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Based on interview and record review, the facility failed to ensure there was documented informed consent prior to surgery being performed for two sampled patients (Patients 10 and 11). This had the potential to result in the patients not being informed of the risks, benefits, and alternatives to their surgical procedures.

Findings:

1a. The record for Patient 10 was reviewed on April 9, 2013. Patient 10 was admitted to the facility on March 29, 2013, for a surgical procedure of an incision and drainage of an abscess to the buttocks.

The "Authorization and Consent to Surgery or Special Diagnostic or Therapeutic Procedures - Physician Certification of Informed Consent" was not completed and was left blank.

The "Short Form History & Physical" did not contain documentation of Patient 10's informed consent.

There was no documented informed consent in Patient 10's record prior to the surgical procedure.

During an interview with RN 2, on April 11, 2013, at 8:25 a.m., she reviewed the record and was unable to find documentation of informed consent being obtained prior to Patient 10's surgical procedure. RN 2 stated informed consent should have been obtained by the physician and documented prior to the surgical procedure.

b. The record for Patient 11 was reviewed on April 8, 2013. Patient 11 was admitted to the facility on April 8, 2013, for a surgical procedure of an excision (surgical removal) of a left axillary (under arm) lymph node.

The "Authorization and Consent to Surgery or Special Diagnostic or Therapeutic Procedures - Physician Certification of Informed Consent" was not completed and was left blank.

The "Short Form History & Physical" did not contain documentation of Patient 11's informed consent.

There was no documented informed consent in Patient 11's record prior to the surgical procedure.

During an interview with RN 3, on April 8, 2013, at 12 p.m., she reviewed the record and was unable to find documentation of informed consent being obtained prior to Patient 11's surgical procedure. RN 3 stated informed consent should be obtained by the physician and documented prior to the patient going to surgery.

The facility policy and procedure titled "Consents" reviewed September 2011, revealed "The informed consent is a three part process; first the physician must speak with the patient concerning the treatment, possible risks, complications and alternatives to the proposed procedure. Secondly the physician must document in the patient record that he has obtained informed consent from the patient..."

Based on observation and record review, the facility failed to ensure the policy and procedure for restraint use was followed when the order for Patient 23's bilateral wrist restraints was not renewed and evaluated within 48 hours. This failure resulted in expired orders for Patient 23's wrist restraints.

Findings:

On April 9, 2013, at 8:35 a.m., Patient 23 was observed in bed, in Room 105. Patient 23 was awake and responded to questions asked of her by nursing staff. Patient 23 had bilateral wrist restraints in place.

On April 9, 2013, the record for Patient 23 was reviewed. Patient 23 was admitted to the facility on April 6, 2013, with diagnoses including pneumonia and urosepsis (secondary infection that occurs when urinary tract infection spreads to the blood stream). Patient 23 was initially seen in the facility's Emergency Department (ED) on April 5, 2013, at 11:35 p.m., as a transfer from a local skilled nursing facility.

The Emergency Department Record indicated Patient 23 was non-verbal, but followed simple commands. On April 6, 2013, at 12:30 a.m., the nurse documented Patient 23 removed her intravenous line (IV). At 1:30 a.m., the nurse documented a second line was established and additional blood work was sent. On April 6, 2013, at 2:45 a.m., a nurse documented "...Restraints to B [bilateral] wrists placed via RBTO [read back telephone order] for pt [patient] safety."

The record contained a "Physical and/or Chemical Restraint Orders," form dated, April 6, 2013, at 2:45 a.m. Further review of the record indicated a second "Physical and/or Chemical Restraint Orders," form dated April 8, 2013, was signed by the physician on April 8, 2013, at 9 a.m., 54 hours after previous order was initiated.

A review of Patient 23's nursing documentation indicated the patient's wrist restraints were in place on April 8, 2013, from 2:30 a.m. to 9 a.m.

The facility policy and procedure titled, "Restraint Use for Voluntary or Involuntary Immobilization," with a last revised dated of November 2011, revealed its purpose was to limit restraint use to clinically appropriate and adequately justified situations. The policy revealed, "Restraint is any manual method, physical or mechanical device, material, or equipment attached to the patient's body that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely...Renewal of orders for continued restraint use is completed every other day not to exceed 48 hours and is based upon an examination of the patient by the Licensed Independent Practitioner."

The facility policy and procedure titled "Verbal and Written Orders-General," with a last revised date of January 2012, revealed "...All orders for medication and treatment shall be written into the medical chart of the patient..."

Based on observation, interview and record review, the facility failed to ensure direct care staff were trained and able to demonstrate competency in providing care to a patient in restraints, according to facility policy and procedure. This had the potential to result in harm to Patient 23 while radiology staff were caring for the patient.

Findings:

On April 9, 2013, at 8:35 a.m., Patient 23 was observed in bed, in Room 105. Patient 23 had bilateral wrist restraints (each of the patient's arms was placed in a soft velcro limb holder, then tied to the bed frame), in place. Patient 23 was transported via her bed to the radiology department by radiology staff. Patient 23 was receiving supplemental oxygen via nasal cannula. Upon her arrival to radiology, Patient 23's restraints were released and the patient was helped to the radiology table, by radiology staff. Patient 23 underwent two procedures, one requiring inhalation of an isotope via an oxygen mask. Patient 23 was observed reaching up, and removing the mask on two occasions. At the conclusion of Patient 23's x-rays she was helped back into her bed, and taken back to the medical/surgical unit.

On April 9, 2013, the record for Patient 23 was reviewed. Patient 23 was admitted to the facility on April 6, 2013, with diagnoses including pneumonia and urospesis (secondary infection that occurs when urinary tract infection spreads to the blood stream).

The Emergency Department Record indicated Patient 23 was non-verbal, but followed simple commands. On April 6, 2013, at 12:30 a.m., the nurse documented Patient 23 removed her intravenous line (IV). At 1:30 a.m., the nurse documented a second line was established and additional blood work was sent. On April 6, 2013, at 2:45 a.m., a nurse documented "...Restraints to B (bilateral) wrists placed via RBTO [read back telephone order] for pt [patient] safety. "

The record contained a "Physical and/or Chemical Restraint Orders," form dated April 6, 2013, at 2:45 a.m. Further review of the record indicated a second "Physical and/or Chemical Restraint Orders," form dated April 8, 2013. The order sheet was signed by the physician on April 8, 2013, at 9 a.m.

The facility policy and procedure titled "Restraint Use for Voluntary or Involuntary Immobilization," with a last revised dated of November 2011, revealed its purpose was to limit restraint use to clinically appropriate and adequately justified situations. The policy revealed " Restraint is any manual method, physical or mechanical device, material, or equipment attached to the patient's body that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely." The following was documented in the section for "Training and Competency of Staff:

All staff that has direct patient contact must have ongoing education and training in the proper and safe use of restraints...providing care for a patient in restraint...Education is initiated at orientation for new and contract staff...is ongoing on at least an annual basis thereafter..."

a. The employee file for Radiology Tech 1 was reviewed on April 10, 2013. Radiology Tech 1 had a hire date of November 17, 2008, was assigned to radiology and was involved in performing Patient 23's x-ray procedure on April 9, 2013.

There was an initial facility orientation document that indicated Radiology Tech 1 underwent restraint training in 2008. There was no additional documentation regarding Radiology Tech 1's ongoing restraint training.

b. The employee file for Radiology Tech 2 was reviewed on April 10, 2013. Radiology Tech 2 had a hire date of December 11, 2007, was assigned to radiology and was involved in performing Patient 23's x-ray procedure on April 9, 2013.

There was an initial facility orientation document that indicated Radiology Tech 2 underwent restraint training. There was no additional documentation regarding Radiology Tech 2's ongoing restraint training.

On April 10, 2013, at 2:10 p.m., the Human Resources (HR) Coordinator was interviewed. The HR Coordinator stated annual restraint training was provided to the nursing staff only; everyone else underwent restraint training during orientation only. The HR Coordinator was asked for information related to annual restraint training for direct care staff, but additional information was not provided prior to the end of the survey.

Based on interview and record review, the facility failed to ensure the quality assurance program included measures to identify and address deficient practices and effectively implement change to improve patient quality of care related to initiation and monitoring of care plans addressing patient nutritional needs.

Findings:

On April 8, 2013, starting at 1:55 p.m., during a review of records, care plans addressing the nutritional status of nutritionally compromised patients were noted to either be not initiated or not monitored and updated (Refer A396).

On April 9, 2013, at 1:45 p.m., in an interview with the Director of Performance Improvement, she acknowledged there was no current monitor in place evaluating the initiation, monitoring and updating of appropriate care plans in response to patient needs.

Based on interview and record review, the facility failed to identify opportunities for improvement that would ensure the sterile processing services provided were consistent with facility policies and procedures and standards of practice by failing:

1. To ensure a Quality Assessment and Performance Improvement (QAPI) process was in place to evaluate the processing of surgical instruments, and to provide education to the Obstetrical Services staff in regards to the processing of surgical instruments.

2. To ensure a Quality Assessment and Performance Improvement (QAPI) process was in place to evaluate the use, types, and number of times specific surgical instruments and equipment were needing to be "flash sterilized (steam sterilization of unwrapped items intended to be used immediately)."

These failures had the potential to result in unsafe processing of surgical instruments to continue without immediately being detected.

Findings:

1. The sterile processing services provided by the facility were not consistent with facility policies and procedures and standards of practice (Refer to A749).

2. On April 8, 2013, the facility's "Flash Sterilizer Log" for January 9, 2013, through April 8, 2013, was reviewed.

The "Laparoscopic Tray/Instruments" were "flash sterilized" on February 4, 12, 14, 15, 19; and March 4, 5, 8, 11 (times four), 2013.

There was no indication on the log as to why the "Laparoscopic Tray/Instruments" were "flash sterilized."

The "Weitlaner tray/Weitlaners (self retaining retractors for small incisions)" were "flash sterilized" on January 15 (times two); February 19, 20, 27; March 19; and April 8, 2013.

There was no indication on the log as to why the "Weitlaner tray/Weitlaners" were "flash sterilized."

During an interview with Operating Room Technician (ORT) 1, on April 8, 2013, at 10:55 a.m., she stated the facility had two sets of "Weitlaners" wrapped as a pair and if more than two orthopedic cases were done in a row, the "Weitlaners" would need to be "flash sterilized." ORT 1 stated sometimes the instruments used on a Friday were not processed until Monday, and this was the reason why the "Weitlanders" were "flash sterilized" on April 8, 2013, at 7:30 a.m.

During an interview with the Director Risk Management/Surgical Services (DRM), on April 8, 2013, at 2 p.m., she stated the facility would sometimes have four or five laparoscopic cholecystectomy(removal of the gallbladder by laparoscopic technique) scheduled in a row and the facility only had two sets of laparoscopic instruments. The DRM stated surgery often times did the same type of case multiple times in a row and would then need to "flash sterilize" the instruments between cases because there were limited number of sets or instruments. The DRM stated she had not recently looked at the types of surgical instruments needing to be "flash sterilized" and how often "flash sterilization" was occurring.

The Association of Perioperative Registered Nurses (AORN) March 9, 2012: Recommended Practices for Sterilization

Recommendation VII

Immediate use flash steam sterilization should be kept to a minimum and should be used only in selected clinical situations and in a controlled manner.

On April 11, 2013, at 11 a.m., an interview was conducted with members of the QAPI committee. The DRM stated Sterile Processing reports through the Surgery Committee and only reports if the sterilizers were not functioning. In addition, the DRM stated there were no current audits in regards to how often instruments were "flash sterilized" and why, and no observations had been done to evaluate the sterile processors techniques.

Based on interview and record review, the facility failed to ensure temporary clinical privileges were granted in accordance with the facility's Medical Staff Bylaws. This result in Physician 2 being granted temporary privileges for 120 days with out a review every 30 days and not to exceed a total of 90 days.

Findings:

On April 10, 2013, at 10 a.m., the medical staff file of Physician (MD) 2 was reviewed with the Medical Staff Services Coordinator (MSSC).

MD 2 applied for facility medical staff "Temporary Privileges" on February 26, 2013, and "Temporary Privileges" were issued on March 1, 2013, with an "End Date: June 26, 2013 (118 days from the effective date)."

The facility "Medical Staff Bylaws" dated 2012, revealed "... may grant Temporary Clinical Privileges to an applicant for a specific time period not to exceed thirty (30) days and/or on a case by case basis. Renewal(s) of Temporary Clinical Privileges may be made by the same procedure during the application processing period. Renewals shall not exceed a total of ninety (90) days. ..."

During a concurrent interview with the MSSC, she stated she thought "Temporary Clinical Privileges" could be granted for 120 days. The MSSC stated she was not aware the Medical Staff Bylaws indicated "Temporary Clinical Privileges" may be granted not to exceed 30 days with renewals not to exceed 90 days.

Based on interview and record review, the facility failed to ensure one sampled patient's (Patient 24),critically low lab value was reported to the patient's physician within one hour. The facility failed to follow its policy and procedure for "Critical Values for Clinical Departments," by failing to inform Patient 24's physician about a blood glucose level within one hour. This had the potential to result in a delay in treatment for Patient 24's low blood glucose.

Findings:

The record for Patient 24 was reviewed on April 9, 2013. Patient 24 presented to the Emergency Department on April 3, 2013, with fever and hypoglycemia (low blood sugar level).

On April 8, 2013, there was a "Critical Result(s) Notification," sticker affixed to the progress notes in Patient 24's record. The form indicated on April 8, 2013, at 9:30 a.m., medical/surgical unit staff received notification that Patient 24's serum glucose level was 48 mg/dL (milligram per deciliter). According to documentation on the form, Patient 24's physician was notified about the results on April 8, 2013, at 12:30 p.m., three hours after the unit had received the results.

In an interview with RN 10, on April 9, 2013, at 10:30 a.m., RN 10 stated "it looks like we were not doing anything, but we were feeding the patient and rechecking her fingerstick blood glucose levels."

In an interview with LN 11, on April 9, 2013, at 11:30 a.m., LN 11 stated it was difficult to get in touch with Patient 24's physician. LN 11 stated three attempts were made to contact Patient 24's physician, but he was unable to get through within one hour. LN 11 stated there was no documentation in the record indicating calls were made prior to 12:30 p.m.

The facility's policy and procedure titled, "Critical Values for Clinical Departments," with a last revised date of November, 2011, was reviewed and revealed its purpose was to communicate critical test results to the licensed independent practitioner and clinician. The policy indicated: "Critical test results are those for which a delay in reporting results has the potential to cause serious adverse outcomes for the patient. Critical test results are identified and approved by the medical staff and clinical staff..." Critical results (values) for the clinical laboratory included Glucose less than 50 ml/dL. According to the policy: "The achievable time-frame for reporting: the expectation is that these critical results will be called to appropriate care giver for inpatient within 60 minutes..."

Based on interview and record review, the facility failed:

1. To ensure a plan of care related to nutritional needs was developed, and kept current, by nursing with input from the Registered Dietitian (RD) and other interdisciplinary team members for three sampled patients (Patients 1, 2, and 4) with compromised nutritional status.

2. To ensure the surgical care plan/interventions accurately reflected the patient's condition and were individualized to the patient for one sampled patient (Patient 11).

This had the potential to result in necessary care and treatment not being provided to the patients.

3. To ensure an obstetrical patient (Patient 7), who was rubella (three day measles) non immune (no antibodies against the three day measles), was given the rubella vaccine or had the opportunity to refuse the rubella vaccine prior to discharge from the facility.

This resulted in Patient 7 not being immunized against rubella or being given the opportunity to refuse the rubella vaccine upon discharge from the facility.

Findings:
1 a. On April 8, 2013, at 2:22 p.m., review of the medical record for Patient 1, revealed the patient was admitted on April 4, 2013, with diagnoses including bloody urine, severe anemia (low iron content of the blood), congestive heart failure and advanced stage chronic kidney disease.

From April 4, 2013 to April 8, 2013, the patient lost 15 pounds. A nutritional assessment was completed on April 5, 2013, and RD 1 documented the patient had lost 70 pounds over the past two years, had difficulty chewing food and required a low protein diet due to chronic kidney disease.

Further review of the record revealed there was no plan of care initiated to address the patient's nutritional status.

In an interview with RD 1,on April 8, 2013 at 2:22 p.m., she acknowledged the absence of a nutritional plan of care. RD 1 stated the nutritional assessment was completed by the per diem RD, who was oriented on the care planning process, and should have initiated a plan of care addressing Patient 1's nutritional status, since no plan of care was initiated by nursing.

b. On April 8, 2013, at 1:55 p.m., a review of the record for Patient 2, revealed the patient was admitted on April 2, 2013, with diagnoses including diabetes mellitus, hypertension (high blood pressure) and severe hyponatremia (low sodium level). The patient was non responsive and had been NPO (nothing by mouth) for six days as of April 8, 2013.

The RD completed a nutrition assessment on April 4, 2013, and recommended Total Parenteral Nutrition (TPN) (nutritional support via the vein) to provide the patient with nutritional intake. Another RD assessment was completed on April 5, 2013, and the same TPN recommendation was made.

Further review of the medical record revealed there was no plan of care initiated to address the resident's nutritional status.

In a concurrent interview with RD 1, she acknowledged the absence of a nutritional plan of care. RD 1 stated care plans may be initiated by nursing or dietary staff, but she did not know why a care plan related to nutritional status had not been initiated for Patient 2.

c. On April 8, 2013, at 3 p.m., review of the record for Patient 4, revealed the patient was admitted on March 24, 2013, with diagnoses including liver cirrhosis and End Stage Renal Disease (ESRD) with dialysis.

A nutritional assessment was completed on April 5, 2013, and the RD documented the patient was receiving a renal, NCS (no concentrated sweets), puree diet, and was choking on thin liquids. The RD recommended pudding thick liquids. A nutritional supplement (Nepro) was ordered for Patient 4, as of April 3, 2013, to improve nutritional status.

Review of the plan of care revealed a care plan titled, "Imbalanced Nutrition" was initiated. There was no mention of the patient's nutritional supplement as an intervention, the need for a puree diet or the patient's renal status.

Another plan of care titled, "Risk for Aspiration" was noted. One of the interventions was, "Consider speech therapy consult." However, there was no evidence the patient was evaluated by a speech therapist.

In a concurrent interview with RD 1, she stated the nutritional assessment completed on April 5, 2013, was completed by the per diem RD, who should have updated the plan of care and recommended a speech therapy consult to determine the most appropriate fluid consistency for the patient.

Review of the facility policy titled "Care Plans, Patient" reviewed January 2011, revealed, "The Patient Care Plan will be based upon the data obtained by the RN (Registered Nurse) conducting the admission assessment interview. It is the responsibility of the Registered Nurse admitting the patients, to see that the plans are instituted."

Review of the Registered Dietitian "Job Summary" revealed, part of the responsibilities of the RD was to, "Prepare and document nutritional care plans and nutritional progress achieved."



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2. The record for Patient 11 was reviewed on April 8, 2013. Patient 11 was admitted to the facility on April 8, 2013, for a surgical procedure of an excision (surgical removal) of a left axillary (under arm) lymph node.

The "Pre-Procedure Checklist" dated April 8, 2013, at 8:22 a.m., indicated "Blood Consent Completed and Signed - N/A (Not Applicable)" and "Physician Verified and Marked Surgical Site - Y (Yes)."

The "Surgery - Risk for injury" documentation dated April 8, 2013, at 8:24 a.m., indicated "Blood band present on patient, blood consent signed, and blood available in lab (laboratory)" and "Purple wrist band in place with correct information on pt (patient) who refused site marking or who is unable to be marked."

During an interview with RN 2, on April 11, 2013, at 8:25 a.m., she reviewed the record for Patient 11 and was unable to find documentation of a blood consent or blood available in the laboratory, and the patient's refusal to have his left axillary marked. RN 2 stated the "Risk for injury" was the plan of care for surgical patients, the interventions were automatic, and interventions that do not apply to the specific patient should be deleted. In addition, RN 2 stated for Patient 11, the nurse should have deleted the "Blood band present on patient, blood consent signed, and blood available in lab (laboratory)" and "Purple wrist band in place with correct information on pt (patient) who refused site marking or who is unable to be marked" because these interventions did not apply to Patient 11.

The "Care Plans, Patient" reviewed January 2011, revealed "... The Patient Care Plan will be based upon the data obtained by the RN (Registered Nurse) ... Goals shall be reflected in the Nursing documentation..."

3. The record for Patient 7 was reviewed on April 9, 2013. Patient 7 was admitted to the facility on April 7, 2013, with diagnoses of pregnancy in labor with rupture of fetal membranes.

The Physician's Pre-natal record, dated December 12, 2012, indicated Patient 7 was "Rubella (three day measles) - Non Immune (did not have antibodies against the three day measles)."

The "Admission Record" dated April 7, 2013, indicated "Rubella/Titer: Non-Immune."

Patient 7 was discharged home from the facility on April 9, 2013.

There was no indication in the record Patient 7 had received the rubella vaccine or been provided the opportunity to refuse the rubella vaccine.

During an interview with RN 4, on April 10, 2013, at 3 p.m., she reviewed the record and was unable to find documentation of the rubella vaccine being given to or refused by Patient 7. RN 4 stated if a patient was rubella non immune, the nurse would contact the physician to obtain an order for the rubella vaccine and the rubella vaccine would be given to the patient prior to discharge. RN 4 stated part of the procedure prior to discharging an obstetrical patient was to check the patient's rubella status and vaccinate the patient if they were rubella non immune. In addition, RN 4 stated Patient 7 should have received or refused a rubella vaccine prior to discharge.

The facility policy and procedure titled "Discharge Teaching--Postpartum" reviewed October 2011, revealed "... The following will be addressed by the staff nurses by the time of discharge as applicable: Vaccine Information (..., Rubella if non-immune)..."

Based on observation, interview, and record review, the facility failed:

1. To administer medications in accordance with acceptable standards and the facility's policy and procedure by failing to ensure a physician's order for Haldol (an anti-psychotic medication) was verified prior to the administration of the medication. Patient 23 was given Haldol 5 milligrams (mg) intramuscularly (IM) on April 6, 2013, without evidence of a written or verbal order from the physician for the medication.

2. To ensure medications were administered in accordance with the physicians' orders and the facility's policy and procedure.

Findings:

1. On April 9, 2013, at 12:15 p.m., Patient 23 was observed in bed, in Room 105. Patient 23 was awake and responded to questions asked of her by nursing staff.

On April 9, 2013, the record for Patient 23 was reviewed. Patient 23 was admitted to the facility on April 6, 2013, with diagnoses including pneumonia and urosepsis (secondary infection that occurs when urinary tract infection spreads to the blood stream). Patient 23 was initially seen in the facility's Emergency Department (ED) on April 5, 2013, at 11:35 p.m., as a transfer from a local skilled nursing facility.

The Emergency Department Record indicated Patient 23 was non-verbal, but followed simple commands. On April 6, 2013, at 1:30 a.m., the nurse documented a new IV (intravenous line) was established and additional blood work was sent. On April 6, 2013, at 2:30 a.m., a nurse documented Patient 23 was given Haldol 5 mg IM.

There was no evidence of an order for Haldol on the Physician Order Sheet. There was no evidence a verbal or telephone order was received for this medication.

The record was reviewed with the ED Director on April 11, 2013, at 10:30 a.m. The ED Director verified there was no order for the medication. The ED Director stated it appeared a verbal order was received to cancel another medication and give Haldol instead. The ED Director stated the medication order should be in the record.

The facility policy and procedure titled, "Medication Administration," with a last reviewed dated of January 2010, revealed its purpose was to standardize procedures for safe administration of medications on all patient care units. The policy indicated "...Before administering a medication, the licensed independent practitioner or appropriate health care professional administering the medication does the following...Verifies the medication selected for administration is the correct one based on the medication order and product label.."

The facility policy and procedure titled "Verbal and Written Orders-General," with a last revised date of January 2012, revealed "...All orders for medication and treatment shall be written into the medical chart of the patient..."



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2a. During a medication pass observation conducted on April 9, 2013, at 1:45 p.m., RN 8 programmed the IV (intravenous - fluid given directly into a vein) pump to set the rate of infusion at 100 ml (milliliters) per hour and VTBI (volume to be infused) to 249 ml to infuse Vancomycin, an IV antibiotic, for Patient 14 using the facility's programmable pump manufactured by B. Braun.

It was observed the IV Vancomycin bag's label indicated the volume of the bag was 300 ml and the Vancomycin needed to be infused in 90 minutes.

A review of the electronic Medication Administration Record (eMAR) for Patient 14 also indicated the Vancomycin was to be infused over 90 minutes.

During an interview on April 9, 2013, at 2 p.m., RN 8 acknowledged the IV pump was programmed for the Vancomycin with the volume of 249 ml to be infused at 100 ml per hour and explained the VTBI was set just short of the actual volume to be infused in order for the pump to prevent air entering the IV line.

RN 8 did not indicate the Vancomycin total volume prepared by the pharmacy, as indicated by the Pharmacy label, was 300 ml and did not provide the reason the IV pump was programmed in that way. RN 8 stated the setting of the VTBI was not important and did not matter since the IV pump would sound an alert to indicate the end of infusion and whatever the volume left over in the bag would be reprogrammed to be fully infused.

During an interview on April 9, 2013, at 2:40 p.m., the ICU Director indicated she would not have programmed the IV pump to run at 100 ml per hour when the Vancomycin IV bag had the volume of 300 ml to be infused in 90 minutes and set the VTBI at 249 ml when the total volume of the IV bag was 300 ml.

Review of the facility ' s policy and procedure titled, " Medication Administration " indicated,

" Before administering a medication ...appropriate health care professional administering the medication ...verifies the medication is being administered ...in the prescribed dose ... "

b. During a medication pass observation conducted on April 10, 2013, at 10:40 a.m., RN 9 was observed preparing nitroglycerin topical ointment (for chest pain) on the manufacturer supplied paper, by applying the full amount of the nitroglycerin (NTG) topical ointment prepared by the Pharmacy in a 3-ml syringe that was filled with the medication to 1 ml. RN 9, using the tape, applied the medicated paper to Patient 16 ' s right shoulder.

A review of the physician order indicated there was an order to apply Nitropaste (nitroglycerin ointment) 1 inch to the chest wall every 6 hours and hold if the systolic blood pressure was below or equal to 110.

During a concurrent interview, RN 9 stated the Pharmacy supplied the exact dose of the NTG ointment in a syringe according to the physician order and the full content of the Pharmacy supplied syringe containing the NTG ointment would be used to administer the dose.

During a concurrent interview, the Director of Pharmacy did not indicate the Pharmacy supplied the exact dose of NTG in a syringe according to the physician order and each NTG syringe containing 1 ml of the ointment was premeasured and prepared in 3-ml syringes from the manufacturer's NTG tube by the pharmacy (i.e., unit-dosed in syringes).

During an interview on April 10, 2013, at 12 p.m., Pharmacist 1 indicated the nurse administering the ointment needed to use the appropriate amount of the ointment from the Pharmacy supplied syringe and the manufacturer supplied paper used for measuring the amount needed.

Pharmacist 1 did not indicate the pharmacy supplied the exact dose in the syringe according to the physician's order.

According to the manufacturer's package insert and the pharmacy reference, Lexi-Comp, the usual doses of the NTG ointment was 1/2, 1 and 2 inches.

Review of the facility's policy and procedure titled, " Medication Administration " indicated,

" Before administering a medication ...appropriate health care professional administering the medication ...verifies the medication is being administered ...in the prescribed dose ... "

Based on interview and record review, the facility failed to ensure there was documented informed consent prior to surgery being performed for two sampled patients (Patients 10 and 11), and in addition, "informed consent was verified" was documented by nursing prior to the surgical procedure. This failure had the potential for consents not being accurately written.

Findings:

1. The record for Patient 10 was reviewed on April 9, 2013. Patient 10 was admitted to the facility on March 29, 2013, for a surgical procedure of an incision and drainage of an abscess to the buttocks.

The "Authorization and Consent to Surgery or Special Diagnostic or Therapeutic Procedures - Physician Certification of Informed Consent" was not completed and was left blank.

The "Short Form History & Physical" did not contain documentation of Patient 10's informed consent.

The "Pre-Procedure Checklist" dated March 29, 2013, at 11:36 a.m., indicated "Informed Consent Notation - Y (Yes)."

The "Surgery" documentation dated March 29, 2013, 3:02 p.m., indicated "Verified Informed Consent, Consent, H&P (History and Physical), pre-anesthesia and nursing assessment before procedure."

There was no documented informed consent in Patient 10's record prior to the surgical procedure.

During an interview with RN 2, on April 11, 2013, at 8:25 a.m., she reviewed the record and was unable to find documentation of informed consent being obtained prior to Patient 10's surgical procedure. RN 2 stated informed consent should have been obtained by the physician and documented prior to the surgical procedure. RN 2 stated she did not know why the pre-operative nurse and the surgical nurse documented that the informed consent by the surgeon was in the record.

2. The record for Patient 11 was reviewed on April 8, 2013. Patient 11 was admitted to the facility on April 8, 2013, for a surgical procedure of an excision (surgical removal) of a left axillary (under arm) lymph node.

The "Authorization and Consent to Surgery or Special Diagnostic or Therapeutic Procedures - Physician Certification of Informed Consent" was not completed and was left blank.

The "Short Form History & Physical" did not contain documentation of Patient 11's informed consent.

The "Pre-Procedure Checklist" dated April 8, 2013, at 8:22 a.m., indicated "Informed Consent Notation - Y (Yes)"

The "Surgery" documentation dated April 8, 2013, 8:24 a.m., indicated "Verified Informed Consent, Consent, H&P (History and Physical), pre-anesthesia and nursing assessment before procedure."

There was no documented informed consent in Patient 11's record prior to the surgical procedure.

During an interview with RN 3, on April 8, 2013, at 12 p.m., she reviewed the record and was unable to find documentation of informed consent being obtained prior to Patient 11's surgical procedure. RN 3 stated informed consent should be obtained by the physician and documented prior to the patient going to surgery. In addition, RN 3 stated she should not have marked the "Informed Consent Notation - Y (Yes)" until she verified the informed consent had been obtained by the physician.

The facility policy and procedure titled "Consents" reviewed September 2011, revealed "The informed consent is a three part process; first the physician must speak with the patient concerning the treatment, possible risks, complications and alternatives to the proposed procedure. Secondly the physician must document in the patient record that he has obtained informed consent from the patient. ... The informed consent is obtained by the physician. ... The nurse is responsible to assure that the patient's informed consent was obtained by the physician, prior to obtaining the operative or special procedures or blood transfusion consent signature of the patient. ..."

Based on interview and record review, the facility failed to control safe and effective use of medications by failing:

1. To ensure a medication used for sedating Intensive Care Unit (ICU) patients was used in accordance with the complete physician order that included the level of sedation, which was not clarified by the pharmacist.

2. To ensure test agents were separately stored from medications in the Surgical Services medication refrigerator.

Findings:

a. Patient 14's medical record was reviewed on April 11, 2013, and the following was noted from the physician order written on April 1, 2013, at 3:15 p.m. and the electronic Medication Administration Record (eMAR):

"Propofol (IV drug used for sedation) 1000 mg (milligrams)/100 ml (milliliters) D5W (Dextrose 5% Water).
Initial (rate) 5 mcg/kg/min (micrograms per kilogram per minute).
Titrate by 1 mcg/kg/min up to max of 10 mcg/kg/min."

"Propofol 100 ml.
Give Propofol 5mcg/kg/min x 5 min(utes) then increase 1 mcg/kg/min every 15 min until Ramsey Score of 2-5 is achieved. Max 10mcg/kg/min."

Review of the pharmacy record for the Propofol order for the patient indicated the following:

"Give Propofol 5mcg/kg/min x 5 min(utes) then increase 1 mcg/kg/min every 15 min until Ramsey Score of 2-5 is achieved. Max 10mcg/kg/min."

There was no documented evidence from the review of the patient's record how and at what level of sedation the patient was maintained and how the propofol rate was adjusted.

During an interview on April 11, 2013, at 2 p.m., the Director of Pharmacy (DOP) acknowledged the order was missing the sedation level and stated that the verifying pharmacist had added the information from the preprinted Propofol Protocol. The DOP did not indicate the physician's order for propofol was questioned and clarified with the physician by the verifying pharmacist.

During an interview on April 11, 2013, at 3 p.m., Intensive Care Unit (ICU) Director agreed the physician order did not include the sedation level at which the patient was to be titrated and maintained. The ICU Director stated the ICU did not use the Ramsey Scale for sedation and used another sedation rating called RASS Scale. The ICU Director stated there was no nursing documentation of which sedation level was used to maintain Patient 14's sedation.

b. During a tour of the facility's Surgery Department on April 9, 2013, at 3 p.m., it was noted in the medication refrigerator there were four (4) HP-Fast boxes containing 177 tests used to detect H. pylori infection stored with medications.

During a concurrent interview, the Director of Pharmacy acknowledged the testing agents were stored with medications in the medication refrigerator.

According to Title 22 of California Code of Regulation Section 70263(q)(4),

"Test agents, germicides, disinfectants and other household substances shall be stored separately from drugs."

Based on observation, interview and record review, the facility failed to ensure drugs and biologicals were properly stored, maintained and not expired per facility policies and procedures. This had the potential to result in patients receiving drugs and biologicals that were expired or contaminated.

Findings:

During a tour of Surgical Services on April 8, 2013, at 8:55 a.m., with RN 1, the following was observed:
- In OR#3, two (2) Chlora Prep Triple Swabstick with an expiration date of March 2013.
- In the "scope room," a 2,000 milliliter (ml) bottle of 0.9% Sodium Chloride Irrigation Solution with 700 milliliters remaining in the bottle was opened and not dated.
- In the fluid warming cabinet, a 1,000 ml bag of normal saline intravenous solution (IV - fluid given directly into a vein) dated March 21, 2013 (18 days after being placed in the warming cabinet).

During a concurrent interview with RN 1, she stated the Chlora Prep Triple Swabsticks were expired and should have been discarded, the irrigation solution should have been dated when opened, and warmed fluids were only good for 14 days and should then be discarded.

The facility policy and procedure titled "Monitoring of the Temperature of the Warming Cabinets" reviewed September 2011, revealed "... Solutions placed in the cabinet must be dated at the time they are placed in the cabinet. I.V. (intravenous) fluids in the cabinet for warmth should not remain in the cabinet longer than 2 weeks (14 days)..."

The facility policy and procedure titled "Checking Outdated Supplies" dated January 2013, revealed "... Items found that have an expired date will be removed from service..."

During a tour of Surgical Services on April 9, 2013, at 3 p.m., it was noted that in the Epidural Cart, there was a vial of opened Omnipaque injection (Intravenous contrast media) with an open date of March 28, 2013.

The vial indicated it was a single-dose vial that should have been used only once and any remainder would need to be discarded.

During a concurrent interview, the DOP acknowledged the Omnipaque injection was a single-dose vial and should not have been in the cart.

During a tour of the Obstetrical Unit on April 8, 2013, at 2:35 p.m., with RN 5 and the Director Nursing Resources and Cardio/Pulmonary (DNRCP), the following was observed:
- On top of the IV supply cart, a blue top laboratory collection tube with an expiration date of February 2013.
- In the supply room, a box of 4-0 vicryl suture with an expiration date of July 2012; one, 3-0 vicryl suture with an expiration date of January 2008; and eight, 2-0 vicryl sutures with an expiration date of January 2011.
- In the Broselow Roll - Pediatric Emergency bag, the IV Delivery Modules for Yellow, Purple, White, Blue, and Red with an expiration date of September 2012; the IV Delivery Module for Pink with an expiration date of January 2013; and the Oxygen Delivery System for Pink, Yellow, Purple, White, Blue, and Red with an expiration date of September 2012.

During a concurrent interview with RN 5 and the DNRCP, they stated the supplies were expired and should have been discarded. The DNRCP stated the Broselow Roll - Pediatric Emergency had a tag on the outside of the bag with an expiration date of September 2012, and the Obstetrical staff were responsible to check the supplies for outdates, discard the expired supplies and obtain new supplies that were not outdated.

During a subsequent tour of the Obstetrical Unit on April 9, 2013, with the Director Obstetrical Services (DOS) the following was observed in the Newborn Emergency Crash Cart:
- Four blood gas sampling kits with an expiration date of April 2010.
- A 20 ml syringe with an expiration date of June 2012.
- Umbilical tape with an expiration date of July 2012.
- A silk suture with an expiration date of July 2010.
- All of the endotrachael tubes were opened with a stylet (hard, guide wire) inserted.

During a concurrent interview with the DOS, she stated the nursing staff should be checking the Newborn Emergency Crash Cart each month for expired supplies and replacing any supplies that have expired.

The facility policy and procedure titled "Storing, Handling and Monitoring Sterile Supplies" reviewed September 2011, revealed "... If there is an expiration date on the package, dispose of the item no later than the expiration date. If there is no date, consider the item sterile unless the integrity of the package is compromised. ..."

The facility policy and procedure titled "Single Use Items" reviewed September 2011, revealed "... Single use items opened during a procedure, that did not touch the patient, may be returned to the manufacturer for reprocessing, provided that the company offers the service. ..."

The facility policy and procedure titled "Expired Laboratory Reagents and Collection Tubes" dated January 2012, revealed "... we will not use reagents that have expired, nor collection tubes or items that are expired. ..."

Based on observation, interview and record review the facility failed to ensure the Condition of Participation for Food and Dietetic Services were met for all patients as evidenced by failure:

1. To ensure policies were monitored for day to day clinical and foodservice practices. (Refer to A620, A630, A749);

2. To ensure the nutritional needs of patients were met as evidenced by the lack of a comprehensive and accurate nutritional analysis of all the menus used at the facility, meals not served in accordance with prescribed diet orders, lack of Registered Dietitian (RD) contribution to the patient plan of care, and lack of established RD competency. (Refer to A622, A630, A396);

3. To ensure the disaster plan addressed the needs of patients prescribed therapeutic diets, and the integrity of disaster supplies was maintained to ensure adequacy in the event of a disaster as determined by the facility. (Refer to A701, A620); and,

4. To ensure safe and effective food storage/production practices were integrated into the facility's Infection Control Surveillance System (Refer to A749).

The cumulative effect of these systemic problems resulted in the inability of the facility's food and nutrition services to direct and staff in such a manner to ensure the nutritional needs of the patients were met in accordance with practitioners' orders and acceptable standards of practice.

Based on observation, interview, and record review, the facility failed to ensure the Director of Food and Nutrition Services (DFNS):

1. Monitored written procedures/manufacturer recommendations for foodservice operational processes relating to food safety and service.

2. Ensured the integrity of disaster food supplies for all patients, and the appropriateness of disaster foods for all therapeutic diets.

This had the potential to result in patients being exposed to foodborne illness and cross contamination which may further compromise medical status, and inadequate food supplies in the case of a disaster.

Findings:

1. On April 8, 2013, starting at 8:50 a.m., during an inspection of the kitchen, the following observations were made:

a. In the walk-in refrigerator, cooked meatloaf was noted to be stored on a rack in a cart, next to two bags, approximately five pounds each, of thawing raw beef stew pieces. The sheet pan containing the cooked meatloaf and raw beef stew pieces, was stored above two boxes of partially cooked cubed beef sirloin.

In a concurrent interview with the Director of Food and Nutrition Services (DFNS), he acknowledged the raw meat product should not have been stored next to or above cooked or partially cooked food.

Review of the facility policy titled, "Refrigerated and Frozen Storage" dated March 2011, revealed "To prevent cross-contamination when thawing meats, wrap or cover food and label it. Store refrigerated raw meat, poultry, and seafood separately from ready to eat food. Store raw meat, poultry, and seafood in the following top-bottom order:
Ready-to-eat food
Sea Food
Whole cuts of beef and pork
Ground meat and ground fish
Whole and ground poultry."

b. In the walk-in refrigerator, a container of egg salad and a container of tuna salad were noted.

In a concurrent interview with the DFNS, he stated the facility prepared these items from chilled items, and therefore did not have a process to monitor the cool down process or temperature of these items.

Review of the facility policy titled, "Leftovers - Usage and Storage" reviewed April 2012, revealed "All meat salads, poultry salads, potato salads, egg salads, cream filled pastries and other potentially hazardous foods shall be prepared from chilled products and refrigerated below 41 degrees F (Fahrenheit) immediately after preparation."

Upon request, the temperature of the egg salad and tuna salad in the walk-in refrigerator were measured by the DFNS and recorded at 48 degrees F (Fahrenheit) for each item. The DFNS, could not explain why the egg salad and tuna salad, both potentially hazardous foods, were not stored at 41 degrees F or below.

c. In a reach-in refrigerator, plates containing cut cantaloupe were noted.

On April 8, 2013, at 11:55 a.m., in an interview with Diet Aide 1, she stated she prepared the cantaloupe by washing it under water in the preparation sink. Diet Aide 1 did not indicate any other process of cleaning the cantaloupe prior to cutting it for service.

The DFNS, present at the time of the interview, stated it was facility policy to scrub the cantaloupe, but the scrub brushes were currently "missing."

Review of the facility policy titled, "Cleaning Melons and Potatoes" dated September 2006, revealed "Purpose: To provide safe food to an at risk population for food borne illness. Procedure: ...Melons will be thoroughly washed and scrubbed with the yellow handle scrub brush and water prior to cutting."

d. In the trayline reach-in refrigerator, six cartons of "Mighty Shakes" (nutritional supplement) did not have an expiration date.

In a concurrent interview with Diet Aide 2, she stated she retrieved the cartons of "Mighty Shakes" from the walk-in refrigerator where the box of "Mighty Shakes" was dated.

The DFNS, present at the time of the observation, acknowledged once the cartons of "Mighty Shakes" were removed from the original case, they would have to be labeled individually with a discard date.

e. In the food preparation area, three bottles of "Prostat 64" (nutritional supplement) were noted to have been opened. One bottle was not dated as to when it had been opened or when it should be discarded. Two of the bottles were not dated as to when they had been opened, but were dated with a discard date of "8/14/14."

Inspection of the manufacturer recommendations, imprinted on each "Prostat 64" bottle", revealed, "Discard in 3 months after opening."

In a concurrent interview with the DFNS, he acknowledged it was difficult to determine when the three bottles of "Prostat 64" had been opened, in order to determine when they should be discarded per manufacturer recommendations.

f. On a shelf in the cook's area, numerous plastic containers of spices were noted.

In a concurrent interview with the DFNS, the DFNS stated the spices would typically be kept between six months and one year and should be labeled with discard dates. The following was noted:
- Blackened fish seasoning blend -- Use by February 11, 2013
- Whole Rosemary -- Use by January 13, 2013
- Ground nutmeg -- Use by June 5, 2012
- Tarragon -- Use by September 11, 2012
- Ground pepper -- Use by September 1, 2012
- Bay leaves -- Use by January 3, 2013
- Ground marjoram -- No use by date - but delivered on June 19, 2009.

The DFNS could not explain why the spices were kept past the "use by" dates indicated on the labels affixed to the spice containers.

g. Large ingredient bins containing items such as flour and rice were noted. Affixed to the containers was a plastic holder in which the serving scoops were kept. Inspection of the scoop holder affixed to the flour bin and brown rice bin respectively were noted to be dirty with dried food debris, and spills.

In a concurrent interview with the DFNS, he acknowledged the scoop holders needed to be cleaned.

h. Ceiling vents, located above stored, clean equipment, and racks of bread, were noted to have a heavy accumulation of gray/black dirt and dust.

In a concurrent interview with the DFNS, he acknowledged the ceiling vents needed to be cleaned, and stated it was the responsibility of the Environmental Services Department (EVS). The DFNS stated EVS had been notified, but follow-up had not been done to ensure the task was completed.

i. In the dry storage room, debris was noted underneath the food storage racks. In addition, one storage shelf was noted to be dirty with a dried brown liquid adhering to the shelf and the wall behind the shelf.

In a concurrent interview with the DFNS, he acknowledged the dry storage room and shelves needed to be cleaned.

Review of the facility policy titled, "Cleaning of the Store Room" reviewed April 2012, revealed "Wash the top and underside of the shelves with hot, soapy water."

Further observation of the dry storage room, indicated:
- Three boxes of decaffeinated ground coffee with a use-by date of November 3, 2012.
- A box of individual packets of Italian dressing was imprinted with manufacturer use by date of February 5, 2013.
- A box containing diet Italian dressing was imprinted with a manufacturer use by date of February 23, 2013.
- A box of assorted diet jelly was imprinted with a manufacturer use by date of April 2, 2013.
- A box of graham cracker shells was imprinted with a manufacturer use by date of December 1, 2012.

The DFNS, present at the time of the observation, acknowledged the above identified food items should have been discarded.

j. The freezer designated for storage of frozen vegetables and potatoes was noted to contain a thermometer that was not functional. The temperature of the freezer could not be discerned from the thermometer. In addition, the thermometer located in the walk-in refrigerator was also noted to be not functional.

The DFNS, present at the time of the observations, acknowledged the thermometers needed to be replaced.

Review of the facility policy titled, "Safe Food Handling and Storage" reviewed June 2008, revealed "Use a refrigerator thermometer to verify refrigerator temperature at 40 degrees F (Fahrenheit) or below and freezer temperature at 0 degrees F or below."

k. Observation of the ovens used for patient cooking revealed an accumulation of dirt and dried food debris next to the oven, debris underneath the oven and spills around the oven handle and knobs.

In an interview with Cook 1, he stated it was each cook's responsibility to clean their cooking area at the end of their shift.

In a concurrent interview with the DFNS, he acknowledged the area around the oven needed to be cleaned and represented more than one day's worth of dried food and debris.

l. On April 8, 2013, at 12:15 p.m., during an observation of the lunch trayline process, the cook was observed serving patients prescribed pureed diets an entree consisting of pureed beef, pureed carrots and cream of rice.

Review of the planned menu indicated the planned lunch menu consisted of chicken with mushroom sauce, green beans and brown rice for service to all patients.

In a concurrent interview with Registered Dietitian (RD) 1, she stated she was not sure why the cook was not following the planned menu. RD 1 asked the cook why the menu was prepared as observed, and the cook stated he "ran out of chicken" and, therefore, pureed beef instead. The cook stated he made a mistake with the vegetable, pureeing carrots instead of green beans. RD 1 acknowledged the cook should have followed the menu as planned.

Review of the facility policy titled, "Pureed Diet" reviewed April 2012, revealed "Items are pureed according to the menu for that day. Pureeing is done after cooking."

2a. On April 8, 2013, starting at 8:50 a.m., during an inspection of the kitchen, disaster food supplies were noted in the store room. An "Emergency Disaster Menu" plan was posted in close proximity to the disaster food supplies. Inspection of the "Dietary Disaster Inventory" for patients revealed the quantities of food items to be maintained on hand for service to 100 people, including those patients prescribed therapeutic diets, and pediatrics. It was noted numerous food items were outdated based on manufacturer imprinted dates and/or facility labels indicating "use by dates" as follows:
- One case of puree chicken with a use by date of December 13, 2012.
- One case of puree beef with a use by date of December 13, 2012.
- Two cases of puree green beans with a use by date of December 13, 2012.
- Two cases of puree carrots with a use by date of December 13, 2012.
- Three number 10 cans of fruit cocktail with a use by date of July 13, 2012.
- Three number 10 cans of sliced Pineapple with a use by date of November 7, 2012.
- Three number 10 cans of applesauce with a use by date of January 13, 2013.
- Three number 10 cans of pears with a use by date of December 29, 2012.
- Three number 10 cans of peaches with a use by date of December 29, 2012.
- One number 10 can of cheese sauce with a use by date of December 31, 2012.
- One number 10 can of refried beans with a use by date of January 11, 2013.
- Five, 303 cans of Spaghettio's with a use by date of June 6, 2012.
- Two cases of peanut butter with a use by date of January 28, 2013.
- Cold cereal: Two cases (72 boxes) with a use by date of January 18, 2013, and two cases (72 boxes) with a use by date of January 24, 2012.

In a concurrent interview with the DFNS, present at the time of the observation, he could not explain why numerous disaster food supply items were outdated. He stated the inventory should have been monitored and rotated every six months.

b. Further review of the "Emergency Disaster Menu" revealed directions which included: "Renal diet - for juice only serve apple, cranberry or grape juice, no bran or oats for cold cereal, for vegetable give corn, peas, green beans, cauliflower or carrots. Use low sodium crackers as available and limit milk to 4 oz at breakfast."

On April 9, 2013, at 8:55 a.m., in an interview with the Registered Dietitian (RD) 1, she acknowledged the canned food items proposed on the disaster menu were high in sodium (approximately 1000 mg per serving) and potassium (in the case of beans), nutrients typically contraindicated on a renal diet.

Further review of the disaster food supplies revealed an assortment of boxes of cold cereal, including corn flakes, frosted flakes, apple jacks, etc. Cold cereal was noted on the "Emergency Disaster Menu" to be served to all patients, including those prescribed puree diets.

On April 9, 2013, at 8:55 a.m., in an interview with RD 1, she stated she was not sure if the consistency of the cold cereal with milk would be appropriate for patients prescribed puree diets, who may have difficulty swallowing, and whether all types of cereal would be recommended for patients prescribed puree diets.

Concurrent review of the facility Clinical Diet Manual revealed, for pureed diets, "Solid food should be the consistency of applesauce to mashed potatoes."

On April 8, 2013, at 11:40 a.m., and on April 9, 2013, at 8:50 a.m., in an interview with the DFNS and RD 1, they stated they shared the responsibility of oversight of the food and nutrition department. The DFNS stated a monthly "Food Service Audit" was completed by the DFNS, RD 1 or a lead supervisor in the kitchen, in addition to weekly/bi-weekly "Dietary Sanitation Checks."

Review of the most recent "Food Safety Audit" dated March 25, 2013, and the most recent "Dietary Sanitation Checklist" dated March 28, 2013, revealed the only area of concern identified, that was consistent with the survey observations, was that the oven "needs cleaning."

In a concurrent interview with RD 1, she stated on occasion, the person completing the inspection forms, relies on staff account of compliance versus a visual inspection of compliance, as in the case of the outdated food products noted in the dry storage room.

Review of the facility dietary policy titled, "Departmental Philosophy and Responsibilities" reviewed April 2012, revealed "Responsibilities: to plan, organize and direct all phases of the dietetic operation, which includes menu planning, food preparation and service, administrative record keeping, patient therapy and education, analysis an appraisal of personnel requirements and sanitation programs."

Review of the "Director of Dietary Services - Job Summary" signed by the DFNS on September 11, 2012, revealed "Plans organizes, develops and directs the overall operations of the Dietary Services Department for the acute hospital and Transitional Care Unit."

Review of the "Registered Dietitian - Job Summary" signed by RD 1 on September 22, 2008 revealed "Relieves the Director in his or her absence ....Has oversight for safe and sanitary food service and general sanitation of the dietary department."

Based on observation, interview and record review, the facility failed to ensure the competency of a per diem Registered Dietitian (RD) upon hire. The RD documented recommendations that were not within the scope of practice of an RD for one sampled patient (Patient 4), and did not complete nutritional care plans for two sampled patients (Patients 1 and 2).

Findings:

1. On April 8, 2013, at 3:00 p.m., review of the record for Patient 4, revealed the patient was admitted on March 24, 2013, with diagnoses including liver cirrhosis and End Stage Renal Disease (ESRD) with dialysis.

A nutritional assessment was completed on April 5, 2013, and the per diem RD documented the patient was receiving a puree diet, and was choking on thin liquids. The RD recommended, "Thickened liquids - pudding thick."

A plan of care titled, "Risk for Aspiration" was noted. One of the interventions was, "Consider speech therapy consult." However, there was no evidence the patient was evaluated by a speech therapist.

In a concurrent interview with RD 1, she stated the nutritional assessment completed on April 5, 2013, was completed by the per diem RD, who should have recommended a speech therapy consult to determine the most appropriate fluid consistency for the patient. RD 1 acknowledged it was not within the scope of practice of the RD to make recommendations with regards to fluid consistency.

Review of the policy titled, "Thickened Liquids" reviewed May 2012, revealed, "Speech therapist or M. D. (medical doctor) may alter the thickness of the liquids."

2 a. On April 8, 2013, at 2:22 p.m., review of the record for Patient 1, revealed the patient was admitted on April 4, 2013, with diagnoses including bloody urine, severe anemia (low iron content of the blood), congestive heart failure and advanced stage chronic kidney disease.

From April 4, 2013, to April 8, 2013, the patient lost 15 pounds. A nutritional assessment was completed on April 5, 2013, and the per diem RD documented the patient had lost 70 pounds over the past two years, had difficulty chewing food and required a low protein diet due to chronic kidney disease.

Further review of the record revealed there was no plan of care initiated to address the patient's nutritional status.

In a concurrent interview with RD 1, she acknowledged the absence of a nutritional plan of care. RD 1 stated the nutritional assessment was completed by the per diem RD, who was oriented on the care planning process, and should have initiated a plan of care addressing Patient 1's nutritional status, since no plan of care was initiated by nursing.

b. On April 8, 2013, at 1:55 p.m., review of the record for Patient 2, revealed the patient was admitted on April 2, 2013, with diagnoses including diabetes mellitus, hypertension (high blood pressure) and severe hyponatremia (sodium level). The patient was non responsive and had been NPO (nothing by mouth) for six days as of April 8, 2013.

The per diem RD completed a nutrition assessment on April 4, 2013, and recommended Total Parenteral Nutrition (TPN) (nutritional support via the vein) to provide the patient with nutritional intake. Another per diem RD assessment was completed on April 5, 2013, and the same TPN recommendation was made.

Further review of the record revealed there was no plan of care initiated to address the patient's nutritional status.

In a concurrent interview with RD 1, she acknowledged the absence of a nutritional plan of care. RD 1 stated care plans may be initiated by nursing or dietary staff, but she did not know why a care plan related to nutritional status had not been initiated for Patient 2.

On April 9, 2013, at 12:22 p.m., a review of the personnel file of the per diem RD revealed the per diem RD was hired on September 10, 2012. There was no initial competency check of the per diem RD's clinical skills completed upon hire.

On April 9, 2013, at 2:35 p.m., in an interview with RD 1, she stated she completed an, "Orientation Checklist for Food and Nutrition" with the per diem RD upon hire, and the per diem RD conducted side by side reviews of patient records with RD 1 during orientation.

Review of the "Orientation Checklist for Food and Nutrition" revealed charting guidelines reviewed included "care plans."

A competency form, dated, November 15, 2012, and titled, "Food Management and Clinical Skills - Registered Dietitian" was completed by RD 1 regarding the per diem RD's job performance. The per diem RD's performance was deemed "Unsatisfactory" in the areas of: "Completes timely nutritional assessments using standards of care accepted by the American Dietetic Association," and "Communicates with MD's and ancillary staff regarding patient nutritional needs." The recommendation was to extend the probationary period for the per diem RD for further observation of duties.

Based on interview and record review, the facility failed:

1. To ensure standard menus were accurately and comprehensively analyzed for the nutritional components to meet the current national standards including the RDA (Recommended Dietary Allowances) and the DRI (Dietary Reference Intake) of the Food and Nutrition Board of the National Research Council for all diets/populations served at the facility, and adjusted for the nutritional needs of the populations served by the facility.

2. To ensure patient diets were prepared and served as planned and in accordance with prescribed orders and the planned menu.

This had the potential for the patients in the facility to not receive adequate nutrition to meet the estimated recommended dietary allowances, and in accordance with prescribed physician orders.

Findings:

1. The DRI/RDA consisted of nutrient based references whose purpose was to plan diets for individuals, focusing on optimizing health status, disease prevention and ensuring consumption of nutrients in adequate amounts. The provisions of the Dietary Reference Intakes, which included the Recommended Dietary Allowances (RDA's), Adequate Intake, and Acceptable Macro and Micronutrient distribution ranges, developed by the Food and Nutrition Board under the auspice of the Institute of Medicine were used to evaluate nutritional adequacy of patient/resident menus.

On April 8, 2013, at 10:35 a.m., review of the facility's nutrient analysis for the hospital diets revealed it did not include an analysis of all micronutrients specified in the RDA or DRI such as manganese, copper, selenium, biotin, pantothenic acid, etc.

Further review of the nutrition analysis, indicated, for April 8, 2013, the lunch meal components analyzed, for a regular diet, included chicken, brown rice, green beans, wheat bread, gravy, butter, milk and apple pie. Condiments were not noted in the analysis.

Review of the planned menu indicated the main entree to be served on a regular, non-select diet was chicken with mushroom sauce.

Concurrent review of the recipe for chicken with mushroom sauce, revealed the mushroom sauce ingredients included clarified butter and heavy cream.

On April 8, 2013 at 10:35 a.m., in an interview with the Registered Dietitian (RD) 1, she stated she did not utilize the menu recipes when analyzing all components of planned meals. For the lunch meal on April 8, 2013, RD 1 stated she analyzed a regular brown gravy, and not the planned mushroom sauce in accordance with the facility recipe. RD 1 confirmed that condiments such as salt, pepper and sugar packets, provided on the patients' trays, were not included as part of the menu nutritional analysis.

Further review of the planned menus indicated there was no special consideration for patients who were pregnant or lactating.

Concurrent review of the facility Clinical Nutrition Manual guidelines for the "Pregnancy and Lactation Diet" revealed, "Nutritional recommendation for pregnancy ... an addition of 300 calories per day over normal calorie needs is recommended, ...Lactation: To meet extra nutritional demands for milk production, an addition of 500 calories per day over normal calorie needs is recommended."

In a concurrent interview with RD 1, she confirmed the menus were not adjusted calorically for pregnant or post-partum patients. RD 1 stated patients were offered regular diets and the non-select regular menu mirrors were the menus that would be sent to any patient prescribed a regular diet at the facility.

2. On April 8, 2013, at 12:15 p.m., during an observation of the lunch trayline process, the diet tray slip for Patient 1 was noted and indicated the patient's diet was a 2 gm (gram), protein restriction, puree. Patient 1 was served the same puree entree served to patients not prescribed a protein restriction, which consisted of 2/3 of a cup (5.3 ounces) of pureed beef, equivalent to approximately 3 ounces of protein.

Concurrent review of the facility "Diet Report," revealed the patient's prescribed protein restriction was 40 grams protein.

On April 8, 2013, at 3:20 p.m., review of the planned menu revealed directions for service of a low protein diet included: 4 oz (ounces) milk B (breakfast) & D (dinner), 2 oz mt (meat) L (lunch), and no dairy desserts.

In a concurrent interview with Registered Dietitian (RD) 1, she confirmed the directions above were what was provided for staff for service of a low protein diet. A tabulation of how much protein would be provided to patients prescribed low protein diets, utilizing the directions on the planned menu, revealed the patients would receive approximately 60 grams of protein. RD 1 acknowledged the pattern for a 40 gram protein diet was not noted on the patient's cardex or reflected on the planned menu, to ensure Patient 1 received the 40 gram protein diet restriction as prescribed by the physician.

Review of the facility policy titled, "Menus, Checking of" reviewed May 2012, revealed "Modified diets are calculated by the RD and are written on a cycle menu for the non select menus ... Any diet ordered which does not conform to the pre-calculated pattern is brought to the attention of the dietitian."

Further observation of the lunch trayline process revealed mashed potatoes were being served with a #12 (1/3 cup) scoop.

In a concurrent interview with RD 1, she confirmed mashed potatoes should have been served using a #8 (1/2 cup) scoop.

Based on observation, interview and record review, the facility failed to ensure the existing emergency plan for the provision of food during a disaster included appropriate food recommendations for patients prescribed renal and puree diets.

Findings:

On April 8, 2013, starting at 8:50 a.m., during an inspection of the kitchen, disaster food supplies were noted in the store room. An "Emergency Disaster Menu" plan was posted in close proximity to the disaster food supplies. Inspection of the "Emergency Disaster Menu" for patients revealed food items to be served included canned macaroni and cheese, canned baked beans, and canned beef stew.

a. Directions in the "Emergency Disaster Menu" included: "Renal diet - for juice only serve apple, cranberry or grape juice, no bran or oats for cold cereal, for vegetable give corn, peas, green beans, cauliflower or carrots. Use low sodium crackers as available and limit milk to 4 oz at breakfast."

On April 9, 2013, at 8:55 a.m., in an interview with the Registered Dietitian (RD) 1, she acknowledged the canned food items proposed on the disaster menu were high in sodium (approximately 1000 mg per serving) and potassium (in the case of beans), nutrients typically contraindicated for a renal diet.

b. Further review of the disaster food supplies revealed an assortment of boxes of cold cereal, including corn flakes, frosted flakes, apple jacks, etc. Cold cereal was noted on the "Emergency Disaster Menu" to be served to all patients, including those prescribed puree diets.

On April 9, 2013, at 8:55 a.m., in an interview with RD 1, she stated she was not sure if the consistency of the cold cereal with milk would be appropriate for patients prescribed puree diets, who may have difficulty swallowing, and whether all types of cereal would be recommended for patients prescribed puree diets.

Concurrent review of the facility Clinical Diet Manual, revealed for pureed diets, "Solid food should be the consistency of applesauce to mashed potatoes."

Based on observation, interview, and record review, the facility failed:

1. To ensure expired supplies were not available to staff for use on patient care equipment. This had the potential to result in expired products being used for patient care.

2. To ensure two pieces of equipment in the Operating Room (OR) were maintained per the facility's policy and procedure to ensure an acceptable level of safety and quality.


Findings:

1. On April 8, 2013, at 10:15 a.m., a tour of the Emergency Department (ED) was conducted with the ED Director.

A one gallon container of "EM Power," (a detergent cleaner containing two protease enzymes, that works to remove blood, tissue, mucous and other protein-rich body fluids from instruments) with an expiration date of September 2012, was observed.

During a concurrent interview with the ED Director, the ED Director stated the solution was used to process instruments prior to the instrument being sent to sterile processing. The ED Director verified the expiration date on the container.



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2. During a tour of Surgical Services on April 8, 2013, at 8:55 a.m., with RN 1, the following was observed in Operating Room (OR) 1, on a wire rack in the corner of the room:
- A Baxter Fibrinotherm with an electrical safety sticker dated September 19, 2006.
- A Stryker Automatic High Vacuum Pump.

Both pieces of equipment were available for patient care use and neither piece of equipment had a sticker to denote the date the equipment was serviced/inspected by the facility.

During a concurrent interview with RN 1, she verified there were no inspection stickers on the equipment and stated both pieces of equipment should have an inspection sticker because they were available for patient care use.

During an interview with the Director Materials Management (DMM), on April 11, 2013, at 8 a.m., he stated neither the Baxter Fibrinotherm nor the Stryker Automatic High Vacuum Pump had come through Materials Management in order to be logged into the equipment inventory and checked by Biomedical Engineering. He stated all equipment should be processed through Materials Management in order for the equipment to be logged, checked, an inspection sticker applied and placed on a preventive maintenance schedule.

The facility policy and procedure titled "Equipment Guidelines for New Equipment" reviewed March 2012, revealed "... After receipt of any new equipment, but prior to its installation, it must be inspected and determined by the Engineering Department that it meets appropriate safety standards. Each item of equipment must bear a tag designating the proper approval. ..."

The facility policy and procedure titled "Equipment Management" reviewed March 2011, revealed "... All mechanical equipment will be checked at least yearly for optimum functioning and safety capacity. A log of equipment and dates of function and safety monitoring will be maintained in the Materials Mgmt. (Management) department. Each piece of equipment will have a sticker to denote the date equipment was serviced. No piece of equipment will be released for patient care service unless it meets all manufacturer and hospital safety requirements. ..."

Based on observation, interview and record review, the facility failed to ensure a sanitary environment was maintained and an active program was in place to prevent infections for all patients as evidenced by failure:

1. To ensure patients undergoing hemodialysis (process of cleansing the blood of accumulated waste products) were tested for Hepatitis (Hepatitis B is caused by the hepatitis B virus. It is spread through contact with the blood and body fluids of an infected person) prior to beginning treated. (Refer to A748);

2. To ensure hinged surgical instruments were cleaned, processed and sterilized in an open position according to national standards of practice. (Refer to A748);

3. To ensure an Infection Control Risk Assessment was performed prior to initiating a renovation in one of the three operating rooms. (Refer to A748);

4. To ensure raw food items were not stored above/next to ready to eat foods. (Refer to A749);

5. To ensure that foodservice areas and equipment were effectively cleaned and thermometers were in good condition to ensure appropriate refrigerator/freezer temperatures. (Refer to A749);

6. To ensure that the cooling process for potentially hazardous foods (PHF) prepared at ambient air temperature was monitored. (Refer to A749);

7. To ensure day to day use and disaster food items were not kept past manufacturer suggested "Best By" dates, and that tubefeeding products on patient units were not expired. (Refer to A749);

8. To ensure potentially hazardous food products were effectively cleaned. (Refer to A749);

9. To ensure the surgical flash sterilizer was checked daily with a biological indicator per facility policy and procedure. (Refer to A749);

10. To ensure surgical instruments were cleaned, processed and sterilized per facility policies and procedures and in accordance with national standards of practice. (Refer to A749);

11. To ensure the high level disinfectant solution process for scopes was not being performed in a clean instrument, equipment and supply room (Operating Room 3). (Refer to A749);

12. To ensure an optimally clean environment was maintained in Operating Room (OR) 1. (Refer to A749);

13. To ensure an infant (Patient 6) re-admitted to the hospital with a fever was separated from hospital delivered well newborn infants (Patient 8). (Refer to A749); and

14. To ensure staff educated visitors to wear the appropriate personal protective equipment when visiting a patient in droplet isolation. (Refer to A749).

The cumulative effects of these systemic problems resulted in the failure of the infection control program to ensure care was being provided in a safe and effective manner.

Based on observation, interview and record review, the facility failed to implement infection control and prevention policy and procedures by failing to:

1. Ensure patients undergoing hemodialysis (process of cleansing the blood of accumulated waste products) were tested for Hepatitis (Hepatitis B is caused by the hepatitis B virus. It is spread through contact with the blood and body fluids of an infected person), prior to beginning treatment. This had the potential to result in the spread of Hepatitis to other patients and staff;

2. Ensure hinged surgical instruments were cleaned, processed and sterilized in an open position according to national standards of practice. This had the potential to result in cross contamination due to the use of non-sterile surgical instruments.

3. Ensure an Infection Control Risk Assessment was performed prior to initiating a renovation in one of the three operating rooms. This had the potential to result in an increased risk of infection transmission.

Findings:

The facility's "Infection Prevention & Control Plan 2013," was reviewed and indicated its purpose was to fulfill the basic purposes of "Prevention, control, surveillance and reporting the spread of infections and infectious disease within the hospital." The scope of services included inpatient and outpatient areas. Activities included: "Approval of products used for cleaning, disinfection and sterilization; Approval of Sterilization procedures by heat, chemicals or otherwise; Approval of Isolation procedures...Education and training of employee, students and physicians related to methods for infection prevention, control, surveillance...Review and approve policies and procedures related to infection surveillance, prevention and control for the hospital and for each of its department and service."

The Plan further indicated duties of the Infection Control Committee included; "develop, evaluate and revise preventative, surveillance and control standards, policies and procedure, and supervise infection control in all phases of the hospital's activities including: operating room...delivery rooms...sterilization and disinfection..."


1. The Centers for Disease Control (CDC) indicated chronic hemodialysis patients were at high risk for infection because the process of hemodialysis required vascular access for prolonged periods. In an environment where multiple patients received dialysis concurrently, repeated opportunities exist for person-to-person transmission of infectious agents, directly or indirectly via contaminated devices, equipment and supplies, environmental surfaces, or hands of personnel.

According to the CDC, preventing the transmission of Hepatitis B Virus (HBV) depends on timely detection of patient converting from HBV- to HBV + and rapid implementation of isolation procedures before cross-contamination occurs. The CDC's schedule for hepatitis testing indicated all patients should be tested for HBsAG (hepatitis B surface antigen), Anti-HBc (total-antibody to hepatitis B core antigen) and Anti-HBs(antibody to hepatitis B surface antigen), on admission.

The record for Patient 32 was reviewed on April 9, 2013. Patient 32 was admitted to the facility on February 15, 2013, with diagnoses that included hyperkalemia (high levels of potassium in the blood) with acute renal failure (rapid loss of kidney function). Patient 32's record contained several Acute Hemodialysis Treatment Flow Records. (Patient 32's record was thinned and not all records were in the current unit record). Dialysis Records for April 3, 4, 6, and 8, 2013, indicated there were no current results for the patient's hepatitis panel. A review of the patient's lab results indicated there were no records of hepatitis testing for Patient 32.

On April 9, 2013, at 4:10 p.m., a hemodialysis nurse was observed performing hemodialysis in Room 116. Hemodialysis RN 1 indicated he checked in with the staffing office prior to beginning the patient's treatment, then reviewed the patient's record. The hemodialysis nurse stated he completed the treatment as ordered by the physician. Hemodialysis RN 1 stated Patient 32's hepatitis status was unknown, so the dialysis machine would be treated prior to reuse. Hemodialysis RN 1 stated "we treat the machine for possible hepatitis, we use bleach, but we do not sequester the machine."

On April 9, 2013, the "Infection Prevention Record," was reviewed. The form was used to document when a particular dialysis machine was used. Documentation on the form included the patient's medical record number, date of the patient's hepatitis panel, and results, isolation precautions required, and equipment cleaning and disinfection. In the section for "Infection Surveillance," there were areas to document HBsAG, HBsAB, and Total anti HBc. According to documentation on the record, "If HBsAG is unknown, assume positive." According to documentation on the record, Patient 32 underwent dialysis with machine E-42, on March 19, 22, April 1, 3, 4, 6, 8, and 9, 2013. Documentation on the form indicated Patient 32's hepatitis status was "unk [unknown]."

The facility's policy and procedure titled "Hemodialysis Infection Control Precautions," with a last reviewed date of September 2011, indicated standard precautions would be observed to protect the caregivers and patient from infectious disease transmitted through blood and body fluids "especially Hepatitis B." The policy indicated "agency personnel will perform dialysis, and maintain safe and sanitary equipment according to policies and procedures approved by the Infection Control Committee and regulating agency."

The contracted agency's policy and procedure titled "Hepatitis Surveillance, Vaccination and infection Control Measure," with a last reviewed date of March 2010, indicated its purpose was to minimize the spread of hepatitis infections in the dialysis setting. According to the policy, "Hepatitis B serological testing requires a physician order. In order to reduce the risk of transmission of Hepatitis B among patients, all new patients should be tested prior to or at the time of their initial treatment...If the results of this testing are not known at time of inpatient treatment, the patient should be treated as a suspect patient for hepatitis B infection."

The contracted agency's policy and procedure titled "Infection Control and Isolation Measures for Known or Unknown Hepatitis B Surface Antigen Positive Patients," with a last revised date of September 2011, indicated its purpose was to provide additional infection control measures for care of the known or unknown hepatitis B surface antigen (HBsAg) positive patient. The policy indicated "Patients whose hepatitis B surface antigen status (HBsAG) is unknown will be suspect for hepatitis B infection until determined otherwise by the physician...Teammates caring for patients with unknown hepatitis B status will not care for known hepatitis B positive or other susceptible patients at the same time...In situation where the hepatitis B surface antigen status in unknown, the internal pathway of the hemodialysis delivery system will be cleaned using bleach and the external surfaces will be thoroughly cleaned with a 1:1000 bleach solution after every treatment."

On April 10, 2013, at 9 a.m., the contracted hemodialysis agency's Clinical Director and Manager of Biomed were interviewed. The Clinical Director stated when hemodialysis was initiated in the hospital, the Hemodialysis RN should request the patient's hepatitis status be evaluated. The Clinical Director stated a patient with an unknown hepatitis status was assumed to be positive until lab results indicated otherwise. The Manager of Biomed stated it was sufficient to bleach the inner workings of the machine between patients. The Clinical Director stated her staff should contact the patient's physician to obtain orders to evaluate the patient's hepatitis status. The Clinical Director stated the hemodialysis nurses should not continually perform hemodialysis without having the hepatitis panel drawn.

2. On April 11, 2013, at 9:15 a.m., during a tour of Operating Room 3, two peel-open pouches (self-sealed or heat-sealed plastic and paper pouches used to process single surgical instruments) were noted to contain hinged surgical instruments (scissors, hemostats, clamps) in the closed and locked position.

On April 11, 2013, at 9:20 a.m., the sterile processing department was entered. Staff stated they were in the process of reprocessing the obstetrical department instruments. The staff stated they had not looked at equipment stored in their department.

A storage unit containing numerous peel packed, individually processed instruments was observed. The unit contained numerous instruments in the closed position. Two scissors and two needle holders were pulled out and staff verified the items were closed.

In an interview with the Infection Control Coordinator (ICC), on April 11, 2013, at 11 a.m., the ICC stated "vascular clamps go out of alignment so they are processed in the closed position." The ICC stated it was the "heat that kills the bacteria." The ICC stated they were currently reviewing all of their policies in the sterile processing department.

Instructions for processing equipment was requested and reviewed on April 11, 2013. The policy titled "Instrument Tray Assembly," with a last revised date of June 2012, indicated "Instrument trays are assembled in Sterile Processing for all units excluding obstetrics. Trays are assembled in a standard order as defined on the instrument lists for trays... Each tray or pack is identified by name during the assembly process." There were no instructions indicating hinged items were to be processed in the open position.

The Association of Perioperative Registered Nurses (AORN) March 9, 2012:

Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment

XII.c.1. Instruments should be kept in the open and unlocked position using instrument stringers, racks, or instrument pegs designed to contain instruments.

Centers for Disease Control (CDC) document titled, "Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008," indicated once an item was cleaned, dried and inspected, those requiring sterilization, were wrapped or placed in rigid containers. Further instructions indicated "hinged instruments should be opened, items with removable parts should be disassembled ..." The guidelines indicated "Ensuring consistency of sterilization practices requires a comprehensive program that ensures operator competence and proper methods of cleaning and wrapping instruments..."

3. On April 11, 2013, at 8:30 a.m., in an interview with the Infection Control Coordinator (ICC), the ICC stated the facility was replacing the floor in Operating Room (OR)1 today. The ICC stated the remodel was scheduled for a later date, but one of the anesthesiologist was gone, so the OR schedule was reduced. The ICC stated the contractor had pulled up a small portion of the floor and was moisture testing prior to beginning the project.

On April 11, 2013, at 8:30 a.m., the Facility's Manager was asked if an infection control risk assessment had been conducted or if there was a plan for the shutdown of Operating Room 1. The Facility's Manager stated there was no plan.

During an observation of Operating Room 1, on April 11, 2013, at 9 a.m., the surgical table and anesthesia equipment were still in the room. The room still contained equipment needed for surgical cases. A small patch (approximately 4 inches by 4 inches) of flooring had been removed from the floor.

In an interview with RN 2, on April 11, 2013, at 9 a.m., RN 2 stated the equipment would be moved to Operating Room 3. RN 2 stated the facility had three operating rooms and cesarean sections were usually performed in Operating Room 1.

In an interview with the ICC on April 11, 2013, at 9:30 a.m., the ICC stated she did not have a plan yet, "it's in here (pointing to her head)." The ICC stated Obstetrical patients would need to come down the hall and enter the OR through the main door instead of the backdoor.

The facility policy and procedure titled "Infection Control During Construction Renovation and Demolition," with a last reviewed date of September 2011, was reviewed and indicated its purpose was to provide procedures for preventing transmission of infections related to construction, renovation, demolition and maintenance and repair projects. The policy indicated "Preventing transmission of infectious agents to vulnerable patient population...is an important function of the Infection Prevention and Control Program. Environmental dispersal of microorganisms can cause nosocomial infections from airborne contaminants and infectious agents related water and moisture-related conditions." The policy indicated "Prior to any project, an Infection Control Risk Assessment will be completed to determine the potential risk of transmission of infections...Elements of the Risk Assessment include consideration of the following issues:

Patient placement during projects
Placement of Barriers
Evaluation of ventilation needs
Number of isolation rooms affected/required
Potential for utility outages affecting ventilation and water
Movement of debris
Patient and work flow through the buildings."

Based on observation, interview, and record review, the facility failed to ensure the infection control officer provided effective infection control oversight:
Into food services when the dietary staff failed:
1. To ensure raw food items were not stored above/next to ready to eat foods.

2. To ensure foodservice areas and equipment were effectively cleaned and thermometers were in good condition to ensure appropriate refrigerator/freezer temperatures.

3. To ensure the cooling process for potentially hazardous foods (PHF) prepared at ambient air temperature was monitored.

4. To ensure day to day use and disaster food items were not kept past manufacturer suggested "Best By" dates, and that tubefeeding products on patient units were not expired.

5. To ensure potentially hazardous food products were effectively cleaned.

These processes have the potential of promoting food-borne illness if not appropriately implemented/monitored.

The infection control officer also failed:
6. To ensure the surgical flash sterilizer was checked daily with a biological indicator per facility policy and procedure.

7. To ensure surgical instruments were cleaned, processed and sterilized per facility policies and procedures and in accordance with national standards of practice.

8. To ensure the high level disinfectant solution process for scopes was not being performed in a clean instrument, equipment and supply room (Operating Room 3).

9. To ensure an optimally clean environment was maintained in Operating Room (OR) 1.

These practices had the potential to result in contamination to occur during surgical/procedural interventions.

10. To ensure an infant re-admitted to the hospital with a fever (Patient 6) was separated from hospital delivered well newborn infant (Patient 8). This had the potential to result in the spread of an infection
from a re-admitted sick infant to a well newborn infant.

11. To ensure staff educated visitors to wear the appropriate personal protective equipment when visiting a patient in droplet isolation.

Findings:

On April 8, 2013, starting at 8:50 a.m., during an inspection of the kitchen, the following observations were made:

1. In the walk-in refrigerator, cooked meatloaf was noted to be stored on a rack in a cart, next to two bags, approximately five pounds each, of thawing raw beef stew pieces. The sheet pan containing the cooked meatloaf and raw beef stew pieces, was stored above two boxes of partially cooked cubed beef sirloin.

In a concurrent interview with the Director of Food and Nutrition Services (DFNS), he acknowledged the raw meat product should not have been stored next to or above cooked or partially cooked food.

Review of the facility policy titled, "Refrigerated and Frozen Storage" dated March 2011, revealed "To prevent cross-contamination when thawing meats, wrap or cover food and label it. Store refrigerated raw meat, poultry, and seafood separately from ready to eat food. Store raw meat, poultry, and seafood in the following top-bottom order:
Ready-to-eat food
Sea Food
Whole cuts of beef and pork
Ground meat and ground fish
Whole and ground poultry."

2a. In the trayline reach-in refrigerator, six cartons of "Mighty Shakes" (nutritional supplement) did not have an expiration date.

In a concurrent interview with Diet Aide 2, she stated she retrieved the cartons of "Mighty Shakes" from the walk-in refrigerator where the box of "Mighty Shakes" was dated.

The DFNS, present at the time of the observation, acknowledged once the cartons of "Mighty Shakes" were removed from the original case, they would have to be labeled individually with a discard date.

b. In the food preparation area, three bottles of "Prostat 64" (nutritional supplement) were noted to have been opened. One bottle was not dated as to when it had been opened or when it should be discarded. Two of the bottles were not dated as to when they had been opened, but were dated with a discard date of "8/14/14".

Inspection of the manufacturer recommendations, imprinted on each "Prostat 64" bottle, revealed, "Discard in 3 months after opening."

In a concurrent interview with the DFNS, he acknowledged it was difficult to determine when the three bottles of "Prostat 64" had been opened, in order to determine when they should be discarded per manufacturer recommendations.

c. On a shelf in the cook's area, numerous plastic containers of spices were noted:
- Blackened fish seasoning blend -- Use by February 11, 2013,
- Whole Rosemary -- Use by January 13, 2013,
- Ground nutmeg -- Use by June 5, 2012,
- Tarragon -- Use by September 11, 2012,
- Ground pepper -- Use by September 1, 2012,
- Bay leaves -- Use by January 3, 2013, and
- Ground marjoram -- No use by date - but delivered on June 19, 2009.

In a concurrent interview with the DFNS, the DFNS stated the spices would typically be kept between six months and one year and should be labeled with discard dates. The DFNS could not explain why the spices were kept past the "use by" dates indicated on the labels affixed to the spice containers.

d. Large ingredient bins containing items such as flour and rice were noted. Affixed to the containers was a plastic holder in which the serving scoops were kept. Inspection of the scoop holder affixed to the flour bin and brown rice bin respectively were noted to be dirty with dried food debris, and spills.

In a concurrent interview with the DFNS, he acknowledged the scoop holders needed to be cleaned.

e. Ceiling vents, located above stored, clean equipment, and racks of bread, were noted to have a heavy accumulation of gray/black dirt and dust.

In a concurrent interview with the DFNS, he acknowledged the ceiling vents needed to be cleaned, and stated it was the responsibility of the Environmental Services Department (EVS). The DFNS stated EVS had been notified, but follow-up had not been done to ensure the task was completed.

f. In the dry storage room, debris was noted underneath the food storage racks. In addition, one storage shelf was noted to be dirty with a dried brown liquid adhering to the shelf and the wall behind the shelf.

In a concurrent interview with the DFNS, he acknowledged the dry storage room and shelves needed to be cleaned.

Review of the facility policy titled, "Cleaning of the Store Room" reviewed April 2012, revealed "Wash the top and underside of the shelves with hot, soapy water."

Further observation of the dry storage room, indicated:
- Three boxes of decaffeinated ground coffee with a use-by date of November 3, 2012.
- A box of individual packets of Italian dressing was imprinted with manufacturer use by date of February 5, 2013.
- A box containing diet Italian dressing was imprinted with a manufacturer use by date of February 23, 2013.
- A box of assorted diet jelly was imprinted with a manufacturer use by date of April 2, 2013.
- A box of graham cracker shells was imprinted with a manufacturer use by date of December 1, 2012.

The DFNS, present at the time of the observation, acknowledged the above identified food items should have been discarded.

g. The freezer designated for storage of frozen vegetables and potatoes was noted to contain a thermometer that was not functional. The temperature of the freezer could not be discerned from the thermometer. In addition, the thermometer located in the walk-in refrigerator was also noted to be not functional.

The DFNS, present at the time of the observations, acknowledged the thermometers needed to be replaced.

Review of the facility policy titled, "Safe Food Handling and Storage" reviewed June 2008, revealed "Use a refrigerator thermometer to verify refrigerator temperature at 40 degrees F (Fahrenheit) or below and freezer temperature at 0 degrees F or below."

h. Observation of the ovens used for patient cooking revealed an accumulation of dirt and dried food debris next to the oven, debris underneath the oven and spills around the oven handle and knobs.

In an interview with Cook 1, he stated it was each cook's responsibility to clean their cooking area at the end of their shift.

In a concurrent interview with the DFNS, he acknowledged the area around the oven needed to be cleaned and represented more than one day's worth of dried food and debris.

3. In the walk-in refrigerator, a container of egg salad and a container of tuna salad were observed.

In a concurrent interview with the DFNS, he stated the facility prepared these items from chilled items, and therefore did not have a process to monitor the cool down process or temperature of these items.

Review of the facility policy titled, "Leftovers - Usage and Storage" reviewed April 2012. revealed "All meat salads, poultry salads, potato salads, egg salads, cream filled pastries and other potentially hazardous foods shall be prepared from chilled products and refrigerated below 41 degrees F (Fahrenheit) immediately after preparation."

Upon request, the temperature of the egg salad and tuna salad in the walk-in refrigerator were measured by the DFNS and recorded at 48 degrees F (Fahrenheit) for each item. The DFNS, could not explain why the egg salad and tuna salad, both potentially hazardous foods, were not stored at 41 degrees F or below.

4a. On April 8, 2013, starting at 8:50 a.m., during an inspection of the kitchen, disaster food supplies were noted in the store room. An "Emergency Disaster Menu" plan was posted in close proximity to the disaster food supplies. Inspection of the "Dietary Disaster Inventory" for patients revealed the quantities of food items to be maintained on hand for service to 100 people, including those patients prescribed therapeutic diets, and pediatrics. It was noted numerous food items were outdated based on manufacturer imprinted dates and/or facility labels indicating "use by dates" as follows:
- One case of puree chicken with a use by date of December 13, 2012.
- One case of puree beef with a use by date of December 13, 2012.
- Two cases of puree green beans with a use by date of December 13, 2012.
- Two cases of puree carrots with a use by date of December 13, 2012.
- Three number 10 cans of fruit cocktail with a use by date of July 13, 2012.
- Three number 10 cans of sliced Pineapple with a use by date of November 7, 2012.
- Three number 10 cans of applesauce with a use by date of January 13, 2013.
- Three number 10 cans of pears with a use by date of December 29, 2012.
- Three number 10 cans of peaches with a use by date of December 29, 2012.
- One number 10 can of cheese sauce with a use by date of December 31, 2012.
- One number 10 can of refried beans with a use by date of January 11, 2013.
- Five, 303 cans of Spaghettio's with a use by date of June 6, 2012.
- Two cases of peanut butter with a use by date of January 28, 2013.
- Cold cereal: Two cases (72 boxes) with a use by date of January 18, 2013, and two cases (72 boxes) with a use by date of January 24, 2012.

In a concurrent interview with the DFNS, present at the time of the observation, he could not explain why numerous disaster food supply items were outdated. He stated the inventory should have been monitored and rotated every six months.

b. On April 8, 2013, at 1:55 p.m., during an inspection of the Intensive Care Unit (ICU), enteral formula storage area, two eight ounce cans of Ensure Plus were noted to be imprinted with a manufacturer expiration date of December 1, 2012. One, 1000 cc (cubic centimeters) bottle of Osmolite (enteral formula) was imprinted with a manufacturer expiration date of January 1, 2013.

In a concurrent interview with Registered Dietitian (RD) 1 she acknowledged the cans of nutritional supplement and the bottle of enteral formula should have been discarded.

5. In a reach-in refrigerator, plates containing cut cantaloupe were noted.

On April 8, 2013, at 11:55 a.m., in an interview with Diet Aide 1, she stated she prepared the cantaloupe by washing it under water in the preparation sink. Diet Aide 1 did not indicate any other process of cleaning the cantaloupe prior to cutting it for service.

The DFNS, present at the time of the interview, stated it was facility policy to scrub the cantaloupe, but the scrub brushes were currently "missing".

Review of the facility policy titled, "Cleaning Melons and Potatoes" dated September 2006, revealed "Purpose: To provide safe food to an at risk population for food borne illness. Procedure: ...Melons will be thoroughly washed and scrubbed with the yellow handle scrub brush and water prior to cutting."

On April 9, 2013, at 1:35 p.m., in an interview with the Director of Risk Management/Surgical Services/Infection Control (DRM), she stated that monthly "Food Safety Audits" were supposed to be conducted by an Infection Control Representative in conjunction with the DFNS. The DRM stated a walk through of the kitchen was conducted, the results were tallied, and the results were reported through the Infection Control Committee. The DRM stated the "Food Safety Audit" results had been consistently above the established 95% threshold for compliance. The DRM could not explain why the results of the "Food Safety Audits" were not in line with the identified deficient practices related to foodservice safety and sanitation during the course of the survey.

Review of the "Food Safety Audits" completed in February 2013, and March 2013, revealed no involvement by an Infection Control Representative.


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6. On April 8, 2013, at 10:55 a.m., a tour of the Sterile Processing area was conducted with RN 1 and OR Technician (ORT) 1.

The "Steam Sterilizer Record Keeping" indicated a "biological (a sterilization process-monitoring device commercially prepared with a known population of highly resistant spores that tests the effectiveness of the method of sterilization being used. The indicator is used to demonstrate that conditions necessary to achieve sterilization were met during the sterilizer cycle being monitored.) - Attest" was completed for the "flash sterilizer" on January 17, 18, 21, 24, 2013; February 14, 15, 21, 22, 25, 27, 27, 2013; March 1, 4, 5, 8, 11, 13, 21, 26, 29, 2013; and April 1, 2, 3, and 5, 2013 (24 of 82 calendar days).

The "Flash Sterilizer (steam sterilization of unwrapped items intended to be used immediately) Log" indicated instruments, batteries, and/or power sources were flash sterilized on January 23, 29, 30, 2013; February 4, 6, 12, 13, 19, 20, 2013; March 6, 14, 15, 19, 20, 27, 2013; and April 8, 2013, without a "biological - Attest" being performed.

During an interview with the Director Risk Management/Surgical Services (DRM), on April 8, 2013, at 1:40 p.m., she verified instruments had been "flash sterilized" without a "biological - Attest" being performed and/or results documented. The DRM stated an "Attest" should be done first thing each morning with the results documented. In addition, the DRM stated if the "Attest" was not done there was no way to determine if the steam sterilization process was effective in destroying the organisms.

The facility policy and procedure titled "Infection Surveillance in Sterile Processing" reviewed September 2011, revealed "... Each autoclave shall be tested at the beginning of each day, using a biological indicator (Attest), to ensure each autoclave is functioning properly. ... Biological testing is to be done on both autoclaves in Sterile Processing daily. ..."

The facility policy and procedure titled "Biological Indicators" reviewed September 2011, revealed "... autoclaves will have a biological test run on the sterilization cycle every day that the department is open and the autoclaves are used. ... All biological testing results are recorded and filed in a permanent Sterilizer Test book. ..."

7. On April 9, 2013, at 9:25 a.m., a tour of the Obstetrical Unit was conducted with RN 6 and the Director Obstetrical Services (DOS).

RN 6 and the DOS stated Obstetrical Services cleaned and packaged their own instruments.

RN 6 was observed cleaning ten instruments from a vaginal delivery tray in the Obstetrical Unit dirty utility room sink with gloves on but no apron or face shield. RN 6 was utilizing a surgical hand scrub brush to remove the blood and tissue from the instruments. The instruments were cleaned, rinsed in water and placed on a blue towel to air dry in the dirty utility room. The basin used to clean the instruments was hung on the faucet and RN 6 stated the same basin would be used to clean the next set of dirty instruments. RN 6 stated once the instruments were dry, they were wrapped in a blue towel with a sterilization indicator strip and a strip of indicator tape was placed around the towel. The instruments were then placed in a peel pack package and sent to Sterile Processing for sterilization.

On April 9, 2013, at 10:20 a.m., with the DOS, three packages of "OB Instruments" and a single package of clamps were opened. The "OB Instruments" had been processed on April 8, 2013, and the hinged instruments in the "OB Instruments" and the clamps were found to be in the "closed" position. One package of "OB Instruments" contained the initials of the individual who processed the instruments for sterilization.

During a concurrent interview with the DOS, she stated hinged instruments cannot be sterilized if they were "closed." The DOS stated all hinged instruments should be "opened" for the sterilization process in order to ensure all surfaces had an opportunity to be sterilized. In addition, the DOS stated it was not necessary to identify who assembled the instruments for processing.

On April 9, 2013, at 11 a.m., an interview was conducted with RN 1 and the Director Risk Management/Surgical Services (DRM). They stated an individual cleaning dirty/used surgical instruments should wear gloves, an apron, and a face shield in order to protect themselves from contamination. The DRM and RN 1 stated the instruments were cleaned with a bristle or nylon brush, and when asked if it was acceptable to use a surgical hand scrub brush to clean the instruments, both the DRM and RN 1 responded "No." The DRM and RN 1 stated all hinged instruments, for example clamps and scissors, were processed through the sterilizer in the "open" position.

On April 9, 2013, at 11:20 a.m., the observed cleaning/packing process of instruments in Obstetrical Services was reviewed with the DOS and the DRM. The DRM stated the facility had not done an audit and/or an observation of Obstetrical Services process of cleaning/processing instruments in "at least two to three years." In addition, the DRM stated the Obstetrical staff had not been provided an inservice on how to process instruments within the last five years. The DRM stated the current practices/methods used by Obstetrical Services to clean/process instruments was a "concern from an infection control stand point" and no monitoring of the process had occurred.

The facility policy and procedure titled "Infection Surveillance in Sterile Processing" reviewed September 2011, revealed "... Employees shall wear gloves and protective clothing (aprons) and Face shields when handling any contaminated items. ..."

The facility policy and procedure titled "Instruments, Counting, Cleaning & Processing" reviewed January 2011, revealed "... With black marker write on outside of package 'OB Instruments' and your name/initials. ..."

The Association of Perioperative Registered Nurses (AORN) March 9, 2012:

Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment

XII.c.1. Instruments should be kept in the open and unlocked position using instrument stringers, racks, or instrument pegs designed to contain instruments.

Personnel handling contaminated instruments and equipment must wear appropriate personal protective equipment (PPE) and should be vaccinated against the hepatitis B virus.
XVIII.a.1. The appropriate PPE for these types of exposures include, but are not limited to, a fluid-resistant gown,heavy-duty gloves,a mask, and face protection.

Recommended Practices for Selection and Use of Packaging Systems for Sterilization
Recommendation VII - Packages to be sterilized should be labeled.

Packaging systems should be labeled before sterilization. The label information should include, but not be limited to, a description of the package contents, a method to identify the package assembler, and lot control number.

Recommendation XIX - Competency
Personnel should receive initial education and competency validation on procedures, chemicals used, and personal protection and should receive additional training when new equipment, instruments, supplies, or procedures are introduced.

8. During a tour of Operating Room (OR) 3, on April 8, 2013, at 9:15 a.m., with RN 1, the following was observed:
- A cart containing a blue bin filled with a solution of glutaraldehyde (a pungent, solution used to disinfect surgical scopes) was on the top shelf and multiple gallon bottles of glutaraldehyde were being stored on the bottom shelf.

During a concurrent interview with RN 1, she stated OR 3 was used to store clean supplies and equipment needed for surgical cases. RN 1 stated the blue bin of glutaraldehyde was used to disinfect surgical scopes used for procedures such as a colonoscopy (examination of the bowel through the rectum with a scope).

During an interview with the Director Risk Management/Surgical Services (DRM), on April 8, 2013, at 2 p.m., she stated the disinfecting of surgical scopes in a glutaraldehyde solution, following a procedure such as a colonoscopy, in a room where clean surgical supplies and equipment were stored, was not a concern.

9. During a tour of Surgical Services, on April 8, 2013, at 9:25 a.m., with RN 1, the following was observed in Operating Room (OR) 1:

- In the far right hand corner of the room, was a stationary open metal rack with multiple shelves. The shelves contained multiple bins with supplies, equipment, weights, pads, and other items. Some of the items were directly on the shelves. When the inside of the bins were wiped, a layer of dust was removed.

During a concurrent interview with RN 1, she stated the entire room, to include the stationary metal rack, should be cleaned at least weekly when the room was "terminally cleaned." RN 1 stated it did not look like the rack and the items on the rack had been cleaned for some time. RN 1 stated she thought Environmental Services personnel were cleaning the rack and the items on the rack when they "terminally cleaned" the room once a week.

The facility policy and procedure titled "Surgical Suite Environmental Sanitation" reviewed April 2012, revealed "... Patients will be provided with a safe, clean environment free from dust and organic debris. ... Every week, each operating room will be cleaned, including walls, light tracks, furnishings and equipment. This is in addition to routine daily terminal cleaning of the rooms. ..."

10. On April 8, 2013, at 2:35 p.m., a tour of the Obstetrical Unit was conducted with RN 5 and the Director Nursing Resources and Cardio/Pulmonary (DNRCP).

In the Newborn Nursery there were two infants. Patient 8 was observed under a radiant warmer and Patient 6 was being fed by RN 6 in the Newborn Nursery.

On April 8, 2013, at 3:45 p.m., Patient 8 was observed under a radiant warmer and Patient 6 was in an open crib.

During an interview with RN 6, on April 8, 2013, at 3:45 p.m., she stated Patient 8 had just been born and the infant had been brought to the Newborn Nursery for her to "evaluate and complete the assessment." RN 6 stated she could not leave the Newborn Nursery because Patient 6 had been re-admitted to the Newborn Nursery from home on April 7, 2013, for a fever and hyperbilirubinemia (excess of bilirubin in the blood which can lead to brain damage). RN 6 stated a blood culture (test done to detect infections in the blood) had been obtained and Patient 6 was currently receiving two antibiotics (medications used to fight bacterial infections).

On April 8, 2013, the record for Patient 8 was reviewed. Patient 8 was born via a vaginal delivery on April 8, 2013, at 1:07 p.m.

On April 8, 2013, the record for Patient 6 was reviewed. Patient 6 was re-admitted to the Newborn Nursery on April 7, 2013, with diagnoses including fever and hyperbilirubinemia.

The "Vital Sign Report" on April 7, 2013, indicated Patient 6's temperature was 101.6?F (degrees Fahrenheit) at 10:20 a.m., 102.6?F at 6:30 p.m., and 101.3?F at 8 p.m.

The "Physicians Orders" dated April 7, 2013, indicated a complete blood count and blood culture were ordered at 12:30 p.m., and two antibiotics were ordered at 7 p.m.

During an interview with RN 4, on April 9, 2013, at 8:15 a.m., she stated she was awaiting the blood culture results for Patient 6, and Patient 6 was continuing to receive the two antibiotics as ordered by the physician.

During an interview with RN 4 and the Director Obstetrical Services (DOS), on April 9, 2013, at 8:50 a.m., they stated anyone under 28 days of age could be re-admitted to the Newborn Nursery. The DOS stated "sick kids," infants with possible sepsis (an illness in which the body has a severe response to bacteria or other germs), or infants with a fever should be transferred to another facility. The DOS stated Patient 6 should have been admitted to the "Suspect Nursery" and separated from "well newborns." In addition, the DOS stated other infants to include Patient 8 should not have been in the Newborn Nursery with an infant who had been re-admitted with a fever.

The facility policy and procedure titled "Re-admission to Newborn Nursery" reviewed October 2011, revealed "... Infant must be separated from other newborns in either the Suspect Nursery or by rooming in with family as dictated by severity of illness. ... Practice infection control practices (wash hands between infants, no sharing of equipment, separation from hospital delivered newborns). ..."



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11. On April 9, 2013, at 3:30 p.m., staff was observed instructing visitors outside of room 115, how to apply personnel protective equipment (PPE), for entering the room. Staff instructed visitors to apply gown and gloves. A sign posted on the wall, outside room 115 indicated the patient was in "Droplet Precautions," and mask, gown and gloves were required upon entering the room.

On April 9, 2013, between 3:30 and 3:45 p.m., two visitors were observed in room 115. Both were observed wearing gown and gloves, but not wearing a mask. The visitors were observed at the side of the patient's bed, within three feet of the patient.

During an interview with Respiratory Therapist (RT) 1, on April 9, 2013, at 3:40 p.m., RT 1 stated the patient in room 115 had MRSA (methicillin resistant staphylococcus aureas) in the sputum and had a cough. RT 1 stated the patient in room 115 was initially in contact isolation for MRSA of the nares (nose) but now had a cough and MRSA in the sputum.

In an interview with the Infection Control Coordinator, on April 10, 2013, at 9:30 a.m., the ICC stated for a patient in Droplet Precautions, a mask, gown and gloves, should be worn when coming into contact with the patient. The ICC stated she would expect the hospital policy for Droplet Precautions be followed.

The facility's policy titled "Isolation Precautions-Standard Precautions," with a last reviewed date of September 2011, was reviewed and indicated "The risk of nosocomial (hospital acquired) infection transmission may be greatest before a definitive diagnosis...in addition to Standard Precautions, use Droplet Precautions...for a patient known or suspected to be infected with microorganisms transmitted by droplets (large-particle droplets)...that can be generated by the patient during coughing, sneezing, talking..." The policy indicated a mask should be worn when working within 3 (three) feet of the patient

The facility's policy titled, "Methicillin Resistant Staphylococcus Aureus (MRSA)," with a last reviewed date of April 2011, was reviewed. The policy indicated "When the patient's sputum is positive for MRSA wear a mask, gloves and a gown during all DIRECT contacts in patient care."

Based on observation, interview, and record review, the facility failed to ensure it provided organized surgical service was provided to all patients by failing:

1. To ensure the surgical flash sterilizer was checked daily with a biological indicator per facility policy and procedure. (Refer to A951);

2. To ensure surgical instruments were cleaned, processed and sterilized per facility policies and procedures and in accordance with national standards of practice. (Refer to A951);

3. To ensure the high level disinfectant solution process for scopes was not being performed in a clean instrument, equipment and supply room (Operating Room 3). (Refer to A951);

4. To ensure an optimally clean environment was maintained in Operating Room (OR) 1. (Refer to A951);

5. To ensure there was documented informed consent prior to surgery being performed for two sampled patients (Patients 10 and 11). This had the potential to result in the patients not being informed of the risks, benefits, and alternatives to their surgical procedures. (Refer to A955); and

6. To ensure drugs and biologicals were properly stored, maintained and not expired per facility policies and procedures. (Refer to A505); and

7. To ensure the surgical care plan/interventions accurately reflected the patient's condition and were individualized to the patient for one sampled patient (Patient 11). (Refer to 396).

The cumulative effects of these systemic problems resulted in the failure of surgical services to ensure care was being provided in a safe and effective manner.

Based on interview and record review, the facility failed:

1. To ensure the surgical flash sterilizer was checked daily with a biological indicator per facility policy and procedure.

2. To ensure surgical instruments were cleaned, processed and sterilized per facility policies and procedures and in accordance with national standards of practice.

3. To ensure the high level disinfectant solution process for scopes was not being performed in a clean instrument, equipment and supply room (Operating Room 3).

4. To ensure an optimally clean environment was maintained in Operating Room (OR) 1.

These practices had the potential to result in contamination to occur during surgical/procedural interventions.

Findings:

1. On April 8, 2013, at 10:55 a.m., a tour of the Sterile Processing area was conducted with RN 1 and OR Technician (ORT) 1.

The "Steam Sterilizer Record Keeping" indicated a "biological (a sterilization process-monitoring device commercially prepared with a known population of highly resistant spores that tests the effectiveness of the method of sterilization being used. The indicator is used to demonstrate that conditions necessary to achieve sterilization were met during the sterilizer cycle being monitored.) - Attest" was completed for the "flash sterilizer" on January 17, 18, 21, 24, 2013; February 14, 15, 21, 22, 25, 27, 27, 2013; March 1, 4, 5, 8, 11, 13, 21, 26, 29, 2013; and April 1, 2, 3, and 5, 2013 (24 of 82 calendar days).

The "Flash Sterilizer (steam sterilization of unwrapped items intended to be used immediately) Log" indicated instruments, batteries, and/or power sources were flash sterilized on January 23, 29, 30, 2013; February 4, 6, 12, 13, 19, 20, 2013; March 6, 14, 15, 19, 20, 27, 2013; and April 8, 2013, without a "biological - Attest" being performed.

During an interview with the Director Risk Management/Surgical Services (DRM), on April 8, 2013, at 1:40 p.m., she verified instruments had been "flash sterilized" without a "biological - Attest" being performed and/or results documented. The DRM stated an "Attest" should be done first thing each morning with the results documented. In addition, the DRM stated if the "Attest" was not done there was no way to determine if the steam sterilization process was effective in destroying the organisms.

The facility policy and procedure titled "Infection Surveillance in Sterile Processing" reviewed September 2011, revealed "... Each autoclave shall be tested at the beginning of each day, using a biological indicator (Attest), to ensure each autoclave is functioning properly. ... Biological testing is to be done on both autoclaves in Sterile Processing daily. ..."

The facility policy and procedure titled "Biological Indicators" reviewed September 2011, revealed "... autoclaves will have a biological test run on the sterilization cycle every day that the department is open and the autoclaves are used. ... All biological testing results are recorded and filed in a permanent Sterilizer Test book. ..."

2. On April 9, 2013, at 9:25 a.m., a tour of the Obstetrical Unit was conducted with RN 6 and the Director Obstetrical Services (DOS).

RN 6 and the DOS stated Obstetrical Services cleaned and packaged their own instruments.

RN 6 was observed cleaning ten instruments from a vaginal delivery tray in the Obstetrical Unit dirty utility room sink with gloves on but no apron or face shield. She was utilizing a surgical hand scrub brush to remove the blood and tissue from the instruments. The instruments were cleaned, rinsed in water and placed on a blue towel to air dry in the dirty utility room. The basin used to clean the instruments was hung on the faucet and RN 6 stated the same basin would be used to clean the next set of dirty instruments. RN 6 stated once the instruments were dry, they were wrapped in a blue towel with a sterilization indicator strip and a strip of indicator tape was placed around the towel. The instruments were then placed in a peel pack package and sent to Sterile Processing for sterilization.

On April 9, 2013, at 10:20 a.m., with the DOS, three packages of "OB Instruments" and a single package of clamps were opened. The "OB Instruments" had been processed on April 8, 2013, and the hinged instruments in the "OB Instruments" and the clamps were found to be in the "closed" position. One package of "OB Instruments" contained the initials of the individual who processed the instruments for sterilization.

During a concurrent interview with the DOS, she stated hinged instruments cannot be sterilized if they were "closed." The DOS stated all hinged instruments should be "opened" for the sterilization process in order to ensure all surfaces had an opportunity to be sterilized. In addition, the DOS stated it was not necessary to identify who assembled the instruments for processing.

On April 9, 2013, at 11 a.m., an interview was conducted with RN 1 and the Director Risk Management/Surgical Services (DRM). They stated an individual cleaning dirty/used surgical instruments should wear gloves, an apron, and a face shield in order to protect themselves from contamination. The DRM and RN 1 stated the instruments were cleaned with a bristle or nylon brush, and when asked if it was acceptable to use a surgical hand scrub brush to clean the instruments, both the DRM and RN 1 responded "No." The DRM and RN 1 stated all hinged instruments, for example clamps and scissors, were processed through the sterilizer in the "open" position.

On April 9, 2013, at 11:20 a.m., the observed cleaning/packing process of instruments in Obstetrical Services was reviewed with the DOS and the DRM. The DRM stated the facility had not done an audit and/or an observation of Obstetrical Services process of cleaning/processing instruments in "at least two to three years." In addition, the DRM stated the Obstetrical staff had not been provided an inservice on how to process instruments within the last five years. The DRM stated the current practices/methods used by Obstetrical Services to clean/process instruments was a "concern from an infection control stand point" and no monitoring of the process had occurred.

The facility policy and procedure titled "Infection Surveillance in Sterile Processing" reviewed September 2011, revealed "... Employees shall wear gloves and protective clothing (aprons) and Face shields when handling any contaminated items. ..."

The facility policy and procedure titled "Instruments, Counting, Cleaning & Processing" reviewed January 2011, revealed "... With black marker write on outside of package 'OB Instruments' and your name/initials. ..."

The Association of Perioperative Registered Nurses (AORN) March 9, 2012:

Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment

XII.c.1. Instruments should be kept in the open and unlocked position using instrument stringers, racks, or instrument pegs designed to contain instruments.

Personnel handling contaminated instruments and equipment must wear appropriate personal protective equipment (PPE) and should be vaccinated against the hepatitis B virus.
XVIII.a.1. The appropriate PPE for these types of exposures include, but are not limited to, a fluid-resistant gown,heavy-duty gloves,a mask, and face protection.

Recommended Practices for Selection and Use of Packaging Systems for Sterilization
Recommendation VII - Packages to be sterilized should be labeled.

Packaging systems should be labeled before sterilization. The label information should include, but not be limited to, a description of the package contents, a method to identify the package assembler, and lot control number.

Recommendation XIX - Competency
Personnel should receive initial education and competency validation on procedures, chemicals used, and personal protection and should receive additional training when new equipment, instruments, supplies, or procedures are introduced.

3. During a tour of Operating Room (OR) 3, on April 8, 2013, at 9:15 a.m., with RN 1, the following was observed:
- A cart containing a blue bin filled with a solution of glutaraldehyde (a pungent, solution used to disinfect surgical scopes) was on the top shelf and multiple gallon bottles of glutaraldehyde were being stored on the bottom shelf.

During a concurrent interview with RN 1, she stated OR 3 was used to store clean supplies and equipment needed for surgical cases. RN 1 stated the blue bin of glutaraldehyde was used to disinfect surgical scopes used for procedures such as a colonoscopy (examination of the bowel through the rectum with a scope).

During an interview with the Director Risk Management/Surgical Services (DRM), on April 8, 2013, at 2 p.m., she stated the disinfecting of surgical scopes in a glutaraldehyde solution, following a procedure such as a colonoscopy, in a room where clean surgical supplies and equipment were stored, was not a concern.

4. During a tour of Surgical Services, on April 8, 2013, at 9:25 a.m., with RN 1, the following was observed in Operating Room (OR) 1:
- In the far right hand corner of the room, was a stationary open metal rack with multiple shelves. The shelves contained multiple bins with supplies, equipment, weights, pads, and other items. Some of the items were directly on the shelves.

During a concurrent interview with RN 1, she stated the entire room, to include the stationary metal rack, should be cleaned at least weekly when the room was "terminally cleaned." RN 1 stated it did not look like the rack and the items on the rack had been cleaned for some time. RN 1 stated she thought Environmental Services personnel were cleaning the rack and the items on the rack when they "terminally cleaned" the room once a week.

The facility policy and procedure titled "Surgical Suite Environmental Sanitation" reviewed April 2012, revealed "... Patients will be provided with a safe, clean environment free from dust and organic debris. ... Every week, each operating room will be cleaned, including walls, light tracks, furnishings and equipment. This is in addition to routine daily terminal cleaning of the rooms. ..."

Based on interview and record review, the facility failed to ensure there was documented informed consent prior to surgery being performed for two sampled patients (Patients 10 and 11). This had the potential to result in the patients not being informed of the risks, benefits, and alternatives to their surgical procedures.

Findings:

1a. The record for Patient 10 was reviewed on April 9, 2013. Patient 10 was admitted to the facility on March 29, 2013, for a surgical procedure of an incision and drainage of an abscess to the buttocks.

The "Authorization and Consent to Surgery or Special Diagnostic or Therapeutic Procedures - Physician Certification of Informed Consent" was not completed and was left blank.

The "Short Form History & Physical" did not contain documentation of Patient 10's informed consent.

There was no documented informed consent in Patient 10's record prior to the surgical procedure.

During an interview with RN 2, on April 11, 2013, at 8:25 a.m., she reviewed the record and was unable to find documentation of informed consent being obtained prior to Patient 10's surgical procedure. RN 2 stated informed consent should have been obtained by the physician and documented prior to the surgical procedure.

b. The record for Patient 11 was reviewed on April 8, 2013. Patient 11 was admitted to the facility on April 8, 2013, for a surgical procedure of an excision (surgical removal) of a left axillary (under arm) lymph node.

The "Authorization and Consent to Surgery or Special Diagnostic or Therapeutic Procedures - Physician Certification of Informed Consent" was not completed and was left blank.

The "Short Form History & Physical" did not contain documentation of Patient 11's informed consent.

There was no documented informed consent in Patient 11's record prior to the surgical procedure.

During an interview with RN 3, on April 8, 2013, at 12 p.m., she reviewed the record and was unable to find documentation of informed consent being obtained prior to Patient 11's surgical procedure. RN 3 stated informed consent should be obtained by the physician and documented prior to the patient going to surgery.

The facility policy and procedure titled "Consents" reviewed September 2011, revealed "The informed consent is a three part process; first the physician must speak with the patient concerning the treatment, possible risks, complications and alternatives to the proposed procedure. Secondly the physician must document in the patient record that he has obtained informed consent from the patient..."