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Based on staff interview and document review, the Hospital failed to ensure the Food and Nutrition services organization met standards as required by State of California Code of Regulations Title 22 Division 5, Chapter 1. General Acute Hospital, 70275(a) when the Registered Dietitian (Clinical Nutrition Supervisor) did not provide advice to the administrator and guidance to the supervisor (Executive Chef), and approval of all menus.

This failure put patients at risk of compromised nutritional outcomes.

Findings:

On 1/29/19 at 1:30 PM, the Clinical Nutrition Supervisor (CNS) stated she reports directly to the Executive Chef responsible for the management of the Food and Nutrition Services Department.

Review of the Organizational Chart- Kitchen 8320 and Nutrition 8340, the CNS reports to the Executive Chef.
Review of the job description of the CNS states the position "Under general direction, plans, directs, coordinates, evaluates, and supervises the clinical activities if the County Medical Center ..." Review of duties showed there is no responsibility given advice to the administrator, guidance to the supervisor (Executive Chef), and approval of all menus.

Review of the ARMC Executive Chef job description showed, "This is a single position is characterized by its managerial and administrative responsibility for the entire Food Service and Dietary Services Department. This position reports to the Associate Hospital Administrator-Professional Services."

During an interview on 1/30/19 at 3:35 PM, the Executive Chef (EC1) stated he was responsible for the Food and Nutrition operation and he was qualified as a Dietary Services Supervisor with a certificate course from Portland Community College dated 1980. EC1 stated the CNS participated in menu development giving suggestions, and attended meeting with the Assistant Hospital Administrator (AHA2) together with him. EC1 confirmed he was the approver of the menus and reporting department operations to the AHA2.

Based on staff interview and document review, the facility failed to develop a Quality Assessment and Performance Improvement plan (QAPI) for the Food Service and Nutrition Department.

Failure to develop and implement a QAPI program in a Department, that prepares and services meals and nourishments, puts the medically compromised patients at risk.

Findings:

On January 31, 2019 at 11:00 AM, the Food Service 1 (FS 1) stated there was no QAPI program for the food Service part of the department. FS 1 stated the department routinely monitored tray line temperatures and test tray temperatures. FS 1 confirmed there was no formal QAPI program that included plans that identified areas to improve patient care in food service delivery that was ongoing and comprehensive, led by leadership, provided data systems and monitoring, identifies problems systematically.

On January 31, 2019, at 11:00 AM, the Assistant Hospital Administrator 1 (AHA 1) stated the food service quality program was solely the Press Ganey patient satisfaction scores provided by the outside organization. AHA 1 stated the department did well when the scores went up and there was no plan developed or implemented if scores went down. AHA 1 confirmed there were no other QAPI programs in this Department that met the requirements of a QAPI program.

The facility failed to provide nursing services mandated on the Conditions of Participation: Nursing Services, when:

1. The facility failed to ensure the behavioral health nursing staff monitored the weight of one of 47 sampled patients (Patient 13) identified to be at nutrition risk. This failure resulted in the lack of a comprehensive nutrition assessment for Patient 13 who was at nutrition risk. (Refer to A-0392)

2. The facility failed to ensure medications were administered in accordance with the physician's order for heparin (medication used to decrease the clotting ability of the blood) infusion (drip) protocol. This occurred when the medical record did not indicate a physician was notified when one patient (Patient 40) of 47 sampled patients experienced two consecutive (continuous) Critical Values for Activated Partial Thromboplastin Times (APTTs - measurement for amount of time for blood to clot). A Critical Value is a measurement outside of the typical range that may result in life-threatening health consequences, which could increase in severity if clinically appropriate action is not quickly taken. Activated Partial Thromboplastin Times is a laboratory test that measures how long it takes for patient's blood to clot. This failure had the potential for lack of oversight and immediate involvement from the practitioner(s) responsible for the patient's care. (Refer to A-0405)

3. The facility failed to ensure intravenous (IV - into the patient's vein) medications were administered in accordance with policies and procedures (P & P) when:

a. For two patients (Patient 40 and Patient 42) of 47 sampled patients, the medical record indicated IV heparin (blood thinner) infusion (drip) rates were changed with no documentation of a countersignature (second verification signature) to demonstrate an independent double-check system of two nurses checking the settings and rates of infusion pumps. This failure had the potential for the patients to receive the wrong dose or rate of the heparin drip, which could result in ineffective (such as blood clots) or unsafe (such as serious bleeding) drug therapy. (Refer to A-0409)

b. For two patients (Patient 43 and Patient 44) of 47 sampled patients, the medical record indicated the IV insulin (drug to manage high blood sugar) infusion rates were changed with no documentation of a countersignature to demonstrate an independent double-check system of two nurses checking the settings and rates of infusion pumps. This failure had the potential for the patient to receive the wrong dose or rate of the insulin drip, which could result in unsafe (such as serious symptoms of low blood sugar) or ineffective (such as high blood sugar measurements) drug therapy. (Refer to A-0409)

c. For one patient (Patient 46) of 47 sampled patients, the medical record indicated patient controlled analgesia (PCA - patient self-administers pain medication by pushing a button) assessment of vital signs, level of pain, and level of sedation was not completed following initiation (start) of the PCA. This failure had the potential for the patients to increase the risk of PCA-related adverse events, such as unintentional oversedation and respiratory depression (unusually slow breathing). (Refer to A-0409)

The cumulative effects of these failures could affect the health and safety of the patients with the potential to cause death.

Based on staff interviews, medical record review, and hospital review, the hospital failed to ensure the behavioral health nursing staff monitored the weight of one of 47 sampled patients (Patient 13) identified to be at nutrition risk. This failure resulted in the lack of a comprehensive nutrition assessment for Patient 13 who was at nutrition risk.

Findings:

A review of the medical record for Patient 13 indicated that the patient was admitted to the behavioral health unit of the hospital on December 12, 2018 with diagnoses that included dementia (a decline in mental ability severe enough to interfere with daily life) with behavioral disturbances. Review of the nutrition notes included an assessment by Registered Dietitian 1 (RD 1) dated December 26, 2018. RD 1 indicated that Patient 13's weight had been 77 kilograms (kg) during a previous admission in March of 2018. Patient 13's weight was documented in this assessment as 180 pounds (81.8 kg) which represented a 4.8 kg (10.6 pound) increase since March 2018. Further review of the medical record showed that this weight, 180 pounds, was Patient 13's admission weight and no other weight had been documented. RD 1's assessment indicated that the nutrition plan for Patient 13 was to monitor his food intake and his weights for tends. The nutrition plan goals included stable weight. At the time of the assessment, Patient 13 had one recorded weight for this hospital stay, on admission on December 12, 2018.

A Nutrition Services Follow-up note dated January 2, 2019, indicated that Patient 13 had an average meal intake of 55% of meals over the last nine meals. It further stated that Patient 13 was easily distracted from eating due to his dementia and took much prompting and time to eat his meals. The follow-up note also stated, "Will discuss adding supplement to diet with RD in order to increase po [oral] intake." During an interview with the Clinical Nutrition Supervisor (CNS) while reviewing Patient 13's medical record on January 30, 2019, at 10 AM, she verified that the RD approved adding the supplement to Patient 13's diet and it was being sent to the patient on his meal trays three time a day.

A Nutrition Follow-up note written by Registered Dietitian 2 (RD 2) dated January 18, 2019 was reviewed. This note indicated that there still was no new weight in the medical record, only the weight taken on admission. RD 2 indicated that Patient 13's meal intake percentages now ranged from 25 to 100%, no average meal intake was documented. According to this note, the nutrition diagnosis indicated, "Predicted inadequate caloric intakes R/T [related to] mental condition AEB [as evidenced by] variable po intakes 25-100%." Recommended interventions by RD 2 were to add one nutritional supplement daily and monitor intake and Patient 13's weights. RD 2's note indicated Patient 13 was now at moderate nutrition risk.

A review of Patient 13's medical record with the CNS on January 30, 2019, at 10:30 AM, showed that the only weight recorded for Patient 13 during this hospital stay was the one weight taken on admission, 49 days earlier. During a concurrent interview with the Unit Manager for the behavioral health unit, he stated the policy for obtaining follow-up weights for patients on this unit was only if the RD or the physician requested or ordered weights to be done.

The hospital policy number 561.01 issue 2 titled "Patient Weight Frequencies" (revised 8/2017) indicated, "Patients whose length of stay is greater than 30 days in the hospital is weighted monthly."

During an interview with RD 1 on January 30, 2019, at 11:20 AM, RD 1 could not explain how the hospital could monitor Patient 13's weights "for trends" as she had indicated in her plan on December 26, 2019, when there were no follow-up weights being taken.

Based on interview and record review, the facility failed to ensure medications were administered in accordance with the physician's order for heparin (prevents the formation of blood clotts) infusion (drip) protocol. This occurred when the medical record did not indicate a physician was notified when one patient (Patient 40) of 47 sampled patients experienced two consecutive (continuous) Critical Values for Activated Partial Thromboplastin Times (APTTs - measurement for amount of time for the blood to clot). A Critical Value is a measurement outside of the typical range that may result in life-threatening health consequences which could increase in severity if clinically appropriate action is not quickly taken. Activated Partial Thromboplastin Times is a laboratory test that measures how long it takes for patient's blood to clot. This failure had the potential for lack of oversight and immediate involvement from the practitioner(s) responsible for the patient's care.

Findings:

A review of Patient 40's medical record indicated a physician's order dated January 18, 2019, for heparin infusion protocol. The heparin infusion protocol was discontinued on January 26, 2019. The heparin infusion protocol ordered by the Physician indicated,

"Condition ...aPTT > [greater than] 142 [seconds] ...

Instruction ...CALL PHYSICIAN."

A review of Patient 40's medical record indicated the APTT history. Patient 40's APTT collected on January 18, 2019, at 6:44 PM resulted in a Critical Value measurement of "> [greater than] 150 seconds." Patient 40's next APTT collected on January 19, 2019, at 3:05 AM resulted in a Critical Value measurement of "> [greater than] 150 seconds."

On January 31, 2019, at 11:23 AM, during a record review, the Nurse Educator 1 was asked if Patient 40's medical record indicated a Physician was called when the two APTT Critical Value measurements of greater than 150 seconds were measured on January 18, 2019, at 6:44 PM, and January 19, 2019, at 3:05 AM. The Nurse Educator 1 was requested to follow-up with the information.

On February 1, 2019, at 10:25 AM, during an interview, the Registered Nurse 2 (RN 2) was asked on the process when APTT measurements resulted in a Critical Value of greater than 150 seconds, the RN 2 stated "we call the doctor". The RN 2 stated the process was to document what time the Physician called back and if there were any new orders.

On February 1, 2019, at 11:44 AM, during an interview, the Nurse Educator 1 stated she did not see anything in Patient 40's medical record to show a Physician was called on the two APTT Critical Value measurements of greater than 150 seconds that were measured on January 18, 2019, at 6:44 PM, and January 19, 2019, at 3:05 AM. The Nurse Educator 1 stated the staff was expected to follow the heparin infusion protocol to call the Physician.

The facility policy and procedure (P & P) titled, "Medication Administration" dated September 25, 2018, indicated "The administration of medication, while authorized by State law, is a privilege." A further review of the policy indicated, "the individual administering the medication must do the following ...Discusses any unresolved concerns about the medication with the prescriber and/or other staff involved prior to administering the medication."

The facility P & P titled, "High Alert [drugs that have an increased risk of significant patient harm when used in error] Medications" dated September 25, 2018, indicated "POLICY" ...[The name of the facility] has defined a process for identifying and managing the use of high-alert medications and will increase patient safety by preventing errors with high alert medications..." A further review of the policy indicated, "Strategies for Safeguarding the Use of High-Alert Medications" ...Standardization includes the following ...Medication administration procedures."

The facility P & P titled, "Anticoagulation Therapy" dated September 25, 2018, indicated "POLICY: Anticoagulation therapy is associated with high risk due to the use of agents with a narrow therapeutic range [drugs which require careful monitoring due to a small window between safe and toxic doses]. Inadequate anticoagulation can result in further thrombus [blood clot] development as well as severe bleeding."

Based on interview and record review, the facility failed to ensure intravenous (IV - into the patient's vein) medications were administered in accordance with policies and procedures (P & P) when:

1. For two patients (Patient 40 and Patient 42) of 47 sampled patients, the medical record indicated IV heparin (blood thinner) infusion (drip) rates were changed with no documentation of a countersignature (second verification signature) to demonstrate an independent double-check system of two nurses checking the settings and rates of infusion pumps. This failure had the potential to for the patient to receive the wrong dose or rate of the heparin drip which could result in ineffective (such as blood clots) or unsafe (such as serious bleeding) drug therapy.

2. For two patients (Patient 43 and Patient 44) of 47 sampled patients, the medical record indicated the IV insulin (drug to manage high blood sugar) infusion rates were changed with no documentation of a countersignature to demonstrate an independent double-check system of two nurses checking the settings and rates of infusion pumps. This failure had the potential to for the patient to receive the wrong dose or rate of the insulin drip which could result in unsafe (such as serious symptoms of low blood sugar) or ineffective (such as high blood sugar measurements) drug therapy.

3. For one patient (Patient 46) of 47 sampled patients, the medical record indicated patient controlled analgesia (PCA - patient self-administers pain medication by pushing a button) assessment of vital signs, level of pain, and level of sedation was not completed following initiation (start) of the PCA. This failure had the potential for the patients to increase the risk of PCA-related adverse events, such as unintentional oversedation and respiratory depression (unusually slow breathing).

Findings:

1a. A review of Patient 40's medical record indicated a physician's order dated January 18, 2019, for heparin infusion protocol. The heparin infusion protocol was discontinued on January 26, 2019.

A review of "Nurse Notes" for Patient 40 indicated the heparin rates of infusion were changed on January 18, 2019, at 11:32 AM, to 20 units per kilogram (unit of measurement) per hour; January 18, 2019, at 9:01 PM, to 17 units per kilogram per hour; and January 19, 2019 at 5:14 AM, to 14 units per kilogram per hour. For the above dates and times, the medical record did not indicate an electronic countersignature of a second licensed provider verifying independent double check for settings and rates of infusion pumps when Patient 40's heparin infusion was changed.

On January 31, 2019, at 10:54 AM, during a record review and concurrent interview, Patient 40's medical record was reviewed with the Director of Pharmacy (DOP), Associate Director of Pharmacy (ADOP), and Nurse Educator 1. When asked if heparin infusion adjustments require a double check, the Nurse Educator 1 stated "yes." The ADOP acknowledged there was no second electronic countersignature when the medical record indicated the heparin rate of infusion was changed on January 18, 2019, at 11:32 AM. The DOP and ADOP acknowledged there was no second electronic countersignature when the medical record indicated the heparin rate of infusion was changed on January 18, 2019, at 9:01 PM. The Nurse Educator 1 acknowledged there was no second electronic countersignature when the medical record indicated the heparin rate of infusion was changed on January 19, 2019, at 5:14 AM.

On February 1, 2019, at 10:04 AM, during an interview, Registered Nurse 1 (RN 1) was asked about the process of countersignature. The RN 1 stated the person had to type their login name and password into the computer.

On February 1, 2019, at 10:17 AM, during an interview, RN 2 stated she administered approximately one heparin infusion per week. RN 2 stated an electronic countersignature was required when the heparin rate of infusion was changed due to APTT laboratory measurements.

The Joint Commission [an organization which accredits United States healthcare institutions] document titled, "Preventing errors relating to commonly used anticoagulants [blood thinners]" dated September 24, 2008, indicated "For heparin ...10. Before the start of a heparin infusion and with each change of the container or rate of infusion, require an independent double check of the drug, concentration, dose calculation, rate of infusion, pump settings, line attachment and patient identity."

The facility P & P titled, "Anticoagulation Therapy" dated September 25, 2018, indicated "POLICY: Anticoagulation therapy is associated with high risk due to the use of agents with a narrow therapeutic range [drugs which require careful monitoring due to a small window between safe and toxic doses]. Inadequate anticoagulation can result in further thrombus [blood clot] development as well as severe bleeding." On page 5 of 6, the policy indicated, "REFERENCES ...The Joint Commission Sentinel Event Alert: Preventing errors relating to commonly used anticoagulants; September 24, 2008."

The facility P & P titled, "High Alert [drugs that have an increased risk of significant patient harm when used in error] Medications" dated September 25, 2018, indicated "POLICY" ... [The name of the facility] has defined a process for identifying and managing the use of high-alert medications and will increase patient safety by preventing errors with high alert medications ...as recommended by the Joint Commission (TJC)..." A continued review of the policy indicated, "PROCEDURE ...H. Independent Double-Check Systems...

1. An independent double check consists of at least two qualified healthcare professionals verifying the accuracy of the drug, dose, calculation, and/or administration procedure
...c. Two nurses checking the settings and rates of infusions pumps ...

2. The following are the processes that require independent double-check
...e. Anticoagulants
i. Heparin, IV and subcutaneous routes (all heparin preparations ...)

...The medication administration countersignature can be performed by any licensed provider (i.e. nurse, prescriber, or pharmacist) ...
...III. Staff Education and Training
A. Healthcare professionals involved in the ordering, preparing, administering, and monitoring high-alert medications receive orientation and periodic education as noted in attachment A ...

Attachment A - High Alert Medication Policy
High Alert Medication Safety Practices
High Alert Medication Administration
Anticoagulants (heparin IV...) - Dose calculations and smart pumps are double-checked by 2 nurses prior to administration

The facility P & P titled, "Medication Administration" dated September 25, 2018, indicated "The following medications require a dosing double-check by two licensed practitioners prior to administration
...3. Heparin, IV ...The medication administration countersignature can be performed by any licensed provider (i.e. nurse, prescriber, or pharmacist)."

1b. A review of Patient 42's medical record indicated a physician's order dated January 13, 2019, for heparin infusion protocol. The heparin infusion protocol was discontinued on January 15, 2019.

A review of "Nurse Notes" for Patient 42 indicated the heparin rate of infusion was changed on January 14, 2019, at 9 AM to 15 units per kilogram (unit of measurement) per hour. For the above date and time, the medical record did not indicate an electronic countersignature of a second licensed provider verifying independent double check for settings and rates of infusion pumps when Patient 42's heparin infusion was changed.

On January 31, 2019, at 10:54 AM, during an interview, when asked if heparin infusion adjustments require a double check, the Nurse Educator 1 stated "yes."

On January 31, 2019, at 1:55 PM, during a record review and concurrent interview, Patient 40's medical record was reviewed with the DOP, ADOP, and Nurse Educator 1. The Nurse Educator 1 acknowledged there was no second electronic countersignature when the medical record indicated the heparin rate of infusion was changed on January 14, 2019, at 9 AM.

On February 1, 2019, at 10:04 AM, during an interview, Registered Nurse 1 (RN 1) was asked about the process of countersignature. The RN 1 stated the person had to type their login name and password into the computer.

On February 1, 2019, at 10:17 AM, during an interview, RN 2 stated she administered approximately one heparin infusion per week. RN 2 stated an electronic countersignature was required when the heparin rate of infusion was changed due to APTT laboratory measurements.

The Joint Commission [an organization which accredits United States healthcare institutions] document titled, "Preventing errors relating to commonly used anticoagulants [blood thinners]" dated September 24, 2008, indicated "For heparin ...10. Before the start of a heparin infusion and with each change of the container or rate of infusion, require an independent double check of the drug, concentration, dose calculation, rate of infusion, pump settings, line attachment and patient identity."

The facility P & P titled, "Anticoagulation Therapy" dated September 25, 2018, indicated "POLICY: Anticoagulation therapy is associated with high risk due to the use of agents with a narrow therapeutic range [drugs which require careful monitoring due to a small window between safe and toxic doses]. Inadequate anticoagulation can result in further thrombus [blood clot] development as well as severe bleeding." On page 5 of 6, the policy indicated, "REFERENCES ...The Joint Commission Sentinel Event Alert: Preventing errors relating to commonly used anticoagulants; September 24, 2008."

The facility P & P titled, "High Alert [drugs that have an increased risk of significant patient harm when used in error] Medications" dated September 25, 2018, indicated "POLICY" ... [The name of the facility] has defined a process for identifying and managing the use of high-alert medications and will increase patient safety by preventing errors with high alert medications ...as recommended by the Joint Commission (TJC) ..." A continued review of the policy indicated, "PROCEDURE ...H. Independent Double-Check Systems...

1. An independent double check consists of at least two qualified healthcare professionals verifying the accuracy of the drug, dose, calculation, and/or administration procedure
...c. Two nurses checking the settings and rates of infusions pumps ...

2. The following are the processes that require independent double-check
...e. Anticoagulants
i. Heparin, IV and subcutaneous routes (all heparin preparations ...)

...The medication administration countersignature can be performed by any licensed provider (i.e. nurse, prescriber, or pharmacist) ...
...III. Staff Education and Training
A. Healthcare professionals involved in the ordering, preparing, administering, and monitoring high-alert medications receive orientation and periodic education as noted in attachment A ...

Attachment A - High Alert Medication Policy
High Alert Medication Safety Practices
High Alert Medication Administration
Anticoagulants (heparin IV ...) - Dose calculations and smart pumps are double-checked by 2 nurses prior to administration

The facility P & P titled, "Medication Administration" dated September 25, 2018, indicated "The following medications require a dosing double-check by two licensed practitioners prior to administration
...3. Heparin, IV ...The medication administration countersignature can be performed by any licensed provider (i.e. nurse, prescriber, or pharmacist)."

2a. A review of Patient 43's medical record indicated a physician's order dated January 16, 2019, for insulin infusion protocol. The insulin infusion protocol was discontinued on January 17, 2019 at 1:10 PM.

A review of Patient 43's medical record indicated the rates of insulin infusion were changed on January 17, 2019, at 2 AM to 4.5 milliliters (mLs - unit of measurement) per hour, and January 17, 2019, at 3:04 AM to 5.5 mLs per hour. For the above dates and times, the medical record did not indicate an electronic countersignature of a second licensed provider verifying independent double check for settings and rates of infusion pumps when Patient 43's insulin infusion was changed.

On February 1, 2019, at 8:55 AM, during a record review and concurrent interview, Patient 43's medical record was reviewed with Nurse Director 1. The Nurse Director 1 acknowledged there were no second electronic countersignatures when the medical record indicated the insulin rate of infusions were changed on January 17, 2019, at 2 AM, and January 17, 2019, at 3:04 AM.

On February 1, 2019, at 10:04 AM, during an interview, Registered Nurse 1 (RN 1) was asked about the process of countersignature. The RN 1 stated the person had to type their login name and password into the computer.

The facility P & P titled, "High Alert [drugs that have an increased risk of significant patient harm when used in error] Medications" dated September 25, 2018, indicated "POLICY" ...[The name of the facility] has defined a process for identifying and managing the use of high-alert medications and will increase patient safety by preventing errors with high alert medications ...as recommended by the Joint Commission (TJC)..." A continued review of the policy indicated, "PROCEDURE ...H. Independent Double-Check Systems...

1. An independent double check consists of at least two qualified healthcare professionals verifying the accuracy of the drug, dose, calculation, and/or administration procedure
...c. Two nurses checking the settings and rates of infusions pumps...

2. The following are the processes that require independent double-check
...b. Insulin, IV...
...The medication administration countersignature can be performed by any licensed provider (i.e. nurse, prescriber, or pharmacist) ...

III. Staff Education and Training
A. Healthcare professionals involved in the ordering, preparing, administering, and
monitoring high-alert medications receive orientation and periodic education as noted in
attachment A...
Attachment A - High Alert Medication Policy
High Alert Medication Safety Practices
High Alert Medication Administration
Insulin (IV ...) - Smart pump [device] programmed for insulin drips, double-check dose/type and pump settings (for continuous drips) by 2 nurses prior to administration

The facility P & P titled, "Medication Administration" dated September 25, 2018, indicated "The following medications require a dosing double-check by two licensed practitioners prior to administration...
2. Insulin, IV... The medication administration countersignature can be performed by any licensed provider (i.e. nurse, prescriber, or pharmacist)."

2b. A review of Patient 44's medical record indicated a physician's order dated January 20, 2019, for insulin infusion protocol.

A review of Patient 44's medical record indicated the rates of insulin infusion were changed on January 20, 2019, at 5:40 PM to 5.5 mLs (milliliters) per hour, and January 20, 2019, at 6:42 PM to 11 mLs per hour. For the above dates and times, the medical record did not indicate an electronic countersignature of a second licensed provider verifying independent double check for settings and rates of infusion pumps when Patient 44's insulin infusion was changed.

On February 1, 2019, at 9:16 AM, during a record review and concurrent interview, Patient 44's medical record was reviewed with Nurse Director 1. The Nurse Director 1 acknowledged there were no second electronic countersignatures when the medical record indicated the insulin rate of infusions were changed on January 20, 2019, at 5:40 PM, and January 20, 2019, at 6:42 PM.

On February 1, 2019, at 10:04 AM, during an interview, Registered Nurse 1 (RN 1) was asked about the process of countersignature. The RN 1 stated the person had to type their login name and password into the computer.

The facility P & P titled, "High Alert [drugs that have an increased risk of significant patient harm when used in error] Medications" dated September 25, 2018, indicated "POLICY" ... [The name of the facility] has defined a process for identifying and managing the use of high-alert medications and will increase patient safety by preventing errors with high alert medications ...as recommended by the Joint Commission (TJC) ..." A continued review of the policy indicated, "PROCEDURE ...H. Independent Double-Check Systems...

1. An independent double check consists of at least two qualified healthcare professionals verifying the accuracy of the drug, dose, calculation, and/or administration procedure
...c. Two nurses checking the settings and rates of infusions pumps...

2. The following are the processes that require independent double-check
...b. Insulin, IV...
...The medication administration countersignature can be performed by any licensed provider (i.e. nurse, prescriber, or pharmacist) ...

III. Staff Education and Training
A. Healthcare professionals involved in the ordering, preparing, administering, and
monitoring high-alert medications receive orientation and periodic education as noted in
attachment A...
Attachment A - High Alert Medication Policy
High Alert Medication Safety Practices
High Alert Medication Administration
Insulin (IV ...) - Smart pump [device] programmed for insulin drips, double-check dose/type and pump settings (for continuous drips) by 2 nurses prior to administration

The facility P & P titled, "Medication Administration" dated September 25, 2018, indicated "The following medications require a dosing double-check by two licensed practitioners prior to administration...
2. Insulin, IV... The medication administration countersignature can be performed by any licensed provider (i.e. nurse, prescriber, or pharmacist)."

3. A review of Patient 46's medical record indicated a prescriber's order dated January 7, 2019, for morphine sulfate patient controlled analgesia (PCA). The medical record indicated the morphine sulfate PCA was first administered (started) to Patient 46 on January 7, 2019 at 10:16 PM. The morphine sulfate PCA was discontinued on January 9, 2019.

A review of Patient 46's medical record indicated a prescriber's order form titled "Patient Controlled Analgesia (PCA) Physician Orders" dated January 7, 2019, for morphine sulfate PCA. The signed PCA order form indicated, "Vital Signs every 30 minutes for 60 minutes, then every 2 hours for 4 hours, then every 4 hours."

On February 1, 2019, at 8:30 AM, during record review and concurrent interview, Patient 46's "Critical Care Flow Sheet" was reviewed with Registered Nurse 3 (RN 3) and the Associate Director of Pharmacy (ADOP). The RN 3 acknowledged the morphine sulfate PCA was first administered to Patient 46 on January 7, 2019 at 10:16 PM. RN 3 stated the vital signs assessed were blood pressure (BP), pulse oximetry (to monitor a patient's blood oxygen saturation level), and pulse (heartbeat). The medical record did not indicate the vital signs were assessed every fifteen (15) minutes for sixty (60) minutes, then every thirty (30) minutes for sixty (60) minutes, then every two (2) hours for four (4) hours after the morphine sulfate PCA was started on January 7, 2019, at 10:16 PM. RN 3 acknowledged there were no vital signs assessed on January 7, 2018, around 10 PM. RN 3 acknowledged the vital signs were assessed on January 8, 2019, at 12 AM; and on January 8, 2019, at 4 AM. The ADOP stated the vital signs were assessed every four hours.

On February 1, 2019, at 8:41 AM, during record review and concurrent interview, Patient 46's medical record was reviewed with RN 3. The medical record did not indicate the level of pain was assessed every two (2) hours for the first four (4) hours after the morphine sulfate PCA was started on January 7, 2019, at 10:16 PM. RN 3 stated the level of pain was assessed when the PCA was first started and then approximately 1 hour after on January 7, 2019, at 11:16 PM. RN 3 stated there was no more level of pain assessments after January 7, 2019, at 11:16 PM.

On February 1, 2019, at 8:43 AM, during record review and concurrent interview, Patient 46's "Critical Care Flow Sheet" was reviewed with RN 3. The medical record did not indicate the level of sedation was assessed every two (2) hours for the first four (4) hours after the morphine sulfate PCA was started on January 7, 2019, at 10:16 PM. RN 3 stated there should have been a level of sedation assessment on January 7, 2019, at 10 PM, and January 8, 2019, at 2 AM.

The facility P & P titled, "Pain Management Utilizing Patient Controlled Analgesia (PCA)" dated March 2015, indicated "IV. Patient Assessment...

A. The patient is closely observed during the first four (4) hours following the initiation of PCA and with pump setting or drug changes

B. Vital signs are taken every fifteen (15) minutes for sixty (60) minutes, then every thirty (30) minutes for sixty (60) minutes, then every two (2) hours for four (4) hours, then every four (4) hours.

C. Level of Pain: Is assessed every two (2) hours for the first four (4) hours of starting PCA system and then every four (4) hours. Pain level is assessed when the patient complains of inadequate pain relief.

D. Level of Sedation: Is assessed every two (2) hours for the first four (4) hours of starting PCA system or after each increase in either the basal rate and/or PCA dosage and then every four (4) hours.

Sedation Scale:
0 Wide awake, no sedation
1 Rouses with minimal stimuli (i.e., calling patient's name)
2 Needs greater stimulation or does not achieve full awake state
3 Deep Coma or reflex activity only
S Normal sleep"

Based on observation, interview, and record review, the facility failed to ensure compounding (mixing) practices were in accordance with applicable standards of practice. This occurred when a pharmacy technician with visible facial hair was working in the pharmacy compounding room without a beard cover. This failure had the potential to result in patients being exposed to increased risk of microbial (germ) contamination due to flakes (pieces) and particles shed by the compounding staff.

Findings:

On February 1, 2019, at 11:22 AM, during an observation and concurrent interview in the Main Inpatient Pharmacy, an inspection of the Non-Hazardous Compounding Room was conducted. The Pharmacy Technician (Pharmacy Tech) working in the compounding room was observed with facial hair on his cheeks and sideburns not covered by his face mask. The Pharmacy Tech acknowledged he was not clean shaven. He stated he had last shaved his face on the previous weekend (approximately five days before). He stated he had been working in the Non-Hazardous Compounding Room since 6 AM that morning. He acknowledged he was not wearing a beard cover.

On February 1, 2019, at 2:10 PM, during an interview, the Director of Pharmacy (DOP) stated the facility followed The United States Pharmacopeia <797> standards of practice for sterile (germ-free) compounding.

A review of USP (standard of practice for sterile compounding) <797> in the section titled "Personnel [staff] Cleansing and Garbing [attire]" indicated "Garbing activities considered the dirtiest include donning of dedicated shoe or shoe covers, head and facial hair covers (e.g., beard covers in addition to face masks)."

The facility P & P titled, "Intravenous Admixture and Administration" dated July 19, 2018, indicated "Sterile compounding services meet state and federal requirements, professional practice standards and are in compliance with United States Pharmacopeia Chapter <797> standards." A continued review of the policy indicated on page 3, "Compounding personnel are adequately skilled, educated, instructed, and trained to: Select and appropriately don protective garb."

Based on observation, interview, and record review, the facility failed to follow the policy and procedure on receiving radioactive material (dangerous material that can cause various health defects), when the facility staff did not sign the receiving log, as per the policy. This failure had the potential for unsafe storage and placement of the material that may threaten the life of people who come in contact with the material.

Findings:

During an observational tour on January 29, 2019, at 10:55 AM, at the "hot lab" (a room where safe storage and handling of radioactive materials took place) in the radiology department, an incomplete signing log was observed to be hanging on the wall, next to the entrance door. The delivery person signed for the days delivery of the radioactive materials were done. There were multiple days in which the receiving person failed to sign to acknowledge the delivery of the radioactive materials.

During an interview with Nuclear Medicine Staff 1 (NMS 1), on January 29, 2019, at 11:05 AM, he stated the staff signs the log, if the nuclear medicine was delivered during the normal work hours.

During an interview with the Director of Radiology 1 (DR 1) on February 1, 2019, at 8:56 AM, she stated the receiving staff was required to sign off the log, when they received the delivery during normal business hours. She further stated normal business hours were considered as Monday to Friday, 7:30 AM thru 4:30 PM.

A review of the facility policy and procedure titled, "Radioactive Materials: Ordering, receiving, and Disposal of" revised April 2018, indicated "Deliveries ...C. A log is signed by the [Name of the facility] employee (during normal business hours) and the delivery person to track the received isotope container..."

Based on observation, staff interview, and document review, the hospital failed to ensure that three (3) food service staff (FS 1, FS 2, and FS 3) preparing food for hospital patients' practiced safe food handling when:

1. Potentially hazardous food cooling temperatures were not logged as required.

2. Cantaloupe was not washed as required in the FDA Food Code.

3. Food Service staff did not use the handwashing sink for food service equipment.

This failure has the potential to cause food borne illness (illness caused by food contaminated by pathogens {organism causing illness}), bacteria, or parasites in a medically vulnerable hospital patient population.

Findings:

1. On 1/29/19 at 9:40 AM during observation of walk in freezer there was one 10-pound whole piece of frozen roast beef. The roast beef label stated use by 2/21/19. During concurrent interview, FS 2 stated the leftover roast beef was cooled in the freezer and cooks monitored the temperature during cooling hourly. FS 2 stated the cooks do not log the temperatures.

FS 1 acknowledged there were no temperature log documented.

Review of Policy titled, Safe Food handling, revise 7/21/15, showed "...6. A log of cooling time and temperature for each PHF (Potential Hazardous Food) (a food that requires time/temperature control for safety ..."

2. On 1/29/19 at 9:40 AM, FS 3 stated she used whole cantaloupe in the preparation of fruit plates. FS 3 stated the whole cantaloupe were cut on a cutting board, peeled and put on a plate.

FS 1 stated concurrently, the cantaloupe should have been washed before cutting. FS 1 stated there was no policy for the washing and safe preparation of cantaloupe which has a rough outer cover or rind.

Food and Drug Administration (FDA) Food Code 2017 Annex 3-302-25, indicated:

"Scrubbing with a clean brush is only recommended for produce with a tough rind or peel, such as carrots, cucumbers or citrus fruits that will not be bruised easily or penetrated by brush bristles. Scrubbing firm produce with a clean produce brush and drying with a clean cloth towel or fresh disposable towel can further reduce bacteria that may be present."

3. On 1/29/19 at 11:00 AM, FS 4 was observed taking food temperatures. FS 4 washed the thermometer in the handwashing sink two times. During concurrent interview FS 4 stated, she washed the thermometer in the handwashing sink "because it is right there."

On 1/29/19 in an interview FS 1 stated FS 4 should not use the handwashing sink to wash the thermometer.

FDA Food Code 2017 at 5-205.11 Using a Handwashing Sink. Facilities must be maintained in a condition that promotes handwashing and restricted for that use.

Based on observation, interview, and document review, the hospital failed to ensure kitchen maintenance was done timely to ensure clean and sanitary conditions when:

1. Two walk in refrigerator condenser vents had visible black debris.

2. Two kitchen bin ice machines used for food and drink were not cleaned and sanitized per manufacturer and hospital policy.

This failure had to possibility to cause food borne illness in a compromised medical patient population.

Findings:

1. On 1/29/19 at 9:40 AM, observation of the Dairy walk-in refrigerator and Catering walk in refrigerator showed accumulation of black debris on the condenser vents.

During a concurrent interview, Food Service Staff (FS 1) stated the condenser vents were cleaned by the Facilities Department. FS 1 acknowledged the vents on the Dairy and the Catering walk-in refrigerators needed cleaning.

During an interview on 1/30/19 at 11:20 AM, FS 1 and FS 2 stated the walk-in refrigerator compressor vents were cleaned by a contracted vendor last November. FS 1 stated the kitchen had not contacted the Facilities Department requesting condenser vent cleaning.

2. Two bin style ice machines located in the main kitchen were observed.

During an interview on 1/30/19 at 11:20 AM, Food Service Staff 1 and 2 (FS 1 and FS 2), stated the hospital ice machine refrigeration components are on a planned maintenance (PM) schedule. Review of maintenance work orders dated 11/8/19 to 11/16/19, indicated ice machine scheduled for annual cleaning and sanitizing.

Interview with FS 1 and FS 2 on 1/31/19 at 12:40 PM, confirmed the two kitchen bin ice machines were cleaned and sanitized annually by the contracted vendor.

Review of the hospital policy NO. 5011 revised 11/28/18 showed " ...The refrigeration components will be maintained semi-annually..."

Review of the manufacturer's instruction manual issued 11/15/2013, for the two bin ice machines, stated, "The appliance must be cleaned and sanitized at least twice a year ..."

Based on observation, interview, and record review, the facility failed to provide a sanitary environment to avoid sources of infections and communicable disease as mandated in the Conditions of Participation: Infection Control, when;

1. The staff did not sanitized his hands, and the equipment for patient's use before entering patient's room for one patient (Patient 48) of 47 sampled patients. (Refer to A-0748)

2. The trash and dirty linens which came from the patient room were not segregated in separate barrels. (Refer to A-0748)

3. The TB (tuberculosis, an infectious disease that usually affects the lungs) screening of employee was not performed annually as per facility's policy and procedure. (Refer to A-0748)

4. 21 of 21 Operating Rooms were not cleaned as per hospital policy and procedure. (Refer to Tag A-0749)

5. Bottled water for patient use was stored on the floor next to the trash can. (Refer to Tag A-0749)

The cumulative effects of these failures had the potential to spread infection and communicable disease to the patients and community.

Based on observation, interview, and record review, the facility failed to ensure that the Infection Control practices were implemented when:

1. The staff did not sanitized his hands, and the equipment for patient's use before entering patient's room for one of 47 sampled patients (Patient 48).

2. The trash and dirty linens which came from the patient room were not segregated in separate barrels.

3. The TB (tuberculosis, an infectious disease that usually affects the lungs) screening of employee was not performed annually as per facility's policy and procedure.

These failures had the potential for spread of infection that could adversely affect the health and wellbeing of patients in the universe of 387.

Findings:

1. During initial tour of the facility on January 29, 2019, at 10:20 AM, the Physical Therapist (PT) was observed taking a wheelchair with gloves on, and proceeded to the patient room. The PT was not observed disinfecting the wheelchair, nor sanitizing his hands prior to entering the patient's room.

During interview with the PT on January 29. 2018, at 10:23 AM, the PT stated, "Oh yeah, I'm supposed to gel/foam (solution used to sanitize hands in healthcare settings) in." PT further stated, "Normally I gel/foam before I put on my gloves and take off my gloves."

In a concurrent interview regarding the wheelchair, PT stated, "I should've wiped it with Sani wipe (Disinfecting wipe used in healthcare settings) before I brought the wheelchair inside the patient room."

During an interview with the Rehabilitation Service Director (RSD), on February 1, 2019 at 9:26 AM, the RSD stated, "He (referring to the PT) could have foam in, if he needs to use equipment, it has to be wiped with approved wipe."

During review of the facility's policy and procedure titled, "Hand Hygiene", with revised date of October 2016, it indicated, "Policy: Hospital personnel will comply with hand hygiene practices to reduce transmission of pathogenic microorganism to patients and personnel in the healthcare setting, Procedure: 1. When to perform Hand Hygiene. A. Decontaminate hands before and after entering patient's room.

2. During initial tour on January 29, 2019, at 10:51 AM, Environmental Service Custodian (ESC) was observed to place the trash and dirty linen all together in one barrel/gallon with no lid.

During a concurrent interview with the ESC, the ESC stated, "I only have one barrel for trash and dirty linen, there should be 2 barrels, one for the trash and one for the dirty linen." The ESC further stated, "I cannot find another barrel to separate the trash and the dirty laundry."

During an interview with the Environmental Service Supervisor (EVS) on January 29, 2019 at 10:29 AM, the EVS stated, "The trash and dirty linen should be on separate barrels, if there's only on barrel available, the ESC should get the dirty linen first on all the rooms and then the trash."

During review of the facility's policy and procedure titled, "Solid Waste Removal," with reviewed date of 02/25/2018, it indicated, "Policy: All solid waste will be identified, handled, transported and disposed of according to regulatory standards. Procedure: After all solid waste is collected in a 44 gallon rolling, rigid, leak-proof container with lid, it is taken to Soiled Utility Room.

During review of the facility's policy and procedure titled, "Linen Handling, Annual Site inspection of Linen Service," with reviewed date of October 2016, it indicated, "Policy: (Facility Name) will adhere to all linen and laundry handling regulations and recommendations and will have written policies and procedure developed and implemented for handling, storage, transportation and processing of clean and contaminated line. Procedures: II. A Contaminated linen will be placed in designated linen hampers in the patient room or Biohazard Store Rooms ... K. Contaminated linen is never placed in solid waste or biohazard waste container."

3. During a review of the employee health record of Safety Technician (ST), it indicated that ST was hired on August 8, 2015. The most current annual TB screening was done August 1, 2017.

During an interview with Employee Health (EH) in the presence of the Administrative Supervisor on February 1, 2019 at 10:01 AM, the EH stated, "There (referring to the employee TB screening) should be on August 2018." The EH further stated, "There's nothing on the employee's personnel file.

During a review of the facility's policy and procedure titled, "Employee Health." undated, it indicated, "Policy: (Facility name) employees, contractors and their employees, and subcontractors (including house staff) performing duties at the facility are screened to assure they are free from communicable disease. Procedure: II. Screening and immunization Program. H Tuberculosis (TB) Screening. 3. Annual Screening: the responsibilities for ensuring that an effective tuberculosis-screening program is carried out is the function of Department Managers, Administration Human Resources Department and the Employee Health Nurse (EHN). A. Annual TB screening is scheduled according to the HCWs birth month ..."

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

1. The terminal cleaning (a cleaning method used in healthcare environments to control the spread of infections) was performed in, twenty-one (21) of 21 surgical areas (Surgery room 1, 2, 3, 4, 5, 7, 9, 10, 11, 12, 14, 15, 16, 31, 32, 33, E-1, E-2, E-3[E1,2&3 are Endoscopy rooms], Gastro-Enterology Lab [GL] and Cath Lab [CL]) on multiple occasions from December 2018 through January 2019. This failure had the potential for cross contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) and spread of infection for the surgical patients.

2. The bottled water was not stored on the floor next to the trash can. This failure had the potential to contaminate the bottled water that was next to the trash can.

Findings:

1. During the initial tour of Operating Rooms (OR) on January 31, 2019, at 9:01 AM, Physician 1, stated the Environmental Services (EVS) terminally cleans the rooms in turns of two rooms in a day.

A review of the "Operating Room (OR) Terminal cleaning daily schedule" for the past three months (November 2018, December 2018 and January, 2019) was conducted with EVS Manager 1 (EVSM 1) and EVS Assistant Manager (EVSAM) on January 31, 2019 at 3:37 PM.

The terminal log indicated the following with missing documentation of the terminal cleaning was done:

OR 1: 33 days out of 91 days.

OR 2: 33 days out of 91 days.

OR 3: 82 days out of 91 days.

OR 4: 33 days out of 91 days.

OR 5: 30 days out of 91 days.

OR 7: 30 days out of 91 days.

OR 9: 33 days out of 91 days.

OR 10: 30 days out of 91 days.

OR 11: 30 days out of 91 days.

OR 12: 75 days out of 91 days.

OR 14: 51 days out of 91 days.

OR 15: 48 days out of 91 days.

OR 16: 51 days out of 91 days.

OR 31: 49 days out of 91 days.

OR 32: 49 days out of 91 days.

OR 33: 49 days out of 91 days.

E-1: 58 days out of 91 days.

E-2: 58 days out of 91 days.

E-3: 58 days out of 91 days.

GL: 58 days out of 91 days.

CL: 58 days out of 91 days.

During an interview with the Health Care Program Administrator of Epidemiology (HCPAE) on February 1, 2019, at 10:26 AM, she stated the department was not collaborating with EVS department, in regards to terminal cleaning of OR's.

During an interview with the Associate Hospital Administrator (AHA) and Operating Room Manager on February 1, 2019, the AHA stated the management was not aware that the terminal cleaning of OR's were not done per the facility policy and procedure.

A review of the facility policy and procedure titled, "Terminal Cleaning in the Surgery Department", revised February 2018, indicated "...procedures are performed once in every 24-hour period regardless of whether or not the OR room is used..."


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2. During an observation on January 30, 2019, at 1:35 PM, in Medication Room 171 at an off-site outpatient clinic, bottled water for patient use was stored on the floor next to a trash can.

During a concurrent interview with the Clinical Director of Ambulatory Services (CDAS), on January 30, 2019, at 1:35 PM, she stated that she did not know why the water was stored on the floor.

During an interview with CDAS on February 1, 2019, at 10:15 AM, she stated that the water should not have been stored on the floor.

The facility policy and procedure titled "Safe Food Handling" dated July 21, 2015, indicated, " ...Food, Products and Storage ...7. All items shall be stored at least 12 inches off the floor and 18 inches from the ceiling."