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Based on observation, review of facility documents and staff interviews, the hospital failed to meet the Condition of Participation for Food and Dietetic services when the hospital failed to ensure that the food and dietetic department was organized in a manner appropriate to the scope and complexity of the food service operations.

Findings:

As a result of the deficient practices identified during March 10, 2014 through March 14, 2014 inspection, the hospital failed to ensure that the department was organized in a manner to ensure that dietary services met the dietary and nutritional needs of all patients by failing to:

1. Provide organized dietetic services as evidenced by findings of unsafe food handling practices and unclear lines of authority for the supervision of the dietary department (Refer to A-0619 and A-0620).

2. Ensure the nutritional needs of patients were met as evidenced by the lack of a nutritional screening and assessment, accurate nutritional analysis of regular and therapeutic menus, menus that were in compliance with nationally recognized practices. (Refer to A-0630).

3. Lack of menus for all physician ordered diets. (Refer to A-0628)

4. Lack of an effective system to ensure that physician ordered diets were followed (Refer to A-0629).

5. Ensure safe and effective food storage/production practices were in effect. (Refer to A-0620).

6. Ensure adequate water supply was on hand for use in an emergency. (Refer to A-0703).

The cumulative effect of these deficient practices increased the risk of a poor health outcome for all hospital patients.

Based on observation, review of hospital documents and staff interviews, the hospital failed to ensure that the food and dietetic services department was properly organized. There was no clear leadership structure in the department due to conflicting roles and responsibilities created as a result of direction given by hospital management. There was inadequate space in the department appropriate to the scope and complexity of the food service operations. These failures had the potential for affecting the Dietary and nutritional needs of all patients admitted to the hospital.

Findings:

The hospital had a registered dietitian (RD) who was also director of nutrition services (DNS) and a dietary services supervisor (DSS). Review of the job description for the RD/DNS showed that she reported to the CEO (Chief Operating Officer). However, during interview on March 11, 2014 at approximately 10:00 AM, she stated she reported to the Director of Pharmacy (DPh). She explained that a change was made about a year earlier and she was asked to report to a new manager, the DPh. She stated she was asked by the new manager to concentrate on only on nutrition services while the DSS managed food service operations.

Although the job description of the RD stated the position was responsible for the supervision of the DSS, the job description for the DSS stated she reported to the DPh and not the RD. There was duplication of responsibilities with no position responsible for the overall food and nutrition department. The job description for DSS states the position is responsible for monitoring food service systems. RD job description states she will oversee the food service department but in practice she does not.

Both job descriptions stated they are responsible for departmental policy and procedures, however, there were several policies and procedures not in place. There was no departmental organizational chart delineating lines of authority. The confusing and conflicting roles in the job description and in practice had resulted in no clear leadership for the department.

On March 10, 2014 at approximately 2:45 PM, a kitchen tour was conducted. Observations showed a cramped space with too many equipment and supplies. The 2-compartment sink had coffee urns on the drain board on the left side and a meat slicer and food mixer on the other side. There was also a garbage disposal unit with three garbage cans stored in front on the sink, thereby prevent access to the sink. This resulted in a space that was not efficient or available to store either dirty or clean dishes.

Next to the hand washing sink were two plastic containers holding clean and dirty towels. When the clean towel container is open, water splashing during hand washing would cross contaminate the towels. There were mobile food carts and racks all over the kitchen and staff was observed constantly moving them around to allow access to the areas of food production. Staff were also overhead telling other staff "I am behind you" to prevent running into them.

Food supplies were stored under sinks exposing them to moisture and other forms of contamination. The drawer of the two compartment sink was blocked by the plate warmer and could not be completely opened. When the kitchen was in full operation, there was inadequate space to walk through the kitchen without having to turn sideways to navigate the maze created with the equipment, supplies and staff.

The only office in the department had two desks for the director and DSS, book shelves and lockers for the staff. The space did not allow for relaxing space for employees when they were on breaks. It did not allow for privacy for the supervisors to conduct day to day business and employee conferences.

The RD stated in an interview of March 11, 2014 at approximately 10:00 AM that there are times she had to stop conducting assessments or accessing information on the electronic medical record system because she was preventing non-authorized staff from being able to view patient medical information. The windows designed for visual supervision of staff is blocked by carts and other equipment.

The dry storage room across the hall was small and was inadequate to hold food supplies. To gain access to the shelves behind the wall, the door had to be closed first in order to fit in the space left between one of the other shelves.

A review of the hospital architectural plans conducted on March 13, 2014, showed the dietetic department had been modified from how it was originally licensed. The staff lockers which were in the supervisor's office were originally designed to be outside of the department. The present dry food storage space was a linen closet and the large freezer/ refrigerator was a smaller piece of equipment. The DNS stated on March 12, 2014 at approximately 9:45 AM, that in addition to patient meals, the kitchen provides meals to the staff, catering for hospital meetings and also has a contract for meals for an elderly nutrition program. This change of space use has contributed to the cramped condition of the department that has affected operation of the department.

Based on observation, review of hospital documents and staff interviews, the hospital failed to ensure that the person in the position of Director of Nutrition Services was granted the authority to manage the daily operations of the food and dietetic services. This failure contributed to a disorganized department affecting the health and safety and nutritional needs of the patients.

Findings:

The hospital had a registered dietitian (RD) who was also director of nutrition services (DNS) and a dietary services supervisor (DSS). Review of the job description for the RD/DNS showed that she reported to the CEO (Chief Operating Officer). However, during interview on March 11, 2014 at approximately 10:00 AM, she stated she reported to the Director of Pharmacy (DPh). She explained that a change was made about a year earlier on reporting channels and was asked to report to the DPh. She was told by her new manager to concentrate on nutrition services while the DSS managed food service operations.

The job description of the RD stated the position was responsible for the supervision of the DSS, the job description for the DSS stated she reported to the DPh and not the RD. There was duplication of responsibilities with no position responsible for the food and nutrition department. The job description for DSS states the position is responsible for monitoring food service systems. RD job description states she will oversee the food service department but in practice does not.

Both job descriptions state they are responsible for departmental policy and procedures. However, there were several policies and procedures not in place. There were no policy on sanitizing buckets, cleaning the blender and food processor, cooking meats (chicken) to preserve nutritive value. There were no menus written and planned in advance for alternate entrees, no menus for fortified diets etc. There was equipment in need of repair. The stainless steel finish on the part of the meat slicer that held the meat in place had worn off, exposing the interior finish. This could be a source of cross contamination that could support growth of microorganisms.

There were meat items that showed evidence of thawing and refreezing due to presence of ice crystals. There was no departmental organizational chart delineating lines of authority. The confusing and conflicting roles in the job description and in practice had resulted in no clear leadership for the department.

The DPh was on vacation and was not available for interview. The CEO in an interview on March 12, 2014 at approximately 10:45 AM stated the reporting channels for the food and nutrition department will be changed and job descriptions reviewed.

Based on observation, review of hospital documents and staff interviews, the hospital failed to ensure that its dietary staff was competent in their duties in the dietetic service area when they were unable to properly test the sanitizer concentration in the sanitizing bucket, prepare chicken in a manner to preserve the nutritive value, take food temperature and reheat food in the microwave to the recommended temperatures. These failures resulted in improper sanitation and food handling practices that could cause food borne illness.

Findings:

1. According to the dietary services supervisor (DSS) in an interview at approximately 3:27 PM on March 10, 2014, the chlorine concentration in sanitizing buckets is 100 parts per million (ppm) (sanitizing buckets are buckets used to store wet wiping cloths in a chemical sanitizing solution used to clean food contact surfaces to prevent the growth of bacteria. The proper concentration of sanitizer is essential to ensure that bacteria on the surfaces are removed).

At approximately 3:37 PM on March 10, 2014, dietary staff (DS) 1 was asked to test the chemical sanitizer concentration in the sanitizing bucket observed adjacent to the dish machine. Using a test strip, DS 1 immersed the strip in the solution; he continued to immerse the strip in the solution for approximately 4 seconds till the strip changed color and then showed it to the surveyor for validation without checking it against the color chart on the container. According to the manufacturer ' s instructions on the label, the strip needed to be immersed in the solution and removed immediately and checked against the color chart. These instructions were pointed out to DS 1 who proceeded to retest the solution using a new test strip.

On the second attempt, DS 1 immersed the strip and stated it was 50, meaning 50 parts per million (ppm). The number read out loud did not match the corresponding color on the color chart on the label. The color on the test strip appeared to be 10 and 50. DS 1 proceeded to test the solution a third time using a different test strip. DS 1 stated once again that the strip was "50". However, the color strip matched the 25 ppm level. Therefore, there was an inadequate level of sanitizing agents in the bucket tested. Four other buckets were tested with similar results of 25 ppm instead of 100 ppm.

The director of Nutrition Services explained in an interview at approximately 3:40 PM that sanitizing buckets are changed three times a day. The DSS and other dietary staff present during the concurrent interview stated the buckets were prepared before lunch approximately four hours earlier. Review of the temperature and sanitizing log for March 2014 showed the chemical concentration of all five buckets as 100 (ppm). There was no written policy on the use of the sanitizing bucket. The use of the cleaning cloth with inadequate concentration of the sanitizer could result in overgrowth of bacteria on food contact surfaces, while giving a false sense of a sanitized surface.

2. At approximately 3:52 PM on March 10, 2014, a pot was observed on the stove on low heat with approximately eight pieces of chicken breast in liquid (water). The pieces appeared to have been cooked in large amount of water. The DSS explained that the cook who had put the item on the stove was on break and would return to finish cooking the chicken.

At approximately 4:00 PM, Cook 1 returned and stated that she was preparing the chicken as an alternate entrée for the patients. She stated that she was preparing Chicken Parmesan. Cook 1 stated there was no recipe for Chicken Parmesan because they were substituted the chicken for veal in the Veal Parmesan recipe. Review of the Veal Parmesan recipe showed that the "meat" should have been dredged in flour mixture, dipped in an egg mixture, rolled in bread crumbs, browned in oil, topped with tomato sauce and cheese. There was no direction (including alternate method) to cook the meat in water.

Cook 1 continued to explain in the interview that she has always cooked cooking that way to ensure that is soft and easy to chew. She stated she boils it from frozen instead of thawing under running water. Cooking food in a large amount of liquid, that would not be used as part of final cooking; could result in loss of nutrients.

The DSS who was present during the interview stated the chicken should have been to prepare Chicken Spaghetti. The recipe provided for Fettuccini Alfredo with Chicken also did not include instructions on cooking chicken in large volume of water. There was no written menu or recipe for this alternate entree resulting in confusion of what was supposed to be prepared. The DSS stated in the concurrent interview that the alternate is planned based on what was in the freezer and refrigerator and patient preferences. Review of the untitled document with list of entrees served to date showed that chicken was always served almost every day and food items repeated two days in a row as the main item or as an alternate.

3. On March 11, 2014 at approximately 12:00 PM, Cook 2 was observed serving food to patients. She was observed taking the temperatures of a plate that contained pureed chicken, mashed potatoes and pureed green beans. She was observed to take the temperature of two of the items. The mashed potato was 148.9 degrees Fahrenheit (F), pureed chicken was 122.7 degrees F. She proceeded to reheat the plate in the microwave. After a minute or so, she retrieved the plate and retook the temperature of the chicken only. Cook 2 indicated it was 140 degrees F but was 130 degrees after it was rechecked by the surveyor.

The DSS who was observing the interaction with Cook 2 stated the chicken needed to be discarded. She proceeded to puree a piece of chicken breast and replaced it with the initial one. The final temperatures of the pureed diet were as follows: mashed potatoes 150 degrees F, pureed green beans 138 degrees F, pureed chicken 176 degrees F. The final temperatures indicate that the food temperatures of the mashed potato and green beans did not reach the recommended final reheating temperature for microwave cooking.

The final cooking temperature for reheated foods in a microwave are time and temperature controlled for safety (potentially hazardous foods). For hot holding foods, the recommended final reheating temperature is 165 degrees F for 2 minutes, so that all parts of the food are allowed to be properly reheated.

4. On March 10, 2014 at approximately 4:15 PM, a food blender stored away as clean was found with multi-colored food residue and black substances under the rubber gasket. A food processor also stored away as clean was found to have a multi colored food debris under the blade and on the lid.

These failures could result in a food that could support the growth of microorganisms.

Based on review of clinical record, hospital documents and staff interviews, the hospital failed to ensure that one sampled patient received the diet ordered by his physician. The diet was incorrectly entered by nursing staff and resulted in patient receiving more calories than was originally ordered by the physician. Consuming higher than prescribed caloric intake could result in high blood sugar and poor utilization of insulin. In addition, the consistent carbohydrate diet offered by the hospital was above the caloric need of the patient. This deficient practice had the potential to affect the health, safety and nutritional needs of all hospitalized patients.

Findings:

Patient 22 was admitted with diagnoses including comminuted right humeral head and neck fracture (bone fracture to the upper arm extremity from the shoulder to the elbow) and history of insulin dependent diabetes (a medical condition where a patient's blood glucose level is greater than 120 mg/dl). The hand written physician ordered diet was 1800 calorie ADA diet.

Review of the electronic medical record showed the diet was entered as a 2000 calorie diet and was served as such by the dietary services staff. Review of the electronic medical record system showed the choices on the first screen for diet allowed limited diet order choices of which 2000 kcal (kilocalorie) was an option. However, the correct diet order could be entered but with more steps to get to the screen that would have allowed the correct diet to be entered accurately.

In an interview with RN 1 on March 13, 2014 at approximately 3:20 PM, she indicated that all nursing staff was provided with training on how to enter information including diets in the electronic medical record. A copy of reference material/ instructions on entering the information in the system was readily accessible. It was located on the table in the nurses ' area where the computers were located. RN 10 who entered the incorrect information was not available for interview, but training records showed that she had been provided with the appropriate training.

Hospital policy titled "Physicians Orders" dated "11/29/2012" state "Physician's orders shall be transcribed accurately ....." RN 10 failed to accurately transcribe the diet order for Patient 22.

On March 9, 2014, the diet order for Patient 22 was changed to Diabetic/CCD (consistent carbohydrate diet) chopped texture. The hospital CCD was served till the patient was discharged. Patient 22 ' s height was 64 inches and weight was 114 pounds. The approximate caloric need of a female weighing 114 lbs is 1554 to 1800 calories.

A review of the analysis of the hospital CCD diet revealed the carbohydrate level was not always consistent and the caloric level varied from 1507 to 2129 calories per day. Both values are approximately 300 calories above or below the initial order for 1800 calorie diet. Review of Patient ' s 22 blood sugars revealed they were always above the normal range and needed insulin due to high blood sugar levels ranging from 149 to 311. Normal blood sugar range is 70 -120 mg/dl of blood.

Based on review of clinical records, hospital documents and staff interviews, the hospital failed to ensure that the nutritional needs of two sampled patients (Patient 23 and Patient 24 - closed records) were met in accordance with hospital policies and procedures when they failed to refer both patients to the dietitian for nutrition assessments. The hospital menu for consistent carbohydrate diet is not in accordance with recommendations of the American Diabetes Association. These failures resulted in lack on nutritional intervention by the registered dietitian.

Findings:

According to the hospital policy titled "Nutrition Assessment for Acute Patients Screened at Nutritional Risk" dated "03/04/2013", noted that "all patients who meet clinical criteria or have a dietary consult shall be assessed by the registered dietitian (RD) with 24 to 48 hours notification."

The procedure is that nursing staff will complete the initial nutrition screen on admission. There are triggers (an alert) that would result in referral for a nutrition consult. According to the same policy, the RD is to make rounds to the acute care patient department on a routine basis to review charts for dietary triggers. Included in the list of triggers are obesity/overweight, pressure ulcer/unhealed wound, abnormal laboratory values pertinent to nutritional status.

1. Patient 31 was admitted with diagnoses that included uncontrolled diabetes (high blood sugar levels), osteomyelitis (infection of the bone), renal failure (inability of the kidneys to function adequately) and a diabetic foot ulcer (infection of the soft tissue of the food due to diabetes). His admitting diet order was ADA 2 gram sodium. Review of the nutritional screen showed that he was not referred to the RD. His unhealed wound met the trigger and criteria for RD consult and nutrition assessment.

Patient 31 was not assessed by the RD during his three day stay at the hospital. His blood sugar remained high,from 206 to 321. (normal range 70-120 mg/dl), throughout his stay at the hospital.

2. Patient 32 is a 64 year old male admitted with diagnoses that included pneumonia (infection in the lung) and diabetes type 2 (a type of diabetes where not enough insulin is produced to control glucose levels in the blood). Patient 32's height was 69 inches and weight of 205 pounds. Patient 32's BMI (Body mass index) was 30.27. BMI a measure of human body shape based on an individual ' s weight and height (BMI provides a reliable indicator of body fatness for most people and is used to screen for weight categories that may lead to health problems). A BMI of below 18.5 is classified as underweight, 18.5 to 24.9 normal, 25 to 29.9, overweight and 30.0 and above is obese.


Based on the BMI classification and patient 32 ' s BMI of 30.27, he will be classified as obese, therefore meeting the hospital trigger and criteria for nutritional assessment. Review of the nutritional screen conducted on patient 32 on admission showed that he was not referred to the RD because the overweight/obesity was not included on the questions that the nurse needed to check for referral.


For Patient 23's Discharge Summary noted listed "Dietary Consultation" needed. Patient 23 was not assessed or educated by the RD during his hospital stay. There was no documented evidence that Patient 23 received any education after discharge.


In an interview with the RD on March 14, 2014 at approximately 11:00 AM, the RD stated that she was not aware that the nursing screen completed by nursing staff did not include the trigger for overweigh/obesity. She stated she had not conducted the nutrition assessment on either of these patients.


3. In 1997, the Professional Practice Committee and the Executive Committee of the American Diabetes Association recommended a new nutritional guideline in the dietary treatment for diabetes with a menu planning guideline called "Consistent Carbohydrate Diabetes Meal Plan". The system uses meal plan without specific calorie level, instead it incorporates a consistent carbohydrate content ...The carbohydrate content would be comparable day to day at breakfast, each day at lunch and each day at dinner as well as snacks. The total carbohydrate content each meal would not necessarily be comparable. For example, the carbohydrate content each day at breakfast may be less than that at lunch. It was also recommended that the term "ADA diet" no longer be used.

Review of the hospital ' s consistent carbohydrate diet from one day to another varied significantly in the amount of carbohydrate. For example on Week 3, the amount of carbohydrate varied from 45 grams to 76 grams for breakfast. The change is as high as 22 grams from one day to another (76 grams on Tues and 54 grams on Monday). For lunch, the variation in the amount of carbohydrate is 47 grams to 93 grams. The largest variation of 46 grams was from Friday (47 grams) to Saturday (93 grams). For dinner, the variation was from 46 grams to 81 grams. The largest variance for dinner was 35 grams. It was from Friday (81 grams) to Saturday (46 grams).

These large variances were not consistent with the principles of the diet and could lead to wide fluctuations in patient blood sugars and poor utilization of insulin (insulin is a hormone central to regulating carbohydrate and fat metabolism in the body). It could also result in patients receiving mixed messages about diets and could negatively affect compliance with medications and diet.

All three sampled patients with diabetes (Sample Patients 22, 31 and 32) did not have good glucose control throughout their stay in the hospital. It is not clear what direct effect the poor diet offered at the hospital had on these patients. The hospital failed to meet the nutritional needs of these patients.

Based on observation, review of hospital documents and staff interviews, the hospital failed to ensure that there was adequate supply of drinking water and water for other purposes were on hand for use in an emergency. The water on hand was less than what had been planned for in the hospital emergency preparedness plan. This failure had the potential to result in an inadequate supple of drinking water and water for other purposes to all patients and staff during a disaster affecting the hospital.

Findings:

A review of the hospital ' s emergency food and water supplies on March 12, 2014, revealed that supplies including food and water were planned for 150 people. Based on water need for drinking and other purpose, the plan was to have a total of 693 gallons of water.

Review of the water supplies stored in a garage on hospital grounds revealed storage of several 5 gallon water bottles. There were 84 5-gallon bottles filled with water and several empty 5 gallon bottles also stored. The water on hand was 293 gallons short of the plan.

The hospital employee responsible for emergency preparedness was not available for interview. The Director of Nutrition (DNS) who was present during the observation stated at approximately 3:40 PM that the plan for emergency water included staff and patients. Another hospital employee, who was responsible for Facilities (FF) stated there was no more water on March 12, 2014, at approximately 4:00 PM.

Based on observations, staff interviews, review of policy and procedure and document reviews, the facility failed to maintain an effective infection control program for the minimization of infections and communicable diseases in accordance with nationally accepted infection control guideline as evidenced by the facilities failure to ensure:

1. Endoscopes were stored in accordance with National Recognized Standards (NRS) and according to manufacturer's recommended instructions.

2. Re-usable surgical instruments were sterilized and stored in accordance with National Recognized Standards.

3. The temperature and humidity of the sterile supply room(s) was maintained in accordance with Nationally Recognized Standards of accepted infection control guidelines.

4. Sterile supplies were maintained in accordance with event-related sterility standards.

5. Disinfectant wet times (the time the disinfectant solution stays wet on the equipment being cleaned to inactivate or kill germs) were not maintained in accordance with manufacturer's recommended instructions in the Phlebotomy room (an area in the hospital where out-patients have their blood drawn).

These failures exposed patients to the potential to increase the risk for the spread of communicable diseases and infections.

Findings:

1a. An observation tour was conducted on March 11, 2014, at 8:30 AM, with the Sterile Processing Technician 1 (SPT1) and Chief Nursing Officer 1 (CNO). It was observed that 4 of 4 endoscopes were hung on the wall in an open room (known as OR 2. Each one of the four endoscopes were hung looped back on itself with the end and tip hanging looped over the next endoscope. The fourth endoscope was looped back on itself with the end piece touching the wall.

1b. During an concurrent interview and on March 11, 2014, at 8:35 AM, SPT 1 stated he was not aware of a policy and procedure regarding the proper storage of endoscopes. He stated, "This is the way he was taught to hang the endoscope." He identified the Infection Control Preventionist (ICP)/Operating Room Supervisor (ORS) as the person that taught him how to process and store endoscopes. During this interview a request was made for the facilities endoscope reprocessing and storage policy and procedures, however, the requested policies and procedures were not provided.

1c. During a subsequent observation and interview with Infection Control Practitioner /Operating room Supervisor ( ICP/ORS), SPT 1 on March 13, 2014, at 3:30 PM, the ICP/ORS acknowledged the endoscopes were in the normal state for storage. The ICP/ORS could not verify the existence of a policy and procedure related to the endoscopes storage. He further added, the facility does follow the Association of Perioperative Nurses (AORN) recommendations and guidelines.

1d. A record review on March 13, 2014, at 4:00 PM of department personnel files was conducted. The files of SPT 1 and the ICP/ORS failed to reveal training regarding proper storage of endoscopies.

1e. A review of the manual endoscope processing instructions from Pentax, the manufacturer of the hospital's endoscopes was conducted on March 15, 201 at 4:00 PM. The manual titled "Pentax, Reprocessing/Maintenance Manual and Operations manual was provided. Instructions found on page 45 of 52 the section titled, "5. POST REPROCESSING," stipulated, "The endoscope should be hung in a clean, dry, well-ventilated storage cabinet at room temperature. The insertion tube and light guide cable should be hung and kept as straight as possible during storage."

1f. A review of records on March 15, 2014, at 4:20 PM, revealed the facilities practice for storing the endoscopes is inconsistent with the AORN standards.

A review of AORN Standard IX. Titled, "Flexible endoscopes should be stored in a manner that protects the device from damage and minimizes microbial contamination."

IX. a. Flexible endoscopes should be stored in a closed cabinet with:

a) venting that allows air circulation around the flexible endoscopes

b) internal surfaces composed of cleanable materials

c) adequate height to allow flexible endoscopes to hang without
touching the bottom cabinet, and

d) sufficient space for storage of multiple endoscopes without
touching

When flexible endoscopes are hung in the vertical position, coiling or kinking is prevented, allowing any remaining moisture to drain out of the endoscope and decreasing the potential development of an environment conducive to microbial growth in the endoscope. Proper storage facilitates drying and decreases potential for contamination. Opening all valves and removing all accessories facilitates drying. The scope protector may create an environment favorable for microbial growth if the flexible endoscope is not dry and cannot hang straight.

2a. During an observation, on March 13, 2014, at 3:10 PM, a sterile tray with instruments labeled "plastics" was opened for a random inspection opportunity. The packet revealed a square 12-inch by 12-inch tray filled with two (2) blue towels folded with an opening resembling a pocket. Each towel contained one surgical instrument in each towel "pocket." The towels were placed on the top of the surgical Instruments placed in the tray.

The next layer of surgical instruments included a long blade and long handle instrument to "string" (a term used to describe a row of surgical instruments were held together on a rod "strung" through the handles of the instruments). This instrument was loaded or strung with a row of 26 instruments that had ratchets unlocked with all 26 instruments tips touching with blades closed.

The tray included a 30 cc (cubic centimeter, a unit of volume equivalent to a milliliter) metal cup turned to lay horizontally on the cups side. A large instrument approximately 8-inch long and 1-inch wide, identified by ICP/ORS as an "Army/Navy" retractor had visible water or mineral markings. All instruments were tightly packed.

2b.During a concurrent interview on March 13, 2014, at 3:12 PM, with the ICP/ORS, and the SPT 1, verified that the observed tray is the usual manner in which the instruments are placed to be sterilized. In a concurrent interview SPT 1, stated, he did not have independent knowledge of the proper placement of the instruments. Both ICP/ORS and SPT 1 acknowledged the position of the instruments with the instrument tips and blades that were in the closed position, or were touching each other could not ensure sterility.

2c. During a review of the hospital policy and procedures on March 12, 2014, at 10:00 AM, a request was made to CNO (Chief Nursing Officer) for policy and procedures related to packing and processing of sterile surgical instruments. During a concurrent interview, CNO did not know if a policy existed related to event related sterility or a policy related to storage of sterile supplies and sterile surgical instruments. During a review of a policy titled, "Care of Sterile Supplies-Surgery was Observed". The policy stipulated conditions for considering supplies or instruments that were contaminated. The staff did not follow their own policy and procedures when they failed to monitor supplies and instruments for the following conditions:

a) when the wrapper is damaged.

b) when the wrapper is damp or dusty.

The AORN Standards and Recommended Practices, 2013 edition, Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment was reviewed. Under Recommendation XII, the following information was provided:

"Cleaned surgical instruments should be organized for packaging in a manner to allow the sterilant to contact all exposed surfaces. Proper organization will facilitate sterilant contact on all surfaces and adequate drying.

XII.a. Instruments should be placed in a container tray or basket that is large enough to evenly distribute the metal mass in a single layer. Instruments should be contained within the tray or basket in a manner that protects the instruments from damage and prevents puncturing of the sterilization wraps. Overloading trays can cause wet packs because an increase in metal mass in the tray results in more condensate, which requires additional drying at the end of the cycle.

XII.b. Broad-surfaced instruments and those with concave surfaces (e.g., malleable retractors, hip skids) should be placed on edge. Instruments placed on edge facilitate drying because in this position, steam condensate will drain off the instrument rather than pool on it.

XII.c. Instruments with hinges should be opened and those with removable parts should be disassembled when placed in trays designed for sterilization, unless the manufacturer has provided validated instructions to the contrary. Sterilization occurs only on surfaces that have direct contact with the sterilant. Disassembly of multiple-part instruments and those with sliding parts (e.g., retractors) enables the sterilant to contact all surfaces.

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

3a. During an interview on March 11, 2014, at 10:30 AM, the SPT1, could not verbalize the method of monitoring sterile supplies and surgical instruments. He could not identify adopted National Recognized Standards to ensure sterility of Surgical Instruments or, the standards regarding humidity and temperatures in Sterile Supply and Operating rooms. SPT1 could not locate policy and procedures that the hospital adopted relating to event-related sterility standards.

3b. An observation on March 11, 2014, at 10:30 AM, revealed Operating Room #2(OR2) was used as a storage room. The temperature and humidity could not be determined due to the lack of monitoring devices such as a thermometer. During a subsequent interview with ICP/ORS on March 13, 2014, at 3:30 PM, revealed the room has been utilized as a storage room for at least the last two years.

3c. A review of policy and procedures was conducted on March 13, 2014, at 2:30 PM, revealed a policy and procedure, titled, " Humidity and Temperature Control in Surgery". It stipulated, a relative humidity between 20-60% shall be maintained in the surgical suite areas." Logs will be available in the department for monitoring. The document further states, "The air temperature in the surgical suite shall be kept between 68-73 degrees. A log sheet will be keep in the surgery department." In a concurrent interview at 2:30 PM, the ICP/ORS and CNO acknowledged, the logs were not available due to the lack of monitoring devices.

4a. An observation on March 11, 2014, at 10:30 AM, of sterile instruments and sterile surgical supplies was conducted in the Operating Room #1 (OR1). It was observed that stored peel packs were dated as far back as March 1998. These peel packs were labeled "Sterilized" and had spots on the backside, yellow discoloration and non-porous tape wrapped handles. On March 14, 2014, at 4:05 PM, the ICP/ORS confirmed the observation.

4b. During a concurrent interview on March 11, 2014, the SPT1 stated he thought the facility adopted an event related sterility policy. SPT1 could not verbalize the events that would cause the packages to be considered compromised. ICP/ORS stated he did not believe the facility had this policy in writing. He stated the operating room staff members would use the Association for Professionals in Infection Control and Epidemilogy book or the internet for Centers for Disease Control and Prevention standards for event related sterility concerns.

4c. An observation on March 14, 2014, at 4:00 PM, located in the hallway storage area of the surgery suites, revealed a storage rack packed with sterile surgery instruments. The supplies/surgical instruments were packed in clear tubs without the directions written: "Sterile Unless Opened or Damaged Before Use", as is required by national recognized standards (CDC or APIC standards). The instruments were packed and stored in peel packs horizontally stacked. It was observed were three (3) wire racks approximately 5 feet high, 4 feet wide and 2 feet in depth. An estimated 1/3 of the instruments packs inspected had visual defects, that included faded yellow covered backs, spotted backs, curled edges and crushed packs. The sterile dates were dated as far back as 2005.

A concurrent interview on March 14, 2014, at 4:05 PM, was conducted with ICP/OR1 and SPT1. Both acknowledged the instrument packs observed were compromised and did not follow CDC or APIC recommended standards. ICP/ORS and SPT1, could not provide hospital/department policy and procedures regarding the storage of sterile supplies or instruments. The ICP/OR1 and SPT1 both acknowledged that sterile instruments and supplies had not been monitored.

According to CDC Guidelines, titled "Guidelines for Disinfection and Sterilization in Healthcare Facilities", dated 2008, "Event related sterility storage ... practice recognizes that the product should remain sterile until some event causes the item to become contaminated (e.g., tear in packaging, packaging becomes wet, seal is broken) 968 . Event-related factors that contribute to the contamination of a product include bioburden (i.e., the amount of contamination in the environment), air movement, traffic, location, humidity, insects, vermin, flooding, storage area space, open/closed shelving, temperature, and the properties of the wrap material 966, 969. There are data that support the event-related shelf-life practice"
CDC 19. Quality Control recommends:

a) Provide comprehensive and intensive training for all staff assigned to reprocess semicritical and critical medical/surgical instruments to ensure they understand the importance of reprocessing these instruments. To achieve and maintain competency, train each member of the staff that reprocesses semi-critical and/or critical instruments as follows:

1) provide hands-on training according to the institutional policy for reprocessing critical and semicritical devices;

2) supervise all work until competency is documented for each reprocessing task;

3) conduct competency testing at beginning of employment and regularly thereafter (e.g., annually); and

4) review the written reprocessing instructions regularly to ensure they comply with the scientific literature and the manufactures instructions. Category 1B.

b) Conduct infection control rounds periodically (e.g., annually) in high-risk reprocessing areas (e.g., the Gastroenterology Clinic, Central Processing); ensure reprocessing instructions are current and accurate and are correctly implemented. Document all deviations from policy.







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5. During an observation of the Phlebotomy (for withdrawing blood from an individuals veing, for blood tests) Room, on March 11, at 10:05 AM, with the Chief Nursing Officer (CNO) present, a Phlebotomist (a staff member who collects blood from patients for testing so the blood can be analyzed in the clinical laboratory) cleaned the phlebotomy blood drawing chair (a special chair with an arm rest that patients sit in during the blood drawing procedure) with Micro-Kill disinfectant wipes (a brand of disinfectant wipes that are pre-moistened disposable cloths containing a solution to disinfect surfaces) and left the surface of the chair visibly wet for about 30 seconds.

The Phlebotomist stated that the chair was ready for reuse after wiping down the chair with one disinfectant wipe and the chair was visibly dry in less than one (1) minute.

A review of the Micro-Kill disinfectant wipes manufacturer's instructions, noted the following: "Overall Kill Time Needed: 10 minutes. (Contact time for a disinfectant is the amount of time a surface must remain wet with the product to achieve disinfection)".

On March 11, 2014 at 10:05AM, the CNO confimred the finding that the Phlebotomy chair was not disinfected properly per manufacturers recommendations/instructions.

Based on interview and record review, the hospital failed to ensure that the appropriate types and numbers of qualified personnel were available to provide surgical services.

The hospital failed to ensure that a surgical team was available at all times.

This failure had the potential for a surgical emergency to not be treated and had the potential to contribute to the death of a patient.

Findings:

During an interview with the Chief Nursing Officer (CNO) on March 10, 2013 at 3:10 PM, the CNO stated that "Currently, we do not have an on-call surgeon (available when requested) and we do not have physician in charge of the surgical service."

During an interview with the Chief of Medical Staff (CMS) on March 11, 2013 at 2:40 PM, the CMS stated that "We do not have a surgical on-call team. We are working on getting an on-call team."

During an interview with the Chief Executive Officer (CEO) on March 12, 2014 at 10:30 AM, the CEO stated that 24-hour surgical services are not available. The CEO further stated that a General Surgeon physician is on the hospital's medical staff but the physician is not willing to be available for 24-hour on-call for surgical services.

During a review of the Title 22 California Code of Regulations Division 5 for General Acute Care Hospitals, § 70225 (b), regarding Surgical Service Staff, noted "One or more surgical teams consisting of physicians, registered nurses and other personnel shall be available at all times."

Based on observation, review of hospital menu, policies and procedures and staff interviews, the hospital failed to ensure that its menus met the nutritional needs of its patients. There was no menu written for patients on fortified diets, fortified items were left to the discretion of the cooks during meal service. One unsampled patient did not receive a fortified diet based on the hospital policy and procedure. In addition, the nutrient analysis of the carbohydrate controlled diet had significant errors and did not meet recognized professional practices.

Findings:

1. During tray line observation on March 11, 2014 at approximately 12:10 PM, a patient's tray with an order for fortified diet was served with the same food items as a patient receiving a regular diet. There was no evidence of a Fortified diet on the production spreadsheet/menu for that meal.

In an interview with the director of nutrition services (DNS) on March 13, 2014 at approximately 4:15 PM, she stated that there was no written menu for the fortified diets but the policy required the use of two or more fortified items at each meal.

Review of the hospital policy titled "Fortified Food Program" dated December 10, 2010, indicated that the purpose of the fortified food program was to provide nutrient dense foods for individuals requiring extra protein and calories who are unable to consume adequate amounts of foods. The policy states that the diet will " need to be individualized based on items fortified on the menu. A minimum of two items need to be served per meal. FSS with the assistance of the RD need to determine appropriate fortified items.

This failure resulted in inadequate calories and or protein for the patient receiving the fortified diet.

2. In 1997, the Professional Practice Committee and the Executive Committee of the American Diabetes Association recommended a new nutritional guideline in the dietary treatment for diabetes with a menu planning guideline called "Consistent Carbohydrate Diabetes Meal Plan". The system uses meal plan without specific calorie level, instead it incorporates a consistent carbohydrate content ...The carbohydrate content would be comparable day to day at breakfast, each day at lunch and each day at dinner, as well as snacks. The total carbohydrate content each day would not necessarily be comparable. For example, the carbohydrate content each day at breakfast may be less than that at lunch. It also recommended that the term " ADA diet " no longer be used.

A review of the patient consistent carbohydrate diet from one day to another varied significantly in the amount of carbohydrate. For example on Week 3, the amount of carbohydrate varied from 45 grams to 76 grams for breakfast. The change is as high as 22 grams from one day to another (76 grams on Tues and 54 grams on Monday).

For lunch, the variation in the amount of carbohydrate is 47 grams to 93 grams. The largest variation of 46 grams was from Friday (47 grams) to Saturday (93 grams). For dinner, the variation was from 46 grams to 81 grams. The largest variance for dinner was 35 grams. It was from Friday (81 grams) to Saturday (46 grams).

These large variances are not consistent with the principles of the diet and could lead to wide fluctuations in patient blood sugars and poor utilization of insulin (insulin is a hormone central to regulating carbohydrate and fat metabolism in the body). It could also result in patients receiving mixed messages about diets and could negatively affect compliance with medications and diet.

3. A review of the nutrient analysis of the consistent carbohydrate diet revealed there was a significant error in the protein content of one of the vegetables. The protein content of ½ cup of cauliflower is approximately 1 gram. The hospital nutrient analysis listed it as 8 grams (equivalent to 1 ounce of protein). The DNS explained that the nutrient analysis had been purchased from a company and she corrected a lot of errors and that that was one she had missed.