3, 2018, load numbers 52 and 62 failed to indicate whether color indicator had changed or not.
- On April 26, 2018, load number 23 failed to indicate whether color indicator had changed or not

During an interview at the time of reviewing the Log, RN 14 stated it is important to check the result of the color change of the BI to ascertain it passed or failed the test.

b. The hygrometer indicated the room's temperature was 64.9 degrees Fahrenheit (F) and the humidity was 64 %. Further review of the Sterile Processing Daily Temperature/Humidity Log for May 2018 indicated on 5/23/18 the temperature for that day was not taken. Further review of the Log indicated it was checked daily as indicated by a check mark. There was no reading documented.

The following was noted:
1) For general work area temperature (T) was 68 degrees Fahrenheit (F) and Relative Humidity between 30% and 60% (ideal 355-50%).
2) Decontamination Area 60 degrees F - 65 degrees F and Relative Humidity between 30% and 60%.
3) Sterile Storage Area not to exceed 75% and Relative should not exceed 70%.

Supply Room

c. A minor tray which has 72 pieces of instruments and a major tray which has 83 instruments were opened and checked. The clamps were placed on the stringer and the tips were not opened. The instruments were found to have been placed on top of each other during sterilization process.

d. There were three peel packs that contained ring forceps and mosquito where the tips were closed.

e. A metal tray basket handle had a colored tape on it.

5. In the Decontamination Room -

- SPT (sterile processing tech) was requested to demonstrate how to clean the instrument after being brought from the operating room (OR). The instrument tray was brought to the decon room in a red plastic container in a red plastic bag and covered. The SPT transferred the instruments to the sink. The metal sink had two tapes indicating the label of the water to be filled into sink. One of the tapes was peeling off the metal sink. The water in the sink barely reached the 1st level indicator. When the water temperature reader was turned on, it was not working. The SPT started brushing the instruments and placed them in a basket. The basket was sitting on a patient's blanket and towel.

During a concurrent interview SPT stated it (blanket) was there to catch the water dripping after instruments have been washed. She further stated the patient's blanket and towels were changed at the end of her shift.

Review of the SPT's Competencies :
1. Amsco (R) Century "Century Medium Sterilizer 26" X 37.5" indicated there was no result of overall competency rating (blank), evaluation method was observation only, no documentation of repeat demonstration, verbalized knowledge and/or written computer test. Under the section which was asking for date and initial, the date was not indicated only initial. The date indicated was it was completed on January 18.

2. Competency Checklist - Sterrad Cyclesure 24 Biological Indicator indicated there was no staff signature to indicate who performed the competency checklist with SPT.

3. Post Tests on -
a. Protocols for Immediate - Use of Steam Sterilization indicated the SPT signed but there was no documentation of date, and the result of the Post Test whether Passed/Failed.
b. Reprocessing Flexible Endoscopes
c. Inspecting of Surgical Instruments and Devices

All the above mentioned Post Tests indicated the SPT signed but there was no documentation of date, and the result of the Post Test whether Passed/Failed.

During an interview with Education Coordinator while reviewing the personnel file of SPT, she concurred with the above findings.

5. During an initial tour of the various floors from 5/22/18 and 5/23/18, between the hours of 8 a.m. to 3 p.m., the following was noted:

a. Patient 35 has an intravenous fluid (5% Dextrose Sodium Chloride) hanging by the pole. The patient had a peripheral IV (intravenous) on the right hand with a dressing over it that had no label as to when it was started or changed and by whom.

b. Patient 36 had a peripheral IV on the right hand with dressing over it and had no label as to when it was started or changed and by whom.

c. Patient 33 had a peripheral IV on the right hand with dressing over it and had no label as to when it was started or changed and by whom.

d. Patient 37 had a peripheral IV on the right antecubital with dressing over it and had no label as to when it was started or changed and by whom.

e. Patient 38 had a peripheral IV on the right antecubital with dressing over it and had no label as to when it was started or changed and by whom.

f. Patient 34 had a peripheral IV on the right hand with dressing over it and had a date 5/18/18.

According to RN 13, the peripheral IV on the right hand should have been removed as it had been there for 4 days and its potential for on site infection.




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D. 1. During an inspection of a medication room at one of the critical care nursing units on 5/23/2018 at 9:10 a.m., in the presence of the director of pharmacy (DOP), one of the two mobile medication carts inside the medication room had a drawer labeled "sterile preparation". Inside the drawer, there was irregularly shaped brown residues and loose dust-like debris.

During a concurrent interview, the DOP acknowledged the above findings and stated the area should be kept cleaned.

2. During an inspection of one of two operating rooms located in the labor and delivery department on 5/23/2018 at around 11 a.m., in the presence of the director of pharmacy (DOP) and the maternity supervisor, there was a mobile cart referred to as anesthesia cart. The cart had multiple of drawers. The counter top of the mobile cart had visible white sticker residues. Also on top of the cart were a couple of stacked emesis basins. Those basins had visible white residues. In the top drawer, there were two peel packs (single use paper-plastic pouches that contained sterilized surgical instruments) that had been opened; the instruments inside had visible brown residues. Also in the top drawer, there were 2 towel clips and a laryngoscope (an instrument used in a medical procedure to obtain a view of the vocal folds) that were not stored in sealed peel packs; there were sticker residues on the arms of the tower clips, and brown residue on the laryngoscope. Near the mobile cart, there was an operation table. The operation table had a cloth cover wrapped around it. The cloth cover had visible darken stain.

During a concurrent interview, the DOP and the maternity supervisor acknowledged the aforementioned findings. The maternity supervisor indicated opened peel packs should have been replaced and instruments should not have residues/stain. The maternity supervisor also indicated the operating room was last used on 5/19/2018; the room should have been thoroughly cleaned and instruments replaced.


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F. 1. On 5/22/18 at 10:26 a.m., during the observation of a wound care treatment and dressing change, for Patient 13, the following was observed. The wound care specialist and a registered nurse (RN 1) performed the treatment to the wound on the coccyx. Both nurses washed their hands, donned gloves and removed the dressing to the coccyx. The area was cleaned, and a protective skin barrier was applied. Both nurses removed their dirty gloves and donned new gloves, without performing hand hygiene. The nurses continued to pack the wound and apply the dressing to the coccyx.

At 10:46 a.m., charge nurse (CN) stated hand hygiene should be performed after removing gloves.

A review of Patient 13's medical record indicated the patient was admitted to the facility on 5/16/18 for a flap repair of a sacral decubitus ulcer (pressure ulcer, pressure sore, or bed sore).

The facility's policy and procedure titled, "Hand Hygiene" dated 6/2016, specified the indications for hand hygiene. Indications for hand hygiene included, when hands are visibly dirty, contaminated with blood or body fluids, or the if the patient has C. difficile, wash hands with antimicrobial soap and water. When hands are not visibly soiled use an alcohol-based hand rub to decontaminate hands, including, after contact with body fluid or excretions, mucous membranes, non intact skin, wound dressing and after removing gloves.

2. On 5/22/18 at 10:50 a.m., during the tour of the facility with RN 15, Patient 18 was observed in bed, awake and alert. The patient was moving the bed into the desired position. Patient 18 had a urinary collection bag hanging on the bed frame, the tubing was touching the floor.

During a concurrent interview, Patient 18 stated she had not been instructed on how to care for the urinary collection bag or the tubing.

Concurrently, RN 15 stated the tubing connected to the urinary collection bag should not be touching the floor because of infection control issues.

At 11:48 a.m., during an interview, RN 2 stated the tubing should not be touching the floor.

A review of an undated document provided by the facility titled, "Indwelling Urinary Catheter Care and Removal" indicated that a drainage bag should not be placed on the floor.

3. On 5/22/18, beginning at 9:57 a.m., during the initial tour, the following was observed.

a. Patient 17 was observed in bed, awake and alert. Patient 17 had a PIV to the left forearm. The PIV site was not dated.

b. Patient 18 was in bed, awake and alert. The patient had a PIV to the right hand, the site was not dated.

The facility's policy and procedure titled, "IV Therapy Management Guidelines" dated 2/2018, indicated IV sites will be rotated at an interval not longer than 96 hours unless there are no other peripheral sites available. Insertion site will be changed at 96-hours intervals.



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F. 1. During a tour of the facility's various floors there were several instances noted where the dressings over IV sites were not labelled:

During a visit to the room of Patient 13 on 5/22/2018 at 9:55 AM, an IV was observed to be in her right neck. There was no observed labelling on the dressing over the site that indicated when it had been last changed and by whom.

At that time, CNS 1 stated that Patient 13 acknowledged that there was no labelling and the reason for the IV in its current location is that the patient may have a clot (dried blood components in blood vessels that restrict flow) in her left arm and this was probably the best location considering her condition.

During a visit to the room of Patient 29 on 5/22/2018 at 10:45 AM, intravenous fluid (D5NS, used typically to treat low blood sugar or dehydration) was observed hanging from a pole at the patient's bedside. The IV site was on her left forearm without any markings over the IV dressing to indicate when it had last been changed and by whom.

During a visit to the room of Patient 28 on 5/22/2018 at 11:15 AM, an IV catheter was observed to be in the right antecubital area of the patient's forearm (the anterior or front side of the elbow). There was no evidence of any markings over the IV dressing indicating when it had last been changed and by whom.

At that time RN 4 acknowledged that the dressing did not exhibit the correct signage over it.

During a visit to the room of Patient 16 on 5/22/2018 at 2:10 PM, a NS (normal saline solution typically used intravenously for dehydration) solution was running through a pump at 100 cc/hr (cubic centimeters per hour); an IV catheter was observed to be in the patient's right hand; the sign outside this patient's room read "fall risk'. There were no visible markings over the IV dressing showing when it had last been changed and by whom.

At that time, Patient 16 stated that she was admitted because she had a complaint of being dizzy; the physician's plan was to give IV fluids, give medication for the dizziness, and make arrangements for physical therapy. Concurrently, RN commented that IV dressings should be labelled according to hospital policy.

During a visit to the room of Patient 27 on 5/23/2018 at 9:25 AM, the IV dressing to the patient's right wrist was not marked with the name of person who changed the IV catheter last and when it was changed.

During a visit to the room of Patient 26 on 5/22/2018 at 2:25 PM, the dressing to the patient's right hand IV did not have the appropriate notation.

The "IV Therapy Management Guidelines" provided by the hospital stated that all IVs are to be labelled with the patient's name, type and rate of solution, date and time started, and initials of the nurse. Procedure 3.1 of these guidelines indicated the insertion site will be changed every 96 hours.

According to the Centers for Disease Control and Prevention (CDC), studies of short peripheral (not in the chest or abdomen) catheters indicate that incidence of thrombophlebitis (inflammation of a vein caused by a blood clot) and bacterial colonization increases when catheters are left in place more than 72 hours. Rates of phlebitis are not significantly different when catheters are left in 72 hours compared with 96 hours; therefore sites are changed every 72 to 96 hours. (MMWR: Recommendations and Reports, August 9, 2002/51(RR10);1-26)

2. During a visit to the room of Patient 13 on 5/22/2018 at 10:25 AM, the patient was observed during the change of wound dressing on the sacral area (triangular bone at the base of the spine) of her back. The patient was turned on her right side to reveal the dressing over the wound. The Wound Care Specialist removed the dressing and took measurements of the wound: 8.0 centimeters (cm) wide x 8.0 cm long x 3.0 deep with undermining (area of tissue damage around the border of the wound) at the 7 o'clock to 1 o'clock position; the deepest area of undermining was 5.5 cm. Closer examination of the dressing taken off the patient revealed that it had not been labelled properly with date last changed and name of person performing change.

During a short discussion with the Wound Care Specialist at that time she confirmed that this patient's stage 4 wound (deep tissue injury in which muscle, tendon, ligament, cartilage, or bone may be observed and undermining or tunneling may be seen) dressing had not been dated and signed and should be changed daily and as needed.

A review of physician orders for Patient 13 indicated that pressure injury care for a stage 4 injury is as follows: cleanse with normal saline; pat dry; pack with moistened hydrogel gauze; cover with Allevyn foam dressing daily; start date 5/17/18.

3. During a tour of the facility on 5/23/2018 at 8:45 AM, RN 6 passed medications to

Based on observation; record review and interview, the facility failed to reduce the use of IUSS (Immediate Use Steam Sterilization) and monitor and oversee Sterile Processing Department services, including assuring daily biological testing was done with each sterilized load and daily controls were completed.

The facility failed to provide surgical services in a safe and sanitary manner. The facility failed to follow manufacturer guidelines when sterilizing instruments. The facility failed to follow acceptable standards of infection control and to assure that Surgical Procedures were provided in a safe and sanitary manner to avoid sources and transmission of infections and communicable disease.

Findings:

a. During a tour of the MIS (minimum invasive suite) operating room (OR), on 5/23/18 at 11 a.m. with registered nurse (RN 16), the Immediate Use Steam Sterilization (IUSS) was observed in use. There was no case in the room at the time. A log of the IUSS cases for the month of May 2018 was requested but not provided. A review of a document titled, "IMU STATS" included Description of trays used after IUSS included logs from: 10/2017 to 12/2017 IUSS log with description of surgical instruments prepared in IUSS for next cases included: trays documented with "no info"; Total Knee trays; hand and foot tray; Craniotomy tray; ENT Tray; Total Hip tray.

A review of a facility document titled, "IUSS STATS," indicated the following:
the percentage of instruments that underwent flash-sterilization in the Main Operating Room for the Months of 1/2018; 2/2018; 3/2018; 4/2018. A description of what instruments and trays sterilized in the IUSS was not provided for the months of 1/2018 to 4/2018. "#IUSS per month for 1/2018 was 72 and Cases per month for 1/2018 was 468 cases;" IUSS per month for 2/2018 was 49 and Cases per month for 2/2018 was 412 cases; IUSS per month for 3/2018 was 72 and Cases per month for 3/2018 was 505 cases; IUSS per month for 4/2018 was 65 and Cases per month for 4/2018 was 470 cases.

A review of the number or percent of need to follow cases for: 1/18 were 36; for 2/2018 was 47%; for 3/18 was 62%; for 4/18 and 5/18 were not provided. No data was provided for review for 5/18. Overall IUSS STATS for 1/2018 to 4/2018 monthly is documented at 14%.

During an interview with the ID RN on 5/25/18 at 8:35 a.m. she indicated the facility followed: Centers for Disease Control (CDC); AORN (Association of periOperative Registered Nurses) and AAMI (Association for the Advancement of Medical Instrumentation) guidelines. A review of a facility document titled: Infection Control Surgical Services: Sterilization practices for the operating Room: undated indicated "Steam Sterilization for urgently needed instrumentation only."

b. During a Tour of the SPD, on 5/23/18 at 1:45 p.m. with SPD director during a review of the Biological Log: titled, "High temperature sterilization BI LOG (PREVAC) the following information was missing form the log for loads: on 4/26/18 Indicator Color change was not documented as either Y/N; two loads for 5/3/18 at Indicator Color change was not documented as either Y/N; On 5/22/18 A Control Load did not have Date out; Time out; initial; or result of the control documented.

During a tour of SPD decontamination room on patient blankets and patient towels were observed covering on the counters adjacent to the decontamination sinks. During an interview with the Dir of SPD, on 5/23/18 at 2:15 PM she indicated the patient blankets and towels were used to dry surgical instruments after being manually decontaminated. The blankets and towels are then sent back to be washed with the facility linen service. A policy and procedure or reference for using patient blankets and patient towels in the decontamination room was requested and not provided.