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Based on observation, record review, and staff interview, the hospital failed to ensure care for each patient was in accordance with hospital policy, when:

1) There is no documented evidence that nursing staff assessed 2 intravenous (IV) catheter (an apparatus used to administer liquid medication into a vein) insertion sites for Patient 18, for a census of 130, and

2) Nursing staff failed to date glucose (blood sugar) monitoring vials on 3 separate nursing units.

This failure had the potential to cause;

1) Infection or infiltration (IV medication to leak outside of the vein and into the surrounding tissue).

2) Inaccurate results for patients' glucose monitoring.

Findings:

1) Patient 18 was admitted to the Intensive Care Unit (ICU) with a diagnosis of small bowel obstruction (blockage of the small intestine).

Review of Patient 18's medical record indicated 2 IV sites were not assessed by registered nurses for 6 days.

Review of hospital policy titled, "Intravenous (IV) Therapy," with a revised date of 1/18, indicated, "Assess IV site every shift and as needed."

During an interview with Senior Director of Nursing Operations (SDNO) on 1/9/19 at 1:35 p.m., SDNO stated, "It's expected that all nurses assess a patient's IV site every shift. It wasn't documented. They didn't do it."



2.) During an initial tour of the Labor and Delivery Unit on 1/8/19 at 9:35 a.m., an observation was made of a glucometer box containing one opened vial of test strips and two small bottles of opened quality control test solutions. Neither the test strips nor test solutions were dated with a hand written "discard date".

In a concurrent interview with the Director of the Maternal Child Center (DMC), she acknowledged the missing dates. The DMC explained that once opened, the test strips were to be discarded after 6 months and both test solutions were to be discarded after 3 months. She confirmed a date should have been written on the vial of test strips and test solutions once opened, indicating when both should be discarded.

During a tour of the 4th floor Telemetry (heart monitoring) Unit on 1/8/19 at 9:44 a.m., an observation was made of a glucometer box containing two vials of opened quality control test solutions. The red vial, identified as the "high" solution, was dated by hand "12/17/18" on the section of the vial labeled "discard." No other dates were written on the vial. The vial identified as the "low" solution had illegible writing on the "discard date" label.

During a concurrent interview with Registered Nurse 3 (RN 3) on 1/8/19, RN 3 acknowledged the date on the "high" vial was 12/17/18 and was written on the "discard" line. RN 3 acknowledged the date on the "low" vial could not be determined.

During a tour of the 3rd floor Telemetry Unit on 1/8/19 at 10:05 a.m., an observation was made of a glucometer box containing four opened vials of test strips available for use. None of the test strips were dated with a hand written "discard date" or "open date."

During a concurrent interview with Registered Nurse 4 (RN 4) on 1/8/19, RN 4 acknowledged the vials were not properly dated. RN 4 stated the nurse that opens the vial is responsible for writing the "open date" and "discard date," and the discard date is 6 months after the vial is opened. RN 4 confirmed the dates should have been written on the vials.

Review of a March 2018 facility policy titled, "Blood Glucose Testing" indicated that, "Once opened, [control] solutions are stable for 90 days. Write date opened and write date to be discarded. Person opening is responsible for recording dates on Quality Control solution ...Once opened, [test strips] stable for 180 days. Write date opened and write date to be discarded. Person opening is responsible for recording dates on Quality Control solution vials." The policy also indicates, "Licensed Nursing Action ...Check date-opened/expiration dates on test-strips. Discard any expired material."

Review of a March 2017 manufacturers guidelines for (Brand name) Glucose Control Solution indicated, "Use only for 3 months after first opening. When you open a new vial of control solution, count forward 3 months and write that date on the label of the control solution vial. Discard any remaining solution after the date you have written on the vial."

Review of a March 2016 manufactures guidelines for (Brand name) Glucose Hospital Meter Test Strips indicated, "Once opened, the ...[s]trips are stable when stored as indicated for up to 180 days or until the expiration date, whichever comes first."

Based on observation, interview, and document review, the hospital failed to ensure an intravenous (medication administered directly into the vein) medication, normal saline (NS, salt solution), was administered in accordance with the prescriber's order for two days, for one of 33 randomly reviewed patients (Patient 14).

As a result, the hospital could not ensure medications were safely administered to its patients.

Findings:

An observation of medication administration was conducted with Registered Nurse (RN) 31 on 1/9/19 at 8:30 a.m.

During the administration, RN 31 confirmed, NS was infused at 100 milliliter (mL) per hour. RN 31 then changed the infusion rate to 75 mL per hour.

Patient 14's clinical record was reviewed with Pharmacist 1 on 1/9/19 at 10:35 a.m. Pharmacist 1 stated, Patient 14 was prescribed NS to be infused at 75 mL per hour on 1/7/19 (two days prior) at 8:13 p.m.

According to the hospital's policy, Administration of Medication, dated 6/16, "Persons administering medications shall still complete the manual process of performing the "Eight Rights" (... Right Dose...)...."

Based on interview, and document review, the hospital failed to ensure patients receiving Patient-Controlled Analgesia (PCA, patient self-administers intravenous [medication administered directly to the vein] pain medication via a device) for pain was monitored to ensure the PCA was safely administered, for one of 33 randomly reviewed patients (Patient 30).

As a result, the hospital could not ensure intravenous medications were safely administered to its patients.

Findings:

Patient 30's clinical record was reviewed with Registered Nurse (RN) 32 on 1/9/19 at 2:50 p.m.

Patient 30 was admitted to the hospital on 1/7/19. Patient 30 was prescribed morphine (opiate pain medication) PCA from 1/7/19 to 1/9/19 for pain.

According to the hospital's policy, Patient Controlled Analgesia (PCA), dated 2/14, "Baseline vital signs will be obtained and documented prior to initiation of Patient Controlled Analgesia (PCA) therapy then... every hour times two... every two hours times four... then every four hours... Document every four hours...."

RN 32 stated, the vital signs included blood pressure, respiratory rate, and pain levels.

RN 32 acknowledged, the nurse did not monitor Patient 30 while on PCA in accordance with the policy.

Based on observation, interview, and document review, the hospital failed to ensure the clean area used for sterile (germ-free) medications compounding and packaging (IV room) was cleaned according to the policy to maintain cleanliness.

As a result, there was a potential for contamination in the IV room.

Findings:

During a tour of the Pharmacy on 1/8/19 at 9 a.m. with the ADP, Pharmacy Technician (Tech) 1 was cleaning the inside of the hood (equipment used to maintain a clean environment for IV medications compounding and packaging).

Tech 1 was interviewed on 1/8/19 at 9:40 a.m. Tech 1 explained the steps of cleaning the inside of the hood.

During an interview on 1/8/19 at 9:45 a.m., the DOP and ADP stated, housekeeping staff was responsible for the cleaning of the outside of the hood, and the IV room.

Housekeeper (HK) 1 was interviewed on 1/8/19 at 2:50 p.m. with the ADP. HK 1 stated, she would start the cleaning process by washing her hands, taking out the trash, cleaning the counter surfaces, then the floor, in that order.

During the same interview, the ADP stated, housekeeping staff should have cleaned from "clean to dirty."

According to the hospital's policy, Sanitation of the Controlled Sterile Compounding Environment, dated 9/17, "Cleaning occurs generally from the cleanest to the dirtiest... Cleaning of the IV... Room areas shall take place in the following order... remove... trash... perform hand hygiene [such as hand washing]... don sterile gloves... [clean] Surfaces...."

Based on observation, interview, and document review, the hospital failed to ensure medications were labeled and stored to ensure their integrity, and potency (strength):

1. Medications were not stored at the appropriate temperatures and protected from light, as specified by the manufacturers;

2. Medications were not stored under sanitary conditions; and

3. Medications were not labeled with the appropriate beyond-use-date (BUD, a shortened expiration date when storage conditions change).

As a result, the hospital could not ensure medications were safe and effective for administration to its patients.

Findings:

1a. A tour of the Pharmacy was conducted with the ADP on 1/8/19 at 9:01 a.m.

A warmer in the Pharmacy contained 16 glass vials of mannitol (injectable medication to regulate the pressure in the body).

The ADP stated, the BUD was 14 days in the warmer. The ADP also acknowledged, they were not labeled with the 14-day BUD.

According to the manufacturer's specifications, the medication should be stored at 68°F to 77°F.

According to the temperature log for the warmer, the temperatures ranged from 85°F to 86°F from 12/9/18 to 1/8/19.

During an interview on 1/8/19 at 1:20 p.m., the ADP and DOP stated, they did not have evidence to support the storage of mannitol outside of the 68°F to 77°F temperature range.

1b. The medication room on the 5th floor was inspected on 1/8/19 at 11:05 a.m. with the ADP and DOP.

Lorazepam (medication to treat seizure or anxiety) 2 mg per mL injection, made by company A, was stored at room temperature.

According to the manufacturer's specification, lorazepam should have been stored refrigerated.

During an interview on 1/8/19 at 1:20 p.m., the ADP and DOP stated, they did not have evidence to support the storage of lorazepam, made by company A, at room temperature.

1c. The medication room in the Emergency Department was inspected on 1/8/19 at 1:50 p.m. with the ADP and DOP.

Nitroglycerin (medication to treat chest pain) 25 mg per 250 mL was exposed to ambient light, and was not labeled with the BUD.

According to the manufacturer's specifications, the medication should have been protected from light "... until time of use... Exposure to ambient light for up to 72 hours...."

They acknowledged, the medication was exposed to ambient light, and not protected from light.

1d. The medication room in the Intensive Care Unit was inspected with the ADP and DOP on 1/8/19 at 2 p.m.

Nitroglycerin (medication to treat chest pain) 25 mg per 250 mL was exposed to ambient light, and was not labeled with the BUD.

According to the manufacturer's specifications, the medication should have been protected from light "... until time of use... Exposure to ambient light for up to 72 hours...."

They acknowledged, the medication was exposed to ambient light, and not protected from light.

According to the hospital's policy, Storage of Medications, dated 9/15, "The Director of Pharmacy is responsible to ensure that all drugs throughout the Hospital are stored in accordance with the... manufacturer's requirements and that all drugs are transported and stored in such a manner as to ensure their purity, potency...."

2. A tour of the Pharmacy was conducted with the ADP on 1/8/19 at 9:01 a.m.

The medication refrigerator containing vaccines (medications to prevent diseases) had brown powder at the bottom.

The ADP stated, it "... need[ed] to be cleaned."

According to the hospital's policy, Storage of Medications, dated 9/15, "The Director of Pharmacy is responsible to ensure that all drugs throughout the Hospital are ... stored in such a manner as to ensure their purity...."

3. The medication room on the 4th floor was inspected with the DOP and ADP on 1/8/19 at 1:25 p.m.

Latanoprost (eye drop medication to treat glaucoma - eye conditions that damage the optic nerve and can lead to blindness) for Patient 31 was stored at room temperature, and was not labeled with the BUD.

According to the manufacturer's specifications, the medication should be refrigerated, and could be stored at room temperature for up to six weeks (42 days).

They acknowledged, the medication should have been labeled with the BUD.

According to the hospital's policy, Storage of Medications, dated 9/15, "The Director of Pharmacy is responsible to ensure that all drugs throughout the Hospital are stored in accordance with the... manufacturer's requirements and that all drugs are transported and stored in such a manner as to ensure their purity, potency...."

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. Floors in the operating room had multiple areas of "pitting", posing a risk for the harboring/transmission of pathogens.
2. Cardiac Surgery was performed in an operating room where the temperature was out of range.
3. Instruments ready for use, in a general surgery tray were not maintained according to infection control standards.
4. One out of 5 employee health files did not have evidence of the employee's varicella status.
5. Employees did not properly clean and disinfect glucometers after patient use.

These failures put patients at increased risk of hospital acquired infections.

FINDINGS

1. On January 8, 2019 at 9:50 am during an observation of the turnover cleaning of Operating Room #2, multiple areas of small penetration into and below the surface of the flooring were observed. This pitted area consisted of approximately 25% of the entire floor. This was validated by Lead EVS Technician (EVS 1) and Interim OR Manager (Mgr 1). When asked, EVS 1 stated that Ecolab Neutral Disinfectant Cleaner was utilized for the cleaning and disinfection of the floor. According to the product's instructions for use, Neutral Disinfectant Cleaner...Disinfects, cleans and deodorizes the following hard nonporous inanimate surfaces: floors, walls, metal surfaces, stainless steel surfaces, glazed porcelain, [and] plastic surfaces.

According to the CDC/HICPAC, Guidelines for Environmental Infection Control in Health-Care Facilities (2011), Cleaning and Disinfecting Strategies for Environmental Surfaces in Patient-Care Areas: Cleaning and Disinfecting Strategies for Environmental Surfaces in Patient-Care Areas: Select EPA-registered disinfectants...and use them in accordance with the manufacturer's instructions.

On January 9, 2017 at 14:15, during an interview, SVP Patient Services/COO (Adm 1) stated that the facility adopted the Association for PeriOperative Registered Nurses (AORN), as one of the nationally recognized guidelines for their infection control program. According to AORN, Guideline for Design and Maintenance: The integrity of structural surfaces (e.g., doors, floors, walls, ceilings, cabinets) should be maintained, and surfaces should be repaired when damaged. Personnel should report damage to floors, walls, ceilings, cabinets, and other structural surfaces according to the health care organization's policy. [5: Benefits Balanced with Harms] Expand/Collapse section link. Damaged structural surfaces may create a reservoir for the collection of dirt and debris that cannot be removed during cleaning.

2. On January 8, 2019 at 11:10 a.m., during a tour of the Heart Room (surgery room for open heart procedures) the thermometer in the room read 62.6°F. According to the surgery schedule, Patient 21 was scheduled for surgery at 12:30 pm. At 1:39 pm, the automated temperature tracking system (TempTrak) indicated the temperature in the heart room was 65.1°F.

On January 9, 2019 at 11:00 am, during an interview with Biomed Manager (Mgr 2) produced the history of the temperature in the Heart Room for the previous day on the computer based TempTrak system. The temperature was out of range before, during and after the procedure for Patient 21 in the Heart Room on January 8th. There were no notifications from the surgery department to request assistance in raising the temperature. Mgr 2 stated that he maintains the TempTrak system but the responsibility for monitoring the temperature and reporting "out of range" temperatures to Biomedical Department is the responsibility of the monitored department manager.

On January 9, 2017 at 14:15, during an interview Adm 1 stated that the facility adopted the AORN, as one of the nationally recognized guidelines for their infection control program. According to AORN, Guideline for a Safe Environment of Care, Part 2: The recommended temperature range in an OR is between 68°F and 75°F... Personnel who identify an unintentional variance in the predetermined HVAC system parameters should report the variance according to the health care organization's policy and procedures. Rapid communication between affected and responsible personnel can help facilitate resolution of the variance.

3. On January 8, 2019 at 11:00 in the sterile storage room located in perioperative services, a major general surgery tray was inspected. Out of 80 instruments, 7 were found to have engraving on the surface. These findings were validated by Infection Preventionist (IP).

On January 9, 2017 at 14:15, during an interview, Adm 1 stated that the facility adopted the AORN, as one of the nationally recognized guidelines for their infection control program.

According to AORN, Guideline on Instrument Cleaning: Items that are not clean or do not function correctly can put a patient at risk for injury or SSI (Surgical Site Infections). Inspection and evaluation provide an opportunity to identify soiled or damaged instruments and to remove these items from service until they are cleaned or repaired; cleanliness; correct alignment; corrosion, pitting, burrs, nicks, cracks; sharpness of cutting edges; wear and chipping of inserts and plated surfaces; [and] other defects. Use of instruments that are not thoroughly cleaned, are damaged, or do not function correctly poses a risk to patient safety.

4. On January 9, 2019 at 1:00 pm during a review of employee health records, 1 (Sterile Processing Techician; SPT) out of five (IP, Mgr 1, EVS 1, GI Tech, SPT) employee files did not have evidence of the employee's Varicella (Chickenpox) status. This finding was validated by Manager Employee Health (Mgr 3).

According to facility policy "Employee Processing: Pre-employment Health and Processing", dated December 2016,...Laboratory screening: the following labs will be completed by candidates if they do not produce written documentation of immunity: B. Varicella Titer. The Varicella vaccine will be offered to non-immune candidates after their start date. Declination forms will be completed if the candidate refuses the vaccine. Documentation of two (2) Varicella vaccines will be considered proof of immunity.

5. On January 9, 2019 at 11:15 am in the Intensive Care Unit, during a tour with the IP, Registerd Nurse 4 stated that the Oxyvir TB® Wipes are to be used to clean and disinfect the Stat Strip Glucose Hospital Meter. This was verified by the IP.

During a tour of the Labor and Delivery Unit on 1/8/19 at 9:35 a.m., an observation was made of a box for the storage of a Nova Stat Strip Glucose Hospital Meter with the following supplies: test strips, test solutions, lancets, alcohol swabs and Band-Aids (brand). In a concurrent interview with Registered Nurse 1 (RN 1), she was asked what she used to disinfect the glucometer. RN 1 stated, "alcohol".

An observation of a Nova Stat Strip glucometer and supplies on the Postpartum Unit was made on 1/8/19 at 10:45 a.m. In a concurrent interview, RN 2 stated she cleaned the glucometer with alcohol after patient use.

According to the Stat Strip Glucose Hospital Meter instructions for use: when cleaning the meter please follow the guidelines below...10% solution of household bleach may be used; 70% isopropyl (rubbing) alcohol may be used; commercial surface decontamination preparations that are approved by your facility may be used.

According to a 2018 facility policy titled, "Blood Glucose Testing", that references the Nova Stat Strip Glucose Hospital Meter, "the meter is cleaned with a Super Sani Cloth as needed, and allowed to air dry. The meter and strip holder are wiped with a bleach (1:10 dilution) moistened towelette if they have been used for a patient in contact isolation, a patient with Methicillin-Resistant Staphylococcus Aureus/Vancomycin-Resistant Enterococcus (MRSA/VRE) or resistant gram-negative infection, or when visibly soiled with blood. The bleach residue is removed from the meter by wiping with a damp cloth."

According to the Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of In Vitro Diagnostics and Radiological Health, Division of Chemistry and Toxicology Devices, dated October 2016, recommended, "Validated cleaning and disinfection procedures": The disinfectant product you choose should be effective against HIV, Hepatitis B, and Hepatitis C viruses. Of these viruses, Hepatitis B virus is the most difficult to kill and prior outbreak episodes associated with blood glucose meters have been due to transmission of Hepatitis B viruses. Therefore, disinfection efficacy studies should be performed to demonstrate effectiveness of the chosen disinfectant against Hepatitis B virus. Please note that 70% ethanol solutions are not effective against viral bloodborne pathogens, and the use of 10% bleach solutions may lead to physical degradation of your device.