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Based on staff 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.

Findings:

On 1/8/14 at 11:45 a.m., in an interview and document review, the quality appraisal and performance improvement (QAPI) data for food and nutrition services was reviewed with the Area Nutrition Services Director (ANS) D, who actively participated in the hospitals' performance improvement program. The 2013, PI data, related to food service, pertained to cleanliness rounds, temperature, and sanitation monitoring, pre-meal checks, which evaluated the temperature and quality of the food, and hand hygiene compliance. The food service data also included quarterly safety rounds and facility repairs. The data also included dietary departmental checklists, which consisted of hospital safety rounds, and kitchen inspections. It was noted on the Executive Summary, that all measured parameters for food services reflected an acceptable threshold for the department. There was no identification of opportunities for performance improvement activities related to food services for 2013.

In a concurrent interview with ANS D, she acknowledged that the reported activities were reflective of monitoring activities rather than activities for which there would be opportunities for improvement. There was no documentation provided to ensure the QAPI program was developed to fully evaluate the outcomes of processes within hospital food service. There was no indication that the hospital developed a QAPI program that identified opportunities for patient outcome in relationship to clinical nutrition care.

On 1/8/14 at 4:20 p.m., an interview was conducted with the ANS D regarding the nutrition care PI (performance improvement) activities. The performance improvement data for 2013, noted that the PI activities for clinical nutrition care data focused on the Registered Dietitian intervention with complete and timely documentation of the nutrition assessment, medical nutrition goal, care plan completeness, and outcomes documentation. It was noted that all measured parameters for nutrition care reflected an acceptable threshold for the department. There was no identification of opportunities for performance improvement activities related to food and nutrition services for 2013. The ANS D acknowledged that these reported activities were also reflective of monitoring activities rather than activities for which there would be opportunities for improvement.

Review on 1/9/14, of the hospital document titled, "Performance Improvement (PI) Plan 2013," noted that the purpose of the plan was, "to continuously seek and act on opportunities to improve the quality and value of our services that meets the needs of our patients." It was also noted that the scope of the plan was to encompass all departments within the organization. While the food and nutrition department was collecting data, there was no identification of activities that may have led to improvement in the performance of the department.

Based on observation, by two surveyors, of four nurses passing medications to four patients, clinical record review, and staff interview, two patients (Patient 251 and Patient 252) did not receive oxycodone, a narcotic pain reliever, as ordered by their physician, for the pain level they reported to the nurses. Patient 251 received 10 mg of oxycodone for a pain level of 3 (on a pain scale of 0 to 10, with 0 being no pain and 10 being the worst pain imaginable by the patient) when the physician had ordered that Patient 251 receive this dose for a pain level of 7 to 10. Patient 252 received 10 mg of oxycodone for a reported pain level of 7 when the physician had ordered that Patient 252 receive 20 mg (twice the dose actually given) for a pain level of 7 to 10. During the medication pass observed by this surveyor and a medication pass observed by another surveyor, a total of 18 opportunities for error were observed, and two errors were made, for an error rate of 11%. Further clinical record review indicated that nursing staff did not administer 10 out of 18 doses of oxycodone to Patient 251, according to the physician's orders, between 6:15 a.m. on 1/10/14, and the observed medication pass. Further clinical record review indicated that nursing staff did not administer two out of nine doses of oxycodone to Patient 252, according to the physician's order, between 5:55 a.m. on 1/11/14, and the observed medication pass.

Findings:

1. On 1/13/14, Nurse I administered two oxycodone 5 mg tablets to Patient 251 at 9:17 a.m., following Patient's 251's report of a pain level of 3. On 1/13/14, a review of Patient 251's clinical record indicated that on 1/9/14 at 10:30 a.m., a physician had written the following orders for Patient 251:

Oxycodone 5 mg every 4 hours as needed for moderate pain (pain scale of 4 to 6).

Oxycodone 10 mg every 4 hours as needed for severe pain (pain scale of 7 to 10).

Therefore, Patient 251's pain level of 3 did not qualify the patient to receive oxycodone at all, let alone the 10 mg dose (as opposed to the lower 5 mg dose).

On 1/13/14 at 10:42 a.m., during an interview of Nurse I on the 2 Center Nursing Unit, she stated she did not give the oxycodone to Patient 251 as directed by the physician's order. She stated that the reason she did this was Patient 251 had been taking 10 mg (two 5 mg tablets) of oxycodone on a regular basis and that most patients who had had surgery such as Patient 251 had undergone took the pain medication every four hours or the pain would go out of control. She stated she had cared for Patient 251 for the first time on 1/13/14, and she was afraid that if she dropped the dose to a lower dose (5 mg in this case) the pain had a high probability of going out of control. She stated she had not communicated with the physician regarding this issue.

Further review of Patient 251's clinical record on 1/13/14, indicated Patient 251 received the following doses of oxycodone on the following dates and times for the following patient reported pain levels and, therefore, were not given according to the physician's orders:

1/10/14 7:15 p.m. oxycodone 10 mg Reported pain level: 6
1/11/14 6:21 a.m. oxycodone 10 mg Reported pain level: 6
1/11/14 10:20 a.m. oxycodone 10 mg Reported pain level: 6
1/11/14 2:30 p.m. oxycodone 10 mg Reported pain level: 6
1/11/14 11:36 p.m. oxycodone 10 mg Reported pain level: 5
1/12/14 6:04 a.m. oxycodone 10 mg Reported pain level: 6
1/12/14 10 p.m. oxycodone 10 mg Reported pain level: 5
1/13/14 12:28 a.m. oxycodone 10 mg Reported pain level: 5
1/13/14 5:02 a.m. oxycodone 10 mg Reported pain level: 4
1/13/14 9:17 a.m. oxycodone 10 mg Reported pain level: 3 (this was the dose the surveyor saw administered to Patient 251 on 1/13/14 during the medication pass observation).

Note: The 1/13/14 dose at 12:28 a.m., was given 2.5 hours after the prior dose, not 4 hours, as ordered by the physician.

Administrative Staff K verified the above observations at the date and time of the record review.

In summary: From 1/10/13 starting at 6:15 a.m., through 1/13/14 at 9:17 a.m., Patient 251 received 18 doses of oxycodone and 10 of these doses were not given as ordered by the physician.

2. On 1/13/14, Nurse J administered two oxycodone 5 mg tablets to Patient 252 at 9:02 a.m., for Patient 252's report of a pain level of 7. On 1/13/14, a review of Patient 252's clinical record indicated that on 1/10/14 at 2:15 p.m., a physician had written the following orders for Patient 252:

Oxycodone 5 mg every 4 hours as needed for mild pain (pain scale of 1 to 3).

Oxycodone 10 mg every 4 hours as needed for moderate pain (pain scale of 4 to 6).

Oxycodone 20 mg every 4 hours as needed for severe pain (pain scale of 7 to 10).

Therefore Patient 252 received 50 percent less oxycodone than ordered by the physician, for the reported pain level of 7.

On 1/13/14 at 10:42 a.m., during an interview of Nurse J on the 2 Center Nursing Unit, she stated the patient has only been getting the 10 mg dose of oxycodone and it had controlled Patient 252's pain. She stated her reasoning was, why give 20 mg when 10 mg controlled the pain. She stated she had not communicated with the doctor. She stated she did not know that she had to call the doctor to give less pain medication than was ordered. She stated that she could not imagine calling the doctor to adjust pain medications (according to the patient's individual needs), as if she did so she would not get her work done.

Further review of Patient 252's clinical record on 1/13/14, indicated Patient 252 received the following doses of oxycodone on the following dates and times for the following patient reported pain levels, that were not given according to the physician's orders:

1/11/14 3:06 p.m. oxycodone 10 mg Reported pain level: 8
1/13/14 9:02 a.m. oxycodone 10 mg Reported pain level: 7 (this was the dose the surveyor saw administered to Patient 252 on 1/13/14, during the medication pass observation).

Administrative Staff B and Administrative K verified the above observations at the date and time of the record review.

In summary: From 1/11/13 starting at 5:55 a.m., through 1/13/14 at 9:02 a.m., Patient 252 received nine doses of oxycodone and two of these doses were not given as ordered by the physician.

Based on medical record review and nursing staff interview, the hospital failed to ensure that all medical record entries were fully authenticated with the signature, date or time of all medical record entries.

Findings:

Patient 300 was admitted with diagnosis including a resection of the right side of the neck/cheek. Medical record review was conducted on 1/7/14 beginning at 9:30 am. Admission orders dated 12/27/13, included a speech therapy (ST) evaluation. The ST evaluation was completed on 12/18/13. Review of hospital document titled, " Physician Orders," noted that there was an order titled, "Diet Clarification," which made recommendations to the physician regarding diet texture, liquid consistency, staff supervision as well as nursing guidance regarding crushing the patients' medications. While the entry was dated and timed, it did not have an authenticating signature. It was also noted that the physician signed the order; however it was not dated or timed. An additional entry completed by the speech therapist dated 12/30/14, failed to have an authenticating signature. Similarly while it was signed by the physician there was no dating or timing of the order.

In an interview with Registered Nurse MMM, she was asked to describe the process for documenting orders in the hard copy of the medical record. She stated that in the acute rehabilitation unit, order entry was done on paper. She also stated that when the speech therapist completed an, "order clarification," it was written in the physician order section of the medical record. She also stated that the order entry was generally not signed. She further stated that once the order was signed by the physician the order would be entered into the electronic medical record after which the orders would be transmitted as appropriate to the dietary department for implementation.

Based on document review and staff interview, the hospital failed to ensure that medical records were completed within 14 (fourteen) days following discharge, as required by their medical staff bylaws, rules and regulations. This failure had the potential to result in the lack of pertinent information being available for the patient's continuing care after discharge.

Findings:

On 1/7/14 the Medical Staff Rules and Regulations, last approved 12/3/13, were reviewed. Section 2.10, "Timely Completion of the Medical Records," states in part: "Medical records shall be completed promptly and authenticated or signed by a practitioner within fourteen (14) days following the patient's discharge...." Also, Section 2.4.f, "Discharge Summary," states in part: "The discharge summary shall be dictated by the responsible practitioner and completed within seven (7) days after the patient's discharge.

On 1/9/14 beginning at 9:50 am, the report of delinquent records (those still incomplete 14 days following discharge) was received and reviewed with HIS Staff SS. This report listed 281 delinquent records awaiting completion by 89 physicians. Of these, there were 48 delinquent discharge summaries. In addition, a separate report of the Emergency Department delinquent records was received and reviewed at the same time. This report listed a total of 58 delinquent records awaiting completion by 13 physicians.




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Based on document review and staff interview, the hospital failed to ensure that medical records were completed within 14 (fourteen) days following discharge, as required by their medical staff bylaws, rules and regulations. This failure had the potential to result in the lack of pertinent information being available for the patients' continuing care after discharge.

Findings:

On 1/7/14, the Medical Staff Rules and Regulations, last approved 12/3/13, were reviewed. Section 2.10, "Timely Completion of the Medical Records," indicated in part: "Medical records shall be completed promptly and authenticated or signed by a practitioner within fourteen (14) days following the patient's discharge...." Also, Section 2.4.f, "Discharge Summary," indicates in part: "The discharge summary shall be dictated by the responsible practitioner and completed within seven (7) days after the patient's discharge."

On 1/9/14 beginning at 9:50 am, the report of delinquent records (those still incomplete 14 days following discharge) was received and reviewed with HIS Staff SS. This report listed 281 delinquent records awaiting completion by 89 physicians. Of these, there were 48 delinquent discharge summaries. In addition, a separate report of the Emergency Department delinquent records was received and reviewed at the same time. This report listed a total of 58 delinquent records awaiting completion by 13 physicians.

Based on observation, interview, and record review, the hospital failed to ensure the pharmacy administration staff consulted the organized medical staff through the auspices of the Pharmacy and Therapeutics Committee (committee with oversight of the pharmaceutical services and with representatives from the medical, pharmaceutical, nursing, and administrative departments) before discontinuing the production of a non-drug substance, Alum, for the treatment of hemorrhagic cystitis (bleeding inside of the bladder), a potentially serious complication of radiation therapy of the pelvic region. As a result, physicians who may have cause to prescribe this therapy, as described in the medical literature, did not have an opportunity to provide input as to the need for the use of alum as opposed to other therapies, including the relative risks and benefits of these alternative therapies, and were not so informed of this decision by the Pharmacy Department so that they could make informed prescribing decisions, at a future date, for any given patient with this condition. As a result, therapy might be delayed or a decision may have been made, to proceed with compounding alum irrigation solution from non-sterile ingredients, when pharmacy administration staff had not evaluated the compounding pharmacists' competency to perform terminal sterilization of the alum solution.

Findings:

The American Society of Health System Pharmacists (ASHP) is a nationally recognized organization that sets standards of practice for hospital pharmacies. This organization has documented that the executive leadership of the pharmacy has responsibility for the pharmaceutical services, but decisions regarding the pharmaceutical services are made in consultation with other professionals in the hospital, especially the medical staff, under the oversight of the Pharmacy and Therapeutics committee.

This organization has published ASHP GUIDELINES: MINIMUM STANDARD FOR PHARMACIES IN HOSPITALS in which it documents:

"A pharmacist shall be a member of and actively participate in hospital ...committees responsible for establishing and implementing medication-related policies and procedures ..." (Under "Committee Involvement").

"There shall be policies and procedures that describe how the pharmacy shall seek and obtain documented authorization from appropriate medical staff and hospital committees prior to the medical use of any chemical substance that has not received Food and Drug Administration (FDA) approval for use as a drug or medical nutrition therapy."

In ASHP STATEMENT ON PHARMACIST'S RESPONSIBILITY FOR DISTRIBUTION AND CONTROL OF DRUG PRODUCTS, the ASHP has documented:

"The pharmacist is responsible for the development, in consultation with appropriate other professionals, departments, and interdisciplinary committees in the setting, of all drug-use control policies."

"For purposes of this document, drugs include ...other chemicals ...administered to patients to evoke or enhance pharmacologic responses."

In summary: the hospital pharmacist is responsible for the pharmaceutical services, but policy and procedure development is conducted in consultation with other health professionals, especially the organized medical staff, through appropriate committees. This is especially important when a chemical substance that is not FDA approved is used as a medication to treat patients in a hospital.

Alum is a compound that describes various aluminum containing compounds. Two that appear in the UNITED STATES PHARMACOPEIA/NATIONAL FORMULARY are Ammonium Alum and Potassium Alum (USP 32/NF 27). Alum has been used to treat hemorrhagic cystitis. The effect of Alum results from the precipitation of proteins over bleeding site in the bladder. Constriction of the blood vessels in the bladder and decreased permeability of the capillaries in the bladder also contribute to the mechanism of Alum in the treatment of hemorrhagic cystitis. Alum is not sterile while the bladder is normally sterile (an exception occurs during bacterial infection of the bladder), and Alum solutions must be sterilized prior to installation into the bladder, to prevent infection of the bladder. Currently, there are no FDA approved preparations of Alum.

On 1/10/14, a review of the contents of a binder entitled, COMPOUNDING BOOK, in the pharmacy, indicated it contained two printed sheets documenting the use of a preparation of Alum, for irrigation of the bladder, to treat hemorrhagic cystitis. Pharmacy staff had downloaded the first sheet on 11/14/12, from the University of Illinois College of Pharmacy website. The information on the sheet documented it was from the Drug Information Group and was entitled, WHAT IS ALUM IRRIGATION THERAPY FOR BLADDER HEMORRHAGE?

This paper documented that infection, cancer, radiation, and medications could all be, "potential causes of severe bladder hemorrhage," and that this could, "be life threatening." The paper provided directions for preparing a solution of Alum for irrigation. It documented Alum irrigation of the hemorrhaging bladder had a 66 to 100% response rate and a low occurrence of side effects. It described the risk of aluminum toxicity as patients with bladder wall damage could be at increased risk of aluminum toxicity. In the left hand margin of the paper, someone had handwritten in directions for compounding this solution.

The second paper in the COMPOUNDING BOOK was an e-mail dated 12/1/12. It documented: "The way we have been compounding alum for bladder irrigation is not sterile. According to USP 797, high risk compounding techniques such as this need a final product sterilization." This e-mail then provided directions to compound and sterilize the Alum solution by filtration. A second method to prepare a sterile solution was taped to this e-mail.

These documents indicated three things:

The preparation of alum had been considered by pharmacy personnel in November and again in December 2012.

The 12/1/12, e-mail documented that prior to the e-mail, this product had been compounded in the pharmacy from non-sterile products.

The 12/1/12, e-mail documented (correctly) that compounding sterile products from non-sterile ingredients is considered high-risk compounding according to USP 797 (which in fact is documented in USP 797).

On 1/10/14 at 10:47 a.m., during an interview of the Director of Pharmacy, he stated this was a one-time product, not a batch, and therefore there was no log. During an interview of the Pharmacy Clinical Coordinator at that time, she stated she recalled one product was made for a patient in 2013.

At that time the surveyor requested that the Director of Pharmacy provide evidence that staff competency to compound sterile compounded products from non-sterile materials had been assessed, as documented in USP 797. He was also asked for any policies regarding compounding sterile products from non-sterile ingredients. The Director of Pharmacy stated he would look into these requests.

On 1/10/14 at 2:03 p.m., the Director of Pharmacy produced a document entitled, PHARMACY HUDDLE NOTES, dated 9/30/13. A review of those notes indicated that the Director of Pharmacy and the Clinical Coordinator had attended a meeting of the pharmacy staff that day at which it was announced that the pharmacy was not certified to make alum solutions for irrigation, and that the pharmacy would no longer make this product. During an interview of the Director of Pharmacy at that time, he stated that the alum compounding recipes had been left in the COMPOUNDING BOOK in error and it should have been taken out. He stated the hospital would use mitomycin to treat hemorrhagic cystitis.

On 1/10/14, a review, in the office of the Director of Pharmacy, of the 2010 AMERICAN HOSPITAL FORMULARY SERVICE, published by ASHP, indicated it documented mitomycin was used to treat bladder cancer, but it did not indicate it was used to treat hemorrhagic cystitis.

On 1/10/14 at 2:11 p.m., during an interview of the Director of Pharmacy, he could provide no evidence that mitomycin was used to treat hemorrhagic cystitis. He stated that the Pharmacy Operations Manager (POM) had told him the alum issue had not been discussed at the Pharmacy and Therapeutics Committee Meetings.

On 1/10/14 at 3 p.m., during a telephone interview of MD II, he stated that he was familiar with hemorrhagic cystitis. He stated it was not that rare and he had seen lots of cases in multiple patients in hospitals. He stated mitomycin was not used to treat hemorrhagic cystitis: It was used to treat bladder cancer. MD II stated he had not been told that alum was not available in this hospital and that he did not feel good about that. He stated alum was in an algorithm to treat hemorrhagic cystitis, resulting from radiation therapy, which was difficult to treat. MD II stated the first line treatment of hemorrhagic cystitis was continuous bladder irrigation, and the second line treatment was irrigation with alum solution. This was followed by irrigation with a solution of Amicar (used to treat certain bleeding conditions), but that Amicar had an increased risk of deep vein thrombosis (blood clot in leg veins that could break loose and result in a lung clot or a stroke). Other treatments included surgery, embolization (blockage) of blood vessels supplying the bladder, removal of the bladder (he stated this was a high risk procedure), and installation of formalin (a preservative that fixed tissue) into the bladder. MD II stated he felt he had ordered alum at least once in the last six months, and he would like to have it available. MD II concluded the interview by saying that he would like to be informed by the hospital of the ultimate decision, as to the availability of alum solution for irrigation, so he could make an informed decision when treating his patients for hemorrhagic cystitis and so he could inform his partner of this decision.

Based on facility observation, interview, and document review:

1. The hospital failed to ensure that the Department of Pharmacy IV Room compounding policy stipulated that compounding staff wear shoe covers and, for those with a beard, a facial hair cover (in addition to a face mask) when working in the intravenous solution compounding room (IV room) as required by Chapter 797 of the United States Pharmacopeial Convention (USP 797: Sets standard for compounding compounded sterile products or CSPs), which the hospital pharmacy staff identified as a standard the hospital followed. The policy did not require that staff remove all cosmetics, as required by USP 797, when working in the IV room. The policy did not address the cleaning of the walls and ceiling of the IV room, as stipulated in USP 797. It provided for beyond use dates, based on stability of the CSPs, rather than their stability as documented in USP 797. Finally, there was an, "If," statement in the policy without the following conclusion as embodied by a, "Then," clause instructing staff what to do if the first condition was noted by staff (see finding 1).

2. The hospital failed to ensure the Environmental Services (EVS) policy, regarding the cleaning of the IV room by EVS staff, reflected actual hospital practice, when it failed to stipulate that EVS staff must wear a hair cap and, if they had a beard, a facial hair cover (in addition to a gown, gloves, face mask, and shoe covers) when, in fact, the director of EVS stated staff had been taught to wear all of those items (see finding 2).

3. The hospital failed to ensure that 1,774 vials of nitroglycerin 100 micrograms(mcg)/10 milliliters (ml) for bolus compounded between 2/28/13 through 12/29/13, had been assigned a beyond use date of nine days under refrigeration (or less), as stipulated by USP 797, for medium risk CSPs. Staff had assigned a 15-day beyond use date to these products, as documented in the pharmacy compounding log. This had the potential to make potentially contaminated products available for patient use. The Pharmacy Director of Clinical Services stated this CSP was used in the Catheter Lab to help visualize the coronary arteries (see finding 3).

4. The hospital failed to ensure that irrigation solutions of normal saline (0.9% sodium chloride) and sterile water, for irrigation packaged in 1000 ml plastic irrigation containers, were stored for no more than 28 days, as specified by the manufacturer (Manufacturer JJJ), when warmed in the Ambulatory Surgery Center warmer (used to warm solutions before they were applied to or infused into patients). This had the potential to have solution available for patient use beyond the time that Manufacturer JJJ would warrant the suitability of these solutions for use on patients (see finding 4).


Findings:

1. 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. The USPs revised general chapter <797> entitled, PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS, documents that: "The objective of this chapter is to describe conditions and practices to prevent harm, including death that could result from (1) microbial contamination (nonsterility) ..."

USP 797 described a compounding hood in a clean room. The hood must provide an ISO 5 environment (not more than 3520 particles per cubic meter of air) and be stationed in a clean room, with filtered air, that met an ISO 7 standard (not more than 352,000 particles per cubic meter of air) in order to assign a
48 hour beyond use date to a low risk compounded sterile product (only sterile products used to compound the compounded sterile product and only single transfers made from vials into the final container with only two punctures of the final container) or a 30-hour beyond use date for an intermediate risk compounded sterile product (more complex compounding than the low risk compounding). These beyond use dates are based on sterility concerns because USP 797 assigns them, "...in the absence of passing a sterility test ...," as described in USP Chapter 71.

USP 797 documented that the buffer area was the area where the hoods were located and could be walled off with doors and a wall or left open, but demarcated in some fashion, such as placing a prominent line on the border between the buffer and ante-area. Staff members must cover their hair, cover their facial hair if they have a beard, wear a face mask over their mouth, wear a gown, wear shoe covers, and wear gloves in the buffer area. USP 797 stipulated that staff must remove all cosmetics before entering the clean room. The ante-area was where labeling and distribution activities occur. This area (buffer and ante-area), in order to be an ISO 7 area would be walled off from the rest of the pharmacy and accessed via a door. The IV room walls and ceiling (buffer and ante area) must be cleaned and disinfected at least once a month, according to USP 797.

On 1/6/14 at 10:15 a.m., during an interview of the Director of Pharmacy, he stated that the IV room policy had been changed to follow best practices, including USP 797 (USP 797 documented that, "...this chapter provides minimum practice and quality standards for CSPs ...").

On 1/6/14, a review of Policy and Procedure MM 4.2 entitled, STANDARD OPERATING PROCEDURES FOR STERILE COMPOUNDING (No Effective Date, Review/revised 9/13), indicated it did not stipulate and provide for the cleaning and disinfection of the walls and ceilings of the IV room. It did not address the need for staff to wear shoe covers and a facial hair cover (if needed to cover a beard in addition to a face mask). It documented that staff should not wear, "excessive," makeup in the IV room. Under, "Admixture Checking," it documented that the standard BUD (beyond use date) would be 48 hours, "...unless stability data of the drug was different." USP 797 beyond use dates were based on sterility concerns, while the product stability was only taken into consideration in assigning beyond use dates of shorter duration relative to the USP specified beyond use dates. Finally, under, "Preparation of Labels," #4 the policy had an, "IF," statement that was not followed by a, "THEN," statement telling the reader what to do.

On 1/6/14 at 11:46 a.m., during an interview of the Director of Pharmacy, he stated that he was not sure why the policy and procedure did not address the use of shoe covers and facial hair masks. He could not explain why the policy deviated from USP 797 with regard to the wearing of makeup in the IV room. He felt that linking the beyond use date in the policy and procedure to stability alone, rather than to sterility of the compounded product, was an error. With regard to the, "IF ...THEN," issue the Director of Pharmacy stated he would look into it to see if there was something that could be changed: This had not been done by the end of the survey.

2. On 1/6/14, a review of the Environmental Services (EVS: Housekeeping) policy and procedure entitled, IV ROOM CLEANING (Effective 9/11, Reviewed/revised 8/13), documented that EVS staff were to don shoe covers, gowns, and gloves when cleaning the IV Room. It did not stipulate that staff needed to wear a hair cover, a face mask, and a facial hair cover (if the staff member had a beard) when cleaning the IV Room.

On 1/9/14 at 9:22 a.m., during an interview of the Director of Pharmacy, he stated he had seen the EVS staff cleaning the IV room floors, and he recalled they wore a hair cover, gown, and shoe covers, but he did not, "feel," they were wearing face masks. He volunteered this may have been covered in the competency exam given to the EVS staff.

On 1/9/14, a review of the EVS IV ROOM COMPETENCY exam answer key, provided by the Director of Pharmacy, indicated that question 11 was the only question that addressed personal protective covering (PPE: The shoe covers, gowns, gloves, etc. worn by staff in the IV Room). Question 11 queried EVS staff what the correct steps to take prior to performing any work in the IV room. The correct answer, indicated in yellow highlighter on this document, was: "Put on shoe covers, put on head cover, perform hand hygiene procedure, wear gown, then wear gloves. (sic)" It was silent regarding facial hair covers (for those staff with beards) and facial masks used to cover the mouth. This observation was verified at that time, with the Director of Pharmacy by interview.

On 1/91/14 at 10:09 a.m., during an interview of the Director of EVS AAA, he stated that EVS staff had been taught to wear shoe covers, gown, hair cap, gloves, face mask, and a facial hair cover (if needed) when cleaning the IV Room. At that time, the Director of Pharmacy went to look for the facial hair masks, but he returned and stated that none were available in the pharmacy at that time.

3. On 1/9/14 at 12:07 p.m., during an inspection of the refrigerator in the Ambulatory Surgery Clinic sterile core, the surveyor observed one 10 ml vial labeled as Nitroglycerin (NTG) Bolus 100 mcg/10 ml. It had been labeled with a printed label from the pharmacy indicating it was a pharmacy compounded product and had an assigned batch number of, "#047 kg," on the label and an assigned beyond use date of, "Discard After 01/13/2014."

On 1/9/14 at 1:56 p.m., a review of the COMPOUNDING AND REPACKAGING LOG in the pharmacy, indicated it contained a sheet on which pharmacy staff documented the compounding of this product, and it documented staff were to give it a, "15 DAY EXPIRATION." Batch #47 kg appeared on this sheet. It had been compounded on 12/29/13, and been assigned a beyond use date of 1/13/14, which, in fact, was 15 days after the compounding date. It documented that pharmacy staff had compounded 75 vials of this product on 12/29/13. Further review of the log indicated it documented that pharmacy staff had compounded 1,774 such vials between 2/28/13 through 12/29/13, and the designated beyond use date documented on the log for this period was 15 days after the compounding date.

On 1/9/14 at 2:21 p.m., during an interview of Pharmacy Tech JJ regarding the compounding of the NTG Bolus solution for injection, she stated staff used a 50 ml vial of NTG 50 milligrams (mg)/10 ml for injection (purchased from a manufacturer), and 0.2 ml was injected into a 10 ml vial of sterile normal saline (0.9% sodium chloride: Also from a manufacturer) for injection. She stated that one would need one and a half vials of the commercially-manufactured NTG solution for injection to make 75 vials. She stated she used the same syringe throughout the compounding process, but changed the needles each time after three vials had been compounded. Hence the commercially available NTG vial would be penetrated 50 times to make 50 vials of the compounded NTG Bolus, which made the compounded product a medium risk product. USP 797 stipulated that medium risk products be assigned a 9-day beyond use date when stored under refrigeration, in the absence of sterility tests being conducted on the product. During an interview of the Director of Pharmacy at 2:25 p.m., conducted at that time he verified the above observations. He stated the NTG Bolus for injection solution was a medium risk product secondary to the repeated puncturing of the commercially available NTG vials used to compound the NTG Bolus solution for injection. He stated he could not justify the 15 day beyond use date the hospital assigned to the compounded NTG Bolus solution for injection.

4. On 1/9/14, at an inspection of the single warmer in the Ambulatory Surgical Clinic Sub Sterile Room, indicated it contained 1000 ml plastic irrigation containers (PICs) of normal saline for irrigation and sterile water for irrigation made by Manufacturer JJJ.

On 1/9/14 at 12:26 p.m., during an interview of the Ambulatory Surgical Center Manager, she stated that staff assigned a 30-day beyond use date to the PICs stored in warmers at 104 degrees F. This statement was seconded by an interview of the Director of Surgical Services at that time.

Manufacturer JJJ had documented in a letter available upon request to providers, that it's PICs can be stored, "...up to one month (4 weeks) storage at 40 [degrees] C." Forty degrees C equals 104 degrees F. Four weeks is 28 days.

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 (Cross Reference A749);
2. Provide a comprehensive therapeutic diet manual that reflected the diets offered in the hospital (Cross Reference A631);
3. Ensure the nutritional needs of patients were met, as evidenced by the implementation of regular and therapeutic menus that did not consistently meet the Dietary Reference Index for nutrients (Cross Reference A630);
4. Lack of menus for all physician-ordered diets (Cross Reference A628);
5. Lack of an effective system to ensure that all diets were ordered by physicians' responsible for patient care (Cross Reference A629);
6. Ensure adequate food supplies, per the hospitals' disaster preparedness plan, and effective preventive maintenance of all dietetic services areas, to minimize the risk of cross-contamination of foods (Cross Reference A701); and
7. Ensure that performance improvement activities demonstrated opportunities for improvement of services and fully reflected the depth and scope of the department (Cross Reference A283).
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 staff interview and document review, the facility failed to ensure: 1) there was a seven day non-select menu for the vegetarian diet or nutrient analysis, to ensure they met the needs of the patients; and 2) there was a
seven-day non-select menu for the Pediatric menu, aged 9-12 months and 1-3 years, or daily nutrient analysis to ensure they met the needs of the patients. This put patients at risk of menus not providing required nutrients and compromising medical care.

Findings:

1. A review of the hospital's patient menus showed that there was no seven day non-select menu for the vegetarian diet or nutrient analysis, to see if they met the Dietary Reference Intakes (DRIs). The hospital had a one-page sheet that included vegetarian and vegan selections, Nondairy Milks and condiments.

During an interview with the Area Nutrition Services Director (ANSD), on 1/6/14 at 2:05 p.m., she stated patients on a vegetarian diet would get a menu for the regular diet then they would also get the one-page sheet with their selections, and the patient could write on their menu what they wanted. The ANSD acknowledged there was not a full menu or a nutrient analysis of this diet.

Review of the hospital 's policy and procedure titled, "Master Patient Menu" dated 5/89 revised/reviewed 8/13, indicated the standard menu had a one-week cycle.

2. A review of the hospital's patient menus showed that there was no seven-day non-select menu for the pediatric menu ages 9-12 months or 1-3 years. The nutrient analysis was just for a one-day menu to see if they met the Dietary Reference Intakes (DRIs). For the Pediatric menu ages 1-3 years, there was a one-day menu with a non-select breakfast. The lunch and dinner had the option of either pasta or fine cut meat; then an option of vegetable of choice: Soft broccoli, carrots, green beans, peas, or zucchini; soft fruit cup, ½ slice wheat bread, butter and whole milk. For the Pediatric diet ages 9-12 months, there was a one-day menu with only choice of infant meat: Chicken or beef for lunch and dinner. The one-day menu for all three meals showed there were only three choices of fruit (bananas, pears, apples), two choices of vegetables (peas and carrots) and infant rice cereal.

During an interview with the ANSD, on 1/6/14 at 4:05 p.m., she stated the pediatric menu was parent driven. The ANSD stated there was a three-day menu in the kitchen- and this was what was in the nutrient analysis. The ANSD stated they had more options that followed the regular menu, however acknowledged this was not on the menu for them to be aware of or to choose from.

Review of the hospital's policy and procedure titled, "Master Patient Menu" dated 5/89 revised/reviewed 8/13, indicated the standard menu had a one-week cycle.

Based on observations, medical record review, staff interview, and document review, the hospital failed to ensure: 1) diet texture changes, as a result of speech therapy evaluation, were ordered by the physician prior to implementation; and 2) a house-made nutrition supplement was ordered by the physician prior to implementation. Failure to obtain physicians' orders may result in further compromise of medical status.

Findings:

1. Patient 302 was admitted with a diagnosis of Huntington's Disease (an incurable brain disorder that affects muscle coordination and behaviors, National Institute of Medicine). Patient 302 also had a long-standing history or poor appetite and dietary intake. Medical record review was conducted on 1/7/14 beginning at 1:30 pm.

A comprehensive nursing admission assessment dated 1/5/14, noted that the patient was at nutritional risk. Admission physician orders dated 1/5/14, requested a speech therapy (ST) evaluation. The ST evaluation dated 1/6/14, noted the patient had a history of esophageal resection with a pureed diet at home. It also noted that the speech therapist had initiated a trial of soft chewable foods, which was unsuccessful. In a follow-up assessment on 1/7/14, ST Staff LLL changed the diet order to dysphasia ground with thin liquids.

In an interview on 1/7/14 beginning at 2 pm, with ST Staff LLL, she was asked to describe the ST evaluation process, in particular if there was a recommendation for a diet change. She stated that upon referral from a physician, a swallowing evaluation would be conducted. She also stated that upon completion of the evaluation she would log into the electronic medical record under the, "orders," section and enter the desired diet change, at which point the order would automatically print in the dietary department to be implemented at the next meal. ST Staff was also asked if the physician signed diet change orders prior to their implementation, to which she replied, "no." ST Staff LLL also stated that altering the texture of physician-ordered diets was within the California Scope of Practice for Speech Pathologists.

Review of the California Business and Professions Code §2530.2 summarized the practice of Speech Language Pathology as the application of principles, methods, instrumental procedures, and non-instrumental procedures for measurement, testing, screening, evaluation, identification, prediction, and counseling, related to the disorders of speech, language, and swallowing. There was no authority within the practice act that allowed for the Speech Language Pathologist to implement diet orders.

Review of hospital policy titled, "Dysphagia Assessment and Treatment," dated 7/12, allowed the speech pathologist to edit or initiate a diet order through the electronic medical record, the practice was not supported by the professions' scope of practice within California Law. It was also noted that while the policy included references from national professional organizations and professional publications, it did not include any references associated with the California Business and Professions Code.

2. Clinical Record review was initiated on 1/7/14 for Patient 351. Patient 351 was admitted to the hospital for further management of necrotizing fasciitis (a rare infection of the deeper layers of skin and subcutaneous tissues, easily spreading across the fascial plane within the subcutaneous tissue). Patient 351 was emergently sent to the operating room for an above knee amputation on the right lower extremity.

Review of the Nutrition Re-Assessment dated 12/26/13, indicated by the Registered Dietitian (RD) that she recommended an oral supplement of a fat-free protein supplement twice a day. The RD interventions were food preferences/menu assistance, nutritional shake, and for the RD to monitor intake/menu. The RD follow-up plan for progress towards goals was 1-2 times per week. Review of the Nutrition Re-Assessment dated 1/2/14, indicated Patient 351 was receiving a 2000-calorie diabetic diet, Boost Glucose Control (nutrition supplement) twice a day, and Real Fat-free protein shakes twice a day. The RD indicated to continue with the Boost Glucose Control and fat-free protein shakes twice a day. Review of the Nutrition Re-Assessment dated 1/7/14, indicated Patient 351 was receiving a 2000-calorie diabetic diet, Boost Glucose Control (nutrition supplement) twice a day, and Real Fat-free protein shakes twice a day. The RD indicated to continue with the Boost Glucose Control (no chocolate per patient preference) and fat-free protein shakes twice a day.

Review of the physician's orders dated 12/28/13, indicated a 2000-calorie diet and Boost Glucose Control twice a day with meals.

Review of the Diet list dated 1/7/14, indicated Patient 351 was receiving Boost Glucose Control at breakfast and dinner, large protein portions, real vanilla fat-free shake at lunch, strawberry fat-free shake at dinner, and a 2000-calorie diet. The Diet List was what the kitchen used to know what to send the patients. There was no physician's order for large protein portions or the in-house protein shake for Patient 351.

On 1/8/14 at 11:34 a.m., in an interview with the Registered Dietitian (RD P), she stated the fat-free protein shakes were made in the kitchen. RD P stated they use fat-free milk, fat-free No sugar added ice cream and two scoops of protein powder. RD P stated the RDs would order it in the food preferences section on the diet list. RD P acknowledged they did not get a physician;s order for these protein shakes.

Review of the diet list for the whole hospital census dated 1/8/14, indicated there were 12 patients receiving the in-house protein shakes without a physician's order.

Review of the hospital's document titled, "Nutrition Supplements Available" (Oral) updated 10/31/13, indicated there were eight different in-house protein shakes available to be made by the kitchen.

On 1/8/14 at 11:45 a.m., an interview was conducted with the Area Nutrition Services Director (ANSD), regarding in-house supplements. The ANSD stated they did not have a system in place for the in-house supplements and acknowledged their practice was not to obtain a physician's order.

Review of the hospital's policy and procedure titled, "Diet Orders" dated 3/87, revised/reviewed 8/13, indicated that all patients would receive a diet order for food or other nutrition products. It indicated the physician orders a diet for each patient.

Based on trayline observations, dietary staff interview, and departmental document review, the hospital failed to: 1) ensure that physician diet orders were followed as evidenced by: a) Patient 300 receiving a mechanical soft entrée for a physician-ordered pureed diet; b) Patient 355, 356, 357, not receiving a physician-ordered diabetic diet with a specific calorie level; and 2) ensure the nutritional needs of the patients were met, in accordance with recognized dietary practices, when menus were not analyzed by day, to ensure they met Recommended Dietary Allowances or the Dietary Reference Intake (DRI) of the Food and Nutrition Board or the National Research Council. This put patients at risk of menus not providing required nutrients and compromising medical care. Failure to provide meals of the proper texture may result in choking, aspiration, and in severe instances, may result in death.

Findings:

1. During trayline observation on 1/3/14 beginning at 11:45 am, it was noted that Patient 300's meal tray consisted of chicken salad with ½ cubes of chicken and celery with mayonnaise, a soft fruit cup, puree clam chowder, and grape juice. It was also noted that during the trayline, process the dietary staff member checking trayline requested a different chicken salad. In a concurrent interview with Dietary Staff (DS) NN, she stated that the patient was to receive a dysphasia chicken salad which did not contain celery.

Medical record review was conducted on 1/7/11 beginning at 10 am. Patient 300 was admitted with a surgical history of resection of the right side neck/cheek. Admission diet order dated 12/17/13, was a dysphasia puree diet. A speech therapy evaluation completed on 12/28/13, recommended that the diet remain the same. Review of hospital menu for 1/3/14, revealed that the choice of chicken salad was not appropriate for patients with a physician-ordered pureed diet.

Review of departmental document that described trayline accuracy totals, revealed that, while accuracy checks were completed, there was no indication that the trays were checked for compliance with physician diet orders. Additionally it was also noted that of 307 trays checked, there were eight errors that were limited to missing items such as straws, oatmeal, and beverage preferences.

2. During a lunch trayline observation on 1/6/14 beginning at 11:40 am, it was noted that random patients (Patients 355, 356, 357) had tray tickets labeled as a specific calorie diabetic diets. On the tray tickets it was noted there were variations in the number of, "additional items," listed either as two or three, depending on the calorie level. The patients receive a select menu, therefore they would select what items they wanted. The patients would need to select the certain amount of additional items to reach that specific calorie level. There was an asterisk noted next to the food items that the non-select menu would receive. It was noted for the random patients that if they did not choose the amount of additional items stated on the ticket, then they would not receive that many items on their tray.

On 1/6/14 at 2:05 p.m., in an interview with the ANS D, she stated if the patient did not choose the correct number of additional items, then the diet coordinator would either notify the RD or call the patient, to encourage them to choose other items. The ANS D stated the diet coordinator would wait two meals or one day to notify the RD if they were not choosing enough items, and they could not encourage them to choose more. The ANS D stated they were trying to follow patient preference. The ANS D acknowledged that this could lead to not providing adequate calories as specified by the physician's order.

3. A review of the hospital's nutrition analysis of the patient menus showed that, for the all the diets, there was no daily analysis to see if they met the Dietary Reference Intakes (DRIs). The DRIs are published by the Food and Nutrition Board of the Institute of Medicine, National Academy of Sciences and serve as the standard of practice in menu planning. There was no analysis of the linoleic acid and linolenic acid. Further review of the weekly summary of the regular diet showed that for Potassium, the menus met 70% of the DRIs for week one of the menu cycle. For Magnesium, they met 66% of the DRIs. For Choline, they met 59% of the DRIs. For the weekly summary of the soft diet, it showed for Iron, they met 61% of the DRIs. For the Magnesium, they met 44% of the DRIs. For Potassium, they met 53% of the DRIs. For Zinc, they met 80% of the DRIs. For Manganese, they met 73% of the DRIs. For Choline, they met 53% of the DRIs. For the weekly summary of the No Added Salt diet, it showed for Magnesium, they met 63% of the DRIs. For Potassium, they met 68% of the DRIs. For Choline, they met 49% of the DRIs. For the weekly summary of the Diabetic (ADA) No Added Salt diet, it showed for Calcium, they met 61% of the DRIs. For Magnesium, they met 53% of the DRIs. For Potassium, they met 61% of the DRIs. For Phosphorous, they met 79% of the DRIs. For Choline, they met 43% of the DRIs. For the weekly summary of the cardiac diet, it showed for Calcium, they met 82% of the DRIs. For Magnesium, they met 66% of the DRIs. For Potassium, they met 72% of the DRIs. For Iron, they met 87% of the DRIs. For Choline, they met 50% of the DRIs.

During an interview with the Area Nutrition Services Director (ANS)D, on 1/6/14 at 2:05 p.m., she verified that the menus were not broken down by day. She stated they had lost the hard drive, which contained their analysis, so a new company did the new analysis, and at this time they only had a weekly summary. During an interview with the ANS D on 1/6/14 at 4:05 p.m., she acknowledged the linoleic and linolenic acid was not analyzed at this time. She acknowledged after getting the daily analysis she would need to make sure all the DRIs were met.

Review of the hospital's policy and procedure titled, "Master Patient Menu" dated 5/89 revised/reviewed 8/13, indicated the purpose was for menu standards to be based on the Recommended Dietary Allowance and the Recommended Dietary Intakes (2002) of the Food and Nutrition Board of the National Research Council of the National Academy of Science. It noted a computer analysis was used to determine the nutritional adequacy of the master patient menu.

Based on dietary staff interview, and dietary document review, the hospital failed to ensure the hospital's approved diet manual was consistently utilized to develop the hospitals' diets. Lack of a current and comprehensive diet manual' that reflected hospital developed diets' may result in inaccurate guidance to dietary and hospital staff' when following physician-ordered diets and meeting the nutritional needs of patients, further compromising medical status.

Findings:

During a review of the hospital's diet manual' it was noted that there was a physician's guidelines for ordering diets, however it did not encompass how to order all of the diets in the manual. It was noted under certain types of diets for specific diseases (e.g., diet for renal disease), there would be further information on how to order the diet. It noted that the diet orders should be written by specifying the levels of sodium and potassium electrolytes in grams. However, the hospital's renal diet's parameters were 80 grams of protein, 3 grams of sodium, and 2-3 grams of potassium. This was not reflected in the diet manual. Another example would be the Cardiac diet; the parameters set by the hospital were 50 grams of fat and 2 grams of sodium, however this was not indicated in the diet manual.

Further review of the diet manual indicated that there was no reference to show the adequacy of the diets, in accordance with the current national standards, such as the Dietary Reference Intakes (DRIs). For example, the adequacy in the diet manual for the diabetic diet was more about what was adequate for someone with diabetes, not what was the adequacy of the diabetic diet that was offered in the hospital.

Further review of the diet manual, indicated there were diabetic patterns with different calorie levels. The calorie levels were as follows: 1000, 1200, 1400, 1500, 1600, 1800, 2000, 2200, 2400, and 3000. Review of the electronic medical record for types of diets that could be ordered, indicated the following diabetic diets could be ordered: 1200, 1500, 1600, 1800, 2000, 2200, 2400, 2500, 2800, and 3000. The diet manual should be consistent with what could be ordered at the hospital.

Further review of the diet manual, indicated there was a high-protein, high-calorie diet. however the diet manual did not explain how many calories or grams of protein would be provided for this diet. Review of the electronic medical record for types of diets that could be ordered, indicated a high-protein diet and a high- calorie diet could be ordered together or separately. There was no nutrient analysis of this diet, however it was indicated that the suggested meal plan met the Recommended Dietary Allowance of the National Research Council.

The Diet Manual should encompass: The diets ordered at the hospital, the parameters of the diet, the nutrient analysis, including if it was inadequate of any Recommended Dietary Intakes or Allowances, and how to order the diet.

On 1/6/14 at 4:05 p.m., an interview was conducted with the Area Nutrition Services Director (ANSD) regarding the diet manual. She stated that as a system, all the dietitians have worked together on a new diet manual. The ANSD stated since they have been working on the new diet manual, she had not updated the current one. She stated their plan was to change over in February.

Review of the hospital's policy and procedure titled, "Diet Manual" dated 5/89 reviewed/revised 8/13, indicated the Diet Manual was developed by the Dietitians, using the Manual of Clinical Dietetics, 6th Edition by the American Dietetic Association (ADA), as a basis for most diets. It indicated the manual development and maintenance process included documenting the nutrition deficiencies of any diet that did not comply with the Recommended Dietary Allowances (RDAs) and the Recommended Dietary Intakes (RDIs). It indicated the Diet Manual represented a complete selection of diets ....and was used as a resource when ordering or prescribing diets.

Based on dietetic services observations, staff interviews of emergency preparedness, and document review, the hospital failed to ensure: 1) the required food supplies, planned for use in a disaster, were adequate to meet the
hospital-developed plan; and 2) the installation of air gaps in two food production sinks. Failure to ensure adequate food supplies were on hand may result in unavailability of the supplies, in the event of a disaster. Lack of air gaps in food productions sinks may result in contamination of food during preparation.

Findings:

1. On 1/6/14 beginning at 10:30 a.m., food service for disaster preparedness was reviewed. Concurrent review of the hospitals' disaster menu noted the plan included the provision to provide meals for 1,394 patients and staff, three times/day for four days. A random comparison of the hospital-developed inventory and available food supplies, revealed there was inadequate supplies of items such as canned green beans (two cases short), canned chili (four cases short), canned ravioli (two cases short), and canned beef stew (two cases short). In a concurrent interview with the Area Nutrition Services Director(ANSD), she verified they were short those cases of the food items.

2. During general kitchen observations on 1/3/14 beginning at 10:30 am, and 1/4/14 beginning at 9:30 am, it was noted that there were two sinks in the food production areas of the kitchen; one was directly adjacent to the stove and ovens and the second adjacent to a food production counter. In an observation on 1/3/14 at 11 am, Dietary Staff (DS) L was washing vegetables in the sink adjacent to the stove, and on 1/4/14 at 10:40 am; Dietary Staff (DS) MM was utilizing the sink for manual washing of food production utensils. Both of the sinks were directly plumbed into the wastewater system. It would be the standard of practice to ensure the presence of an air gap between the water supply inlet and the flood level rim of the plumbing fixture, equipment or non-food equipment, that was at least twice the diameter of the water supply inlet and not be less than one inch (Food Code, 2013).

Based on facility personnel record review and staff interview, the facility failed to ensure that all physicians with facility privileges, who came in direct contact with patients, were tested for Tuberculosis. This failure could result in a spread of tuberculosis infections in an environment considered to be high risk for infections.

Findings:

On 1/9/14 at 10:05 a.m., Mgr. Medical Staff Services CCC provided a list of the facility's physicians who had current privileges. The document of active medical staff PPD (purified protein derivative), skin testing for Tuberculosis, as of 1/9/14, indicated the physician's name and the date the physician was due for his or her next PPD skin test. Sixty-seven physicians, out of three hundred and ninety-eight physicians, were past due for their PPD skin test.

In an interview with Mgr of Medical Staff Services CCC on 1/9/14 at 1:30 p.m., she acknowledged that the facility's physicians should all be current in the Tuberculosis skin test. She stated that the person who was responsible for entering the due dates on the physician's list, made mistakes on those dates, and the list did not accurately reflect those physicians who were due their PPD skin testing.

Facility policy reviewed/revised on 4/11, titled, "Health Screening Requirements for Healthcare Worker,s" in the Infection Control Manual indicated: "A. Tuberculosis: Documentation of Tuberculosis screening is required prior to association with the hospital and annually thereafter." The policy further indicated, "Screening procedures shall be consistent with CDC recommendations and meet the requirements of California State Title 22, Sonoma County Public Health Department and Cal/OSHA."

Based on dietetic services observations, dietary staff interview, and departmental document review, the hospital failed to ensure:

A) effective departmental processes to ensure safe food handling practices, as evidenced by 1a and 1b) lack of comprehensive procedures for time/temperature monitoring systems for partially-cooked foods and foods that were fully cooked, to be served at a later time; 2) extended holding times for thawed, raw meat; 3) lack of comprehensive procedures in the café salad bar, for time/temperature monitoring for foods capable of supporting bacterial growth; 4) ineffective manual dishwashing procedures; 5) storage of unclean utensils and storage of serving utensils in dry products; 6) ice machines not being maintained in a sanitary environment; and 7) infant formula or breast milk fortification not being mixed in a sanitary environment in the Intensive Care Unit for Neonates. Failure to develop and/or maintain operational procedures consistent with safe food handling practices may cause food-borne illness, further compromising patients' medical status and, in severe instances, may result in death.

B) The facility further failed to minimize the risk of transmitting infections by implementing practices in order to provide patients, personnel, and visitors a safe environment protected from infection, as evidenced by:

8. Toys used by children/pediatric patients in the hospital's Pediatric Unit were not stored in the designated labeled container after usage;

9. An etiquette station (receptacles containing hand sanitizer and face masks) was not provided for visitors at the entrance of the main hospital in the hallway accessing the cafeteria and the Center and East Wings;

10. Two plastic bags with clean pillows, were lying on the floor in the medication room of a nursing unit;

11. Four 30-gallon clear plastic bags, filled with soiled patient linen, were lying on the utility room floor. In addition, the utility cart, containing soiled linen bags, was overflowing;

12. A hand-held shower head was laying on the shower floor within four inches of the shower drain;

13. The Imaging Department's waiting room etiquette station's container, for dispensing face masks, was empty;

14. Blanket warmers on two units had a dark-brown substance on the internal shelves; and

15. Floors in the laboratory were soiled.
These failures had the potential to be the sources and methods of transmission for infecting patients, visitors, and personnel.

Findings:

1. Potentially hazardous foods (PHF's) are defined as those capable of supporting bacterial growth associated with food-borne illness. PHF's require time/temperature control at all times, to ensure food safety. Protein-based foods, such as meats, are PHF's. Raw animal foods that are cooked using a non-continuous cooking process, must be handled following multiple parameters related to time/temperature control for food safety (Food Code, 2013, Chapter 3, §401.14).

a. During food storage practices on 1/3/14 beginning at 10:30 am, it was noted that in the walk-in refrigerator there were multiple trays of partially-cooked salmon. In a concurrent interview with Dietary Staff (DS) L, he stated that he
partially-cooked the fish earlier that morning, and that the final cooking of the item would occur at a later time. The temperature of the fish, taken with the hospitals' thermometer, was noted to be 50°F. He also stated that if meat was partially cooked, a temperature was recorded on the cook's cooling log at the time it was placed in the refrigerator. He also stated that there would be no additional temperatures taken while the item was in the refrigerator. In a follow-up interview on 1/6/14 beginning at 11 am, with Dietary Staff (DS) M, he stated that generally there were three instances per week, on Wednesdays and Fridays, whereby the preparation process would call for partially-cooking meat and completing the cooking process at a later time. He also stated that the non-continuous cooking process occurred at lunch and dinner on each of the days. In a review of undated standardized recipes on 1/6/14 at 11 am, for citrus salmon and grilled chicken, revealed that in each of the recipes, while it guided staff to place grill marks on the meat, the guidance for staff was to complete the cooking process, rather than holding for cooking at a later time. In an interview on 1/6/14 beginning at 11:15 am, with the Nutrition Services Supervisor, she acknowledged that the recipe did not reflect the current food production process, and that the items were not comprehensively monitored for food safety, utilizing time/temperature control. Review on 1/6/14 at 3 pm, of departmental documents titled, "Cooks Cooling Log" from 11/29/13-1/3/14, revealed that with the exception of the documentation of one temperature for fish on 1/3/14, there was no monitoring of the
partially-cooked items on Wednesdays or Fridays. Review of departmental reports, completed by Infection Control Practitioners, dated 9/24, 10/21, 11/19, and 12/20/13, respectively, revealed that, while there was evaluation of whether or not staff were able to demonstrate training and knowledge of time/temperature control for foods capable of causing food-borne illness, the evaluation did not fully encompass all at-risk foods prepared within the department.

b. PHF's that are cooked and held for later use must be comprehensively monitored for time/temperature control for food safety. Cooked PHF's must be cooled from 135°F 70°F within two hours and to 41°F within an additional four hours, a total of six hours (Food Code, 2013).

During food storage practices on 1/3/14 beginning at 10:30 am, it was noted that in the walk-in refrigerator there was a tray containing multiple pot roasts, each measuring approximately 12" x 8" x 3." In a concurrent interview with DS L, he stated that the item was cooked earlier in the day and was being held until 1/5/14. The temperature of two of the pieces of meat was noted to be 70° and 75°F, respectively. DS L also stated that after the meat was cooked, it was placed in the walk-in refrigerator and the temperature was checked two hours later, at which time the temperature would be recorded. The surveyor asked if at any time temperatures of items were recorded when they were placed in the walk-in. He stated they were not. It was also noted that in the walk-in refrigerator there was leftover chicken-ala-king with an expiration date of 1/4/14. Additionally in the freezer there was a deep pan of an item identified as chili by the Nutrition Services Supervisor. While the item was labeled with an expiration date, there was no preparation date. In a concurrent interview with the Nutrition Services Supervisor, she stated that the item was, "probably prepared within the last two days. "

In an interview and concurrent document review on 1/6/14 beginning at 11 am, with the Nutritional Services Supervisor, revealed that staff was not monitoring the cool-down process, as per departmental policy. She also acknowledged that, while she reviewed the log, she had not identified that the process was not completed in accordance with policy. Departmental document titled, "Cooks Cooling Log" from 11/29/13-1/3/14, guided staff to describe the cooling method, the start time of the cooling process, with temperatures to be taken at two hours and within an additional four hours, as applicable. It was also noted that the log did not delineate the temperature of the item at the beginning of the cool-down process. The Nutritional Services Supervisor also acknowledged that without recording the starting temperature of items, it would not be possible to assure that monitoring parameters for food safety were followed. Review of departmental document dated 10/13, titled, "Temperature Maintenance," provided staff with a practice alert which noted that the starting temperature for cool-down monitoring was 135°F. She also acknowledged that the chicken-ala-king or the chili, both which required time/temperature monitoring for food safety, was not completed during the cool-down process.

Review of departmental reports, completed by Infection Control Practitioners dated 9/24, 10/21, 11/19 and 12/20/13, respectively revealed that, while there was evaluation of whether or not staff were able to demonstrate training and knowledge of time/temperature control for foods capable of causing food-borne illness, the evaluation did not fully encompass all food production processes within the department.

2. During review of food storage practices on 1/3/14 beginning at 10:30 am, it was noted in the walk-in refrigerator there were multiple trays of raw meat that included chicken, ground turkey, and pork. It was noted that one of the meat was labeled with the thaw-date of the items, and the items were not consistently labeled with the date by which they should be used. In a concurrent interview with DS N, he stated that the items would be held for up to seven days, depending on whether the item was frozen or thawed during receiving. He also acknowledged that without identifying information, it would not be possible to ensure when the item was placed in the refrigerator. The surveyor asked DS N to describe how the seven-day timeframe was determined. He replied it was unsure; however it was the longstanding practice within the department. The United States Department of Agriculture (USDA), Food Safety and Inspection Service (May 2000) guidance for hold time of thawed ground meats and poultry is 1-2 days under refrigeration, and 3-4 days for whole cuts of meat and poultry.

In an interview on 1/6/14 beginning at 1:30 pm, with the Area Nutrition Services Director, she stated that the guidelines were developed utilizing a publication from the National Restaurant Association, rather than regulatory references such as the USDA. She also acknowledged that after completing some research, the 7-day general timeframe likely needed to be modified. Review of departmental policy titled, "Storage," dated 8/2013, revealed that the guideline for refrigerated, thawed ground meats, was two days and refrigerated meats, may last 3-5 days.

Review of departmental reports, completed by Infection Control Practitioners dated 9/24, 10/21, 11/19 and 12/20/13, respectively revealed that, while one of the elements evaluated the storage of thawing meats, there was no evaluation of the effectiveness of labeling/dating of thawing meats or the length of time that meats were stored once thawed.

3. On 1/3/14 beginning at 2:15 pm, food storage practices in the café were reviewed. It was noted that the salad bar, as well as the sandwich deli bar, contained numerous protein-based items, including as an example, seafood salad and deli meats, in addition to other foods that supported bacterial growth associated with food-borne illness. Food items that support bacterial growth require time/temperature control monitoring for food safety (USDA Food Code, 2013).

In a concurrent interview with the Nutrition Services Supervisor, she stated that café temperatures were monitored daily at 1 pm. She also stated that, while protein-based breakfast items were pulled mid-morning, items at the deli and salad bar were placed for service beginning at approximately 10:30 am, were replaced when items were sold, and remained continuously available for service from 11 am through 7:30 pm. She also acknowledged that, while the items were tested at 1 pm, it would not be possible to ensure that items were within food safety parameters with only one reference point. It was also noted that, while there was a temperature log in place, there was no guidance to ensure that staff were monitoring high-risk foods capable of supporting bacterial growth.

The standard of practice would be to ensure that foods requiring time/temperature control for food safety, were not held in the food danger zone (41°F-135°F) for greater than four hours. Hospital policy titled, "Temperature Maintenance" dated 10/13, noted that, "To be safe, our practice is to dispose of foods that have been out [of temperature range] more than 2 hours."

4. During general food production observations on 1/3/14 at 10:30 am, DS MM was observed preparing pureed items. Upon completion of the task, he was observed rinsing the blender under running water and replacing it on the base. On 1/6/14 at 10:45 am, in the presence of the Nutrition Services Supervisor, DS MM was observed completing a food production task, after which he rinsed the knife under running water and returned it to the utensil drawer. In a concurrent interview with the Nutrition Services supervisor, she acknowledged that this was not an acceptable method for washing food production utensils.

Hospital policy titled, "Dishwashing, Dishmachine" dated 8/08, guided staff that the manual dishwashing procedure consisted of three distinct steps of washing, rinsing, and sanitizing.

5. During general observations on 1/6/14 beginning at 9:30 am, the following was noted:
a. There were numerous utensils, such as knives and cooking utensils, that had dried food particles on them. In a concurrent interview with the Nutrition Services Supervisor, she stated that the expectation would be to check for the cleanliness of utensils prior to storage and to re-wash dirty utensils. Review of hospital policy titled, "Dishwashing, Dishmachine" dated 8/08, noted that the expected outcome of the dishwashing process was to ensure that, "Equipment is used and maintained in a safe and sanitary manner."

b. Dietary staff was storing scoops in a can of protein powder, as well as in the flour bin. In a concurrent interview with the Nutrition Services Supervisor, she stated that scoops should not be stored in food products. Departmental policy titled, "Storage" dated 8/13, guided staff that, "Scoops are not stored in bins of flour, rice, ice etc."

c. On 1/6/14 at 9:50 a.m., a scoop was observed to be in the bin of flour. A concurrent interview was conducted with the Nutrition Services Supervisor; she stated the scoop was not supposed to be in the flour bin.

6. On 1/7/14 at 2:44 p.m., in nourishment room #N426 (4 North), a joint observation was made of the ice-machine with the Administrative Staff F, in which the chute of the ice-machine had a white-colored substance surrounding the lower end of the chute, in which the ice was dispensed from. A concurrent interview was conducted at this time with Administrative Staff F. Administrative Staff F stated the descaling needed to be done.
On 1/7/14 at 3:05 p.m., in nourishment room on 4 West, a joint observation was made of the ice machine with Administrative Staff F, in which the chute and the tray of the ice machine had a white-colored substance surrounding the lower end of the chute, in which the ice was dispensed from and throughout the tray. The Administrative Staff F verified the white substance on the ice machine.
On 1/8/14 at 9:25 a.m., an interview was conducted with the Administrative Staff PP regarding cleaning of the ice machine. The Director of Environmental Service (EVS) AAA stated his staff was responsible for wiping down the outside of the ice machine, including the chute, grate, and trough/tray twice a week. The Director of EVS AAA stated they would use a disinfectant from Ecolab, called N20 or 20 Neutral. He stated his department did not do any daily or weekly cleaning, as described in the manufacturer's directions.
Review of the label of the 20 Neutral Cleaner and Disinfectant revealed this product was harmful if swallowed.
On 1/8/14 at 2:38 p.m., an interview was conducted with the Administrative Staff BB and Administrative Staff O. The Administrative Staff O stated all the ice machines in the hospital were on a Preventive Maintenance (PM) Program and were cleaned and sanitized every six months. The Administrative Staff O stated they did not do any daily or weekly cleaning of the ice machines.
Review of the PMs for the 4 West and 4 North ice machines, revealed the last time they were cleaned and sanitized was 10/9/13 and 12/19/13, respectively.
Review of the hospital policy and procedure titled, "Ice Machine Maintenance" dated 1/89, revised 5/11, indicated all ice machines were inspected semi-annually and sanitizing of ice machines was done semi-annually, using food safe chemicals and per the manufacturer's recommendations.
Review of the manufacturer's directions of the ice machine, revealed they recommended daily cleaning of the drain pan by slowly pouring one gallon of hot water into drain pan to keep drain lines clear. It recommended weekly cleaning of the drain pan and grille with a cleaning solution (200 parts per million of available chlorine content) of Ecolab Mikro-chlor cleaner or equal, rinse thoroughly. Then slowly pour solution of one cup household bleach, mixed with one gallon hot water, into drain pain to help prevent algae growth in drain lines. It recommended semi-annual cleaning of the dispenser hopper, however it further indicated units with ice makers required cleaning at least every six months and more often, if conditions dictated.
7. On 1/7/14 at starting at 2:30 p.m., an interview was conducted during a tour of the Intensive Care Neonate (ICN) unit with the Management Staff E and the Clinical Educator, Woman's & Children's, regarding formula preparation. It was observed in the ICN unit, there was no specific area to mix formula on the counter. Management Staff E stated they would just mix it on the counter above the reach-in freezer and in front of the Medela warmers. Management Staff E stated they used human milk fortifier with breast milk at times. The Clinical Educator for Women's & Children's stated they tried to separate the charting from the mixing. She stated they kept the charting on the other side of the room.
On 1/8/14 at 10:10 a.m., an interview was conducted with Management Staff E. Management Staff E stated the nurses enter the ICN unit and wash their hands. They would wash them again or gel their hands then start the preparation of the fortifiers with breast milk. They would prepare it in the area in front of the warmers. They would always have a co-check by another nurse after they pulled any breast milk out of the refrigerator or freezer and before it was given to the baby. She stated the counter was cleaned daily by environmental care services, with the 20 Neutral cleaner that was used throughout the hospital.
On 1/8/14 at 9:35 a.m., an interview was conducted with the Administrative Staff F (Administrative Staff F). Administrative Staff F stated she was not aware of any of the ICN procedures, and she would need to start including this on her Infection Control Rounds she did throughout the hospital.
Review of the label of the 20 Neutral Cleaner and Disinfectant revealed this product was harmful if swallowed.
Review of the Infant Feedings: Guidelines for Preparation of Human Milk and Formula in Health Care Facilities, Second Edition published by the American Dietetic Association, dated 2011, indicated that before the infant formula was prepared, all work surfaces must be cleaned with an antibacterial sanitizing solution that was appropriate for food contact surfaces. The solution should be wiped off with individual paper towels from a dispenser. Surfaces should be cleaned after any spills during the preparation process and again and the end of the day's formula preparation. Cleaning supplies must be stored separately from infant formula products and ingredients. The guidelines also indicated aseptic technique must be practiced in the preparation of all infant formula in the health care facility, to control the microbiological quality of the formula. It indicated aseptic technique, as described by the Centers for Disease Control and Prevention (CDC) and others, incorporated hand hygiene in conjunction with, "no-touch," technique. Aseptic technique provided stringent control of all actions to exclude contact-contamination from personnel (e.g., skin and clothing), work surfaces, equipment, and the environment. It also indicated a laundered, short-sleeved scrub suit or uniform should be worn when preparing infant feedings. The scrubs must be covered by a fully buttoned, clean lab coat when employees leave the formula room to enter other areas of the health care facility. The lab coat should be removed before entering the infant feeding preparation room.
Review of the hospital policy and procedure's titled, "Formula Preparation, Breast Milk Fortification and Storage" dated 12/01, revised/reviewed 5/11, indicated the procedure for the equipment used and the steps to add either human milk fortifier or formula fortification of breast milk. The policy did not speak to the specifics regarding hand-hygiene, gowning, or the sanitation of the work surfaces during preparation.


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8. During an observational tour of the Pediatric Unit on 1/3/14 at 2:20 p.m., a sign was posted immediately to the left and above a 3' x 24" x 24" dark brown chest, at the entrance to the, "Play Room," on the Pediatric Unit. The sign read, "Dirty toys here please." On the top of the chest was a bag of large size Lego's (interlocking plastic bricks), a plastic dump truck, and Lego's interlocked, but not in a container.

During a second observation of the, "Play Room," with a concurrent interview on 1/8/14 at 11:20 a.m., a large fire truck was positioned on the chest's lid. Licensed Nurse D stated the chest was to contain toys played with by children and waiting to be cleaned by volunteers or staff. Facing the chest, approximately 10 inches to the right, on the floor, there were two plastic toys with wheels that children could use to sit on and ride. When queried, Management Staff E stated that these toys were clean, but corroborated that there was not a definitive method of determining if they were clean or soiled, based on their location next to the chest used for the soiled toys.

During a review of the hospital's policy and procedure titled, "Toy Cleaning," reviewed on 6/11, indicated under IV. Procedure - A. 'General Guideline' # 7: "When a toy requires cleaning, it should be done immediately or stored in the designated labeled container separate from toys that are clean and ready for use."

According to the Center for Disease Control (CDC), "Shared toys may become a vehicle for transmitting respiratory viruses (e.g., respiratory syncytial virus or pathogenic bacteria [e.g., Pseudomonas aeruginosa]) among pediatric patients ..."

9. During an observational tour of the entrances to the main hospital on 1/10/14 at 10:30 a.m., the entrance to the hallway accessing the cafeteria and the Center and East Wings, did not have an etiquette station. Administrative Staff F corroborated that an etiquette station would be appropriate for patients, staff, and visitors accessing the cafeteria, and the Center and East Wings.

During review of the hospital's policy and procedure titled, "Isolation/ Placement of Patients" date of revision/reviewed 9/13, indicated under Procedure II. Respiratory Etiquette C., "Signs are posted at entry points into the hospital requesting that coughs, sneezes and cold symptoms be covered with a mask or tissue. Prompt disposal of used tissue and hand hygiene after contact with respiratory secretions is also required."

10. During an observation with concurrent interview on 1/3/14 at 1:20 p.m., two plastic bags with clean pillows were lying on the floor in the medication room of a nursing unit. Management Staff DD stated, looking at the two plastic bags filled with clean pillows, "I know they are not supposed to be there."

11. During an observation with concurrent interview on 1/7/14 at 11:45 a.m., of the Medical Surgery Unit's (3 East) Soiled Utility Room, there were four 30-gallon clear plastic bags on the utility room floor. In addition, the utility cart was overflowing with bags of soiled linen. Management Staff EE stated that when staff was aware of such a situation, they do call to have the linen removed.

During review of the hospital's policy and procedure titled, "Environmental Services Policy and Procedure" with a review/revision date of 9/2012, indicated, "Bulk soiled linen is removed from the soiled utility rooms between the hours of 7:30 a.m. - 4:00 p.m. and 4:00 p.m. - 12:30 a.m."

12. During an observation of the shower (number 3019) in the Pediatric Unit on 1/3/14 at 2:20 p.m., a hand-held shower head was lying on the shower floor within four inches of the shower drain. A holder to support the shower head was not visible.

During an observation of the shower (number 3019) in the Pediatric Unit on 1/8/14 at 11:20 a.m., the shower door was locked and a sign on the door indicated, "Out of Service." The nurses on the unit stated they had a key to the locked shower door, but ultimately were not able to unlock the door at the time of this observation. The Environmental Services Department was called and they confirmed the shower was not in use.

13. During an observation of the Imaging Department's waiting room on 1/6/14, an etiquette station was provided for visitors and patients. The container dispensing face masks was empty; and

14. During an observational tour on 1/3/14 at 2:50 p.m., a dark-brown residue was on the outer edge of the internal shelves of the blanket warmer on, "Three West." Utilizing a white paper material and swiping it across the outer edge of the shelf, a dark-brown substance adhered to the swab. Administrative Staff FF corroborated that the unit needed to be cleaned.

Continuing the observational tour on 1/3/14, a dark-brown residue was seen on the outer edge of the internal shelves of the blanket warmer on 3 East. Utilizing an alcohol swab and swiping it across the outer edge of the shelf a dark-brown substance adhered to the swab. Management Staff touring with the surveyor corroborated that the unit needed to be cleaned.

During review of the hospital's policy and procedure titled, "Cleaning Policy" with a review/revision date of 12/13, under Patient Rooms / Patient Care Areas B 2, indicated, "Items that will be wiped clean with an approved disinfectant by individual designated department personnel on designated frequency and when visibly soiled may include, but are not restricted to: ...Blanket warmers-EVS (Environmental Services) / Engineering quarterly."



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15. On 1/7/14 at 10 am, the laboratory was toured with Laboratory Director CC. The floor had multiple areas throughout the laboratory, between laboratory equipment, that were heavily soiled. Laboratory Director CC acknowledged the soiled areas and stated the floors were being cleaned every day by the Environmental Services' staff

During a follow-up tour of the Laboratory, on 1/10/14 at 1:20 p.m., with Director of EVS (Environmental Services) AAA and the Regional Director of EVS BBB, Director of EVS AAA acknowledged the
dark-brown stains on the flooring, in various areas of the laboratory, and stated that any one noticing dirt like this should notify Environmental Services. Regional Director of EVS BBB stated that the cleaning of the floor was sloppy and acknowledged the need to clean those areas between the laboratory equipment.

The facility infection control policy and procedure, for the clinical laboratory, last reviewed/revised on 6/11/2011 indicated, "4. Floors are cleaned daily by Environmental Services using an EPA approved disinfectant solution."