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Based on observation, interview, and record review, the facility failed to ensure it provided reliable laboratory services to meet the needs of its patients, when facility staff tested the specimens of six Emergency Department (ED) patients, using Point-of-Care (POC) lab equipment, which had not been Quality Control (QC) tested. This failure had the potential to result in misdiagnoses, delay in care and services, and prolonged discomfort.

Findings:

During an observation and interview on 12/10/19, at 10:30 a.m., the ED had POC lab equipment located in its dirty utility room. Posted to the wall behind the POC equipment was a poster indicating, "please check daily." ED Nurse EE stated the POC equipment was the ED's "[urinalysis] machine," which facility staff performed quality control checks on, "[each] day." ED Nurse EE reviewed the QC testing log for the month of December 2019. ED Nurse EE stated the QC log indicated the facility did not perform a QC test on 12/8/19 or 12/9/19. ED Nurse EE stated the last QC was performed on, "12/7/19." ED Nurse EE stated a, "nurse will be here at noon today," to perform the 12/10/19, QC and update the log. ED Nurse EE stated, if staff did not perform a QC on a given day, but still tested a patient's specimen, the nurse must audit the patient record to, "double-check," the ED physician did not diagnose the patient based on a no-QC POC test.

During an interview on 12/11/19, at 2:02 p.m., Lab Director FF stated the hospital's laboratory service monitored the ED's compliance with QC testing of POC equipment in the ED. Lab Director FF stated the hospital laboratory service audited the ED's record of QC testing for POC equipment to identify opportunities for improvement and to assist ED leadership with compliance concerns.

During a review of the POC testing log, located inside the dirty utility room on 12/10/19, at or around 10:30 a.m., the log indicated the ED performed six tests on POC equipment, which was not QC-tested. The ED performed the tests during patient care provided 12/8/19 and 12/9/19.

The facility policy and procedure titled, "Point of Care Testing (POCT) Quality Assurance Policy," revised 4/18/19, indicated the, "frequency for running quality controls," for the POC testing equipment. The policy and procedure indicated ED staff must QC the POC equipment, "daily," for occult blood, urine dipstick, or whole blood glucose testing. The policy and procedure indicated staff should not use equipment for POC testing unless QC was performed and the results of the QC were satisfactory.

Based on observation, interview, and record review, the facility failed to ensure the Condition of Participation for §485.635 Provision of Services was met, when:

1) The Operating Rooms (OR) were not maintained in a sanitary condition, when the OR sanitizer was not used per manufacturer's directions (Cross reference C-278);

2) Surgery staff did not have documented competencies for cleaning and sanitizing the OR in their employee files (Cross reference C-278);

3) Clinic staff did not process contaminated instruments, per hospital policy, when they rinsed them in clean hand washing sinks (Cross reference C-278);

4) A utilized Hopper (toilet-like fixture used to dispose/flush human waste) was located directly next to the head of a patient's bed (Cross reference C-278 );

5) Patient 31's central line (an intravenous catheter inserted so its tip is in the vein near the heart) dressing was not completely covering the line's insertion site (Cross reference C-278);

6) Wall-mounted hazardous waste sharp's containers (used to hold contaminated, used needles and other sharp implements) were not emptied, per hospital policy (Cross reference C-278);

7) An ice machine was not clean, and preventive maintenance was not completed, in accordance with manufacturer's guidance (Cross reference C-278);

8) Various pharmacy policy and procedures were inadequate, medication expiration dates were not accurate, contents of an emergency medication cart were not updated, and a verbal order was not documented timely (Cross reference C-276);

9) The dietary departmental operations did not comprehensively meet food safety and patient needs, when: A) one food production sink and one ice machine was directly connected to the waste water system; B) three food production staff lacked facial hair restraints; C) the location of a paper towel dispenser resulted in cross-contamination of a food production surface; and, D) the nutritional content of the menu had excessive Vitamin A and low levels of Vitamin E (Cross reference C-279);

10) The facility did not use the least restrictive means to restrain one emergency medical patient (Cross reference C- 271); and,

11) The facility did not care plan an activity pursuit for one swing-bed (skilled care services provided in an acute care hospital) patient (Cross reference C- 271).

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality health care in a safe environment.

Based on observation, interview, and record review, the facility failed to provide care and services consistent with its policies and procedures, when it failed to:

1) Use the least restrictive means of restraint when caring for one emergency department patient; and,
2) Care plan one Swing Bed (a special payment status for post-level care) patient's activity pursuits.

These failures had the potential to promote restraint use for staff convenience and diminish Patient 33's quality of life, respectively.

Findings:

1) A review of Patient 32's clinical record indicated she presented for emergency services on 12/5/19, at 1:55 a.m. The clinical record indicated Patient 32 was intoxicated with alcohol and in custody of law enforcement. It also indicated nursing staff first screened Patient 32 for violence and suicide risk on 12/5/19, at 2:40 a.m. The clinical record indicated Patient 32 was, "agitated, at 2:40 a.m., using, "profanity" and, "verbally threaten[ed] [sheriff's officers], postured her body (5'1," 180 pounds) in a, "threatening" way, and threatened elopement (leaving without medical consent) from the Emergency Department. The clinical record did not indicate Patient 32 demonstrated physical violence on law enforcement or staff during this visit.

On 12/5/19, at 3 a.m., Patient 32's clinical record indicated, in the presence of law enforcement and facility security, clinical staff applied, "4 point locking restraints," related to Patient 32's, "unsafe/combative behavior." By 3 a.m., the clinical record indicated Patient 32 received a one-to-one sitter at the bedside providing, "continuous observation." On 12/5/19, at 3 p.m., clinical staff additionally administered injections of "Ativan, 2 [milligrams]," and Geodon, "20 [milligrams], intramuscular[ly]."

Ativan is a controlled substance used to treat anxiety and agitation, and assist with alcohol withdrawals (Lexicomp, 2019). "Frequently reported side effects," of Ativan included, "fatigue," and, "other side effects," of Ativan included, "passing out" (Lexicomp, 2019). Geodon is a non-controlled substance used to treat agitation and psychosis (Lexicomp, 2019). "Frequently reported side effects," of Geodon included, "fatigue," and, "other side effects," of Geodon included, "passing out" (Lexicomp, 2019). Ativan and Geodon are both psychotropic medications.

During a concurrent interview and record review on 12/11/19, at 2:50 p.m., Coordinator H stated the facility's emergency department referenced the policy titled, "Restraints (Acute & Swing Beds)" when using restraints during patient care.

During a concurrent interview and record review, beginning 12/13/19, at 10:30 a.m., Nurse Manager BB reviewed the medical record from Patient 32's Emergency Room visit on 12/5/19. Nurse Manager BB stated the record indicated facility staff applied four-point restraints (restraints applied to both wrists and both ankles) to Patient 32 and medicated Patient 32, secondary to Patient 32's agitation on 12/5/19, at 3 a.m. Nurse Manager BB stated facility policy required nurses to assess for continued use of physical restraints one hour after applying the restraints. Nurse Manager BB reviewed a clinical assessment note, ("V Restraint"), dated 12/5/19, at 3:45 a.m., in Patient 32's medical record. Nurse Manager BB stated the clinical assessment indicated Patient 32 was, "asleep" at 3:45 a.m., forty-five minutes after the facility initiated physical restraints and other, less restrictive measures, to manage behavior. Nurse Manager BB reviewed a clinical assessment note ("V Restraint"), dated 12/5/19, at 4 a.m., in Patient 32's medical record. Nurse Manager BB stated this restraint assessment indicated the facility's assessment of Patient 32, one-hour after initially applying restraints, and further indicated Patient 32 was, "asleep." Nurse Manager BB stated the assessment indicated Patient 32's, "impulsivity" justified the facility continuing four-point restraints. Nurse Manager BB stated the assessment indicated Patient 32 was both, "asleep" and, "impulsive," at the same time. Nurse BB stated, "I don't know," how the nurse assessed Patient 32 to be impulsive while asleep.

During a review of Patient 32's clinical record, the "Patient Care Timeline," dated 12/5/19, between 3 a.m. and 5 a.m., indicated Patient 32's four-point restraints continued between the hours of 3:45 a.m. and 5 a.m., while Patient 32 was pharmacologically subdued and asleep. The clinical record did not indicate staff titrated (removing restraints piecemeal, until none remain) or removed the four-point restraints between 3:45 a.m. and 5 a.m., while Patient 32 slept.

During a review of Patient 32's clinical record, the "ED Rounding" note, dated 12/5/19, at 4 a.m., indicated Patient 32 was, "in bed.....quiet," with her, "eyes closed." The note indicated the facility had, "given [Patient 32] medication to calm down/go to sleep." The note indicated Patient 32 was, "in 4 point restraints."

Patient 32's, "ED Notes," dated 12/5/19, at 5 a.m., indicated staff woke Patient 32, who had been sleeping, to remove the four-point restraints. The note indicated Patient 32 was calm and cooperative, and, "fell back asleep shortly [after]," staff removed the restraints and provided care. The note did not indicate why the facility did not attempt to remove Patient 32's physical restraints earlier.

Patient 32's, "Emergency Department Physician Note," dated 12/5/19, at 4:35 a.m., indicated Patient 32, "had to be restrained so that she could be evaluated." The physician note indicated Patient 32 was, "very aggressive and uncooperative," on arrival to the Emergency Department.

The facility policy and procedure titled, "Restraints (Acute & Swing Beds)," revised 8/26/16, indicated a, "physical restraint shall only be used ... where least restrictive treatment interventions have not been immediately effective in preventing harm." The policy indicated the facility's goals when using restraints, included, " ... to get the patient out of restraints as soon as less restrictive methods can be implemented." The policy defined, "Less Restrictive," methods to include the use of, "psychotropic medication, per physician order." The policy indicated a registered nurse, "every hour.....must [revaluate] the patient's clinical condition," for, "criteria," to verify if continuing restraints is appropriate. The policy indicated two, "criteria for continuation of restraints (or for titrating restraints): 1. Patient verbally threatens to harm self or others, or 2. Patient demonstrates continued attempts to harm self or others."

2) During an observation on 12/9/19, at 4 p.m., an activities calendar was posted in the facility's medical-surgical unit. The calendar showed activities planned for December 1-14, 2019. The calendar did not include activities scheduled after December 14, 2019.

During an interview on 12/9/19, at 4:15 p.m., Nurse Manager BB stated the medical-surgical unit had an activity coordinator for Swing Bed services. Nurse Manager BB stated the activities coordinator was a Certified Nurse Assistant, but had received training as an activity coordinator. Nurse Manager BB stated the medical-surgical unit's activity program provided activity programming daily. Nurse Manager BB stated the facility documented patient participation with activities. Nurse Manager BB stated the facility did not post December's entire activity calendar because the activity coordinator, "does not come until tonight, and she will update the schedule," for the rest of December.

During an observation on 12/10/19, at 2:15 p.m., the activity program calendar, posted in the facility's medical-surgical unit, had changed. The new calendar indicated activities planned for December 8-28, 2019.

During an observation and interview at Patient 33's bedside on 12/10/19, at 2:30 p.m., Patient 33 stated he contributed to his plan of care at the facility. Patient 33 stated staff provided care and support in a time that met his needs. Patient 33 stated watching television was his preferred activity. "Keep TV on [smiley face]," was written on the staff communication's board mounted on the wall across from the head of Patient 33's bed.

During a concurrent interview and review of Patient 33's clinical record on 12/11/19, at or around 8:25 a.m., Nurse Manager BB stated the clinical record contained the facility's activity assessment for Patient 33 and also tracked a tracking flow sheet for Patient 33's participation in activities. Nurse Manager BB stated the facility did not document Patient 33's activity pursuits in a care plan, though. Nurse Manager BB stated the facility's electronic health record did not provide an option for documenting a care plan specific to activities.

During a concurrent interview and review of Patient 33's clinical record, on 12/13/19, at or around 11:05 a.m., Nurse Manager BB stated the facility performed Patient 33's initial activities assessment on 11/22/19, at 9 p.m. Nurse Manager BB stated the initial assessment did not indicate staff asked Patient 33 his preferences for where he preferred to pursue individual or group activities, or whether he desired to exercise religious, spiritual, or political beliefs.
Patient 33's clinical record contained no care plan for Patient 33's activity needs, routines, or preferences.

The facility policy and procedure titled, "Activity Program," revised 10/21/18, indicated the facility's activity coordinator was responsible to post a monthly schedule of activities for the current month, on the "[Medical-Surgical] Bulletin Board." The policy and procedure indicated the activity coordinator was also responsible to, "develop an individual activity plan" for Swing Bed patients. The policy and procedure indicated the activity plan would be devised from input by the patient, family, activity coordinator, and nursing staff. The policy and procedure indicated the patient's, "attending physician," must review the activity plan and document written approval that a patient's activity plan did not conflict with the patient's treatment plan.

Based on inspection of one out of one Broselow Cart (an emergency supply cart containing equipment and medications used to manage pediatric emergencies), located near the Medical/Surgical Unit, one out of one malignant hyperthermia (MH: A rare but potentially lethal side effect of certain medications used in the practice of anesthesiology) cart, located in the Surgery Department, one Electronic Health Record (EHR) of a patient, Patient 21, currently in the hospital, who had recently received the blood thinner, heparin, document review and staff interview:

1. The hospital policy failed to ensure the policy, which established the contents of the medication tray stored in the Broselow Cart, provided for the concentration of lidocaine to match the concentration of lidocaine on the Broselow Tape (a color-coded tape used to estimate the weight of a child and which then provides dosing guidelines for emergency medications based on the child's weight), available in the Broselow Cart and identified, by hospital staff and hospital policy, as the reference the hospital would follow to guide proper dosing of emergency medications in children during a pediatric code blue (a medical emergency involving the heart and/or lungs), with the potential staff may administer an incorrect dose of lidocaine to a child during the management of a pediatric code blue (see finding 1 below);

2. The hospital failed to ensure the policy, which established the contents of the medication tray stored in the Broselow Cart, provided for enough epinephrine 1:1000 (used to re-establish spontaneous circulation of the blood) in the medication tray, for all weight classes of children, as provided for in the Broselow Tape (see finding 1 below);

3. The hospital policy, which established the contents of the medication tray, stored in the Broselow Cart, failed to include magnesium sulfate, used to treat a dangerous abnormal heart rhythm (arrhythmia) called Torsades de Pointes, in the medication tray, with the potential therapy of this arrhythmia could be delayed during a code blue (see finding 1 below);

4. The hospital failed to ensure accurate expiration dates were written on the medication content list, posted on the Broselow Cart, which mislabeled the expiration dates of the affected medications within the cart, with the potential expired medications could eventually be available within this emergency supply (see finding 2 below);

5. The hospital failed to ensure pharmacy staff followed a pharmacy procedure to place a laminated information card on a pre-filled syringe (PFS) of sodium bicarbonate (used to lower the high acid levels in the blood that can occur during a pediatric medical emergency), in the Broselow medication tray, which notified staff this syringe had been substituted for the smaller PFSs of sodium bicarbonate normally placed in the cart, with the potential this could temporarily confuse staff during a pediatric code blue (see finding 3 below).

Between 12/1/18 and 12/13/19, 3627 pediatric patients were seen in the Emergency Department (ED) and could potentially have been affected by any irregularities involving the Broselow Cart;

6. The hospital failed to update the content list of the MH Cart contained in the policy, regarding the management of MH, which accurately documented the volume of the vials of sterile water for injection, currently placed in the cart (see finding 4 below);

7. The hospital failed to provide a proper procedure for sealing the MH cart with a breakable plastic seal. As a result, staff failed to seal the cart properly, with the result unauthorized access to the contents of the cart was then possible (see finding 5 below); and,

8. The hospital failed to ensure a verbal order to discontinue heparin was immediately entered into Patient 21's Electronic Health Record (EHR), as stipulated by hospital policy (see finding 6 below).

Findings:

1. The Broselow Tape is a nationally recognized tool providing a rapid way to estimate the weight of a pediatric patient and containing information regarding the dosing of medications used in urgent and emergent situations, based on the child's estimated weight. The tape is divided into color-coded sections corresponding to specific weight ranges for children. A child's weight is estimated by placing the top of the tape at the top of the child's head and then reading the estimated weight range off the corresponding color-coded section the child's feet reaches while lying down next to the tape. The tape lists the medications and corresponding dosages, both in mass units (milligrams) and volume units (milliliters), which are used to manage a pediatric code blue. These medications, and the associated dosage guidelines, appear in all the color-coded sections of the tape. The dosages listed with the medications in each color-coded section are specific for the weight class of children the color-coded section represents.

The Broselow cart is a color-coded emergency cart containing equipment in color-coded drawers. The colors correspond to specific weight ranges so the drawers would contain equipment suitable for use for children of the weight class represented by the color. The cart also contains the medications used to manage pediatric emergencies.

On 12/9/19 at 12:11 p.m., during an interview with RN T, she stated the hospital had Broselow Carts containing their own medication trays. She stated hospital staff followed the Broselow Tape medication guidelines to guide dosing of medications during a pediatric code blue (a medical emergency in which the patient has stopped breathing and/or in which the patient's heart is beating irregularly, such that it cannot pump blood through the body, or the heart has stopped beating).

On 12/10/19 at 3:25 p.m., a review of Policy and Procedure 5535834, titled, CODE BLUE (Effective 3/27/19, Revised 3/27/19), indicated it documented the pediatric medication tray contained medications, "that are used in accordance with the most current Pediatric Color-Coded Tape ...." During an interview with the Regional Pharmacy Director at that time, he stated this language referred to the Broselow Tape.

On 12/10/19 at 11:02 a.m., an inspection of the Broselow Cart stored in Room 220, off the Medical/Surgical unit, indicated the medication tray, located in the top drawer, contained two 5 milliliter (ml) pre-filled syringes (PFSs) of lidocaine 1% (10 milligrams/ml) for injection and three 1 ml ampules of epinephrine 1 milligram (mg)/ml for injection. It did not contain any magnesium sulfate for injection.

Inspection of the bottom drawer, indicated it contained a 2017, edition of the Broselow Tape. A review of the Broselow Tape indicated the following issues:

The Broselow Tape documented doses of lidocaine (used to treat dangerous abnormal heart rhythms) for all weight classes of infants and children documented on the tape, from 3 kilograms (kg) up to 36 kg; it provided the doses in mg and ml. However, the concentration of lidocaine documented on the tape was 2% (20 mg/ml), so a nurse who relied solely on the dosage volume of lidocaine printed on the Broselow Tape, would only give half of the required dose when using the 1% lidocaine, which was placed in the medication tray.

The Broselow Tape documented children in the color-coded, "Green" zone (30 to 36 kg), would need 3.3 ml of epinephrine 1%. The cart only contained three one ml ampules of this medication.

The Broselow tape documented all weight classes may require administration of magnesium sulfate at a concentration of 40 mg/ml or 80 mg/ml.

On 12/11/19 at 11:14 a.m., inspection of the pharmacy indicated it had a bin containing 50 ml and 100 ml intravenous (IV: in the vein) bags of magnesium sulfate 40 mg/ml.

On 12/12/19 at 10:23 a.m., during a concurrent review of a Broselow Cart medication tray, the 2017, Broselow Tape, and interview with RN Q, she was asked to locate the lidocaine in the cart and, using the Broselow Tape, indicated the dose to be given to child in the color-coded, "Yellow," section of the tape (12, 13, 14 kg children). She picked up the 1% lidocaine available in the medication tray and noted the concentration listed on the Broselow Tape for lidocaine was 2%. She stated, "I am a little lost with that," and stated it was not the, "right percentage." When asked what dose of magnesium sulfate she would give to a child in this weight class, she reviewed the content list, and stated magnesium sulfate did not appear on the content list.

On 12/12/19 at 10:35 a.m., during a concurrent review of a Broselow Cart medication tray, the 2017, Broselow Tape, and interview with RN R, she was asked to locate the lidocaine in the cart and, using the Broselow Tape, indicated the dose to be given to child in the color-coded, "Yellow," section of the tape (12, 13, 14 kg children). She identified the medication tray contained 1% lidocaine, not 2%, as on the Broselow Tape, and then doubled the dosage volume printed on the tape from 0.65 ml to 1.3 ml (which was correct, as the available lidocaine was half as concentrated as the lidocaine listed on the tape), in order to deliver the 13 mg dose documented on the tape for this weight class. When asked what dose of magnesium sulfate she would give to a child in this weight class, she stated magnesium sulfate was not available in the medication tray. She stated the lack of availability of magnesium sulfate in the pediatric medication tray, had been identified in the past. She stated she would pull the magnesium sulfate from another crash cart (the Adult Crash Cart).

On 12/12/19 at 10:49 a.m., during an interview with Physician S in the ED, he stated the magnesium sulfate would be used to treat Torsades de Pointes. He stated it would need to be administered, "immediately," to a patient presenting with Torsades the Pointes.

2. On 12/10/19 at 11:02 a.m., an inspection of the Broselow Cart stored in Room 220, which was located just off of the Medical/Surgical unit, indicated the content list posted outside of the cart documented the following expiration dates for the following medications:

flumazenil (a sedative) 0.5 mg/5 ml, expired 11/20 (November 2020)

lidocaine 1% 10 mg/ml (50 mg Syringe), expired 9/20 (September 2020)

sodium bicarbonate 4.2% neonatal, expired 6/20 (June 2020)

Inspection of the contents of the medication tray in the Broselow Cart at that time, indicated the manufacturers' expiration dates for these medications were 11/21 (November 2021), for both flumazenil vials, 9/1/20, for both lidocaine PFSs, and 6/1/20, for the 4.2% sodium bicarbonate PFS.

These observations were verified at that time, by interview with the Regional Director of Pharmacy.

Therefore, the flumazenil would expire one year later than listed on the content list, and both the flumazenil and sodium bicarbonate would expire 29 days earlier than listed on the content list.

3. On 12/10/19 at 11:02 a.m., an inspection of the Broselow Cart stored in Room 220, off the Medical/Surgical unit, indicated the content list posted outside of the cart documented the cart was to contain three 5 ml PFSs of atropine 0.1 mg/ml. The, "5" on the, "5 ml" volume entry on the list was crossed off and replaced with a, "10" (so three 5 ml PFSs were replaced with three 10 ml PFSs). Staff wrote in the following after the, "atropine" entry on the content list: "See Laminated Card."

The content list documented the cart was to contain four 10 ml PFSs of sodium bicarbonate 8.4%, "PEDIATRIC." The, "10" on the, "10 ml" volume entry on the list was crossed off and replaced with, "50" while the, "4" under the, "Amount" column (indicating how many units of a medication were available in the tray) was crossed of and replaced with, "1" (so four 10 ml syringes were replaced with one 50 ml syringe). Staff wrote in the following under the, "sodium bicarbonate," entry: "Adult -See Laminated Card" (indicating an adult size PFS had replaced the pediatric sized PFSs).

Inspection of the medication tray indicated it contained three PFSs of atropine with a laminated card attached to them which read: "ATTENTION!!! Pediatric Atropine 0.1 mg/ml, 5 ml syringes are unavailable. Please use the inserted adult Atropine 0.1 mg/ml, 10 ml. Please note there is NO concentration difference!" The 50 ml PFS of 8.4% sodium bicarbonate PFS had no such laminated card attached to it. These observations were verified at that time, by interview with the Regional Director of Pharmacy. He stated the substitutions had been made secondary to shortages (unavailability from the manufacturers) of the products which were supposed to be in the medication tray.

On 12/11/19 at 9:52 a.m., during an interview with the Director of Pharmacy, she stated pharmacy staff were supposed to have put a laminated card in with the adult PFS of sodium bicarbonate (observed in the Broselow Cart medication tray on 12/10/19). She stated her staff had failed to put a laminated information card on the sodium bicarbonate PFS, as required by pharmacy procedure. An inspection of a replacement pediatric medication tray in the pharmacy at that time, indicated staff had placed a laminated card on the adult sodium bicarbonate PFS, informing staff who might use the tray that the 10 ml PFSs were not available, and the 50 ml PFS was substituted for them.

4. Malignant hyperthermia (MH) is a rare but potentially lethal adverse effect of certain medications, the anesthetic gases and succinylcholine (a muscle relaxant used during surgery), used in anesthesia and surgery. It is characterized by a rapid rise in a patient's temperature up to 110 degrees Fahrenheit or more. If not treated immediately it can result in injury to, or death, of a patient.

On 12/10/19 at 3:55 p.m., a review of Policy and Procedure 2813643, titled, MALIGNANT HYPERTHERMIA: ASSESSMENT, IDENTIFICATION & TREATMENT (Effective 11/15/18, Revised 11/15/18), indicated Attachment A to this policy was a content list of the medications for this emergency supply. A review of Attachment A at this time, indicated it documented the cart contained two 250 ml containers of sterile water for injection.

On 12/10/19 at 3:54 p.m., a review, in the pharmacy, of a fill list provided by Pharmacy Tech U, indicated the fill list documented the MH Cart was to contain two 10 ml vials of sterile water for injection, not two 250 ml containers of sterile water for injection. During a concurrent interview with Pharmacy Tech U conducted at that time, she stated staff used the fill list to restock the MH Carts in the hospital.

On 12/10/19 at 4:28 p.m., an inspection of medication contents of the MH Cart, located in the Surgery Department, indicated the contents of the cart matched the MH Cart fill list provided by Pharmacy Tech U, in that it contained 10 ml vials of sterile water for injection. This observation was verified at that time, by interview with the Director of Pharmacy. The Director of Pharmacy stated Attachment A associated with Policy 2813643, needed to be updated.

5. On 12/10/19 at 4:13 p.m., an inspection of the MH Cart located in the Surgery Department, indicated staff had attached a plastic breakable seal to a handle on the cart used to gain access to the contents of the cart. When the handle was pulled out, the seal did not break, and an eyelet was noted where the handle had originally been located. Further inspection of this mechanism indicated, if staff had placed the breakable seal through the eyelet and a matching hole in the handle, this would have sealed the cart, and pulling the handle out would have broken the plastic seal. Hence, the cart was not sealed properly. This observation was verified at that time, by interview with the Director of Pharmacy and the Interim Surgery Nurse Manager. The Interim Surgery Nurse Manager stated it was a practice of the hospital to seal the MH Cart with a plastic seal which needed to be broken to gain access to the contents of the cart. She stated the fact that the handle could be pulled out, thus opening the cart without breaking the plastic seal, indicated the MH Cart had not been sealed properly.

A concurrent review of Policy 2813643, at 4:18 p.m., with the Director of Pharmacy, indicated it provided no direction to staff to seal the cart or how to seal the cart.

6. On 12/11/19 starting at 1:24 p.m., a review of Patient 21's Electronic Health Record (EHR) indicated Patient 21 was admitted to the hospital via the ED, with a diagnosis of non-ST elevated myocardial infarction (myocardial infarction means heart attack and ST segment refers to part of the electrocardiogram which is a tracing of the electrical impulses generated in the heart. This segment can be elevated during a myocardial infarction. When the ST segment is not elevated, the damage done to the heart is less than when the ST segment is elevated). On 12/7/19 at 6:01 p.m., Physician W ordered a heparin (used to treat blood clots) infusion (administered intravenously at an ordered rate of administration) for treatment of Acute Coronary Syndrome (a heart attack)/Atrial Fibrillation (an abnormal rhythm of the upper chambers of the heart, which can result in blood clots forming in the heart and then transporting elsewhere in the body) Protocol.

Further review of the EHR, indicated staff started the infusion, as ordered, at 8:07 p.m., on 12/7/19. On 12/9/19 at 7 p.m., ICU Nurse CC stopped the heparin infusion, but there was no order entered in the EHR to discontinue the heparin until 11:38 a.m. on 12/10/19. This observation was verified during a concurrent review of the EHR and interview of ICU Nurse AA.

On 12/11/19 at 4:51 p.m., a review of Nursing Communication 1137921936, indicated ICU Nurse CC documented the heparin infusion was turned off at 7 p.m. on 12/9/19, on the order of Physician X.

On 12/13/19 at 9:41 a.m., a review of Policy and Procedure 3549981, titled, PHYSICIAN ORDERS (Effective 1/17/19, Revised 1/17/19), indicated it stipulated physicians would be expected to directly enter most orders for their patients into their EHRs. The policy documented nurses could take telephone orders from a physician when it involved an emergency and, "when computer access (was) an issue for the ordering provider."

On 12/13/19 at 9:59 a.m., during a concurrent review of Patient 21's EHR, with the ICU and Med/Surg Director, she stated the order to discontinue the heparin infusion on 12/10/19, at 11:38 a.m. was a telephone order taken by ICU Nurse CC, which was countersigned by Physician X on 12/10/19 at 5:17 p.m. The ICU and Med/Surg Director stated she could find no comment in this order that it was a late entry. During a concurrent review of the Nursing Communication 1137921963, the ICU and Med/Surg Director stated it was not a physician's order, rather, it was ICU Nurse CC's documentation that ICU Nurse CC had received direction from Physician X to turn off the heparin infusion at 7 p.m. on 12/9/19. The ICU and Med/Surg Director stated it was her understanding the order of 12/10/19 at 11:38 p.m., to discontinue the heparin infusion, referred to the event which took place at 7 p.m. on 12/9/19. During a concurrent review of Policy 3549981, the ICU and Med/Surg Director stated that entering the order to discontinue heparin on 12/10/19 at 11:38 a.m., when the original order was received by ICU Nurse CC at 7 p.m. on 12/9/19, violated Policy 1137921936.

Based on observation, interview, and record review, the facility failed to ensure an effective infection control program and infection control practices were implemented, in accordance with hospital policy and procedure, when:

1) The facility did not adequately sanitize the Operating Rooms (OR) when the OR sanitizer (Neutral Disinfectant Cleaner) was not used, per manufacturer's directions. The sanitizer's 10 minute, "contact time" (also called dwell or wet time; time product must remain wet on surfaces to ensure death of disease-causing microbes) was not maintained, per manufacturer's instructions;

2) Surgery staff did not have documented competencies (skills required to perform job function) for cleaning and sanitizing the OR, in their employee files;

3) Clinic staff did not process contaminated instruments, per hospital policy, when they rinsed used instruments in clean, hand-washing sinks, located in patient exam rooms;

4) A utilized hopper (toilet-like fixture used to dispose/flush human waste, such as urine, etc.) was located directly next to the head of a patient bed;

5) Patient 31's central line (an intravenous catheter, inserted in the neck, where its tip rests in the large vein near the heart; it is used to administer medication/fluids) dressing was not completely covering the line's insertion site;

6) Wall-mounted hazardous waste sharp's containers (used to hold contaminated, used needles and other sharp implements) were not emptied, per hospital policy;

7) An ice machine was not clean and preventive maintenance was not completed, in accordance with manufacturer's guidance.

The cumulative effect of these systemic problems resulted in the facility's potential inability to ensure a system for identifying and controlling infections of patients and personnel.

Findings:

1) During an interview on 12/11/19 at 10:30 a.m., ESP M (environmental services/housekeeping) was asked what product she used to clean the OR's. ESP M stated she used, "Neutral," disinfectant (located inside the blue bucket on her cleaning cart).

During an observation on 12/11/19 at 10:35 a.m., four OR staff (RN L, ESP M, and Surgical
Techs J and K) began to clean OR #3. They used towels dipped into the Neutral solution, located in the blue bucket. ESP M wiped down the table (bed) at approximately 10:39 a.m. The table appeared to be dry at 10:42 a.m. (approximately three minutes after it was wetted).

Review of facility-provided manufacturer's directions for Neutral solution titled, "Product Specification Document," subtitled, "Neutral Disinfectant Cleaner," further subtitled, "Directions For Use" (dated 4/08), indicated, "...thoroughly wet surface ...Let solution remain on surface for a minimum of 10 minutes..." The document revealed special instructions for cleaning and decontamination against HIV-1 (AIDS virus) or Hepatitis B and C viruses on surfaces/objects soiled with blood/body fluids (as in an OR), which indicated the, "contact time," to inactivate HIV-1 was, "4 minutes." The document indicated, "HBV (Hepatitis B virus) and HCV (Hepatitis C) are inactivated after a 10 minute contact time. Use a 10-minute contact time for all other viruses, fungi, and bacteria..."

During an interview on 12/11/19 at 4:40 p.m., ESP P stated he worked (cleaned) in the OR and in other units in the hospital. He stated staff used the Neutral disinfectant in the OR. ESP P stated the Neutral sanitizer had a ten minute dry time (not wet time). He stated he cleaned by wiping and wetting (the equipment/items) and ensured the item was not touched for ten minutes. ESP P stated it took ten minutes for the solution to kill everything. When asked if items needed to stay wet for ten minutes, ESP P stated, "no." He stated they needed ten minutes to dry.

During an interview on 12/11/19 at 4:55 p.m., the Infection Control Coordinator (ICC) was asked what her expectation was for contact time (with the Neutral product). The ICC stated surfaces needed to stay wet for ten minutes. She stated the OR had used a product with a shorter contact time in the past, but (staff) had a problem with the product's smell. When asked how the facility was ensuring surfaces stayed wet for ten minutes, the ICC stated staff set a timer for ten minutes after the final mopping in the OR. When asked how the facility knew if surfaces stayed wet (as the door was closed after the timer was set), the ICC stated she did not have an answer for that. When asked if she was aware the bed (OR table) was not staying wet for ten minutes, the ICC stated she was not aware the bed was drying before ten minutes, and stated someone needed to wipe (the surface) again.

During the same interview on 12/11/19 at 4:55 p.m., the ICC was asked if the facility had conducted cleaning audits in the OR. The ICC stated she was not sure.

Review of facility-provided OR audits titled, "Daily Metrics For Tier 2 Board Turn Over Version 3" (from 10/21/19 - 12/10/19), indicated OR turnover time was monitored during the identified timeframe. Documentation indicating the facility monitored OR cleaning/sanitizing and maintenance of contact times/wet times, was not located on the audits.

During an interview on 12/12/19 at 8:40 a.m., the ICC and Administrator NN stated the facility had a new, "enhanced," process for cleaning the OR's.

During an observation on 12/12/19 at 10:41 a.m., four staff cleaned an OR using the new process. The cleaning began at 10:41 a.m., and concluded at 11:23 a.m. RN I timed and supervised the cleaning. All surfaces remained wet for ten minutes utilizing the new process (which included using wetter clothes and re-wetting surfaces when they began to dry).

Review of facility policy titled, "Cleaning & Disinfection In The Perioperative Environment," subtitled, "Standards," (revised 4/3/18), indicated, "5. ...hospital approved disinfectant is used for cleaning. Manufacturer's directions will be followed for use of cleaning and disinfecting solutions...C. Between Case Cleaning:...5. Clean and disinfect all equipment per manufacturer's recommendation..."

2) Review of employee files on 12/13/19 at 10:05 a.m., revealed multiple OR staff did not have documented competencies regarding cleaning (including maintaining sanitizer contact time) the OR. The Interim Surgery Manager (ISM) confirmed competencies for cleaning the OR were not located in Surgical Tech K's file. The ISM and Manager V confirmed competencies for cleaning the OR were not located RN L's file. The ISM and Manager V confirmed Surgical Tech J's file contained competencies for using UV (ultraviolet) light to sanitize the OR, but her file did not contain competencies for cleaning/maintaining contact time. The ISM stated these staff members had participated in training's offered by the facility.

Review of facility provided training sign-in sheet titled, "Disinfecting Wipe Wet Times," indicated Surgical Tech K, Surgical Tech J and RN L, had placed their signature on the sign-in sheet on 1/21/19 (RN L and Surgical Tech J), and on 1/17/19 (Surgical Tech K). No information on maintaining a ten minute contact time for Neutral sanitizer was located in the educational material.

Review of facility policy titled, "Staff Competency," subtitled, "Policy" (revised 8/22/19), indicated, "...all staff shall demonstrate competency in their assigned department/position...Competency is defined as the demonstration of proficiency through written and/or practical examination, the individual's ability to provide care or services in accordance with the standards of practice...

3) During an interview and concurrent tour of an offsite facility clinic on 12/12/19 at 3:45 p.m.,
a dirty utility room contained clean storage items and laboratory equipment and dirty equipment. A red line on the floor demarcated the dirty side (containing a sink) from the clean side. Medical Assistant Y (MA Y) was asked how staff processed dirty instruments after use (prior to transport to the hospital where they were decontaminated/sanitized). MA Y stated instruments were rinsed in patient rooms or in the sink located in the utility room. She stated they were then sprayed with enzymatic solution, placed in a Humipak (a package to keep instruments moist so debris did not stick), and placed in a red hazard box (that was taken to the hospital for processing). MA Y was asked if the sinks used to rinse instruments, located in the patient rooms, were hand washing sinks. MA Y confirmed they were hand washing sinks. MA Y and Director Z were asked if spraying the enzymatic cleaner in the utility room could potentially contaminate the clean items (if the spray were aerosolized). MA Y stated they sprayed the instruments while inside the Humipack.

During an interview on 12/13/19 at 9 a.m., the ICC was asked how dirty instruments at the clinic should be handled. The ICC stated the red hazard box should be brought to the patient room, dirty instruments should be placed inside, and the red box should then be brought back to the utility room. She stated instruments should be sprayed with the enzymatic cleaner in the utility room and placed in the Humipack. The ICC stated instruments should not be rinsed with water, and washing instruments in a clean sink (like a hand washing sink) could spread germs.

During an interview on 12/13/19 at 9 a.m., the ICC stated the facility had a new policy for processing instruments, in draft form.

Review of facility policy titled, "Cleaning & Transport of Reusable Instruments Used Outside of Surgery," subtitled, "Procedure" (retrieved 12/13/19, Copyright 2019), indicated, "2. Cleaning & transport of instruments...B. Once soiled instruments are contained at the point of use they will be transported to the dirty utility room for cleaning...D. Instruments shall be cleaned, as soon as possible, using an approved instrument cleaning solution to remove all fluids and gross solid materials. a. Instruments that cannot be immediately cleaned shall be: i. treated with and instrument cleaner... ii. covered with a towel moistened with water...E. After cleaning, instruments shall be rinsed in cold water and left...on a dry towel to air dry. F. Once dry, instruments will be placed in hospital approved tray fro(m) transport to central processing (at the hospital)..."

Review of the new facility process titled, "Care, Cleaning & Transport of Used Surgical Instruments Outside of the OR," subtitled, "Standard Work for Cleaning & Transport" (dated 2018), indicated, "At the point of use prior to removal from point of care; 1. Grab a clean bagged red container from Room 30. Bring the container to the room...3. Open all instruments & wipe with a plain sponge to remove any visible gross tissue or blood...4. Place wiped instruments in red biohazard container for transport to the dirty utility room. 5. Upon arrival in dirty utility room...7. Spray enzymatic cleaner directly onto soiled instruments...8. Place instruments in appropriately sized Humipak...11. Transport to central supply (in the hospital)..."

4) During a tour of the PACU (Post-Anesthesia Care Unit: Unit where surgical patients go immediately after surgery to be closely monitored) and concurrent interview on 12/10/19 at 11:10 a.m., a hopper was located in patient Room 15 and was approximately two feet from the head of the patient's bed. The hopper had a splash-guard on the front, but the sides of the hopper were not covered. RN I was asked if the hopper was used by staff. RN I confirmed the hopper was used by staff, and stated it was used to flush patient's urine.

During a tour of the PACU and concurrent interview on 12/12/19 at 11:45 a.m., a photo was taken of the hopper and bed location in Room 15. The Interim Manager was asked if use of the Hopper could cause microbes to be aerosolized (become airborne) when it was flushed. The Interim Manager stated the facility could potentially stop using the Hopper (as a solution), or it could be covered.

Review of facility policy titled, "Risk Assessment and Infection Control Plan," subtitled, "Infection Control Plan 2019" (approved 6/26/19), indicated, "6. Additional goals...c. Use evidence-based department-specific procedures to limit the transmission of infections associated with procedures...devices, and supplies."


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5) During an observation on 12/9/19, at 11:45 a.m., Patient 31 was out of his bed, seated in a bedside chair. A transparent adhesive dressing was applied to the right side of Patient 31's neck. The dressing held loosely against Patient 31's skin. Half of the dressing's adhesive seal had come off, no longer providing a sterile barrier. Under the loose dressing, the plastic end of a central line catheter was visible against Patient 31's neck. The plastic end, and surrounding skin, were exposed to air and the environment. Three intravenous (administered by vein) access lines extended from the plastic end. An infusion pump infused fluids mechanically into Patient 31's veins through one of the three access lines.

During an interview on 12/9/19, at 11:50 a.m., Patient 31 stated the facility staff used the central line for patient care, to, "take blood or give an injection," of medication.

During an observation and interview on 12/9/19, at or around 2:50 p.m., Patient 31's central line dressing was in the same condition as three hours earlier. Fluid no longer infused into any of the three access lines. ICU Nurse AA stated central line dressings had to be changed when, "compromised." ICU Nurse AA stated Patient 31's dressing, "need[ed] to be changed." ICU Nurse AA stated the secure adhesion of Patient 31's central line dressing came off because Patient 31 had been, "pulling" at the central line. ICU Nurse AA stated she intended to change the dressing, "tonight."

During a concurrent interview and record review on 12/10/19, at 3:12 p.m., Nurse Manager BB reviewed Patient 31's Electronic Medical Record, including the nursing care plans, and stated the facility did not plan Patient 31's care to minimize the infection risk associated with using a central venous catheter.

During a review of Resident 31's clinical record, the, "Flowsheets," no date, indicated the facility placed Patient 31's central line on 12/5/19, at 11:15 a.m., in Patient 31's, "internal jugular," vein.

The facility policy and procedure titled, "Central Venous Catheter," revised 11/21/19, indicated central venous catheters (devices used to access central veins near the heart, for long-term treatment with medicines, fluids, blood products, or nutrients) required staff use, "sterile procedure," for dressing changes. The policy indicated, "the [registered nurse] and the patient are to wear masks," during the dressing change, and the registered nurse must wear, "sterile gloves," for cleaning the catheter site and apply a, "sterile ... dressing," when cleaning is complete. The policy indicated to change a central line dressing, "every seven days or as needed."

The facility policy and procedure titled, "Care Plan Policy," revised 11/21/17, indicated, "each patient will have a plan of care that is appropriate to his/her specific assessed needs." The policy indicated the registered nurse is accountable to initiate, coordinate, and revise a patient's plan of care.

According to the CDC, CLABSIs are preventable and result in thousands of deaths each year. (http://www.cdc.gov/HAI/bsi/bsi.html.)

Regarding central line dressing management, "once the dressing is in place, follow the basics of central line care and maintenance, including ... site assessment, and maintaining a clean, dry, and intact dressing." (DeVries, M., Revisiting CLABSI prevention strategies: Part 2. American Nurse Today, 14(6). July, 2019). "If ... [the] dressing is damp, soiled, or loose: Change immediately." (DeVries, 2019).

6) During an observation on 12/9/19 at 2:10 p.m., Room 5, in the Intensive Care Unit (ICU), had two waste containers mounted to the wall. One container was marked for sharps' disposal and the other was marked for biohazard disposal. The lid for the sharps container indicated, "FULL." A blood collection device was lodged inside the container, positioned against the lid and interior wall. The sharps receptacle was visibly full.

During an interview on 12/9/19, at 2:15 p.m., ICU Nurse CC stated the facility's, "housekeeping," or Environmental Services (EVS) emptied sharps containers which appeared, "close to full." ICU Nurse CC stated housekeeping visited the ICU daily to empty sharps containers on the unit. ICU Nurse CC stated she planned to notify housekeeping of the full container in Room 5.

During an observation on 12/9/19, at 2:30 p.m., Environmental Services staff entered ICU Room 5 and replaced the room's sharps container.

During an observation on 12/10/19, at 9:30 a.m., Room 5 in the Emergency Department (ED) had two waste containers mounted to the wall. One container was marked for sharps' disposal and the other was marked for biohazard disposal. The lid for the biohazard container indicated, "FULL." The lid could be opened, but with difficulty. Biohazard waste filled the receptacle to the lid.

During an observation on 12/10/19, at 9:40 a.m., ED Nurse DD approached the biohazard container in ED Room 5, holding a used medical supply in a gloved hand. With the other hand, ED Nurse DD pulled open the biohazard container's, "FULL," lid and quickly deposited the medical supply into the container before the plastic container's lid audibly snapped back into position.

During an interview on 12/10/19, at 9:42 a.m., ED Nurse DD stated the biohazard container in ED Room 5 was full when he disposed the medical supply into it minutes earlier. ED Nurse DD stated biohazard and sharps containers were full when it was hard to put things into them or when they were, "two-thirds" full. ED Nurse DD stated nursing, "will call housekeeping," to empty or replace a sharps or biohazard container. ED Nurse DD stated he planned to contact EVS to empty the biohazard container in ED Room 5.

During an interview on 12/13/19, at 11:50 a.m., Manager N stated EVS staff visited all patient care areas every day, except weekends. Manager N stated EVS staff were trained to remove biohazard and sharps containers when the containers were, "two-thirds," full or when the, "flap is up," to indicate the container was full and would further remove the biohazard container if its contents were, "stinky."

The facility policy and procedure titled, "Disposal of Sharps Containers," revised 4/3/18, indicated, if the sharps container was, "[one-half] to [three-quarters]," full, the container must be, "closed and removed." The policy indicated sharps containers were, "hazardous waste."

The facility policy and procedure titled, "Hazardous Materials and Waste Program," revised 3/29/18, indicated Manager N had primary responsibility for, "sharps," and other, "hazardous waste," in the facility. The policy did not indicate how frequently EVS staff must empty or replace biohazard containers in patient care areas.


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7) An observation of the facility ice machine in the kitchen and concurrent interview with the Director of Food and Nutrition (DFAN) and the Dietary Aide (DA) A, was conducted on 12/9/19 at 11:15 a.m. Upon opening the machinery panel on the top of ice machine, there was a significant amount of discolored residual, on the surface of the water curtain (a white plastic cover resting over the front of the evaporator to keep water from splashing out of the ice making zone and help keep the water channeled back into the trough) and the sides of ice making zone. When wiped with white paper towel, a significant amount of rusty-orange, brown and whitish slimy residue came off from those areas. The DA A stated she only cleaned and sanitized the outside and inside of the ice bin and never took off the machinery panel on the top of ice machine to clean and sanitize. The DFAN stated dietary was responsible for cleaning and sanitizing the ice holding bin monthly, but the maintenance department was responsible for the top machinery part of the ice machine.

An interview was conducted with the Director of Plant Operation (DPO) on 12/9/19 at 3:50 p.m. The DPO stated the maintenance department cleaned the air filter and the drain, of the ice machine, quarterly. The top machinery part was cleaned and sanitized, annually, by an outside company.

Review of facility document title, "Sales and Service for Ice Machine ...Invoice," dated 10/8/18, showed the ice machine was cleaned and sanitized on 9/24/18, by the outside company. During a concurrent interview, conducted on 12/11/19 at 9:20 a.m., the DPO stated the invoice indicated the last service of the ice machine was on 9/24/18, from the outside company.

Review of undated manufacturer's guidance, recommended cleaning and sanitizing frequency once every six months for the ice producing mechanism.

Based on food service observations, dietary and administrative staff interview, and departmental document review, the hospital failed to ensure departmental operations comprehensively met food safety and patient needs when: 1) One food production sink and one ice machine was directly connected to the waste water system; 2) There was lack of facial hair restraints for three food production staff; 3) The location of a paper towel dispenser resulted in cross-contamination of a food production surface; and, 4) The nutritional content of the menu had excessive Vitamin A and low levels of Vitamin E.

Findings:

1. The standard of practice is to ensure the presence of an air gap in food production related equipment. An air gap means the unobstructed vertical distance through the free atmosphere, between the lowest opening from any pipe or outlet supplying fixture, or other device, and the flood level rim of the receptacle. The vertical physical separation shall be not less than one inch (Food Code, 2017).

During initial tour on 12/9/19, beginning at 10:40 a.m., there were two packages of fully-thawed chicken breast, each approximately five pounds, dated 12/8/19. In an interview on 12/10/19 at 10:55 a.m., Cook B stated the chicken was previously frozen, and he thawed it on 12/8/19, by placing the chicken with running water in the multi-compartment sink, located in the food production area. Cook B also confirmed this was the sink used for all food production activities. Concurrent observation revealed the food production sink did not have an air gap, rather was directly plumbed to the waste water system.

In an observation on 12/9/19 at 3:45 p.m., in the medical surgical annex, the ice machine was also directly plumbed to the waste water system. In a concurrent interview, the Director of Plant Operations confirmed the absence of an air gap and acknowledged it was not properly installed.

In an interview on 12/10/19 at 10:55 a.m., Registered Dietitian (RD) D acknowledged she had not identified the lack of an air gap as an issue. RD D also stated she completed daily rounding in the kitchen. Facility document titled, "Daily Kitchen Checklist," dated 10/6/19 -10/12/19, was limited to a check of refrigerator, freezer and dry storage room temperatures, as well as dishwasher, thermometer calibration and tray delivery times. There was no additional documentation of RD oversight.

2. Food Service standards of practice require that food employees shall wear hair restraints such as hats, hair coverings or nets, beard restraints, and clothing which covers body hair, designed and worn to effectively keep hair from contacting exposed food; clean equipment, utensils, and linens; and unwrapped single-service articles (Food Code, 2017, Section 2-402.11).

During general food production observations on 12/9/19 at 2:28 p.m., Cook B had exposed facial hair. A follow-up observation on 12/10/19 at 11:05 a.m., revealed Cook C also had exposed facial hair. In an interview on 12/11/19 at 9 a.m., the Director of Food and Nutrition Services (DFNS) stated policy guidance was closely-cropped facial hair did not need to be covered.

Departmental policy titled, "Infection Control-Food and Nutrition Services," dated 11/15/18, confirmed the policy was not consistent with standards of practice, in that the section on personal hygiene/dress code did not guide staff to cover mustaches, rather indicated facial hair must be kept trimmed.

3. During initial tour of the kitchen on 12/9/19 at 11:22 a.m., there was a hand-washing sink adjacent to the cold food production area, at the corner of hallway leading to the dry storage area. The sink was spaced less than five inches from the edge of the food production counter. The paper towel dispenser was mounted directly above the food production surface. The surface of the counter, underneath the paper towel dispenser was wet. There were also three boxes of sterile nitrile on the counter, each of which showed signs of water dripping on the boxes.

In a concurrent interview, RD D acknowledged the water on both the food production surface and glove boxes was likely due to staff reaching across the area, after hand washing, to get paper towels.

Follow-up food production observations on 12/9/19 at 11:44 a.m., noted staff utilizing the gloves for food production activities.

In an interview on 12/10/19, beginning at 9 a.m., Registered Dietitian D described she was new to the position, and a typical day included completing nutritional screening and nutritional assessments for inpatients. RD D also stated she checked in with the DFNS daily, as well, however had not completed any formal oversight of food production and related activities.

Facility document titled, "Third Party Food Safety Audit," dated 7/10/19 and 10/29/19, failed to identify the cross-contamination of food production areas from hand-washing activities. Additional, "Food Safety Audits," dated September, October and November 2019, completed by the DFNS, also did not identify the cross-contamination of food production surfaces. There was no documented review of food production, and related activities, by a Registered Dietitian.

Review of undated document titled, "Food and Nutrition Services Department Organizational Chart," depicted a peer relationship between the Clinical Dietitian and the DFNS. Oversight responsibilities were depicted via a dotted line to cooks and diet aides. Review of Contracted Vendor (CV) E's position description titled, Clinical Dietitian 2, described duties related to providing clinical nutrition care to patients, medical staff education and promotion of food and nutrition programs. Food service oversight was limited to communication with culinary, on special diets and menu requests. The position description did not demonstrate guidance and/or oversight of food services activities.

4. The standard of practice for menu planning was the use of the Dietary Reference Intakes (DRIs), which are reference values that are quantitative estimates of nutrient intakes, to be used for planning and assessing diets for healthy people. They include both recommended intakes and Upper Limits (UL), as reference values. The Tolerable Upper Intake Level (UL) is the highest level of daily nutrient intake, likely to pose no risk of adverse health effects to almost all individuals in the general population. As intake increases above the UL, the risk of adverse effects increases. The term Tolerable Intake is chosen to avoid implying a possible beneficial effect. Instead, the term is intended to connote a level of intake that can, with high probability, be tolerated biologically (National Institutes of Health).

On 12/10/19, beginning at 3 p.m., the hospital's menus were reviewed for nutritional adequacy, in relationship to the hospital's demographics. It was noted, the hospital designated men and women, above the age of 70, as the benchmark for evaluating the menus' nutritional adequacy. The hospital document, dated 1/11/19, and signed by a Registered Dietitian, indicated there were nine standardized non-select diets, two of which were a regular and Carbohydrate Consistent Diet (CCD). The Carbohydrate Consistent Diet was intended to aid in the treatment of patients with diabetes.

Three random days of the regular diet (Days 1, 3 and 5) were selected for review. It was noted the Vitamin A content of the diet was listed as 990, 368 and 990% (percent), respectively, of the recommended DRI. Similar values were also noted in Days 1, 2 and 6, of the CCD. Additionally, the Vitamin A content was listed as 1184, 210 and 210%, respectively, for each of the reviewed days of the CCD.

Vitamin A is fat soluble; the body stores excess amounts, primarily in the liver, and these levels can accumulate. The UL for Vitamin A is listed as 10,000 IU (International Units-a unit of measure) for both males and females, above the age of 19. The Food and Nutrition Board (FNB) has established ULs for pre-formed Vitamin A, which apply to both food and supplement intakes. The FNB based these ULs on the amounts associated with an increased risk of liver abnormalities in men and women (National Institutes of Health, Office of Dietary Supplements). The ability of the liver to metabolize many substances, including fat soluble vitamins, decreases with aging (Merck Manual).

It was also noted the Vitamin E content of the regular diet was listed as 43, 39 and 43% for each of the reviewed days. The goal of the regular diet was to provide 15 milligrams (a metric unit of measure) of Vitamin E. Vitamin E is also a fat-soluble vitamin and is important in the support of the immune system. Numerous foods provide Vitamin E. Nuts, seeds, and vegetable oils are among the best sources, and significant amounts are available in green leafy vegetables and fortified cereals. Most vitamin E in American diets is from soybean, canola, corn, and other vegetable oils and food products (National Institutes of Health, Office of Dietary Supplements). Menu analysis review also revealed there was no vegetarian menu.

In an interview on 12/11/19 at 4 p.m., with Registered Dietitians (RD) D and F, they stated the analysis was reviewed by a previous RD. RD D acknowledged she had not yet reviewed the menu for nutritional adequacy or identified any abnormally-low or high values. RD F stated she felt Vitamin E may be under-reported in some foods. While under-reporting may be an issue, the hospital had not evaluated the potential cause of the low Vitamin E levels or the potential accuracy of values entered into the data base from which the analysis was derived. The surveyor also asked RD F to demonstrate the plant-based menu. RD F stated, while there were vegan and vegetarian options, there was no developed menu ensuring patient nutritional needs were met, in accordance with standards of practice. It is the current standard of practice, within the State, that public hospitals offer plant-based menus that meet patient needs (Health and Safety Code, Division 2, Chapter 2, Health Facilities 1265.10).

Review of the hospitals' diet manual, approved by hospital leadership on 6/21/19, confirmed there was no menu for vegetarian or vegan (plant-based) diets.