HospitalInspections.org

Based on interview and record review, the hospital failed to provide an advance directive notice (a written statement of a person's wishes regarding medical treatment) at the time of registration for four of 31 sampled patients (4, 5, 10, and 17). This resulted in Patients 4, 5, 10, and 17 not having an advance directive and the potential for patient's decisions and rights not to be provided.

Findings:

During a review of the clinical record for Patient's 4, 5, 10, and 17 the document titled "Health Plan Obligation", indicated multiple questions to answer including "Do you have an: 1) Advance Directive. . . 2)Would you like further information?" Both questions were not marked for Patients 4, 5, 10, and 17.

During an interview with the Health Information Management (HIM), on 6/27/17, at 10:16 AM, she reviewed the clinical records for Patient 4 and 5 and confirmed the findings. HIM stated "The form is filled out upon admission and it was the responsibility of the Emergency Technicians to ensure the form was completed."

During an interview with the Privacy Officer (PO), on 6/28/17, at 9:30 AM, she reviewed the clinical records for Patient 10 and 17 and confirmed the findings. The PO stated, "Staff should have made sure the form was completely filled out."

The hospital policy and procedure titled "Advance Directives" revised date 4/20/12, indicated "It is the policy of [Facility Name] to: Document in each patient medical record whether or not he/she has executed an advance directive."

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

1. Ensure updated restraint training was provided for six direct care staff (License Vocational Nurse [LVN] 1, Certified Nursing Assistant [CNA] 1, 2, Registered Nurse [RN] 1, 2, and Emergency Technician [ET] 1).

2. Ensure one ET 1 staff had a valid Cardiopulmonary Resuscitation (CPR- an emergency lifesaving procedure that is performed when the heart stops beating) card.

These failures has the potential to place patients at risk of receiving care from unqualified and untrained staff.

Findings:

1. During a review of the employee file with the Human Resource Manager (HRM), on 6/28/17, at 12:30 PM, she was unable to find documented evidence restraint training was provided for LVN 1, CNA 1, CNA 2, RN 1, RN 2, and ET 1. The HRM stated the training "should be done annually."

2. During a review of the employee file with the HRM, on 6/28/17, at 12:30 PM, the CPR card for ET 1 had an expiration date of 3/3/17. The HRM confirmed the finding.

The hospital policy and procedure titled "Healthcare Providers Basic Life Support (BLS) and Cardiopulmonary Resuscitation (CPR)" dated 12/05/12, indicated "A. All staff members providing direct patient care services are required to have a valid BLS provider card within three (3) months of employment and maintain a valid card throughout their entire period of employment. The BLS provider card must be renewed within 30 days of the expiration date. Each staff member requiring a BLS provider card must present the original card to HR [Human Resource] in order for a copy to be generated for inclusion in their personnel file."

Based on observation, interview, hospital document review, and hospital policy review, the hospital failed to maintain and monitor life-saving drugs and an outside inventory list for emergency cases when it did not:

1. Ensure a Pharmacist completed a monthly inspection of the intensive care unit (ICU - a hospital unit for seriously ill patients) medication storage areas in accordance with the hospital's policies and procedures. This occurred when the last documented inspection of one of one ICU crash carts (storage area of life-saving medications) occurred in 8/16. This failure had the potential for patients to be administered deteriorated (reduced quality) medications.

2. Ensure one of one ICU crash carts displayed the medication contents on the outside of the crash cart in accordance with the hospital's policies and procedures. This occurred when the contents list was missing on the outside of the ICU crash cart. This failure had the potential for hospital staff to be unaware of which emergency drugs were kept inside of the crash cart.

Findings:

1. During a concurrent observation, in the ICU, with the Pharmacist-In-Charge (PIC), on 6/28/17, at 9:10 AM, an inspection of the ICU crash cart was conducted. The ICU crash cart contained the following expired medications:

- Two items of naloxone (an antidote for overdose) 2 milligram (mg - a unit of measurement) in 2 milliliters (mL - a unit of measurement) expired 1/17,

-Two items sodium bicarbonate (drug to correct high acid levels in the body) 8.4% (drug strength) 50 mLs expired 4/1/17,

-Three items of atropine (drug to treat slow heart rate) 1 mg in 10 mL expired 1/17,

-One IV (intravenous - into a patient's vein) bag of dextrose (sugar) 5% (drug strength) expired 11/16,

-Four items of amiodarone (an antiarrhythmic - to treat heart rhythm problems) 150 mg in 3 mL expired 2/17,

-One IV bag of lidocaine (an antiarrhythmic - to treat heart rhythm problems) 2 grams (gm - a unit of measurement) in 500 mLs expired 2/17; and,

-Two items of magnesium sulfate (for heart rhythm problems) 1 gm in 100 mLs expired 2/17.

The PIC acknowledged the above medications were expired.

During an interview with the PIC, on 6/28/17, at 10:07 AM, the PIC acknowledged a Pharmacist last conducted a monthly inspection of the ICU medication storage areas in 8/16.

During an interview with the Executive Assistant, on 6/28/17, at 9:32 AM, she acknowledged the ICU unit was still licensed by the Department (CDPH - California Department of Public Health).

The hospital's form titled "Pharmacy Services - ICU Unit" indicated that a Pharmacist completed a monthly inspection of the ICU Unit on 8/15/16. The hospital's form indicated the crash cart was to be inspected by the Pharmacist. The time period from the date of the last Pharmacist monthly inspection to the date of review of the hospital's form was calculated to be 10 months.

The hospital policy and procedure titled "Medication Storage" dated 3/2/16, indicated, "A Pharmacist or his/her qualified designee shall conduct a monthly inspection of all medication storage areas."

The hospital policy and procedure titled, "Drug Procurement/Inventory Control" dated 7/03, indicated, "Inspection: All storage drug areas within the facility will be inspected monthly by the Pharmacy Department."

2. During an observation and concurrent interview with the PIC in the ICU on 6/28/17 at 9:05 AM, an inspection of the ICU crash cart was conducted. The medication contents list was observed to be missing from the outside of the ICU crash cart. The PIC acknowledged the above observation.

The hospital policy and procedure titled "Emergency Medication (Crash Cart, E-Kits, Etc.)" dated 9/2/15, indicated, "The contents of each crash cart or emergency kit shall be displayed on the outside of the kit/cart."

Based on observation, interview, and record review, the hospital failed to ensure one emergency (crash) cart was maintained and readily available to use in patient emergencies when:

1. Emergency equipment was not monitored.

2. Emergency supplies were not expired.

These failures had the potential for life saving equipment to not be available in the event of an emergency.

Findings:

1. During an interview with the Infection Control Professional on 6/28/17, at 8:25 AM, she stated she had taken the Intensive Care Unit (ICU) out of service for her monitoring purposes in July of 2016, due to lack of staff and patients. The ICU was still licensed.

During an observation, on 6/28/17, at 12 PM, in the ICU, an unsealed crash cart was noted. On the top of the crash cart was a defibrillator (delivers a dose of electric current to the heart for treatment for life-threatening cardiac dysrhythmias). No Crash cart log documenting the defibrillator was checked, or that the unit was closed was noted.

The hospital policy and procedure titled "Crash Cart Checks", dated 4/6/11, indicated "All crash carts will be checked on a regular basis by each department assigned staff: Crash cart is checked at the beginning of each shift and the checklist is completed; . . . d. Document "Closed" on the log, when the department is closed and the unit will not be in use. . .Crash cart checks include:. . .Defibrillator watt checks with unit unplugged at prescribed joules. . ."

2. During a concurrent observation and interview with the Chief Executive Officer (CEO), on 6/28/17, at 3 PM, in the ICU, an unsealed crash cart was noted. In a drawer, two adult colorimetric (measures color change) CO2 (carbon dioxide) detector devices (confirm proper endotracheal tube (emergency breathing device) placement by assessing exhaled CO2) were noted to have expired on 1/17. No Crash cart log documenting the crash cart was checked was noted. The CEO verified both CO2 detector devices were expired.

The hospital policy and procedure titled "Crash Cart Checks", dated 4/6/11, indicated "Monthly crash cart checks:. . .a. Respiratory staff will check the respiratory drawer for functionality of the laryngoscope lights and outdated supplies; b. Drawer will be resealed with a yellow tag and documented on the crash cart log."

Based on observation, interview, and hospital policy review, the hospital failed to store medications properly in a secure manner in the intensive care unit (ICU - a hospital unit for seriously ill patients). This occurred when one of one ICU crash carts containing medications was observed to be unsealed without a colored plastic tag in accordance with the hospital's policies and procedures. This failure had the potential for theft and/or unauthorized access to medications.

Findings:

During an observation and concurrent interview with the Pharmacist-In-Charge (PIC), in the ICU, on 6/28/17, at 9:10 AM, an inspection of the ICU crash cart was conducted. The top drawer of the ICU crash cart containing emergency medications was observed to be unsecured, without a colored plastic tag. This allowed the top drawer of the ICU crash cart to be easily pulled open to access the emergency medications. The PIC acknowledged the above observation.

The hospital policy and procedure titled, "Emergency Medication (Crash Carts, E-Kits, Etc.)" dated 9/2/15, indicated, "All emergency medications will be stored in containers or cabinets that are sealed. Seals will be utilized to allow staff to determine if the package/container has been opened." On page 2, the policy indicated, "When an emergency kit/cart has been restocked and ready for patient use, the Pharmacist will seal the cart with a red tag."

The hospital policy and procedure titled, "Medication Security" dated 11/4/15, indicated, "Crash cart medications will be stored in containers closed with seals, which allows the Pharmacist to determine if the package has been opened ...All medications at the Nurse's station shall be in lockable storage at all times."

The hospital policy and procedure titled, "Drug Procurement/Inventory Control" dated 7/03, indicated, "Storage: Medications are stored under proper conditions of temperature and security."

Based on interview and record review, the Governing Body failed to ensure the Medical Staff operated under the current bylaws when:

1. One Medical Staff member (Medical Doctor [MD]) 2 was reappointed without a completed performance based reappraisal.

2. Two provisional Medical Staff members (MD 3 and MD 4) were not proctored while engaging in clinical care activities as a means of ensuring competence of newly appointed physicians granted clinical privileges.

These failures placed patients at risk of receiving care from someone not qualified to provide those services.

Findings:

1. During a review of five credential files, it was noted one member of the Medical Staff (MD 2), who had previously been granted privileges was reappointed without a performance based reappraisal completed for 1. Professional Performance, 2. Judgement and 3. Clinical/Technical Skills.

During an interview with the Medical Staff Secretary (MSS), on 6/27/17, at 11:45 AM, she was unable to provide performance based reappraisals for MD 2 and stated, "They all know each other's work so they probably just signed him off."

During an interview with the Chief Executive Officer (CEO), on 6/28/17, at 9:43 AM, he stated "These [performance evaluations] should be written."

The hospital document titled, "Medical Staff Rules" dated 2008, indicated "The application shall request information pertinent to the applicant's qualifications, such as. . . experience, abilities and current competencies, . . .Failure to comply with the bylaws, policies and procedures of the Medical Staff and the facility can be inadvertant. . .places the Medical Staff or the facility in jeopardy with respect to licensing or accreditation requirements. . ."

The hospital document titled, "Medical Staff Bylaws" dated 2008, indicated "The credentialing and privileging processes described in Bylaws, Article 4, Procedures for Appointment and Reappointment, and Article 5, Privileges, require that the Medical Staff develop ongoing performance evaluation and monitoring activities to ensure that decisions regarding appointment to membership on the Medical Staff and granting or renewing of privileges are, among other things, detailed, current, accurate, objective, and evidence-based. Additionally, performance evaluation and monitoring activities help assure timely identification of problems that may arise in the ongoing provision of services in the hospital. . . Medical Staff shall regularly monitor all members' privileges in accordance with the provisions set forth in these Bylaws..The results of any practitioner-specific performance monitoring shall be considered when granting, renewing, revising, or revoking clinical privileges of that practitioner. . ."

2. During a concurrent review of MD 3's credentialing file and an interview with the MSS, on 6/27/17, at 10:49 AM, the MSS confirmed MD 3 was appointed to the Medical Staff on 6/7/17. The MSS was unable to provide proctoring records for MD 3 and stated "[MD 1] had shadowed her for two days in May," but had not completed and returned the proctoring forms.

During a concurrent review of MD 4's credentialing file and an interview with the MSS, on 6/27/17, at 11:12 AM, the MSS confirmed MD 4 was appointed to the Medical Staff on 11/2/16. The MSS was unable to provide proctoring records for MD 4 and stated MD 1 had not completed and returned the proctoring forms.

During an interview with MD 1, on 6/27/17, at 11:24 AM, he stated he did not have a "paper trail for MD 4." He had reviewed several charts but had not completed any proctoring forms for MD 4. MD 1 further stated he had not completed any proctoring forms for MD 3.

During an interview with the CEO, on 6/28/17, beginning at 9:43 AM, he stated the (proctoring) process is spelled out in the Medical Staff Rules and Regulations. The CEO confirmed both MD 3 and MD 4 were provisional Medical Staff and then stated MD 1 needed to complete the proctoring forms faster.

The hospital document titled, "Medical Staff Bylaws" dated 2008, indicated "A Focused Professional Practice Evaluation shall be used in at least the following situations: A. All initial appointees to the Medical Staff and all members granted new privileges shall be subject to a period of focused professional practice evaluation in accordance with these Bylaws. Such focused evaluation will generally include a period of Level I proctoring. . .Level I proctoring shall be considered routine and is generally implemented as a means to review initially requested privileges. . ."

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

1. Ensure one of one bottle of the controlled substance (CS - a scheduled drug with potential for abuse) medication dronabinol (Marinol® - for severe nausea or loss of appetite) was stored locked in the Pharmacy Refrigerator accordance with the hospital's policies and procedures. Dronabinol is a Scheduled III (high potential for abuse) CS medication. This failure had the potential for CS theft.

2. Ensure current and accurate CS records were maintained for the CS medication, dronabinol. This occurred when the physical (observed) dronabinol count (60 capsules) did not equal the CS record count (zero capsules). This failure resulted in inaccurate CS records.

3. Ensure one of one opened regular (short-acting) insulin (medication to manage high blood sugars) was stored with a labeled expiration date in accordance with hospital's policies and procedures in the Emergency Department (ED) Medication Refrigerator. This failure had the potential for patients to receive deteriorated (reduced quality) medications.

4. Ensure one of one opened 70/30 insulin (combination of two insulin forms) was stored with a labeled expiration date in accordance with the hospital's policies and procedures in the in the Acute Care Medication Room. This failure had the potential for patients to receive deteriorated medications.

5. Ensure three of three 100 milliliters (mLs - a unit of measurement) normal saline intravenous (IV - into the patient's vein) solution bags removed from the plastic overwrap were dated with an expiration date when stored in the Acute Care Medication Room at room temperature. This failure had the potential for patients to receive deteriorated medications.

6. Ensure one of one Intensive Care Unit (ICU - a hospital unit for seriously ill patients) crash carts did not contain outdated and expired medications in accordance with the hospital's policies and procedures. This failure had the potential for patients to receive deteriorated medications.

7. Ensure ED "Banana Bags" (IV fluid bags with vitamins and minerals) were prepared in accordance with the immediate-use (for urgent situations) requirements of The United States Pharmacopeia (USP) <797> standards of practice. Per USP <797>, immediate-use compounded (mixed) sterile (germ-free) preparations (CSPs) must be prepared under conditions described for Low-Risk Level (category of contamination risk) CSPs. Medium-Risk Level CSPs (category of contamination risk) must not be prepared as immediate-use CSPs. The ED "Banana Bags" were not prepared adhering to Low-Risk Level criteria when the compounding process involved the simple transfer of more than three commercially manufactured packages of sterile nonhazardous products to ten of ten patients (Patient 21, Patient 22, Patient 23, Patient 24, Patient 25, Patient 26, Patient 27, Patient 28, Patient 29, and Patient 30). This failure had the potential to expose patients to increased risk of infections.

8. Ensure the IV compounding hood (device to maintain sterile work area) was cleaned with sterile isopropyl alcohol (IPA - a colorless alcohol). This failure had the potential to expose seven patients of seven patients to compounded sterile preparations (CSPs) that did not meet USP <797> requirements.

9. Ensure compounding personnel completed gloved fingertip/thumb sampling procedure (assessment of staff putting on gloves without contamination) prior to compounding medications. This occurred when the hospital could not provide documentation Registered Pharmacist (RPh) 1 passed the evaluation. This failure had the potential to expose seven patients (census) to CSPs that did not meet USP <797> requirements.

Findings:

1. During an observation and concurrent interview with Pharmacist (RPh) 1, in the Pharmacy, on 6/26/17, at 10:45 AM, the Pharmacy Refrigerator was inspected. A bottle of dronabinol 2.5 milligrams (mg - a unit of measurement) containing 60 capsules was observed, stored unlocked, mixed with the non-CS medications. The bottle of dronabinol was labeled Scheduled III. There was no lock and key needed to access the unsecured dronabinol capsules in the refrigerator. RPh 1 acknowledged the above observation.

The hospital policy and procedure titled "Medication Storage" dated 3/2/16, indicated, "Scheduled drugs shall be stored separately from other medications and secured with lock and key ..."

2. During an observation and concurrent interview with RPh 1, in the Pharmacy, on 6/26/17, at 10:45 AM, the Pharmacy Refrigerator was inspected. Sixty capsules of dronabinol 2.5 mg were observed stored in the refrigerator. RPh 1 acknowledged the above observation.

During an interview with the Pharmacy Technician (Pharmacy Tech), on 6/26/17, at 11:10 AM, the Pharmacy Tech acknowledged the observed count of dronabinol 2.5 mg was 60 capsules compared to zero capsules of dronabinol logged on the CS record.

During an interview with the Executive Assistant, on 6/26/17, at 2:44 PM, she stated that no acute care policy and procedures on controlled drug distribution and security had been approved by the hospital committees.

Review of the invoice sheet, dated 6/23/17, indicated 60 capsules of dronabinol 2.5 mg were received at the hospital.

Review of the hospital's controlled substance perpetual inventory record, dated 6/22/17, indicated a balance of zero for dronabinol 2.5 mg.

3. During an observation and concurrent interview with the Pharmacy Tech and House Supervisor (House Sup), in the ED Medication Room, on 6/26/17, at 2:55 PM, the Pharmacy Refrigerator was inspected. An opened regular insulin vial, without a labeled expiration date, was observed in the refrigerator. The House Sup and Pharmacy Tech acknowledged the above observation. The House Sup stated "Let's discard it [the regular insulin vial]."

The hospital policy and procedure titled, "Insulin Vials - Usage and Distribution" dated 11/4/15, indicated "Regular Insulins ("R" insulin) will continue to be utilized as a "bulk" medication for the patients at each of the medication use areas (e.g. Acute Care, ED, ICU) ... When a new vial is opened, the "Discard date_________" will be written on the vial per the multiple dose vial (MDV) policy."

The hospital policy and procedure titled, "Single and Multiple Dose Medication Containers (SDV and MDV)" dated 4/5/17, indicated:

"B. Multiple Dose Containers (MDV)
2. Once opened, the staff that opens the container is responsible for labeling the container correctly ...
b. Staff will put the EXPIRATION date on the label."

The hospital policy and procedure titled, "Medication Storage" dated 3/2/16, indicated "Outdated drugs shall not be used."

4. During an observation and concurrent interview with Pharmacy Tech, in the Acute Care Medication Room, on 6/26/17, at 3:12 PM, an opened Novolin® 70/30 insulin vial was observed without a labeled expiration date. The Pharmacy Tech acknowledged the above observation.

The hospital policy and procedure titled, "Insulin Vials - Usage and Distribution" dated 11/4/15, indicated, "All other insulins ( ...70/30 ...) ...these vials are acceptable to use for 28 days when stored at room temperature per the MDV policy."

The hospital policy and procedure titled, "Single and Multiple Dose Medication Containers (SDV and MDV)" dated 4/5/17, indicated:

"B. Multiple Dose Containers (MDV)
2. Once opened, the staff that opens the container is responsible for labeling the container correctly ...
b. Staff will put the EXPIRATION date on the label."

The hospital policy and procedure titled, "Medication Storage" dated 3/2/16, indicated "Outdated drugs shall not be used."

5. During an observation and concurrent interview with the Pharmacy Tech, in the Acute Care Medication Room, on 6/26/17, at 3:20 PM, an inspection was conducted of the automated dispensing cabinet (stores and electronically tracks medications). Three 100 milliliter (mLs - a unit of measurement) normal saline IV solutions bags from Manufacturer A were observed out of the plastic overwrap with no indication of the beyond use date (expiration date). The Pharmacy Tech acknowledged he could not determine how long the three 100 mLs normal saline IV solution bags had been removed from the plastic overwrap.

Review of a document from Manufacturer A, dated 6/27/17, indicated the purpose of the plastic overwrap used was to act as a moisture barrier. The document indicated the 100 mL normal saline IV solution bags must not be stored out of the plastic overwrap for longer than 30 days out the plastic overwrap at room temperature.

The hospital policy and procedure titled, "Medication Storage" dated 3/2/16, indicated "Outdated drugs shall not be used."

6. During a concurrent observation, in the ICU, and interview with PIC, on 6/28/17, at 9:10 AM, an inspection of the ICU crash cart was conducted accompanied by the PIC. The ICU crash cart contained the following expired medications:

- Two items of naloxone (an antidote for overdose) 2 milligram (mg - a unit of measurement) in 2 milliliters (mL - a unit of measurement) expired 1/17,

-Two items sodium bicarbonate (drug to correct high acid levels in the body) 8.4% (drug strength) 50 mLs expired 4/1/17,

-Three items of atropine (drug to treat slow heart rate) 1 mg in 10 mL expired 1/17,

-One IV (intravenous - into a patient's vein) bag of dextrose (sugar) 5% (drug strength) expired 11/16,

-Four items of amiodarone (an antiarrhythmic - to treat heart rhythm problems) 150 mg in 3 mL expired 2/17,

-One IV bag of lidocaine (an antiarrhythmic - to treat heart rhythm problems) 2 grams (gm - a unit of measurement) in 500 mLs expired 2/17; and,

-Two items of magnesium sulfate (for heart rhythm problems) 1 gm in 100 mLs expired 2/17.

The PIC acknowledged the above medications were expired.

The hospital policy and procedure titled, "Emergency Medication (Crash Carts, E-Kits, Etc.)" dated 9/2/15, indicated, "Pharmacy is responsible for ensuring the medication contents of the emergency kits/carts are complete and not expired."

The hospital policy and procedure titled, "Medication Storage" dated 3/2/16, indicated "Outdated drugs shall not be used."

7. Review of prescribers' "Banana Bags" orders from 5/31/17 to 6/22/17 indicated that ten of ten patients (21, 22, 23, 24, 25, 26, 27, 28, 29, 30) were administered "Banana Bags" in the ED during this time period. The clinical record indicated nine of ten patients (21, 22, 23, 24, 25, 26, 28, 29, 30) were administered IV Banana Bag solutions containing the following ingredients: injectable multivitamins, thiamine (vitamin B1) 100 milligrams (mg - a unit of measurement), and folic acid (vitamin) 1 mg in 1000 mLs of normal saline. The clinical record indicated one of ten patients (27) was administered IV Banana Bags solutions with the above ingredients (injectable multivitamins, thiamine, and folic acid) plus magnesium sulfate (a supplement) 2 grams in normal saline 1000 mLs.

Review of the hospital document titled "Banana Bag 1000 mL IV - Medication Compounding Formula" dated 9/26/16, indicated the preparation of the "Banana Bags" included transferring the contents of both the 5 mL blue-capped vial and 5 mL white-capped vial for a total of 10 mLs injectable multivitamins.

During an observation and concurrent interview, in the ED, with the Pharmacy Tech and House Sup, an inspection of the ED refrigerator was conducted. The ED refrigerator contained injectable folic acid 5 mg/mL and 5 mL blue-capped and 5 mL white-capped injectable multivitamins. The Pharmacy Tech acknowledged the above findings. The House Sup acknowledged the folic acid and multivitamins were in the ED refrigerator for after-hours preparation of the "Banana Bags" when Pharmacy was closed.

During a review of the electronic clinical record for Patient 23 and concurrent interview with the PIC, on 6/27/17, at 3:07 PM, the PIC acknowledged the preparation of the "Banana Bags" did not meet the USP <797> immediate-use requirements when the compounding process involved simple transfer of more than three packages from the manufacturers' original containers.

USP <797> is an accepted standard of practice for sterile compounding. The objective of USP <797> is to describe conditions and practices to prevent harm, including death, to patients that could result from microbial contamination (nonsterility).

Review of USP <797> on page 7 indicated, "Preparations that are medium-risk level and high-risk level shall not be prepared as immediate-use CSPs. Immediate-use CSPs are exempt from the requirements described for Low-Risk Level CSPs only when all of the following criteria are met: The compounding process involves simple transfer of not more than three commercially manufactured packages of sterile nonhazardous products ...from the manufacturers' original containers and not more than two entries into any one container or package (e.g., bag, vial) of sterile infusion solution or administration container/device." Continued review of USP <797> on page 5 indicated, "Examples of Low-Risk Compounding ...simple aseptic measuring and transferring with not more than three packages of manufactured sterile products, including an infusion or diluent solution to compound drug admixtures and nutritional solutions."

The compounding process for hospital staff preparing "Banana Bag" involved simple transfers of more than three commercially manufactured packages of sterile nonhazardous products from the manufacturers' original containers. For nine of ten patients (21, 22, 23, 24, 25, 26, 27, 28, 29, and 30), the items included were normal saline 1000 mL (#1 - diluent solution), multivitamin vial 1 (#2 - simple transfer of sterile product from original container), multivitamin vial 2 (#3 - simple transfer of sterile product from original container), thiamine (#4 - simple transfer of sterile product from original container), and folic acid (#5 - simple transfer of sterile product from original container). For one of ten patients (27), the above items were included in addition to magnesium sulfate (#6 - simple transfer of sterile product from original container).

8. During an observation and concurrent interview with RPh 1, in the Pharmacy, on 6/26/17, at 11:25 AM, a refillable spray bottle labeled "Isopropyl Alcohol (IPA)," was observed on a supply cart, near the IV compounding hood. RPh 1 acknowledged the above observation. He stated the spray bottle was refilled with 70% IPA from Manufacturer B. RPh 1 stated the IPA was not sterile.

During an observation and concurrent interview with RPh 1, in the Pharmacy, on 6/26/17, at 11:40 AM, RPh 1 was observed using the spray bottle containing non-sterile IPA to clean the IV compounding hood. RPh 1 acknowledged he used the spray bottle with non-sterile IPA to clean the IV hood.

During an interview with the PIC, on 6/28/17, at 1:46 PM, the PIC acknowledged the hospital did not develop and implement a sterile compounding policy regarding the cleaning and disinfecting practices of the compounding area.

USP <797> is the minimum standard of practice for sterile compounding. The objective of USP <797> is to describe conditions and practices to prevent harm, including death, to patients that could result from microbial contamination (nonsterility).

Review of USP <797> section titled "Cleaning and Disinfecting the Compounding Area" indicated " ...The cleaning and disinfecting practices and frequencies in this section apply to ISO Class 5 [measurement of air quality] compounding areas for exposure of critical sites [areas at risk of direct contact with air, moisture, or touch contamination]...Surfaces in LAFWs [IV hood]...which are intimate to the exposure of critical sites, require disinfecting more frequently...Trained compounding personnel are responsible for developing, implementing, and practicing the procedures for the DCAs [area in IV hood exposed to filtered air] written in the SOPs [standard operating procedures]. Cleaning and disinfecting shall occur before compounding is performed. Items shall be removed from all areas to be cleaned, and surfaces shall be cleaned by removing loose material and residue from spills; for example, water-soluble solid residues are removed with sterile water (for injection or irrigation) and low-shedding wipes. This shall be followed by wiping with a residue-free disinfecting agent such as sterile 70% IPA, which is allowed to dry before compounding begins."

9. During a document review and concurrent interview with the PIC, on 6/28/17, at 2:03 PM, the PIC acknowledged he could not provide documentation that RPh 1 completed gloved fingertip/thumb sampling procedure before RPh 1 was initially allowed to compound medications.

During an interview with RPh 1, on 6/28/17, at 2:45 PM, RPh 1 acknowledged he did not recall completing gloved fingertip/thumb sampling procedure before compounding medications at the hospital. He acknowledged he had prepared CSPs in the IV hood in the Pharmacy.

USP <797> is an accepted standard of practice for sterile compounding. The objective of USP <797> is to describe conditions and practices to prevent harm, including death, to patients that could result from microbial contamination (nonsterility).

Review of USP <797> section titled "Competency Evaluation of Garbing and Aseptic Work Practice" indicated "Gloved Fingertip Sampling - All compounding personnel shall successfully complete an initial competency evaluation and gloved fingertip/thumb sampling procedure (zero cfu [colony forming units]) no less than three times before initially being allowed to compound CSPs for human use.

Based on observation, record review, and interview, the hospital failed to maintain a system for controlling sources of infections in accordance with its policies and procedures, nationally recognized infection control practices and guidelines and applicable regulations when the hospital:

1. Failed to ensure expired supplies were removed from the patient care areas.

2. Failed to ensure clean and dirty supplies were stored separately.

3. Failed to ensure six endoscopes (Endoscope is a long, flexible tube with camera at one end, which are used to visualize structures within the body, such as the digestive tract and genitourinary system) were stored appropriately.

4. Failed to ensure three faucet spouts in the surgical scrub sink were free of blue-green and white deposits.

These failures had the potential to increase the risk of spreading infections to patients, visitors, and staff.

Findings:

1. During a concurrent observation of the perioperative area (includes surgery, preparation and anesthesia, sterile preparation for the surgeon, instrument and materials sterilization and storage, instrument cleaning, and recovery room) and interview with Surgical Services (SS), on 6/26/17, at 10:10 AM, several boxes of expired sutures (material used to make surgical stitches) were noted on a supply cart. All of the following boxes of sutures expired on 1/17: 1 box Vicryl 2-0 sutures; 1 box Vicryl 5-0 sutures; 1 box Prolene 4-0, 1 box Prolene 4-9, and 1 Box PDS 11 3-0. SS verified the expiration dates.

1. b. During a concurrent observation and interview with the Infection Control Professional (ICP), on 6/28/17, at 8:37 AM, in the Intensive Care Unit (ICU), a neonatal incubator (provides a controlled heat, humidity, and oxygen microenvironment) was noted. On top of the incubator, were supplies which would be needed for the birth of a baby. Some of the supplies were noted to be expired. Sterile basin expired 10/28/15, Forceps (handheld, hinged instrument used for grasping and holding objects) expired 12/10/15, 5-in-1 connector expired 9/11/16. Infant clothing set 1 expired 6/3/17 and infant clothing set 2 expired 6/7/17. The ICP confirmed the expired supplies.

1. c. During a concurrent observation and interview with the ICP, on 6/28/17, at 8:43 AM, in the ICU, a blood glucose (sugar) testing kit, containing high and low control solutions and test strips, was noted. The high and low control solutions were dated opened 8/16. Neither solution indicated an expiration date. The ICP stated the solutions are good for 90 days after opening. The test strips were dated 5/17. The ICP verified the test strips were expired.

The hospital was unable to provide a policy on expired medications and supplies.

2. During an observation on 6/27/17, at 8:57 AM, in Room 7, multiple pieces of patient care items were noted. The equipment was not arranged in a manner to suggest organized storage with easy access to various types of equipment. In the rear right corner were two mechanical lifts with cloth slings over them. No tags were noted on the mechanical lifts or slings to identify if they were clean or dirty. In front of the mechanical lift was an overbed table with two intravenous (IV-in the vein) pumps (02 and 17). Pump 02 had a clean tag readily visible. No tag was noted on the overbed table to identify if it was clean or dirty. To the left of the mechanical lifts was a portable ultrasound (produces images through sound waves) machine with a stack of white wash cloths on it. In front of the ultrasound machine were two bedside commodes, one on top of the other. A third bedside commode was next to the other commodes. Each commode had a piece of white tissue paper between the lid and the container. No tags were noted on the commodes to identify if they were clean or dirty. To the left of the commodes and the IV pumps was some additional equipment and a size E oxygen cylinder. Next to the oxygen was a "ReadyBath" warmer (a device to warm bathing products) on a cart. It was plugged in and heating several bathing products. In front of the ReadyWarmer was a locked treatment cart with sterile dressings on top and a canister of sanitizing wipes. To the left of the ultrasound machine was an isolation cart with open drawers. To the left of the commodes was a fan, with the front blade guard off, and brown and gray stringy residue was noted on the fan blades and the front and rear blade guards. To the left of the fan were two IV poles without tags to identify if they were clean or dirty.

During an interview with Licensed Vocational Nurse (LVN) 1, on 6/27/17, at 9:02 AM, she stated, "It used to be a patient room, but now we're just using it as storage. Everything in there is clean, ready to go." When questioned further, LVN 1 verified the fan was broken and dirty.

During a concurrent observation and interview with the ICP, on 6/28/17, at 8:25 AM, in Room 7, she stated it was the Director of Nursing's decision to store equipment in Room 7. She stated she does not go into Room 7 that often. She verified the washcloths should not be left on the ultrasound machine and clean and dirty equipment should not be stored together.

2. b. During a concurrent observation and interview with the ICP, on 6/28/17, at 8:35 AM, in a small room off the ICU, a hopper (large, square toilet disposal unit with a faucet above ) with yellowish water was noted. The ICP was unable to identify the cause of the water discoloration. Above the hopper and to the right, a shelf with a paper file sorter was noted. In the file sorter were nine hanging paper folders and several manila folders. To the right of the hopper, a shelf with a drawer was noted. In the drawer, were two boxes of sterile syringes, a box of sterile blunt needles, a box of sterile filter needles, a box sterile port caps for IV tubing. A blanket was noted on the open shelf. The ICP stated "They should not be storing sterile items in with the hopper."

The hospital policy and procedure titled "Storage of Dirty, Clean, and Sterile Supplies" undated, indicated "Dirty supplies will not be stored with clean and sterile supplies."

3. During a concurrent observation of the perioperative area and interview with the SS, on 6/26/17, at 10:10 AM, in the sterile supply area, six endoscopes were noted hanging on a wall, covered by a sheet. No tags were noted on the endoscopes to identify if they were clean or dirty. The SS identified the endoscopes as three EGD (esophagogastroduodenoscope - used examine the lining of the esophagus, stomach, and first part of the small intestine), two bronchs (bronchoscope - used to view the airways), and a "manual." The SS stated the scopes would need to be processed before they could be used.

During an interview with the ICP, on 6/28/17, at 9 AM, she stated she was unaware endoscopes were hanging in the sterile supply area, and stated endoscopes are not sterile and should not be stored there.

The hospital policy and procedure titled "Infection Control Endoscope Asepsis" dated 8/09, indicated "Endoscopes must be stored in the cabinet in the G.I. (Gastrointestinal) Lab."

The Association of periOperative Registered Nurses (AORN - is the leader in advocating for excellence in perioperative practice and healthcare) standard titled "Guideline for Cleaning and Processing Flexible Endoscopes and Endoscope Accessories" dated 1/1/09, indicated "Flexible endoscopes should be stored in a manner that protects the device from damage and minimizes microbial contamination. Flexible endoscopes should be stored in a closed cabinet...with scope protectors applied if the protector does not interfere with the flexible endoscope hanging straight or restrict movement around channel openings."

4. During a concurrent observation of the perioperative area and interview with the SS, on 6/26/17, at 10:10 AM, the surgical scrub sink was noted. All three faucets in the surgical scrub sink had blue-green and white deposits on the end of the spout. The SS confirmed the finding.

During an interview with the ICP, on 6/28/17, at 9 AM, she stated she was unaware of the blue-green and white deposits on the surgical scrub skink faucets.

The hospital policy and procedure titled "Cleaning the Surgery Department" dated 3/11, indicated "Clean all scrub sinks and fixtures beneath the sinks with a hospital-approved germicide solution."

The AORN standard titled "Guideline for Environmental Cleaning-Guidelines for Perioperative Practice" dated 11/15/13, indicated ". . . thorough cleaning and disinfection of perioperative areas is essential to preventing the spread of potentially pathogenic microorganisms. . . Sinks and wash basins. . . should be cleaned and disinfected on a routine basis."

Based on interview, clinical record review, and hospital policy review, the hospital failed to clarify two of two "PRN" medications ordered for Patient 2. "PRN" medication orders were prescribed "as needed" without clear instructions on when to administer the medication to the patient. Patient 2 was administered the pain medication morphine IV (intravenous - into the vein) with missing "PRN" indications (reason for the medication's use). This failure resulted in physician's orders being carried out without clarification.

Findings:

During a clinical record review and concurrent interview with the Pharmacist-In-Charge (PIC), on 6/28/17, at 3:15 PM, Patient 2's medical chart was reviewed. The clinical record indicated active physician's orders for the pain medications hydrocodone/acetaminophen 10 milligrams (mg - a unit of measurement) tablet by mouth PRN every 6 hours and morphine 4 mg IV PRN every 4 hours. The electronic medication record indicated morphine 4 mg IV was administered to Patient 2 on 6/28/17 at 10:21 AM. The physician's orders for hydrocodone/acetaminophen 10 mg and morphine 4 mg did not indicate the indication for the PRN order. The PIC acknowledged the above medication orders were both missing the PRN indications. The PIC stated the PRN indication should be listed in the "Instructions" field of electronic medication order.

During an interview with Licensed Vocational Nurse (LVN) 2,on 6/28/17, at 3:21 PM, she stated Patient 2 was administered morphine 4 mg IV, earlier that day, at 10:21 AM. She acknowledged the medication order for morphine 4 mg IV was missing a PRN indication. Upon inquiry on when to give the hydrocodone/acetaminophen 10 mg versus the morphine 4 mg to the patient since both were missing the PRN indications, LVN 2 stated it was "not written, so it would not be clear."

Review of ASHP (American Society of Health-System Pharmacy) Guidelines: Minimum Standard for Pharmacies in Hospitals, dated 2013, on page 504 in the section titled "Review of Medication Orders" indicated "Any questions regarding an order shall be resolved with the prescriber prior to administration ..."

The hospital policy and procedure titled, "Health Information Management" dated 12/3/14, indicated "Orders shall be written clearly, legibly and completely. Orders, which are unclear, illegible or incomplete, will not be carried out until rewritten and understood."

The hospital policy and procedure titled, "Pharmacist Order Verification" dated 6/03, indicated "Orders requiring clarification will be discussed with the prescriber before verification."

Based on interview and record review, the hospital failed to ensure the Physicians Directives For Life Sustaining Treatment form (a legal form that communicates wishes about life sustaining medical treatment) was authenticated by the attending/admitting Physician for six of 31 sampled patients (1, 2, 4, 5, 6, and 7). This had the potential for life sustaining treatment to be provided or not provided without authorization.

Findings:

During a review of the clinical record for Patient 1, 2, 4, 5, 6, and 7, the document titled "Physicians Directives For Life Sustaining Treatment", was not authenticated by the attending/admitting physician. The attending/admitting physicians signature, date, and time was blank.

During an interview with the Health Information Management (HIM), on 6/27/17, at 10:16 AM, she reviewed the clinical record for Patient 1, 2, 4, 5, 6, and 7 and confirmed the findings. The HIM gave no additional information and provided no policy and procedure.