HospitalInspections.org

PATIENT SAFETY
CFR(s): 482.21(a), (c)(2), (e)(3)

(a) Standard: Program Scope
(1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors.
(2) The hospital must measure, analyze, and track ...adverse patient events ...

(c) Program Activities .....
(2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital.

(e) Executive Responsibilities, The hospital's governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ...

(3) That clear expectations for safety are established.
This Standard is not met as evidenced by:

Based on record review, review of facility's documentation and interview, it was determined the hospital failed to ensure the performance improvement activities of the hospital tracked an adverse patient event, analyzed the cause of the adverse event, and implemented preventive action for 1 of 7 patients, Patient (P) 17, seen in the Emergency Department (ED) of the hospital. The facility's failure affected the ability of the hospital to identify an adverse event where P17 received a delay in treatment for a diagnosis of appendicitis.

Findings include:

Review of the "Variance Report", dated 11/13/17, revealed P17 was seen in the ED of the hospital on 10/06/17 for lower abdominal pain. The report stated, "Patient see in the ED and discharged with referral to OB/GYN (Obstetrics/Gynecology), no blood work drawn and no ultrasound or Computed Tomography (CT) scan completed for abdominal pain. Patient seen less than 12 hours later at Hospital 2 and admitted for acute appendicitis."

Review of P17's medical record indicated the patient was seen in the ED on 10/06/2017. The "Admission record" revealed P17 presented to the ED on 10/06/2017 with complaints of lower abdominal pain for the past couple of days and P17 reported to the ED she had taken "Ibuprofen without help." According to the "Patient History" record dated 10/06/2017, P17 had a history of ovarian cysts and urinary tract infections and denied dysuria. A review of the "physician's orders," dated 10/06/2017, the record revealed an order to obtain a urine for urinalysis and pregnancy test. Review of the "Physician Notes," dated 10/06/2017 indicated the clinical impression was documented as lower abdominal pain and the plan was to refer P17 to a gynecologist and prescribe NSAIDs (nonsteroidal anti-inflammatory drug) of inflammation and pain. Review of the "laboratory reports" in the record, dated 10/06/2017 at 12:26 p.m., revealed the urinalysis of P17 was within normal range.

Review of the "nurse's progress notes" in the record, dated 10/06/2017, revealed P17 was diagnosed with a left ovarian cyst on 10/03/2017 by ultrasound and P17 reported having increased pain at home and Tylenol and Advil (over-the counter medications used to treat pain) were not effective. Review of a "nursing pain assessment" conducted on 10/06/2017 at 12:20 p.m., revealed P17's pain was sharp and continuous with an intensity of 8 on a pain scale of 1 to 10, with 10 being the most severe. The assessment further noted P17 presented with guarding, splinting, and tenseness regarding the pain. Review of P17's "Nurses' Notes," dated 10/06/2017, indicated P17's vital signs revealed a temperature of 98.0 Fahrenheit, blood pressure of 126/79, pulse of 88 beats per minute, and a respiratory rate of 18 per minute (all vitals were within normal limits). A further review of the record revealed a "Medication Administration Record", dated 10/06/2017 at 3:12 p.m., indicating P17 was administered Toradol (nonsteroidal anti-inflammatory drug for moderate to severe pain) 60 milligrams (mg) and Phenergan (medication for treating nausea and vomiting) 25 mg as a one-time dose intramuscular (IM) injection. A review of the "Discharge Instructions" in the record, dated 10/06/2017 at 3:24 p.m., revealed P17 was discharged home with adult abdominal pain instructions and to follow up with a Gynecology appointment on 10/09/2017.

Review of Hospital 2's documentation titled, "Emergency Department-Admission, dated 10/07/2017 revealed P17 presented to the ED with a history of lower quadrant pain originating on the evening of 10/05/2017. P17 presented with guarding in the right lower quadrant and a high White Blood Cell count (WBC) of 13.2 (normal range is 4.5 to 10.0). The record further revealed a CT scan, dated 10/07/2017, indicated P17 had acute appendicitis and the patient was admitted for a laparoscopic appendectomy. In addition, the discharge diagnosis of the record revealed P17 was diagnosed with acute appendicitis with localized peritonitis.

On 04/12/2018 at 11:50 a.m., an interview was conducted with the Medical Doctor (MD) #9. MD
#9 stated the hospital's normal protocol when a patient presents to the ED with abdominal pain is to conduct a comprehensive abdominal assessment that includes checking for referred pain and rebound tenderness. MD #9 further stated a complete blood count (CBC) would be obtained to check the patient's white blood cell count to determine if the patient had an infection. In addition, MD #9 stated an ultrasound or CT scan should be ordered to assist in determining a diagnosis and the cause of the pain. MD #9 stated that since P17 had an ultrasound on
10/03/17 identifying an ovarian cyst, a CT scan should have been ordered to determine the cause of the patient's abdominal pain. MD #9 stated he/she, "did not know why he did not order blood work, a CT scan, and conduct a comprehensive abdominal assessment when P17 presented to the ED with abdominal pain."

Review of the hospital's policy titled, "Quality Assessment Performance Improvement Plan (QAPIP)", dated revised 05/2017, revealed the QAPIP is responsible for ensuring the hospital assesses and evaluates the quality of patient
care by collecting data, tracking quality indicators, and identifying opportunities for improvement to patient safety and quality, to include addressing, "variances when the patients did not receive the intended benefits from their care." Further review of the policy revealed the Quality Management Director (QMD) is responsible for providing, consultative assistance to the Medical Staff , hospital departments and other organizational entities in performance improvement plan development." In addition, the policy revealed the QAPIP's process is responsible for identifying critical patient care services and, "variations recognized from ongoing monitoring process will be reported as they occur, along with plans for corrective action."

On 04/12/2018 at 12:45 p.m., an interview was conducted with the ED Medical Director (MD) 10 of the hospital. MD10 stated he/she did not have any knowledge of the variance report, dated 11/13/2017, or P17's encounter in the ED on 10/06/2017. In addition, MD10 stated there had been no concerns brought to his attention about the care MD9 provided to patients in the ED. MD10 further stated a peer review of P17's record would be presented to him/her through the processes as outline in the QAPIP policy .

On 04/12/2018 at 1:15 p.m., an interview was conducted with the QMD11. The QMD11 stated variances are reviewed and assigned for peer review by a quality committee. QMD stated the committee met every other month (even numbered months) and the variance, dated 11/13/2017, was scheduled to be assigned for peer review during the month of 12/2017. However, there was a delay in the peer review due to the gathering of additional information of P17's encounter in the ED and subsequent visit to Hospital 2. In addition, the QMD10 stated the physician who was assigned to conduct a peer review of the variance, dated 11/13/2017 was not present at the committee meeting in 02/2017. QMD further stated the peer review for the variance related to P17 was scheduled to be reviewed in 04/2017. The QMD could not provide any additional explanations for delay in the review of the variance related to P17's encounter in the ED on 10/06/2017.

UNUSABLE DRUGS NOT USED CFR(s): 482.25(b)(3)

§482.25(b)(3) - Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use This Standard is not met as evidenced by:

Based on observation and interview for 1 of 5 patient unit medication rooms, the facility failed to ensure outdated medications were disposed and/or failed to date medication when opened. Failure to discard outdated medications and date medication when opened when there was a beyond use date (BUD) on the vial had a potential to affect patient safety.

Findings include:

Observation during the tour of the Medical/Surgical/Pediatric unit on 04/09/2018 at 10:00 AM with Registered Nurse (RN) 2 revealed in the Cardinal Butterfly medication room refrigerator, three vials of Racepinephrine Inhalation Solution with expiration dates 07/2017. Observation in the locked medication refrigerator in the Cardinal Butterfly medication room identified one (1) vial of Lorazepam 20 milligram per 10 milliliters that was opened and undated. The vial indicated a beyond use date (BUD) of 28 days after opening.

Interview with RN2 at the time stated, "the charge nurses are responsible to ensure outdated medications are removed from the unlocked medication refrigerator." RN2 stated, "the Pharmacy was responsible to remove outdated medications and medications that are opened and not dated from the locked medication refrigerator." RN2 stated the staff "missed removing the medications."

FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE
CFR(s): 482.41(c)(2)

Facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality.
This Standard is not met as evidenced by: Based on observations, review of the hospital's policy and staff interviews, the facility failed to monitor the temperature of the blankets in the blanket warmer for 2 of 4 blanket warmers.
Failure to monitor the temperature of the warming blankets had the potential to affect patient safety .

Findings include:

1.Tour of the Medical/Surgical/Pediatric unit on 04/09/2018 at 10:25 AM with Registered Nurse (RN) 2 identified a blanket warmer in the clean utility room. The blanket warmer thermometer indicated the internal temperature was 125 degrees Fahrenheit (F). RN2 in an interview on 04/09/2018 at 10:25 AM stated, "the unit was not monitoring the temperature of the blanket warmer." RN2 stated he/she "did not know the temperature of the blanket warmer should be monitored." RN2 stated, "the hospital had a blanket warmer policy, however, it did not indicate to monitor temperatures."

A second observation on 04/10/2018 at 9:10 AM of the blanket warmer on the Medical/Surgical/Pediatric unit identified the blanket warmer thermometer registered a temperature of 135 degrees F.

Interview with RN2 on 04/10/2018 at 9:12 AM identified the unit would start to monitor the temperature of the blanket warmer to ensure the temperature did not exceed the facility's policy of 130 degrees F. RN2 stated she would report the elevated temperature to Materials Management so the blanket warmer could be checked.

2. Tour of the Radiology Services on 04/11/2018 at 8:00 AM with the Director of Radiology identified a blanket warmer in a room outside the Fluoroscopy Room identified a blanket warmer. The blanket warmer thermometer was not functioning. The Director of Radiology in an interview at this time stated, "the temperature of the blanket warmer is checked quarterly during safety audits." The Director of Radiology stated, "temperatures were not monitored daily when the unit was open."

Review of the hospital's policy # PC-45 titled, "Storage of Warmed Blankets" effective 02/2010 indicated in part "Temperature settings on cabinets designed to warm blankets should not exceed 130 degrees Fahrenheit (F)." The policy failed to identify when temperature checks were to be conducted.

INFECTION CONTROL PROGRAM CFR(s): 482.42(a)(1)

The infection control officer or officers must develop a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel.

This Standard is not met as evidenced by:

Based on observation, interviews, review of the facility's policy and review of the manufacturer's instructions, the facility failed to implement measures to control infections and communicable diseases within the hospital. Specifically, 1. The hospital failed to ensure staff followed aseptic precautions for intravenous catheter insertion. 2. The hospital failed to ensure germicides used to clean glucometers were used in accordance with manufacturer's instructions. These failures had the potential to affect the 44 patients admitted to the hospital and numerous outpatient surgical patients were placed at risk for acquiring infections.

Findings include:

1. Observation on 04/10/2018 at 9:05 AM in Pre-Op Room 1 revealed that Patient (P) 18 received assessment and preparation for surgery from a Registered Nurse (RN)1 in the surgery area. RN1 collected supplies, sanitized his/her hands, donned gloves, and placed the supplies (including a roll of tape) on an overbed table. RN1 failed to clean the top of the overbed table and did not place a barrier under the supplies. RN1 then requested P18 place his/her arm on top of the overbed table while RN1 inserted an intravenous catheter (IV) in the back of P18's
right hand. During the insertion, RN1 used a foam sponge impregnated with an antiseptic solution to wipe the area where the IV was to be inserted. RN1 then placed the sponge on the bare table top. RN1 palpated the area of IV insertion, picked up the sponge and, again, wiped the area. RN1 placed the sponge on the bare table top and completed the IV insertion. Following the procedure, RN1 moved the table to the side without sanitizing it and placed on it various documents and educational materials that the patient was to take home.

Interview on 04/10/2018 at 10:00 AM with RN1 at the nurses' station in the surgery department revealed RN1 did not include cleaning the overbed table following patients' release from Pre-Op when they were taken to surgery. Interview at this time with the unit's clinical supervisor (RN4) indicated that the overbed tables were cleaned by housekeeping staff at the end of the day.

2. Observation on 04/11/2018 at 8:50 AM of P19 preparing to undergo a colonoscopy (endoscopic examination of the colon) revealed the patient received an IV in the left arm. RN3 inserted the IV while P19 rested the left arm on an overbed table with no barrier between the arm and the tabletop. Following the insertion, RN3 placed a television remote control device, various papers and a plastic portfolio on the overbed table without first cleaning the top.

The Director of Surgical Services (RN4) was interviewed on 4/10/2018 at 11:55 AM. RN4 stated that nursing practice required there should have been a barrier on the table top and tape should not be placed on a bare table top during IV insertion.

Review of the facility's policy titled, "IntravenousTherapy" revised 7/2010 revealed the following: "Purpose: To safely initiate and maintain intravenous access, administer fluids and prevent complications. . .Insertion Guidelines. . .2. IV site will be accessed following strict aseptic technique. . ."

2. Observation on 04/11//2018 at 10:30 AM of the Behavioral Medicine unit revealed that blood glucose levels were monitored on the unit with an "Accu-Check Inform II" glucometer. "Sani Cloth Wipes" in a container in the medication room near the device were available for sanitizing the device after it was used. Per the container label, the wipes were EPA registered (registration #9480-9) and contained alcohol.

Interview with the Director of Nursing (RN6) on 04/12/2018 at 8:10 AM revealed the entire hospital utilized the "Accu-Check Inform II" glucometer. RN6 stated he/she believed that the Sani-Cloth Wipes were acceptable for cleaning the devices per manufacturer's recommendations.

Review of the manufacturer's instructions revealed the "Acceptable Cleaning/Disinfecting Agents" for the Cobas "Accu-check Inform II" glucometer were as follows: ". . .Acceptable active ingredients and products for cleaning and disinfecting are: Clorox Germicidal Wipes ( EPA reg. no 67619-12) pre-moistened disinfecting cloths (active ingredient 1% or less solution of sodium hypochlorite in water (bleach). Super Sani-Cloth Germicidal Disposable Wipes ( EPA reg. no. 9480-4) Pre-moistened disinfection cloths (active ingredient 0.5 quaternary
ammonium chlorides and up to 60% isopropanol). Note: Always use (above products). . .to clean and disinfect the meter. Do not use any other cleaning or disinfecting solution. . .could result in damage to the system components."