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Based on observation, staff interview, and administrative document review, the hospital failed to comply with the California Code of Regulations Title 22 section 70005(a) when the hospital did not have basic services that included surgical and anesthesia services. This failure resulted in the hospital not complying with the basic definition of a general acute care hospital in California and placed patients who required surgical services at risk of harm when transferred to other local hospitals for surgery.

Findings:

On 6/25/13 at 9:40 a.m., the doors to the operating room (OR) suite were observed to be locked. And the OR was not in use.

On 6/27/13 at 9:50 a.m., the OR suite observation was conducted with the Operating Room Technician Coordinator (ORTC). The hospital had a three bed recovery room with all new equipment. A Certified office for anesthesia was all set up. An equipment storage for an extra anesthesia machine, and portable suction machine was set up and maintained, and instruments were stored in two cabinets. There was a medication cart without medications. There was a central supply area. Two operating rooms were all set to go with equipment in place. There was a decontamination area room with sterile storage. Sterilization was done for small instruments for the emergency department and clinics. All documents for sterilization were in place.

On 6/25/13, at 10:00 a.m., during an interview, the Chief Executive Officer (CEO) stated, "Surgical service has not been operational. The OR has never reopened since the last recertification in 2009. We have been unable to recruit a surgeon."

On 6/27/13 at 9:40 a.m., during an interview, the CEO stated she had submitted numerous candidates for surgery that were rejected by the contracted physician's service even though their background check was done and no issues were detected. She stated she had hired operating room staff, a supervisor, and anesthesia staff. All the operating room equipment was in place, set up, and maintained.

On 6/28/13 at 8:40 a.m., three clinical records of patients (Patients 36, 37 and 38) who were transferred to a higher level of care due to a need for surgical services was reviewed. Patient 36 born on 5/29/78 was transferred to a local hospital on 5/12/13 with a diagnosis of a fracture. Patient 37 born on 5/21/50 was transferred to a local hospital on 4/30/13 with a diagnosis of an abdominal wall abscess (localized pocket of infection) with an intestinal obstruction. Patient 38 born on 9/20/08 was transferred to a local hospital on 9/28/08 with a diagnosis of appendicitis (inflammation of the appendix).

The California Code of Regulation Title 22 stated in section 70005 "General Acute Care Hospital (a) General acute care hospital means a hospital, licensed by the Department, having a duly constituted governing body with overall administrative and professional responsibility and an organized medical staff which provides 24-hour inpatient care, including the following basic services: medical, nursing, surgical, anesthesia, laboratory, radiology, pharmacy and dietary services..."

Based on staff interview and administrative document review, the medical staff failed to have a process by which the competence of medical staff members would be assessed on a periodic basis. The medical staff failed to have a process for reappraising its members when two (2) out of a total of ten (10) credential files examined indicated medical staff members MD 4 and MD 5 had been reappointed with no evidence of periodic appraisals which considered the respective practitioners competencies. These failures placed patients at risk of receiving care from someone not qualified to provide those services.


Findings:

On 6/25/13 at 11:00 a.m., the hospital Medical Staff Bylaws were reviewed. It indicated on page 13 "ARTICLE IV PROCEDURES FOR APPOINTMENT AND REAPPOINTMENT 4.1 GENERAL The Medical Staff shall consider each application for appointment, reappointment and privileges, and each request for modification of Medical Staff category using the procedure and the criteria and standards for membership and clinical privileges set forth in the Bylaws and the Rules. The Medical Staff shall investigate each applicant for appointment or reappointment. The Medical staff shall investigate each applicant for appointment and reappointment and and make an objective, evidence-based decision based upon assessment of the applicant vis-a-vis the hospital's "general competencies". It indicated on page 15 " 4.4-2 BASIS FOR REAPPOINTMENT Recommendation for reappointment to the Medical Staff and for the renewal of privileges shall be based upon a reappraisal of the member's health status, current proficiency in the hospital's general competencies in light of his/her performance at this hospital and in other settings."

The Hospital's Medical Staff Rules and Regulations were reviewed on 6/25/13 at 11:00 a.m.. It indicated on page 7 "RULE IV-2.3 Processing the Application for Reappointment (b) The Committee of the Whole shall appraise his/her performance over the previous two years and shall consider his/her physical and mental health status. The foregoing appraisal shall be documented, together with the appraiser's recommendations for reappointment."

On 6/25/13 at 1:00 p.m., Medical Staff credential files were reviewed with the Chief Executive Officer (CEO) and Credential Coordinator (CC). Review of the credential files revealed 2 (two) out of a total of 10 (ten) practitioner's credential files which showed no evidence of periodic appraisals which demonstrated the practitioner's competence prior to reappointment. CC 2 stated practitioners were not routinely reappointed without appraisals/reappraisals of their competence. She stated MD 4 simply had no hospital admissions with which to evaluate her competence prior to reappointment. She stated MD 5 had no admissions for year prior to his latest reappointment.

On 6/25/13 at 2 p.m., the facility CEO was interviewed. The CEO stated she was familiar with the process by which practitioners were reappointed. She stated there was a process for collecting information which was used to evaluate the competence of practitioners who had previously been given privileges prior to their reappointment. She stated MD 4 and MD 5 had been reappointed without reappraisals as called for in the Medical Staff bylaws, rules and regulations. She stated MD 4's lack of admissions did not allow for an assessment of her competence prior to reappointment as called for in the Medical Staff bylaws, rules and regulations. She stated MD 5's lack of admissions in the year prior to his reappointment did not allow for an assessment of his competence prior to his latest reappointment as called for in the Medical Staff bylaws, rules and regulations. She stated the Governing Body was ultimately responsible for appointments and reappointments.

Based on observation, staff interview, and administrative document review, the hospital failed to monitor the storage condition for medications to ensure storage temperatures were followed as specified by manufactures' recommendations. This failure resulted in medications being stored outside of the recommended temperature range and the risk of administering to patients medications with less than optimal effectiveness.

Findings:

On 6/25/13 at 11:00 a.m., during an inspection of the inpatient pharmacy, a refrigerator containing numerous temperature-sensitive vaccines and protein-based drugs were found inside. Medications included Havrix (vaccine indicated for active immunization against Hepatitis A), Engerix B (vaccine indicated for immunization against Hepatitis B virus), and Imovax Rabies (vaccine indicated for immunization against Rabies) which required refrigeration storage between 2? and 8?C (36? and 46?F) according to their respective manufacture package inserts.

On 6/25/13, review of the current temperature log (June 2013) for this refrigerator revealed that temperature monitoring was not consistently carried out by staff on the weekend and was missing on the following dates: 6/1/13, 6/2/13, 6/8/13, 6/9/13, 6/13/13, 6/14/13, 6/15/13, 6/18/13, 6/19/13, 6/24/13, 6/25/13, and 6/26/13. Further review of the past temperature log of the same refrigerator for the month of May 2013 revealed similar failure in monitoring temperature consistently on the weekends.

On 6/25/13 at 11:10 a.m., during an interview with the Director of Pharmacy (PD), he acknowledged the temperatures for the pharmacy refrigerator should have been monitored on those days to ensure acceptable storage conditions were met. He also stated that no one was available in pharmacy to monitor temperature for this refrigerator when the pharmacy closed on the weekend.

On 6/25/12, according to the Refrigerator Temperature log obtained by the hospital from Vaccines for children of California (VFC), it indicated "Record temperatures twice a day ...If the temperature is unacceptable (above 46 F or below 35 F, write the temperature in the space provided and Take Action!"

Based on staff interview, and clinical record review, the hospital failed to ensure the safe and effective administration of Lidicaine (local anesthetic agent) when the medication order included neither the specific dose of the medication nor the route for the administration of the medication. This failure could potentially have caused an adverse drug reaction and could have resulted in harm to the patient.

Findings:

On 6/26/13 at 3:43 p.m., during an inspection of Radiology department, the record of Patient 15 was reviewed. Patient 15 was in the Radiology Department for a liver biopsy. The radiology report indicated on 4/27/2012, Medical Doctor (MD) ordered one percent Lidocaine and was utilized for local anesthesia. Further review of Patient 15's clinical record with the Radiology Manager (RM) did not reveal the amount of Lidocaine that was used or its route of administration during the biopsy procedure.

On 6/26/13 at 3:52 p.m., during the interview with the RM, he acknowledged the amount of Lidocaine used and its route of administration were not documented anywhere on the patient 's clinical record. RM acknowledged that the Lidocaine order was not consistent with his interpretation of a complete medication order according to the hospital policy.

California Code of Regulations (CCR), Title 22, section 70263c (1) requires the pharmacy and therapeutics Committee to develop and implement policies and procedures for the safe use of medications and CCR, Title 22, 70263(g), states, "...The order shall include the name of the drug, the dosage and the frequency of administration, the route of administration, if other than oral, and the date, time and signature of the prescriber ..."

Based on observations, staff interviews, and clinical and administrative document reviews, the hospital failed to develop an effective infection control surveillance system for identifying unsafe food handling practices in the dietary department when:

1. The ice machine was noted to have a pink and rust colored residual on the ice maker and did not follow hospital procedures for cleanliness.

2. The dietary staff lacked knowledge and did not demonstrate appropriate cleaning of melons prior to consumption.

3. The can opener was observed to have a moderate accumulation of dry crusted residual and was not cleaned prior to each use.

4. The filters over the stove were observed to have an accumulation of dust and debris.

5. The dietary staff lacked knowledge and did not demonstrate the appropriate sanitizer concentration for sanitizing patient dishes in an emergency.

The lack of surveillance of these unsafe food handling practices had the potential to result in a food borne illness outbreak in a highly susceptible patient population in a hospital with a licensed bed capacity of 24.

Findings:

1. On 6/25/13 at 9:25 a.m., during an observation in the kitchen a clean paper towel swipe of the interior of the ice maker produced a pink and rust colored residue. The observation was concurrently verified by Maintenance Staff 1 (MS 1) and the Dietary Manager (DM). They both verified that this residual had the potential to contact the stored ice.

During a concurrent interview with MS 1, he stated that the ice machine was scheduled to be cleaned every three months. The last time the machine was cleaned was on 4/29/13, two months ago. He further stated that when he cleaned the ice machines he usually saw a build up of this residue on the ice maker's water trough and the curtain that covers the ice maker. He stated that the ice machine should be cleaned more frequently to prevent this accumulation.

A review of the hospital's policy titled "Ice" dated 7/1/11 noted that the "Ice machines will be maintained in a clean and sanitary condition by the Maintenance department to prevent ice contamination."

The 2009 FDA Food Code indicated that in equipment such as ice bins and enclosed components of equipment such as ice machines, surfaces shall be cleaned at a frequency necessary to preclude accumulation of soil or mold.

On 6/26/13 at 10:00 a.m., during an interview with the Infection Control Preventionist (ICP) she stated that she did not monitor the cleanliness of the ice machine. She further stated that the DM and the Registered Dietitian (RD) did not participate in or report to the Infection Control Committee.

2. On 6/25/13 at 9:45 a.m., during an observation in the kitchen, a half of a cantaloupe was observed in the walk-in refrigerator dated 6/23/13. During a concurrent interview with the DM she stated that 6/23/13 was the date it was cut.

During an interview with Dietary Staff 1 (DS 1) the same day at 11:05 .m., she stated that when she washed fresh fruits and vegetables, she rinsed them under cold running water. She further stated that she rinsed the melons under cold running water before she cut them. She stated that she did not scrub the cantaloupe before she cut it.

A review of the hospital's policy titled "General Food Preparation and Handling" dated 7/1/11 noted that the policy stated, "Raw, unprocessed fruits and vegetables are thoroughly washed under clean, potable, running water before use." There was no guidance to the staff to scrub the melons before cutting.

According to the U.S. Food and Drug Administration, a clean vegetable brush should be used to scrub firm produce, such as melons and cucumbers, before cutting.

On 6/26/13 at 10:00 a.m., during an interview with the ICP, she stated that she did not monitor the dietary staff to ensure safe handling of unprocessed fruits and vegetables. She did not provide surveillance in the kitchen related to infection control.

3. On 6/25/13 at 9:20 a.m., during an observation in the kitchen, the table mounted can opener blade was observed to have a moderate amount of a dry, black, crusty residue. The observation was concurrently verified by the DM.

During a concurrent interview with the DM she stated that the can opener was supposed to be cleaned at the end of each day. She said that the can opener was used to open cans of green beans earlier in the day. She stated that it didn't appear to have been cleaned the previous night.

A review of the hospital's policy titled "Cleaning Instructions: Can Opener" dated 7/1/11 noted that "The can opener will be cleaned after each use."

On 6/26/13 at 10:00 a.m., during an interview with the ICP, she stated that she did not monitor the can opener cleanliness. She did not provide surveillance in the kitchen related to infection control.

4. On 6/25/13 at 12:00 p.m., during an observation in the kitchen, the filters located in the hood over the stove/grill were noted to have a moderate accumulation of dust.

On 6/26/13 at 3:50 p.m., during an interview with the DM, she verified that the filters were dusty and were located directly over the area where the patient food was cooked. She stated the filters were cleaned every three months and the last time they were cleaned was on 4/4/13.

A review of the hospital's policy titled "General Food Preparation and Handling" dated 7/1/11 noted that it was the policy that the kitchen and equipment were to be clean.

On 6/26/13 at 10:00 a.m., during an interview with the ICP, she stated that she did not monitor the cleanliness in the kitchen. She did not provide surveillance in the kitchen related to infection control.

5. On 6/25/13 at 2:15 p.m., during an interview with DS 2 , she stated that her duties included dishwashing. She verbalized the emergency dishwashing procedures the staff was to use if the dish machine did not function properly. In order to wash, rinse and sanitize the dishes in the three compartment sink, she stated that the third sink was to be filled with a sanitizer solution. DS 2 was unable to state what the concentration of the sanitizer must be to effectively sanitize the dishes. She attempted to find the appropriate concentration in the hospital's policies and she was unable to find it.

A review of the hospital's policy titled "Sanitizing Dishes During a Disaster" dated 7/1/13 noted the procedure. It indicated "Sanitize: After the dish has been rinsed, it is run through the third basin, which contains a sanitizing solution." The policy did not provide guidance to the staff on how to determine if the sanitizer solution was at an effective concentration for sanitizing the patient's dishes.

On 6/26/13 at 10:00 a.m., during an interview with the ICP, she stated that she did not review the policies and procedures for the dietary department to ensure the policies were consistent with standards of practice for infection control.