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354 SANTA FE DRIVE

ENCINITAS, CA 92024

CONTENT OF RECORD

Tag No.: A0449

Based on interview and record review, nursing staff failed to document pre-medication and post-medication pain assessments for 2 of 38 sampled patients (11, 12), per the facility's nursing standards of practice. As a result, information was not available for other care providers to use in making assessments of the patient's condition.

Findings:

1. The hospital admitted Patient 11 on 1/8/15 for rehabilitation services with a diagnosis of CVA (cerebrovascular accident or stroke - loss of brain function due to a disturbance in the blood supply to the brain), per the Face Sheet.

According to Patient 11's admission orders, dated 1/8/15, the physician ordered Hydrocodone/APAP 5/325 milligrams (a combination medication of hydrocodone and acetaminophen used to treat moderate to severe pain), 1 tab (tablet), po (by mouth), q 6°(every 6 hours) prn (as needed) pain - NTE (not to exceed) 3 grams per 24 hours.

On 1/21/15, the night shift nurse, Registered Nurse (RN) 11, completed Patient 11's initial assessment and documented on the patient's flowsheet that the patient had a pain level of "7" on a 0-10 scale (0 = No pain; 10= Highest level of pain). There was no documentation to indicate what time the pain assessment was completed.

Per the electronic Medication Administration Record (eMAR), Patient 11 received 1 tablet of Hydrocodone/APAP 5/325 mg at 12:04 A.M. on 1/21/15.

On 1/21/15 at 6 A.M., RN 11 documented a shift summary note on the Interdisciplinary Progress Record that Patient 11 "...c/o pain 7/10 on right leg - gave Norco® (Hydrocodone/APAP 5/325) at 00:04 per request with good relief." There was no documentation to indicate what time a pre and post-medication pain assessment was completed.

On 1/26/15, the day shift nurse, RN 12, completed Patient 11's initial assessment and documented on the patient's flowsheet that the patient had a pain level of "6" on a 0-10 scale. There was no documentation to indicate what time the pain assessment was completed.

Per the eMAR, Patient 11 received 1 tablet of Hydrocodone/APAP 5/325 mg at 7:07 A.M. on 1/26/15.

On 1/26/15 at 11:45 A.M., RN 12 documented a shift summary note on the Interdisciplinary Progress Record. RN 12 documented that Patient 11 complained of a headache and "...medicated with 1 Norco® at 0800 with relief." There was no documentation to indicate what time a pre and post-medication pain assessment was completed.

2. The hospital admitted Patient 12 on 1/19/15 for rehabilitation services with the diagnoses of BKA (below the knee amputation) and stroke (loss of brain function due to a disturbance in the blood supply to the brain), per the Face Sheet.

According to Patient 12's admission orders, dated 1/19/15, the physician ordered "Acetaminophen (an analgesic), 650 mg, po, q 4° prn for H/A (headache); Hydrocodone/APAP 5/325 milligrams, 1 po, q 4° prn mild pain. May repeat x1 in 30 min (minutes) if pain not relieved; and Hydrocodone/APAP 10/325, 1 po, q 4° prn moderate pain. May repeat x1 in 30 min if pain not relieved."

On 1/21/15, the night shift nurse, RN 11, completed Patient 12's initial assessment and documented on the patient's flowsheet that the patient had a pain level of "5" on a 0-10 scale. There was no documentation to indicate what time the pain assessment was completed.

Per the eMAR, Patient 12 received 1 tablet of Hydrocodone/APAP 5/325 mg at 12:16 A.M. on 1/21/15.

On 1/21/15 at 12 A.M., RN 11 documented a shift summary note on the Interdisciplinary Progress Record that Patient 12 "...stated he was in pain." At 2 A.M., RN 11 documented on the progress record she medicated Patient 12 with Norco® 10/325 per his request with good result at 00:16." There was no documentation to indicate what time a pre and post-medication pain assessment was completed.

On 1/26/15, the day shift nurse, RN 12, completed Patient 12's initial assessment and documented on the patient's flowsheet that the patient had a pain level of "0" on a 0-10 scale. There was no documentation to indicate what time the pain assessment was completed.

According to the eMAR, Patient 12 received 1 tablet of Hydrocodone/APAP 5/325 on 1/26/15 at 9:56 A.M., and received another tablet of Hydrocodone/APAP 5/325 at 10:38 A.M. There were no pre-medication or post-medication assessments documented.

On 1/26/15 at 12:55 P.M., RN 12 documented, "Appears oriented x4, no c/o pain..."
On 1/26/15, the evening shift nurse, RN 13, completed Patient 12's initial assessment and documented on the patient's flowsheet that the patient had a pain level of "6.5" on a 0-10 scale. There was no documentation to indicate what time the pain assessment was completed.

According to the eMAR, Patient 12 received 1 tablet of acetaminophen 650 mg on 1/26/15 at 3:15 P.M. The patient also received 1 tablet of Hydrocodone/APAP 10/325 at 8:28 P.M.

On 1/26/15 at 9:20 P.M., RN 13 documented that the patient, "Request Norco® 10/325 mg 1 tab @2028 for 6.5/10 pain RLE (right lower extremity) and HA....Request Tylenol® (acetaminophen) 650 mg at 1508 for pain state partial relief." There was no documentation to indicate what time a pre and post-medication pain assessment was completed.

When interviewed on 1/27/15 at 2:20 P.M., RN 14 stated, the type, level, location and characteristic of the patient's pain should be documented before pain medication is given and the pain should be reassessed within 1 hour for po medications. In addition, RN 14 stated, if the patient is unable to verbalize their pain level, another scale such as a scale to show facial expressions should be used.

When interviewed on 1/27/15 at 2:37 P.M., the Unit Manager verified that the RNs should complete a pain assessment and document the level, type, and location of the patient's pain before and after administering pain medication.

Per the facility's Medical-Surgical Nursing Standards of Practice (S-FW-PC-8200), dated 11/14, the RNs are directed to assess the patient's pain on "...admit, Q shift, transfer, PRN... and document the location, characteristics, pain level, and sedation level." In addition, pain reassessment should be completed "...post pain management intervention once a sufficient time has elapsed for treatment to reach effect, not to exceed 1 hour..."

MEDICAL RECORD SERVICES

Tag No.: A0450

2. Patient 21 was admitted to the facility on 1/25/15 through the emergency department, per the Facesheet.

Patient 21's medical record was reviewed 1/28/15. Physicians orders, dated 1/25/15 and 1/26/15 did not have a licensed nurse's signature, date, or time, indicating the physicians orders were acknowledged by the Registered Nurse (RN).

Patient 22 was admitted to the facility on 1/26/15 through the emergency department, per the Facesheet.

Patient 22's medical record was reviewed on 1/27/15. Physicians orders dated, 1/25/15, 1/26/15 and 1/27/15, did not have a licensed nurse's signature, date, or time, indicating the physicians orders were acknowledged by the RN.

Patient 23 was admitted to the facility on 1/26/15 through the emergency department, per the Facesheet.

Patient 23's medical record was reviewed on 1/28/15. Physicians orders dated, 1/27/15 did not have a licensed nurse's signature, date, or time, indicating the physicians orders were acknowledged by the RN.

Patient 24 was admitted to the facility on 1/25/15 through admissions, per the Facesheet.

Patient 24's medical record was reviewed on 1/28/15. Physicians orders dated 1/25/15 and 1/26/15, did not have a licensed nurse's signature, date, or time, indicating the physicians orders were acknowledged by the RN.

RN 24 stated during an interview on 1/28/15 at 2 P.M., "Nurses are supposed to note orders with the date, the time the order was taken off, then sign their name."

RN 25 stated during an interview on 1/29/15 at 2 P.M., "Nurses are to note the physician orders with their name, date, time, and credential." RN 25 further said, "All entries into a patient's record need to have the staff signature, date, time, and credential."

According to the facility's policy, Orders: Physician, Licensed Independent Practitioners and Allied Health Professionals, for Hospital Services and Medication, revised 7/14, "RN will check each transcribed order for accuracy and sign name, title, date and time."


28183

Based on interview and record review, the facility failed to ensure staff authenticated stamped entries in the medical record for 4 of 38 patients (31, 32, 33, 34). The facility also failed to ensure nurses noted physician orders in the medical record with his/her signature, dated, and timed for 4 of 38 sampled patients (21, 22, 23, 24).

Findings:

1. The medical records were reviewed on 1/28/15 and 1/29/15.

Patient 31 was admitted on 1/26/15 with a diagnosis of COPD (Chronic Obstructive Pulmonary Disease) exacerbation, per the Facesheet. Physicians orders, dated 1/26/15, were stamped with Registered Nurse (RN) 1's name and corporate identification (id) number. There was no signature, date or time by RN 1 to authenticate the stamped entry.

Patient 32 was admitted on 1/19/15 with a diagnosis of left pleural effusion (excess fluid around the lung), per the Facesheet. Physicians orders, dated 1/24/15, were stamped with RN 1's name and corporate id number. There was no signature by RN 1 to authenticate the stamped entry.

Patient 33 was admitted on 1/19/15 with a diagnosis of elevated troponin (a test to diagnose a heart attack), per the Facesheet. Physicians orders, dated 1/26/15, were stamped with RN 1's name and corporate id number. There was no signature by RN 1 to authenticate the stamped entry.

Patient 34 was admitted from the ED (Emergency Department) on 1/25/15 with a diagnosis of shortness of breath, per the Facesheet. According to the ED Nursing Flowsheet, there was a stamp with RN 2's name and corporate id number in two separate sections of the flowsheet. There was no signature by RN 2 to authenticate the stamped entries.

Patient 34's medical record also included physicians orders and a separate pre-printed Telemetry Orders form, both dated 1/26/15. Both documents were stamped with RN 1's name and corporate id number, however there was no signature by RN 1 to authenticate the stamped entries on either form.

When interviewed on 1/28/15 at 2:30 P.M. the Nurse Manager (NM) of 2-West stated that she was not aware of the unit nurses using stamps. The NM further stated, "The stamp should be signed, dated and timed by the nurse."

On 1/28/15 at 3:30 P.M., RN 2 stated, "My understanding is that I only have to sign and date the stamp on the last page of the flowsheet."

When interviewed on 1/28/15 at 3:35 P.M., the ED Director (EDD) stated that there is no policy on the use of stamps. The EDD further stated that nurses should sign, date and time every stamped entry, not just the last page."

During an interview on 1/29/15 at 1:15 P.M. the Medical Records Director (MRD) stated that the Health Information Management is ultimately responsible for ensuring all patient records are accurate, complete and entries are authenticated. The MRD further stated that every entry requires a signature, date and time.

According to the facility's policy, Health Record, Authors and Authentication, acceptable forms of authentication include a hand written legal signature by the author. The policy further indicated, "Rubber signature stamps may only be used as supplemental for the purpose of legibility and must be accompanied by authentication by the author."

PHARMACY ADMINISTRATION

Tag No.: A0491

Based on observation, document review, and staff interview, the hospital failed to ensure the temperature of pharmacy refrigerators and freezer were monitored per hospital's policy and procedure (P&P). The main pharmacy refrigerator and freezer used for storing vaccines were not monitored twice a day; other pharmacy refrigerators used for storing medications were also not consistently monitored daily. This failure may result in patients receiving ineffective vaccinations.

Findings:

Review of the hospital P&P titled "Medication Management: Medication Storage and Security" dated 4/14, showed under temperature monitoring: "All areas where medications are stored (Patient care areas, Ambient, Warmer, Refrigerator, Freezer) will be monitored and recorded at least daily, and a minimum of twice daily if containing vaccinations..."

During tour of the hospital Pharmacy on 1/27/15 at 10:25 AM, in the presence of the Director of Pharmacy (DOP) and Pharmacy Clinical Manager (PCM), vaccines were observed stored in the freezer and the main pharmacy refrigerator.

Varicella (to protect against chickenpox disease) and zoster (to help reduce the risk of getting shingles) vaccines were stored in the freezer.

The vaccines stored in the main pharmacy refrigerator included: DTP vaccines (diphtheria, pertussis - whooping cough, and tetanus), hepatitis B pediatric and adult vaccines, meningococcal vaccines (to protect against bacterial meningitis), MMR vaccines (measles, mumps and rubella), rabies vaccines, pneumovax vaccines (to protect against pneumococcal disease), hepatitis A vaccines and tetanus diphtheria vaccines.

Review of the pharmacy refrigerator/freezer temperature logs for the current month was initiated in the presence of the DOP, PCM and Medication Safety Officer (MSO) on 1/28/15 at 3:20 PM. This review showed the temperature was not documented on 1/3/15 for the chemotherapy drugs refrigerator, IV clean room refrigerator and the narcotic refrigerator.

There was no temperature documented for the main pharmacy refrigerator in the morning of 1/4/15, 1/6/15, 1/18/15, and 1/21/15; the afternoon of 1/2/15 and 1/3/15, 1/19/15, and 1/20/15.

There was also no temperature documented for the pharmacy freezer in the morning of 1/4/15, 1/6/15, 1/18/15, and 1/21/15; the afternoon of 1/2/15, 1/3/15, 1/19/15, and 1/20/15.

During the concurrent staff interview, the DOP, PCM and MSO acknowledged the temperature logs were missing documentation. The DOP stated twice a day monitoring was supposed to be documented in the morning and in the afternoon.

DELIVERY OF DRUGS

Tag No.: A0500

Based on document review and staff interview, the hospital failed to ensure a medication order with a range of doses clarification was documented for 1 of 38 sampled patients (62). This failure may result in patients not receiving adequate pain medication or being overmedicated.

Findings:

Review of the hospital's policy and procedure (P&P) titled "Pharmacist Medication Management Authority as granted by the Pharmacy and Therapeutics Committee" dated 1/14, showed Pharmacists are granted authority to clarify medication order with a range of doses/frequencies by writing a clarifying medication order in the patient's medical chart.

Review of the hospital's P&P titled "Medication Administration" dated 11/14, showed under procedures: "...Prior to administration, staff will review medication orders for appropriateness and accuracy against eMAR/MAR..."

On 1/28/15 at 1:30 PM, reconciliation of the medication administration observed for Patient 62 was initiated in the presence of Nurse Supervisor and the Director of Pharmacy (DOP). One of the medications administered during observation that morning was two tablets of oxycodone/acetaminophen (controlled drug to treat severe pain)10mg/325mg (milligram).

Review of the physician's medication order showed oxycodone/acetaminophen 10mg/325mg 1-2 tablets before morning and afternoon therapy was ordered on 1/28/15 at 8:35 AM. Review of the eMAR documentation showed two tablets of oxycodone/acetaminophen 10mg/325mg were administered before morning and afternoon therapy. Review of the eMAR did not show a clarification order from the physician, Registered Nurse (RN) 1 or pharmacist contrary to above hospital's P&Ps.

During concurrent staff interview, the DOP stated pharmacist clarified the range doses with RN 1 prior to computer entry. The pharmacist thought RN 1 was going to write a clarification order. RN 1 was busy with patient care, therefore was unable to be interviewed.

UNUSABLE DRUGS NOT USED

Tag No.: A0505

Based on observation, document review, and staff interview, the hospital failed to ensure their policy and procedure (P&P) was implemented when opened undated tuberculin purified protein derivative (PPD) injection vial and sterile water for irrigation bottle were available for patient use. This failure may result in patients receiving medications outside the manufacturers' guidelines.

Findings:

Review of the hospital's P&P titled "Sterile Products Compounding Program" dated 5/14, showed under attachment F: Multiple Dose Vials (MDVs) - "The BUD (beyond use date) for MDVs once punctured that are kept at their proper storage temperature is 28 days subsequent to initial use or less based on expiration date on packaging or other manufacturer instructions. MDVs of this type must be dated with the specific beyond use date and time based on the time and date of initial use..."

Under attachment F Single Dose Containers: "Single use vials, bags, bottles that are sterile but have been opened or punctured must be used for compounding within 1 hour if exposed to air quality less than ISO class 5... Single use containers of this type must be dated with specific beyond use date and time based on time and date of initial use. Contents remaining past the established BUD must be properly discarded."

Review of PPD's manufacturer's package insert and PPD vial's label showed to discard opened vial after 30 days.

Review of the sterile water for irrigation bottle label showed "Single use bottle, discard unused portion."

The hospital Pharmacy was toured on 1/27/15 at 10:25 AM, in the presence of the Director of Pharmacy (DOP) and Pharmacy Clinical Manager (PCM). During the tour, opened undated tuberculin PPD 5 ml (milliliter) vial was found in the main pharmacy refrigerator contrary to the above hospital's P&P and the manufacturer's guideline.

Opened undated sterile water for irrigation 1000 mL bottle was also found in the compounding area contrary to above manufacturer's labeling and hospital's P&P.
The DOP acknowledged the opened undated PPD and sterile water for irrigation.

STOP-ORDERS FOR DRUGS

Tag No.: A0507

Based on document review and staff interview, the hospital failed to ensure implementation of their automatic stop order policy and procedure (P&P). This failure resulted in 1 of 38 sampled patients (61) missing a dose of their medication and may also result in patients receiving unnecessary medications.

Findings:

Review of the hospital's P&P titled "Physician, Licensed Independent Practitioners and Allied Health Professionals, for Hospital Services and Medications" dated 7/14, showed under Medication Order: "All medications will require a new order after 30 days...The pharmacy shall monitor automatic stop order compliance."

Review of the hospital's P&P titled "Medication Administration" dated 11/14, showed under procedures: "...Prior to administration, staff will review medication orders for appropriateness and accuracy against eMAR/MAR..."

On 1/29/15 at 1:20 PM, the medical chart review for Patient 61 was initiated in the 2 West unit in the presence of the the Director of Pharmacy (DOP), Pharmacy Clinical Manager (PCM), Medication Safety Officer (MSO) and Nurse Manager. The medical chart had a medication stop notice/Order form for Dronedarone 400 mg tablet (to treat cardiac arrhythmias) with a stop date of 1/26/15 at 23:59.

Review of the eMAR showed Dronedarone 400 mg tablet was documented to start on 1/28/15. The eMAR also showed Dronedarone 400 mg tablet was not administered on 1/27/15, but was documented as administered on 1/28/15. Investigation showed Dronedarone 400 mg tablet order was renewed on 1/29/15. The above hospital P&Ps was not implemented.

During concurrent staff interview, Registered Pharmacist (RPh) 1 confirmed Dronedarone 400 mg tablet was renewed on 1/29/15. RPh 1 also stated that automatic stop order was a soft stop; this meant nurses have access to continue giving medication prior to MD renewing the order.

The MSO acknowledged Dronedarone 400 mg tablet was administered on 1/28/15; the order was renewed on 1/29/15. The MSO explained that Dronedarone 400 mg tablet did not drop off the eMAR after 1/26/15; it remained on the eMAR with a stop date of 1/26/15 until it was renewed on 1/29/15.

During concurrent interview, the MD stated he, "meant for the medication to be continued."

DIRECTOR OF DIETARY SERVICES

Tag No.: A0620

Based on interview and record review, the hospital failed to ensure the interdisciplinary health care team was clear on the hospitals expectations as related to care of a patient with a latex allergy and the potential for cross-reactivity with certain foods related to latex allergy.

As a result, there was the potential for a latex-related food allergy to not be addressed which may adversely affect a patient's health outcome.

Findings:

On 1/28/15 at 10:30 A.M., Patient 51's medical record was jointly reviewed with the Clinical Nutrition Manager (CNM). Patient 51 was admitted to the hospital on 1/25/15. According to Patient 51's medical record under the category of "Allergen and Reaction", Patient 51 was allergic to "Keflex [an antibiotic]; unknown reaction, Codeine; unknown reaction, Latex; rash, Food -shellfish; unknown reaction."

Concurrently, the CNM was asked if the documented latex allergy would trigger an action of some type from the food and nutrition department, and she stated, "No. Her only food allergy is shellfish, and we do not serve shellfish in the hospital."

On 1/28/15 at 11:40 A.M., a copy of the "Latex Allergy" guidance that was in the hospital's approved diet manual was provided by hospital staff 52. The "Latex Allergy" guidance indicated, "...studies show that approximately 40% of individuals with a natural latex allergy are also sensitive to a plant-derived food ..., prevalence of latex allergy is increasing, and has reached epidemic proportions in the past 20 years ...Nutrition Prescription Synonym; The link between latex allergy and food allergy has been referred to as "latex diet syndrome," and is the result of cross-reactivity between natural rubber latex proteins and fruit proteins. Nutrition Intervention; Dietitians should obtain a thorough diet history in order to ascertain if the latex sensitive patient must avoid certain fruits, vegetables, seeds, or nuts. The foods most frequently causing clinical reactions that can lead to anaphylaxis [a severe, potentially life-threatening allergic reaction] in patients with latex allergy are avocado, kiwi, banana, and chestnut. Other implicated foods include apricot, bell pepper, carrot, dill, fig, grape, mango, oregano, passion fruit, pineapple, sage, tomato, sunflower seeds, and tree nuts. Patients with latex allergy should be advised to be cautious when eating these foods..., Goals; Nutrition counseling should enable patients with latex allergy to do the following: Define possible cross-reactive foods associated with latex allergy, understand the risk involved when eating these foods, explain cross-contamination risks and describe steps to take to minimize the risk, identify problem-solving avoidance skills, describe symptoms of a food-induced allergic reaction and what should be done during a reaction, identify online resources for reliable medical information ..."

The hospital's policy and procedure entitled Food and Nutrition Services: Diet Manual, Diet Orders and Diet Restrictions (Effective: 9/26/14) indicated, "Policy; ...A diet manual developed by the Academy of Nutrition and Dietetics is used as the basis for all diets and planning modified diets ..."

On 1/28/15 at 3:15 P.M., the CNM, and Administrative Director Facilities & Support Services, acknowledged they were unaware that the hospitals approved diet manual contained latex allergy guidance that would have related to the dietary office, and the registered dietitians. They confirmed that the food and nutrition department had not had a policy and procedure related to latex allergy in order to provide guidance and procedures on how to implement the guidance located in the diet manual as related to patient care. The Food and Nutrition Services Director was not available for an interview as related to this matter.

According to the hospital's job description for Food and Nutrition Services Director, "...Responsible for the oversight and leadership of the activities ..., Directs policy and procedure formation for guiding and supporting the provisions of the service ..., Directs, plans, and coordinates the operational systems for Food and Nutrition Services including ...clinical nutrition care ..."

DIETS

Tag No.: A0630

Based on observation, interview and record review, the hospital failed to ensure that dietary staff served accurate portion sizes in accordance with the planned menu to ensure the nutritional needs of the patients were met.

Findings:

On 1/27/15 at 11:35 A.M., lunch preparation tray line was observed.

The dietary staff preparing the patients lunches used a spreadsheet that indicated food item and quantity to provide for regular and therapeutic diets per the Food Service Supervisor (FSS). According to the spreadsheet the FSS provided, "Regular diet: 6 oz [ounce] mexican tortilla soup, 2 ea [each]+ 2 Tbsp [tablespoon] chicken tacos w/salsa, 1/3 C [cup] cilantro lime rice, 1/2 C cabbage tomatillo slaw, 1 pkg [package] saltine crackers x 2, 2/3 C fruit cup, 1 each margarine x 2, 8 oz iced tea."

The FSS stated a #12 scoop was used to serve the cilantro lime rice which was equivalent to a 1/3 cup portion as planned.

A dietary employee was observed using tongs to serve the cabbage tomatillo slaw. The FSS stated the patients were to be served 1/2 cup of the cabbage tomatillo slaw. The FSS acknowledged dietary staff were serving the slaw with tongs, and stated, "We're eyeballing it."

A dietary employee was observed using tongs to serve the shredded chicken in the corn tortilla with tongs. The FSS was asked how much chicken should be served to ensure the planned amount of protein per the menu was served, and she stated, "two tacos each."

At that time, the Clinical Nutrition Manager (CNM) was asked what the quantity of planned protein from the chicken tacos were planned per the menu, and she stated, "Should be serving 3 ounces of the chicken, so 1 1/2 ounce of chicken per chicken taco."

The Registered Dietician (RD) was asked how the dietary staff were to know that each taco should contain 1 1/2 ounces of the shredded chicken, as the spreadsheet for regular diet indicated "2 ea + 2 Tbsp", and she stated, "The recipe indicates the quantity of protein to be served."

The CNM was asked who was responsible for ensuring the appropriate measuring utensils were available and correct in accordance with the planned menu before start of the meal preparation trayline, and she stated, "Any manager or cook walking by can check. It's not a delegated task."

A review of the recipe for the chicken tacos indicated, "Portion: 2 tacos, 1.5 oz meat in each."

A review of the spreadsheet for a diet order of "Renal without Dialysis" indicated to provide 2 tacos with 1 oz of chicken in corn tortilla."

The CNM stated, "The protein served should be measured because that relates to the menu and nutrient analysis." The CNM acknowledged that without dietary staff measuring the portion being served that it had the potential to affect the therapeutic diet of renal without dialysis not being served correctly, as well."

The facility's policy and procedure entitled "Food Safety, Preparation And Service", last revised 9/14 indicated, "E. Serving; 10. Portion sizes have been established and employees have been trained on proper portion sizes..."

VENTILATION, LIGHT, TEMPERATURE CONTROLS

Tag No.: A0726

Based on observation, interview and document review, the hospital failed to maintain records that demonstrated maintenance of the required levels for operating room (OR) humidity. The humidity for the 4 operating rooms and the endoscopy suite contained a daily entry for humidity level in each room. The acceptable range for humidity is specified on each page of the log as 20-60%. There were numerous instances when some or all of the values for the operating rooms were above 60%. In all cases there is documentation that a work order was initiated. Multiple interviews suggested that the humidity readings were obtained early in the morning, about 03:30 AM, and that the humidity was back in range by the time the ORs were opened for the day. However, there was no documentation in the log that the humidity levels had been back in range during the day. This resulted in the hospital not being able to provide evidence of compliance with acceptable OR humidity levels, resulting in the potential for growth of infectious micro-organisms.

Findings:

Logs of humidity measurements for the past three months were reviewed, and the Surgical Suite was toured, on 1/27/15 at 10:00 AM and again 1/28/15 at 3:00 PM. The Director of Services and the Manager of the Operating Rooms were present at both times. During the first visit, the Director explained that and pointed out that each OR had a humidity display on the wall, visible to the nurses. She explained that the humidity was measured daily by staff from Engineering, and any adjustments made as needed. She stated the nurses could also monitor the humidity during the day by viewing the humidity display in the ORs. She could not describe how environmental services recorded the data, how they would adjust the humidity or how they would be made aware if the humidity fell out of range.

The Senior Director of Facilities and Support Operations was interviewed on 1/28/15 at 1:15 PM. She confirmed that the humidity in the ORs was checked very early each day, and remedied, if needed, prior to the start of surgical procedures. She also stated that the OR nurses checked the humidity in the OR rooms before each case.

Humidity logs for the past 3 months were reviewed several times during the remaining survey period. The humidity readings in the log demonstrated that at least 3, and usually 4, rooms had humidity readings above 60 for 11 days (6 in November and 5 in December), with a maximum value of 78%. In each case there was an entry indicating a work order was initiated.

Engineering Staff 1 was interviewed 1/29/15 at 8:00 AM. He provided a sample of one of the work orders showing how remediation was accomplished. He explained that in each case, adjustment of air flow settings resulted in humidity values in the accepted range of 20-60% but stated that the repeat humidity levels were not recorded in any fashion.

On the second visit to the OR, the Director and Manager were again questioned about OR humidity. They stated that the nurses checked the humidity readings in the ORs before each surgical case but did not document these readings.

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on interview and record review, the hospital failed to ensure hospital staff complied with the hospital's expectations to sanitize the ice-machine's in the hospital (15 of 15 ice-machines) in accordance with manufacturer's guidelines, and per the hospital's preventative maintenance instructions as related to infection control.

Findings:

On 1/27/15 at 11:15 A.M., the supervising Chef stated that the hospital's engineering staff was responsible for maintaining the top-portion, internal components, of the ice-machine located in the kitchen. Concurrently, the Facility Support Services Administrative Director (FSAD) stated to speak to Engineering Staff (ES 51) who was responsible for maintaining the ice-machine in the kitchen.

On 1/28/15 at 9:25 A.M., ES 51 stated that he had been in the role of cleaning the ice-machines for approximately five years at the hospital. ES 51 stated that he used nickel safe ice-machine cleaner in the top part of the ice-making apparatus. ES 51 stated he used a food grade sanitizer that was in the kitchen for the sanitizing portion of the ice-machine. ES 51 stated that the procedure was the same for the ice-machines hospital-wide which were approximately 15 ice-machines, and was completed on a quarterly basis. ES 51 stated, "I follow manufacturer's specifications." When ES 51 was asked how he knew to use the nickel safe ice-machine cleaner, and the food grade sanitizer from the kitchen, he stated, "That was how I was trained by a previous engineer employee about five years ago."

On 1/28/15 at 10 AM, the manufacturer's guidelines for the ice-machine located in the kitchen was provided by ES 51. According to the manufacturer's guidelines the specified sanitizing agent was "sodium hypochlorite".

On 1/28/15 at 11:45 A.M., ES 51 confirmed that he used the food-grade sanitizer from the kitchen to sanitize the ice-machine's hospital-wide. ES 51 confirmed the food-grade sanitizer that he used was Oasis 146 Multi-Quat Sanitizer.

On 1/28/15 at 12:00 P.M., according to directions located on a "quarterly inspection procedure checks" related to ice-machines, "Quarterly; Clean and sanitize operating portions where ice is made with sodium hypochlorite solution. See manufacturer's recommendations for recommended PPM [parts per million] and detailed procedures..."

On 1/28/15 at 3:15 P.M., FSAD acknowledged that the engineering staff had not been sanitizing the ice-machines hospital wide in accordance with the hospital's policy and procedure which was to follow manufacturer's guidelines.

The hospital's policy and procedure entitled, "Ice Equipment, Cleaning and Maintenance of ", (revised 11/14) indicated, "Policy...B. Ice machines will be cleaned on a regular basis to reduce the potential for transmission of disease following manufacturer instructions..."

OPERATING ROOM SUPERVISION

Tag No.: A0942

Based on interview, the Director of Surgical Services was not knowledgeable of all elements of the operating room (OR) environment. She could not explain the finding of out of range values in the OR humidity log or describe if and how this was remedied for each occurrence. She also was unable to describe the products and procedures involved in terminal (end of day) cleaning of the ORs. These findings resulted in the inability of the hospital to validate that the Director of Surgical Services was responsible for all aspects of the provision of care provided by surgical services.

Findings:

Logs of humidity measurements for the past three months were reviewed, and the Surgical Suite was toured, on 1/27/15 at 10:00 AM and again 1/28/15 at 3:00 PM. The Director of Services and the Manager of the Operating Rooms were present at both times. During the first visit, the Director explained that and pointed out that each OR had a humidity display on the wall, visible to the nurses. She explained that the humidity was measured daily by staff from Engineering, and any adjustments made as needed. She stated the nurses could also monitor the humidity during the day by viewing the humidity display in the ORs. She could not describe how environmental services recorded the data, how they would adjust the humidity or how they would be made aware if the humidity fell out of range.

Humidity logs for the past 3 months were reviewed several times during the remaining survey period. The humidity readings in the logs demonstrated that at least 3, and usually 4 rooms, had humidity readings above 60 for 11 days (6 in November and 5 in December), with a maximum value of 78%. In each case there was an entry indicating a work order was initiated.

On the second visit to the OR, the Director and Manager were again questioned about OR humidity. They stated that the nurses checked the humidity readings in the ORs before each case but did not document these readings. At that time, the Director was also asked to describe the process and materials used for terminal cleaning of the ORs. She stated that Environmental Services performed this task and she could not speak to the specifics. She could not describe the process or what agents were used. She did not know the contact time for the disinfectant cleaners or how she could be sure that the contact time was being followed.

Engineering Staff 1 was interviewed on 1/28/15 at 1:00 PM. He was able to identify the disinfectant cleaner as Blue Skies II, with a contact time of 10 minutes. He validated that staff were trained in the contact time and the need to be sure that surfaces remained wet for a minimum of ten minutes.