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5880 SOUTH HOSPITAL DRIVE

GLOBE, AZ 85501

COMPLIANCE FED, ST, AND LOCAL LAWS AND REGS

Tag No.: C0812

Based on review of policies and procedures, hospital documents, Centers for Disease Control and Prevention (CDC) guidelines, Arizona Administrative Code (A.A.C.) Title 18 Chapter 13 Article 14, observations and staff interviews, it was determined the Hospital failed to ensure that:

1. biohazardous waste is being stored properly. Failure to ensure proper storage of biohazardous medical waste poses a potential risk for unauthorized individuals to have access to biohazardous waste and be exposed to infectious or contaminated supplies and materials.

2. posted and written patient rights, schedule of fees and rates and contact information for the Arizona Department of Health given to patients were current. Failure to provide current information on patient rights may inhibit and impede patients from exercising their rights.

Findings include:

1. Biohazardous Waste

Policy titled "Biohazard Storage and Disposal" revealed: " ...All biohazards should be properly disposed of. All contaminated waste should be placed in a red biohazard bag ...When a red bag becomes full, it should be tied and then placed in the red biohazard barrel in the designated location ...."

Review of the hospital document titled "Stericycle Master Service Agreement" dated 10/02/2017 revealed: "Services provided regulated medical waste disposal: treatment and disposal of medical and biohazardous waste ...Service locations and service frequency: Cobre Valley Regional Medical Center pick up weekly...."

CDC guidelines titled "Infection Control: Environmental Infection Guidelines: Medical Waste requires: "...Medical wastes requiring storage should be kept in labeled, leak-proof, puncture-resistant containers under conditions that minimize or prevent foul odors. The storage area should be well ventilated and be inaccessible to pests. 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...."

Arizona Administrative Code R 18-13-1408 A requires: "... A generator may place a container of biohazardous medical waste alongside a container of solid waste if the biohazardous medical waste is identified and not allowed to co-mingle with the solid waste. The storage area shall not be used to store substances for human consumption or for medical supplies...."

Arizona Administrative Code R 18-13-1408 B requires: "... Once biohazardous medical waste has been packaged for shipment off site, a generator shall provide a storage area for biohazardous medical waste until the waste is collected and shall comply with both of the following requirements:1. Secure the storage area in a manner that restricts access to, or contact with the biohazardous medical waste to authorized persons...2. Display the universal biohazard symbol and post warning signs worded as follows for medical waste storage areas: (in English) "CAUTION -- BIOHAZARDOUS MEDICAL WASTE STORAGE AREA -- UNAUTHORIZED PERSONS KEEP OUT" and (in Spanish) "PRECAUCION -- ZONA DE ALMACENAMIENTO DE DESPERDICIOS BIOLOGICOS PELIGROSOS -- PROHIBIDA LA ENTRADA A PERSONAS NO AUTORIZADAS ...C. Beginning at the time the waste is set out for collection, a generator who stores biohazardous medical waste shall comply with all of the following requirement: 1. Putrescible biohazardous waste may be kept unrefrigerated up to 72 hours if it would not otherwise cause odor detectable beyond the property line or attract vermin. 2. Refrigerate at 40Ã '° F. or less from hour 72 through day 90 putrescible biohazardous medical waste kept for up to 90 days. 3. Nonputrescible biohazardous medical waste may be kept unrefrigerated for up to 90 days. 4. Store biohazardous medical waste for 90 days or less unless the generator has obtained facility plan approval under A.R.S. § 49762.04 and is in compliance with the design and operational requirements prescribed in R18-13-1412. 5. Keep the storage area free of visible contamination. 6. Protect biohazardous medical waste from contact with water, precipitation, wind, or animals. A generator shall ensure that the waste does not provide a breeding place or a food source for insects or rodents.

Observation during tour of facility on 03/01/2022 revealed the hospital biohazardous waste storage area was outside the facility. The biohazardous waste storage area was a cement pad and gravel area enclosed by a chain link fence and gate. The gate was padlocked. The biohazardous waste storage area enclosure did not have a roof or any barriers at the base to prevent vermin to enter the storage area. The enclosure had a biohazard waste sign posted.

Employee #3 confirmed during an interview conducted on 03/01/2022 that the biohazardous waste storage area did not have a roof and was not properly secured.

2. Current Patient Rights

Policy titled "Patient Rights and Responsibilities" revealed: " ...All patients receiving care, inpatient and outpatient at Cobre Valley Regional Medical Center (CVRMC) will receive a copy of "Patient Rights and Responsibilities" at time of registration ...."

Hospital document titled "Patient Rights and Responsibilities" revealed a revision date of 06/2008. Further review of the document revealed the Patient Rights listed were not a current version.

Observation on tour revealed postings of Patient Rights in the main lobby and Emergency Department (ED) waiting room were not current, the postings had a date of 2017. Further observation revealed no evidence of a current schedule of fees and rates posted in the main lobby or ED waiting room. Further observation revealed the posted contact information for the Arizona Department of Health did not include the suite number or phone number for the Department.

Employee #1 confirmed during an interview conducted on 03/01/2022 that the posted Patient Rights in the main lobby and ED waiting room where out of date and not current. Employee #1 confirmed the notice of schedule of rates and fees were not posted. Employee #1 confirmed that the address for the Department was incomplete and the phone number for the Department was not posted.

Employee #40 confirmed during an interview on 03/01/2022 that the written copy of "Patient Rights and Responsibilities" that is provided to patients is not current and is out of date.



45618

EQUIPMENT, SUPPLIES, AND MEDICATION

Tag No.: C0884

Based on review of policies and procedures, manufacturer guidelines, observations and staff interview, it was determined the Hospital failed to ensure Point of Care (POC) laboratory testing controls were removed from use and disposed of at time of expiration. Failure to remove expired laboratory test controls from use and disposing of them poses a potential risk to the health and safety of patients if the expired controls are utilized for the processing of patient lab specimens possibly affecting test accuracy.

Findings include:

Policy titled "Point of Care Testing Glucometer" revealed no evidence of when testing control solutions expire or when controls should be discarded.

Roche Diagnostics manufacturer instructions for Accu-Chek Inform II Controls revealed: " ...Write the discard date on the bottle label. The control solution is stable for 3 months after opening or until the Expiration date on the bottle label, whichever comes first ...."

Observation on 03/01/2022 in the Emergency Department revealed Accu-Chek II control solution with open date of 11/18/2021 and an expiration date of 02/18/2022.

Employee #36 confirmed during an interview on 03/01/2022 the Accu-Chek II control solution was expired and should not be in use.

Observation on 03/02/2022 revealed Accu-Chek II control solution on the MOSU unit that was opened and did not have an open date or expiration date on the label.

Employee #9 confirmed during an interview on 03/02/2022 the Accu-Chek II control solution did not have an open date or expiration date on the label. Employee #9 confirmed the control solution should be labeled with open and expiration dates.

Observation on 03/02/2022 on the Observation Unit revealed Accu-Chek II control solution in use without an open date or expiration date on the label.

Employee #1 confirmed during an interview on 03/02/2022 that the Accu-Chek II control solutions should be labeled with an open date and expiration date. Employee #1 confirmed the control solutions in use on the Observation unit did not have the required labeling.


45618

GOVERNING BODY OR RESPONSIBLE INDIVIDUAL

Tag No.: C0962

Based on review of policies and procedures, medical staff rules and regulations, medical record, and staff interview, it was determined the Governing Body failed to ensure physician orders for restraints were written and renewed for one (1) patient. This deficient practice could pose a risk to the health and safety of patients by keeping patients restrained unnecessarily and against their will, violating the patients' rights.

Findings include:

Policy titled "Restraint Policy" revealed: " ...IV. General Application of Restraints ...B. Content of the Physician Order: A valid order for restraint contains the following elements: Category of restraint (medical; versus behavioral); Type of restraint; Specific reason for restraint; Specified time period for restraint use (up to 24 hours); Is signed by the Physician/Licensed Independent Practitioner (LIP), date and timed. The Physician Order for Medical Restraints or Behavioral Order foe each restraint episode and place in the patient's electronic medical record. C. Renewal Orders: Renewal of orders for continued restraint use is completed once every 24 hours and is based upon an examination of the patient by the LIP. D. Removal of Restraints: ...If the determination is made that the patient needs to be restrained again, a new order is needed...."

Hospital document titled "Medical Staff Rules and Regulations" revealed: " ...5.6 Restraints and Seclusion: Cobre Valley regional Medical Center Restraint policy governs the use of restraints within the institution. Practitioners must abide by the restraint policy whenever restraints are to be used ...."

Medical record review was conducted on 03/01/2022. Review revealed one (1) patient was hospitalized from 01/19/2022 through 01/28/2022. Further review revealed the patient was in restraints from 01/22/2022 until 01/28/2022. Review of the medical record physician orders revealed an order for restraints on 01/22/2022 for a 24 hour time frame. A review of the physician orders revealed an order for restraints written on 01/26/2022 for a 24 hour time frame. Further review of the physician orders revealed no evidence of restraint orders for the other 5 days the patient was in restraints.

Employee #5 confirmed during an interview conducted on 03/03/2022 that the patient was in restraints from 01/22/2022 through 01/28/2022. Employee #5 confirmed the patient was kept in restraints after restraint orders had expired. Employee #5 confirmed renewal orders were not obtained for 5 out of 7 days when restraints were used with the patient. Employee #5 confirmed an order was needed for every day the patient was in restraints and a renewal was required whenever restraints had been discontinued and then reapplied.



45618

NURSING SERVICES

Tag No.: C1048

Based on review of policy and procedure, medical record and staff interview, it was determined the Hospital failed to ensure assessment and re-assessment of patient status was documented at least every two (2) hours for one (1) patient while the patient was in restraints. The deficient practice of not assessing patients while in restraints poses a risk to the health and safety of patients by not identifying and preventing potential or actual injuries sustained while in restraints or possible death in a timely manner.

Findings include:

Policy titled "Restraint Policy" revealed: " ...E. Documentation of Restraint use: ...Ongoing: 1. Re-assessment of patient status and care given (must be documented at least every two (2) hours, or more often based on the patient's assessment).2. continuing descriptions of patient behaviors necessitating restraints. 3. The patient's response to the use of the restraint ... Monitoring: At a minimum, a patient in Medical Restraints is monitored every two hours ...Nursing documentation for all patients in restraints shows evidence every two hours of attention to: 1. Nutrition,2. Hydration, 3. Toileting, 4. Ambulation, 5. Circulation, 6. Maintenance of skin integrity, 7. Range of motion, 89. And other care as appropriate. This documentation will be completed by an RN who has completed required training and demonstrated competence ...."

Medical record review was conducted on 03/01/2022. Review revealed one (1) patient was hospitalized from 01/19/2022 to 01/28/2022. Further review revealed the patient was placed in medical restraints on 01/22/2022 through 01/28/2022. Review of the nursing restraint/seclusion assessment form revealed incomplete and late assessments during the 6 days the patient was in restraints. Further review revealed the patient remained in restraints after restraint orders expired. Further review revealed seven (7) incidents were assessments were greater than every 2 hours. One of the time periods with no assessments documented was for a time frame of twenty-two(22) hours with no documentation indicating the restraints had been discontinued during that timeframe.

Employee #5 confirmed during an interview conducted on 03/03/2022 that the nursing restraint/seclusion form for the patient was incomplete and assessments were not completed at a minimum of every two (2) hours. Employee #5 confirmed the patient remained in restraints with no current order in place. Employee #5 confirmed that the restraint assessments were not done per hospital policy.


45618

NURSING SERVICES

Tag No.: C1049

Based on review of policies and procedures, medical staff rules and regulations, Centers for Disease Control and Prevention (CDC) guidelines, medical records and staff interviews, it was determined the Hospital failed to ensure automatic stop dates were implemented on four (4) patients receiving antibiotics during their hospital stay. Failure to implement automatic stop dates on medications poses a risk to the health and safety of patients by patients unnecessarily receiving medications for a longer period of time than recommended or needed.

Findings include:

A policy regarding automatic stop dates for medications was requested. No policy was provided.

Hospital document titled "Medical Staff Rules and Regulations" revealed: " ...4.4.11 Drugs and Medications: ...m. Automatic Stop Orders: Drugs and biologicals not specifically prescribed as to time or number of doses must automatically be stopped after a reasonable time that is established by the Medical Executive Committee upon the recommendation of the Pharmacy Director, the Medical Management Committee, and the Medical Staff Performance Improvement and Patient Safety Committee.

CDC guidelines titled " Core Elements of Hospital Antibiotic Stewardship Programs, 2019" revealed: " ...Pharmacy-based Interventions: The following interventions are often initiated by pharmacists and/or embedded into pharmacy sections of electronic health records: ...Time-sensitive automatic stop orders: for specified antibiotic prescriptions, especially antibiotics administered for surgical prophylaxis ...."

Medical record review revealed four (4) patients received antibiotics that were ordered without automatic stop dates.

Employee #1 confirmed during an interview conducted on 03/01/2022 that there was no policy regarding automatic stop dates for antibiotics.

Employee #39 confirmed during an interview conducted on 03/01/2022 that there are no automatic stop dates for antibiotics. Employee #39 stated that medi-tech has automatic stop dates built into the order sets for the medical staff but that option is turned off per physician request. Employee #39 stated the physicians do not like the automatic stop dates. Employee #39 stated the hospital does not utilized "soft stop dates" to remind pharmacy and the physician to review the antibiotic order.




45618

RECORDS SYSTEM

Tag No.: C1110

Based on review of policies and procedures, medical staff rules and regulations, medical records and staff interview, it was determined the Hospital failed to ensure discharge summaries were written and included in the medical record for two (2) patients. This deficient practice poses a risk to the health and safety of patients as discharge summaries serve as a document communicating a patient's hospital care and treatments to a patient's post-hospital care team.

Findings include:

A request was made during the survey for a policy regarding discharge planning/summaries, one was not provided.

Hospital document titled "Medical Staff Rules and Regulations" revealed: " ...Article III Medical Records 3.3 General Requirements ...To facilitate consistency and continuity of patient care, the medical record shall include: ... t. a discharge summary or final progress note or transfer summary ...3.18 Medical Records Completion 3.18.1 Requirements for Timely Completion of Medical Records ...i. A discharge summary must be entered into the medical record by the attending physician or his/her designee within 14 days of an inpatient or observation discharge, transfer, or death ...."

Medical record review revealed two (2) patients were discharged with no discharge summary present in the patients' medical record.

Employee #9 confirmed during an interview conducted on 03/01/2022 that the discharge summaries were not in the medical records for the two patients. Employee #9 stated all patients discharged should have a discharge summary in their medical records.



45618

ANESTHETIC RISK AND EVALUATION

Tag No.: C1144

Based on review of policies and procedures, medical staff rules and regulations, medical records and staff interview, it was determined the Hospital failed to ensure a pre-anesthesia evaluation was completed on four (4) of six (6) surgical patients and a post-anesthesia evaluation was completed on two (2) of six (6) surgical patients. Failure to complete a pre-anesthesia and post-anesthesia evaluations on patients poses a risk to the health and safety of patients if anesthesia is provided to a patient who has an unidentified health issue or risk that anesthesia is contraindicated.

Findings include:

Policy titled "Quality Management Plan- Anesthesia" revealed: " ...VII. Required Elements of Care: All care rendered to the patient must be thoroughly, accurately and legibly documented in the patient's medical record. A. Pre-operative/Pre-procedure: 1. Before administration of any anesthetic, analgesic, or sedative agent(s), the following activities MUST be completed. 2. The anesthesiologist is responsible for performing or reviewing the physical examination, assessing the patient's health status and developing an anesthetic care plan that is unique to each patient based on findings. 2. On day of surgery, if different from the date of the original assessment and examination, a reassessment is performed to identify any changes in the patient's medical record ...C. Post-operative/Post-procedure: 1. At the end of the case, the anesthesia provider (MD, DO, CRNA, or AA) is responsible for the transition of care...A complete record should be provided to the nurse who is assuming care for the patient. A complete set of vital signs is obtained and documented. The patient's mental, cardiac and respiratory/airway status is assessed...."

Hospital document titled "Medical Staff Rules and Regulations" revealed: " ...6.3 Anesthesia ...The anesthesiologist/anesthetist will maintain a complete anesthesia record (to include evidence of pre-anesthesia evaluation and post-anesthetic follow-up) of the patient's condition for each patient receiving moderate or deep sedation and anesthesia ...."

Medical records for six (6) post surgical patients were reviewed. Review of the anesthesia records revealed four (4) of the patients' pre-anesthesia evaluation were incomplete. Further review revealed two (2) of the patients' post-anesthesia evaluation was incomplete.

Employee #5 confirmed during an interview conducted on 03/02/2022 that all areas of the anesthesia record are required to be completed.



45618

INFECTION PREVENT SURVEIL & CONTROL OF HAIs

Tag No.: C1208

Based on a review of hospital policies and procedures, hospital documents, observation, and interviews, the Hospital failed to ensure that:

1. Dietary personnel documented kitchen and food service areas being cleaned appropriately.
2. Food for patient, visitor, and employee consumption was used or discarded by their use by or expiration date.
3. Test strips used to test sanitizer concentration for dishes being washed in the kitchen were not expired.

This deficient practice poses the potential risk of patients being exposed to foodborne illnesses due to inadequate cleaning and surveillance.

1. Hospital policy titled "Dietary," received on 03/01/2022, revealed " ...Departmental personnel are responsible for maintaining the cleanliness of the countertops, tables, refrigerators, all food prep areas, and the other work areas ...there is a schedule of floor cleaning, which department personnel are responsible for ...Trash cans ...are on a schedule for cleaning ...Cleaning of storage areas is on set schedule ...."

Hospital document titled "Master Cleaning list" posted in the kitchen dated February 2022, revealed a list of tasks to be done in the kitchen. The list revealed 28 tasks to be done on a daily basis. On these tasks, 22, had one set of initials indicating they were done in February. There were 27 items identified to be done on a weekly basis. There was one set of initials documented for 14 of these tasks and no documentation for the others. Sixteen tasks were required to be done twice weekly with one set of initials documented for the month on eight of these items. The cleaning list included five tasks to be done three times a week, on which three of these items, one set of initials was documented.

Employee #8 confirmed in an interview, on 03/01/2022, that for the month of February 2022, the daily items were not being documented as done on a daily basis. S/He also confirmed that they could not tell if weekly items to be cleaned were cleaned every week because there is one set of initials for the month. S/He stated that most of the items were only documented one time for the month and there was no indication when that was or if it was being done on the set schedule.

2. On 03/01/2022, during a tour of the food service area, in the kitchen there was found a bread tray containing loaves of bread, with a sticker on the tray indicating an expiration date of 2/20/2022. In a walk in refrigerator, there were two containers of lime juice with an expiration date of 1/11/2022. In a retail refrigerated case containing items for purchase, there was a peach yogurt parfait with an expiration date of 02/28/2022 and two chef salads and one orange jello with no expiration sticker present. Also in the retail area, there were two cookies found with an expiration date of 02/25/2022 and 12 cookies with an expiration date of 02/28/2022. In a walk in deep freezer containing shelving units on all four sides, and a shelving unit in the center, only the first unit of the entrance wall and the first unit of the middle shelves were inspected. On these two units there was found, diced vegetables with a use by date of 08/26/2021, meatloaf with a use by date of 02/28/22, a clear plastic container holding various single wrapped bread puddings with a use by date of 11/21/20, peach cobbler with a use by date of 01/29/22, oreo crumble cake with a use by date of 12/30/21, penne pasta with a use by date of 02/21/22, and two pies with use by dates of 01/15/22.

Hospital policy titled "Dietary," last reviewed 04/2017, and received on 03/01/2022, identifies " ...Hospital utilizes FIFO rotation (first in, first out) and department personnel check expiration dates ...."

Employee #8 confirmed in an interview on 03/01/2022, that these items were expired or past the use by dates.

3. On a tour of the kitchen, on 03/01/2022, there was observed two clear plastic envelope on the wall next to the three compartment sink, with Hydrion QT-10 test strips for sanitation, inside each one, with an expiration date of 08/30/2015.

Hospital policy titled "Dietary," received on 03/01/2022, revealed " ...All equipment and utensils are cleaned after each use ...Cleaning must include ...adherence to written procedure for sanitizing ...."

Hospital document titled "Quaternary Sanitizer Testing Procedures," posted on the wall in the kitchen next to the three compartment sink revealed, " ...Important: Verify expiration date on QT-10 Test Kit before use. Out of date kits should be discarded ...."

Employee #8 confirmed in an interview on 03/01/2022, that the test strips were expired, stating that s/he did not know they had an expiration date.

LEADERSHIP RESPONSIBILITIES

Tag No.: C1231

Based on hospital documents, observation, and interview, the Hospital failed to ensure:

1. Staff follow CDC COVID-19 guidelines and wear masks correctly at all times when having contact with patients.
2. Vaginal ultrasound probes are being rinsed appropriately following manual reprocessing.
3. Multi use masks used in sleep studies are cleaned using a high level disinfectant prior to reuse.

These deficient practices pose the potential risk of infection causing microorganisms being spread to patients, employees, and/or visitors.

Findings include:

1. Hospital document titled "Infection Prevention and Control Plan," last reviewed 03/2020, and received on 02/28/2022, identifies " ...CVRMC's IPC program shall be conducted in accordance with applicable federal and state rules and regulations, accrediting standards, as well as nationally recognized IPC practices and guidelines, including evidence based guidelines and recommendations from organizations including but not limited to a. Centers for Disease Control and Prevention (CDC) ...."

Hospital document titled "COVID-19 Response Plan," dated 11/19/2021, and received on 03/01/2022, identified " ...Effective Nov 22, All employees will be required to wear a mask and may unmask at your work station when able to maintain social distancing ...All employees will wear their masks correctly (which is above the nose) the entire time they are on campus ...."

On a tour of the facility on 03/01/2022, an employee in the Emergency Department (ED), was observed with a face mask hanging from one ear and not covering his/her face. In the pharmacy, an employee entered without a face mask. The employee was provided a mask by Employee #1. The pharmacy employee donned the mask, but pulled it down to his/her chin so it was not covering the face.

On 03/02/2022, an employee was registering a patient in the ED, wearing his/her mask hanging from one ear.

Employee #1 confirmed in an interview on 03/01/2022 and 03/02/2022, that the employees in the ED and pharmacy were not wearing face masks appropriately.

2. Hospital policy titled "Ultrasound Imaging Probe Cleaning," received on 03/01/2022, identifies " ...Employee will review documents and training material regarding use of Cidex OPA ...Employee will demonstrate the appropriate process for high level disinfection (HLD) to supervisor ...."

Document titled "Cidex OPA Instructions for Use," reveals " ...Rinsing Instructions 1. RINSING PROCEDURE a) Manual Processing: Following removal from CIDEX OPA Solution, thoroughly rinse the semi-critical medical device by immersing it completely in a large volume (e.g. 2 gallons) of water ...Keep the device totally immersed for a minimum of 1 minute in duration ...Remove the device and discard the rinse water. Always use fresh volumes of water for each rinse. Do not reuse the water for rinsing or any other purpose. Repeat the procedure TWO (2) additional times, for a total of THREE (3) RINSES, with large volumes of fresh water to remove CIDEX OPA ...THREE (3) SEPARATE, LARGE VOLUME WATER IMMERSION RINSES ARE REQUIRED ...."

Employee #23 revealed in an interview on 03/01/2022, that when reprocessing vaginal ultrasound probes, the procedure is to soak in cidex for 12 minutes, then after removal, they rinse the probe under the faucet in the sink, then hang the probe up to dry.

3. On a facility tour of the area used for sleep studies, on 03/02/2022, located in a box next to the murphy bed, there were plastic bags containing a ResMed AirFitP10 CPAP mask, F&P Eson2 CPAP mask, F&P Brevida nasal pillow CPAP mask, and ResMed AirFit F30 CPAP mask. Each mask was in a separate bag.

Hospital policy titled "Cleaning and Maintenance of Sensors including Linens and Carpets, Area: Sleep Lab," last revised on 03/2021 and received on 03/02/2022, identified " ...Item: Masks ...Frequency: After each use ...Procedure: Wash in warm soapy water, rinse thoroughly. Wipe mask with Germicidal Wipes ...."

Manufacturer's document for F&P Brevida and F&P Eson2 CPAP mask, titled "Disinfection and Sterilization Guide" reveals " ...This guide is intended for multi-patient use of a Fisher and Paykel Healthcare Mask in the hospital, or other clinical healthcare settings, where proper disinfection/sterilization of the device must occur ...Cleaning: Soak all reprocessable parts of the mask in a solution of mildly alkali, anionic detergent according to manufacturer's instructions. Using a soft non metallic brush, vigorously brush the mask parts until visibly clean, but not for less than 10 seconds. Rinse by submerging ...and agitating for at least 10 seconds. Repeat rinse ...Disinfection or Sterilization: High Level Thermal Disinfection ...Soak in a water bath or run a disinfection cycle in an automatic washer-disinfector using one of the time/temperature guides ...High Level Chemical Disinfection ...Immerse completely in an undiluted bath of Cidex OPA, Metricide OPA Plus, of Rapicide OPA/28 ...for 12 minutes ...Sterilization: Utilize a Sterrad NX, 100S or 100NX Sterilization System ...using the pouch method ...."

Manufacturer's document for ResMed CPAP masks titled "Disinfection Guide" identifies " ...This guide is intended for multi-patient re-use of the AirFit F30 full face mask in a sleep lab, clinic or hospital ..." The guide includes a table outlining how long to rinse each piece in water, followed by how long to soak each piece in an Alconox solution, to then clean each piece with a bristle brush for times from 1-2 minutes, then rinse each piece for 1 minute while vigorously agitating. The guide then identifies the disinfection process as " ...Soak the mask components in a hot water bath using the following temperature-time combinations. Ensure there are no air bubbles. o Cushion / frame / standard elbow 167°F (75°C) 30 minutes soak OR 194°F (90°C) 1 minute soak o Headgear 167°F (75°C) 30 minutes soak OR 200°F (93°C) 10 minutes soak ...."

Employee #15 confirmed in an interview on 03/02/2022, that all CPAP masks were multi patient use and between uses they were washed with soap and water in the sink and wiped with a germicidal wipe.

Development of EP Policies and Procedures

Tag No.: E0013

Based on review of the facility Emergency plan, record review and staff interview, it was determined, the facility failed to develop and implement certain CMS required emergency preparedness policies and procedures based on the Emergency Plan. Failure to develop policies and procedures related to processes for handling an emergency situation could cause potential harm to staff and patients if they are not aware of what they are expected to do.

Findings include:

Observation during the emergency plan review March 02, 2022 revealed The plan did not include all of the hazards identified on the facility based hazardous vulnerablity assessment (HVA).

Employees #1 and #2 conformed during the exit conference that the Emergency Plan did not include some emergency preparedness policiesthat were identified on the HVA.

Roles Under a Waiver Declared by Secretary

Tag No.: E0026

Based on review of the Emergency Plan (EP), facility record review, and interview, it was determined the facility failed to develop and implement emergency preparedness policies and procedures to describe its role in providing care at alternate care sites during an emergency. Failure to develop emergency policy and procedure at alternative care sites may cause harm to the residents during an emergency.


Findings include:

During emergency plan document review on March 02, 2022 it was revealed the facility's Emergency Plan related to the section which addresses policies and procedures did not include policies and procedures describing the facility's role in providing care and treatment at alternate care sites under an 1135 waiver.

Employee #1, #2 confirmed or acknowledged during an interview that the facility EP plan did not include policies and procedures describing the facility's role in providing care and treatment at alternate care sites under an 1135 waiver.