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500 HOSPITAL DRIVE

WETUMPKA, AL 36092

QAPI PERFORMANCE IMPROVEMENT PROJECTS

Tag No.: A0297

Based on review of the hospital policy, Quality Assessment and Performance Improvement (QAPI) Program documentation and interviews, the facility failed to ensure Performance Improvement Projects (PIP) were developed, measurable progress was achieved and incorporated into the hospital-wide QAPI program.

This had the potential to negatively affect all patients served by this facility.

Findings include:

Policy: Quality Assurance
Written: May 29, 1992
Revised: October 2016

Quality Assurance Department Program Plan

Purpose: The role of the Quality Assurance Program is to assure the quality of patient care provided by the hospital. The purpose of the program is to provide for planned systematic, on-going monitoring and evaluation of patient care activities; to determine important aspects of care; to determine indicators and criteria for measurements; to analyze findings; to seek opportunities to improve care and solve problems identified; and to assure that action is taken and that the effectiveness of the action taken is assessed.

Goals: The goals of the Quality Assurance Program are to assure the right of the patient to optimum level of health care and to minimize liability.

Objectives:
1. To achieve optimum level of health care in compliance with established standards of care/services.
...3. To evaluate quality and appropriateness of patient/care services through selected monitors.
4. To identify opportunities to improve care and take actions to resolve identified problems...

On 2/20/2020 at 12:40 PM, Employee Identifier (EI) # 3, Director of Nursing (DON), and EI # 4, Assistant DON, who confirmed were both over the Hospital-Wide QAPI program, provided to the surveyor the facility QAPI Program.

Review of the facility QAPI Program revealed no documentation of a PIP.

An interview was conducted on 2/20/2020 at 1:20 PM with EI # 3, who confirmed there were no hospital-wide PIPs.

STAFFING AND DELIVERY OF CARE

Tag No.: A0392

Based on review of facility policy, medical records (MR), Employee Handbook, job descriptions and staff interviews, it was determined the facility failed to ensure staff :

1) Performed and documented wound assessments according to policy, provided wound care according to physician orders and documented the specific wound care preformed.

2) Performed a dietary consult for MR # 13 who met criteria for inadequate meal intake and low protein (albumin levels).

3) Performed blood glucose monitoring and administered SSI (sliding scale insulin) according to the blood glucose results and physician orders.

4) Training included Basic Cardiac Life Support (BCLS) Certification/CPR (cardiopulmonary resuscitation) for Nurse and NA (Nurse Assistant) staff.

This affected 1 of 1 closed records for diabetic/wound reviews which included MR # 13 and this had the potential to negatively affect all patients admitted to the facility.

Findings include:

Nursing Service Polices and Procedures
Subject: Prevention and Management of Wounds
Reviewed: 04/14

Policy:

3. Status and condition of pressure ulcers...should be assessed upon admission and at every dressing change. The location, state, type of,wound, width (W), length (L), depth (D), exudates, odor, presence of necrotic or granulation tissue, presence or absence of undermining or sinus tract formation and condition of surrounding skin should be documented on a daily basis as well as the condition of wound edge or every time the nurse changes the dressing.

5. If doctor ordered dressing changes on admission order should be specific inc;include cleaning solution, type of bandage and amount of dressing changes...
6. Provide wound care as doctor ordered...
7. Chart in patient's record.
10. Consider a nutritional consult...


Policy/Procedure-Nursing Service
Revised: March 2011
Subject: Management of Skin Breakdown/Pressure Ulcers

Guidelines

1. The nurse will assess the skin and document every shift and PRN (as needed) the following on the "Wound Documentation Flow sheet"...
a. Anatomical location of the wound
b. Dimensions and depth of wound (in centimeters)
c. Stage of wound
d. Characteristics of wound bed
e. Presence or absence of tunneling or sinus tract formation.
f. Drainage type and amount (color and consistency)
g. Odor
h. Condition of surrounding skin
i. Condition of wound margins
j. Narrative description of all dressing changes...

IVY Creek Healthcare...Employee Handbook

Orientation Program

...All employees are required to successfully completed CPR (cardiopulmonary resuscitation) training and renew their certificated eery two (2) years...

Policy: BCLS (Basic Cardiac Life Support) and ACLS (Advanced Cardiovascular Life Support) Certification
Effective Date: 07/10
Reviewed: 06/13

Policy: All personnel who have direct patient contact will maintain CPR skills as evidenced by annual update review or recertification class...

...Existing Employees:
It is the responsibility of the employee to maintain current BCLS/ACLS certification and provide evidence of recertification according to policy and procedure.

A copy of the card will be kept in each employee's file current and updated according to policy and procedure.

...BCLS Recertification:
Each direct patient contact employee will recertify his/her BCLS card every two (2) years, at least 30 days before expiration...

1. MR # 13 was admitted to the facility on 1/30/2020 with diagnoses including Dehydration, Acute/Chronic Renal Insufficiency, Sacral Stage IV (4) Pressure and Diabetes Type II.

MR review include physician orders dated 1/30/2020 for blood glucose monitoring at 7:00 AM, 11:00 AM, 4:00 PM and 9:00 PM with SSI Standing orders per blood glucose results.

MR review revealed nurse documentation on 1/30/2020 at 2:15 PM, eats only about 1/2 of any food offered, nutrition total assist and 1/30/2020 laboratory results revealed MR # 13's albumin level was low at 2.3 g/dl (grams/deciliter), normal albumin 3.4-5.4 g/dl. There was no documentation a nutritional consult was performed.

Record review revealed no documentation of the initial pressure ulcer assessment on 1/30/2020 which included wound dimensions, wound bed and surrounding skin, drainage amount, type and odor, wound margins and no narrative dressing change on 1/30/2020.

MR review revealed a physician order dated 1/31/2020 at 2:33 AM as followed: "Dakins w/d (wet to dry) q d (every day) dsg (dressing) change, wash skin with soap and water daily, silvadene or xeroform qd." The order failed to include the wound location and wound cleaning and dressing application was unclear for the order of application of the silvadene or xeroform and the dakins w/d.

On 1/31/2020 at 7:05 AM, the nurse documented "multiple areas to back with xeroform dressings intact, sacrum is packed with dakins solution and abd (abdominal pad) intact." There was no documentation the skin was washed with soap and water.

There was no documentation of the specific pressure ulcer care staff completed on 1/31/2020 or wound assessment.

Review of the wound flowsheet dated 2/1/2020 revealed the following:

Location (A), "Sacrum", and "tunneling". There was no documentation of the tunneling location and depth, the amount of purulent drainage and the presence/absence of odor of an odor. There was no documentation of the surrounding skin condition or the specific wound care provided.

MR review revealed nurse documentation on 2/2/2020 at 6:30 PM, eats only about 1/3 of any food offered. No dietary consult was performed.

Further review revealed on 2/2/2020 at 6:50 AM, nurse documentation which included wound flowsheet of the ulcer location, "A", "Sacrum". The presence of tunneling/measurements were not documented, the amount of serosanginuous exudate, the presence or absence of exudate odor was not documented. There was no surrounding skin assessment and no documentation of the specific pressure ulcer care staff completed on 2/2/2020.

There was no documentation glucose monitoring was performed on 2/2/2020 at 11:00 AM for blood glucose monitoring, on 2/3/2020 at 7:00 AM and on 2/5/2020 at 4:00 PM. The albumin level also decreased to 1.6 g/dl on 2/3/2020.

There was no documentation of the specific wound care staff completed from 2/3/2020 and 2/4/2020 and there was no pressure ulcer assessment documentation.

Record review revealed the following wound orders dated 2/5/2020 at 2:59 PM, "Wound care: 1. Cover skin splits and breakdown with bacitracin AM and PM, Wound care 2. Cover bacitracin with strips of xeroform gauze QHS (every hour of sleep), Wound care 4. Santyl or medihoney to right hip daily. There was no documentation for how the skin splits were to be cleaned and no of the location of 'skin splits". There was no skin assessment of the "skin splits" documented. There was no documentation the wound care was performed on 2/5/2020.

Review of nurse documentation dated 2/6/2020 at 2:00 PM revealed "bacitracin ointment applied to open areas on back, side, groins, buttocks. black eschar on right hip-santyl applied." There was no documentation the skin was cleansed with soap and water, dakins w/d and silvadene or xerofrom was applied.

In an interview on 2/20/2020 at 9:26 AM, EI (Employee Identifier) # 3, Director of Nurses, confirmed staff failed to follow facility policy for wound/ulcer assessment, measurements and wound care documentation, no dietary consult was complete and physician orders for diabetic blood glucose monitoring and SSI were not followed.

2. Review of New Direction unit nurse and nurse assistant personnel files on 2/2/2020 at 10:30 AM failed to include documentation for current BCLS certification for EI # 18, New Direction, Registered Nurse, DOH (date of hire) 8/16/11 whose current certification expired 11/2019. Review of EI # 18's R.N Job description revealed qualifications included BCLS certifcation.

There was no BCLS/CPR training documentation for EI # 19, New Direction, NA, whose DOH was 3/20/19.

In an interview on 2/20/2020 at 11:45 AM, EI # 3 confirmed EI's # 18 and # 19 failed to maintain current BCLS/CPR certification.




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3. Review of the Medical-Surgical (Med-Surg) Unit NA personnel file on 2/2/2020 at 11:00 AM failed to include documentation for current BCLS certification for EI # 13, Med-Surg NA. EI # 13's DOH 10/9/2018 and current certification expired 5/19 (May 2019).

During an interview conducted on 2/20/2020 at 11:50 AM, EI # 4, Assistant Director of Nursing (ADON), confirmed BCLS/CPR certification is required for all nursing staff including the NA on the Med-Surg Unit. During a separate interview on 2/20/20 at 1:33 PM, EI # 14 confirmed EI # 13 failed to maintain current BCLS/CPR certification.

ADMINISTRATION OF DRUGS

Tag No.: A0405

Based on medical record (MR) review and staff interviews, it was determined the facility failed to ensure medications were administered according to physician orders in the New Direction chemical dependency unit. This affected MR # 18 in 1 of 1 New Direction record reviews and had the potential to negatively affect all patients treated at the facility.

Findings include:

1. MR # 18 was admitted on 2/17/2020 with diagnoses including Alcohol Abuse and Alcohol Dependence.

Record review revealed admitting physician medication orders for daily Thera M plus Vitamin and Thiamine (vitamin B1). The Medication Record documentation dated 2/18/2020 at 8:22 AM revealed the 2 medications (used during alcohol detoxification) were omitted due to patient "sleeping".

During review of the MR on 2/19/2020 at 8:25 AM, New Direction Staff RN (Registered Nurse), Employee Identifier (EI) # 18, reported the nurse should have attempted to administer the routine medications at a later time during the day on 2/18/2020.

On 2/20/2020 at 9:20 AM, EI # 3, Director of Nurses, confirmed staff failed to administer medications as ordered. EI # 3 reported the nurse should have attempted to administer the medications that day at a later time and there was no documentation staff notified the physician about the omitted medications.

BLOOD TRANSFUSIONS AND IV MEDICATIONS

Tag No.: A0410

Based on review of medical record (MR), hospital policy and interview, it was determined the facility failed to ensure staff obtained vitals signs (VS) every hour during blood administration per its own policy. This affected MR # 12, 1 of 1 patient records reviewed with blood transfusions and this had the potential to negatively affect all patients who received blood transfusions.

Findings include:

Policy: Blood Administration
Reviewed 8/2012

...Monitoring During Infusion

The nurse observes the patient closely. VS are taken immediately prior to obtaining the blood, within fifteen (15) minutes after initiating the transfusion and every hour until 1 hour AFTER the transfusion has been discontinued...The patient is...monitored during the transfusion for signs and symptoms of reactions...Document observations...Monitor the patient's temperature, pulse, respiration and blood pressure....

1. MR # 12 was admitted to the facility as an outpatient for a blood transfusion 12/13/19 with diagnoses including Myeloysplastic Syndrome.

MR review revealed an outside physician orders dated 12/12/19 which included infuse 1 unit PRBC (Packed Red Blood Cell) for hemoglobin less than 9.

Review of the MR documentation dated 12/12/19, titled, Blood Transfusion Record which revealed the time the PRBC was started at 12:20 PM. VS were documented at 12:20 PM, and at 12:35 PM, which was 15 minutes after the transfusion was started. VS were documented at 2:20 PM, which was the end of the blood transfusion and at 3:20 PM, which was 1 hour after transfusion was discontinued.

The patient's VS were not documented between 12:35 PM and 2:20 PM, which was 1 hour 45 minutes. The facility staff failed to monitor VS every hour until 1 hour after the transfusion was completed.

In an interview on 2/20/2020 at 9:16 AM, Employee Identifier # 3, Director of Nursing, confirmed the nurse failed to follow their own policy for VS monitoring during the blood transfusion.

UNUSABLE DRUGS NOT USED

Tag No.: A0505

Based on review of the facility's policies and procedures, observations, and staff interviews it was determined the facility failed to ensure:

1) All expired medications were removed and not available for patient use.

2) All medications available for patient use were correctly labeled according to facility policy.

3) All medications available for patient use were stored according to facility policy.

Policy:

Department of Pharmacy Policies and Procedures
Subject: Crash Cart
Original Date: 05/00
Revisions: 3/14

1. Policy: The Department of Pharmacy, as well as each department will jointly maintain standardized emergency carts throughout the hospital.

2. Purpose: To ensure any medication or supply is available when needed in time of emergency or otherwise.

3. Procedure:
a. All carts in each department will be maintained as full and in date...

...5. Cart Inspections:
a. Emergency carts will be inspected monthly for dating and integrity by pharmacy.
...e. The pharmacy will replace outdated and/or used medications.

Policy: Crash Cart
Effective Date: 1/1975
Date of Revision: 03/13

Purpose: To insure (ensure) that crash carts are properly maintained and sealed.

Policy:
..Pharmacy will also check all carts and drug supplies monthly for expired items.

Policy: Checking for Expired Supplies
Effective Date: 03/14
Reviewed: 03/14

Purpose: To prevent the use of expired supplies.

Policy:
1. All departments that have supply rooms, supply closets, refrigerators or other will maintain a monthly check of inventory to make sure supplies are in date and properly stored...

Policy/Procedure: Emergency Room (ER)
Written: 06/25/00
Reviewed: 8/2/10

Subject: Supplies and Equipment: Location, Storage, Procurement and Maintenance

Note: The supplies and equipment in the ED (Emergency Department) will be readily available and systemically restocked, checked and maintained.

Guidelines:
...7. A Pharmacist will inspect the emergency carts and drugs at least once each month. He/She will inspect for out-of-date drugs and discolored drugs. As the inspection is made, the drugs will be replaced accordingly.

Policy: Storage of Medications
Effective Date: 7/27/00
Revised Date: 2/16

Policy:
All medications will be stored according to the manufacturer's recommendations.

Purpose:
For the protection of the patient, regulations and procedures regarding the administration and storage of drugs have been designed.

Procedures:
f. No cardboard boxes stored on floor...

A tour of the ED was conducted on 2/18/2020 at 8:56 AM with Employee Identifier (EI) # 6, RN (Registered Nurse)-ER Nurse Manager.

During the tour, the ED medication refrigerator was observed and opened for inspection with EI # 6. The following medications were observed in the medication refrigerator as expired and/or not labeled after use:

1. 1 tube of Silver Sulfadiazine Cream 1%-25 grams with open date 12/28/19 with label to discard after 28 days. From the day the medication tube was opened on 12/28/19 to the day of the tour on 2/18/2020 with the surveyor, it had been a total of 51 days since the tube had been opened.

2. 1 opened jar of Silver Sulfadiazine cream 1%-400 grams. EI # 6 confirmed the medication jar had been opened and the cream had been used. There was no label or documentation of when the jar of medication was opened.

During the tour at 9:10 AM the ED emergency crash cart was observed and opened for inspection with EI # 6. The following medications were observed on the crash cart available for patient use, and expired:

1. 2 vials of Potassium Chloride 40 mEq (milliequivalent)-2 mEq/mL (milliliter) 20 mL single vial dose
Expired 11/19 (November 2019)

2. 1 vial of Sodium Chloride Inj. (injection) 0.9%-10mL single dose vial
Expired 01/20 (January 2020)

3. 2 of 2 vials of Solu-Medrol (Methylprednisolone Sodium Succinate for Inj.) 40 mg (milligram) per vial-single dose vial
Expired 11/19

4. 1 injection vial of Calcium Chloride Inj., USP (United States Pharmacopeia)10%-1.36 mEq/mL (100mg/mL)
Expired 12/19

5. 3 out of the 4 vials of Lidocaine HCL (Hydrochloride) Inj. USP 2%-100mg (20mg/mL)
Expired 11/19

6. 1 injection vial of Epinephrine Inj. 1mg/mL (0.1mg/mL)
Expired 11/19

7. 1 injection vial of Sodium Bicarbonate Inj., USP 8.4%- 50 mEq/mL (1mEq/mL)
Expired 12/1/19

8. 1 IV (intravenous) glass bottle of Nitroglycerin in 5% Dextrose Inj.-50mg per 250mL (200mg/ml)
Expired 11/19

9. 1 IV solution bag of Lactated Ringer's Inj. USP 1,000mL
Expired 10/19 (October 2019)

An interview conducted at the time of the tour on 2/18/2020 at 9:10 AM with EI # 6, who confirmed the expired and open unlabeled medications.




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During a tour of surgical services on 2/18/2020 at 9:15 AM, an emergency cart located in the hallway adjacent to the pre and post anesthesia care unit revealed numerous expired medications available for patient care and included:

Atropine Sulfate 0.1 mg/ml, 2 luer jets expired 1/2020
Calcium Chloride 10 % 100 mg/ml- 1 luer jet expired 5/19 and 1 expired 9/19
Epinephrine 1 mg/10 ml- 3 expired 7/19, 2/19, 10/19.
Lidocaine 2 % HCL 100 mg injection 1 expired 11/19
Amiodarone 150 mg vial, 1 expired 7/19
Adenosine 6 mg/2 ml , 1 vial expired 7/19
Solumedrol 125 mg vials, 2 expired 6/19.
Metoprolol Tartrate 5 mg/5 ml 2 vials, expired 4/19 and 1 vial expired 8/19.
Diphehydramine 50 mg, 2 vials expired 8/19 and 1 expired 1/19.
Bicarbonate 8.4 % injection, 1 vial expired 5/1/18 and 1 vial expired 9/1/19.

In an interview with EI # 24 Surgical Services (Holding Room), RN (Registered Nurse) on 2/18/2020 at 9:30 AM, reported emergency medications were last checked December 2019 and a list of expired drugs was given to both surgery services and pharmacy department heads. EI # 24 also reported the next emergency drug check would be due in March 2020.

On 2/18/2020 at 10:10 AM outside the procedure room, the surveyor observed an emergency cart which contained Malignant Hyperthermia medications. There was one (1) 1000 milliliter bag Sodium Chloride, 0.9 %, expired 11/18 on the cart.

During a tour of OR # 1 and OR # 2 on 2/18/2020 at 12:30 PM with EI # 17, CRNA, (certified registered nurse anesthetist), the surveyor found one open unlabeled medication vial of Labetotol and Xylocaine 1%. EI # 17 confirmed all open medication vials were to be labeled with date opened.

During a tour of the New Direction chemical detoxification unit on 2/19/2020 at 8:00 AM, one 50 ml vial of sterile water was open and not labeled.

In an interview on 2/19/2020 at 8:05 AM, EI # 18, RN, New Direction unit confirmed staff failed to label medication vial when opened.


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A tour of the Pharmacy Department was conducted on 2/19/2020 at 9:45 AM with EI # 15, Pharmacist.

During the tour, the medication storage areas were observed. The following medications were observed in the medication storage areas and available for patient use as expired, incorrectly stored and/or not labeled after opening:

1. 4 bottles of Mannitol injection 25%, 12.5 g (grams)/50 ml single dose vial with an expiration date of 11/19. EI # 15 confirmed the medication had expired.

2. 10 capsules of Vancomycin HCL 125 mg per capsule distinguished from other medications by a label with a patient's name, a pharmacy and physician. Per EI # 15, the capsules were brought to the hospital by the family of a hospice patient admitted to the hospital for a respite stay and restocked in the pharmacy when the patient expired. EI # 15 confirmed the medication should not have been in the pharmacy for patient use.

3. 1 opened bottle of Almacone Double Strength liquid Antacid without a label identifying the date it was opened. EI # 15 confirmed the bottle had been opened and there was no label to identify the date it had been opened.

4. 1 tablet of Hydrochlorothiazide 25 mg with an expiration date of 1/2019. EI # 15 confirmed the medication had expired.

5. 2 boxes of IV Potassium Chloride 20 mEq were stored on the floor in cardboard boxes.

6. 12 IV bags of Potassium Chloride 20 mEq per 100 ml Injection stored on the floor in a cardboard box.

During the tour with the surveyor, EI # 15 confirmed the IV medications were incorrectly stored.

At 1:17 PM, the surveyor continued the tour with EI # 15 to a locked storage cabinet containing controlled substances and found the following expired medications and/or opened and unlabeled with date opened medications:

1. 41 tablets of Methadone Hydrochloride 10 mg tablets expiration date 11/2019.

2. 1 16 ounce opened bottle of Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended Release Suspension with no opened date but per EI # 15, the bottle was opened 12/2018 and would have expired 28 days after opened.

3. 3 syringes of Morphine Sulfate 0.5 cc (Cubic Centimeter) expiration date 4/2019.

4. 1 opened bottle of Morphine Sulfate 100 mg/5 ml (20 mg/ml) expiration date 4/2019.

An interview was conducted at the time of the tour on 2/19/2020 at 1:17 PM with EI # 15, who confirmed the above medications identified for patient use were expired medications and/or opened and unlabeled medications and should not be available for patient use.

ORGANIZATION

Tag No.: A0619

Based on United States Health Public Food Code 2017 regulations, observations and interview, it was determined the hospital failed to ensure food was stored and served in a safe and sanitary manner. This had the potential to negatively affect all patients.

Findings include:

United States Health Public Food Code 2017

3-302.12 Food Storage Containers, Identified with
Common Name of Food.
Except for containers holding FOOD that can be readily and unmistakably recognized such as dry pasta, working containers holding FOOD or FOOD ingredients that are removed from their original packages for use in the FOOD ESTABLISHMENT, such as cooking oils, flour, herbs, potato flakes, salt, spices, and sugar shall be identified with the common name of the FOOD...

3-501.17 Ready-to-Eat, Time/Temperature Control for Safety Food, Date Marking.
...commercially processed food open and hold cold
(B) Except as specified in (E) - (G) of this section, refrigerated, READY-TO-EAT, TIME/TEMPERATURE CONTROL FOR SAFETY FOOD prepared and PACKAGED by a FOOD PROCESSING PLANT shall be clearly marked, at the time the original container is opened in a FOOD ESTABLISHMENT and if the FOOD is held for more than 24 hours, to indicate the date or day by which the FOOD shall be consumed on the PREMISES, sold, or discarded, based on the temperature and time combinations specified in
(A) of this section and: Pf (1) The day the original container is opened in the FOOD ESTABLISHMENT shall be counted as Day 1; and (2) The day or date marked by the FOOD ESTABLISHMENT may not exceed a manufacturer's use-by date based on FOOD safety. Pf
(C) A refrigerated, READY-TO-EAT TIME/TEMPERATURE CONTROL FOR SAFETY FOOD ingredient or a portion of a refrigerated, READY-TO-EAT TIME/TEMPERATURE CONTROL FOR SAFETY FOOD that is subsequently combined with additional ingredients or portions of FOOD shall retain the date marking of the earliest- prepared or first prepared ingredient.
(D) A date marking system that meets the criteria stated in (A) and (B) of this section may include:...
(2) Marking the date or day of preparation, with a procedure to discard the FOOD on or before the last date or day by which the FOOD must be consumed on the premises, sold, or discarded as specified under (A) of this section;
(3) Marking the date or day the original container is opened in a FOOD ESTABLISHMENT, with a procedure to discard the FOOD on or before the last date or day by which the FOOD must be consumed on the premises, sold, or discarded as specified under (B) of this section...

Policy:
Calibrating A Probe Thermometer
Section 6: Food Preparation

Procedure:
Probe food thermometers should be calibrated weekly to assure accuracy.

Recording:
1. On the Food Temperature Chart (Form 401), once a week put the date the thermometers are calibrated.

Observation on 2/19/2020 at 9:00 AM during a tour of the food storage in the dietary department:

Unrefrigerated shelf foods: 1 box of dried kidney beans with a best by date of 9/17/19 on the cardboard box and a date of 10/17/19 on the plastic bag containing the beans (expired). Progresso Italian Style Bread Crumbs, four 24 ounce containers with expiration date of 1/26/2020 (expired). One bag of opened Craisens with no date opened and bag torn. One opened bag of Uncle Bens Stuffing with no date opened. One bag of colored Roseli Noodles without a label indicating when food was placed on shelf. Opened bottle of Paprika with a label dated 12-31-2019 but per EI # 11, unsure if the date is the expiration date or the date the container was opened. Opened bottle of Mild Chili Powder with a label dated 1-30-2019 but per EI # 11, unsure if the date is the expiration date or the date the container was opened.

Refrigerated foods: An opened container of Zucchini, Brussels Sprouts and Carrots with no label to indicate the date opened. Opened bottle of Buttermilk Ranch Dressing with opened date of 2-15-2020 but expired date of 12/2019. Opened bottle of Kens Golden Italian Dressing with opened date of 12/10/2019 but expired date of 10/2019.

During an interview conducted on 2/19/2020 at 9:41 AM with Employee Identifier (EI) # 11, Dietary Manager/Supervisor, confirmed the food items were not dated and labeled correctly and/or expired.

A tour of the dietary department was conducted on 2/20/2020 at 10:50 AM to observe the plating of lunch foods. The surveyor observed EI # 14, Food Prep staff obtain a probe thermometer to check food temperatures.

An interview was conducted with EI # 11, Dietary Manager/Supervisor who confirmed a thermometer probe was routinely used to check food temperatures. The surveyor asked for the log to confirm calibration of the thermometer probes and EI # 11 confirmed there was not a log of calibration per policy and the probe thermometers had never been calibrated per policy.

QUALIFIED DIETITIAN

Tag No.: A0621

Based on review of the facility Dietary Policy and Procedure Manual and interviews with staff, it was determined the facility failed to ensure Employee Identifier (EI) # 21 Dietitian, reviewed and approved the Policy and Procedure manual for the Dietary Department. This had the potential to negatively affect all patients served by the facility.

Findings include:

During a tour of the Dietary Department on 2/19/2020 at 9:00 AM, the Policy and Procedure Manual was reviewed with EI # 11, Dietary Manager/Supervisor. A review of the Approval Of Policies and Procedures signature page of the manual revealed the Dietitian had failed to review and sign the Policies and Procedures for the Dietary Department. EI # 11, Dietary Manager/Supervisor confirmed the Dietitian had not reviewed or signed the manual.

In a phone interview conducted with EI # 21, Dietitian on 2/20/2020 at 7:56 AM, EI # 21 confirmed he/she had never reviewed and signed the Dietary Department's Policies and Procedures.

An Interview was conducted on 2/20/2020 at 12:50 PM with EI # 2, COO (Chief Operating Officer) who confirmed, the Dietitian should have reviewed and signed the Dietary Department's Policies and Procedures and the Policies and Procedures for the Dietary Department should be reviewed and updated annually.

PHYSICAL ENVIRONMENT

Tag No.: A0700

Based on observations during facility tour with hospital staff by the Fire Safety Compliance Officer and staff interviews, it was determined that the facility was not constructed, arranged and maintained to ensure patient safety. This had the potential to negatively affect all patients served by the hospital.

Findings include:


Refer to Life Safety Code violations and A- 724 for finding.

FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE

Tag No.: A0724

Based on observations, review of facility policies and procedures, Emergency Department (ED) Crash Cart Shift Check Sheet, Medication Refrigerator Temp (temperature) Log documentation and interview with facility staff, it was determined the facility failed to ensure:

1) The emergency carts and defibrillator/monitor were checked daily.

2) All equipment was tested for performance and safety on an annual basis.

3) Medication refrigerator temperatures were checked daily and documented.

Findings Include:

Policy/Procedure: Emergency Room (ER)
Written: 06/25/00
Reviewed: 8/2/10

Subject: Supplies and Equipment: Location, Storage, Procurement and Maintenance

Note: The supplies and equipment in the ED will be readily available and systemically restocked, checked and maintained.

Guidelines:
...8. The emergency carts will be inspected every shift by an ED nurse. The defibrillator/monitor will be tested and the missing supplies replaced. The ED nurse will sign in the crash cart checklist log after completing the inspection.

Policy: Medical Equipment Maintenance
Effective Date: n/a
Date policy signed (per Administrator): 6/28/19

Purpose: To establish a Policy and Procedure to be followed that allows for routine service, inspection, and calibration of Hospital owned Medical Equipment.

Policy Statement: All Hospital Medical Devices that are deemed Medical Equipment by the Biomedical Department are to be inspected on a consistent basis...

Procedure:
...The following policy is a list of intervals on which this facility will conduct routine maintenance and calibration of equipment on.

Semi-Annual:
Vital Sign Machines...
...Infusion Pumps

Quarterly:
Defibrillators

Annual:
...Battery Chargers...
...Suction Machines...
...Telemetry Units...
...Vital Sign Machine...
...Refrigerator...

Department of Pharmacy Policies and Procedures
Subject: MEDICATION REFRIGERATOR
Revisions: 03/2014

A. Policy: All medications requiring refrigeration will be stored in a refrigerator capable of maintaining the temperature the particular medication required...

C. Procedure:

d. ONCE daily temperature checks must be recorded in all refrigerators that store medications.
f. If the temperature is out of range, the maintenance department must be contacted...pharmacy must be notified...
g. Medication stored in refrigerators should be maintained between 36-46 degrees F. (Fahrenheit)...

1. A tour of the Emergency Department was conducted on 2/18/2020 at 8:56 AM with Employee Identifier (EI) # 6, RN (Registered Nurse)-ER Manager.

At 9:10 AM the surveyor reviewed the (ER) Emergency Room Crash Cart Shift Check Sheet for December 2019, January 2020 and current February 2020. Staff failed to document the crash cart was inspected which included testing of the defibrillator on the following shifts and dates:

1. 7 AM to 7 PM shifts for 1/23/2020, 1/24/2020, 1/30/2020,

2. 7 PM to 7 AM shifts for 1/26/2020, 1/27/2020, 1/28/2020, and 1/29/2020.

An interview conducted at the time of the tour on 2/18/2020 at 9:10 AM with EI # 6, who confirmed there was no documentation the ED crash cart was inspected every shift which included testing of the defrillator monitor.

During the tour at 9:30 AM, the surveyor and EI # 6 entered the nurses' station area adjacent to Room 5 where the ED emergency crash cart was stored. The surveyor inspected the defibrillator monitor on the crash cart. During the inspection, the surveyor observed a Preventive Maintenance (PM) sticker located on the defibrillator monitor with documentation of "Date 8/18" and "Due 12/18".

The surveyor then entered the Trauma Room at 9:31 AM and observed the Outlook Safety Infusion System monitor with a PM sticker with documentation of "Date 7/18" and "Due 7/19". The surveyor observed a portable ventilator machine, 10K Ventilator, with PM sticker documentation of "Date 5/18" and "Due 5/19".

As the tour continued, the surveyor entered Room 3 of the ED where the medication refrigerator was observed with PM sticker documentation of "Date 3/18" and "Due 3/19". The ECG (Electrocardiogram) machine in Room 3 PM sticker documentation revealed "Date 7/18" and "Due 7/19". The "blanket warmer" in Room 3's PM sticker documentation revealed "Date 12/18" and "Due 12/19". The Accucheck machine, located at the nurse's station, PM sticker documentation revealed "Date 12/18" and "Due 12/19".

EI # 6 confirmed during the tour that the documentation of the "Date" on the above-mentioned items of equipment were of the last date preventive maintenance was completed and the "Due" was when the items of equipment should have had preventative maintenance scheduled again.

An interview was conducted on 2/18/2020 at 3:30 PM with EI # 2, Chief Operating Officer (COO), who confirmed the above mentioned items had not had preventive maintenance completed in accordance to facility policy and there was no "up to date" documentation for any of the previously mentioned equipment items.



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2. A tour of the Medical Surgical Floor was conducted on 2/18/2020 at 11:30 AM with Employee Identifier (EI) # 10, RN (Registered Nurse) on the Medical Surgical Floor.

The surveyor entered unoccupied patient room # 130. The PM sticker on the wall mounted suction metor read last date for PM was on 6-14-2014. There was no PM sticker on the electric hospital bed.

During the tour, EI # 10 verified that Room # 130 was available for patient use and there was no current PM sticker on the wall mounted suction metor or the electric hospital bed.

The surveyor continued the tour to the Utility Room utilized for equipment ready for patient use. The surveyor noted two IV (Intravenous) Pumps. One IV pump had a PM sticker with a PM date of 9/2019. The other IV pump did not have a PM sticker.

During the tour, EI # 10 verified that both IV pumps were available for patient use and did not have current PM stickers.

The surveyor continued tour to a supply closet containing telemetry units available for patient use. Unit # 0813 had a PM sticker with a due for maintenance date of 9/2017. Unit # 0840 had a PM sticker with a due for maintenance date of 9/2018.

During the tour, EI # 10 confirmed the telemetry monitors were available for patient use and did not have current PM stickers.

The surveyor continued tour down the patient hallway and observed a vital sign machine in the hallway utilized to check patient's vital signs. The PM sticker on the machine stated due for PM 11/2018.

During the tour, EI # 10 verified that the vital sign machine was utilized to monitor the patient's vital signs and did not have a current PM sticker.

The surveyor continued the tour to the nurse medication room. An Eye and Ear Scope plugged in for use did not have a PM sticker. An Acucheck Blood Sugar Machine had a PM sticker with a due for maintenance date of 12/2018.

During the tour, EI # 10 verified the Eye and Ear Scope and the Accucheck Blood Sugar Machine did not have a current PM sticker.

The surveyor continued the tour to the crash cart and Electric Scales. The Defibrillator Machine on the crash cart had a PM due date of 12/2018. The Electric Scales had a PM sticker due date of 4/2018.

During the tour, EI # 10 verified the crash cart Defibrillator Machine and the Electric Scales did not have a current PM sticker.

An interview was conducted on 2/18/2020 at 3:30 PM with EI # 2, Chief Operating Officer (COO), who confirmed the above mentioned items had not had preventive maintenance completed in accordance to facility policy and there was no "up to date" documentation for any of the previously mentioned equipment items.




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3. Observations of care included medication administration were conducted on 2/19/2020 from 7:30 AM to 9:15 AM on the New Direction Chemical Dependency Unit with EI # 18, New Direction, RN.

Located in the nurse medication room was a small refrigerator which contained a vial for Levemir Insulin.

Review of the New Direction Unit Medication Refrigerator Temp Log revealed no documentation staff monitored the medication refrigerator temperatures to ensure temperatures were within acceptable range on the following dates:

October 13, 2019
October 22-29, 2019
November 7-13, 2019
November 22-26, 2019
November 31, 2019
December 5-10, 2019
December 18-26, 2019
December 29, 2019
January 2-7, 2020
January 16-21, 2020
January 25-27, 2020
January 30-31, 2020
February 1-4, 2020.

In an interview on 2/19/2020 at 9:00 AM, EI # 18 confirmed staff failed to ensure refrigerated medications including insulin was stored in the proper temperature range.

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on observations, review of facility policies and procedures, Potter and Perry Fundamentals of Nursing, Centers for Disease Control and Prevention (CDC) Frequently Asked Questions (FAQ's) regarding Safe Practices For Medical Injection, CDC Management of Regulated Medical Waste in Health-Care Facilities and interviews with the staff, it was determined the facility failed to ensure:

1. The staff followed the facility policy and procedure for proper hand hygiene.

2. The staff cleaned the rubber diaphragm of the medication vial prior to drawing up Intravenous (IV) medications as recommended per CDC and facility policy.

3. The staff followed the the CDC recommendation of "Management of Regulated Medical Waste in Health-Care Facilities"

4. The staff followed the cleaning guidelines for the Accu-Check glucometer in 2 of 2 observations of care.

5. The respiratory staff followed facility policy and procedure for cleaning of reusable equipment in between patients.

This did affect MR (Medical Record) # 5, 1 of 1 patients observed for IV (Intravenous) medication administration, 1 of 1 Unsampled Patients (UP) UP # 1 observed for respiratory treatment administration, and 2 of 2 unsampled patients, UP # 2 and UP # 3 observed for blood glucose (Accu-Check) monitoring.

This had the potential to negatively affect all patients in this facility.

Findings include:

Potter and Perry Fundamentals of Nursing
6th edition
Chapter 34: Medication Administration page 847

Correct Administration ...For safe administration, the nurse uses aseptic technique and proper procedures when handling and giving medications.

CDC: Frequently Asked Questions (FAQs) regarding Safe Practices for Medical Injection

"Medication Preparation Questions

1. How should I draw up medications?

Parenteral medications should be accessed in an aseptic manner (free from contamination caused by harmful bacteria, viruses, or other microorganisms). This includes using a new sterile syringe and sterile needle to draw up medications while preventing contact between the injection materials and the non-sterile environment. Proper hand hygiene should be performed before handling medications and the rubber septum should be disinfected with alcohol prior to piercing it."

Facility Policy: Department of Pharmacy Policies & Procedures
Number: 10
Effective Date: 07/00
Revision Date 03/14

Subject: Use of Single/Multi Dose Sterile Containers

A. Policy: ...all hospital personnel will strictly adhere to the policies regarding use of single and multi dose sterile containers.

B. Purpose: To ensure that single and multi dose sterile containers must be used properly in the hospital to ensure protection of patients from exposure to contaminated products.

C. Definitions:
1. Sterile Single Dose Containers: All sterile single dose containers including vials...

D. Procedures:
1. The tops of all vials shall be swabbed with alcohol before an entry is made.

Facility Policy: Hand Hygiene
Effective Date: 5/2009
Revised Date: 11/2012

Purpose: To decrease the risk of transmission of infection by appropriate hand hygiene.

Policy: ...This facility has implemented the CDC Category I recommendations for hand hygiene.

I. Indications for Handwashing and Hand Antisepsis.

C. Decontaminate hands before having direct contact with patients.

I. Decontaminate hands after contact with inanimate objects (including medical equipment) in the immediate vicinity of the patient.

II. Handwashing

C. Wash well under running water for a minimum of 15 seconds, using a rotary motion and friction.

D. Rinse hands well under running water.

E. Turn off faucet with paper towel and discard.

Facility Policy: Infectious Waste Management
Date: May 6, 2009

Purpose: To decrease the potential of exposure of hazardous waste by appropriate management and disposal.

Policy: ...it is preferable to close the container and pace in an appropriate area for pick-up, decontamination and disposal.

CDC Guidelines: Management of Regulated Medical Waste in Health-Care Facilities:

Health-care facilities are instructed to dispose medical wastes regularly to avoid accumulation.

Medical wastes requiring storage should be kept in labeled, leak-proof, puncture-resistant containers under conditions that minimize or prevent foul odors...

Any facility that generates regulated medical wastes should have a regulated medical waste management plan to ensure health and environmental safety as per federal, state, and local regulations.

Policy: Standard Precautions
Department: Respiratory Care/EKG (Electrocardiogram)
Effective: July 2010
Revised: Sept (September) 2016
...Patient Care Equipment ...Makes sure that all reusable equipment has been cleaned and reprocessed appropriately, prior to use on another patient.
...Occupational Health and Bloodborne Pathogens ...Place all contaminated needles, syringes, scalpel blades and other sharp items in designated puncture-resistant containers ...

Policy: Glucose Testing, Bedside Accu-Check Advantage AccuData Glucose Station (GTS)
Effective Date: 07/07
Reviewed: 8/12

Policy: Trained...eligible Nursing Support Technicians may perform bedside glucose testing...Universal precaution guidelines will be followed for proper handling and disposal of blood-contaminated items in compliance with OSHA (Occupational Safety and Health Administration) and CDC (Centers for Disease Control) regulations...

...Procedure...
...12. Remove test strip and discard it and lancet in sharps container...
13. Dispose of lancet using universal precautions...

1. An observation was conducted on the Medical Surgical Floor by the surveyor on 2/19/2020 at 8:25 AM to observe Employee Identifier (EI) # 7, Registered Nurse (RN) administer medications to MR # 5.

EI # 7 obtained a vial of Zofran and withdrew the IV medication into a syringe without cleaning the vial top with alcohol as recommended per CDC.

EI # 7 then washed hands at the sink in the medication room and turned off water with cleaned bare hands and failed to turn off the water with a papertowel as recommended per CDC.

An interview was conducted on 2/19/2020 at 9:20 AM with EI # 3 who verified he/she did not follow recommendations for medication preparation and hand hygiene.

2. The surveyor conducted a tour of the Medical Surgical Floor on 2-18-2020 at 11:30 am with EI # 10, RN (Registered Nurse).

During the tour, the surveyor reviewed the dirty utility room where a large open red biohazard container was filled to over-flowing with biohazard waste and a full sharps container was laying across the top of the over-filled biohazard waste container.

An interview was conducted on 2/19/2020 at 9:20 AM with EI # 3, Director of Nursing (DON) who stated the staff should always contact the DON prior to containers overflowing to remove the biohazard waste. EI # 3, RN, DON confirmed the staff did not follow the CDC guidelines for removal of waste.


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3. An observation was conducted on 2/18/2020 at 1:58 PM to observe EI # 5, Respiratory Therapist, administer a respiratory treatment on an unsampled patient, Unsampled Patient (UP) # 1.

Prior to entering UP # 1's room, EI # 5 proceeded to the computer on wheels (COW). As EI # 5 checked the medical record for the respiratory treatment to be administered, EI # 5 proceeded to remove a pulse oximetry monitor out of his/her scrub top pocket. After confirming the medication to be given and obtaining the medication, EI # 5 then proceeded to administer the medication and utilized the pulse oximetry monitor throughout the administration of the respiratory treatment. After completion of the treatment, EI # 5 removed the pulse oximetry monitor from UP # 1's finger and then placed the pulse oximetry monitor back on the COW and exited the patient's room to chart. As EI # 5 began to chart, he/she placed the pulse oximetry monitor back in his/her scrub top pocket and proceeded to document on the COW.

During an interview directly after the observation, EI # 5 confirmed the pulse oximetry monitor was not cleaned prior to use or after. EI # 5 confirmed the pulse oximetry should have been cleaned prior to and after each patient use.

4. Two observations were conducted on 2/19/2020 starting at 10:40 AM on the Medical-Surgical (Med-Surg) Unit to observe EI # 13 perform blood glucose testing (Accu-Check) on two unsampled patients, UP # 2 and UP # 3.

During the observation at 10:40 AM, EI # 13 retrieved the Accu-Check machine from a cart adjacent to the nurses' station. The surveyor did not observe EI # 13 perform hand hygiene prior to obtaining the Accu-Check machine or clean the cart that the Accu-Check was placed on.

EI # 13 then donned gloves that were observed already laying on the cart that had not been cleaned. EI # 13 proceeded to clean the Accu-Check machine. After preparing the Accu-Check machine and supplies, EI # 13 proceeded to enter UP # 2's room. Upon entering the room and confirming UP # 2's identification, EI # 13 obtained the Accu-Check test strip, placed the test strip in the Accu-Check machine, then placed the Accu-Check machine on the patient's bed along with an alcohol prep. EI # 13 then obtained the alcohol prep, opened the pack, obtained the alcohol prep from the pack and then placed the opened pack from the alcohol prep on the bed adjacent to the Accu-Check machine. EI # 13 proceeded to clean UP # 2's right index finger with the alcohol prep and then placed the used alcohol prep on the bed adjacent to the Accu-Check machine that was on the bed. EI # 13 then obtained a lancet and used the lancet to obtain blood from UP # 2's right index finger. EI # 13 then placed the lancet on the bed after use. The Accu-Check monitor was then picked up off the bed by EI # 13, blood was obtained on the test strip, then the Accu-Check machine was placed back on the bed. EI # 13 proceeded to clean the index finger with a gauze then collect the trash and the Accucheck monitor off the bed. The opened packets, used alcohol prep, and used gauze were discarded in the trash and the lancet discarded in the sharps container. EI # 13 performed hand hygiene after removing gloves, upon exiting the room.

At 10:45 AM, EI # 13 proceeded back to the cart to prepare to obtain UP # 3's blood glucose. EI # 13 proceeded back to the cart adjacent to the nurses' station and placed the Accu-Check machine on the cart. EI # 13 did not clean the cart prior to placing the Accu-Check machine on the cart. EI # 13 then proceeded to clean the Accu-Check machine with a Sani-Cloth. After EI # 13 cleaned the Accu-Check machine, he/she proceeded to place the machine back on the cart that had not been cleaned prior to use.

EI # 13 proceeded to UP # 3's room and confirmed patient identification. The alcohol prep, gauze, and the Accu-Check machine were then placed on the bed adjacent to UP # 3. EI # 13 then obtained a test strip and placed the test strip in the monitor. EI # 13 obtained the alcohol prep from the bed, cleaned UP # 3's index finger with the alcohol prep then proceeded to put the opened packet and the used alcohol prep on the bed. EI # 13 then obtained a lancet, used the lancet to obtain blood from UP # 3's index finger and then proceeded to place the used lancet on the bed. EI # 13 obtained the blood, then cleaned UP # 3's finger with the dry gauze then placed the used gauze on the bed.

After completing the Accu-Check for UP # 3 and completing hand hygiene upon exiting the room, EI # 13 proceeded to place the Accu-Check machine back on the cart adjacent to the nurses' station.

During an interview with EI # 13 after observation of UP # 2 and UP # 3, EI # 13 confirmed the cart had not been cleaned each time prior to and after the monitor was placed on the cart.

EI # 13 failed to perform hand hygiene prior to obtaining UP # 2's blood glucose/Accu-Check monitor and clean the cart used for placement of the Accu-Check monitor in between patients. EI # 13 failed to maintain a clean environment by placing the Accu-Check monitor on unclean surfaces such as the patients beds in addition placing used alcohol preps, gauzes, and lancets on patients beds.

An interview was conducted 2/19/2020 at 11:55 AM with EI # 3, Director of Nursing, and the above findings presented by the surveyor. EI # 3 confirmed hand hygiene not being performed prior to and after each blood sugar check, the cart not being cleaned before and after the Accu-Check machine was placed on the cart, placing of the Accu-Check machine on the patients' beds, placing used alcohol preps and gauze, lancets, and opened packets were not in accordance to the facility's infection control policy.

OPERATING ROOM POLICIES

Tag No.: A0951

Based on facility policies, 2016 Guideline for Perioperative Practice, Surgery Daily Logs 2019 and 2020, surgery services medical records (MR), personnel file reviews and staff interviews, it was determined the facility failed to ensure:

1) All preoperative monitoring was ordered and performed according to surgery services policy in 1 of 3 surgical services record reviews.

2) All preoperative and surgical care orders were signed by the surgeon in 2 of 3 outpatient surgery records reviewed.

3) Staff followed their own policy and assured operating rooms were monitored for safe parameters of temperature and humidity per the facility policy and the procedure room and central sterile environment temperature and humidity were maintained according to periopearative practice standards.

4) All surgical nurse staff maintained current ACLS (advanced cardiac life support) certification.

This affected MR # 17, MR # 15 and MR # 16 and had the potential to affect all patients who received surgical services at the facility,

Findings include:

Elmore Community Hospital (ECH) Surgical Service Policy and Procedure: Preoperative Testing and Assessment
Revised: 11/2017

Purpose...To ensure that each patient undergoing an operative and/or invasive procedure requiring any type of anesthetic medication is appropriately assessed for clinical stability prior to the procedure.

Purpose: The following items must be present in the patient's MR prior to operative or invasive procedures:

3. Diagnostic and therapeutic preoperative orders must be present and completed in the patient's MR prior to admission to the OR (operating room) suite.
6. Preoperative lab testing to include but not limited to; CBC (complete blood count) and CMP (complete metabolic profile) within 14 days of procedure...
8. EKG (electrocardiogram) and CXR (chest x ray) on all patients over the age of 45, exception CXR...required on any patient under...45 with...pulmonary compromise...Additionally EKG...on any patient...under 45...with history of cardiac compromise...EKG and CXR within 6 months is acceptable provided ...no change in...health status...

Facility Policy:
Subject: Humidity and Temperature Checks/Air Exchange
Revised: 12/2016

Purpose: To adhere to OSHA (Occupational Safety Health Administration) requirements for engineering controls in the OR (operating room).

Procedure:
" Humidity and Temperature checks are monitored and recorded daily...The normal humidity range is between 40% (percent)-60%. The recommended temperature range is between 62 F (Fahrenheit)-73 F...If the surgical suite humidity...is outside the normal ranges, case will not proceed until normal ranges are met and maintained..."

2016 Guidelines for Perioperative Practice
Environment of Care, Part 2
page 270-272

Recommendation IV

The health care organization should create and implement a systematic process for monitoring HVAC (heating, ventilation, and air conditioning) performance parameters and a mechanism for resolving variances.

...The HVAC system is intended to reduce the amount of environmental contaminates...

Table 2: HVAC Design Parameters...

Preparation and packaging/clean workroom....Humidity maximum 60 %, Temperature 72 F (Fahrenheit) to 78 F...
Procedure room....Humidity 20 % to 60 %, Temperature 70 F to 75 F...

Surgical Services Policy: Certifications
Revised Date: 12/16

Policy:

...ACLS Certification:
All RN's...working in the PACU (post acute care unit) will be certified within 6 months...and recertify every 2 years...


1. MR # 17 was admitted to surgical services on 2/14/2020 for a Bilateral Nasal Antral Window with Tissue (Bilateral), Submucous Resection, Fracture Nasal Turbinates (Therapeutic). MR # 1 was 73 years old.

MR review revealed an Anesthesia Evaluation dated 2/14/2020 which included a medical history of high blood pressure, treated with Metoproprol, and a thyroid condition, Hyperthyroidism, treated with Methimazole. The Consent for Anesthesia revealed plans for general anesthesia to be administered by the CRNA.

Review of the ECH Surgery Pre-Admission Physician Orders dated 2/14//2020 revealed no laboratory and no cardiopulmonary pre admission testing was ordered by the surgeon and none was included in MR # 17's surgical record.

There was no documentation the surgical staff inquired regarding the need for pre operative testing per the surgery service policy.

In an interview on 2/19/2020 at 3:30 PM, EI (Employee Identifier ) # 16, Surgery Service Director reported there was no preoperative testing ordered by the surgeon. EI # 16 confirmed surgical staff failed to follow its own policy for preoperative testing and assessment.

2. MR # 15 was admitted to surgical services on 2/18/2020 for Right 5th Toe Angioplasty. MR # 15's medical history included Diabetes Mellitus.

MR review revealed Outpatient Surgery Orders which were faxed to the surgery services on 2/11/2020 that included pre surgical testing, CBC, BMP, anesthesia, MAC (monitored anesthesia conscious), pre-operative Ancef 1 gram IV. There was no physician signature on the outpatient surgery orders.

Review of the ECH Pre-Operative Physician Orders included start IV (intravenous) Ringers Lactate (RL) or Normal Saline (NS) 500 milliliter start in holding room, blood sugar finger stick if patient is known diabetic, Zofran 4 mg IV as needed. The was no physician signature on the preoperative orders dated 1/28/2020.

During an interview on 2/19/2020 at 3:33 PM, EI # 16 confirmed there were no surgery orders and pre operative orders signed by the physician.

3. MR # 16 was admitted to surgical services on 01/28//2020 Polyp Removal with Myringoplasty Right Ear.

Review of the ECH Pediatric Pre-Operative Physician Orders included start IV (intravenous) RL or NS 500 milliliter start in holding room, oral Versed 0.5 mg/kg (milligram/kilogram) and Zofran 4 mg IV. The was no physician signature on the preoperative orders dated 1/28/2020.

During an interview on 2/19/2020 at 3:35 PM, EI # 16 confirmed the preoperative orders had not been signed by the surgeon.


During a tour of the surgery department 2/18/2020 at 9:10 AM, the surveyor observed 2 OR suites, 1 endoscope procedure room, pre-operative and post acute care areas and Central Sterile prep and processing. All surgical areas had Humidity/Temperature monitors present.

Review of the Surgery Daily Log documentation for July 2019 revealed the Temperature and Humidity was outside acceptable ranges and no documentation of actions taken.
OR 1-Temperature(s) greater than 73 degrees Fahrenheit for 8 days from 7/1/19 to 7/15/2019 and Humidity greater than 60 % on 8 days from 7/1/2019 to 7/31/19.
OR 2 -Humidity greater than 60 % for 9 days from 7/3/19 to 7/31/19.
Sterile Supply- Prep (preparation)-Humidity greater than 60 % for 4 days from 7/18/19 to 7/29/19 and Sterile Supply- Core temperature outside acceptable range on 7/1/19.

Review of the Surgery Daily Log documentation for August 2019 revealed the Temperature and Humidity was outside acceptable ranges and no documentation of actions were taken for:

OR 1-Humidity greater than 60 % on 4 days from 8/12/19 to 8/15/19.
OR 2-Humidity greater than 60 % on 7 days from 8/1/19 to 8/13/19.
Endoscopy- Humidity greater than 60% on 4 days from 8/9/19 to 8/24/19.
Sterile Supply-Prep-Humidity greater than 60 % on 4 days from 8/6/19 to 8/14/19.

Review of the Surgery Daily Log documentation for September 2019 revealed the Humidity was greater than 60 % on 9/10/19 and 9/11/19 in Endoscopy. OR 2 and Sterile Supply-Prep temperature was outside acceptable range on 9/11/19 and there was no documentation of any actions taken.

An interview was conducted on 2/18/2020 at 1:59 PM with Employee Identifier (EI) # 16, Surgery Department Head, who validated the findings and reported no documented action was taken for documented values outside acceptable temperature and humidity ranges.

Review of 1 of 2 surgery staff personnel files on 2/202/2020 at 11:45 AM revealed EI # 24, Registered Nurse, Surgical Services (Holding Room), date of hire 9/18/17, failed to include current ACLS certification.

In an interview on 2/2/2020 at 11:45 AM, EI # 4, Assistant Director of Nurses, verified there was no documentation of EI # 24's current ALCS certification.

REQUIRED OPERATING ROOM EQUIPMENT

Tag No.: A0956

Based on facility policy, surgical service department observation, and interview, it was determined the facility failed to ensure:

1) Staff performed and documented daily defibrillator test checks.

2) All surgery equipment had current preventative maintenance (PM) performed.

This had the potential to negatively affect all patients who received care in the surgery department.

Findings include:

Policy: Emergency Crash Carts
Review Date: 12/16

To ensure the proper functioning of the defibrillator and availability of medication in an emergency situation MUST be checked daily for each day of potential use....

The emergency crash carts are to be checked daily each day of potential use by a designated RN (registered nurse), assigned by the RN in charge...

A tour of the surgery services department was conducted on 2/18/2020 at 9:10 AM with Employee Identifier (EI) # 16, Surgery Services Director.

During the observations in the surgery department, the surveyor noted multiple pieces of equipment in the two operating room (OR) suites, one Endoscopy procedure room, and the Post Acute Anesthesia Unit without current PM documentation which included:

Stryker Smart Pump # 00159, PM due 5/19.
Quantum System 5000 Orthocare, # 000033, PM due 8/19.
Bair Hugger Model 505 # 93089, PM due 9/19.
AccuChek II- # 000324, PM due 12/19.
ZOLL SurePower Defibrillator, PM due 12/18.
Olympus Evis Exera II, CV 180, no PM documentation

Review of the Surgery Daily Log documentation for February 2020 revealed no documentation of the defibrillator test on 2/11/2020 and 2/18/2020.

In an interview on 2/18/2020 at 1:55 PM, EI # 16 confirmed staff had failed to ensure all surgical equipment had current PM documented at the time of the surgery tour and daily defribillator checks had not been documented.