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Based on observations, interviews with facility staff, document reviews and record reviews, the hospital's governing body, the legally responsible entity for the conduct of hospital operations, failed to provide oversight to the pharmaceutical and dietary departments which resulted in the identification of systemic deficiencies in these areas. In addition, the governing body failed to ensure that the quality assessment and performances improvement program involved all hospital departments and services and reflected the complexity of the hospital's organization and services in order to identify concerns and implement corrections to improve and prevent systemic problems.

Findings:

1. The hospital failed to develop and implement policies and procedures to ensure the safe use of fentanyl transdermal patches. Patient 21 and 40 were prescribed and administered fentanyl transdermal patches not in accordance with the boxed warning issued for the drug, which had the potential to cause fatal respiratory depression as a result of opiate overdose. (A500)

2. The hospital failed to maintain the temperature in medication refrigerators in accordance with hospital policy (2-8 degrees Celsius) and the manufacturer's recommendations. (A500)

3. Medication orders were not reviewed by a pharmacist before the first dose was administered in non-emergent situations. Physicians ' orders written between the hours 10 p.m. to 7 a.m. Mondays to Fridays, and 6 p.m. to 7 a.m. on Saturdays and Sundays were not reviewed by a pharmacists prior to the first dose being given to patients. (A500)

4. The hospital failed to account for 202 medications, based on a one month audit, which could be attributed to medication errors such as administering extra doses, missing doses, and administering the wrong medications. (A500) (267)

5. The hospital failed to update expiration dating on intravenous bags of solutions once taken out of the overwrap. (A500)

6. The hospital pharmacists failed to review medication orders for appropriateness. (A500)

7. The hospital pharmacy administration failed to develop and supervise all the activities in the pharmacy. Two staff pharmacists did not have record of training and passing competency tests prior to being assigned to perform pharmacist duties independently. (A492) (A267)

8. The hospital failed to ensure that the dietetic service department had a dietetic service manager responsible for daily management of the dietary department so as to ensure organization, healthful nutrition care, safe, and sanitary food service. (A619, A 620).

9. The dietary Department failed to ensure that diets were in accordance with standard dietary practices as well as practitioner's orders. (A630)

10. The hospital's systemic concerns under Pharmacy services, Radiology, and Rehabilitation services were not identified or integrated with the Quality Improvement Program in order to identify, measure, and track quality data to improve hospital performance. (A 267)

The cummulative effects of these systemic problems resulted in the failure of the hospital's governing body to ensure that its patients were provided with safe, effective, quality care.

Based on interview and record review, the facility failed to include anticipated sources of financing for the projects on its three-year capital plan. The deficient practice sidestepped opportunities for strategic planning and had the potential to limit future enhancements.

Findings:

Review of the facility's three-year capital plan indicated that the funding sources for capital projects over $600,000 were not specified.

In an interview on 8/31/10 at 11:12 a.m., Staff A stated that he could have the completed list of capital projects the following day. He stated that some of the projects were funded by grants, particularly from a hospital foundation, but that capital needs not funded by grants were funded by the county which owned the facility. He stated that the capital commitments by the foundation were not determined until the foundation took proposals and decided which projects it would raise funds for.

Based on interview and record review, the facility failed to document that it had updated its capital plan annually. The deficient practice had the potential to circumvent the periodic strategic planning required to create such documentation.

Findings:

Review of the facility's capital plan indicated that it included capital projects planned for the current year and two future years. There was no documentation of capital plans from prior years.

In an interview on 8/31/10 at 11:12 a.m., Staff A stated that the capital projects were on a perpetual list. In an interview and record review on 9/1/10 at 10:22 a.m., Staff B presented the capital plan from 2008-2009. She stated that she could look for the budget from 2009-2010, but "that was it" regarding prior years' capital plans.

Based on observation, staff interview and document review the hospital failed to ensure that contracted services pertinent to dietetic services had been provided in a safe and effective manner. By not having service contracts stipulating that the hospital retained administrative authority, retained reports and had assured effectiveness and safety via surveillance, there was the potential for undetected, unsafe provision of care and services in a hospital with a licensed bed capacity for 509 patients. Additionally, the hospital failed to ensure that contracted services for dialysis had been provided in an effective manner when Patient 21's pre-dialysis weight was not recorded. By not closely monitoring the patient's weight for dialysis, there was a potential not to meet the fluid balance needs of the patient.

Findings:

On 8/24/10 between 11:15 a.m. and 11:50 a.m. while in an administrative conference room, review of contracts pertinent to dietetic services with the Dietetic Service Manager and Materials Management Director revealed no covered administrative authority. Review revealed that those contracts which had provisions for educating nursing staff as to the utilization of tube feeding pumps, routine pest control and on-going dishmachine maintenance within the foodservice operations and a coffee vending service near the admissions office had no stipulations relating to the authority for ensuring surveillance, effectiveness, quality and safety.

On 8/24/10 at 11:45 a.m. the Materials Management Director stated that there had been a lack of recording on the effectiveness of the education provided to nursing staff and that there had not been any quality controls over the other services. At 11:48 a.m. the Dietetic Service Manager stated that he did not know what foaming product had been put in kitchen drains by the pest control service as well as the intended purpose. At 11:50 a.m. the Dietetic Services Manager added that he was unaware of any internal quality control to ensure safety of the four contracted services.



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2. Record review on 8/25/10 showed Patient 21 was admitted to the hospital on 8/20/10 from a long term care facility with multiple medical conditions that included acute renal failure that required dialysis daily. The patient was initially admitted to the general medical surgical unit but had to be transferred to the ICU (intensive care unit) on 8/21/10 for continued decline in renal and mental status.

The dialysis treatments were performed by a contracted company where the nurse delivered the services in the patient's room. In order to monitor the fluid balance of the patient, the weight is taken before and after the dialysis treatments. On 8/24/10, the weight was not taken before the initiation of the dialysis. Of note, the nursing staff also did not weigh the patient that day even though there was a standing order to weigh the patient daily. So, the patient's weight and fluid balance was unknown for an entire day.

The hospital's procedure titled, "Dialysis Responsibilities for Acute Nursing Units", dated 9/08/09, stated, "weigh and record patient weight pre- and post-dialysis."

The hospital agreement with the contracted dilaysis company effective 9/1/08 through 8/31/11 stated in Exhibit A, page 10: "Report post-dialysis status to floor and nephrologist including weight loss." And on the same contract agreement on page 13 which stated: " Contractor will contribute to patient documentation on forms provided to Contractor, patient care plan and patient tracking and provide assistance to the (hospital team)."

Based on interview and record review, the facility failed to include the address and phone number for filing complaints with the responsible state agency in its notice to patients regarding their rights. The deficient practice had the potential to prevent patients from filing complaints regarding the facility.

Findings:

Review of the facility's notice regarding patient rights indicated, "You have the right to file a complaint with the State Department of Health Services or the Joint Commission. The state Department of Health Service's telephone number is (877) 696-6775." The notice provided the address for the Joint Commission, but not for the California Department of Public Health (the successor to Department of Health Services for regulation of hospitals).

A telephone call placed to (877) 696-6775 on 8/16/10 at 1:08 p.m. connected to a recording indicating that the phone number was the "HHS hotline". After pressing 1 to continue in English, the recording offered a website regarding healthcare reform, then a menu of options including contact information to apply for assistance programs from the caller's state, information regarding child support, information regarding HIPAA (a privacy law), information regarding the Centers for Medicare and Medicaid Services, and the Office of the Secretary. There was no mention on the recording suggesting that the phone number had connected to the California Department of Public Health.

Review of http://www.hhs.gov/ContactUs.html indicated that the phone number belonged to the U.S. Department of Health and Human Services and was the main number for contacting that agency.

Review of the California Department of Public Health website listing of contacts regarding licensing and certification of health facilities (http://www.cdph.ca.gov/certlic/facilities/Pages/LCDistrictOffices.aspx) indicated that facilities in San Mateo county were in the jurisdiction of the Daly City District Office and that the correct phone numbers were (650) 301-9971 or (800) 554-0353.

In an interview on 8/26/10 at 2:02 p.m., Staff C stated that the facility would revise the patient rights notice to include the address and phone number of the Daly City District Office of the California Department of Public Health.

Based on interview and record review, the facility failed to maintain policies requiring that the subset of grievances it considered complaints were resolved by the grievance committee. For 3 of 3 sampled grievances (Patients 55, 56, and 57) which were addressed by the grievance committee, the facility failed to include the county legal counsel and county risk manager as members of the grievance committee as required in its own policy. The deficient practices reduced the facility leadership's involvement in issues which its patients considered problematic.

Findings:

Review of the hospital's policies indicated that it had both a "PATIENT COMPLAINTS / SATISFACTION" policy approved by the Hospital Board in 1/07 and a "PATIENT GRIEVANCE PROCEDURE" approved by the Hospital Board in 10/05. Handwritten notations at the top of both policies indicated that they were "In process of revision".

Review of the "PATIENT COMPLAINTS / SATISFACTION" policy indicated, "a. When a patient/family member files a complaint, the issue is solved at the lowest possible level b. A patient concern form is filled out by the patient or staff... c. This form is forwarded to the department/clinic manager d. The manager: - Follows up with the patient/family member in person, by phone, or in writing - Resolves complaint working with staff and multidisciplinary team when necessary - Uses other management as resource when needed - Refers patient/family member to grievance process when, in spite of best efforts to resolve the complaint, the patient/family member is not satisfied - Maintains records of patient complaints - When a patient complaint cannot be resolved at the department level, discusses it with the appropriate administrator (if needed, please see Ethics Chapter policy 1.47 Patient Grievance Procedure)". There was no language indicating that the patient complaints would be considered by the grievance committee unless the patient was dissatisfied with the manager's response.

Review of the "PATIENT GRIEVANCE PROCEDURE" indicated "A. Complaints or Concerns Whenever possible, San Mateo Medical Center (SMMC) resolves complaints or concerns at the point of service. All patients will be fully informed of the process to obtain prompt resolution of their complaints. See Complaint Management Policy. B. Grievances If a patient feels a complaint is not adequately resolved, s/he may file a grievance... DEFINITIONS: Complaint: any communication, oral or written, by a patient or a person acting on behalf of a patient questioning or complaining about the clinical or personal care or treatment received by the patient, the environmental conditions, denial of care, abuse, or violation of the rights of the patient including, discrimination on the basis of disability. Grievance: any unresolved written complaint initiated either verbally or in writing..." The "PATIENT GRIEVANCE PROCEDURE" also indicated, "The Grievance Committee consists of the County Legal counsel, County Risk Manager, Quality Manager, and the Medical Director of Quality Management."

Review of the Centers for Medicare and Medicaid Services (CMS) Interpretive Guidelines for Hospitals indicated, "If a patient care complaint cannot be resolved at the time of the complaint by staff present... then the complaint is a grievance... A written complaint is always considered a grievance... All verbal or written complaints regarding abuse, neglect, patient harm... are considered grievances..." Comparison of the hospital's policies to the interpretive guidelines indicated that the hospital's consideration of newly communicated concerns as complaints to be addressed by the manager and only unresolved complaints as grievances to be addressed by the grievance committee was inconsistent with CMS' interpretation of its regulations.

Review of a "PATIENT COMPLAINT/GRIEVANCE PROCEDURE" presented by the facility indicated that it had been labeled "DRAFT".

In an interview on 8/26/10 at 2:02 p.m., Staff C stated that the facility tries to address a patient written or verbal concern, that if it cannot be addressed immediately or satisfactorily, then it is referred as a complaint. Staff C corrected himself to state that the referral was a grievance and not a complaint. He stated that the form comes to the committee, but that the committee's composition was defined by the issue. Staff C stated that the language in the policies defining a grievance as an unresolved complaint was not consistent with the facility's practice and that the policy language would be refined.

Review of the facility's grievance files indicated that for Patient 55's grievance dated 5/10/10, for Patient 56's grievance dated 6/11/10, and for a grievance regarding Patient 57 dated 7/2/10, the listing of committee members at the bottom of the patient complaint worksheets did not include the county legal counsel or the county risk manager.

In an interview on 8/30/10 at 10:20 a.m., Staff D stated that the facility's current policy was the one marked draft and agreed that it had not yet been approved. She stated that the county legal counsel and risk manager became involved "only for legal action".

Based on interview and record review, the facility failed to include procedures in its grievance policies to ensure that Medicare beneficiaries were notified of their right to request referral of concerns regarding quality of care, coverage, or premature discharge to the Medicare Quality Improvement Organization (QIO). The facility also failed to include procedures in its grievance policies to make such referrals to the QIO when requested by the beneficiary. The deficient practices had the potential to deprive Medicare beneficiaries of their rights.

Findings:

Refer to A-119 regarding the existence of a facility policy regarding complaints, another facility policy regarding grievances (both under revision), and a third draft policy regarding both complaints and grievances. Review of the three policies indicated that none contained provisions regarding notifying Medicare beneficiaries of their rights regarding QIO review, and none contained procedures for making a referral to the QIO.

In an interview on 8/26/10 at 2:02 p.m., Staff C stated that his role on the grievance committee included looking for quality of care issues and referring those to the hospital's quality assurance committee. When the surveyor asked regarding referrals to the QIO, Staff C requested clarification regarding the regulation requiring those referrals.

Based on interview and record review, the facility failed to include a timeframe for response in its complaint policy; the scope of the policy included some grievances. The facility also failed to either respond within the timeframe in its grievance policy or inform the patient's representative that its response would be delayed in 1 of 3 sampled grievances (Patient 57). The deficient practices diminished institutional expectations that grievances would be resolved promptly.

Findings:

Refer to A-119 regarding the facility's miscategorization of a subset of grievances as complaints. Review of the facility's "PATIENT COMPLAINTS/SATISFACTION" policy indicated that there was no timeframe specified for the facility's response to complaints. Review of the "PATIENT GRIEVANCE PROCEDURE" indicated that only unresolved written complaints would be considered grievances, and that "The Grievance Committee shall issue a written decision in response to the grievance no later than 30 days from receipt of the grievance."
Review of the grievance file regarding Patient 57 indicated that the patient's mother came in person to hospital administration on 7/2/10 with a concern which was referred to other staff for later resolution. The facility mailed a letter to the grievant on 7/6/10 stating that her complaint was being reviewed and that the facility would contact her again as soon as the results were available. The file indicated that the grievance was closed and another letter was sent to the grievant on 8/9/10, 38 days after the grievance was made and 34 days after the last communication with the grievant.

In an interview on 8/30/10 at 10:20 a.m., Staff D acknowledged that the grievance regarding Patient 57 had taken more than 30 days to resolve.

Based on interview and record review, the facility failed to provide a written reply to 1 of 3 sampled grievances (Patient 55).

Findings:

Review of the grievance file for Patient 55 indicated that he had phoned the hospital's patient advocate on 5/10/10 with a concern which was referred to other staff for later resolution. The file indicated that the grievance was closed on 5/19/10 after facility staff had been unable to contact the patient, then reopened and closed on 7/28/10 when the patient was readmitted to the facility and staff were able to discuss the concern with the patient. There was no documentation of a written response to the grievance in the file.

In an interview on 8/30/10 at 10:20 a.m., Staff D stated that the facility had not sent a written response to Patient 55 because it was their judgment that a letter would have resulted in Patient 55 becoming more agitated. She stated that she did not have documentation from Patient 55's providers to substantiate that decision.

Based on interview and record review, the hospital failed to provide the patients the right to make decisions regarding care and treatment when complete the informed consent form for medications for 4 patients (Patient 9, 19, 25 and 26). Pt. 9 did not have a copy of the consent form signed by the conservator. Patient 25 's consent form did not list the names of the medications to be given. Patient 26's consent form was not witnessed by licensed staff and the drugs to be given were not listed. Additionally, the facility failed to follow through with Patient 19 after he verbally consented but declined to sign the medication consent form. These failures did not ensure the legal completion of a consent and the patients' ongoing involvement in the care planning and treatment.

Findings:

1. Patient 19 was admitted to the hospital on 7/16/10 for schizophrenia and alcohol abuse. He was alert and oriented and able to give consent for treatment.

Record review on 8/24/10 showed the "Verification of Consent to Medication" consent for Resperdal, Benadryl, and Ativan was dated and timed on 7/16/10 at 1434. The form showed the box was checked for the "Patient concurs, but chooses NOT to sign". The physician signed the form but failed to verify with a witness' signature.

In an interview on 8/24/10 at 3:45 PM, the Deputy Director for Acute Psychiatric Services stated that the policy after a patient verbally consents to a medication but declines to sign the consent form "is to attempt to obtain a signature each time the medication is offered."

Review of the patient's medication history on 8/24/10 with the Deputy Director showed the patient was administered Risperdal on 7/17/10 at 21:24, 7/18/10 at 08:26, 7/18/10 at 21:39, and on 7/19/10 at 08:07. The patient did not require Bendadryl or Ativan. The Deputy Director stated there was no documentation of the staff's attempts to obtain written consent from the patient when the Risperdal was given.

The hospitals's policy and procedure titled, "Consent for Medication", dated 5/05, under Patients who retain authority to refuse treatment documented the following: under item #2, "If the patient consents verbally to the psychiatric medications or otherwise indicates willingness to take them, but when presented with the consent form does not sign, the physician must document the patient's consent on the consent form by checking the box, "Patient concurs, but chooses not to sign," and signing the form. The patient's consent and willingness to take the medications must also be verified by nursing staff who must sign the form as a witness. Treatment can then proceed. In such cases the patient will be asked regularly to sign the form." And under item #3, "If the patient does not give consent, the physician is responsible for making and documenting repeated attempts to obtain the patient's consent for medication, and for ongoing review of the medication treatment plan.


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2. Patient 9 was admitted to the facility on 7/29/10 with diagnosis of psychosis. Review of clinical record showed a court order dated 7/13/10 granting temporary conservatorship to LCSW 1 (Licensed Social Worker). On 8/10/10, that temporary conservatorship was extended and continued in effect until termination of the trial on the issue of grave disabillity.

Review of Doctor's Orders dated 7/29/10 showed the following orders: "Risperdal MT 4mg po (by mouth) at night. If refused, give Haldol 8 mg. IM (intramuscular). If PRN (when necessary) Ativan is refused, give same dose IM. If PRN Zyprexa is refused, give same dose IM. Depakote 500 mg. po BID (twice a day)."

Review of "Verification of Consent to Medication" Form showed a telephone consent was obtained on 7/28/10 but the copy of the consent was not signed by the conservator.

During an interview on 8/23/10 at 2:30 PM with the Director of Psychiatric Services, she stated that a telephone consent was obtained from the conservator on call because it was after regular office hours but a copy of the consent form should have been faxed to the conservator for his signature.

3. Patient 25 was admitted to the facility on 8/24/10 with diagnosis of depression with suicidal ideation.
Review of physician orders dated 8/24/10 showed an order for "Ativan 2 mgs. (milligrams) po times 1 now." The Medication Record showed that Ativan 2 mgs. was given bby mouth at 6:25 PM. Review of "Verification of Consent to Medication" Form indicated that the patient signed the consent but the form did not identify the name of the medication to be given.

24. Patient 26 was admitted to the facility on 8/24/10 with diagnosis of bipolar affective disorder with psychosis. Pt. was conserved. Review of the Medication Record showed that the following medications were administered on 8/24/10: Ativan 2 mgs. one tablet was given on at 10:00 PM. Depakote1500 mgs. one tablet and Ambien 10 mgs. were given at 11:00 PM. There were two "Verification of Consent to Medication" Forms found in the clinical record. The first consent form was dated 8/24/10 at 9:23 PM indicated that a telephone consent from the conservator was obtained but was not witnessed and the psychoactive meds to be given was not listed. The second consent form was dated 8/24/10 at 10:30 PM listed the following psychoactive medicatons including Zyprexa, Cogentin, Depakote, Ativan and Ambien but was signed by the patient but was not signed by the conservator.

During an interview with the Director of Psychiatric Services on 8/25/10 at 3:00 PM, she acknowledged that the licensed nurse should have faxed that copy of the "Verification of Consent to Medication" Form to the conservator for signing after a telephone consent has been obtained.

Review of facility's policy and procedure entitled "Consent for Medication" dated May, 2005 indicated that for patients on conservatorship who do not retain authority to refuse treatment, the explicit consent of the conservator or designee must be obtained before psychiatric medicaqtions can be administered as follows:
Nursing staff in PES ( Psychiatric Emergency Services) will notify the conservator to obtain consent when psychiatric medications have been ordered. When consent is needed urgently, the physician may obtain it verbally from the conservator over the telephone with a witness (physician or nurse) verifying the verbal consent. The physician and witness will sign the consent form and place it in the chart.

Whenever possible, the conservator's consent will be obtained by fax. The physician will complete and sign the consent form. The form will then be faxed to the conservator who will sign it and fax back a signed copy, which will in turn be placed in the chart along with the original form."

Based on interview and record review, the facility failed to document that its medical staff had been advised of hospital policies regarding restraint and seclusion. The deficient practice had the potential to lead to inappropriate use of restraint or seclusion.

Findings:

Review of the hospital's policy "PHYSICAL RESTRAINT AND/OR SECLUSION FOR ACUTE SERVICES" indicated, "All staff members that have direct patient contact will receive annual training that includes the hospital's philosophy on restraint reduction and techniques in the proper and safe use of seclusion and restraint application."

Review of the hospital's training records regarding restraint and seclusion indicated that the participants included the nursing staff but not the medical staff.

In an interview on 8/30/10 at 3:57 p.m., Staff B stated that the only recent documentation of medical staff restraint training would be in the psychiatry department meeting minutes.

At the conclusion of the survey, the facility had not presented documentation of restraint training for the medical staff.

Based on interview and record review, the facility failed to accurately report two deaths (Patients 33 and 34) which occurred within 24 hours after discontinuing restraints. Instead, the facility reported the deaths as occurring within seven days of restraints. Based on record review, the facility also failed to report Patient 33's death by the end of the next business day. The deficient practices had the potential to diminish regulatory oversight of the facility's practices.

Findings:

1. Review of Patient 33's medical record on 8/27/10 at 2:46 PM indicated that physical restraints were discontinued on 6/3/10 at 8:00 a.m. and that the patient died on 6/3/10 at 4:40 p.m. Review of a 2010 calendar indicated that 6/3/10 was a Thursday. The "HOSPITAL RESTRAINT/SECLUSION DEATH REPORT WORKSHEET" indicated that the Centers for Medicare & Medicaid Services regional office was notified on 6/7/10 (the following Monday) instead of the next business day. The checkboxes on the worksheet indicated that Patient 33 died "Within 1 Week Where Restraint, Seclusion or Both Contributed to the Patient's Death" instead of "Within 24 Hours of Removal of Restraint, Seclusion, or Both".

2. Review of Patient 34's medical record on 8/27/10 indicated that physical restraints were discontinued on 5/18/10 at 6:20 a.m. and that the patient died on 5/18/10 at 8:30 a.m. The "HOSPITAL RESTRAINT/SECLUSION DEATH REPORT WORKSHEET" indicated that Patient 34 died "Within 1 Week Where Restraint, Seclusion or Both Contributed to the Patient's Death" instead of "Within 24 Hours of Removal of Restraint, Seclusion, or Both".

In an interview on 8/27/10 at 1:52 p.m., Staff E (RN Clinical Manager) stated that the restraints had not contributed to the deaths and that the wrong boxes had been checked on the worksheets. In an interview on 8/27/10 at 3:23 p.m., Staff E again stated that the wrong boxes had been checked on the worksheets and acknowledged that the deaths had occurred within 24 hours of restraints.

Based on interview, obervation, and document review, the hospital failed to maintain an effective quality assessment and performance improvement program when Pharmacy and Dietary Services were not involved in the identification of systemic problems. The hospital failed to provide its facility leadership on quality assessment and performance improvement projects in order to evaluate and make necessary actions or adjustments as needed.

Findings:

1. The hospital failed to identify and involve other departments and services to identify systemic problems in areas of: pharmacy (Refer to A 500).

2. The hospital failed to have the nutrition department's quality assessment and performance improvement (QAPI) activities reported to the Quality Improvement Committee (QIC) for subsequent consideration and approval by the governing body. The deficient practice reduced the integration of the nutrition department into the overall QAPI program (Refer to A 0277, A 267, and A 288).

3. The hospital failed to conduct an accurate annual enumeration of its performance improvement (PI) projects. The deficient practice eliminated an opportunity for the facility leadership to obtain an overview of its quality assessment and performance improvement (QAPI) program and to make adjustments as warranted (Refer to A 0317).

The cumulative effects of these systemic problems resulted in the hospital's inability to provide an effective quality assessment and performance program in accordance with the statutorily-mandated Conditions of Participation for quality assessment and performance imorovement.

Based on interview and document review the hospital failed to measure, analyze, and track quality data in order to improve hospital performance in the areas of Pharmacy, Dietary, Radiology, and Rehabilitation services: compromised medications were not stored at proper temperature; inadequate monitoring of the Pyxis machines to make sure that the right medications were administered to the right patients as ordered by the physician; Magnetic Resonance Imaging services was not developed and integrated to the quality assessment and improvement program; lack of orientation and training in documentation of Rehabilitation evaluations to make sure that the patients received accurate rehabilitation services.

These failures are potential risks that would affect the patients' health and safety.

Findings:

1. The hospital failed to improve hospital performance by not identifying out of range medication refrigerator temperatures (below or above 2-8 C) in which compromised or ineffective medications were being administered to patients.

2. The hospital failed to identify, measure and analyze quality data for unaccounted medications in the Pyxis machines when the hospital failed to account for missing and extra medications that could indicate that a patient received too much, missed a dose, or were given the wrong medication when a one month audit revealed 202 unaccounted for medications.

3. The hospital failed to develop and implement a quality program to improve Magnetic Resonance Imaging (MRI) images.

4. The hospital failed to have a program for surveillance of effective orientation and work by substituting outside staff e..g. an occupational therapist who had conducted an evaluation of an ICU patient (Patient *) and who had inaccurate documentation and had utilized a questionable, incomplete form prior to the evaluation.

5. The hospital failed to develop and maintain a surveillance and reporting mechanism for four contracted services pertinent to dietetic services.

The interviewed Quality Assurance (QA) Manager on 08/26/10 at 11:10 am stated he was not aware of the " all facilities letter " dated 12/10/09 entitled Medication Safety: Storage of Medications. He also stated that he was unaware of any issues throughout the hospital in regards to monitoring, documenting, and follow up when temperatures were out of range for refrigerated medications.

On 08/24/10 at 2:50 pm in the acute psychiatric unit it was observed the digital thermometer which would record minimum (min) and maximum (max) temperatures in degrees Celsius (C). The thermometer had measured refrigerator temperatures of -7 C and 21 C. The observed medications stored at these temperatures were several vials of Insulin and a vial of Tuberculin Skin Test (PPD). An estimated average of 144 PPD patients and 54 insulin patients could have received subzero stored medications. The hospital had not properly monitored medication refrigerator temperatures and that freezing temperatures could have caused false negative PPD results and administration of adulterated insulin.

On 08/24/10 at 1:30 pm it was observed on the digital thermometer pharmacy intravenous (IV) room medication refrigerator a min/max temperature of 8 C to 10 C. It was also observed that there were hundreds of doses of medications that were stored between min/max temperatures of 8 C to 10 C. The IV room medication refrigerator temperature log, for the months of May, June, July, and August; indicated there was no documentation for the min/max temperatures. The temperature log was blank under the sections "Temp C Min " (temperature celsius minimum) and " Temp C Max" (temperature celsius maximum) .

The IV room medication refrigerator temperature log for the months of May, June, July, and August; indicated temperatures that were out of range (2-8 C) or were not documented on the following dates: 05/03/10, 05/05/10, 06/18/10, 07/02/10, 07/20/10, 07/23/10, 07/30/10, 08/01/10, 08/11/10, 08/12/10, 08/17/10, 08/18/10, 08/20/10, and 08/21/10. These corresponding dates did not have any documentation indicating any action taken for out of range temperatures.

A review of the Outpatient Pharmacy refrigerator medication refrigerator temperature log, for the months of May, June, and July; indicated temperatures that were out of range (2-8 C) or were not documented on the following dates: 05/30/10, 06/08/10, 06/12/10, 06/13/10, 06/14/10, 06/16/10, 06/25/10, 06/30/10, and 06/31/10. These corresponding dates did not have any documentation indicating any action taken for out of range temperatures.

A review of the Acute Psych medication refrigerator temperature log, for the month of August; indicated temperatures that were out of range (2-8 C) or were not documented on the following dates: 08/04/10, 08/09/10, and 08/16/10. These corresponding dates did not have any documentation indicating any action taken for out of range temperatures.

A review of the Psychiatric Emergency Services medication refrigerator temperature log, for the month of May; indicated temperatures that were out of range (2-8 C) or were not documented on the following dates: 05/24/10 and 05/26/10. These corresponding dates did not have any documentation indicating any action taken for out of range temperatures.

A review of the Emergency Department medication refrigerator temperature log, for the month of July and August; indicated temperatures that were out of range (2-8 C) or were not documented on the following dates: 07/20/10, 07/21/10, 07/29/10, 08/05/10, and 08/09/10. These corresponding dates did not have documentation indicating any action taken for out of range temperatures.

According to the hospital policy entitled Storage of Medications indicates "Medications requiring refrigerated storage will be stored at a range of between 2 and 8 degrees Celsius ...Temperature logs for refrigerators and vaccines that contain vaccines are recorded at the beginning and at the end of the day."

A review of the IV room medication refrigerator (contained vaccines) temperature logs, for the months of May, June, July, and August. There was no documented evidence to indicate that refrigerator temperatures were checked two times a day as required per hospital policy.

The Outpatient Pharmacy medication refrigerator temperature logs for vaccines for the months of January, February, March, April, May, June, July, and August had no indication that the refrigerator temperatures were checked twice daily.

During an interview on 08/26/10 at 11:10 am, the Quality Assurance (QA) Manager stated he was not aware of the unaccounted medications (missing and extra doses) through out the hospital. He also stated he never received any data regarding unaccounted medications. He said he was not aware that the unaccounted medications could be medication errors for: the wrong medication given, extra medication given, or not administering the medication.

During an interview on 08/25/10 at 10:47 am the DOP stated there were unaccounted medications in Pyxis machines (automated dispensing cabinets). He also stated he was not aware of the actual causes of the unaccounted medications (missing and extra doses) because it had not been investigated.

A review of a monthly discrepancy report for non-narcotic medications in the Pyxis machines indicated a report of the quantity of unaccounted medications (missing and extra doses) for a one month audit from 07/26/10 to 08/25/10. The total unaccounted number of doses was 202 missing or extra doses of medications.

6. In an interview on 08/26/10 at 12:20 pm, the Deputy Director stated that there was no quality program to improve the Magnetic Resonance Imaging (MRI) images. She also stated there has not been any quality program in the past to improve the clarity of the MRI images.

During an interview on 08/24/10 at 10:00 am the Radiologist MRI subspecialist stated it was not uncommon to have unclear MRI images. The unclear MRI images occurred daily. He also stated that the cause for the unclear images could be related to multiple issues and in addition these issues could be solved by multiple solutions. The contract service representative stated the company had not received complaints of any MRI image issues related to unclear images. She also stated that if there were unclear image issues the contracted service would investigate the issues to improve clarity to the MRI images. She said that the contracted service relied on communication from the hospital in order to investigate, fine tune, and improve the clarity of the MRI images.


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7. On 8/24/10 between 3:30 p.m. and 4 p.m. during medical record review of Patient 37's care in the ICU there were two concerns. One was the inaccurate documentation of using "blue dye" to test for aspiration on 8/23/10 when in fact per interview of Dietitian 1 on 8/24/10 revealed that she thought blue foods had been used, not blue dye which has the potential for adverse reactions in patients with severe infections. Also, there had been the implementation of a "Dysphagia Waiver" which was not only incomplete and unclear as to approval, but unsigned by Patient 37 or his surrogate decision-maker prior to testing for aspiration.

8. On 9/1/10 by 4:15 p.m. Rehabilitation Therapist 1 stated that the orientation of the outside occupational therapist had been minimal and it had been considered sufficient based upon her prior work experience. However, Rehabilitation Therapist 1 stated that she had not been aware of this questionable documentation of blue dye and current form usage as well as the need for oversight as part of the surveillance for quality care.

9. On 8/24/10 between 11:15 a.m. and 11:50 a.m. review of four contracted services pertinent to the dietetic services (i.e. for tube feeding administration which had necessitated education for nursing staff, a pest control service and a dishmachine service within the kitchen and kitchen areas and for a coffee vending company responsible for maintenance and replenishment of a machine near admissions) revealed that these services had not been in the hospital-wide quality assurance program. Also, review revealed that there was no documentation of surveillance, reports and remediation. The latter was of concern as on 8/24/10 at 11:50 a.m. the Dietetic Service Manager stated that neither he nor any member of the Safety and Infection Control Committees had integrated these services into the quality assurance program. Also, at 11:50 a.m. the Director of Materials Management stated that there had not been administrative authority pertinent to the surveillance and quality assurance of these contracted services.

Based on interview and record review, the facility failed to have the nutrition department's quality assessment and performance improvement (QAPI) activities reported to the Quality Improvement Committee (QIC) for subsequent consideration and approval by the governing body. The deficient practice reduced the integration of the nutrition department into the overall QAPI program.

Findings:

Review of the hospital's Quality Improvement Plan indicated, "The following services will develop annual quality improvement plans: ...Food and Nutrition Services... These ancillary departments will provide QIC with an annual QA/QI Plan for approval. These will be forwarded to MEC and the Hospital Board."

Review of a binder of QIC minutes indicated that a calendar specifying the reporting cycles of each department was at the bottom of each meeting's agenda. Review of the reporting calendar at the bottom of the 7/27/10 QIC agenda indicated that the calendar was for the entire year, but did not include Food and Nutrition Services.

In an interview on 9/1/10 at 2:15 p.m., Staff B stated that the nutrition department had not reported to QIC within the past year.

Based on interview and record review, the facility failed to implement 1 of 12 recommendations from its root cause analysis (RCA) regarding the rape of a patient by another patient. The deficient practice reduced the efficacy of the RCA process.

Findings:

Review of the RCA regarding the rape of one patient by another patient on 3/30/10 indicated that there were 12 action items. Action item 12 regarding room assignment guidelines did not have an adjacent entry regarding its implementation status.

In an interview on 8/31/10 at 3:39 p.m., Staff E stated that the facility had been concentrating on lower hanging fruit. In an interview on 9/1/10 at 10:43 a.m., Staff E stated that action item 12 from the RCA had not yet been implemented.

Based on interview and record review, the facility failed to define the role death reviews played in its quality assessment and performance improvement (QAPI) program and failed to maintain its efforts at conducting death reviews. The deficient practices eliminated expectations regarding how quickly death reviews would be conducted and allowed the facility's self-scrutiny regarding patient deaths to lapse.

Findings:

In an interview on 8/27/10 at 1:52 p.m., Staff E stated that the patient records sampled by the survey team regarding deaths following restraint had not generated any internal action since the use of restraints had not contributed to the deaths. In an interview on 8/30/10 at 1:24 p.m., Staff E stated that all deaths at the facility were reviewed, but that there was a backlog of several months due to staff reductions. Staff E stated that he would look for the policy regarding death reviews but went on to explain what the facility's practice was. In an interview on 8/30/10 at 2:25 p.m., Staff E stated that there was no policy on death reviews but that the facility tried to do them within a month.

Review of the facility's listing of patient deaths awaiting review indicated printed discharge dates beginning 4/23/10. Eight entries for the emergency department did not have discharge dates; two of those had handwritten entries indicating discharge dates of 11/4/08 and 11/6/08 plus handwritten notes in the margin indicating that the deaths awaiting review from 2008 had been expected deaths after the patient had been found down in the field after an extended period before being transported to the emergency room.

Review of the facility's QAPI plan, medical staff bylaws, and medical staff rules and regulations revealed no provisions regarding death reviews.

Based on interview and record review, the facility failed to conduct an accurate annual enumeration of its performance improvement (PI) projects. The deficient practice eliminated an opportunity for the facility leadership to obtain an overview of its quality assessment and performance improvement (QAPI) program and to make adjustments as warranted.

Findings:

In an interview regarding the facility's QAPI program on 8/31/10 from 1:29 p.m. to 3:45 p.m., Staff E (Quality Manager) stated that the facility had eight PI projects.

Review of a listing entitled "SMMC Performance Improvement Projects 2010" indicated that the listing included six categories of projects, that the "LEAN" project (number of projects as part of the grant) had four subordinate projects, that the clinic redesign category had two subordinate projects, and that the "ICU Measures" category had four subordinate projects, for a total of 13 projects on the listing provided by the facility. Review of the listing indicated that it did not include any projects in the radiology, psychiatry, or food and nutrition departments.

Review of the psychiatry department's "Annual Quality Improvement Plan 2010" indicated that the department was conducting assault and violence reviews, admission safety plan reviews, patient observation reviews, nursing supervisor rounds, a restraints and seclusion study, a case review series, patient satisfaction surveys, and monitoring seven core measures.

Review of the radiology department's report to the quality improvement committee revealed that the department was conducting studies regarding correlation of interpretations between radiologists and emergency department providers, documentation of breast ultrasound critical value notification, discrepancies found in teleradiologist interpretations, and patient satisfaction surveys. Review of the
radiology department's 2010-2011 quality improvement plan indicated that the department was also conducting mammography outcome audits, radiologist peer review, and patient complaint reviews.

Based on interview and record review, when conducting medical staff reappointments the facility failed to consistently verify credentials, grant privileges only after obtaining evidence of current competence, and consider appropriate quality assurance data. The deficient practices reduced the facility's ability to determine the competence of its medical staff.

Findings:

Review of the facility's medical staff bylaws "ARTICLE 6 - APPOINTMENT AND REAPPOINTMENT" indicated that the application form would request peer references (plural) and that, "The credentials committee, and the administrator when requested to assist by the credentials committee, shall expeditiously seek to collect or verify the references, licensure status, and other evidence submitted in support of the application."

1. For 5 of 8 sampled credentials files (Practitioners 1, 2, 4, 5, and 8), the facility did not check both references at the most recent reappointment.

Review of the credentials files for Practitioners 1, 2, 5, and 8 indicated that each practitioner had listed two references on the reappointment application. However, in each file the portion addressing the most recent reappointment contained no peer references other than a single sheet with both a competence questionnaire and a recommended disposition which had been completed by either the department chair or the credentials committee chair, then reviewed and approved by the medical executive committee and governing body.

Review of Practitioner 4's credentials file indicated that the portion addressing the most recent reappointment contained no peer references other than the department chair's competence questionnaire and recommended disposition. An evaluation from the physician's teleradiology group was present but had been completed by a non-physician.

In an interview on 8/25/10 at 2:04 p.m., Staff B stated that Practitioner 2's references had not been checked at reappointment. In an interview on 8/25/10 at 2:22 p.m., Staff B stated that Practitioner 5's references had been checked when he first applied in 2006.

2. For 2 of 8 sampled credentials files (Practitioners 1 and 4), the facility did not document that the requirements for courtesy status were met at reappointment.

Review of the facility's medical staff bylaws indicated, "The Courtesy Staff shall consist of members who: ...are members in good standing of an Active Medical Staff of another JCAHO accredited and California licensed hospital, although exceptions to this requirement may be made by the Medical Executive Committee for good cause subject to approval by the Board of Directors..."

Review of Practitioner 1's credentials file indicated that he was reappointed to courtesy status on the facility's medical staff for a two-year period beginning 11/1/08. The most recent verification of medical staff membership at another hospital was dated 2005.

Review of Practitioner 4's credentials file indicated that she was reappointed to courtesy status on the facility's medical staff for a two-year period beginning 9/1/09. The most recent verification of medical staff membership at another hospital was dated 12/19/05, and that hospital was located in Pennsylvania rather than California. The department chair's recommended disposition of the reappointment application had the notation "Exception; not Active Staff elsewhere", but no documentation was present specifying the good cause for granting such an exception.

In an interview on 8/25/10 at 1:58 p.m., Staff B stated that the facility only checks hospital affiliations at initial appointment.

In an interview and record review on 8/25/10 at 2:40 p.m., Staff B stated that the facility would in the future move all the teleradiologists to the telemedicine category of medical staff membership. She acknowledged that Practitioner 4 only had privileges at the hospital in Pennsylvania but stated that the facility had evoked reciprocity since the teleradiology group was accredited by the Joint Commission. Review of the medical staff bylaws indicated that the telemedicine category of medical staff membership would not have required Practitioner 4 to maintain medical staff membership at another hospital if she was a member of an accredited organization. Staff B did not explain why Practitioner 4 had been appointed to courtesy status rather than telemedicine status.

3. For 2 of 8 sampled credentials files (Practitioners 4 and 5), the facility granted privileges for which there was no documentation that the practitioner had recent experience and for which its own privileging criteria were not met.

Review of Practitioner 4's credentials file indicated that the facility's privileging criteria for radiology stated, "Only physicians who are Board Certified in Radiology and possess a current California State Operator's Certificate issued by the Department of Health Services are eligible for inclusion in the Radiology service." There was no documentation in the credentials file that Practitioner 4 possessed a California State Operator's Certificate. Review of Practitioner 4's privileges indicated that she had not responded to the facility's request to list the number of procedures performed in the last two years for those privileges requested, but the facility had nevertheless approved her requests. No other information regarding procedure-specific experience was present in the portion of the credentials file supporting the most recent reappointment. An evaluation by a non-physician from Practitioner 4's teleradiology group indicated that she felt Practitioner 4 exceeded professional standards, that Practitioner 4 was in good standing at 284 institutions, that no pattern of deficiencies, disciplinary actions, or malpractice claims had been identified, and that Practitioner 4 had performed 90 radiologic studies for the facility in one year. No information regarding which of the privileges requested had been included in the 90 studies or the quality of the service provided was present in the credentials file.

Review of Practitioner 5's credentials file indicated that he was a dentist who had completed a one-year oral and maxillofacial surgery fellowship but had not been board certified in oral surgery. Review of Practitioner 5's privileges indicated that the facility's privileging criteria required a dental license for general dentistry privileges and board certification as an oral surgeon for oral surgery privileges. Practitioner 5's privileges indicated that he had requested and been granted oral surgery privileges even though he was not board certified. Review of Practitioner 5's general dentistry privileges indicated that Practitioner 5 requested and was granted privileges in three procedures (topical fluoride treatment, sealants, stainless steel crown) for which he had not any recent experience and an additional 4 procedures (amalgam restoration, composite restoration, crown/bridge recementation, pulpotomies) in which Practitioner 5 indicated he had performed fewer than 5 cases in the past two years but failed to specify whether he had in fact performed any cases. The department chair's recommendation regarding Practitioner 5's reappointment indicated, "Outside Experience Verified&On File", however no documentation regarding Practitioner 5's outside experience was present in the portion of the credentials file addressing the most recent reappointment. A quality assessment profile regarding Practitioner 5 did not document how many of which procedures Practitioner 5 had recently performed at the facility or whether the outcomes of those procedures had been satisfactory.

In an interview on 8/25/10 at 2:22 p.m., Staff B stated that the facility had verified that Practitioner 5 had completed his fellowship in oral surgery in 1989 but that he was not board certified. In an interview on 8/25/10 at 2:40 p.m., Staff B stated that the teleradiologists did not complete the column on the privileges form indicating how many of each procedure they had performed recently.

4. For 2 of 8 sampled credentials files (Practitioners 4 and 5), the facility failed to maintain basic quality assessment data in the practitioner's files.

Refer to item 3 above regarding the lack of documentation of procedure-specific experience and the contents of a non-physician evaluation from the teleradiology group in Practitioner 4's credential file. Review of Practitioner 4's credentials file further revealed that the non-physician's evaluation stated the radiology group maintained a quality assurance program in which any concerns would be evaluated, and that no problems regarding Practitioner 4 had been identified. No specific information was present, however, to indicate that the program included assessment of Practitioner 4's quality beyond absence of objections. Specifically, there was no information regarding practitioner-specific outcomes of interpretation discrepancy studies, no information whether or not any of Practitioner 4's cases had been subject to peer review, and no information what the outcomes of the peer reviews had been which lead to the conclusion that there were no problems regarding Practitioner 4.

Review of the American College of Radiology Position Statement on Quality Control and Improvement, Safety, Infection Control, and Patient Education (accessed at http://www.acr.org/SecondaryMainMenuCategories/quality_safety/guidelines.aspx) indicated, "Examinations should be systematically reviewed and evaluated as part of the overall quality improvement program at the facility. Monitoring should include evaluation of the accuracy of interpretation as well as the appropriateness of the examination."

In an interview on 8/25/10 at 2:40 p.m., Staff B stated that the facility did not have its own quality assessment data regarding the teleradiologists. She stated that the facility performed overreads, but that they could not be sorted into results for specific teleradiologists.

Review of additional documentation presented by the facility subsequent to the review of Practitioner 4's credentials file revealed an updated non-physician evaluation of Practitioner 4 from her medical group, this time indicating that Practitioner 4's "Medical Quality Score" regarding accuracy and quality was "found to be acceptable" and once again indicating that no specific problems had otherwise been identified. No specific information regarding the quantity and quality of Practitioner 4's services was in the medical group's evaluation. An attached chart presented the facility's discrepancy rates over time for all teleradiologists in the group, but contained no information specifically regarding Practitioner 4.

Review of the facility's quality profile for Practitioner 5 indicated that Practitioner 5 had conducted 683 outpatient visits, had a "Clinical Pertinence" score of 92% for "documentation review, abbrev., etc.", and that he used the facility's dictation system. The profile included no information regarding how many procedures Practitioner 5 had performed and whether or not the outcomes had been satisfactory. Indicators for mortality rate, complications, core measures, procedure reviews, informed consent, and compliance with patient safety practices all were marked "NA".

In an interview on 8/25/10 at 2:13 p.m., Staff B stated, "We need to make the assumption that this is what was available." In an interview on 8/25/10 at 2:22 p.m., Staff B stated that numbers of procedures should be on Practitioner 5's quality profile.

Based on interview and record review, the facility failed to follow its own privileging criteria for a newly appointed member of the medical staff in 1 of 8 sampled credential files (Practitioner 3), failed to document recent experience in the privileges granted to a newly appointed member of the medical staff in 1 of 8 sampled credentials files (Practitioner 6), and failed to maintain relevant credentials in the credentials file for 8 of 8 sampled credentials files (Practitioners 1 through 8). The deficient practices circumvented consensus opinions articulated in privileging criteria regarding who would be allowed to practice at the facility and reduced the facility's ability to determine the competence of newly appointed members of the medical staff.

Findings:

1. Review of Practitioner 3's credentials file indicated that she was granted temporary privileges on 7/5/09 and appointed to provisional status on the facility's medical staff on 11/5/09. Review of Practitioner 3's privilege request indicated that the facility's "MINIMUM THRESHOLD CRITERIA" for privileges in internal medicine included, "The successful applicant must be either Board Certified... or meet the criteria for board eligibility... e.g. successful completion of an approved residency... at the time of their appointment..." Review of the facility's credentialing report indicated that Practitioner 3 was on maternity leave from her residency program 7/1/09 to 6/24/10.

In an interview on 8/24/10 at 3:42 p.m., Staff B stated that Practitioner 3 had not completed residency and so did not meet the requirements in the privileging criteria.

2. Review of Practitioner 6's credentials file indicated that he was granted temporary privileges on 4/28/10 and appointed to provisional status on the facility's medical staff on 7/1/10. Practitioner 6's privilege request indicated that the facility's psychiatry privileging criteria required either completion of a psychiatry residency or current good standing in a psychiatry residency with specified minimum experience. For physicians who had completed their residency training, no experience requirement was included in the privileging criteria. The credentials file indicated that Practitioner 6 had been board certified in psychiatry and forensic psychiatry in 2003. There was no documentation in the credentials file regarding Practitioner 6's recent experience in the privileges he requested and was granted.

In an interview on 8/24/10 at 4:13 p.m., Staff B agreed that Practitioner 6's credentials file did not contain documentation of his recent experience in the privileges granted.

3. Review of the credentials file for Practitioner 3 revealed that two peer references were in the credentials file and a third peer reference was in a separate manila folder. Review of the credentials file for Practitioner 6 revealed that one peer reference was in the credentials file and two additional peer references were in a separate manila folder. Review of the credentials files for Practitioners 1, 2, 4, 5, 7, and 8 revealed that the most recent query to the National Practitioner Data Bank (NPDB) was not in the credentials file but in a separate manila folder.

In an interview on 8/24/10 at 3:14 p.m., Staff B stated the manila folder for each practitioner was kept separate from the credentials file so that the information was protected from legal discovery. She stated that the NPDB inquiries and peer references for permanent privileges were kept in the manila folders but for temporary privileges those documents were kept in the credentials files.

Based on interview and record review, the facility failed to enforce a provision in its medical staff bylaws requiring a biannual delineation of the categories and modes of practice of mid-level practitioners. The deficient practice reduced the governing body's leadership regarding the role of mid-level practitioners at the facility.

Findings:

Review of the facility's medical staff bylaws indicated, "Affiliates to the Medical Staff (AMS's) will be individuals holding a license, certificate, or such other legal credentials, if any, as required by California law and combined approval of the Hospital, which authorize the AMS's to provide certain professional or clinical service within the limit and scope of awarded delineated privileges... The Board of Directors shall, as often as necessary but at least every two (2) years, identify the categories of AMS's, based upon occupation or profession, and shall identify the mode of practice in the Hospital setting (i.e., independent or dependent) of such category... The delineation of categories of AMS's... shall be set forth in the Medical Staff Rules and Regulations."

Review of the table of contents of the Medical Staff Rules and Regulations as well as the section of the rules and regulations regarding the Interdisciplinary Practice Committee both indicated there was no delineation of categories of AMS's.

In an interview on 8/24/10 at 2:23 p.m., Staff B stated that there was no delineation of AMS categories.

Based on interview and record review, the facility failed to require an update to the medical history and physical examination (H&P) after registration in circumstances where outpatient invasive procedures were being performed and an H&P had been completed less than 24 hours prior to the procedure. The deficient practice allowed an exception to H&P updates not permitted in federal hospital regulations.

Findings:

Review of the facility's medical staff bylaws indicated that the medical staff rules and regulations had "the force and effect of Medical Staff Bylaws." Review of the facility's medical staff rules and regulations section on "Operative or Invasive Procedures" indicated, "If an H&P has been performed more than 24 hours but less than 30 days before before the operative or invasive procedure, this H&P may be used as the current examination provided an updated H&P note is present in the progress notes section of the medical record. The updated note written by a physician or surgeon or other individual qualified to perform an H&P shall state that the findings on the existing H&P are still current or shall specify any changes since the last H&P." There were no other provisions requiring an H&P update after registration when the full H&P had been performed within 24 hours prior to registration.

In an interview on 8/30/10 at 2:44 p.m., Staff H stated that the facility's practice was for patients presenting for outpatient surgery to get an H&P update, and that they would change the policy to reflect the practice.

Based on observation, interview, and record review, the facility failed to incorporate accepted professional standards requiring listening for breath sounds and obtaining a gastric aspirate during feeding tube placement into its nursing policy. The deficient practice resulted in a delay detecting that a feeding tube had been inserted into the lung for one sampled patient (Patient 33). In addition, the facililty failed to assess Patient 6 and 21's admission assessments regarding their nutritional needs. This failure had the potential to delay further evaluations and consults to meet the patients' immediate care needs.

Findings:

1. Review of Patient 33's medical record indicated an order for enteral nutrition dated 6/2/10 at 12:30 p.m. which indicated that the route of feeding was "Nasoduodenal (see Enteral Nutrition policy for duodenal protocol)". A nursing progress note dated 6/2/10 at 5:00 p.m. stated, "Unable to remove wire from FT [feeding tube]. New FT inserted [after] 2 attempts. CXR [chest X-ray] ordered to [check] placement." No notation was present to indicate that the nurse who replaced the feeding tube had used another method to check the placement of the tube in addition to the chest X-ray. The radiologist's interpretation of a portable chest X-ray taken 6/2/10 at 6:56 p.m. indicated, "Feeding tube appears to be ending in the left lung base and is associated with complete left lung collapse. This was reported to the patient's nurse... on 6/3/10 at 8:20 a.m. She reported that the feeding tube had been removed last night." Review of the physician orders for Patient 33 revealed a telephone order dated 6/3/10 at "0000" (nine hours after the tube was replaced) which stated, "Remove NGT [nasogastric tube] and reinsert in AM".

In an observation and interview on 8/31/10 at 4:09 p.m., Staff J read the nursing progress note in Patient 33's medical record dated 6/2/10 at 5:00 p.m. and stated that she could not recall the particulars nearly three months later but that the progress note was in her handwriting. She stated that she did not trust auscultation to determine tube placement with a small diameter tube and that was the reason why she obtained a chest X-ray. Staff J did not state that she had also used another method in addition to the chest X-ray to determine the tube placement.

Review of the nursing textbook "Clinical nursing skills: basic to advanced skills" (7th edition, Pearson Prentice Hall, 2008), section titled "Inserting a Large-Bore Nasogastric (NG) Tube" confirmed Staff J's assertion that "Auscultation of air insufflation as a method for determining tube placement can be dangerously misleading and has no scientific basis." However, review of the section titled "Inserting a Small-Bore Feeding Tube", indicated: "15. Listen at tube end for air exchange at carina level; if no sound is heard, advance tube. 16. Advance tube to premeasured position; stop and listen at tube tip for breath sound. Rationale: If you can hear air exchange, tube may be in respiratory tract. 17. Tape tube securely in place (loosely if advancement intended). 18. Flush tube side port with 30-50 mL of air, then attempt to slowly aspirate gastric contents; reposition client to left side and repeat aspiration if necessary to obtain a specimen. 19. Test aspirated secretion for color, character, and pH. Rationale: As tube advances into small intestine, pH becomes higher (>5). 20. Obtain x-ray to determine feeding tube placement."

Review of the facility's policy "NASOGASTRIC TUBE INSERTION" revealed that it was intended to be used with large diameter (16-18 French) tubes.

Review of the facility's policy "ENTERAL NUTRITION" revealed that it included a protocol for nasoduodenal tube placement: "a. Measure patient for gastric tube placement b. Measure the tube another 6 inches for duodenal placement position c. Mark the tube with a marker at the duodenal placement position d. Insert the tube to gastric position e. Loop the extra 6 inches up and tape to the cheek or forehead f. Place the patient on the right side - minimum of 2 hours g. Give Reglan 10 mg IV x 1 h. Confirm the tube position by X-ray i. Start the feeding as ordered". The facility's protocol did not include listening for air exchange or breath sounds or obtaining gastric aspirate as outlined in the nursing textbook.


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2. Record review on 8/23/10 of Patient 6's history and physical dated 8/18/10 showed the patient was admitted to the hospital on 8/18/10 with a gastrointestinal bleed. The patient's chief complaint was "nausea and vomiting with associated hematemesis (vomiting of blood) and melena (darkening of stool by blood pigments). The patient...had onset of diarrhea approximately 3 or 4 months ago. These were 6 to 10 loose bowel movements per day. Bowel movements were intermixed with blood and stool. The patient subsequently went for an EGD (esophagogastroduodenoscopy) and colonoscopy in July 27, 2010...(the patient) was found to have scattered ulcerations in the right transverse colon and the cecum, possibly consistent with Chron's versus a vasculitis (inflammation of blood or lymph vessel). The patient was subsequently started on a prednisone taper for approximately 2 weeks which he completed 2 days ago. Over the past 5 days however, the patient has had increased abdominal pain in the epigastrum 5 to 7/10 in nature, associated with nausea and vomiting."

Record review on 8/23/10 of the "Initial Inpatient Interdisciplinary Assessment" completed by a registered nurse on 8/18/10 showed the admission evaluation which did not reflect the patient's recent history of gastrointestinal symptoms: "Pain: location of pain: abdomen, level of pain (0-10): 8/10. Gastrointestinal: no nausea or vomiting, no hematemesis or melena, no diarrhea. Nutritional Referral Criteria: no needs identified." In the the nutritional referral criteria section, a dietary consult would have been triggered if the nurse had checked the box that stated, "daily vomiting and/or diarrhea for more than 3 days."

Patient 6 had an initial dietary evaluation on 8/21/10, three days after admission.

The hospital's policy and procedure, "Interdisciplinary Assessment Form Guidelines - Adult", dated 3/20/08 stated the following: "Purpose: To obtain information to enable the multidisciplinary team to formulate a patient problem list and appropriate treatment plans for patient care." "Procedure: #8 If a box is marked other than "No Need Identified" in the Nutrition Referral Criteria section, a dietician consult will be requested by calling the Food and Nutrition Services Department. The dietician will document the consult in the progress notes."

During an interview on 8/23/10 at 1:30 PM, the department nurse manager agreed that the nursing assessments should have been more accurate to reflect the patient's history and condition.

2. Record review on 8/25/10 of Patient 21's medical record showed he was admitted from a long term care facility on 8/20/10 for mental status change, acute renal failure, poorly controlled diabetes, and was on dialysis.

The "Initial Inpatient Interdisciplinary Assessment" was completed by a registered nurse on 8/20/10. The nurse did not complete the "Nutritional Referral Criteria" section that would have indicated a nutritional consult if the box was checked off for "Diabetes Melitus". The initial dietary evaluation was done on 8/21/10.

Based on interview and record review, the facility failed to follow the nursing care plans for Patients 7 and 21 regarding daily weight monitoring. This failure potentially could have affected the care needs and responses to interventions of these patients who were NPO (nothing by mouth)and on dialysis (Patient 21 only).

Findings:

1. Record review on 8/25/10 showed Patient 21 was admitted to the hospital from a long term care facility on 8/20/10 for acute renal (kidney) failure, altered mental status, acute myocardial infarction, and dialysis. His medical history included poorly controlled type 2 diabetes, and neurogenic bladder for which he required a suprapubic cystostomy catheter. He was initially admitted to the medical surgical unit, but on 8/21/10, the patient was transfered to the intensive care unit (ICU) due to a continued decline in his renal and mental status. The patient was placed on NPO and had intravenous fluids.

There were physician orders dated 8/21/10 when the patient was transfered to the ICU for daily weights to be taken. The nursing care plan titled, "Multidisciplinary Inpatient Treatment Plan, Patient Problem: Management of Patient with Acute/Chronic Renal Failure", dated 8/21/10, indicated to "monitor daily weights and assess weight gain pattern."

The patient's daily weight was recorded for three consecutive days when the patient was admitted into the ICU but then there was none recorded in the nursing flowhseets for the following three days as noted in the following:
8/20/10 = 106.3 kg
8/21/10 = 114 kg
8/22/10 = 110.4 kg
8/23/10 = no weight was recorded
8/24/10 = no weight was recorded
8/25/10 = no weight was recorded

On 8/25/10 at 3:40 PM, this surveyor requested the nursing staff to take the patient's current weight. The patient had a Hill-Rom bed that had a programmed internal scale so the patient remained in bed while the nurse took the weight of the patient who did not have to be transfered to a standing or hoyer lift type scale. The patient had been on this same bed since admission into the ICU. The patient's weight was 110.1 kg.

The nursing staff did not implement the care plan to monitor the patient's weight.

2. Record review on 8/25/10 showed Patient 7 was admitted to the hospital's ICU on 8/22/10 with a history of significant weight loss, and generalized lymphadenopathy with fever, cough, chest pain, and hypotension.

The records showed a care plan titled, "Multidisciplinary Inpatient Treatment Plan, Patient Problem: Fluid and Electrolyte Management", initiated 8/22/10 that documented to "weigh daily and monitor trends". The patient's weight was not taken since the day of admission.

In an interview on 8/25/10 at 2:54 PM, the charge nurse stated weights are taken with physician orders and could not explain why this patient had a care plan to weigh the patient without physician orders.










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Patient 4 was admitted to the facility on 8/13/10 with diagnoses of pneumonia, lung cancer, diabetes mellitus, hypertension, and crhonic renal insufficiency.

Review of physician order dated 8/13/10 indicated an order to weigh patient daily.
Review of the weight record which was included in the Vital Signs Sheet showed Patient 4 weighed 71 kg. (kilograms) on 8/14/10. He was weighed on 8/15/10 and he weighed 68 kgs. He lost 3 kilograms (or 7.5 pounds) in one day. There were no documented evidence to indicate that Patient 4's weight was measured again until patient was discharged on 8/23/10.

Review of the nursing admission assessment record dated 8/13/10 indicated that Patient 4 required nutritional consult because he was at risk for nutritional problems related to his diagnoses of diabetes, lung cancer, and chronic renal insufficiecy.

During an interview with RN1 on 8/23/10 at 12:15 PM, he acknowledged that the facility failed to monitor the patient's weight daily as ordered. There was no care plan developed that identified the weight loss problem and other risk factors for nutrition and no interventions to meet the nutritional needs of the patient.

Patient 2 was admitted to the facility on 8/22/10 with diagnoses of chronic obstructive pulmonary disease exacerbation and diabetes mellitus. Review of physician's admit orders dated 8/22/10 showed Patient 2 had no known drug allergies.The Medication Reconciliation List/Orders dated 8/22/10 also indicated that the patient had no known allergies. Review of the nursing Initial Inpatient Interdisciplinary Assessment Form dated 8/22/10 indicated that Patient 2 was allergic to Sulfa drugs and the patient described his reaction to the drug as "closes up my throat."

During an interview with RN 1 on 8/23/10 at 2:00 PM, he acknowledged the inconsistent and inaccurate documentation of Patient 2's allergy history that could potentially result to the patient receiving medication that would result to adverse drug reaction.

Patient 4 was admitted to the facility on 8/13/10 with diagnoses of pneumonia, lung cancer, diabetes, hypertension, ad chronic renal insufficiency. Review of physician admit orders dated 8/13/10 indicated Patient 4's code status was "Full Code."

Review of Progress Record by Dietitan 1dated 8/16/10, she stated that, "Pt. is to hospice care in Phillipnes. No nutritional intervention..." On 8/23/10, Dietitian 1 also documented in th Progress Record that, "Patient is hospice- to go back to the Philippines."

During an interview with Dietitian 1 on 8/26/10 at 2:00 PM, she acknowledged that there was no documented physician order to place the patient on hospice care. She stated that she heard from the social worker that patient was on hospice. She also thought that the patient was on hospice because there was no chemotherapy planned for the patient's lung cancer.




26674

Based on interview and record review, the facility failed to ensure all medical record entries were legible and dated for 2 sampled records (Patients 33 and 34). The deficient practice diminished the usefulness of the medical records. The facility also failed to ensure that the medical record entries were accurate and complete for 2 patients (Patient 2 and 4). The MD admit orders and Medical Reconciliation List for Patient 2 showed no known allergies but the Initial Interdisciplinary Assessment record showed Patient 2 was allergic to Sulfa. The dietitian documented that Patient 4 was on hospice but there was no MD order to place patient on hospice care.


Findings:

Review of Patient 33's medical record revealed that portions of the attending physician progress notes dated 6/3/10 at 10:00 a.m. and 6/3/10 at 5:00 p.m. were not legible.

In an interview on 8/30/10 at 1:31 p.m., Staff E stated that he would ask the physician "to decipher" the progress notes since he could not read them.

Review of Patient 34's medical record indicated that the "MULTIDISCIPLINARY INPATIENT TREATMENT PLAN" regarding restraints was not dated.

Based on document review, the facility failed to ensure that all verbal orders are authenticated within 48 hours. "Medical Staff Bylaws, Rules and Regulations are not in compliance with this Regulation.

Findings:

On August 24, 2010 at 11;30am, review of the "Medical Staff Bylws, Rules and Regulations" revealed the following "Page 10 #B 1. Written and Verbal Orders: .........Verbal orders for medications must be signed by the attending practitioner within 48 hours. All other verbal orders shall be signed by the attending practitioner as soon as possible, unless more stringent standards apply for specific types of orders (i.e. restraint)."

Based on interview and record review, the facility failed to document and file dietary and speech consultation reports into the correct patient health record. The consultants charted in the incorrect patient chart (Patient 7) rather than in Patient 37's whose last name sounded and spelled similar to Patient 7's. By not documenting their evaluations in the correct chart, the evaluations and recommendations were stated for the wrong patient (Patient 7)and were not available for the correct patient (Patient 37)which potentially could alter the treatment plan and care needs for both. Also, there was the failure to: denote source of information in an admisssion nursing screen(Patient 58 )so as to better ascertain reliabilty of information; document the need to carry-forth concerns regarding weight (Patient 58 and Patient 59 who were in a psychiatric unit and obese; correctly identify hypothermia in history and physical (Patient 60); ensure accuracy in documented weight for a patient who was HIV+ (Patient 63) and complete data entries regarding height for two pediatric patients (Patient 61 and 62).

Findings:

1. Record review on 8/23/10 showed Patient 37 was admitted to the hospital on 8/09/10 with a cheif complaint of esophageal perforation and Patient 7 was admitted on 8/22/10 with a cheif complaint to rule out pulmonary embolus.

The record revealed the speech pathologist on 8/23/10 at 9:45 AM documented on Patient 7's chart that "MD requested blue dye study - consult with MD who indicated that decrease in edema at neck indicates patient is positive candidate to resume eating."

During an interview on 8/23/10 at 3:00 PM, the charge nurse immediately indicated that the speech pathology consult for the blue dye study was not done on Patient 7. The charge nurse brought in Patient 7's nurse who confirmed that the blue dye study was actually done on Patient 37. Both the charge nurse and staff nurse stated the speech pathologist performed the study on the correct patient (Patient 37)but charted the findings in the wrong patient chart (Patient 7)since both last names were similar in spelling and sound.

On further review, both Patient 37 and 7 even had "Name Alert" sticker tags on their charts and cardex to make the staff aware of the similar sounding and spelling of the the patients' last names.

Additionally, the RD (registered dietician) also charted on Patient 7's chart rather than Patient 37. The RD followed the speech pahologist's note on 8/23/10 at 11:45 AM. The RD's note stated, "Seen by ST (speech therapist) - recommend pureed with HTL." "Current patient condition/ dysphagia." Patient 7 did not have dysphagia (swallowing difficulty)so the diet would not have been appropriate.

On an interview on 8/25/10 at 2:54 PM, the RD admitted to charting on the incorrect patient and was just following the speech therapist's information. The RD was aware of the incorrect charting since it was identified but had not gone back to either patient's records to correct the documentation yet. The RD stated, " I will follow up on the diet today."

This surveyor requested from the Deputy of Director for Acute Care Services their policy and procedure for name alerts with patients with similar sounding and spelling of names on 8/23/10. The Quality Assurance Diector stated on 8/31/10 at 8:40 AM that the hospital did not have this type of policy.



05041

2. On 8/27/10 between 3 p.m. and 4:20 p.m. while in a psychiatric unit, review of the medical records of Patient 58 and Patient 59 revealed shortcomings.

a) For Patient 58 who had been admitted on 8/16/10 with psychosis, the nursing admission screen had his height as five feet five inches and an approximated weight of 250 lbs without having noted who had determined/stated this. At 3:10 p.m. Nurse V stated it had likely been done by a nurse rather than it being a stated weight by Patient 58 . Also, as there had been a nutrition assessment conducted by Dietitian 2 on 8/20/10 who had recommended weight loss without a carry-over for care planning. As such, it remained unclear what the goal weight was and if weight loss was realistic during this hospitalization.

b) Additionally, at 4 p.m. review of Patient 59's record revealed that while obese, there was a diagnosis of of being psychotic with undifferentiated schizophrenia and a medical history significant for diabetes, hypertension, dyslipidemia and non-compliance. As of 8/25/10 Patient 59 had a physician's order for an 1800 Calorie ADA (diabetic) diet that was also Low Fat, Low Cholesterol. However, review with both Dietitian 2 and Nurse W revealed that while the pattern of consuming snacks on 8/25/10, 8/26/10 and 8/27/10 had been documented, there had been the failure to record data on 8/26/10. Also, it remained uncertain as to the types and amounts of snacks consumed. At 4:20 p.m. Nurse W stated that knowing the types and amounts of snacks would be important in assessing not only intake, but compliance to the diet order.

3. Patient 60 was admitted on 8/25/10 with a diagnosis of hypothermia although the history and physical had the condition identified as hyperthermia. A retrospective review of Patient 60's medical record conducted on 8/27/10 by 4 :30 p.m. revealed that the discrepancy had not been corrected and that given the diagnosis of schizophrenia there was potential for inattention to the sensorium for thirst.

4. Patient 63 was admitted 8/26/10 with left-sided weakness and diagnosis of HIV +. At the time of admission, Patient 63 who was five feet seven inches weighed 73.6 kg (161.9 lbs), yet by 8/30/10 he weighed 72 kg (158.4 lbs). Patient 63 had been prescribed a Regular Diet on 8/27/10 and while there was intake data for all meals, there was the failure to record dinner on 8/30/10. Also, there was the lack of related documentation when percent meal intakes for lunch on 8/27/10 and dinner on 8/28/10 were 50% . It was unclear if substitutes had been offered.

On 8/31/10 between 12:33 p.m. and 2:40 p.m. Nurse T stated that she did not know why Patient 63 had lost weight, except if "there was a fluid problem" or a problem in taking weight. However, upon learning of this change, there was no attempt to re-weigh Patient 63.

5. On 8/31/10 between 4 p.m. and 4:30 p.m. closed record reviews of two pediatric patients was done in an administrative conference room. Review revealed that neither Patient 61 nor Patient 62 had height data entered in the admission order field, although respective weights were 11.1 kg (24.42 lbs) and 15.6 kg.(34.32 lbs) .Although Patient 61 was discharged the day of admission (8/19/10) and had not had a nutrition assessment, Patient 62 who had been admitted 8/18/10 and discharged 8/19/10 had been admitted with significant symptoms which could impact status. Patient 62 had gastroenteritis, vomiting, bloody diarrhea and abdominal pain and without height data, it was impossible to determine the relative significance of the documented weight.

Based on record review and staff interview, the facility failed to document the nurses' assessment in the clinical record by failing to write the Brosset Score which is an assessment of patient behavior that was used as a tool for predicting violent behavior of 7 patients in the psychiatric unit (Patient 9, 10, 12, 17, 18, 19, and 38).

Findings:

Patient 38 was admitted to the psychiatric unit on 8/25/10 with diagnoses of mood disorder and alcohol dependence. He has history of bipolar affective disorder.

During an interview with the Nurse Manager on 8/30/10 at 3:30 PM, she stated that last Friday 8/27/10 at afternoon, Patient 38 wanted to go home to his apartment but was served 5250 court order to stay 14 days more. This made the patient very upset and he threatened to throw the bedside table. "Code Gray" was called to control violent behavior. The patient had a laceration on his arm during the takedown.The staff applied 4 point leather restraints on the patient and placed him in the seclusion room.

Review of the nursing shift report dated 8/27/10 showed that on the day hift, the BVC score (Broset Violence Scale scoring) was 0 to 2. The report indicated that Patient 38 was depressed, focusing on leaving... He made threatening phone calls to the North County Mental Health Social Worker."

The nursing shift report dated 8/27/10 for the PM shift, showed the BVC score was 5 to 0. The report stated that Patient 38 "attempted to break patio door with bedside table after he was served 14 hold papers. Bloody takedown. Took 6-7 staff to contain patient on the floor. 4 point restraints from 6:25 PM to 7:10 PM."

The nursing shift report dated 8/27/10 for the night shift showed a BVC score of 0. The report indicated that the patient slept the entire shift...."

According to the nursing report:
The risk of violence is moderate for scores 1 and 2- preventive measures are taken;
The risk of violence is very high for scores 3 or more- immediate preventive measures are required, and plans for handling an attack is activated;
A score of 2 or more predicts a violent event in the next 24 hour period.

According to Title 22 of the California Code of Regulations section 70215 (a) the "RN shall directly perform ongoing assessments as defined in Title 16 and shall document the findings in the patient record. The assessment shall be performed at least once a shift and upon receipt of a patient that has been transferred from another patient area.


Review of clinical records for Patients 9, 10, 12, 17, 18, 19, and 38 showed no evidence that the BVC score was documented.
During interview with the Nurse Manager of the Psychiatric Department on 8/30/10 at 3:30 PM, she stated that the BVC score was not documented in the patients' chart. It was only used for change of shift report and was not part of the clinical record.

Based on document review and staff interview, the facility failed to ensure that medical record were completed per the "Medical Staff Bylaws, Rules and Regulations". This failure had the potential to result in records that lack vital patient care data and are not available for continuity of patient care.

Findings:

On August 24, 2010 at 10:00 am, interview with Staff Member Y revealed that on August 23, 2010, there were no physicians on suspension.

However, an audit performed on August 24, 2010 at 2:30pm of the "Chart Fact, Incomplete Charts Status Report for Monday, August 23, 2010 revealed that there were 89 physcians with 410 deficiencies within records. The oldest deficiency dated back to patient discharge date of March 24, 2010.

On August 23, 2010 at 2:30pm, review of the "Medical Staff Bylaws" Page 41, #8.3.5 Medical Records revealed the following "Members of the Medical Staff are required to complete medical records within such reasonable time as may be prescribed by the Board on recommendation of the Medical Records/Utilization Committee through the Medical Executive Committee. A limited suspension in the form of withdrawal of admitting and other related privileges until medical records are completed, shall be imposed by the Chief of Staff, or his designee, after notice of delinquency for failure to complete medical records within such period.'

On August 23, 2010 at 3:30pm, review of the "Medical Staff General Rules and Regulations" Page 9, #b. Definitions.......Delinquent Records-The subset of incomplete records , that are 14 or more days post discharge at the time of the weekly mailing of notices.

c. Sanctions: The Medical Staff through the Medical Executive Committee, the Chief of Staff and the department chairs will sanction physicians who do not complete their medical records in a timely fashion.
Upon issuing a third notice, the Department of Medical Records will notify the Medical Staff Office. The MSO will notify the Department Chair, the Chief of Staff, and place a medical records sanction notice in the credentialing file for OPPE/professionalism. Until the records have been completed, a physician who receives a medical record sanction will not be able to perform the following:
admit non-emergency patients to the hospital; Perform consultations; Schedule new procedures or operations; Treat patients in clinic and attend in clinics."

Based on interviews and document reviews, the hospital failed to ensure the provision of pharmaceutical services and care that meets the needs of the patients.

Findings:

1. The hospital failed to develop and implement policies and procedures to ensure the safe use of fentanyl transdermal patches. Patient 21 and 40 were prescribed and administered fentanyl transdermal patches not in accordance with the boxed warning issued for the drug, which had the potential to cause fatal respiratory depression as a result of opiate overdose. (A500)

2. The hospital failed to maintain the temperature in medication refrigerators in accordance with hospital policy (2-8 degrees Celsius) and the manufacturer's recommendations. (A500)
a. Tuberculin Skin Test (PPD) and Insulin was stored at freezing temperatures as low as -7 degrees Centigrade (C) which could cause false negative PPD tests or adulterated insulin being administered to patients.
b. Medications were stored between 8 degrees to 10 degrees C in the intravenous medication refrigerator.
c. The hospital failed to take action when medication refrigerators were not within range in accordance with hospital policy (2-8 C).
d. The hospital failed to monitor and document twice daily refrigerator temperatures for vaccines.

3. The hospital failed to ensure that medication orders were reviewed for appropriateness before the first dose was administered to patients in non-emergent situations. Physicians' orders written between the hours 10 p.m. to 7 a.m. Mondays to Fridays, and 6 p.m. to 7 a.m. on Saturdays and Sundays were not reviewed for appropriateness prior to the first dose being given to patients.

4. The hospital failed to account for 202 medications, based on a one month audit, which could be attributed to medication errors such as administering extra doses, missing doses, and administering the wrong medications. (A500)

5. The hospital failed to update expiration dating on intravenous bags of solutions once taken out of the overwrap. (A500)

6. The hospital pharmacists failed to review medication orders for appropriateness. (A500)

7. The hospital pharmacy administration failed to develop and supervise all the activities in the pharmacy. Two staff pharmacist (Pharmacist 11 and 12) did not have record of training and passing competency tests prior to being assigned to perform pharmacist duties independently. (A492)

The cumulative effects of these systemic problems resulted in the pharmacy's inability to provide pharmaceutical services and care in a safe and effective manner in accordance with the statutorily-mandated Conditions of Participation for Pharmaceutical Services.

Immediate Jeopardy (IJ) was identified on 8/26/10 at 10:44 AM. The Administrative staff and the Director of Pharmacy were notified at 11:10 AM. The IJ was abated after an acceptable plan of correction was presented on 8/26/10 at 4:10 PM.

Based on interview and record review, the hospital pharmacy administration failed to develop and supervise all the activities in the pharmacy. Two staff pharmacist (Pharmacist 11 and 12) did not have record of training and passing competency tests prior to being assigned to perform pharmacist duties independently.

Findings:

A review of Staff Pharmacist 11 ' s personnel record at approximately 11:45 a.m. on 8/31/10 showed that the pharmacist was hired on 8/1/2009. There was no training or competency record in Pharmacist 11 ' s personnel file.

A review of Staff Pharmacist 12 ' s personnel record at approximately 12:00 p.m. on 8/31/10 showed that the there was no training or competency record in Pharmacist 12 ' s personnel file. There was no document indication Pharmacist 12's hiring date. Administrative Staff 2 stated that Pharmacist 12 had been a pharmacist at the hospital for over one year.

During an interview at approximately 12:20 p.m. on 8/3/10, Administrative Staff 2 stated that it was the department requirement that all pharmacists received on-the-job training and passed competency tests on renal dosing, oral/intravenous medications and oncology before performing pharmacist duties independently. Renal dosing was a monitoring function performed by the pharmacists to make appropraite recommendations to physicians on dosage changes of some medications prescribed to patients with compromised kidney function. Administrative Staff 2 also stated Staff Pharmacist 11 and Staff Pharmacist 12 performed all pharmacist duties independently including renal dosing, review orders for chemotherapeutic agents and dispensing chemotherapeutic agents.

A review of the pharmacist competency test log with Administrative Staff 2 at approximately 12:30 p.m. on 8/30/10 showed that Pharmacist 11 and Pharmacist 12 did not have record of completing competency tests on renal dosing, oral/intravenous medications and oncology.

Based on observation, interview, and document review the hospital failed to deliver pharmaceutical services to meet the needs of the patients when medications where not controlled and distributed in accordance with standards of practice, federal and state laws as evidence by:

1. The hospital failed to develop and implement policies and procedures to ensure the safe use of fentanyl transdermal patches. Patient 21 and 40 were prescribed and administered fentanyl transdermal patches not in accordance with the boxed warning issued for the drug, which had the potential to cause fatal respiratory depression as a result of opiate overdose.

2. The hospital failed to maintain the temperature in medication refrigerators in accordance with hospital policy (2-8 degrees Celsius) and the manufacturer's recommendations.
a. Tuberculin Skin Test (PPD) and Insulin was stored at freezing temperatures as low as -7 degrees Centigrade (C) which could cause false negative PPD tests or adulterated insulin being administered to patients.
b. Medications were stored between 8 degrees to 10 degrees C in the intravenous medication refrigerator.
c. The hospital failed to take action when medication refrigerators were not within range in accordance with hospital policy (2-8 C).
d. The hospital failed to monitor and document twice daily refrigerator temperatures for vaccines.

3. The hospital failed to ensure that medication orders were reviewed for appropriateness before the first dose was administered to pateints in non-emergent situations. Physicians ' orders written between the hours 10 p.m. to 7 a.m. Mondays to Fridays, and 6 p.m. to 7 a.m. on Saturdays and Sundays were not reviewed for appropriateness prior to the first dose being given to patients.

4. The hospital failed to account for 202 medications, based on a one month audit, which could be attributed to medication errors such as administering extra doses, missing doses, and administering the wrong medications

5. The hospital failed to update expiration dating on intravenous bags of solutions once taken out of the overwrap.

6. The hospital pharmacists failed to review medication orders for appropriateness.




An immediate jeopardy situation was declared pertaining to the failure of the hospital to ensure the safe use of fentanyl patches at 11:05 a.m. on 8/26/10 in the presence of the hospital Chief Operating Officer and the Director of Pharmacy (DOP).

The immediate jeopardy was abated at 4:10 p.m. on 8/26/10 in the presence of the hospital Chief Operating Officer and Director of Pharmacy after an immediate corrective action plan was accepted by the Department.



Findings:

1. A review of Patient 21 ' s clinical record showed that the patient was admitted to the hospital on 8/20/10 for acute renal failure. Physicians ' progress notes indicated that Patient 21 was on MS Contin 30mg (an opiate, extended release form of morphine sulfate, a pain control) one tablet at bedtime and vicodin (an opiate pain relief medication containing 5 mg of hydrocodone and 500mg of acetaminophen per tablet) as needed prior to admission. Clinical record indicated that Patient 21 presented with signs of opiate overdose on admission and was prescribed Narcan (Naloxone) for reversal of opiate effect. Patient 21 received one and two doses of Narcan 0.4mg injection on 8/20/10 and 8/21/10 respectively. Narcan drip (slow intravenous infusion) 0.1mg every one hour as needed for obtundation was ordered and administered on 8/22/10. On 8/22/10, Patient 21 was prescribed fentanyl transdermal patch 25mcg/hr, an equianalgesic dose to 60mg of oral morphine according to the prescribing information of fentanyl patch, which was twice the dose of the morphine the patient was on when admitted for opiate overdose. Patient 21's fentanyl patch dose was was subsequently increased to fentanyl transdermal patch 50mcg/hr on 8/24/10, two days after the initiation of fentanyl patch. There was no documented evaluation of Patient 21 ' s opioid tolerance status prior to the initiation of fentanyl patch on 8/20/10 and dose increase on 8/22/10. There was no documented clinical rationale that supported the use of fentanyl patch not in accordance with the manufacturer' recommendations.


A review of Patient 40 ' s clinical record showed that the patient was admitted to the hospital on 7/4/10. Patient 40 ' s home medication prior admission including Percocet 5/325 ( an opiate pain medication containing 5 mg oxycodone and 325 mg of acetaminophen per tablet) one tablet every 6 hours as needed for pain. Patient 40's medication administration record showed that the patient received a total dose of 5.5mg hydrmorphone (an opioid pain medication) intravenously on 7/5/10. On 7/6/10, Patient 40 was prescribed and administered fentanyl transdermal patch 25 mcg/hr. Patient 40' s fentanyl patch dose was increased to 50 mcg/hr in 2 days, on 7/8/10. Patient 40's clinical record did not show that the patient had been on another opiate with an equianalgesic dose of fentanyl patch 25 mcg/hr (6 tablets of Percocet daily) for 7 days prior to the initiation of the patch. There was no documented evaluation of Patient 40' s opioid tolerance status prior to the initiation of fentanyl patch on 7/6/10. There was no documented clinical rationale that supported the use of fentanyl patch not in accordance with the manufacturer' recommendations.


According to the manufacturer's prescribing information, fentanyl transdermal patch is a controlled delivery system that releases a very potent narcotic medicine, fentanyl, at a determined rate through the skin for pain relief. Fentanyl patch is indicated for management of persistent, moderate to severe chronic pain in patients who have demonstrated opioid tolerance. The patch is designed to deliver a consistent amount of fentanyl continuously while the patch is applied to skin. Cutting of the patch can cause damage to the controlled release delivery system of the patch and lead to rapid release and absorption of fentanyl though the skin which may result in fatal fentanyl overdose. A boxed warning (Black Box Warning) was issued on fentanyl patches which indicated that (1) fentanyl patch is indicated for management of persistent, moderate to severe chronic pain. (2) fentanyl patch should ONLY be used in patients who are receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to fentanyl transdermal system 25 mcg/hr. Patient who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60mg of morphine daily, or at least 30 mg of oxycodone daily (6 tablets of Percocet a day in Patient 40's case), or at least 8mg of oral hydromorphone daily or an equianalgesic dose of another opioid. (3) Fentanyl transdermal system is ONLY for use in patients who are already tolerant to opioid therapy of comparable potency. Dose titration should not be more frequent than every 3 days after initial dose or every 6 days thereafter. Use in non-opioid-tolerant patients may lead to fatal respiratory depression.

During an interview at approximately 3:45 p.m. on 8/25/10, ICU (Intensive Care Unit ) nurse, RN 31, stated that fentanyl patch should be used in patients who had been on narcotics for at least 7 days but RN 31 was not able to state the amount of narcotic that a patient had to be on for 7 days prior to the initiation of fentanyl patch to be considered appropriate and safe.

During an interview at approximately 3:55 p.m. on 8/25/10, Staff Pharmacist 1 stated that it would be appropriate for a patient to be initiated on fentanyl patch 25 mcg/hr who had an opiate use history of oral morphine 15 mg for 3 days.


During a group meeting at approximately 11:00 a.m. on 8/26/10, the hospital DOP stated that there was no hospital policy and procedures on the use of fentanyl patches. The DOP also stated that he considered Patient 21 and 40 ' s orders for fentanyl patches to be appropriate because he knew Patient 21 ' s prescribing physician well and he was confident that the physician prescribed the medication appropriately. DOP added that Patient 40 and was prescribed fentanyl patches appropriately because the patients was on palliative care (comfort care).

A review of the hospital pre-printed order form for comfort care indicated that long acting opioid such as fentanyl patch, long-acting morphine or oxycodone should not be continued for patient on comfort care.

FDA issued a Public Health Advisory in July 2005 emphasizing the safe use of fentanyl transdermal system, also known as the fentanyl patch (marketed as Duragesic and generics). The fentanyl patch is a potent narcotic (opioid) pain medicine applied to the skin for treating persistent moderate to severe pain in opioid-tolerant patients who needed to be on a narcotic pain medicine around-the-clock. Despite the advisory issued in July 2005, FDA continued to receive reports of death and life-threatening side effects in patients who were prescribed fentanyl patches. On 12/21/2007, FDA again issued a Public Health Advisory to alert patients, caregivers, and healthcare professionals of important information on the safe use of fentanyl transdermal patch. On the public health advisory, FDA indicated that fentany patch was only intended for treating persistent, moderate to severe pain in patients who were opioid-tolerant, meaning those patients who took a regular, daily, around-the-clock narcotic pain medicine. Patients who were opioid-tolerant were more resistant to the dangerous side effects of narcotic pain medicines than patients who only occasionally took these medicines. For patients who were not opioid-tolerant, the amount of fentanyl in one fentanyl patch of the lowest strength is large enough to cause dangerous side effects, such as respiratory depression (severe trouble breathing or very slow or shallow breathing) and death.


Patient 21and 40 were ordered and administered fentanyl transdermal patches not in accordance with the boxed warning issued for the medication. Both patients were not evaluated for their opioid tolerant status prior to the initiation of fentanyl patch to ensure patient safety and to minimize adverse effects. Based on the patients ' opiate usage prior to the initiation of fentanyl patches, Patient 21 and 40 were not opioid tolerant, as defined by the boxed warning, to be started on fentanyl patches for pain control.

An immediate jeopardy situation was declared pertaining to the failure of the hospital to ensure the safe use of fentanyl patches at 11:05 a.m. on 8/26/10 in the presence of the hospital Chief Operating Officer and the Director of Pharmacy.

The immediate jeopardy was abated at 4:10 p.m. on 8/26/10 in th presence of the hospital Chief Operating Officer and Director of Pharmacy after an immediate corrective action plan, which included immediate removal of all fentanyl patches from automated dispensing cabinets and temporary suspending all new initiation of fentanyl patched until completion of staff training, was accepted by the Department.

2a. On 08/24/10 at 2:50 pm in the acute psychiatric unit it was observed that the digital thermometer which would record minimum (min) and maximum (max) temperatures in medication refrigerator. The digital thermometer would measure the min and max temperatures from the last time it had been reset. The thermometer had measured refrigerator temperatures of -7 C and 21 C. The observed medications stored at these temperatures were several vials of Insulin and a vial of Tuberculin Skin Test (PPD).

According to Lexi-comp online, a nationally recognized drug information resource, and the manufacturers' package inserts indicated a "do not freeze and to discard if frozen" warning for insulin products and PPD.

During an interview on 08/25/10 at 12:39 pm the Nurse Manager stated she did not know how long the digital thermometer had been registering a min/max of -7 C to 21 C because the nurses were not documenting the min/max as indicated by the temperature log.

A review of the acute psychiatric unit refrigerator temperature log, for the months of June, July, and August; indicated there was no documentation for the min/max temperatures. The temperature log was blank under the sections " Temp C Min " and " Temp C Max " .

In an interview on 08/25/10 at 3:15 pm the Engineer stated the thermometer had been purchased in February 2009. The Engineer did not know when the digital thermometer had been reset. The refrigerator min/max temperatures could have been -7 C to 21 C from the time of the purchase which was 18 months ago.

The interviewed Nurse Manager on 08/25/10 at 3:15 pm stated on average there would be eight PPD patients and three insulin patients per month. An estimated average of 144 PPD patients and 54 insulin patients could have received improperly stored medications over the 18 month period. She acknowledged that the hospital had not properly monitored medication refrigerator temperatures and that freezing temperatures could have caused false negative PPD results and administration of adulterated insulin.

2b. On 08/24/10 at 1:30 pm it was observed on the digital thermometer pharmacy intravenous (IV) room medication refrigerator a min/max temperature of 8 C to 10 C. It was also observed that there were hundreds of doses of medications that were stored between min/max temperatures of 8 C to 10 C.

A review of the IV room medication refrigerator temperature log, for the months of May, June, July, and August; indicated there was no documentation for the min/max temperatures. The temperature log was blank under the sections " Temp C Min " and " Temp C Max " .

During an interview on 08/24/10 at 1:30 pm the Director of Pharmacy (DOP) stated he did not know when the last time the min/max was reset and did not know how long the medications were stored outside of the manufactures ' recommended storage temperatures of 2 C to 8 C. He also stated that the pharmacy had not documented the min/max temperatures. Since the min/max temperatures were not being documented and monitored it was unknown how long the medications were stored out of range.

2c. According to the hospital policy entitled "Storage of Medications" indicates " Medications requiring refrigerated storage will be stored at a range of between 2 and 8 degrees Celsius ...If temperatures are outside of the required range, the user will adjust the thermostat, document the action and observe the temperature after 2 hours. If the temperature remains outside of the desired range, Facilities Engineering will be called to address any problems ...If the temperature of a medication storage refrigerator remains outside the range of a time deemed to be incompatible with medication storage, the medications will be transferred to another freezer or refrigerator. "

A review of the IV room medication refrigerator temperature log, for the months of May, June, July, and August; indicated there were temperatures that were out of range (2-8 C) or were not documented on the following dates: 05/03/10, 05/05/10, 06/18/10, 07/02/10, 07/20/10, 07/23/10, 07/30/10, 08/01/10, 08/11/10, 08/12/10, 08/17/10, 08/18/10, 08/20/10, and 08/21/10. These corresponding dates did not have any documentation indicating any action was taken for out of range temperatures.

A review of the Outpatient Pharmacy refrigerator medication refrigerator temperature log, for the months of May, June, and July; indicated there were temperatures that were out of range (2-8 C) or were not documented on the following dates: 05/30/10, 06/08/10, 06/12/10, 06/13/10, 06/14/10, 06/16/10, 06/25/10, 06/30/10, and 06/31/10. These corresponding dates did not have any documentation indicating any action was taken for out of range temperatures.

A review of the Acute Psych medication refrigerator temperature log, for the month of August; indicated there were temperatures that were out of range (2-8 C) or were not documented on the following dates: 08/04/10, 08/09/10, and 08/16/10. These corresponding dates did not have any documentation indicating any action was taken for out of range temperatures.

A review of the Psychiatric Emergency Services medication refrigerator temperature log, for the month of May; indicated there were temperatures that were out of range (2-8 C) or were not documented on the following dates: 05/24/10 and 05/26/10. These corresponding dates did not have any documentation indicating any action was taken for out of range temperatures.

A review of the Emergency Department medication refrigerator temperature log, for the month of July and August; indicated there were temperatures that were out of range (2-8 C) or were not documented on the following dates: 07/20/10, 07/21/10, 07/29/10, 08/05/10, and 08/09/10. These corresponding dates did not have documentation indicating any action was taken for out of range temperatures.

2d. According to the World Health Organization (WHO), an internationally recognized health organization in the document titled, "Temperature Sensitivities of Vaccines" indicated, "More than two million deaths were averted by immunization, as well as an additional 600,000 hepatitis B related death that would otherwise have occurred in adulthood...However, despite this, more deaths could be prevented and illnesses avoided, if vaccines which are sensitive both to excessive heat and excessive cold, were transported and stored correctly...Liquid formulations of vaccines containing diphtheria, pertussis, tetanus, hepatitis B, Hemophilus influenzae type b, IPV and their combinations should not be frozen...When a vaccine containing an antigen absorbed to an aluminum adjuvant (e.g. hepatitis B, tetanus toxoid,..) is damaged by freezing, the loss of potency can never be restored; the damage is permanent...Freezing affects the adsorbed vaccines through changing their physical form...Freezing brings changes in the structure and morphology of the adsorbed vaccines...ice crystals formed during freezing force aluminum particles to overcome repulsion, thereby producing strong interparticle attraction resulting in aluminum particle coagulation/agglomeration.... The size of the granules seems to increase on repeated freezing and thawing cycles."

According to the hospital policy entitled Storage of Medications indicated " Medications requiring refrigerated storage will be stored at a range of between 2 and 8 degrees Celsius ...Temperature logs for refrigerators and vaccines that contain vaccines are recorded at the beginning and at the end of the day. "

According to the Centers for Disease Control publication Mortality and Morbidity Weekly Report dated 12/01/06 vol.55 in the entitled publication General Recommendations on Immunization indicated " Temperature monitoring is a critical component of cold chain management. One person in the office should be assigned primary responsibility for maintaining temperature logs, with a second person assigned as backup. Temperatures for both the refrigerator and freezer should be documented twice a day and recorded. The backup person should review the log each week ...Thermometers should be placed in a central location in each compartment near the vaccine "
According to the All facilities letter from the California Department of Public Health dated 12/10/09 entitled Medication Safety: Storage of Medications Requiring Refrigeration indicated " Failure to store medications at the appropriate temperature, as specified by the manufacturer, can have significant impact on patient care. Numerous medications have minimal tolerances for temperatures outside a relatively narrow range and once the manufacturer ' s established limits are breached, the product may be rendered less than optimally effective or ineffective. This is particularly true for the majority of vaccines ... For refrigerators used to store vaccines, the temperature should be monitored and recorded twice a day. "
During an interview on 08/24/10 at 1:15 pm the DOP stated that the pharmacy did not document and monitor the refrigerated vaccines twice daily. He also stated that he did not know why the refrigerators were not being monitored and temperatures were not being documented twice a day. He acknowledged that the pharmacy was not following the Centers for Disease Control guidelines and the all facilities letter that was sent by the California Department of Public Health.

A review of the IV room medication refrigerator (contained vaccines) temperature logs, for the months of May, June, July, and August; indicated there were no documented twice daily refrigerator temperatures as required per hospital policy.

A review of the Outpatient Pharmacy medication refrigerator (contained vaccines) temperature logs, for the months of January, February, March, April, May, June, July, and August; indicated there were no documented twice daily refrigerator temperatures as required per hospital policy.

3. During an interview at 10:55 a.m. on 8/24/10, RN 32 stated that new medication orders written by physicians when the pharmacy was closed were not reviewed by a pharmacist prior to the medications being administered. RN 32 added that there was no after-hour process to review such physicians' orders for appropriateness before the first dose was administered. RN 32 further stated that if she needed to administer medications for new orders during those hours, she would have to get the medications from the automated drug dispensing cabinet using the override function or to ask a nursing supervisor to obtain the medications from the pharmacy night locker.

During an interview at 10:00 a.m. on 8/26/10, the hospital DOP stated that the hospital pharmacy hours were 7 a.m. to 10 p.m. Monday to Friday and 7 a.m. to 6 p.m. on Saturday and Sunday. DOP further stated that physicians' orders for medication written during the hours when the pharmacy was closed were not reviewed by a pharmacist until the pharmacy opened at 7 a.m. the following day The DOP stated that the reason for not having a pharmacist reviewing medication orders for 9 of 24 hours on weekdays and 13 of 24 hours on the weekends was because it was not cost -effective to hire a night shift pharmacist or to contract the service out during those hours.

An audit of the physicians' written medication orders from 6 p.m. to 7 a.m. on 8/28/10 and 8/29/10 on 8/30/10 showed 45 and 32 physicians' orders respectively were not reviewed by a pharmacist until the pharmacy opened again at 7:00 a.m. the following day. Administrative staff 2 stated that medications that were due for administration prior to the pharmacy opened the next day would have been administered to patients prior to the orders being reviewed by a pharmacist.

The American Society of Health-System Pharmacists published guidelines on minimum standards for pharmacies in hospitals stated that all prescribers ' medication orders (except in emergency situations) must be reviewed for appropriateness by a pharmacist before the first dose is dispensed.


4. During an interview on 08/25/10 at 10:47 am the DOP stated there were unaccounted medications in Pyxis machines (automated dispensing cabinets). He also stated he was not aware of the actual causes of the unaccounted medications (missing and extra doses) because it had not been investigated. He acknowledged that Pharmacy was responsible for accounting for all medications administered within the hospital.

A review of a monthly discrepancy report for non-narcotic medications in the Pyxis machines indicated a report of the quantity of unaccounted for medications (missing and extra doses) for a one month audit from 07/26/10 to 08/25/10. The total unaccounted number of doses was 202 missing or extra doses of medications.

The interviewed DOP on 08/26/10 at 1:20 pm stated that the Pyxis drawers were matrix drawers (drawers with open pockets). The nurses could accidently take the wrong medication, give extra, or not give the medications which would cause medication errors. When patients are given too much medication, not administered medication or given the wrong medication these types of medication errors could cause significant harm and/or death. The DOP acknowledged that these unaccounted medications should be investigated.

5. An observation on 08/24/10 at 1:30 pm in the IV room revealed several IV bags outside of the overwrap without any updated expiration dates. The IV bags were solutions from 50 ml to 1000 ml.

According to the Baxter letter dated 04/27/10 indicated " The purpose of the overwrap pouch is to retard moisture evaporation ....Water will permeate the container wall and dissipate into the surrounding atmosphere as water vapor in response to the concentration gradient of water vapor inside versus outside the container ...When water transpires from a solution, there will be a corresponding increase in the concentration of any drug in solution ...Storage recommendations (maximum time out of overwrap ...50 ml or less 15 days ...100 ml or greater 30 days. "

In an interview on 08/24/10 at 1:30 pm the DOP stated that they were not updating the expirations dates when taking intravenous solutions (IV) bags out of their overwrap. There were IV bags distributed throughout the hospital without the updated expiration dates for IV bags out of their overwrap. He acknowledged that IV bags out of their overwrap throughout the hospital units maybe expired and would be used for patient use.

6a. During medication administration observation at approximately 8:35 a.m. on 8/24/10, Patient 42 was observed being administered 6 tablets of Spironolactone 25mg by RN 33, a total dose of 150mg of Spironolactone.
Spironolactone is a diuretic indicated for the management of congestive heart failiure and edema.
A review of Patient 42 ' s clinical record on 8/24/10 at 9:00 a.m. showed that the admitting physician signed the medication reconciliation form to continue Patient 42 on Spironolactone 50mg daily (the dose Patient 42 was on prior to admission) and also wrote another order for Spironolactone 100mg daily at 5:00 p.m. on 8/21/10. There was no documented clarification of the duplicated orders with the physician. Patient 42 ' s medication administration record showed that the patient was administered 150mg of Spironolactone on 8/23/10 and 8/24/10.

During an interview at approximately10:45 a.m. 8/2/10, the DOP stated that the administration of 150mg of Spironolactone to Patient 42 was an error made by the pharmacy. The DOP further stated that the reviewing pharmacist should have contacted the prescribing physician to clarify the orders.

6b. A review of Patient 21 ' s clinical record on 8/24/10 showed that on a pre-printed admission order dated 8/20/10, Physician 32 ordered morphine 1mg every one hour with route of administration checked off for all route of administration including " orally " , " IV " (intravenously) and " IM " (intramuscularly).

Morphine is a narcotic medication for pain relief. According to Lexi-Comp, a national drug information provider for health care professionals, the bioavailability of oral morphine is about 17% to 33% of morphine by parenteral (IV/IM) route and that oral to parenteral effectiveness reportedly varies from 1 to in opiod naive patients to 1 to 3 with chronic use. Bioavailability is a measure of the amount of drug that is actually absorbed from a given dose.


During an interview at approximately10:45 a.m. on 8/25/10, the DOP stated that pharmacy record showed that Patient 21' s morphine order was entered for intravenous route and there was no record that the reviewing pharmacist clarified the order with the physician.

The American Society of Health-System Pharmacists published guidelines on minimum standard for pharmacies in hospitals indicates that all prescribers ' medication orders (except in emergency situations) must be reviewed for appropriateness by a pharmacist before the first dose is dispensed and any questions regarding the order must be resolved with the prescriber at this time, and a written notation of these discussions must be made in the patient ' s medical record or pharmacy copy of the prescriber ' s order. Information concerning changes must be communicated to the appropriate health professional.

Based on interview and record review the hospital failed to identify issues related to unclear Magnetic Resonance Imaging (MRI) images and failed to improve the clarity of the MRI images.

Findings:

During an interview on 08/24/10 at 10:00 am the Radiologist Magnetic Resonance Imaging (MRI) subspecialist stated it was not uncommon to have unclear MRI images. The unclear MRI images occurred daily. He also stated that the cause for the unclear images could be due to multiple reasons which would include patient movement, technologist technique, or equipment problems. He said that he would report these issues to the Radiology Supervisor then the Radiology Supervisor would contact Alliance the contracted company that would scan the patients and then send the MRI images to the Radiologist.

In an interview on 08/24/10 at 10:47 am the Alliance representative stated Alliance had not received complaints of any MRI image issues related to unclear images. She also stated that if there were unclear image issues Alliance would investigate the issues to improve clarity to the MRI images. She said that Alliance relied on communication from the hospital in order to investigate, fine tune, and improve the clarity of the MRI images.

A review of MRI summaries dated for 05/01/10-05/31/10; 06/01/01-06/30/10; and 07/01/10-07/31/10 indicated monthly totals of the number of patients that were scanned for MRI. The average monthly total based on the three months of data indicated an average of 98 patients a month.

During an interview on 08/26/10 at 12:54 pm the Radiologist MRI subspecialist stated that there were many methods and techniques to improve MRI image quality. He acknowledged that improving MRI clarity would help Radiologists identify pathology.

The interviewed Deputy Director stated on 08/26/10 at 12:20 pm stated that the Radiology department had not looked into improving the MRI images. She also stated the lack of clarity of the MRI images had not been identified as a problem.

Based on observation, staff interview and document review the hospital failed to ensure that the dietetic service department had been organized administratively for the delivery of both foodservice and clinical nutrition care. By not having an organized department there was the potential for unsafe, unhealthful nutrition care in a hospital with a licensed bed capacity for 509 patients.

Findings:

1. On 8/23/10 between 10:30 a.m. and 10:45 a.m. while in an administrative conference room, initial interview with the Dietetic Service Manager revealed that there had been "no substantial changes in staffing in the past year" despite the failure to have documentation to support the on-going scheduling or work of the "Lead Clinical RD" . However, on 8/24/10 at 1 :40 p.m. Dietitian 1 reported that there had not been "a full-time Lead Clinical RD since February" and on 8/24/10 at 2:45 p.m. Dietitian 2 corroborated this. As reported by both Dietitian 1 and Dietitian 2 they had assumed the duties of the Lead Clinical RD, been consulting for community nutrition programs (e.g. Meals on Wheels, Congregate Meal Program, Child Care Food Program and Head Start) and internal services (e.g. for the cafeteria service Heart Healthy Program which provided foods for visitors and staff, not patients), conducted policy and menu reviews, consulted for non general acute care services within their assigned time to serve the general acute care patients and had not been able to cover outpatient renal, pediatric and mental health services. On 8/31/10 at 3 p.m. review of the job description for the Lead Dietitian revealed that the duties assumed by Dietitian 1 and Dietitian 2 had been those identified in this job description.

Although review of data collection, inclusive of timeliness of services had been done per review on 8/31/10 by 4 p.m., it was incomplete as it had not captured: the inability for membership and attendance on committees, e.g. Pharmacy and Therapeutics; the failure to completely cover outpatient services; the lack of ongoing education for medical and nursing staffs; and the lack of involvement in guiding the Dietetic Service Manager in patient foodservice which had dietetic service staff who had unsafe practices and a foodservice with cross-contaminating, unsanitary conditions, e.g. the failure to track shelf-life of foods and temperatures of food during all phases of production--given use of blast-chilling for early preparation and storage, chill-plating and rethermalization.

2. On 8/24/10 between 1:40 p.m. and 2:20 p.m. while in an administrative conference room review of hospital policies and procedures with the Dietetic Service Manager, Dietitian 1 and Dietitian 2 revealed that at least one-fourth of the manual was under revision such that there were edits, insertions and deletions and that there was no intact, approved manual for reference by medical and nursing staff as well as dietetic service and other staff. Policies referred to practitioners other than physicians and osteopaths as the health care prescribers authorized to order tests and modify diets, inclusive of liquid supplements. Further, although there was interdepartmental documentation to show that the a policy pertaining to dietetic practice practice had been rescinded and there was no observed or documented implementation during the survey, at 2:20 p.m. both Dietitian 1 and Dietitian 2 stated that it had been an oversight to have retained it in the manual.

Policies also referred to Diet Technicians--a position which did not exist at the hospital and,meal service interval greater than 14 hours between dinner and breakfast the subsequent day At 2:20 p.m. Dietitian 1 stated that the policies were "in error" and that she had not been aware of the extended meal interval which could have potentially affected patient care, e.g. coordination with medication administration and timing of treatments and services..

3. On 8/24/10 between 1:40 p.m. and 2:20 p.m. while in an administrative conference room review of departmental systems with Dietitian 1 and Dietitian 2 revealed that: patient profile cards (rands) had not been utilized within the past year; there were no pediatric menus for regular and emergency/disaster service; and that there had been a failure to ensure continuing education for dietitians in this specialty area and this was of concern given only sporadic, acute care admissions of infants, children and adolescents. Also, there was no list of menu substitutions for therapeutic and modified diets; a lack of professional reference for the calculation of caloric and fluid needs during fever; and the lack of a medically-approved, defined transitional feeding plan for patients who have been on long term nutrition support and are advancing to oral diets. Additionally, on 9/1/10 at 2 p.m. while in an administrative conference room, Dietitian 1 and Dietitian 2 stated that they had not had the "time" to have ensured these standards due to their multiple responsibilities.

4. On 8/24/10 between 1:40 p.m. and 2:20 p.m. while in an administrative conference room reviewing departmental systems, Dietitian 1 stated that scheduled rounds and conferences as well as the continuing education records of hospital dietitians revealed that there had not been any educational updates pertaining to the nutritional needs of psychiatric patients, inclusive of food-drug interactions and items pertaining to eating behaviors and disorders. The latter was of relevance as review of the schedule for afternoon nourishments (snacks) was at 3 p.m. per policy, yet a sign observed in the psychiatric unit on 8/27/10 at 4:30 p.m. identified the delivery to be at 4 p.m.

On 8/27/10 at 4:20 p.m. upon completion of two medical record reviews (Patient 58, admitted 8/16/10 who was obese and Patient 59, admitted 8/24/10 who was an obese diabetic) revealed lack of attention to the types and amounts of snacks provided. The reviews, conducted on the psychiatric unit with Dietitian 2 and finding that there had been the failure on the part of nursing staff to have documented the types and amounts of snacks and the corresponding failures to coordinate with the dietetic service staff as to the types of foods meeting the nutritional needs of these patients, Dietitian 2 stated that there needed to be "a better system" for providing nourishments .Of concern was the inability of Nurse Z as well as Dietitian 2 to track the amount and types of snack foods consumed by Patient 59 who as of 8/25/10 was on an 1800 Calorie, Low Fat, Low Cholesterol diet.

5. On 8/23/10 between 2:30 p.m. and 3 p.m. while in an administrative conference room review of the organizational chart with the Dietetic Service Manager revealed that he no longer reported to the manager within Support Services due to vacancy and that per concurrent verbal report he had reported concerns to administration. However, as of conclusion of the survey on 9/1/10, neither he nor the two dietitians (Dietitian 1 and Dietitian 2) providing coverage for the "Lead Clinical RD" could demonstrate that there had been an intact system, inclusive of a quality assurance program to identify, monitor, intervene, remediate and document chronic, well-known problems.

These problems identified by 9/1/10 included: non-adherence to job descriptions; insufficient coverage of outpatient services; inability to represent clinical nutrition services on the P&T Committee, lack of time to provide advice, continuing education and guidance; lack of continuous follow-through of implementing foodservice safety and sanitation standards; the failure to have an approved current departmental manual for policies and procedures; the discontinued use of rands; the lack of developed, consistent and maintained pediatric menus for regular and emergency/disaster conditions; the omission of attendance at conferences specific to the needs of pediatric and psychiatric patients; the inattention to the need to use references specific to food choices, caloric and fluid needs during fever and transitional feeding; and the failure to have reviewed the scheduling of nourishments which may be necessary in light of coordinating patient care.

Based on observation, staff interview and document review the hospital failed to ensure that the dietetic service department had a dietetic service manager responsible for daily management of the department so as to ensure organization, healthful nutrition care and a safe, sanitary foodservice. By not having such oversight there was the potential for systemic failures in clinical nutrition and foodservice which could compromise patient safety in a hospital licensed for 509 patients.

Findings:

1.On 8/24/10 between 11:15 a.m. and 11:50 a.m. while in an administrative conference room reviewing contracts for outside services pertinent to the dietetic service department (i.e. for tube feeding pump usage, pest control, dishmachine servicing and a vending service revealed that these contracts had not included administrative authority, e.g. for surveillance Also, there had been the failure to have these service incorporated in the hospital-wide quality assurance program. At 11:50 a.m. both the Dietetic Service Manager and the Materials Management Director acknowledged these oversights and potentials for lack of safety, e.g. during tube feeding administration, preventative treatment for pests, dishmachine maintenance and dispensing of hot beverages.

2.On 8/24/10 between 1:40 p.m. and 2:20 p.m. while in an administrative conference room, review of departmental systems requiring review of documents revealed that there had been a lack of managerial oversight for: maintenance of a current, intact manual for departmental policies and procedures; use of patient profile cards (rands); development of pediatric menus sets for regular and emergency/disaster conditions; a plan for registered dietitians to attend and provide continuing education programs; and have departmental materials, i.e. a list of menu substitutes for patients on therapeutic and modified diets. As of 2:20 p.m. both Dietitian 1 and Dietitian 2 stated upon review of the documents and absence thereof that they had been aware of the potentials for negative impact in clinical nutrition care. Further, at 2:20 p.m. the Dietetic Service Manager confirmed that these concerns had not yet been addressed.

3. On 8/25/10 between 12:25 p.m .and 12:45 p.m. while in the kitchen there were unsafe, unsanitary conditions increasing the potential for foodborne illness. These included the failures to have ensured that refrigerated, potentially hazardous foods had been effectively chilled during cool-down and that there had been both a reference and surveillance to demonstrate that foods had not been kept past recommended shelf-life to ensure not only quality, but food safety. As such, there was the potential for unsafe service of cooked cereals, refried beans, and scrambled eggs (though made from pasteurized eggs) due to respective inattention to labeling and dating of production and use-by dates for the cereals and eggs as well as the failure to have documented the temperatures during cool-down of a wheat cereal and refried beans.

Observation at 12:25 p.m. in a walk-in refrigerator revealed portioned wheat cereal was at 50 degrees F and refried beans were at 55 degrees F. Upon questioning why the foods were at these temperatures (rather than 41 degrees F or below) irrespective of instrumentation showing the capacity to have ambient air temperature at 39 degrees F-41 degrees F, the Dietetic Service Manager at 12:55 p.m. attributed it to periodic exposure to warm ambient air temperature of the kitchen during portioning, panning, transfer and periodic exposure during stocking and procurement. However, due to the absence of documented time/temperature controls, at 12:30 p.m. the Dietetic Service Manager stated that these foods would have to be discarded.

Observation at 12:40 p.m. in a walk-in refrigerator revealed that there were 14 pans (containing at least 25 servings each) of prepared hot cereals (i.e. Malt-O-Meal, oatmeal and Cream of Wheat) which had been kept in excess of the " three day standard " reported by the Dietetic Service Manager and hence the potential for unsafe as well as unappealing service of these foods to patients as labeling indicated four to nine day intervals from production to use-by.

Although the Dietetic Service Manager doubted per observation and scheduled service that the cereals more than four days had or would be served, at 12:40 p.m. he acknowledged departure from stated standard. By 12:45 p.m. the Dietetic Service Manager stated that all foods " more than three days old " would be discarded and added that the inattention to accuracy in labeling and dating was a " concern " that could create " problems " . Likewise, by 12:45 p.m. the Dietetic Service Manager had the scrambled eggs removed from potential service and stated that there needed to be more surveillance of retained, prepared foods. The Dietetic Service Manager added that he would discuss " this item " with the Infection Control Nurse and " get some references " .

4.On 8/31/10 between 3:45 p.m. and 4 p.m. while in administrative conference room review of departmental records (e.g. job descriptions, scheduling, committee memberships and quality assurance data) following interviews with Dietitian 1 and Dietitian 2 on 8/24/10 between 1:40 p.m. and 2:45 p.m. revealed failures in clinical nutrition care. There had been the failure to ensure that in the absence of a Lead Dietitian for at least six months that there had been replacement clinical nutrition management staffing to meet the job specifications for this position. Without this replacement, full-time registered dietitians typically assigned patient care services were working beyond the scope of their job descriptions and in doing so, failing to: participate in hospital committees pertinent to patient care (e.g. Pharmacy and Therapeutics); meet patient needs in specialty clinics; and identify continuing education needs for medical and nursing staffs. The latter included: transitional feeding; special dietary concerns for pediatric and psychiatric patients; and importance of weight data in tracking patients ' nutritional status.

Based on observation, staff interview and document review the hospital failed to ensure that there were competent dietetic service staff. By not having competent dietetic service staff, there was the potential for the service of food that was not appealing and which could cause diminished food intake.

Finding:

1. On 8/23/10 between 12:55 p.m. and 1:30 p.m. while in the kitchen, trayline observation of chill-plating breakfast foods for the following day revealed that fried eggs were at 46 degrees F to 50 degrees F (rather than the maximum for chilled foods, 41 degrees F) and sausage was at 45 degrees F. At 1:20 p.m. the Dietetic Service Manager stated that the eggs and sausage had been previously blast-chilled and refrigerated. The Dietetic Service Manager stated that while the form (document) presented was lacking in regards to timing of entries pertaining to temperature (as is standard for food safety), there was uncertainty as to effect on food quality given the potential for periodic substantive increased temperature. Although the Dietetic Service Manager stated at 1:30 p.m. that he recognized the inability of dietetic service staff to maintain temperature at or below 41 degrees F as "a problem" and directed dietetic service staff to discard the two foods, there was no explanation provided by dietetic service staff as to how this occurred.

2. On 8/25/10 between 12:25 p.m. and 12:45 p.m. while inspecting two kitchen walk-in refrigerators, there were observed departures from safe food storage, including 14 pans (containing at least 25 servings each) of prepared hot cereals (i.e. Malt-O-Meal, oatmeal and Cream of Wheat) and a pan of scrambled eggs which had labels indicating production and use-by intervals greater than the three-day interval stated by the Dietetic Service Manager. Also, there was the failure to have documented cool-down of two foods, a wheat cereal and refried beans. These conditions and practices resulted in discard and the conclusion of the Dietetic Service Manager at 12:50 p.m. that " staff need training here."

Based on closed medical record and document reviews as well as staff interview the hospital failed to ensure that nutritional needs had been met in accordance with recognized dietary practices and the orders of the practitioners. By not having this adherence there was the potential for problems in transitional feeding in addition and not meeting nutritional needs (Patient 37) as well as the potential for pediatric patients to not have nutritional needs met in accord with professional standards as well as prescribed diet. (Patient 61 and Patient 62).

Findings:

1. Patient 37 was an adult male admitted 8/9/10. Patient 37 was admitted with an esophageal perforation and had medical history and diagnoses including;necrotizing neck infection and abscess post debridement as well as rectal cancer with metastases to the liver (although the admission nursing screen had failed to capture this potential GI (gastrointestinal) problem, hypertension, diabetes and osteomyelitis During the duration of stay (part of which was during the survey) Patient 37 received care in the ER, ICU and a unit on the second floor.

Medical Record review on 8/24/10 review between 3:30 p.m. and 4 p.m. revealed that Patient 37 who was five feet, three inches tall and who had weighed 57.2 kg (125.84 lbs) upon admission had been on nutrition support (i.e. intravenous, peripheral parenteral nutrition) until a diet trial was conducted on 8/23/10 indicating potential for a puree diet was deemed possible. However, during the duration of stay: there had not been any daily weight data while in the ICU; the on-going nutrition assessments had neither referenced weight goal nor need to monitor weight although the form of nutrition support was identified by Dietitian 1 as not meeting caloric needs; and when weighed on 8/24/10, Patient 37 weighed "103 lbs". Further, upon interview of Patient 37 on 8/24/10 at 4 p.m. he stated that neither he nor a surrogate decision -maker had been informed regarding the mode of feeding and had not been aware of his severe weight loss and further review of the medical record revealed that these items had not been addressed with the patient.

On 8/24/10 at 4 p.m. Dietitian 1 stated that there was on-going concern regarding Patient 37's potential for transitioning to an oral diet, not only from the standpoint of needing to have the capacity to safely swallow, but the duration of the mode of nutrition support increased the potential for intolerances (e.g. to lactose-containing foods and foods high in fat) during refeeding which could result in gastric problems, poor intake and overall failure to transition. Dietitian 1 added that she had not presented these concerns to the Pharmacy and Therapeutics Committee because there was no representation by a registered dietitian on this committee.

Further, on 8/24/10 while weighing Patient 37, Nurse Z stated that there were no standards available to review for the method of taking weight and this was of concern. Patient 37 was weighed in a chair scale, with a towel on the seat and he was wearing pajama bottoms, a cap, a gown and shoes. When initially weighed, Nurse Z stated Patient 37's weight as 47.6 kg (104.72 lbs) and then subsequently estimated the subtracted weight of clothing and shoes to derive the weight of "103 lbs". Nurse Z added that he had not been aware of Patient 37's recent severe weight loss during hospitalization in part due to the lack of documentation and lack of correlation with actual intake.

2. During record review on 8/31/10 of the nutritional care of two pediatric patients indicated that Patient 61 admitted and discharged on 8/19/10 was diagnosed with asthma exacerbation, acute respiratory infection, contact dermatitis/eczema and had allergies to eggs and seafood. Patient 62 --admitted 8/18/10 and discharged 8/19/10 was diagnosed with gastroenteritis, vomiting, abdominal pain and bloody diarrhea. Both patients had vague diet orders. Patient 61 had a vague diet order, "Diet age appropriate" and Patient 62 had an order for "Clears and advance special diet as tolerated". Upon interview with Dietitian 1 on 8/31/10, ending at 4:30 p.m. she disclosed that for pediatric patients, each admission had: required time-consuming verification of intended diet; potential for errors in planning in the event of unknown functional incapacities and possible decompensation during hospitalization; on-going inconsistency in regards to diet terminology (as found in the hospital diet manual versus prescribed diet); and the failure to have retained documentation pertaining to individualized diets in both the medical records and departmental documents.

Based on observation and interview, the facility failed to ensure safe egress from a fire when: one of the two exit doors in the Infusion Center was blocked by a bench and on two occasions.


Findings:

On 8/30/10 at 11 a.m., during a tour of the Infusion Center (a small space, with several alcoves and large padded chairs sitting a few inches behind a privacy curtain near the front door) it was noted that the one of the exit doors was blocked by a visitor who was sitting on a bench , with her things spread out, next to the patient, in the back part of the room. This door led to the hallway that could be used as egress during fire or other emergency requiring an evacuation.

On 8/31/10 at 2:40 p.m., a second visit was made to the Infusion Center. The was bench with storage cubes underneath it was found blocking the back door again.
The Infusion Nurse 1 acknowledged that it was important to keep exit doors free of obstruction and removed the bench to allow free access to the exit door.

On 8/31/10 at 2:45 p.m., Infusion Nurse 1 was asked if they ever have patients in wheelchairs in the Infusion Center. She stated sometimes but the patient must be able to transfer from the wheelchair to the padded chair in the room. When asked where the wheelchairs are kept as the space is quite small (and more stored items could impede an evacuation), she stated the patient's wheelchair is folded and if it is the hospital's wheelchair it is returned to the hospital.

At 3:05 p.m. on 8/31/10, the Acute Care Manager stated that ideally they would like more space in the Infusion Center.

Based on staff interview, the facility failed to ensure that two staff were knowledgeable of their responsibilities during fire to ensure safety of patients, staff and visitors when one housekeeping staff in Nursing Unit 2 AB and one MSA II (Certified Nursing Assistant) from Infusion Center were not able to describe the procedure for operating the fire extinguisher.

Findings:

During an interview with Housekeeking Staff 1 on 8/26/10 at 2:00 PM, she stated that she has been employed in th facility for 9 years. She was asked if she knew how to operate a fire extinguisher. She said, "I am not sure how to use it. I will ask my supervisior."operating thee fire extinguisher.

During an interview on 8/31/10 at 3:20 PM with a MSA II from the Infusion Center, she could not describe the procedure for using the fire extinguisher.

Based on observation, staff interview and document review the hospital failed to ensure that facilities, supplies and equipment had been maintained to ensure an acceptable level of safety and quality. By not having ensured safety and quality, there were potentials for injury, contamination, unsightliness, attraction of pests, inaccurate surveillance, unsafe emergency/disaster water treatment and undetected depletion of supplies.

Findings:

1. On 8/25/10 between 11:40 a.m. and 11:59 a.m. during the inspection of the kitchen and ancillary areas there were potentially hazardous conditions. In the dry storage room there was a flickering florescent insect zapper and in the chemical closet there was a dangling metal mesh ceiling light cover . Also, the room had shelved chemical solutions within eighteen inches of two stacks of five cardboard boxes filled with used departmental forms. At 11:59 a.m. the Dietetic Service Manager acknowledged the potentially hazardous conditions and the need for remediation.

2. On 8/25/10 between noon. and 12:16 p.m. during the inspection of outdoor refuse disposal with the Dietetic Service Manager there were two concerns. One was the failure to have secured (locked) a large mechanical compactor and the other was the failure to have covered and contained food debris and organic materials in a dumpster designated for composting. At 12:02 p.m. the Dietetic Service Manager stated that he had been surprised by the failure of staff to have kept the compactor secure as it posed a potential threat to wandering individuals. Upon this identification, the Dietetic Service Manager concurrently learned from a staff member that the compactor had been left in this condition for "two years". Also, upon further inspection of the compost bin and finding it odorous and attracting flying insects, the Dietetic Service Manager stated at 12:16 p.m. that the refuse needed to be kept "under sanitary conditions".

3. On 8/25/10 between 12:20 p.m. and 1 p.m. inspection of kitchen refrigerators and freezers revealed inoperable, malfunctioning equipment. There was: a trayline refrigerator stocked with milk which had an internal thermometer registering 26 degrees F (six degrees below the freezing point of water); a walk-in refrigerator with frayed insulation below the compressor; and a reach-in freezer stocked with frozen foods which had an unreadable internal thermometer. At 1 p.m. the Dietetic Service Manager stated that the thermometers and insulation needed to be replaced.

4. On 8/25/10 between 1:30 p.m. and 1:35 p.m. inspection of the emergency/disaster plans and storage revealed that while there was the potential for disinfection of non-potable water using a commercial grade bleach, there had not been specificity as to product usage, given that bleach products may contain unhealthful additives e.g. dyes and fragrances which are unsuitable for consumption and which lack manufacturer's use directions for disinfecting water for consumption. At 1:35 p.m. the Dietetic Service Manager acknowledged the potential for unsafe usage and the need to revise the plan.

5. On 9/1/10 between 2 p.m. and 2:05 p.m. inspection of the emergency/disaster storage room revealed that while the policies and procedures had included all diets except pediatric types, the only plan posted was the Regular Diet for adult patients. Further, although there was ample tank water outdoors to meet the needs of patients and staff, there had been pilferage as four 16.9 oz bottles of water formerly in a plastic wrapped case were missing. At 2:05 p.m. Dietetic Supervisor 1 stated that he had not been aware of the status of the menus and the pilferage and stated he was concerned, given that the room had been locked.

Based on observation, interview, and record review the hospital failed to implement a system to maintain and control infections and communicable diseases of patients and personnel by not doing the following:
1. Maintain a sanitary environment when a bloody test strip was left in one glucoscan (a machine to test blood sugar) ; 2 staff did not know how to properly clean the glucose meters; there were no records indicating who cleaned the meters or when they were cleaned.
2. Ensure a safe, sanitary food service operation for the storage, preparation, distribution and service of food.
3. Screen hospital staff for tuberculosis.

Findings:

1. During a tour of the SSU (Short Stay Unit) on 8/30/10 at 10:35 a.m., the Short Stay Unit Nurse was asked to demonstrate the procedure for cleaning the glucoscan. She brought out the machine and found a test strip with dried blood left inserted in the strip holder of the machine. The SSU Nurse immediately removed the test strip and threw it in the waste basket. She stated the machine was cleaned once a day, not after every patient use, with Gluco-Chor (a bleach pad).

2. During a tour of the Medical Surgical Unit (2B) on 8/30/10 at 3:45 p.m., RN 2 (Registered Nurse) stated that the night shift usually cleans the glucose meters with a "Chlorascrub Swab" which contained Chlorhexidine Gluconate 3.15% and Isopropyl Alcohol 70%. She then used this swab to clean the part of the machine that reads the test strip. RN 2 said the glucose machine was sensitive and that alcohol should not be used to clean it. RN 2 stated that the bottles of test reagents that are used to test the machine to see if it is working properly are good for 28 days once opened.

At 3:55 p.m. on 8/30/10, RN 1who was also the Nurse Educator, stated that Gluco-Chlor must be used to clean the glucose meter and test reagents are good for 90 days after the bottle is opened.

3. During a tour of the Medical Surgical Unit (2A) on 8/30/10 at 4 p.m., RN 3 stated that the glucose meters were cleaned by the night shift. When asked to demonstrate how the machine was cleaned, she took it out of the case and said it was washed in the sink and walked toward the sink with the meter. She stopped before reaching the sink. She stated that bottles of test reagents were good for 28 days and that bottles of Chemstrips were good until consumed.

When asked for a policy about cleaning the glucose meters (glucometers), the hospital responded with a memo dated 4/1/10 from the "POCT Co-ordinator." This memo indicated "As a safeguard to prevent the spread of infectious diseases, glucometers . . . must be de-contaminated after EACH (emphasis theirs) use. Cleaning of the instrument is accomplished through use of Gluco-Chlor (10% bleach) wipe . . . Do not use household bleach or alcohol as these products can be harmful to the instrument. Clean the outside of the device with the wipe. A 5 minute contact is recommended for effectiveness against organisms. Residual bleach may be removed with a cloth moistened with water."

The staff in the units above stated there were no records kept that documented when the glucose meters were cleaned or who cleaned the meters.









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4. On 8/25/10 between 11:51 a.m. and 11:58 a.m. inspection of the kitchen dry storage room revealed unsanitary conditions.

a. At 11:51 a.m. there were three dislodged, dusty ceiling panels immediately above food packages and canned goods and at least three flying insects. Two dislodged ceiling panels were near the entrance and the other was within the room. At 11:55 a.m.the Dietetic Service Manager stated that the area immediately above the ceiling was vacant crawl space and that "despite treatment", there was an on-going problem "with flies".

b. At 11:56 a.m. on a rolling rack there was a #10 can (which contains 20-25 half-cup servings) of mandarin oranges with a rim dent and on a shelf, a #10 can containing cherry pie filling with a rim dent. At 11:58 a.m. the Dietetic Service Manager stated that although there was a subsequent inspection by dietetic service staff prior to food preparation, he was surprised by the condition of the cans as they had been inspected prior to placement in the rack.

5. On 8/25/10 between 11:59 a.m. and 12:20 p.m. inspection of kitchen ancillary areas revealed unsanitary, potentially cross-contaminating conditions. In one area off a main corridor, there was an uncovered hamper filled with soiled work shirts and in an alcove there were two uncovered hampers filled with a variety of soiled cloth items and synthetic work gloves with food debris. In one instance, there were sleeves of clean cloth work tops touching the rim of one of the hampers. At 12:20 p.m. the Dietetic Service Manager commenced taking pictures, "so that I can inservice the staff about this problem"

6. On 8/25/10 between 12:18 p.m. and 12:57 p.m. inspection of ice storage as well as the conditions with refrigerated and frozen storage revealed unsafe, unsanitary and potentially cross-contaminating conditions.

a. At 12:18 p.m. within two feet of an ice bin there was an uncovered scoop for the procurement of ice and upon opening the door of the bin, there was a thin streak of brown liquid of uncertain origin at least six inches long on the gasket. At 12:18 p.m. the Dietetic Service Manager stated that there should have been a cover for the scoop and that he was surprised by the presence of the brown liquid as there had been "monthly cleaning" inclusive of use of a sanitizing agent. However, upon review of records, he stated that the last time the bin had been cleaned was on 8/2/10 and that he was uncertain as to the consistent use of the (same) sanitizing agent. Further, as of 8/27/10 at 3 p.m. he stated that he did not know what the manufacturer of the ice bin had recommended as safe, effective products for cleaning and sanitizing the bin.

b. At 12:25 p.m. in a walk-in refrigerator, there was a deep individual serving bowl containing cooked wheat cereal which was at 50 degrees F (which is nine degrees above the maximum for safe chilling, 41 degrees F) and another pan filled with refried beans at 55 degrees F although the gauge registered 39 degrees F. Although the internal thermometer momentarily rose to 46.5 degrees F, it quickly dropped to 41 degrees F , but it remained unclear as to the frequency and duration of stocking and procuring foods which could cause ambient air temperature elevation

Additionally, despite the verbal report by the Dietetic Service Manager at 12:30 p.m. that both foods had been blast-chilled to sub-refrigeration temperatures prior to portioning, panning and placement, he could not locate any time/temperature records for cooling and as a consequence directed dietetic service staff to discard the foods.

c. At 12:40 p.m.in another walk-in refrigerator there were pans of foods which upon inspection had been misdated as to production and use-by dates. These included: a pan of Malt-O-Meal dated 8/26 for production date and 9/3 for use-by; a pan of oatmeal with a production date of 8/29 and a use-by date of 9/2; a pan of oatmeal with a production date of 8/27/10 and a use-by date of 9/2; a pan of oatmeal with a production date of 8/29 and a use-by date of 9/3; four pans of Cream of Wheat dated 8/23 for production date and 9/1 for use by; four pans of oatmeal dated 8/29 for production and 9/3 for use-by, two pans of Malt-O-Meal dated 8/26 for production and 9/3 for use-by; a pan of cooked, pureed scrambled eggs dated 8/24 for production and 9/1 for use-by. At 12:45 p.m.Dietetic Service Manager stated that he was "surprised" by these errors as well as the lack of surveillance which he stated necessitated discard of the questionable foods and replenishment.

When reviewed by the Dietetic Service Manager between 12:45 p.m. and 12:48 p.m. he stated that none of the identified foods should have been kept past three days and that the reason why Dietetic Service Staff 1 had made the errors was due to not being certain of the calendar date and probably not knowing that August had 31 days in the month. Further, the Dietetic Service Manager attributed the errors to uncertainty regarding shelf-life of foods and lack of a reference for dietetic service staff.

d. At 12:50 p.m.in a stocked walk-in refrigerator there was a large metal bin (the size of a standard garbage can) which the Dietetic Service Manager stated contained "only grease" which had a lid sprinkled with loose brown matter of uncertain origin. Although shelved foods were covered and more than eighteen inches away, the Dietetic Service Manager stated at 12:52 p.m. that "something should be done".

e. At 12:57 p.m. in a bank of units stocked with foods, there was a reach-in refrigerator with a grimy gasket and above the bank there were two ceiling panels coated with gray and brown matter of uncertain origin. At 12:57 p.m. Engineer 1 stated upon wiping the matter that he thought it was "dust". Likewise, upon inspection of two grimy ceiling vents in this area which was above a food preparation counter where the refrigerated and frozen foods were set-up, he stated, "That's dust too".

7. On 8/25/10 between 1 p.m. and 2:20 p.m. there were unsafe, unsanitary conditions and practices in the kitchen.

a. At 1 p.m. in the pot and pan area , there was a red sanitizing bucket which contained only water (rather than sanitizing solution) and while Dietetic Service Supervisor 1 stated at 1:10 p.m. that its sole use had been for wiping down equipment before sanitizing, he stated that he did not know why dietetic service staff had resorted to this potentially confusing practice, except for possibly-- a lack of wash buckets.

b. At 1:40 p.m. in a hot food preparation area near the steam-jacketed kettles, there was a hose with a spray nozzle left on the wet floor. At 1:40 p.m. the Dietetic Service Manager acknowledged the potential for cross-contamination and removed the hose from the wet floor, but did not direct dietetic service staff to clean and sanitize the spray nozzle.

c. At 2:10 p.m. at the floor level in the food preparation area there was a failure to have a safe air gap (of at least six inches) in one drain area as a pipe drained onto a grated region with less than six inches of clearance, creating the potential for splashing and in another drain, there was a combination of two pipes and a tube creating an insufficient air gap. At 2:10 p.m. the Dietetic Service Manager acknowledged the potential for contamination and need for repair.

d. At 2:20 p.m. in the food preparation area there were five conditions of concern. There was a drawer which had an unprotected roll of plastic wrap and loose white matter of uncertain origin; a nearby unlabeled bin containing white matter which the Dietetic Service Manager stated was "probably flour"; two plastic containers and one measuring pitcher with worn adhesive labels still affixed; three opened boxes of plastic wrap with greasy matter of uncertain origin on the exteriors; and an opened box of aluminum foil with a greasy exterior. At 2:20 p.m. the Dietetic Service Manager stated that he had not been aware of the conditions.

8. On 8/26/10 between 4 p.m. and 4:30 p.m. review of five dietetic service staff health records revealed that four were PPD + (for tuberculosis) and that the most current questionnaire for symptoms for two staff had not been done since 2008, one staff person had not completed a questionnaire since 2005 and another staff person's record revealed that the most current questionnaire was 2003 . For the staff person who was negative as of 2005, this person was tested in 2006, but there was no subsequent questionnaire. At 4:30 p.m. the Infection Control Nurse stated that she had utilized county standards in determining which classifications of employees were exempt from the questionnaires, but could not locate a support reference for this practice. The latter was of concern as two PPD + dietetic service staff had on-going contact with patients and another PPD+ staff person had periodic contact. Internet access on 8/27/10 between 8 a.m. and 8:20 a.m. revealed that there was 2005 CDC (Center for Disease Control) guidance recommending that dietetic service staff be routinely evaluated.






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9. During the record review of hospital staff health files on 8/30/10, there were 3 direct care staff files out of 16 that did not have consistent follow up with their PPD annual screening questionares for tuberculosis. The following staff categories did not have their annual PPD screening questionare done: PTA (physical therapy assistant)since 2008, occupational therapist between 2005 to 2007 and then none during 2009, and a radiology technologist supervisor since 2008.

The facility's policy and procedure, "Infection Control Practitioner Role", number 11.1.4, dated 3/10, documented the following under "Purpose": "The ICP (Infection Control Practitioner) has the primary responsibility for the implementation and coordination of the program of infection control, prevention and surveillance as defined by the Infection Control Program..." The policy further described the role of the ICP to include the following: "Conducts and keeps an accurate record of ongoing surveillance of infections in patients and staff (of the facility)as directed by the Infection Control Committee."

Additionally, the facility's policy and procedure, "Employee Health Program", number 11.2.1, dated 5/10, documented the following under "Purpose": "Infection Control/Employee Health shall perform annual Tuberculin skin testing (TST) or health screening as defined by the job description."

On 9/01/10, the facility presented a document titled, "PPD Job Classifications", for TB screening, dated 9/01/10, and listed the following job classifications that would qualify: RN (registered nurse), LVN (licensed vocational nursing), MSA (medical surgical assistant), radiology tech, rehab, laboratory techs, respiratory, and housekeeping.

During an interview on 8/30/10 at 1:30 PM, the ICP stated that the managers of each department are responsible for their unit's tuberculosis surveillance and she reviews the questionares as they are submitted but she does not have the employee's health files to track past histories at the time of her questionare reviews.

Based on interview and record review, the facility failed to delineate specific surgical privileges for 1 of 8 sampled credentials files (Practitioner 1), failed to follow its requirements for registered nurse first assistants (RNFA's) in 1 of 8 sampled credentials files (Practitioner 7), and failed to follow its own privileging criteria in 1 of 8 sampled credentials files (Practitioner 5). The deficient practices limited the facility's ability to ensure that surgical privileges and prerogatives were granted only in accordance with the demonstrated current competencies of each practitioner.

Findings:

1. Review of Practitioner 1's credentials file indicated that he was a board-certified general surgeon. Practitioner 1's privileges included, "Performance of surgical procedures... to correct or treat various conditions, illnesses, and injuries of the Alimentary Tract; Abdomen (and its contents); Breasts... Endocrine System..." and that no specific surgical procedures were delineated for these regions of the body.

Review of the Surgical Council on Resident Education's (SCORE) General Surgery Residency Curriculum Outline (accessed at http://home.absurgery.org/xfer/curriculumoutline2010-11.pdf) indicated that for each of the categories delineated in Practitioner 1's privileges, there were some specific surgical procedures in which competency could be expected by the end of a surgery residency as well as other surgical procedures which were complex and were "Not consistently performed by general surgeons in training and not typically performed in general surgery practice." The curriculum stated that competence in specific complex procedures was not a requirement of surgery training programs although some programs might "provide sufficient experience for competence" in some of them.

Comparison of Practitioner 1's privileges to the SCORE curriculum indicated that Practitioner 1's privileges by region of the body included complex procedures for which competency could not be inferred based on general surgery training such as total esophagectomy, open retroperitoneal lymph node dissection, stereotactic breast biopsy, and laparoscopic adrenalectomy. Practitioner 1's credentials file did not contain documentation of additional training and experience to support a determination of current competence in these complex procedures.

In an interview on 8/25/10 at 11:41 a.m., Staff B stated that Practitioner 1 and the department chair worked together at another facility and that Practitioner 1 had demonstrated some competencies there, but she did not have documentation of those.

2. Review of Practitioner 7's credentials file indicated that he was an RNFA. The facility's RNFA standardized procedure stated, "The RNFA must: ...demonstrate continued proficiency by taking continuing education courses... Annual performance evaluations on RNFA will be completed by the operating surgeon(s) who were assisted by the RNFA with input by the Nurse Manager of Surgical Services." No documentation of Practitioner 7's continuing education courses or the annual evaluation by the operating surgeons he assisted was present in the portion of Practitioner 7's credentials file addressing the most recent reappointment.

In an interview on 8/25/10 at 3:24 p.m., Staff B stated that the facility did not have documentation of Practitioner 7's continuing education courses.

3. Refer to A-340 regarding the facility's failure to follow its own privileging criteria for Practitioner 5's oral surgery privileges.

Based on interview and record review, the hospital failed to ensure that one of six surgical records reviewed contained the surgeon's complete report of the surgical procedure as required by hospital policy.

Findings:

Patient 39's medical record was reviewed on 8/26/10 at 2 p.m. Patient 39 had surgery on 8/24/10 to remove a mass from the thymus (gland under the breastbone). The "Post-procedure Note" dated 8/24/10 at 10:45 a.m. indicated that Patient 39 lost 400 milliliters of blood. Under the "Findings & explanation" section it indicated "thymus mass." The only indication in the medical record that a tissue specimen was removed for examination was in the Peri-Operative Nursing Record. No other notes were found indicating what happened to Patient 39 during surgery.

The physician checked a box on the 8/24/10 "Post-procedure Note" that indicated the operative report had been dictated. The hospital was unable to produce a copy of this dictation until 8/31/10 at 3:40 p.m. This "Operative Report" indicated it had been dictated six days after surgery on 8/30/10 at 7:10 p.m. It also indicated that Patient 39 lost approximately 200 milliliters of blood (half of the amount from the 8/24/10 estimate). This dictation detailed the surgical procedure and indicated the mass was sent to the pathology laboratory (where specimens are examined for disease).

The hospital's policy, "Med Staff R & R" revised on 5/25/10, indicated the following. "Operative reports shall be dictated immediately after surgery. The report shall include the name of the primary surgeon and assistants, findings, technical procedures used, specimens removed, and postoperative diagnosis . . . When the operative report is not placed in the medical record immediately after surgery, a progress note is entered immediately after completion of the procedure, identifying the planned and actual surgical procedures, post-op diagnosis, and any unusual occurrence/complications. This progress note shall assure continuity of care until the report is available in the chart. When a progress note is entered immediately after completion of the procedure, the full operative report shall be dictated within 24 hours of the procedure."

In an interview and record review with the medical analyst on 9/1/10 at 9:30 a.m., she stated that the operative report was to be dictated immediately unless the surgeon writes a progress note and then they have 24 hours to dictate the report. She said (Patient 39's) operative report was not dictated in this manner. At 10:22 a.m. on 9/1/10, she stated after checking the records, there were no other notes regarding the patient's surgical procedure.

Information about what happened during surgery helps the staff caring for the patient after surgery to plan the patient's care and try to prevent any complications from occurring.