HospitalInspections.org

Based on administrative staff interview and document review, for 96 of 96 listed contracts, the Governing Body (GB) failed to assure that the hospital had maintained a complete list of all contracted services which included accurate and current information about the scope and nature of those services.

This failure had the potential of allowing for some contracted services to be utilized without undergoing regular assessment and overview to assure the quality of those services and to assure they were provided in a safe and effective manner, without risk of harm to patients or staff.

Findings:

On 8/25/15 the hospital provided their list of contracted services. Beginning at 10:30 a.m., the hospital's administrator (Admin) was interviewed, while concurrently reviewing the list of contracted services. Review of the list showed it consisted of 6 pages, in a spread-sheet format with four columns titled: 1) "Contract Service List"; 2) "Phone /Fax"; 3) "Servicing"; and 4) "Expiration / Renewal Date." The first column contained the name of the service provider or contracted entity. The third column, titled "Servicing" contained varying information, most often a few words or a short phrase, expressing some information about the type of service and/or beginning dates or terms for the contract. Admin acknowledged that the list did not contain a full description of the scope or nature for each of the services provided under contract. Admin also acknowledged that the hospital had not identified performance or quality indicators for each contracted service which could be used to monitor if the provided services were safe, efficient and provided in accordance with applicable conditions of participation and/or standards for the contracted services.

Based on interview and record review, the facility was unable to confirm that two of 27 sampled patients (Patients 11 and 17) received copies of patient rights information upon admission. This had the potential to result in lack of information regarding patient rights for Patients 11 and 27.

Findings:

A review of Patient 11's record indicated she was admitted on 6/29/15. A review of the Conditions of Admission form included the following sentence, "I have read, understand and received copies of: Advance Directives: Your Right to Make Decisions About Your Medical Treatment, Important Message from Medicare, Patient's Rights and Responsibilities, and Notice of Privacy Practice." Each of these items had a box, which if checked, indicated the patient had received these copies. None of these boxes were checked.

A review of Patient 17's record indicated she was admitted on 8/25/15. None of the boxes included in the Conditions of Admission form were checked to indicate she had received copies of these forms.

During an interview on 8/26/15 at 1:30 pm, DPCS stated these forms should be included in the admission packet given to all newly admitted patients. DPCS confirmed there was no documentation to confirm this had been done since the boxes had not been checked.

Based on interview and record review, the facility failed to develop and implement individualized care plans for 11 of 27 sampled patients (Patients 1-11). This failed practice can lead to a break down in communication between various care providers and decreased continuity of care which could cause negative clinical outcomes.

Findings:

1. A review of Patient 1's record indicated he was admitted on 7/22/15. A review of his care plan indicated a standardized (universal) care plan that had not been individualized to reflect which problems, expected outcomes/goals, and interventions were needed for Patient 1.

2. A review of Patient 2's record indicated he was admitted on 7/215. A review of his care plan indicated a standardized (universal) care plan that had not been individualized to reflect which problems, expected outcomes/goals, and interventions were needed for Patient 2.

3. A review of Patient 3's record indicated she was admitted on 7/17/15. A review of her care plan indicated a standardized (universal) care plan that had not been individualized to reflect which problems, expected outcomes/goals, and interventions were needed for Patient 3.

4. A review of Patient 4's record indicated she was admitted on 7/23/15. A review of her care plan indicated a standardized (universal) care plan that had not been individualized to reflect which problems, expected outcomes/goals, and interventions were needed for Patient 4.

5. A review of Patient 5's record indicated she was admitted on 6/29/15. A review of her care plan indicated a standardized (universal) care plan that had not been individualized to reflect which problems, expected outcomes/goals, and interventions were needed for Patient 5.

6. A review of Patient 6's record indicated she was admitted on 8/11/15. A review of her care plan indicated a standardized (universal) care plan that had not been individualized to reflect which problems, expected outcomes/goals, and interventions were needed for Patient 6.

7. A review of Patient 7's record indicated she was admitted on 7/24/15. A review of her care plan indicated a standardized (universal) care plan that had not been individualized to reflect which problems, expected outcomes/goals, and interventions were needed for Patient 7.

8. A review of Patient 8's record indicated she was admitted on 7/24/15. A review of her care plan indicated a standardized (universal) care plan that had not been individualized to reflect which problems, expected outcomes/goals, and interventions were needed for Patient 8.

9. A review of Patient 9's record indicated she was admitted on 7/28/15. A review of her care plan indicated a standardized (universal) care plan that had not been individualized to reflect which problems, expected outcomes/goals, and interventions were needed for Patient 9.

10. A review of Patient 10's record indicated she was admitted on 7/10/15. A review of her care plan indicated a standardized (universal) care plan that had not been individualized to reflect which problems, expected outcomes/goals, and interventions were needed for Patient 10.

During a concurrent interview and record review, on 8/26/15 at 8:05 am, the Director of Patient Care Services (DPCS) reviewed the care plans for Patients 1-10 and confirmed that they had not been individualized to reflect the needs of each patient.




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11. A review of Patient 11's record indicated she was admitted on 6/29/15. A review of her care plan indicated a standardized (universal) care plan that had not been individualized to reflect which problems, expected outcomes/goals, and interventions were needed for Patient 11.

During a concurrent interview and record review, on 8/26/15 at 1:30 pm, DPCS reviewed the care plan and confirmed it had not been individualized to reflect the needs of this patient.

The facility's policy and procedure titled, "Care Plans," dated 11/14, indicated that individualized patient care planning enhances communication between departments, and improves continuity of care and patient outcomes. Patient problems will be initiated as either actual or potential for each patient using the date, time and nurse's initials on the left side of the universal care plan page. Expected outcomes and goals will be completed with each problem initiated. A check mark will indicate interventions and approaches to be used for each problem. The care plan will be personalized, focused and updated/revised if necessary each shift.

Based on interview and record review, the facility failed to ensure that medical records were accurately written for three of 27 sampled patients (Patients 1, 7 and 42). This had the potential for patients to experience a lack of continuity of care between providers, due to incomplete or inaccurate information.

Findings:

The "Rules and Regulations of the Professional Staff", approved 12/3/14, were reviewed on 8/24/15. Section 15.h. stated: " ...A discharge summary shall include all of the required elements as summarized below: Date of admission and date of discharge .... "

1. Patient 42's record was reviewed on the afternoon of 8/25/15. The discharge summary documented an incorrect date of discharge of the patient. The report had been transcribed by the hospital's contracted service.

Health Information Management (HIM) Staff A confirmed the finding on 8/26/15 at approximately 11:30 am. There was no way to determine if the error was due inaccurate dictation by the physician or by the transcriptions who typed the report.




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2. A review of Patient 1's record indicated he was admitted on 7/22/15. A review of his discharge summary indicated that he was admitted on 7/23/15. This date was inconsistent with the rest of Patient 1's medical record.

3. A review of Patient 7's record indicated she was admitted on 7/24/15. A review of her discharge summary indicated that she was discharged on 7/26/15. The physician signed and dated this discharge summary as 7/3/15, this date was inconsistent with the rest of Patient 7's medical record.

During a concurrent interview and record review, on 8/26/15 at 8:05 am, the Director of Patient Care Services acknowledged the above findings (2-3) and confirmed that the dates recorded on the discharge summaries for Patient 1 and 7 were not accurate.

The facility's policy and procedure titled, "Medical Record Content," dated 11/14, indicated that all patient medical entries must be made only by the health care personnel directly involved in patient care and must be legible, complete, accurate, dated, timed and authenticated in writing by the person responsible for providing or evaluating the service provided, consistent with hospital policy and procedures.

Based on interview, and record review, the hospital failed to ensure three of 27 sampled patient's medical records were complete. (Patients 1, 4, and 43) This had the potential for patients to experience a lack of continuity of care between providers, due to missing health care information.

Findings:

1. A review of Patient 1's record indicated he was admitted on 7/22/15. A review of his physician orders revealed a surgical admit order dated 7/22/15, for patient controlled analgesia (PCA, a device that allows a patient to control their own pain medication). The physician wrote, "PCA with M.S." (M.S. is an abbreviation that can be used for two different medication, morphine sulfate, a strong pain medication and magnesium sulfate a mineral supplement).

During a concurrent interview and record review, on 8/26/15 at 8:05 am, the Director of Patient Care Services (DPCS) reviewed this order and stated that this meant a PCA with Morphine Sulfate (a strong narcotic pain medication). The DPCS acknowledged that this was an inappropriate abbreviation and was never supposed to be used because it can be misinterpreted for other medications.

The facility's policy and procedure titled, "Un-Acceptable Abbreviations," dated 11/14, indicated that MS is included on the 'Do Not Use' Abbreviation List as it can mean morphine sulfate or magnesium sulfate. If a physician uses an abbreviation on the, "Do Not Use" list a clarification order should be obtained.

2. A review of Patient 4's record indicated she was admitted on 7/23/15. A review of her physician orders revealed a discharge medication order dated 7/24/15, that read, "Patient may be given Tylenol #3 (pain medication), instead of Norco 5/325 mg (milligrams) prescription for discharge. Patient may take one every 4-hour PRN (as needed)."

During a concurrent interview and record review, on 8/26/15 at 8:05 am, the DPCS reviewed this order and acknowledged that there was no indications as to why the Tylenol #3 needed to be given. The assumption would be for pain, but this order needed to have stated that.

The facility's policy and procedure titled, "Medication Administration," dated 11/14, indicated that all medication orders in accordance with the standard practice must include all the required elements, including the reason for PRN administration.




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3. The Health Information Management Policy and Procedure, "Medical Record Content," was reviewed on 8/25/15. The section on nursing discharge instructions, stated: "Discharge instructions are dictated by the patient's physician and include such things as: 9. Patient's signature. "
Patient 43's record was reviewed on 8/25/15. The discharge instructions form was not signed by the patient. Staff Health Information Management (HIM) confirmed the finding on 8/26/15 at approximately 11:20 am.

Based on interview and record review, the facility failed to ensure that physician telephone orders were authenticated (signed and dated) promptly (within 48-hours) for five of 27 sampled patients. This failure may result in miscommunications among care providers which could lead to negative clinical outcomes. (Patients 1, 3, 4, 5 and 10)

Findings:

1. A review of Patient 1's record indicated he was admitted on 7/22/15. A review of his physician orders revealed a telephone order obtained on 7/22/15 for patient controlled analgesia (a device that allows a patient to control their own pain medication). This telephone order was authenticated by the physician on 8/4/15 (13 days later).

2. A review of Patient 3's record indicated she was admitted on 7/17/15. A review of her physician orders revealed a telephone order obtained on 7/19/15 regarding this patient's discharge. This telephone order was authenticated by the physician on 8/10/15 (22 days later).

3. A review of Patient 4's record indicated she was admitted on 7/23/15. A review of her physician orders revealed a telephone order obtained on 7/24/15 for discharge pain medications. This telephone order was authenticated by the physician on 7/27/15 (3 days later).

4. A review of Patient 5's record indicated she was admitted on 6/29/15. A review of her physician orders revealed a telephone order obtained on 6/30/15 regarding this patient's discharge. This telephone order was authenticated by the physician on 7/13/15 (13 days later).

5. A review of Patient 10's record indicated she was admitted on 7/10/15. A review of her physician orders revealed a telephone order obtained on 7/11/15 regarding this patient's pain medication. This telephone order was authenticated by the physician on 7/14/15 (3 days later).

During a concurrent interview and record review, on 8/26/15 at 8:05 am, the Director of Patient Care Services acknowledged the above findings (1-5) for Patients 1, 3, 4, 5 and 10 and confirmed that the physician telephone orders had not been authenticated within 48-hours per facility policy.

The facility's policy and procedure titled, "Verbal Orders," dated 11/14, indicated that telephone and verbal orders shall be verified and authenticated by either the attending or covering physician or another practitioner responsible for the care of the patient within 48-hours.

Based on medical record and document review and staff interview, the facility failed to ensure that all records documented an updated examination of the patient in 1 of 5 records reviewed. (Patient 41)

Findings:

The "Rules and Regulations of the Professional Staff", approved 12/3/14, were reviewed on 8/24/15. Section 15.b.i. 1) and 2) stated: "The H&P update note should compliment the original H&P and specify any changes to the original document/findings ....If, upon examination, the licensed practitioner finds no change in the patient's condition since the H&P was completed, he/she may indicate in the patient's medical record that the H&P was reviewed, the patient was examined, and that "no changes" have occurred in the patient's condition since the H&P was completed."

Patient 41's record was reviewed on the afternoon of 8/25/15. The H&P (History and Physical report) was done the day prior to the patient's admission for a total mastectomy (surgical removal of a breast). The dictated, "Preoperative History and Physical" report contained the, "H&P update (if H&P done prior to admission)" for the physician to complete. Two of the boxes were checked, however the box to check to indicate, "Patient was examined" was left blank, and the physician had signed the entry. Staff Health Information Management (HIM) confirmed this finding on 8/26/15 at approximately 11:25 am.

Based on observation, record review and interview, the hospital failed to ensure three of six medication storage areas (e.g. Administration (ADM), Medical Office Building (MOB), also known as Pharmacy Storage, and the basement) were administered in the hospital in accordance with accepted professional principles (e.g. USP standards and ASHP standards) when medications which required storage under refrigeration or controlled room temperature conditions were not monitored to ensure drug potency and stability. Monthly unit inspections failed to identify lack of oversight of medication storage conditions throughout the survey period between 1/1/14 and 8/24/15. The hospital placed all patients (the hospital census was three) at risk for treatment failure as a result of loss of potency or quality (deterioration) of medications administered. The hospital failed to ensure their IV (intravenous) solutions were maintained at an acceptable level of safety and quality when they were stored with no temperature monitoring. This failure could lead to medications degrading because temperatures reached an unacceptable level without the facility's knowledge.

Definitions:

The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the strength, quality, and purity of medicines ... manufactured, distributed and consumed worldwide. USP's drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries." [Reference: www.usp.org ]

The USP describes packaging and storage standards for mediations. According to the USP, the acceptable temperature range for mediation storage for medications requiring Controlled Room Temperature is between 20 to 25 degrees Celsius (68 to 77 degrees Fahrenheit). [Reference: General Chapter 659 Packaging and Storage Requirements in the USP-NF publication]

State of California regulations specify standards for maintenance of medications under refrigeration as follows, "Refrigerator temperature shall be between 2.2 degrees Celsius (36 degrees Fahrenheit) and 7.7 degrees Celsius (46 degrees Fahrenheit)." Reference Social Security Act Title 22 Section 70263(q)(6).

The American Society of Health System Pharmacists (ASHP) develops official professional policies, in the form of policy positions and guidance documents (statements and guidelines), for the continuum of pharmacy practice settings in integrated systems. The section, Standard IV, "Medication Distribution and Control" of the ASHP publication, titled, "ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals", describes guidance for aspects of pharmaceutical care in hospital (e.g. medication storage, and medication storage area inspections. [Reference: Am J Health-Syst Pharm 1995; 52:2711-7.]

Findings:

1. On 8/25/15 at 9:25 a.m. in an interview, the Pharmacist in Charge (PIC) said, "Mediations were stored in the following areas of the hospital, "PAR 1 [Operating Room], PAR II, PACU [Post Anesthesia Care Unit], the Administrator's office, the Medial Office Building (a drug room), and the Medical Surgical Unit."

On 8/26/15 at 12 p.m. in an interview, the Administrator (ADM) indicated the Pharmacist in Charge (PIC) was responsible for inspecting all medication storage areas in the hospital and ensuring standards for ensuring mediation temperatures were maintained. The ADM indicated the hospital had stored large volume intravenous solutions in the basement for years. The ADM said, "I don't believe [PIC] was aware they [the intravenous fluids] were there. They've been there for years." In the same interview, the ADM indicated that, according to temperature logs, the hospital had some gaps in monitoring temperatures in some areas where mediations were stored.

A review of the hospital's policy, titled, "Pharmacist Monthly Inspection", dated 1/13, "Drugs and drug storage area maintained in the hospital are inspected at least monthly by the Pharmacist in Charge ....Reports of these inspections are submitted monthly by the Pharmacist in Charge...They are reviewed and approved by the Clinical Care Coordinator and the Director of Patient Care Services, who will them submit them to the Administrator. These reports are reviewed by Pharmacy and Therapeutics (a medical staff committee) on a monthly basis."

A review of documents titled, "Monthly Inspection Drug Storage Areas Consultant Pharmacist", showed as a line item "3.c" that, "Mediation stored appropriately per policy ...Drugs shall be stored at appropriate temperatures, not less than 20 degrees C [Celsius] (68 degrees F [Fahrenheit]) or more than 25 degrees C (77 degrees F). Refrigerated drugs will be stored between 36 degrees and 46 degrees F."

A review of the USP standard for controlled room temperature (CRT) shows the acceptable temperature range for mediation storage is between 20 to 25 degrees Celsius (68 to 77 degrees Fahrenheit). [Reference: General Chapter 659 Packaging and Storage Requirements in the USP-NF publication]

The hospital provided a document titled, "USP 797.org" from an educational provider which described "Controlled Cold Temperature" as, "This temperature is defined as the temperature maintained thermostatically between 2 degrees and 8 degrees (36 degrees and 46 degrees F [Fahrenheit]..." [Reference: USP 29-NF 24]

A review of the ASHP Standard IV, section, "Medication Storage Area Inspection", showed, "...Storage conditions that would foster medication deterioration and storage arrangements that might contribute to medication errors also must be assessed, documented, and corrected.

A review of the hospital's temperature logs, titled, "Drug Storage Temperature Logs", showed absence of assessment, documentation, or correction related to temperature monitoring in two of six drug storage areas ( Administration (ADM) and Medical Office Building (MOB)), 182 times between 1/4/14 and 7/29/15 as evidenced in 38 of 48 available temperature logs, detailed as follows:

* On 1/1/14 no time, date, temperature, or initials were documented for ADM
* On 1/4/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 1/5/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 1/11/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 1/12/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 1/18/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 1/19/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 1/25/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 1/26/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 1/28/14 no time, date, temperature, or initials were documented for ADM
* On 2/1/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 2/2/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 2/8/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 2/9/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 2/15/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 2/16/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 2/22/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 2/23/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 3/1/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 3/2/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 3/8/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 3/9/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 3/15/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 3/16/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 3/22/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 3/23/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 3/29/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 3/30/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 4/5/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 4/6/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 4/11/14 no time, date, temperature, or initials were documented for ADM
* On 4/12/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 4/13/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 4/19/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 4/20/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 4/26/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 4/27/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 5/3/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 5/4/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 5/10/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 5/11/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 5/17/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 5/18/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 5/24/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 5/25/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 5/26/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 6/1/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 6/7/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 6/8/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 6/14/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 6/15/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 6/21/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 6/22/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 6/28/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 6/29/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 7/4/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 7/5/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 7/6/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 7/12/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 7/13/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 7/19/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 7/20/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 7/25/14 no time, date, temperature, or initials were documented for MOB
* On 7/26/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 7/27/14 no time, date, temperature, or initials were documented for ADM
* On 8/2/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 8/3/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 8/9/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 8/10/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 8/16/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 8/17/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 8/22/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 8/23/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 8/24/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 8/24/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 8/30/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 8/31/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 9/1/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 9/6/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 9/7/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 9/13/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 9/14/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 9/20/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 9/21/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 9/27/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 9/28/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 10/4/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 10/5/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 10/11/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 10/12/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 10/18/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 10/19/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 10/25/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 10/26/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 11/1/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 11/2/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 11/8/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 11/9/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 11/15/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 11/16/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 11/22/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 11/23/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 11/27/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 11/28/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 11/29/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 11/30/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 12/6/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 12/7/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 12/13/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 12/14/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 12/20/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 12/21/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 12/25/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 12/26/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 12/27/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 12/28/14 no time, date, temperature, or initials were documented for MOB or ADM
* On 1/1/15 no time, date, temperature, or initials were documented for ADM
* On 1/2/15 no time, date, temperature, or initials were documented for ADM
* On 1/3/15 no time, date, temperature, or initials were documented for ADM
* On 1/4/15 no time, date, temperature, or initials were documented for ADM
* On 1/10/15 no time, date, temperature, or initials were documented for ADM
* On 1/11/15 no time, date, temperature, or initials were documented for ADM
* On 1/17/15 no time, date, temperature, or initials were documented for ADM
* On 1/18/15 no time, date, temperature, or initials were documented for ADM
* On 1/24/15 no time, date, temperature, or initials were documented for ADM
* On 1/25/15 no time, date, temperature, or initials were documented for ADM
* On 1/31/15 no time, date, temperature, or initials were documented for ADM
No record was provided for the month of January 2015 for MOB
* On 2/1/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 2/7/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 2/8/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 2/14/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 2/15/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 2/21/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 2/22/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 2/28/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 3/1/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 3/7/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 3/8/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 3/14/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 3/15/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 3/21/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 3/22/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 3/28/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 3/29/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 4/4/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 4/5/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 4/11/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 4/12/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 4/18/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 4/19/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 4/25/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 4/26/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 5/2/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 5/3/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 5/9/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 5/10/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 5/16/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 5/17/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 5/23/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 5/24/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 5/25/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 5/30/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 5/31/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 6/6/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 6/7/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 6/13/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 6/14/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 6/19/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 6/20/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 6/21/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 6/27/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 6/28/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 7/3/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 7/4/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 7/5/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 7/11/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 7/12/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 7/18/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 7/19/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 7/25/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 7/26/15 no time, date, temperature, or initials were documented for MOB or ADM
* On 7/29/15 no time, date, temperature, or initials were documented for MOB

A review of unit inspection reports for pharmacy showed the hospital and a pharmacist did not identify that medications were not monitored to ensure they were not stored outside the recommended temperature ranges for Controlled Room Temperature and Refrigeration Temperature between 1/1/14 and 8/24/15 in all areas of the hospital."

A review of available monthly unit inspections showed a pharmacist identified five instances between 1/1/14 and 8/24/15 where staff had not documented a refrigeration temperature as follows:

* A Medical Surgical Unit report, dated 8/31/14, had the comment, "Temp log for 9/3 was not completed. Day shift."

* A Medical Surgical Unit report, dated 9/4/14 had the comment, "Temp log for 9/3 was not completed. Day shift."

* An OR/PAR 1 (Operating Room) report, dated 10/1/14, had the comment, "9/10/14 and 9/20/14 temp log for refrigerator missing for PM shift."

* An OR/PAR 1 report, dated 5/3/15, had the comment, "Room temp and humidity not recorded for 5/2/15."

* An OR/PAR 1 report, dated 8/6/15, had the comment, "A.M. refrigerator temp missed on 8/3/15."



28650


2. During an initial tour of the facility with the Administrator and Director of Patient Care Services (DPCS) on 8/24/15 starting at 9:30 am, the basement area where medical supplies and devices were stored was observed. The DPCS and Administrator confirmed that there was no thermometer present and that the temperatures in this area was not routinely monitored or documented.

During an interview and observation, with the Materials Manager (MM) on 8/24/15 at 11:05 am, she acknowledged that it can get rather warm in this area especially during the summer months. The MM confirmed that there was no thermometer present and that the temperatures in this area were not routinely monitored or documented.

Multiple bags of IV (intravenous) solutions were observed as being stored in this area. The outer packaging on the IV solution read, "Store unit in moisture barrier over wrap at room temperature (25° Celsius[C] / 77° Fahrenheit [F] ) until ready to use. Avoid excessive heat.

According to the National Weather Service website (www.weather.gov) the outside temperature in this city was 94° F as of 8/24/15 at 2:53 pm.

During an interview and observation, with the Facility Manager on 8/24/15 at 3:50 pm, the temperature was taken in the area where the IV solutions were stored and it was 77° F. FM acknowledged that this was at the upper end of the acceptable temperature storage perimeter.

The facility's policy and procedure titled, "Drug Storage," dated 2/15, indicated that drugs shall be stored at the appropriate temperatures. Drugs required to be stored at room temperature shall be stored at a temperature of not less than 20° C (68° F) or more than 25° C (77° F). With allowable excursions between 59° F and 86° F permitted as long as they do not exceed 24-hours.

Based on observation, interview and record review, drugs and biologicals were not controlled and distributed in accordance with applicable standards of practice consistent with Federal and State law (e.g. American Society of Health-Systems Pharmacists (ASHP), the Food and Drug Administration-approved manufacturers' drug labels for controlled substance schedule II opiate (for treatment of pain) medications, and State requirements) as evidenced by:

1. The hospital failed to ensure a pharmacist prospectively (ahead of time) reviewed 15 non-urgent physicians' orders and clarified them with prescribers, as warranted, prior to administration to patients, in a manner consistent with ASHP standards. Prescriptions for controlled substance schedule II opiate medications used to treat surgical pain (e.g. Demerol, morphine, and hydromorphone, hydrocodone/acetaminophen combination, and oxycodone/acetaminophen combination) which did not meet the indication for use requirements of the Food and Drug Approved- manufacturers' labels, were not identified as ambiguous (not clear) or without a labeled indication, or clarified by a pharmacist, which placed seven of seven sampled patients (Patients 1, 11, 31, 32, 33, 34 and 35) at risk for opiate-related adverse outcomes (e.g. respiratory depression, circulatory depression, respiratory arrest, and shock). An ambiguous prescription (potential duplicate order) for a preoperative (before surgery) antibiotic, Vancomycin, was not clarified by a pharmacist for Patient 31. An incomplete prescription (missing dosage) for an antiemetic (for vomiting), Scopolamine, was not clarified for Patient 31.

2. The hospital failed to ensure "High Alert Mediations" as defined in hospital polices (e.g. intravenous diazepam, midazolam, calcium chloride and Lovenox) were stored in stock without cautionary labels as required and as recommended by the Institute of Safe Mediation Practices (ISMP), a patient safety organization devoted to reducing medication errors who publishes High-Alert Medication Lists for Acute Care Setting. The hospital's failure placed all patients (census three) at potential serious patient harm resulting from a medication error (e.g. wrong product selection of a mediation known to cause serious adverse outcomes for patients, including death).

3. The hospital failed to implement policies and procedures to ensure crash carts in PACU and PAR II were sealed by a pharmacist consistent with to State regulations. The hospital's failure placed all patients (census three) at potential harm related to unavailability of medications required to treat potentially fatal medical emergencies (respiratory failure or cardiac emergencies).

Definitions:

ASHP is an organization who publishes policy positions and guidance documents (statements and guidelines) for pharmacy practice settings in integrated systems, including hospitals. In the publication, "ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals", the organization describes guidance for aspects of pharmaceutical care in hospitals (e.g. acquiring essential patient data, review of mediation orders, medication storage, and medication storage area inspections. [Reference: Am J Health-Syst Pharm 1995; 52:2711-7.] The ASHP Standard I, section, "Practice Management", showed, "The practice standards and guidelines of ASHP, appropriate accrediting bodies ... and the Centers for Medicare and Medicaid Services shall be viewed as applicable, and the hospital should strive to meet all applicable standards."

The FDA is a federal regulatory agency with oversight of what a manufacture can put on its drug product label. [Reference: www. FDA.gov]

"High Alert Medications" are defined by ISMP as "drugs that bear a heightened risk of causing significant patient harm when used in error." [Reference: ISMP.org]

Findings:

1. On 8/26/15 at 9:15 a.m. in an interview, the Consultant Pharmacist (CP) indicated he conducted a daily retrospective (after the fact) review of physicians' orders. CP said, "I am scheduled to work here two days per month" ..." The nurses fax orders to me. I do one hundred percent of the review retrospectively unless it's important." The CP indicated that preprinted orders were anticipated orders and that he did not review them prospectively. The CP indicated that the hospital did not have an automated dispensing system; rather, nurses had access to medications stocked in the Administrator's office, on patient care units, and from across the street in a drug room located in a Medical Office Building. The CP indicated the nurses could call him if they had a question about an order. He indicated that the medical records were maintained using a manual system and he did not have access to the entire chart for drug regimen review. The CP described a typical workday at the hospital as follows: "Two hour chart review, two hours inspections, a half-hour Pharmacy and Therapeutics Committee." (Pharmacy and Therapeutics Committee is a medical staff committee responsible for safe use of mediations in the hospital).

On 8/26/14 at 2:05 p.m. in an interview, the Administrator (Admin) said, "[CP] looks at medication orders on a daily basis. He does not look at the drug order before it is administered but he does review them ...medication orders ...on a daily basis. The Admin indicated that none of the physicians' orders were reviewed prospectively before they were dispensed or administered or that there was a mechanism in place to do so. The Admin indicated she was not familiar with ASHP standards, and was not familiar with the publication, "ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals." The Admin said, "That a really good idea to incorporate these standards into our policies and job description for the pharmacist."

A review of the ASHP Standard III, section, "Optimizing Medication Therapy", subsection, "Acquiring Essential Patient Data", showed, "Pharmacists should obtain, prepare, or have immediate access to comprehensive mediation histories for each patient, from the patient's medical record or other databases (e.g. a medication profile) ..."

A review of the hospital's policy, titled, "Medication Administration", dated 3/15, showed, "All drugs and biologicals will be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. The policy showed, "Any questions about medication orders should be resolved prior to the preparation, dispensing or administration of the mediation." The policy showed, "Both written and verbal orders for medications should be recorded in the patient's chart and in accordance with the standard of practice, must include the following elements to ensure safe preparation and administration: name of medication ordered, dose ..."

A review of the hospital's job description, titled, "Pharmacist in Charge", showed "Completes review of the drug regimen of at least 10 percent of inpatients and 10 outpatient charts at least monthly, and report any irregularities to the attending physician and Administrator" ..."Recognizes and reports unsafe conditions ..." and... "Clarifies physicians' orders as needed." The job description did not describe any requirement to meet standards for ASHP, USP, or to ensure compliance with State or Federal laws.

A review of the ASHP Standard IV, section, "Medication Dispensing and Delivery, subsection "Review of Medication Orders", showed, "All medication orders shall be prospectively reviewed by a pharmacist and assessed in relation to pertinent patient and clinical information before the first dose is administered or made available in an automated dispensing device, except in emergent situations in which the treatment of the patient would be significantly compromised by the delay that would result from pharmacist review of the order."

A review of Patient 1's medical record, admission record, showed he was a 47 year old male admitted 7/22/15 for lumbar spine surgery to treat low back pain.

A review of Patient 1's physicians' orders showed he had a preprinted document, titled, "PHYSICIAN ORDERS - Patient Controlled Analgesia (PCA)", signed and dated 7/22/15 at 10 p.m., by a physician, surgeon, and Chief of Staff (MD 1). A PCA is a device filled with pain medication which administers medication on-demand to the patient at the touch of a button.

The PCA order had instructions to the prescriber, "Check Appropriate Column" above two medications, "Morphine" and "Hydromorphone."

Morphine is a controlled substance Schedule II opiate agonist (binds to opiod receptors to give pain relief) indicated for the management of pain not responsive to non-narcotic analgesics. [Reference: Hospira product package insert, 11/2011].

Hydromorphone (Dilaudid is the brand name) is a controlled substance Schedule II narcotic analgesic (semisynthetic phenanthrene alkaloid of opium) indicated for the relief of moderate to severe pain..." Hydromorphone resembles morphine pharmacologically. Hydromorphone is reported to produce analgesia with less sedation than morphine. Hydromorphone produces dose-related respiratory depression (decrease in breathing) by acting directly on the brain stem respiratory centers. The major hazards of hydromorphone, as with other narcotic analgesics, are respiratory depression and, to a lesser degree, circulatory depression, respiratory arrest, and shock and cardiac arrest have occurred ..." [Reference: Westward Pharmaceuticals product package insert, 6/2011].

Four rows beneath the columns on the PCA order, instructed the prescriber in completing the order. The first instruction (row 1) was to choose the type of medication for use in the PCA. The second instruction (row 2) suggested a dosing range. The third instruction (row 3) suggested a lockout interval (the time in minutes the patient has to wait for the next demand dose). The fourth instruction (row 4) suggested rates for a basal (continuous) infusion. Highlights of the order and medical record review showed the following:

* On the first row, titled, "Analgesic PCA", both "Morphine 1 mg/ml (milligram per milliliter)" and "Hydromorphone 0.2 mg/ml" were checked. The order was not clarified in the record by a pharmacist or any other healthcare professional to determine which of the two opiate analgesic controlled substances was intended by the prescriber. Concurrent PCAs for morphine and hydromorphone are duplicative and, if dispensed, could cause oversedation, respiratory failure or death.

A review of the ASHP Standard VI, section, "Medication Dispensing and Delivery", subsection, "Review of Medication Orders", showed, "All medication orders shall be prospectively reviewed by a pharmacist and assessed in relation to pertinent patient and clinical information before the first dose is administered or made available in an automated device, except in emergent situations in which the treatment of the patient would be significantly compromised by the delay that would result from pharmacist review of the order."

* On the second row, titled, "PCA Dose", both "1 mg" and "0.2 mg" were checked. The dose was not clarified by a pharmacist or any other healthcare professional to determine which of the two doses of opiate was intended by the prescriber.

* On the third row, titled, "Lockout interval", "10 minutes" was chosen for both morphine and hydromorphone. The lockout interval was not clarified by a pharmacist or any other healthcare professional as to which medication the prescriber intended.

* On the fourth row, titled, "Continuous rate", a "no" was checked for hydromorphone. The basal rate was not clarified by a pharmacist or any other healthcare professional to determine if the prescriber wanted a basal rate.

A review of Patient 11's medical record, history and physical, showed she was a 53 year old female admitted 6/30/15 for spinal disc surgery.

A review of Patient 11's physicians' orders showed she had a preprinted document, titled, "PHYSICIAN ORDERS - Anesthesia Orders Recovery Room Only" signed and dated 6/30/15 at 1:45 p.m., by a physician and anesthesiologist (MD 4) showed mild to moderate pain correlated to a numerical score of between 1-6. The orders instructed nurses to administer as a first choice, "Dilaudid (strong pain medication) 0.2 mg every 5 minutes [for mild to moderate pain]." The order for Dilaudid was not clarified when its use for mild pain was not indicated by the manufacturer.

A review of the hospital's policy, titled, "Pain", dated 3/13 showed nurses were to use a single-dimensional scale (a 0-10 Numeric Pain Intensity Scale) which defined "mild pain" as any score between 1 and 3; defined "moderate pain" to any score between 4 and 6, and defined "severe pain" as any score between 7 and 10." The order for Dilaudid was not clarified when its use for mild pain was not reflected in the nursing policy for as a number between 1-3.

A review of the hospital's standing order, titled, "Physician Orders - Anesthesia Orders Recovery Room Only", dated 8/14, showed "Mild to Moderate Pain" was defined as any numerical score between "1 and 6" and "Severe Pain" was defined as any numerical score between 7-10."

The order set instructed nurses to administer "morphine", "Demerol", and "Dilaudid" according to the choice indicated by the prescriber. The orders showed, "Nursing is to give the drug noted as the # 1 choice first. If ineffective, proceed to #2 choice, then to choice #3 as applicable." None of the choices included an indication to treat mild pain.

A review of the manufacturer's indication for Demerol showed Demerol is indicated, "For the relief of moderate to severe pain."

On 8/25/15 at 2:05 p.m. in an interview, a registered nurse (RN 5) was shown the orders for Patient 33. RN 5 said, "If I have a pain score of one I'm going to give 2 milligrams of morphine. If I have a pain score of two I'm going to give 2 milligrams of morphine. If I have a pain score of three I'm going to give 2 milligrams of morphine. I'm going to give a dose every five minutes. I'll stick with morphine for a couple of dioses then I'd try the Dilaudid."

On 8/26/15 at 1 p.m.; in an interview, a physician and surgeon (MD 2) said, "We need to change those order sets." He indicated pain can be assessed a variety of ways other than a one-dimensional scale. MD 2 indicated the hospital's patients were surgical patients with the potential to experience severe pain. MD 2 acknowledged the orders sets needed to be changed. He said, "I know exactly what to do."

A review of Patient 11's physicians' orders, titled, "PHYSICIAN ORDERS - Neuro POST-OP", signed and dated 6/30/15 at 2:30 p.m., by MD 1, showed orders for "Norco (hydrocodone/acetaminophen) 10/325 mg 1 tab PO q 4 hrs prn (by mouth every four hours as needed) pain score 1-3 for mild pain." The order was not clarified by a pharmacist or any other healthcare professional when the manufacturer label did not support its use for mild pain as an indication.

Hydrocodone and acetaminophen tablets (Norco is the brand name) are a controlled substance Schedule II opiate analgesic indicated for the relief of moderate to moderately severe pain. [Reference: Qualitest/Vintage Pharmaceuticals product package insert, 9/2014].

A review of Patient 11's physicians' orders, titled, "PHYSICIAN ORDERS - Patient Controlled Analgesia (PCA)", signed and dated 6/30/15 at 1:12 p.m., by MD 4, had instructions to the prescriber, "Check Appropriate Column" above two medications, "Morphine" and "Hydromorphone." Four rows beneath the columns instructed the prescriber in completing the order. The first instruction (row 1) was to choose the type of medication (morphine or hydromorphone). The second instruction (row 2) suggested a dosing range. The third instruction (row 3) suggested a lockout interval (the time in minutes the patient has to wait for the next demand dose). The fourth instruction (row 4) suggested rates for a basal (continuous) infusion. Highlights of the order and medical record review showed the following:

* On the first row, titled, "Analgesic PCA", both "Morphine 1 mg/ml [milligram per milliliter]" and "Hydromorphone 0.2 mg/ml" were checked. The order was not clarified in the record by a pharmacist or any other healthcare professional to determine which of the two opiate analgesic controlled substances was intended by the prescriber. Concurrent PCAs for morphine and hydromorphone are duplicative and, if dispensed, could cause oversedation, respiratory failure or death.

A review of the manufacturer's package insert showed, "Morphine sulfate is an opioid agonist indicated for the management of pain not responsive to non-narcotic analgesics." It also showed, "In severe overdosage, apnea [cessation of spontaneous breathing], circulatory collapse, cardiac arrest, and death may occur. The section "Drug interactions" included, "CNS [central nervous system depressants] depressants ...may increase the risk of respiratory depression." [Reference: Hospira product package insert11/2011.

* On the second row, titled, "PCA Dose", both "1 mg" and "0.2 mg" were checked. The dose was not clarified by a pharmacist or any other healthcare professional to determine which of the two doses of opiate was intended by the prescriber.

* On the third row, titled, "Lockout interval", "10 minutes" was chosen for both morphine and hydromorphone. The lockout interval was not clarified by a pharmacist or any other healthcare professional as to which medication the prescriber intended.

* On the fourth row, titled, "Continuous rate", a "yes" was checked for hydromorphone at a rate of 0.2 mg/hr. The basal rate was not clarified by a pharmacist or any other healthcare professional to determine if the prescriber wanted a basal rate for morphine.

A review of Patient 11's MAR showed she received a morphine PCA infusion on 6/29/15 at 6:15 p.m. and a hydromorphone 0.2 mg / ml PCA infusion on 6/30/15 at 1 a.m.

A review of two PCA flow sheets showed Patient 11 received a morphine PCA on 6/29/15 between 6:16 p.m. and 11:30 p.m. for pain scores ranging from 6-8.

A review of a third PCA flow sheets showed Patient 11 received a hydromorphone PCA on 7/1/15 between 1 a.m. and 12 p.m. for pain scores ranging from 1-6.

A review of Patient 31's medical record showed under the section, Admission Record and History and Physical, that she was a 40 year old female admitted 8/24/15 for breast reconstruction following surgical removal of breasts.

A review of Patient 31's physicians' orders, titled, Physician Orders - Surgical Admit Orders, signed and dated 8/20/15 at 7 a.m., by a physician plastic surgeon, (MD 3) showed an order for the antibiotic, "Vancomycin IV" to be given preoperatively. The order had no dose and was not clarified by a pharmacist or any other healthcare professional to determine whether Levaquin or Vancomycin or both antibiotics were intended by prescribers to be administered.

A review of Patient 31's physicians orders, titled, Breast Clinic, signed and dated 8/23/15 at 3:25 a.m., by MD 2 showed an order for the antibiotic, "Levaquin 500 mg IV" to be given preoperatively. A review of Patient 31's MAR showed she was administered Levaquin 500 mg IV on 8/24/15 at 10:15 a.m., which conflicted with the previous order above.

A review of Patient 31's physicians' orders, titled, "PHYSICIAN ORDERS - Anesthesia Orders Recovery Room Only" signed and dated 8/24/15 at 11:03 a.m., by MD 4 showed mild to moderate pain correlated to a numerical score of between 1-6. The orders instructed nurses to administer as a first choice, "Morphine 2 mg every 5 minutes (for mild to moderate pain). The order showed as a second choice, "Dilaudid 0.2 mg every 5 minutes (for mild to moderate pain)." The order for morphine and Dilaudid was not clarified when its use for mild pain was not indicated by the manufacturer.

A review of Patient 31's physicians' orders showed she had a preprinted document, titled, "PHYSICIAN ORDERS - [MD 2]", signed and dated 8/24/15 at 4:30 p.m., by a physician and surgeon, MD 2. The orders showed, "Norco 10/325mg PO (by mouth) q4 prn (every 4 hours as needed for) pain. 1 for mild pain (1-3)". The orders also showed, "Percocet 10/325mg PO q4 prn pain. 1 for mild pain (1-3).

Oxycodone and acetaminophen tablets (Percocet is the brand name) is a controlled substance Schedule II semisynthetic pure opioid agonist/ non-opiate salicylate combination medication indicated for the relief of moderate to moderately severe pain. [Reference: Mallinckrodt Pharmaceuticals product package insert, 2/2014].

According to the manufacturers, Norco and Percocet (a controlled substance schedule II opiate analgesic) are not indicated for mild pain. The orders were not clarified for Patient 31 by a pharmacist or other healthcare professional when the manufacture of these medications did not support their use for mild pain as a labeled indication. Further review of the order showed an order for "Scopolamine patch prn N/V (nausea and vomiting)". Scopolamine is a mediation indicated for nausea. No dose for scopolamine was specified on the order and the order was not clarified by a pharmacist or other healthcare professional.

Oxycodone and acetaminophen tablets (Percocet is the brand name) is a controlled substance Schedule II semisynthetic pure opioid agonist/ non-opiate salicylate combination medication indicated for the relief of moderate to moderately severe pain. [Reference: Mallinckrodt Pharmaceuticals product package insert, 2/2014].

A review of Patient 31's physicians' orders showed she had a preprinted document, titled, "PHYSICIAN ORDERS - Patient Controlled Analgesia (PCA)", signed and dated 8/24/15 at 3:30 p.m., by MD 2.

The PCA order for Patient 31 had instructions to the prescriber, "Check Appropriate Column" above two medications, "Morphine" and "Hydromorphone." Four rows beneath the columns instructed the prescriber in completing the order. The first instruction (row 1) was to choose the type of medication (morphine or hydromorphone). The second instruction (row 2) suggested a dosing range. The third instruction (row 3) suggested a lockout interval (the time in minutes the patient has to wait for the next demand dose). The fourth instruction (row 4) suggested rates for a basal (continuous) infusion. Highlights of the order and medical record review showed the following:

* On the first row, titled, "Analgesic PCA", both "Morphine 1 mg/ml (milligram per milliliter)" and "Hydromorphone 0.2 mg/ml" were checked. The order was not clarified in the record by a pharmacist or any other healthcare professional to determine which of the two opiate analgesic controlled substances was intended by the prescriber.

* On the second row, titled, "PCA Dose", both "1 mg" and "0.2 mg" were checked. The dose was not clarified by a pharmacist or any other healthcare professional to determine which of the two doses of opiate was intended by the prescriber.

* On the third row, titled, "Lockout interval", "10 minutes" was chosen for both morphine and hydromorphone. The lockout interval was not clarified by a pharmacist or any other healthcare professional as to which medication the prescriber intended.

* On the fourth row, titled, "Continuous rate", a "yes" was checked for hydromorphone. The basal rate was not clarified by a pharmacist or any other healthcare professional to determine what rate the prescriber wanted for the basal rate or if the prescriber wanted a basal rate of morphine.

A review of PCA Flow sheets showed Patient 31 received a hydromorphone PCA infusion on 8/24/15 between 3:30 p.m. and 8/25/15 at 9:30 a.m. for pain scores between 6-8.

A review of Patient 32's electronic health record (EHR) showed under the sections, "Admission Record" and "History and Physical", that she was an 89 year old female admitted 8/24/15 for a breast wound exploration and had a history of breast cancer.

A review of Patient 32's physicians' orders showed she had, "Physician Orders - Anesthesia Orders Recovery Room Only", dated, 8/24/15 at 3:25 p.m., signed by MD 4, which instructed nurses to give, "Morphine 2 milligrams (mg) every 5 minutes (for mild to moderate pain)." There were no other orders for pain management with non-opiates. The orders were not clarified by a pharmacist or other healthcare professional when the manufacture of morphine did not support their use for mild pain as a labeled indication not responsive to non-narcotic analgesics.

A review of Patient 32's physicians' orders showed she had a preprinted document, titled, "PHYSICIAN ORDERS - [MD 2]", dated 8/24/15 at 11 a.m., and signed by MD 2. The orders showed, "Norco 10/325mg PO q4 prn pain. 1 for mild pain (1-3). The orders were not clarified by a pharmacist or other healthcare professional when the manufacture of this medication did not support their use for mild pain as a labeled indication.

A review of Patient 33's medical record showed he was a 47 year old man admitted 8/4/15 for cervical spine surgery.

A review of Patient 33's physicians' orders showed he had "Physician Orders -- Patient Controlled Analgesia (PCA)", dated 8/4/15 at 10:15 a.m., signed by MD 4.

The PCA order for Patient 33 had instructions to the prescriber, "Check Appropriate Column" above two medications, "Morphine" and "Hydromorphone." Four rows beneath the columns instructed the prescriber in completing the order. The first instruction (row 1) was to choose the type of medication (morphine or hydromorphone). The second instruction (row 2) suggested a dosing range. The third instruction (row 3) suggested a lockout interval (the time in minutes the patient has to wait for the next demand dose). The fourth instruction (row 4) suggested rates for a basal (continuous) infusion. Highlights of the order and medical record review showed the following:

* On the first row, titled, "Analgesic PCA", both "Morphine 1 mg/ml (milligram per milliliter)" and "Hydromorphone 0.2 mg/ml" were checked. The order was not clarified in the record by a pharmacist or any other healthcare professional to determine which of the two opiate analgesic controlled substances was intended by the prescriber.

* On the second row, titled, "PCA Dose", both "1 mg" and "0.2 mg" were checked. The dose was not clarified by a pharmacist or any other healthcare professional to determine which of the two doses of opiate was intended by the prescriber.

* On the third row, titled, "Lockout interval", "10 minutes" was chosen for both morphine and hydromorphone. The lockout interval was not clarified by a pharmacist or any other healthcare professional as to which medication the prescriber intended.

* On the fourth row, titled, "Continuous rate", a "no" was checked for hydromorphone. The basal rate was not clarified by a pharmacist or any other healthcare professional to determine what rate the prescriber wanted for the basal rate or if the prescriber wanted a basal rate of morphine.

A review of PCA Flow sheets showed Patient 33 received a hydromorphone PCA infusion on 8/4/15 between 12:40 p.m. and 8/5/15 at 12 p.m., he was administered a 1 mg dose of hydromorphone via a PCA in 11 of 13 opportunities in response to reports of mild pain as follows:

*On 8/4/15 at 12:40 p.m. for a pain score of 2
*On 8/4/15 at 12:55 p.m. for a pain score of 2
*On 8/4/15 at 1:10 p.m. for a pain score of 2
*On 8/4/15 at 1:25 p.m. for a pain score of 2
*On 8/4/15 at 1:40 p.m. for a pain score of 3
*On 8/4/15 at 1:40 p.m. for a pain score of 3
*On 8/4/15 at 10:00 p.m. for a pain score of 3
*On 8/5/15 at midnight for a pain score of 2
*On 8/5/15 at 4:00 a.m., for a pain score of 3
*On 8/5/15 at 8:00 a.m. for a pain score of 3
*On 8/5/15 at 12:00 p.m. for a pain score of 3

A review of Patient 34's medical record showed she was a 27 year old female admitted 7/31/15 for a reproductive system-related complication.

A review of Patient 34's physicians' orders showed he had, "Physician Orders - Anesthesia Orders Recovery Room Only", dated, 7/31/15 at 1:45 p.m., signed by MD 4, which instructed nurses to give as a first choice, "Morphine 2 milligrams (mg) every 5 minutes (for mild to moderate pain.)" The same orders showed nurses were instructed to give as a second choice, "Dilaudid 0.2 mg every 5 minutes (for mild to moderate pain.)" The orders were not clarified by a pharmacist or other healthcare professional when the manufacture of morphine did not support its use for mild pain as a labeled indication not responsive to non-narcotic analgesics. The order for Dilaudid was not clarified when its use for mild pain was not indicated by the manufacturer.

A review of Patient 35's medical record showed she was a 19 year old female admitted 8/10/15 by MD 2 for exploratory surgery of a breast lesion.

A review of Patient 35's physicians' orders showed she had "Physician Orders - Anesthesia Orders Recovery Room Only", signed and dated, 8/10/15 at 3:15 p.m., which instructed nurses to give as a first choice, "Morphine 2 milligrams (mg) every 5 minutes (for mild to moderate pain)." The same orders showed nurses were instructed to give as a second choice, "Dilaudid 0.2 mg every 10 minutes (for mild to moderate pain)." The orders were not clarified by a pharmacist or other healthcare professional when the manufacture of morphine did not support its use for mild pain as a labeled indication not responsive to non-narcotic analgesics. The order for Dilaudid was not clarified when its use for mild pain was not indicated by the manufacturer.

A review of the hospital's High Alert Drug list showed it included, "Drugs used in Patient Controlled Analgesia ..., calcium chloride, Lovenox, IV diazepam ..."

A review of the hospital's policy, "High Alert Medication", dated 1/12, showed, "High alert drugs are those drugs that require special handling due to a narrow therapeutic index, multiple drug / disease interactions, severe life-threatening side effects ... or require special monitoring before or during the administration of the drug." The policy showed, "The Consultant Pharmacist or the patient's physician shall be contacted for any unresolved concerns." The policy showed, "Because of the size and scope of service of the hospital, staffing on weekends or nights may preclude the ability to have another nurse confirm. In this case, the RN MUST review the resources mentioned above (Mosby's, etc.). If the RN has any question about administering any medication they are encouraged to call the Consultant Pharmacist, attending physician, Director of Patient Care Services, Clinical Care Coordinator or the Administrator." Further review of the policy showed, "All medication orders should be reviewed for appropriateness and safety before the first dose is administered and document this review on the MAR."

A review of Drug Regimen Reviews by CP for the previous survey period 8/24/12 to 8/24/15 showed none of the orders above were identified as requiring clarification by the CP, the Administrator, or the attending physician until the current survey.

2. On 8/24/15 at 1:37 p.m. during an inspection of a medication storage in the Medical Surgical Unit with the Director of Patient Care Services (DPC) a total of 19 syringes of intravenous diazepam 1milligrams (mg) per 2 milliliters (mL) were observed in the controlled substance mediation stock without a high risk label to caution staff. Diazepam is a controlled substance schedule IV skeletal muscle relaxant and sedative of the benzodiazepine drug class. Diazepam is the generic drug name for the proprietary brand name Valium. [Reference: www.dailymed.org ]

A review of the hospital's policy, "High Alert Medication", dated 1/12, showed, "High alert medications will be labeled as such and will be marked with a red star next to them on the MAR (Medication Administration Record).

On 8/24/15 at 1:37 p.m. during an interview, the DPC said, "They should be marked." She said, "Diazepam is a high alert mediation."

On 8/24/15 at 1:37 p.m. during an inspection of medication storage in the Administrator's office, 60 vials of midazolam 5mg per 5 ml were observed in stock without a high risk label. Midazolam is a controlled substance schedule IV sedative of the benzodiazepine drug class used in conjunction with surgical or other procedures requiring conscious sedation. Midazolam is the generic drug name for the proprietary brand name Versed. [Reference: www.dailymed.org]

On 8/24/15 at 1:37 p.m. during an interview, the Consultant Pharmacist (CP

Based on observation, interview, and record review, the facility failed to ensure drugs listed in Schedules II and IV of the Comprehensive Drug Abuse Prevention and Control Act of 1970 were locked within a secure area in the Perioperative Anesthesia Care Unit (PACU), also known as Recovery Room, when a registered nurse, Operating Room/Recovery Room (RN 2) stored a syringe of hydromorphone at the bedside of Patient 31. A physician and anesthesiologist (MD 4) stored a syringe of Versed in her pocket in PACU prior to administration of a dose to Patient 32. The hospital's census was three. The hospital's failure had the potential to result in the loss of control of drug supplies associated with a high potential for abuse and diversion (theft). This had the potential to contribute to treatment delay for 2 of 3 sampled patients (Patient 31 and Patient 32) as a result of drug diversion.

Definitions:

Versed is a controlled substance schedule IV sedative used in conjunction with surgical or other procedures requiring conscious sedation.

Hydromorphone is a controlled substance schedule II opiate analgesic used to treat moderate to severe pain.

Findings:

On 8/24/15 at 2:44 p.m., during a medication pass observation in the PACU, RN 2 was observed administering a dose of hydromorphone 0.5 milligrams (mg) from a syringe to Patient 31. The syringe was labeled "hydromorphone 2 milligrams (mg) per milliliter (ml)." After administering the dose, RN 2 placed the syringe on the bedside table of Patient 31.

On 8/24/15 at 2:44 p.m., during an interview, RN 2 indicated she left the syringe on the bedside table because she anticipated Patient 31 might need more pain medication. RN 2 indicated she was not aware of any requirement not to leave a controlled substance medication at the bedside. The hospital did not provide training records to show RN 2 received instruction that State requirements (a standard of practice) prohibit leaving controlled substances at the bedside.

State of California regulations specify standards for distribution of controlled substances as follows, ""Drugs shall not be left at the bedside which are listed in Schedules II, II and IV of the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970 as amended." [Reference Social Security Act Title 22 Section 70263(l)]


On 8/24/15 at 2:44 p.m., during a medication pass observation in the PACU, a physician anesthesiologist (MD 4) was observed with a syringe of Versed sticking out of her front shirt pocket.

On 8/24/15 at 2:44 p.m., in an interview with MD 4, she indicated she had not secured the syringe of Versed as she intended to use it for Patient 32.

A review of the hospital's document, titled, "OR (Operating Room) Narcotic Sheet Versed", dated 8/17/15, showed MD 4 signed out a vial of Versed, 2 mg per 2 milliliters on 8/24. There was no year documented and the form did not indicate a requirement for staff to note the time dispensed.

On 8/24/15 at 3 p.m. in an interview, the registered nurse Surgical Services Manager (RN Manager 1) said, "There is no system to show what time something was pulled from stock." She clarified that this form was specific to anesthesiologists and that nurses were required to document the date and time for whenever a controlled substances was taken from stock.

On 8/24/15 at 3:41 p.m. in an interview, the Consultant Pharmacist (CP) indicated he was unaware of a hospital policy that had been developed to prevent storage of controlled substances at the bedside. He said, "Controlled substances should always be secured." The CP provided recordkeeping for controlled substances and audits; however, he was unable to show how the hospital was able to track the flow of controlled substances retrieved from stock by the anesthesiologists.

A review of the hospital's policy, titled, "MEDIATION ADMINISTRATION", dated 3/15, showed under a section "Discarding Partially Used or Contaminated Medication", that, "Medication prepared but not administered to a patient for any reason must be discarded in the white container in the drug room." In the same policy, under the section, "Patients' Home Medications Administration", showed, "No mediation will be left at the patient's bedside." The hospital did not provide polices which ensured continuous secured storage of controlled substances.

Based on observation, interview, and record review, the facility failed to ensure mislabeled repackaged intravenous medications (e.g. versed, and cefazolin) were not available in the in the Perioperative Anesthesia Care Unit (PACU), also known as Recovery Room, when a registered nurse, Operating Room/Recovery Room (RN 3) and a physician and anesthesiologist (MD 4) did not label medications with the patient's name, drug strength, expiration date and time, and the initials of the preparer as required by hospital policies. The hospital's failure had the potential to result in treatment failure as a result of administration of a deteriorated mediations (e.g. did not meet standards for quality or purity) to two of three sampled patients (Patient 31 and Patient 32).

Definitions:

Versed is a controlled substance schedule IV sedative used in conjunction with surgical or other procedures requiring conscious sedation.

Cefazolin [brand name Ancef] is an antibiotic.

The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the strength, quality, and purity of medicines ... manufactured, distributed and consumed worldwide. USP's drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries." [Reference: www.usp.org ]

Immediate Use Compounded Sterile Products (IUCSP) relates to the "immediate-use provision" of USP-NF Chapter 797 intended only for those situations where there is a need for emergency or immediate patient administration of a CSP. IUCSPs are not intended for storage ...and unless complete administration is witnessed ...the CSP shall bear a label listing the exact 1-hour BUD (beyond use date) and time...and ... if administration has not begun within 1 hour following the start of preparing the CSP, the CSP shall be promptly, properly, and safety discarded. [Reference: www.usp.org]

Beyond-Use-Date (BUD) for the purpose of USP Chapter 797 is "the date or time after which a CSP shall not be stored or transported. The date is determined from the date or time the preparation is compounded (combined). BUDs for CSPs that lack justification from either appropriate literature sources or by direct testing evidence shall be assigend as described in Stability Criteria and Beyond Use Dating under Pharmaceutical Compoiunding - Nonstewrile Preparations (Chapter 795)." [Reference: www.usp.org]

Findings:

On 8/24/15 at 2:44 p.m., during a medication pass observation in the PACU, RN 3 was observed reconstituting (adding fluid to powdered medication) and administering a dose of cefazolin 1 g (gram) to Patient 32. RN 3 did not ensure the syringe had a label affixed which contained an expiration date and time or his initials. In the same observation, MD 4 was observed with a syringe of versed sticking out of her pocket. The syringe was not labeled with an expiration date and time or her initials.

On 8/24/15 at 2:44 p.m., in an interview with a registered nurse Surgical Services Manager (RN Manager 1), said, "Medications on and off the sterile field (area with no germs) need to be labeled with the drug name, expiration, strength, dose, and expiration time."

On 8/24/15 at 2:44 p.m., in an interview, RN 3 indicated he did not label the cefazolin syringe with the expiration, strength, dose, or his initials prior to administering it to Patient 32.

On 8/24/15 at 2:44 p.m., in an interview, MD 4 indicated she had not labeled the syringe of Versed with the expiration, strength, dose, or her initials. She said, "I just got it from the other room." MD 4 indicated she intended to use it prior to administering it to Patient 32.

On 8/24/15 at 3:41 p.m. in an interview, the Consultant Pharmacist (CP) indicated the hospital had a requirement to label all mediations and he was unaware of any quality assurance process to ensure that was being accomplished consistently.

On 8/26/15 at 11:48 a.m., in an interview, MD 4 said, "I was not trained or informed as to labeling with expiration dates and times or how these expirations were assigned. MD 4 indicated that at her former workplace labels for mediations were not an issue. She said, "I never heard about it."

A review of the hospital's undated training material, titled, "USP 797.org", showed no reference to the USP requirement for assigning BUDs. The USP section "Immediate Use CSPs" required, "Unless immediate and completely administered by the person who prepared it or immediate and complete administration is witnessed by the preparer, the CSP shall bear a label listing patient identification information, the names and amounts of all ingredients, the names or initials of the person who prepared the CSP, and the exact 1-hour BUD and time." According to the USP Chapter 797, a BUD is the time or date after which a CSP shall not be stored or transported."

A review of the hospital's undated written procedure, "Intravenous Admixture IV Therapy", showed next to 18 drug names, instructions for staff for "administration rates" and "diluent for infusion" but the procedures contained no information on assigning BUDs.

A review of the hospital's policy, titled, "MEDICATION ADMINISTRATION", dated 3/15, showed, "All drug labels must be legible and in compliance with state and federal requirements. All patient medications, regardless of source, shall be properly labeled only by persons legally authorized to prescribe or dispense, or under supervision of a pharmacist."

A review of the hospital's undated policy, titled, "MEDICATION & SOLUTION LABELING FOR INVASIVE PROCEDURES", showed, "All medications and solutions in procedural areas shall be labeled. This includes medications and solutions on and off the sterile field. The label will include: the name of the medication, strength of the mediations/solution, date, and initials of the individual preparing and labeling the mediation. The following mediations and solutions must be labeled when removed from their original containers: prescription medications ..."

A review of Patient 31's electronic health record (EHR) showed under the section, Admission Record and History and Physical, that she was a 40 year old female admitted 8/24/15 for breast reconstruction following surgical removal of breasts. Under the heading for physicians' orders, there was an order for Ancef 1g signed by the attending physician and surgeon MD 2.

A review of Patient 32's electronic health record (EHR) showed under the sections, Admission Record and History and Physical, that she was an 89 year old female admitted 8/24/15 for a breast wound exploration and had a history of breast cancer.

Based on observation and interview, the hospital failed to ensure information relating to drug interactions and information of drug therapy, side effects, toxicology, dosage, indications for use, and routes of administration was available to the professional staff when a nursing drug information book from 2008 was maintained in the Pharmacy Storage area (also known as Medical Office Building (MOB)) and Drug Room when a more current edition was available (Mosby's 2016, Edition 29). The hospital's failure placed patients at risk for potential adverse outcomes as a result of nurses accessing outdated drug information during times when a pharmacist was unavailable or during a utility failure when electronic references (Internet resources) may be unavailable.

Findings:

On 8/25/15 at 9:25 a.m. in an interview, the Consultant Pharmacist (CP) described how the hospital ensured current drug information was available to staff. The CP indicated that he worked at the hospital two days a month on average and was available by phone to answer questions related to medication management and use of medications in the hospital. The CP indicated the hospital had put a link to an authoritative drug monograph (reference) source on all the hospital desktop computers in clinical care areas. He said, "We put a link on the desktops for Daily Med." Reference: Daily Med is an authoritative medication information source published by the National Institute of Health, a federal government agency.

On 8/25/15 at 9:59 a.m. during an inspection of the MOB an outdated nursing drug reference was observed outside the drug room, titled, "Mosby's 2008 Nursing Drug Reference, 21st Edition. The ISBN number was 978-0-323-04700-5. During that observation, in an interview, the CP indicated that if there was a power outage or utility failure nurses could potentially refer to outdated drug information from the book. The CP said, "Sometimes you look at it. You know it may not be up-to-date."

Based on document review and staff interview, the facility failed to ensure that the radiology films (x-rays), which are considered part of the patient' s medical record, were stored in an approved off-site location, in accordance with State regulation. In addition, there was no written agreement with the outside company to ensure the films were maintained securely and confidentially.

Findings:

California Code of Regulations, Title 22, section 70751 states in part: (b) " The medical record, including X-ray films, is the property of the hospital and is maintained for the benefit of the patient, the medical staff and the hospital. The hospital shall safeguard the information in the record against loss, defacement, tampering or use by unauthorized persons. (f) Medical records shall be filed in an easily accessible manner in the hospital or in an approved medical record storage facility off the hospital premises."

The Health Information Management policies and procedures were reviewed on 8/25/15. The policy, "Radiology Film Storage" stated in part that x-ray films prior to 2001 are archived with Pro Med (a contracted company).

The Radiology policy and procedure, "Record Retention Radiology" was received and reviewed on 8/26/15 at 11:30 am. It stated, in part: "Films older than 3 years will be stored by contractor according to all record retention requirements."

During an interview with Staff Health Information Management (HIM) and Adminstrator on 8/26/15 at approximately 11:05 am, they stated that the films were stored by the same company that performs copying of medical records for releasing to outside requestors, and confirmed that the contractual agreement did not include any mention of storage of x-ray films; nor was there approval from the California Department of Public Health for the films to be stored off the hospital premises.

Based on observation, interview and document review, the hospital failed to ensure effective food and nutrition service systems to prevent foodborne illness. Failure to implement effective food handling procedures may result in unsafe food handling practices, putting all in-patients at risk for foodborne illness, compromising their medical and nutritional status.

Findings:

1. On 8/24/15 at 1:05 p.m. during kitchen observations, a hand pump dispenser of hand antiseptic (anti-germ) was on the handwashing sink. When asked if it was approved for use in foodservice operations, Dietary Services Manager (DSM) stated he did not know, that it was used throughout the hospital, and food service staff sometimes used it in-between food production tasks.

A review of the hospital policy dated 10/09 entitled, "Food Service, Dietary Employee Personal Appearance and Hygiene", indicated, "Alcohol-based hand antiseptics may only be used after handwashing (never in place of) or limited to situations where bare hands do not come in direct contact with food." The Policy did not indicate the hand antiseptic must be approved for use in food service operations.

Review of the label for the hand antiseptic used in the kitchen indicated, "Warning: if swallowed, get medical help or contact a poison control center right away."

The Federal Food Code 2013, the standard of practice for food service operations, section 2-301.16 specified the requirements hand antiseptics must meet to be approved for use in food service operations.

2. On 8/24/15 at 3 p.m. during observations of the nourishment room, a container of disinfecting (anti-germ) wipes were on the counter. DSM stated the Diet Aide (DA) used the wipes to clean patient refrigerators. He stated the DA used a spray bottle of disinfectant (sanitizer) cleaner, provided by the hospital's housekeeping department, to clean the nourishment room counter tops. He stated he did not know if these chemicals were approved for food contact surfaces.

Review of the hospital policy dated 5/08 entitled, "Food Service, Sanitizing Patient Room Refrigerator", indicated, "Refrigerators in patient rooms will be sanitized and restocked upon discharge of each patient by Diet Aide." The policy did not indicate the sanitizer must be approved for use on food contact surfaces.

During a subsequent interview on 8/25/15 at 2:25 p.m., Facilities Manager confirmed the disinfectant cleaner in the spray bottle used to sanitize the nourishment room counter tops was not approved for food contact surfaces.

The hospital did not provide a policy on what chemicals to use to sanitize the nourishment room counter tops.

Review of the label for the disinfecting wipes indicated, "Caution: wash hands thoroughly with soap and water after handling and before eating, drinking, chewing gum, using tobacco, or using the toilet."

Federal Food Code 2013 specifies under section 7-204.11 the criteria sanitizers must meet when used on food contact surfaces. Use of unapproved chemicals can become indirect food additives.

3. Review of the August 2015 hospital's Food and Nutrition Department document entitled, "Temperature Log Sheet", indicated the dishmachine chemical sanitizer (anti-germ) concentration test strips for August 14 through 24, 2015 measured 200 ppm (parts per million). The chemical test strips used by the facility had a concentration test ranging from 10 to 200 ppm. There was no way to determine if a chemical concentration was greater than 200 ppm.

Review of the label for the chemical sanitizer used in the dishmachine indicated, "Do not exceed 200 ppm."

During a subsequent interview on 8/26/15 at 8:15 a.m., Dietary Cook (DC), who recorded the test strip results on the "Temperature Log Sheet", stated she would notify DSM if the test strip indicated 10 ppm or more than 200 ppm, and concentrations between 50-150 ppm were ideal. DC further stated she did not report the 200 ppm readings to DSM because she thought 200 ppm was acceptable.

The hospital did not provide a policy or in-service training documentation on what to do if the test strips measured 200 ppm.

Federal Food Code 2013 section 4-302.14 indicated, "Testing devices to measure the concentration of sanitizing solutions are required for two reasons:
1) The use of chemical sanitizers requires minimum concentrations of the sanitizer during the final rinse step to ensure sanitization; and
2) Too much sanitizer in the final rinse water could be toxic."

4. On 8/24/15 at 1:05 p.m., during kitchen observations, a container of raw alfalfa sprouts was located in the walk-in refrigerator. The DSM stated the sprouts were served raw to patients, either as a garnish or in sandwiches and wraps. He was not aware that raw sprouts were not approved to be served to hospital patients.

Review of hospital recipes that the DSM stated raw sprouts were served in, indicated for the recipe dated 2/12 entitled, "Garden Salad" that one of the ingredients was bean sprouts. The recipe dated 3/12 entitled, "Grilled Chicken Wrap" did not include spouts as an ingredient. The DSM further stated that any recipe or menu item that indicated "crudités garnish" (vegetable garnish) very regularly contained raw sprouts.

The hospital did not provide a policy on hazardous foods that if served could cause foodborne illness in highly susceptible populations such as hospitalized in-patients.

Federal Food Code 2013 section 3-801.11 indicated, "In a food establishment that serves a highly susceptible population, the following foods may not be served or offered for sale in a ready-to-eat form..." The list includes raw seed sprouts.

5. On 8/24/15 at 1:05 p.m. during kitchen observations, the following expired items were located in the walk-in refrigerator: flan (egg custard) dated 8/19/15, garlic and herb wraps thawed on 8/11/15, and cheesecake dated 8/16/15. DSM stated these items were good for seven days.

Review of the hospital policy dated 12/11 entitled "Food Service, Food Storage, Dry Refrigerated, and Freezer Storage Chart" indicated it did not include wraps or cheesecake. It did indicate under the subsection, "Egg containing products: custards, puddings, custard filled-pastries and cakes" that they were good refrigerated for 1-2 days.

6. On 8/26/15 at 8:30 a.m. during food production observations, a food preparation sink was filled with water and several heads of iceberg lettuce were soaking in the standing water. DSM stated he was not aware that this was not the proper way to wash fresh produce to prevent cross-contamination and foodborne illness.

The hospital did not provide a policy on the correct method to wash fresh produce.

The Federal Food Code 2013 section 3-302.15 indicated: "All fresh produce, except commercially washed, pre-cut, and bagged produce, must be thoroughly washed under running, potable water. Infiltration of microorganisms can occur through stem scars, cracks, cuts or bruises in certain fruits and vegetables during washing. Once internalized, bacterial pathogens cannot be removed by further washing or the use of sanitizing solutions. To reduce the likelihood of infiltration, wash water temperature should be maintained at 10°F warmer than the pulp temperature of any produce being washed. Because certain fruits and vegetables are susceptible to infiltration of microorganisms during soaking or submersion, it is recommended that soaking or submerging produce during cleaning be avoided."

Based on observation, interview and document review, the hospital failed to ensure their supplies and equipment were maintained at an acceptable level of safety and quality when medical supplies and devices were stored with no temperature monitoring. This failure could lead to supplies degrading because temperatures reached an unacceptable level without the facility's knowledge.

Findings:

During an initial tour of the facility with the Administrator and Director of Patient Care Services (DPCS) on 8/24/15 starting at 9:30 am, the basement area where medical supplies and devices were stored was observed. The DPCS and Administrator confirmed that there was no thermometer present and that the temperatures in this area were not routinely monitored or documented.

During an interview and observation, with the Materials Manager (MM) on 8/24/15 at 11:05 am, she acknowledged that it can get rather warm in this area especially during the summer months. The MM confirmed that there was no thermometer present and that the temperatures in this area were not routinely monitored or documented.

Multiple bags of IV (intravenous) solutions were observed as being stored in this area. The outer packaging on the IV solution read, "Store unit in moisture barrier over wrap at room temperature (25° Celsius[C] / 77° Fahrenheit [F] ) until ready to use. Avoid excessive heat.

According to the National Weather Service website (www.weather.gov) the outside temperature in this city was 94° F as of 8/24/15 at 2:53 pm.

During an interview and observation, with the Facility Manager on 8/24/15 at 3:50 pm, the temperature was taken in the area where the IV solutions were stored and it was 77° F. FM acknowledged that this was at the upper end of the acceptable temperature storage perimeter.

The facility's policy and procedure titled, "Drug Storage," dated 2/15, indicated that drugs shall be stored at the appropriate temperatures. Drugs required to be stored at room temperature shall be stored at a temperature of not less than 20° C (68° F) or more than 25° C (77° F). With allowable excursions between 59° F and 86° F permitted as long as they do not exceed 24-hours.