HospitalInspections.org

Based on interviews with facility staff and document review, the hospital failed to ensure personnel evaluations were done annually for two employees;

1. Nuclear Medicine Technician (NMT 1) and,
2. Registered Nurse (RN 20).

This failure had the potential for competency to not be assessed which could negatively impact patients' health status.

Findings:

1. On 3/14/19 at 10:30 a.m., during a concurrent interview and personnel file review with Radiology First Line Supervisor, (RFLS), nuclear medicine staff members' personnel records and qualifications were reviewed.

Review of Nuclear Medicine Technician's (NMT 1) personnel file revealed his last annual evaluation was dated 9/25/17.

On 3/14/19 at 2:00 p.m., an interview was conducted with the Human Resources Director (HRD). She stated annual performance evaluations were required for all staff members. She confirmed NMT1's annual performance appraisal should have been completed September 2018.

2. On 3/15/19 at 10:35 a.m., during a concurrent interview and personnel file review with the Director of Patient Safety (DPS) indicated RN 20's personnel records did not provide evidence of RN 20's 2018 performance appraisal. Per the DPS, the HRD confirmed, "There is not a 2018 performance evaluation for RN 20." The DPS was unable to provide a reason as to why the evaluation was not available.

The "Human Resources Policies and Procedures Employee Performance Appraisals," stipulated, "It is the policy of [facility name] to review each employee's performance no less frequently than annually. Management will complete employee's probationary and annual evaluations..."

The "California Code of Regulations, Title 22. Division 5., 70719 (a)(3) Personnel Policies", revealed the following:
"(a) Each hospital shall adopt written personnel policies concerning qualifications, responsibilities and conditions of employment for each type of personnel, which shall be available to all personnel. Such policies shall include but not be limited to:
(3) A plan for at least an annual evaluation of employee performance ..."



39797

Based on interview and record review, the hospital failed to ensure records of staff training and competency related to restraint application and use were completed for 2 employees.

This failure had the potential to contribute to inappropriate restraint use or application which could lead to patient harm and violation of patient rights.

Findings:

a. During a review of Respiratory Therapist (RT) 1's employee record, no evidence of restraint training or competency for 2018 was found.

In a 3/15/19, 1:00 p.m. interview with Registered Nurse (RN) 18, she acknowledged there was no documentation of restraint training.

b. On 3/15/19 at approximately 11 a.m., an employee record review was conducted for RN 16. RN 16's training record was reviewed from a transcript provided by the facility Human Resources office. The document revealed the Restraint Training for RN 16 was completed 3/2016.

During a concurrent interview and record review on 3/15/19 at approximately 11 a.m. with Specialist III Human Resources (SHR), the SHR confirmed the training date.

During an interview on 3/15/19 at approximately 12:30 p.m., the Director of Patient Safety stated there was no additional documentation for RN 16's Restraint training.

A review of the hospital policy titled, "Restraints", revised May 2017, directed, "... Training and Competency of Staff 1. Staff that are involved with applying restraints and/or providing care for patients in restraint, or with assessing and monitoring the condition of restrained patients shall be trained and able to demonstrate competency in the application of restraints, monitoring, assessment, and providing care for a patient in restraint prior to doing so. 2. Staff shall complete restraint training... on a periodic basis consistent with hospital policy."

The above referenced policy did not stipulate how often restraint training should be completed.

A review of the hospital policy titled, "Competency Assessment Program", revised April 2017, included, "The Competency Assessment Program is designed to verify that all employees have been trained and are capable of achieving job requirements and performance standards...3. Mandatory topics, such as general Safety..., ect. will be included in annual Mandatory Education process."

The above referenced policy did not include specific information regarding restraint training completion expectations.

INTERVIEW (From JH)


36586


On 3/15/19 at approximately 11 a.m., an employee record review was conducted for RN 16. RN 16's training record was reviewed from a transcript provided by the facility Human Resources office. The document revealed the Restraint Training RN 16 completed was 3/2016.

During a concurrent interview and record review on 3/15/19 at approximately 11 a.m. with SHR, the SHR confirmed the training date and further stated the training was part of the yearly skills lab requirements.

During an interview on 3/15/19 at approximately 12:30 p.m., the Director of Patient Safety stated there was no additional documentation for RN 16's Restraint training.

Based on interview and document review, the hospital failed to ensure that a patient safety event involving Patient 16 was reported into its Event Reporting System.

This failure precluded patient safety leaders from becoming aware of, investigating, and acting on this incident in a timely manner.

Findings:

Review of a 12:19 p.m., 3/4/19 "Physician Note" indicated Patient 16 presented to the Emergency Department (ED) for severe pain management related to multiple broken ribs received during a fall three days earlier.

Review of Patient 16's physician orders reflected the following:
- 12:23 p.m., 3/4/19, laboratory tests including creatinine, which evaluates kidney function, to be completed "stat" (without delay),
- 12:26 p.m., 3/4/19: Computerized tomography (CT, an imaging procedure which scans body areas) of the chest, abdomen & pelvis with contrast "stat,"
- 2:27 p.m., 3/4/19: Discontinue CT with contrast, and
- 2:27 p.m., 3/4/19: CT of the chest, abdomen & pelvis without contrast "stat."

Review of laboratory test "Result Details" in the electronic health record indicated the following:
- 2:20 p.m., 3/4/19: An abnormally high creatinine level result of 2.4 milligrams per deciliter (a unit of measure, normal range is 0.6 - 1.3 mg/dL) was made available, and
- 2:20 p.m., 3/4/19: An associated kidney function test for glomerular filtration rate (GFR, calculated from the creatinine level), also resulted at that time and indicated an abnormally low rate of 19.7 milliliters per minute per meters squared (a unit of measure, 60 mL/min/m2 is low normal).

Imaging Department "Order Information" reflected the following:
- 2:27 p.m., 3/4/19: The "with contrast" order was acknowledged by a CT technologist,
- 2:43 p.m., 3/4/19: CT with contrast began, according to a 10:57 a.m., 3/15/19 interview with the Imaging Department's Picture Archiving and Communication System Administrator (PACSA), and
- 2:54 p.m., 3/4/19: The "without contrast" order was acknowledged and cancelled.

A 12:19 p.m., 3/4/19 ED "Physician Note" read:
"2:28 p.m. Labs [laboratory tests] notable for...acute renal [kidney] failure when compared to prior from Jan [January]. Will change CT chest/abd/pelvis to non-contrast given renal function
2:49 p.m. Informed by CT tech that contrast was accidentally used despite change in order...."

Review of the hospital's 8/23/18 "Administration of Iodinated [containing iodine] Contrast Media" policy indicated, "All patients receiving contrast media are screened for contraindications prior to radiological examination. Relevant history should be brought to the attention of the supervising physician prior to contrast injection...prior to examinations requiring contrast media injections...Obtain serum creatinine level with estimated GFR within 48 hours of the procedure ...Questions regarding potential contraindications are discussed with a physician prior to contrast media administration ...For patients with eGFR [estimated GFR] <30: Higher risk for contrast-induced nephropathy. Contrast should not be administered unless the patient is on dialysis or anuric [not making urine], or if contrast is considered diagnostically imperative and the benefits of contrast outweigh the risk of post-contrast acute kidney injury...."

In a 1:18 p.m., 3/15/19 interview, the Radiology First Line Supervisor stated that on 3/15/19 the CT technologist (CTT 1) was contacted about the scans and the technologist acknowledged having failed to review Patient 16's laboratory values before starting the exam.

Review of the hospital's 8/24/18 "Patient Safety Event Reporting and Management" policy reflected, "Employees are required to report events that result in/pose an actual or potential risk of harm...Timely and consistent reporting of events provides a mechanism to reduce or eliminate circumstances that present risk of harm, improve quality of care by preventing future similar events and identifying opportunities to improve internal processes...Event Notification...Staff who...are directly involved in an event should initiate an event report within 24 hours of becoming aware of the event...."

At 1:37 p.m., 3/15/19, the Chief Nurse Executive Officer stated that the hospital's event report database had been searched and "no event report was completed" for the incident.

In a 1:18 p.m., 3/15/19 interview, the Imaging Director stated the incident "should have been reported" into the event system at the time it occurred.

Based on observation, interview, and facility record review, the hospital failed to ensure a policy for blood glucose testing was consistent and accurate.

This failure had the potential to cause expired control vials to be used.

Findings:
During an initial tour of the Medical/Surgical Unit (2 West) on 3/12/19 at 10:15 a.m., an observation was made of two glucometer (equipment to test level of sugar in the blood) boxes, labeled "2W-1," and "2W-3." Box 2W-1 contained two bottles of opened quality control test solutions. Each bottle had a hand written date on the label, one for 3/2/19, and the other 3/10/19. Box 2W-3 contained a bottle of opened quality control test solution dated 4/4/19.

In a concurrent interview with Registered Nurse 11 (RN 11) she acknowledged that the bottles dated 3/2/19 and 3/10/19 were expired and should not be in use. RN 11 explained that it was her understanding that nurses were to write the expiration date on the control bottles when they are opened.

During an initial tour of the Surgical Intensive Care Unit on 3/12/19 at 10:50 a.m., an interview was conducted with RN 12. RN 12 stated that nurses were to write the expiration date on the control bottles when they are opened.

Review of a November 2018 facility policy titled, "Glucose Testing with Glucose Meter / Whole Blood Glucose Testing" indicated two variations of instructions. The policy stated, "Upon opening a vial of controls or linearity solution, write the date the bottle was opened on the bottle label. The Control solution is stable for 3 months from that date or until the Use By date on the bottle label, whichever comes first."

The same policy also stated, "Upon opening a vial of controls or linearity solution, handwrite the expiration date on the vial. Record the 30-day expiration date on the vial once opened. Open vials are usable within 30 days after opening. Discard any unused vials 30 days after opening."

Based on interview and clinical record review, the hospital failed to ensure nursing staff developed appropriate care plans for 3 of 57 sampled patients when:
1) Nursing staff failed to implement the hospital Skin Care Protocol for Patient 57, who was assessed for being high risk for the development of a pressure ulcer. A pressure ulcer is localized injury to the skin and/or underlying tissue usually over a bony prominence, as a result of pressure, or pressure in combination with shear and other wounds and subsequently developed a friction wound (a wound caused by the action of one surface or object rubbing against another) seven days after admission;
2) Patient 30 had no documented evidence of nursing care plan initiation;
3) No care plan was initiated for behavioral issues and subsequent psychotropic medication treatment for Patient 13; and
4) A current nursing care plan for pain management was not maintained for Patient 56.

This failure had the potential to preclude the interdisciplinary team from meaningful information including treatment goals, care needs, and interventions used to guide clinical care decision making and the intention of better patient outcomes.

Findings:

1) Patient 57 was admitted to the hospital on 3/4/19 with diagnoses including high blood pressure, diabetes type II (diabetes type II is a disease resulting from the body's inability to make enough, or to properly use, insulin that develops especially in adults and most often in obese individuals), end stage renal disease, (The kidneys remove waste and excess water from the body. ESRD occurs when the kidneys are no longer able to work at a level needed for day-to-day life). stroke-like symptoms and seizure.

According to electronic medical records, on the Readmission Risk Assessment completed on 3/5/19, Patient 57 was admitted with no wounds. Other documentation in the clinical records including nutrition and nursing progress notes described the patient 's skin was "intact". A Braden Skin Assessment was conducted on admission, Patient 57 received a score of 12. According to the instructions on the screen, a score of less than 18 results in the implementation of the Skin Care Protocol. A score of 12 puts the patient at "high risk" for the development of a pressure ulcer.

The Braden Scale for Predicting Pressure Ulcer Risk, "is a tool that was developed to help health professionals, especially nurses, assess a patient's risk of developing a pressure ulcer". The lower the score, the higher the risk of developing a pressure ulcer.

Review of nursing notes showed continued assessment of the skin with scores fluctuating but with scores between 9 and 13 showing Patient 57 at high to very high risk of development of pressure ulcer. There was no documented evidence of the Skin Care protocol being put in place.

On 3/10/19, nursing progress notes indicate "skin intact". On 3/11/19, there was a documentation with photograph in the "Wound/ Skin Documentation Record" which indicated Patient 57 had a 2 cm x 2 cm x 0.1 blister on the left buttock with a purulent (consisting of, containing, or discharging pus) scant wound drainage.

On 3/13/19, a wound care nurse (WCN) 1 documented Patient 57 was "admitted with" a wound.

On 3/14/19 at 12:20 p.m., WCN 1, who conducted the wound assessment, was interviewed on the inaccurate documentation. WCN 1 stated she believed Patient 57 had just admitted the day before and that was why she erroneously documented in that manner. WCN 1 stated in the same interview that she believed the wound was not pressure related but was as a result of shear or friction. Friction is the "mechanical force exerted when skin is dragged across a coarse surface such as bed linens." Friction alone is not a direct cause of a 'pressure ulcer', but rather is a risk factor that may contribute to or exacerbate pressure ulcer development due to the shear it creates." (National Pressure Ulcer Advisory Panel 2012)

WCN 2 was present during the interview on 3/14/19 at 12:20 p.m., described the hospital policy that should have been put in place when Patient 57 was assessed at a high risk of the development of pressure ulcer. The WCN 2 explained the Skin Care Protocol would have required the use of heel lifts (the use of pillows or other method to raise the heel off the bed, preventive sacral (a triangular bone in the lower back formed from fused vertebrae and situated between the two hipbones of the pelvis) dressing, a special bed with a pressure redistribution pump. Heel lifts were implemented but none of the other items on the protocol, as described by WCN 2, was carried out for Patient 57.


35598


2) Patient 30 was admitted to the hospital on 3/11/19 with a diagnosis of pneumonia (a lung infection).

On 3/14/19 at 2:00 p.m., a concurrent interview and review of the electronic medical record was conducted with Registered Nurse (RN) 17. RN 17 acknowledged there was no documentation of any nursing care plans in Patient 30's medical record.

Hospital policy titled, "Documentation and Planning for the Care of Patients", revised February of 2018, directed, "...It is the responsibility of all care givers to assess and plan for the individualized and appropriate care to meet the needs of all patients... 15. Scope of daily/shift documentation will be reviewed/updated by all staff that provides care to the patient: a. Registered Nurse 1) Each patient's need for plan of care related to their admission will be reviewed within the first shift of admission and then at a minimum of once per shift..."

3) Patient 13 was admitted to the Medical/Surgical Unit with a diagnosis of gastrointestinal bleeding (blood in the stool).

Review of the clinical record for Patient 13 included:

A physician's assessment, dated 3/6/19 at 2:51 p.m., documented, "Plan ...Agitation ...Pt [patient] having episodes of agitation in ER (Emergency Room) -was apparently A/O 4 [alert and oriented to person, place, time, and situation] earlier in ER. [g]iven iv [intravenous] Ativan [anti-anxiety medication] PRN [as needed] for agitation."

A nursing progress note, dated 3/7/19 at 12:38 p.m. documented, "Patient is quite agitated while looking at him today."

A nursing progress note, dated 3/10/19 at 5:00 p.m. documented, "Pt yells and swings arms when attempts to move pt are made. Pt has been uncooperative with staff and frequently yells random words repeatedly, such as '47,' '56,' and 'Jojo white.'"

A nursing progress note, dated 3/11/19 at 8:51 p.m. documented, "Pt has been consistently agitated throughout the day and hostile towards staff. Pt was frequently yelling all day. Pt would yell random expressions, such as 'where's the chicken' and '12.' Pt will occasionally yell for water, but pt is very impatient and unable to wait longer than 10 seconds before yelling.

A physician's order, dated 3/14/19 at 7:04 a.m., for Geodon (an antipsychotic medication) 10 mg (milligrams, a dose measurement), for "agitation."

There was no documented evidence of a care plan for Patient 13's behavioral issues.

In an interview on 3/14/19 at 10 a.m., RN 17 confirmed his expectation would be for Patient 13 to have a plan of care to address his behavioral issues and psychotropic medications. RN 17 was unable to locate documentation that could address the plan of care for Patient 13's agitation and confusion.

Review facility policy titled, "Documentation and Planning for the Care of Patients," revised February 2018, indicated, "There should be evidence that the needs of the patient have been assessed and used for planning provision of the patient's care, specifically including the following elements ...The patient care plans used to address the identified patient diagnosis(es) and/or patient care needs."

4) On March 15, 2019 at 10:15 am, during a concurrent interview and electronic health records (EHR) review with Nurse Educator (NE) and RN 24, Patient 56's record was noted to contain orders for two pain medications "Tylenol 650 mg PRN (as needed) for mild pain of 1-3 out of 10" and "Norco 5/325 mg PRN moderate to severe pain of 4-10 out of 10". The chart was flagged to indicate a pain management care plan was to be initiated. RN 24 stated there was no patient care plan for pain management.

Hospital policy titled, "Documentation and Planning for the Care of Patients", revised February of 2018, directed, "...It is the responsibility of all care givers to assess and plan for the individualized and appropriate care to meet the needs of all patients..."

Based on observation, interview and record review, the facility failed to ensure that policies and procedures for safe and effective administration and use of medications were developed and implemented when:

Three of three emergency department (ED)nurses who were interviewed were not aware of malignant hyperthermia (MH, is an inherited muscle disorder triggered by certain drugs including succinylcholine, which is a paralytic agent used in anesthesia, and volatile anesthetics that may cause a fast-acting life-threatening crisis) supply locations and procedures. Competencies were not done for ED staff for MH for 2 years. These failures had the potential of not being able to manage an MH crisis timely likely to cause serious injury or death to a patient.

Findings:

On 3/12/19 at 10:30 a.m. during the tour of the ED registered nurse (RN) 1 was asked where the malignant hyperthermia (MH) supplies were, RN 1 stated he was not aware of the MH supplies. RN 1 said he did not know what the processes for MH were and would have to follow the protocol ordered.

In an interview on 3/12/19 at 10:35 a.m., RN 2 stated that MH supplies were located in Rooms 1 and 2. When asked about MH processes, RN 2 stated they would notify the physician and the charge nurse.

On 3/12/19 at 10:45 a.m., RN 3 stated that she was not aware of the MH supply location or procedures.

During an interview on 3/12/19 at 10:40 a.m., the ED Director (EDD) stated that the MH supplies were located in the surgery department and acknowledged that nurses were not aware of the MH supply locations. The EDD stated there was a training module on MH a long time ago, but she was not sure if the new staff had any MH training.

Observation of the ED medication room on 3/12/19 at 10:50 a.m., indicated syringes of succinylcholine. The ED pharmacist (RPH 3) stated the MH kit was in the surgery department and not in Room 1 and 2 (as identified by RN 2).

In an interview on 3/12/19 at 2:10 p.m., RN 6 verified the presence and use of succinylcholine in the ED. RN 6 verified that there were no MH supplies in the ED.

Review of the facility policy "Malignant Hyperthermia," dated April 2011, indicated various affected departments and services but did not list the ED as one of them. The policy indicated "If MH is suspected, the following steps are taken: 1 Call 444 and notify PBX [hospital] Operator of CODE BLUE-Malignant Hyperthermia and Location ...MH carts are located in the Main Surgery Area and L&D (labor and delivery) C-Section Surgical Area ...Education will be documented in the electronic health record. All Surgery staff and L&D Staff must know the location of the respective MH cart in their area." The policy did not identify education for the ED staff.

During an interview on 3/13/19 at 9:25 a.m., the Director of Nursing Operations (DNO) stated that no MH competencies were found for ED staff for the past 2 years.

Review of MHAUS (Malignant Hyperthermia Association of the United States, also referred to in the facility policy) website www.mhaus.org indicated "The general signs of the MH crisis include increased heart rate, greatly increased body metabolism, muscle rigidity and/or fever that may exceed 110 degrees F along with muscle breakdown, derangements of body chemicals and increased acid content in the blood. Severe complications include: cardiac arrest, brain damage, internal bleeding or failure of other body systems. Thus, death, primarily due to a secondary cardiovascular collapse, can result."

Based on observation, record review and staff interview, the facility failed to ensure medication administration was in accordance with specified protocols, manufacturer's specifications and facility's policy for two patients as follows:

1. Patient 21 was administered two different medications (eye drops) without allowing 5-10 minutes between administering the first and second (eye drop) medications to allow for contacts with the surface of the eye, and

2. Patient 49 was administered continuous insulin (to lower blood sugar), but the protocol for insulin titration (adjustment of the administration rate in accordance with the blood sugar level) was not implement as ordered.

These failures put patients at increased risks of possible harm resulting from delays in achieving the intended effects or treatment failure.

Findings:

1. On 3/13/19 at 9:20 a.m., Registered Nurse (RN) 21 was observed administering the morning medications to Patient 21. RN 21 was observed pulling the following different eye drops from the medication drawer designated for Patient 21,

Brimonidine 0.15%. Brimonidine is used to help reduce redness or pressure in the eye in patients with a condition called glaucoma, and
Timolol 0.5%. Timolol is also a medication used to reduce elevated pressure in the eye (glaucoma).

Patient 21 was prescribed the eye drops on 3/10/19 as follow: Brimonidine 0.15% one drop in the right eye two times every day.
Timolol 0.5% one drop in both eyes twice every day.

The nurse administered one drop of brimonidine into the right eye and administered timolol one drop in each eye for Patient 21. The nurse administered both medications one after another without waiting any time between the different medications so the first medication did not get washed out by application of the second medication.

On 3/13/19 at approximately 10 a.m., RN 21 did not provide any explanation for not waiting between medications.

The package insert for brimonidine was obtained from the pharmacy. The package insert, under patient counseling information, included: "If more than one topical [applied directly to a part of the body.] ophthalmic [relating to the eye] drug is being used, the drug should be administered at least five minutes apart."


On 3/13/19 at approximately 12 noon, the issue of the eye drops was discussed with the Pharmacy Director, who indicated that the facility had this issue addressed in their policy.

The Medication Administration Policy: MM.06.01.01, revised on 1/19, was presented and reviewed. The policy had the following: "When administering multiple ophthalmic medications, separate administration by at least 10 minutes."


2. On 3/14/19 at 2:15 p.m., the medical record for Patient 49 was reviewed with Registered Pharmacist (RPH) 1. Patient 49 was admitted to the hospital on 3/7/19 had a history of diabetes (high blood sugar).

Patient 49 was started on insulin infusion protocol to control blood sugar. According to the facility's insulin infusion protocol, the goal of treatment was a blood sugar level of 125-175 mg/dL (mg/dL are units of measuring weight and volume: milligram per deciliter). The protocol includes directions on what rate to infuse the insulin drip based on the most recent blood sugar and the changes during the last hour.

The protocol had different algorithms, and the instructions for moving between algorithms were as follows:
"Move up to the next higher algorithm if the blood glucose concentration is above the goal range and does not decrease by at least 60 mg/dL within 1 hour."


The protocol was ordered on 3/13/19 at 9:52 p.m., and the infusion started on 3/13/19 at 8:46 p.m.

a. On 3/13/19 at 9:55 a.m., the blood sugar was documented as 326 mg/dL, and according to the protocol the infusion rate should have been started on Algorithm 1 (level of dosing) at 3 units of insulin per hour.

The electronic documentation on the diabetic and insulin medication administration record (MAR) showed documentation that the insulin infusion was started at 1 unit per hour, not 3 units per hour as it should have been.

On 3/14/19 at approximately 2:30 p.m., RPH 1 confirmed the finding and checked the record for any documentation or clinical justifications for starting the insulin at a lower rate, but none were found.

b. On 3/14/19 at 1:07 a.m., the blood sugar was recorded as 326 mg/dL down from 415 mg/dL. The documentation showed that the rate was changed to algorithm 3 at 10 units per hour.

The blood sugar was above the goal, but it dropped from 415 to 326 within 1 hour (more than 60 mg/dL). Therefore, it did not meet both conditions for moving to the next algorithm. According to the protocol the infusion rate should have been reduced to 6 units per hour on the same algorithm (algorithm 2).

c. On 3/14/19 at 2:09 a.m., the blood sugar was recorded as 264 mg/dL, a drop from 326 mg/dL. The documentation showed that the insulin rate was moved up to algorithm 4 at 12 units per hour.

The blood sugar was above the goal, but it came dropped from 326 to 264 within 1 hour (more than 60 mg/dL). Therefore, it did not meet both conditions to move from one algorithm to another. According to the protocol the insulin infusion rate should have been reduced to 4 units per hour on the same algorithm (algorithm 2).

The protocol specified moving up or down, from one algorithm to another, but it did not address moving up or down within the same algorithm.

d. On 3/14/19 at 7:02 a.m., Patient 49 developed low blood sugar (hypoglycemia) of 69 mg/dL and needed to be given intravenous (IV) dextrose per protocol.

The protocol to treat hypoglycemia included instructions to repeat the point of care (recheck blood sugar) within 30 minutes of first low blood glucose.

There was no documented evidence that the blood sugar was rechecked within 30 minutes. The repeated blood sugar was done at 8:01 a.m., on 3/14/19, which was about one hour from the "first low blood sugar" and not within 30 minutes as ordered.

On 3/14/19 at 2:40 p.m., RN 5 confirmed the findings and did not know where additional documentation to explain or justify deviation from the insulin protocol may be found. RN 5 did not provide any justification or clinical rational for not checking the blood sugar within 30 minutes when Patient 49 needed treatment and monitoring for low blood sugar.

Based on interviews and clinical record reviews the facility failed to ensure informed consents (an individual's full knowledge of the possible risk and benefits) were verified per policy and procedures for blood transfusions for 1 of 4 sampled residents (Patient 42).

This failure failed to ensure Patient 42 was informed of risk and benefits of medical treatment.

Findings:

During a review of Patient 42's electronic health record (EHR), the record indicated on 3/7/19, Patient 42 received one unit of blood at Outpatient [IV therapy].

During a concurrent record review and interview with the Registered Nurse (RN 19) on 3/12/19 at 1:45 p.m., RN 19 expressed documents are received through FAX transmittal from the physician's (MD) office to IV therapy prior to the scheduled date of service. The required documents from the MD are the "Patient's history and physical (H/P), latest laboratory results (labs), and blood transfusion orders." Per RN 19, upon arrival to IV therapy the patients are asked to sign a "consent to blood transfusion" form. RN 19 shared it was not the department's practice to verify informed consents were obtained by the MD prior to the scheduled blood transfusion. RN 19 expressed there was an assumption the MD had addressed risk and benefits with the patients.

During a concurrent record review and interview with RN 18 on 3/14/19 at approximately 9:30 a.m., RN 18 confirmed Patient 42's scanned medical documents did not include a copy of the informed consent for blood transfusion administered on 3/7/19.

During an interview with the Cancer Center Director (RDT) on 3/14/19 at 10:00 a.m., the RDT confirmed the patient's H/P, orders, labs and insurance authorization for treatment were the required documents needed from the MD's office. Per the RDT, currently there was an assumption of informed consent. The RDT was asked if further record reviews would provide evidence of informed consent compliance, the RDT stated, "You will probably find that we do not have an informed consent documented in the record of the blood transfusion patients."

A review of a facility's form titled "Consent to Blood Transfusion: Your signature below indicates that: 1. You have received a copy of the brochure, A Patients Guide to Blood Transfusions, 2. You have received information from your doctor concerning the risks and benefits of blood transfusion and of any alternative therapies, and their risk and benefits, 3. You have had the opportunity to discuss this matter with your doctor, including predonation, and 4. Subject to any special instructions listed below, you consent to such blood transfusions as your doctor may order in connection with the operations or procedures described in this consent form..."

A review of a facility's form titled "A Patient's Guide to Blood Transfusion...dated January 2018 indicated " This brochure is provided as a source of information and is not considered a replacement for the Informed Consent process prior to the transfusion of blood..."

A review of a facility's form titled "[Facility name] Patient Care Policy and Procedure" revised February 2019, described informed consent as "Whenever it seems likely that a patient will need a blood transfusion, the physician should discuss this matter with the patient beforehand and obtain the patient's informed consent. The discussion should include the risk and benefits of transfusion, the alternatives to the transfusion, and the possibility of directed donations and autologous (blood donated by a donor with the intent to be reinfused back to the donor at a later date) transfusions, where this is feasible and available. This discussion should be documented by a physician's signed note in the patient's medical record and verified by having the patient sign... a consent for the administrations of blood or blood products."

A review of a facility's form titled "[Facility name] Administrative Manual" revised 12/2018, indicated the following staff responsibilities as "A. Physician: It is the physician's exclusive responsibility to obtain informed consent...B. Nursing Staff: The nurse is responsible for verifying that the patient's informed consent was obtained by the physician...Nursing staff will witness the patient's signature on the consent form...When Consent is Necessary:...All medical treatments of procedures which are considered "complex", require that the patient's informed consent is obtained. These procedures include ...c. administration of whole blood or blood components (ingredients found in blood)...Once informed consent has been documented, then the caregiver may have the consent form signed..."

Based on record review and staff interview, the facility failed to ensure timely reporting of adverse drug reactions. Patient 16 was administered a controlled substance (morphine, a pain medication) and developed adverse effects (decrease in breathing rate) that required the administration of another medication (Narcan) to reverse the effects of morphine. The event was not reported in the facility system for reporting medication related events.

Such failure put patients at increased risk of possible harm by not protecting patients from future episodes and potentially exposing them to experiencing worse adverse consequences.

Findings:

On 3/13/19 at 2:10 p.m., the electronic medical record for Patient 16 was reviewed with Registered Pharmacist 1 (RPH 1). The record showed that Patient 16 came to the hospital because of rib fractures, and had no pain medications (in general) or narcotics such as morphine prior to admission to the hospital.

Review of the record showed that Patient 16 was ordered pain medications as follows:
Morphine 1-3 mg (milligram: unit of weight measurement) every four hours as needed for pain. The order comment included instructions to give morphine as follows:
1 mg for pain intensity (1-3) out of 10,
2 mg for pain intensity (4-6) out of 10
3 mg for pain intensity (7-10) out of 10.
The second order for pain medication was for Norco 5/325 (a combination of 5 mg hydrocodone and 325 mg of acetaminophen) 1- 2 tables to be given every four hours as needed for moderation to severe pain (pain intensity of 4-10 out of 10).
Both orders were entered on 3/4/19 at 6:46 p.m. and on 3/4/19 at 6:47 p.m.

The record showed documentation that Patient 16 was administered 1 mg of morphine on 3/4/19 at 8:47 p.m., one tablet of Norco on 3/5/19 at 6:19 a.m., and another table on 3/5/19 at 10:35 a.m.

According to the American Society of Health-System Pharmacists online drug information, for morphine, Warnings included :
"Respiratory depression
The major toxicity associated with morphine.
Occurs most frequently in geriatric (elder) and debilitated patients, and those with conditions accompanied by hypoxia (low oxygen level) or hypercapnia (high carbon dioxide) when even moderate therapeutic doses may dangerously decrease pulmonary (lung) ventilation.
May be severe, requiring maintenance of an adequate airway, use of resuscitative equipment, and administration of oxygen, an opiate antagonist (medication that counteract the effect of opiate such as morphine), and/or other resuscitative (medication that support blood pressure, heart rate, or breathing) drugs.
Use with extreme caution in patients with COPD (lung disease) or cor pulmonale (enlargement of the right side of the heart), and in patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or preexisting respiratory depression. In such patients, even therapeutic morphine doses may decrease respiratory drive while simultaneously increasing airway resistance to the point of apnea (no breathing)."

Concurrent review of the record with RPH 1 showed that Patient 16 was an elder person and had a history of sleep apnea (a disorder in which breathing repeatedly stops and starts). Patient 16, during this hospital stay, had problems breathing (respiratory failure), which according to physician note, dated 3/12/19, was " ...likely due to opioids probably with underplaying COPD and obstructive sleep apnea..."

Further review of the record showed documentation that Narcan 0.04 mg was administered to Patient 16 on 3/5/19 at 4:59 p.m., and 0.2 mg again at 5:10 p.m., on the same day. Narcan (naloxone) is used to reverse the effect related to excessive use of opiates/opioid medications (morphine like medications).

RPH 1 confirmed the absence of any documented evidence that the use of the reversal agent (Narcan) was evaluated by pharmacist for identification of potential medication error. Evaluating use of reversal/rescue medications is important for identifying adverse drug reactions (ADR), medication errors, or overdoses. Such information can help identify causes for medication errors and ADRs and can be used to prevent future occurrences.

RPH 1 was asked if this event was reported into the facility system for reporting medication related events. It was confirmed on 3/14/19 at approximately 9:30 that no ADR event was reported for Patient 16's related to Narcan use.

The facility's policy, titled, Medication Reaction Program, last reviewed on 8/18, was reviewed. The policy did not have detailed, clear, and specific information on when to report medication reactions.

"Establishing a planned, systematic and comprehensive program to identify, report and assess medication reactions reports ...The program ... includes:
2. Identification via "alerting" orders, ..."

Alerting orders were not defined in the policy.

In addition, under Pharmacy Procedure, the policy included:
1. A medication reaction report is completed whenever:
...
b. a medication reaction in noted which prompts discontinuation of the medication with or without an antidote, ... "

According to Merriam Webster dictionary (online), antidote is defined as "a remedy to counteract the effects of poison."
The facility's policy did not define antidote.

The policy, however included: "Instances where a medication reaction report is not completed:
a. The medication reaction does not result in change in the patient's medication regimen (no changes in dosages, discountenance of medication, or addition of adjunctive therapy..."

Patient 16's reaction caused changes in the medication regimen and required the use of a reversal medication (Narcan); the orders for morphine and Norco were discontinued, on 3/5/19 at 12:42 p.m., and 1:09 p.m. respectively; however, the event was not reported as a medication reaction.

Based on interview, medical record and document review, the hospital failed to ensure the accuracy of clinical records when a procedural note following the placement of an epidural catheter (tube placed into the space outside the spine for injection of pain relief medication) was not found in Patient 16's chart.

This failure resulted in significant information being omitted from the health record, which could have affected subsequent care decisions by healthcare providers and others relying on the accuracy and completeness of the clinical document.

Findings:

Review of Patient 16's medical record included a 1:08 p.m., 3/5/19 physician note which indicated, "Anesthesiology consulted for placement of thoracic [chest] epidural. Spoke with [name of anesthesiologist]." A 6:55 p.m., 3/5/19 critical care physician consultation note read, "...an epidural catheter was placed this afternoon for pain control." An 11:26 a.m., 3/12/19 physician note stated, "3/7/19 - removed epidural catheter today per anesthesia/surgery...."

During an 8:53 a.m., 3/15/19 interview and concurrent review of Patient 16's medical record, the Critical Care Clinical Nurse Specialist (CCCNS) stated she was unable to find a procedural note by the anesthesiologist documenting the epidural catheter placement.

Review of the hospital's 12/21/18 "Medical Staff Bylaws, Rules & Regulations" indicated, "A full Operative Report should be created by the performing Provider [physician] using electronic provider documentation...immediately following any invasive procedure...If the full Operative Report is not immediately available after any invasive procedure, including bedside procedures, a Brief Operative Note must be created prior to the Provider leaving the care area...."

29821


Based on interview, medical record and document review, the hospital failed to ensure the accuracy of clinical records for 10 of 57 patients (Patient 10, 16, 21, 24, 27, 28, 32, 33, 34, 53, and 54) when:

1. patients were not assessed for pain upon admission to the hospital,
2. patients were not reassessed after receiving pain medications,
3. patients were not monitored for pain,
4. a patient was not accurately monitored for fluid intake and output,
5. the medication administration record did not reflect the ordered strength of eye medication,
6. a patient was not assessed with the use of restraints, and
7. a patient document was missing a page from the electronic health record (EHR).

These failures had the potential to cause unnecessary pain for patients, contribute to injury or harm related to restraint use, and resulted in significant information being inaccurate or omitted from medical records, which could have affected subsequent care decisions by healthcare providers and others relying on the accuracy and completeness of the clinical documents.

Findings:

1. Pain assessments were not documented upon admission for Patients 28, 34, 54, and 53.

1.(a.) Patient 34 was admitted to the hospital with diagnoses which included non-healing wounds.

A review of Patient 34's (EHR), indicated no pain assessment was documented upon admission (3/11/19 at 2:02 a.m.). The last pain assessment was documented two hours earlier in the emergency room and was scored an "8" using the numeric scale (a patient self-rating scale of 0-10, 10 being the highest level of pain). The next pain assessment was documented at 9 a.m., seven hours after admission.

During an interview on 3/15/19 at 10:30 a.m., the Director of Nursing, telemetry (DNTELE), validated Patient 34's EHR lacked pain assessment documentation upon admission.

1.(b.) Patient 54 was admitted to the hospital with diagnoses which included colon cancer and was placed on hospice (comfort care).

A review of Patient 54's EHR, indicated there was no pain assessment documented upon admission (3/9/19 at 9:13 p.m.). An hour after admission, the EHR showed a score of "4" relating to pain intensity without any other pain assessment documentation. The next pain assessment was documented on 3/10/19 at 4 a.m., seven hours after admission.

During an interview with Registered Nurse (RN) 13, she validated the pain assessment documentation for Patient 54 was not done upon admission.

1.(c.) Patient 53 was admitted to the hospital with diagnoses which included a viral infection and fever.

A review of Patient 53's EHR indicated no pain assessment was documented upon admission (3/14/19 at 4:23 a.m.). The last pain assessment was documented four hours earlier in the emergency room and was rated a "5" using the Wong-Baker FACES scale (0-10, scale used to assess children's pain with 10 being the highest level of pain). The next pain assessment was documented at 8 a.m., four hours after admission.

During an interview with RN 13 on 3/14/19 at 9:15 a.m., she validated the pain assessment documentation for Patient 53 was not done upon admission.

1.(d.) Patient 28 was admitted after delivery to the postpartum unit to room with it's mother.

During an observation of Patient 28 on 3/13/19 at 1:40 p.m., Patient 28 was observed sleeping being held by mom.

During a concurrent interview and EHR review on 3/14/19 at approximately 10:00 a.m. with the Director of Maternal Child (DMC), Patient 28's EHR reflected Patient 28 was born at approximately 8 p.m. on 3/12/19. A pain assessment was first completed on 3/13/19 at 8 a.m. There was no documentation of a pain assessment prior to the 3/13/19 8 a.m. assessment. The DMC confirmed the lack of pain assessments and stated pain assessments should be done at a minimum of every four hours.

A review of the facility's "Medication Management Policy and Procedure: Pain Management," indicated "All patients will be assessed for presence, absence and history of pain upon admission."

2. Pain assessments were not documented after Patient 34, 54, 16 and 33 were given pain medications.

2.(a.) Patient 54 was admitted to the hospital with diagnoses which included colon cancer and was placed on hospice (comfort care) on 3/13/19.

A review of Patient 54's EHR, indicated the patient was on a continuous intravenous (administered through the veins) medication which had reached the therapeutic dose on 3/13/19. The EHR further indicated pain assessment was not documented from 3/14/19 at 9 a.m. through 3/15/19 at 3:15 a.m., 18 hours.

During an interview on 3/15/19 at 10:15 a.m., the DNTELE validated Patient 54's pain assessment was not documented for 18 hours on 3/14/19 while on the continuous intravenous pain medication.

A review of the hospital's policy titled "Medication Management Policy and Procedure:Adult Opioid Analgesic IV infusion," indicated the patient's pain scale should be documented every four hours when the therapeutic dose is achieved.

2.(b.) Patient 34 was admitted to the hospital with diagnoses which included non-healing wounds.

A review of Patient 34's Physician's Orders indicated a 3/11/19 order for morphine (medication used to treat severe pain) 2 milligrams (mg, a unit of measurement) to be administered intravenously (through the vein) every four hours, when necessary for severe pain (7-10, self-rating numeric scale).

A review of Patient 34's Medication Administration Record (MAR) indicated 2 mg of morphine was given on 3/12/19 at 4:19 p.m.. The record indicated Patient 34 rated her pain as a "9" using the numeric scale. There was no documentation of pain reassessment until 6 p.m., 2 hours later.

During an interview on 3/15/19 at 10:30 a.m., the DNTELE validated Patient 34's EHR lacked pain reassessment documentation after administration of pain medication.

2.(c.) Patient 16 was seen in the Emergency Department for rib cage pain and diagnosed with multiple rib fractures.

Review of Patient 16's EHR indicated a 6:46 p.m., 3/4/19 order for "Acetaminophen-Hydrocodone [Norco]...1 - 2 tab [tablets for] Pain Moderate to Severe (4 - 10) [on a patient self-rating scale of 0 - 10]...Start with 1 tab, assess response after 30 minutes...."

EHR "Order Information Results" reflected one Norco tablet had been given at 6:19 a.m., 3/5/19 for a pain assessment of "5." The next pain assessment of "7" was documented at 10:35 a.m., 3/5/19, more than four hours later.

In a 9:16 a.m., 3/15/19 interview, the Critical Care Clinical Nurse Specialist (CCCNS) indicated she was unable to find a pain assessment documented between 6:19 a.m. - 10:35 a.m., 3/5/19.

2.(d.) Patient 33 was admitted to the hospital with diagnoses which included back pain and had back surgery on 3/12/19.

A review of Patient 33's Physician's Orders indicated a 3/11/19 order for acetaminophen 650 mg every six hours routine.

A review of Patient 33's MAR indicated 650 mg of acetaminophen was given on 3/14/19 at 6 p.m. There was no documentation of pain assessment until 8 p.m., 2 hours later.

During an interview on 3/15/19 at 9:45 a.m., RN 14 and RN 15 validated Patient 33's EHR lacked pain reassessment documentation on 3/14/19, as noted above.

A review of the facility's "Medication Management Policy and Procedure: Pain Management," indicated that all patients should be reassessed for pain "After each pain management intervention once sufficient time has elapsed for the treatment to peak effect [not greater than one hour after interventions]."

3. Pain assessment was not documented when Patient 27, 34, 54, and 33 were being monitored for pain.

3.(a.) Patient 34 was admitted to the hospital with diagnoses which included non-healing wounds

A review of 34's EHR, indicated there was no pain assessment documented on;

3/11/19 at 9 a.m. - 2 p.m. (5 hours),
3/11/19 at 2 p.m. - 8 p.m. (6 hours),
3/12/19 at 9 a.m. - 4 p.m. (7 hours),
3/12/19 at 8 p.m. - 3/13/19 at 1 a.m. (5 hours),
3/14/19 at 10 a.m. - 4 p.m. (6 hours), and
3/14/19 at 4 p.m. - 9 p.m. (5 hours).

During an interview on 3/15/19 at 10:30 a.m., the DNTELE validated Patient 34's EHR lacked pain assessment documentation on 3/11/19, 3/12/19, 3/13/19, and 3/14/19, as noted above.

3.(b.) Patient 54 was admitted to the hospital with diagnoses which included colon cancer and was placed on hospice.

A review of Patient 54's EMR, indicated there was no pain assessment documented from 3/10/19 at 11:00 p.m. through 3/11/19 at 6:00 a.m. (seven hours). The EHR further indicated pain assessment was not documented from 3/14/19 at 9 a.m. through 3/15/19 at 3:15 a.m., 18 hours.

During an interview, on 3/15/19 at 10:15 a.m., the DNTELE validated Patient 54's EHR lacked pain assessment documentation on 3/11/19, 3/14/19, and 3/15/19 as noted above.

3.(c.) Patient 33 was admitted to the hospital with diagnoses which included back pain and had back surgery on 3/12/19.

A review of Patient 33's EHR, indicated there was no pain assessment documented from 3/14/19 at 5 a.m. through 7 p.m. (14 hours).

During an interview on 3/15/19 at 9:45 a.m., RN 14 and RN 15 validated Patient 33's EHR lacked pain assessment documentation on 3/14/19, as noted above.

3.(d.) Patient 27 was admitted to the facility's postpartum unit from labor and delivery after the birth of her infant.

During an observation and interview with Patient 27 on 3/13/19 at 1:30 p.m., Patient 27 was observed in bed, holding her baby, smiling and conversing with her mother. Patient 27 stated she was offered pain medication by the staff when she asked for it. She currently denied pain.

During a concurrent interview and EHR review on 3/14/19 at approximately 10:30 a.m. with the DMC, Patient 27's EHR reflected a pain assessment was completed on 3/12/19 at 10:10 p.m. There was no documentation of a pain assessment again until 3/13/19 at 5:55 a.m. The DMC confirmed the almost 8 hour time frame between pain assessments and stated pain assessments should be done at a minimum of every four hours.

A review of the facility's "Medication Management Policy and Procedure: Pain Management," indicated that all patients should be assessed for pain "Routinely every four hours while awake (associated with vital signs)."

4. Review of the 11:44 a.m., 3/12/19 Emergency Department (ED) physician notes indicated Patient 32 was diagnosed with rhabdomyolisis (a serious condition in which muscle breakdown can cause kidney failure) and severe sepsis (a serious response to infection with reduced blood flow to tissues or malfunction of an essential body system). A 7:52 p.m., 3/12/19 physician "History and Physical" also included diagnoses of dehydration and acute kidney injury (sudden kidney failure which may be fatal).

A kidney specialist asked to examine Patient 32 noted in the 5:43 p.m., 3/12/19 consultation notes, "Plan ...aggressive volume repletion [fluid replacement]...strict Urine output [measurement and documentation]...."

Physician orders and nursing response included:
- 12:42 p.m., 3/12/19, "Lactated Ringers 2070 ml...2000 ml/hr" [2070 milliliters (a unit of measure) of an intravenous (IV) solution to be infused at a rate of 2000 ml per hour]. The infusion was begun at 12:42 p.m., 3/12/19,
- 2:58 p.m., 3/12/19, LR [Lactated Ringers], 1000 ml...125 ml/hr" [1000 ml size IV solution bags continuously infused at a rate of 125 ml/hr]. The first bag was begun at 5:30 p.m., 3/12/19 and a second bag started at 2:41 p.m., 3/13/19, and
- 3 p.m., 3/12/19, "I & O [measurement and documentation of fluid intake and output] per unit protocol."

Review of electronic health record (EHR) "Intake and Output" summaries were as follows:
6 a.m. - 6 p.m., 3/12/19: 500 ml of IV fluid infused, with no indication of any LR administered and no urine output documented, and
6 p.m. - 6 a.m., 3/12 - 3/13/19: 50 ml of IV fluid, no LR and no urine output documented.

In an 11:24 a.m., 3/15/19 interview and concurrent medical record review, ED RN 7 confirmed that on 3/12/19, Patient 32 received the 2070 ml of LR plus an additional 1000 ml. RN 7 stated that the RN infusing the fluid "did not enter [infusion] stop times [into the EHR]" so the I & O summary did not reflect the IVs as having been administered. RN 7 indicated the documenting of IV fluid stop times was "a standard of work."

The 7:54 p.m., 3/4/19 physician "History and Physical" indicated, "She is still making urine." During the 11:24 a.m., 3/15/19 interview, RN 7 also noted that Patient 32 must have had urine output because the chart included 4:13 p.m., 3/12/19 results from a urine laboratory test. RN 7 stated, "It appears the urine output just wasn't documented."

In a 9:44 a.m., 3/15/19 interview, the Director of Nursing Operations stated that "I & O per unit protocol" would include a fluid summary for at least every shift. She also indicated fluid volumes were expected to be included in the "I & O" section of the EHR because physicians relied on the information for use in their clinical practice.

Review of the hospital's February 2018 "Documentation and Planning for the Care of Patients" policy reflected, "All caregivers will be responsible for accurately recording/documenting the care provided for each patient concurrently with the completion of the patient care actions/interventions...Every shift documentation requirements include...Intake and Output...."

5. On 3/13/19 at 9:20 a.m., RN 21 was observed administering the morning medications to Patient 21. RN 21 was observed preparing the medications which included: Brimonidine 0.15%. Brimonidine is used to help reduce redness of the eyes or to reduce the pressure in the eye in patients with a condition called glaucoma.

Patient 21 was prescribed the eye drops on 3/10/19 as follows: Brimonidine 0.15% one drop in the right eye two times every day.

On 3/13/19 at 9:30 a.m., the EHR was reviewed with RN 4. A print out of the medication administration record (MAR) showed the brimonidine strength as 0.2%, not 0.15%, with the order date 3/10/19 at 2100.

On 3/13/19 at approximately 12 noon, another observation was made with Registered Pharmacist 1 (RPH 1) to confirm the strength of the brimonidine eye drop that was administered in the morning. It was confirmed with the RPH 1 that the brimonidine eye drops, in the medication drawer designated for Patient 21 and dispensed on 3/10/19 for Patient 21, were 0.15%.

Review of the order history with RPH 1 showed the order was entered as Brimonidine 0.2%, on 3/10/19 at approximately 7:50 p.m., but it was modified to 0.15% strength and verified within a few minutes after the initial entry. The order history also showed that the 0.15% strength was dispensed on 3/10/19, which was consistent with the modified physician order.

RPH 1 did not know what caused the MAR to pick up the first entry of the medication (0.2%) and not correct after the change was made to the other strength (0.15%). RPH 1 did not find any documented evidence in Patient 21's medical records showing that nurses administering the medication clarified the order or checked with the pharmacy about the mismatch. The strength of the medication available for administration (Brimonidine 0.15%) did not match the strength that appeared on the MAR (Brimonidine 0.2%), still the medication was administered without any evidence of clarifying or questioning the error.

6. A review of Patient 10's clinical record and concurrent interview with RN 17 was conducted on 3/14/19 at 1:45 p.m.

The record indicated required "Restraint Monitoring" and "Restraint Assessment" flowsheets were blank between 10:00 a.m. and 7:59 p.m. on 3/13/19, ten hours.

RN 17 acknowledged the lapse in documentation and stated the expectation was for the monitoring and assessments of restraints to be completed at a minimum of every 2 hours.

A review of the policy titled, "Restraints", revised May 2017, stipulated, " ... G. Monitoring the patient in restraint or seclusion 1. The frequency, nature, and extent of monitoring and evaluation are dependent on the needs and health status of the individual patient. 2. At a minimum, patients in restraints must be evaluated and monitored as follows: a. At least every two hours for all patients in medical restraint ..."

7. Review of the facility document titled Procedure Note indicated Patient 24 was admitted to the facility in January of 2019 in labor. Patient 24 subsequently had a cesarean section (a surgical operation for delivering a child by cutting through the wall of the mother's abdomen), during which a Code Crimson (a facility designation of a patient with an acute blood loss requiring emergency interventions including blood products and medications) was called.

During a concurrent interview and record review on 3/14/19 at 10:15 a.m. with the Chief Nurse Executive Officer (CNEO) and the DMC, the Code Crimson records for Patient 24 were reviewed in the electronic health record (EHR). The DMC stated the Code Crimson was recorded on a paper document during the code and then scanned and uploaded into the EHR. Further review of a blank Code Crimson packet provided by the CNEO was reviewed with the DMC and the CNEO. There was no evidence of the final page of the packet titled Code Crimson Team Response and Notification in the EHR. The CNEO and DMC confirmed the missing page in the EHR.

Further review of Patient 24's EHR revealed the document titled Anesthesia Record, which indicated the Code Crimson for Patient 24 occurred less than 90 days from the record review conducted on 3/14/19.

In an interview on 3/13/19 at 9:30 a.m., the Director of Health Information Management (DHIM) stated all paper documents were scanned and uploaded into the EHR within 1-2 hours. The DHIM further stated all scanned documents were kept for at least 90 days.

In an interview on 3/15/19 at approximately 8:30 a.m., the CNEO confirmed the DHIM was not able to locate the missing page of Patient 24's Code Crimson documentation.

The facility policy titled Record Retention, dated 1/22/19, stipulated "Paper Medical Records that have been scanned into the Electronic Health Record... [Facility Corporation Name] recommends a retention period of no less than 90 days..."


35598




36586




39700

Based on interview, medical record and document review, the hospital failed to ensure safety during an imaging procedure when Patient 16 was injected with contrast dye (solution used to enhance images) contraindicated for her kidney condition.

This failure had the potential to cause additional kidney injury with associated long-term complications.

Findings:

Review of a 12:19 p.m., 3/4/19 "Physician Note" indicated Patient 16 presented to the Emergency Department (ED) for severe pain management related to multiple broken ribs received during a fall three days earlier.

Review of Patient 16's physician orders reflected the following:
- 12:23 p.m., 3/4/19, laboratory tests including creatinine, which evaluates kidney function, to be completed "stat" (without delay),
- 12:26 p.m., 3/4/19: Computerized tomography (CT, an imaging procedure which scans body areas) of the chest, abdomen & pelvis with contrast "stat,"
- 2:27 p.m., 3/4/19: Discontinue CT with contrast, and
- 2:27 p.m., 3/4/19: CT of the chest, abdomen & pelvis without contrast "stat."

Review of laboratory test "Result Details" in the electronic health record indicated the following:
- 2:20 p.m., 3/4/19: An abnormally high creatinine level result of 2.4 milligrams per deciliter (a unit of measure, normal range is 0.6 - 1.3 mg/dL) was made available, and
- 2:20 p.m., 3/4/19: An associated kidney function test for glomerular filtration rate (GFR, calculated from the creatinine level), also resulted at that time and indicated an abnormally low rate of 19.7 milliliters per minute per meters squared (a unit of measure, 60 mL/min/m2 is low normal).

The 12:19 p.m., 3/4/19 ED "Physician Note" indicated:
"2:28 p.m. Labs notable for ...acute renal [kidney] failure when compared to prior from Jan [January]. Will change CT chest/abd/pelvis to non-contrast given renal function
2:49 p.m. Informed by CT tech that contrast was accidentally used despite change in order...."

Imaging Department "Order Information" reflected the following:
- 2:27 p.m., 3/4/19: The "with contrast" order was acknowledged by a CT technologist,
- 2:43 p.m., 3/4/19: CT with contrast began, according to a 10:57 a.m., 3/15/19 interview with the Imaging Department's Picture Archiving and Communication System Administrator (PACSA), and
- 2:54 p.m., 3/4/19: The "without contrast" order was acknowledged and cancelled.

Review of the hospital's 8/23/18 "Administration of Iodinated [containing iodine] Contrast Media" policy indicated, "All patients receiving contrast media are screened for contraindications prior to radiological examination. Relevant history should be brought to the attention of the supervising physician prior to contrast injection...prior to examinations requiring contrast media injections...Obtain serum creatinine level with estimated GFR within 48 hours of the procedure...Questions regarding potential contraindications are discussed with a physician prior to contrast media administration...For patients with eGFR [estimated GFR] <30: Higher risk for contrast-induced nephropathy [kidney injury related to the injection of a solution used to enhance radiological images]. Contrast should not be administered unless the patient is on dialysis or anuric [not making urine], or if contrast is considered diagnostically imperative and the benefits of contrast outweigh the risk of post-contrast acute kidney injury...."

In a 1:18 p.m., 3/15/19 interview, the Radiology First Line Supervisor stated that on 3/15/19 the CT technologist had been contacted about the scans and acknowledged having failed to review Patient 16's laboratory values before starting the exam.

In a 1:18 p.m., 3/15/19 interview, the Radiology First Line Supervisor stated that on 3/15/19 the CT technologist (CTT 1) was contacted about the scans and the technologist acknowledged having failed to review Patient 16's laboratory values before starting the exam.

In an 11:05 a.m., 3/15/19 interview, the PACSA stated that the CT technologist "has the responsibility to check labs and call the doctor" for any abnormalities before beginning a scan. At 11:42, 3/15/19, the PACSA acknowledged there was "definitely some opportunity for improvement" in Patient 16's care in the Imaging Department.

Based on observations, staff interview and departmental document review the hospital failed to ensure staff training for 1 dietary staff member who did not sanitize patient meal carts in accordance with manufacturers' guidance. Failure to ensure proper sanitation and correct solution strength may expose patients to excess cleaning chemicals.

Findings:

On 3/12/19 beginning at 3:15 p.m., Dietary Staff (DS) 1 was observed cleaning patient meal carts. DS 5 was observed wiping down the carts with a solution from a green bucket. The bucket was approximately ½ full of the solution. DS 1 was observed wiping down 2 carts, then pushing them to the side. DS 1 then proceeded to the handwashing sink adding additional water to the bucket.

In a concurrent interview DS 1 explained he obtained the sanitizing product from the chemical closet. He demonstrated he poured an unmeasured amount of sanitizer into the bucket then filled it with water after which he began sanitizing the carts. DS 1 explained the strength of the sanitizer was tested using a strip. The surveyor asked DS 1 to demonstrate the process for testing the sanitizer strength. DS 1 replied he did not know how to do it. The surveyor tested the strength of the sanitizer using departmental testing strips. Manufacturers guidance for the testing sanitizer strength was to hold the strip in the solution for 10 seconds after which the color of the strip was compared to a color guide printed on the side of the package. The color of the strip indicated solution strength was 500 parts per million, the maximum range on the strip. Manufacturers' guidance indicated the desirable range was 150-400 parts per million. Additional observation on 3/12/19 at 3:40 p.m., noted DS 1 again filled the bucket with water from the handwashing sink in the dish room.

In an interview on 3/15/19 beginning at 10:25 a.m., the Director of Food Service stated there were no defined policies and procedures for the department, rather operational guidance was given to staff utilizing standardized operating procedures (SOP) which were developed by a consulting company. These SOP's were then the basis for a monthly quality assurance inspection.

Hospital SOP listed step number 4 " ...Bottles of sanitizers ....and concentration based on manufacturer recommendation ..."

Based on observation, review of hospital documents and staff interviews, the hospital failed to ensure that individual patient nutritional needs were met in accordance with recognized dietary practices when it failed to:

1. Provide nutrition to one of 57 sampled patients (Patient 57). The patient's physician had ordered the nursing staff to provide nutrition via naso-gastric tube (NGT-a tube inserted through the nose into the stomach) when the NG was inserted, but the nursing staff did not follow the order. Patient 57 received only water and no nutrition via the NG for three days.
2. Serve patients on the Dysphagia (difficulty or discomfort in swallowing) 3 diets the appropriate diet as ordered by the physician and described in the diet manual. Patients on the Dysphagia 3 diets received cantaloupe pieces that were too large and could result in aspiration and choking. There were eight patients on the Dysphagia 3 diet.
3. Serve patients the appropriate portion of brown rice as planned on the menu. A smaller scoop size was used for an undetermined number of patients.

Findings:

1. Patient 57 was admitted to the hospital on 3/4/19 with diagnoses including high blood pressure, diabetes type II (diabetes type II is a disease resulting from the body's inability to make enough, or to properly use, insulin that develops especially in adults and most often in obese individuals), end stage renal disease (ESRD-The kidneys remove waste and excess water from the body. ESRD occurs when the kidneys are no longer able to work at a level needed for day-to-day life), stroke-like symptoms and seizure (uncontrollable shaking that is rapid and rhythmic, with the muscles contracting and relaxing repeatedly.)

The registered dietitian (RD) 2 completed a nutrition assessment on 3/6/19, two days after admission because the patient was unable to eat orally since being admitted. The RD 2 assessed Patient 57 with a malnutrition score of 4, which is considered high risk. RD 2 made nutrition recommendations for tube feeding and water flushes to meet both hydration and nutrition needs for Patient 57.

On 3/6/19, the physician wrote in the patient's progress note under plan "Insert NG tube" .... Initiate feeds once NGT in". Patient 57 had a NGT inserted on 3/7/19. A radiology report dated 3/7/19 showed the NGT was correctly placed.

Review of nursing notes from 3/7/19 through 3/10/19 showed that water flushes were the only thing Patient 57 received through the NG tube. There was no documented evidence that any of the nursing staff reached out to the physician to find out what kind of nutrition the Physician wanted for Patient 57.

Registered Nurse (RN) 9 reviewed the electronic medical record with the surveyor on 3/14/19 starting at 10:50 am. RN 9 acknowledged the information was not there.

RN 9, who was the nurse who carried out the NGT order was unavailable for interview.

On 3/9/19 Patient 57's physician documented in the progress notes to advance diet. On 3/10/19, RD 3 completed a nutrition follow -up because Patient had not received any nutrition by mouth for five days. The RD 3 documented a nutrition diagnosis of inadequate protein -energy with a malnutrition score of 4. RD 3 made another recommendation for tube feeding by NG tube because of inadequate oral intake. Tube feeding was started on 3/10/19.

In a phone call with Patient 57's physician (MD 1) on 3/15/19 at 9:14 a.m., MD 1 stated he could not explain why Patient 57 did not receive any nutrition until 3/10/19 when he initially wrote it in the plan to initiate feeding after NGT insertion.

2. During lunch tray line observation on 3/13/19 at 11:56 a.m., a clear plastic container with cantaloupe pieces was observed on a non-sampled patient on a Dysphagia 3 diet. The cantaloupe pieces were large. The surveyor shared the observation with the director of food services (DFS ) who was present. The DFS did not comment. Other patients on Dysphagia 3 diets received similar sized cantaloupe pieces. The RD 1, on 3/13/19 stated the cantaloupe met the requirements of the diet.

The Academy of Nutrition and Dietetics describe "Dysphagia as a disruption of a normal swallowing process "that could occur from multiple causes "making it difficult to manipulate and propel a bolus (a small rounded mass of a substance, especially of chewed food at the moment of swallowing) or initiate the swallow reflex." Without effective treatment it could lead to inadequate oral intake, unintended weight loss, and eventually malnutrition resulting in death. It can also lead to serious consequences such as aspiration pneumonia (a lung infection that develops after inhalation of food, liquid, or vomit into the lungs). A Dysphagia 3 diet, according to the hospital's nutrition care manual (the Academy of Nutrition and Dietetics (AND) Nutrition Care Manual) "is a diet to provide foods that can be successfully and safely swallowed. This diet consists of food that are easy to swallow because they are bite-sized pieces (less than one inch)."

On 3/15/19 at 11:19 am, the surveyor examined a similar container of cantaloupe that had been prepared for patient meal service. The pieces were not uniformly sized. There were pieces that were about one inch, but there were other pieces that were 1-1/2 inches, 1-3/4 inches and at least one piece that was 2 inches in size.

The large pieces posed a choking hazard to all patients who received the Dysphagia 3 diet. The nutrition care manual document by AND titled "National Dysphagia Diet Advanced Nutrition Therapy" lists under the subheading "Tips", Food in large chunks or food that are too hard to be chewed thoroughly should be avoided."

The undated document titled "NDD (National Dysphagia Diet) III" from the hospital Diet Manual Hand book, also used by the nutrition staff, did not include the information on the size of the pieces of food. Under the subheading of foods allowed, it lists "all canned and cooked fruits. Soft peeled fresh fruits such as peaches, nectarines ..... cantaloupe ...." No other information was included.

The first observation was on 3/13/19, the practice continued through 3/15/19 when the surveyor measured the cantaloupe pieces. According to the Patient List used by the food and nutrition staff to prepare meals, there were eight patients receiving the NDD 3 diets for lunch on 3/13/19.

2. During lunch service on 3/13/19 at starting at 11:40 a.m., the surveyor observed the Diet Aide 9 using a #12 scoop to serve brown rice. The therapeutic spreadsheet did not list the serving size of the brown rice. However, the customary practice for a size for starches including brown rice is ½ cup.

In an in interview with the director of food services (DFS) on 3/13/19 at 11:47 am, the DFS acknowledged, the correct serving and scoop size should be ½ cup. The DFS stated the diet assistant (DA) should have checked all the serving scoops for accuracy. There were approximately eight patient food trays that had been served when the surveyor identified the error.

Based on observation, review of hospital documents and staff interview, the hospital failed to ensure that its diet manual was current when it failed to include information in the diet manual including adequacy of the routinely ordered diets in accordance with current national standards such as RDA (Recommended Dietary Allowance-the amount of nutrient and calorie intake per day) or DRI (Daily Recommended Intake-a system of nutrition recommendations from the Institute of Medicine (IOM) of the National Academies).

Findings:

In an interview with the clinical nutrition manager (RD 1) on 3/14/19 starting at 3:00 p.m., RD 1 explained the hospital had a diet manual handbook. A review of the National Dysphagia (difficulty or discomfort swallowing) Diet III (NDD III- this diet includes moist foods in bite-size pieces) taken from the diet manual handbook, did not have all the necessary components of a therapeutic diet manual.

The components of a diet in a diet manual typically includes Purpose, Description, Approximate Composition of nutrients and the nutritional adequacy of the diet. The hospital's regular diet was global and had some of these components but did not specify how the diets and meals provided by the hospital met the nutritional needs of patients. For example, the document states "The chart below shows DRIs and RDAs are understated because only 7% or less of the nutritional values are available." It was not clear from the chart how many calories the actual diet provided. It had minimum target and upper limit of the nutrients.

In the interview with the RD 1, RD 1 did not provide information on how the diet provided by the hospital was nutritionally adequate. The RD 1 read out to the surveyor the document that had been provided.

Based on observation, staff interview and document review, the hospital failed to ensure 1) The safe operation of portable and fixed Emergency Department (ED) cardiac monitors when alarm parameters were capable of being manually set at dangerously low rates and pressures, and 2) A freezer used for storing breast milk in the Neonatal Intensive Care Unit (NICU) was certified by the National Sanitation Foundation (NSF).

These failures had the potential to 1) Allow critically low heart rates and blood pressures to go unnoticed by staff, and 2) Compromise the integrity of stored breast milk as a result of equipment failure linked to using food storage equipment designed for household versus institutional functional capacity.

Findings:

1) During an 11:43 a.m., 3/12/19 tour of the ED, a portable cardiac monitor was observed at the bedside of the "Hallway E" adult patient. The accompanying Critical Care Clinical Nurse Specialist (CCCNS) was asked to display how low heart rate alarm parameters could be manually set on the device. The CCCNS demonstrated that the heart rate alarm could be set as low as 15 beats per minute (BPM).

Review of the hospital's electronic health record (EHR) reference range for heart rate indicated a rate below 51 to be considered low.

During an 8:43 a.m., 3/13/19 ED tour, the portable monitor heart rate alarm for the "Hallway F" adult patient was able to be set as low as 15 BPM. The CCCNS was able to set the alarm for the diastolic blood pressure (the bottom number in a blood pressure measurement, representing the pressure in the arteries when the heart is between beats) as low as 10 millimeters of mercury (mm Hg).

In an 11:08 a.m., 3/13/19 interview, the ED Educator (EDE) noted that the monitors observed in the hallways were rental equipment. In an 11:13 a.m., 3/13/19 interview, Biomedical Engineer 1 (BE 1) stated his department did not set alarm parameters on rental monitors which were brought into the hospital; it was "up to the user" to choose alarm settings.

At 11:25 a.m., 3/13/19, the alarm setting parameters of the permanently-installed patient monitor for designated Code Bed 58 (bed kept available for patients with cardiac or respiratory emergencies) was checked with Biomedical Engineering Department representatives. The monitor's alarm for heart rate was able to be set as low as 15 BPM. The diastolic blood pressure alarm could be set as low as 30 mm Hg.

Review of the EHR reference range for blood pressure indicated a diastolic pressure below 50 mm Hg to be considered low.

In a concurrent interview, the Manager of Biomedical Engineering (MBE) stated that clinical departments were responsible for setting their own alarm parameters.

In an 11:29 a.m., 3/13/19 interview, the Director of Nursing Operations (DNO) indicated there were "no defined numbers in the system [parent company] policy" mandating where alarm parameters should be set. The DNO was asked if there was a clinical reason for alarm parameters to be able to be set as low as they were. The DNO stated, "From a nursing perspective, there is no reason to set the diastolic and heart rate alarms as low as they're set."

Review of the hospital's 9/24/18 "Clinical Alarm Management" policy reflected, "It is the policy of [the parent company] to ensure patient safety through the consistent and safe use of clinical alarms. Clinical alarms are designed to alert staff to high risk clinical conditions...Clinical alarm parameters will...be adjusted/individualized in a manner consistent with the patient's presentation and care needs...Clinical alarms with critical alarm signals:...Physiologic monitors...Risk if Alarm Not Attended To...Potential for serious injury or death...."



17065

2) It would be the expectation that all new and replacement food-related and utensil-related equipment be certified or classified for sanitation by an American National Standards Institute (ANSI)-accredited certification program. In the absence of an applicable ANSI certified sanitation standard, food-related and utensil-related equipment shall be evaluated for approval by the enforcement agency (Food Code Annex 2017). ANSI-certified products includes equipment such as freezers that are manufactured according to strict standards and procedures. From extensive product testing and material analyses to unannounced plant inspections, every aspect of a product's development is thoroughly evaluated before it earns certification. In contrast, household equipment is not consistently approved by ANSI. As such, according to the NSF,the integrity and reliability of equipment associated with food storage cannot be guaranteed.

During review of breast milk storage practices in the NICU, it was noted there was one industrial rated freezer and a second freezer similar to a routine household freezer. In a concurrent interview on 3/14/19 at 10:20 a.m., the NICU Manager stated that approximately one year ago, a second industrial freezer broke. One industrial freezer was inadequate to meet breast milk storage needs. The second industrial freezer was replaced at that time by a household freezer.

Based on observation, review of hospital documents and staff interviews the hospital failed to ensure an effective infection control program as evidenced by:

1. Six sampled cold foods in the café area were held at temperatures greater than 41 degrees Fahrenheit (Cross Reference A749)
2. The final rinse water temperature of the dishwasher was not maintained to ensure food service equipment and utensils were properly cleaned and sanitized (Cross Reference A749).
3. Infant formula preparation in the Neonatal Intensive Care Unit was conducted using chemicals that were not in compliance with food safety standards (Cross Reference A749).
4. The chemical utilized in the pantry of the Pavilion building was not intended for food contact surfaces (Cross Reference A749).
5. Partially eaten and uneaten meal trays were openly stored in one Pavilion pantry area (Cross Reference A749).
6a.Two cabinets in a second pantry area of the Pavilion building were not clean (Cross Reference A749).
b. Five of seven beverage carafes were stored wet.
c. Greater than 25 expired nutritional supplements were retained.
d. Ten pounds of thawing raw meat were not labeled with a thaw date;
7. Dishwashing of cookie trays occurred in one Pavilion pantry without proper dishwashing equipment (Cross Reference A749).
8. Greater than 50 cardboard boxes were retained in the dry storage area (Cross Reference A749).
9. One food processor blade was not free of nicks and chips (Cross Reference A749).
10. One dish washing sink was not maintained effectively to prevent growth of microorganisms which resulted in standing water in a pan and the development of a biofilm that could attract pests (Cross Reference A749).
11. One ice machine in the kitchen had a buildup of an unidentified black and pink slimy material (Cross Reference A749).
12. Two ice machines in the kitchen did not have adequate clearance between the drain line and the floor which could result in contamination of ice (Cross Reference A749).
13. One Storage cabinet in the café did not have a non-porous cleanable surface (Cross Reference A749).
14. There were multiple unidentified food particles in the main kitchen including but not limited to steam kettle area and café service area (Cross Reference A749).
15. One patient food trays was uncovered during transport (Cross Reference A749).

The cumulative effect of these systematic failures resulted in the inability of the hospitals' food and nutrition services to direct and staff in such a manner to ensure effective infection control procedures in relationship to foodservice operations were maintained and in accordance with food safety standards of practice when the existing infection control surveillance system did not detect practices that may contribute to bacterial, chemical or physical contamination of food.

Based on observation, interview and document review, the facility failed to maintain a system for controlling sources of infections in accordance with internal policies and procedures, nationally recognized infection control practices and guidelines, and regulations, when:

1. Cabinets in perioperative services were in a state of disrepair which prevented the process of disinfection, and
2. Hand hygiene during administration of medications was not followed, and
3. Employee Health requirements were not being met,
4. Effective surveillance procedures in relationship to foodservice operations and in accordance with food safety standards of practice were not implemented.

These failures put patients at increased risk of infections, and possibly harm related to infection complications

Findings:

1. On March 12, 2019 at 10:35 am, during a tour of operating room 6, a supply cabinet was observed to be in a state of disrepair, with many scrapes in the paint, exposing the metal surface below. This observation was validated by Registered Nurse (RN) 23 and RN 24.

On March 12, 2019 at 10:15 am, RN 23 and RN 24 stated that they adopted the Association for the Advancement of Medical Instrumentation (AAMI), the Association of peri-Operative Registered Nurses (AORN) and the Centers for Disease Control and Prevention (CDC) as the nationally recognized guidelines for the facility's infection control program.

According to ANSI/AAMI ST79: 2017 Comprehensive Guide To Steam Sterilization and Sterility Assurance in Health Care Facilities, 3.3.5 General facility design requirements: All surfaces (e.g., floors, walls, ceilings, cabinets) should be durable, smooth, and cleanable. Unless otherwise stated ...all processing work areas should conform to the following recommendations. Surfaces that are durable, smooth, and cleanable allow for ease of cleaning and assist in preventing buildup of dirt and debris in crevices.; be constructed of non-particulate or non-fiber shedding materials that will withstand daily or more frequent wet cleaning and the application of chemical cleaning agents.

2. During medication administration, two nurses were observed preformed hand hygiene before donning gloves and going to patient's rooms. Both nurses performed many patient care tasks: checking blood pressure, touching patient, food, computer, and other things in the room, and proceeded to administer medication by intramuscular (IM) (injections into the muscle) injection and eye drops without changing the potentially contaminated gloves.

2a. On 3/13/19 at 8:53 a.m., RN 22 was observed administering morning medications to Patient 20. The nurse prepared the medications (six different oral tablets in addition an injection medication), performed hand hygiene by using alcohol rub, then donned a pair of gloves. RN 22 used a device to scan the medication, the patient's arm band, check the patient's blood pressure and pulse, and handed the food tray to another staff outside the patient's room. Then with the same gloves on, RN 22 removed the outer wrap of the medication to be given by IM injection. At that time, RN 22 was questioned if she was going to change the gloves. RN 22 changed the gloves and without performing any hand hygiene donned a new pair gloves.

2b. On 3/13/19 at 9:20 a.m., RN 21 was observed administering morning medications to Patient 21. RN 21 prepared the medications (three oral medications, two eye drops, and one to be given by injections. RN 21 performed hand hygiene by using alcohol rub, then donned a pair of gloves. RN 21 handled the bed sheets, checked the patient's blood pressure, pulse and temperature, scanned the medications and the name band, raised the head of the bed, then gave the medication to the patient. RN 21 proceeded to start the eye drops. At that time, RN 21 was questioned if she was going to change the gloves before administering the eye medication. RN 21 changed the gloves, and without performing any hand hygiene donned a new pair of gloves.

The facility's policy for Hand Hygiene, dated February 8, 2017, listed the "Indications for Hand Hygiene" as follows:
"3. Health care workers shall decontaminate hands using alcohol- based hand rub or washing with soap (plain or antimicrobial) and water under the flowing circumstances:
a. Before and after patient contact ...
g. After contact with Patient's intact or non-intact skin, mucous membranes...or other objects likely to be contaminated
h. After contact with inanimate objects that are used for direct patient care in the immediate vicinity of the patient
i. After removing gloves."

3a. On March 14, 2019 at 9:00 am, during a review of employee (EE) files, two employee files (RN 24, EE 3), did not show evidence of mumps contagious disease that is caused by a virus, with fever, headache, muscle aches, tiredness, and loss of appetite, swelling of salivary glands, puffy cheeks and a tender, swollen jaw) immunity status: one employee file (RN 24) did not show evidence of Varicella (Chickenpox - a contagious viral disease causing a blister-like rash, itching, tiredness, and fever) immunity status. These omissions were validated by Human Resources Director (HRD).

3b. On 3/15/19 at approximately 11 a.m., an employee record review was conducted for RN 16. RN 16's immunization record was reviewed. There was no documented evidence RN 16 had declined or had received a TDap vaccine (Tetnus, Diptheria, Pertussis - a combination vaccine that protects against three potentially life-threatening bacterial diseases: tetanus, a bacterial infection characterized by muscle spasms, diphtheria, a contagious infection that makes it difficult to breathe and can cause heart and nerve damage, and pertussis, or whooping cough, a contagious respiratory infection that can lead to severe breathing problems).

During a concurrent interview and record review on 3/15/19 at approximately 11 a.m. with Specialist III Human Resources (SHR), the SHR confirmed RN 16 did not have documentation of TDap immunization status.

During an interview on 3/15/19 at approximately 12:30 p.m., the SHR confirmed there was no documentation RN 16 had declined or received the TDap vaccine.

According to the facility policy titled Immunization and Tuberculosis Screening Policy, dated April 25, 2018, "Vaccine requirements for Mumps [include]; All HCP [health care provider] must have valid documentation (vaccination record or laboratory titers) ...[and] Varicella Vaccine: All HCP must have valid documentation (vaccination record or laboratory titers) ...All HCP must have valid documentation of receiving a Tdap vaccine as an adult ...Declinations for MMR, Varicella and Tdap (Tetanus, Diphtheria and Pertussis) will only be considered for medical reasons that are documented (note from a treating physician) and/or religious reasons and a declination form must be signed."

For current California requirements, Cal. Code Regs. tit. 8, § 5199, relating to "aerosol transmissible diseases". Cal. Code Regs. tit. 8, § 5199(h)(5) requires employers to make available to all susceptible healthcare workers with occupational exposure all vaccine doses listed in Appendix E. Doses listed in Appendix E include seasonal influenza vaccine, measles, mumps, and rubella vaccine, varicella vaccine, and tetanus-diphtheria-acellular pertussis (Tdap) vaccine. Employers are required to ensure that employees who decline to accept a recommended and offered vaccination sign the declination statement in Appendix C1 for each declined vaccine. Cal. Code Regs. tit. 8, § 5199 applies to hospitals, skilled nursing facilities, clinics, medical offices and other outpatient medical facilities, among others.

4.a Time/Temperature Control for Safety (TCS) is required for foods capable of supporting bacterial growth associated with food borne illness. Protein based foods such as meat, eggs as well as cooked starches such as rice, and cut melons are capable of bacterial growth. All require time and/or temperature monitoring for food safety. The standard of practice would be to ensure except during preparation, cooking, or cooling, or when time is used as the public health control TCS shall be maintained as 41 degrees Fahrenheit (F) or less. Similarly, ready to eat, packaged foods, held in a food establishment shall be held at a temperature of 41 degrees F or less (Food Code, 2017).

In an observation on 3/12/19 beginning at 2: 45 p.m., food holding procedures were evaluated in the café area. In a concurrent interview the Director of Food Services (DFS) stated the mid-day café hours, specifically the salad bar, were from 10:30 a.m.-7p.m. It was also noted there was an open front refrigerator containing sandwiches, milk and sushi with cooked seafood that were purchased from an outside food vendor. Observed temperatures were as follows: cut melons-55 degrees Fahrenheit (F); cooked grain salad-54 degrees F; hard boiled eggs-53 degrees F; tuna-50 degrees F and sushi-49 degrees and egg salad 50 degrees F. The standard of practice would be to ensure cold foods are stored at a temperature of 41 degrees F or below (Food Code, 2017).

In an interview on 3/12/19 at 2:55 p.m., the Café Manager stated temperatures were recorded of a sampling of items on the salad bar every two hours. Concurrent review of the departmental document titled "Line Check" dated 3/11/19 revealed that while cold holding temperatures were recorded for chicken and cottage cheese, the monitoring did not reflect temperature monitoring for all areas of cold holding. Temperature monitoring was limited to one cold holding unit. Additionally, four of the six items monitored for temperature control were salad dressings, an item that would not be considered high risk for bacterial growth (Food Code, 2017). Review of the "Line Check" document 3/11/19 revealed there was no temperature monitoring of the open front refrigeration unit which contained dairy and ready to eat products or the salad bar refrigeration unit. In a concurrent interview the DFS stated temperatures of foods were monitored at the time of delivery. The DFS acknowledged the receiving log, which recorded temperatures at the time of delivery, did not include ready to eat items.

In an interview on 3/12/19 at 2 p.m., Dietary Staff 2 stated she was responsible for maintaining the food products of the open front refrigerator. DS 2 food items in the open front refrigerator was restocked at approximately 10:30 a.m., and was refilled throughout the day as necessary. DS 2 also stated that if items were not purchased they would remain in the open front refrigerator until they expired.

Additional temperatures were taken in the presence of DS 3 on 3/12/19 at 3:15 p.m., with calibrated surveyor and facility thermometers were as follows: cut melon-47 degrees F; grain salad-50 degrees F. There was also a pre-packaged tuna pasta salad with an expiration date of 3/13/19-49 degrees F.

In an interview on 3/14/19 beginning at 1 p.m., during an Infection Control Committee meeting, the Infection Preventionist (IP), described infection control oversight of food services as a quarterly review of the department conducted by the DFS. The committee also had a consultative relationship with the DFS if he had issues that arose.

In a follow up interview on 3/15/19 beginning at 10:25 a.m., the DFS stated there were no defined policies and procedures for the department, rather operational guidance was given to staff utilizing standardized operating procedures (SOP) which were developed by a consulting company. These SOP's were then the basis for a monthly quality assurance inspection.

Review of departmental document titled "QI Assessment", a departmental surveillance tool, dated 2/28/19, failed to identify lack of effective comprehensive temperature monitoring for TCS foods in the café area. Review of departmental document titled "PC030: Food Handling Procedures (HACCP) dated 2/19 listed it was the responsibility of the DFS to ensure the use of "HACCP [Hazard Analysis Critical Control Points] and regulatory guidelines for ...storage ...of food. This is important to follow in order to guarantee safety of food." While the SOP guided staff to use HACCP principles it failed to provide procedural guidance to implement an effective plan.

HACCP is a systematic approach to identifying, evaluating, and controlling food safety hazards. Food safety hazards are biological, chemical, or physical agents that are reasonably likely to cause illness or injury in the absence of their control. Because a HACCP program is designed to ensure that hazards are prevented, eliminated, or reduced to an acceptable level before a food reaches the consumer, it embodies the preventive nature of "active managerial control." Active managerial control through the use of HACCP principles is achieved by identifying the food safety hazards attributed to products, determining the necessary steps that will control the identified hazards, and implementing on-going practices or procedures that will ensure safe food (Food Code, 2017).

4b. During the initial tour of the dish room starting at 10:12 a.m. on 3/12/19, the following temperatures were displayed on the dish washing machine while the machine was running with dishes being loaded and unloaded:

Prewash 135 degrees Fahrenheit (F)
Wash 150 degrees F
Rinse 155 degrees F
Dual Rinse 160 degrees F
Final Rinse 165 degrees F

According to the manufacturer instructions on a metal plate affixed to the machine the minimum wash temperature is 150 degrees F, Rinse is 160 degrees F, Dual Rinse is 160 degrees F and Final Rinse 180 degrees minimum.
The observed readings indicated the rinse and final rinse temperatures were lower than the manufacturer recommended water temperatures. To validate these water temperatures, the surveyor used a Plate Simulating Dishwasher Tester (PSDT-a thermometer which simulated the surface temperature of a plate). The thermometer indicated the dish surface temperature at the final rinse was 153 degrees F. This temperature is lower than the recommended dish surface temperature of 160 degrees F. According to the Food Code, 2017 "mechanical sanitization shall be accomplished in the final sanitizing rinse by ... (a) by being cycled and achieving a utensil surface temperature of 160 degrees F as measured by an irreversible registering indicator.

The surveyor brought concerns regarding the low final rinse water temperature to the attention of the Director of Food Service (DFS) on 3/12/19 at 10:15 am. Subsequent testing of the machine showed the dish surface temperature rise from 154 .4 degrees F. Concurrent observation revealed the FSD did not guide food service staff to rewash the dishware that was improperly sanitized.

The DFS stated the machine in a concurrent observation and interview that the Dishmachine was newly installed and proceeded to retest the machine using the hospital's dish simulating tester. The tester read 154.4 degrees F. The DFS was observed to make some adjustments to the machine to increase the water temperature. After the adjustments, the final water temperature was observed to go from 165 degrees to as high as 203 degrees F. At 10: 28 am on 3/12/19, the display panel on the dish machine showed the following temperatures (F): "200 Final rinse, 163 Dual rinse, Rinse 159, wash 151". The plate simulating dish washer tester indicated the dish surface temperature was 163 degrees F. The water temperature was now too high. The DFS did not appear to notice the water temperature was in the 200 - degree F range.

An observation on 3/12/19 at 3:17 p.m., the displayed final rinse temperature was 198 degrees F. The dual rinse was 159 degrees F, wash was 143 degrees F. These temperatures were not within the manufacturer recommended and food safety standards. The PSDT surface temperature was 152. 2 degrees F at 3:19 p.m. Further testing showed improvements in rinse water temperature at 154 degrees F, however the observed rinse temperature continued to register below manufacturers' guidance. In a concurrent interview the DFS stated he would become concerned if the temperature was greater than 206 degrees F.

Review of the hospital standard operating procedure titled "Dish Machine Documentation of Temperatures" dated 2019 states Dish machine and rinse temps must be maintained based on manufacturer guidelines. According to 2017 Food Code Section 4-501.112 "in a mechanical operation, the temperature of the fresh hot water sanitizing rinse as it enters the manifold may not be more than 194 degrees F. The temperature of hot water delivered from a ware washer sanitizing rinse manifold (the point at which hot water enters the dish machine) must be maintained according to the equipment manufacturer's specifications and temperature limits specified in this section to ensure surfaces of multiuse utensils such as kitchenware and tableware accumulate enough heat to destroy pathogens that may remain on such surfaces after cleaning".

When the sanitizing rinse temperature exceeds 90ºC (194ºF) at the manifold, the water becomes volatile and begins to vaporize reducing its ability to convey sufficient heat to utensil surfaces. (Food Code Annex, 2017).

Interview with the DFS and DS 5, and concurrent document review, on 3/12/19 at 10:40 a.m., review of the hospital document titled "Dishmachine Temp Record (high Temp Machine") dated Mar-19 indicated that the dish machine water temperatures had been recorded earlier that morning. The DFS stated DS 5 completed the temperature log. In an interview with DS 5 on 3/12/19 at 10: 40 a.m., DS 5 stated the number on the final rinse column was that of the dual wash cycle and under the wash cycle column was the temperature of the prerinse. DS 5 stated he documented the temperature at 6:50 a.m. that morning when the dish machine was not running. DS 5 stated the display under the Final Rinse were three dashes (- - -) and that was why he wrote the "Prerinse" temperature. The surveyor had observed this display when the machine was not running.

Review of the hospital standard operating procedure titled "Dish Machine Documentation of Temperatures" dated 2019 states "Testing should be done at the start of each meal service wash cycle.

Further review of the log showed that on 3/1/10, showed the final rinse temperature recorded was 198 degrees F. There was a number next to temperature in the corrective action box. This implied the hospital was aware that the final rinse temperature was a concern.

4c. The standard of practice would be to ensure a work area for preparation of infant feeding be designed and maintained to support the utilization of aseptic techniques as described in the Centers for Disease Control and Prevention in an effort to exclude contact contamination from personnel, work surfaces equipment and the environment. The standard of practice suggests an area of 18-27 square feet of preparation area for facilities when a dedicated space in the nursery is designed for infant formula preparation. Additionally, the standard of practice for food production surfaces would include procedures for cleaning/sanitation utilizing chemicals in strength and type in accordance with food safety standards (Infant Feeding Guidelines in Healthcare Facilities, American Dietetic Association, 2011).

4d. On 3/14/19 beginning at 10:20 a.m., infant formula preparation was reviewed with Registered Nurse 8. RN 8 demonstrated when infant formula or breast milk required the addition of caloric modification the process was conducted on a plastic tray adjacent to the breast milk refrigerator. The plastic tray measured approximately 24 x 24 inches and had a 1-inch ledge on 3 of the 4 sides. RN 7 listed the steps as 1) cleaning the plastic tray with a purple top germicidal wipe; 2) preparing the formula as necessary and 3) wiping the tray with another purple top germicidal wipe.

Review of manufacturers' indications for usage indicated the chemical wipe may be used on hard nonporous surfaces of patient equipment such as bed railings, blood glucose meters (glucometers), cabinets, carts, chairs, counters, and diagnostic equipment. The chemical wipe was not approved for use on food contact surfaces.

While the hospital had policies titled "Breastfeeding" dated 8/18 and "Use of Prolacta Human Milk Fortifier and Donor Human Milk (DHM)" dated 6/2/17 was limited to procedural guidance for the collection and labeling of breast milk. The standard of practice also guides staff after sanitizing infant formula preparation surfaces should be wiped with a clean paper towel (Infant Feeding Guidelines in Healthcare Facilities, American Dietetic Association, 2011).

On 3/13/19 beginning at 11:50 a.m., patient meal delivery from the main kitchen to the Pavilion was evaluated. Patient meal trays were delivered to a pantry area in the ground level of the parking garage. It was noted that on the counter there was a plastic container of sanitizing wipes with a grey plastic top labeled "AF3." In a concurrent interview Dietary Staff 4 stated the wipes were used for cleaning counters. In an interview on 3/14/19 at 10:50 a.m., the DFS stated the hospital ran out of the usual sanitizing wipes so materials management supplied the "AF3" wipes to the dietary department.

In an interview on 3/14/19 beginning at 1 p.m., during an Infection Control Committee meeting, the Infection Preventionist (IP) stated the types of products allowed into the hospital was determined at the corporate level. As a result, the infection control committee did not review or evaluate the placed products.

Review of manufacturers' indications for usage indicated AF3 may be used on hard nonporous surfaces of patient equipment such as bed railings, blood glucose meters (glucometers), cabinets, carts, chairs, counters, and diagnostic equipment. The product was not approved by the manufacturer for use on food contact surfaces.

4e. The standard of practice would be to develop procedures to guide dietary staff which ensure food storage practices are conducted in such a manner that a pest free environment is maintained including eliminating harborage conditions (Food Code, 2017). Similarly, in all places of employment where all or part of the food service is provided, food must be handled, processed, prepared, and stored in such a manner as to promote basic infection control procedures and to protect against contamination of areas that are designated as clean (Occupational Safety and Health Administration). Additionally, hospital infections may be transmitted indirectly by placing soiled patient meals trays in an environment intended to be clean (Association for Professionals in Infection Control and Epidemiology, 2013).

An observation on 3/13/19 beginning at 3 p.m., the clean nourishment pantry was reviewed in medical-surgical unit. It was noted there were three uneaten meal trays in tray slots underneath the counter. Of the three meal trays two appeared to be untouched and a third was partially eaten. None of the meal trays were enclosed. In a concurrent interview the DFS stated when staff delivered dietary meal trays they arrived in an enclosed cart. Once the cart was emptied it was left in the hallway to allow nursing staff to place soiled meal in the cart. The DFS further stated that approximately 60 minutes after meal delivery the cart with soiled meal trays was removed and returned to the kitchen. The observed trays were those which were either refused in which case the meal would have been placed in the patient room; the patient discharged or were picked up by nursing staff after dietary staff removed the soiled meal cart. The DFS also stated this was the routine procedure.

Departmental SOP dated 2019, titled "PC080: Pantry Stock ...If food is taken into patient room it cannot be stored in patient fridge in pantry ..." An additional departmental SOP dated 2019 titled "PC076: Meal Tray Ticket Identification" failed to provide guidance on uneaten meal trays, rather was limited to guidance on delivering meals to patients.

4f. The standard of practice is to ensure equipment, food contact surfaces and utensils are clean to sight and touch (Food Code, 2017).

In an observation on 3/13/19 beginning at 3 p.m., the nourishment station at the Pavilion in the labor and delivery unit was reviewed. It was noted in one of the upper cabinets there was a beverage cup that was warm to the touch. It was also noted in the lower cabinets there was a build-up of unidentified food particles.

In a concurrent interview the DFS stated the cup probably belonged to a nursing staff member as staff were not allowed to have beverages in the nourishment station. He further stated the hospital policy for employees was to store their beverages in the unit associated employee break room, however he routinely found the beverages in the patient nourishment room. The DFS also stated that dietary staff were responsible for cleaning the nourishment room areas on a monthly basis. The DFS provided a blank document titled "Pantry Inspection Sheet" that listed all nourishment areas within the two hospital towers as well as affiliated areas such as the doctors' lounge and emergency room.

Departmental SOP titled "PC080: Pantry Stock" limited the responsibility of food and nutrition staff to clean the refrigerator and ice/coffee machines. Cleaning responsibility for the interior or the cabinets was not part of the SOP.

4g. During initial tour of the kitchen on 3/12/19 beginning at 9:45 a.m., the following was noted:

1. Items must be allowed to drain and to air-dry before being stacked or stored. Stacking wet items such as pans prevents them from drying and may allow an environment where microorganisms can begin to grow (Food Code, 2017).

In the catering area there was a floor to ceiling cabinet that contained beverage carafes. Three of five carafes were wet inside. In a concurrent interview the Director of Food Services (DFS) confirmed they were clean and should have been air dried prior to storage. Similarly, in the catering area there were two pump beverage containers that were also wet inside.

In a follow up interview on 3/15/19 beginning at 10:25 a.m., the DFS stated there were no defined policies and procedures for the department, rather operational guidance was given to staff utilizing standardized operating procedures (SOP) which were developed by a consulting company. These SOP's were then the basis for a monthly quality assurance inspection. Departmental document titled "PC068: Dish Room Standard Precautions" dated 2019, provided by the DFS as the document that provided operational guidelines for dish room staff, failed to provide procedural guidance for air drying dishes rather described the procedure for dishwashing staff when handling isolation trays.

2. On 3/12/19 at 10:50 a.m., in the walk-in refrigerator there was a ½ filled box of nutritional supplements dated 2/13/19. Manufacturers' guidance printed on the outside of the box was to keep frozen. The box was dated 2/13/19. In a concurrent interview the DFS stated the date on the box indicated the date the item was thawed. The DFS stated the item was received frozen and was good for 30 days in the refrigerator. Concurrent review of the manufacturers' guidance printed on the side of the carton indicated the product was good for 14 rather than 30 days in the refrigerator. As a result, the product expired on 2/28/19.

3. On 3/12/19 at 10:50 a.m., there was plastic bin containing greater than three 5-pound packages of ground turkey all of which were thawed and unlabeled with the thaw or use by date. In a concurrent interview the DFS stated the items were delivered the day prior and were shipped thawed and were intended to be used on 3/13/19. The DFS also stated the hospitals' procedure would be to label all items with either a received or use by date. Review on 3/12/19 at 12:30 p.m., of the 3/8/19 invoice revealed the ground turkey was received frozen. In a concurrent interview with the DFS he acknowledged the ground turkey was received frozen rather than thawed. It would be the standard of practice for food safety to ensure thawed, ground poultry is cooked within 1-2 days (USDA Food Safety and Inspection Service, 2018).

In a follow up interview on 3/15/19 beginning at 10:25 a.m., the DFS stated there were no defined policies and procedures for the department, rather operational guidance was given to staff utilizing standardized operating procedures (SOP) which were developed by a consulting company. These SOP's were then the basis for a monthly quality assurance inspection. The DFS also stated that he did not have the authority to modify the SOP's.

4h. Observation on 3/14/19 beginning at 11:50 a.m., during observation of the Pavilion meal pantry area in the ground level of the parking garage it was noted there was an oven on the counter adjacent to the handwashing sink. It was also noted there were small baking trays resting on the counter leaning against the refrigerator.

In an interview on 3/14/19 beginning at 2:15 p.m., the DFS stated the oven was used to bake cookies for guests and patients in the post-partum unit. DFS stated the sink in the pantry was intended as a handwashing sink. He also stated the baking trays were washed in the hand washing sink. There was no separate area for manual dishwashing procedures.

The standard of practice is to ensure handwashing sinks are not used for purposes other than handwashing (Food Code, 2017).

4i. Corrugated cardboard boxes are susceptible to moisture, water, insects, vermin and bacteria during warehouse or storeroom storage, as well as transportation environments. The hospital must provide and maintain a sanitary environment to avoid sources and transmission and all areas of the hospital must be clean and sanitary. This includes all hospital units, campuses and off-site locations. Cardboard boxes are manufactured and imported from many areas. Prior to delivery to a hospital cardboard boxes have been stored in different types of warehouses. Cardboard boxes are usually delivered to hospital receiving docks from other shipping dock locations on carts or pallets, prior to arriving into a health care facility. Mice, insects, and vermin can be carried into a hospital within the cardboard boxes used as external shipping cartons.

It is also recommended that hospitals complete a risk assessment of having a container to determine the appropriateness of having the container type used in a particular area. As a result of a risk assessment a course of action should be determined, a policy generated and implemented. Upon implementation the organization is expected to assess whether the desired affect was achieved and adjusted accordingly (Joint Commission on Accreditation of Hospitals).

During initial tour of the dry storage area on 3/12/19 beginning at 9:45 a.m., in the dry storage area it was noted that the department routinely maintained corrugated cardboard boxes, the outer shipping container for food products. In a concurrent interview the DFS stated this was the routine practice within the department as boxes were labeled with receipt date as well as other information.

Departmental SOP titled "PC020: Stockroom" guided staff to "3. Remove outside shipping boxes prior to storage of products and bulk items ..." Review of departmental document titled "QI Assessment" dated 2/28/19 listed three unmet standards, none or which were related to the retention of outside boxes.

During the Food and Nutrition exit conference on 3/15/19 beginning at 1 p.m., the DFS stated the department completed a risk assessment, however throughout the survey process from 3/12-3/15/19 the hospital did not demonstrate the completion of a risk assessment in relationship to food and nutrition services. It was also noted the SOP was not inclusive of a risk assessment, rather guided staff to remove outside shipping boxes.

4j. During the tour of the kitchen on 3/12/19 at 10:45 a.m., the blade of the food processor stored away as clean had several nicks and chips.
According to the 2017 Food Code Section 4-202.11 (a) multiuse food-contact surfaces shall be: (1) smooth; (2) free of breaks, open seams, cracks, chips, inclusions, pits, and similar imperfections.

"Equipment and utensils must be designed and constructed to be durable and capable of retaining their original characteristics so that such items can continue to fulfill their intended purpose for the duration of their life expectancy and to maintain their easy c

Based on observations, staff interview and document review, the facility failed to ensure compliance with the facility's surgical attire policy and accepted standards of practice regarding the designated areas of the Cardiac Catheterization Laboratory (Cath Lab, an area for invasive procedures).

These failures put patients at an increased risk of surgical and procedural site infections.

Findings:

According to the facility adopted 2018 Association of Perioperative Registered Nurses (AORN) Guidelines for Perioperative Practice: Environment of Care, Part II.b., "The surgical suite [and invasive procedure suite] should include three designated areas that are defined by the activities performed in each area. a) [The] unrestricted area includes a central control point for the designated personnel to monitor the entrance of patients, personnel and materials into the semi-restricted areas. This area may include locker rooms, break rooms, offices and waiting rooms...Street clothes are permitted in this area...b) [The] semi-restricted area is the peripheral support areas of the surgical [or invasive procedural] suite. The area may include...scrub sink areas, corridors leading from the unrestricted to the restricted area of the surgical suite and the entrances to locker rooms...Semi-restricted areas have specific HVAC (heating ventilation and air conditioning) design requirements associated with the intended use of the space. Personnel in the semi-restricted area should wear surgical attire and cover all head and facial hair. c) [The] restricted area is a designated space contained within the semi-restricted area and accessible only through a semi-restricted area. The restricted area includes the operating and other rooms in which operative or other invasive procedures are performed. Restricted areas have specific HVAC design requirements associated with the intended use of the space. Personnel in the restricted area should wear surgical attire and cover head and facial hair. Masks should be worn when the wearer is in the presence of open sterile supplies or of persons who are completing or have completed a surgical hand scrub...II.b.1. The designated areas should be separated by doors separating the restricted area from the semi-restricted area...The progression of restrictions is intended to provide the cleanest environment in the restricted area."

A tour was made of the Cardiac Cath Lab Department on 3/12/19 at 10:20 a.m. with the Cardiac Cath Lab Manager (CLM), the Chief Medical Officer (CMO) and the Communication Manager (COM). Upon entering through a door to the department, a corridor was observed. To the left, doors to each Cath Lab and scrub sinks were observed. CMO and COM were observed entering this semi-restricted corridor without surgical attire. The CLM, already dressed in appropriate surgical attire, was observed providing surgical attire to CMO and COM. COM was observed donning a scrub suit, a head covering, a surgical mask and shoe covers in the corridor. The CMO did not don any surgical attire. The CLM, CMO and COM were observed entering the control room (or ante-room) of Cath Lab #2.

As the tour continued, observations were made of Cath Lab #2. The control room was connected to the procedure room by a open walkway (without the use of a door) making the control room and procedure room one contiguous, restricted area. The open walkway allowed Cath Lab staff to move from the control room to the procedure room and back. Sterile supplies were observed in the procedure room open and exposed on the back table.

During an interview on 3/12/19 at 10:55 a.m., CLM acknowledged the CMO was not wearing surgical attire in the corridor or control room."Some physicians come into the control room without changing into scrubs," CLM said.

According to the 2018 facility policy and procedure titled, "Surgical Attire", "All individuals that enter/re-enter semi-restricted and restricted areas where surgery and other invasive procedures are performed will wear surgical attire...This includes such areas as Operating Room suites, Interventional Radiology suites and Cath Labs...Surgical attire should be donned in the facility's designated dressing area...All staff members in the organization have the authority and responsibility to monitor proper surgical attire compliance for their assigned areas as well as for public areas. Variances should be corrected immediately."