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Based on observation, interview, and record review, the hospital failed to ensure that a registered dietitian provided guidance to the dietary services supervisor and dietetic services staff in regards to safe food handling and sanitation as required by state law.

1. A potentially hazardous food was not cooled down to ensure food safety.
2. Non-pasteurized shell eggs were used to serve as under cooked eggs in the cafe.
3. The wash cycle on the dish machine did not reach a high enough temperature per the manufacturer's guidelines.
4. Frozen roast beef was not dated.
5. Three of three ice machine's inspected were not maintained in a sanitary manner.
6. Dirty meal tray delivery carts were stored in the dirty utility room located on a patient floor and was directly pushed up against a red biohazard can.

These failures had the potential to result in unsanitary conditions which could spread germs throughout the hospital.

Findings:

During the course of the survey the following unsafe practices were identified: 1) A potentially hazardous food was not cooled down to ensure food safety, 2) non-pasteurized shell eggs were used to serve under cooked eggs in the cafe, 3) The wash cycle on the dish machine did not reach a high enough temperature per manufacturer's guidelines, 4) Frozen roast beef was not dated, 5) Three of three ice-machine's inspected were not maintained in a sanitary manner, and 6) dirty meal tray delivery carts were stored in the dirty utility room located on a patient floor and was directly pushed up against a red biohazard can.

During a joint interview with Director of Food & Nutrition Services and the Lead Registered Dietician (LRD) on 3/13/12 at 9:15 AM, LRD stated she provided oversight over trayline and ensured accuracy of therapeutic diets at trayline, as well as provided in-services to dietary staff. When asked why the LRD had not identified the above areas in order to provide guidance, the LRD stated there was not a mechanism in place in which and LRD would have known that there were issues with unsafe food handling and sanitation.

According to Title 22 70275 (A), "A registered dietitian shall be employed on a full-time, part-time or consulting basis. Part-time or consultant services shall be provided on the premises at appropriate times on a regularly scheduled basis and of sufficient duration and frequency to provide...guidance to the supervisor and staff of the dietetic service..." A state law, Health and Safety Code 1265.4 indicated, "...The dietetic services supervisor shall receive frequently scheduled consultation from a qualified dietitian."

Based on observation, interview and record review, the hospital's governing body failed to provide operating direction as evidenced by:

1. The hospital failed to ensure that a registered dietitian provided guidance to the dietary services supervisor and dietetic services staff in regards to safe food handling and sanitation as required by state law. (Refer to A 0023)

2. The hospital failed to obtain appropriate informed consent from two of 17 sampled patients (2 and 4) prior to treatment and services. (refer to A 0131)

3. The hospital failed to ensure an adequate evaluation of potential candidates for membership to the medical staff prior to granting them privileges. (Refer to A 0355)

4. The hospital failed to ensure nursing staff evaluated the care for patients. (Refer to A 0395)

5. The hospital failed to ensure that unauthorized individuals could not gain access to patient records. (Refer to A 0442)

6. The hospital failed to properly execute informed consent forms for patient treatment and procedures. (Refer to A 0466)

7. The hospital failed to A) Document and monitor temperature for intravenous (IV) fluid stored in a warmer which had the potential to result in unacceptable storage temperatures which could alter the integrity of the IV fluid. B) Monitor and store medications at the appropriate temperature in a freezer as specified by the manufacturer's storage guideline and hospital policy. Temperatures registering outside the manufacturer's recommended range and duration could result in the loss of integrity of the medication and potentially harm patients by not providing the expected therapeutic effect. C) Obtain competences for their pharmacist staff to ensure the safe administration of medications where pharmacists calculate and adjust doses, and provide safe and effective treatment. D) Ensure there was an adequate supply of a medication used to treat malignant hyperthermia [a disease that causes a fast rise in body temperature (fever) and severe muscle contractions when the affected person gets general anesthesia]. (Refer to A 0491)

8. The hospital failed to A) Ensure medication was available in the event of medical emergency in the operating room which could result in an inability to properly prepare the medication in the event of a medical emergency. B) Ensure the safe and effective use of medications in the Emergency Department (ED) to protect patients from potential undue adverse medication consequences as evidenced by the lack of pharmacy monitoring and oversight. (Refer to A 0500)

9. The hospital pharmacist failed to provide supervision for the distribution and use of controlled substances stored in the Cancer Treatment Center (CTC). This had the potential to result in medication diversion. (refer to A 0501)

10. The hospital failed to ensure expired drugs and biologicals were not made available for patient use. (Refer to A 0505)

11. The hospital failed to ensure an organized food and nutrition services department when the Director of Food and Nutrition Services was not dedicated full-time to that specific department. (Refer to A 0619)

12. The hospital failed to employ a director of food and dietetic services that was full-time in that capacity. (Refer to A 0620)

13. The hospital failed to ensure that A) Therapeutic diet orders were defined to ensure the patients received a therapeutic diet order as intended by the practitioner responsible for the care of the patient, and B) One patient received a therapeutic diet in accordance with the physician's diet order (Refer to A 0629)

14. The hospital failed to ensure the nutritional needs of the patients were met in accordance with recognized dietary practices. (Refer to A 0630)

15. The hospital failed to customize their on-line diet manual to be hospital specific which should have included the hospital's approved therapeutic diet orders. (Refer to 0631)

16. The hospital's infection control officer failed to develop effective systems for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel in accordance with hospital policy and nationally recognized infection control guidelines. (Refer to A 0749)

17. The hospital failed to arrange for qualified Registered Nurses to perform circulating duties during stomach and bowel surgical procedures in accordance with State law, and nationally accepted standards to ensure immediate availability of nursing interventions for patient safety. (Refer to A 0944)

The cumulative effect of these systemic problems resulted in the hospital's governing body inability to ensure the delivery of quality health care.

Based on interview and record review, the hospital failed to obtain appropriate informed consent from two of 17 sampled patients (2 and 4) prior to treatment and services.

1. For Patient 2 the hospital failed to ensure the informed consent obtained by the patient included all the anticipated treatments.
2. For Patient 4, two consents in English were signed by a Spanish speaker and reader and contained no indication that the form was translated to the patient or her responsible party in Spanish.

These failures violated the patients' rights to be fully informed prior to making an informed decision about the proposed treatment.

Findings:

1. The clinical record for Patient 2 was reviewed on 3/13/12 at 4 PM with the Director of Performance Improvement (DPI). Patient 2 was scheduled for a surgical procedure on 2/6/12. According to the history and physical dictated on 2/2/12 the surgeon documented the patient would be consenting for "an exploration of the right neck with abscess drainage and irrigation." A review of the informed consent obtained on 2/3/12 indicated the patient consented for "Right Neck Exploration", there was no mention of the abscess drainage and irrigation which was also an anticipated procedure.

During an interview with the DPI, on 3/13/12 at 4:15 PM, she confirmed the informed consent signed by the patient was incomplete and did not include all the proposed procedures that would be performed on the day of surgery.

The policy and procedure titled, "INFORMED CONSENT" last revised 6/07, was reviewed with the DPI on 3/13/12. Under the policy statement it read under the types of consents, "Authorization for Consent to Surgery or Special Diagnostic or Therapeutic Procedures - A special consent must be signed by the patient or representative for all surgical procedures... The wording of the surgical consent must reflect the proposed procedure and any reasonably anticipated procedures that may be necessary at the same time..." A continued review of the policy and procedure included the list of procedures that have been identified by the medical staff requiring informed consent. The list included, "Incision and drainage (any site)..."



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2. The clinical record for Patient 4 was reviewed on 3/14/12 at 2 PM with the DPI. Patient 4 was scheduled for a surgical procedure on 3/6/12. Two consents in English were signed by Patient 4, the consents contained no indication the form was translated to the patient or her responsible party in Spanish. One of these consents was a Consent for Surgery dated 3/06/12 and the other consent was an Informed Consent to the Administration of Anesthesia dated 3/06/12. The record also contained consents for admission in Spanish. The DPI stated, "All of our consents are available in Spanish."

During an interview with Patient 4 on 3/13/12 at 10 AM, she stated she was unable to speak or read English.

The facility Policy and Procedure titled Informed Consent, dated 6/10, indicated in part:
1. "If a patient or their legal representative cannot communicate with their healthcare providers, because of a language or or other communication barrier, the hospital will arrange for an appropriate interpreter."

Based on interview and administrative record review, the hospital failed to ensure there was sufficient supervision of the medical staff's processes to ensure quality medical care was provided to the patients in the hospital. There was a failure to ensure the proctoring process for the initial appointment to the medical staff was completed timely, correctly, specific to the area proctored according to the hospital's rules and regulations for eight sampled allied health professional. (Refer to A 355)

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure the medical staff provided quality health care.

Based on interview and administrative record review, the hospital failed to ensure an adequate evaluation of potential candidates for membership to the medical staff prior to granting them privileges. There was a failure to ensure the proctoring process for the initial appointment to the medical staff was completed timely, correctly, or specifically to the area proctored according to the hospital's medical staff rules and regulations for eight sampled allied health professionals (AHP) (Medical Doctor [MD] 1, 2, 3, and 4 and CRNA [Certified Registered Nurse Anesthestist] 1, 2, 3, and 4) which had the potential to affect the quality of medical care provided to patients in the hospital.

Findings:

During an interview with the Director of Medical Staff (DMS), on 3/13/12 at 9:50 AM, he was asked the hospital's process for accepting candidates for medical staff membership. He indicated for initial appointment the AHP must meet certain eligibility criteria and if the AHP professional met the criteria then they were assigned a proctor to supervise. The rules and regulations for the proctoring process varied for each department.

1. The rules and regulations titled, "DEPARTMENT OF EMERGENCY MEDICINE RULES AND REGULATIONS" approved 12/28/10, were reviewed with the DMS on 3/13/12. On page 2 of 3, under section VI titled, "PROCTORS" it read in part, "A. upon initial appointment a proctor from the department will be assigned to oversee work for three months, or at least 20 shifts. 20 cases will be reviewed with at least three pertaining to general medical adult care, and at least one pertaining to pediatric care, adult trauma care, pediatric trauma care, ob-gyn, general surgical care, and orthopedic care..."

The credential file for MD 1 (Department Head of Emergency Services) was reviewed with the DMS on 3/13/12 at 11:15 AM. There was an insufficient number of cases proctored and there were no cases proctored in the areas pertaining to pediatric care, adult trauma care, pediatric trauma care, general surgical care and orthopedic care as indicated in the hospital's rules and regulations. The DMS confirmed the proctoring conducted with MD 1 did not meet the rules and regulations of the hospital.

The credential file for MD 2 was reviewed with the DMS on 3/13/12 at 3 PM. MD 2 requested privileges to work in the Emergency Room (ER). MD 2 was initially appointed on 12/18/08. There were 10 cases proctored in 11/09, almost a year after his initial appointment. There was one undated case proctored, making it difficult to determine when the proctoring was conducted. There was insufficient documented evidence the proctored cases were completed in all the specified areas according to the hospital's rules and regulations for the emergency department, i.e. general medical adult care, pediatric care, adult trauma care, pediatric trauma care, ob-gyn, general surgical care and orthopedic care. Therefore, there was an insufficient number of cases proctored, far less than the required 20 cases, the proctoring was not completed within the first three months of MD 2's initial appointment and the cases which were proctored did not include all the specified areas. DMS confirmed the proctoring conducted with MD 2 did not meet the rules and regulations of the hospital.

The credential file for MD 3 was reviewed with the DMS on 3/14/12 at 9:45 AM. MD 3 was requesting privileges to work in the ER. MD 3 was initially appointed 6/24/08. There were 20 cases proctored, all signed as completed on 12/13/09, almost 1 1/2 years after his initial appointment. The cases did not meet the criteria set by the hospital's rules and regulations. The DMS confirmed the proctoring conducted with MD 3 did not meet the rules and regulations stipulated by the hospital.

2. The rules and regulations titled, "DEPARTMENT OF RADIOLOGY/PATHOLOGY RULES/REGULATIONS 12/21/2010" were reviewed with the DMS on 3/13/12. On page 1 of 3 under the heading VI titled "PROCTORING/MONITORING REQUIREMENTS" it indicated, "A. General Guidelines for the granting and maintaining of Clinical Privileges shall be in accordance with Medical Staff Bylaws Article V." The Medical Staff Bylaws under the proctoring subheading indicated,

"Practitioners to be proctored shall include the following:
All new members of the medical staff; Practitioners granted temporary privileges pending appointment to the medical staff...

Duration of Proctoring Period:
Proctoring will be for a period of six (6) months, unless the status is extended by the medical executive committee for an additional period up to twelve (12) months upon a determination of good cause...

Proctor's Responsibility:
Required to maintain a written record of all cases concurrently or retrospectively reviewed...
Provide a review of no less than ten (10) cases that broadly reflective the scope of privileges granted. The documentation must be forwarded to the Medical Staff Office before approval can be granted by the respective medical staff department, to remove an applicant from proctoring..."

A continued review of the rules and regulations for the department of radiology/pathology was conducted. Under the subheading, "PHYSICIANS PLACED WITH A PROCTOR" under section 2. "Responsibilities of the physician being proctored....b. At the discretion of the Proctor, procedures, patient contacts, and or specimens reviewed by the new provisional staff member will be reviewed by the proctor. A report consisting of the review of at least 5% of total number of diagnosis, exams or procedures is necessary before final approval can be made. c. New applicants are required to advise their proctor of each procedure..."

The credential file for MD 4 (Radiologist) was reviewed with DMS on 3/14/12 at 9:45 AM. There was insufficient documented evidence 5% of MD 4's cases were reviewed by a proctor. In the credential file it was documented MD 4 had completed over 45,000 cases. According to the DMS, he indicated the 45,000 cases were from a telemedicine organization and was not an accurate accounting of the number of cases MD 4 had reviewed in the hospital. During a subsequent interview with the DMS, he indicated he left a message with the Director of Radiology to determine if the Director of Radiology had proctored MD 4 for 5% of his cases in the hospital. No further evidence was provided by the DMS that MD 4 was proctored for 5% of his cases as indicated on the hospital's rules for radiology.

3. The rules and regulations titled, "ANESTHESIA MEDICAL STAFF RULES AND REGULATIONS" were reviewed with the DMS on 3/13/12. Under the policy subheading section 3. titled, "Proctoring" it read in part, "Proctoring shall be in accordance with Medical Staff Bylaws Article V. Section 3... In order to properly evaluate the qualifications of new applicants requesting Medical Staff privileges, and for applicants requesting additional privileges in the Department of Anesthesia... the Department of Anesthesia has established a Proctorship program. Every provisional physician and CRNA (Certified Registered Nurse Anesthetist) will be evaluated by his assigned Proctor for a minimum of six months."

The credential file for MD 5 (Department Head for Anesthesia) was reviewed with the DMS on 3/13/12 at 11 AM. There were 12 cases proctored. The forms which documented each of the 12 cases were incomplete, undated and were not specific to anesthesia services. There was no indication what type of anesthesia was administered i.e. general, local, regional, etc... The DMS confirmed the 12 cases proctored for MD 5 were not specific to anesthesia, were undated and were incomplete making the proctored cases difficult to evaluate for the quality of the anesthesia services rendered.

The credential file for CRNA 1 was reviewed with the DMS on 3/13/12 at 11:15 AM. CRNA 1 was appointed to the medical staff on 8/25/09. There were 10 cases proctored in 8/09, but the proctoring forms were unclear, not specific to the administration of anesthesia with no mention of the type of anesthesia administered, making it difficult to evaluate the quality of the anesthesia services rendered in the cases. The DMS confirmed the proctoring conducted with CRNA 1 made it difficult to assess the quality of the anesthesia services rendered.

The credential file for CRNA 2 was reviewed with DMS on 3/15/12 at 2 PM. CRNA 2 was appointed to the medical staff on 8/25/09. There were 10 cases proctored in 7/09 but the proctoring forms were unclear, not specific to the administration of anesthesia and there was no mention of the type of anesthesia administered making it difficult to evaluate the quality of the anesthesia services rendered in the proctored cases. The DMS confirmed the findings.



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The credential file for CRNA 3 was reviewed with the DMS on 3/15/12 at 3:30 PM. CRNA 3 was appointed to the medical staff on 8/16/10. MD 5 proctored 10 anesthesia cases for CRNA 3 in 9/2010. Upon review of the medical records of the proctored patients, three of ten proctored patients were children. The proctoring records were unclear as to what type of anesthesia was administered and to what age groups. All ten of the Proctoring Review forms were signed on 9/21/10 by MD 5. The Review forms indicated the anesthesia procedures were done from 9/10/12 through 9/21/12. The DMS confirmed the findings. Upon further review it was noted CRNA 4 had an expired PALS (Pediatric Advanced Life Support) card.

During an interview with the DMS on 3/13/12 at 2 PM, he stated, "Yes, PALS (Pediatric Advanced Life Support) is a requirement for the CRNA's. Yes, CRNA 3 seems to have an expired PALS card." By the end of the survey the DMS was unable to provide a current PALS card.

The American Association Of Nurse Anesthetists document, dated 2005, titled, "Guidelines for Core Clinical Privileges for Certified Registered Nurse Anesthetists" indicated, "Basic qualifications for clinical privileges shall include: 4. Compliance with relevant requirements for continuing education and competence in Advanced Cardiac life Support (ACLS) and Pediatric Advanced life Support (PALS) as applicable."

Based on observation, interview, and record review, the hospital failed to ensure nursing staff evaluated the care for one of 17 sampled patients (15) when one nurse (Registered Nurse 2) was not familiar with a physician's order to restrict the fluid for Patient 15. This had the potential to impact the patient's overall recovery.

Findings:

The clinical record for Patient 15 was reviewed on 3/13/12 at 3:10 PM. The physician's orders were reviewed. A physician's order read, "Restrict fluids to 1200 cc/24 hour oral."

During an interview with Registered Nurse (RN) 2, on 3/13/12 at 3:47 PM, she stated she was the assigned nurse for Patient 15. RN 2 was asked if Patient 15 was on a fluid restriction, and RN 2 stated, "I don't think so." RN 2 then proceeded to review Patient 15's clinical record and acknowledged the physician did place the patient on a fluid restriction of 1200 cc per day on 3/12/12. RN 2 at this time, verified she had not known that Patient 15 had a physician order for a fluid restriction. RN 2 stated that the way she would have known was via the hand off communication from the previous nurse when she began her shift at 7 AM on 3/13/12. RN 2 stated the previous nurse had not informed her the patient should be on a fluid restriction.

RN 2 proceeded to post a sign on the patient's door that indicated "1500 cc fluid restriction", despite the physician's order was for a 1200 cc fluid restriction.

The hospital's policy and procedure entitled STANDARDS OF NURSING CARE indicated, "8. A Registered Nurse plans, supervises and evaluates the total care of each patient."

Based on observation of the Third Floor Nursing Department and staff interview, the hospital failed to ensure unauthorized individuals could not gain access to patient records, which had the potential to result in unauthorized access to patient records.

Findings:

During a concurrent interview and tour of the third floor Nursing Department with the Medical Records Manager (MRM) on 3/14/12 beginning at 3:05 PM, it was observed that Registered Nurse (RN) 3 was documenting on a portable electronic device. The twenty-inch computer screen had no privacy screen attached to it so patient information was fully visible to any person walking by. When asked about this arrangement, The MRM indicated they had purchased privacy screens and could not understand why they were not in use. She further indicated the nursing staff was trained to document facing a wall so information could not be seen. When RN 3 was questioned regarding her documentation in the middle of the hallway she indicated, "I was just looking up the patient's labs."

Based on interview and medical record review, the hospital failed to properly execute informed consent forms for three of 17 patient treatment and procedures 4, 17, and 18). This failure had the potential for the patients to not be fully informed of their care before treatment and procedures were performed, as evidenced by the following inconsistencies:

Findings:

During a record review on 3/14/2012 at 3 PM, the following was found:

1. For Patient 17, the medical record contained the following, an informed consent for a procedure dated 3/12/12, which lacked the name of the responsible practitioner who would be performing the procedure and the procedure was spelled incorrectly. The informed consent also had no signed statement the procedure or treatment, including the anticipated benefits, material risks, and alternative therapies, were explained to the patient or the patient's legal representative. The "Financial Agreement" and the "Condition of Admission" were signed by a party other than the patient, with no indication of the relationship to the patient. This document was not dated, timed or witnessed. A "Fall Information Sheet, dated 3/12/12, was witnessed with only the first name of the hospital employee.

2. For Patient 18, the medical record contained the following, a verbal "Emergency Department Consent to Treatment", dated 3/11/12 which was witnessed by one employee and not timed.

3. For Patient 4, the medical record contained the following, an English "Consent to Surgery" and an English "Informed Consent to the Administration of Anesthesia", dated 3/6/12, signed by the patient. The Spanish "Emergency Consent to Treatment", was signed by the patient on 3/02/12. During an interview with Patient 4, on 3/14/12 at 3:30 PM, she stated in Spanish that she did not speak English.

During an interview with the Medical Records Manager on 03/14/12, at 1:30 PM, she stated, "all of our consents are available in Spanish, we expect our consents to be filled out completely including full names and dates."

The facility Policy and Procedure titled Informed Consent, dated 6/2010, indicated in part:

1. "It is the physician's responsibility to obtain and document that the patient has given informed consent. Informed consent should contain the following, the nature of the proposed care and treatment and the potential risks and benefits of treatment".
2. "Once informed consent has been obtained the hospital employee must witness this fact by signing their full name."
3. "All consents are to be dated and timed by both the patient and hospital employee."
4. "If a patient or their legal representative cannot communicate with the healthcare providers, because of a language or or other communication barrier, the hospital will arrange for an appropriate interpreter."
5. "If a person is unable to make a mark, documentation should be made that verbal consent is given. Two persons should witness both marks and verbal consents."

Based on observation, interviews, review of the hospital's policies and procedures, and review of patient clinical records, the hospital failed to:

1. Document and monitor the temperature for intravenous (IV) fluid stored in a warmer. (A 0491)

2. Monitor and store medications at the appropriate temperature in a freezer as specified by the manufactures storage guideline and hospital policy. (A 0491)

3. Obtain competences for their pharmacist staff to ensure the safe administration of medications. (A 0491)

4. Ensure there was an adequate supply of a medication used to treat malignant hyperthermia [a disease that causes a fast rise in body temperature (fever) and severe muscle contractions when the affected person gets general anesthesia]. (A 0491)

5. Provide pharmaceutical services that would ensure patient safety by providing pharmacy oversight of all medications removed from the Pyxis (Automated Dispensing Cabinets). (A 0500)

6. Ensure adequate amount of sterile water for injection was available to reconstitute dantrolene (muscle relaxant) during medical emergency. (A 0500)

7. Provide security of stored medications located in the Cancer Treatment Center. (A 0501)

8. Remove expired medication and biologicals from availability for use. (A 0505)

The cumulative effects of these systematic problems resulted in the hospital's inability to ensure the provisions of quality health care in a safe environment.

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

1. Document and monitor temperature for intravenous (IV) fluid stored in a warmer which had the potential to result in unacceptable storage temperatures which could alter the integrity of the IV fluid.
2. Monitor and store medications at the appropriate temperature in a freezer as specified by the manufacturer's storage guideline and hospital policy. Temperatures registering outside the manufacturer's recommended range and duration could result in the loss of integrity of the medication and potentially harm patients by not providing the expected therapeutic effect.
3. Obtain competences for their pharmacist staff to ensure the safe administration of medications where pharmacists calculate and adjust doses, and provide safe and effective treatment.
4. Ensure there was an adequate supply of a medication used to treat malignant hyperthermia [a disease that causes a fast rise in body temperature (fever) and severe muscle contractions when the affected person gets general anesthesia].

These failure resulted in the hospital's inability to ensure safe patient care.

Findings:

1. During an inspection of the Emergency Department (ED) with Pharmacist 1 (Pharm 1, the Assistant Director of Pharmacy) and Pharm 2 (Director of Pharmacy) on 3/14/12 at 2:32 PM, a fluid warmer was found inside the ED medication room. Five bags of one liter 0.9% of Sodium Chloride intravenous fluid were found inside. There was no temperature log found with this warmer to ensure acceptable storage conditions were met.

During interview with the Emergency Department Manager (EDM) at 2:38 PM, she acknowledged that they had not been monitoring the temperatures for the ED fluid warmer.

2. During an inspection of the inpatient pharmacy freezer with Pharm 1 and Pharm 2 on 3/12/12 at 4:12 PM, the temperature log for the month of March was posted on the door outside of the freezer. Review of the temperature log revealed the temperature of the freezer was between the ranges of -8C (Celsius) to -6C over the past 12 days. Medications that were found inside included the following frozen premix antibiotics: Mefoxin, Zosyn, Ceftriaxone, and Vancomycin.

Further review of the temperature log revealed the temperature of the freezer was to be maintained at or below -20C according to page 3 of the hospital policy and procedure entitled "Medication Distribution and Control," and the manufacturer's storage guideline.

During an interview with Pharm 1 and Pharm 2 on 3/13/12 at 9:12 AM, they acknowledged the temperature of the freezer was improperly set and maintained at level far above the required storage condition recommended by the drug manufacturer's.

3. During an interview with Pharm 1 on 3/12/12 at 3:21 PM, Pharm 1 stated all pharmacy staff were competent to provide clinical services for the following medications, "warfarin (blood thinning medication), heparin (blood thinning medication), low molecular weight heparin (blooding thinning medication), and renal dosing (adjust doses to reduce potential for toxicity for patients that have poor kidney function). The pharmacists were currently providing these clinical services which involve calculating, adjusting doses, and providing safe and effective treatment. There is a protocol for each medication, approved by the Pharmacy and Therapeutics Committee, which the pharmacists follow. When Pharm 1 and Pharm 2 were asked to provide documentation to demonstrate staff pharmacists were competent to provide these clinical services, they provided a copy of the competencies completed by Pharm 3.

Review of the competencies completed by Pharm 3 revealed the following sections: validation of performance on IV therapy, the code of conduct of the hospital and the 2011 Joint Commission/OSHA Compliance courses. There was no other examination found in Pharm 3's record the competencies in the area of anticoagulation, and renal dosing.

ASHP (American Society of Health-System Pharmacists) has published, "Guidelines on Preventing Medication Errors in Hospitals", approved June 23, 1993, which stated, policies and procedures should be developed that ensure proper evaluation of competency and supervision. Review of the hospital policy entitled, "competency assessment process" on page 1 under policy; it read, "Each department is responsible for identifying competencies to meet the job performance standards ...



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4. During the tour of the hospital's ambulatory surgery on 3/13/12 at 12:15 PM, 24 vials of Dantrolene were observed in the medication cart in the ambulatory surgery center.

During an interview with the Ambulatory Surgery Manager on 3/13/12 at 12:20 PM, she acknowledged the clinic did not have the required 36 vials of Dantrolene (muscle relaxant)and indicated it was the hospital 's policy to always have 36 vials of Dantrolene present in the ambulatory surgery center.

Review of the hospital's policy titled, "Malignant Hyperthermia, (malignant hyperpyrexia is a rare life-threatening condition that is usually triggered by exposure to certain drugs used for general anesthesia). Patient Treatment Guidelines" dated 4/8/10, stipulated "A sufficient supply (referring to the medication Dantrolene) must be available. 36 vials of Dantrolene are available in the Surgical Services Department. Vials are available in the ASD (referring to the ambulatory surgery department)."

Review of the Malignant Hyperthermia Association of the United States (MHAUS) guidelines,
indicated if any potent volatile agents are used, a full supply of Dantrolene (36 vials) should be
available on site. Thirty-six (36) vials of Dantrolene will allow for initial stabilization and
treatment while more vials are being acquired to continue treatment, as needed. The patient
experiencing an Malignant Hyperthermia (MH) episode must be stabilized before being transported. Stabilization of an MH episode may take 30 minutes or more with multiple doses of dantrolene because, in some cases, MH progresses with explosive rapidity. The full 36 doses of Dantrolene should be available within five minutes of the diagnosis of MH.

This failure placed patients undergoing procedures requiring general anesthesia in
the hospital's ambulatory surgery center at increased risk for safety.

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

1. Ensure medication (sterile water vials) was available in the event of a medical emergency in the operating room which could result in an inability to properly prepare the medication in the event of a medical emergency.
2. Ensure the safe and effective use of medications in the Emergency Department (ED) to protect patients from potential undue adverse medication consequences as evidenced by the lack of pharmacy monitoring and oversight.

Findings:

1. During an inspection with Pharmacist 2 (Pharm 2 / Director of Pharmacy) in the Operating Room (OR) on 3/15/12 at 10:46 AM, the malignant hyperthermia emergency cart was inspected. The cart contained only twenty five 50 ml (milliliter) vials of sterile water for injection instead of the forty vials listed on the inventory sheet. Also the manufacturer and the Malignant Hyperthermia Association of the United States (MHAUS) recommend using 60 ml of sterile water for injection for each vial of dantrolene (muscle relaxant). So 2160 ml of sterile water would then be needed to dissolve the contents of the 36 vials of dantrolene in the cart; therefore, the cart did not contain sufficient amount of sterile water for injection to reconstitute all of the dantrolene. In the interview with Operating Room Manager (ORM) on 3/15/12 at 10:58 AM, he acknowledged an additional 910 ml of sterile water for injection would need to be added to their Malignant Hyperthermia cart.

2. During an interview with Pharm 1 and Pharm 2 on 3/13/12 at 3:11 PM, Pharm 2 stated pharmacists do not currently review medication orders in the Emergency Department (ED) unless the patient was admitted to the hospital. There was no medication review or oversight if the patient was admitted to the ED and treated with medications and then sent home. In addition, Pharm 1 and Pharm 2 stated pharmacists do not perform a concurrent or retrospective review of drugs removed by nurses from the ED's ADC (automated drug cabinet) for administration to patients. This is contrary to in-patients of the hospital, where medication orders were reviewed by pharmacists.

ASHP (American Society of Health-System Pharmacists) Guidelines: "Minimum Standard for Pharmacies in Hospitals," approved September 22, 1995, outlines the minimum requirements for pharmaceutical services in hospitals. The guideline under Medication Orders states, "All prescribers' medication orders (except in emergency situations) must be reviewed for appropriateness by a pharmacist before the first dose is dispensed."

ASHP Guidelines on the Safe Use of Automated Medication Storage and Distribution Devices," approved April 22, 1998 states:

"All medication distribution systems, both automated and non-automated, have features that give nurses and other care-givers access to some medications before order review and approval by a pharmacist, especially in patient emergencies. Clearly stated organizational policies should be developed that limit access to medications before orders have been reviewed and approved by a pharmacist. Access to medications should be limited to the following cases:

1. The order has been reviewed and approved by a pharmacist.
2. The drug product has been approved by a multidisciplinary committee of physicians, pharmacists, and nurses who agree that it has minimal risk for misadventures.
3. There is a clinically urgent need for the medication that outweighs the potential risk.
4. Medication retrieval and administration are supervised by an identifiable, responsible physician (in the emergency department, catheterization laboratory, etc).

Provision should be made for the retrospective review and reconciliation by a pharmacist of orders that were initiated without a pharmacist's review and approval."

Also, the Institute for Safe Medication Practices' (ISMP) recently issued "Guidance on the Interdisciplinary Safe Use of Automated Dispensing Cabinets" revalidated the "ASHP Guidelines" by listing twelve "Core Processes" that should be present for the use of Automated Dispensing Cabinets (ADCs). Two of the "Core Processes" state:

"Core Process # 3 Use Pharmacy-Profiled ADCs
Rationale: The use of a "profiled "ADC ensures that the pharmacist will validate the new medication order, including first doses, in the pharmacy computer system prior to the medication being dispensed or accessed by the nurse or other healthcare professional.

Core Process # 9 Establish criteria for ADC System Overrides
Rationale: Use of ADC overrides should be situationally dependent, and not based merely on a medication or list of medications. While there may be a list of drugs with the potential to be obtained emergently, there may be many other situations when there is sufficient time for the pharmacist to review the medication prior to retrieving the dose. Criteria for systems overrides should be established that allow emergency access in circumstances in which waiting for a pharmacist to review the order before accessing the medication could adversely impact the patient's condition.

The Guidelines included implementing strategies that reduce the risk of error when an override is used, including:

? Requiring an independent double-check with another licensed healthcare provider when removing organization-identified high-alert medications on override.
? Requiring documentation of override rationale.
? Developing a staff competency assessment related to the safe use of overrides.
? Routinely reviewing override reports to identify and address barriers to the pharmacist's review of the drug order prior to administration."

The hospital did not have written policies and procedures that established and followed the guidelines of both ASHP and ISMP.

Based on observation and interviews, the pharmacist failed to provide supervision for the distribution and use of controlled substances stored in the Cancer Treatment Center (CTC). This had the potential to result in medication diversion.

Findings:

During a visit to the CTC with Pharmacist 1 (Pharm 1) and Pharm 2 on 3/14/12 at 11:25 AM, controlled substances were found in a locked drawer inside the Pharmacy IV (intravenous) room. Medications found were indicated for anxiety and pain.

The pharmacy restocks these medications but does not reconcile the missing doses with a physician's order. Since the nurses have access to a key to the controlled substance drawer when the pharmacist is away from the IV room, Pharm 1 and Pharm 2 both acknowledged that a nurse can remove a medication leaving no record of its removal. And since pharmacy does not reconcile the restocking of the medication with a physician's order, pharmacists are unaware of whether or not drugs in the drawer is used for patients or simply taken by staff for personal or other use. This results in a lack of supervision of the controlled substances and non-compliance with hospital policy.

Based on observation, interview, and record review, the hospital failed to ensure expired drugs and biologicals were not made available for patient use. This had the potential to result in ineffective and/or adverse reactions due to expired drugs and biologicals.

Findings:

1. During an initial tour of the Medical Surgical Floor (3rd floor) with the Director of the Medical Surgical (DMS) Unit on 3/12/12 at 10:15 AM, the following biologicals were observed in the clean utility room:
a. Three bottles of Povoiodine opened with no open date or initials of who opened the bottles.
b. One bottle of Hydrogen Peroxide opened with no open date or initials of who opened the bottle.
c. Three bottles of an oral debriding agent with the expiration dates 6/07, 6/07 and 12/06 and with no open dates or initials of who opened the bottles.
d. One 500 milliliters bottle of Normal Saline irrigating solution with an expiration date of 7/10 with no open date or initials of who opened the bottle.
e. One tube of topical surgical lubricant with no lid, opened with no open date or initials of who opened the tube.
f. One bottle of topical skin cleanser with an expiration date of 5/10.

Also observed during the initial tour with the DMS on 3/12/12 at 10:35 AM, in the clean equipment storage room, were three bottle of rubbing alcohol, open with no open date or initials of who opened the each of the bottles.

The hospital policy and procedure titled, "MULTI-DOSE VIAL EXPIRATIONS" reviewed 6/20/07, indicated under the procedure subheading, "All multi-dose medication containers shall be dated (with the expiration date...) and initialed when opened... Follow the expiration date on the container or the guidelines delineated below, whichever is sooner.

Saline, Water - 24 hours...
Alcohol, Betadine - 3 months after opening..."



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2. During an inspection of the fluid warmer located in the center core area of the Operating Room on 3/15/12 at 10:32 AM, one 1000 ml bag of 0.9% sodium chloride intravenous (IV) fluid was found inside with an expiration date of 5/5/12.

During the interview with the Operating Room Manager on 3/15/12 at 10:33 AM, he acknowledged the bag of IV fluid was expired and should be removed out of the fluid warmer.



28991

3. During an observation in the emergency room medication cupboards on 3/14/12 at 10:15 AM, the following was noted: Six Swine flu specimen collection devices dated expired 7/12/10, Osmolite (A nutrition supplement) expired 6/29/10, 5% dextrose intravenous fluid dated expired 12/11. In a concurrent interview, Infection Control Nurse 2 (ICN 2) stated, "We will have to take all supplies out and replace the containers and products."

During an observation of the dirty utility room of the emergency room on 3/14/2 at 10:30 AM, one half full bottle of povidone iodine (unlabeled with date/time it was opened).

Based on observation, interview and record review, the hospital failed to ensure organized dietary services as evidenced by:

1. The Director of Food and Nutrition Services (DFNS) was not dedicated full-time to that specific department. The DFNS failed to ensure the daily management of dietary services to provide patients, staff and visitors with safe and high quality food due to a lack of monitoring the high risk practice of the safe cool down of potentially hazardous food (food that has the potential for bacterial growth), and by providing undercooked, non-pasteurized eggs in the cafe. (Refer to A 023, A 0619, A 0620)

2. The DFNS failed to ensure an effective system with the Infection Control Practitioner to ensure provisions and criteria which would identify and prevent unsafe food handling and sanitation practices. (Refer to A 0749)

3. The Food and Nutrition Services Department failed to ensure that the hospital's diet manual was customized to be hospital specific, and that therapeutic diet orders were defined by the hospital's physicians in order to be implemented in accordance with physician's orders. (Refer to A 0631)

4. The hospital allowed the clinical dietitians to perform aspects of an independent practitioner by varying levels of protein that was provided to patients, depending on the patient's medical status that involved renal and hepatic therapeutic diets. Registered Dietitians may not act as an independent practitioner. (Refer to A 0629, A 0631)

5. The Food and Nutrition Services Department failed to analyze patient menus to ensure the nutritional needs of the patients were met in accordance with recognized dietary practices. (Refer to A 0630)

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure the provision of dietetic services for the health and safety needs of patients.

Based on interview and record review, the hospital failed to ensure an organized food and nutrition services department when the Director of Food and Nutrition Services (DFNS) was not dedicated full-time to that specific department, which had the potential to affect the quality in dietary services.

Findings:

During an interview with the DFNS on 3/13/12 at 9:15 AM, she stated she was also the Director of Environmental Services (DES). The DFNS stated she had been the DES since July 2010. The DFNS verified she had the authority and responsibility for the operation of the food and dietetic services department, but also was responsible for oversight of the manager of environmental services.

According to the DFNS's job description, "Position: Director of Nutrition/Food and Environmental Services...,POSITION SUMMARY: Under the direction of the Chief Financial Officer the Nutrition/Food and Environmental Services Director is responsible for overall function of Dietary & Nutritional Service as well as Environmental Services and Linen. The Director will plan, coordinate, and manage all patient/resident nutritional care processes, environmental cleaning and disinfecting processes, and linen services complying with the standards established by [name of hospital] and regulatory agencies."

This organizational structure diminishes the DFNS hours to less than full-time over the food and nutrition services department.

Based on food service observation, interview, and record review, the hospital failed to employ a director of food and dietetic services that was full-time in that capacity. This failure resulted in the hospital failing to ensure safe food handling practices as evidenced by:

1. A potentially hazardous food was not cooled down to ensure food safety.
2. Non-pasteurized shell eggs were used to serve under cooked eggs in the cafe.
3. The wash cycle on the dish machine did not reach a high enough temperature per manufacturer's guidelines.
4. Frozen roast beef was not dated.
5. The planned disaster menu did not contain provisions on how to meet the nutritional needs of those patients on a therapeutic diet in the event of a disaster.

Findings:

During an interview with the Director of Food and Nutrition Services (DFNS) on 3/13/12 at 9:15 AM, she stated she was also the Director of Environmental Services (DES). The DFNS verified she had the authority and responsibility for the operation of the food and dietetic services department, but also was responsible for oversight of the manager of environmental services.

According to DFNS's job description, "Position: Director of Nutrition/Food and Environmental Services...,POSITION SUMMARY: Under the direction of the Chief Financial Officer the Nutrition/Food and Environmental Services Director is responsible for overall function of Dietary & Nutritional Service as well as Environmental Services and Linen. The Director will plan, coordinate, and manage all patient/resident nutritional care processes, environmental cleaning and disinfecting processes, and linen services complying with the standards established by [name of hospital] and regulatory agencies."

This organizational structure diminishes the DFNS hours to less than full-time over the food and nutrition services department.

1. During an observation in the kitchen area on 3/12/12 at 10:12 AM, inside the walk-in refrigerator, were two full sized 4 inch deep pans that was overfilled with cooked noodles with a sticker that indicated "Use-by 3/14".

On 3/12/12 at 10:34 AM, the cool down log was requested. The DFNS stated there was not a cool down log because all food was prepared and served on the same day, and that leftovers from tray line were discarded. At that time, DFNS and Cook 1, observed the cooked pasta in the walk-in refrigerator, and Cook 1 stated, "That was cooked yesterday."

At that time, Cook 2, stated he cooked the noodles yesterday. He stated after he cooked the noodles, he then ran cool running water over the noodles and placed them in the full-sized pan, then placed in the walk-in refrigerator. Cook 2 stated he had not checked the temperature of the noodles after they were cooked. Cook 1 and Cook 2 stated they were not aware that the noodles were considered a potentially hazardous food (capable of supporting microbial growth) and should have been cooled down. Cook 2 stated noodles were cooked a day in advance on a weekly basis.

The DFNS had not been aware that noodles were cooked in advance, and acknowledged it was a potentially hazardous food that should have been cooled down.

The DFNS provided a log entitled COOLING TIME/TEMPERATURE LOG FOR POTENTIALLY HAZARDOUS FOODS, "Food is cooled quickly and safely to 70 degrees F within 2 hours and then to 40 degrees F within an additional 2 hours (total cooling time 4 hours.)..."

According to standards of practice in the food service industry, cooling provides for cooling from 135?F to 41?F within 6 hours, with cooling from 135?F to 70?F in 2 hours. Safe cooling requires removing heat from food quickly enough to prevent microbial growth. Excessive time for cooling of potentially hazardous foods (time/temperature control for safety foods) has been consistently identified as one of the leading contributing factors to food borne illness. (FDA Food Code 2009)

2. During an observation of the kitchen area on 3/12/12 at 10 AM, in the walk-in refrigerator was a box of shelled eggs with a label that indicated "fresh eggs." Also in the kitchen was a reach-in refrigerator with a box of shelled eggs labeled as "pasteurized eggs". Cook 1 stated he would provide an "over easy egg" prepared with a non-pasteurized egg to customers in the cafe. Cook 1 indicated he used the pasteurized shell eggs when he prepared an over easy egg for patients. The DFNS confirmed it was the practice of the hospital's food service operations to use the fresh shell eggs when undercooked eggs were prepared for customers of the cafe, and to use the pasteurized shell eggs when undercooked eggs were prepared for patients.

During an interview with the DFNS on 3/12/12 at 12:55 PM, she stated, "I looked it up and we cannot serve undercooked eggs in retail using non-pasteurized eggs."

During an interview with the DFNS on 3/14/12 at 10:05 A.M., she stated there were times when patients were offered the cafe menu to select items from if the patient was on a regular diet.

According to standards of practice in the food service industry, when honoring the food preferences for a soft-cooked egg, the eggs used must be pasteurized, or otherwise treated in an acceptable manner to kill or inactivate bacteria and other harmful microorganisms. (FDA Food Code 2009, California Retail Food Code 2009)

3. During an observation in the kitchen on 3/12/12 at 1 PM, a dietary staff member ran the dish machine in the kitchen. The external gauge that was labeled "power wash" reached 138 degrees F. According to the label that was around the "power wash" temperature gauge the wash temperature should have been "between 140 degrees-150 degrees F." Food Service Employee (FSE) 1, confirmed the wash temperature gauge indicated 138 degrees F, and stated, "As long as it reaches 130 degrees F, it is okay."

FSE 1 then showed a log entitled, "[name of hospital] FOOD NUTRITION SERVICES DISH ROOM TEMPERATURES PPM'S", and stated the log was used to record the dish machine temperatures and sanitation. According to the log for February and March 2012, the wash machine temperature had been logged 153 times. Only 92 of the 153 logged entries for the wash tank temperature reached at least 140 degrees F, or only 60% of the time.

During an observation of the kitchen on 3/12/12 at 1:58 PM, a food service worker ran dirty dishes through the dish machine. It was observed the external temperature gauge for the wash tank which reached 130 degrees F. A thermometer was used to test the water on the inside of the machine and stated it was "129 degrees F-130 degrees F."

According to a metal plate affixed to the dish machine by the manufacturer, "Operating Instructions For Chemical Sanitizing Type Conveyor Machines; ...National Sanitation Requirements: ...a wash water min. [minimum] Temperature 140 degrees F..."

4. On 3/12/12 at 10:15 AM, inside the walk-in freezer were three, 5 lb roast beefs that were individually covered and placed on top of a cardboard box. Cook 1 stated the roast beefs were not dated. The DFNS acknowledged that without a date staff would be unable to ensure the item was used within the hospital's shelf life policy and procedure.

According to the Food and Nutrition Policy entitled FOOD SUPPLIES & STORAGE, "24. All foods are dated when received to ensure proper rotation."

5. On 3/12/12 at 2:15 PM, the hospital's "MENU EXAMPLE TO USE DURING DISASTER SAMPLE MENU" was reviewed. The disaster menu did not include a plan that would meet the nutritional needs of those patients on a therapeutic diet, such as a renal diet.

The DFNS stated, "I thought for a disaster we needed to ensure textures such as puree and mechanical soft." The DFNS stated the current disaster menu did not provide direction to hospital staff on how to meet the nutritional needs for those patients needing a renal diet, especially when dialysis could be delayed in the event of a disaster. The DFNS stated the disaster menu had not been analyzed to determine if it met the needs of a variety of routine therapeutic diets that were ordered at the hospital. The DFNS indicated if dietary staff were present that adjustments could be made to the disaster menu at the time the disaster occurred. The DFNS acknowledged in the event of a disaster in which non-dietary hospital staff may need to implement the disaster menu that the planned menu lacked directions on how to meet some therapeutic diets.

According to the Food and Nutrition policy and procedure entitled DISASTER PLAN- FOOD & NUTRITION SERVICE, "This policy serves as basic guidelines for Food & Nutrition Service to provide food services to patients, staff and physicians during the event of a disaster..., Adjust and establish the menu for both the regular and therapeutic diets for twenty-four (24) hours. Update as needed. Remember to include modified consistencies, such as puree. Use the preplanned disaster menu food options as a guide. Therapeutic diets will be adhered to when possible."

A disaster menu that had not incorporated the needs of patients on a therapeutic diet could exacerbate a patient's medical status.

Based on observation, interview, and record review, the hospital failed to ensure: 1. Therapeutic diet orders were defined to ensure the patients received a therapeutic diet order as intended by the practitioner responsible for the care of the patient, and 2. One patient received a therapeutic diet in accordance with the physician's diet order (17). (Refer to A 0631)

Findings:

The clinical record for Patient 17 was reviewed on 3/13/12 at 10:39 AM. On 3/11/12 a physician wrote an order for "Diet: Hepatic Diet (special diet given to patients who's liver is not functioning properly)."

When the Clinical Registered Dietician (CRD) was asked how the hospital defined hepatic diet, she stated there was not a uniform definition. She stated the clinical dietitians would assess the patient and would then determine how much protein the patient should have, which would vary from patient to patient with a physician prescribed hepatic diet order. The practice of the clinical dietitians was to communicate to the diet office via the patient's electronic medical record (EM) on quantity of protein to provide to the patient, instead of providing recommendations to the physician who was responsible for care of the patient.

For Patient 17, the CRD completed a nutrition assessment on 3/12/12 in which estimated caloric and protein needs were determined based on the patient's weight, height, adjusted body weight and in consideration of laboratories that were noted on the nutrition assessment. The Clinical Dietitian (RD) used the EM screen entitled "Enter/Edit Dietary Data", and under Misc wrote "50 gm protein/day." The CRD stated the dietary department would view the entry of 50 gm protein per day, and would monitor the menu for that patient to meet that protein specification. The CRD stated the patient was determined by the RD to be at moderate nutrition risk and per policy that meant a follow up by an RD in 4-5 days.

The CRD was asked to use the hospital's diet manual to indicate the approved therapeutic renal diet (diet given to patients who's kidneys are not functioning properly). The CRD was unable to utilize the hospital's on-line diet manual, while at the nursing station, to obtain guidance on how the hospital defined and implemented a therapeutic renal diet. The CRD stated there was not a specific approved house definition for "renal diet", which should be directed by the physicians whom practice at the hospital. The CRD stated the clinical registered dietitian would complete a nutrition assessment for the patient who received a "renal" diet order which would take into account whether on dialysis or not. The RD would then communicate to the diet office via the EM by specifying the amount of protein to provide the patient. The CRD verified that a "renal" diet could vary from "renal" diet order depending on the patient, as determined by the RD.

During an interview with Lead Registered Dietician on 3/13/12 at 11:10 AM, she stated she was aware that the hospital's on-line diet manual was not customized to be hospital specific. The LRD showed a binder that was entitled, "[name of hospital] FOOD & NUTRITION SERVICE CLINICAL DIET MANUAL", and stated the binder was what was approved by the medical executive committee and governing body. There was a signage page that was signed by the Lead Clinical Dietitian, Pharmacy and Therapeutic and Infection Control Committee, Medical Executive Committee, Vice President Patient Care Services, CEO, and the Governing body, ranging in approval dates from 3/25/11 - 4/26/11. Inside the diet manual binder was 3 pages of "Diet Types Brief Summary". The summary listed diets that included high fiber, low fat, cardiac diet, renal diet, and low residue diet. There were no parameters listed for the diets that would indicate how a physician would want a patient meal tray implemented when the physician writes "renal" "diet ", for example. The Diet Types Brief Summary under Renal Diet indicated, "Renal Diet is used for patients with severe kidney disease. Sodium, potassium, phosphorous, protein, and liquids may be limited. This is a very hard diet to follow and to prepare. Follow the facilities menu and diet manual if you have questions. A renal diet is also ordered for patients on dialysis (a procedure that removes toxins from a patient who's kidneys are not working properly) in which case the patient needs MORE protein."

According to the hospital's policy entitled DIET ORDERS, "PURPOSE: To establish procedure for processing diet orders. POLICY: A written prescription is required for all diet orders, including therapeutic diets, NPO orders, tube feedings and parenteral orders..., 8. All diet orders should follow the terminology approved in the diet manual."

2. The clinical record for Patient 15 was reviewed on 3/13/12 at 3 PM. According to the hospital's "Census for Dietary", dated 3/13/12, the food and nutrition services department was providing the patient with a "Cardiac/salt ok per RN (registered nurse), High Protein, 1200 cc/24 hour" fluid restriction.

During an interview with the CRD on 3/13/12 at 3 PM, she reviewed Patient 15's clinical record and stated there was not a physician's order for the high protein diet, nor was there a physician's order for "salt ok."

On 3/13/12 at 3:29 PM, Registered Nurse (RN) 6, reviewed Patient 15's medical chart, and verified there was not a physician's order for the high protein diet, nor was there a physician's order for "salt ok."

On 3/13/12 at 3:32 PM, RN 7, stated the technologist entered the "salt Ok per RN, and high protein" comments in the electronic medical record and "it was a mistake." RN 7 stated, "I told the tech that the patient wanted more protein; she must have mistaken it as an order." During an interview with the Director of Telemetry (DT) she stated a licensed nurse did not have authority to modify a physician's order. The physician wrote an order for "cardiac diet" on 3/9/12 per the patient's medical record. A 1200 cc fluid restriction was added on 3/12/12. The DT stated the nurse did not have authority to add "salt ok", and stated a physician's order would have been needed.

According to the hospital's policy entitled DIET ORDERS, "PURPOSE: To establish procedure for processing diet orders. POLICY: A written prescription is required for all diet orders, including therapeutic diets, NPO orders, tube feedings and parenteral orders..., 8. All diet orders should follow the terminology approved in the diet manual..., 12. When a patient requests an item not allowed on the special diet, the Dietitian should be consulted. When possible the diet will be modified to accommodate the request. If the request is unable to be accommodated within the prescribed order, the charge nurse or Dietitian should consult the physician for possible order changes if appropriate."

Based on interview and record review, the hospital failed to ensure the nutritional needs of the patients were met in accordance with recognized dietary practices. Menus were not analyzed to ensure they met Dietary Reference Intakes (DRIs) of the Food and Nutrition Board or the National Research Council. Lack of nutrient analysis of patient menus could potentially place patients at risk of not receiving required nutrients thereby compromising medical care.

Findings:

During an interview with the Lead Registered Dietician (LRD) on 3/13/12 at 11:10 AM, she stated she was aware the hospital's on-line diet manual was not customized to be hospital specific. LRD showed a binder that was entitled, "[name of hospital] FOOD & NUTRITION SERVICE CLINICAL DIET MANUAL", and stated the binder contained documents that were presented for approval entitled, "ADDENDUM TO CLINICAL DIET MANUAL 2010", and was approved by the medical executive committee and governing body. There was a signage page that was signed by the Lead Clinical Dietitian, Pharmacy and Therapeutic and Infection Control Committee, Medical Executive Committee, Vice President Patient Care Services, CEO, and the Governing body, ranging in approval dates from 3/25/11-4/26/11. Inside the diet manual binder was 3 pages of "Diet Types Brief Summary". The summary listed diets that included high fiber, low fat, cardiac diet, renal diet, and low residue diet. There were no parameters listed for the diets that would indicate how a physician would want a patient's meal tray implemented when the physician wrote "cardiac diet". There were no parameters listed to determine what a "high fiber" diet meant in accordance with a physician order for a high fiber diet. The Diet Types Brief Summary under Renal Diet indicated, "Renal Diet is used for patients with severe kidney disease. Sodium, potassium, phosphorous, protein, and liquids may be limited. This is a very hard diet to follow and to prepare. Follow the facilities menu and diet manual if you have questions. A renal diet is also ordered for patients on dialysis in which case the patient needs MORE protein."

Without approved defined therapeutic diets, it would inhibit adequate nutrient analysis of menus to ensure that patient meal trays were implemented in accordance with a physician's order.

During an interview with Director of Food and Nutrition Services (DFNS) on 3/14/12 at 9:55 AM, she stated the patient's menus had not had a completed nutrient analysis, and she had just recently discussed with the clinical dietitian's the need to do so. According to the hospital's job description for the Director of Nutrition/Food and Environmental Services job description included, "The Director of Nutrition & Food will have full responsibility for Registered Dietitian services. The Lead Clinical Dietitian will act as a point person for the staff Registered Dietitian services. The Director of Nutrition & Food will work with the Lead Clinical Dietitian to assure nutritional needs of patients are within policy and regulations."

During the same interview, the DFNS, provided a document entitled [name of hospital] NUTRIENT ANALYSIS PATIENT MENU that indicated, "UPDATED 7/18/2006 cj", which listed the following diets; Regular, Puree, Mech [mechanical] soft, Fiber Restricted, Cardiac, 2 gram sodium, 80 gram Renal, Low Fat/Chol [cholesterol], 1800 ADA." The same document indicated that the nutrient analysis was limited to the following for all the above listed diets; calories, protein, fat, carbohydrates, fiber, cholesterol, iron, sodium, calcium, phosphorous, vitamin A, thiamin, riboflavin, vitamin C, potassium, zinc, niacin, vitamin B6, vitamin B12 and folacin.

According to the "ADDENDUM TO CLINICAL DIET MANUAL 2010" the hospital utilized the DRI'S- Food and Nutrition Board, Institute of Medicine, National Academies 2002.

The DFNS acknowledged there was not a complete analysis of the patient menus to ensure the quantifiable amounts of all nutrients, such as vitamins and minerals to ensure the nutritional needs of patients were met in accordance with the DRIs and physician orders.

According to the hospital's job description for the Clinical Dietitian Lead position, under RESPONSIBILITIES included, "Reviews menus for appropriateness of nutritional content."

Based on observation, interview and record review, the hospital failed to customize their on-line diet manual to be hospital specific which should have included the hospital's approved therapeutic diet orders.

Findings:

The clinical record for Patient 17 was reviewed on 3/13/12 at 10:39 AM. On 3/11/12 a physician wrote an order for "Diet: Hepatic Diet."

At that time, the Clinical Registered Dietician (CRD) was asked to utilize the hospital's diet manual to indicate the approved therapeutic diet definition as determined by the physician. The CRD accessed the on-line "Nutrition Care Manual" while at the nursing station, and clicked on "hepatitis", in which a general list of foods allowed and disallowed displayed on the screen. The CRD was unable to locate on the hospital's on-line diet manual how the hospital had defined how a hepatic diet would be implemented at the hospital. The CRD stated the clinical dietitians would assess the patient and would then determine how much protein the patient should have, which would vary from patient to patient with a physician prescribed hepatic diet order.

For Patient 17 the CRD completed a nutrition assessment on 3/12/12 in which estimated caloric and protein needs were determined based on the patient's weight, height, adjusted body weight and in consideration of laboratories that were noted on the nutrition assessment. The clinical dietitian used the electronic medical record screen entitled "Enter/Edit Dietary Data", and under Misc wrote "50 gm (grams) protein/day." The CRD stated the dietary department would see the entry of 50 gm protein per day and would monitor the menu for that patient to meet that protein specification.

The CRD was asked to use the hospital's diet manual to indicate the approved therapeutic renal diet. The CRD was unable to utilize the hospital's on-line diet manual, while at the nursing station, to obtain guidance on how the hospital defined and implemented a therapeutic renal diet. The CRD stated there was not a specific approved house definition for "renal diet", which should be directed by the physicians whom practice at the hospital. The CRD stated the clinical dietitian (RD) would complete a nutrition assessment for the patient who received a "renal" diet order which would take into account whether the patient was on dialysis or not. The RD would then communicate to the diet office via the EMR (Electronic Medical Record) by specifying the amount of protein to provide the patient. The CRD verified a "renal" diet could vary from "renal" diet order depending on the patient, as determined by the RD.

On 3/13/12 at 11:10 AM, the Lead Registered Dietician (LRD), stated she was aware the hospital's on-line diet manual was not customized to be hospital specific. The LRD showed a binder that was entitled, "[name of hospital] FOOD & NUTRITION SERVICE CLINICAL DIET MANUAL", and stated the binder was what was approved by the medical executive committee and governing body. There was a signage page that was signed by the Lead Clinical Dietitian, Pharmacy and Therapeutic and Infection Control Committee, Medical Executive Committee, Vice President Patient Care Services, CEO, and the Governing body, ranging in approval dates from 3/25/11 - 4/26/11. Inside the diet manual binder was 3 pages of "Diet Types Brief Summary". The summary listed diets that included high fiber, low fat, cardiac diet, renal diet, and low residue diet. There were no parameters listed for the diets that would indicate how a physician would want a patient meal tray implemented when the physician writes "cardiac diet", for example. There were no parameters listed to determine what a "high fiber" diet meant in accordance with a physician's order for a high fiber diet. The Diet Types Brief Summary under Renal Diet indicated, "Renal Diet is used for patients with severe kidney disease. Sodium, potassium, phosphorous, protein, and liquids may be limited. This is a very hard diet to follow and to prepare. Follow the facilities menu and diet manual if you have questions. A renal diet is also ordered for patients on dialysis in which case the patient needs MORE protein."

Without approved defined therapeutic diets, it would inhibit adequate nutrient analysis of menus to ensure that patient meal trays were implemented in accordance with a physician's order. In addition, this binder diet manual was limited to the food and nutrition department, and was not readily available to all medical and nursing personnel.

The hospital's diet manual did not reflect how the hospital's physicians defined routinely prescribed therapeutic diet orders. The hospital's diet manual could not be used as a guide to ensure the physician's diet orders were prepared and implemented in accordance with physician's orders. The hospital's diet manual was not customized to be hospital specific and was not available to all medical and nursing personnel which had the potential for miscommunication from the multidisciplinary team members to the patient, and had the potential for interpretations by staff of a physician's diet order.

Based on observation and interview, the hospital failed to ensure expired patient supplies were not made available for patient use. This had the potential to result adverse consequences from expired supplies.

Findings:

1. During an observation on 3/14/2 at 10:30 AM. the following was observed in the cupboards of the dirty utility room of the emergency room: two trochanters (one with packaging open) both dated expired 9/11.

2. During an initial tour of the Medical Surgical Floor (3rd floor) with the Director of the Medical Surgical (DMS) Unit on 3/12/12 at 10:15 AM, the following was observed in the clean utility room:

a. One guide wire with an expiration date of "12-2011".
b. One vaginal speculum in a peel package with a date written on it which read, "6/21/05".
c. One Trocar Thoracic Catheter with an expiration date of 5/10.
d. One Trocar kit in sterilized blue wrap (surgical kit) with a date written on it of 11/27/05.
e. One sterilized surgical kit with the date written on it of 12/04.

The DMS, at the time confirmed the above items should not have been in the clean utility room and the sterilized packages were expired.

Review of the undated hospital's policy titled, "Environmental Facility Cleanliness" and presented as current stipulated "Separate clean items from soiled items at all times and ensure a process for cleaning and disinfection of all equipment/supplies that are used in patient care ...Only clean supplies and equipment shall be kept in the clean utility room. No clean supplies shall be kept in the soiled utility room."

Based on observation, interview, and medical record reviews, the hospital failed to provide an environment to avoid sources and transmission of infections and communicable disease as evidenced by the hospital's failure to have effective systems in place to ensure:


A. Surgical instruments were not sterilized in accordance with nationally accepted infection control standards when hinged instruments were not sterilized in the open position. (Refer to A 0749, item 1)

B. Shared equipment potentially exposed to bloodborne pathogens (Hepatitis B, C, and the virus that causes immunodeficiency), was safely and effectively cleaned and disinfected between each patient use. (Refer to A 0749, item 2)

C. A functional and sanitary environment for the provision of surgical services so that the types of surgery conducted can be performed in a manner that protects the lives and assures the physical safety of all individuals in the area cross reference. (A 0749, item 3i, 3ii, 3iii, iv, and v)

D. Emergency equipment, airway devices (LMA device used to keep a patient's airway open during surgery), were maintained in a manner to protect patients from the devices failing. (Refer to A 0749, item 4)

E. Staff were screened for vaccine preventable diseases in accordance with nationally accepted infection control standards. (Refer to A 0749, item 5)

F. A safe and sanitary emergency room environment and medical surgical floor environment. (Refer to A 0749, item 6)

G. Staff followed the hospital's intravenous infusion policies and procedures and professional standards of practice. (Refer to A 0749, item 7)

H. A safe and sanitary environment in the laboratory department. (Refer to A 0749, item 8)

I. A safe and sanitary environment in the kitchen area. (Refer to 0749, item 9 and A 0620)

Due to the hospital's failure to have an effective method to sterilize hinged instruments (Refer to A above), an Immediate Jeopardy (IJ) situation was called on 3/12/12 at 6 PM. On 3/13/12 at 10:54 AM, with an acceptable plan of correction, the IJ was abated.

The cumulative effects of these systemic problems resulted in the hospital's inability to provide infection control services and care in a safe and effective manner in accordance with the statutorily-mandated Condition for Coverage for Infection Control Services.

Based on observation, staff interview, and document review, the infection control officer failed to develop effective systems for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel in accordance with hospital policy and nationally recognized infection control guidelines as evidenced by the failure to ensure:

1. Hinged surgical instruments were sterilized in the open position.

2. Shared patient glucometer's were effectively cleaned and disinfected between each patient in accordance with nationally accepted infection control standards and manufacturer's recommendations.

3. A functional and sanitary environment for the provision of surgical services so that the types of surgery conducted can be performed in a manner that protects the lives and assures the physical safety of all individuals in the area when:

i. Sterile surgery supplies were stored in an area where cross contamination with infectious agents was not likely.

ii Staff were trained and competent to effectively disinfect the perioperative environment.

iii. Restricted areas and traffic patterns in the GI procedure areas (area where a physician does a procedure that allows the patients colon and stomach to be visualized) were identified and implemented in accordance with nationally accepted standards of practice.

iv. The hospital staff persons wore appropriate surgical attire in the GI procedure area in accordance with nationally accepted standards of practice.

v. The monitoring of air temperature and humidity was performed in accordance with standards of practice in the GI procedure areas.

4. The reusable laryngeal masks (LMA's - an airway device used for anesthesia and airway support) were tracked for the number of times they were cleaned and reused and for their expiration.

5. Medical staff persons were screened for vaccine preventable diseases in accordance with nationally accepted infection control standards for five physicians (6, 7, 8, 9, and 10 ).

6. A safe and sanitary emergency room environment and medical surgical floor environment.

7. Staff followed the hospital's intravenous infusion policies and procedures and professional standards of practice for five patients (10, 11, 12, 13 and 14 ).

8. A safe and sanitary environment in the laboratory department.

9. A safe and sanitary environment in the kitchen area. (Refer to A 0620)

These failures placed patients at risk of coming into contact with disease causing organisms.

Findings:

1. During an initial tour of the Medical Surgical Floor (3rd floor) with the Director of the Medical Surgical (DMS) Unit on 3/12/12 at 10:15 AM, the following was observed in the clean utility room: Five clamps/scissors in 1 peel package, indicating the instruments had undergone the sterilization process. All five clamps/scissors were closed during the sterilization process not allowing the inner surfaces to be sterilized.

During the initial tour of the perioperative sterile supply storage area on 3/12/12 at 3:50 PM, multiple pairs of instruments of various types were in the closed position in sealed peel pouches (Peel pouches are flexible packaging materials that combine a paper or synthetic barrier material and a transparent plastic film. Peel pouches are used primarily when visibility of the instrument is critical for its effective use).

During an interview with Registered Nurse (RN) 5 on 3/12/12 at 3:50 AM, was shown the instruments with blades closed in the peel pouches and he stated the blades should be processed in the open position. RN 5 acknowledged he could not ensure the instruments were sterilized unless the blades were open. RN 5 indicated the hinged instruments would need to be inspected and reprocessed if found in the closed position. RN 5 indicated this would involve reprocessing hundreds of instruments and pulling sterile packs from the floors that contained hinged instruments.

The 2012 Perioperative Standards and Recommended Practices published by AORN was reviewed. Direction was given that, "Cleaned surgical instruments should be organized for packaging in a manner to allow the sterilant to contact all exposed surfaces and instruments with hinges should be opened..."

Failure of the hospital to sterilize hinged instruments in accordance with nationally accepted infection control guidelines placed surgical patients at risk for exposure to serious life-threatening infectious agents.

2a. During an interview with Licensed Vocational Nurse (LVN) 1, on 3/12/12 at 1:30 PM, she was asked about the cleaning of the Life Scan Sure Step Flexx Life Scan [glucometers (a medical device used to measure the blood sugar levels)]. She indicated there were two glucose meters for all the patients on the unit, one for each nursing station. She worked a 12 hour shift and cleaned it "at least once in 12 hours" with "Gluco Chlor" wipes.

During an interview with RN 1, on 3/12/12 at 1:35 PM, she was asked about the cleaning of the glucometers. She indicated she did not take the meter into the patients' rooms. After she used it with each patient she cleaned it with a "Sani cloth" or an alcohol swab.

During an interview with the Director of Education (DE), she was informed LVN 1 cleaned the glucose meter once in her 12 hour shift and RN 1 indicated she uses a sani cloth or an alcohol swab. The personnel files for each of the nurses was reviewed with the DE. Both demonstrated competency in the use of the glucose meter on 9/29/11. The competency procedures were reviewed with the DE and it did include as part of the competency the "Cleaning of the meter". No further information was provided.

2b. During an interview with RN 3 on 3/12/12 at 3:20 PM, he indicated the shared Life Scan Sure Step Flexx Life Scan patient glucometer was cleaned daily on the night shift with a bleach wipe called Gluco-Chlor. RN 3 acknowledged the glucometer was not cleaned after each patient use.

The undated hospital's policy titled, 'Environmental Facility Cleanliness" presented as current stipulated glucometers shared between patients be cleaned daily and only after use on isolated patients.

On the ONLINE LifeScan web site under Professional Resources, accessed 3/12/12, stipulated, "If a single meter is used to treat multiple patients, the meter must be cleaned and disinfected after each use whether or not blood contamination is suspected."

An article published in volume 38, number 3 (April 2010), of the American Journal of Infection Control, by the Association for Professionals in Infection Control and Epidemiology, provided the following guidance: "Assign a glucometer to each patient if possible. Clean and disinfect glucometers if they must be shared between multiple patients. Thoroughly clean all visible soil or organic material (e.g., blood) from the glucometer before disinfection. Disinfect the exterior surfaces of the glucometer after each use following the manufacturer's directions. Use an E.P.A. (Environmental Protection Agency) registered disinfectant effective against HBV, HCV, and HIV (bloodborne pathogens) or a 1:10 bleach solution (1 part bleach to 9 parts water)."

The hospital failed to develop a policy and procedure to ensure the glucometer was cleaned after each patient use to reduce the risk of cross contamination and transmission of bloodborne pathogens (HBV, HCV, and HIV).

3a. On 3/13/12 at 9:50 AM four boxes of orthopedic surgical pins (metal instruments implanted in the body to stabilize bone) were observed on the bottom shelf of a metal cart located in the perioperative dirty utility room. The boxes of pins were a few feet from a hopper (a large toilet without a lid/or cover used to clean dirty items).

During an interview with RN 5 on 3/13/12 at 9:50 AM, he stated "This environment is way too dirty for these (referring to the boxes of orthopedic pins) to be stored here. We need to get them out of here and reprocess (meaning to sterilize) them again." RN 5 acknowledged storing soiled equipment in close proximity with clean equipment could result in soiling of the clean equipment. Additionally, RN 5 acknowledged storing clean equipment in close location to a hopper, which was used to clean/decontaminate soiled equipment, could result in contamination of the packaging of the pins and the potentially the pins themselves when removed from the packaging.

Review of the undated hospital's policy titled, "Environmental Facility Cleanliness" and presented as current stipulated "Separate clean items from soiled items at all times and ensure a process for cleaning and disinfection of all equipment/supplies that are used in patient care ...Only clean supplies and equipment shall be kept in the clean utility room. No clean supplies shall be kept in the soiled utility room."

A review of the 2012 Perioperative Standards and Recommended Practices, published by the AORN, under Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment, Recommendation VII indicated, "Instruments should be decontaminated in an area separate from locations where clean activities are performed... Physical separation from areas where clean items are handled minimizes the risk of contamination. Cross-contamination can occur when soiled items are placed in close proximity to clean items or placed on surfaces upon which clean items are later placed. Aerosols created during cleaning can also result in cross-contamination."

The 6/03 Recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC) for Environmental Infection Control in Health-Care Facilities were reviewed and provided the following information, "The most common point-of-use fixtures for water in patient-care areas are sinks, faucets, aerators, showers, and toilets. The potential for these fixtures to serve as a reservoir for pathogenic microorganisms has long been recognized. Wet surfaces and the production of aerosols facilitate the multiplication and dispersion of microbes."

3b. On 3/13/12 at 9:45 AM Housekeeper (HSK) 3 was observed cleaning Operating Room (OR) 2. HSK 3 was using a cloth to wipe multiple surfaces. HSK 3 cleaned three metal tables, and three metal carts with one cloth. The surfaces began to dry 2.5 minutes after they were wiped and were completely dry in 4 minutes. HSK 3 did not re-moisten any of the surfaces. In a concurrent interview, RN 5 acknowledged HSK 3 was not adequately cleaning the room, and he stated "We need to change this process."

During an interview with HK 4 on 3/13/2 at 9:50 AM in OR 2, she indicated she had been trained to use two and sometimes three cloths to clean an entire operating room. HK 1 indicated the cleaner/disinfectant on the cloths was called Virus 256. When asked how long surfaces must remain wet with the disinfectant to kill microorganisms, HK 3 stated, "It kills right away."

During an interview with the Environmental Services Manager (ESM) on 3/13/12 at 10:15 AM, he stated Virus 256 had a required contact time (time required for the surface to remain wet with the disinfectant solution to kill microorganism) of 10 minutes.

3c. On 3/13/12 at 2:30 PM the endoscopy procedure area [referred to as the GI (gastrointestinal) area] was observed. The GI area contained two GI surgical procedure rooms. The room where the scopes were decontaminated and disinfected was immediately adjacent to each procedure room. A door separated each procedure room from its decontamination/disinfection room and the door was found open to the procedure rooms. When entering the GI area there was no signs that indicated authorized personnel only, environmental controls, attire required, or indicated the permitted movement of staff and patients.

An interview was conducted with Endoscopy Technician (ET) 1 and the Endoscopy Manager (EM) on 3/13/12 at 2:30 PM. When asked about the traffic patterns in the GI area, the Infection Control Nurse (ICN) 1 indicated the GI area was not considered a sterile area therefore there was no restriction of entry or requirements related to attire and environmental controls in the GI area. ET 1 indicated the types of procedures performed in the GI area included colonoscopy (the visualization of the colon [portion of the large intestine] with a long, flexible instrument consists of a tube and a light), EGD (Esophagogastroduodenoscopy or upper endoscopy - a procedure that enables the examiner to examine the swallowing tube, stomach, and the first portion of small bowel using a thin flexible tube that can be looked through on a monitor), and biopsy (the removal of a small piece of living tissue from an organ or other part of the body for microscopic examination), peg insertion (the placement of a tube in the abdomen through which nutrition can be given).

On 3/14/12 at 8:30 AM a review of the definition of surgery developed by the American College of Surgeons dated 4/2007 was conducted with Director of Surgical Services (DSS) and the EM. The definition of surgery indicated "Surgery is performed for the purpose of structurally altering the human body by the incision or destruction of tissues and is part of the practice of medicine. Surgery is also the diagnostic or therapeutic treatment of conditions or diseases processes by any instruments causing localized alteration or transposition of live human tissue which include lasers, ultrasound, ionizing radiation, scalpels, probes, and needles... All of these surgical procedures are invasive, including those that are performed with lasers, and the risks of any surgical intervention are not eliminated by using a light knife or laser in place of a metal knife or scalpel". In a concurrent interview, The DSS acknowledged the procedures in the GI area would be considered surgeries under this definition.

Review of the The Perioperative Standards and Recommended Practices published by the AORN, 2012 edition indicated "Traffic patterns should be designed to facilitate movement of patients and personnel into, through, and out of defined areas within the surgical suite. Signs should clearly indicate the appropriate environmental controls and surgical attire required. The semirestricted area includes the peripheral support areas of the surgical suite. It has storage areas for clean and sterile supplies, work areas for storage and processing of instruments, scrub sink areas, and corridors leading to the restricted areas of the surgical suite. Traffic in this area is limited to authorized personnel and patients. The restricted area includes operating rooms, procedure rooms, and the clean core area."

3d. On 3/13/12 at 2:30 PM EM, ET 1, and ICN 2 were observed moving throughout the GI area without wearing hair coverings and surgical attire.

During an interview with ET 1 and EM on 3/13/12 at 2:35 PM, they indicated staff physicians did not wear surgical scrubs or hair coverings because the GI area was not considered a surgical area.

On 3/14/12 at 8:30 AM, during an interview with the DSS, EM, and ICN 2, a review of the definition of surgery developed by the American College of Surgeons dated 4/2007 was conducted. After reviewing this definition along with the types of procedures performed in the GI area, the DSS acknowledged the procedures performed in the GI area were surgeries.

Review of the hospital's policy titled, "Attire in the Operating Room", dated 6/98, stipulated "All persons who enter the semi-restricted and restricted areas of the surgical suite will wear approved surgical attire intended for use within the surgical suite. Head and facial hair shall be covered when in the semi-restricted and restricted areas of the surgical suite."

Review of the 2012 AORN Perioperative Standards and Recommended Practices, under Recommended Practices for Surgical Attire, Recommendation II documented, "Clean surgical attire, including shoes, head covering, and all individuals who enter the semirestricted and restricted areas of the surgical suite should wear freshly laundered surgical attire intended for use only within the surgical suite." Item II.c. documented, "Persons entering the semirestricted or restricted areas of the surgical suite for a brief time for a specific purpose should cover all head and facial hair and should don either freshly laundered surgical attire; single-use attire, or a single-use jumpsuit designed to completely cover outside apparel." Recommendation III documented, "All individuals who enter the semirestricted or restricted areas should wear freshly laundered attire that is laundered at a health care-accredited laundry facility or disposable surgical attire provided by the facility and intended for use within the perioperative setting." Recommendation VI documented, "All individuals entering the restricted areas should wear a mask when open sterile supplies and equipment are present."

3e. An interview was conducted with the DSS on 3/14/12 at 8:30 AM in the GI area. When asked about monitoring the GI areas for temperature and humidity, the DSS indicated the GI area had not previously been considered a surgical/perioperative area by the hospital. After reviewing this definition along with the types of procedures performed in the GI area, the DSS acknowledged the procedures performed in the GI area were surgeries and she indicated environmental monitoring of temperature, humidity, and room air exchange rates in the GI areas would need to be performed.

The 2012 edition of Perioperative Standards and Recommended Practices, published by the AORN , made the following recommendations related to Safe Environment of Care: "Temperature should be monitored and recorded daily using a log format or documentation provided by the HVAC system. Temperature should be maintained between 68? F to 73? F (20? C to 23? C) within the operating room suite and general work areas in sterile processing. Self-regulating, area-specific chiller units may be required because operating rooms are filled with personnel and heat-emitting equipment; therefore, achieving the low end of this range can be difficult. The decontamination area temperature should be maintained between 60? F to 65? F (16? C to 18? C). A temperature > of 70? F to 75? F (21? C to 24? C) should be maintained in recovery areas.

The air-exchange rate in the perioperative areas should be carefully controlled. The number of air changes per hour is based upon the need to remove microbiological or chemical contaminants from the environment. The minimum rate of total air exchanges per hour should be maintained at a constant level as follows. Operating room: minimum of 15 air exchanges per hour with a recommended range of 20 to 25 air exchanges. Post anesthesia care unit: six air exchanges per hour. Sterile storage area: four air exchanges per hour.

Relative humidity should be maintained between 30% and 60% within the perioperative suite, including operating rooms, recovery area, cardiac catheterization rooms, endoscopy rooms, instrument processing areas, and sterilizing areas and should be maintained below 70% in sterile storage areas.

Low humidity increases the risk of electrostatic charges, which pose a fire hazard in an enriched environment or when flammable agents are in use and increases the potential for dust. High humidity increases the risk of microbial growth in areas where sterile supplies are stored or procedures are performed. Free-standing humidifiers should not be used because they can harbor microorganisms in fluid reservoirs and aerosolize these microorganisms into the clean environment. Humidity should be monitored and recorded daily using a log format or documentation provided by the HVAC system.

4. On 3/13/12 at 2:30 PM, during the initial tour of the hospital's ambulatory surgery center 14 laryngeal mask airways (LMAs - an airway device used for anesthesia and airway support) were observed wrapped in sterile processing packs that were dated 2006. There was no record available for the number of times the LMAs had been used and reprocessed since the date of purchase.

On 3/13/12 at 2:30 PM, during an interview, the Ambulatory Surgery Manager (ASM) staff indicated they did not track the number of times a LMA was cleaned or reused. The ASM indicated she was not sure when the LMAs were last replaced.

Review of a document titled "The 40 Use Program," dated 4/04 from LMA North America Inc., retrieved from http://www.lmana.com/docs/40 Use Package-LMA412.pdf, indicated the LMA manufacturer (The Laryngeal Mask Company) warrants reusable LMA products for 40 uses or a period of one year from date of invoice, whichever comes first. Pre-use performance checks were recommended by the manufacturer. If the LMA fails the performance check prior to 40 uses, it should also be discarded. With repeated use, the LMA materials break down and the device may fail to function to permit a patient to breathe, or may injure a patient.

5. Review of five of five medical staff files (Medical Doctor's [MD] 6, 7, 8, 9, and 10) was conducted on 3/15/12 at 8:40 a.m. and five of five medical files (MD's 6, 7, 8, 9, and 10) did not contain documentation of screening for varicella, measles, mumps, rubella, or hepatitis B. MD 8 had a positive TB skin test on 10/11 but no documentation of a check for tuberculosis symptoms was found. MD 9's date of hire was 7/27/10. MD 9 had a negative result one- step TB skin test on 2/17/10. MD 6 had a positive TB skin test on file dated 1995 and there was no evidence of any chest x-rays or tuberculosis symptom checks. MD 10 had no TB screening information found in his medical file. MD 7 had a negative one-step TB skin test on file dated 9/09 and no further evidence of retesting was found.

During an interview with the Director of Medical Staff (DMS) on 3/15/12 at 10:05 AM, he indicated the hospital's policy required physicians to only provide a current tuberculosis test (one-step) upon hire and then every two years at the time of their reappointment. The DMS stated, "We need to change our TB (referring to tuberculosis) screening program to annual screening to meet CDC (Centers for Disease Control and Prevention) standards." The DMS acknowledged all physicians were likely to have intimate contact with patients and also potential exposure to blood. The DMS acknowledged the potential risk to hospital patients and physicians related to not screening physicians for the CDC recommended vaccine preventable diseases.

Review of the undated hospital's policy titled, "Exposure Control Plan for Tuberculosis" stipulated, "Participation in the MTB (Tuberculosis) screening program is mandatory initially for all, and for HCW's (Health Care Workers) annually thereafter."

Review of the hospital's policy titled, "Screening and Immunization", dated 6/01, indicated all hospital employees, all contracted workers and volunteers, and all healthcare workers will have evaluation prior to employment that included screening for tuberculosis, rubella, mumps, rubeola, and varicella. Hepatitis B vaccine is recommended for all employees and strongly encouraged for those health care workers who have frequent contact with blood and body fluids.

The CDC Guidelines for Preventing the Transmission of Mycobacterium tuberculosis (in a Health-Care Setting, 2005, page 10, indicated "The classification of medium risk should be applied to settings in which the risk assessment has determined that health care workers will or will possibly be exposed to persons with TB disease or to clinical specimens that might contain M. tuberculosis. The recommendations for medium risk included, "All HCWs should receive baseline TB screening (checked to identify presence of the disease) upon hire, using two-step TST (skin test) or a single BAMT (alternate test) to test for infection, and after baseline testing for infection, HCWs should receive TB screening annually."

The CDC Morbidity and Mortality Report (MMWR Volume 46, Number RR-18, December 26, 1997) documented on page 24: "Persons who work within medical facilities should be immune to measles and rubella. Immunity to mumps is highly desirable for all Healthcare Workers. Because any HCW (i.e., medical or nonmedical, paid or volunteer, full time or part time, student or nonstudent, with or without patient-care responsibilities) who is susceptible can, if exposed, contract and transmit measles or rubella, all medical institutions (e.g., inpatient and outpatient, public and private) should ensure that those who work within their facilities are immune to measles and rubella. Likewise, HCWs have a responsibility to avoid causing harm to patients by preventing transmission of these diseases on page 25, the MMWR documented: "All HCWs should ensure that they are immune to varicella."

The Occupational Safety and Health Administration (OSHA) requires that hepatitis B vaccine be offered to HCWs who have a reasonable expectation of being exposed to blood on the job.

Review of the 7/30/09 Association for Professionals in Infection Control and Epidemiology (APIC) Position Paper: Safe Injection, Infusion, and Medication Vial Practices in Healthcare indicated that healthcare workers whose activities involved contact with blood or body fluids be offered hepatitis B vaccination.

6a. During a tour of the emergency room on 3/14/12 at 10:15 AM, nine trays were observed on a counter next to the nurse's station. Blackish brown particles were observed on the bottom of the trays. The trays contained sugar packets, four baby nipple wrapped in plastic-one nipple package was stuck to the bottom of a tray, a blood -pressure cuff with grey matter on it, goggles, a paper towel stained with a brown liquid substance. A nearby cabinet drawer contained the following: 95 masks, next to a fan that had gray and black particles on it, patient socks, blood culture sampling equipment, and sterile obstetrics (OB) pads. A pill crusher was observed on top of the counter. The crusher's handle was sticky to touch and a build-up of red/black residue was observed on the crusher's surfaces. During a concurrent interview, the Emergency Department Manager (EDM) stated, "That's gross. We need new trays. That drawer shouldn't exist. I can't tell you who cleans the pill crusher. We don't use it too often."

On 3/14/2 at 10:30 AM the following was observed in the cupboards of the dirty utility room of the emergency room: a disinfectant called Oxivir located immediately next to patient denture cups, and patient specimen cups, toilet paper immediately next to a container of an automotive product labeled as "Prestone Driving Heat Melter, gloves, a box of specimen fixative, two open chest tube evacuation bottles with fluid in them situated next to cleaning pads and blood collection kits.

On 3/14/12 at 10:40 AM the sink in the dirty utility room was observed to contain dirty instruments. A scrub brush with yellow discolored bristles was observed at the top of the sink. Ten clean bedside commodes were observed located ? inch from the hopper (a large toilet that does not have a lid or cover) in the dirty utility room.

During an interview with ESM on 3/14/12 at 10:45 AM, in the dirty utility room he stated, "I make rounds daily. I overlooked this area."

During an interview with ICN 2 on 3/14/12 at 11:20 AM in the dirty utility room he stated. "We need to broaden what we are looking at when we make rounds. Currently we are just looking at a few specific things. There is no question staffing is an issue with infection control."



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7. During an initial tour of the Telemetry Floor (2nd floor) with the Telemetry Clinical Manager (TCM) on 3/12/12 at 10:15 AM, the following was observed:

a. In Patient 10's room a bag of Normal Saline IV solution was infusing into the patient with no label indicating the patients name or time and date the solution was started. The TCM stated, "This is a flush bag we don't label them."

b. In Patient 11's room an antibiotic in a piggyback (a secondary intermittent infusion delivered through a port on the primary infusion set) was hanging from a pole, the end of the tubing was dangling and had no cap at the end to protect it from contaminants.

c. In Patient 12's room an antibiotic in a piggyback was hanging from a pole, the end of the tubing was dangling and had no cap at the end to protect it from contaminants. The TCM stated, "The nurses have a cap they need to use at the end of the line."

d. In Patient 13's room an Intra-venous (IV) solution was hanging and infusing into the patient with no label indicating the patient's name, time or date started. The patient had two IV sites that were not labeled as to the date and time they were inserted. The IV sites were covered with a gauze dressing. The TCM stated, "This patient probably just came from the Emergency Room, they should have labeled the IV sites."

e. In Patient 14's room an IV solution, that was not infusing into the patient, was hanging with the end of the line plugged into a higher port of the primary infusion tubing. The TCM stated, this is the way we usually cap off our IV lines. We don't always have caps available."

The facility policy and procedure titled, "Intravenous Therapy" dated 6/2010, indicated in part:

1. "VENIPUNCTURE: Label transparent occlusive dressing with date time and initials. Transparent occlusive dressings are to be used on all peripheral IV sites (catheter inserted through the skin)."

2. "IV THERAPY: Label IV tubing with date, time and initials. Label bag with medication, dose, time, date and initials.

The "Guidelines for the Prevention of Intra-vascular-Related Infections, 2011" published by the National Institute for Health indicated, "Secondary intermittent infusions delivered through a port on a primary infusion set pose a risk for contamination of the intravascular fluid if it is exposed to air or if it comes into contact with other surfaces."



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8. During a concurrent observation and interview on 3/14/12 at 1:30 PM, in the laboratory service area, the following was found:

a. Cabinets and drawers contained dust and debris as well as food items next to supplies used to process specimens. The Laboratory Manager (LM) stated they should be clean and no food items in the work area.

b. Blood specimens in collection tubes (over 200) were sitting in racks stacked on each other next to equipment at several work stations. Laboratory Technician (LT) stated these specimens were collected that morning and had already been ran. She stated they are collected at the end of the day and disposed of by housekeeping.

c. Urine specimen in specimen containers were stacked on each other in pink plastic basins, sitting next to and touching clean blood specimen collection carts and equipment in several of work station areas. The LM stated they were specimens which had been ran and were being held in case the provider wanted further testing of the specimen. The LT stated she was finished with the specimen and because they were not refrigerated were of no further use. She described at the end of the day she would empty the contents in the sink and put the containers in the red trash for housekeeping to dispose of.

d. One blood specimen was sitting in one of the racks without a cap. The LM stated that all specimens should be capped unless they are being processed.

e. Supply and equipment areas had dust on supplies, shelves and floors. The LM stated housekeeping was responsible for cleaning and should be done daily.

f. The refrigerator contained a half full bottle of "Glucose Drink" with no date or label on it. The LM stated the glucose drinks are one time use only and should not have been returned to the refrigerator.

g. An uncapped needle was found in a tray on a shelf, unlabeled. The LM stated the needle should have been disposed of when they were finished using it.



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9. During the course of the survey, the following unsafe practices were identified: 1) A potentially hazardous food was not cooled down to ensure food safety, 2) Non-pasteurized shell eggs were used to serve under cooked eggs in the cafe, 3) The wash cycle on the dishmachine did not reach a high enough temperature per manufacturer's guidelines, 4) Frozen roast beef was not dated, 5) Three of three ice-machine's inspected were not maintained in a sanitary manner, and 6) Dirty meal tray delivery carts were stored in the dirty utility room lo

Based on staff interview and document review, the hospital failed to arrange for qualified registered nurses (RN) to perform circulating duties during stomach and bowel surgical procedures in accordance with State law, and nationally accepted standards to ensure immediate availability of nursing interventions for patient safety.

Findings:

1. During an interview with the Endoscopy Manager on 3/13/12 at 2:40 PM, she was asked about the staffing during GI (gastrointestinal) procedures, she stated, "Only one licensed person (nurse) is necessary when moderate sedation is being provided. The (sedation) RN provides minimal assist (meaning to assist the technician providing scrub/assist) if needed."

During an interview with RN 4, she confirmed she provided moderate sedation during the GI procedures, and stated, "I guess I am supervising the technician (referring to the technician who is providing scrub/assist) along with the physician.

Review of a position statement from the California Board of Registered Nurses (BRN) effective January 2011 documented, "The Board of Registered Nursing interprets any individual not licensed to practice professional nursing who performs scrub nursing functions may do so only as an assigned technical function under the direct supervision of a perioperative registered nurse."

Review of the 2011 AORN Guidance Statement on Perioperative Staffing documented as minimum intraoperative requirements: One RN per patient per OR in the role of the circulating nurse. One scrub person per patient per room (RN, LPN, or surgical technologist); in some circumstances a scrub person may not be required. One dedicated RN to manage moderate sedation different from the dedicated RN circulator.

Review of the California Code of Regulations Title 22, a state standard for general acute care hospitals, under Chapter 1, section 70217(a)(2) documented, "The surgical service operating room shall have at least one registered nurse assigned to the duties of the circulating nurse and a minimum of one additional person serving as scrub assistant for each patient-occupied operating room.

The 2011 AORN Position Statement on One Perioperative Registered Nurse Circulator Dedicated to Every Patient Undergoing a Surgical Or Other Invasive Procedure documented the minimum requirement for one perioperative registered nurse circulator to be dedicated to each patient undergoing a surgical/invasive procedure, physically present during the patient's entire intraoperative experience, to permit access to the unique clinical knowledge, judgment, and critical-thinking skills possessed by the perioperative RN.

This failure placed patients at increased risk for safety during GI procedures requiring moderate sedation.