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Based on observation, document review, and staff interviews the Critical Access Hospital (CAH) staff failed to ensure emergency medication, equipment and supplies commonly used in life saving procedures were readily available for treating emergency cases in 1 of 1 Pediatric Crash Cart and 1 of 1 Adult Crash Cart located in the Emergency Department (ED). Outdated medications, supplies and torn/compromised sterile supply packages are unable to be used in the care of a patient. Failure to ensure the pediatric and adult crash carts were fully stocked and ready to use may result in lack of lifesaving medications, supplies, and equipment needed to resuscitate (to revive from apparent death) a child or adult, potentially resulting in significant injury and or death. The CAH administrative staff reported approximately 490 patients came to the emergency department for emergency care per month.


Findings include:

1. Observations during a tour of the Emergency Department on 6/24/19 at 12:25 PM, revealed the following expired supplies and medications in and on the Pediatric Emergency Crash Cart:

Supplies:

a. 2 of 3 Introducer Pediatric Bougie (a firm and flexible tube introducer used to place an endotracheal (breathing) tube), expired 3/2019 and 5/2019.
b. 2 of 2 6.0 mm Mallinckrodt Hi-Lo Oral Nasal cuffed Tracheostomy tubes, expired 4/2019

Medications:
a. 1 of 1 Furosemide injection vial 100 mg/10 ml, expired 5/2019
b. 4 of 4 Epinephrine 1 mg/ml 1:1000 ampoules, expired 5/2019
c. 5 of 5 Adenosine 6 mg/2 ml vials, expired 4/2019
d. 1 of 1 8.4% Sodium Bicarbonate injection 50 mEq, expired 5/1/19
e. 2 of 2 Pediatric 8.4% Sodium Bicarbonate 10 mEq, expired 4/1/2019
f. 3 of 3 Atropine Sulfate 1 mg, 10 ml syringes, expired 5/1/2019
g. 2 of 2 Calcium Chloride 1.36 mEq/ml syringes, expired 4/2019
h. 1 of 3 5% Dextrose 250 ml IV bag, expired 4/2019
i. 1 of 1 Sodium Chloride 500 ml IV bag, expired 5/1/2019

2. Observations during a tour of the Emergency Department on 6/24/2019 at 12:25 PM, revealed the following outdated and unusable supplies in and on the Adult Crash Cart:

a. 3 of 3 22 GA 1 inch Nexiva closed IV catheter system, expired 3/31/2019
b. 5 of 7 Cotton Tipped Applicators, 2 in pack, expired 8/30/18
c. 1 of 1 32 Fr Soft PVC Nasopharyngeal airway, expired 6/2018
d. 1 of 1 34 Fr PVC Nasopharyngeal airway, expired 3/2018

Sterile supplies with torn/compromised packaging:

a. 1 of 1 30 Fr PVC Nasopharyngeal airway, torn package
b. 1 of 1 20 Fr PVC Nasopharyngeal airway, torn package
c. 4 of 4 Suction Catheter 14 FR Whistle tip, stored folded in half in a manner which compressed the internal diameter of the catheter and prevents possible air/fluid from being suctioned through the tube, damaged

3. Review of "Crash Cart Checking Policy and Procedure" last revised 2/2018, revealed in part, "..medication on the crash cart will be checked by Pharmacy on a monthly basis....remainder of the crash cart will be checked by unit staff..."

4. Review of "Inspections for Outdated Medications, Nutritional Supplements, and Supplies Policy and Procedure Doc" effective 6/2019 revealed in part, " Any medication...or supply bearing an expiration date shall not be given or used beyond the expiration date of the drug...or supply...ER..Crash Carts..each department shall be responsible to inspect for outdated medications ...supplies...on a regular basis..outdated medications...supplies shall be removed from stock..."

5. Review of "Pediatric Crash Cart Check List" for ED revealed the checklist lacked direction and guidance to check for outdated medications and supplies.

6. Review of "Crash Cart Checklist" for Adult Crash Cart revealed it lacked direction and guidance to check for outdated medications and supplies.

7. During an interview on 6/24/2019 at the time of the ED tour, the ED Nurse Manager and the CNO verified the outdated medications, supplies and torn/compromised packages had expired and staff should not use in the care of a patient. The ED Nurse Manager divulged they did not have a good system in place for checking outdated medications and supplies.

I. Based on observation, document review and staff interviews the Critical Access Hospital's (CAH) Emergency Department (ED) Staff failed to follow the manufacturer's directions for quality control testing when staff utilized 1 of 1 True Metrix Pro Professional Monitoring Blood Glucose System in the Emergency Department. Failure to follow the True Metrix Pro Blood Glucose Monitoring System manufacturer's instructions for performing quality control testing could potentially result in inaccurate blood glucose readings and inadequate treatment of a patient's abnormally high or low blood glucose level. The CAH administrative staff reported the True Metrix Pro Blood Glucose Monitoring System was utilized to perform blood glucose testing on Emergency Department patients approximately 22 times per month.


Findings include:

1. Observations on 6/24/2019 at 12:50 PM, during a tour of the Emergency Department, revealed a bottle of True Metrix Pro Blood Glucose test strips, lot # MV 3148 with an expiration date 7/31/2020, marked opened 6-15-19 and a staff's initials written on the cap of the bottle.

2. Review of CAH form "True Metrix Pro BLOOD GLUCOSE MACHINE" ER June 2019 log revealed in part, " ...QC should be performed on every newly opened vial..." and the form contained an area to document newly opened blood glucose strip bottle lot numbers, expiration dates and QC bottle low/high test results.

The True Metrix BLOOD GLUCOSE MACHINE June log lacked documentation of the blood glucose test strip bottle, MV 3148, expiration date of 7/21/2020, and lacked documentation of low/high quality control testing.

3. Review of the True Metrix Pro Professional Monitoring Blood Glucose System manufacturer's booklet, dated 2014, revealed in part, "...Control Test(s) should be performed:...When opening a new vial of test strips..."

4. Review of "WBG Policy" dated effective 2/2019 revealed in part, "..Follow manufacturer directions for...quality control performance...manufacturer recommendations for QC performance will be used."

5. During an interview on 6/24/2019 at the time of the observation, the ER Nurse Manager acknowledged the True Metrix Blood Glucose Monitor June log lacked documentation of the lot number, expiration date and the low/high quality control tests of the Blood Glucose Test strips in current use.





II. Based on observation, document review, and staff interviews, the Critical Access Hospital (CAH) staff failed to remove outdated supplies from 1 of 1 Emergency Department Supply Room and 2 of 2 Surgery Exam Rooms. Failure to remove outdated patient supplies from the CAH's supplies, available for use in patient care, could potentially result in staff using the expired items for patient care after the manufacturers' expiration date, indicating the staff should not use the supplies for patient care. The CAH Administrative staff reported approximately 490 patients presented to the emergency department for emergency care each month and 26 patients presented to the specialty clinic each month for specialty care.

Findings included:

1. Review of " Inspections for Outdated Medications, Nutritional Supplements, and Supplies Policy and Procedure Doc" effective 6/2019, revealed in part, " Clinics..ER...Any supply bearing an expiration date shall not be given or used beyond the the expiration date...outdated supplies shall be removed from stock.."

2. During a tour on 6/24/2019 at around 12:25 PM of the Emergency Department, an observation of the ED Supply Room: revealed:

a. 2 of 2 Eswab Collection and Transport Culture swab kits, expired 4/30/2019

b. 1 of 1 4.5 mm ID Maelinckrodt Oral/Nasal Tube Cuffed, expired 1/2018

c. 1 of 3 Guard IVa-antimicrobial hemostatic IV dressing, expired 1/2019

3. During an interview at the time of the observation, the ED Nurse Manager verified the supplies had expired and staff should not use the supplies.

4. During a tour on 6/24/2019 at around 1:25 PM of the Surgical Exam Rooms, observations of the exam rooms revealed:

Surgery Exam Room 1:

a. 1 of 1 SuperSani Cloth, large wipes, expired 12/2018

b. 1 of 1 PVP Prep Solution, Povidone Iodine 10%, 8 oz, opened, not dated

Surgery Exam Room 2:

a. 1 of 1 Super Sani Cloth, large wipes, expired 12/2018

5. During an interview at the time of the observation, the Specialty Clinic Coordinator confirmed the supplies had expired and staff should not use the supplies.






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III. Based on observations, document review, and staff interviews, the Critical Access Hospital (CAH) staff failed to maintain hot water temperatures between 110 and 120 degrees Fahrenheit in 2 of 7 sinks tested in the Specialty Care Clinics (Surgical Exam Room 1 and Surgical Exam Room 2), and 2 of 3 sinks tested in the off-site Primary Care Clinic (Exam Room 2 and Exam Room 3). Failure to maintain water temperatures between 110 and 120 degrees Fahrenheit in patient care areas could potentially result in the water causing burns to patients of the CAH. The CAH identified an average of 276 patient visits/year in the Specialty Clinic, and an average of 297 patient visits/year in the off-site Primary Care Clinic.

Findings include:

1. Observations on 6/24/19 at approximately 1:00 PM, during a tour of the Specialty Clinic, revealed:

a. Surgical Exam Room 1 sink, water temperature was 121.5 degrees Fahrenheit
b. Surgical Exam Room 2 sink, water temperature was 122.4 degrees Fahrenheit

2. During an interview, at the time of the tour, Clinic Director acknowledged the water temperatures were greater than 120 degrees Fahrenheit.

3. Observations on 6/24/19 at 4:00 PM, during a tour of the off-site Primary Care Clinic, revealed:

a. Exam Room 2 sink, water temperature was 126.5 degrees Fahrenheit
b. Exam Room 3 sink, water temperature was 122 degrees Fahrenheit

4. During an interview, at the time of the tour, RN A acknowledged the water temperatures were greater than 120 degrees Fahrenheit.

5. Review of the policy, "Water Temperature in Patient Rooms Policy", last approved 11/2018, revealed in part: "The maximum hot water temperature available in patient rooms will be maintained between 110 [degrees Fahrenheit] - 120 degrees [Fahrenheit]."

6. During an interview on 6/26/19 at 12:45 PM, Director of Maintenance revealed maintenance staff had not been monitoring water temperatures at the off-site Primary Care Clinic.

I. Based on observation, document review and staff interview, the Critical Access Hospital (CAH) staff failed to check and document the temperature of the refrigerator storing insulin, Intravenous (IV) fluids and CLOtest (a test used to diagnosis stomach infection) in the the Anesthesia Work Room. Failure to ensure CAH staff checked and documented the temperature in the refrigerator could potentially result in patients receiving medications that do not work in the body as expected resulting in unintended consequences or side effects, or tests that give inaccurate results. The CAH's administrative staff identified the surgical services staff performed an average of 700 surgical procedures and 232 endoscopies per year.

Findings include:

1. Observations on 6/25/19, at approximately 4:15 PM, during a tour of the Operating Room, revealed a refrigerator located in Anesthesia Work Room that contained 1 vial of Novolin insulin (100 units/10 miilliliters), 3 1 Liter bags of Normal Saline IV fluid, and 1 box of Clotest, Rapid Urease test containing 25 tests.

2. Review of the refrigerator temperature log for June 2019, at the time of the tour, revealed CAH staff failed to document refrigerator temperatures 8 out of 25 days on week-ends, when the OR staff did not utilize the operating rooms.

3. During an interview at the time of the tour, RN C acknowledged the staff failed to monitor the temperature of the refrigerator every day. RN C confirmed that the medication refrigerator had a temperature alarm to indicate if the temperature went outside the required temperature range, but the staff would not know if the refrigerator's temperature had gone outside the required range if the staff did not monitor the area or if the refrigerator returned to the required temperature before staff returned on the next business day.

4. Review of pharmacy policy, "Medication Refrigerators and Freezers Temperature Maintenance Policy and Procedure", last reviewed 1/2019, revealed in part: "Departmental staff will check and record the temperature in all medication refrigerators and freezers...at least once every 24 hours while the unit is open."

5. Review of Manufacturer's Recommendations for CLOtest, revealed in part: "The CLOtest...has a shelf life of 18 months when stored at 36 - 48 degrees Fahrenheit."

6. During an interview on 6/26/19 at 9:25 AM, Pharmacist F confirmed that the refrigerator in the Anesthesia Work Room is not tied to the system the hospital used to monitor medication refrigerators 24 hours a day/7 days a week. Pharmacist F also acknowledged insulin should not be stored more than 28 days at room temperature and staff would not know if temperature fell outside acceptable range for storage.

II. Based on observation, document review and staff interview, the Critical Access Hospital (CAH) staff failed to ensure temperatures in the Operating Room (OR 1, OR 2 and Decontamination Room) were in the range specified by the CAH. Failure to ensure OR temperatures are in an appropriate range may result in conditions where bacteria and other infectious contaminants can multiply potentially causing patient to become infected. The CAH's administrative staff identified the surgical services staff performed an average of 700 surgical procedures and 232 endoscopies per year.

Findings include:

1. Review of OR 1 "Surgical Services Room temperature Check graph" for the month of June, on 6/25/19 during a tour at approximately 3:30 PM, revealed in part: "Room Temperature should be 68 degrees - 73 degrees F [Fahrenehit}". Document also revealed room temperatures were below 68 degrees 15 out of 17 days when the OR was in use and the temperature was monitored. Document also showed maintenance had been contacted on 6/17/19.

2.. Review of OR 2 "Surgical Services Room temperature Check graph" for the month of June, on 6/25/19 during a tour at approximately 3:35 PM, revealed in part: "Room Temperature should be 68 degrees - 73 degrees F [Fahrenheit]". Document also revealed room temperatures were 67 degrees F or less on 18 of 18 days when the OR was in use and the temperature was monitored. Document also showed maintenance had been contacted on 6/17/19.

3. Review of Decontamination Room "Surgical Services Room temperature Check graph" for the month of June, on 6/25/19 at approximately 4:00 PM, revealed in part: "Room tempeature should be 60 degrees - 65 degrees F [Fahrenheit]." Document also revealed room temperatures were 70 degrees or above on 17 of 17 days when the Decontamination Room was in use and the temperature was monitored. Document also showed maintenance had been contacted on 6//17/19 and 6/24/19.

4. During an interview at the time of the tour, RN C acknowledged the temperatures were out of range. RN C stated their process was to contact maintenance when the temperatures were out of range.

5. Review of surgery policy, "Temperature and Humidity", last revised 6/19, revealed in part: "...Temperatures [are kept] between 68-72 degrees."

6. During an interview on 6/26/19 at 12:45 PM, the Director of Maintenanace stated were aware of temperature issues in the OR. Director of Maintenance revealed the Decontamination Room needed a new air handling system and would not be fixed until the CAH built their new OR. Also revealed that surgeons liked the OR to be a bit colder so that was why they kept the temperature a bit cooler.

Based on document review, policy review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure a physician periodically reviewed the care provided for emergency department (ED) and clinic patient medical records, in conjunction with the mid-level provider, for 2 of 3 applicable mid-level providers selected for review. (Provider Q and Provider R).

The hospital staff identified the mid-level providers provided care to patients from January 2019 through May 2019 as follows:

- Provider Q, Advanced Registered Nurse Practitioner (ARNP): 69 ED patients and 915 clinic patients
- Provider R, Physician Assistant (PA): 43 ED patients

Failure to ensure a physician periodically reviewed mid-level provider's patient medical records, in conjunction with the mid-level provider, could potentially result in misdiagnosing patient and/or providing inappropriate or substandard patient care.

Findings include:

1. Review of the CAH policy "Mid-Level Provider (MLP) Supervision Policy", revised 5/2014, revealed in part "...The Emergency Department Medical Director shall ensure MLP charts are reviewed per regulatory requirements in a timely manner. The Emergency Department Medical Director shall review appropriateness of diagnosis, treatment and disposition with each MLP on a routine basis. The Clinic Medical Director shall ensure MLP charts are reviewed per regulatory requirements in a timely manner. The Clinic Medical Director shall review appropriateness of diagnosis, treatment and disposition with each MLP on a routine basis..."

Two attachments to the policy "Clinic MLP Chart Review Process" and "ED MLP Chart Review Procedure" both identified Quality Assurance (QA) ensures 10% of MLP charts are reviewed per quarter, MLP has face-to-face discussion with reviewing physician, and a summary report is sent to QA.

2. During an interview on 6/25/19, at 3:00 PM, the Director of Quality and Compliance reported a physician completed MLP assigned chart review and, following the chart review, the MLP and physician are supposed to meet in conjunction with each other and discuss the findings. However, the Chief Nursing Officer confirmed the CAH lacked documentation to show the process occurred for mid-level provider Q and R.

3. During an interview on 6/26/19, at 2:50 PM, the Director of Quality and Compliance confirmed that as part of the CAH's process to review the provided to patients by MLPs, the MLP and physician review patient medical records, in conjunction with each other. The reviews should occur prior to the MLP's reappointment to the medical staff, and the CAH staff failed to complete the quality review for the identified MLPs.

Based on document review, policy review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure a mid-level provider participated in a periodic review of the care provided for emergency department (ED) and clinic patient medical records, in conjunction with a physician, for 2 of 3 applicable mid-level providers selected for review. (Provider Q and Provider R).

The hospital staff identified the mid-level providers provided care to patients from January 2019 through May 2019 as follows:

- Provider Q, Advanced Registered Nurse Practitioner (ARNP): 69 ER patients and 915 clinic patients
- Provider R, Physician Assistant (PA): 43 ER patients

Failure to ensure a mid-level provider participated with a physician in a periodic review of the mid-level provider's patient medical records could potentially result in the mid-level misdiagnosing patient and/or providing inappropriate or substandard patient care.

Findings include:

1. Review of the CAH policy "Mid-Level Provider (MLP) Supervision Policy", revised 5/2014, revealed in part "...The Emergency Department Medical Director shall ensure MLP charts are reviewed per regulatory requirements in a timely manner. The Emergency Department Medical Director shall review appropriateness of diagnosis, treatment and disposition with each MLP on a routine basis. The Clinic Medical Director shall ensure MLP charts are reviewed per regulatory requirements in a timely manner. The Clinic Medical Director shall review appropriateness of diagnosis, treatment and disposition with each MLP on a routine basis..."

Two attachments to the policy "Clinic MLP Chart Review Process" and "ED MLP Chart Review Procedure" both identified Quality Assurance (QA) validates 10% of MLP charts are reviewed per quarter, MLP has face-to-face discussion with reviewing physician and a summary report is sent to QA.

2. During an interview on 6/25/19, at 3:00 PM, the Director of Quality and Compliance reported a physician completed MLP assigned chart review, and following the chart review, the MLP and physician are supposed to meet in conjunction with each other and discuss the findings.

The Chief Nursing Officer confirmed the CAH lacked documentation to show the process occurred for mid-level provider Q and R.

3. During an interview on 6/26/19, at 2:50 PM, the Director of Quality and Compliance confirmed that as part of the CAH's process to review the provided to patients by MLPs, the MLP and physician review patient medical records, in conjunction with each other. The reviews should occur prior to the MLP's reappointment to the medical staff, and the CAH staff failed to complete the quality review for the identified MLPs.

Based on review of policies/procedures, meeting minutes, and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure the required group of professionals, including a physician and a mid-level provider, reviewed all patient care policies annually for 20 of 20 patient care departments (Medical Staff, Health Information Management, Patient Rights, Respiratory Therapy, Physical/Occupational Therapy, Speech Therapy, Infusion, Nutrition, Cardiac Rehabilitation, Diabetic Education, Emergency Room, Imaging, Pharmacy, Clinics, Infection Prevention, Surgery, Anesthesia, Laboratory, Environmental Services, and Medical/Surgical). The CAH administrative staff identified a census of 13 patients at the beginning of the survey. Failure to ensure the required group of professionals reviewed all patient care policies annually could potentially result in failure to identify patient care needs not addressed in the CAH policies/procedures.

Findings include:

1. Review of the CAH policy "Document Management Policy and Procedure," revised 2/2019, revealed in part, "...Policies are developed with the advice of a group of professional personnel, the Policy Committee, that includes one or more doctors of medicine or osteopathy and one or more mid-level providers appointed by the medical staff...Policies are reviewed at least annually by appropriate leaders and the Policy Committee...."

2. Review of "CAH Policy Committee Meeting Minutes" dated 8/16/2018, revealed in part, approval for new policies and policies with changes for Medical Staff, Health Information Management, Patient Rights, Respiratory Therapy, Physical/Occupational Therapy, and Speech Therapy.

The CAH Policy Committee Meeting Minutes lacked annual approval of all patient care policies for Medical Staff, Health Information Management, Patient Rights, Respiratory Therapy, Physical/Occupational Therapy, and Speech Therapy.

Review of "CAH Policy Committee Meeting Minutes" dated 11/15/2018, revealed in part, approval for new policies and policies with changes for Infusion, Nutrition, Cardiac Rehabilitation, Diabetic Education, Emergency Room, Imaging, and Pharmacy.

The CAH Policy Committee Meeting Minutes lacked annual approval of all patient care policies for Infusion, Nutrition, Cardiac Rehabilitation, Diabetic Education, Emergency Room, Imaging, and Pharmacy.

Review of "CAH Policy Committee Meeting Minutes" dated 2/21/2019, revealed in part, approval for new policies and policies with changes for Clinics, Infection Prevention, Surgery, Anesthesia, and Laboratory.

The CAH Policy Committee Meeting Minutes lacked annual approval of all patient care policies for Clinics, Infection Prevention, Surgery, Anesthesia, and Laboratory.

Review of "CAH Policy Committee Meeting Minutes" dated 5/16/2019, revealed in part, approval for new policies and policies with changes for Environmental Services, and Medical/Surgical.

The CAH Policy Committee Meeting Minutes lacked annual approval of all patient care policies for Environmental Services, and Medical/Surgical.

3. During an interview on 6/26/2019 at 3:30 PM, the Director of Quality and Compliance and the Executive Assistant verified the CAH Committee only reviewed and approved new policies and policies that had revisions. The Director of Quality and Compliance and the Executive Assistant further acknowledged the required group of professionals, including a physician and mid-level provider, failed to annually review the CAH's existing policies.

I. Based on observation, document review and staff interview, the Critical Access Hospital (CAH) staff failed to store succinylcholine (medication used to relax muscles during surgery) according to manufacturer's recommendations. Failure to ensure succinycholine is stored according to manufacturer's recommendations could potentially result in patients receiving a medication that does not work in the body as expected resulting in unintended consequences or side effects. The CAH's administrative staff identified the surgical services staff performed an average of 700 surgical procedures per year.

Findings include:

1. Observations on 6/26/19, at 9:30 AM, in the Endoscopy Room after Patient #2 had undergone a colonoscopy, revealed the anesthesia cart contained a 10 milliliter vial of succinylcholine (200 milligrams/milliliter), unopened, dated 4/24/19.

2. During an interview at the time of the observation, Certified Registered Nurse Anesthetist (CRNA) E stated the CAH practice was to store succinycholine for up to 5 months outside the refrigerator. CRNA E confirmed the succinylcholine had been removed from the refrigerator on 4/24/19.

3. Review of manufacturer's recommendations for the storage of succinylcholine revealed, in part: "Refrigeration of the undiluted agent will assure full potency until expiration date...Store in refrigerator 2 degrees - 8 degrees C [Celsius]...the multi-dose vials are stable for up to 14 days at room temperature without significant loss of potency."

4. During an interview on 6/26/19 at at 1:30 PM, Pharmacist F confirmed CAH practice was to store succinycholine outside the refrigerator for up to 5 months. Pharmacist F acknowledged the manufacturer recommended succinylcholine be stored outside the refrigerator for up to 14 days.

II. Based on observation, document review and staff interview, the Critical Access Hospital (CAH) staff failed to store intravenous (IV) fluids according to manufacturer's recommendations. Failure to ensure IV fluids are stored according to manufacturer's recommendations could potentially result in bacterial or other infectious agents contaminating the IV fluids. The CAH's administrative staff identified the surgical services staff performed an average of 700 surgical procedures per year.

Findings include:

1. Observations during a tour of the Operating Rooms on 6/26/19, at approximately 10:00 AM, revealed a fluid warmer containing 8, 1 liter bags of Normal Saline IV fluid, and 5, 1 liter bags of Lactated Ringers.

2. Review of "Warmer Flow Sheet" at the time of the tour revealed the temperature of the fluid warmer was 110 degrees Fahrenheit 7 out of 18 days in the month of June. The flow sheet also revealed, in part: "Solutions for injection...can remain in the oven for a period not longer than 14 days at a temperature not to exceed 104 degrees Fahrenheit."

3. During an interview at the time of the tour, RN C acknowledged IV fluids should not be stored at temperatures greater than 104 degrees Fahrenheit and staff documented fluid warmer temperature as 110 degrees 7 out of 18 days during the month of June.

4. Review of manufacturer's recommendations revealed, in part: "Solutions for injection...may be warmed at a temperature not to exceed 104 degrees Fahrenheit..."

Based on review of policy/procedure, documentation, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure timely physician notification for the occurrence of a medication error for 3 of 8 medication errors reviewed. (Patient #3, Patient #4, Patient #5). Failure to notify the physician of medication errors could potentially result in life threatening conditions that could lead to serious harm. The CAH administrative staff reported a census of 13 patients upon entrance.

Findings include:

1. Review of the CAH Pharmacy "Medication Variance Reporting Policy and Procedure", effective 11/2018, revealed in part, "...notify physician or doctor on call... date and time of notification must be documented on a Medication Variance Report. NO EXCEPTIONS...."


2. Review of the medication errors from January 2019 to June 2019 revealed:

a. the CAH nursing staff made a medication error involving Patient #3 on 1/8/19 at 1:32 PM. Review of the documentation revealed the nursing staff failed to notify Patient #3's physician of the medication error.

b. the CAH nursing staff made a medication error involving Patient #4 on 1/1/19 at 12:40 PM. Review of the documentation revealed the nursing staff failed to notify Patient #4's physician of the medication error.

c. the CAH nursing staff made a medication error involving Patient #5 on 1/22/19 at 2:00 AM. Review of the documentation revealed the nursing staff failed to notify Patient #5's physician of the medication error.


3. During an interview on 6/25/2019 at 11:10 AM, the Director of Quality and Compliance verified the medical record and the Medication Variance Report lacked documentation that the nursing staff notified Patient #3, Patient #4, or Patient #5's physician of the medication errors.

I. Based on observations, document review, and staff interviews, the Critical Access Hospital (CAH) failed to ensure surgical staff performed the high-level disinfectant test following endoscope disinfection in 1 of 1 observed disinfections (Patient #2) in accordance with the CAH's policy and manufacturer's recommendation. Failure to ensure surgical staff performed the high-level disinfectant test in accordance with the CAH policy and manufacturer's recommendations could potentially cause inaccurate test results. Inaccurate test results could potentially expose future patients to an endoscope that had not been properly disinfected which could cause severe illness and/or death to the patient. The CAH's administrative staff identified the surgical staff performed an average of 232 endoscopies per year.

Findings include:

1. During an interview on 6/26/19 at approximately 9:42 AM in the Endoscopy Decontamination Room during disinfection of endoscope used for Patient #2's Endoscopy, RN D reported the Medivator (a machine used to disinfectant endoscopes using the disinfectant "Rapicide") prompts the staff to test the use disinfectant solution. RN D went on to report when prompted by the Medivator machine RN D obtained a Rapicide test strip, dipped the strip into the use disinfectant solution port for 1 minute, removed the strip and waited 30 seconds to ensure the test strip turned "black" before documenting the disinfection process of the endoscope had "passed".

2. During an interview on 6/26/19 at 9:50 AM, RN C explained when the Medivator machine prompted the staff to test the use disinfectant solution, RN C would obtain a Rapicide test strip, dip the test strip into the use disinfection solution port for 1 minute, remove the strip and wait 30 seconds to read the strip to ensure the color block turned black before documenting the disinfection process had "passed". RN C went on to report the instructions to ensure the test strip remained in the use disinfection port of the Medivator machine was located on the Rapicide test strip bottle.

3. Review of policy "Use of the Medivators DSD Edge Endoscope Reprocessor", revised 6/2019, included in part, " ...PURPOSE: To ensure patient safety and consistency by using an automated reprocessor to provide high-level disinfection of endoscopes ...When the disinfection process is complete, the ...screen will prompt the user to verify Rapicide PA's [disinfectant] minimum recommended concentration ...The user must dip a Rapicide PA Test Strip into the disinfectant sample port, located within the front-left corner of the respective basin, for 1 second. The results of the test strip should be read after and at 30 seconds ..."

4. Review of the manufacturer's directions, "Medivators Rapicide PA High-Level Disinfectant Test Strips", included in part, " ...Dip the strip into the solution for one (1) second. Shake off the excess solution. Wait for 30 seconds and then compare the strip color to the color chart on the bottle. Read within one (1) minute of testing to determine if the result matches PASS or FAIL. Any test strip color other than solid black is a FAIL result..."



II. Based on observation, document review, and staff interviews, the Critical Access Hospital (CAH) failed to ensure surgical staff wore gloves and/or sanitized hands before and after glove use during 1 of 1 observed surgeries (Patient #1) and 1 of 1 observed endoscopies (examination of inside of the body using a flexible scope) procedures (Patient #2) in accordance with the CAH's policy and Center for Disease Control (CDC) recommendations. Failure to ensure surgical staff follow approved infection control techniques in accordance with the CAH policy and CDC recommendations could potentially cause bacterial and other infectious contaminants to remain on the skin. The CAH staff could unknowingly touch equipment, surfaces, patients and other staff causing the cross contamination of bacterial and/or other infectious contaminants which could cause severe illness and/or death. The CAH's administrative staff identified the surgical staff performed an average of 700 surgical procedures per year and an average of 232 endoscopies per year.

Findings include:

1. Review of "Hand Hygiene Policy," revised 02/19, included in part: "Purpose: To provide recommendations on when and how to perform hand hygiene ...It is the policy ...to adhere to the Center For Disease Control [CDC]guidelines for hand hygiene in a healthcare facility ...If hands are not visibly soiled, use an alcohol-based hand rub for routinely decontaminating hands in all other clinical situations ...Decontaminate hands before having direct contact with patients ...Decontaminate hands after contact with a patient's intact skin...Decontaminate hands after contact with inanimate objects (including medical equipment) in the immediate vicinity of the patient ...Decontaminate hands after removing gloves ..."

2. Review of CDC guidelines revealed, in part: "Gloves are not a substitute for hand hygiene.
If your task requires gloves, perform hand hygiene prior to donning gloves, before touching the patient or the patient environment. Perform hand hygiene immediately after removing gloves."

3. Observations on 6/25/19 during Patient #1 surgery in OR #1, revealed the following:

-- 1:55 PM, CRNA E donned gloves without performing hand hygiene and obtained a syringe filled with clear fluid located on top of the crash cart. Further observation showed CRNA E administered the clear fluid filled syringe into Patient #1's intravenous (IV) catheter.

--2:00 PM, CRNA E donned gloves without performing hand hygiene, performed a chin-lift maneuver on Patient #1 and inserted an oral airway.

--2:09 PM, CRNA E pushed a button on the machine identified by the OR staff as the "anesthesia machine" with ungloved hands, went to the crash cart and removed an unpackaged oral airway, donned gloves without performing hand hygiene then inserted the oral airway into Patient #1's mouth.

--2:21 PM, CRNA E removed garbage/packaging from OR #1 floor with ungloved hands, discarded the packaging and began writing on a form located on the desktop area of the anesthesia machine. Further observation showed CRNA E obtained a vial of white fluid, a new syringe and needle from the crash cart, removed the white fluid from the vial into a syringe and attached needle and attached the syringe to Patient #1's IV catheter without performing hand hygiene or using gloves.

--2:29 PM, CRNA E donned gloves without performing hand hygiene, stood next to Patient #1 with arms wrapped around his waist, removed the gloves and donned new gloves without performing hand hygiene, obtained disinfectant wipes and began cleaning the electrode cords previously attached to Patient #1.

-- 2:36 PM, CRNA E donned gloves without performing hand hygiene prior to assisting with the transfer of Patient 1.

4. Observations on 6/26/19 during Patient #2's Endoscopy in the Endoscopy Room, revealed the following:

--8:55 AM, CRNA E wiped the port of Patient #2's IV line with a white pad, attached a syringe filled with clear fluid, and administered the clear fluid with ungloved hands and without performing hand hygiene.

--9:02 AM, CRNA E rubbed his nose with his ungloved hand, moved to the crash cart and removed a vial of white fluid, a syringe and a needle. Continued observation showed CRNA E removed the white fluid from the vial into the syringe and attached the syringe to the patient's IV line and began to slowly administer the white fluid with ungloved hands and without performing hand hygiene.

--9:04 AM, CRNA E adjusted his eye glasses with his left ungloved hand then wiped his mouth with the back of his right ungloved hand. Further observation showed CRNA E applied gloves without performing hand hygiene and began disconnecting the monitoring cords from the patient.

5. During an interview on 6/25/19 at 2:39 PM, RN B reported all staff were to perform hand hygiene before and after glove use.

6. During an interview on 6/26/19 beginning at 9:20 AM, CRNA E acknowledged he did not perform hand hygiene before glove use and was not aware it was to be performed. CRNA E reported it was difficult to apply gloves after hand hygiene but would start the process in the future.











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III. Based on document review and staff interview the Critical Access Hospital (CAH) administrative staff failed to ensure their system to identify and prevent transmission of infections and communicable diseases to patients included health exams for volunteers. The problem was identified for 3 of 3 volunteers selected for review (Volunteer N, Volunteer O and Volunteer P). The administrative staff identified 12 volunteers provided service to CAH patients. Failure to identify infections and communicable diseases among volunteers could potentially result in the transmission of a communicable disease to patients.

Findings include:

1. Review of volunteer files revealed the following:

a. Volunteer N's volunteer file revealed the CAH staff last performed a heath exam on Volunteer N on 8/1/11 (greater than the 4 years allowed).

b. Volunteer O's volunteer file lacked documentation the CAH staff performed a health exam on Volunteer O.

c. Volunteer P's volunteer file lacked documentation the CAH staff performed a health exam on Volunteer P.


2. During an interview on 6/26/19, at 1:35 PM, the Employee Health and Education Coordinator confirmed the CAH currently did not require a health exam for volunteers. The Employee Health and Education Coordinator and the Director of Quality and Compliance confirmed the CAH lacked a policy to define the health requirements for volunteers, including the requirement to perform a health exam every 4 years.

Based on document review and staff interview, the Critical Access Hospital (CAH) failed to ensure the periodic evaluation of its total CAH program included a review of the CAH's patient care policies. The CAH administrative staff identified a current census of 13 patients at the beginning of the survey. Failure to include a review of patient care policies as part of the CAH's total program evaluation could potentially result in the failure of staff to evaluate and update policies as needed to improve patient care and meet the needs of the patient and the community.

Findings include:

1. Review of the CAH policy "Periodic Program Evaluation and Quality Assurance Policy", revised 2/2019, revealed in part, "...Knoxville Hospital and Clinics carries out or arranges for a periodic evaluation of its total program. The evaluation is completed by the Director of Quality, done at least once a year and includes review of:...The KHC's [Knoxville Hospital and Clinics] health care policies. The purpose of the evaluation is to determine whether the utilization of services was appropriate, the established policies were followed, and any changes are needed..."

2. Review of document titled "Critical Access Hospital Annual Report July 1, 2017 - June 30, 2018" failed to include the review of the policies as part of the Annual Critical Access Hospital report.

3. During an interview on 6/27/2019 at 8:25 AM, the Director of Quality and Compliance acknowledged the CAH staff failed to include a review of policies as part of the Annual Critical Access Hospital report.

I. Based on document review, policy review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure 2 of 2 active family medicine physicians and 3 of 3 applicable courtesy physicians selected for review (Physician I, Physician J, Physician K, Physician L and Physician M), received outside entity peer review by the appropriate entity, to evaluate the appropriateness of diagnosis and treatment furnished to patients at the Critical Access Hospital. Failure to ensure all medical staff members received outside entity peer review by the appropriate entity, affects the CAH's ability to assure physicians provide quality care to the CAH patients.

The CAH administrative staff identified the physician provided care to patients from January 2019 through May 2019 as follows:

- Physician I: 837 patients
- Physician J: 903 patients
- Physician K: 316 patients
- Physician L: 437 patients
- Physician M: 347 patients

Findings include:

1. Review of the CAH network agreement, effective July 1, 2016, revealed in part, "Medical records review as part of the quality and medical necessity of medical care at CAH ... shall be included in the services provided by [Hospital A] to CAH ... Such review may be performed by direct inspection by Member or physician affiliated with [Hospital A] by analysis of CAH's internal chart audits, or by examination of external peer review reports ..."

2. Review of the "Peer Review Services Agreement," with the CAH network hospital, effective February 20, 2105, revealed in part " ... The CAH is ... required to have the quality and appropriateness of the diagnosis and treatment furnished by physicians at the CAH ... by an outside entity... [Hospital A] shall, upon the request of CAH, evaluate the diagnosis and treatment provided by physicians at CAH and/or clinics ..."

3. Review of external peer review completed for the applicable physicians selected for review revealed the following:

- Physician I's file contained the results of one external peer review completed by Hospital B on 2/17/19.
- Physician J's file contained the results of one external peer review completed by Hospital B on 2/17/19.
- Physician K's file contained the results of one external peer review completed by Hospital B on 2/13/19.
- Physician L's file contained the results of one external peer review completed by Hospital B on 2/13/19.
- Physician M's file contained the results of one external peer review completed by Hospital B on 2/13/19.

4. During an interview on 6/25/19, at 3:00 PM and 4:00 PM, the Director of Quality and Compliance reported the CAH utilized their network provider to complete external peer review but verified the CAH recently began utilizing Hospital B for external peer review. She reported the CAH encountered problems with Hospital A completing the external peer review in a timely manner and increased cost.

The Director of Quality and Compliance confirmed Hospital B conducted external peer review for Physician I, Physician J, Physician K, Physician L and Physician M and the CAH did not have a network agreement with Hospital B.




II. Based on document review, policy review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure 1 of 1 applicable teleradiologists selected for review (Physician H), received outside entity peer review prior to reappointment, to evaluate the appropriateness of diagnosis and treatment furnished to patients at the Critical Access Hospital. Failure to ensure all medical staff members received outside entity peer review, in the appropriate time frame, affects the CAH's ability to assure physicians provide quality care to the CAH patients.

- The CAH administrative staff reported Physician H provided services to 336 patients from January 2019 to June 26, 2019.

1. Review of Physician H credential file and external peer review revealed the medical staff approved re-appointment on 11/12/18 and the governing body approved re-appointment on 12/10/18 and one external peer review completed by Hospital A on 1/10/19.

2. During an interview on 6/25/19, at 3:00 PM, the Director of Quality and Compliance confirmed the CAH failed to have external entity peer review completed for Physician H prior to reappointment to the medical staff.

3. Review of a CAH policy "Credentialing Policy", effective 11/2017, revealed in part " ... Before an applicant's re-credentialing packet can proceed to the Medical Executive Committee (MEC) meeting and Board of Directors meeting, there must be a minimum of 2 charts sent off for external peer review during the 2-year reappointment cycle
... "

III. Based on document review, policy review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure 2 of 2 active family medicine physicians and 5 of 5 applicable courtesy physicians selected for review (Physician G, Physician H, Physician I, Physician J, Physician K, Physician L and Physician M), received a minimum of two outside entity peer review during the 2-year reappointment cycle, per CAH policy, to evaluate the appropriateness of diagnosis and treatment furnished to patients at the Critical Access Hospital. Failure to ensure all medical staff members received outside entity peer review, in the appropriate time frame, affects the CAH's ability to assure physicians provide quality care to the CAH patients.

The CAH administrative staff identified the physician provided care to patients from January 2019 through May 2019 as follows:

- Physician G: 10 patients
- Physician I: 837 patients
- Physician J: 903 patients
- Physician K: 316 patients
- Physician L: 437 patients
- Physician M: 347 patients

- Physician H: 363 patients from January through June 2019

2. Review of external peer review completed for the applicable physicians selected for review revealed the following:

- Physician G's file contained the results of one external peer review completed on 6/13/16.
- Physician H's file contained the results of one external peer review completed on 1/10/19.
- Physician I's file contained the results of one external peer review completed on 2/17/19.
- Physician J's file contained the results of one external peer review completed on 2/17/19.
- Physician K's file contained the results of one external peer review completed on 2/13/19.
- Physician L's file contained the results of one external peer review completed on 2/13/19.
- Physician M's file contained the results of one external peer review completed on 2/13/19.

3. During an interview on 6/26/19, at 9:30 AM, the Director of Quality and Compliance confirmed the CAH had only 1 external peer review completed for the identified physicians, prior to their reappointment to medical staff, and acknowledged the CAH peer review policy identified only 1 per 2-year appointment in conflict with the CAH credentialing policy.

4. Review of a CAH policy "Peer Review Policy", effective 5/2017, revealed in part " ... peer review will be used to provide oversight for the quality of care, treatment, and service provided by privileged providers ... Providers will have a minimum of one external peer review completed every two years, as part of the reappointment process. External peer review is completed by [Hospital B] or [Hospital A - network hospital], per the [Hospital A] Network Management Agreement.

5. Review of a CAH policy "Credentialing Policy", effective 11/2017, revealed in part " ... Before an applicant's re-credentialing packet can proceed to the Medical Executive Committee (MEC) meeting and Board of Directors meeting, there must be a minimum of 2 charts sent off for external peer review during the 2-year reappointment cycle
... "

Based on policy and patient medical record review, and staff interviews, the Critical Access Hospital (CAH) staff failed to ensure activity personnel developed and implemented an ongoing activity program that included an activities care plan for 6 of 6 open swing bed patients (Patients #6, #7, #8, #9, #10, and #11). Failure to provide an activity program that meets the physical and psychosocial needs of the individual patients could potentially impede the patient's progression toward attaining goals and achieving the highest level of well being and independence possible. The CAH administrative staff identified a census of 7 swing bed patients at the beginning of the survey and an average of 15 swing bed patient admissions per month.

Findings include:

1. Review of the CAH policy "Skilled Activity Policy," revised 1/2018, revealed in part, "...Activities planned should reflect the care plan...."

2. Review of open swing bed patient medical records for Patients #6, #7, #8, #9, #10, and #11 as follows:

a. Patient #6 admitted for swing bed skilled on 6/4/2019. Patient #6's medical record lacked evidence an activity care plan that directed staff to provide individual or group activities chosen by the patient.

b. Patient #7 admitted for swing bed skilled on 5/26/2019. Patient #7's medical record lacked evidence an activity care plan that directed staff to provide individual or group activities chosen by the patient.

c. Patient #8 admitted for swing bed skilled on 6/13/2019. Patient #8's medical record lacked evidence an activity care plan that directed staff to provide individual or group activities chosen by the patient.

d. Patient #9 admitted for swing bed skilled on 6/18/2019. Patient #9's medical record lacked evidence an activity care plan that directed staff to provide individual or group activities chosen by the patient.

a. Patient #10 admitted for swing bed skilled on 6/16/2019. Patient #10's medical record lacked evidence an activity care plan that directed staff to provide individual or group activities chosen by the patient.

a. Patient #11 admitted for swing bed skilled on 6/21/2019. Patient #11's medical record lacked evidence an activity care plan that directed staff to provide individual or group activities chosen by the patient.

4. During an interview on 6/27/2019 at 10:40 AM, the Utilization Coordinator verified the lack of an activities care plan for swing bed skilled Patients #6, #7, #8, #9, #10, and #11.