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Based on staff interviews and document reviews, the governing body failed to ensure that services performed under a contract or agreement were provided in a safe and effective manner for 57 of 65 identified agreements.

Findings:

During an interview on 4/9/10 at 8:30 a.m. with AS 2, contracted services oversight was discussed. AS 2 stated that the hospital was currently working on identifying all contracted services provided in the hospital's various departments. As of now there was no complete list of contracted services available. AS 2 presented a document titled "North Valley Contract Oversight: List of Contracts" naming 65 services provided under contracts and stated that currently no quality assurance or performance improvement (QAPI) activities were available for all of the listed contract. AS 2 stated that currently there was no written process or a person responsible for oversight of contracted services, to formally evaluate contractors/vendors for safety and effectiveness of their services. Only eight of the contracted services were actively monitored for their quality of services provided through the hospital QAPI program; however for 2 of the 8 contracts monitored, the monitoring was performed for quality of services of the hospital in relation to those services and not the quality of the contracted services themselves.

AS 2 indicated that the hospital was in process of developing a formalized process to ensure quality of services for all contracts/agreements that were currently used by all departments in the hospital. AS 2 presented P&P titled "Northern California Regional Hospital Contract Oversight" (indicated as approved by Quality Oversight Committee on 9/9/2009) but the P&P was not yet fully implemented and it was pending the approval of the Governing Body. Currently there was no standardized process or approach for reviewing the contracts/agreements, or the services that they provided.

Based on interviews and record review the hospital failed to inform 1 of 54 sampled patients' representative (Patient 41) of admission protocols or patient's rights in a language he could understand (Spanish) during the admission process, and also failed to provide any other information to Patient 41's representative in Spanish up until the survey.

Findings:

Patient 41 was admitted on 3/9/10 with a diagnosis of acute left-sided stroke with a craniectomy and resultant aphasia. On 4/6/10, at 3:00 p.m., Patient 41's husband, identified as the patient's representative, was interviewed. During the course of the interview it was noted that Spanish was his and his wife's primary language but he did speak some English. Some of the questions asked during the interview needed to be rephrased and asked again to gain his understanding of the question and get answers appropriate to the question. In light of this information he was asked if he had received any information or documents in Spanish when his wife was admitted. He said no, that she was admitted through the emergency room and the documents he received were in English. He said his son helped interpret but that he was very frantic about his wife's condition and did not really know what he had signed. He was asked if he had received any information in Spanish regarding consents, admission information, etc. since that time and he said "No", but he wants to know what he signed and asked if there were any copies in Spanish.

Review of Patient 41's electronic medical record (EMR) showed under the Demographics section that this patient did not need an interpreter and that she spoke and wrote in English. Review of Patient 41's paper record at the nursing station revealed that the Hospital Conditions of Admission, Informed Consent for Operation, Anesthesia, Medical Services and Informed Consent for Transfusion of Blood or Blood Products were all in English and signed by Patient 41's husband. These same papers were requested in Spanish and were provided within 15 minutes.

The Nurse Manager for 1 North was asked about any type of interpretive services available and she said there is an interpretive phone line available on this unit and demonstrated it's use. Another nurse was also asked to walk through the use of this phone line and confirmed the demonstration.

Review of a hospital policy titled "Qualified Interpreter Services for Limited English Proficient Persons" effective date 1/1/09" showed under heading 1.0 Policy statement, 1.1 "Qualified interpreter services are provided during all hours of operation... to members/patients, their medical decision makers and their companions." Under 2.0 Purpose, 2.1 "to ensure that qualified interpreter services are available at all administrative and clinical points of contact where the need for interpreter services can be reasonably anticipated."

Based on staff interviews and document reviews, the hospital failed to measure, track and analyze quality indicators to evaluate all aspects of performance that assess processes of care and hospital operations. The QAPI program did not include all services performed under a contract or agreement.

Findings:

The 4/8/10 review of the List of Contracts presented by the facility and of the QAPI reports for the past few quarters showed that only a select few clinical contracts were monitored by the hospital QAPI program.

In an interview on 4/9/10 at 8:30 a.m. with Administrative Staff (AS) 2, AS 2 stated that currently the hospital was monitoring only 8 contracts through the QAPI program. The facility was currently working on identifying of all contracted services provided in the hospital's various departments and up to date had identified 65 services provided under contracts. AS 2 confirmed that currently no QAPI activities were available for all of those contracts listed.

Based on interview and document review, the hospital failed to enforce its bylaws related to Pharmacy and Therapeutics Committee composition requirements when the hospital administrator, or his designated representative, failed to attend scheduled monthly Pharmacy and Therapeutics Committee meetings.

Findings:

On 4/9/10, review of the hospital's 2009 Pharmacy and Therapeutics Committee meeting minutes indicated eleven consecutive monthly meetings between January and November 2009. Review of the attendance document for each of these meetings revealed that there was no "Hospital Administration" representative, or designee, at four of the eleven monthly meetings (January, March, May, and July).

Concurrent review of the hospital's 2010 Pharmacy and Therapeutics Committee meeting attendance document revealed three consecutive monthly meetings between January and March 2010. There was no "Hospital Administration" representative, or designee, at the March meeting. At 9:40 am, during an interview with RPh 1 he confirmed the aforementioned 2009 and 2010 findings.

On 4/9/10, review of the hospital's "Professional Staff Bylaws," dated 2007, indicated under "Section E-12. Pharmacy and Therapeutics Committee" that, "The committee membership shall consist of representatives of the Professional Staff, the Chief Hospital Pharmacist, a representative from the Nursing Service, and a representative from hospital administration. On 4/9/10, at 11:15 am, RPh 1 confirmed the hospital bylaw Pharmacy and Therapeutics Committee composition requirements.

Based on medical record review and Registered Dietitian interview the hospital failed to ensure comprehensive nutritional care planning for 2 of 54 sampled patients (Patients 2 and 3) as evidenced by the absence of integrated nutrition care planning. Failure to incorporate nutritional care planning may result in unmet patient needs, further compromising nutritional status.

Findings:

1. Patient 2 was admitted with diagnoses including acute chronic respiratory failure secondary to pulmonary hypertension, possible pneumonia and hypertension. Admission diet order dated 3/21/10 was an 1800 calorie diabetic diet, with no caffeine. A final diet order dated 3/26/10 was for a regular diet with the addition of carnation instant breakfast with each meal.

Medical record review was conducted on 4/6/10 beginning at 9:30 am. A nutrition screening dated 3/22/10 and completed by the Registered Dietitian (RD) noted that the referral was completed for a low braden score (an assessment that determines risk for skin breakdown). The RD determined that the patient had nutrition sub score of 3, which equated with low nutritional risk with guidance for the RD to asses patient per facility policy. A comprehensive nutrition assessment dated 3/24/10 and completed by the RD noted that Patient 2's nutritional risk was elevated to moderate.

A nutrition reassessment dated 3/29/10 noted that Patient 2 was categorized as high nutritional risk secondary to decreased intake. The RD documented a goal for Patient 2 to increase intake to greater that 50% or consume 3 cans of regular Carnation Instant Breakfast nutrition supplement daily. The RD also reported that Patient 2's blood sugar range for the previous two days was 96-273 mg/dl (normal 70-110 mg/dl).

A final nutrition reassessment dated 4/2/10 noted that the patient was at high nutritional risk with the recommendation to continue the current diet and supplements and a suggestion for improved blood glucose control. It was also noted there was no system for nursing staff to document the acceptance of the nutritional supplements. Review of Patient 2's integrated care plan revealed there was no documentation of nutritional risk factors, decreased dietary intake or measurable nutrition goals and objectives.

In an interview on 4/6/10 at 10:30 am, with RD 3 she stated that the RD's did not contribute to the integrated care plan, rather it was the responsibility of nursing staff to develop the care plan.

2. Patient 3 was admitted with diagnoses including a right hip fracture and a history of alcohol abuse. Admission diet order dated 3/29/10 was a regular diet.

A comprehensive nutrition assessment dated 3/30/10 and completed by the RD revealed that Patient 3 was at moderate nutritional risk. The assessment also noted there were currently no nutritional interventions indicated. A nutritional reassessment dated 4/5/10 noted that the patient was at high nutritional risk and was eating less than 50% of meals, likely due to altered mental status. The recommendation was to continue the diet. It was also noted that on 4/5/10 the RD entered an order for nutritional supplements listed as "Diet, Adult, Nutritional supplement. If product not available here, select this and choose from last question; Dinner only; health shake chocolate."

Review of dietary intake beginning on 4/3/10 revealed that Patient 3's average dietary intake was an average of 34% for 10 meals. It was also noted that while there was an order for a supplement, there was no mechanism for nursing to record the amount of supplement consumed. It was also noted there was no care plan documented in the integrated care plan regarding Patient 3's nutrition risk, measurable goals and objectives for the nutrition risk or notation of the patients' decreased intake.

Based on interviews and review of non-employee files and other facility documents, the facility failed to provide an appropriate orientation to 6 of 12 non-employee (traveler) registered nurses (RN).

Findings:

On 4/6/10 at approximately 9:00 a.m., a staff member from Human Resources-Compliance (HR) was interviewed during a review of 3, non-employee (traveler) RN files. The HR staff stated that all traveler RN's received the same orientation as the hospital employee RN's. The HR staff stated that all RN travelers's attended an 8 hour, Patient Care Services class (PCS) and two 8-hour computer classes before they could work on the unit. When those classes were completed, the traveler was then oriented on the unit for 2 days with a designated nurse preceptor and together the two nurses would complete the traveler's orientation checklist before the nurse worked independently on the unit.

All 3 traveler RN's were contracted for the newborn intensive care area (NICU). A review of the files showed:

1. Traveler 1's (TR 1) contract was for 3/22/10 to 6/19/10 and attended the PCS class on 3/22/10. HR was unsure of TR 1's first day on the unit, however, a packet in the file titled, "Orientation Skills Checklist (Traveler) ICN/INT/CC Nursery-RN" (dated 6/07), showed documentation by TR 1 and a NICU nurse on 3/26/10. The checklist included a self-assessment of designated skills on which the traveler would document the extent of his/her expertise. There were two columns next to each skill set for documenting the discussion of the skill set and/or the date it was observed to be performed. These areas were to be initialed by the nurse who precepted the traveler. Some of the skill sets were noted to be mandatory items for that unit and the understanding was that the preceptor either discussed the item with the traveler or observed the traveler performing the skill.

2. TR 2's unit orientation began 12/29/09, a review of the forms showed:
a. TR 2's orientation packet was titled, "Orientation Skills Checklist ICN/INT/CC Nursery-RN". The word, "Traveler" was not in the title.
b. Multiple documented areas where skills were not discussed until several days after the original orientation date (i.e.,1/16/10).
c. Multiple areas where TR 2 had documented performed skills with no preceptor initials.
d. TR 2's checklist did not indicate the mandatory unit skill items, such as ventilators.
e. Under the respiratory skills, TR 2 had assessed herself as a level of 4 which meant she was proficient both in theory and practice with these particular skills. However, in the area marked, CPAP (continuous positive airway pressure), there was a documented performed date of 1/4/10 with TR 2's initials. Included was documentation that read, "Not familiar with vents (ventilator) used here. Will need orientation on setting and alarms." There was no documented evidence that TR 2 was inserviced on the unit's ventilators.

3. Traveler 3 (TR 3) had three contract dates, 11/2/09 to 12/20/09, 12/21/09 to 3/14/10, 3/14/10 to 6/19/10. HR was unable to find a date of when TR 3 attended the PCS class which was part of the facility's orientation process for traveler nurses. TR 3's unit orientation checklist also showed that this form was missing the word,"Traveler" in the title and the skill area delineated as mandatory (XXX). There were multiple dates written on the "discussed" area that were more than 2 days past the original orientation date of 11/2/09 (for example, 11/9/09, 12/7/09, 12/10/09 and 12/17/09).
On 4/6/10 at 11:30 a.m., an interview was conducted with the managers of education (EDM) and employee staffing (ES). The EDM stated that all travelers had to go through an 8-hour PCS class and a 2, 8-hour computer course before they were allowed to physically work on the unit. The EDM stated that the PCS class included orientation to many topics, some of which were mandatory like, blood therapy, medication administration, aseptic technique and abuse and environment of care. The EDM stated that the travelers also have a 2-day unit orientation with one of the unit nurses. The EDM was asked to locate TR 3's PCS class and she could not. The EDM stated that if the facility is having the employee orientation when the traveler arrived, he/she would attend it, otherwise, the traveler (s) would attend a traveler PCS class prior to beginning his/her assignment. The EDM was asked how TR 3 was oriented per the facility's process and she pointed out an 11/2/09 form in the file titled, "New Intensive Care (Traveler Checklist). The EDM stated that the preceptor's signature was one of her Clinical Nurse Specialist's and she had oriented TR 3 using this form. The EDM stated that she was not sure why TR 3 had not attended the PCS class and agreed that the checklist form did not evaluate TR 3's understanding of the listed topics.

On 4/6/10 at 12:00 p.m., the NICU manager (NICUM) was interviewed regarding the orientation process for traveler RN's in her unit. The NICUM stated that the NICU traveler's must take the PCS class, computer classes and orient with a NICU nurse on the unit for 2 days before they are allowed to work independently. The NICUM stated that the orientation skills checklist should have all the areas discussed during that 2-day timeframe. The NICUM stated that in this way, the RN would be aware of all the skills that may be needed even if he/she never performed them while working there. The NICUM was asked to locate TR 3's PCS class in the file and she could not, however, she stated that the form used by the education staff was only a scavenger hunt list and was not used as a form of orientation. The NICUM reviewed TR 2's comments about the difference in vents and stated that different equipment is very common in facilities. The NICUM could not find any verbiage related to the discussion between the traveler and preceptor and agreed that after reviewing all three files, the orientation tool was not being used correctly or effectively.

During the interview with the NICUM, the HR staff member and EDM returned with more of TR 3's orientation documents. The EDM stated that these documents and tests were part of the orientation TR 3 received. A review of the documents showed that many were taken in January 2010 and February 2010 during TR 3's second contract assignment.

On 4/7/10 at approximately 9:00 a.m., a review of 4 traveler RN's assigned to the cardiac cath lab were reviewed with the HR Manager (HRM) and the cardiac cath lab manager (CCM). Traveler 4's (TR 4) file was reviewed and showed no documented PCS class. The CCM stated that she personally orients the traveler staff to the same topics that are covered in the PCS class and showed an abbreviated packet in TR 4's file. The CCM stated that it is critical to be able to put the travelers on the unit as quickly as possible due to staff needs. The CCM stated that all cath lab staff also had to take the facility's,"Procedural Sedation Module".

On 4/8/10 at approximately 8:30 a.m., 5 traveler files were reviewed with the HRM and EDM. The EDM was asked to verify the units that were mandated to complete the sedation class and she produced a form which indicated what units had to have the sedation class. Two of the five travelers were assigned to units (ICU, PICU) that were mandated to take the class. The EDM stated that traveler's did not take the sedation class, even though it was mandatory in that assigned nursing area. The EDM was asked if she provided oversight to the cath lab RN's for the different orientation process and the sedation module and she stated, "No, they are not under nursing." The EDM was asked if there was a P&P or process that outlined the orientation/oversight of travelers's in the assigned nursing areas and the P&P titled, "Supplemental Nursing Personnel" (revised 2/10) was submitted as current practice. Under the P&P area, "Purpose, A. A system that assures all supplemental nursing personnel meet clinical and professional standards and receive appropriate supervision and orientation to meet the job expectations and patient care needs of the hospital environment." Under, "B. Supplemental nursing personnel", it is documented that all travelers must attend the established orientation program and that the travelers may perform all tasks associated with their assigned units.

This STANDARD is not met as exhibited by: Based on interview, medical record, and document review the hospital failed to ensure that licensed staff correctly administered medication in accordance with the physician order, hospital policy, and regulatory requirements for two of fifty-four sampled patients (Patients 21 and 32).

Findings:

1. On 4/6/10, accompanied by RPh 1 and RPh 3, review of Patent 21's medical record revealed she was a 53 year-old female admitted to the ICU on 4/4/10 with a diagnosis of diabetes mellitus type 2. Review of Patient 21's medication administration record revealed that on 4/4/10, at 12:24 pm, 8 units of Human Regular Insulin was documented as being given to her for an elevated finger-stick blood sugar reading of 372 mg/dL. Continued review of Patient 21's medical record revealed two sliding scale insulin orders, both dated 4/4/10, one for use three times a day before meals, the other to be used only at bedtime. The before meals insulin order specified that 12 units of Human Regular Insulin was to be given for a blood sugar reading between 351 to 400 mg/dL; while the bedtime insulin order indicated that 8 units of Human Regular Insulin was to be given for a blood sugar reading between 351 to 400 mg/dL. Continued review of Patient 21's medical record revealed no documentation as to why only 8 units of Human Regular Insulin was given as opposed to the physician ordered 12 units. At 8:25 am, RN 11 confirmed these findings, and stated that her expectation was that "the MD order would be followed," and that she would attempt to contact the nurse in question who was not otherwise available for interview. At 11:55 am, RN 11 stated she contacted the licensed nurse who administered Patient 21's Human Regular Insulin on that day and time as previously described; RN 11 indicated that the nurse told her "to the best of her recollection she probably looked at the bedtime sliding scale insulin coverage [order] instead of the before meals coverage [order].

On 4/7/10, review of the hospital's policy "Medication Administration," revised 02/2010, indicates under the heading "Expected Outcome" that "The patient can expect to receive medications based on the following principles: [the] Five Rights of Medication Administration [including] 3.) [the] right dose, and all governing laws and regulations." On 4/7/10, at 1:55 pm, RN 1 confirmed these principles.

California Code of Regulations. Title 22. Social Security. Division 5. Licensing & Certification of Health facilities stipulates at ?70263(g)(2) [that] Medications and treatments shall be administered as ordered.



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2. During an observation of medication administration on 4/6/10, at approximately 9:20 a.m., RN 4 was observed to carry two 10 mL (milliliters) prefilled syringes of sterile normal (0.9%) saline and a vial of intravenous Protonix (a stomach acid reducing medication) 40 mg (milligrams) into Patient 32's room with her other morning medication. RN 4 was observed to reconstitute (mix) the vial of Protonix 40 mg sterile powder in the vial with one of the 10 mL normal saline prefilled syringes. RN 4 then used the other 10 mL syringe of normal saline to flush Patient 32's right arm saline lock (short plastic tubing connected to an intravenous catheter). Finally, RN 4 injected the Protonix/saline mixture into Patient 32's saline lock over approximately 30 seconds. No additional normal saline flush was observed.

At 9:50 a.m., reconciliation of observations made during the medication pass with the Patient 32's current physician orders and the MAR (medication administration record) revealed "Administration Instructions" for Protonix 40 mg injection indicated "For IV push, reconstitute with 10 mL of normal saline. Give over 2 minutes." During a concurrent interview, RN 6 confirmed the facility administration guidelines regarding the rate of intravenous Protonix 40 mg administration.

Manufacturer guidelines indicate that intravenous Protonix 40 mg should be administered over at least two minutes.

Review of the facility policy "IV Management," Standard I-80, revised 2/10, indicated under item A3: "Maintain a patent peripheral Saline Lock as appropriate: Flush the catheter with 2 to 3ml of 0.9% sodium chloride (NS) [normal saline] before and after intermittent medication administration."

During an interview at 10:20 a.m. RN 4 acknowledged that she had not administered the intravenous Protonix over two minutes (consistent with manufacturer guidelines and facility policy) during Patient 32's morning medication administration. RN 4 indicated that she felt the saline lock had been flushed correctly before and after the intravenous Protonix administration.

Based on medical record review and staff interview, the hospital failed to ensure that consent forms were properly executed in 1 of 7 anesthesia/operation consents reviewed (record 76)and for all babies born in the hospital, the Hospital Conditions of Admissions form was not signed by the babies' mother.

Findings:

1. Record 76 was reviewed the morning of 4/8/10. The adult patient had a diagnosis of "mental retardation." The informed consent note documented by the anesthesiologist stated: "The risks, benefits and alternatives were discussed with the patient and/or guardian. Questions invited and answered to the patient's/guardian's satisfaction. The patient and/or guardian agrees to proceed." On the afternoon of 4/8/10, Health Information Management staff and Information Technology staff confirmed that this field in the electronic record is to be modified with the appropriate information by the anesthesiologist.

Also, the Informed Consent for Operation form documented the operation as: "Full mouth dental restoration under general anesthetic." However, extraction of a molar tooth was performed in addition to the dental restoration, but this was not specifically written on the consent.

2. Record 74 was reviewed the afternoon of 4/7/10. The record did not contain a Hospital Conditions of Admission form at all. Upon further investigation, Health Information Management staff confirmed that the facility's practice did not include having the mother sign one of these consents for her newborn. This has been the practice for at least more than a year.

Based on medical record and document review and staff interview, the facility failed to ensure that 3 of 9 records reviewed (Records 75, 77, 79) documented a discharge summary in accordance with hospital policy.

Findings:

1. Record 75 was reviewed on the morning of 4/8/10. The patient was put on a ventilator the day of admission until the day of death 7 days later. This significant aspect of the hospital course was not mentioned in the discharge summary.

The Bylaws, Rules and Regulations of the Professional Staff were reviewed on 4/7/10. Section II-G states: "A concise discharge summary shall be included in the medical records at discharge which contains the following elements:...Hospital Course including Significant Findings and Treatment Rendered...."

2. Records 77 and 79 were reviewed on the morning of 4/8/10. In the discharge summary, the physicians documented the final diagnosis and operation using abbreviations. This practice is not in accordance with the Rules and Regulations of the Professional Staff, Section II-A, item 1.C., which states that all final diagnoses and complications are recorded without the use of symbols or abbreviations.

The above findings were confirmed by Health Information Management staff on the morning of 4/8/10.

Based on observation, interview and facility document review, the facility failed to sequester and discard two bottles of outdated sterile water for irrigation in accordance with facility policy in one of two satellite pharmacies.

Findings:

On 4/5/10 at 3:15 p.m. (accompanied by RN 2 and RPh 2) an inspection of the 1 West satellite pharmacy revealed two partially used 1000 mL (milliliters) labeled plastic bottles of sterile water for irrigation in the corner of the counter with other assorted pharmacy supplies. One bottle, which had a hand-written date of 2/4/10 on the label, contained 600 mL of water for irrigation; the other bottle, undated, contained 750 mL of water for irrigation. RPh 2 verified the findings.

Sterile water for irrigation in plastic bottles contains no preservative to prevent growth of bacteria or fungal spores. Therefore, manufacturers include the wording "Discard unused portion" on the product labeling.

During a concurrent interview, RPh 4 indicated that the water for irrigation was used to mix a soap solution for cleaning of the Barrior Isolator Hood (an enclosed laminar flow hood used to prepare sterile solutions for intravenous administration). RPh 4 further indicated that the undated 750 mL bottle of water for irrigation had just been opened that morning, and that usually the bottles are discarded after they are first opened. RPh 2 stated "both bottles should have been discarded."

Review of the facility policy 500.6, "Injectable and Ophthalmic Single and Multiple Dose Containers," revised 2/24/10, indicated under "Single - Dose Containers," item 2: "Opened or needle-punctured single-dose containers, such as syringes, vials of sterile products, shall be used within 1 hour if opened in worse than ISO Class 5 air quality (see Table 1) and any remaining contents discarded."

USP <797> (which refers to chapter 797 of the United States Pharmacopoiea and is commonly regarded as the standard of practice for compounding sterile products) defines ISO 5 air quality as that which is produced in a laminar flow hood where the particle count (dust, etc.) is 100 per square feet. Air outside of the laminar flow hood has a higher particle count and therefore is worse than ISO Class 5 air quality.

During an interview on 4/8/10 at 11 a.m. RPh 2 indicated the 1 West satellite pharmacy was inspected monthly for expired medications, but the inspections performed in February and March 2010 did not include the corner where the outdated bottles of sterile water for irrigation were observed.

Based on observation, interview and facility document review the facility failed to follow policies and procedures and applicable standards of practice to ensure safe and controlled drug delivery when:

1. During a simulated pediatric cardiac resuscitation scenario, three of four licensed nurses were unable to correctly utilize the Broselow-Luten Pediatric Emergency Tape.

2. The director of pharmacy, in consultation with appropriate hospital staff and committees, failed to develop and implement policies and procedures for subsequent approval by the governing body, administration and medical staff for the provision of pharmaceutical services that ensure patient safety related to the use of emergency medications and medication-related devices for the pediatric age group.

3. The facility failed to implement their own guidelines and policies for safe medication administration when droperidol (an antinauseant), a medication with a known " black box " warning, was administered in the presence of a known contraindication to 3 of 54 sampled patients (Patients 34, 35 and 36).

4. The facility failed to update its written guidelines regarding the intravenous push administration of Protonix (a stomach acid reducing medication) consistent with current facility practice and manufacturer specifications.

Findings:

1. The Broselow-Luten Pediatric Emergency Tape (commonly referred to as the Broselow Pediatric Emergency Tape) is a color-coded system designed to aid nurses and other medical personnel with proper medication dosage and equipment sizing for pediatric emergencies when the weight of the child is unknown. The tape itself is a long-strip of laminated paper that folds out to a length of 146.5 cm (approximately 58 inches). The tape is divided into different colored regions, which correspond to a patient's height. The colors are then subdivided into estimated kilogram weights for that height. Each color-coded weight lists the appropriate dosage for emergency medications commonly used during cardiac resuscitation. The tape is designed for children twelve years old and younger, up to a maximum weight of 36 kg (approximately 79 pounds). Correct use of the tape requires that the patient lay supine (on their back) with their legs fully extended (knees straight), the red arrow of the tape that reads "Measure from this end" is placed at the top of the child's head ("red to the head"). The tape is unfolded to the child's heel, not his toes-the correct color zone is found at the child's heels. (Broselow J. et al. Color coding to reduce errors. American Journal of Nursing. 2005; 105: 68-71; and, . Accessed April 10, 2010.)

On 4/6/10, at approximately 9 am, accompanied by RPh 1, a tour of the Emergency Department was conducted. At 9:10 am, RN 3 was asked if she was Pediatric Advanced Life Support (PALS) certified, and if she had recently participated in a pediatric code blue (cardio-pulmonary arrest) situation. She indicated that she was, and had previously participated in a pediatric code. RN 3 was then asked to participate in a simulated pediatric cardiac resuscitation scenario utilizing the Broselow Pediatric Emergency Tape. RN 3 proceeded to incorrectly use the tape when she measured the simulated child's height from the top of its head to the tip of its toes-not the heels-resulting in an incorrect over-weight estimation. RN 3 was then asked to calculate the dosage of two intravenous medications commonly used in cardiac resuscitations, sodium bicarbonate and lidocaine, based on this height determination and corresponding weight estimate. Continuing to use the weight-based color coded information obtained from the Broselow Tape RN 3 over-estimated the correct dose for both medications. Upon completion of the exercise RN 3 acknowledged that she had not used the Broselow Pediatric Emergency Tape correctly-that she should have measured the child's height from the top of its head to its heels, and used that estimated weight for all dosage calculations.

On 4/6/10, at approximately 10 am, accompanied by RPh 1, a tour of the Pediatrics Unit was conducted. At 10:15 am, RN 5 was asked if she was PALS certified, and if she had recently participated in a pediatric code blue situation. She indicated that she was, and had previously participated in a pediatric code. RN 5 was then asked to participate in a simulated pediatric cardiac resuscitation scenario utilizing the Broselow Pediatric Emergency Tape. RN 5 proceeded to incorrectly use the tape when she measured the simulated child's height from the top of its head to the tip of its toes-not the heels-resulting in an incorrect over-weight estimation. RN 5 was then asked to calculate the dosage of two intravenous medications commonly used in cardiac resuscitations, sodium bicarbonate and lidocaine, based on this height determination and corresponding weight estimate. Continuing to use the weight-based color coded information obtained from the Broselow Tape RN 5 over-estimated the correct dose for both medications. Upon completion of the exercise RN 5 acknowledged that she had not used the Broselow Pediatric Emergency Tape correctly-that she should have measured the child's height from the top of its head to its heels, and used that estimated weight for all dosage calculations.

On 4/6/10, at 10:25 am, while accompanied by RPh 1, a second Pediatrics Unit nurse (RN 7) was asked if she was PALS certified, and if she had recently participated in a pediatric code blue situation. She indicated that she was, and had previously participated in a pediatric code. RN 7 was then asked to participate in a simulated pediatric cardiac resuscitation scenario utilizing the Broselow Pediatric Emergency Tape. RN 7 proceeded to incorrectly use the tape when she measured the simulated child's height from the top of its head to the tip of its toes-not the heels-resulting in an incorrect over-weight estimation. RN 7 was then asked to calculate the dosage of two intravenous medications commonly used in cardiac resuscitations, sodium bicarbonate and lidocaine, based on this height determination and corresponding weight estimate. Continuing to use the weight-based color coded information obtained from the Broselow Tape RN 7 over-estimated the correct dose for both medications. Upon completion of the exercise RN 7 acknowledged that she had not used the Broselow Pediatric Emergency Tape correctly-that she should have measured the child's height from the top of its head to its heels, and used that estimated weight for all dosage calculations.

At 10:35 am, in an interview with RN 9, she stated that it was her expectation that all nurses on the Pediatrics Unit should know how to use the Broselow Pediatric Emergency Tape correctly.

2. On 4/7/10, at approximately 7:30 am, in an interview with RN 13 he stated that the hospital did not have a policy or procedure in place for the use of the Broselow Pediatric Emergency Tape. He further indicated that the hospital had no policy or procedure in place for the use of the "Broselow Crash Cart Drug Calculation Sheets Drip Charts."

On 4/7/10, at 8:45 am, RPh 1 stated that a pharmacy, nursing, and physician collaborative had developed the hospital's "Broselow Crash Cart Drug Calculation Sheets Drip Charts" sometime last year, and that these "drip charts" had been made available for use, approximately six months ago, on all emergency resuscitation carts during pediatric emergencies. Continued review of these "drip charts," dated 4/22/09, revealed that they included "pediatric emergency medications calculations" for use which were based on a child's weight as determined through use of the Broselow Pediatric Emergency Tape. RPh 1 further stated that the "drip charts" had been approved for use by both the hospital's Code Blue and Pharmacy and Therapeutics Committees. When asked if there was a policy and procedure addressing the use and application of the Broselow Pediatric Emergency Tape, or for the "Broselow Crash Cart Drug Calculation Sheets Drip Charts," he indicated there was not.

On 4/9/10, at 9:30 am, RPh 1 stated that he had misspoke when he had indicated that the Pharmacy and Therapeutics Committee had previously approved the use of "Broselow Crash Cart Drug Calculation Sheets Drip Charts." Concurrent review of the 4/21/09 Pharmacy and Therapeutics Committee meeting minutes, provided by RPh 1, revealed under "Continuous Readiness" that "The Broselow Carts are being revamped to meet survey requirements and nursing educational tools are being developed." RPh 1 stated that the "drip charts had not been officially approved" and that "they had dropped the ball."

California Code of Regulations. Title 22. Social Security. Division 5. Licensing & Certification of Health facilities stipulates at ?70263(c)(1) The [Pharmacy and Therapeutics] committee shall develop written policies for establishment of safe and effective systems for procurement, storage, distribution, dispensing and use of drugs and chemicals. The pharmacist in consultation with other appropriate health professionals and administration shall be responsible for the development and implementations of procedures. Policies shall be approved by the governing body. Procedures shall be approved by the administration and medical staff where such is appropriate.


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3. On 04/08/10 at 9 a.m. a list of patients receiving droperidol (an injectable antinauseant medication) within the past 90 days was received from RPh 2. The list revealed three patients had received droperidol while in the emergency room (ED) and one after admission to the intensive care unit (ICU). Review of the selected patients' clinical records beginning at 2 p.m. (with RPh 2 and RN 2) revealed that three of four patients had ECG (also knows as EKG, or electrocardiogram) results indicating a prolonged QTc interval as specified by the "black box" warning of the manufacturer product labeling.

Droperidol's "black box" warning indicated that the drug carries a significant risk of serious or even life-threatening adverse effects. The U.S. Food and Drug Administration (FDA) could require a pharmaceutical company to place a "black box" warning (the strongest warning regarding serious medication adverse effects) on the labeling of a prescription drug, or in literature describing the drug. The FDA required that "black box" warnings be separated from other text in the package insert labeling and was typically framed with a black box border.

The following is the "black box" warning for droperidol (brand name Inapsine):

"Cases of QT prolongation and/or torsades de pointes [a potentially fatal abnormal cardiac rhythm] have been reported in patients receiving Inapsine at doses at or below recommended doses. Some cases have occurred in patients with no known risk factors for QT prolongation and some cases have been fatal.

"Due to its potential for serious proarrhythmic effects and death, Inapsine should be reserved for use in the treatment of patients who fail to show an acceptable response to other adequate treatments; either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs (see Warnings, Adverse Reactions, Contraindications and Precautions).

"Cases of QT prolongation and serious arrhythmias (e.g., torsades de pointes) have been reported in patients treated with Inapsine. Based on these reports, all patients should undergo a 12-lead ECG (electrocardiogram) prior to administration of Inapsine to determine if a prolonged QT interval (i.e., QTc greater than 440 milliseconds for males or 450 milliseconds for females) is present. If there is a prolonged QT interval, Inapsine should NOT be administered. For patients in whom the potential benefit of Inapsine treatment is felt to outweight the risks of potentially serious arrhythmias, ECG monitoring should be performed prior to treatment and continued for 2 - 3 hours after completing treatment to monitor for arrhythmias.

"Inapsine is contraindicated in patients with known or suspected QT prolongation, including patients with congenital long QT syndrome.

"Inapsine should be administered with extreme caution to patients who may be at risk for development of prolonged QT syndrome (e.g., congestive heart failure, bradycardia, use of a diuretic, cardiac hypertrophy, hypokalemia, hypomagnesemia, or administration of other drugs known to increase the QT interval). Other risk factors may include age over 65 years, alcohol abuse, and use of agents such as benzodiazepines, volatile anesthetics, and IV opiates. Droperidol should be initiated at a low dose and adjusted upward, with caution, as needed to achieve the desired effect."

a. Clinical record review for Patient 34 at 2 p.m. revealed a 29 year-old male admitted to the ED on 3/13/10 with nausea and vomiting and a history of daily alcohol use. Review of Patient 34's baseline ECG assessment performed 3/13/09 at 1:44 p.m. revealed a QTc of 462 milliseconds (msec), which exceeded the maximum recommended "boxed warning" QTc (for males) by 22 msec. Patient 34 was administered droperidol 1.25 mg (milligrams) intravenously in the ED on 3/13/10 at 3:12 p.m. Review of Patient 34's ED physician progress notes revealed the following regarding the ECG: "EKG Results: My reading - Sinus arrhythmia with big voltage and QTc of 462."

During a concurrent interview, RPh 2 and RN 2 confirmed that the ED physician had not documented risk versus benefit of droperidol use in his progress note for Patient 34 given his prolonged QTc.

b. Clinical record review for Patient 35 at 2:45 p.m. revealed a 36 year-old female admitted to the ED on 3/21/10 with nausea and a history of migraine headaches. Review of Patient 35's baseline ECG assessment performed 3/21/09 at 10:17 a.m. revealed a QTc of 462 msec, which exceeded the maximum recommended "boxed warning" QTc (for females) by 12 msec. Patient 35 was administered droperidol 1.25 mg intravenously in the ED on 3/21/09 at 10:52 a.m. Review of Patient 35's ED physician progress notes revealed the following: " Cardiovascular - normal rate, normal rhythm, no murmurs, rubs or gallops; normal to palpation; no peripheral edema."

During a concurrent interview, RPh 2 and RN 2 confirmed that the ED physician had not documented risk versus benefit of droperidol use in his progress note for Patient 35 given her prolonged QTc.

c. Clinical record review for Patient 36 at 3:05 p.m. revealed a 31 year-old female admitted to the ICU through the ED on 1/25/10 with abdominal pain, vomiting and a history of Chronic Myeloid Leukemia (cancer of the white blood cells). Review of Patient 35's baseline ECG assessment performed 1/25/10 at 1:38 a.m. revealed a QTc of 469 msec, which exceeded the maximum recommended "boxed warning" QTc (for females) by 19 msec. Review of Patient 36's Consult/History and Physical (written 1/25/10 at 3:37 a.m.) revealed the following: "EKG: sinus tachycardia 170 with slight ST depression associated with the tachycardia." Patient 36 was administered droperidol 0.625mg intravenously on 1/25/10 at 10 a.m. At 12:30 p.m., the prescriber (who was following Patient 36 in the ICU) documented "Cor [heart] neg [negative]."

During a concurrent interview, RPh 2 and RN 2 confirmed that the ICU physician who prescribed droperidol had not documented risk versus benefit of use in his progress note for Patient 36 given her prolonged QTc.

Review of the facility document, "Black Box Warning Guidelines," undated, under the column heading of "Synopsis of Black Box Warning" that droperidol/Inapsine is "Contraindicated in patients with known or suspected QT prolongation; should be used with caution inpatients (sic) at risk for developing prolonged QT syndrome.

Review of the facility policy "Medications with Black Box Warnings," revised 6/08, indicated "There may be clinical situations when there is a need to use a medication in a manner that does not appear to coincide with boxed warning guidelines. In those instances, documented evidence of the benefits outweighing the risks should be documented in the medical record."

During an interview on 4/9/10 at 9:45 a.m. in the ER MD 2 indicated that he would not prescribe droperidol in the presence of a prolonged QTc due to the associated "black box" warning cardiac arrhythmia risks.

During an interview at 11:45 a.m. ER MD 4 indicated that droperidol is considered a "last line" choice of antinauseants due to the associated "black box" warning cardiac arrhythmia risks. MD 4 further indicated that board-certified prescribers are aware of the need to do cardiac monitoring and, in the presence of a prolonged QTc, the risk versus benefit is implied when droperidol is prescribed.

During an interview at 1:25 p.m. RPh 2 (who provided pharmacist intervention notes supporting the clinical need for droperidol in Patients 35 and 36 during their hospital admissions) indicated that, with regard to "boxed warning" contraindications and facility policy adherence, "I would hope that the physician would document his clinical thought process (in the progress note) regarding the use of droperidol when the QTc is prolonged."

4. During an observation of medication administration on 4/6/10, at approximately 9:20 a.m., RN 4 was observed to carry two 10 mL (milliliters) syringes of sterile normal (0.9%) saline and a vial of intravenous Protonix (a stomach acid reducing medication) 40 mg (milligrams) into Patient 32's room with her other morning medication. RN 4 was observed to reconstitute (mix) the vial of Protonix 40 mg sterile powder in the vial with one of the 10 mL normal saline prefilled syringes. RN 4 then used the other 10 mL syringe of normal saline to flush Patient 32's right arm saline lock (short plastic tubing connected to an intravenous catheter). Finally, RN 4 injected the Protonix/saline mixture into Patient 32's saline lock over approximately 30 seconds.

At 9:50 a.m., reconciliation of observations made during the medication pass with the Patient 32's current physician orders and the MAR (medication administration record) revealed "Administration Instructions" for Protonix 40 mg injection indicated "For IV push, reconstitute with 10 mL of normal saline. Give over 2 minutes." During a concurrent interview, RN 6 confirmed the facility administration guidelines regarding the rate of intravenous Protonix 40 mg administration.

Review of the facility "Guidelines for the Intravenous Administration of Commonly Used Drugs in the Adult Patient," updated 12/04, did not indicate an intravenous push rate for intravenous Protonix; under "Nursing Considerations," the guideline indicated "Must use in-line filter (1.2 micron)."

Manufacturer information indicated that in April 2004 Protonix 40mg injection was re-formulated with EDTA (edetate disodium) 1mg to stabilize the product for room temperature storage and the ability to administer the medication intravenously over 2 minutes without a 1.2 micron in-line filter.

During an interview at 3:10 p.m. RPh 2 acknowledged the facility guidelines for intravenous administration of Protonix were outdated, and did not reflect the updated guidelines for EDTA-stabilized product and the ability to give the product I.V. push over 2 minutes without an in-line filter.

Based on medical record review, Registered Dietitian interview and dietary document review, the hospital failed to ensure the nutritional needs of 1 of 54 sampled patients (Patient 2) was met as evidenced by lack of comprehensive nutritional supplement planning. Patient 2 was given non-diabetic supplements and experienced elevated blood glucose levels. Elevated blood glucose levels may further compromise the clinical status of patients.

Findings:

Roseville Campus

1. Patient 2 was admitted with diagnoses including acute chronic respiratory failure secondary to pulmonary hypertension, possible pneumonia and hypertension. Admission diet order dated 3/21/10 was an 1800 calorie diabetic diet, with no caffeine. A final diet order dated 3/26/10 was for a regular diet with the addition of carnation instant breakfast with each meal.

Medical record review was conducted on 4/6/10 beginning at 9:30 am.

A nutrition screening dated 3/22/10 and completed by the Registered Dietitian (RD) noted that the referral was completed for a low Braden score (an assessment that determines risk for skin breakdown). The RD determined that the patient had nutrition sub score of 3, which equated with low nutritional risk with guidance for the RD to asses patient per facility policy. A comprehensive nutrition assessment dated 3/24/10 and completed by the RD noted that Patient 2's nutritional risk was elevated to moderate. It also noted that the patients' meal consumption was mostly 70-100% with occasional documented intake between 0-50%.

A nutrition reassessment dated 3/29/10 noted that Patient 2 was categorized as high nutritional risk secondary to decreased intake. The RD documented a goal for Patient 2 to increase intake to greater that 50% or consume 3 cans of regular Carnation Instant Breakfast nutrition supplement daily. The RD also reported that Patient 2's blood sugar range for the previous 2 days was 96-273 mg/dl (normal 70-110 mg/dl). The RD also documented a recommendation for tighter glucose control through an adjustment of insulin. There was no evaluation/documentation of the amount of supplement consumed, of the effectiveness of the implementation of nutritional supplementation and/or review of the potential correlation between the ordered nutritional supplement and blood sugar control. Review on 4/8/10 of the manufacturers' label for the nutritional supplement revealed that the second and third ingredient was listed as corn syrup solids and sugar.

A final nutrition reassessment dated 4/2/10 continued to note that the patient was at high nutritional risk with the recommendation to continue the current diet and supplements with the recommendation to suggest improved blood glucose control. There was no assessment of the effectiveness of the ordered nutritional supplements or whether or not the ordered supplement best met Patient 2's clinical nutritional needs.

Review of physicians' orders revealed that on 3/26/10 nursing staff entered an order for a regular diet with carnation instant breakfast with each meal. It was also noted that on 3/26/10 at 11:36 am, the RD entered a similar order for the chocolate supplement to be delivered with each meal.

In a concurrent interview with RD 3 she was asked to describe the supplement ordering process. She stated that the system was set up for the physician to order a supplement after which the RD would assess the patient and determine the most appropriate supplement based on the patients' diet. She also stated that after the assessment the RD would enter the supplement as a physicians' order. She further confirmed that the order did not require additional review.

The supplement list for a regular diet noted the inclusion of the carnation instant breakfast as well as an additional supplement that had no sugar added. The supplement list for a diabetes diet listed only supplements with no added sugar.

Based on food storage observations and dietary management staff interview the hospital failed to ensure total food supplies needed to implement the disaster menu were adequate at both campuses, and there was no plan for specific foods to serve to patients on therapeutic diets (such as renal or diabetic diets). In a disaster that required the hospital to be self sufficient for 96 hours, this planning would potentially put acutely ill patients at risk of further compromised health due to inadequate calories and being provided foods or nutrients which impaired metabolism would not manage, such as simple concentrated carbohydrates, potassium, and sodium.

Findings:

Roseville Campus

During review of disaster meal planning beginning on 4/5/10 beginning at 1:30 pm, revealed that while the hospital had a plan to provide food services in the event of a widespread disaster, the plan did not fully meet the nutritional needs of the licensed bed count as well as a full complement of staff to care for patients. It was noted that within the licensed facility there was 1680 meals, ready to eat (MRE's). It was also noted that the hospital planned to provide for disaster services for 96 hours.

In an interview on 4/5/10 at 1:30 pm, with Dietary Management Staff (DMS) 1 she stated that the hospital had frozen entrees which would be used in the event of a disaster; however she was unsure of the number of entrees currently on site. In a follow up interview with DMS 1 on 4/6/10 at 4:30 pm, she presented the surveyor with a list outlining that that there were currently 342 entrees in the freezer. It was also noted that while the hospital had stored entrees, these entrees were also used on a daily basis for patient meals. There was no documentation that the hospital maintained a par level, specifically for use in disaster meal planning. It was also noted that while the hospital had a disaster menu, for both perishable and shelf stable items, with the exception of 1 MRE per day, there were no other food portions outlined on the menu.

In a follow up interview on 4/6/10 at 1:30 pm, with DMS 1, and Administrative Staffs 5 and 7, who were responsible for meal planning they stated that the intent of the plan would be to use any stored perishable foods for the first 24 hours and to utilize the MRE's for the remaining 3 days, for a total of 4 days. They also stated that the perishable foods in the dietary department would be reserved for patients and that the contracted cafeteria would allow the hospital to take over the space, equipment and food supplies to be used in the event of a disaster. Additionally it was noted that the hospital had a total of 1640 MRE's to be utilized by patients and staff.

Document review was conducted on 4/6/10 at 3:30 pm. Hospital policy 7000 titled "Emergency Management" and dated 10/8 revealed that the hospital intended to provide meals for 292 patients, this excluded enteral fed patients and patients on liquid diets. Hospital document titled "Roseville Emergency Operations Plan" noted 292 patients would require a total of 876 MRE's. It was also noted that the hospital required 592 staff to care for the full licensed bed capacity. The plan also noted that the hospital planned to feed MRE's to staff for a total of 4 days which would require 2156 MRE's for a total of 3,032 MRE's for patients and staff.

Review of the hospital cafeteria contract revealed that while the contractor agreed to prepare meals in emergency situations it also noted that the contract was not "intended to modify or supersede any evacuation or emergency response procedures ...that may be in effect for the premises."


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Sacramento Campus

On 4/5/10 between 1:30 p.m.-3:00 p.m. the written disaster menu was reviewed and the supporting food supplies were observed concurrently with RD 2 and Environmental Health and Safety Officer 8 (EHSO). EHSO 8 was identified as in charge of the hospital disaster plan. EHSO 8 provided hospital Environmental Health and Safety Policy #4.5, revised 3/09 concerning "Emergency Supplies and Resource Management." Planning Estimates within the policy revealed the hospital planning estimates were for 75 per cent of staff and patients rather than 100 percent of patents and staff. When asked what would be provided if the hospital were 100 per cent full, EHSO 8 stated "We would need help."

Further document review revealed the planned food supplies were Meals Ready to Eat (MRE) for four days. During a concurrent interview, RD 2 stated that there were some additional food items that could be used in the refrigerator and freezers, and provided Food Service Department policy #7000 that provided a generic menu which revealed clear liquid, puree and solid diets would be offered with no consideration or guidance indicated for therapeutic modifications such as diabetic, renal or sodium controlled diets. When asked if there was an inventory to review to verify availability of additional foods to meet the dietary needs of patients and staff, RD 2 stated "I'm not sure."


At 2:50 p.m. the total count of available MRE units was determined to be 2040. According to the hospital planning estimates in Policy #4.5, total MRE needed for 100 percent of licensed bed capacity and 432 staff was 3168, based on each patient receiving one-half of a MRE each day. Total MRE needed for 75% of licensed bed plus staff was 2376, again with patients receiving one-half MRE per day. During an interview, EHSO 8 acknowledged there were not enough MRE on hand for either estimate.

On 4/6/10 at 9:15 a.m. further review of the MRE unit revealed that all components of a single MRE would provide a total of 1200 Calories. Further review of the hospital planning estimates specified the patients were each to receive one-half of a MRE for a total of 600 Calories per day (the average hospital diet plan provides 1800-2200 Calories per day), while staff would receive an entire MRE and be provided 1200 Calories per day. At 9:25 a.m. during an interview, EHSO 8 stated " I don't know why the plan is for patients to only get that much. I guess the kitchen would just cut the rations in half." During a concurrent interview, DMS 1 revealed she had thought both dietary and Environmental Health had separate MREs, and it was news to her that the total supplies were all stored in one location and inadequate.

Based on staff interview and P&P review the hospital failed to:
A. Ensure nursing staff was knowledgeable about P&Ps related to maintenance and disinfecting of medical equipment. RNs providing care in the surgical services areas did not know how to maintain glucometers per the hospital P&P.
B. Clean and sanitize all ice machines following manufacturer's recommendations.

Findings:

A.
1. During a tour of the surgery services on 4/5/10 at 11:30 a.m. RN 10 stated that glucometer was used for surgery patients with diabetes. Inspection of the quality test reagent for the glucometer showed that high and low reagent bottles were open and labeled with dates of 3/11/10 and 1/22/10 respectively. The RN was asked what did the dates indicate and how long were the reagents good for once opened as per the facility P&P. RN 10 stated that the printed manufacturer's date indicated expiration of 6/20/10 therefore the reagents were good till that date regardless of the open dates. She stated that the dates written on the labels indicated the dates the reagents were opened. The RN stated that the cleaning of glucometer should be performed with disinfecting wipes that were usually kept next to the glucometer, but the wipes were not available now. The RN located "Super Sani-Cloth" wipes and indicated that those were the wipes to be used for cleaning of the glucometer.

On 4/7/10 at 10 a.m. an interview was conducted with RN 16 regarding the use and maintenance of the glucometer used in the outpatient surgery center. The RN stated that parts of the glucometer were cleaned with soap and water and that the outside of the unit was cleaned with the alcohol wipes.

The 4/7/10 review of the hospital-wide P&P titled "Glucose Monitoring: Waived/Point of Care Testing Laboratory" (rev 5/2007) indicated in section B, Maintenance of Equipment: "1. Preventative maintenance for the monitor must be completed daily. 2. Clean Test Strip Holder using a 10% bleach solution such as 'Gluco-Chlor" cleaning pads. Then rinse well with water. Wear gloves when using gluco-chlor. 3. Remove test strip holder from dock. 4. Wash test Strip Holder with water. Rinse well ...6. Clean test area on dock with water moistened cotton swab or if blood is found on dock use cleaning solution (Gluco-Chlor pads) NOTE: DO NOT USE CLEANING SOLUTIONS CONTAINING ALCOHOL OR ABRASIVES." Section C, Maintenance of Reagents, indicated that all reagents and test strips must be labeled with initials and expiration date when opened and that open reagents are good for 90 days. Open test strips are good for 120 days.


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2. During the course of the Infection Control review a Clinical Educator was interviewed on 4/8/10 about the process used for cleaning glucometers on the patient floors. The Clinical Educator verbally reviewed the cleaning process that the nursing staff had been trained to follow. After the interview the Department, the Clinical Educator and two other Kaiser nurses toured the nursing units 1 North, 1 West, 3 East, 3 ICU and 5 West and asked floor nurses to demonstrate cleaning the glucometers.

The results were as follows: A nurse on 5 East wiped down the out side of the machine with a wipe supplied with the machine but did not know how to remove the test strip holder to clean it. A nurse on 3 ICU wiped down only the outside of the glucometer with the wipe and did not attempt to remove the test strip holder. A nurse on 3 East did not know about cleaning the test strip holder. A nurse on 1 North removed the test strip holder, opened and cleaned all parts of it and allowed it to air dry but did not clean the outside casing of the glucometer. A nurse on 1 West pulled out the test strip holder and cleaned it then cleaned the rest of the glucometer casing but did not clean the back of the casing. Two of five nurses were observed to don gloves prior to the cleaning of the glucometers. At the end of these observations the Clinical Educator acknowledged that multiple incorrect techniques were observed.

A policy & procedure regarding cleaning of the glucometers was requested and reviewed on 4/8/10. The policy was titled Glucose Monitoring and last reviewed on 5/2007. Under IV. Procedure for LifeScan SureStep Flexx Monitor, B. Maintenance of Equipment. Step 2 noted; Clean test strip holder with "Gluco-chlor" cleaning pads. Then rinse well with water. Wear gloves when using Gluco-chlor. Step 6 noted, Clean test area on dock with water moistened cotton swabs, or if blood is found on docks us Gluco-chlor pads. Step 7 noted, Dry all components thoroughly and replace test strip holder on dock.


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B.
Sacramento Campus
The hospital failed to clean and sanitize all ice machines following manufacturer's recommendations. This put the patients at risk of food-borne illness which can compromise the health of acutely ill patients.

1. On 4/6/10 at 12:30 p.m. the ice machine in the intensive care unit was observed to have a crusty dark substance on the ice and water distribution surfaces that would come into contact with ice and water as it was dispensed. During an interview at 12:35 p.m., Nurse 14 revealed the engineering department was responsible for cleaning the ice machine.

At 3:45 p.m. hospital engineer 12 confirmed he was responsible for cleaning all hospital ice machines at the Sacramento Campus, and was cleaning one exactly like the one in ICU. Engineer 12 demonstrated the product used to clean the machine and the product used to sanitize the ice machine. Additionally, Engineer 12 stated he "Sandblasted the auger and then cleaned it with a sanitizing solution containing ammonium chloride." Review of the products the manufacturer recommended were "Lime-A-Way" (a descaler) to clean, and sodium hypochlorite to sanitize. The manufacturer did not recommend sandblasting any equipment parts. The manufacturer recommendations included "Do not use ammonia products." Engineer 12 stated he had not read the manufacturer's cleaning and sanitizing recommendations and did not realize he was not following the manufacturer's recommendations.

At 4:15 p.m. the hospital provided preventive maintenance reports dated 9/30/2009 and 1/6/2010 for the Hoshizaki ice machine in the ICU. Item #9 on both reports read "Refer to Manufacturer's Ice Machine Cleaning Instructions." When the surveyor asked who had provided training on cleaning the ice machines to Engineer 12, Chief Engineer 8 stated "Kevin." When the surveyor asked whether Engineer 12 had competencies determined on each of the ice machines he did preventive maintenance on, Chief Engineer 8 stated "no."


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2. In an interview on 4/5/10 at 2:30 pm, Maintenance Staff (MS) 9 was asked to describe the maintenance process for the ice machine. He stated that on a monthly basis filters and the drain were cleaned. He also stated that on a quarterly basis the electrical components were checked. He further described that on a yearly basis the ice machine was removed from the unit and was taken apart for maintenance. He stated that he would place a descaler in the augur and let if flush through for a period of time. The surveyor also asked MS 9 if there were any additional chemicals that were placed in the augur, to which he replied "no." He further stated that he would clean the tubing and other contact surfaces in the ice machine with bleach wipes. The surveyor also asked if the cleaning process for the other ice machines in the hospital was similar, to which he replied that it was.

Review of manufacturers' guidance for the ice machine guided staff to pour a sanitizing solution into the reservoir and flushing the system. The hospital document titled "PM Notes Ice Machine Cleaning and Sanitizing Instructions" revealed that while there were preventive maintenance notes, they did not fully reflect the manufacturers' guidance. Review of the manufacturers' guidance for the bleach wipes revealed that they were not intended to be used on food contact surfaces. It was also noted that 41 ice machines were located throughout the hospital.

Based on observation, staff interview and P&P review, staff in the OR/Procedure rooms did not wear attire suitable for the kind of surgical cases performed. Surgery staff was observed wearing street shoes into OR suites where spills of blood and body fluids were likely to occur.

Findings:

1. During observations on 4/5/10 and 4/7/10 of the surgical suites of the hospital at the Roseville Campus and the Folsom/Rancho Cordova outpatient surgery suites, staff was observed wearing street shoes without protective foot coverings.

Review of the facility P&P for OR titled "Dress code" (rev10/08) indicated in section E that Fluid-resistant shoe covers will be worn when it can be reasonably anticipated that splashes or spills may occur.

In an interview on 7/7/10 at 9 a.m. with the Director of Perioperative Services (RN 8), RN 8 stated that staff in the OR was allowed to wear their own street shoes and that foot coverings were optional but not required. The foot coverings were available for use at the discretion of staff since the AORN did not recommend the use of shoe covering. RN 8 acknowledged that spills and splashes are very likely to occur in the OR suites.

The 2009 (no change from 2008) perioperative standards and recommended practices published by the Association of periOperative Registered Nurses (AORN) on page 302 recommended that: "Protective barriers must be made available to reduce the risk of exposure to potentially infectious materials. ...5. Additional protective attire (eg. liquid-resistant aprons, gowns, shoe covers) should be worn when exposure to blood or potentially infectious materials is anticipated. Protective barriers are worn to reduce the risk of exposure to blood, body fluids, or other liquids that may contain potentially infectious agents. There is evidence that supports the need for circulating personnel to wear PPE appropriate to the task being performed. 6. Fluid-resistant shoe covers are considered part of PPE and must be worn when it can be reasonably anticipated that splashes or spills may occur ..."


17335


2. On 4/6/10 at 9:20 a.m., during a tour of the Department for Nuclear Medicine, the circulating nurse (RN 12) was observed walking in and out of the procedure room without shoe coverings. When the Department inquired, the nurse replied, "These are designated shoes only worn within the area I am working, and shoe covers are not required for the circulating nurse". The circulating nurse was positioned approximately 6-8 feet from a patient during the time a procedure was being conducted (VAP: Venous access port). However, there were no floor strips or color distinction determining the sterile area from the non-sterile area.

3. On 4/8/10 at 9 a.m., during a tour of the Out Patient Services (ASC), the area designated as semi restricted was marked on the floor with a blue strip. The floor marking alerted staff to wear the appropriate attire before entering the area. Following a tour of the center, staff were observed walking within the semi restricted area without shoe coverings. When the Department inquired, the Assistant Manager stated, "Staff are permitted to wear designated shoes and are required to wear shoe coverings when they are in the operating rooms. They change their shoes when they arrive and leave the designated shoes here, in their locker".

When the facility provided the policies and procedures on 4/8/10 regarding surgical attire and infection control, the polices did not reflect designated shoes or how the facility would ensure staff compliance.

Based on medical record review and staff interview, the facility failed to ensure that a post-anesthesia evaluation was documented in 1 of 7 surgical records.

Findings:

Record 72 was reviewed on the afternoon of 4/7/10. The patient had back surgery with a hospital stay of 5 days. There was no post-anesthesia evaluation found in the record. This omission was verified after further review by Health Information staff on the morning of 4/8/10.