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Based on interview and document review, the hospital failed to ensure there was a hospital wide QAPI program as evidenced by:

The failure to ensure development of an effective program for the Food and Dietetic Service (Cross Reference 265).

The cumulative effect of these systemic problems resulted in the hospitals' failure to meet statutorily mandated compliance with the Condition of Participation for Quality Assurance Performance Improvement.

Based on interview and document review, the hospital failed to have an ongoing quality appraisal and performance improvement program that addressed the complexity and scope of Food and Dietetic Services resulting in failure to identify quality issues in food storage and sanitation which could cause food borne illness, and failure to recognize inadequacies in the dietician services that could lead to patient nutritional needs being unmet.

Findings:

On 1/27/11 at 10:30 a.m., the quality appraisal and performance improvement (QAPI) activities for 7/09 through 6/10 were reviewed. It was noted that while the dietary department submitted performance improvement information, the submitted report focused on the hospitals' customer satisfaction indicators and implementation of a room service menu for pediatric patients.

Review of intra-departmental indicators for food production activities noted that the studies monitored the frequency of recording refrigerator temperatures, dish machine cycle temperatures and food and beverage temperatures. It was also noted that from 7/09 through 6/10, all of the elements were consistently greater than 95% compliant. Additionally, for the same timeframe, dietary staff completed a tray accuracy study. The reported results for the study varied from 74%-80%; however there was no documentation of interventions that were implemented. The target compliance set by the hospital was 95% accuracy. There was no evaluation of clinical nutrition services.

In an interview of Administrative Staff F (AS F) on 1/27/11 at 2:30 p.m., the surveyor asked how the hospital ensured that the QA programs accurately reflected the depth and breadth of the dietary program. He stated that there were 9 people working on quality issues, that each unit had it's own performance improvement plan, and that the Administrative Staff D (AS D) was responsible for the dietary area. He thought that incident reports and staff/patient complaints, various committee reviews, and infection control surveillance were ways of identifying quality issues.

In an interview on 1/27/11 at 3 p.m., with Administrative Staff M (AS M), a member of the performance improvement committee and governing board he stated that the board gets their information from the QA committee, adverse event reports, sentinel events, and the monthly reports from the CEO.

There was no documentation that the hospitals' existing performance improvement systems or data submitted by Food and Nutrition Services effectively identified deficient practices or implemented an effective ongoing program to improve identified departmental issues (Cross Reference A620, A628, A629, A630, A701, A749).

Based on staff interview, medical record review, and document review, the hospital failed to ensure that: 1. There was an RN available to supervise and evaluate the nursing care of each patient in the wound clinic and sleep laboratory, and ensure that there was a second RN to monitor the patient who was administered intravenous sedation in the pain clinic and, 2. Nursing staff effectively evaluated patient needs of 1 of 4 patients reviewed for nutritional care as evidenced by the absence of a comprehensive nursing admission assessment, including screening for nutrition risk factors, for a patient who was at nutritional risk. (Patient 202) Failure to effectively screen all admissions may result in delayed nutrition intervention, further compromising clinical status.

Findings:

1. On 1/25/11 at 10 a.m., a tour was conducted of the wound clinic department. When asked about staffing at the wound clinic, Staff KK stated that the wound clinic was staffed by two physical therapists. When asked about the types of services provided, Staff KK stated that wound care, including dressing changes, and deep wound debridement (wounds are debrided to remove dead and decaying tissue) were provided. When asked if an RN was assigned to work in the wound clinic, Staff KK stated that besides the two physical therapists an aide worked in the wound clinic. Staff KK added that no RN worked or assisted with patient care in the wound clinic.

On 1/26/11 at 4 p.m., Patient 301's medical record was reviewed. Documentation in the medical record showed that the patient began care at the wound clinic on 1/20/11. The medical record contained no evidence that an RN had supervised or evaluated Patient 301's nursing care.

On 1/26/11 at 4 p..m., Patient 302's medical record was reviewed. Documentation in the medical record showed that the patient began care at the wound clinic on 10/8/10. The medical record contained no evidence that a RN had supervised or evaluated Patient 302's nursing care.

On 1/25/11 at 10:30 a.m., a tour was conducted of the sleep laboratory. During the tour Staff LL was asked to explain the various types of staff that worked in the sleep laboratory (area where sleep studies are performed to diagnosis sleep apnea, a condition in which breathing stops for more than 10 seconds during sleep). Staff KK stated that staff who worked in the sleep laboratory were sleep technicians, two of whom were certified. When asked if a registered nurse was involved in assessing the sleep laboratory patients, Staff KK replied, "No."

On 1/25/11 at 4 p.m., Patient 307's medical record was reviewed. Documentation in the medical record showed that Patient 307, had a sleep study performed 1/11/11. The medical record contained no evidence that an RN supervised or evaluated the care of Patient 307 before, during, or after the study to diagnosis sleep apnea.

On 1/25/11 at 4:20 p.m., Patient 308's medical record was reviewed. Documentation in the medical record showed that Patient 308 had a sleep study performed on 1/16/11. The medical record contained no evidence that an RN supervised or evaluated the care of Patient 308 before, during, or after the study to diagnosis sleep apnea.

On 1/25/11 at 2 p.m., a tour was conducted of the North Coast outpatient surgery department. During the tour Staff II was asked about staff present in the surgical suite during pain management procedures. Staff II stated that there was a registered nurse and the physician present in the surgical suite when pain management procedures were performed. When asked if intravenous sedation was administered to the patients having pain management procedures, Staff II stated, "Yes, sometimes." When asked to clarify if there was only one RN in the surgical suite besides the physician, who acted as the scrub technician, and who monitored the patient after administration of intravenous sedation, Staff II stated that the single RN performed all of the tasks.

On 1/25/11 at 2 p.m., Patient 304's medical record was reviewed. Documentation in the medical record showed that the patient had a pain management procedure on 1/3/11. Documentation showed that 10 mg of Versed (a drug that is used to cause sedation and memory loss during surgeries or medical procedures), was administered intravenously for the procedure. Documentation in the medical record showed that one RN and the physician were present in the operating room suite during the procedure.

On 1/26/11 at 3 p.m., Patient 306's medical record was reviewed. Documentation in the medical record showed that the patient had a pain management procedure on 1/4/11. Documentation in the medical record showed that the patient was given 5 mg of Versed Documentation in the medical record showed that one RN and the physician were present in the operating room suite during the procedure.

On 1/26/11 at 4 p.m., the hospital's policy and procedure dated 10/2010 and titled, "Staffing patterns: NCSC" (North Coast Surgery Center) was reviewed. On page 1, under item B, direction was that there should be, "One RN circulator and one scrub person (RN or tech) per patient/per room...."

On 1/26/11 at 4:30 p.m., the 2011, AORN (Association of periOperative Registered Nurses), Perioperative Standards and Recommended Practices was reviewed. On page 329, under Recommendation IV, AORN recommended that, "The perioperative registered nurse monitoring the patient receiving moderate sedation/analgesia should have no other responsibilities that would require leaving the patient unattended or would compromise continuous monitoring during the procedure."



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2. Patient 202 was admitted with diagnoses including multiple lung tumors. Medical record review was conducted on 1/26/11 beginning at 1:30 p.m. A history and physical, dated 1/18/11, noted the patient had a diagnosis of a left lung mass. There was no documented nursing admission assessment. Admission lab work dated 1/18/11 noted an albumin (a measure of protein stores) of 2.6 gm/dl (normal 3.5-5.0) and total protein of 6.0 gm/dl (normal 6.0-8.5 gm/dl).

Follow up lab work dated 1/20/11 revealed Patient 202's albumin decreased to 2.1 gm/dl and total protein decreased to 4.9 gm/dl. In a concurrent interview with AS L, a registered nurse, she acknowledged that the nursing admission assessment was missing and in light of the patients' admission diagnosis and lab values he was likely at nutritional risk.

Based on interview, medical record review, document review, the hospital failed to implement its policies requiring all patient medical record entries to be legible, dated, timed, and authenticated in 11 of 18 patient records reviewed. Failure to implement the rules and regulations could result in untoward patient outcomes.

Findings:

On 1/25 and 1/26/11, review of the records of 18 Patients demonstrated that the records of Patients 303, 102, 103, 104, 105, 106, 108, 109, 110, 111, and 112 contained illegible progress notes. The records of Patients 303, 102, 103, and 108 contained illegible orders. In addition, the records of Patients 303, 102, 103, 108, and 110 contained untimed notes and/or orders.

In interview on 1/25/11 at 11:30 a.m., Staff Nurses AA and BB acknowledged that they were unable to read the handwritten history and physical report and the handwritten brief operative note in Patient 109's record.

In interview on 1/26/11 at 2:30 p.m., Monitor Tech CC acknowledged that she was unable to read handwritten progress notes and orders in Patient 303's record.

On 1/26/11, review of the hospital's 2010 medical staff rules and regulations demonstrated the requirement that all entries in the patient's medical record shall be legible, accurate, dated, timed, and signed by the responsible practitioner.

Based on staff interview, and medical record and document review, the hospital failed to ensure that pre printed orders for restraints were completed and signed by physicians per policy in 2 cases.

Findings:

During observation on 1/25/11 at 8:30 a.m., Patient 500 was in the ICU on the ventilator with both wrists in restraints.

Medical record review on 1/25/11 at 8:30 a.m., indicated that Patient 500 was on a ventilator for respiratory difficulty. The record included a pre printed, "Restraint Orders." The pre printed order sheet included sections for the reason for the restraint, the type of restraint, the length of the order and the criteria for release. Each section had check boxes for the doctor to indicate the selections specific to the patient. None of the boxes were checked. The bottom of the pre printed orders had an area for the doctor to sign and date the sheet. There was no signature or date.

A second page of pre printed orders was signed by the doctor and dated 1/25/11. None of the boxes indicating reason for or type of restraint to be used were checked.

Review of Patient 303's medical record on 1/25/11 at 9 a.m., revealed that the patient was on a ventilator in the ICU. The medical record included the same pre printed order sheet for restraints. The doctor had signed and dated the form on 1/22/11, but had not checked any of the boxes to indicate the reason for the restraint or the type of restraint.

During concurrent interview, Administrative Staff C stated that patients on ventilators were at high risk of pulling out their airways if not restrained. The doctor was responsible for selecting the rationale for, and the type of restraint to be applied, by checking the boxes on the order sheet but had not done so.

Review of facility policy titled, "Restraints" indicated under the section, "ordering restraints" that, "the order includes the following elements: reason or behavior requiring the restraint, type of restraint and order time limit." Under the section, "order/Reorder time Frames," it indicated that, "there must be documentation in the patient's medical record that describes the findings of the physician's...reevaluation supporting the continued use of restraint."

Based on medical record review and document review, the hospital failed to ensure that a medical history and physical (H&P) examination completed and documented no more than 30 days prior to surgery or to a procedure requiring anesthesia services was placed in the record prior to surgery in 4 cases. Failure to enforce the regulations could lead to inappropriate surgical procedures and/or untoward outcomes.

Findings:

On 1/25/11 and 1/26/11, review of 18 medical records demonstrated that the record of Patient 100 was absent a preoperative history and physical report. The records of Patients 114, 115, and 116 contained history and physical examination reports that were dictated after the procedure had been completed.

Review of the hospital's 2010 rules and regulations on 1/27/11, demonstrated that the history and physical report must be physically present prior to surgery, either on the paper record or in the electronic medical record. When the H&P is not recorded before any elective operation, the procedure will not proceed until the appropriate H&P documentation has occurred. The procedure will be canceled absent an H&P.

Based on staff interview, and medical record and document review, the facility failed to ensure that medical records were complete and closed within 30 days of the patient's discharge.

Findings:

During a tour of the medical records department on 1/27/11 at 8:25 a.m., Administrative Staff X pointed to rows of shelves around the room and stated that they were the incomplete records waiting for physician signatures and other issues before they could be closed. Upon request, Staff X produced a computer printout listing the incomplete records.

Concurrent review of the computer printout indicated that 168 records, dated between 11/22/09 and 12/27/10, were incomplete. Reasons for the records being incomplete included: missing physician signatures on orders, history and physicals, emergency room reports, delivery room records, consent forms, operative reports, and discharge summaries. Additionally, some of the records were missing physician's dictated operative reports and discharge summaries.

Staff X stated that one staff member was responsible for notifying the physician's of records that needed signature. Physician's were expected to come in once a week to sign off records but not all of them did despite the reminders. Staff X stated that the bylaws indicated that the medical records were supposed to be closed within 2 weeks of discharge.

Review of the, "Bylaws and Rules and Regulations of the Medical Staff" indicated that, "Members of the Medical Staff are required to complete medical records within such reasonable time as may be prescribed by the Medical Executive Committee. A limited suspension in the form of withdrawal of admitting and other related privileges until medical records are completed shall be imposed by the Chief of Staff, or his or her designee after notice of delinquency for failure to complete medical records within such period."

Based on staff interview, and medical record and document review, the hospital failed to ensure that nursing staff had specific guidelines in place for nurses to determine the dosage of Fentanyl (a narcotic medication given to relieve pain) to be given by intravenous (IV) drip to patients in the intensive care unit (ICU). This failure resulted in nursing staff being required to decide the dosage without a specific doctors order and therefore, acting outside of their scope of practice.

Findings:

Medical record review on 1/25/11, indicated that on 1/21/11 Patient 500 was admitted to the ICU and placed on a ventilator to provide assistance with breathing. On 1/21/11 at 5:14 p.m., the doctor ordered, "Fentanyl drip range 10-100 mcg/hr (micrograms per hour ) per IV."

Review of the ICU Flow Sheet indicated that on 1/21/11 at 5 p.m., the nurse documented that the Fentanyl infusion was started at 25 mcg per hour. There was no documentation of a specific order by the doctor to start the infusion at 25 mcg, and no documentation indicating why the nurse selected 25 mcg as the initial starting rate instead of 10 mcg, the lowest rate authorized by the order.

Medical record review of Patient 303 indicated that Patient 303 was in the ICU on a ventilator. Physician's orders dated 1/22/11 at 7:36 p.m., indicated that the patient was to receive a Fentanyl drip of 10-100 mcg/hr IV per the titration policy. Behind the order in the medical record was a Xerox copy of page 9 of the Medication Administration Policy. The copy indicated the following:

Medication: Fentanyl Continuous Infusion for Critical Care Patients Requiring Mechanical Ventilation
Concentration: 500 micrograms (mcg) per 100 milliliters (ml) = 5 mcg/ml
Infusion rate: 10-100mcg/hr; increase every 15 minutes to achieve and maintain sedation
Monitor: Respirations, blood pressure, pulse, and RASS level.
Side effects: Respiratory depression, decreased blood pressure/pulse, rapid heart rate, and over sedation.

During interview on 1/25/11 at 9:30 a.m., when asked how she decided when and by how much to increase the rate at which the Fentanyl drip should run, Licensed Staff Nurse U stated that she would observe and assess the patient every hour and increase the rate by 10 mcg if she determined that the patient was in pain. She was unaware of any written guidelines for increasing the Fentanyl drip rate.

During interview on 1/25/11 at 9:45 a.m., Administrative Staff C (AS C)reviewed the medical records of Patients 500 and 303. AS C agreed that there was no order for the initial infusion rate for Patient 500 and that it was unclear why the nurse chose to start the infusion at 25 mcg. Staff AS C acknowledged that it was not the role of the nurse to determine dosages of medications.

Review of Policy titled Medication Administration, revised 10/08 indicated the same protocol that was found in the medical record and on the Xeroxed sheet in the patient ' s medical record: Fentanyl continuous infusion concentration of 5 mcg per ml at an infusion rate of 10-100 mcg per hour, to be increased every 15 minutes to achieve and maintain sedation. There was no specific guidance on what dosage to start the infusion, no specific guidance on how much to increase the dosage when needed, and no specific guidance for interpreting the criteria prior to increasing the dosage.

Administrative Staff C stated that the facility was in the process of revising the intravenous infusion protocols. She provided a copy of the revisions in process. The revision was as follows: Concentration 5 mcg/ml. Initial Dose: 25-200 mcg over 1-5 minutes. Infusion Rate: 1-2 mcg/kg/hr. Increase every 15 minutes to achieve and maintain sedation. Monitoring: Record initial blood pressure, pulse, respiration rate, oxygen saturation, and RASS, then every 5 minutes after each change, and then every 1 hour once desired level of sedation achieved.

Based on observation, interview, and document review, the hospital failed to ensure that dietary services met the needs of all patients as evidenced by failure to:

1. Provide organized dietetic services as evidenced by findings of unsafe food handling practices and supervision of the dietary department (Cross Reference A620, A749).

2. Ensure the availability of organized dietary services that are directed and staffed by adequate qualified personnel (Cross Reference A622).

3. Ensure comprehensive disaster planning (Cross Reference A701)

4. Develop performance improvement activities that reflected the scope and nature of the services (Cross Reference A265).

5. Ensure safe and effective food storage/production practices (Cross Reference A749)

6. Ensure the development of comprehensive policies and procedures that accurately reflected the scope and nature of services (Cross Reference A 619, A620, A749)

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

Based on food service observations, dietary and administrative staff interview, and dietary document review, the hospital failed to ensure the Director of Nutrition services provided comprehensive oversight to dietetic services activities as evidenced by:

1. lack of effective sanitizer testing in kitchen areas,
2. storage of unlabeled, undated and/or expired food items,
3. retention of dented cans,
4. overall kitchen cleanliness,
5. time/temperature control monitoring of potentially hazardous foods that did not accurately reflect the standard of practice,
6. lack of correct use hand sanitizers in dietetic services,
7. storage of foods with chemicals and equipment and,
8. development of procedures that allowed RD's to independently change physician diet orders, and
9. lack of an effective disaster food plan.

Failure to provide effective oversight in dietetic and nutrition care services may result in compromising food safety and palatability of patient foods. Revising physician ordered diets without physician guidance may result in compromising medical status of patients.

Findings:

Main Campus

On 1/25/11 at 9:10 a.m., sanitation practices were reviewed. In a concurrent interview DS QQ stated that part of his position responsibility was to sanitize meal carts after each meal. He demonstrated that he used a spray bottle with sanitizer. He further stated the bottles were filled using a pump station. The surveyor asked him to describe how he ensured there was enough chemical in the spray bottle, to which he replied that he did not have a mechanism to do that.

In an interview on 1/25/11 at 9:35 a.m., DS NN stated that the hospital relied on the chemical vendor, who came in monthly, to test the sanitizer. He acknowledged that there was no departmental system to ensure the pump station was working effectively and dispensed effective amounts of chemical sanitizer in between visits by the chemical vendor.

On 1/25/11 at 10:10 a.m., the manual dishwashing process was reviewed with DS SS. She was asked how she ensured there was enough chemical dispensed for sanitation. She proceeded to drop a test strip in the sink water and let it float to the bottom, a process that required approximately 45 seconds. Concurrent review of manufacturers guidance, printed on the test strip label, guided staff to immerse the strip for 10 seconds. There was no indication that immersing the strips in for longer than the manufacturers guidance would result in accurate test results.

In an interview on 1/25/11 at 3:30 p.m., AD D stated that he guided staff to drop the strip in the water as a mechanism to ensure that when staff washed dishes manually they could verify sanitizer strength. There was no evidence that this method would provide accurate results.

On 1/25/11 at 10:45 a.m., DS TT was observed preparing pureed meat. DS TT was observed placing an unmeasured amount of turkey scraps into a blender after which she added an unmeasured amount of water, estimated by the surveyor to be approximately 1 cup. In a concurrent interview DS TT stated that she was preparing meat for 7 patients. She also stated she routinely started with 1 cup of water and would add additional water as needed.

Review of hospital guidance titled, "Pureed Meat" dated 6/22/06, guided staff to measure specific amounts of meat for 3, 6, or 9 servings. It was also noted that the recipe guided staff to add hot water or unseasoned cooking broth. While it may be necessary to add liquids to some foods while pureeing, the addition of non-nutritive fluids such as water may dilute the nutritional quality of the item being pureed. The standard of practice would be to utilize minimal amounts of nutritional fluid such as milk or meat drippings (Foundations and Clinical Applications of Nutrition, 2004).

During initial tour on 1/24/11 at 2:15 p.m., the following was noted:
a. In the walk-in refrigerator there was chopped garlic dated 2/28/11; mustard, opened undated; parmesan cheese-opened, undated; cooked sausage with a preparation date of 1/24 and use by date of 1/30 (a hold time of 6 days). Additionally, there was pre-cooked turkey breast and 2 pans of frozen vegetable soup, being thawed, with no pull date (date removed from the frozen state). And dietary staff was storing raw pork products above raw fish.

In a concurrent interview DS NN acknowledged that the fish should not have been stored below raw pork products. He also stated that the hospital policy was to date foods according to their expiration date, rather than their production date. He acknowledged that all items should have been dated. Additionally he stated that opened products such as the cooked sausage should not be held longer than 3 days. The standard of practice would be to ensure that raw fish products would be stored above pork products (ServeSafe, 2007).

Review of hospital guidance titled, "Dating Potentially Hazardous Foods" dated 4/23/07, revealed that items such as the garlic should not be held greater than 30 days. The observed date on the garlic would allow the garlic to be held greater than 30 days. The policy indicated that, "When an item is removed from the freezer ...the use by date is immediately written on the package."

In the dry storage area adjacent to the kitchen there were numerous cans with varying degrees of dents ranging from dents on the rim to sharp v-dents on the sides. Observed cans included marinara sauce with a dent on the rim that was folded over, mandarin oranges, applesauce and Ensure nutritional supplement. It was also noted there was pasta, no open date; split peas and white beans that were opened and stored in their original container.

In an interview on 1/24/11 at 3:30 p.m., Administrative Staff D (AS D) was asked to describe the departmental procedure for utilization of dented cans. He stated that they would use cans that had minor dents and also acknowledged that he did not have a written policy that guided staff which cans to use and those to discard. It would be the standard of practice to remove products from their original shipping container once opened (Food Code, 2009).

Review on 1/24/11 at 3:45 p.m., of the downstairs dry storage area noted containers of allspice, ginger, cloves and food coloring that were opened, with no dates. In a concurrent interview AS D stated that the downstairs storage area was intended only for unopened products. He was unsure why the products were returned to storage after use.

Within the dry storage area there were dented cans of cream of chicken soup, artichoke hearts, cherry pie filling, beets and plum sauce. In addition there was a bag of unsealed wild rice.

In this storage area, there was a small closet that contained canned products. There was peeling paint measuring approximately 7"-8" in diameter on both the wall and ceiling. Additionally on a plywood surface where food products were stored there were unidentified dried liquid spills. The standard of practice would be to ensure that all foods were stored on non-porus washable surfaces (Food Code, 2009).

Review on 1/24/11 at 4:10 p.m., of cafeteria storage practices noted numerous items including corn dogs, chicken breast, vegetarian patties, cooked chicken, chicken strips, fish, and a brown sauce all of which were undated and unlabeled. In a concurrent interview AS D stated he had not guided staff to label and/or date items in cafeteria storage.

During general kitchen observation on 1/24/11 at 2:15 p.m., there were food production areas and equipment that were not clean. The wire rack holding cleaned and sanitized pots had a buildup of gray material, resembling dust. It was also noted that the ceiling mounted utensil holder was also covered with a similar dust-like material. The door handles of the wall mounted refrigerators/freezers had a build up of a clear sticky substance.

Observations in the cafeteria area on 1/24/11 at 4:30 p.m., revealed there was a build up of unidentified food particles on the oven/grill area as well as the fryer and steam table. There was also a build up of food particles on the door gaskets and the inside of both the cafeteria refrigerators and the freezer. Observation on the back loading dock revealed that both the refrigerator and freezer located there were covered with brown dust-like material resembling dirt on the outside and unidentified food particles on the inside.

In a concurrent interview AS D was asked to describe the cleaning schedule for kitchen areas. He stated that there were individual schedules for each of the areas that outlined the frequency in which areas were cleaned. He also stated that for general areas the policy was for staff to, "clean as you go."

Review on 1/28/11 at 8 a.m., of departmental cleaning assignments for the week of 1/23-29/11, there was a set schedule for cleaning equipment and surfaces. The form also guided staff to, "initial when task completed." Review of the schedule revealed that 50% of the assigned tasks were not initialed as complete for 1/23-1/26. Review of cafeteria cleaning schedules also revealed that food production equipment was not listed.

During initial tour beginning on 1/24/11 at 2:15 p.m., it was noted there were numerous previously cooked foods in the walk-in refrigerator and walk-in freezer. The refrigerator contained items such as beef barley soup and lasagna. The freezer contained items such as refried beans, spicy chicken meat, pasta, meat based marinara sauce, lemon chicken, and 3 containers of cooked pork, all with different production dates.

In an interview on 1/25/11 at 3:30 p.m., Dietary Staff UU (DS UU) was asked to describe the processing of leftover foods. She stated that if a significant quantity of a hot item was leftover after the evening patient tray line or cafeteria meal the process would be to place it in the freezer to cool down. She stated the parameters for cooldown would be from 135?F-70?F within 2 hours and to 45?F within an additional 4 hours and that the process would be recorded in the log.

Review of hospital document in the presence of Dietary Staff NN (DS NN) and AS D titled, "Cool-Down Temp Recording Sheet," revealed that the documented parameters did not meet current standard of practice. The standard of practice for cooldown would be to ensure that food was cooled to135-70?F within 2 hours and down to 41?F within an additional 4 hours, in a timeframe not to exceed 6 hours (Food Code, 2009).

In a concurrent interview AS D stated that he was following state regulatory requirements for the policy and was unable to offer explanations for not following the more stringent federal regulatory requirements. PHF's are those foods capable of supporting bacterial growth associated with foodborne illness and require comprehensive monitoring for time/temperature control (Food Code, 2009).

During general kitchen observations on 1/24/11 from 2:35-4:30 p.m., it was noted there were several instances in which dietary staff were not following handwashing procedures (Cross Reference A749) per hospital infection control guidance or manufacturers' guidance of hand sanitizers.

During an interview, and concurrent document review on 1/25/11 at 4 p.m., dietary staff training records revealed that on 8/20/10 an in-service for handwashing and processing dishware was conducted. AS D stated that dietary staff was asked to review guidelines for the 2 topics and sign an attestation that they understood and would follow the procedures. AS D was asked if he performed evaluations on sanitation procedures within the department. He stated that he did a regular walk-through of the department and if he identified an issue he would address it at that time. Asked if he maintained any documentation of the evaluations or issues that he may have identified, he replied that he did not. There was no system in place to ensure that staff was competent in the procedures on the attestation.

Review of the job description for the Director of Nutrition Services dated 6/2010 revealed that this was the position that was responsible for the daily management of the hospitals' food services and clinical nutrition services.

On 1/26/11 at 4 p.m., the plan for disaster feeding was reviewed with AS D. In a concurrent interview AS D stated that he had a written disaster plan. Review of the disaster plan revealed that while there was a basic meal pattern consisting of categories of foods to be served, there was no defined menu for regular or therapeutic diets, nor was there any guidance for food preparation or portions to be served. It was also noted that the disaster plan was specific to the main hospital campus (Cross Reference A701). In an interview on 1/27/11 at 9:30 a.m., AS D acknowledged the hospital was unable to demonstrate the implementation of an effective disaster plan.

Satellite Campus

On 1/25/11 beginning at 9 a.m., food storage areas at the Satellite Hospital campus were reviewed. It was noted that dietary staff was storing food, equipment and chemicals in the dry storage area. In a concurrent interview with AS D he stated that meal trays were delivered to the campus for each of the meals and since there was no food production or kitchen equipment the only foods stored were those that were used to replenish nourishment areas. He also stated that this was the only storage area for dietetic services for both food and equipment. The standard of practice would be to store food, equipment and chemicals in separate areas (Food Code, 2009).

Nutrition Care

During medical record review on 1/26/11 at 10:30 a.m., it was noted that Registered Dieticians (RD's) were changing physician ordered diets (Cross Reference A629).

In an interview on 1/26/11 at 12 p.m., AS D stated that the hospital developed a policy that allowed RD's to change diet textures, based on an assessment, without physician's orders. He further stated that the policy was reviewed and approved by the medical executive committee.

In an interview on 1/26/11 at 12:30 p.m., with AS J, a physician, he stated that while he considered the RD as an integral member of the health care team, it was the physician that was responsible for the overall care of the patient. He further stated he would expect the physician to be notified for any recommended diet changes.

Review of hospital's medical staff bylaws dated 9/2010 revealed that while the hospital had a medical staff category titled, "Limited Licensed Practitioner" which was defined as a non-medical staff member whose licensure or certification permits, and the hospital authorizes the independent provision of patient care services without supervision. RD's are neither licensed or certified and therefore unable to practice independently (California Business and Professions Code, 1265.4) within the scope of a non-medical staff member per the hospital's bylaws.

Review of dietary department procedure titled, "Dietary Nourishments Provision Protocol" dated 8/08, revealed that the department developed a procedure for RD's to provide dietary nourishments per protocol. It was noted that the criteria included nutritional risk factors such as unplanned weight loss, pressure ulcers or decreased oral intake among others. While the protocol described categories of patients that may receive nutritional nourishments, and provided a variety of nutritional products that might be used, there was no disease specific supplementation guidance that was approved by the medical staff nor did the policy give RD's the authority to change physician ordered diets. As of 1/27/11 the hospital was unable to provide documentation of medical staff approval of order writing privileges for RD's.

Review of the job description for the Director of Nutrition Services dated 6/2010 revealed that this was the position that was responsible for the daily management of the hospital's food services and clinical nutrition services.

Based on medical record review, and dietary and administrative staff interview, the hospital failed to ensure that Registered Dietitians followed up on recommendations of nutrition interventions in a timely manner. Failure to develop timely systems for evaluating the effectiveness of nutrition recommendations and/or interventions may further compromise patients' nutritional and clinical status.

Findings:

1. Patient 201 was admitted with diagnoses including left hip fracture and diabetes. Medical record was reviewed on 1/26/11 beginning at 9:30 a.m. Admission nutrition screen dated 1/23/11 noted that Patient 200 was at nutritional risk due to the presence of pressure sores. An admission diet order dated 1/22/11 was NPO (nothing by mouth). A follow up order dated 1/23/11 was for a soft diet. A comprehensive nutrition assessment dated 1/24/11 revealed that the Registered Dietitian noted that there was no recorded dietary intake since admission. The assessment also recommended the initiation of Vitamin C, 500 milligrams daily as well as consideration of a speech therapy evaluation and initiation of a medication to better facilitate blood glucose control.

Review of Patient 201's physician's orders, physician's progress notes and medication administration records beginning on 1/25/11 revealed there was no indication that the physician reviewed or ordered the RD recommended changes in therapies.

In an interview on 1/26/11 at 11:45 a.m., the Registered Dietitian (RD) was asked to describe how she would follow up on recommendations intended for physician review. She stated that upon completion of the nutrition assessment the RD would decide when to schedule a follow up visit. She stated that on a daily basis the RD's prioritized their schedules according to the census and nutrition risk, the first priority being those patients with physician ordered dietary consults, followed by those patients identified through nursing assessment at nutritional risk, then patients who were not identified at risk.

The RD was asked when she might follow up on RD assessment recommendations. She stated that the RD's would follow up if they had time but it was more likely that the RD's would follow up at the next scheduled visit which may be 3-4 days. When asked if she would contact the physician after recommendations were made RD replied they may on occasion however as an RD she would expect that the physician review the recommendations documented in the nutrition progress notes.

In an interview on 1/26/11 at 12:10 p.m., AS D was asked to describe RD scheduling. He stated that RD's were available Monday-Friday on a regular schedule. On Saturdays there was 1 RD to cover both the main and satellite campuses. There was no regular RD coverage on Sundays, rather the coverage was on-call and the RD would rely on the diet aide or nursing staff to call them with issues.

In an interview on 1/26/11 at 12:30 p.m., AS J, a physician, stated that while he considered the RD an integral member of the health care team, it was the physician that was responsible for the overall care of the patient. He further stated he would expect the physician to read the recommendations by the RD, however acknowledged that not all physicians did.

Based on food production observations,interview, and record review, the hospital failed to ensure staff was effectively trained as evidenced by incorrect testing of sanitizer strength and improper sanitation of fixed food production equipment. Failure to develop effective procedures to test and utilize sanitizer may result in foodborne illness associated with contaminated equipment. Foodborne illness may result in gastrointestinal distress, further compromise of clinical condition and in severe instances may result in death.

Findings:

1. On 1/25/11 at 10:10 a.m., the manual dishwashing process was reviewed with Dietary Staff SS (DS SS). She stated that she washed and rinsed the dishes after which they were sanitized using a chemical obtained from a pump station directly above the sink. The surveyor asked her how she ensured there was enough chemical dispensed. She proceeded to drop a test strip in the sink water and let it float to the bottom, a process that required approximately 45 seconds. Concurrent review of the manufacturers guidance, printed on the test strip label, guided staff to immerse the strip for 10 seconds. On 1/25/11 at 2:25 p.m., the surveyor tested the sanitizer strength following manufacturers' guidance. As a comparison the surveyor also immersed the strip for 10 seconds in plain water. It was noted that the strip which was immersed, per manufacturers' guidance, in sanitizer was a slightly darker shade of orange than plain water immersion. The color did not change to the specified 200 parts/million of sanitizer. Review of manufacturers' guidelines for the test strips revealed that when the sanitizer strength is at 200 ppm, the strip turned a light forest green color.

2. On 1/25/11 at 9:40 a.m., Dietary Staff TT (DS TT) was observed slicing meat using an electric slicer. During this process DS TT was leaning her bare arm against the platform that held the finished meat slices. Upon completion of the task DS TT began to clean the slicer. She sprayed an orange degreaser on the equipment and then wiped it down. After wiping she proceeded to brush off remaining food particles, sprayed a sanitizer on all exposed surfaces, and patted the sanitizer off with a towel. In a concurrent interview DS TT stated this was her usual method of cleaning the meat slicer.

Hospital policy titled, "Cleaning of Equipment" reviewed 10/10, guided staff to wash the stationary parts with a cleaner, wipe off with clear water and then sanitize. The standard of practice for sanitation of equipment would be to allow it to air dry (Food Code, 2009).

Based on medical record review, dietary staff interview, and dietary document review, the hospital failed to ensure that the menus met the needs of patients as evidenced by lack of nutritional analysis of regular and therapeutic diets.

Findings:

Patient 204 was admitted with diagnoses including renal insufficiency and a history of alcohol abuse. Medical record review was conducted on 1/26/11 beginning at 3:30 p.m. The admission diet, dated 1/24/11, was NPO with the exception of medications. A comprehensive nursing assessment dated 1/24/11 noted there were no nutritional risk factors. A physicians order dated 1/24/11 requested a nutritional consult. A comprehensive nutrition assessment was completed on 1/25/11 by the RD. It was noted that the patient was currently NPO, and was well nourished. The assessment documented estimated nutritional needs of 2200-2300 calories, and 95-115 grams or protein. It was also noted that the patient required a high protein diet for healing needs.

In a concurrent interview AS D was asked to describe what a high protein diet would consist of. He stated that the regular diet was based on the food pyramid, a menu planning tool for healthy adults. He also stated he did not know what the nutritional analysis of the hospital's regular or therapeutic menus. In a concurrent interview the RD was asked how she would modify a patient's diet without an analysis of the current menu. She acknowledged that she would not know if the patients' nutritional needs were met.

Hospital document titled, "Appendix A-UDSA Food Guide" dated 2005, revealed that the USDA Food guide divided into calorie levels ranging from 1,000-2,000 calories/day. As an example it was noted that the food guide recommended for a 2,000 calorie diet the menu should include 3 cups of dark green vegetables/week. Review of the non-select spreadsheet noted that broccoli, a dark green vegetable was offered once during a 7 day cycle. Similarly the food guide recommended 2 cups or 4 servings/day of fruit/day, however fruit appeared on the menu only 3 times/day. While the USDA Food Guide meets the needs of a healthy population, the hospital was unable to demonstrate that the menu met the nutritional needs of an acutely ill patient population.

Based on medical record review, dietary staff interview, and dietary document review, the hospital failed to ensure that diets were ordered by the physician, as evidenced by Registered Dietitians (RD) modifying diet orders. Modification of diet orders by non-practitioners may result in compromising the clinical status of patients.

Findings:

1. Patient 201 was admitted with diagnoses including left hip fracture and diabetes. The medical record was reviewed on 1/26/11 at 10:30 a.m. The admission nutrition screen dated 1/23/11, noted that Patient 200 was at nutritional risk due to the presence of pressure sores. The admission diet order dated 1/22/11, was NPO (nothing by mouth). A follow up order dated 1/23/11 was for a soft diet. A comprehensive nutrition assessment dated 1/24/11, completed by the RD, noted that there was no recorded dietary intake since admission. The RD recommended a diet change to a controlled carbohydrate-standard, pureed, as well as initiating a nutritional supplement three times daily with meals. The assessment also recommended the initiation of Vitamin C, 500 milligrams daily and consideration of a speech therapy evaluation and a initiation of a medication to better facilitate blood glucose control.

Concurrent review of a hospital document titled, "Current Diet Listing" revealed that the diet was changed on 1/23/11, however, there was no documented physician order for the change. In an interview on 1/26/11 at 11:45 a.m., the RD stated that after completion of the nutrition assessment she may change the physician ordered diet based on patient needs. She stated, for example, that if a patient had problems chewing or swallowing she might change the texture of the diet. Similarly she also stated that if she noticed that a patient had diabetes with elevated blood glucose levels and the physician had not ordered a diabetic diet she might order additional restrictions to the diet.

In an interview on 1/26/11 at 12 p.m., AS D stated that the hospital developed a policy that allowed RD's to downgrade diets, based on an assessment, without physician's orders. He further stated that the policy was reviewed and approved by the medical executive committee.

In an interview on 1/26/11 at 12:30 p.m., with AS J, a physician, he stated that while he considered the RD as an integral member of the health care team, it was the physician that was responsible for the overall care of the patient. He further stated he would expect that the physician be notified for any recommended diet changes.

Review of dietary department procedure titled, "Dietary Nourishments Provision Protocol" dated 8/08, revealed that the department developed a procedure for RD's to provide dietary nourishments per protocol. It was noted that the criteria included nutritional risk factors such as unplanned weight loss, pressure ulcers or decreased oral intake among others. While the protocol described categories of patients that may receive nutritional nourishments, and provided a variety of nutritional products that might be used, there was no disease specific supplementation guidance that was approved by the medical staff.

2. Patient 202 was admitted with diagnoses including multiple lung tumors. Medical record review on 1/26/11 at 1:30 p.m. included the patient's history and physical (H&P) dated 1/18/11. The H&P indicated that the patient had a diagnosis of a left lung mass. The admission diet order dated 1/19/11, was NPO (nothing by mouth).

On 1/21/11 the RD completed a comprehensive nutrition assessment. The assessment noted the patient was on a ventilator (a machine to facilitate breathing) as well as a plan of care that included the start of enteral feeding (feeding though a tube in the stomach) within 24 hours if the patient was unable to breath on his own. The recommendation for feeding was Glucerna 1.2 at a goal rate of 80 cc's/hour. On 1/21/11 at 11 a.m., the RD documented in the physician's order section of the chart, a verbal order to, "Start TF [tube feeding] Glucerna 1.2 goal rate 80 cc/hour." There was no start rate for the tube feeding. On 1/22/11 the RD completed a follow up and noted the recommendation to switch the feeding to Nepro at a goal rate of 30 cc's/hour. The RD documented a telephone order for, "TF rate 30 mL/? using Nepro formula."

Patient 202's flow sheet dated 1/21/11, revealed that nursing staff started the tube feeding at 30 cc's/hour for 3 hours at which time the tube feeding was increased to 60 cc's for an additional 9 hours, after which the feeding was increased to 70 cc's for the ensuing 6 hours. There was no documentation that the physician ordered the feeding to run beyond a rate of 30 cc's/hour. In a concurrent interview AS L, a registered nurse, acknowledged that it would be the standard of practice to obtain a start and goal rates for enteral feedings.

Based on medical record review, nursing and dietary staff interview, and hospital document review, the hospital failed to ensure physicians orders and/or nutritional needs were met for 3 of 5 patients reviewed for nutrition care. (Patients 200, 202 and 203) Failure to effectively implement physician's orders or identify patients at nutritional risk may result in compromising the clinical status of patients.

Findings:

1. Patient 200 was admitted with diagnoses including a right sided stroke. Admission diet order dated 1/17/11, was for a regular diet with a fluid restriction of 1200 cc's/24 hours. There was also an order dated 1/17/11, for a diet consult. On 1/18/11 the physician added the additional restriction of a "renal diet". A comprehensive nutrition assessment dated 1/18/11, noted that the patient had a target requirement of 55 gram/protein per day. The assessment indicated that the patient had a history of chronic kidney disease, and a good intake, eating 61-80% of her meals. The RD recommended Ensure (a nutritional supplement) twice each day. On 1/18/11 there was a telephone order for Nepro (a nutritional supplement) 1 can at lunch, which would provide an additional 19 grams/protein per can.

Review of daily intake and output records beginning on 1/21/11 revealed that for the period from 1/21-1/24/11 the physician's order for fluid restriction was not followed. During this period Patient 200 consumed an average of 253 cc's of additional fluid/day.

In an interview on 1/26/11 at 11 a.m., AS D was asked to describe the protein content of a renal diet. He stated that per the nutritional department the renal diet had no protein restriction, rather was restricted only in sodium, potassium and phosphorus.

In an interview on 1/26/11 at 3 p.m., AS K, a physician, stated he expected that a renal diet would consist of both protein and mineral restrictions. The standard of practice for a renal diet would be to include protein and mineral restrictions in an effort to preserve the function of the kidneys (National Kidney Foundation, 2011).

2. Patient 202 was admitted with diagnoses including multiple lung tumors. Medical record review was conducted on 1/26/11 beginning at 1:30 p.m. A history and physical dated 1/18/11, noted the patient had a diagnosis of a left lung mass. The admission diet order dated 1/19/11, was NPO (nothing by mouth).

On 1/21/11 the RD completed a comprehensive nutrition assessment. The assessment noted the patient was on a ventilator (a machine to facilitate breathing) as well as a plan of care that included the start of enteral feeding (feeding though a tube in the stomach) within 24 hours if the patient was unable to breath on his own. The assessment documented estimated nutritional needs of 1950-2340 calories and 94 grams of protein. There were no assessed fluid needs. The recommendation for feeding was Glucerna 1.2 at a goal rate of 80 cc's/hour. On 1/21/11 at 11 a.m., the RD documented in the physician's orders a verbal order to, "Start TF [tube feeding] Glucerna 1.2 goal rate 80 cc/hour." There was no start rate. On 1/21/11 at 11:45 a.m., nursing staff obtained a clarification order for a medication, however did not obtain clarification orders for the feeding. A second entry dated 1/21/11 completed by the RD, noted that the patient was experiencing fluid overload with Lasix (a medication to reduce excess fluid). The RD also documented that the patient was at risk for refeeding syndrome, a fluid and electrolyte disorder in patients who are malnourished (British Medical Journal, 2008). Despite identification of the risk of refeeding syndrome and documented fluid overload, there was no assessment of Patient 202's fluid needs.

On 1/22/11 the RD completed a follow up and noted the recommendation to switch the feeding to Nepro at a goal rate of 30 cc's/hour. The RD documented a telephone order for, "TF rate 30 mL/? using Nepro formula."

Patient 202's flow sheet dated 1/21/11 revealed that nursing staff started the tube feeding at 30 cc's/hour for 3 hours at which time the tube feeding was increased to 60 cc's for an additional 9 hours, after which the feeding was increased to 70 cc's for the ensuing 6 hours. There was no documentation that the physician ordered the feeding to run beyond a rate of 30 cc's/hour.

In a concurrent interview AS L, a registered nurse, acknowledged that it would be the standard of practice to obtain start and goal rates for enteral feedings. In an interview on 1/26/11 at 11:30 a.m., DS VV stated that she would rely on the physician to determine the fluid needs of patients.

Hospital policy titled, "Tube Feeding" revised 7/10, revealed that it was the responsibility of nursing staff to safely administer the tube feeding. The policy also guided nursing staff, "To achieve goal tube feeding rate ...by 20 ml every 8 hours." The policy indicated that it was the responsibility of the RD to assess formula and free water needs.

3. Patient 203 was admitted with a diagnosis of status post bilateral lung transplant. Medical record was reviewed on 1/26/11 at 3:45 p.m. A history and physical dated 1/21/11 noted the patient was admitted with symptoms including nausea, vomiting and difficulty swallowing. Admission lab work dated 1/21/11, noted an albumin, a measure of protein stores of 2.4 gm/dl (normal 3.5-5.0 gm/dl) and total protein of 5 gm/dl (normal 6-8.5 gm/dl). Follow up labs dated 1/22, 1/23 and 1/26 noted a decreasing albumin 2.2 gm/dl and total protein of 4.6 gm/dl.

Review of dietary intake beginning on 1/22/11 revealed an average intake of 40% for 10 meals. The admission diet order dated 1/21/11 was a regular diet with 1,000 cc's fluid restriction. As of 1/26/11 (5 days after admission) there was no nutrition assessment.

In a concurrent interview, RD WW stated that there was no nutrition assessment because the patient did not trigger as being at nutritional risk at admission. She further stated that patients who had a physician ordered diet would not receive an assessment until day 7 of their stay. She stated that there was no mechanism to notify the RD's of abnormal nutritionally related lab values such as albumin. In an interview AS L was asked if there was referral guidance for nursing staff to follow when patients had poor dietary intake, she stated there was not. It would be the standard of practice to develop an implement effective systems to identify and develop interventions for patients who were at nutritional risk (American Dietetic Association).

Based on interview and document review the hospital failed to ensure effective maintenance of the physical plant as evidenced by:

1. Lack of a comprehensive meal plan and the inability of the hospital to demonstrate inventories of food that would be utilized in a disaster and,

2. Effective maintenance of food storage equipment (Cross Reference A701).

The cumulative effect of these systemic problems resulted in the hospital's failure to meet statutorily mandated compliance with the Condition of Participation for Physical Environment (Cross Reference A701).

Based on dietary staff observations, dietary and administrative staff interview, and administrative document review, the hospital failed to ensure dietetic equipment was effectively maintained. The hospital also failed to ensure the development of an effective plan for meal delivery in the event of a widespread disaster. Failure to effectively maintain equipment may result in cross contamination of patient food or put patient foods at risk for bacterial growth associated with foodborne illness. Foodborne illness may further compromise clinical status and in severe instances may result in death. Failure to develop an appropriate plan for dietetic services in a disaster may result in the inability of the hospital to provide safe and adequate food and water, further compromising patients' clinical status.

Findings:

1. During initial tour on 1/24/11 at 2:35 p.m., in the walk-in refrigerator a dark brown smudge resembling rust was observed on the seams of the ceiling above the door. There was also an area on the lower right wall where the tile was removed and covered with duct tape. There was a sign taped to a food storage rack dated 10/1/10 that advised staff that the refrigerator was leaking. In a concurrent interview, DS NN stated that in October the ceiling of the unit began leaking water. Engineering services was notified and was working on the problem.

In an interview on 1/27/11 at 9:20 a.m., AS M was asked to describe the status of the repair for the leaking unit. He stated that his first documented communication from engineering was 11/9/10, at which time the hospital obtained a quote for repair of the unit. The hospital determined that they would need to contact the Office of Statewide Health Planning and Development (OSHPD) for review. Documentation dated 12/16/11 revealed that hospital staff was planning for a rebuild of the unit in January 2011 (3 months after the problem was identified). AS M stated that once the hospital clarified with OSHPD that state approval was not required they decided to wait until after the holiday season. As of 1/27/11 there was no documentation that the hospital secured necessary repair of dietary equipment in a timely manner.

2. During initial tour on 1/24/11 at 3:30 p.m., on the loading dock there was a 3-door refrigerator and freezer. In the freezer there was a build up of ice along the back wall, estimated to be approximately ?" - 1" thick resulting in food products being encased in a layer of ice estimated at ?" thick. Additionally, it was noted that the gaskets on the freezer unit were hard.

3. On 1/26/11 at 4 p.m., the plan for disaster feeding was reviewed. In a concurrent interview, AS D stated that he had a written disaster plan. Review of the disaster plan revealed that while there was a basic meal pattern consisting of categories of foods to be served, there was no defined menu for regular or therapeutic diets, nor was there any guidance for food preparation or portions to be served. It was also noted that the disaster plan was specific to the main hospital campus. There was no guidance for meal service at the satellite campus. Review of disaster meal planning on 1/25/11 at 9:25 a.m., revealed there was no food production equipment or emergency food supplies located at the satellite campus which was located several blocks away.

In a follow up interview on 1/27/11 at 9:30 a.m., AS D stated he was unable to complete an inventory of the food supply that would be utilized as well as the number of servings that would be available and that the only inventory he had was several years old and was likely not current. He also acknowledged that while there were basic guidelines there was not a comprehensive plan for the provision of dietetic services in an emergency. Additionally, AS D acknowledged that there was no food production equipment and no emergency disaster supplies located at the satellite campus.

4. During review of disaster preparedness on 1/27/11 at 9 a.m., the hospital's disaster plan for the provision of water in an emergency was reviewed. In a concurrent interview MS N stated that the hospital had two-6,000 gallon water tanks that would be utilized in the event that the domestic water supply was interrupted. He stated that each of the tanks was equipped with pumps that were wired to the hospitals' generator. The tanks were connected with approximately 30 feet of underground piping, but he was unsure if the installation of the water system was approved by OSHPD. He was unsure if this system for emergency water would hold up in the event of an earthquake. When asked if this was the only supply for emergency water, he replied that it was. The hospital was unable to demonstrate that this integrity of the water supply could be maintained during a widespread disaster.

5. Review on 1/26/11 at 3:30 p.m. of the nutrition pantry on 3-main nursing unit revealed that there was a brown-black material on the water trough of the ice machine. It was also noted there was a build up of ice on the freezer door that extended around the opening of the door as well as along the back wall.

Based on observation, staff interview, medical record review, and document review the hospital failed to provide a sanitary environment by failing to ensure that:

1. The surface of gel positioning pads were intact (Refer to A 748, item 1).

2. Single use items were only used for one patient (Refer to A 748, item 2).

3. The hospital's influenza vaccination policy and procedure was fully implemented (Refer to A 748, item 3).

4. The hospital's surgical attire policy and procedure was implemented in all areas where surgical procedures were performed (Refer to A 951, item 1).

5. All areas where surgery was performed were clean and sanitary in accordance with national standards of practice (Refer to A 951, item 2).

6. The hourly air exchange rate in all areas where surgery was preformed met national recommendations (Refer to A 951, item, 3).

7. Surgical masks were only worn for one surgical procedure and discarded (Refer to A 951, item 4).

8. Surgical masks were worn when surgical procedures were performed and when sterile supplies and equipment were open (Refer to A 951, item 5).

9. Alcohol pads that had been recalled were removed from all patient care areas. (Refer to A 748, item 4)

10. Dietetic Services were delivered safely and effectively. (refer to A 749)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure patient care was provided in a sanitary environment.

Based on observation and interview, the hospital failed to develop and/or implement policy and procedures that ensured that: 1. The surfaces of gel positioning pads were intact and could be disinfected between patients, 2. Single use items were used for one patient and then discarded , 3. During flu season medical staff and allied professionals who did not receive the flu vaccination wore masks while providing patient care, and 4. Alcohol pads that had been recalled were removed from all patient care areas including the neonatal intensive care unit. These failures could result in patients being exposed to bacterial/viral cross contamination.

Findings:

1. On 1/25/11 at 2 p.m., a tour was conducted of the North Coast outpatient surgery area. During the tour the equipment and supply storage area was inspected. During the inspection gel pads (gelatinous pads used to position patients during surgery to prevent pressure ulcers), were observed sitting on a shelf. It was noted that the exterior surfaces of four of the gel pads were cracked and the gelatinous contents were exposed to air.

During a concurrent interview, Staff II was asked about the process for cleaning the gel positioning pads. Staff II stated that the gel positioning pads were disinfected between patients using the hospital approved disinfectant. When asked if the cracked surfaces of the gel positioning pads would interfere with the disinfection process, Staff II replied yes, she thought the cracked surfaces would interfere with disinfecting the positioning gel pads. Staff II was asked if the outpatient surgery center had a policy and procedure for cleaning the gel positioning pads, she replied, "not to my knowledge."

On 1/25/11 at 5 p.m., the 2011, AORN (Association of periOperative Registered Nurses), Perioperative Standards and Recommended Practices was reviewed. On page 339, under Recommendation III, under item III.b., AORN recommended that, "Surfaces of positioning and transporting equipment should be smooth and intact. Loss of equipment surface integrity can result in bacterial growth. Surfaces that hold moisture or wrinkle contribute to skin breakdown."

2. On 1/25/11 at 2 p.m., a tour was conducted of the North Coast outpatient surgery area. During the tour the equipment and supply storage area was inspected. During the inspection, 10 pressure bags (devices that are pumped or inflated to rapidly infuse intravenous fluids or to maintain the pressure of intravenous fluids), were observed hanging from a hook in the storage room. Inspection of the pressure devices revealed that the pressure bags were stamped, "For infection control purpose, recommended for single patient use" by the manufacturer. It was noted that there were 10 pressure bags, hanging on the hook, that were available for patient use.

During a concurrent interview, Staff II was asked if she was aware that the pressure bags were for single patient use? Staff II stated that she was not aware that the pressure bags were manufactured for single patient use.

3. On 1/26/11 at 4 p.m., a request was made to review the number of medical staff members and allied health professionals (mid wife, nurse practitioners, and physician assistants) who had been vaccinated against influenza.

During an interview on 1/27/11 at 9:50 a.m., Staff K, stated that no one tracked influenza for members of the medical staff or allied health professionals. Staff K stated that until the past 18 months or so, tracking of influenza for medical staff members and allied health professionals was non existent. Staff K also stated that if medical staff members or allied health professional had received the influenza vaccine, they would wear a yellow seal on their name badge or they would wear a surgical mask when providing direct patient care. Staff K was informed that no medical staff members or allied health professional were observed wearing the yellow tag on their name badges (other that Staff K), or wearing a surgical mask during the survey. Staff K repeated that if they hadn't received the influenza vaccination they were to wear a surgical mask when providing direct patient care.

On 1/27/11 at 10:15 a.m., the hospital's 1/2011 policy and procedure titled, "Influenza vaccination and patient safety" was reviewed. Documented on page 4 of the policy and procedure, under the section titled, "Physician management" item B, direction was that physicians who do not have an identifying marker available during their shift will contact the medical staff office to get a one day sticker or wear a surgical mask while providing patient care. Under item C, direction was that, "Physicians who choose not to be vaccinated will wear the required surgical mask while in a building in which patient care is rendered .....during the influenza season." On page 4 of the policy and procedure, under item E, direction was given that, "Those physicians who do not comply with the requirement to wear a surgical mask while providing direct patient care as stated above, will be subject to the medical staff disciplinary process."




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4. Observation of the Newborn Intensive Care Unit (NICU), on 1/25/11 at 3 p.m., revealed that recalled medical supplies(specifically Cardinal Health alcohol prep pads) were available to staff for use in three (3) isolette bases (furniture with drawers used for supplies and on which a newborn baby's incubator is placed) as follows:

The first base contained 2 alcohol prep pads by Cardinal Health.

A second base contained 33 alcohol prep pads by Cardinal Health.

A third base contained 20 alcohol prep pads by Cardinal Health.

Further observation of the NICU revealed 2 alcohol prep pads by Cardinal Health in a drawer near the isolette bases and 20 alcohol prep pads by Cardinal Health in an IV supply bag. Administrative Staff K stated during a concurrent interview that the supply bag was used for Cesarean Sections.

Another NICU supply bag contained 14 alcohol prep pads by Cardinal Health and 16 alcohol prep pads by Cardinal Health were observed in a third bag. Administrative Staff K, who was present during the observation, stated that the third bag was used for emergencies that involved vaginal births.

Observation of the Labor and Delivery nursing station, on 1/25/11 at 3:20 p.m., revealed a mobile stainless steel cart that was used to store blood pressure cuffs. The cart contained 3 alcohol prep pads by Cardinal Health in a drawer.

Observation of Labor and Delivery Room # 1113, on 1/25/11 at 3:30 p.m., revealed 10 alcohol prep pads by Cardinal Health in a supply drawer.

Observation of the Medical Surgical Unit, on 1/25/11 at 4 p.m., revealed that Presource Custom sterile dressing change packages, Version C, 03-1739C were available for staff use. The packages contained the recalled product: (1) swabstick alcohol 70% by Cardinal Health.

Administrative Staff G stated during an interview, on 1/27/11 at 5:15 p.m., that the facility had not determined the number of the sterile dressing packages, that contained the recalled products, that were still available for staff use.

On January 5, 2011 the United States Food and Drug Administration (FDA) published a firm press release which directed a nationwide recall of all lots of alcohol prep pads, alcohol swabs and alcohol swabsticks due to potential microbial contamination involving product manufacturers including Cardinal Health. The recall cited potential contamination of the products with Bacillus cereus which had the potential to cause illness in humans.

Administrative Staff F stated during an interview, on 1/26/11 at 2:45 p.m., that all hospital units had been notified of the recall and were instructed to remove all specified products from use.

Review of written documentation requested from administrative staff, on 1/25/11, how the hospital units were notified was obtained on 1/26/11 and included the following:

Written communication from Administrative Staff M addressed to various recipients including nursing leadership dated, 1/10/11 at 2:09 p.m., instructing for the removal of all recalled products from all areas to ensure the products were not accessible for staff use. Administrative Staff L was assigned to monitor the process and provide updates as needed.

Administrative Staff L stated during an interview, on 1/26/11 at 2:05 p.m., that she had not been aware that the recalled products were still available for staff use prior to the surveyor's observations which were communicated to her by hospital staff.

Based on foodservice observations, dietary and administrative staff interview, and dietary document review, the hospital failed to ensure dietetic services were delivered safely and effectively as evidenced by, 1. Lack of effective cooldown monitoring of potentially hazardous foods, 2. Storage, preparation and distribution of foods in a manner that did not prevent cross contamination, 3. lack of effective handwashing, 4. Lack of effective sanitation of hospital ice machines, 5. Storage of chemicals in food production areas, 6. Storage of wet beverage containers, 7. Lack of effective hair restraints, 8. Storage of employee beverage containers in kitchen areas and, 9. Cross contamination of clean dishes.

Main Campus

During initial tour beginning on 1/24/11 at 2:15 p.m., it was noted there were numerous previously cooked foods in the walk-in refrigerator and walk-in freezer. The refrigerator contained items such as beef barley soup and lasagna. The freezer contained items such as refried beans, spicy chicken meat, pasta; meat based marinara sauce, lemon chicken and 3 containers of cooked pork, all with different production dates.

In an interview on 1/25/11 at 3:30 p.m., with DS UU she was asked to describe the processing of leftover foods. She stated that if a significant quantity of a hot item was leftover after the evening patient tray line or cafeteria meal the process would be to place it in the freezer to cool down. She also stated the parameters for cooldown would be from 135?F-70?F within 2 hours and to 41?F within an additional 4 hours and that the process would be recorded in the log.

Review of hospital document in the presence of Dietary Staff NN (DS NN) and Administrative Staff D (AS D) titled, "Cool-Down Temp Recording Sheet" starting on 9/26/10 revealed that 11 of the 15 items did not have any recorded cooldown temperatures. Additional review of the cooldown log revealed that a pasta dish prepared on 12/30/10 ; lemon chicken prepared on 11/30/10 or cooked pork prepared on 9/30; 12/10 and 12/30/10 respectively were recorded on the cooldown log. In a concurrent interview with AS D, he stated that since the hot items were placed in the freezer he did not guide staff to monitor temperatures because they were usually frozen by the next morning, at which time they would be labeled and covered. It was also noted that the form guided staff that, "foods must cool down fast enough to achieve 70 degrees F or less within the first 2 hours ..." There was no documentation that the facility effectively monitored the cooldown of potentially hazardous foods (PHF). PHF's are those foods capable of supporting bacterial growth associated with foodborne illness and require monitoring for time/temperature control (Food Code, 2009).

In an interview on 1/27/11 beginning at 8:50 a.m., with Administrative Staff J (AS J) she was asked to describe the environment of care process in relationship to the dietary department. She stated the rounds reviewed elements such dishwashing and refrigerator temperatures, labeling/dating of food items and handwashing. She also stated that there was no evaluation of food production activities and that the employees participating on the environment of care rounds would rely on the Director of the department as being the expert in the field to identify systems problems within the department.

In the interior walk-in freezer there was soup, identified by DS NN as white bean soup, undated and uncovered. It was also noted that there was a pan that contained sliced, cooked meat which was identified by DS NN as pork that was sitting directly underneath the blower, uncovered. It was also noted that drops of clear fluid, dripping from the blower, fell directly onto the uncovered meat.

In an interview on 1/24/11 beginning at 3 p.m., with AS D he stated that their procedure for cooling hot foods was to place them in the freezer uncovered then cover and date them the following day.

Hospital guidance titled, "Dating Potentially Hazardous Food" dated 4/23/07, guided staff that, "All perishable products are covered or closed in ...frozen ...areas."

During review of the dish washing process on 1/25/11 at 8:50 a.m., Dietary Staff DS (DS QQ) was entering the dish room with soiled trays. Upon entering the dish area DS QQ was observed using a hand sanitizer after which he began handling cleaned, sanitize dishes. In an interview on 1/25/11 at 9:10 a.m., with DS QQ he stated that he uses the hand sanitizer when he comes back to the work area from collecting the soiled trays or when he returns from the patient pantry areas.

Concurrent review of the manufacturers' guidance for the product revealed that the intent of the hand sanitizer gel was, "to supplement routine handwashing." Review of hospital dishwashing policy dated 8/2010, revealed the policy was limited to the functional elements such as checking temperatures/chemicals rather than the full dishwashing procedure. The undated hospital procedure titled, "Handwashing" revealed that while the policy guided staff on handwashing procedures, it did not provide guidance when handwashing would be required. Review of hospital guidance dated 11/30/10 titled, "Sanitation Regulations" revealed that hands must be washed, "before handling clean food or dishware ..."

In an interview on 1/25/11 at 4 p.m., with AS D and concurrent document review of dietary staff training records revealed that in 8/2010 an in-service for handwashing and processing dishware was conducted. AS D stated that dietary staff was asked to review guidelines for the 2 topics and sign an attestation that they understood and will follow the procedures. There was no system in place to ensure that staff was competent in the procedures on the attestation. In an interview on 1/27/11 beginning at 8:50 a.m., with AS J she stated that she had done in-service with dietary staff on glove use, in particular the standard changing gloves and handwashing when there was a break in tasks.

On 1/25/11 at 3 p.m., ice machine maintenance was reviewed with Maintenance Staff (MS O). It was noted that there was a pink slimy substance on the ice deflector inside the ice bin. In a concurrent interview with MS O he stated that it was probably a type of mildew. The surveyor asked him to describe the internal maintenance of the machine. He stated that once each year the ice producing mechanism was sanitized by running a chemical through it. He further stated that he did not do any maintenance on the interior of the bin. It was also noted that the ice machine was plumbed directly into the wastewater system.

In a similar interview on 1/26/11 at 9:25 a.m., with Maintenance Staff P (MS P) at the Satellite Hospital site he was asked to describe the maintenance for the ice machines at that location. He described an identical process of maintenance as MS O. It was also noted that there was a build up of a white, hard substance on the ice machine tray as well as a build up of dust on the interior ice production area of the machine as well as the exterior back and front panels of the machine.

Observation on 1/26/11 at 10:20 a.m., at the outpatient surgery center it was noted the ice machine drain system was connected inside a black plastic pipe. It was also noted that when the drain system from the ice machine was pulled from inside the black plastic pipe it was covered with a black slime type substance. There was no observed air gap installed in the system.

On 1/27/11 at 9 a.m., Maintenance Staff N (MS N) provided the chemical used on the machines. The chemical was labeled as an ice machine cleaner, not a sanitizer. Review of hospital document titled, "Preventive Maintenance Procedure Form" guided staff on 3 preventive maintenance levels and 1 safety procedure. Neither of the 4 levels included comprehensive guidance for cleaning/sanitizing of the machine. Additional hospital document titled, "Test Procedure Document-Ice Machine" dated 1/25/11, provided a step by step guide to de-lime the interior of the machine as well as guidance for sanitation. It was noted that the sanitation of the ice machine was limited to the ice holding bin of the machine and exterior surfaces. Review of the hospital inventory of ice machines dated 1/25/11 revealed there were a total of 4 different manufacturers, totaling 22 ice machines between the 2 hospital campuses. In an interview on 1/27/11 beginning at 8:50 a.m., with AS J she stated she was unaware that ice machines were not being sanitized during preventive maintenance.

Manufacturers' guidance for one the Manitowoc brand of machines outlined procedures to clean, sanitize and de-scale the ice machine on a semi-annual basis. The guidance also required both a de-scaling solution as well as a sanitizing solution to be run through the internal components of the machine. Manufacturers' guidance as well as the standard of practice require that ice machines be installed with air gaps (Food Code, 2009).

Food handling practices in the cafeteria were reviewed on 1/24/11 at 4 p.m. In a concurrent interview with Dietary Staff PP (DS PP) she was asked to provide a general description of the observed salad bar. She stated the cafeteria was in operation from 6:30 a.m. to 7:30 p.m. She also stated that at the end of the day she would reuse salad bar items such as pickles, onion, and the tomatoes. DS PP stated that when an item was running low she would replenish it by placing a new supply of the item on the bottom and placing the previous supply on top of it so it would be used first. It was also noted that at the deli bar there was a jar of mustard that was opened with no serving utensil.

In a concurrent interview AS D stated that this was the normal service for mustard and that any leftovers would be used on following days. It would be the standard of practice to ensure that if items are not hermetically sealed that in-use utensils be provided. It would also be the standard of practice to ensure foods, such as those found on a salad bar not be re-served (Food Code, 2009).

During observation of food production activities on 1/25/11 beginning at 9:40 a.m., with Dietary Staff RR (DS RR) she was observed preparing nourishments with gloves on. She was observed answering the phone, changing gloves, and then returning to food production activities, she did not wash her hands. In an interview on 1/25/11 at 10:30 a.m., DS RR acknowledged that she did not wash her hands prior to re-gloving. Hospital guidance titled, "Sanitation Regulations" dated 11/10/10 guided staff that, "Before handling clean food or dishware, hands are to be re-washed."

During observation on 1/25/11 at 12:05 p.m., of patient meal delivery services it was noted that dietary staff would deliver the meal carts to a central location on the unit. Nursing staff would remove the meal tray from the cart that contained uncovered food items, walk down the hall to the patient rooms, which in some instances was estimated by the surveyor as 200-300 feet. It was also observed that nursing staff delivered a tray to a patient whose urinal was on the overbed table. In an interview on 1/27/11 beginning at 8:50 a.m., Administrative Staff J acknowledged storage of urinals on overbed tables may promote cross contamination of meal trays as well as other activities. She also stated urinals should not be stored on overbed tables. In an interview on 1/27/11 at 9:30 a.m., with AS D he acknowledged he was aware of the delivery of the meal cart to a central location; however had not evaluated the delivery of uncovered items to patient rooms. The standard of practice would be to ensure the meal delivery process was implemented in a manner to prevent potential cross contamination (Food Code, 2009).

During initial tour on 1/24/11 at 2:35 p.m., in the catering area dietary staff was storing cleaning products in the area where fresh produce was stored. Review on 1/27/11 at 10 a.m., of the dietary department policy and procedure manual revealed there was no policy that addressed storage of chemicals. The departmental policy titled, "Avoiding Food Contamination," revised 8/10, guided staff that, "...cleaning products ...are stored separately from foods..." It would be the standard of practice to ensure that chemicals are not stored near food (Food Code, 2009). In a follow up interview on 1/27/11 at 11:30 a.m., AS D stated the referenced policy was the only one that addressed food contamination and that it did not address chemical storage.

It was also noted that in the catering area dietary staff was storing clothing and an umbrella directly adjacent to canned items. In an interview on 1/24/11 at 3:15 p.m., AS D stated that he was unsure why the clothing items were stored there but he believed that staff used these items to bring patient foods in from the outside food storage area. It would be the standard of practice to store personal clothing items away from food storage/production areas (Food Code, 2009). Hospital environment of care rounds dated 8/2/10 noted that the hospital identified the deficient practice or storing chemicals near foodstuffs as an issue.

During initial tour on 1/24/11 beginning at 2:35 p.m., in the catering area it was noted that there were stored beverage carafes that were wet inside. In an interview on 1/24/11 at 3:30 p.m., DS NN stated that these items were used every several days. He acknowledged that the items were washed and were put on the shelves upright and sealed for storage. He also stated the items should have been thoroughly dried prior to storage. Storing wet dishware, may result in bacterial growth which may be of particular concern when providing foodservice to patients who are immunocompromised (Journal of the American Dietetic Association, 2001).

During initial tour on 1/24/11 at 2:35 p.m., the sink in the catering production area as well as the manual dishwashing sink did not have fully functional air gaps. An air gap is designed to prevent waste water from flowing backwards from the plumbing fixture, equipment and non-food equipment (Food Code, 2009). While it was noted that the catering food production sink had a waste water pipe that discharged into a floor sink, the end of the pipe was situation below the flood rim level of the floor sink, rather than above the flood level. It was also noted that the dishware washing sink directly plumbed into the waste water system.

In a concurrent interview on 1/24/11 at 3:15 p.m., AS D acknowledged he was unaware of the necessity for effective air gaps within the department.

Review on 1/24/11 at 3:30 p.m., of food storage on the loading dock revealed there was a refrigerator that contained cheese and salad dressings. It was also noted that there were mosquitoes in the area. When the door was opened a mosquito flew into the refrigerator. There was no mechanism to ensure that foods stored outside of the kitchen area were free from pest cross contamination. In the outdoor walk-in freezer there were chicken enchiladas, pot stickers, and chicken breast, all of which were opened and undated.

During general food production observations on 1/25/11 at 9:20 a.m., dietary staff was storing measuring scoops in an opened cans of fiber and protein supplement. In a concurrent interview, AS D acknowledged this was the normal process for storage of scoops in these products and thought that since the scoop came with the product it was acceptable. Hospital policy titled, "Avoiding Food Contamination" revised 8/10, revealed there was no staff guidance for the proper storage of scoops. The standard of practice would be to remove utensils such as scoops to prevent potential cross contamination (Food Code, 2009).

During initial kitchen tour on 1/24/11 at 2:35 p.m., there were several areas throughout the kitchen that had wall mounted beverage holders. In a follow up observation on 1/25/11 at 8:50 a.m., Dietary Staff OO (DS OO) was observed pushing a meal cart into the dishroom. It was also noted that while he was pushing the cart he was drinking a beverage.

In an interview on 1/24/11 at 4:30 p.m., AS D stated he allowed employees to drink beverages in food areas in order to maintain hydration. In an interview on 1/27/11, AS J, who was responsible for the environment of care rounds within the hospital, stated that she had not noticed any of the beverage holders. Hospital policy titled, "Avoiding Food Contamination" revised 8/10, revealed that beverage containers must at all times be in the employee's hand or the wall mounted holder. It was also noted that the policy permitted staff to drink fluids in the kitchen while abiding by sanitation principles..." The standard of practice would be to allow staff to drink only in designated areas where contamination of areas/equipment/food would not be possible (Food Code, 2009).

On 1/24/11 at 2:35 p.m., several staff members were not wearing full hair coverings while in food production areas, rather wore visors. In an interview on 1/25/11 at 9 a.m., AS D stated that he was using another states guidelines for hair restraints as a basis. In an interview on 1/27/11 at 9 a.m., Administrative Staff J, an infection control preventionist responsible for environment of care rounds, was asked whether or not she identified the use of visors in place of hair restraints as an issue She replied she was aware of the practice, however had not identified it as an issue.

Hospital policy titled, "Avoiding Food Contamination" dated 8/10, noted that it was the expectation that employees wear hairnets, or approved head coverings ...during food production..." The standard of practice would ensure that all staff wears hair restraints that are designed and effectively worn to restrain hair (Food Code, 2009).

During general kitchen observation on 1/24/11 at 4:30 p.m., DS OO was observed placing a tub of clean/sanitized dishes on the floor in the dessert preparation area. After he stacked the dishes he placed the tubs in the cleaned/sanitized dishwashing area for re-use. The tubs which were on the floor were not rewashed prior to putting them back into service.

Based on observation, interview, and document review, the hospital failed to ensure that surgical services were provided in accordance with acceptable standards of practices as evidenced by:

1. Failure to ensure that the hospital's surgical attire policy and procedure was implemented in all areas where surgical procedures were performed. (Refer to A 951, item 1)

2. Failure to ensure that all areas where surgery was performed were clean and sanitary in accordance with national standards of practice. (Refer to A 951, item 2)

3. Failure to ensure that the hourly air exchange rate in all areas where surgery was performed met national recommendations. (Refer to A 951, item, 3)

4. Failure to ensure that surgical masks were only worn for one surgical procedure and discarded. (Refer to A 951, item 4)

5. Failure to ensure that surgical masks were worn when surgical procedures were performed and when sterile supplies and equipment were open. (Refer to A 951, item 5)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure surgical services were provided in a sanitary environment.

Based on observation, interview, and document review, the hospital failed to ensure that surgical care was designed to assure the achievement and maintenance of high standards of medical practice and patient care by failing to ensure that: 1. Hospital staff followed guidelines for surgical attire and wearing of masks in the surgical suite and during procedures, 2. All areas within the surgical suite were cleaned and disinfected, 3. Air flow patterns within the surgical services area were functioning effectively. These problems created the potential for surgical patients to be exposed to microorganisms and to develop post operative surgical site infections.

Findings:

1. On 1/26/11 at 10 a.m., a tour was conducted of the women's services department.
During a concurrent interview, Administrative Staff E stated that Patient 300 was going to surgery for an emergency Caesarean section (surgical incision used to deliver infant).

On 11/26/11 at 11:20 p.m., a tour was conducted of the surgical suite located inside the women's services department. During the tour, an inspection of the surgical services area was conducted. During an inspection of the restricted area, a surgical viewing window was observed. Through the viewing window it was noted that Patient 300's emergency surgical procedure was in progress. During observations of the surgical procedure, a female wearing jeans and a tee shirt was observed walking into the restricted surgical area. It was noted that Staff HH opened the door to the surgical suite, and stuck her head inside the surgical suite.

Administrative Staff E informed Staff HH, that the area was restricted and surgery was in progress. Administrative Staff also informed Staff HH that surgical attire including hair covering and surgical mask was required. Staff HH replied that the surgeon had called and wanted to talk to her. Administrative Staff E again informed Staff HH, that the area was restricted, surgical attire was required, and hair covering and a surgical mask was required. Staff HH was observed leaving the restricted surgical area.

During the unit observation on 1/26/11 at 12:40 p.m., a medication / procedure cart was stored in the restricted area outside the surgical suite. During concurrent interview, Administrative Staff E stated that the cart contained supplies used to insert an epidural catheter (epidural - a form of anesthesia involving injection of drugs through a catheter placed into the epidural space of the spinal canal), for women in labor.

On 1/26/11 at 3 p.m., during an interview with Administrative Staff F and Staff JJ, Staff JJ confirmed that registered nurses working in department entered the restricted surgery area, wearing street clothes, to access the cart containing the epidural supplies.

On 1/26/11 at 3 p.m., the hospital's 10/10 policy and procedure titled, "Surgical attire" was reviewed. On page 1, under the policy section direction was, "All individuals who enter the semi restricted and restricted areas of the surgical suite should wear freshly laundered surgical attire intended for use only within the surgical suite. On page 2, under the section titled, "Proper attire in Semi-restricted and Restricted areas" item 1, direction was, "Hair must be contained in a cap. If a cloth cap is worn it must be covered with a disposable cap." Under item 3, direction was given that, "masks are required in the restricted areas of the OR suite when opening sterile supplies..."

On 1/26/11 at 5 p.m., the 2011, AORN (Association of periOperative Registered Nurses), Perioperative Standards and Recommended Practices was reviewed. On page 95, under item 1, the restricted surgical area is defined as, "The restricted area includes ORs, procedure rooms, and the clean core area. Surgical attire and hair coverings are required. Masks are required where open sterile supplies or scrubbed persons are located . All persons entering the restricted area should follow the AORN "Recommended practices for surgical attire.""

On 1/24/11 at 2:45 p.m., during the initial tour of the emergency department, two female staff were observed wearing surgical attire. It was noted that the two staff were wearing surgical masks that were pulled down under their chins. During a concurrent interview, Administrative Staff J, identified the two staff as surgical services personnel. Staff J stated they were taking an emergency department patient to surgery.

On 1/25/11 at 11 a.m., an initial tour was conducted of the North Coast outpatient surgery area. During the initial tour, a female wearing surgical attire was observed in the sterile core hallway. It was noted that the female was wearing a surgical mask that was pulled down under her chin. During a concurrent interview, Administrative Staff K identified the female as a circulating nurse. Administrative Staff K stated that the circulating nurse had assisted with a surgical procedure that was completed earlier. During the concurrent interview, a second female, identified as the sterile processing technician, was observed walking in the sterile core hallway, wearing a surgical mask and it was pulled down under her chin.


On 1/26/11 at 9:30 a.m., two male staff members were observed outside the sterile processing area wearing surgical masks that were pulled down under their chins. During an interview on 1/26/11 at 10 a.m., Administrative Staff E stated that it was hospital policy that surgical masks be removed, and not saved for later use when leaving the surgical suite or the sterile processing area.


On 1/26/11 at 2 p.m., the hospital's 10/10 policy and procedure titled, "Surgical attire" was reviewed. On page 2 of the policy and procedure, under item 3, OR staff were directed, "Masks are changed between cases and as needed due to wetness or contamination and must be removed before leaving the department. Masks may be removed in the operating room after competition of the surgical procedure."


On 1/26/11 at 5 p.m., the 2011, AORN (Association of periOperative Registered Nurses), Perioperative Standards and Recommended Practices was reviewed. On page 65, under Recommendation VI, AORN recommends under item V.I.b., that, "A fresh surgical mask should be worn for every procedure." Under recommendation VI.b.1., "Masks should not be worn hanging down from the neck." Under Recommendation VI.c., "Surgical masks should be discarded after each procedure. Masks should be removed carefully by handling on the mask ties."


On 1/26/11 at 2 p.m., the hospital's 10/10 policy and procedure titled, "Surgical attire" was reviewed. On page 2 of the policy and procedure, under item 3, OR staff were directed that, "Masks may not be required for non invasive procedures such as dental, cystoscopy, etc."


On 1/26/11 at 4 p.m., an interview was conducted with Administrative Staff E. Administrative Staff E was asked to clarify the, "Surgical attire" policy and procedure indicating that surgical masks were not required during dental, and cystoscopy procedures. Administrative Staff E stated that urologists (physicians specializing in diseases of the urinary system), dentists, and pain management physicians (physicians performing invasive procedures for chronic pain relief), had requested and approved that surgical masks were not required when performing these procedures. When asked if these procedures were performed in operating rooms, and were sterile supplies opened during these procedures, Administrative Staff E replied, "Yes." Administrative Staff E was asked if she was aware of the CMS (Centers for Medicare and Medicaid Services), definition of what constitutes surgery? Administrative Staff E responded, "I think so."


On 1/26/11 at 4:30 p.m., Administrative Staff E was read the Interpretative Guidelines for Federal Code of Regulations ? 482.51, that defines "Surgery is performed for the purpose of structurally altering the human body by the incision or destruction of tissues and is part of the practice of medicine. Surgery also is the diagnosis or therapeutic treatment of conditions or disease processes by any instruments causing localized alteration or transposition of live human tissue which includes lasers, ultrasound, ionizing radiation, scalpels, probes, and needles. The tissue can be cut, burned, vaporized, frozen, sutured, probed, or manipulated by closed reductions for major dislocations or fractures, or otherwise altered by mechanical, thermal, light-based, electromagnetic, or chemical means. Injection of diagnostic or therapeutic substances into body cavities, internal organs, joints, sensory organs, and the central nervous system....." When asked if dental, cystoscopy, or pain management procedures would be considered surgery according to the CMS definition, Administrative Staff E, replied, "Yes, they would."


On 1/26/11 at 5 p.m., the 2011, AORN (Association of periOperative Registered Nurses), Perioperative Standards and Recommended Practices was reviewed. On page 65, under Recommendation VI, AORN recommends that, "All individuals entering the restricted areas should wear a surgical mask when open sterile supplies and equipment is present. A surgical mask protects both the surgical team and the patient from transfer of microorganisms."



2. On 1/25/11 at 2 p.m., a tour was conducted of the North Coast Surgery Center. During the tour the following was noted:
Operating Room (OR) 3:
Personal pictures of children and animals were scotch taped to the wall of the surgical suite.
White cloth (non surgical attire), was hanging over a metal bar located under the X-ray view box.
Three lead aprons (used to protect staff when X-ray equipment is used), were draped over a stool, over a metal bar of the fluoroscopy machine (an imaging technique commonly used by physicians to obtain real-time moving images of the internal structures of a patient through the use of a fluoroscope), and over the OR table.
Surfaces such as medication carts, metal tables, OR table, monitoring equipment, OR light, fluoroscopy machine, and a cabinet used to hold video equipment were covered with a white dusty film.
Extra patient care equipment and some card board boxes being stored in OR 3 had to be moved before staff could walk around the OR suite.

Operating Room 4:
Four miniature figurines sitting on top of the X-ray view box. Staff II stated that figurines belonged to MD I, and that he placed them on the X-ray view box.
Work surfaces such as anesthesia machine, medication carts, metal tables, OR table, OR light were covered with a white dusty film.

Sterile Processing Room:
The counter where clean instruments are wrapped and prepared for sterilization were covered with a white dusty film.
The computer key board was covered with a thick white film. When the computer key board was lifted up, a small ant was observed walking across the counter where clean instruments were stored before being wrapped for sterilization.

During a concurrent interview, Administrative Staff E and II confirmed that they had seen the ant that walked across the work station counter in the sterile processing room.

Sterile Core Hallway:
Shelf above the scrub sink was covered with a white dusty film.
Patient care supplies were being stored in cardboard boxes on the floor of the sterile core hallway.

During a concurrent interview, Staff II was asked if a housekeeper was assigned to the surgery center. Staff II stated that the surgery center was cleaned every night by an outside janitorial service.

On 1/25/11 at 4 p.m., the contract for the company who was providing terminal cleaning for the surgery center was reviewed and indicated that the contractual agreement went into effect 2/2/07. Additional documentation in the contractual agreement disclosed that the company was providing services for the public areas of the surgery center, but not the restricted surgical areas.

On 1/26/11 at 9, a.m., during an interview, Administrative Staff E confirmed that the janitorial service did not clean the restricted surgery areas. Administrative Staff E stated that nursing staff were responsible for cleaning the restricted surgery areas. Administrative Staff E also stated that the surgery center did not have a policy and procedure explaining the frequency and process to follow when cleaning the surfaces and equipment within the surgical suite.

On 1/26/11 at 5 p.m., the 2011, AORN (Association of periOperative Registered Nurses), Perioperative Standards and Recommended Practices was reviewed. On page 241, under Recommendation IV, AORN recommended that, "Surgical and invasive procedure rooms and scrub/utility areas should be terminally cleaned daily. Additional direction under the recommendation was that terminal cleaning should be done when scheduled procedures are completed for the day, and every 24-hour period during the regular work week. On page 247, under Recommendation X, AORN, recommended that, "Policies and procedures establish authority, responsibility, and accountability and serve as operational guidelines. Policies and procedures also assist in the development of patient safety, quality assessment, and improvement activities..... Item X.a., define that policies and procedures for environmental cleaning and disinfectant should include, but not be limited to, identification of responsible personnel; competency validation; standard disinfection procedures; frequency of cleaning and disinfection procedures; chemicals approved for use..."

3. On 1/24/11 at 2 p.m., a request was made for the air exchange reports for all of the surgical services areas. On 1/25/11 at 8 a.m., an air measurement report was provided by plant operations staff. The air measurement report was reviewed and revealed that the report was dated 7/13/10. Documentation in the air measurement report disclosed that OR 2 had 4.88, and OR 4 had 13.79 air exchanges per hour at the North Coast surgery center. The air measurement report did not include the sterile processing or sterile storage areas at North Coast surgery center.

On 1/25/11 at 9 a.m., Staff J confirmed that according to the 7/13/10 air measurement report, OR 2 at North Coast surgery center did not have the necessary number of air exchanges per hour that were required in operating rooms. Staff J also confirmed that the hospital had no evidence that the number of air exchanges had been determined for the sterile processing and sterile storage areas at North Coast surgery center.

On 1/26/11 at 5 p.m., the 2011, AORN (Association of periOperative Registered Nurses), Perioperative Standards and Recommended Practices was reviewed. On page 219, under Recommendation V, item V.d.1., AORN recommended that, "The minimum rate of total air exchanges per hour should be maintained at constant levels as follows. Operating room: minimum of 15 air exchanges per hour with a recommended range of 20 to 25 air exchanges." On page 221, under recommended HVAC (heating ventilation and air condition) settings. For soiled decontamination areas, AORN recommends 10 air exchanges per hour, and sterile storage 4 exchanges per hour.