HospitalInspections.org

Based on interview and record review, the facility did not provide Advance Directive (a written document providing a patient's desire to have or withhold medical treatment if they cannot make their wishes known) information to two of 10 patients, (Patients 9 and 16). These failures had the potential to result in patients not having their wishes met regarding their care in the hospital.

Findings:

During a review of the clinical records for Patient 9 and Patient 16, on April 26, 2016 at 2:10 PM, the clinical records did not indicate Advance Directive information was provided to the patients.

During an interview on April 27, 2016, at 7:30 AM, the Director of Nursing (DON) confirmed that Advance Directive information was not present in Patient's 9 and 16's medical records.

The facility policy and procedure titled "Advance Directives", dated February 2013, indicated "An inquiry will be made by the Admitting Department during the admissions process of the patient , or if the patient is incapacitated, to the patient's significant other, as to whether or not the patient has complete an advance directive..."

Based on observation, interview and record review, the facility did not ensure daily monitoring of the Emergency Room (ER) crash cart (contains emergency medications, equipment and supplies for life-threatening emergencies) and defibrillator (a common treatment for life-threatening heart rhythms) for readiness in case of an emergency. This practice increased the risk of defibrillator failure or inadequate equipment and supplies for all ER patients.
Findings:
During an observation on April 25, 2016, at 2:15 PM, the facility document titled "Emergency Department Daily Crash Cart checklist" dated "2/2012" indicated no documented evidence that the emergency crash cart/defibrillator daily check had been performed on April 25, 2016. During a concurrent interview with RN 1 he agreed there was no evidence that the crash cart and defibrillator were checked on April 25. 2016.
The facility policy and procedure titled "Emergency Crash Cart/Defibrillator Daily Check" dated May 2012, indicated "Crash carts will be checked daily."

Based on observation, interview and record review, the facility did not:

1. Ensure the annual Medical Physicist Radiography Safety Report (a safety evaluation of all equipment that emit radiation) was performed in a timely manner. This practice increased the radiation risk for all radiology patients receiving radiologic services at the hospital.

2. Ensure the Preventative Maintenance (PM, a check to make sure equipment is working properly) was done annually on an Audiometer (a machine used to check hearing) for all patients requiring hearing exams in the Outpatient Clinic.
These deficient practices increased the risk of unnecessary radiation and possible equipment failure for patients who require medical equipment for their medical care at the facility.
Findings:
1. During an observation on April 25, 2016, at 3:10 PM, in the Radiology area, it was noted that the last annual Medical Physicist Evaluation of the Radiographic equipment (a safety evaluation of all equipment that emit radiation) was performed on March 19, 2015. During a review of the "Radiographic Equipment Evaluation" indicated the report was dated March 19, 2015.
During a concurrent interview with the Radiologic Technician (RT 1), she stated the physicist was last at the facility on March 19, 2015, and she acknowledged that the annual safety check was overdue.
According to the American College of Radiology (ACR) "Technical standard for diagnostic medical physics performance monitoring of Radiographic and fluoroscopic equipment" revised 2011, indicated...The performance of all Radiographic and fluoroscopic equipment must be evaluated upon installation and monitored at least annually by a Qualified Medical Physicist to ensure that the equipment is functioning properly and that patients are not exposed to unnecessary doses of radiation."


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2. During an observation on April 25, 2016, at 2:53 PM, in the Outpatient Clinic Point of Care (simple lab tests performed by nurses) testing room with the Clinic Manager (CM), one Audiometer was noted on a shelf in a black case. The PM sticker on the Audiometer indicated, "PM done July 2014, due July 2015."


During a concurrent interview with the CM, she stated the PM for the Audiometer was overdue and should have been done.

34772


The CONDITION is not met as evidenced by:
The hospital failed to ensure the Condition of Participation: CFR 485.627, Organizational Structure was met by failing to:

1. Provide Advance Directive (a written document providing a patient's desire to have or withhold medical treatment if they cannot make their wishes known) information to all patients who were admitted to the hospital. (Refer to C-151)

2. Ensure the Emergency Crash Cart and defibrillator (standard treatment for life-threatening heart rhythms) were monitored daily. (Refer to C-204).

3 a. Ensure the annual Physicists Radiography Safety Report was performed in a timely manner. (Refer to C-222).

3 b. Ensure the Preventative Maintenance (PM, a check to make sure equipment is working properly) was done annually on an Audiometer used in the Outpatient Clinic. (Refer to C-222)

4 a. Ensure five of five physician credential files (a file of documents to prove physician education and skill) contained complete documentation of experience, training and competency (ability). (Refer to C-241).
4 b. Ensure all physician credential files contained a complete list of privileges (tasks the physician is allowed to do in the hospital) granted. (Refer to C-241).


5 a. Ensure that the hospital had a current and active drug room permit licensed by the California State Board of Pharmacy which is required for California state licensure. Without an active drug room permit, the hospital is not able to purchase medications and would not be able to meet the pharmaceutical needs of it's patients which could lead to harm. (Refer to C-276)

5 b. Ensure opened and used multi-dose medication vials were dated with a 28 day expiration per hospital policy. One opened and used vial of insulin was found in a medication storage refrigerator in the Emergency Department without a label to indicate when it was opened or when it expires. Without proper labeling, the medication could be used past the manufacturer's designated expiration date or the hospital's medication expiration date for multi-dose vials. Using a medication past it's expiration date can expose the patient to medication with microbial growth or medication that is not as effective as the prescriber and manufacturer intended use which can lead to patient harm. (Refer to C-276)

5 c. Ensure opened and used single-dose medication vials were properly discarded and not available for patient use. Single-dose vials contain no preservative which prevents microbial growth. Exposing a patient to medication with microbial growth can lead to significant patient harm. (Refer to C-276)

5 d. Ensure that hospital policy & procedure reflected proper Beyond Use Dating (BUD) for compounded (mixing 2 or more medications or solutions) IV (intravenous - in the vein) medications and that nursing staff were aware of acceptable BUD for the types of compounded IV medications the hospital provides to patients. Hospital policy & procedure does not guide nursing personnel on the BUD or expiration date to be placed on the drug product after compounding. In addition, nursing personnel were not aware of the BUD of immediate use compounded IV medications as described by accepted professional standards (quality monitored by healthcare professionals). Placing an inappropriate beyond use date on a compounded IV medication may expose the patient to microbial growth which can lead to patient harm. (Refer to C-276)

5 e. Ensure that controlled drug record inventory matched actual controlled drug inventory available for immediate patient use for two medications. Controlled drug inventory records that do not match actual medication inventory can lead to diversion of controlled medication which can potentially lead to impaired hospital personnel caring for patients. Impaired hospital personnel that are under the influence of controlled medications can potentially lead to serious patient harm. (Refer to C-276)

5 f. Ensure that drugs maintained in the patient care areas were inspected at least monthly by a pharmacist or the Director of Nursing Services (DON) as required by hospital policy and procedure. Medication areas not reviewed regularly by a pharmacist or the DON can lead to medications not being stored appropriately or nursing personnel not following hospital policy and procedure in regards to medications. Improper storage or medication policy and procedure that is not followed can potentially lead to patient harm. (Refer to C-276)

5 g. Ensure the Physical Therapy (PT) supply room and cabinets containing needles and medications were locked when unattended. These failures had the potential to result in unauthorized persons having access to the needles and medications within the hospital and out-patient areas which could result in harm. (Refer to C-276)

6 a. Non-sterile and expired equipment, instruments and supplies were not in the patient care area and available for patient use. (Refer to C-278).

6 b. Ensure that glucose control solutions were dated when opened in the Outpatient Clinic. (Refer to C- 278)
6 c. Ensure that food was not stored in the Emergency Room patient care area. (Refer to C-278)
6 d. Adequately monitor cooked potentially hazardous foods (PHF - foods that support harmful bacterial growth when not safely stored) for safe cool down to prevent the growth of disease causing bacteria. (Refer to C-278)

6 e. Ensure that the quaternary ammonia sanitizer solution, used to sanitize food contact surfaces, was at an effective concentration. (Refer to C-278)

6 f. Ensure equipment used for patient food preparation was adequately cleaned and allowed to air dry to prevent food borne illness. (Refer to C- 278)

6 g. Ensure the ice machine's storage bin drain pipe maintained an air gap to prevent waste water backflow into the ice storage bin. (Refer to C- 278)

6 h. Ensure there was a written and defined role of the hospital's registered dietitian (RD) in the organizational structure, the RD's clinical role and the RD's oversight of sanitary conditions and safe food handling in the dietary services. (Reference C-278)

7 a. Ensure that the nutrition needs of the inpatients were met in accordance with recognized dietary practices and orders of the practitioner. (Refer to C-279)

7 b. Ensure inpatients received nutritional risk screens and assessments. (Refer to C-279)

7 c. Ensure a quality assurance program was established for the food and nutrition department. (Refer to C-279)

8. Ensure Nursing Care Plans (a tool for nurses used to assess, plan, implement and evaluate patient care) were developed and implemented on each patient admitted to the hospital. (Refer to 289)

9. Ensure the hospital had an effective ongoing quality assurance program. (Refer to C-336)

The cumulative effects of these systemic failures resulted in the failure of the hospital to deliver care in a safe environment in order to be in compliance with the Condition of Participation of Organizational Structure.

Based on interview and record review, the governing body did not ensure that:
1. Five of five physician credential files (a file of documents to prove physician education and skill) contained complete documentation of experience, training and competency (ability).
2. One of five physician credential files contained a complete list of privileges (tasks the physician is allowed to do in the hospital) granted.
This practice increased the risk of poor quality of care for patients requiring Emergency Room or Outpatient Services.
Findings:
1. During a review of the credential files for five physicians (MD 1, MD 2, MD 3, MD 4 and MD 5), there was no documented evidence of past experience, peer references or activity lists to document competency of the physicians. Also, five of five physician credential files (MD 1, MD 2, MD 3, MD 4 and MD 5) did not contain complete independent verification (double checking from an outside source) of all physician medical training. During an interview with the Director of Medical Records (DMR), on April 26, 2016, at 8:40 AM, she reviewed the credential files for five physicians (MD 1, MD 2, MD 3, MD 4 and MD 5) and was unable to find documentation of peer references, activity lists or documented past experience for five of five physicians. The DMR was also unable to find documentation of independent verification of all medical training for five of five physicians. The Bylaws of the Medical Staff, dated February 28, 2015, indicated "...Article IV. Procedures for Appointment and Reappointment 4.01-4 Processing the application (a) Applicant's Burden: The applicant shall have the burden of producing adequate information for proper evaluation of his/her experience, background, training and demonstrated ability...(b) Verification of Information: The applicant shall fill out and deliver an application...The application will be deemed complete when all necessary verifications have been obtained, including current license, DEA (Drug Enforcement Agency) certificate (allows the practitioner to prescribe medications) if appropriate, verification of all practice from professional school, reference letters..."2. During a review of the credential files for five physicians (MD 1, MD 2, MD 3, MD 4 and MD 5), One of five physician credential files (MD 4) did not contain a complete list of privileges granted. A review of MD 4's "Advanced Procedures" list, dated March 9, 2016, indicated only three of 31 privileges listed had a check mark beside the privilege. The remaining 28 privileges did not have a check mark beside the privilege. During an interview with the DMR, on April 26, 2016, at 10:00 AM, she reviewed the credential file for MD 4 and was unable to find a complete list of privileges granted. The Bylaws of the Medical Staff, dated February 28, 2015, indicated "...Article V. Determination of Clinical Privileges 5.01 Exercise of privileges. Except as otherwise provided in these Bylaws or the Medical Staff Rules and Regulations, every practitioner or other professional providing services at this hospital shall be entitled to exercise only those privileges or services specifically granted to him/her..."


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The CONDITION is not met as evidenced by:
The hospital failed to ensure the Condition of Participation: CFR 485.635, Provision of Services was met by failing to:

1 a. Ensure that the hospital had a current and active drug room permit licensed by the California State Board of Pharmacy which is required for California state licensure. Without an active drug room permit, the hospital is not able to purchase medications and would not be able to meet the pharmaceutical needs of it's patients which could lead to harm. (Refer to C-276)

1 b. Ensure one of one opened and used multi-dose medication vials were dated with a 28 day expiration per hospital policy. One opened and used vial of insulin (a medication to control blood sugar) was found in a medication storage refrigerator in the Emergency Department without a label to indicate when it was opened or when it expired. Without proper labeling, the medication could be used past the manufacturer's designated expiration date or the hospital's medication expiration date for multi-dose vials. Using a medication past it's expiration date can expose the patient to medication with microbial (life only visible with a microscope) growth or medication that is not as effective as the prescriber and manufacturer intended use which can lead to patient harm. (Refer to C-276)

1 c. Ensure two of two opened and used single-dose medication vials were properly discarded and not available for patient use. Single-dose vials contain no preservative which prevents microbial growth. Exposing a patient to medication with microbial growth can lead to significant patient harm. (Refer to C-276)

1 d. Ensure that hospital policy & procedure reflected proper Beyond Use Dating (BUD) for compounded (mixing 2 or more medications or solutions) IV (intravenous - in the vein) medications and that all nursing staff were aware of acceptable BUD for the types of compounded IV medications the hospital provides to patients. Hospital policy & procedure does not guide nursing personnel on the BUD or expiration date to be placed on the drug product after compounding. In addition, nursing personnel were not aware of the BUD of immediate use compounded IV medications as described by accepted professional standards (quality monitored by healthcare professionals). Placing an inappropriate beyond use date on a compounded IV medication may expose the patient to microbial growth which can lead to patient harm. (Refer to C-276)

1 e. Ensure that controlled drug (medications that can lead to addiction) record inventory matched actual controlled drug inventory available for immediate patient use for two medications out of all controlled medications available for use in the Omnicell. Controlled drug inventory records that do not match actual medication inventory can lead to diversion (misuse) of controlled medication which can potentially lead to impaired hospital personnel caring for patients. Impaired hospital personnel that are under the influence of controlled medications can potentially lead to serious patient harm. (Refer to C-276)

1 f. Ensure all that drugs maintained in the patient care areas were inspected at least monthly by a pharmacist or the Director of Nursing Services (DON) as required by hospital policy and procedure. Medication areas not reviewed regularly by a pharmacist or the DON can lead to medications not being stored appropriately or nursing personnel not following hospital policy and procedure in regards to medications. Improper storage or medication policy and procedure that is not followed can potentially lead to patient harm. (Refer to C-276)

1 g. Ensure the Physical Therapy (PT) supply room and cabinets containing needles and medications were locked when unattended. These failures had the potential to result in unauthorized persons having access to the needles and medications within the hospital and out-patient areas which could result in harm. (Refer to C-276)

2 a. Non-sterile and expired equipment, instruments and supplies were not in the patient care area and available for patient use, for all patients receiving care in the hospital or Outpatient Clinic. (Refer to C-278).

2 b. Ensure that one of one glucose control solutions were dated when opened in the Outpatient Clinic. (Refer to C- 278)
2 c. Ensure that staff food was not stored in the Emergency Room patient care area leading to unsanitary conditions for all patients receiving care. (Refer to C-278)
2 d. Adequately monitor cooked potentially hazardous foods (PHF - foods that support harmful bacterial growth when not safely stored) for safe cool down to prevent the growth of disease causing bacteria for all patients receiving food prepared in the kitchen. (Refer to C-278)

2 e. Ensure that the quaternary ammonia sanitizer solution, used to sanitize food contact surfaces, was at an effective concentration for all patients receiving food prepared in the kitchen. (Refer to C-278)

2 f. Ensure equipment used for patient food preparation was adequately cleaned and allowed to air dry to prevent food borne illness for all patients receiving food prepared in the kitchen. (Refer to C- 278)

2 g. Ensure the ice machine's storage bin drain pipe maintained an air gap to prevent waste water backflow into the ice storage bin for all ice made in the kitchen. (Refer to C- 278)

2 h. Ensure there was a written and defined role of the hospital's registered dietitian (RD) in the organizational structure, the RD's clinical role and the RD's oversight of sanitary conditions and safe food handling in the dietary services for one of one dietitian employed at the hospital. (Reference C-278)

3 a. Ensure that the nutrition needs of the inpatients were met for all patients admitted to the hopsital in accordance with recognized dietary practices and orders of the practitioner. (Refer to C-279)

3 b. Ensure all inpatients received nutritional risk screens and assessments. (Refer to C-279)

3 c. Ensure a quality assurance program was established for the food and nutrition department. (Refer to C-279)

4. Ensure Nursing Care Plans (a tool for nurses used to assess, plan, implement and evaluate patient care) were developed and implemented on all patients admitted to the hospital. (Refer to C-289)


The cumulative effects of these systemic failures resulted in the failure of the hospital to deliver care in a safe environment in order to be in compliance with the Condition of Participation of Provision of Services.

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

1) Ensure that the hospital had a current and active drug room permit licensed by the California State Board of Pharmacy which is required for California state licensure. Without an active drug room permit, the hospital is not able to purchase medications and would not be able to meet the pharmaceutical needs of it's patients which could lead to harm.

2) Ensure one of one opened and used multi-dose medication vials were dated with a 28 day expiration per hospital policy. One opened and used vial of insulin (a medication to control blood sugar) was found in a medication storage refrigerator in the Emergency Department without a label to indicate when it was opened or when it expired. Without proper labeling, the medication could be used past the manufacturer's designated expiration date or the hospital's medication expiration date for multi-dose vials. Using a medication past it's expiration date can expose the patient to medication with microbial (life only visible through a microsope) growth or medication that is not as effective as the prescriber and manufacturer intended use which can lead to patient harm.

3) Ensure two of two opened and used single-dose medication vials were properly discarded and not available for patient use. Single-dose vials contain no preservative which prevents microbial growth. Exposing a patient to medication with microbial growth can lead to significant patient harm.

4) Ensure that hospital policy & procedure reflected proper Beyond Use Dating (BUD) for compounded (mixing 2 or more medications or solutions) IV (intravenous - in the vein) medications and that all nursing staff were aware of acceptable BUD for the types of compounded IV medications the hospital provides to patients. Hospital policy & procedure does not guide nursing personnel on the BUD or expiration date to be placed on the drug product after compounding. In addition, nursing personnel were not aware of the BUD of immediate use compounded IV medications as described by accepted professional standards (quality monitored by healthcare professionals). Placing an inappropriate beyond use date on a compounded IV medication may expose the patient to microbial growth which can lead to patient harm.

5) Ensure that controlled drug (a medication that can lead to addiction) record inventory matched actual controlled drug inventory available for immediate patient use for two medications. Controlled drug inventory records that do not match actual medication inventory can lead to diversion (misuse) of controlled medication which can potentially lead to impaired hospital personnel caring for patients. Impaired hospital personnel that are under the influence of controlled medications can potentially lead to serious patient harm.

6) Ensure that all drugs maintained in the patient care areas were inspected at least monthly by a pharmacist or the Director of Nursing Services (DON) as required by hospital policy and procedure. Medication areas not reviewed regularly by a pharmacist or the DON can lead to medications not being stored appropriately or nursing personnel not following hospital policy and procedure in regards to medications. Improper storage or medication policy and procedure that is not followed can potentially lead to patient harm.

7) Ensure one of one Physical Therapy (PT) supply room and one of one cabinets containing needles and medications were locked when unattended. These failures had the potential to result in unauthorized persons having access to the needles and medications within the hospital and out-patient areas which could result in harm.


Findings:

1) During a tour of the hospital medication storage areas on April 26, 2016, at 9:00 AM, it was observed that the hospital had a posted drug room permit from the California State Board of Pharmacy on the door of the hospital's designated drug storage room. The permit indicated that it would expire on November 1, 2016.

During a review of the California State Board of Pharmacy's website on April 26, 2016, at 12:00 PM, the hospital's drug room permit was listed as "DELINQUENT" and had an expiration date of December 31, 2015.

During an interview with a California Board of Pharmacy Inspector on April 26, 2016, at 12:30 PM, the Inspector confirmed that the hospital's drug room permit was inactive and stated that the hospital would not be able to purchase drugs from a wholesaler without an active drug room permit. When asked why the hospital had a permit that indicated the drug room permit was still active, the Inspector stated that the permit was issued prior to the permit being inactivated.

During a review of hospital policy and procedure, titled, "Pharmacy Service Manager", last reviewed/revised with a date of "2/15", the policy states, "It is the policy of [ the hospital] that the Director of Nursing Services will act as the Pharmacy Services Manager and shall be responsible for the procurement, storage, and distribution of all drugs within the facility." The policy further indicated under the Procedure section, "The pharmacy service manager will act under the direction of the Consulting Pharmacist."

During an interview with the Director of Nursing Services (DON) on April 26, 2016, at 2:15 PM, the DON was asked if she was aware that the hospital's drug room permit was inactive. The DON stated that she was not aware.

During an interview with the hospital's Consultant Pharmacist on April 26, 2016, at 3:00 PM, the Consultant Pharmacist was asked if he was aware that the hospital's drug room permit was inactive. The Consultant Pharmacist stated that he was not aware.

2) During a tour of the Emergency Department on April 25, 2016, at 2:15 PM, the drug storage refrigerator was inspected. One open and used vial of Novolin R (regular insulin medication used to reduce blood sugar levels in patients) was found stored in the refrigerator in the original manufacturer box. There was no labeling to indicate when it was opened or how long it would be acceptable to use found attached to the bottle or the manufacturer box.

During a concurrent interview with Registered Nurse 1 (RN 1), RN 1 confirmed that the Novolin R vial was open and used and did not have labeling to indicate when the medication was opened or when it will expire. RN 1 also stated that he did not know when the medication was opened.

A review of the Novolin R medication package insert (a document created by the manufacturer that provides important medication information including storage and use recommendations) under the section "Storage Conditions for Novolin R vials", the package insert states that opened and in-use vials may be stored for 42 days in temperature up to 77° F.

A review of hospital policy and procedure titled, "Use of Multiple Dose Vials (MDVs)", dated as reviewed/revised in "2/2016", states, "The beyond-use date (BUD) for an opened or entered (i.e. needle punctured) multiple dose container with antimicrobial preservatives shall be 28 days, unless otherwise specified by the manufacturer." The policy further stated, "The healthcare provider shall write the expiration date on the vial, when it is opened."

3) During a tour of the hospital's outpatient rural health clinic on April 25, 2016, at 3:15 PM, the clinic medication storage room was inspected. Medications were found to be stored in a stainless steel cabinet within the room. In the cabinet, one opened and used vial of Sensorcaine-MPF 0.5% (generic name bupivacaine - a medication used to numb a patient's body area and prevent pain or feeling in that area) was found. The vial was labeled by hospital personnel with the information, "open 3/14/16; exp 4/11/16", indicating that the vial was available for use for 28 total days. Manufacturer information printed on the vial stated, "Single dose vial" and "Single dose container. Discard unused portion." Also found in the cabinet was one opened and used vial of Sodium Chloride 0.9% (a medication used to mix with other drugs for injection, it is commonly referred to as normal saline). The vial was labeled by hospital personnel with the information, "opened 4/18/16; exp 04/16 (with the manufacturer expiration date circled indicating that the expiration date is April 30, 2016)". Manufacturer information printed on the vial stated, "Single dose vial" and "Preservative free. Discard unused portion."

During a concurrent interview with Licensed Vocational Nurse (LVN 1), LVN 1 confirmed that the Sensorcaine vial was labeled with a 28 day beyond use date/expiration date despite being a single dose vial. LVN 1 further confirmed that the Sensorcaine vial had already expired as well and should not have been stored in the cabinet and available for patient use. LVN 1 also confirmed that the Sodium Chloride vial was labeled with an extended beyond use date despite the vial being a single dose vial only.

A review of hospital policy and procedure titled, "Use of Multiple Dose Vials (MDVs)", dated as reviewed/revised in "2/2016", indicated, "Opened single-dose ampules shall not be stored for any period of time."

4) A review of hospital policy and procedure titled, "IV (intravenous - in the vein) Admixtures", dated as reviewed/revised on "2/16", the policy indicated, "Medication Added labels shall be attached to the IV bag with the following information: ....f. Expiration date of medication". No further information was listed in the policy.

During an interview with the Director of Nursing Services (DON) on April 25, 2016, at 4:30 PM, the DON was asked what would nursing be expected to place on the label of a compounded immediate use IV medication as the expiration date. She stated, "24 hours. Isn't that what it is?" There was further discussion regarding the guidance provided by the hospital policy and procedure for IV admixtures, specifically, immediate use compounded medications, which are commonly administered to patients whenever IV medications are required. There was no pharmacy in the hospital to prepare IV medications. Therefore, nursing personnel compound IV medications just prior to use and label these IV medications with an appropriate beyond use date (BUD) or expiration date.

During an interview with Registered Nurse 1 (RN 1) and Registered Nurse 2 (RN 2) on April 26, 2016, at 8:30 AM, RN 1 and RN 2 were asked what the expiration date would be for an IV medication bag if they had to reconstitute (mix and make into a solution) a vial of medication and inject into the IV bag for administering to a patient. RN 1 stated, "We use the infusion time", referring to the amount of time that the IV medication would take to be completely administered to the patient. RN 1 further stated, "If the infusion is only 30 minutes, we put 30 minutes down (on the label). If it's an hour, we put 1 hour." When asked if there was a definitive beyond use date or expiration date that nursing is expected to label a compounded IV medication with, that is described by hospital policy and procedure or provided during an inservice by their DON or consultant pharmacist, they both stated that they were not aware of any such beyond use dating.

A review of USP 797 (United States Pharmacopeia Chapter 797 is a IV compounding related chapter from the United States Pharmacopeia which is considered the authoritative standards regarding minimum standards of safe practice in compounding IV medications), under the section "Immediate-Use CSPs (Compounded Sterile Products)", it states, "Administration begins not later than 1 hour following the preparation of the CSP. Unless immediately and completely administered by the person who prepared it or witnessed by the preparer, the CSP shall bear a label listing......the exact 1-hour BUD and time. If administration has not begun within 1 hour following the start of preparing the CSP, the CSP shall be promptly, properly, and safely discarded."

5) During an inspection of the hospital drug storage room on April 26, 2016, at 9:30 AM, controlled medication inventory was reviewed with Registered Nurse 2 (RN 2). Schedule II controlled medications were stored in the hospital's automated dispensing cabinet (a machine that stores and dispenses medication and is referred to as the OmniCell). Medications categorized as Schedule II by the DEA (Drug Enforcement Administration) are considered medications with high potential for abuse and require constant monitoring and inventory control in order to prevent diversion (unauthorized use). One such medication, hydrocodone/acetaminophen (brand name Norco - a medication used for pain) 10mg/325mg (milligram, a unit of measurment) tablets, were stored in the OmniCell.

During a concurrent interview, RN 2 was asked for the current inventory records for hydrocodone/acetaminophen 10mg/325mg in the OmniCell. RN 2 pulled up the inventory on the OmniCell screen and it showed that there should be 310 tablets stored in the OmniCell. RN 2 was asked to count the actual inventory stored in the OmniCell. After several actual counts, RN 2 confirmed that there were only 290 tablets in the OmniCell.

During the inspection of the hospital drug storage room on April 26, 2016 at 9:45 AM, a second medication stored in the OmniCell was reviewed, hydrocodone/acetaminophen 5mg/325mg (same ingredients but with a lower dose of the hydrocodone 5mg vs. 10mg). The hydrocodone/acetaminophen 5mg/325mg is also categorized as a Schedule II medication requiring constant monitoring and inventory control.

During a concurrent interview with RN 2, when asked for the current inventory records for hydrocodone/acetaminophen 5mg/325mg in the OmniCell. RN 2 pulled up the inventory screen for hydrocodone/acetaminophen 5mg/325mg and the screen indicated that there was supposed to be 240 tablets stored in the OmniCell. RN 2 was asked to count the actual inventory stored in the OmniCell for hydrocodone/acetaminophen 5mg/325mg. After several counts, RN 2 confirmed that there were only 180 tablets stored in the OmniCell.

During a concurrent interview with RN 2, RN 2 was asked what the hospital policy and procedure was in regards to controlled drug inventory control. RN 2 stated that she ordered the medications from the wholesaler supplier, they would be delivered to the hospital, and she would stock the drug room OmniCell and adjust the inventory count at that time. RN 2 presented a folder with documents associated with ordering of controlled medications and the amounts received from the hospital wholesale drug supplier. RN 2 was asked whether there is a hospital policy regarding review of controlled drug inventory amounts. RN 2 stated, "I count them every month with (the first name of the Director of Nursing Services (DON))." RN 2 was asked if she documents the confirmation of the inventory counts done monthly on a log or sheet. RN 2 stated that she did not.

During an interview with the DON on April 26, 2016, at 2:15 PM, the DON was asked if the hospital had a policy and procedure regarding controlled drug use. The DON stated that she could not find a written policy and procedure regarding controlled drug use.

A review of the Pharmaceutical Services Agreement between the hospital and the consultant pharmacist indicates, "Direct Oversight by Consultant shall include the following: 1) Inventory entire stock of medications....."

During an interview with the consultant pharmacist (Pharm 1) on April 26, 2016, at 3:00 PM, Pharm 1 was asked if he reviewed the monthly inventory of Schedule II medications during his monthly visits. Pharm 1 stated that he had not been reviewing the inventory of Schedule II medications. Pharm 1 was asked if he was just signing the inventory forms and trusting the nurse for the information without verifying. Pharm 1 stated, "Yes."

6) During an inspection of the hospital drug storage room on April 26, 2016, at 9:30 AM, RN 2 was asked if the pharmacist does any inspections of the drug storage areas in the hospital. RN 2 stated that she inspected the drug storage areas once monthly and that the pharmacist would come in once a month and sign off on the inspection records. RN 2 presented inspection records that were dated approximately once every month. Inspection records dated March 31, 2016 were reviewed. Three different records, each labeled for a different drug storage in the hospital (Emergency Department, Acute, and Clinic) were signed by RN 2. The area for Pharmacist's signature was blank. A "Sign Here" sticker with an arrow was attached to the record. RN 2 was asked what the "Sign Here" arrow stickers were for. RN 2 stated that she used them to remind their pharmacist that he needed to sign the records.

During an interview with the hospital's pharmacist (Pharm 1) on April 26, 2016, at 3:00 PM, Pharm 1 was asked if he inspected drug storage areas. Pharm 1 stated, "(The name of RN 2) does the work and I sign off." Pharm 1 was asked if he was just signing the forms and trusting the nurse for the information without verifying, Pharm 1 stated, "Yes." After discussing some of the inappropriate drug storage concerns in the clinic discovered during survey by the survey team, Pharm 1 was asked if he inspects the clinic drug storage area monthly. Pharm 1 stated, "I don't check the clinic monthly, maybe every other month."

A review of hospital policy & procedure titled "Medication Storage", dated as reviewed/revised on "5/11", under the section Procedure, the policy states, "Medication rooms are inspected daily by licensed nursing personnel on each shift and monthly by the Pharmacist or the Director of Nursing Services."




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7) During an observation on April 25, 2016 at 2:15 PM, in the PT hallway, accompanied by the Director of Nursing (DON), the PT supply room door was open to a hallway used for out-patients to go to therapy. The supply room housed 1 glass cabinet which was unlocked. The cabinet stored 6 vials of dexamethasone (a steroid) 10 mg/ml (milligram per milliliter, units of measurement), one 10 ml bottle of Lidocaine (a medication used for numbing), and five hypodermic needles (needles long enough to go through the skin and into muscle). No staff member was present.

During a concurrent interview with the DON, she confirmed the supply room door was left open, the cabinet doors were unlocked, and the room was unattended. The DON confirmed the door and cabinets should have been locked when no staff member was present.

No current policy and procedure approved by the Governing Body was provided.

Based on observation, interview and record review the facility failed to maintain an environment free from expired, open and undated items, from personal food storage in a patient care area, and to ensure that their infection control program included oversight of food sanitation practices in the dietary services department. This occurred when they did not:

1. Ensure that all expired items were removed from the Medical Unit for use on patients admitted to the medical unit.

2. Ensure that all expired items were removed from the Outpatient Clinic for patient's requiring care at the Outpatient Clinic.

3. Ensure that one of one glucose control solutions were dated when opened in the Outpatient Clinic.

4. Ensure that all non-sterile and expired equipment, instruments and supplies were removed from the Emergency Room (ER) patient care area for patients being cared for in the ER.
5. Ensure that staff food was not stored in the Emergency Room (ER) patient care area which could result in unsanitary conditions for patients being cared for in the ER.
6. Adequately monitor cooked potentially hazardous foods (PHF - foods that support harmful bacterial growth when not safely stored) for safe cool down to prevent the growth of disease causing bacteria for all patient's receiving food prepared in the kitchen.

7. Ensure that the quaternary ammonia sanitizer solution, used to sanitize food contact surfaces, was at an effective concentration for all patient's receiving food prepared in the kitchen.

8. Ensure equipment used for patient food preparation was adequately cleaned and allowed to air dry to prevent food borne illness for all patients receiving food prepared in the kitchen.

9. Ensure the ice machine's storage bin drain pipe maintained an air gap to prevent waste water backflow into the ice storage bin for all patients receiving ice made in the kitchen.


These failures had the potential for unsterile, expired, and ineffective supplies to be used resulting in potential infection, and for the potential to result in food borne illness in a highly susceptible patient population.


Findings:

1. During an observation on April 25, 2016 at 2:29 PM in the Medical Unit's supply room with the Director of Nursing (DON), three Hemoccult cards (a card to test for blood in feces) dated March 2016 were found.


During a concurrent interview with the DON, she confirmed the Hemoccult cards were expired and stated they should have been removed from the unit.


2. During an observation on April 25, 2016 at 2:53 PM in the Outpatient Clinic's supply room with the Clinic Manager (CM);
a. One Hemoccult card was found expired March 2016.
b. Four Purple top lab tubes were found expired March 2016.
c. Six Sutures were found expired March 2016.


During a concurrent interview with the CM, she confirmed the supplies were expired and stated they should have been removed from the unit.


3. During an observation on April 25, 2016 at 2:53 PM in the Outpatient Clinic's Point of Care Testing room, with the Clinic Manager (CM), the opened blood glucose monitor control bottles (bottles containing solution to check to ensure the monitor is giving accurate results) did not have a date written on them.


During an interview with the CM, she verified the bottles were open and not dated.


The manufacturer guide titled "Glucose and Ketone Control Solutions" dated 2015, indicated, "When you open a new bottle, write the date of opening on the bottle label...Discard control solution 3 months after opening or on the expiration date printed on the bottle, whichever comes first."


4. During an observation on April 25, 2016 at 1:52 PM in the Emergency Department with Registered Nurse (RN 1), three blood collection kits were found in a cabinet, expired in March, 2016.


During a concurrent interview with RN 1, he confirmed the blood collection kits were expired and stated they should have been removed from the unit.



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During an observation on April 25, 2016, at 2:20 PM, in the Emergency Room, non-sterile and expired equipment, instruments and supplies were observed in a cabinet and available for patient use. These included:
a. A central venous tray (a special catheter to monitor blood pressure and give medications) was observed to be open (no longer sterile).
b. An expired 40 ml (milliliter) blood culture tube (for sampling blood for microorganisms such as bacteria and fungi) "expired 3/31/2016".
c. An expired lumbar puncture tray (to sample cerebrospinal fluid- fluid around the brain and spinal cord-for abnormalities) "expired 4/1/2016".
d. Two oral airways (device to keep patient airway open) were not covered to prevent contamination.
e. A laryngoscope handle (used with laryngoscope blades to visualize patient airway) was next to the sink not covered to prevent contamination.
f. A thoracotomy set (to perform a life-saving procedure for a chest injury patient) had brown spots on the blue covering (indicating possible contamination).
During a concurrent interview with RN 1, he acknowledged the open central venous tray and stated" it is for training." RN 1 acknowledged the expired blood culture tube and lumbar puncture tray and removed the items from the area. RN 1 acknowledged the two uncovered oral airways and the uncovered laryngoscope handle. RN 1 acknowledged the multiple brown spots on the blue cloth covering the thoracotomy set and stated "it has to do with sterilization."The facility policy and procedure titled "Outdated Supplies" dated April 2016, indicated "It is the policy of [the hospital] Emergency Room (ER) that all equipment, instruments and supplies are checked and re-ordered on a regular basis by the ER personnel...To ensure that adequate supplies with current dates are available at all times."5. During an observation on April 25, 2016, at 2:00 PM, in the Emergency Room, a package of almonds in a plastic bag was observed in a drawer in the Emergency Room patient care area. During a concurrent interview with RN 1, he agreed that food should not be stored in the patient care area. The facility policy and procedure titled "Food & Beverage Control" dated April 2016, indicated "Employees and visitors may consume food and beverages only in the cafeteria or other designated areas (such as the outdoor patios). Employee workstations are NOT designated areas for food consumption."




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6. During a tour of the kitchen on April 25, 2016, at 2 PM, cooked PHF were noted in the freezer: a plastic bag of cooked chicken was dated April 25, 2016, and a container labeled "Lasagna April 12, 2016." During a concurrent interview with the Director of Dietary Services (DDS), he stated that the dates on the items indicated the dates that they were cooked and cooled for storage.

A concurrent review of the facility's "Leftover Cool Down Log" dated April 6 through 23, 2016, indicated that the chicken was not on the logs. There was an entry dated April 12 that was for the lasagna but the log indicated that the lasagna was "all gone." The DDS stated that he had written "all gone" when he did not find the lasagna on that date. He could not explain why the chicken was not monitored for safe cool down.

According to the 2013 Food and Drug Administration Food Code, cooked PHF shall be cooled within 2 hours from 135 °F (degrees Fahrenheit) to 70 °F, and within a total of 6 hours from 135 °F to 41°F or less. Safe cooling requires removing heat from food quickly enough to prevent microbial growth. Excessive time for cooling of PHF has been consistently identified as one of the leading contributing factors to foodborne illness. During slow cooling, PHF are subject to the growth of a variety of pathogenic (disease causing) microorganisms. If the food is not cooled in accordance with this Code requirement, pathogens may grow to sufficient numbers to cause foodborne illness.

Further review of the hospital's Cool Down Logs for the same timeframe indicated that only three of 16 PHF items logged on the form were cooled according to this code.

During a concurrent interview with Cook 1, she stated that she worked the afternoon shift and cooked dinner. She stated that when she cooled down food leftover from dinner, she left at the end of her shift before the food had cooled to safe temperatures. She stated that the food should have been tossed out when it could not be monitored until it was safe. She could not explain why she did not do that.

Written directions to the staff on the Leftover Cool Down Log stated, "You must cool the food down from 140 ° - 70 °F or less in 2 hours. This is the most critical time. Any food that does not get below 70 °F in that two hours you must reheat the food to 165 °F for 15 seconds, and start the cooling process over again. Once the food is cooled down to 70 °F then in 4 hours you must cool the food down to less than 41 °F."

During an interview with the hospital's registered dietitian (RD) on April 26, 2016, at 3:37 PM, she stated that she had not reviewed the cool down logs. She was not aware that the leftover food was not being cooled down safely.

7. During an observation the kitchen on April 26, 2016, at 7:55 AM, a red bucket was observed that contained a quaternary ammonia sanitizer solution (an ammonia based, food- safe sanitizer) used to clean surfaces. Cook 2 used a test strip to check the concentration of the solution. Cook 2 determined that the concentration was 100 parts per million (ppm). The temperature of the solution was measured at 92.7 °F. Cook 2 stated that the concentration should be 200 ppm and the solution in the red bucket was not at an effective concentration. She further stated that the temperature of the solution should be 70 °F when it was tested, it was too warm. Cook 2 stated that the red bucket was "just changed." She could not state why the concentration was not at least 200 ppm. She stated that the concentration of the sanitizer buckets are logged on the Sanitizer Log.

A review of the Multi-Quat (Quaternary Ammonia) Sanitizer Log dated April 2016, showed log entries for the sanitizer solution three times a day from April 1 - 25, 2016. Nine entries out of 75 indicated that the solution concentration was 100 ppm. Eight of the 9 entries had the initials of Dietary Staff 1 (DS 1).

During a concurrent interview with DS 1, she stated that she did not know that the concentration should have been 200 ppm. She stated that she had worked in the kitchen since April 11, 2016. She was unable to state why the sanitizer concentration should be 200 ppm. She verified that she regularly tested the concentration of the sanitizer for about a week, but did not know it should be 200 ppm.

A review of the directions to the staff on the log indicated, "Test the concentration of the ammonia in the sanitizer using the proper (test) strips. Dip the paper in Quat Sanitizer. Test at room temperature 65 °F to 75 °F ... ...Sanitizer reading should be at least 200 ppm. Alert supervisor if Sanitizer levels are below minimum."

During a concurrent interview with the Director of Dietary Services (DSS), he stated that he was not aware that DS 1 was finding and documenting 100 ppm. He was unable to state why he did not notice entries back to April 14, 2016 that were recorded at 100 ppm. He stated that he depended on the more experienced dietary staff to train the new staff. He was not aware that DS 1 did not know that the sanitizer had to be 200 ppm to be effective.


8. During a tour of the kitchen on April 25, 2016, at 2:05 PM, a coffee carafe was observed on the clean side of the sink. The carafe had food residual on the neck of the container.

During a concurrent interview with the DDS, he stated that the coffee carafe was stored after it was clean. He stated that the carafe "was not clean and it could be a whole lot cleaner."

The same day at 2:09 PM, the food processor was inspected. The bottom of the blade of the processor had food residual on it and was stored wet with the lid on it.

During a concurrent interview with the DDS, he stated that the previous shift should have cleaned it and it should be air dried. He stated that it was not clean.

A policy on cleaning of equipment was requested. The DDS stated that the hospital did not have a policy.

According to the 2013 Food and Drug Administration Food Code, equipment food contact surfaces and utensils shall be clean to sight and touch. Items must be allowed to drain and to air-dry before being stacked or stored. Stacking wet items such as pans prevents them from drying and may allow an environment where microorganisms can begin to grow.

9. During an observation of the ice machine on April 26, 2016, at 8:47 AM, the drain pipe from the ice storage bin did not maintain an air gap between the end of the pipe and the drain pipe.

According to the 2013 Food and Drug Administration Food Code, an air gap is the gap between the bottom of the outlet pipe and the flood level of the drain. The purpose of an air gap is to prevent the backflow of waste water in the event of a negative water pressure event. If a connection exists between the ice bin and a source of contaminated water during times of negative pressure, contaminated water may be drawn into and foul the ice bin.

During a concurrent interview with the Maintenance Technician (MT), he stated that there was no air gap.


During an interview with Registered Nurse 1 (RN 1) on April 27, 2016, at 8 AM, he stated that he was the Infection Control nurse at the hospital. When asked about his role in monitoring for and preventing food borne illnesses in the dietary services department, he stated that he did not know a lot about safe food handling in the kitchen. He stated that he looked at the logs in the kitchen to be sure the staff were filling them out, but he did not know what the concentration of the sanitizer should have been or about safe cool down of PHF.

Based on interviews and record reviews, the hospital failed to ensure that the nutrition needs of the inpatients were met in accordance with recognized dietary practices and orders of the practitioner as evidenced by:
1. A lack of inpatients receiving nutritional risk screens and assessments for 5 of 6 sampled patients (Patients 1, 2, 3, 5, and 6).
2. A lack of quality assurance program for the food and nutrition department.
3. A lack of a written and defined role of the hospital's registered dietitian (RD) in the organizational structure, the RD's clinical role and the RD's oversight of sanitary conditions and safe food handling in the dietary services. (Reference C-278)
These deficient practices had the potential to result in the nutritional and safe food handling needs of these patient not being met. It also resulted in allowing the lack of nutrition risk screen and assessments to continue in absence of a quality assurance program and remedy.

Findings:

1. The closed medical records for Patients 1, 2, 3, 5 and 6 were reviewed for nutrition assessment and care.

a. Patient 1 was admitted to the hospital on September 12, 2013 and discharged on September 15, 2013. Patient 1 was admitted for exacerbation of chronic obstructive pulmonary disease or COPD which is a sudden worsening of shortness of breath. According the history and physical dated September 12, 2013, the patient had a long history of COPD and diabetes (high blood sugars).

Laboratory data dated September 12, 2013 indicated his blood glucose was 136 milligrams per deciliter or mg/dl (normal was 85-110 mg/dl). On September 13, 2013, at 9 PM, Patient 1's blood glucose was 208 mg/dl.

Clinical Notes Record dated September 13, 2013 indicated that Patient 1's weight was 299 pounds and his Body Mass Index (BMI - a measure of body fat based on height & weight) was 44.15 (according to the National Institutes of Health, BMI 30 and greater is considered obese).

The nursing Nutrition Risk Screen form in the medical record was blank. In addition, there was no nutrition assessment of the patient.


A review of the hospital's policy titled, "Nutrition Screening/Monitoring" (revised May 2013) indicated, "there is an initial screen of each patient's nutritional status by a licensed nurse within 24 hours of inpatient admission to determine the nutritional risk and the need for nutritional care and monitoring." According to the policy, nutrition screening risk factors included high risk diagnoses of diabetes, COPD and abnormal laboratory values. The scoring guidelines indicated that a patient was considered at moderate nutrition risk when one risk factor was identified and at high nutrition risk when two or more risk factors were identified. It further indicated that a dietary referral needed to be done on all patients with moderate or high risk determination. A high risk patient required the nurse to call the registered dietitian (RD).

The policy further indicated that for patients with moderate or high nutrition risk (1 or more indicators identified), "The Registered Dietitian will complete a nutrition assessment."

b. Patient 2 was admitted to the hospital on April 23, 2013 and discharged on April 28, 2013. Patient 2 was admitted to the hospital for pyelonephritis (a kidney infection) with other diagnoses that included uncontrolled diabetes (high blood sugars).

A review of the physician's orders dated April 24, 2013, indicated an order for a Dietary Consult and a diabetic 1500 calorie diet. A review of the record indicated that there was no dietary consult recorded. There was no nutrition assessment of Patient 2 in the record.

A review of the Clinical Notes Record indicated that the patient's height was 5 feet and weight was 190 pounds and the BMI was 37.1 (according to the National Institutes of Health, BMI 30 and greater is considered obese).

A review of the Diabetic Flowsheet indicated the patient's blood glucose levels throughout the stay were 75 - 220 mg/dl where normal was 85-110 mg/dl.

A review of the Nutrition Risk Screen form undated indicated that Diabetes was not checked as an indicator of a "High Risk Diagnosis" for Patient 2 to indicate the patient was at moderate nutrition risk. Directions on the screen form indicated that a referral was to be sent to the Dietitian for moderate or high risk determinations. The form incorrectly indicated "Low Risk (no indicators)."

c. Patient 3 was an 89 year old patient admitted to the hospital on April 11, 2013 and discharged on April 14, 2013. The admitting diagnoses included diarrhea and dehydration. According to the history and physical dated April 11, 2013, the patient had a change in appetite, weight loss, fatigue, malaise (general discomfort) and lethargy (lack of energy).

A physician's note dated April 12, 2013 indicated the patient's weight was in the low 130's (pounds) 2-3 weeks before and now was 117 pounds.

A laboratory report dated April 12, 2013 indicated an albumin level was 3.3 grams per deciliter or gm/dl (normal was 3.5 to 5 gm/dl). Albumin is a protein in the blood that can be an indicator of nutritional status.

A review of the medical record indicated that there was no Nutrition Risk Screen and no nutrition assessment completed.

d. Patient 5 was admitted to the hospital on June 3, 2014 and discharged on June 4, 2014. The patient was admitted with a diagnosis of Diabetic Ketoacidosis, uncontrolled (a serious condition that can lead to diabetic coma - passing out for a long time - or even death). The blood glucose was 317 mg/dl (normal was 85-110 mg/dl).

There was no Nutrition Risk Screen or nutrition assessment in the medical record.

e. Patient 6 was a 93 year old patient admitted to the hospital on February 8, 2013 and discharged on February 13, 2013. The patient was admitted with diagnoses that included pneumonia, weight loss and dehydration.

A review of the laboratory values dated February 10, 2013 indicated an albumin level of 1.9 gm/dl (normal was 3.5 - 5.0 gm/dl) and total protein was 4.9 gm/dl (normal 6.3 - 8.2 gm/dl).

A review of the Nutrition Risk Screen dated February 9, 2013 indicated the patient was at high nutrition risk and a referral to the dietitian was sent. There was no nutrition assessment in the medical record.

During an interview with the Director of Medical Records (DMR) on April 26, 2016 at 3:35 PM, she stated that in 2014 and 2015 the medical records were electronic and if a documents were not on the chart, then the document was not completed.


2. A review of a recertification survey conducted by the California Department of Public Health, dated May 4, 2012, indicated that the lack of nutrition assessment was a repeat deficient practice that was identified on that survey. On the May 2012 survey, this occurred when 6 of 6 inpatient medical records that were reviewed for nutrition care did not have appropriate nutrition assessments. The documented hospital's plan of correction for this deficient practice indicated that audits would be conducted of patients to verify adequate communication between nursing and the RD. Any deviations were to be written and submitted to the QA (Quality Assurance) committee for review and further corrective action as needed.

During an interview with the Director of Nursing on April 27, 2016, at 8 AM, she stated that this monitoring probably did not happen. She was unable to provide documentation that these audits were conducted. She was unable to explain why the deficient practice was allowed to continue despite being identified on the last recertification survey.

The RD responsible for completing the nutritional assessments in 2013 and 2014 was no longer working for the hospital during this survey. During an interview with the hospital's current RD on April 26, 2016 at 3:37 PM, she stated that her focus was on clinical (nutrition assessment and monitoring of patients). She stated that the hospital had not had any patients admitted to the hospital since she started working there, about 2 months ago. She was unable to state why the previous RD did not complete the required nutrition assessments.

3. During a review of the hospital's organizational chart and concurrent interview with the Vice President of Ambulatory Care Services (VP of ACS), on April 26, 2016, at 1:36 PM, the VP of ACS stated that the registered dietitian (RD) was not on the organizational chart for the hospital. She stated that the RD reported to her (VP of ACS). When asked where she (the VP of ACS) was on the organizational chart, she stated that her position was also not on it.

A review of the employee file for the RD indicated that there was no job description in the file. The job description was requested and the VP of ACS provided a job description (undated) that stated the RD's Position Summary: "The role of the dietitian is to advise and counsel patients on food and nutrition in conjunction with the patient's overall medical treatment plan. The Dietitian is responsible for creating, managing and administering the organization's outpatient nutrition program."

During a concurrent interview with the VP of ACS, she stated that the job description was not specific for the RD's role at the hospital, but was for outpatient services in the ambulatory care portion of their business. There was no indication in the job description of the role of the RD in oversight of the dietary services for sanitation and safe food handling.

During a phone interview with the RD on April 26, 2016, at 3:37 PM, she stated that since she started at the hospital in February 2016 she had worked there two days, total. She stated that most of her time spent at the facility was spent looking at patient records and documenting in the medical record. She had not spent time reviewing safe food handling and sanitary practices in the dietary services department.

According to the California Health & Safety Code 1265.4, a licensed health facility, shall employ a full-time, part-time, or consulting dietitian. A health facility that employs a registered dietitian less than full time, shall also employ a full-time dietetic services supervisor ... ...The dietetic services supervisor shall receive frequently scheduled consultation from a qualified dietitian.

Based on interview and record review the facility failed to provide Nursing Care Plans (a tool for nurses used to assess, plan, implement and evaluate patient care) for seven out of 10 closed patients records (Patients 7,8,9,10,11,12,and 15). These failures had the potential for patients not to receive optimal care when the nursing process was not followed.

Findings:

During a review of the closed patient records for Patients 7, 8, 9, 10, 11, 12, and 15 on April 26, 2016, at 2:10 PM, no Nursing Care Plans were noted.

During an interview with the Director of Medical Records (DMR) on April 26, 2016 at 3:35 PM, she stated that in 2014 and 2015 the medical records were electronic and Nursing Care Plans were not built into the system. The nurses at that time had to pull a manual paper Nursing Care Plan and place it in the chart. The DMR stated if the nurses wrote a Care Plan it would be in the chart.

During an interview with the Director of Nursing (DON) on April 26, 2016, at 5:00 PM, she stated she was unaware the electronic medical records used in 2013 and 2014 did not include a Nursing Care Plan, or that the nurses had to use a paper Nursing Care Plan.

The facility policy and procedure titled "Care Planning", dated July 2012 indicated, "Care, treatment and services are planned to ensure that they are individualized to the patient's needs. [The hospital] shall provide an individualized, interdisciplinary plan of care for all patients that is appropriate to the patient's needs, strengths, results of diagnostic testing, limitations and goals... Nursing staff shall develop a plan of care for each patient within 24 hours of admission..."

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The CONDITION is not met as evidenced by:
The hospital failed to ensure the Condition of Participation: CFR 485.641, Periodic Evaluation and Quality Assurance Review was met by failing to:

1. Provide Advance Directive (a written document providing a patient's desire to have or withhold medical treatment if they cannot make their wishes known) information to all patients who were admitted to the hospital. (Refer to C-151)

2. Ensure the Emergency Crash Cart and defibrillator (standard treatment for life-threatening heart rhythms) were monitored daily. (Refer to C-204).

3 a. Ensure the annual Physicists Radiography Safety Report was performed in a timely manner. (Refer to C-222).

3 b. Ensure the Preventative Maintenance (PM, a check to make sure equipment is working properly) was done annually on an Audiometer used in the Outpatient Clinic. (Refer to C-222)

4 a. Ensure five of five physician credential files (a file of documents to prove physician education and skill) contained complete documentation of experience, training and competency (ability). (Refer to C-241).
4 b. Ensure all physician credential files contained a complete list of privileges (tasks the physician is allowed to do in the hospital) granted. (Refer to C-241).


5 a. Ensure that the hospital had a current and active drug room permit licensed by the California State Board of Pharmacy which is required for California state licensure. Without an active drug room permit, the hospital is not able to purchase medications and would not be able to meet the pharmaceutical needs of it's patients which could lead to harm. (Refer to C-276)

5 b. Ensure opened and used multi-dose medication vials were dated with a 28 day expiration per hospital policy. One opened and used vial of insulin was found in a medication storage refrigerator in the Emergency Department without a label to indicate when it was opened or when it expires. Without proper labeling, the medication could be used past the manufacturer's designated expiration date or the hospital's medication expiration date for multi-dose vials. Using a medication past it's expiration date can expose the patient to medication with microbial growth or medication that is not as effective as the prescriber and manufacturer intended use which can lead to patient harm. (Refer to C-276)

5 c. Ensure opened and used single-dose medication vials were properly discarded and not available for patient use. Single-dose vials contain no preservative which prevents microbial growth. Exposing a patient to medication with microbial growth can lead to significant patient harm. (Refer to C-276)

5 d. Ensure that hospital policy & procedure reflected proper Beyond Use Dating (BUD) for compounded (mixing 2 or more medications or solutions) IV (intravenous - in the vein) medications and that nursing staff were aware of acceptable BUD for the types of compounded IV medications the hospital provides to patients. Hospital policy & procedure does not guide nursing personnel on the BUD or expiration date to be placed on the drug product after compounding. In addition, nursing personnel were not aware of the BUD of immediate use compounded IV medications as described by accepted professional standards (quality monitored by healthcare professionals). Placing an inappropriate beyond use date on a compounded IV medication may expose the patient to microbial growth which can lead to patient harm. (Refer to C-276)

5 e. Ensure that controlled drug record inventory matched actual controlled drug inventory available for immediate patient use for two medications. Controlled drug inventory records that do not match actual medication inventory can lead to diversion of controlled medication which can potentially lead to impaired hospital personnel caring for patients. Impaired hospital personnel that are under the influence of controlled medications can potentially lead to serious patient harm. (Refer to C-276)

5 f. Ensure that drugs maintained in the patient care areas were inspected at least monthly by a pharmacist or the Director of Nursing Services (DON) as required by hospital policy and procedure. Medication areas not reviewed regularly by a pharmacist or the DON can lead to medications not being stored appropriately or nursing personnel not following hospital policy and procedure in regards to medications. Improper storage or medication policy and procedure that is not followed can potentially lead to patient harm. (Refer to C-276)

5 g. Ensure the Physical Therapy (PT) supply room and cabinets containing needles and medications were locked when unattended. These failures had the potential to result in unauthorized persons having access to the needles and medications within the hospital and out-patient areas which could result in harm. (Refer to C-276)

6 a. Non-sterile and expired equipment, instruments and supplies were not in the patient care area and available for patient use. (Refer to C-278).

6 b. Ensure that glucose control solutions were dated when opened in the Outpatient Clinic. (Refer to C- 278)
6 c. Ensure that food was not stored in the Emergency Room patient care area. (Refer to C-278)
6 d. Adequately monitor cooked potentially hazardous foods (PHF - foods that support harmful bacterial growth when not safely stored) for safe cool down to prevent the growth of disease causing bacteria. (Refer to C-278)

6 e. Ensure that the quaternary ammonia sanitizer sloution, used to sanitize food contact surfaces, was at an effective concentration. (Refer to C-278)

6 f. Ensure equipment used for patient food preparation was adequately cleaned and allowed to air dry to prevent food borne illness. (Refer to C- 278)

6 g. Ensure the ice machine's storage bin drain pipe maintained an air gap to prevent waste water backflow into the ice storage bin. (Refer to C- 278)

6 h. Ensure there was a written and defined role of the hospital's registered dietitian (RD) in the organizational structure, the RD's clinical role and the RD's oversight of sanitary conditions and safe food handling in the dietary services. (Reference C-278)

7 a. Ensure that the nutrition needs of the inpatients were met in accordance with recognized dietary practices and orders of the practitioner. (Refer to C-279)

7 b. Ensure inpatients received nutritional risk screens and assessments. (Refer to C-279)

7 c. Ensure a quality assurance program was established for the food and nutrition department. (Refer to C-279)

8. Ensure Nursing Care Plans (a tool for nurses used to assess, plan, implement and evaluate patient care) were developed and implemented on each patient admitted to the hospital. (Refer to 289)

9. Ensure the hospital had an effective ongoing quality assurance program. (Refer to C-336)

The cumulative effects of these systemic failures resulted in the failure of the hospital to deliver care in a safe environment in order to be in compliance with the Condition of Participation Periodic Evaluation and Quality Assurance Review.

Based on observation, interview and record review, the facility Quality program did not identify the following:
1. Physician credential files contained complete documentation of training, experience, competency (ability) and privileges granted (tasks the physician is allowed to perform in the Hospital).
2. Non-sterile and expired equipment, instruments and supplies were not in the patient care area and available for patient use.
3. The Emergency Crash Cart and defibrillator (standard treatment for life-threatening heart rhythms) were monitored daily.
4. The annual Physicists Radiography Safety Report (a safety evaluation of all equipment that emit radiation) was performed in a timely manner.
5. The hospital failed to ensure that the nutrition needs of the inpatients were met in accordance with recognized dietary practices when a lack of inpatients receiving nutritional risk screens and assessments.

These practices had the potential to increased the likelihood that these events could recur in the future and result in reoccurance of deficient practices of all patients admitted to the hospital.
Findings:1 a. During a review of the credential files for five physicians (MD 1, MD 2, MD 3, MD 4 and MD 5), there was no documented evidence of past experience, peer references or activity lists to document competency of the physicians. Also, five of five physician credential files (MD 1, MD 2, MD 3, MD 4 and MD 5) did not contain complete independent verification (double checking from an outside source) of all physician medical training. During an interview with the Director of Medical Records (DMR), on April 26, 2016, at 8:40 AM, she reviewed the credential files for five physicians (MD 1, MD 2, MD 3, MD 4 and MD 5) and was unable to find documentation of peer references, activity lists or documented past experience for five of five physicians. The DMR was also unable to find documentation of independent verification of all medical training for five of five physicians. The Bylaws of the Medical Staff, dated February 28, 2015, indicated "...Article IV. Procedures for Appointment and Reappointment 4.01-4 Processing the application (a) Applicant's Burden: The applicant shall have the burden of producing adequate information for proper evaluation of his/her experience, background, training and demonstrated ability...(b) Verification of Information: The applicant shall fill out and deliver an application...The application will be deemed complete when all necessary verifications have been obtained, including current license, DEA (Drug Enforcement Agency) certificate (allows the practitioner to prescribe medication) if appropriate, verification of all practice from professional school, reference letters..."
The facility policy titled "Organizational Performance Improvement Plan" dated February 2016, indicated "Purpose: SIHD Services' Performance Improvement Plan is designed to monitor, evaluate and improve the quality, appropriateness and outcomes of care, treatment and services by...Identifying opportunities through continuous assessment of systems and processes of care through a collaborative, interdisciplinary focus...Scope of Activities...Assessment of the performance of the following patient care and organizational functions are included...Medical Staff..."
1 b. During a review of the credential files for five physicians (MD 1, MD 2, MD 3, MD 4 and MD 5), One of five physician credential files (MD 4) did not contain a complete list of privileges granted. A review of MD 4's "Advanced Procedures" list, dated March 9, 2016, indicated only three of 31 privileges listed had a check mark beside the privilege. The remaining 28 privileges did not have a check mark beside the privilege. During an interview with the DMR, on April 26, 2016, at 10:00 AM, she reviewed the credential file for MD 4 and was unable to find a complete list of privileges granted. The Bylaws of the Medical Staff, dated February 28, 2015, indicated "...Article V. Determination of Clinical Privileges 5.01 Exercise of privileges. Except as otherwise provided in these Bylaws or the Medical Staff Rules and Regulations, every practitioner or other professional providing services at this hospital shall be entitled to exercise only those privileges or services specifically granted to him/her..."
The facility policy titled "Organizational Performance Improvement Plan" dated February 2016, indicated "Purpose: SIHD Services' Performance Improvement Plan is designed to monitor, evaluate and improve the quality, appropriateness and outcomes of care, treatment and services by...Identifying opportunities through continuous assessment of systems and processes of care through a collaborative, interdisciplinary focus...Scope of Activities...Assessment of the performance of the following patient care and organizational functions are included...Medical Staff..."
2 a. During an observation on April 25, 2016, at 2:20 PM, in the Emergency Room, non-sterile and expired equipment, instruments and supplies were observed and available for patient use. These included:2 b. A central venous tray (a special catheter to monitor blood pressure and give medications) was observed to be open (no longer sterile).2 c. An expired 40 ml (milliliter) blood culture tube (for sampling blood for microorganisms such as bacteria and fungi) "expired 3/31/2016". 2 d. An expired lumbar puncture tray (to sample cerebrospinal fluid- fluid around brain and spinal cord-for abnormalities) "expired 4/1/2016". 2 e. Two oral airways (device to keep patient airway open) were not covered to prevent contamination.2 f. A laryngoscope handle (used with laryngoscope blades to visualize patient airway) was next to the sink not covered to prevent contamination. 2.g. A thoracotomy set (to perform a life-saving procedure for a chest injury patient) had brown spots on the blue covering (indicating possible contamination).
During a concurrent interview with RN 1, he acknowledged the open central venous tray and stated" it is for training." RN 1 acknowledged the expired blood culture tube and lumbar puncture tray. RN 1 acknowledged the two uncovered oral airways and the uncovered laryngoscope handle. RN 1 acknowledged the multiple brown spots on the blue cloth covering the thoracotomy set and stated "it has to do with sterilization."
The facility policy and procedure titled "Outdated Supplies" dated April 2016, indicated "It is the policy of Southern Inyo Hospital Emergency Room (ER) that all equipment, instruments and supplies are checked and re-ordered on a regular basis by the ER personnel...To ensure that adequate supplies with current dates are available at all times."
The facility policy titled "Organizational Performance Plan" dated February 2016, indicated "...Identifying opportunities through continuous assessment of systems and processes of care through collaborative, interdisciplinary focus...Scope of Activities...Assessment of the performance of the following patient care and organizational functions are included...Infection Prevention and Control..."3. During an observation on April 25, 2016, at 2:15 PM, the facility document titled "Emergency Department Daily Crash Cart checklist" " dated "2/2012" indicated no documented evidence that the emergency crash cart/defibrillator daily check had been performed on April 25, 2016. During a concurrent interview with RN-1 he agreed there was no evidence that the crash cart and defibrillator were checked on April 25. 2016. The facility policy and procedure titled "Emergency Crash Cart/Defibrillator Daily Check" dated May 2012, indicated "Crash carts will be checked daily."
The facility policy titled "Organizational Performance Plan" dated February 2016, indicated "...Identifying opportunities through continuous assessment of systems and processes of care through collaborative, interdisciplinary focus...Scope of Activities...Assessment of the performance of the following patient care and organizational functions are included...Emergency Management. "

4. During an observation on April 25, 2016, at 3:10 PM, in the Radiology area, it was noted that the last annual Medical Physicist Evaluation of the Radiographic equipment (a safety evaluation of all equipment that emit radiation) was performed on March 19, 2015. During a review of the "Radiographic Equipment Evaluation" indicated the report was dated March 19, 2015. During a concurrent interview with theRadiological Technician (RT 1), she stated the physicist was last at the facility on March 19, 2915, and she acknowledged that the annual safety check was overdue. According to the American College of Radiology (ACR) "Technical standard for diagnostic medical physics performance monitoring of Radiographic and fluoroscopic equipment" revised 2011, indicated...The performance of all Radiographic and fluoroscopic equipment must be evaluated upon installation and monitored at least annually by a Qualified Medical Physicist to ensure that the equipment is functioning properly and that patients are not exposed to unnecessary doses of radiation."
The facility policy titled "Organizational Performance Plan" dated February 2016, indicated "...Identifying opportunities through continuous assessment of systems and processes of care through collaborative, interdisciplinary focus...Scope of Activities...Assessment of the performance of the following patient care and organizational functions are included...Environment of Care. "



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5. A review of a recertification survey conducted by the California Department of Public Health, dated May 4, 2012, indicated that the lack of nutrition assessment was a repeat deficient practice that was identified on that survey. On the May 2012 survey, this occurred when 6 of 6 inpatient medical records that were reviewed for nutrition care did not have appropriate nutrition assessments. The documented hospital's plan of correction for this deficient practice indicated that audits would be conducted of patients to verify adequate communication between nursing and the RD. Any deviations were to be written and submitted to the QA (Quality Assurance) committee for review and further corrective action as needed.

During an interview with the Director of Nursing on April 27, 2016, at 8 AM, she stated that this monitoring probably did not happen. She was unable to provide documentation that these audits were conducted. She was unable to explain why the deficient practice was allowed to continue despite being identified on the last recertification survey.

The RD responsible for completing the nutritional assessments in 2013 and 2014 was no longer working for the hospital during this survey. During an interview with the hospital's current RD on April 26, 2016 at 3:37 PM, she stated that her focus was on clinical (nutrition assessment and monitoring of patients). She stated that the hospital had not had any patients admitted to the hospital since she started working there, about 2 months ago. She was unable to state why the previous RD did not complete the required nutrition assessments.