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Based on review of patient clinical records, document review, and staff interview, the hospital failed to: 1. Ensure that pharmacists, who adjusted medication doses according to hospital approved protocols, did so in accordance with training described in hospital policies and procedures, to ensure they understood and complied with the protocols; and 2. The hospital failed to document approval of these protocols in the minutes of the Pharmacy and Therapeutics Committee. No evidence was provided that the hospital had training procedures for three out of five dosing protocols used in the hospital (the nutrition support protocol, the renal dosing adjustment protocol, and the anticoagulation protocol). No evidence was provided in the Pharmacy and Therapeutics Committee meeting minutes that it had approved the anticoagulation or nutrition support protocols. These issues had been initially discovered during a previous survey conducted during June 2012.

Findings:

1. California Business and Profession Code, Section 4052.1, allows a pharmacist, in a licensed health care facility (such as a hospital) to order drug therapy related laboratory tests and to initiate or adjust the drug regimen of a patient pursuant to a prescriber's order. However, this must be done in accordance with the policies, procedures, or protocols of the licensed health care facility and only after the pharmacist has received appropriate training, as described in the aforementioned policies and procedures.

During a previous survey conducted during June 2012 on 6/18/12, a review of the MEDICAL STAFF BYLAWS, RULES, AND REGULATIONS indicated that it stipulated at, "10.13 Pharmacy and Therapeutics Committee," (P&T Committee) that the, "Duties," of this committee were to formulate professional practices and policies regarding the evaluation, appraisal, procurement, storage, distribution, use, safety procedures, and all other matters, relating to drugs.

On 6/18/12, a review of Policy and Procedure 14-02, entitled PHARMACOKINETIC DOSING SERVICE (Effective date 6/92, Reviewed 10/11, no revision date available) indicated the policy of the hospital was as follows: "The pharmacy shall provide a pharmacokinetic dosing service to assist the medical staff in dosing and monitoring patients in order to minimize toxic side effect and to reduce overall facility stay costs by giving therapeutically efficacious doses." Under procedures it stipulated that: "The medical staff, through its pharmacy and therapeutics function, shall select drugs, for example, aminoglycosides, vancomycin, ... for the pharmacokinetic dosing service." It also stipulated: "The medical staff, through its pharmacy and therapeutics function, shall select dosing and monitoring protocols to be followed by the pharmacist performing the service."

On 6/21/12 at 1:56 p.m., during an interview of the PIC (Pharmacist In Charge), she stated that Pharmacist U and V had told her they had not received any formal training in this hospital with respect to adjusting doses of medications, pursuant to hospital- approved dosing protocols.

As part of the plan of correction for the June 2012 survey, the hospital developed a Plan of Correction that included developing procedures for the hospital to follow to ensure pharmacists received training in hospital-approved dose adjustment protocols.

On 12/5/12, the surveyor reviewed five dosage adjustment protocols: One each for intravenous vancomycin (an antibiotic) dosing (no number or effective date), aminoglycosides (a class of antibiotics) dosing (as a draft policy); a Nutrition Support Policy (for managing total parenteral nutrition or TPN, a process where a patient receives calories and nutrients intravenously); a policy for Dosing Adjustments for Renally (by the kidney: Adjust medication doses in patients whose renal function is decreased) Excreted Medications (revised 6/12); and a policy on Anticoagulation (blood thinners such as warfarin used to treat or prevent blood clots) - management of Patients Placed on Therapeutic Anticoagulant Therapy, written 6/12. There was no provision for training of the pharmacists to carry out the last three policies and procedures (Nutrition Support, Renal Adjustment, and Anticoagulation) in any of these policies and no evidence was provided that such training was described elsewhere.

On 12/12/12 at 9:58 a.m., during an interview of the PIC, she stated that she had not, "transitioned," the draft policies to the active format, although she stated they had been approved. She stated she would check for pharmacist training provisions that had been developed by the hospital.

On 12/12/12 at 2:21 p.m., during a second interview of the PIC, she stated she had not been able to find anything regarding the training of the pharmacists with respect to the Renal Dosing, the Nutrition Support, and the Anticoagulation protocols.

2. California Business and Profession Code, Section 4052.1 allows a pharmacist, in a licensed health care facility (such as a hospital) to order drug therapy related laboratory tests and to initiate or adjust the drug regimen of a patient pursuant to a prescriber's order. However, this must be done in accordance with the policies, procedures, or protocols of the licensed health care facility and only after the pharmacist has received appropriate training as described in the aforementioned policies and procedures.

During a previous survey on 6/18/12, a review of the MEDICAL STAFF BYLAWS, RULES, AND REGULATIONS indicated that it stipulated at, "10.13 Pharmacy and Therapeutics Committee," (P&T Committee) that the, "Duties," of this committee was to formulate professional practices and policies regarding the evaluation, appraisal, procurement, storage, distribution, use, safety procedures, and all other matters, relating to drugs.

On 6/18/12, a review of Policy and Procedure 14-02, entitled PHARMACOKINETIC DOSING SERVICE (Effective date 6/92, Reviewed 10/11, no revision date available) indicated it stipulated: "The medical staff, through its pharmacy and therapeutics function, shall select dosing and monitoring protocols to be followed by the pharmacist performing the service."

The hospital provided a plan of correction for the June 2012 survey, that dosage adjustment protocols were now approved by the Pharmacy and Therapeutics Committee.

On 12/5/12, the surveyor reviewed five dosage adjustment protocols: ;ne each for intravenous vancomycin (an antibiotic) dosing (no number or effective date), aminoglycosides (a class of antibiotics) dosing (as a draft policy); a Nutrition Support Policy (for managing total parenteral nutrition, a process where a patient receives calories and nutrients intravenously); a policy for Dosing Adjustments for Renally (by the kidney: adjust medication doses in patients whose renal function is decreased) Excreted Medications (revised 6/12); and a policy on Anticoagulation (blood thinners such as warfarin used to treat or prevent blood clots) - management of Patients Placed on Therapeutic Anticoagulant Therapy, written 6/12.

On 12/5/12, a review of the Pharmacy and Therapeutics Committee meeting minutes, dated 7/17/12, indicated that approval of the anticoagulation and total parenteral nutrition form and dosing protocol had been put on hold for further review. A review of the Medical Executive Committee (to which the Pharmacy and Therapeutics Committee reported) meeting minutes, dated 8/14/12, indicated all five protocols were approved by that committee.

On 12/12/12 at 9:58 a.m., during an interview of the PIC, she stated that the anticoagulation and total parenteral nutrition protocols had been approved at a subsequent meeting of the Pharmacy and Therapeutics Committee, but this action had not been captured in the committee meeting minutes.



26290

Based on inspection of the Medical Surgical Nursing Unit, inspection of the anesthesia carts in Operating Room (OR) No. 1 and No. 2, document review, and staff interview:

1. The hospital failed to ensure that updated pre-printed insulin forms (approved for use pursuant to a plan of correction for findings on a previous survey conducted during June 2012) were available to staff for use in the Medical Surgical Nursing Unit. Seven out of seven forms in a file on that unit, proved to be the old form seen on the previous survey, with the potential that obsolete and unclear orders, regarding rapid acting insulins (Humalog and Novolog Insulin), were available to be placed in patient charts (finding 1).

2. The hospital failed to ensure that staff dated a multi-dose vial of Quelicin (succinylcholine: Used to paralyze muscles during surgery) in one of the two anesthesia carts (the cart in OR No. 1), with the date of opening, as required by hospital policy, with the potential that the vial may not be discarded after 28 days, and could expose patients to a contaminated medication (finding 2).

3. The hospital failed to ensure that the AUTOMATIC STOP ORDERS policy provided procedures for the pharmacist to follow to ensure a physician was notified of all drugs that would expire, so that the orders could be renewed if the physician felt this was indicated. There was no process to ensure the physicians had acted on the information, with the potential that medications might be discontinued, when the physician intended they were to be continued or, in the case of ketorolac (a pain reliever that has potential toxicities if used more than five days), that the physician be provided the opportunity to select a different pain medication if indicated, when the ketorolac was discontinued. This had been an issue on the previous survey conducted during June 2012 (finding 3).

Findings:

1. On 12/4/12 at 10:03 a.m., the surveyor asked for an example of the pre-printed insulin forms that were available for staff use on the Medical/Surgical Unit. The Director of Patient Care Services provided a copy of an order set entitled PREPRINTED SUBCUTANEOUS INSULIN ORDERS. A date, "4/2/07," was printed in the lower left corner. The Director of Patient Care Services obtained this order set from a file labeled, "Insulin," located in a file folder box resting on the back counter in the Medical Surgical Nursing Station. After the Director of Patient Care Services left the area, the surveyor removed all order sets in the, "Insulin," file. A review of these orders sets indicated that there were seven order sets in the, "Insulin," file including the one provided by the Director of Patient Care Services and all of them were identical.

The order set provided for the selection of insulin regimens based on a patient's blood sugar levels. It also provided for selection of the type of insulin to be used via a checkbox. There were two insulin types available for selection: Regular insulin and, "Lispro (Humalog or Novalog) ..." The problem: Humalog is insulin lispro and Novalog is insulin aspart. Both are rapid acting insulins with an onset of action that is faster than regular insulin, but they have chemically different structures and are not generically equivalent. The order set provided one generic name of one type of rapid acting insulin (lispro) but provided two brand names of chemically distinct insulins (Humalog and Novalog). As written, it was not clear if one should only dispense insulin lispro (Humalog), as the authors of the order set failed to recognize that Novalog was chemically distinct from Humalog, or if the authors intended to allow the hospital pharmacy to dispense either insulin as a, "therapeutic equivalent," drug (chemically distinct drugs that produce essentially the same result) they had failed to add, "Aspart," to, "Lispro," at the beginning of the order. This order set had been found in a patient's clinical record (Patient 27) during the recertification survey, conducted during June of 2012, and the plan of correction provided by the hospital indicated this order set would be clarified.

On 12/5/12, a review of 12 closed patient records that contained pre-printed orders for insulin during the previous three months, indicated that none of them contained the order set found on the Medical Surgical Unit on 12/4/12; all contained a newer, corrected order set.

On 12/12/12, the surveyor brought this issue to the attention of the Pharmacist-In-Charge (PIC) and then re-inspected the Medical Surgical Unit with the PIC. The, "4/2/07," preprinted insulin order set was no longer available for staff use on the Medical Surgical Unit.

2. The United States Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the quality, purity, identity, and strength of medicines ...USP's drug standards are enforceable in the United States by the Food and Drug Administration (FDA). The USPs revised general chapter <797> entitled PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS documents in the Introduction that, "The objective of this chapter is to describe conditions and practices to prevent harm, including death to patients, that could result from microbial contamination and excessive bacterial toxins among other things." Under the section, "Single-dose and multiple-dose containers," it documented that opened multi-dose vials (those that had been punctured with a needle) had a beyond-use date of 28 days, "unless otherwise specified by the manufacturer."

On 12/3/12 at 3:01 p.m., an inspection of the anesthesia cart (contains equipment and medications used by an anesthesiologist during a surgical procedure) in OR No. 1, indicated that it contained an open multi-dose vial (contains a preservative that will inhibit bacterial growth, but which has no activity against viruses such as the Hepatitis B virus or the Hepatitis C virus) of Quelicin. It had, "Exp 12-13-12," written on the side of the vial (Quelicin is stored under refrigeration because it is unstable at room temperature and has a shortened shelf life of 30 days once brought to room temperature).

On 12/3/12 at 3:10 p.m., during an interview of Staff Surgery Nurse W in OR No. 1, she stated that the Quelicin vial did not have an, "opened," date written on it. She stated that the date it was removed from the refrigerator (and from which the expiration date would be calculated) was not necessarily the date it was opened.

On 12/4/12, a review of Policy and Procedure 21-06, entitled MULTI-DOSE VIALS: USE OF indicated that it stipulated that, "All multi-dose vials will be dated and initialed upon opening by the person opening the vial." It also documented that the vials were to be removed from use 28 days after opening.

3. During a previous survey conducted at the hospital during June 2012, on 6/21/12, a review of Policy and Procedure 10-5, entitled AUTOMATIC STOP ORDERS (Effective Date: 6/92, Revised: 2/01, Reviewed: 10/11) indicated the hospital policy was: "There shall be an automatic cancellation or temporary stoppage of orders on specific toxic and dangerous drugs as established by the medical staff. The medical staff shall establish reasonable time limits for specified drugs." It also provided that the drug was not to be stopped until the prescriber had been provided an opportunity to verify that the drug was to be stopped, continued, or modified. However, there was no established procedure in this policy directing staff how they were to notify physicians of impending discontinuation of a medication. It provided for seven-day stop dates for six classes of drugs and all the others were assigned a 30 to 45 stop-date period. Ketorolac was not included among the six classes of drugs with an automatic seven day stop-date, so based on the policy, this drug would be automatically stopped after 30 to 45 days. Ketorolac has the potential for significant toxicity to the kidney and stomach, and significant risk of bleeding and adverse effects to the heart if used contrary to manufacturer guidelines. The manufacturer had documented in a boxed warning (the most serious warning required by the FDA-, that documents adverse effects that can result in death or serious injury) in the FDA approved product labeling that the drug was not to be given for more than five days.

On 6/21/12 at 4:30 p.m., during an interview of Pharmacist V, he stated there was a process to notify physicians of impending discontinuation of drug orders. He stated that a set of, "Expiring Drug Orders," was printed out each Monday covering the period from that Monday to the following Monday.

On 6/21/12 at 4:28 p.m., during an interview of the PIC, she stated that ketorolac should have been included in Policy and Procedure 10-5. She said the pharmacy computer system provided for a five-day stop date for ketorolac, but there was no policy to do this. The surveyor pointed out that the current process could miss a ketorolac order that was ordered on a Tuesday and would be stopped sometime during the following Sunday, and the PIC verified this observation. She verified there was no hospital-approved established procedure documented in an approved written policy to notify physicians of impending discontinuation of medications.

The hospital subsequently provided a plan of correction that included providing for a five-day stop date for ketorolac. However, it did not provide a plan of correction that addressed the failure of the hospital to provide written procedures for pharmacists to follow, in the policy, that would ensure physicians were notified in a consistent fashion, of pending discontinuation of drugs and provide a process to ensure the pharmacy was made aware of the physicians' ultimate intent (continue or discontinue the medication), so that medications were not discontinued contrary to the wishes of the physician.

On 12/3/12, a review of Policy and Procedure 10-05, entitled ORDERS: AUTOMATIC STOP ORDERS (Effective 6/92, Reviewed 7/12) indicated that it only stipulated that, "The pharmacy shall be responsible for stop order implementation and physician notification," but it did not provide a procedure to ensure physicians would be notified that a medication was going to be stopped, and that the physician actually acted on the notification and notified the pharmacy, so that medications would not be stopped against the wishes of the physician, or that ketorolac would be stopped, without giving the physician the opportunity to order alternate pain medications if so required.

On 12/12/12 at 2:21 p.m. during an interview of the PIC, she stated that the pharmacist would run an expiration report on Monday, that covered the period to the following Monday. When the surveyor pointed out that a ketorolac order, written on Tuesday morning, would not be picked up on this report, as the stop date would be Sunday morning (one day before the new stop report was to be printed), the PIC agreed with this assessment. After review the policy with the surveyor, the PIC acknowledged the policy did not provide procedures for the pharmacists to follow, to notify the physicians regarding medication orders that were due to expire.



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15338


Based on an observation of an employee crossing a red line in the surgery department, document review, inspection of two anesthesia carts, located in Operating Room (OR) No. 1 and No. 2, and staff interview:

1. The hospital failed to meet standards of practice established by the Association of Perioperative Registered Nurses (available to the Surgery Department administrative staff) and the hospital policy and procedure, when an employee crossed a red line into a restricted area (required wearing surgical garb and hair covering) while dressed in street clothes, with the potential she could have cross-contaminated the area immediately adjacent the operating rooms.

2. The hospital failed to ensure that opened multi-dose vials were not available for more than one patient use in one out of two anesthesia carts (the cart on OR No. 1), contrary to recommendations made by the Association of Professionals for Infection Control and Epidemiology. The hospital administrative staff (the Chief Nursing Officer and the Pharmacist-In-Charge) could provide no reason as to why these recommendations should not be followed with the potential that patients were exposed to the possible use of potentially contaminated medications.

Findings:

1. The Association of Perioperative Registered Nurses (AORN) is a nationally recognized organization that establishes standards of practice for the delivery of nursing care in the surgical environment (such as a Surgery Department in a hospital).

On 12/3/12 at 2:47 p.m., during an inspection of the Surgery Department, the surveyor noted that the Clinical Educator crossed a red line in the Surgery Department and followed the surveyor and the Director of Perioperative Services into a hallway that opened into two surgical suites: Operating Room (OR) No. 1 and OR No. 2. The Clinical Educator was wearing street clothes, while the Director of Perioperative Services was wearing a cap to cover his hair and surgical scrubs. The surveyor was wearing a paper coverall provided by the hospital, a cap to cover his head, and paper covers over his shoes. The Clinical Educator followed the surveyor and Director about ten feet past the red line into this hallway.

On 12/4/12, a review of the AORN publication entitled PERIPERATIVE STANDARDS AND RECOMMENDED PRACTICES, 2012 Edition, provided by the Director of Perioperative Services, indicated it documented the following under "Recommendation 1:"

Clearly defined and enforced traffic control practices protect personnel, patients, supplies, and equipment from potential sources of cross contamination.

It defined, "three designated areas," for the environment, the first two of which were, "unrestricted," where street clothes could be worn and, "semi-restricted," in which surgical attire and hair covering were to be worn. The semi-restricted area included the hallways that opened, or were adjacent to, operating rooms.

It documented the following under, "Recommendation IV:" Policies and procedures for traffic patterns for ...personnel ...should be developed. It documented that policies and procedures should include perioperative nursing diagnoses, interventions, and outcomes, such as the associated nursing diagnosis, "risk of infection," and the associated intervention: "Initiates traffic control," and, "protects from cross contamination."

On 12/4/12, a review of Policy and Procedure 3.23, entitled TRAFFIC PATTERNS IN SURGERY indicated it documented that staff would be required to wear scrub attire complying with AORN operating room attire in the, "semi-restricted," area.

On 12/4/12 at 2:49 p.m., during an interview of the Director of Perioperative Services, he stated that the red-line marked off a semi-restricted area that started at the red line. He stated that he was quite surprised when the Clinical Educator crossed the red line the previous day. He stated that the Clinical Educator did not follow the hospital policy regarding the wearing of surgical attire in the semi-restricted area.

2. The Association of Professionals for Infection Control and Epidemiology (APIC) had published a position paper in the American Journal of Infection Control entitled APIC POSITION PAPER: SAFE INJECTION, INFUSION, AND MEDICATION VIAL PRACTICES IN HEALTH CARE (2010; Vol 38: pages 167-72). This paper documented that multi-dose vials should be assigned to one patient, whenever possible, to avoid the transmission of infectious agents such as the Hepatitis B virus (page 170). It documented that: "The risk of viral hepatitis transmission posed by multi-dose vial has been clearly demonstrated and mandates a practice of using 1 vial for 1 patient whenever possible," (page 170).

On 12/5/12 at 3:01 p.m., an inspection of the anesthesia cart (contains equipment and medications used by an anesthesiologist during a surgical procedure) in OR No. 1 indicated that it contained four open multi-dose vials of injectable medications (contains a preservative that will inhibit bacterial growth, but which has no activity against viruses such as the Hepatitis B virus or the Hepatitis C virus), three of which had handwritten dates identified as, "opened dates," by the Director of Perioperative Services. These vials were:

One 10 milliliter (ml) vial of neostigmine (used to reverse the effects of paralyzing agents, used during surgery, to relax muscles such as vecuronium), with a handwritten date of 11/19/12, on the label.

One 20 ml vial of atropine (used to reduce airway secretions), with a handwritten date of 11/29/12, on the label.

One 50 ml vial of lidocaine 2% (a local anesthetic), with a handwritten date of 12/1/12, on the label.

On 12/4/12 at 10:29 a.m., during an interview of the Director of Perioperative Services, he stated that OR No. 1 had been used on 11/29/12, 11/27/12, 11/28/12, 11/29/12, and 11/30/12.

On 12/4/12 at 12:43 p.m., the surveyor reviewed an e-mail from the Pharmacist-In-Charge (PIC) in which she indicated that she would change the hospital policy regarding multi-dose vials to indicate that one vial should be reserved for use on one patient when the vial was brought to the patient's bedside, especially in the Emergency Department or the Surgery Department.

On 12/5/12 at 2:26 p.m., during an interview of the Chief Nursing Officer, she identified herself as the source for information regarding infectious disease issues at the hospital as they had no infectious disease nurse at the hospital at that time. She stated that the PIC had been trying to restrict the use of one multi-dose vial to one patient. The Chief Nursing officer stated she supported the PIC with regard to this opinion. She said she could not think of a reason why the hospital would not comply with the APIC recommendation.

On 12/12/12, a review of 17 closed record of patients who had been in OR No 1 between 11/19/12 through 12/1/12, indicated there was no evidence that the open vials had been used on more than one patient.

On 12/12/12 at 1:41 p.m., during an interview of the PIC, she stated that she could provide no reason as to why the hospital should not follow the APIC recommendation. She said if the multi-dose vial was used in a restricted area (such as drawing insulin up in a locked medication room and leaving the vial in the medication room) as opposed to use at the bedside she felt it acceptable to use it on more than one patient. However, she stated that in the OR the medication was at the patient' s bedside all the time.

Based on dietetic services observations, dietary, administrative, and engineering staff interview, administrative document review, and medical record review, the hospital failed to ensure the development of effective dietetic services as evidenced by: 1) Storage of foods in a manner that may promote cross- contamination; 2a) Failing to implement physician-ordered diets for four of eight inpatients (Patients 10, 11, 12, and 14); 2b) Failing to follow the menu for one of one patient, with a physician-ordered pureed diet (Patient 13); 3) Failing to develop a comprehensive diet manual that fully described the nutritional elements of the physician-ordered diets; 4) Failing to develop regular and therapeutic menus that met the nutritional needs of inpatients; 5) Failing to ensure food production activities that minimized cross-contamination of patient foods; 6) Absence of effective air gaps (a plumbing method between the food production equipment to prevent sewage backflow) in dietetic services; 7) Lack of effective manual dishwashing procedures; 8) Lack of sanitation of the hospital's ice machines per manufacturer's guidance; 9) Implementation of nutritional supplementation with no physicians' order for one of four patients (Patient 11), reviewed for nutrition care; and 10) Lack of a consistent plan for a high-protein diet for one of four patients (Patient 17), reviewed for nutrition care.

Failure to ensure the development of comprehensive food and nutrition services may result in practices associated with putting patients at risk for food-borne illness, delivery of patient meal trays that did not meet physicians' orders and effective nutrition.

Dietetic Services

1. During initial tour on 12/3/12, beginning at 9 am, in the dry storage room, there were multiple bags/boxes of items such as brown sugar, rice, and beans, that were opened and stored in the original shipping bag/box that was not protected during transportation. The surveyor also noted that the items had receipt dates beginning November 1, 2012. In a concurrent interview with Dietary Management Staff (DMS) she stated that while she was aware of the necessity to remove items from original packaging, she did not have enough food containers. The surveyor also noted that there was a plastic storage tote that contained bread crumbs. DMS stated that the container was purchased at a local warehouse retailer. She further stated she was unsure if the container was manufactured for the storage of food.

Review of hospital policy titled, "Safe Handling and Storage of Potentially Hazardous Foods," dated 2/12, revealed that while the hospital developed guidelines for food storage, in the dry storage area; the policy did not delineate the necessity to remove products from contaminated shipping bags/boxes. It would be the standard of practice to ensure that foods were stored in a manner to prevent cross-contamination by removing foods from original shipping bags once opened. Additionally it would also be the standard of practice to ensure that containers used for food storage were constructed from materials that did not allow the migration of deleterious substances or impart colors, odors, or tastes, to food under normal use conditions (Food Code, 2009).

2a. During trayline observation on 12/3/12, beginning at 11:45 am, the surveyor noted that there were physician-ordered 1800- and 2000-calorie American Diabetes Association (ADA) diets for Patients 10, 11, 12, and 14. The surveyor also noted that these patients selected either a turkey sandwich or a salmon and wild rice entrée. The surveyor also noted that there was no difference in the meal pattern for the patients, despite variations in the physician-ordered calorie-restricted diets. The surveyor also noted that the tray card guided patients to order their meal based on the amount of carbohydrate in foods, rather than caloric content.

In an interview on 12/3/12, with the Registered Dietitian (RD) and the Quality Assurance Manager, they stated that while they were aware that inconsistencies in diet orders were identified during the June 2012 survey, and while they completed a nutritional analysis of the menus, they had not yet implemented corrective measures. They further stated that the hospital's medical staff approved the implementation of carbohydrate-controlled diets instead of calorie- restricted diets for patients with diabetes; however the conversion had not occurred. They also acknowledged that the physicians' diet orders were not implemented, as written, and utilizing the current method of meal selection, would not allow one to determine the number of calories patients were receiving either per meal and/or per day.

b. During trayline on 12/3/12, beginning at 11:45 am, the surveyor noted that Patient 13 had a physician-ordered pureed diet. The surveyor also noted that the meal was served in an oblong bowl, with all of the menu items in the same bowl. In a concurrent interview with Dietary Staff 1, she stated that the bowl consisted of pureed beef, gravy, mashed potatoes and broccoli. Concurrent review of the regular menu for 12/3/12, noted that the non-select patient entrée was poached salmon with wild rice and cauliflower. In an interview on 12/3/12, beginning at 3 pm, with the RD, she acknowledged that the pureed entrée should have been the same as the regular entrée. She also stated that there was no menu or nutritional analysis for physician-ordered pureed diets.

3. On 12/3/12, beginning at 3 pm, the hospital's diet manual was reviewed. The surveyor noted that while the hospital had developed an undated document titled, "Facility Specific Guide to Common Diets at Healdsburg District Hospital," to be used as reference for ordering and preparing diets. The surveyor noted that the document contained 25 diets, and that for each diet there was the indication for the diet, foods allowed, foods to avoid, and one sample meal. While the document contained some of the elements of a diet manual, the document did not include the nutritional adequacy of the diet or a sample menu for three meals, that were consistent with the hospital's menu. While the diet manual had some of the elements, not all were present to allow for hospital and/or dietary staff to use as a comprehensive resource to order and/or prepare patient diets

4. On 12/4/12, beginning at 1:30 pm, the hospital's nutritional analysis was reviewed with the Registered Dietitian. The surveyor noted that while the hospital developed a non-select menu for the hospital's most commonly ordered diets and completed a nutritional analysis of these menus, the menus did not meet the nutritional needs of inpatients based on age and gender of hospital inpatients. As an example: The calcium and Vitamin D and E content of the regular menu provided less than 50% of patient nutritional needs for seven of seven days, and the fiber content of the diet was below the recommended intake for seven of seven days.

The provisions of the Dietary Reference Intakes (DRI), which included the Recommended Dietary Allowances (RDA's) Adequate Intake and Acceptable Macronutrient Distribution Range, developed by the Food and Nutrition Board, under the aegis of the Institute of Medicine, were used to evaluate nutritional adequacy of patient menus. The menus used were not effectively evaluated or adjusted for the complete array of macro and micro nutrients, specified by the DRI to ensure patient nutritional needs were met.

5. During food production observation on 12/3/12, beginning at 10 am, the surveyor noted that there were two instances, with two separate employees, touching patient foods with gloves that were not clean. The surveyor observed the DMS touching the handle of the walk-in refrigerator with gloved hands, removing a container of parsley and placing the parsley on patient plates, without removing the contaminated gloves. Similarly, the surveyor observed DS 2 wash his hands, put on gloves, open the utensil drawer, and proceed to handling ready-to-eat foods, without changing gloves or washing his hands. In a concurrent interview with the RD, the surveyor asked if she had provided in-service training regarding proper glove use. She acknowledged that she had not.

6. During general kitchen observations on 12/3/12, beginning at 10 am, the surveyor noted that while the hospital installed air gaps in the food production equipment, the installation of the air gaps did not meet the standard of practice. It would be the standard of practice to ensure that the presence of an air gap between the water supply inlet and the flood level rim of the plumbing fixture, be at least twice the diameter of the water supply inlet and may not be less than one inch (Food Code, 2009).

7. During initial tour on 12/3/12, beginning at 9:45 am, the surveyor noted that each of the 3-compartment sinks was filled. The first sink was filled with detergent, the second with plain water, and the third with a sanitizing agent. During general food production observations on 12/3/12, beginning at 12:05 pm, the surveyor observed DS 2 manually washing utensils that were utilized in food production activities in the 3-compartment sink. The temperature of the wash water was 94°F.

In an interview on 12/4/12, beginning at 2 pm, with the RD, she stated that the hospital policy was to keep the water temperature between 100-110°F. In a follow up interview on 12/4/12, beginning at 2:30 pm, she stated she checked the manufacturer's specifications for temperature requirements of the detergent which required a minimum water temperature of 110°F.

While the hospital policy titled, "Three Pot Sinks Washing and Sanitizing," dated 2/12, was developed to have a temperature range of 100-110 F in the wash cycle, it would be the standard of practice to ensure that. "The temperature of the wash solution in manual warewashing equipment shall be maintained at not less than 43°C (110°F) or the temperature specified on the cleaning agent manufacturer's label instructions," (Food Code, 2009).

8. On 12/4/12, beginning at 9 am, the process for ice machine maintenance was reviewed with Engineering Staff 1. The surveyor asked ES 1 to provide the chemicals used in the process. The surveyor noted that, in addition to a descaler, the hospital was utilizing lavender scented bleach as a sanitizing solution in the internal components of the ice machine. In a concurrent interview with ES 1, he was asked how the hospital ensured that the chemicals being utilized for food contact equipment were consistent with manufacturer's recommendations. He stated that as head of the engineering department, it would be his responsibility to ensure that maintenance was correctly completed and acknowledged he had not reviewed the product prior to implementation. The surveyor also noted that the bleach product was a 6.25% concentration. Concurrent review of the manufacturer's recommendations guided staff to use a 5.25% bleach product as a sanitizing agent.

Nutrition Care

9. Patient 11 was admitted with diagnoses including pneumonia and diabetes. A nutrition screening, dated 11/25/12, and completed by the admitting Registered Nurse (RN), failed to identify any nutrition risk factors. Admission physician orders, dated 11/25/12, was an 1800-calorie diabetic diet. A comprehensive nutrition assessment, dated 11/29/12, and completed by the Registered Dietitian, recommended a change in diet order to 2,000 calories/day, in addition to a daily nutritional supplement. A follow-up assessment recommended the implementation of a nutritional supplement twice/day. The surveyor also noted that the RD placed an undated sticker in the progress notes of the chart recommending the increase of the supplement to twice/day. There was no signature from the physician ordering this change. Review of Patient 11's meal intake indicated that on 12/1/12, Patient 11 received two nutritional supplements; however there was no signed physician order for the change.

In an interview on 12/4/12, beginning at 9:30 with the RD, she stated that nutritional supplements should have had a physician's order prior to implementation. She also stated that the supplements were routinely stocked in the nursing station and were readily available for patient use.

10. During trayline observation on 12/3/12, the surveyor noted Patient 17 had a physician-ordered high protein diet. The surveyor noted that the meal tray included salmon, wild rice, cauliflower, and dessert. Medical record review on 12/4/12, beginning at 9:30 am, revealed that Patient 17 was admitted for a surgical hip replacement. Admitting lab work, dated 11/27/12, included an albumin level (a measure of protein stores) of 2.4 gm/dl (normal 3.5-5.0 gm/dl). A post-operative diet order, dated 11/27/12, was for a high protein diet. A comprehensive nutrition assessment, dated 11/29/12, completed by the RD, noted a protein requirement of 81-102 grams of protein based on an adjusted weight of 149 pounds, rather than the admission weight of 207 pounds. The intervention also included patient teaching for a high protein diet; however there was no documentation of how that would be accomplished.

In an interview on 12/4/12 at 2 pm, with the RD, she confirmed that while she had discussed the need for additional protein with Patient 17 a plan for how that would be implemented was not developed. In a follow-up written communication with the RD on 12/5/12 at 8:50 am, she wrote that the cook added cottage cheese to the meal tray; however that was not observed by the surveyor. She also stated that the cook chose the cottage cheese because she thought adding additional salmon would be too much meat. There was no indication that patient preferences were taken into consideration when developing this nutritional intervention.

Review of undated hospital document titled, "Facility Specific Guide to Common Diets at Healdsburg District Hospital," revealed that the meal pattern for the high protein/calorie diet would include whole milk, cream of mushroom soup, 5 ounces of meat, 1 cup vegetables, 1 cup starch and ½ cup of ice cream. There was no indication that the hospital prepared the diet in accordance with the hospital's diet manual or in accordance with patient preferences.