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Based on observation, interview, and record review, the hospital did not meet the Condition of Participation in Governing Body by failing to:

1. Have an ongoing Quality Assessment Performance Improvement (QAPI) program that included ongoing studies that: monitored temperature and humidity including: Surgical Operating Rooms (OR); sterile supply storage rooms, Medication storage rooms. Maintain the OR as a sterile restricted area. Assure medical staff had documented Hepatitis B status. Oversight and supervision in radiologic services and Nuclear Medicine. Assure CRTs (Certified radiology technician) administering IV contrast and radiopharmaceuticals received authorization. Monitoring of the weekly fluoroscopy reading and assuring physicist recommendations for monitoring and maintenance of C-ARM are followed by the radiology department. Assure medication by CRT's is documented in the medical records. (Refer to A 0263, A 0537, A 726)

2. Ensure patients' pain level was assessed and reassessed after medication administration. Ensure nursing staff developed and kept current nursing care plans. Follow acceptable standards with regard to timely administration of medication. Monitor Patient 10' weight. Patent 10 was at high nutrition risk, unable to take food by mouth, was on parenteral nutrition and had a 14.5 pound weight loss in 15 days. (Refer to 395).

3. Assure Medication was prepared stored and distributed in a Safe Manner (Refer to A 500, A 501)

4. Ensure the Director of Food and Nutrition Service was effective in managing the day-to-day operations of the department and maintaining safe food handling practices. (Refer to A 618, A 749)

5. Ensure Dietary staff and management were competent in safe food handling when multiple TCS foods were routinely not monitored for safe cooling despite policies and procedures addressing the need for this monitoring to prevent food borne illness. (Refer to A 618, A 622)

6. Coordinate and oversee hospital wide infection control program including: Implement an infection control program that followed acceptable standards of practice: Monitoring temperature and Humidity in Surgical Operating Rooms, sterile supply storage rooms, Medication storage rooms throughout the facility. Provide and maintain a sanitary environment for surgical services to avoid sources and transmission of infections and communicable disease by creating a restricted and sterile Operating room environment for the surgical procedures; monitor storage of sterilized supplies and assure the OR was a sterile restricted area; assure medical staff have documented Hepatitis B status. (Refer to A 0749)

7. Have oversight and assure employees were trained and authorized to administer radiopharmaceuticals intravenously. Oversee and participate in decision making when radiopharmaceutical were reordered after a spill on the patient's skin. (Refer to A 1035)

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 interview and record review, the hospital failed to document a patient, or their representative, had acknowledged the receipt of the patient's rights information by signing the condition of admission (a form of agreement for treatment that also denotes the patient's rights and responsibilities) for one of 40 sampled patients (Patient 1).

Findings:

Review of Patient 1's admission record indicated Patient 1 was admitted on 5/2/2018 and discharged on 5/9/2018.

On 5/11/2018 around 10:30 a.m., during a concurrent interview and a review of Patient 1's Conditions of Admission, dated 5/2/2018, the Director of Women's services confirmed Patient 1, or their representative, did not sign the Conditions of Admission.

A review of the Conditions of Admission indicated a patient's signature would acknowledge the receipt of the Notice of Privacy Practices and Information on Rights/Responsibilities.

Based on observation interview and record review the Governing Body failed to oversee and implement a QAPI program that monitored and assured Patient care was provided in a safe and sanitary environment. The facility failed to have an ongoing Quality Assessment Performance Improvement (QAPI) that included:

1. Monitoring temperature and Humidity in patient care areas including in: Surgical Operating Rooms; sterile supply storage rooms, Medication storage rooms. (Refer to A 0749)

2. Assuring food was stored and handled in a sanitary environment. (Refer to A 618, A 749)

3. Maintaining the operating room (OR) as a sterile restricted area. Assure sterilized surgical supplies were not stored by the trash and soiled linen baskets or cleaning solution carts. Monitor storage of OR surgical supplies. (Refer to A 749, A 940)

4. Assuring medical staff have documented Hepatitis B status. (Refer to A 749)

4. Monitoring of the weekly fluoroscopy reading and assuring physicist recommendations are followed by the radiology department when C-ARMS were repaired. (Refer to A 1035)

5. Monitoring oversight and supervision in radiologic services and Nuclear Medicine. Assure CRTs administering radiopharmaceuticals received oversight and authorization. Assure radiopharmaceuticals medication spills on patient skin was reported to the Medical director and radiopharmaceuticals reorders by CRT's is approved by the medical director and the nuclear medication spill is documented in the patients' medical record. (Refer to A 1035)

Facility Document titled, "Performance Improvement 2018", indicated the Board of Directors is ultimately accountable for the "safety and quality of care, treatment and services" and the facility "Performance Improvement Coordinating Committee (PICC) responsibility included "Monitoring patient safety and quality related functions".

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the Condition of Participation for quality assurance and performance improvement was met.

Based on observations, interviews and record reviews, the hospital failed to ensure the Food and Nutrition Service department participated in Performance Improvement activities which focused on high-risk, problem-prone areas in the department. Many of these high-risk, problem-prone activities in the department were identified during the survey as deficient practices capable of resulting in food borne illness in the patient, staff and visitors at the hospital. Additionally, the lack of weight monitoring performed by nursing and the impact this has on the dietitian's accuracy of assessments was not monitored despite being identified as a problem.
The failure to ensure the Food and Nutrition Service participated in these activities allowed these deficient and unsafe food handling practices to continue without remediation.

Additionally, the hospital failed to ensure concerns identified in surgical services, radiology and nuclear medicine departments were included in the facility's quality assurance and performance improvement projects to assure patient safety and quality of care, treatment and services.

Findings:

a. During the survey, multiple unsafe food handling practices were identified, including:

1. Time and Temperature Control for Safety foods (TCS foods are foods capable of supporting bacterial growth that can result in food borne illness when not safely stored and prepared) that had been cooked and cooled, were not monitored to ensure they were safely cooled to prevent food borne illness (cross refer A0749).

2. Final cooking temperature of TCS foods were not monitored to ensure the destruction of disease causing microorganisms was accomplished (cross refer A0749).

3. Expired milk and enteral formula (a nutritionally complete product that is fed to the patient through a tube that delivers it directly to the stomach or intestines) were not discarded after their expiration dates (cross refer A0749).

4. An air gap was not maintained between the two ice machine drainage pipes and the floor sink in the kitchen. An air gap is a space between the drainage end of the pipe and the flood level of the floor sink and must be at least one inch. This air gap was necessary to prevent contamination of the pipes and the ice machines in the event of a backflow of wastewater into the system (cross refer A0749).

5. Nursing failed to obtain follow-up weights on one patient for 15 days and once the patient's weight was taken, the patient had lost 15.4 pounds in 15 days. This was identified as an ongoing issue for the dietitians in order to complete an accurate assessment on the patients. The Clinical Nutrition Manager stated in an interview on 5/10/18, at 10:36 AM, this lack of weight monitoring by nursing was "brought up to nursing as an issue but no Performance Improvement process was initiated." (cross refer A0283).

During a review of the Food and Nutrition Service Performance Improvement indicators, none of the above high-risk, problem prone practices were being studied.

During an interview with the Clinical Nutrition Manager (CNM) on 5/10/18 at 10:36 AM, the CNM stated that in order to accurately assess patients nutrition needs and status, the dietitians need to have accurate weights including any weight changes. The CNM stated that the issue of nursing failing to monitor patient's weights was "brought up to nursing as an issue" but it remained an issue. She stated that she had not turned this into a Performance Improvement project.

During an interview with the Director of Food and Nutrition Service on 5/11/18, at 10 AM, he verified that the deficient practices identified during the survey had been identified or were a part of the Performance Improvement activities for the department.



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b. During a review of the facility ongoing quality assurance and performance improvement (QAPI) projects with QAPI coordinator, on 5/11/18 at 10:55 a.m. did not include: Monitoring temperature and humidity in patient care areas including in: Surgical Operating Rooms (OR); sterile supply storage rooms, Medication storage rooms; assure sterilized surgical supplies were not stored by trash and soiled linen cart or next to cleaning solution carts; Maintaining the OR as a sterile restricted area; Monitoring storage of OR surgical supplies; Assuring medical staff have documented Hepatitis B status; Monitoring of the weekly fluoroscopy reading and assuring physicist recommendations are followed by the radiology department when C-ARM were repaired. Monitor oversight and supervision in radiologic services and Nuclear Medicine. Assure CRTs (Certified radiology technician) administering radiopharmaceuticals received oversight and authorization. Assure radiopharmaceuticals medication spills and reorders by CRT's is documented in the medical records and authorized by the medical Director.

Facility Documented titled, "Performance Improvement 2018", indicated the Board of Directors is ultimately accountable for the" safety and quality of care, treatment and services" and the facility "Performance Improvement Coordinating Committee (PICC) responsibility included " Monitoring patient safety and quality related functions".

Based on observations, record reviews, and interviews, the facility failed to meet the Condition of Participation (CoP) for Nursing Services by failing to:

1. Monitor Patient 10' weight. Patent 10 was at high nutrition risk, unable to take food by mouth, was on parenteral nutrition and had a 14.5 pound weight loss in 15 days. (Refer to 395)

2. Ensure patients' pain level was assessed and reassessed after medication administration (Refer to 395).

3. Ensure the dietary supplements were accurately documented. (Refer to 395).

4. Ensure the parental feeding bag was accurately labeled. (Refer to 395).

5. Ensure nursing staff developed and kept current nursing care plans. (Refer to 396).

6. Ensure the medications/drugs in the Rehab Unit were dated once opened in accordance with the facility's policy. (Refer to 405).

7. Follow acceptable standards with regard to timely administration of medication. Timeliness and completion of physician orders ensure the safety and effectiveness of medications to be given. (Refer to 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 record reviews and interviews, the facility failed to:
1. Monitor one of 40 sampled patients (10). Patient 10 was on parenteral nutrition and had a 14.5 pound weight loss in 15 days.
2. Ensure patients' pain level was assessed and reassessed after medication administration.
3. Ensure the dietary supplements were accurately documented.
4. Ensure the parental feeding bag was accurately labeled.

These deficient practices had the potential not to meet the patients' need.

Findings:

1. The medical record for Patient 10 was reviewed on 5/10/18. Patient 10 was admitted to the hospital on 4/25/18 with diagnoses including partial large bowel obstruction (an obstruction in the intestines) with sigmoid colon stricture (a narrowing of a section of the large intestines). Patient 10 had surgery on 4/27/18.

A review of the dietitian reassessment note dated 5/3/18 indicated Patient 10 did not tolerate an oral diet so parenteral nutrition (a method of getting food into the body through the veins) was initiated. According to the dietitian's note, Patient 10's weight on admission (4/25/18) was 70.3 kg (kilograms) or 155 pounds.

A review of Patient 10's medical record indicated her weight was recorded as 70.3 kg thirteen different times throughout her stay from 4/25/18 through 5/9/18. On 5/10/18, Patient 10's weight was recorded in the medical record as 63.3 kg, or 139.5 pounds, at the same time as the surveyor review of the medical record. This represented a 14.5 pound weight loss or 9.4% in 15 days.

During a review of the hospital's policy titled Nursing Standards of Care - Adult Services (CP-IIIH.1), dated 3/2018, the policy for monitoring patients weights was reviewed. The policy stated, "General assessment includes the following: ....Weight: a. On admission in kilograms. Actual weight preferred ..." There was no guidance on follow-up weights for patients on parenteral nutrition.

A review of the hospital's policy titled Pharmacist - Managed Adult TPN (total parenteral nutrition)(RX#8.14), dated 12/2017, indicated, "Management of the TPN: a. Monitoring to determine the need for TPN formulation adjustments, every 24 hours the pharmacist will: i Assess the following patient variables: 1. weight ...."

During an interview with the Clinical Nutrition Manager (CNM) on 5/10/18 at 10:36 AM, she stated that in order to accurately assess patients' nutrition needs and status, the dietitians need to have accurate weights including any weight changes. The CNM stated that the issue of nursing failing to monitor patient's weights was "brought up to nursing as an issue" but it remained an issue. She stated that she had not turned this into a Performance Improvement project.

During an interview with the Director of Pharmacy on 5/10/18, at 1:40 PM, he stated that the weights pharmacy uses to assess the patients are the weights that are recorded in the medical record. If the medical record's weights are inaccurate because the same weight is recorded multiple times, the pharmacist does not know that the weight is inaccurate.

During an interview with the Director of Nursing Administration on 5/10/18, at 1:51 PM, she agreed accurate weights are needed by both the pharmacy and the dietitians to complete accurate assessments.

During an interview with the Clinical Informatics Specialist Nurse on 5/10/18, at 3:14 PM, she stated that the same weight auto-populated in the medical record every time the nurse completed a nursing assessment. She stated that this was a flaw in the electronic medical record system.



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2. Review of the Face sheet indicated Patient 21 was admitted to the facility on April 4, 2018, with diagnosis of sepsis and respiratory failure.

During an electronic record review and concurrent interview, on May 11, 2018, at 9:15 a.m., RN 7 stated the pain assessments indicated Patient 21 was confused/unable to comprehend. She further stated there should be an alternative for patient's who were unable to verbalize their pain level. RN 7 stated would provide the pain flow sheets.

A review of a Vital Signs/Pain assessment dated May 11, 2018, indicated the patient was unable to state. There was no indication of an alternative for pain was assessed.

Review of the Face sheet indicated Patient 23 was admitted to the facility on May 2, 2018, with diagnosis of pubic fracture status post fall.

During an electronic record review and concurrent interview, on May 11, 2018, at 9:57 a.m., RN 7 stated the pain assessment on May 8, 2018, at 5:20 a.m., indicated Patient 23 complained of pain, moderate pain to right leg post repositioning. Pain intensity was 7. The action taken indicated Norco (a combination medication, is used to relieve moderate to severe pain. It contains an opioid (narcotic) pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen) 1 tablet was administered and would continue to monitor. The Assessment at 5:40 a.m., indicated patient awake, talked about earthquake earlier this morning, and pain medication effective. The action, would continue to monitor. She further stated the vital signs and pain dated May 8, 2018, at 5:20 a.m., indicated Patient 23 complained of moderate pain to right leg post repositioning, and was administered Norco 1 tablet for pain. There was no documented evidence to indicate the patient's pain level was re-assessed after medication was administered. The medication administered was not for severe pain, level 7-10.

Review of physician order dated May 3, 2018, at 10:49 a.m., indicated;
Norco 1 tablet, by mouth, every 4 hours as needed (PRN) for moderate pain (level 3-6) for 7 days.
Norco 2 tablets, by mouth, every 4 hour, PRN for severe pain (level 7-10) for 7 days.

Patient 24 was admitted to the facility on May 6, 2018, with diagnosis of shortness of breath.

a. A review of the History and Physical dated May 6, 2018, at 3:01 a.m., indicated pain was assessed and location was chest. There was no numeric score. There was no documented reassessment of pain.

b. The clinical Notes dated May 10, 2018, at 8:07 p.m., indicated Patient 24 complained of pain 7/10 and administered Morphine 2 mg per PRN order. There was no documented reassessment of pain after administration of pain medication.

During an electronic record review and concurrent interview, on May 11, 2018, at 9:57 a.m., RN 7 stated the pain assessment on May 6, 2018, at 3:01 a.m., did not have a numeric score. She reviewed the physician's order dated May 6, 2018, indicated Morphine 2 milligrams intravenous push every 4 hours for moderate pain (level 3-6) for 7 days. RN 7 further stated there was no order for severe pain (level 7-10) and Patient 24 was given Morphine 2 mg IV push for moderate pain.

3. Patient 22 was admitted on March 3, 2018, with diagnosis which included influenza B.
A review of a physician's order dated March 5, 2018, at 11:10 a.m., indicated an order for oral dietary supplement - Ensure Compact Chocolate (is perfect for those having difficulty drinking a full shake or looking for a more convenient nutrition option, providing 9 grams of protein, 220 calories and 26 essential vitamins and minerals, in an easy to drink 4 fluid ounces) T.I.D. (three times a day).

The Nutritional Initial Assessment dated March 5, 2018, indicated registered dietician visited today, breakfast tray at bedside, ate only 25% of his tray, encouraged good oral intake (P.O.), will try to eat more later, and patient receptive to offer of ensure chocolate. Patient currently inappropriate for diet education "tired and falling asleep." Nutritional recommendation discussed with nurse. The nutritional diagnosis "inadequate oral intake." Provide Ensure Compact T.I.D. with meals. Encourage P.O. intake.

Reviews of physician's order dated;
a. On March 5, 2018, at 11:10 a.m., indicated Dietary Supplement Ensure chocolate T.I.D.
b. On March 5, 2018, at 12:35 p.m., indicated NPO after breakfast.
c. On March 9, 2018, at 8: 59 a.m. and at 9:28 a.m., indicated NPO after breakfast except for medications.

Reviews of Intake/Output Detail Report dated;
a On March 5 through March 6, 2018, indicated oral intake 240 cubic centimeter(s)(cc), between 10 -11 a.m. The documentation did not indicate oral dietary supplement. The oral intake tab had "Ensure T.I.D." written in ink pen when provided to the surveyor.
b On March 6 through March 7, 2018, indicated oral intake was 240 cc, between 9-10 a.m. The documentation did not indicate the oral dietary supplement.
c. On March 7 through March 8, 2018, indicated oral intake 240 cc between 9-10 a.m. The documentation did not indicate oral dietary supplement.
d. On March 9 through March 10, 2018, indicated oral intake Nutritional Supplement 50 cc between 10-11 a.m.

Patient 25 was admitted to the facility on March 21, 2018, with diagnosis trauma status post fracture pelvis and femur fracture.

During an observation on May 8, 2018, at 10:42 a.m., Patient 25 had an oral dietary supplement Ensure on his over head table.

A review of a physician's order dated March 21, 2018, indicated dietary supplement of Ensure chocolate, 1 bottle, twice a day.

A review of Patient 25's Intake/Output Summary Report dated May 4 through May 10, 2018, indicated oral intake. There was no documentation of the dietary supplement Ensure.

4. Patient 26 was admitted to the facility on May 2, 2018, with diagnoses of respiratory failure history of trauma.

During an observation, on May 8, 2018, at 11:20 a.m., Patient 26 had an enteral feeding bag. There was no label to indicate what the feeding was. At 11:30 a.m., RN 8 stated, "the feeding bag was hung last night and turn off now." RN 8 verified the enteral feeding bag was not labeled with type of feeding, rate, date/time, initials. RN 8 further stated, "Yes, the enteral feeding bag should be labeled."

A review of a physician's order dated May 4, 2018, indicated Suplena (Supplemental or sole-source feeding for patients with chronic or acute kidney failure who are not receiving dialysis. Provides 475Cal/8oz (2000Cal/L). May give orally or via feeding-tube. Low-protein medical nutritional supplement) starting rate 20 cc/hr and goal rate 40 cc/hr.

Review of the facility policy number: HW#3.320 titled, "Pain Management" indicated pain is whatever the experiencing person says it is, existing whenever he/she says it does.
Pain is the 5th vital sign and assessed at routine intervals. Pain will be assess/reassessed as per unit standard of care and as needed for the incidence and level of pain. An approved pain scale will be used to assess and treat the pain based on the patient's age or ability. The patient's self-report of pain is the most reliable indicator of pain and the sole indicator of pain intensity. Pain Scale/Tool Addendum # 2 Mac Caffrey's Behavioral Check List for Non-Verbal Patients for adults indicated facial expression (grimacing, looking sad, tense, looking frightened), body language (bracing, guarding, agitated, noisy breathing, fidgeting, restlessness, rocking, social withdrawal, beckoning), vocalization (moaning, grunting, crying, calling out, protesting "no" profanity), changes in behavior (sleep, appetite, mobility, confusion, agitation, and irritable).
Pain interventions would be provided to the patient's pharmacological and non-pharmacological modalities. Translation of physician's orders using the numeric score was as follows: Mild - 1 to 3, Moderate - 4 to 6 and Severe - 7 to 10. Pain reassessment must be completed and documented within 60 - minutes. The documentation for pain assessment and reassessment included patient's behavior, position of comfort, activity level, the pain assessment tool used, interventions provided/response, and medications administered.

Based on record review and interview, the facility failed to ensure nursing staff developed and kept current nursing care plans for 1 of 40 sampled patients (Patient 29).

For Patient 29, there was no care plan developed for the care while the patient was receiving hemodialysis treatments.

This deficient practice had the potential for not meeting the physical and mental needs of each patient.

Findings:

During the tour with RN 6, in the Acute Hemodialysis Unit on May 9, 2018 between the time of 10:45 a.m. and 11 a.m., Patient 29 was observed receiving hemodialysis treatment on the bed. RN 6 also stated Patient 29 had an AV fistula (dialysis access site) on her left arm for hemodialysis treatment.

A review of the electronic clinical record was conducted with the Manager indicated there were no care plans developed for managing Patient 29 who required hemodialysis treatment.

During the concurrent interview, RN 6 stated the nursing staff failed to develop the care plans for hemodialysis.

Based on interviews and medical record reviews, the hospital failed to:

1. Ensure the nursing staff followed the policy and procedure for patients who were on medications for pain management. There were incorrect dosages administered based on the documented pain levels and the prescribed orders for two of 40 sampled patients (1, 6). There was a lack of documented pain assessment and reassessment for the administrations of as needed pain medications for one of 40 sampled patients (5).

2. Ensure the medications/drugs in the Rehab Unit were dated once opened in accordance with the facility's policy.

3. Follow acceptable standards with regard to timely administration of medication. Timeliness and completion of physician orders ensure the safety and effectiveness of medications to be given.

These deficient practices 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:

1. Review of Patient 1's physician orders dated 5/4/2018 indicated Patient 1 had two pain medications: hydromorphone (generic for Dilaudid, a schedule II controlled substance used to treat pain) 1 mg (milligram) intravenously every 2 hours as needed for severe pain (level 7-10); hydrocodone / acetaminophen (generic for Norco, also a schedule II controlled substance used to treat pain) 5/325 mg 1 tablet orally every 6 hours as needed for moderate pain (level 3-6).

Review of Patient 1's medication administration record (MAR) indicated the nursing staff had administered one dose of hydromorphone on 5/4/2018 at 8:19 p.m.

Review of the nursing assessment report for Patient 1 reflected a pain level of 5 on 5/4/2018 at 8:19 p.m.

During a concurrent interview on 5/11/2018 at 10:30 a.m. the registered nurse and the director of women services acknowledged the pain level of 5 did not reflect the prescribed use of hydromorphone (pain level 7-10). The registered nurse (RN20) indicated the pain medication prescribed for moderate pain would be more appropriate and/or the administering nurse should have contacted the physician.

The hospital policy and procedure, Medication Management, reviewed 1/2018, indicated the licensed personnel should ensure that the dosage of the medication matches the prescribed dose.

Review of Patient 6's physician orders dated 4/29/2018 indicated Patient 6 had two pain medications: morphine (an opioid and a schedule II controlled substance used to treat pain) 4 mg intravenously every 4 hours as needed for severe pain (level 7-10); morphine 2 mg intravenously every 4 hours as needed for moderate pain (level 3-6).

In the presence of registered nurses, RN 25 and RN 40, the review of Patient 6's nursing assessment report and medication administration record (MAR) indicated that a nursing staff had administered one dose of morphine 4mg with a documented pain level of 6 on 5/2/2018 at around 2 a.m. A further review of the MAR indicated Patient 6 received a dose of naloxone (Narcan, a medication used to reverse the effects of an opioid) approximately 5 hours later.

The hospital policy and procedure, Medication Management, reviewed 1/2018, indicated the licensed personnel should ensure that the dosage of the medication matches the prescribed dose.

Review of Patient 5's physician orders dated 5/6/2018, for morphine 6 mg intravenously every three hours as needed for severe pain (level 7-10). The medication administration record (MAR) for Patient 5's reflected the nursing staff had administered fifteen (15) doses of morphine to Patient 6 from 5/6/2018 to 5/9/2018.
During a review of the electronic nursing assessment reports and a concurrent interview on 5/9/2018 at 2:30 p.m., the registered nurse (RN 35) confirmed the nursing staff did not document the pain level for four of the above mentioned 15 doses of morphine. RN 35 also confirmed the nursing staff did not document the reassessment of pain level after the administrations for ten of the 15 doses of morphine. RN 35 indicated there should be documentation of pain level assessment prior to the administration of the morphine and the post administration reassessment of pain level.
The hospital policy and procedure, Medication Management, reviewed 1/2018, indicated the licensed personnel to monitor vital signs, pain level, respiratory status, and sedation level for patients receiving opioids.


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2. During the tour in the Rehab Unit, on May 9, 2018 between 11:25 a.m. and 11:45 a.m. with the Rehab Director, the following topical medications in the medication cabinet were opened but not dated:

Iodosorb 40 grams expired on 1/19
antibiotic ointment 1 ounce expired on 1/19

During the concurrent interview, the Rehab Director stated they were not required to date the aforementioned topical medications once opened.

During the interview with the Director of Pharmacy on May 10, 2018, at 1:38 p.m., he stated the topical medications were required to be dated once opened.

According to the facility's policy and procedure, titled, "Medication: Multi-Dose Containers and Community Use":

"1. POLICY:

A. Medication containers labeled as "multi-dose" or containing preservatives (alcohol, metabisulfite, phenol, methylparaben, benzyl alcohol, benzethonium chloride etc.) will be discarded when empty, when suspected or visible contamination occurs, 28 days after initially entering or opening (e.g. needle puncture), unless otherwise specified by the manufacturer."




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3. During a tour of the sixth floor of the facility on 5/8/2018 at 11:00 AM, a 100 milliliter (ml) bag of magnesium sulfate solution was hanging from a pole next to the bed of Patient 40. At that time, the IV line from the solution of magnesium sulfate to the patient's IV catheter (thin plastic tubing placed under the skin and into a blood vessel in order to administer medication or fluids) was not connected. The bag of solution was marked "STAT" (immediately) and still contained approximately 50 ml that had not been infused into the patient.

At that time, the attending nurse (RN 2) stated that Patient 40 pulled out the IV catheter at 8 AM when she went to the restroom. RN 2 confirmed that he did not have time to reinsert another IV catheter as he was busy assisting another patient.

A review of the "Medication Administration Record" (MAR) of Patient 40 indicated that an order of magnesium sulfate in 100 ml of normal saline (a mixture of sodium chloride salt used to dilute medications given by injection) was to be given over 2 hours. The MAR also showed that the medication had been started at 8:17 AM on 5/8/2018 at a rate of 53 milliliters per hour.

Based on observation and interview, the facility failed to ensure patient medical records were stored in such a manner as to their integrity, security, and protection.

Findings:

During a tour of the facility's Second Outpatient Services Location on 5/11/2018 at 9:30 AM, several patient record files were kept in two racks on a counter top adjacent to where the receptionist was stationed. There were approximately 40 such records plainly visible upon walking past the receptionist. Next to these files were lockable cabinets filled with other patient records.

When asked why these particular files were kept outside the filing cabinets at that time, the Associate Director 1 stated that they remained outside the cabinets to be more accessible to staff members with patients at the facility at that time or for those patients who were expected at the facility within the near future. When asked who had access to the interior of the building after business hours, she stated that cleaning staff come after hours of operation. She affirmed that these staff members underwent all the necessary background checks before employment. Finally, she confirmed there are times when patient records are left out in these racks after business hours.

Based on record reviews and staff interviews, the facility failed to ensure the History & Physical and the Pre-Op evaluation were timed for two (2) of 40 sampled patients (Patient 31 and 32).

For Patient 31, the History & Physical was not timed.
For Patient 32, the Pre-Op evaluation was not timed.

Finding:

1. A review of Patient 31's closed record with Infection Preventionist 2 (IP2), on May 9, 2018, indicated the patient was admitted to the facility on May 7, 2018. The History & Physical (H&P) was dated on 5/7/18 but not timed.

2. A review of Patient 32's closed record indicated the patient was admitted to the facility on March 2, 2018. The patient was discharged on March 7, 2018. Further review of the "Anesthesia Record-Short Form" indicated the Pre-Op evaluation was dated on 3/2/18 but not timed.

During the concurrent interview, IP2 stated the H&P and the Pre-Op evaluation should have been timed.

Based on interview and record review, the hospital failed to ensure pharmacists would review medication orders override (bypassing the pharmacist review process) for therapeutic appropriateness at least retrospectively if not prior to medication administration. The hospital also failed to ensure an emergency drug supply (a malignant hyperthermia cart) had a list of the contents on the outside of the cart. This deficiency has the potential to affect patient safety.

Findings:

On 5/9/2018 at 9:40 a.m., during a discussion of medication orders reviewed by pharmacists, the director of Pharmacy (DOP) stated the pharmacy department did not generally review override transactions of their automated dispensing cabinets (ADC), partially due to staffing issues.

During a concurrent discussion, the DOP presented data analysis indicated the pharmacy department had an average of quantifiable workload (work activities such as medication orders verification and documented clinical interventions) about 4000 events per day. The pharmacy department operated twenty-fours per day with ten pharmacist shifts; therefore, there were approximately 400 quantifiable events per pharmacist shift (which would translate to about 50 events per hour for a pharmacist working an eight-hour shift). The DOP acknowledged the duties of pharmacists would also include other non-quantifiable activities that could be time-consuming (such as overrides reviews, controlled drug inventory audits, clinical interventions that did not get recorded due to the lack of quantifiable outcomes, and medication areas inspection ...etc). The DOP acknowledged the potentially missed opportunities to identify medication errors. There were a total of 52 ADC installed in the hospital and 16 out of 52 were non-profiled (all override functions).

On 5/9/2018 at around 10:20 a.m., the registered nurse (RN 40) confirmed with a nursing administrator that all overrides audits were expected to be done by pharmacists.

According to a nationally recognized professional association, American Society of Health-System Pharmacists (ASHP, which published numerous authoritative guidelines in pharmacy practice referred by the industry as the standard of practices), the guideline titled "Minimum Standard for Pharmacies in Hospitals", dated 4/13/2012, indicated "All medication orders shall be prospectively reviewed by a pharmacist and assessed in relation to pertinent patient and clinical information before the first dose is administered or made available in an automated dispensing device, except in emergent situations ... There shall be a procedure for retrospective review of these orders." The guideline further suggested "use of [ADC] shall be structured so as to not hinder the pharmacist's review of (and opportunity to intervene in) medication orders before the administration of first doses ..."

The hospital policy and procedure, Override of Pharmacist Review Prior to medication Administration, revised 4/2018, indicated an audit process of 30 overrides per unit per quarter would be performed for full override locations (non-profiled). For profiled locations, there would be monthly reviews of all medication orders to confirm appropriateness of override.

2. On 5/8/2018 at 1:50 p.m., during an inspection of the Malignant Hyperthermia (MH, is a rare but potentially fatal medical emergency in reaction to certain medications used in anesthesiology) cart located in the G.I. Lab (gastro-intestinal laboratory), the director of pharmacy confirmed the MH cart did not have a content list on the outside of the cart.

Cross reference to the California Code of Regulations, Title 22 section 70263 (f)(2), "The emergency drug supply shall be stored in a clearly marked portable container ... The contents of the container shall be listed on the outside cover and shall include the earliest expiration date of any drugs within."

Based on interview and record review, the hospital failed to ensure a pharmacy staff wore their mask properly while participating in the pharmaceutical compounding of sterile 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 two counts of a compounded sterile medication for one of 40 sampled patients (Patient 4).

These deficient practices had the potential for patients requiring IV medications be exposed to avoidable contamination that may or may not affect the safety or health of the patients.

Findings:

1. During a tour of the pharmacy department on 5/8/2018 at 10:15 a.m., there were several pharmacy staff inside the IV room (a room designated for the compounding of sterile medications). One of the pharmacy staff had on a mask with the bottom pair of strings untied, leaving the mask loosely covering the mouth and chin. The top of the mask was molded closely around the bridge of the pharmacy staff's nose.

During a concurrent interview, the director of pharmacy (DOP) confirmed the pharmacy staff did not wear the mask properly.

2. During an inspection of a medication room located in the Intensive Care Unit on 5/8/2018 at around 3:30 p.m., there was a Ziploc bag labeled for Patient 4 in the medication refrigerator. The label indicated the two syringes inside the bag contained alteplase (generic for Cathfol Activase, used to clear blood clots out of catheters or to treat blood clots) 2 milligram. The same label did not have a BUD or expiration date. The syringes inside the bag had a label indicated they were made on 4/23/2018 and would be expired on 9/24/2018.

During an interview on 5/9/2018 at 11:10 a.m., the director of pharmacy (DOP) presented a compounding formula worksheet for the alteplase syringes. The mixing directions indicated to freeze the compounded alteplase syringes immediately and could be stored for 22 weeks frozen, hence the expiration date of 9/24/2018 mentioned above. However, the syringes were to be thawed prior to dispensing to the nursing unit and they would be for immediate use or within an hour from thawing. The DOP confirmed the alteplase syringes found in the medication room were thawed on 5/7/2018 around 7:29 a.m. and thus they should have been used or removed. The DOP acknowledged there should be a correct BUD on the dispensing label and be removed if not used immediately.

The facility policy and procedure, Pharmacy Prepared Sterile Products, reviewed in 3/2018, indicated sterile product label shall include beyond use date and the date compounded.

Based on observation, interview and record review, the facility failed to provide radiologic services in a safe manner: The facility failed to follow the physicist' recommended guidelines for the safe use of the C-ARMS provided by the physicist after repair or preventive maintenance (PM). There was no oversight to assure Baseline values for Fluoroscopy was reset after repair or PM of C-ARMS.
This failure had the potential of an unsafe radiation exposure to the patients.

Findings:

On 5/11/18 at 2:45 p.m. the Facility Preventative maintenance (PM) and repair documents for the facility C-ARMS were reviewed with Director of Biomed (Dir4) and Supervisor of Nuclear Medicine (RD2). Dir 4 provided documentation of 14 service calls for PM and repairs between 5/11/17 and 11/16/17. No documentation of PM or repairs were provided 5/2017 to 5/11/18.

RD2 indicated the facility had 8 C-ARMS. RD2 indicated all C-ARMS have weekly fluoroscopy reading by a Certified Radiology technician (CRT). A review of the Fluoroscopy log titled, "Weekly Fluoroscopy Monitoring" for randomly selected: C-ARM28; C-ARM58 and C-ARM68 there were no initials or documentation of oversight or review of the weekly Fluoroscopy readings documented weekly by the CRTs. RD2 indicated the weekly fluoroscopy readings for all C-ARMS are reviewed by the Radiation Safety officer. RD2 indicated all C-ARMS are evaluated once a year and a report is provided by a contracted Physicist. A review of the weekly Fluoroscopy monitoring logs did not document dates of repair or dates of out of service.

A review of the list of service calls for repair of the C-ARMS included from 5/17 to 11/17 had 14 service calls including PM's and repair of the Facility C-ARMS reviewed. When asked if the physicist had evaluated the three reviewed C-ARMS after repair. Both Dir4 and RD2 indicated the physicist had not evaluated the C-ARMS after repair or PMs service. There was no documentation that the fluoroscopy reading Baselines were recalculated by the physicist as instructed on the weekly fluoroscopy log. Yearly Physicist reports dated 11/10/17 were provided for C-ARM28; C-ARM58 and C-ARM68. There were no other physicist reports.

A review of a facility document titled, "Weekly Fluoroscope Monitoring indicated "Baseline values are the measurements taken at the time the yearly physicist report is performed. New baseline values must be established if any repairs or maintenance is performed on this machine. If indicated kept or mA is outside of the above range, notify your Department Manager immediately. This machine CANNOT be used until repaired."

A review of the Facility Policy and procedure titled, "Weekly Fluoroscopic Monitor Log" reviewed 12/17 indicated ..." If the monitored output still exceeds the defined minimum/ maximum range, If a repair /or adjustment is required, a copy of the field service report will be maintained."

Based on observations, interviews and record reviews, the hospital failed to:

1. Ensure the Director of Food and Nutrition Service was effective in managing the day-to-day operations of the department and maintaining safe food handling practices. This occurred when Time and Temperature Control for Safety foods (TCS foods are foods capable of supporting bacterial growth that can result in food borne illness when not safely stored and prepared) were not monitored for safe cooling after being cooked and then being stored in the refrigerator. Additionally, final cooking temperatures were not monitored for TCS foods to ensure bacteria that can cause food borne illness were killed. Also, the department did not monitor the thawed 14 day shelf life for frozen nutritional supplements. (cross refer A0749)

2. Ensure Dietary staff and management were competent in safe food handling when multiple TCS foods were routinely not monitored for safe cooling despite policies and procedures addressing the need for this monitoring to prevent food borne illness. Additionally, hospital policies required the Manager on Duty to visually monitor safe cooling of TCS foods and sign off on logs daily that the staff were required to complete. The logs were not being kept and there was no monitoring of many foods and no monitoring completed for an eight month period. There was also a failure to ensure one cook was competent with respect to safe final cooking temperatures for TCS foods. And according to the hospital's standard operating procedures, final cooking temperature were to be logged with monitoring of the logs by the Manager on Duty. This was not being monitored to ensure food was cooked so that microorganisms that can cause food borne illness were killed. (cross refer A0622)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the Condition of Participation for Food and Dietary Services was met.

Based on observations, interviews and record reviews, the hospital failed to ensure effective oversight of the Food and Nutrition Services by the Director of Food and Nutrition Service to maintain sanitary conditions in the department. This oversight failure also resulted in inadequate portion sizes of some foods being served to patients, a lack of technical competency of staff and management and a lack of performance improvement activities that addressed the deficient and noncompliant practices in the department. These failures resulted in continued deficient practices that put the patients, staff and visitors at risk for food borne illness. (cross refer A0749, A0622)

Findings:

1. The cooling of previously cooked foods that were Time and Temperature Controlled for Safety (TCS) foods was not monitored to ensure these foods were safe for consumption. TCS foods are foods that are capable of supporting bacterial growth that can result in food borne illness unless stored, prepared and served safely. Additionally, methods for safe cooling were not being utilized. And logs that indicated food items were not safely cooled did not have documentation that the food was discarded or other remedies were taken to ensure those foods were safe for consumption by the patients.

According to the 2017 USDA Food Code, cooked Time and Temperature Control for Safety (TCS) foods shall be cooled within two hours from 135 °F (degrees Fahrenheit) to 70 °F, and within a total of six hours from 135 °F to 41 °F. It further states that if TSC foods are not cooled according to this code, harmful bacteria may grow to sufficient numbers to cause food borne illness. The initial two hour cool is a critical element of this cooling process.

In addition, according to the 2017 USDA Food Code, Time and temperature control for safety food includes an animal food that is raw or heat-treated; a plant food that is heat-treated or consists of raw seed sprouts, cut melons, cut leafy greens, cut tomatoes ...

During a tour of the kitchen on 5/8/18, between 10:20 and 10:30 AM, multiple previously cooked TCS foods were noted in the walk-in refrigerator: a pan of vegetable soup; a pan labeled Tomatillo Salsa; a pan of Country Gravy; and, a pan of approximated 10 chicken breasts.

During an interview with Food Service Manager 1 (FSM 1) the same day at 10:30 AM, he stated that all of the noted foods had been cooked in the kitchen before being stored in the refrigerator.

The cooling logs for these foods was requested and the following logs were provided. A review of the Nutritional Services Hot Food Cooling Log, dated 4/20 through 5/6 [2018] indicated that the log did not include any of the above food items. All the items on the log were either Pot Roast or Pork.

During a concurrent interview with the Director of Food and Nutrition Services (DFNS), he stated that the department did not monitor the cool down of the above TSC foods, just roasts. The DFNS said that the management was monitoring the Hot Food Cooling Logs until last year. At that time, a decision was made to stop monitoring these logs.

The Nutritional Services Hot Food Cooling Logs were reviewed. The log dated 4/20/18 through 5/6/18 indicated that only pot roast and pork were listed on the log. No other TCS foods were monitored for safe cooling. Logs for the previous three month were requested, but had not been kept. Logs that were kept before 4/20/18 were dated 8/8/17 through 8/28/17. There was an eight month gap when cooling logs were not kept. There was no indication on any of the cooling log forms that a manager or supervisor reviewed the forms.

A review of the hospital's HACCP Food Safety Plan, 19- Cooling Potentially Hazardous Foods, dated 10/01/10, indicated that for "Verification and Record Keeping: Food service employees will record temperatures and corrective actions taken on the Cooling Temperature Log or other appropriate log when establishing safe cooling procedures for each type of food. The Manager on Duty will verify that food service employees are cooling food properly by visually monitoring food service employees during the shift and reviewing, initialing, and dating appropriate logs. The logs will be retained with other records for 1 year." HACCP is Hazard Analysis Critical Control Points, a systematic preventative approach to food safety that is designed to reduce risk to food during storage and production to a safe level.

2. During an interview with Cook 2 on 5/9/18, at 9:46 AM, Cook 2 was asked what was the final cooking temperature for chicken when he cooked it. Cook 2 stated that chicken needed to be cooked to 135 or 140 °F. Cook 2 stated that the previously cooked roast beef should be reheated to 165 °F but if he cooked chicken to 165 °F it would get too dry. Cook 2 further stated that he does not record the final cooking temperature for the foods he cooks. Instead, the temperature was recorded when the food was placed on trayline (on the steamtable used to serve patient food for meal service).

A review of the Food and Nutrition HACCP/Infection Control policy and procedure (FNS#J.1), dated 07/2017, indicated, "Potentially hazardous foods are cooked to at least the following safe internal temperatures and held for at least 15 seconds: Poultry ....165 °F ...Fish 145 °F ..." The policy further stated "Leftovers and advanced prepared foods are thoroughly and rapidly reheated to 165 °F or higher for 15 seconds before being served or being placed in warming units." It also indicated, "Hold hot food at a minimum of 135 °F." HACCP is Hazard Analysis Critical Control Points, a systematic preventative approach to food safety that is designed to reduce risk to food during storage and production to a safe level.

During an observation of the trayline service for lunch on 5/9/18, at 11:30 AM, the temperature of ground chicken, chopped pot roast and shrimp on the steamtable were taken. The temperature of the chicken was 150-153 °F. The temperature of the chopped pot roast was 156 °F. The temperature of the shrimp was 120-125 °F, less than the required hot holding temperature indicated in the policy.

During a concurrent interview with Food Service Manager 1 (FSM 1), FSM 2, the Sous Chef and the Executive Chef, they were all asked how they knew that the chicken, pot roast and shrimp were cooked to a safe final cooking temperature. No one was able to answer. They were asked what temperature was logged on the trayline temperature log. FSM 2 stated the temperature for ground chicken, chopped pot roast and shrimp were not on the log.

A review of the hospital's HACCP Food Safety Plan, 12 - Cooking Potentially Hazardous Foods, Standard Operation Procedure (SOP), dated 10/01/10, indicated in bold lettering, "Record final cooking temperatures of each menu item on the appropriate log." It further indicated for "Monitoring: Temperatures will be taken at the end point of cooking and recorded on logs. These logs will be monitored by the Manager on Duty to ensure that the temperatures meet the minimum standards."

According to the 2017 USDA Food Code, to kill microorganisms, food must be held at a sufficient temperature for the specified time. Greater numbers and varieties of pathogens (disease causing organisms) generally are found on poultry than on other raw animal foods. Therefore, a higher temperature, in combination with the appropriate time is needed to cook these products.

3. During an observation of the trayline (patient meal tray assembly) on 5/9/18, at 12:20 PM, mashed potatoes were portioned on two patient trays using a #16 size scoop, a two ounce portion.

A review of the patient menus indicated that a four ounce portion was supposed to be served using a #8 scoop size.

During a concurrent interview with the Clinical Nutrition Manager (CNM), she verified that the wrong scoop size was being used for the regular size portion of mashed potatoes. Patients on a regular diet who ordered the potatoes were receiving a half size portion of mashed potatoes.

4. During an interview with the Director of Food and Nutrition Service (DFNS) on 5/11/18, at 10 AM, the DFNS was asked if any of the deficient practices identified during the survey were being studied as part of the departments' Performance Improvement (PI) process. The DFNS stated that he had one PI project that he had been monitoring in which over two years the metrics consistently met 99-100%. None of the deficient practices identified during the survey were being monitored, despite being high risk, problem prone processes.

Based on observation, interviews and record reviews, the hospital failed to ensure staff and management were competent in safe and effective food handling practices when:

1. One cook (Cook 1), the Executive Chef, Food Service Manager 1 (FSM 1) and the Sous Chef were not competent in safe cooling of cooked Time and Temperature Control for Safety (TCS) foods. TCS foods are foods that are capable of supporting bacterial growth that can result in food borne illness unless stored, prepared and served safely. (cross refer A0749)

2. One cook (Cook 2) was not knowledgeable on the safe final cooking temperature for chicken. (cross refer A0749)

3. One dietary Staff (Dietary Staff 2) was not knowledgeable regarding sanitizing the scrub brush used to scrub vegetables.

4. Spices were not being consistently monitored for shelf life per established department guidelines.

These failures in competency had the potential to result in unsafe food handling practices and suboptimal food quality practices that affected the food served to patients, staff and visitors in the hospital.

Findings:

1. According to the 2017 USDA Food Code, cooked Time and Temperature Control for Safety (TCS) foods shall be cooled within two hours from 135 °F (degrees Fahrenheit) to 70 °F, and within a total of six hours from 135 °F to 41 °F. It further states that if TSC foods are not cooled according to this code, harmful bacteria may grow to sufficient numbers to cause food borne illness. The initial two hour cool is a critical element of this cooling process.

In addition, according to the 2017 USDA Food Code, Time/temperature control for safety food includes an animal food that is raw or heat-treated; a plant food that is heat-treated or consists of raw seed sprouts, cut melons, cut leafy greens, cut tomatoes ...

During an investigation of the food service cooling procedures for cooked TCS foods on 5/8/18, between 10:12 and 10:50 AM, Food Service Manager 1, the Sous Chef, the Executive Chef and Cook 1 all stated the only foods that were monitored for safe cooling were roasts. Other cooked TCS foods identified in the refrigerators that were cooked in the department but were not monitored or being monitored for safe cooling were: a vegetable soup, salsa, country gravy and chicken breasts.

During a concurrent review of the Nutritional Services Hot Food Cooling Log, dated 4/20 through 5/6 [2018] indicated that the log did not include any of the above food items. All the items on the log were either Pot Roast or Pork. A review of the Nutritional Services Hot Food Cooling Logs that were requested for the last three months indicated that the last logs that were kept before 4/20/18 were dated 8/8/17 through 8/28/17. There was an eight month gap when cooling logs were not kept.

A review of the hospital's HACCP Food Safety Plan, 19- Cooling Potentially Hazardous Foods, dated 10/01/10, indicated that for "Verification and Record Keeping: Food service employees will record temperatures and corrective actions taken on the Cooling Temperature Log or other appropriate log when establishing safe cooling procedures for each type of food. The Manager on Duty will verify that food service employees are cooling food properly by visually monitoring food service employees during the shift and reviewing, initialing, and dating appropriate logs. The logs will be retained with other records for 1 year." HACCP is Hazard Analysis Critical Control Points, a systematic preventative approach to food safety that is designed to reduce risk to food during storage and production to a safe level.

A review of the Job Descriptions for Executive Chef and Food Service Managers indicated a competency requirement that stated, "Operates the kitchen in compliance with standards exceeding regulatory requirements. Develops and implements and updates policies and procedures that guide and support provision of services." It further requires the Executive Chef and Food Service Managers to "Recommend a sufficient number of qualified and competent people to provide care. Establishes standard skill mix needed to provide service."

A Review of the Job Description for Cook indicated a competency requirement that stated, "Prepares, stores and distributes food safely as if all were to be consumed by patients at risk. Controls temperature of potentially hazardous food according to procedures with 100% compliance."

2. During an interview with Cook 2 on 5/9/18, at 9:46 AM, Cook 2 was asked what was the final cooking temperature for chicken when he cooked it. Cook 2 stated that chicken needed to be cooked to 135 or 140 °F. Cook 2 stated that the previously cooked roast beef should be reheated to 165 °F but if he cooked chicken to 165 °F it would get too dry. Cook 2 further stated that he does not record the final cooking temperature for the foods he cooks. Instead, the temperature is recorded when the food is placed on trayline (on the steamtable used to serve patient food for meal service).

According to the 2017 USDA Food Code, to kill microorganisms, food must be held at a sufficient temperature for the specified time. Greater numbers and varieties of pathogens (disease causing organisms) generally are found on poultry than on other raw animal foods. Therefore, a higher temperature, in combination with the appropriate time is needed to cook these products.

A review of the Food and Nutrition HACCP/Infection Control policy and Procedure (FNS#J.1) dated 07/2017, indicated, "Potentially hazardous foods are cooked to at least the following safe internal temperatures and held for at least 15 seconds: Poultry ....165 °F ..."

A Review of the Job Description for Cook indicated a competency requirement that stated, "Prepares, stores and distributes food safely as if all were to be consumed by patients at risk. Controls temperature of potentially hazardous food according to procedures with 100% compliance."

3. During an observation of the cold preparation area on 5/9/18, at 9:20 AM, there was a brush that was stored above the sink where vegetables were washed.
During a concurrent interview with Dietary Staff 2 (DS 2), he stated that he uses the brush to scrub vegetables such as potatoes. DS 2 further stated that once he is done with scrubbing vegetables he then rinses the brush and stores it on the wall hanger above the sink. When asked if the brush is sanitized or washed in dish machine, DS 2 stated no.
During a review of Food and Nutrition Department in-service on Fruit and Vegetable Wash, dated 3/10/18, attended by DS 2, the in-service did not include how to clean the brush used for scrubbing fruits and vegetables.
During a concurrent interview with Director of Food and Nutrition Services (DFNS), the DFNS stated the brush should be washed and sanitized in the dishwasher. He further stated that the in-service on fruit and vegetable washing did not include how to clean the brush and it should have.

4. During a tour of the kitchen on 5/8/18, at 11:03 AM, there was a container of dried whole leaf basil that was expired with the date of 4/21/17, a container of ground white pepper that had a date of 8/15 (no year), a container of dried whole thyme leaves dated 2/19/19 and dried parsley that had no date.

During a concurrent interview with Cook 1, when asked if he dated the containers of spices per receive date, he did not respond. During concurrent interview with Sous Chef, he was not able to explain the different dates on the containers.

During a concurrent interview with Executive Chef (EC), he stated that the procedure was to always put the received date on the containers. The EC further stated that he monitored this and kept everything organized. The Executive Chef verified that the dates did not reflect receive dates and that there was no system to maintain the dates on the spices and dried herbs per policy. He further stated that he was responsible for assuring that items that had exceeded their use by date were discarded.

A review of the posted sign attached to the shelf that holds the spices, indicated that containers of dried herbs and spices should have the received dates on them and they were good for one year after received.

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

Findings:

On 5/8/18 between 10:30 a.m. and 2:00 p.m. the following was observed:

1. Main Hospital Basement Sterile Processing Unit

a. A broken air conditioner (AC) vent cover inside the Infusion Pump Repair room (EB17-A) was held to the ceiling with a masking tape.

During an interview at the time of observation the assigned staff member stated that the broken AC vent cover will me repaired.

2. The evaluator in the presence of the Director of Environmental Safety observed water inside the hand washing sink in G.I. (gastrointestinal) Lab [Laboratory] nurses station was clogged-up.

In an interview during the observation, the Environmental Safety Director acknowledged the findings and requested for immediate repair.


16281

3. On 5/8/18 between 8:55 a.m. and 3:10 p.m. the following was observed:

A. Main Hospital 6th floor Telemetry

The evaluator observed the wall mounted toilet in staff restroom C6N1L had a separation of the caulking seal between the back of the toilet and the wall. Closer observation revealed the toilet was loose as evidenced by the toilet moving when the evaluator touch it with the side of his leg.

During an interview at the same time as the observation, the Director of Facilities acknowledged that the toilet was loose and stated that a maintenance would tighten the toilet to the wall.

B. Main Hospital 3rd floor Maternity

The evaluator observed signs of water damage at a ceiling tile and ceiling light fixture diffuser in storage closet room BC325A.

During an interview at the same time as the observation, the Director of Facilities stated that he would call someone to investigate it.

The evaluator observed signs of water damage at two ceiling tiles at the corridor near room B319.

C. Main Hospital 3rd floor CardioRespiratory

The evaluator observed a three foot long crack above the shelving in the clean linen closet. The crack had small pieces of plaster hanging from it an there were small pieces of plaster and dust on the top shelf.

D. Main Hospital 3rd floor Telemetry

The evaluator observed a sign of water damage at a ceiling tile at the corridor next to room 339.

The evaluator observed three feet of wall cove displaced from the wall in room E360.

The evaluator observed a sign of water damage at a ceiling tile at the corridor next to room 375.


4. On 5/9/18 between 8:40 a.m. and 2:45 p.m. the following was observed:

A. Outpatient Chino Hills Suite 115 Imaging

The evaluator observed an eyewash station had one of two of its covers off exposing the nozzle to the ambient environment.

Provision of ANSI Z358.1-2014 Section 5.1.3 indicates that emergency eyewash equipment must be protected from airborne contaminants.

B. Outpatient Chino Hills Suite 100 Physical Therapy

The evaluator observed the pull string/cord of a call station laying on an ultrasound and into the side compartment of a cart at bay one.

The evaluator observed the pull string/cord of a call station laying on an ultrasound and under a bottle of ultrasound gel at bay two.

The evaluator observed a vertical ceiling tile was not in place at the changing room of hydrotherapy pool room.

During an interview at the same time as the observation, the Vice President of Support Services stated that the ceiling tile was there but had fallen out of place.

The evaluator observed the pull string/cord of a call station tied to a cloth stockinette.

During an interview at the same time as the observation, the Satellite Manager of Rehabilitation Services stated that the pull string/cord had to be tied to the stockinette to make it long enough to reach the patient bed.


C. Outpatient Pomona Suite 103 Imaging

The evaluator observed the DXA (dual X-ray absorptiometry) scanner table pad had four 1-inch horizontal tears through its side where the pad attaches to the table.

During an interview at the same time as the observation, the Administrative Director of Radiology stated that the tears were probably caused when the DXA scanner was moved from the Claremont outpatient site about a month ago between 4/10/18 to 4/15/18.

The evaluator observed the general X-ray room had a 1 1/2 inch by 1-inch hole in the wall.

The evaluator observed the general X-ray room had a damaged electrical cover plate with a 1-inch jagged edge.

The evaluator observed the data closet had two 2-inch by 2-inch holes in the wall.

During an interview at the same time as the observation, the Vice President of Support Services stated that there was probably an intention to install electrical boxes in the wall.


D. Outpatient Claremont Suite 220 Physical Therapy

The evaluator observed signs of water damage at six ceiling tiles at the gym.

During an interview at the same time as the observation, the Manager of Rehabilitation Services stated that about three weeks ago during heavy rains the roof leaked causing staining of the ceiling tiles. That the property manager asked them to leave the stained tiles in place so the roofer could identify the location of the leaks. That the roofer was there last week, and that the replacement tiles had been ordered.

The evaluator observed the pull string/cord of a call station taped to a wall in the
gym.


E. Outpatient Claremont Suite 270 Sleep Study

The evaluator observed a sign of water damage at a ceiling tile in the control room.

The evaluator observed a sign of water damage at a ceiling tile in the EVS (environmental services closet), the tile was also observed to be out of place.

The evaluator observed a loose ceiling tile in the clean linen closet.


F. Outpatient Pavilion (OPP) Pomona Physical Therapy

On 5/10/18 at 9 a.m. the evaluator observed the high-low treatment table pad had four 1/2-inch horizontal tears through its side exposing the foam material within.

During an interview at the same time as the observation, the Associate Director of Rehabilitative Services stated that an electric wheelchair hit the table three weeks ago, that the table has been in use since then, and that there is an order in for refurbishment of the table.

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

Findings:

Medical Center Pomona

1. On 5/8/18 at 2:50 p.m., 3rd floor room 339 corridor door failed to hold closed.

During an interview at the same time as the observation, the Director of Facilities stated that the door did not hold because the door had a loose strike plate.

2. At 3:10 p.m., 3rd floor room 361 corridor door failed to hold closed.

Basement

3. On 5/10/18 at 9:35 a.m., in the E building basement trash chute discharge room there was an overfilled trash bin creating a condition that could obstruct the chutes door from closing in the event of a fire.

During an interview at the same time as the observation, the Environmental Services Facilities Manager stated that the removal of the trash from the bottom of the trash chutes is continuous.

Out Patient Pavilion (OPP) Pomona

4. On 5/10/18 at 9 a.m., there was storage of ceiling tiles in the main electrical panel room.

Out Patient Oncology Pomona

5. On 5/9/18 at 1:45 p.m., there was storage of a mobile step ladder with a plywood base in the main electrical panel room.

During an interview at the same time as the observation, the Vice President of Support Services stated that the ladder would be removed from the electrical panel room.

6. There were three holes at one side of the north corridor smoke barrier wall. There was a half inch hole, a 2 inch by 4 inch hole, and a one inch by two inch wall.

During an interview at the same time as the observation, the Vice President of Support Services acknowledged the holes at the smoke barrier wall.

7. There was a half inch diameter penetration through the south corridor smoke barrier wall.

Out Patient Chino Hills

8. On 5/9/18 at 10:10 a.m., at Suite 150C there was a door to an exit corridor with out signage

Out Patient Claremont

9. On 5/9/18 at 11:20 a.m., in Suite 170 there was a sprinkler escutcheon down at the ceiling sprinkler head

10. At Suite 270 at 11:55 a.m., there was a loose electrical receptacle at the corridor by room 7.

11. At Suite 270 at 11:55 a.m., there was a loose escutcheon at the clean linen closet ceiling sprinkler.

Based on document review and interview, the hospital staff failed to provide documented evidence of regular inspection and approval by State or local fire control agencies.

Finding:

On 5/10/18 at 11 a.m., during document review there was no documented evidence of regular inspection of the hospital by the local fire agency.

During an interview at the same time as the observation, the Vice President of Support Services stated that the local fire department conducts a walk through of the hospital annually but does not leave any documented evidence unless there is a deficiency.

Based on observation, interview, and record review, the hospital failed to ensure equipment installed were compliant at all time by ensuring timely equipment inspection and/or calibration. This deficient practice had a potential for the equipment to perform in a subpar level affecting the patient safety.

Findings:

During a visit to the hospital's pharmacy on 5/11/2018 at 11:50 a.m., there was a pressure gauge installed on the wall to the left of the entrance into the "IV room" (an area to prepare compounded sterile intravenous solutions, IV). On the pressure gauge, there was an instrument calibration sticker indicated a calibration was due in the month of October 2017.

During a concurrent interview, the director of pharmacy (DOP) confirmed the calibration of the pressure gauge was past due.

A review of USP chapter 797, Pharmaceutical Compounding-Sterile Preparations, indicated a pressure gauge shall be installed to monitor the pressure differential or airflow between the IV compounding area and the general pharmacy area outside the IV room. The monitoring shall be documented on a log at least every work shift or by a continuous recording device.

Based on observation, interview, and record review, the hospital failed to ensure there were temperature monitoring devices installed in the medication storage and preparation areas, such as medication rooms at each nursing unit. This deficient practice had a potential affecting the integrity and/or potency of the products.

Findings:

During an inspection of the medication room inside the intensive care unit (ICU) on 5/8/2018 at 3:30 p.m., there was no temperature monitoring unit. During a concurrent interview, the nursing manager of the unit stated there was no monitoring records for the ambient temperature within the medication room.

During an interview on 5/11/2018 at 1:30 p.m., the director of pharmacy (DOP) indicated there were thirty-one medication rooms inclusive of outpatient and off-campus areas. The DOP confirmed none of the medication rooms had temperature monitoring devices. There were no documented monitoring of the ambient temperature inside those rooms.

Review of the hospital policy and procedure, Medication Handling - Storage Non-Controlled Substances, reviewed 10/2017, indicated a controlled room temperature range to maintain the integrity of medications.

Review of another hospital policy and procedure, Medication Area Inspections, reviewed 5/2017, did not delineate the procedure of monitoring and maintaining the controlled room temperature in the medication rooms.

Based on observation, interview, and record review, the facility did not meet the condition of participation in infection control by failing to ensure a sanitary environment as follows:

1. Develop a system to identify, report, investigate and control unsafe food sanitation practices in the Food and Nutrition Service Department, the infant feeding preparation room and one nursing station nourishment refrigerator. (Refer to A 749)

2. Assure temperature and humidity in the Operating rooms were within acceptable range and action taken or adjustment made for those out-of-range humidifies or variances occurred were monitored and documented. (Refer to A 749)

3. Provide and maintain a sanitary environment for surgical services, to avoid sources and transmission of infections and communicable disease by creating a restricted and sterile Operating room environment for the surgical procedures. (Refer to A 749)

4. Assure Medical Staff had documented Hepatitis B status or Hepatitis B waiver in order to provide patient care in a safe and sanitary environment. (Refer to A 749)

5. Ensure sanitary physical environment was maintained. (Refer to A 749)

6. Follow accepted standards of practice when attending to patients. (Refer to A 749)

7. Ensure staff would wear appropriate PPE during disinfection of hemodialsyis machine.

8. Ensure hand hygiene was perform after removal of gloves. (Refer to A 749)

9. Ensure a designated area for compounding intravenous solution inside a medication room was free of residues. (Refer to A 749)

10. Ensure bio-hazardous waste container in the main hospital laboratory was not overflowing with discarded items and faucets in the sinks in main hospital sub-sterile room had no aerators and mineral deposit in the spigot of the faucet and base of the faucet. (Refer to A 749)

The cumulative effect of these systemic problems resulted in the hospital's inability to provide an effective hospital wide infection control program in a safe and effective manner.

Based on observations, interviews and record reviews, the hospital failed to develop a system to identify, report, investigate and control unsafe food sanitation practices in the Food and Nutrition Service Department, the infant feeding preparation room and one nursing station nourishment refrigerator including the following deficient practices:

1. The cooling of previously cooked foods that were Time and Temperature Controlled for Safety (TCS) foods was not monitored to ensure these foods were safe for consumption. TCS foods are foods that are capable of supporting bacterial growth that can result in food borne illness unless stored, prepared and served safely. Additionally, methods for safe cooling were not being utilized. And logs that indicated food items were not safely cooled did not have documentation that the food was discarded or other remedies were taken to ensure those foods were safe for consumption by the patients.

2. The final cooking temperatures for TCS foods were not monitored to ensure meat and poultry were cooked or reheated to a safe temperature sufficient to kill harmful microorganisms (bacteria, virus or fungus too small for the unaided human eye to see). Additionally, one cook (Cook 1) was not able to accurately verbalize safe final cooking temperatures for poultry.

3. An air gap was not maintained between the two ice machine drainage pipes and the floor sink in the kitchen. An air gap is a space between the drainage end of the pipe and the flood level of the floor sink and must be at least one inch. This air gap was necessary to prevent contamination of the pipes and the ice machines in the event of a backflow of wastewater into the system.

4. Meatballs were stored in the freezer open to the air, not covered or sealed to prevent freezer burn and cross-contamination.

5. A scoop was stored in contact with the food in a dry food storage bin and where the scoop handle was stored in contact with the food.

6. Nutritional supplements labeled "Store Frozen" with manufacturer's instruction to use within 14 days of thawing, were not monitoring for the date they were thawed to ensure expired shakes were discarded after this timeframe. The hospital did not have a system in place for this monitoring.

7. Expired milk and enteral feeding formula (a nutritionally complete product that is fed to the patient through a tube that delivers it directly to the stomach or intestines) were stored in the kitchen.

8. A refrigerator in one nursing station nourishment room (Room B2N1B) did not maintain safe food storage temperatures for TCS foods stored in the refrigerator.

9. Shelving in the pot washing area, used to store clean pots and pans, was noted to be rusted with a sticky film.

10. The sanitizer used in the infant feeding preparation room to sanitize food contact surfaces was labeled by the manufacturer for nonfood contact surface use only.

11. The hospital's Infection Control Committee did not identify, report, investigate or control these deficient practices in the food and nutrition services, nursing unit nourishment room and infant feeding preparation room.

The lack of a system to identify, report, investigate and control these unsafe food handling practice in the food and nutrition service, nourishment room and infant feeding preparation room had the potential to result in food borne illness in a medically vulnerable patient population of 232 patients in addition to staff and visitors who consume the food prepared by the hospital.

In addition the hospital failed to:

12. Assure temperature and humidity in the Operating rooms were monitored and documented within acceptable range including when variances occurred.

13. Provide and maintain a sanitary environment for surgical services, to avoid sources and transmission of infections and communicable disease by creating a restricted and sterile Operating room environment for the surgical procedures.

14. Assure Medical Staff had documented Hepatitis B status or Hepatitis B waiver in order to provide patient care in a safe and sanitary environment.

15. Ensure sanitary physical environment was maintained.

16. Follow accepted standards of practice when attending to patients.

17. Ensure staff would wear appropriate PPE during disinfection of hemodialsyis machine.

18. Ensure hand hygiene was perform after removal of gloves.

19. Ensure a designated area for compounding intravenous solution inside a medication room was free of residues.

20. Ensure bio-hazardous waste container in the main hospital laboratory was not overflowing with discarded items and faucets in the sinks in main hospital sub-sterile room had no aerators and mineral deposit in the spigot of the faucet and base of the faucet.

These deficient practices had the potential to increase outbreaks of hospital acquired infection.

Findings:

1. According to the 2017 USDA Food Code, cooked Time and Temperature Control for Safety (TCS) foods shall be cooled within two hours from 135 °F (degrees Fahrenheit) to 70 °F, and within a total of six hours from 135 °F to 41 °F. It further states that if TSC foods are not cooled according to this code, harmful bacteria may grow to sufficient numbers to cause food borne illness. The initial two hour cool is a critical element of this cooling process.

In addition, according to the 2017 USDA Food Code, Time and temperature control for safety food includes an animal food that is raw or heat-treated; a plant food that is heat-treated or consists of raw seed sprouts, cut melons, cut leafy greens, cut tomatoes ...

During a tour of the kitchen on 5/8/18, between 10:20 and 10:30 AM, multiple previously cooked TCS foods were noted in the walk-in refrigerator: a pan of vegetable soup, approximately 6 inches deep, labeled 5/9/18; a pan labeled Tomatillo Salsa made 5/8/18, use by 5/10/18, that was tightly covered with two layers of plastic wrap and hot to the touch; a pan labeled Country Gravy, 5/9/18; and, a pan of approximated 10 chicken breasts, unlabeled. The temperature of the salsa was taken with the surveyors thermometer which registered 107.4 °F.

During an interview with Food Service Manager 1 (FSM 1) the same day at 10:30 AM, he stated that some of the dates indicated the date the food was cooked and some of the dates indicated the "use by" dates for the food. FSM 1 stated that all of the noted foods had been cooked in the kitchen before being stored in the refrigerator.

The cooling logs for these foods was requested and the following logs were provided. A review of the Nutritional Services Hot Food Cooling Log, dated 4/20 through 5/6 [2018] indicated that the log did not include any of the above food items. All the items on the log were either Pot Roast or Pork.

Continuing the same interview with FSM 1, he stated that for the soup, "It's just a soup," further stating, "We only monitor cool down on protein foods like pot roast which is a protein food." He could not explain why the chicken breasts were not included on the log.

During a concurrent interview with the Director of Food and Nutrition Services (DFNS), he stated that the department did not monitor the cool down of soup, just roasts. He further stated that the salsa, country gravy and the chicken breasts were made by the catering cook (Cook1). The DFNS said that the management was monitoring the Hot Food Cooling Logs until last year. At that time, a decision was made to stop monitoring these logs.

During an interview with Cook 1 the same day at 10:35 AM, Cook 1 stated that he just made the salsa at 10 AM and placed it in the refrigerator. Cook 1 stated that he tightly covered the salsa to prevent it from spilling and the temperature of the salsa was 140 ° F (degrees Fahrenheit) when he placed it in the refrigerator. Cook 1 further stated that he would check the temperature in two hours to monitor the cool down. Cook 1 further stated that he had cooked the country gravy and the chicken breasts that were found in the refrigerator. He stated that these two items were not monitored for safe cool down.

The Nutrition Service's HACCP/Infection Control Policy and Procedure (FNS#J.1), dated 07/2017, was reviewed. HACCP is Hazard Analysis Critical Control Points, a systematic preventative approach to food safety that is designed to reduce risk to food during storage and production to a safe level. The procedure indicated, "Leftovers and advanced prepared foods are placed uncovered in shallow pan (2") for rapid cooling ..."

During the same interview, Cook 1 was asked to show the surveyor on the cool down logs the last time he had cooled down salsa. A review of the Nutritional Services Hot Food Cooling Logs Cook 1 provided, indicated the last log was dated 2015. Cook 1 continued the interview indicating that there were no current logs for any foods cooked in his area. When asked if the salsa, chicken breast and country gravy should have been monitored for safe cool down, Cook 1 indicated "yes."

During an interview with the hospital's Sous Chef (SC), the same day at 10:43 AM, he stated that the vegetable soup was cooked to serve to patients and confirmed that it was not monitored for safe cool down on the logs. The SC further stated that the log is only for meats. He could not explain why the chicken breasts were not on the log.

During an interview with the Executive Chef (EC) the same day at 10:50 AM, the EC stated that there was no system in place for monitoring the cool down of cooked TCS foods except for roasts.

During a further review of the Nutritional Services Hot Food Cooling Log, dated 4/20 through 5/6 [2018], the log indicated an entry on 4/25 [2018] for "Pot Roast". The start time and temperature for monitoring indicated "9:45 AM, 170 °F." The next entry for the "2 Hour Check" indicated "12:45 PM, 158 °F." The guidance on the form indicated "Discard food item(s) if checked after the 2 hour check time" and "Discard food item(s) if temperature > (greater than) 70 °F." There was a three hour gap between temperature recordings and the pot roast did not reach less than 70 °F. For the same food item, the column labeled "Discard? Circle one" (yes or no), the entry was circled "no." There was no further documentation on the log to indicate the pot roast was not served to the patients.

During an interview with the EC the same day at 10:54 AM, the EC stated that the roast dated 4/25 [2018] was cooked for patient food service. He stated that he did not review the log to determine if the pot roast was safe for service. He could not explain why the pot roast was not discarded. He verified that based on the log, the pot roast was not safe to serve to patients.

During an interview with Food Service Manager 2 (FSM 2) the same day at 11:51 AM, the Nutritional Services Hot Food Cooling Logs for the last 3 months were requested. FMS 2 stated that there were no logs kept from January 2018 until the current log dated 4/20 through 5/6 [2018]. She stated that the managers were not monitoring the logs, and apparently they were not being done by the cooks.

On 5/9/18 at 10 AM, FSM 2 provided the Nutritional Services Hot Food Cooling Logs that were requested. The last logs that were kept before 4/20/18 were dated 8/8/17 through 8/28/17. There was an eight month gap when cooling logs were not kept. A review of this log indicated an entry dated 8/23/17 for Pot Roast in which the "2 Hour Check" was 75 °F (greater than the required 70 °F), yet the log indicated that the pot roast was not discarded. There was no indication on any of the cooling log forms that a manager or supervisor reviewed the forms.

A review of the hospital's HACCP Food Safety Plan, 19- Cooling Potentially Hazardous Foods, dated 10/01/10, indicated that for "Verification and Record Keeping: Food service employees will record temperatures and corrective actions taken on the Cooling Temperature Log or other appropriate log when establishing safe cooling procedures for each type of food. The Manager on Duty will verify that food service employees are cooling food properly by visually monitoring food service employees during the shift and reviewing, initialing, and dating appropriate logs. The logs will be retained with other records for 1 year."

2. During an interview with Cook 2 on 5/9/18, at 9:46 AM, Cook 2 was asked what was the final cooking temperature for chicken when he cooked it. Cook 2 stated that chicken needed to be cooked to 135 or 140 °F. Cook 2 stated that the previously cooked roast beef should be reheated to 165 °F but if he cooked chicken to 165 °F it would get too dry. Cook 2 further stated that he does not record the final cooking temperature for the foods he cooks. Instead, the temperature was recorded when the food was placed on trayline (on the steamtable used to serve patient food for meal service).

A review of the Food and Nutrition HACCP/Infection Control policy and procedure (FNS#J.1), dated 07/2017, indicated, "Potentially hazardous foods are cooked to at least the following safe internal temperatures and held for at least 15 seconds: Poultry ....165 °F ...Fish 145 °F ..." The policy further stated "Leftovers and advanced prepared foods are thoroughly and rapidly reheated to 165 °F or higher for 15 seconds before being served or being placed in warming units." It also indicated, "Hold hot food at a minimum of 135 °F." HACCP is Hazard Analysis Critical Control Points, a systematic preventative approach to food safety that is designed to reduce risk to food during storage and production to a safe level.

During an observation of the trayline service for lunch on 5/9/18, at 11:30 AM, the temperature of ground chicken, chopped pot roast and shrimp on the steamtable were taken. The temperature of the chicken was 150-153 °F. The temperature of the chopped pot roast was 156 °F. The temperature of the shrimp was 120-125 °F, less than the required hot holding temperature indicated in the policy.

During a concurrent interview with Food Service Manager 1 (FSM 1), FSM 2, the Sous Chef and the Executive Chef, they were all asked how they knew that the chicken, pot roast and shrimp were cooked to a safe final cooking temperature. No one was able to answer. They were asked what temperature was logged on the trayline temperature log. FSM 2 stated the temperature for ground chicken, chopped pot roast and shrimp were not on the log.

A review of the hospital's HACCP Food Safety Plan, 12 - Cooking Potentially Hazardous Foods, Standard Operation Procedure (SOP), dated 10/01/10, indicated in bold lettering, "Record final cooking temperatures of each menu item on the appropriate log." It further indicated for "Monitoring: Temperatures will be taken at the end point of cooking and recorded on logs. These logs will be monitored by the Manager on Duty to ensure that the temperatures meet the minimum standards."

According to the 2017 USDA Food Code, to kill microorganisms, food must be held at a sufficient temperature for the specified time. Greater numbers and varieties of pathogens (disease causing organisms) generally are found on poultry than on other raw animal foods. Therefore, a higher temperature, in combination with the appropriate time is needed to cook these products.

3. During a tour of the kitchen on 5/8/18, at 9:40 AM, two ice machines were noted. Two drain pipes were observed under the ice machines with the end of the pipes touching the grate on the floor sink, failing to maintain an air gap. These pipes drained melting ice from the ice storage bins of the ice machines.

An air gap is a minimum of one inch gap between the end of a draining pipe and the flood level of a sink. According to the 2017 USDA Food Code, providing an air gap between the water supply outlet and the flood level rim of a plumbing fixture or equipment prevents contamination that may be caused by backflow of wastewater. During periods of extraordinary demand, drinking water systems may develop negative pressure in portions of the system. If a connection exists between the system and a source of contaminated water during times of negative pressure, contaminated water may be drawn into and foul the entire system, or in this case, the ice storage bins.

During a concurrent interview with the Director of Food and Nutrition Services (DFNS), he confirmed that the end of the pipes were touching the grate on the floor sink. He stated that they may have gotten knocked down since there was no support to prevent the pipes from being knocked down.

During an interview with Maintenance Staff 1 (MS 1) on 5/8/18, at 11:10 AM, MS 1 stated that the pipes should have a support to prevent them from being knocked down in order to maintain an air gap. MS 1 could not state why there was no support.

4. During a tour of the kitchen on 5/8/18, at 11:45 AM, a box of frozen meatballs was noted in the walk-in freezer (RK12). The box was noted to be open with the meatballs exposed to the freezer air.

During a concurrent interview with the Sous Chef and the Director of Food and Nutrition, both stated the meatball should be sealed closed.

A review of the hospital's HACCP Food Safety Plan, Standard Operating Procedure (SOP) 6- Preventing Cross-Contamination During Storage and Preparation, dated 10/01/10, indicated, "Store all food in covered containers or packages ..." HACCP is Hazard Analysis Critical Control Points, a systematic preventative approach to food safety that is designed to reduce risk to food during storage and production to a safe level.

5. During a tour of the kitchen on 5/8/18, at 11:08 AM, in one of the bulk dry food storage bins which contained pinto beans, the scoop was stored on the food so that the handle of the scoop was touching the beans.

During a concurrent interview with the Executive Chef (EC), he stated the scoop should not be stored in the food.

A review of the Food and Nutrition Policy titled "Food Supply and Storage" (FNS#F.6), dated 07/2017, indicated "Scoops for dispensing dry bulk items and ice will be stored separately of the product."

According to the 2017 USDA Food Code, during pauses in food preparation or dispensing, food preparation and dispensing utensils shall be stored, in food that is not time/temperature control for safety food with their handles above the top of the food within containers or equipment that can be closed, such as bins of sugar, flour, or cinnamon. It further states the handles of utensils, even if manipulated with gloved hands, are particularly susceptible to contamination.

6. During a tour of the nursing station nourishment room, C5N1B, on 5/8/18, at 3:25 PM, a nutritional supplement was noted in the refrigerator, not dated. The nutritional supplement was labeled by the manufacturer "Store Frozen". The supplement was refrigerated, not frozen. Further review of the manufacturer's guidance on the label indicated that once the supplement was thawed, it should be used within 14 days. Since there was no thaw date on the supplement, there was no way to determine how long the supplement had been thawed.

During a concurrent interview with Food Service Manager 2 (FSM 2), she stated that the food service staff did not stock the nutritional supplement in the nourishment refrigerators on the nursing unit. She stated that the supplement likely was put in the refrigerator from a patient's meal tray. No one could state how long the supplement was in the refrigerator.

During a subsequent tour of the kitchen the same day at 4:05 PM, there were approximately 12 thawed nutritional supplements stored in the air curtain refrigerators that were not dated.

During a concurrent interview with FSM 2 and Director of Food and Nutrition Service (DFNS), FSM 2 verified that there was no system for monitoring the 14 day thawed shelf life of the nutritional supplements. The DFNS could not state how the shelf life was monitored without keeping track of a thaw date for the supplements.

A review of the Food and Nutrition Food and Supply Storage Policy (FNS#F.6), dated 07/2017, indicated, "Previously frozen foods that are defrosted and stored in refrigeration will be labeled with a use by date. Frozen products purchased as ready to use will be labeled with a use by date when being defrosted and stored refrigerated. The use by date will be determined by the manufactures recommendations."

7. During a tour of the dry storage area on 5/8/18, at 11:18 AM, there was a case of enteral feeding formula (a nutritionally complete product that is fed to the patient through a tube that delivers it directly to the stomach or intestines), which contained 6 units of one liter bottles. The box of enteral formula had a manufacturing expiration date of 4/1/18. This item had exceeded the manufacturer's expiration date by 37 days.
During a concurrent interview with the Executive Chef (EC), he stated that he checked the dry storage area once a week and storage room clerk also checked it for expired items once a week. The EC verified that the item was expired and was unable to explain why it was still stored more than a month after it had expired.
During a tour of the kitchen on 5/8/18, at 11:50 AM, there were three dairy crates full of individual containers of milk that were stored towards the back wall of walk in refrigerator number RK14. One of the dairy crates contained milk cartons with an expiration date of 5/5/18.
During a concurrent interview with Director of Food and Nutrition Services, he stated that dairy delivery was on Tuesdays, Thursdays and Saturdays. He further stated when delivery arrives today he will pick up expired crate and give us credit for it. There was no sign or label on the crate that indicated expired milk for pick up. During a concurrent interview with the EC, he verified that milk was expired and there was no sign on the milk to notify dietary staff not to use it.
A review of the Food and Nutrition HACCP/Infection Control Policy (FNS#J.1), dated 07/2017, indicated "Milk will be discarded after the expiration date on the label." HACCP is Hazard Analysis Critical Control Points, a systematic preventative approach to food safety that is designed to reduce risk to food during storage and production to a safe level.
8. During an observation of the nourishment room number B2N1B in Obstetrics unit on 5/8/18, at 3:30 PM, the temperature of the below the counter refrigerator was 44 °F (degrees Fahrenheit). Inside the refrigerator were juices and milk for patients. A temperature check of the milk carton indicated it was 42.8 - 43 °F.
A review of the Food and Nutrition HACCP/Infection Control Policy (FNS#J.1), dated 07/2017, indicated that fluid milk's recommended product storage temperature was 38-41 °F. HACCP is Hazard Analysis Critical Control Points, a systematic preventative approach to food safety that is designed to reduce risk to food during storage and production to a safe level.
During a concurrent interview with Food Service Manager 2 (FSM 2), she stated that Dietary Staff checked the temperature of the nourishment refrigerators once a day. FSM 2 further stated that when dietary staff checked the temperature at 5:00 AM this morning, the temperature was 37 °F. Since that was the last time the temperature was checked, FSM 2 could not determine how long the milk had been out of temperature.
According to the 2017 USDA Food Code, time/temperature control for safety food shall be maintained 135 °F or above or at 41 ºF or less.

9. During an observation of the kitchen on 5/8/18, at 10:00 AM, there were six metal wire shelving units adjacent to the 3 compartment manual wash sink area to hold washed, cleaned and dried pots and pans. Two of the racks were rusted, some of the paint was peeled off, had a sticky residue and were sticky to touch.
During a concurrent interview with the Director of Food and Nutrition Services, he stated these racks were cleaned once a month. He agreed that you cannot clean around rust and peeled off paint. He verified that the racks that contained clean pots and pans were covered with a sticky residue.
According to the 2017 USDA Food Code, nonfood-contact surfaces of equipment shall be cleaned at a frequency necessary to preclude accumulation of soil residues. Additionally, nonfood-contact surfaces shall be free of unnecessary ledges, projections, and crevices, and designed and constructed to allow easy cleaning and to facilitate maintenance.

10. During a tour of the infant feeding preparation room in the Neonatal Intensive Care Unit (NICU) on 5/10/18, at 11:10 AM, the product used to sanitize the feeding preparation area was observed to be Super Sani-Cloth.

A review of the manufacturer's instructions on the container of Super Sani-Cloths indicated, "To disinfect nonfood contact surfaces only."

A review of the hospital's policy titled, Formula Use, Mixing and Storage (N3.6/P3.5), dated 08/2016, indicated, "Aseptic technique is used in all mixing procedures in the formula room. All preparation/mixing is done on a clean, dry and disinfected surface. The surface (counter) is disinfected before and after each mixing of formula." The policy further indicated "References: American Dietetic Association (2011) Guidelines for preparation of formula and breastmilk in healthcare facilities. 2nd Edition. S.T. Robbins and Meyers, R. Editors."

A review of American Dietetic Association (2011) Guidelines for Preparation of Formula and Breastmilk in Healthcare Facilities. 2nd Edition. S.T. Robbins and Meyers, R. Editors., page 23 states, "Cleaning Supplies: Dishwasher detergent, bleach, sanitizing solutions and other cleaning supplies used in the infant feeding preparation room must be approved for foodservice use by the health care facility's infection control committee." On page 14, it states "Appropriate chemicals are those that are acceptable for food contact surfaces and approved by the facility's infection control committee."

11. During an interview with the hospital's three Infection Preventionists (IP 1, IP 2 and IP 3) on 5/10/18, at 2:30 PM, IP 1 stated that the Infection Prevention Committee had not identified the above deficient practices in sanitary conditions in the kitchen, nursing nourishment room and the infant feeding preparation room. They stated that although surveillance was conducted related to safe food handling, these deficient practices were not identified.

A review of the hospital's checklist titled, Food and Nutrition Service Infection Prevention Rounds, dated 2/27/15, indicated one of the items investigated was rapid cooling of all perishable foods. Even though the dietary staff had not kept logs on safe cooling of perishable foods, this had not been identified as a deficient practice. Another item on the list to investigate was that hot foods were cooked/rethermalized to greater than 165 °F prior to being placed into service. This was not identified as an issue even though there were no logs to indicate final cooking temperatures of food before being placed into service.

A review of the hospital's Infection Prevention Program, 2018-2019 general goals indicated goals to, "Protect patients, visitors, associates, healthcare workers and the community by reducing risks of healthcare acquired infections, minimizing the transmission of communicable diseases, providing timely exposure follow-up and management ....[and] Performance improvement activities to address areas needing improvement identified by the organization and/or the Infection Preventionist Committee."


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12. During a tour of the Operating room (OR) on 5/8/18 at 9:40 a.m., with Nursing Director of OR the following Temperature (T) and Humidity (H) were observed in the Operating Rooms OR 1 - T 64.7 ° F (degrees Fahrenheit) and H - 63.3%; OR 2: T- 63.9 ° F and H- 64.5%; OR Center; in OR 4 was T- 63 ° F and the H - 76%; Anesthesia Supply room: T - 64.8 ° F and H - 82%. The implant storage room with no monitor of temperature and humidity.

During an interview with the OR director on 5/8/18 at 10:30 a.m., when asked for the operating room log for evaluating and correcting variances in temperature and humidity, none were provided. Nursing director of OR and OR director indicated there were no logs and no monitoring of temperature and humidity in the OR or any logs or variances and correction time of variances throughout the day. When asked who checks temperature and humidity throughout the day in the OR, Nursing director of OR and Director of OR indicated Plant Operations Maintenance (POM) monitors and checks temperature and humidity.

During an interview with the and the Plant Operations Maintenance (POM) director on 5/11/18 at 2:40 p.m., he indicated the temperature and humidity of the OR is checked in the morning, various locations in the facility were recorded and evaluated each day at 5 a.m. Any variances at the 5 a.m. reading were reported to all departments including OR. When asked was there any ongoing monitoring or documentation of the temperature and humidity by the OR or alarms. There were none.

A review of Facility Policy and Procedure titled, "Humidity and Temperature Monitoring in Surgical and Procedural Areas" dated 10/2017 indicated the "Humidity range is 20-60%" and".. Surgical/procedural room temperature 68-75 degrees Fahrenheit."

13. During an observation with Infection Control Director on 5/8/18 at 10:20 a.m., in the Operating room Central hallway, housekeeping was observed moping the floor in OR 3. When she finished she brought the mop out of the room, brought the mop out and removed the mop base into a plastic bin in the central OR hallway across from the sterile surgical instruments on an open cart in a high traffic hallway. Next to the trash bin was a soiled linen hamper. Next to the sterile surgical instrument cart was a cart with cleaning supplies.

14. During a review of the medical staff credentialing file, ten out of ten reviewed medical staff credentialing files did not have documentation of Hepatitis B status or Hep B waiver on file.
During an interview with the Medical Staff director on 5/11/18 at 1:20 p.m., HR director indicated the facility required Medical Staff to provide documentation of yearly flu vaccine and updated TB testing yearly. Medical Staff Director indicated there was no policy and procedure requiring Medical Staff to provide documentation of Hepatitis B status or Hep B waiver.


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15. During a tour of the facility's off-campus Sleep Disorder Center on 5/10/2018 at 11:45 AM, the maintenance room was observed to contain assorted cleaning solutions for cleaning floors, windows, and walls. Against one wall of the room was a clean and rise bucket used for mop floors; one side of the bucket contains cleaning solution and the other side holds clean water for rinsing a mop. A mop was stored in the bucket with the mop head inside the cleaning solution side of the bucket.

The Sleep Center Director acknowledged at that time that the mop should not be stored in that manner.

According to the Center For Disease Control and Prevention (CDC) online article, titled, "Guidelines For Environmental Infection Control In Health Care Facilities-Recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC)", dated 6/3/2003, indicated to clean mops and cloths after use and allow to dry before reuse; or use single-use, disposable mop heads and cloths (282,286--288). Category II (https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5210a1.htm)

During a tour of the Outpatient Surgical Clinic on 5/9/2018 at 9:10 AM, two hand washing stations were observed to have aerators on the ends of their spouts.

During a conversation with the OP Surgery Manager at that time, she stated that those aerators were in fact laminar flow devices that were satisfactory for use at hand cleaning stations in the post operative area of the surgery center.

According to the California Building Code Section 420A (for OSHPD 1) - Hospitals Section 420A.3 Definitions, Handwashing Fixture - The fixture cannot be equipped with an aerator (device that splits the flow of water out of a faucet and prevents splashing by adding air to its flow), or wrist and elbow blade handles.

Another study presented by Infection Control Today found that microbial volume was up to 10 times greater when aerators were in place than after they had been sterilized. Microorganisms such as Legionella, Acinetobacter, and other gram negative bacteria had significantly higher concentrations in aerators than in the general plumbing system. Low water temperature and low

Based on observation, review of facility documents and staff interview, the facility failed to meet the Condition of Participation in Surgical Services by failing to:

1. Assure temperature and humidity in the operating rooms were within acceptable range and variances were corrected and documented. Ensure the relative humidifies were monitored in the operating room in accordance with the facility's policy and procedure, titled "Humidity and Temperature Monitoring in Surgical and Procedural Areas". (Refer to A 951).

2. Assure surgical services were provided in a safe environment for surgical services, to avoid sources and transmission of infections. Ensure trash collection area should be separated from personnel and patient traffic areas in accordance with the recommendation from the Association of Perioperative Room Nursing (AORN). Refer to A 951)

3. Ensure a tracheostomy set was available in the operating room suites in Women Center.
This deficient practice created the risk of poor health outcome in the event that a patient required a tracheostomy tray. (Refer to A 956).

The cumulative effect of these systemic issues resulted in the facility's inability to ensure and provide a safe patient care environment.

Based on observation, interview and record review, the facility failed to provide a safe environment and maintain high standards of care for patients receiving surgical services by failing to:

1. Assure temperature and humidity in the operating rooms were within acceptable range and variances were corrected and documented. Ensure the relative humidifies were monitored in the operating room in accordance with the facility's policy and procedure, titled "Humidity and Temperature Monitoring in Surgical and Procedural Areas".

This deficient practice promote microbial growth and can result in contamination of sterile items.

2. Assure surgical services were provided in a safe environment for surgical services, to avoid sources and transmission of infections. Ensure trash collection area should be separated from personnel and patient traffic areas in accordance with the recommendation from the Association of Perioperative Room Nursing (AORN).

This deficient practice had the potential for contamination of the surgical room with microorganisms which may affect the health and safety of the patients receiving surgical services in the hospital.

Findings:

1. a. During a tour of the Operating room (OR) on 5/8/18 at 9:40 a.m., with Nursing Director of OR the following Temperature (T) and Humidity (H) were observed in the Operating Rooms OR 1 - T 64.7 ° F (degrees Fahrenheit) and H - 63.3%; OR 2: T- 63.9 ° F and H- 64.5%; OR Center; in OR 4 was T- 63 ° F and the H-76%; Anesthesia Supply room: T - 64.8 ° F and H - 82%. The implant storage room with no monitor of temperature and humidity.

During an interview with the OR director on 15/8/18 at 10:30 a.m., when asked for the operating room log for evaluating and correcting variances in temperature and humidity, none were provided. Nursing director of OR and OR director indicated there were no logs and no monitoring of temperature and humidity in the OR or any logs or variances and correction time of variances throughout the day. When asked who checks temperature and humidity throughout the day in the OR, Nursing director of OR and Director of OR indicated Plant Operations Maintenance (POM) monitors and checks temperature and humidity.

During an interview with the and the Plant Operations Maintenance (POM) director on 5/11/18 at 2:40 p.m., he indicated the temperature and humidity of the OR is checked in the morning, various locations in the facility were recorded and evaluated each day at 5 a.m. Any variances at the 5 a.m. reading were reported to all departments including OR. When asked was there any ongoing monitoring or documentation of the temperature and humidity by the OR or alarms. There were none.

A review of Facility Policy and Procedure titled, "Humidity and Temperature Monitoring in Surgical and Procedural Areas" dated 10/2017 indicated the "Humidity range is 20-60%" and".. Surgical/procedural room temperature 68-75 degrees Fahrenheit."

2. a. During an observation with Infection Control Director on 5/8/18 at 10:20 a.m., in the Operating room Central hallway, housekeeping was observed moping the floor in OR 3. When she finished she brought the mop out of the room, brought the mop out and removed the mop base into a plastic bin in the central OR hallway across from the sterile surgical instruments on an open cart in a high traffic hallway. Next to the trash bin was a soiled linen hamper. Next to the sterile surgical instrument cart was a cart with cleaning supplies.


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1. b. During the initial tour with Manager, in the operating room (OR) suites 5/8/18 between 9:52 a.m. and 10:55 a.m., the following were observed:

RH(%)(Relative Humidity)

OR RH(%)
#2 64.5
#4 76.2
#6 82.0
#9 61.0

During the concurrent interview, the manager stated the staff notified the facility operation if there was abnormal range of humidity identified in the daily Temp (Temperature)/RH (Relative Humidity) Report early in the morning.

A review of the Surgery Temp /RH Report, dated from 4/8/18 to 5/8/18, indicated as follows:

4/8/18
OR RH(%)
#1 65.6
#2 64.0
#3 69.2
#4 70.6
#9 71.2
Heart Room 73.4

4/12/18
OR RH(%)
#1 62.1
#4 62.3
#7 61.0
#9 60.7
Heart Room 64.9

4/16/18
OR RH(%)
Heart Room 63.2

4/20/18
OR RH(%)
Heart Room 61.1

4/21/18
OR RH(%)
Heart Room 62.0

4/23/18
OR RH(%)
#1 69.8
#2 68.4
#3 69.1
#4 69.9
#7 68.1
#8 71.4
#9 71.0
Heart Room 74.2

4/25/18
OR RH(%)
#1 64.6
#2 63.9
#3 62.8
#4 65.8
#7 63.7
#8 67.2
#9 65.9
Heart Room 69.6

4/26/18
OR RH(%)
#1 69.2
#2 63.4
#3 73.1
#4 74.6
#7 69.5
#8 75.2
#9 74.0
Heart Room 75.9

4/28/18
OR RH(%)
#1 65.0
#2 66.0
#3 68.1
#4 67.7
#7 64.8
#8 70.9
#9 70.1
Heart Room 73.4

4/29/18
OR RH(%)
#1 68.3
#2 66.2
#3 69.2
#4 79.6
#7 67.4
#8 71.0
#9 70.5
Heart Room 75.5

4/30/18
OR RH(%)
#1 69.3
#2 67.0
#3 70.0
#4 71.0
#7 67.2
#8 71.5
#9 71.0
Heart Room 75.1

5/1/18
OR RH(%)
#1 61.0
#2 62.9
#3 65.6
#4 66.7
#7 62.0
#8 67.1
#9 64.8
Heart Room 71.3

5/2/18
OR RH(%)
#1 67.3
#2 66.4
#3 64.2
#4 70.4
#7 67.7
#8 71.2
#9 69.3
Heart Room 68.7

5/3/18
OR RH(%)
#1 62.9
#2 62.3
#3 63.7
#4 67.0
#7 67.7
#8 68.0
#9 66.7
Heart Room 66.2

5/4/18
OR RH(%)
Heart Room 65.3

5/7/18
OR RH(%)
#4 62.5
#8 62.1
Heart Room 63.6

5/8/18
OR RH(%)
#1 64.1
#2 64.7
#3 67.1
#4 67.5
#7 63.3
#8 67.8
#9 64.8
#10 61.4
Heart Room 65.8


According to the facility's policy and procedure, titled "Humidity and Temperature Monitoring in Surgical and Procedural Areas":

"II. Definitions:

A. Humidity will be maintained as recommended by the California Mechanical Code, Title 24, chapter 4 and CMS Code 482.41. (c)(a). Humidity Range is 20-60%.

V. Procedures:

3. The facilities department will submit an action plan to resolve on-going issues related to humidity and /or temperature levels that are out-of-range."

During the interview on May 11, 2018 at 9 a.m., the Supervisor of Facility Plant Operation stated the daily Surgery Temp /RH Reports were printed and sent out to the OR. According to the Supervisor, they make adjustment for those out-of range humidifies daily but they did not have action plan on out-of-range humidifies after the adjustment was made. There was no documentation that the ongoing out-of-range humidifies had been resolved.

2. b. There was one trash container on one side of the corridor with a cart of sterile supplies and instruments on the opposite side of the corridor between OR#2 and OR#3. There was another trash container and janitor cleaning cart on one side of the corridor with a cart of sterile supplies and instruments on the opposite side of the corridor between OR#6 and OR#7. A custodian was observed dumping soiled supplies from the OR into both trash containers. The same custodian cleaned a mop in the janitor cleaning cart.

During the concurrent interview, the OR Manager stated trash collection area should be separated from personnel and patient traffic areas (corridor). The OR Manager stated the janitor room was too small to hold the trash container when the evaluator was asking why the trash containers could not be stationed in the janitor room.

According to Perioperative Standards and Recommended Practices from AORN (2013), Aseptic Practice, Traffic Patterns:

"Recommendations IV

The movement of clean and sterile supplies and equipment should be separated from contaminated supplies, equipment, and waste by space, time, or traffic patterns.

3. When there is a clean core, the movement of supplies should be from the clean core through the operating or procedure room to the peripheral corridor.

Soiled supplies, instruments, and equipment should not re-enter the clean core area. They should be contained in closed or covered carts or containers for transport to a designated decontamination area.

The decontamination area and soiled linen and trash collection area should be separated from personnel and patient traffic areas. Separation of clean and sterile supplies and equipment from soiled materials by space, time, and traffic patterns decreases the risk of infection."

Based on observation, interview and record review, the facility failed to ensure a tracheostomy set was available in the operating room suites in Women Center. This deficient practice created the risk of poor health outcome in the event that a patient required a tracheostomy.

Findings:

During the initial tour with in the Operating Room Suite of Women Center on May 8, 2018 between 11:40 a.m. and 11:50 a.m., there was no tracheostomy set available. According to Supervisor of OR, there was no a tracheostomy set available in the operating room suites.

According to the facility's policy and procedure for "Required Emergency Equipment:" " 4.1 Policy C. The following equipment will be maintained in the Surgical Services Department: 7. tracheostomy set "

Base on record review and interview, the facility failed to ensure the post-anesthesia evaluation completed and documented for one of 40 sampled patients (32) by an anesthesiologist.

Findings:

A review of Patient 32's closed record indicated the patient was admitted to the facility on March 2, 2018. The patient was discharged on March 7, 2018. Further review indicated there was no assessment and entry in the Post-Anesthesia Note, including if PACU [Post Anesthesia Care Unit] discharge criteria met, respiratory function adequate, vital signs within 20% of baseline met, mental status baselines, temperature normothermia, nausea and vomiting controlled, pain controlled, and postoperative hydration adequate.

During an interview with Infection Preventionist (IP2) on May 9, 2018, at 11:35 a.m., IP2 stated the Post-Op evaluation should have been completed.

Based on interview and record review, the facility failed to:
1. Administer Radioactive Isotopes to patients in a safe manner by an authorized certified radiology technician (CRT).

2. Monitor and assure the medical director oversight and authorization to reorder and administer radiopharmaceuticals after the spill, including immediate medical evaluation and documentation of clearing the patient and reordering the radiopharmaceutical medication.

Findings:

On 5/11/18 at 3:30 p.m., during an interview with the Supervisor of Nuclear Medicine (RD2), when asked how the Nuclear Technicians were trained and evaluated yearly. She indicated Dir of Radiology does yearly online skills training. She indicated only authorized CRTs can inject radiopharmaceutical.

A review of the Radiation safety minutes, dated 2/7/18 indicated a Nuclear medicine spill. A review of the documentation provided including the patient medical record documented on 1/24/18 Patient 30 was scheduled for a Whole body scan on 1/24/18. CRT1 and student trainee 1 administered radiopharmaceuticals when the spill occurred. The physician order for technetium-99m methelene diphosphonate22.4Ci(828.8MBq) initial order was dated 1/24/18. RD2 indicated the radiopharmaceutical was reordered by the CRT per RD2. When asked if Medical Director was contacted, RD2 indicated the radiation safety director was involved. There was no documentation that the Medical director had examined the patient after the spill. There was no documentation of an MD clearing the patient and reordering the radiopharmaceutical medication. There was no documentation in the medical record of any MD noted clearing the procedure, how much spilled on the patient's skin or instruction about skin care on the patient's arm and pillow. RD2 indicated CRT1 was trained and could inject radiopharmaceuticals and clean up and contain a spill. RD2 indicated the spill was considered a minor spill.

A review of a policy titled, "Authorized Personnel to inject Radiopharmaceuticals" dated 3/31/18 indicated a list of CRT's authorized to inject Radiopharmaceuticals and did not include CRT1. A review of a policy and procedure titled, "Technologist supervision protocol" indicated "Nuclear medicine Technologists perform the procedures under the supervision of a radiologist .... The supervision can either be direct or general." A review of the facility policy and procedure titled, "Major Spill emergency procedure" included instructions for spill on skin to wash skin thoroughly and then wash with mild soap and lukewarm water and to remove contaminated clothing.