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Based on observations, interviews and record reviews, the hospital did meet the condition of participation in Governing Body and Management as follows:

1. The Governing Body failed to identify the deficient practice of the hospital's Registered Dietitians (RDs) writing nutritional supplement and tube feeding orders without a physician order. The Governing Body also approved a hospital policy allowing RDs to write these orders, a practice that is not within the scope of practice for RDs according to the California Business and Professions Code. (Refer to A 0618, A-0630)

During an interview with the Chair of the Governing Body on February 23, 2018, at 12:15 PM, the Chair stated that the Governing Body depended on the expertise of the department heads and the contracted dietary service to oversee the policy development and provide guidance on the standards of practice for the RDs. The Governing Body was not aware that the RDs were practicing outside their scope of practice and the hospital policy allowed this practice.

The cumulative effect of this systemic failure to prevent the hospital RDs from practicing outside their scope of practice as stipulated in the California Business and Professions Code resulted in the inability to ensure the Condition of Participation for Governing Body was met.

Based on record review and interview, the facility failed to inform patients they had the right to implement specific instructions regarding the provision of healthcare in the event they become incapacitated.

Findings:

During a random record review of patients who were scheduled for surgery during December 2017, 3 of 3 patients' (Patients 2, 3, 4,) files did not include notification of patients' rights to formulate advance directives.

A review of the surgery schedule for December 2017 revealed the following: Patient 2 was diagnosed with a right side hemorrhoid and was scheduled and procedure performed on 12/30/17; Patient 3 was diagnosed with an incarcerated hernia and was scheduled and surgery performed on 12/29/17; Patient 4 was diagnosed with right shoulder tendon tear of the humeral head and surgery was scheduled and performed on 12/27/17.

According to the policy "Advance Healthcare Directives Information", advance directives is a legal document allowing a patient to document his or her desires concerning health care decisions, particularly decisions concerning end of life and /or designate another person to make decisions when the patient becomes incapacitated. Article 11 of the policy stated that PIH Health is not required by law to provide healthcare directives to out-patients but one will be honored if provided to the facility by the out-patient.

During a conversation with the Quality Manager on 2/20/18 at 1:30 PM, she stated that information regarding advanced directives does not need to be distributed to out-patients.

A review of the U.S. Code of Federal Regulations, specifically 42 CFR 489.102(b)(1) stated that the facility's policy regarding advanced directives must be presented at the time a patient is admitted as an inpatient. However the more general requirement of 42 CFR 482.13(a)(1) is that hospitals must take reasonable steps to determine the patient's/ representative's wishes concerning designation of a representative whether they are inpatient or outpatient. Hospitals, therefore, should give notice of advance directive to the patient or patient's representative who are in the emergency department, in an observation status, or undergoing same-day surgery. (California State Operations Manual, Appendix A - Survey Protocol, Regulations and Interpretive Guidelines for Hospitals).

Based on observation and interview, the facility failed to ensure patients' presence or location in the hospital was safeguarded.

Findings:

During a tour of the emergency department (ED) on the morning of 2/22/18 at 9:30 AM, the TEAM 1 tracker screens, mounted at eye level, were clearly visible to persons walking down the aisle perpendicular to the screens. On the screens were the names, location of patient, and reason for admission to the ED.

At that time, the ED Director acknowledged that she could see the names of the patients currently in that part of the ED. Another room that was located on the above mentioned aisle had monitors which were obstructed so only the person sitting in front of the screen could see the information. Photos were taken by PIH staff demonstrating the locations of the screens.

Based on observation, interview and record review, the facility failed to ensure the patient was provided personal privacy:
a. During provision of care when the privacy curtain was not drawn when the Nephrologist/ Dialysis Registered Nurse was providing assessment of Patient 16's access site, listening to the heart/lungs sounds and assessing bilateral lower extremities prior to initiation of dialysis.
b. For Patients Personal Information such as patient's presence or location in the hospital, demographic information such as patient's name, age, medical condition, MD/nurse assigned to patient.

This deficient practice had the potential for the patients' personal information to be disclosed and physical privacy violated.

Findings:

1. On February 20, 2018, at 2 p.m., Patient 16 was observed being prepared by the Dialysis RN prior to initiation of hemodialysis treatment. The Dialysis RN checked the right upper arm fistula then prepared the hemodialysis. The Nephrologist came and conducted his medical assessment of the access site in the right upper arm, assessed the patient's bilateral lower extremities, discussed with the patient her concerns then left. The Dialysis RN initiated the hemodialysis via the access site on the right upper arm. Meanwhile, the privacy curtain was not drawn and the room door was open. The treatment procedure the patient was undergoing was visible to visitors passing by the room. The Hospital Administrative Staff Members were present by the open door.

Review of the facility policy no. 100.87200 titled, "Patients Rights and Responsibilities" indicated have personal privacy respected, case discussion, consultation, examination and treatment are confidential and should be conducted discreetly. Privacy curtains will be used in semi-private rooms.

2. During the initial tour of the Emergency Room (ER) with the ER Administrator, it was observed that Status Board in Team I Area contained the following information such as patient location, name, age, chief complaint, Nurse, which were viewable and accessible to other patient and visitors passing by the area.

The ER Administrator was interviewed while the Status Board was presented to her as a potential unauthorized access of personally identifiable information to others as they pass by the hallway. The ER had a total of five Status Boards, each of the 5 teams use during the 24 hour provision of services.

Review of the facility policy number 100.87200.704 titled, "Patients' Rights and Responsibilities" indicated confidential treatment of all communications and records pertaining to your care and stay in the hospitals ....disclose your protected health information.

Based on observation and interview, the facility failed to ensure the patient's environment is free and safe by not having patient's medications kept at the bedside.

This deficient practice had the potential for patients to self-administer medication without the physician order.

Findings:

On February 20, 2018, at 10:25 a.m., during the initial tour with Medical Surgical Director, the following was observed:

1. In Patient 17's room, there were medications found at the patient's bedside such as a tube of Calmoseptine Ointment, and a tube of Santyl which was labeled with patient's name and instruction for use. There was also a tube of Solosite Wound Gel which has no label.

During an interview with Director of Medical Surgical Unit, after reviewing the clinical record stated that there was no physician order to keep these medications at the bedside.

2. In Patient 18's room there was a tube of Calmoseptine Ointment by the bedside.

Review of the facility policy number: 100.87200.611 titled Medication Administration in Adults and Pediatrics indicated no medications may be left at the bedside except for Labor, Delivery and Maternal Newborn. Topical items such as dermoplast spray tucks, may be left at bedside upon education to patient for proper use.

Based on observation, interview, and record review the facility failed to ensure that less restrictive measures were taken to protect the patient (PT 1) from injury or ensure continuity of care.

Findings:

During a tour of the ICU (Intensive Care Unit, hospital space in which is concentrated special equipment and specially trained personnel for the care of serious ill patients requiring immediate and continuous attention) on 2/20/18 at 3:45 PM, Patient 1 was spotted in room ET1. The patient presented with a wrist restraint on the left side; she was attached to a mechanical ventilator (machine that helps people breathe when they are not able to do so on their own); her head was raised approximately 45 degrees from vertical; relatives were at bedside and attending to her needs.

A review of the patient's Facesheet and Emergency Department Note indicated that Patient 1 was admitted to the Emergency Department (ED) on 2/19/18 at 11:02 PM related to a complaint of right sided weakness. There is no apparent history of stroke but the paramedic's notation stated patient had systolic pressure of 230. The patient was diagnosed with hemorrhagic CVA (cerebrovascular accident, in this instance the event caused by the rupture of a blood vessel in or on the surface of the brain with bleeding into the surrounding tissue) and subsequently transferred to the ICU after being intubated (placement of a flexible plastic tube into the windpipe to maintain an open airway or to serve as a way to administer certain drugs).

According to the order for restraint, it was to begin 2/20/18 at 3 AM for the reason of protecting the patient from injury.

A review of the documentation of Patient 1 observations specified, at 2 AM on 2/20/18 that the patient was removing or attempting to remove lines, tubes, drains, etc., not following safety instructions. The accompanying Restraint Alternative Measures taken at that same time were: re-orientation, transfer of patient for closer observation, contact family member/other to sit at bedside, cover exposed lines or tubes, comfort measures/pain relief..continues to attempt/remove lines. There was no notation that a sitter had been sought. The next documented observation was at 8 AM.

During a conversation with RN1 on 2/20/18 at 3:45 PM, she asserted that Patient 1 had been given Propofol (a drug used as an anesthetic during some procedures and surgeries) before coming to the ICU but that medication had no effect on the patient's attempting to remove tubing from the ventilator and that the patient was not ready to be left alone. When asked about the availability of sitters (persons responsible for direct observation of patients and reporting of any patient changes in condition to an appropriate staff member) for patients in a similar situation, RN 1 stated that in the ICU there is not an immediate pool of sitters but there is definitely a resource for getting sitters in the ICU.

A review of the policy "Restraints, Non-Violent/Non Self-Destructive and Violent, Self-Destructive" stipulated that physical restraint is any manual method or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely. Definition 2.1.2 of this policy indicated that restraints may be used only when less restrictive interventions have been determined to be ineffective in protecting the patient, staff, or others. According to "Ongoing monitoring & assessment of a patient in restraint" 1.2.2, minimum frequency of monitoring a patient in restraints for non-violent, and non-destructive behavior is at least every 2 hours.

Based on interviews and record reviews, the hospital failed to identify that the routine practice by the Registered Dietitians (RDs) of ordering patient nutritional supplement and tube feedings and the development of a policy allowing this practice was outside the parameters of practice allowed by the California Business and Professions Code. This failure to identify this deficient practice allowed the practice to continue without remediation. (cross refer A-0630)

Findings:

During an interview with the Director of Quality on February 23, 2018, at 12:30 PM, she stated that the Quality Committee had not identified that the RDs were writing orders for nutritional supplements and tube feedings outside their scope of practice as set forth by the California Business and Professions Code. She stated that the Quality Committee relied on the expertise of the contracted Food and Nutrition Services Department to know the scope of practice for the RDs and practice within their scope.

A review of the hospital's Organizational Quality and Patient Safety Program Plan, FY 2017-18 indicated that the purpose of the plan was to, "Ensuring quality and safety requires a coordinated, interprofessional approach of measurement and continuous process improvement." The plan "relates specifically to a systemic hospital-wide program to identify and mitigate risks and hazards in order to minimize patient injury during hospitalization."

Based on observation, interview and record review, the facility failed to:
1. Maintain a licensed nurse-to-patient ratio of 1:1 and/or 1:2 in the Neonatal Intensive Care Unit (NICU) at all times. There was inadequate numbers of staff to provide nursing care to all patients as needed during meal and/or break time. One (1) licensed nurse was taking care of more than 2 patients during meal and or break time. This deficient practice had the potential to cause the facility's inability to provide the nursing assessment and care to meet the patients' needs.
2. Follow Manufacturer's Recommendation to perform quality control test on the glucometer used for patients.

This deficient practice had the potential for patients not to meet their individual needs.

Findings:

1. On February 22, 2018, at 3 p.m., during the initial tour of the unit with the NICU Manager, the unit's census for 7 a.m., to 7 p.m. was 20 babies.

Review of the NICU Daily Assignment Sheet (7 a.m. - 7 p.m.) indicated there was one (1) 1:1 (nurse to patient ratio); seven (7) 1:2 (nurse to patient ratio) and twelve (12) 1:3 nurse to patient ratio. Further review of the assignment sheet dated 2/22/18 indicated one RN had one (1) 1:1 nurse to patient ratio and one (1) 1:2 nurse to patient ratio during the shift,

Further review of the NICU Daily Assignment Sheet did not have documentation to indicate who was relieving who. The assignment sheet had the time indicating when each RN break time was.

During an interview with RN 1, after reviewing the assignment sheet, she stated that each RN is "breaking off" for each other during (30 and 15 minutes) breaks. She further stated before they go on break they briefly inform the RN who will take care of his/her patients of the patient's condition. In this instance, if the relief RN has her own 2 patients and take care of the other RN's patient who could be a 1:1 nurse to patient ratio or 1:2 nurse to patient ratio, the RN will be taking care of more patients than she/he should was allowed to care for during the shift.

Further review of the Assignment Sheets indicated the following:
a. On 2/16/18, the p.m. shift indicated a RN had 1 patient who was assessed as 1:1 nurse to patient ratio and one (1) patient assessed as 1:2 nurse to patient ratio. This RN should have one 1:1 nurse to patient ratio or two (2) 1:2 nurse to patient ratio in a shift but not both type of patient.

c. On 2/18/18, the a.m. shift indicated a RN had a total of three (3) patients, one patient was assessed as a 1:3 nurse to patient ratio and two (2) patients were assessed as 1:2 nurse to patient ratio. This RN should have two 1:2 nurse to patient ratio or three (3) 1:3 nurse to patient ratio in a shift.

A review of the facility policy number :100.87200.134 titled, Staffing indicated under Neonatal ICU stipulated the NICU is a level II unit and is staffed according to acuity levels 1:1, 1:2, and 1:3 nurse to patient ratios.

2. On February 22, 2018, at 8:30 a.m., during observation of the performance of quality control monitoring of the Glucometer machine , RN 2 prepared the glucometer, control solution and control strip. The RN checked the solution bottles and strips for expiration dates and found the bottle of strip was opened and undated. The RN picked up a strip and inserted the strip on the glucometer port. The RN shook the solution (hi) and applied a drop on the strip and the reading was shown. The process was repeated for the solution (lo) and reading came out.

Review of the Instructions for Use Manual for Quality Control Test indicated .... With the test strip correctly inserted, then Apply Sample screen displays. Gently mix the StatStrip Glucose Control Solution before each use. Discard the first drop of control solution from the bottle to avoid contamination.

During an interview with RN 2, she was made aware that she failed to follow the manufacturer's instruction to perform the quality control test which was to gently mix the control solution and discard the first drop to prevent cross contamination.

Based on record review and interview, the facility failed to obtain an informed consent prior to initiation of hemodialysis treatment.

This deficient practice had the potential for patients to miss the vital information regarding the dialysis procedure.

Findings:

1. On February 20, 2018, at 2 p.m., Patient 16 was observed in her room receiving hemodialysis treatment via right upper arm fistula (vascular access where the artery and a vein are joined under the skin).

Review of the Facesheet Report indicated Patient 16 was admitted to the facility on February 19, 2018, with chief complaint of intractable vertigo. The patient has a diagnosis of end stage renal disease.

The physician treatment order dated 2/20/18 indicated dialysis, frequency of dialysis was three (3) times a week, Tuesday, Thursday and Saturday [T-TH-S], duration was 3 hours, calcium bath was 2.5 mEq/liter (milliEquivalent/liter), potassium bath was 2 mEq/L, dialyzer was F160, BFR (blood flow rate - is the speed the patient's blood is moving in the dialysis tubing) was 400 ml/min and no DFR (dialysate flow rate (DFR - is the rate the dialysate is moving through the dialyzer (artificial kidney) order.

The patient received hemodialysis on 2/20/18 at the general acute hospital. Further review of the clinical record failed to show written documentation of a consent for hemodialysis treatment.

According to the facility policy number: 100.87200.603 titled, "Consents and Informed Consents" indicated initial dialysis procedure requires informed consent and procedural consent when first initiated.

During an interview with registered nurse (RN) 3 at the time of record review, stated consent is obtained on patient receiving hemodialysis treatment for the first time in the hospital not a chronic dialysis patient.

Based on interviews and record reviews, the hospital failed to ensure the records of sterile (germ-free) and chemotherapy compounding process (a process of making sterile medications) contained all the elements required by its policies and the standard of practices as referenced. The missing elements included but not limited to: the personnel who prepared and checked the end products, the preparation date and time, and the beyond use dates (BUD, expiration dates which describe when the medications should no longer be used) which would be determined from the preparation time. This deficient practice had the potential for incomplete records for quality control or assurance purposes, as well as possible negative patient outcome if compounded products were assigned inaccurate beyond use dates.

Findings:

1. On 2/22/2018 at 10:45 a.m. during a tour of the pharmacy department, the surveyor requested the sterile compounding log. A pharmacist presented a basket full of loose papers that were stacked up to approximately four inches in height. During a concurrent review, the top page of the stack, titled "Compounding Tracking Log", for area "SPA" (Sterile Products Area) on 2/21/2018, listed 12 lines of prepared items containing compounding information. One of twelve lines did not have expiration date and time for the compounded product; the space for "Exp + Time" was blank. Three of those twelve lines did not have the initials of the pharmacy personnel who prepared the item.

A review of the second page retrieved from the basket of compounding log, revealed a title of "SPA - IVPB Demand", dated and timed 2/21/2018 at 6:11 a.m. A further review of the "SPA - IVPB Demand" paper revealed ten rows of items. However, there was no indication the quantity per item made. Also, the area designated for "Time made" did not contain such time info; instead, the areas appeared to contain personnel initials. There was no indication who prepared and who checked the prepared products. Additionally, the fifth row of items did not contain the expiration date and time for the compounded product.

During a concurrent interview, the Director of Pharmacy (DOP) indicated the "SPA - IVPB Demand" contained a list of intravenous medications that were requested by the nursing units and it was sometime being used as the compounding log. The DOP acknowledged the missing information in the aforementioned compounding records.

A review of the hospital policy and procedure, Compounding Preparation Requirements for Pharmacy, dated 6/12/2012, indicated " ...Record keeping for any compounded preparation must have the following information logged: ... Expiration (BUD) of the END product ... The final quantity or amount, or number of items made ... Initials of the Technician or Pharmacist preparing the item ... Initials of the Pharmacist checking the prepared item ..."

2. On 2/22/2018 at 11:25 a.m. during a tour of the pharmacy department, a Pharmacy Technician (PTech) presented a folder containing a stack of compounding records. Those compounding records were untitled. During a concurrent interview, the PTech indicated those were the compounding records for intravenous chemotherapy (chemos). PTech stated he had prepared twenty one chemos in the morning.

A review of the aforementioned records indicated the top pages were dated 2/22/2018 and the prep times were all recorded as 8 a.m. During a concurrent interview, PTech stated 8 a.m. was the start time of the work shift and not the actual preparation time. During another concurrent interview, the Director of Pharmacy acknowledged the preparation time would be crucial to determine the expiration date/time, in situation when much shorter expiration date be warranted.

A review of the hospital policy and procedure, Chemotherapy Preparation and Delivery, dated 6/12/2017, indicated " ... Chemotherapy preparations should be recorded in the chemotherapy compounding log and should include ... Preparation date and time ..."

Based on observations, interviews and record reviews, the hospital did not meet the condition of participation in Food and Dietetic services by failing to:

1. Ensure that 19 of 20 patients with electronic orders for nutritional supplements and tube feedings were ordered by the physician responsible for the care of the patients. Registered Dietitians were routinely ordering nutritional supplements an tube feedings without a physician order. (cross refer A-0630).

2. Dietary Staff and management were not competent in regards to how to test to ensure the sanitizer for manual dish washing was at an effective concentration to sanitize pots and pans used for patient food service (cross referA-0622)

3. Previously cooked potentially hazardous foods (PHF - foods capable of supporting illness-causing bacterial growth when held at temperatures between 41 and 135 degrees Fahrenheit) were not temperature monitored for safe cooling per standards of practice that are critical to prevent the growth of disease causing bacteria and the potential to result in food borne illness. And the can opener blades were not maintained intact to prevent biofilm biofilms (a thin, slimy film of bacteria that adheres to a surface) build up that could result in food borne illness. (cross refer A-0749)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the Condition of Participation for Food and Dietary Services was met.

Based on observations, interviews and record reviews, the hospital Food and Nutrition Services failed to ensure staff was competent with respect to testing the concentration of the sanitizer to ensure it was effective in sanitizing pots and pans. This failure was evident when Dietetic Staff 1 (DS 1) did not follow manufacturer's guidance when testing the concentration of the sanitizer. This failure had the potential to result in effectively sanitizing the pots and pans used to cook patient food. Ineffective sanitizing of pots and pans had the potential to result in food borne illness in a medically vulnerable patient population of 217 patients who were served the food.

Findings:

During an observation of the manual ware washing area on February 20, 2018, at 2:40 PM , Dietary Staff 1 (DS 1) was washing pots and pans after lunch service. DS 1 was using the 3-compartment sink to wash the utensils. During a concurrent observation and interview, DS 1 demonstrated how he tested the concentration of the sanitizer in the final rinse step of ware washing. He placed the test strip in the third sink of sanitizer solution, and then compared the test strip to the color chart. The water temperature of the solution was tested and it registered 91.8 °F. DS 1 stated that the temperature of the sanitizer was okay.

A review of the manufacturer's direction on the test strip label indicated that the solution must be tested at 65-75 °F for accuracy.

During a concurrent interview with the Lead Coordinator, she stated that she was not aware of the temperature requirement for testing the sanitizer. She stated that the sanitizer dispenses from the faucet, premixed and hot. She verified that the staff would have to wait until the water cooled to room temperature before checking the concentration in order to follow this guidance. She stated that the solution should be dispensed at room temperature.

A review of the Food and Nutrition's policy titled, "Dishwashing Procedures, Policy No. 100.83200.036" (revised 3/16) indicated the purpose of the policy was "To ensure sanitation of dishes, pots, pans and utensils." It further stated, "Policy: Proper procedures and adherence to temperature requirements will be observed when cleaning dishes, pots, pans and utensils ..." The procedures indicated for Manual Dishwashing did not indicate a temperature requirement for testing of the sanitizer concentration. The procedures stated, "Pots, pans and utensils are disinfected in the third sink by the following method: immersion in water with a minimum temperature of 65 degrees F containing [sanitizer solution] ..."

During a concurrent interview with the Clinical Nutrition Manager (CNM), she was unable to state why the Lead Coordinator and DS 1 did not follow the manufacturer's guidance when testing the sanitizer concentration.

Based on observation, interviews and record reviews, the hospital failed to ensure all patient diets, including therapeutic diets were ordered by the practitioner responsible for the care of the patients. This failure occurred when the policy of the hospital indicated that it had established means to delegate authority to the qualified Registered Dietitian (RD) for ordering a patient's prescribed diet order or other medical nutrition therapy interventions.." According to the California Business and Professions code, RDs may not prescribe dietary treatments. Electronic orders for nutritional supplements and tube feeding, entered by the RD and carried out by the nursing or Food and Nutrition Services, were noted in 19 of 20 medical records reviewed.

Findings:

According to the California Business and Professions Code 2586(a) (1) Notwithstanding any other law, a registered dietitian, or other nutritional professional meeting the qualifications set forth in subdivision (e) of Section 2585 may, upon referral by a health care provider authorized to prescribe dietary treatments, provide nutritional and dietary counseling, conduct nutritional and dietary assessments, and develop and recommend nutritional and dietary treatments, including therapeutic diets, for individuals or groups of patients in licensed institutional facilities or in private office settings. The referral for medical nutrition therapy shall be accompanied by a written prescription signed by the health care provider detailing the patient's diagnosis and including either a statement of the desired objective of dietary treatment or a diet order. The registered dietitian, or other nutritional professional meeting the qualifications set forth in subdivision (e) of Section 2585, may perform nutritional assessments and initiate nutritional interventions within the parameters of the prescribed diet order pursuant to a licensed health care facility's approved nutrition screening policy and procedure. The registered dietitian, or other nutritional professional meeting the qualifications set forth in subdivision (e) of Section 2585, shall collaborate with a multidisciplinary team, which shall include the treating physician and the registered nurse, in developing the patient's nutrition care plan. Unless otherwise stated in the diet order by a patient's provider, the registered dietitian, or other nutritional professional meeting the qualifications set forth in subdivision (e) of Section 2585, may individualize the patient's nutritional or dietary treatment when necessary, by modifying the distribution, type, or quantity of food and nutrients within the parameters of the diet order. Any modification, and the rationale for the modification, shall be documented in the patient's record for review by the practitioner, or other licensed health care professional, who is legally authorized to prescribe and is responsible for the care of the patient. Nothing in this subdivision shall be construed to authorize a registered dietitian, or other nutritional professional meeting the qualifications set forth in subdivision (e) of Section 2585, to order or administer a central vein or peripheral vein nutrition.

During an observation of trayline (patient meal tray assembly) on February 201, 2018, between 11:30 am and 12:30 PM, multiple patient meals included a nutritional supplement.

A review of the hospital's diet list (a list of patients and their diet orders) indicated that 24 patients had orders for a nutritional supplement.

During medical record reviews of 20 patients who had electronic orders for nutritional supplements or tube feedings (the use of a feeding tube medical device to provide nutrition to patients who cannot obtain nutrition by mouth), it was noted that 19 of the medical records indicated there was no physician order for the supplement or the tube feedings. The electronic orders in the medical records for the 19 records without physician orders were all entered by a Registered Dietitian (RD).

During an interview with the Clinical Nutrition Manager (CNM) on February 22, 2018, at 3:30 PM she stated that the hospital's policy was for RDs to write diet and tube feeding orders without obtaining a physician order. She stated that she had a written policy indicating that the medical staff and the governing body had approved this practice.

A review of the hospital's policy titled, "Nutrition: Hospital Approved Orders Written by the Registered Dietitian, Policy No. 100.83400.357" indicated, "It is our policy to establish a means to delegate authority to the a qualified Registered Dietitian (RD) for ordering a patient's prescribed diet order or other medical nutrition therapy interventions in order to provide our patients with optimal nutrition care in a timely fashion ....The qualified RD may initiate specific nutrition interventions consistent with the dietitian's scope of practice for the State and which do not contradict medical patient care orders. The medical staff, with the approval by the hospital governing body, will grant specific nutrition care order writing privileges to the RD through approved protocols to facilitate implementation of patients' medical nutrition care plan ..."

In the state of California, the Business and Professions Code for Dietitians does not permit RD's to write diet or tube feeding orders.

Based on observation and interview, the condition of the physical plant and the overall hospital environment was not maintained.

Findings:

On 2/21/18 between 8:45 a.m. and 3:15 p.m. the following was observed:

Main Hospital Lower Level Operating Room (OR)

1. Thee scrub sink faucet between OR 1 & 2 had accumulation of mineral deposits.

2. The scrub sink faucet between OR 1 & 2 failed to provide water when activation plate was pressed.

During interviews at the same time as the observation, the Administrative Facilities Director stated that he did not know if anyone was working on the faucet or activation plate, and the Clinical Director of Surgery stated that the activation plate sticks often.

3. The scrub sink surgical hand scrub dispenser next to CYSTO room was missing the foot activator to dispense the surgical hand scrub.

During an interview at the same time as the observation the Clinical Director of Surgery identified the missing foot activator as the device that activates the surgical hand scrub dispenser.

4. Two cooling racks (carts) used to cool and transport hot sterilized equipment from the sterilizing room to the OR CORE, had rust on the outer hooks of the cart.

Main Hospital Lower Level Post Anesthesia Care Unit (PACU)

5. There was a one inch by two inch missing finish at a wall in bay 32 creating an uneven surface and exposing the bare wall board and wall board tape beneath.

During an interview at the same time as the observation the Clinical Director of PACU stated that she hadn't noticed the damaged wall and did not know how the wall became damaged.

Review of the both the cleaning and disinfecting solutions labels/literature indicated that the products are effective on hard non-porous surfaces.
Absorbent building materials (e.g., wallboard) serve as an ideal substrate for the proliferation of organism if they become and remain wet. Scrubbable materials are preferred for use in patient-care areas.

Same Day Surgery

6. Four of four scrub sink faucets next to OR 4 had accumulation of mineral deposits at their spouts.

Breast Health Center

7. There was a half inch by two inch missing finish at a wall in Ultrasound room D creating an uneven surface and exposing the bare wall board beneath.

During an interview at the same time as the observation the Director of the Breast Health Center stated she didn't remember the damaged wall being there.

Review of the both the cleaning and disinfecting solutions labels/literature indicated that the products are effective on hard non-porous surfaces.
Absorbent building materials (e.g., wallboard) serve as an ideal substrate for the proliferation of organism if they become and remain wet. Scrubbable materials are preferred for use in patient-care areas.

Outpatient Gastro-Intestinal (GI)

8. There was a half inch by two inch missing finish at a wall in the Endoscopy Reprocessing room creating an uneven surface and exposing the bare wall board beneath.

Review of the both the cleaning and disinfecting solutions labels/literature indicated that the products are effective on hard non-porous surfaces.
Absorbent building materials (e.g., wallboard) serve as an ideal substrate for the proliferation of organism if they become and remain wet. Scrubbable materials are preferred for use in patient-care areas.

9. On 2/23/18 at 11 a.m., in the Radiology Pavilion Lower Level patient holding room there was a one inch by four inch missing finish at a wall creating an uneven surface and exposing the bare wall board beneath.

Review of the both the cleaning and disinfecting solutions labels/literature indicated that the products are effective on hard non-porous surfaces.

Absorbent building materials (e.g., wallboard) serve as an ideal substrate for the proliferation of organism if they become and remain wet. Scrubbable materials are preferred for use in patient-care areas.

Based on observation, interview and document review, facility staff failed to ensure that life safety from fire requirements were met.

Findings:

1. On 2/21/18 between 9:14 a.m. and 9:30 a.m., the self-closing corridor door at Equipment room 1 failed to fully self-close to latch at lower level OR in Main Hospital.

During an interview at the same time as the observation the Administrative Facilities Director stated the door needed to be adjusted.

The deficiency had the potential to delay or not prevent the passage of smoke, heat and fire.

2. On 2/21/18 at 2:58 p.m., there was storage of instrument packs with less than an 18 inch clearance between the sprinkler deflector and the top of storage at instrument packet storage room at lower level operating room (OR) in Main Hospital.

During interviews at the same time as the observations the Administrative Facilities Director acknowledged the storage with less than an 18 inch clearance from the sprinkler deflectors.

Based on observation, interview, and record review, the hospital failed to ensure an equipment on a pediatric crash cart (mobile cart holding equipment and medication that would be used in medical emergency situations) was up-to-date on its scheduled maintenance inspection. This deficient practice had a potential for a medical equipment performs in a subpar affecting the patient outcome during a medical emergency.

Findings:

On 2/21/2018 at around 9:10 a.m. during a tour of the surgery department area with the Administrative Director of Maternal Child Health services (ADM10), there was a pediatric crash cart parked at the alcove in the Surgery Holding area. On top of the pediatric crash cart, there was a suction machine (an aspirator used to extract mucus and other fluids from the patient) with a label indicated "inspection due January 2018". During a concurrent interview, ADM10 acknowledged that the maintenance inspection of the suction machine was past due.

A review of the hospital policy and procedure, Equipment Scheduled Maintenance, dated 4/12/2016, indicated "Maintenance of medical equipment ... shall be planned and implemented ... to keep it safe and performing according to original functional specifications ..."

Based on observation, interview, and record review, the facility failed to:

1. Follow accepted standards which maintain a sanitary physical environment.

2. Follow standard of practice of not using a single Chloraprep swab to cleanse the arterial and venous access sites; not stirring the sample water for residual chlorinhe testing; using a dry, clean plastic cup to obtain water sample; oxygen tubing not labeled in various patients' room, faucet in the sinks in various patient rooms had green mineral deposit around the spigot and base of the faucet; a missing hand gel cover and sticky substance underneath the hand gel container, a bottle of Iodine opened and undated; leather footrest in the C-T Scan machine had a tear/hole; a stained ceiling in one of the rooms in the Pediatric Unit; a saline lock not dated/timed; a yellow tape around the handle of Kelly clamp, peel packs that contained grasper and vaginal speculum closed.

3. Ensure infection control practices were followed in Food and Nutrition Services when: cooked potentially hazardous foods (PHF - foods capable of supporting illness-causing bacterial growth when held at temperatures between 41 and 135 degrees Fahrenheit) were not monitored for safe cooling; and, the can opener blades were worn and nicked with the potential to harbor harmful bacteria that were not easily cleanable. These failures had the potential to result in food borne illness in a medically vulnerable patient population of 193 who were served food.

4. Ensure an air gap (space between the end of the pipe and the flood level of the drain) was maintained between a drain and the drainage pipe from an ice machine in the nursing unit nourishment room in 3 Pavilion Caregiver South. The failure to maintain an air gap had the potential to result in contamination of patient ice in the event of a negative water pressure event and waste water backed up into the drain pipe. This could have resulted in food borne illness in patients and staff who consumed the ice.

5. Ensure the use of a food safe chemical sanitizer for the cleaning of the Neonatal Intensive Care Unit (NICU) infant formula preparation area. This failure had the potential to result in chemical contamination of infant formulas and human breast milk used to feed patients.

6. Ensure trash stored on the dock was maintained in a sanitary manner when the trash compactor was overfilled so that the trash was not covered and multiple trash barrels were left on the dock uncovered. This failure had the potential to attract disease causing pests to harbor in the trash area adjacent to the Food and Nutrition Services department.

Findings:

1. During a tour of the Hyperbaric Therapy room on level on 2/23/18 at 1:15 PM there was a hand washing sink on a wall closest to the entrance door. It had green mineral deposit on the spout of its faucet.

In the middle of the room was a hyperbaric chamber (cylindrical chamber in which patients are placed in a reclining position where 100% oxygen delivery can be performed. Patients also wear a mask for delivery of 100% oxygen. Hyperbaric oxygen treatment was originally used to treat decompression sickness for divers but more recently for bacterial infection that produces gas in tissues such as gangrene and carbon monoxide poisoning). On a wall behind the chamber, on a hook mounted on the wall, was a red, plastic hazardous material bag with a breathing circuit (tubing used by patient to receive oxygen) inside. Hazardous material bags are intended to be used to dispose of substances or chemicals which are a "health hazards" or a "physical hazards" (OSHA definition). Next to this bag were 2 other similar bags containing breathing circuits but were clear colored.

During a conversation with the RCP at that time, she stated the circuit in the hazardous material bag belonged to a patient that was suspected or had a history of multi drug resistant organism infection; the other 2 bags were used by patients without this condition. All sets of breathing circuits would be used by the same patient at a later date.


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2. On February 20, 2018, at 2 p.m., during observation of the initiation of hemodialysis treatment for Patient 16, the Dialysis Nurse (DN) was noted wearing personal protective equipment (gown, glove and mask). The DN cleansed the patient's access site on the right upper arm, which was an antero-venous fistula (is an abnormal connection or passageway between an artery and a vein which could be surgically created for hemodialysis treatments). The DN used a single Chloraprep swab to cleanse the arterial and venous access sites.

During an interview with DN at the time of observation, he stated that he should have used a single swab for each of the access sites to prevent cross contamination.

On February 20, 2018, at 2:30 p.m., during observation of the preparation of the hemodialysis machine for Patient 16, the Dialysis Nurse wearing gown, mask and gloves holding a wet plastic cup to collect a water sample for residual chlorine testing. The Dialysis Nurse stirred the water for 60 seconds and took a test strip, dip into the container, shook the test strip to remove the excess water and waited 20 seconds then compared the result to strip container (RPC) and resulted to 0.01 which is pass.

Review of the Manufacturer's Instruction for Use for Ultra-Low TM Total Chlorine Test Strips indicated the following:
a. Collect a fresh 100 ml sample water in a clean, dry, plastic sample cup. The sample cup should be known to be free of chlorine, or prior to collecting the sample, rinse the clean dry sample cup with the water to be tested.
b. Remove one test strip from its foil package and swish it in the sample of the amount of time indicated such as water sample temperature from 42 degrees Fahrenheit (F) to 61 degrees F, swish time = 60 seconds.
c. Remove the strip and shake once, briskly, to remove excess water.
d. Wait 20 seconds for the test strip to develop.
e. After 20 seconds wait period, immediately compare the strip color to the color chart to determine the Total Chlorine Level in the sample.

During an interview with the Dialysis Nurse, he concurred that he should have wiped the plastic cup prior to collecting the water sample for accurate result of the chlorine test.

During the tour of the different units on February 20, 2018, between the hours of 9:35 a.m. to 4 p.m., the following was observed:

a. In room 13, there was an exposed gauze with other patient's sealed supplies.

b. Oxygen tubing not labeled in various patients' room. During an interview with Medical Surgical Director at the time of observation stated the oxygen tubing are changed every seven (7) days. However, if it's not dated how can it be ascertain when it's time to change the tubing.

c. The faucet in the sinks in various patient rooms had green mineral deposit around the spigot and base of the faucet (example Triage room #1, Exam room #44 nurses station, respiratory room).

d. There was a missing hand gel cover and sticky substance underneath the hand gel container.

e. There was a bottle of Iodine opened and undated in the phlebotomy room.

f. The leather footrest in the C-T Scan machine had a tear/hole.

g. There was a stained ceiling in one of the rooms in the Pediatric Unit.

h. Patient 16 had a saline lock on the left lower hand but was not dated/timed when it was initially placed by a licensed nurse.

i. On February 21, 2018, at 4 p.m., there was a yellow tape around the handle of Kelly clamp found in a major laparotomy tray when opened by the Instrument Technician. Also the instruments were placed on top of each other in a tray noted after it was autoclaved. There were four (4) peel packs that contained grasper where the tip was not opened. There was a peel pack that contained a vaginal speculum the blades were not opened.

During an interview with ICP, stated the vaginal speculum is not being used so it will de discarded.


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3. According to the 2017 USDA Food Code, cooked potentially hazardous foods (PHF) shall be cooled within two hours from 135 °F (degrees Fahrenheit) to 70 °F, and within a total of six hours from 135 °F to 41 °F. It further states that if PHF are not cooled according to this code, harmful bacteria may grow to sufficient numbers to cause food borne illness. The initial two hour cool is a critical element of this cooling process.

During a tour of the kitchen on February 20, 2018, at 10:50 am, two pans of cooked chicken breasts dated February 20, 2018, were noted in the walk-in refrigerator. During a concurrent interview with the Executive Chef (EC), he stated that the chicken was cooked earlier that day and was cooled in the blast chiller. He stated the cooks were supposed to record the temperatures during the cool down process on a log.

A review of the hospital's "Cooling and Reheating Chart: Time/Temperature Log for Potentially Hazardous Foods" (dated February 19-20, 2018) showed seven items on the log: three country gravy, three chicken quesadilla, all dated February 19, and chicken dated February 20. Under the heading "Cooling Procedure" on the log, none of the seven items indicated that a temperature was recorded after starting temperatures. There were no two hour cooling temperatures recorded. There were no final temperatures recorded. The chicken breasts observed in the walk-in refrigerator indicated on the log that the last time the temperature had been recorded was at 8 am.

During an interview with Cook 1 at 11:07 am, Cook 1 stated that he forgot to record the two hour temperatures on the log.

A review of the hospital's policy titled "Food Production and Service, Policy No. 100-83200-048" (revised 8/15) stated, "Foods will be cooled correctly ....Food is cooled to 70 degrees F within 2 hours and 40 degrees F within an additional 2 hours. ...A cooling log will be completed."

During a tour of the kitchen on February 20, 2018 at 2:51 pm, two can opener blades (on one can opener in the cook's area and one can opener in the cold preparation area) were noted to be worn and nicked. The blades were not smooth to the touch due to the nicks in the surface of the blades.

During a concurrent interview with The Lead Coordinator, she stated that she was responsible for monitoring the integrity of the can opener blades and that the blades were changed every month. She could not explain why the blades were worn and nicked.

A policy for maintaining the can openers was requested. The Clinical Nutrition Manager stated the hospital did not have a policy.

According to the 2017 USDA Food Code, cutting or piercing parts of can openers shall be kept sharp to minimize the creation of metal fragments that can contaminate food when the container is opened. It also states food-contact surfaces of equipment shall be smooth, free of breaks, open seams, cracks chips, inclusions, pits, and similar imperfections. Surfaces which have imperfections such as cracks, chips, or pits allow microorganisms to attach and form biofilms (a thin, slimy film of bacteria that adheres to a surface). Once established, these biofilms can release pathogens (disease causing organisms) to food. Biofilms are highly resistant to cleaning and sanitizing efforts.

4. During an observation of the nourishment room in 3 Pavilion Caregiver South on February 21, 2018, at 3:00 pm, the drain pipe from the ice machine was noted to be located behind a door in the wall at the back of the under counter cabinet. There was no air gap maintained between the end of the drain pipe and the flood level of the drain fixture. In addition, there were disposable cups stored in this cabinet.

During a concurrent interview with Engineering Staff 1, he stated that it looked as though someone had added a plastic extension to the drain pipe to prevent spillage. He verified that there was no air gap maintained and there should have been one. He also verified that the cups should not be stored adjacent to the plumbing fixture.

According to the 2017 USDA Food Code, an air gap between the water supply inlet (drain pipe) and the flood level rim of the plumbing fixture (drain), equipment, or non-food equipment shall be at least twice the diameter of the water supply inlet and may not be less than 1 inch. This is required because during periods of extraordinary demand, drinking water systems may develop negative pressure in portions of the system. If a connection exists between the system and a source of contaminated water during times of negative pressure, contaminated water may be drawn into and foul the entire system.

5. During an observation in the NICU on February 21, 2018, at 3:15 pm, the infant formula preparation area was observed. A container of germicidal disposable wipes was stored on the counter. The manufacturer's specifications on the wipes container did not indicate that they were food safe.

During a concurrent interview with the Infection Control Preventionist (ICP), the ICP indicated that the germicidal wipes were used to clean the infant formula and human breast milk preparation counter. The ICP further stated that the germicidal wipes did not need to be food safe if it does not touch the breast milk.

A review of the hospital's NICU policy titled "Formula: Procurement, Preparation and Storage, Policy No. 100.60700.006" (revised 03/16) indicated, "The designated (formula preparation area will disinfected using hospital supplied wipes before and after each formula preparation." The policy did not indicate which wipes to use. The policy further indicated that one of the references used for this policy was "Pediatric Nutrition Practice Group (2011). Preparation of Formula for Infant: Guidelines for Health-Care Facilities. Robbins S, Meyers R. Ed, 3rd edition. American Dietetic Association."

According to this standard of practice [Pediatric Nutrition Practice Group (2011). Preparation of Formula for Infant: Guidelines for Health-Care Facilities. Robbins S, Meyers R. Ed, 3rd edition. American Dietetic Association], sanitizers used to sanitize formula preparation surfaces in formula and breast milk preparation areas should be food safe.

6. During a tour of the hospital's loading dock on February 20, 2018, at 3:15 pm, the hospital's trash compactor was noted to be over filled with expose trash bags that were not covered. Engineering Staff 2 started the trash compactor but the exposed trash was still present after the compactor finished. Also noted was multiple uncovered trash cans overflowing with trash.

During a concurrent interview with Engineering Staff 2, he stated that the compactor was too full because they did not have a trash pick up the previous day since it was a holiday. He further stated that he was cleaning out the adjacent trash grinder because it was not working. He stated that the trash should be covered and not exposed.

According to the 2017 USDA Food Code, proper storage and disposal of garbage and refuse are necessary to minimize the development of odors, prevent such waste from becoming an attractant and harborage or breeding place for insects and rodents, and prevent the soiling of food preparation and food service areas. Improperly handled garbage creates nuisance conditions, makes housekeeping difficult, and may be a possible source of contamination of food, equipment, and utensils. In addition, storage areas must be large enough to accommodate all the containers necessitated by the operation in order to prevent scattering of the garbage and refuse. All containers must be maintained in good repair and cleaned as necessary in order to store garbage and refuse under sanitary conditions as well as to prevent the breeding of flies.