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Based on interview and document review, the hospital did not ensure documentation of effective oversight by the Governing Board that carried out the functions required of a Governing Board to provide a safe and secure environment for patients as evidenced by:

The hospital failed to ensure that Patient's rights were protected and promoted. (See A-0115)

The hospital failed to develop, implement, and maintain an effective, ongoing, hospital wide, data driven quality assessment and performance improvement program. (See A-0263).

The hospital did not ensure a well-organized or well-staffed nursing service to provide appropriate care and meet the needs of patients. (See A-0385).

The hospital did not ensure a pharmaceutical service that met the needs of patients. (See A-0489)

The hospital did not ensure an active hospital-wide program for the surveillance, prevention, and control of health acquired infections and other infectious diseases in accordance to nationally recognized infection prevention and control guidelines. (See A-0747).

A review of the Medical Staff Bylaws 2018 reviewed and approved December 8, 2017, was conducted on June 7, 2022, at 10:30 A.M. The Bylaws specified: The Medical Staff of [name of hospital] is responsible for the quality of medical care provided to patients, and for the ethical and professional conduct of its members. The Medical Staff must accept and discharge these responsibilities subject to the ultimate authority of the Governing Board and the cooperative efforts of the Medical Staff, the Chief Executive Officer, and the Governing Board are necessary to promote quality patient care and efficient operation of the Hospital.

A review of the Governing Board Reports dated October to December 2021 and January to March 2022 was conducted on June 7, 2022, at 2:00 P.M. The Infection control section of the Governing Board report for October to December 2021 and January to March 2022 documented MDRO (Multi drug resistant organism Candida Auris outbreak) however there was no documented data collection and analysis, of recommendation or action items specified by the Governing Body. The October to December 2021 and January to March reports stated medication administration and medication audit for errors was 100% compliant with zero errors, however investigation findings revealed that medication errors involving high risk medications Heparin and Coumadin (both blood thinners) were not documented in the GB report. The report did not document multiple instances of expired medications were identified on survey and were not removed from potential use by clinical staff. The report did not include documentation that respiratory and nursing staff were not documenting oral care for patients on ventilators every shift in accordance with hospital policy. Respiratory staff has not been documenting the ventilator filter changes every 48 hours in accordance with manufacturer and hospital policy. There was no documentation in the report of the lack of initial and ongoing competency training for nursing staff for preparing immediate use IV (intravenous) medications, Intensive Care Unit (ICU) nurse training in high-risk medication drips with multiple errors identified on survey and lack of documentation of Licensed Vocational Nurse (LVN) supervision by Registered Nurse (RN) assigned patients in the Intensive Care Unit (ICU).

A review of the Patient Safety and Reliability (PSR) dashboard dated 2022 was conducted on June 8, 2022, at 11:00 A.M. The dashboard documented an outbreak of C. Auris (Candida Auris a fungus), glo germ (a visual tool for teaching proper handwashing, aseptic techniques (collection of medical practices and procedures that helps protect patients from dangerous germs), general infection control, hand hygiene and adherence to PPE (Personal Protective Equipment) had opportunity for improvement. Under recommendations actions and follow up it was documented director rounds to "encourage an infection control". The responsible party was documented ICP (infection control professional), however there was nothing documented for due date or completion date. There was no documentation of data collection and analysis, description for mitigation plans or person responsible or time frames for measurements of success or performance improvement projects to improve patient outcomes.

A review of the Quality Council (QC) dashboard dated May 26, 2022 was conducted on June 8, 2022, at 3:25 P.M. The dashboard documented under QC recommendations "discussed the close antibiotic use monitoring. C Auris mitigation strategy. Opportunity to change current daily clean disinfectant oxivere to floor specific oxivere". Under new business documentation specified "RT's (Respiratory Therapists) need to go over responsibilities when having trach issues". No other high risk and problem prone issues were mentioned. There was no documentation of data collection and analysis, description for mitigation plans or person responsible or time frames for measurements of success or performance improvement projects to improve patient outcomes.

A review of the hospital's "Strategic Quality Operational Plan" dated 2021 was conducted on June 9, 2022, at 08:00 A.M. The plan specified "the ultimate responsibility for performance improvement rests with the Hospital Governing Board". The plan further specified "The quality council coordinates the performance improvement process by: Establishing a planned, systemic, organization-wide approach to performance improvement ...Ensuring that processes for identifying and managing serious and sentinel patient safety events are defined and implemented."

An interview was conducted with the Chief Executive Officer (CEO) on June 8, 2022, at 4:40 P.M. CEO stated a mitigation plan for the Candida Auris outbreak was approved and Implemented. The CEO acknowledged that the hospital GB minutes, PSR dashboard and the QC minutes lack documentation of data collection and analysis, measures for success of mitigation plan, executive responsibilities for oversight of actions, follow up and performance improvement projects for the identification and mitigation of high-risk problem prone issues.

An interview with Infection Control team (IDMD, ICP, DIC, IP) and CEO was conducted on June 9, 2022, at 2:00 P.M. Per the ICP the IC committee meets quarterly, unit surveillance reports are generated and presented to other committees. Main concerns are C. Auris, cleaning, hand hygiene and PPE compliance. Survey team brought up issues identified on survey such as Glucometers are not being disinfected per Policy after patient use, observed feces under nails of patient with Central line last month and have seen it again on this survey after the hospital had implemented a mitigation plan. Lack of documentation that Suction canisters are changed and one canister measured 1400 ml suction contents leading to potential for infections. Medication labeling not in accordance with policy and appropriate dating of multidose medication vials (potential for contamination), respiratory and nursing staff not documenting tracheostomy and oral care and no documentation of changing the vent filter leading to potential for respiratory infections. Central line dressing not documented as changed for several weeks, no documentation that nurses are trained and competent in preparing immediate use medications from night locker and aseptic technique. IDMD and ICP reviewed the PS&R, QC and GB reports and agreed that the reports did not document identification, data collection and analysis, performance improvement projects, executive responsibilities to provide mitigation plans or follow up for the high risk, problem prone issues that were identified on survey.

An interview with representatives of Governing Board GB/ Quality Committee (QC) committees was conducted on June 10, 2022, at 11:00 A.M., Past Chief of staff (PCS) stated the GB meet once a month, physicians, pharmacists, quality corporate repetitive also attend. QAPI is discussed in Quality Committee (QC). The Board encompasses direction of facility will review quality metrics, focusing on covid and C. Auris outbreak and antibiotic utilization. The CEO stated there is a problem in uploading data into the meeting minutes. The survey team mentioned issues identified on survey that are concern, lack of nurse training and competency for high-risk medication drips, and identified errors that nurses are not following drip protocols. ICUMD acknowledged problems with lack of training in ICU and LVN's lack of documentation of RN supervision, ICUMD stated nurse staffing shortages are impacting the issue. Many expired drugs in the pharmacy and on the nursing units, including expired covid vaccinations. Dir of Pharmacy stated the pharmacists should be responsible for checking expiration. Incorrect medication labeling of night locker meds (medications removed at night when the pharmacy is closed to prepare for patient administration by nursing staff). Lack of documentation of competencies for nurses mixing immediate use IV medications. Lack of aseptic technique competency documentation for nurses preparing IV medications. Concern regarding medication error rate documented on GB report was 0, however the patient safety reported medication errors. CEO stated that is a human error and the hospital is working to correct the inaccurate data to ensure it is correctly reported in the GB report. Representatives of the QC and GB committees acknowledged the lack of documented evidence of executive responsibilities for oversight by QAPI and GB for high risk and problem prone issues. There was no documentation of data collection and analysis, description for mitigation plans or person responsible or time frames for measurements of success or performance improvement projects to improve patient outcomes. No documented evidence is presented that shows GB is receiving any quality data collection or analysis, no documented action plans or performance improvement projects.

The cumulative effect of these systemic problems resulted in the facility's failure to deliver care in compliance with the Condition of Participation for Governing Board and failure to provide a safe and secure environment for patients.

Based on observations, interviews, and record reviews, the hospital failed to implement patient rights in accordance with acceptable standards of practice. This failure resulted in patient rights to be violated when:

1. A central venous catheter (CVC-a device that is inserted into a large vein for fluid and medication administration) access insertion was delayed related to unavailability of supply. (Refer to A-0129)

2. Different types of tube feeding formulas (liquid food to provide nourishment, fluids, and medications by bypassing oral intake through medical device) were provided without patient's representative knowledge. (Refer to A-0131)

3. In Unit 100, the crash cart (an emergency cart containing equipment, supplies, and medication used during a medical emergency) contained expired items. (Refer to A-0144)

4. In Unit 200, in the Medication Room, 14 vacutainers (blood collection tubes with colored rubber stoppers creating a vacuum seal inside of the tubes allowing predetermined amount of liquid to be drawn) were found to be expired. (Refer to A-0144)

5. In the Sterile Storage Room in the Operating Room area, 10 bags of one liter (L - unit of measurement for liquids) sterile water (irrigation solution used during procedures), five (5) burs (small surgical cutting tools), and six (6) Foley catheters (soft, plastic or rubber tube inserted into the bladder to drain urine) were found to be expired. (Refer to A-0144)

6. There was no competency documentation in a staff personnel record to show the training for the use of a glucometer, and care for patients receiving gastronomy enteral feeding (g-tube: tube placed directly through stomach to deliver food). (Refer to A-0208)

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on interview and document review, the hospital did not ensure documentation of the development, implementation, and maintenance of an effective, ongoing, hospital wide, data driven quality assessment and performance improvement program (QAPI) as evidenced by:

The hospital did not ensure high risk problem prone issues were identified and the collection of data and analysis of these issues was documented. (See A-0273)

The hospital did not ensure documentation of high-risk, high-volume, or problem prone areas that affect health outcomes, patient safety, and quality of care were identified, tracked, or documentation of performance improvement actions were implemented and monitored for sustained improvement. (See A-0283).

The hospital did not ensure documentation of Governing Board's oversight of performance improvement activities that tracked medical errors and adverse patient events, analyze their causes, and implement preventive actions. (See A-0286).

The hospital did not ensure documentation that the hospital conducted performance improvement projects that reflected the scope and complexity of the hospital. (See A-0297).

The hospital did not ensure documentation of executive responsibilities regarding a hospital- wide ongoing program for quality improvement and patient safety addressing improved quality of care reduction of medical errors, was defined, implemented, and maintained. (See A-0309).

A review of Medical Executive Committee MEC meeting minutes dated quarter 1, May 26, 2022 agenda included: credentialing, OPPE (Ongoing Professional Practice Evaluation), Peer Review, CDPH (California Department of Public Health) findings: HAI (Health Acquired Infection) Candida Auris outbreak (fungus), environment deficiency, infection control, patient safety and medication administration complaints. Documented under QC (Quality Council) section recommendations: all issues were addressed within time frame. There was no documentation of data collection and analysis, description for mitigation plans or person responsible or time frames for measurements of success or performance improvement projects to improve patient outcomes.

A review of the Patient Safety and Reliability (PSR) dashboard dated 2022 was conducted on June 8, 2022, at 11:00 A.M. The dashboard documented an outbreak of C. Auris (Candida Auris a fungus), glo germ ( a visual tool for teaching proper handwashing, aseptic techniques (collection of medical practices and procedures that helps protect patients from dangerous germs), general infection control, hand hygiene and adherence to PPE (Personal Protective Equipment) had opportunity for improvement. Under recommendations actions and follow up it was documented director rounds to "encourage an infection control". The responsible party was documented ICP (infection control professional), however there was nothing documented for due date or completion date. There was no documentation of data collection and analysis, description for mitigation plans or person responsible or time frames for measurements of success or performance improvement projects to improve patient outcomes.

A review of the Quality Council (QC) dashboard dated 5/26/22 was conducted on June 8, 2022, at 3:25 P.M. The dashboard documented under QC recommendations "discussed the close antibiotic use monitoring. C Auris mitigation strategy. opportunity to change current daily clean disinfectant oxivere to floor specific oxivere". Under new business documentation specified "RT's (Respiratory Therapists) need to go over responsibilities when having trach issues". No other high risk and problem prone issues were mentioned. There was no documentation of data collection and analysis, description for mitigation plans or person responsible or time frames for measurements of success or performance improvement projects to improve patient outcomes.

An interview was conducted with the Chief Executive Officer (CEO) on June 8, 2022, at 4:40 P.M. CEO stated a mitigation plan for the Candida Auris outbreak was approved and Implemented. The CEO acknowledged that the hospital GB minutes, PSR dashboard and the QC minutes lack documentation of data collection and analysis, measures for success of mitigation plan, executive responsibilities for oversight of actions, follow up and performance improvement projects for the identification and mitigation of high-risk problem prone issues.

An interview with Infection Control team (IDMD, ICP, DIC, IP) and CEO was conducted on June 9, 2022, at 2:00 P.M. Per the ICP the IC committee meets quarterly, unit surveillance reports are generated and presented to other committees. Main concerns are C. Auris, cleaning, hand hygiene and PPE compliance. Survey team brought up issues identified on survey such as Glucometers are not being disinfected per Policy after patient use, observed feces under nails of patient with Central line last month and have seen it again on this survey after the hospital had implemented a mitigation plan. Lack of documentation that Suction canisters are changed and one canister measured 1400 ml suction contents leading to potential for infections. Medication labeling not in accordance with policy and appropriate dating of multidose medication vials (potential for contamination), respiratory and nursing staff not documenting tracheostomy and oral care and no documentation of changing the vent filter leading to potential for respiratory infections. Central line dressing not documented as changed for several weeks, no documentation that nurses are trained and competent in preparing immediate use medications from night locker and aseptic technique. IDMD and ICP reviewed the PS&R, QC and GB reports and agreed that the reports did not document identification, data collection and analysis, performance improvement projects, executive responsibilities to provide mitigation plans or follow up for the high risk, problem prone issues that were identified on survey.

An interview with representatives of Governing Board GB/ Quality Committee (QC) committees was conducted on June 10, 2022, at 11:00 A.M., Past Chief of staff (PCS) stated the GB meet once a month, physicians, pharmacists, quality corporate repetitive also attend. QAPI is discussed in Quality Committee (QC). The Board encompasses direction of facility will review quality metrics, focusing on covid and C. Auris outbreak and antibiotic utilization. The CEO stated there is a problem in uploading data into the meeting minutes. The survey team mentioned issues identified on survey that are concern, lack of nurse training and competency for high-risk medication drips, and identified errors that nurses are not following drip protocols. ICUMD acknowledged problems with lack of training in ICU and LVN's lack of documentation of RN supervision, ICUMD stated nurse staffing shortages are impacting the issue. Many expired drugs in the pharmacy and on the nursing units, including expired covid vaccinations. Dir of Pharmacy stated the pharmacists should be responsible for checking expiration. Incorrect medication labeling of night locker meds (medications removed at night when the pharmacy is closed to prepare for patient administration by nursing staff). Lack of documentation of competencies for nurses mixing immediate use IV medications. Lack of aseptic technique competency documentation for nurses preparing IV medications. Concern regarding medication error rate documented on GB report was 0, however the patient safety reported medication errors. CEO stated that is a human error and the hospital is working to correct the inaccurate data to ensure it is correctly reported in the GB report. Representatives of the QC and GB committees acknowledged the lack of documented evidence of executive responsibilities for oversight by QAPI and GB for high risk and problem prone issues. There was no documentation of data collection and analysis, description for mitigation plans or person responsible or time frames for measurements of success or performance improvement projects to improve patient outcomes. No documented evidence is presented that shows GB is receiving any quality data collection or analysis, no documented action plans or performance improvement projects.

The cumulative effect of the facility's failure to have a quality assurance system in place to ensure oversight of the hospital's quality and performance improvement program resulted in the facility's failure to deliver care in compliance with the Condition of Participation for QAPI and failure to provide care to their patients in a safe environment.

Based on observation, interview, and record review, the facility failed to maintain an organized Nursing Services to patients, when:

1. For one of 35 sampled patients (Patient 19), the nursing staff re-inserted a new gastrotomy tube (G-tube-a special tube that is placed directly into the stomach for food, fluids, and medications) without proper supervision and procedure documentation. (Refer A-0043 and A-0386)

2. For six (6) of 35 sampled patients (Patient 1, Patient 2, Patient 3, Patient 10, Patient 15, and Patient 16), the nursing staff did not document oral care provided every shift. (Refer A-0043 and A-0395)

3. For three (3) nursing staff (RN 5, RN 6, and LVN 3) did not have an initial critical care (a special training for nursing staff to take care of seriously or critically ill patients) competency training documentation before assigned to the Intensive Care Unit (ICU) area. (Refer A-0043 and A-0397)

4. For six (6) nursing staff (RN 2, RN3, RN 7, LVN 2, LVN 4, and LVN 5) did not have an annually updated critical care competency training and/or competency evaluation before assigned to the ICU area. (Refer A-0043 and A-0397)

5. For one (1) nursing staff (RN 12) did not have an annually updated Medical/Surgical (Med/Surg) and Telemetry (Tele-continuous electronic monitoring) competency training before assigned to assist in the Med/Surg and Tele area. (Refer A-0043 and A-0397)

6. For three of 35 sampled patients (Patient 1, Patient 21, and Patient 23), the nursing staff had no document evidence within the medical record of repositioning of patients every two hours (Refer A-0043 and A-0398)

7. For one of 35 sampled patients (Patient 19), the Nursing staff did not inform a responsible physician immediately in the event of patient's abnormal heart rate. (Refer A-0043 and A-0398)

8. For one of 35 sampled patients (Patient 14), the nursing staff did not administer a heparin lock flush (agent used to reduce blood clots) into a central line (small catheter or tube placed into a vein close to the heart that can be used to give medicine, fluids, blood, nutrition, and draw blood) ordered by a physician. (Refer A-0043 and A-0398)

9. For three of 35 sampled patients (Patient 20, Patient 21, and Patient 25), Licensed Vocational Nurse (LVN) 7 did not identify patients and check g-tube placement prior to administering medication and did not properly disinfect glucometer after use. (Refer A-0043 and A-0398)

10. For one of 35 sampled patients (Patient 2), the nursing staff did not administer meropenum (antibiotic or medication to treat bacterial infection) as ordered. (Refer A-0043 and A-0405)

11. For two of 35 sampled patients (Patient 1 and Patient 6), the nursing staff did not administer insulin (medication to control blood sugar) as ordered. (Refer A-0043 and A-0405)

12. For one of 35 sampled patients (Patient 7), the nursing staff administered lorazepam (medication to relieve anxiety) and morphine (medication to relieve pain) with no clinical assessment before and/or after administering medication. (Refer A-0043 and A-0405)

13. For one of 35 sampled patients (Patient 16), the nursing staff did not administer Keppra (medication used to treat seizures) as ordered. (Refer A-0043 and A-0405)

14. For one of 35 sampled patients (Patient 17), the nursing staff administered an incorrect dose of Carvedilol (medication used to treat heart failure that lowers blood pressure and heart rate) not ordered by the physician and did not administer the medication as ordered. (Refer A-0043 and A-0405)

15. For one of 35 sampled patients (Patient 15), the nursing staff administered PRN (as needed) morphine (medication to treat pain) and metoprolol (medication used to treat high blood pressure) without documenting pre-assessments and/or post-assessments in the medical record. (Refer A-0043 and A-0405)

16. For one of 35 sampled patients (Patient 19), the nursing staff withheld medications without appropriate medical reason documentation. (Refer A-0043 and A-0405)

17. For one of 35 sampled patients (Patient 19), the nursing staff did not administer Larasidone (Latuda-medication to treat symptoms of mental disorder) as ordered and did not provide appropriate medical reason for omission. (Refer A-0043 and A-0405)

18. For one of 35 sampled patients (Patient 24), a medication was given earlier than the ordered frequency. (Refer A-0043 and A-0405)

19. For one of 35 sampled patients (Patient 25), a medication was omitted (not given) at the scheduled time. (Refer A-0043 and A-0405)

20. For one of 35 sampled patients (Patient 21), Licensed Vocational Nurse (LVN) 7 administered incorrect doses for lansoprazole (medication for acid reflux), atorvastatin (medication to lower cholesterol), and renal vitamin (vitamin for kidney) to PATIENT 21, nursing staff did not administer sevelamer (medication to decrease phosphate levels) to PATIENT 21 according to physician's order. (Refer A-0043 and A-0405)

21. For two of 35 sampled patients (Patient 20 and Patient 34), nursing staff did not administer heparin (blood thinner) according to the physician's order. (Refer A-0043 and A-0405)

22. For two of 35 sampled patients (Patient 1 and 4), there was no second licensed staff verification of heparin dosage, the nursing staff did not follow physician's order with starting dose and/or rate adjustment and did not clarify a physician's order. (Refer A-0043 and A-0406)

23. For one of 35 sampled patients (Patient 5), there was no central venous catheter (CVC-a device that is inserted into a large vein for fluid and medication administration) access for a vasoactive (a group of medications that has the effect of either increasing or decreasing blood pressure and/or heart rate) drug administration. (Refer A-0043 and A-0410)

24. For two of 35 sampled patients (Patient 2 and Patient 5), the nursing staff did not monitor and titrate (the process of adjusting the dose of a medication for the maximum benefit without adverse effects) down Dopamine (a medication to improve blood pressure) continuous IV infusion appropriately during high blood pressure (BP) measurements (any top number of blood pressure measurements above 130 considers high blood pressure). (Refer A-0043 and A-0410)

25. For one of 35 sampled patients (Patient 1 and Patient 6), the nursing staff did not start, monitor, and/or titrate Norepinephrine (Levophed-a medication to treat life-threatening low blood pressure) continuous IV infusion appropriately and as ordered. (Refer A-0043 and A-0410)

26. For one of 35 sampled patients (Patient 15), the nursing staff did not follow the physician's order for titrating morphine (medication to treat pain) IV drip (slow infusion of medication or fluids into the vein). (Refer A-0043 and A-0410)

27 For one of 35 sampled patients (Patient 8) a telephone consent was obtained without the signature of a second witness. (A-0043 and A-0466)

28. The Informed Consent was not signed by the patient/ patient's legal representative for one patient (Patient 22) in a universe of 35 sampled patients. (Refer A-0043 and A-0466)

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure safe and quality nursing care in a safe environment.

Based on observations, interview, and record review, the facility failed to ensure safe and effective pharmaceutical services to meet the needs of patients for a universe of 38 patients when:

1. The facility failed to meet the pharmaceutical needs of one (Patient 19) of 35 sampled patients when the hospital did not administer the patient's own medication (POM) Lurasidone (antipsychotic - drug to treat mental health or mood disorders) stored in the hospital as ordered by the prescriber due to inadequate communication between Nursing staff and the Pharmacy Department. (Refer to A-0043 and A-0490).

2. The facility failed to implement policies to minimize errors when:

a. The hospital failed to ensure safe compounding of intravenous (IV - into the patient's vein) drugs in accordance with the hospital's policies and procedures when nursing staff prepared and administered IV antibiotic medications afterhours when the pharmacy was closed to 2 patients (Patients PATIENT 32, PATIENT 33) without completing aseptic (germ-free) technique and applicable nursing competencies. (Refer to A-0043 and A-0491)

b. Oral vancomycin (antibiotic) was administered to PATIENT 20 for over 2 months without an indication (rationale for medication use or diagnosis). (Refer to A-0043 and A-0491)

c. When Staff Pharmacist 1 (SP 1) did not clarify nurse heparin (blood thinner) order for PATIENT 34. (Refer to A-0043 and A-0491)

3. The facility failed to promote safe patient care and prevent serious medication errors from unsafe Pharmacy dispensing practices when:

a. One (Patient 1) of 35 sampled patients experienced a warfarin (blood thinner) overdose when the Pharmacist entered the wrong dose in the computer system for the wrong patient.

b. One (Patient 4) of 35 sampled patients missed one dose of coumadin when the Pharmacist failed to enter the order in the computer system. (Refer to A-0043 and A-0500)

4. The facility failed to ensure the Pharmacy sterile (germ-free) compounding (mixing medications) procedures were consistent with current United States Pharmacopeia (USP - establishes quality standards for drugs and drug compounding in the United States) sterile compounding standards of practice when:

a. A formal written environmental sampling plan for airborne viable (living) particles (particles carrying living microbes such as bacteria or fungi) was not developed based on a risk assessment of compounding activities performed as required by the USP standard of practice. (Refer to A-0043 and A-0501)

b. The hospital could not demonstrate Gloved Fingertip Sampling (personnel competency assessment) was performed by two (Pharmacy Technician A and Pharmacy Technician B) of two Pharmacy staff with proper technique. (Refer to A-0043 and A-0501)

c. The hospital could not demonstrate Gloved Fingertip Sampling (personnel competency assessment) performed by one (Pharmacy Technician A) of two Pharmacy staff was incubated for the minimum timeframe as required by USP standard of practice. (Refer to A-0043 and A-0501)

5. The facility failed to ensure outdated (expired) and improperly labeled opened medications were not available for patient use when observed stored in the Pharmacy Department, the Medical-Surgical Nursing Unit (patients hospitalized for a wide variety of health conditions), and the Intensive Care Unit (critically ill patients) when (Refer to A-0043 and A-0505):

a. one (1) expired 1000 milliliters (a unit of measurement for volume) IV Fluid solution bag;
b. three (3) outdated aztreonam (antibiotic) medications;
c. three (3) outdated cefazolin (antibiotic) medications;
d. three (3) outdated ceftriaxone (antibiotic) medications;
e. two (2) outdated doxycycline (antibiotic) medications;
f. seven (7) outdated albuterol nebulizer (breathing treatment) ampules;
g. one (1) outdated multi-dose Lantus (insulin) vial;
h. one (1) vial outdated Janssen (manufacturer) COVID-19 (disease) vaccine;
i. ten (10) vials outdated Moderna (manufacturer) COVID-19 vaccine;
j. one (1) vial outdated Pfizer-BioNTech (manufacturer) COVID-19 vaccine;
k. one (1) opened and improperly unlabeled Humulin N (insulin) vial;
l. two (2) opened and improperly unlabeled Humalog (insulin) vial;

6. The facility failed to ensure information relating to drug interactions (reaction between drugs or between drugs and food, beverage, or supplements that can lead to patient harm) and information of drug therapy was available to nursing staff when nursing stuff could not access Micromedex (online drug reference) to look up drug information and 2015-2016 PharMerica (healthcare company) drug book did not have information for drug in question. (Refer to A-0043 and A-0510)

These failures resulted in severe bleeding from a warfarin overdose for Patient 1 and four medication omissions (missed doses) for Patient 19. These failures had the potential for lack of administrative oversight, potential for Patient 19 to experience preventable mental health exacerbations and psychological distress, potential for Patient 34 experiencing medication errors due to no clarification of an unclear medication order, potential for Patient 20 receiving an unnecessary medication resulting in adverse clinical outcomes and developing antibiotic resistance, patients being administered outdated and deteriorated (reduced quality) medications resulting adverse clinical outcomes or ineffective treatments; lack of staff access to current and up-to-date drug information to provide safe patient care, unreliable or a lack of competency evaluations for nursing and pharmacy staff, preventable infections due to cross-contamination, and/or inadequate risk assessment to determine the quality of the pharmacy compounding environment for a universe of 38 patients.

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on interview, and record review, the facility failed to ensure the infection prevention control program demonstrate adherence and control the transmission of infectious diseases including Hospital Acquired Infections (HAIs) when:

1. For six (6) of 35 sampled patients (Patient 1, Patient 2, Patient 7, Patient 8, Patient 15, and Patient 16), the hospital failed to control and prevent the transmission of Candida Auris (C. Auris-fungal infection). (Refer to A-0043 and A-0749)

2. For one (1) of 35 sampled patients (Patient 6), two (2) suction canisters were observed with liquid components and unknown of last date changed. (Refer to A-0043 and A-0750)

3. For one (1) of 35 sampled patients (Patient 16), central line (small catheter or tube placed into a vein close to the heart that can be used to give medicine, fluids, blood, nutrition, and draw blood) assessments and dressing changes were not done routinely. (Refer to A-0043 and A-0750)

4. For one (1) of 35 sampled patients (Patient 14), Dried, black grime was observed underneath patient's fingernails who was grabbing at an existing central line. (Refer to A-0043 and A-0750)

5. The competence of five of five Licensed Vocational Nurses (LVN 2, LVN 10, LVN 11, LVN 12, and LVN 13) and five of five Registered Nurses (RN 16, RN 17, RN 18, RN 19, and RN 20) were not assessed on annual basis. (Refer to A-0043 and A-0775)

6. The competence of Registered Nurses (RN 10, RN 14, and RN 15) were not assessed for initial employment and orientation. (Refer to A-0043 and A-0775)

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure safe and quality infection control program.

Based on interview, and record review, the facility failed to ensure all respiratory care services were provided in accordance with acceptable standards of practice when:

1. For five of 35 sampled patients (Patient 1, Patient 2, Patient 3, Patient 6, and Patient 15), Heat Moisture Exchanger (HME-a device used to help prevent drying of secretion and filter air) were not documented of being changed every 48 hours. (Refer A-0043 and A-1164)

2. For five of 35 sampled patients (Patient 1, Patient 2, and Patient 3, Patient 10, and Patient 23), tracheostomy (trach - a tube placed into the trachea via the neck to assist with breathing) and/or oral (mouth) care were not documented in the medical record every shift. (Refer A-0043 and A-0386)

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure safe and quality respiratory care services.

Based on interview and record review, the facility failed to ensure patient received a reasonable treatment requested for service when a central venous catheter (CVC-a device that is inserted into a large vein for fluid and medication administration) access insertion was delayed related to unavailability of supply for one of 35 sampled patients (Patient 1).

This failure had resulted in delay of patient's care which could potentially compromise patient's condition that needed fluid and medication administration through intravenous (IV-into the vein) access.

Findings:

A review of Patient 1's "History and Physical (H&P)," dated December 9, 2021, at 6:34 PM, the H&P showed, Patient 1 was admitted into the facility for continuation of care related to coronary artery occlusion (blockage in the artery that delivers blood and oxygen to patient's heart), status post thrombectomy (a type of surgery to remove clot from inside an artery), cerebrovascular accident (stroke-loss of blood flow to the brain), chronic anticoagulation (a group of medications to help prevent blood clots) with Heparin (medication to help prevent blood clot), and diabetes (a condition that body cannot control blood sugar).

During an interview, on June 7, 2022, at 9:40 AM, in the Intensive Care Unit (ICU), with the Director of Central Supply and Purchasing (DCSP), the DCSP stated, he oversees in the ordering of supplies and makes sure of their availability. The DCSP stated, he was not aware of an unavailable supply of the central line kit.

A review of Patient 1's "Nurses notes," dated February 9, 2022, at 2:55 PM, showed, the CVC at the right internal jugular (IJ-neck vein) vein was discontinued and removed, on February 9, 2022, at 2:51 PM.

A review of Patient 1's "Physician Orders," dated February 10, 2022, at 2:12 AM, showed, Patient 1 had an order for a CVC insertion.

During a review of Patient 1's "Nurses notes," for "Change of Condition (COC): Central line insertion," dated February 10, 2022, at 3:10 PM, on June 10, 2022, at 9:05 AM, with the SDCO, the "Nurses notes," for COC showed Patient 1 had "no IV line," and a physician attempted to insert a CVC but "there were no available supplies."

A follow-up interview, on June 10, 2022, at 9:20 AM, with the SDCO, the SDCO verified and confirmed, there was a "delay" in patient care. The SDCO stated, the nursing staff should report to the supervisor and request the supply. The SDCO further stated, the facility should always have available supplies for patient care, and it is an acceptable patient's right to receive necessity care and supplies.

A review of the facility's policies and procedures (P&P) titled, "Core: Patient Rights and Responsibilities," release date June 2019, the P&P indicated as follow:

"Purpose: this policy establishes guidelines to provide an environment that both respects and protects the rights of patients and patients' families; and to conduct all activities related to care with primary concern for the values and dignity of patients ...
Policy: the policy of [Hospital Name] is to ensure the following:
1. The list of Patient Rights and Responsibilities (PRR) is provided to each patient at admission as part of the admission packet. The PRR prints from [Electronic Medical Record Program] as a part of the admission package ..."

A review of the facility's document titled, "Patient's Rights and Responsibilities," not dated, indicated as follow:

"[Hospital Name] and its medical staff have adopted these Patient's Rights in the belief and with the expectation that understanding, and observation of the rights will result in more effective patient care and in promotion of the confidence and trust which must exist between the patient, the physician, and [Hospital Name] ...
9. The right to reasonable responses to any reasonable requests made for service ..."



45413

Based on interview and record review, the facility failed to ensure patient's representative was informed and involved in care planning when a different type of tube feeding formulas (liquid food to provide nourishment, fluids, and medications by bypassing oral intake through medical device) was provided without patient's representative knowledge for one of 35 sampled patients (Patient 1).

This failure resulted in no communication between patient's family and healthcare team and had the potential to interfere with patient's family inability to follow and participate in the treatment plan.

Findings:

A review of Patient 1's "History and Physical (H&P)," dated December 9, 2021, at 6:34 PM, the H&P showed, Patient 1 was admitted into the facility for continuation of care related to coronary artery occlusion (blockage in the artery that delivers blood and oxygen to patient's heart), status post thrombectomy (a type of surgery to remove clot from inside an artery), cerebrovascular accident (stroke-loss of blood flow to the brain), chronic anticoagulation (a group of medications to help prevent blood clots) with Heparin (medication to help prevent blood clot), and diabetes (a condition that body cannot control blood sugar).

A review of Patient 1's "Physician Orders," for tube feeding, on June 10, 2022, at 9:50 AM, in the board room, with the Senior Director of Clinical Operation (SDCO), the "Physician Orders" for tube feeding showed as follow:

On December 10, 2022, at 9:02 AM: the Nepro (one type of tube feeding formulars) was ordered to be given to Patient 1.

On December 18, 2022, at 7:15 PM: the Vital 1.5 (one type of tube feeding formulars) was ordered to be given to Patient 1 as a substitute for Nepro.

On December 20, 2022, at 1:31 PM, the TwoCal HN (one type of tube feeding formulars) was ordered to be given to Patient 1 and to switch back to "Nepro once it becomes available."

A follow-up interview, on June 10, 2022, at 9:55 AM, with the SDCO, the SDCO verified and confirmed, there were different types of tube feeding formular ordered for Patient 1 from December 10, 2021, through January 8, 2022. The SDCO stated, she was unable to find any documentation to indication patient's family was notified or educated about the frequent change in diet order.

During an interview, on June 14, 2022, at 9:55 AM, with the Director of Nutrition and Culinary Service (DNCS), the DNCS stated, she remembered the incident since the facility had a problem with the tube feeding supply shortage and patient had to change to different types of tube feeding formulars.

A follow-up concurrent interview and record review, on June 14, 2022, at 10:15 AM, with the DNCS, Patient 1's "Nutrition reassessment," dated January 14, 2022, at 3:50 PM, was reviewed. The "Nutrition reassessment" showed, "Patient's son by bedside; aware of therapeutic EN [Enteral Nutrition or tube feeding] formula." The DNCS verified and confirmed, on January 14, 2022, was the first documentation for family's notification regarding tube feeding. The DNCS stated, family should be informed as soon as possible regarding the change so family can participate in the treatment plan.

A review of the facility's policies and procedures (P&P) titled, "Core: Patient Rights and Responsibilities," release date June 2019, the P&P indicated as follow:

"Purpose: this policy establishes guidelines to provide an environment that both respects and protects the rights of patients and patients' families; and to conduct all activities related to care with primary concern for the values and dignity of patients ...
Policy: the policy of [Hospital Name] is to ensure the following:
1. The list of Patient Rights and Responsibilities (PRR) is provided to each patient at admission as part of the admission packet. The PRR prints from [Electronic Medical Record Program] as a part of the admission package ..."

A review of the facility's document titled, "Patient's Rights and Responsibilities," not dated, indicated as follow:

"[Hospital Name] and its medical staff have adopted these Patient's Rights in the belief and with the expectation that understanding and observation of the rights will result in more effective patient care and in promotion of the confidence and trust which must exist between the patient, the physician, and [Hospital Name] ...
4. The right to receive information about the illness, course of treatment, and prospects for recovery in terms that the patient can understand.
5. The right to receive as much information about any proposed treatment or procedure the patient may need in order to give informed consent or to refuse this course of treatment. Except in emergencies, this information shall include a description of the procedure or treatment, the medically significant risks involved in this treatment, alternate courses of treatment or non-treatment, and the risks involved in each, and the name of the person who will carry out the procedure or treatment.
6. The right to participate actively in decisions regarding medical care. To the extent permitted by law, this includes the right to refuse treatment ..."

Based on observation and interview, the facility failed to ensure the medications and/or necessary equipment are safe, maintained, and readily available for use when:

1. In Unit 100, the crash cart (an emergency cart containing equipment, supplies, and medication used during a medical emergency) contained expired items.

2. In Unit 200, in the Medication Room, 14 vacutainers (blood collection tubes with colored rubber stoppers creating a vacuum seal inside of the tubes allowing predetermined amount of liquid to be drawn) were found to be expired.

3. In the Sterile Storage Room in the Operating Room area, 10 bags of one liter (L - unit of measurement for liquids) sterile water (irrigation solution used during procedures), five (5) burs (small surgical cutting tools), and six (6) Foley catheters (soft, plastic or rubber tube inserted into the bladder to drain urine) were found to be expired.

These failures had the potential to result in unsafe care provided to patients with beyond the use date (expired) supplies, which could potentially cause infection, injuries, and/or death to medically compromised patients.

4. Four equipment items were found with expired preventive maintenance (PM) stickers and one equipment without a PM sticker and were available to be used for patient care in a universe of 38 patients.

This failure resulted in overdue preventative maintenance (PM) equipment being used for patient care and had the potential to cause physical harm and injury to patients from malfunction of the equipment, which could negatively affect patients' health and safety and lead to prolonged hospitalization and/or death.

Findings:


45050

1. During a concurrent observation and interview on June 7, 2022, at 09:45 AM, with the Director of Nursing (DON), in Unit 100, the DON confirmed the following items were found inside the crash cart to be expired:

One vial of Amiodarone (medication to treat heart rhythm problems) 450 milligrams (mg-unit of measurement) with expiration date of May 2022,

One vial of Amiodarone 9 milliliter (unit of measurement) with an expiration date of May 2022,

Two [Brand name] 18-gauge (size of the hole in the needle) needles with an expiration date of July 31, 2021,

Two [Brand name] 22-gauge needles with expiration date on May 31, 2022,

Two [Brand name] 24-gauge needles with expiration date on April 30, 2022, and May 31, 2022

The DON stated the expired items should not be in the crash cart.

During an interview on June 7, 2022, at 10:20 AM, with the Pharmacy Technician (PhT C), PhT C stated, the pharmacy technician should check the crash cart each month for any expired medications and should change and/or replace the items as needed.

During a review of the facility policy and procedure titled, "Crash Cart Availability and Contents" with a revision date February 2012, the Policy and Procedure showed the following:

"PURPOSE: To ensure availability of appropriate supplies to effectively resuscitate a cardiac or respiratory arrest.
POLICY: It is the policy of [Hospital Name] that all crash carts shall be stocked and available for
emergency use in any area of the hospital.
PERFORMED BY:
Licensed Nurses, Pharmacist, and Central Supply Technician
PROCEDURE:
A. Crash cart protocol ...
B. Crash cart contents: see attached list
C. Staff responsibilities
5. Pharmacy shall be responsible for checking their medication tray and expiration date."



42294

2. During a concurrent observation and interview, on June 7, 2022, at 12:20 PM, in Unit 200 Medication Room, with the DON, Infection Preventionist (IP), and Licensed Vocational Nurse (LVN 8), medications and supplies were checked for integrity and expiration dates, and found the following:

12 vacutainers with blue rubber stoppers with an expiration date of March 31, 2022,

One (1) vacutainer with a blue rubber stopper with an expiration date of June 1, 2022,

One (1) vacutainer with a yellow rubber stopper with an expiration date of March 15, 2022.

The DON, IP, and LVN 8 confirmed the vacutainers were expired.

During an interview, on June 14, 2022, at 9:40 AM, in the conference room, with Registered Nurse (RN 11), RN 11 stated she sometimes needs draw a patient's labs (blood draw). RN 11 stated she obtains supplies for lab draws from the medication room and was not aware lab tubes had expiration dates.

During a review of the facility's policy and procedure (P&P) titled, "Purchasing and Inventory Control 14.0," n.d., the P&P indicated,
"Purpose: To ensure consistent and accurate financial reporting, as well as ethical practices and regulatory compliance with regard to purchasing and inventory control.
Scope
This policy applies to all [Facility name] hospitals.
General:
14.1 Introduction
The Purchasing and Inventory Control section provides policies and procedures for the ordering, receiving and management of patient chargeable and non-chargeable supplies, equipment and services .....
14.21 Central Supply, Obsolete, Excessive and Expired Inventory
Excessive, obsolete and expired inventory will be identified and managed on a timely basis.
- The Materials Manager identifies obsolete, excessive or expired inventory, and segregates them from other supplies located in the storeroom ....
- The Materials Manager issues all expired items out of the system to the related expense account. The Manager determines if the vendor accepts returns of expired items. Items are then either returned to the vendor, or disposed if not accepted by vendor..."

3. During a concurrent observation and interview, on June 7, 2022, at 2:30 PM, in the OR Sterile Storage Room, with the Director of Operating Room (DOR), the following items were checked for integrity and expiration dates and found the following:

10 bags of one (1) L sterile water with expiration date of January 2022,

One (1) bur with expiration date of February 1, 2022,

four (4) burs with expiration date of June 1, 2022, and

Six (6) Foley catheters with an expiration date of May 31, 2022.

The DOR confirmed the supplies were expired.

During a review of the facility's policy and procedure (P&P) titled, "Purchasing and Inventory Control 14.0," n.d., the P&P indicated,
"Purpose: To ensure consistent and accurate financial reporting, as well as ethical practices and regulatory compliance with regard to purchasing and inventory control.
Scope
This policy applies to all [Facility name] hospitals.
General:
14.1 Introduction
The Purchasing and Inventory Control section provides policies and procedures for the ordering, receiving and management of patient chargeable and non-chargeable supplies, equipment and services .....
14.21 Central Supply, Obsolete, Excessive and Expired Inventory
Excessive, obsolete and expired inventory will be identified and managed on a timely basis.
- The Materials Manager identifies obsolete, excessive or expired inventory, and segregates them from other supplies located in the storeroom ....
- The Materials Manager issues all expired items out of the system to the related expense account. The Manager determines if the vendor accepts returns of expired items. Items are then either returned to the vendor, or disposed if not accepted by vendor..."



45413

4. During a concurrent observation and interview, on June 7, 2022, at 10:00 AM, in Unit 200, with the Director of Central Supply and Purchasing (DCSP), the following was observed:

In room 208, a Kangaroo pump's (a medical device used to provide liquid food for nourishment, fluids, and medications bypassing oral intake) PM sticker showed an expiration date of September 2021,

In room 213, a pulse oximeter (a medical device to measure oxygen level), in use, the PM sticker showed an expiration date of April 2022,

In room 214, an Intravenous (IV-into the vein) pump's (a medical device to provide fluid and medication into the vein) PM sticker showed an expiration date of April 2022.

In the hallway, outside Room 214, the following was found:

A portable monitor(a) was charging with PM sticker showed an expiration date of March 2022, and

A portable monitor(b) was charging without a PM sticker present.

The DCSP confirmed the above equipment with the PM stickers showed expiration dates, and the pulse oximeter and portable monitors are currently being used. The DCSP stated, PM should be completed by the due date. All equipment should have a PM sticker to show the equipment has been checked and serviced.

During an interview, on June 14, 2022, at 10:30 AM, in the board room via an online meeting, with the Area Service Manager (ASM), the ASM stated, PM frequency is generated electronically using a risk-based scoring system. All incoming equipment receives an inspection and is updated with a PM sticker. PM due dates and service requests are all tracked in the computerized maintenance management system. It is important to keep equipment up to date with maintenance for patient safety and availability for users. PM stated, it was an oversight failure for not maintaining equipment.

A review of the facility's policies and procedures (P&P) titled, "Medical Equipment Management Plan (MEMP)," release date June 2020, indicated as follows:

"Purpose: This policy establishes guidelines for the medical equipment management plan. The Medical Equipment Management Plan (MEMP) is designed to assure selection of appropriate medical equipment to support the medical care processes of Kindred Healthcare (Hospital Division) and to assure effective preparation of staff responsible for the use or maintenance and repair of the equipment. Finally, the program is designed to assure continual availability of safe, effective equipment through a program of planned maintenance, timely repair, ongoing education and training, and evaluation of all events that could have an adverse impact on the safety of patients or staff.
Policy: The policy of Kindred Hospital is to ensure the following:
1. Objectives
a. Preventive Maintenance (PM) Compliance - PM compliance will be tracked and managed to meet established departmental targets of 100% for high-risk devices and for non-high-risk devices ...
2. Medical Equipment Management Processes ...
1) An inventory of all MEMP equipment is maintained in the primary Biomedical Equipment (BME) service provider's computerized maintenance management systems (CMMS). This inventory includes equipment identification information as well as PM frequencies and last inspection dates ...
2) The completion target is 100% within the month they are assigned. PM inspection shall be deemed "on time" if it is completed within the month of the scheduled PM or within 15 days prior to the month of the scheduled PM ...

Based on observations, interview and record review, the hospital failed to document in the staff personnel records the training and demonstration of competency for the use of a glucometer for one of 35 sampled patients (Patient 25), and care for patients receiving gastronomy enteral feeding (g-tube: tube placed directly through stomach to deliver food) for three of 35 sampled patients was successfully completed by Licensed Vocational Nurse 7 (LVN 7).

This failure had resulted in a glucometer not being disinfected according to manufacturer specification which increase the risk of cross contamination amongst patients, and had the potential for aspiration and peritonitis (redness and swelling of the lining of your belly or abdomen) with improperly g-tube medication administration.

Findings:

During a medication pass observation, on June 8, 2022, at 9:07 AM, with LVN 7 in the Med Surg Unit 100, LVN 7 was observed administering one (1) medication via g-tube to PATIENT 20, without first checking for g-tube placement. At 9:50 AM, LVN 7 was observed administering four (4) medications via g-tube to PATIENT 21, without first check for g-tube placement. At 10:04 AM, LVN 7 was observed administering three (3) medications via g-tube to PATIENT 25 without first elevating PATIENT 25's head and checking for g-tube placement.

During an interview, on June 8, 2022, at 12:04 PM, with LVN 7, LVN 7 acknowledged she did not check for g-tube placement prior to administering medications to PATIENT 20, PATIENT 21, and PATIENT 25. LVN 7 stated the importance of checking for g-tube placement prior to administering medications was, "To make sure it's in the stomach and not out, medication can go out of the stomach, and the patient would not be able to absorb the medication, probably would not get therapeutic effect of the medication." LVN 7 also acknowledged she did not elevate PATIENT 25's head prior to administering the medications and did not notice Patient 25's head of the bed was not elevated 30 degrees. LVN 7 stated patients can aspirate if the head of the bed is not elevated 30 degrees.

During a medication pass observation, on June 8, 2022, at 2:36 PM, with LVN 7 in the Med Surg Unit 100, LVN 7 was observed wiping a glucometer for less than 1 minute with Sani-Cloth Germicidal (kills germs) disposable wipes, after checking PATIENT 21's blood sugar. When asked about the wet time (time that a disinfectant needs to stay wet on a surface to ensure efficacy), LVN 7 reviewed the manufacturer instructions for the disinfecting wipes, and stated it was for 1 minute. LVN 7 acknowledged she did not allow the manufacturer specified wet time of 1 minute when disinfecting the glucometer after patient care. LVN 7 acknowledged the risk of infection, stating it could spread contamination from room to room ... and could spread disease from patient to patient.

A review of the Sani-Cloth Germicidal disposable wipe instructions showed "To disinfect: Unfold a clean wipe and thoroughly wet surface. Allow treated surface to remain wet for (1) minute."

During an interview, on June 8, 2022, at 2:52 PM, with Registered Nurse (RN) 8, RN 8 stated the expectation was for nursing staff to check for placement of the g-tube. RN 8 stated, "You can end up giving patient Peritonitis from medication entering peritoneal cavity, the clinical outcome could be death." RN 8 stated nursing staff was expected to ensure the patient is positioned a minimum of 30 degrees prior to medication administration. RN 8 stated the degrees can be seen at the side of the bed, and If not positioned correctly, the patient could aspirate, get aspiration pneumonia and it can cause cardiac arrest.

During an interview, on June 8, 2022, at 3:18 PM, with RN 8, RN 8 stated it was important to appropriately disinfect for infection control. RN 8 stated, "You can introduce another infection to patient, which could extend their stay or cause death depending on how immune compromised they are."

During an interview, on June 8, 2022, at 3:40 PM, with the Director of Nursing (DON), the DON stated glucometer training and g-tube care training for LVN 7 was scheduled for June 16, 2022, through June 18, 2022.

During an interview, on June 8, 2022, at 3:43 PM, with the Chief Executive Officer (CEO), the CEO stated LVN 7 was a rehire as of April 26, 2022.

During a concurrent record review and interview, on June 8, 2022, at 3:57 PM, with Employee Health Nurse (EHN), LVN 7's personnel records were reviewed. EHN stated glucometer training was conducted online annually, and a "Nova Stat Strip Paper" Quiz was conducted on paper with observation before nursing was granted access to glucometer machine. EHN stated the "LVN medical/surgical/Tele Unit Competency Skills Validation Form" completed on May 7, 2022, was the only competency training completed since LVN 7 was rehired in April 2022 and acknowledged the form did not have g-tube placement or glucometer care listed as part of the training. Additionally, EHN acknowledged the form was signed by LVN 6, another licensed vocational nurse who was not an educator. EHN stated, "It's important for nurses to get training so they know what they are doing on floor in regard to patient care."

During an interview, on June 8, 2022, at 4:28 PM, with RN 8, RN 8 stated the expectation was for nursing staff to be competent so they can provide safe care to patients.

During a concurrent record review and interview, on June 8, 2022, at 4:37 PM, with LVN 7, LVN 7's personnel records were reviewed. LVN 7 was unable to provide training and demonstration of competency for the use of a glucometer, and care for patients receiving g-tube feeding. LVN 7 stated that she did not receive competency training on g-tube placement or glucometer care upon rehire in April 2022.

During a review of the hospital's Policy and Procedure (P&P) titled, "Evaluation & Verification of Competency" dated January 2007, the P&P stated, "The competence of the staff members is assessed at but not limited to the following periods: ...annually thereafter ... nursing and respiratory therapy personnel are required to successfully complete standardized competency assessment examinations prior to unsupervised direct patient care of medication administration."

Based on interview and document review, the hospital did not ensure high risk problem prone issues were identified and the collection of data and analysis of these issues was documented. As a result, opportunities for improvement could be missed and potentially could result in adverse patient outcomes.

Findings:

Review of Medical executive committee MEC meeting minutes dated quarter 1, May 26, 2022 was conducted on June 8, 2022, at 9:30 A.M. The agenda included: credentialing, OPPE (Ongoing Professional Practice Evaluation), Peer Review, CDPH (California Department of Public Health) findings: HAI (Health Acquired Infection) Candida Auris outbreak (fungus), environment deficiency, infection control, patient safety and medication administration complaints. Documented under QC (Quality Council) recommendations: all issues were addressed within time frame. There was no documentation of data collection and analysis, description for mitigation plans or person responsible or time frames for measurements of success or performance improvement projects to improve patient outcomes.

A review of the Patient Safety and Reliability (PSR) dashboard dated 2022 was conducted on June 8, 2022, at 11:00 A.M. The dashboard documented an outbreak of C. Auris (Candida Auris a fungus), glo germ (a visual tool for teaching proper handwashing, aseptic techniques (collection of medical practices and procedures that helps protect patients from dangerous germs), general infection control, hand hygiene and adherence to PPE (Personal Protective Equipment) had opportunity for improvement. Under recommendations actions and follow up it was documented director rounds to "encourage an infection control". The responsible party was documented ICP (infection control professional), however there was nothing documented for due date or completion date. There was no documentation of data collection and analysis, description for mitigation plans or person responsible or time frames for measurements of success or performance improvement projects to improve patient outcomes.

A review of the Quality Council (QC) dashboard dated May 26, 2022, was conducted on June 8, 2022, at 3:25 P.M. The dashboard documented under QC recommendations "discussed the close antibiotic use monitoring. C Auris mitigation strategy. opportunity to change current daily clean disinfectant oxivere to floor specific oxivere". Under new business documentation specified "RT's (Respiratory Therapists) need to go over responsibilities when having trach issues". No other high risk and problem prone issues were mentioned. There was no documentation of data collection and analysis, description for mitigation plans or person responsible or time frames for measurements of success or performance improvement projects to improve patient outcomes.

An interview was conducted with the Chief Executive Officer (CEO) on June 8, 2022, at 4:40 P.M. CEO stated a mitigation plan for the Candida Auris outbreak was approved and Implemented. The CEO acknowledged that the hospital GB minutes, PSR dashboard and the QC minutes lack documentation of data collection and analysis, measures for success of mitigation plan, executive responsibilities for oversight of actions, follow up and performance improvement projects for the identification and mitigation of high-risk problem prone issues.

A review of the hospital's "Strategic Quality Operational Plan" dated 2021 was conducted on June 9, 2022, at 08:00 A.M. The plan specified "the ultimate responsibility for performance improvement rests with the Hospital Governing Board". The plan further specified "The quality council coordinates the performance improvement process by: Establishing a planned, systemic, organization-wide approach to performance improvement ...Ensuring that processes for identifying and managing serious and sentinel patient safety events are defined and implemented."

An interview with Infection Control team (IDMD, ICP, DIC, IP) and CEO was conducted on June 9, 2022, at 2:00 P.M. Per the ICP the IC committee meets quarterly, unit surveillance reports are generated and presented to other committees. Main concerns are C. Auris, cleaning, hand hygiene and PPE compliance. Survey team brought up issues identified on survey such as Glucometers are not being disinfected per Policy after patient use, observed feces under nails of patient with Central line last month and have seen it again on this survey after the hospital had implemented a mitigation plan. Lack of documentation that Suction canisters are changed and one canister measured 1400 ml suction contents leading to potential for infections. Medication labeling not in accordance with policy and appropriate dating of multidose medication vials (potential for contamination), respiratory and nursing staff not documenting tracheostomy and oral care and no documentation of changing the vent filter leading to potential for respiratory infections. Central line dressing not documented as changed for several weeks, no documentation that nurses are trained and competent in preparing immediate use medications from night locker and aseptic technique. IDMD and ICP reviewed the PS&R, QC and GB reports and acknowledged that the reports did not document identification of high risk problem prone areas affecting patient care, data collection and analysis, performance improvement projects, executive responsibilities to provide mitigation plans or follow up for the high risk, problem prone issues that were identified on survey.

Based on interview and document review, the hospital did not ensure documentation of the identification and collection of data regarding high-risk problem prone areas that affect patient care, and the documentation of implementation of performance improvement to improve patient outcomes. As a result, potential opportunities for improvement could be missed that could lead to adverse patient outcomes.

Findings:

A review of Medical executive committee MEC meeting minutes dated quarter 1, May 26, 2022, was conducted on June 8, 2022, at 9:30 A.M. The agenda included: credentialing, OPPE (Ongoing Professional Practice Evaluation), Peer Review, CDPH (California Department of Public Health) findings: HAI (Health Acquired Infection) Candida Auris outbreak (fungus), environment deficiency, infection control, patient safety and medication administration complaints. Documented under QC (Quality Council) recommendations: all issues were addressed within time frame. There was no documentation of data collection and analysis, description for mitigation plans or person responsible or time frames for measurements of success or performance improvement projects to improve patient outcomes.

A review of the Patient Safety and Reliability (PSR) dashboard dated 2022 was conducted on June 8, 2022, at 11:00 A.M. The dashboard documented an outbreak of C. Auris (Candida Auris a fungus), glo germ (a visual tool for teaching proper handwashing, aseptic techniques (collection of medical practices and procedures that helps protect patients from dangerous germs), general infection control, hand hygiene and adherence to PPE (Personal Protective Equipment) had opportunity for improvement. Under recommendations actions and follow up it was documented director rounds to "encourage an infection control". The responsible party was documented ICP (infection control professional), however there was nothing documented for due date or completion date. There was no documentation of data collection and analysis, description for mitigation plans or person responsible or time frames for measurements of success or performance improvement projects to improve patient outcomes.

A review of the Quality Council (QC) dashboard dated May 26, 2022, was conducted on June 8, 2022, at 3:25 P.M. The dashboard documented under QC recommendations "discussed the close antibiotic use monitoring. C Auris mitigation strategy. opportunity to change current daily clean disinfectant oxivere to floor specific oxivere". Under new business documentation specified "RT's (Respiratory Therapists) need to go over responsibilities when having trach issues". No other high risk and problem prone issues were mentioned. There was no documentation of data collection and analysis, description for mitigation plans or person responsible or time frames for measurements of success or performance improvement projects to improve patient outcomes.

An interview was conducted with the Chief Executive Officer (CEO) on June 8, 2022, at 4:40 P.M. CEO stated a mitigation plan for the Candida Auris outbreak was approved and Implemented. The CEO acknowledged that the hospital GB minutes, PSR dashboard and the QC minutes lack documentation of data collection and analysis, measures for success of mitigation plan, executive responsibilities for oversight of actions, follow up and performance improvement projects for the identification and mitigation of high-risk problem prone issues.

A review of the hospital's "Strategic Quality Operational Plan" dated 2021 was conducted on June 9, 2022, at 08:00 A.M. The plan specified "the ultimate responsibility for performance improvement rests with the Hospital Governing Board". The plan further specified "The quality council coordinates the performance improvement process by: Establishing a planned, systemic, organization-wide approach to performance improvement ...Ensuring that processes for identifying and managing serious and sentinel patient safety events are defined and implemented."

An interview with Infection Control team (IDMD, ICP, DIC, IP) and CEO was conducted on June 9, 2022, at 2:00 P.M. Per the ICP the IC committee meets quarterly, unit surveillance reports are generated and presented to other committees. Main concerns are C. Auris, cleaning, hand hygiene and PPE compliance. Survey team brought up issues identified on survey such as Glucometers are not being disinfected per Policy after patient use, observed feces under nails of patient with Central line last month and have seen it again on this survey after the hospital had implemented a mitigation plan. Lack of documentation that Suction canisters are changed and one canister measured 1400 ml suction contents leading to potential for infections. Medication labeling not in accordance with policy and appropriate dating of multidose medication vials (potential for contamination), respiratory and nursing staff not documenting tracheostomy and oral care and no documentation of changing the vent filter leading to potential for respiratory infections. Central line dressing not documented as changed for several weeks, no documentation that nurses are trained and competent in preparing immediate use medications from night locker and aseptic technique. IDMD and ICP reviewed the PS&R, QC and GB reports and agreed that the reports did not document identification of high-risk problem prone areas affecting patient care, data collection and analysis of quality indicators, performance improvement projects, executive responsibilities to provide mitigation plans or follow up for the high risk, problem prone issues that were identified on survey.

Based on interview and document review, The hospital did not ensure documentation of Governing Board's oversight of Performance improvement activities that tracked medical errors and adverse patient events, analyze their causes, and implement preventive actions. As a result, opportunities for improvement potentially could be missed resulting in adverse patient outcomes.

Findings:

A review of Medical executive committee MEC meeting minutes dated quarter 1, May 26, 2022, was conducted on June 8, 2022, at 9:30 A.M. The agenda included: credentialing, OPPE (Ongoing Professional Practice Evaluation), Peer Review, CDPH (California Department of Public Health) findings: HAI (Health Acquired Infection) Candida Auris outbreak (fungus), environment deficiency, infection control, patient safety and medication administration complaints. Documented under QC (Quality Council) recommendations: all issues were addressed within time frame. There was no documentation of data collection and analysis, description for mitigation plans or person responsible or time frames for measurements of success or performance improvement projects to track patient medical errors and adverse patient events or improve patient outcomes.

A review of the Patient Safety and Reliability (PSR) dashboard dated 2022 was conducted on June 8, 2022, at 11:00 A.M. The dashboard documented an outbreak of C. Auris (Candida Auris a fungus), glo germ (a visual tool for teaching proper handwashing, aseptic techniques (collection of medical practices and procedures that helps protect patients from dangerous germs), general infection control, hand hygiene and adherence to PPE (Personal Protective Equipment) had opportunity for improvement. Under recommendations actions and follow up it was documented director rounds to "encourage an infection control". The responsible party was documented ICP (infection control professional), however there was nothing documented for due date or completion date. There was no documentation of data collection and analysis, description for mitigation plans or person responsible or time frames for measurements of success or performance improvement projects to improve patient outcomes.

A review of the Quality Council (QC) dashboard dated May 26, 2022, was conducted on June 8, 2022, at 3:25 P.M. The dashboard documented under QC recommendations "discussed the close antibiotic use monitoring. C Auris mitigation strategy. opportunity to change current daily clean disinfectant oxivere to floor specific oxivere". Under new business documentation specified "RT's (Respiratory Therapists) need to go over responsibilities when having trach issues". No other high risk and problem prone issues were mentioned. There was no documentation of data collection and analysis, description for mitigation plans or person responsible or time frames for measurements of success or performance improvement projects to improve patient outcomes.

An interview was conducted with the Chief Executive Officer (CEO) on June 8, 2022, at 4:40 P.M. CEO stated a mitigation plan for the Candida Auris outbreak was approved and Implemented. The CEO acknowledged that the hospital GB minutes, PSR dashboard and the QC minutes lack documentation of data collection and analysis, measures for success of mitigation plan, executive responsibilities for oversight of actions, follow up and performance improvement projects for the identification and mitigation of high-risk problem prone issues.

A review of the hospital's "Strategic Quality Operational Plan" dated 2021 was conducted on June 9, 2022, at 08:00 A.M. The plan specified "the ultimate responsibility for performance improvement rests with the Hospital Governing Board". The plan further specified "The quality council coordinates the performance improvement process by: Establishing a planned, systemic, organization-wide approach to performance improvement ...Ensuring that processes for identifying and managing serious and sentinel patient safety events are defined and implemented."

An interview with Infection Control team (IDMD, ICP, DIC, IP) and CEO was conducted on June 9, 2022, at 2:00 P.M. Per the ICP the IC committee meets quarterly, unit surveillance reports are generated and presented to other committees. Main concerns are C. Auris, cleaning, hand hygiene and PPE compliance. Survey team brought up issues identified on survey such as Glucometers are not being disinfected per Policy after patient use, observed feces under nails of patient with Central line last month and have seen it again on this survey after the hospital had implemented a mitigation plan. Lack of documentation that Suction canisters are changed and one canister measured 1400 ml suction contents leading to potential for infections. Medication labeling not in accordance with policy and appropriate dating of multidose medication vials (potential for contamination), respiratory and nursing staff not documenting tracheostomy and oral care and no documentation of changing the vent filter leading to potential for respiratory infections. Central line dressing not documented as changed for several weeks, no documentation that nurses are trained and competent in preparing immediate use medications from night locker and aseptic technique. IDMD and ICP reviewed the PS&R, QC and GB reports and acknowledged that the reports did not document identification of high-risk problem prone areas affecting patient care, data collection and analysis, performance improvement activities that tracked medical errors and adverse patient events, analyze their causes, and implement preventive actions.

Based on interview and document review, the hospital did not ensure documentation that the hospital conducted performance improvement projects that reflected the scope and complexity of the hospital. As a result, opportunities for improvement were potentially missed and could result in adverse patient outcomes.

Findings:

A review of Medical executive committee MEC meeting minutes dated quarter 1, May 26, 2022, was conducted on June 8, 2022, at 9:30 A.M. The agenda included: credentialing, OPPE (Ongoing Professional Practice Evaluation), Peer Review, CDPH (California Department of Public Health) findings: HAI (Health Acquired Infection) Candida Auris outbreak (fungus), environment deficiency, infection control, patient safety and medication administration complaints. Documented under QC (Quality Council) recommendations: all issues were addressed within time frame. There was no documentation of data collection and analysis, description for mitigation plans or person responsible or time frames for measurements of success or performance improvement projects to improve patient outcomes.

A review of the Patient Safety and Reliability (PSR) dashboard dated 2022 was conducted on June 8, 2022, at 11:00 A.M. The dashboard documented an outbreak of C. Auris (Candida Auris a fungus), glo germ (a visual tool for teaching proper handwashing, aseptic techniques (collection of medical practices and procedures that helps protect patients from dangerous germs), general infection control, hand hygiene and adherence to PPE (Personal Protective Equipment) had opportunity for improvement. Under recommendations actions and follow up it was documented director rounds to "encourage an infection control". The responsible party was documented ICP (infection control professional), however there was nothing documented for due date or completion date. There was no documentation of data collection and analysis, description for mitigation plans or person responsible or time frames for measurements of success or performance improvement projects to improve patient outcomes.

A review of the Quality Council (QC) dashboard dated May 26, 2022, was conducted on June 8, 2022, at 3:25 P.M. The dashboard documented under QC recommendations "discussed the close antibiotic use monitoring. C Auris mitigation strategy. opportunity to change current daily clean disinfectant oxivere to floor specific oxivere". Under new business documentation specified "RT's (Respiratory Therapists) need to go over responsibilities when having trach issues". No other high risk and problem prone issues were mentioned. There was no documentation of data collection and analysis, description for mitigation plans or person responsible or time frames for measurements of success or performance improvement projects to improve patient outcomes.

An interview was conducted with the Chief Executive Officer (CEO) on June 8, 2022, at 4:40 P.M. CEO stated a mitigation plan for the Candida Auris outbreak was approved and Implemented. The CEO acknowledged that the hospital GB minutes, PSR dashboard and the QC minutes lack documentation of data collection and analysis, measures for success of mitigation plan, executive responsibilities for oversight of actions, follow up and performance improvement projects for the identification and mitigation of high-risk problem prone issues.

A review of the hospital's "Strategic Quality Operational Plan" dated 2021 was conducted on June 9, 2022, at 08:00 A.M. The plan specified "the ultimate responsibility for performance improvement rests with the Hospital Governing Board". The plan further specified "The quality council coordinates the performance improvement process by: Establishing a planned, systemic, organization-wide approach to performance improvement ...Ensuring that processes for identifying and managing serious and sentinel patient safety events are defined and implemented."

An interview with Infection Control team (IDMD, ICP, DIC, IP) and CEO was conducted on June 9, 2022, at 2:00 P.M. Per the ICP the IC committee meets quarterly, unit surveillance reports are generated and presented to other committees. Main concerns are C. Auris, cleaning, hand hygiene and PPE compliance. Survey team brought up issues identified on survey such as Glucometers are not being disinfected per Policy after patient use, observed feces under nails of patient with Central line last month and have seen it again on this survey after the hospital had implemented a mitigation plan. Lack of documentation that Suction canisters are changed and one canister measured 1400 ml suction contents leading to potential for infections. Medication labeling not in accordance with policy and appropriate dating of multidose medication vials (potential for contamination), respiratory and nursing staff not documenting tracheostomy and oral care and no documentation of changing the vent filter leading to potential for respiratory infections. Central line dressing not documented as changed for several weeks, no documentation that nurses are trained and competent in preparing immediate use medications from night locker and aseptic technique. IDMD and ICP reviewed the PS&R, QC and GB reports and acknowledged that the reports did not document identification of high-risk problem prone areas affecting patient care, data collection and analysis and performance improvement projects that reflected the scope and complexity of the hospital.

Based on interview and document review, the hospital did not ensure documentation of executive responsibilities regarding a hospital wide ongoing program for quality improvement and patient safety addressing improved quality of care reduction of medical errors, was defined, implemented, and maintained. As a result, opportunities for improvement potentially were missed which could lead to adverse patient outcomes.

Findings:

A review of Medical executive committee MEC meeting minutes dated quarter 1, May 26, 2022 was conducted on June 8, 2022, at 9:30 A.M. The agenda included: credentialing, OPPE (Ongoing Professional Practice Evaluation), Peer Review, CDPH (California Department of Public Health) findings: HAI (Health Acquired Infection) Candida Auris outbreak (fungus), environment deficiency, infection control, patient safety and medication administration complaints. Documented under QC (Quality Council) recommendations: all issues were addressed within time frame. There was no documentation of data collection and analysis, description for mitigation plans or person responsible or time frames for measurements of success or performance improvement projects to improve patient outcomes.

A review of the Patient Safety and Reliability (PSR) dashboard dated 2022 was conducted on June 8, 2022, at 11:00 A.M. The dashboard documented an outbreak of C. Auris (Candida Auris a fungus), glo germ (a visual tool for teaching proper handwashing, aseptic techniques (collection of medical practices and procedures that helps protect patients from dangerous germs), general infection control, hand hygiene and adherence to PPE (Personal Protective Equipment) had opportunity for improvement. Under recommendations actions and follow up it was documented director rounds to "encourage an infection control". The responsible party was documented ICP (infection control professional), however there was nothing documented for due date or completion date. There was no documentation of data collection and analysis, description for mitigation plans or person responsible or time frames for measurements of success or performance improvement projects to improve patient outcomes.

A review of the Quality Council (QC) dashboard dated May 26, 2022 was conducted on June 8, 2022, at 3:25 P.M. The dashboard documented under QC recommendations "discussed the close antibiotic use monitoring. C Auris mitigation strategy. opportunity to change current daily clean disinfectant oxivere to floor specific oxivere". Under new business documentation specified "RT's (Respiratory Therapists) need to go over responsibilities when having trach issues". No other high risk and problem prone issues were mentioned. There was no documentation of data collection and analysis, description for mitigation plans or person responsible or time frames for measurements of success or performance improvement projects to improve patient outcomes.

An interview was conducted with the Chief Executive Officer (CEO) on June 8, 2022, at 4:40 P.M. CEO stated a mitigation plan for the Candida Auris outbreak was approved and Implemented. The CEO acknowledged that the hospital GB minutes, PSR dashboard and the QC minutes lack documentation of data collection and analysis, measures for success of mitigation plan, executive responsibilities for oversight of actions, follow up and performance improvement projects for the identification and mitigation of high-risk problem prone issues.

A review of the hospital's "Strategic Quality Operational Plan" dated 2021 was conducted on June 9, 2022, at 08:00 A.M. The plan specified "the ultimate responsibility for performance improvement rests with the Hospital Governing Board". The plan further specified "The quality council coordinates the performance improvement process by: Establishing a planned, systemic, organization-wide approach to performance improvement ...Ensuring that processes for identifying and managing serious and sentinel patient safety events are defined and implemented."

An interview with Infection Control team (IDMD, ICP, DIC, IP) and CEO was conducted on June 9, 2022, at 2:00 P.M. Per the ICP the IC committee meets quarterly, unit surveillance reports are generated and presented to other committees. Main concerns are C. Auris, cleaning, hand hygiene and PPE compliance. Survey team brought up issues identified on survey such as Glucometers are not being disinfected per Policy after patient use, observed feces under nails of patient with Central line last month and have seen it again on this survey after the hospital had implemented a mitigation plan. Lack of documentation that Suction canisters are changed and one canister measured 1400 ml suction contents leading to potential for infections. Medication labeling not in accordance with policy and appropriate dating of multidose medication vials (potential for contamination), respiratory and nursing staff not documenting tracheostomy and oral care and no documentation of changing the vent filter leading to potential for respiratory infections. Central line dressing not documented as changed for several weeks, no documentation that nurses are trained and competent in preparing immediate use medications from night locker and aseptic technique. IDMD and ICP reviewed the PS&R, QC and GB reports and acknowledged that the reports did not document identification high risk problem prone areas affecting patient care, data collection and analysis, performance improvement projects. The leadership reports lacked documentation of executive responsibilities regarding a hospital wide ongoing program for quality improvement and patient safety addressing improved quality of care reduction of medical errors, was defined, implemented, and maintained.

Based on interview and record review, the facility failed to ensure the nursing service was supervised for providing appropriate care when the nursing staff re-inserted a new gastrotomy tube (G-tube-a special tube that is placed directly into the stomach for food, fluids, and medications) without proper supervision and procedure documentation for one of 35 sampled patients (Patient 19).

This failure had contributed to the dislodgement of the G tube that resulted in abdominal infection and had the potential to negatively impact Patient A's health and welfare.


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Findings:

During a review of Patient 19's "History and Physical (H&P)," dated May 20, 2022, the H&P indicated, with past medical history of osteoarthritis (degeneration of joint cartilage and the underlying bone, it causes pain and stiffness) who initially presented to [Hospital Name] Emergency Department on April 16, 2022, as a trauma alert, she was an auto versus pedestrian and was found down initially hypotensive (low blood pressure).

A review of Patient 19's "Nurses Notes," Gastrointestinal (related to stomach and intestines) assessment, dated September 15, 2020, at 12:10 PM, showed, the G tube placement was done at bedside by the surgery team.

During a concurrent interview and record review, on June 8, 2022, at 03:37 PM, with the Outcome Manager (OM), Patient 19's electronic medical record (EMR) was reviewed. The EMR showed, on October 14, 2020, Change of condition, Patient 19 pulled out the G-tube and Nursing staff reinserted a new G-tube. Per the facility's policy, a new G-tube "(approximately 2 to 6 weeks after placement) replacement should be done by a physician." The OM stated the G-tube was reinserted by the nursing staff. The OM confirmed, there was no procedure note documentation after the procedure completed.

During a review of Patient 19's "Invasive/ Operative procedures", dated October 17, 2020, the Invasive/ Operative procedures showed, the operative procedures include the following: exploratory laparotomy (surgical operation where the abdomen is opened and the abdominal organs are examined for injury), drainage of peritonitis (redness and swelling of the lining of the belly), lysis of adhesions (procedure that destroys scar tissue that is causing abdominal pain), new Gastrostomy tube placement (tube inserted through the wall of the abdomen directly into the stomach), placement of two (2) ten (10) flat Jackson Pratt drains (closed suction medical device that is used for collecting body fluids from surgical sites).

During an interview, on June 10, 2022, at 4:10 PM, in the board room, with the Director of Nursing (DON), the DON stated, the facility has been having issue with nursing services and she was unable to provide much assistance to any specific areas. The DON confirmed, there was oversight and competency issues with nursing staff. The DON stated, she expected the nursing staff would follow a physician's order and/or the facility's policies and procedures.

During a review of the facility's policy and procedure (P&P) titled "CORE: Naso, Gastric, and Jejunal Tube Management & Site Care" dated June 2021, the P&P indicated,

"PURPOSE
The policy established a guideline for naso, gastric, and jejunal tube site care.
POLICY
The policy of Kindred Hospital is to ensure the following:
1. Tube care performed at minimum daily and as needed
2. Signs and symptoms of infection or tube migration are immediately reported to the physician.
3. All site care and procedures are documented in the patient's medical record.
Definitions ...
Procedure: Site care for Naso Tube ...
PROCEDURE: SITE CARE FOR GASTROSTOMY OR JEJUNOSTOMY TUBE
15. Document the procedure.
a. Note the date and time that you performed exit site care.
b. Document the exit site care interventions.
c. Record the appearance of the exit site and whether you noted any signs of infection, such as
redness, swelling, and drainage.
d. If you observed signs of infection, document the date and time and the name of the practitioner notified. Record prescribed interventions and the patient's response to those interventions.
e. Document patient and family teaching, their understanding of the teaching provided, and whether they require follow-up teaching.
PROCEDURE : GASTROSTOMY TUBE REPLACEMENT
1. If the gastric tunnel and stoma are new (approximately 2 to 6 weeks after placement), replacement should be done by a physician. A registered nurse may replace older tubes. When tube replacement is necessary, reinsertion should occur within 6 hours to prevent stoma closure.
2. Notify physician to obtain an order.
16. Document all problems, interventions, and assessments in the Change of Condition section of the medical record. An event report should be completed."

A review of the facility's "Job Description," for the Director of Nursing and Clinical Service, not dated, indicated as follow:

"Summary: Directs and coordinates functions and activities of nursing department and assigned clinical operation departments. Consults with and advises Administrator on the general operation of the hospital. Develops nursing and clinical department's goals, objectives, standards of performance, policies and procedures. Organizes nursing and clinical departments according to administrative and nursing service guidelines; ensures compliance with legal, organizational, and medical staff standards. Has authority and responsibility for establishing, directing, and implementing the Standards of Nursing Practice and the clinical operations and financial matters related to all nursing and clinical care areas and functions ..."

Based on interview and record review, the facility failed to ensure the nursing staff supervised and evaluated the nursing care for patients' oral hygiene when the nursing staff did not document oral care provided every shift for six of 35 sampled patients (Patient 1, Patient 2, Patient 3, Patient 10, Patient 15, and Patient 16).

This failure had the potential to increase the risk of oral infection from bacterial growth such as tooth decay and gum disease which could jeopardize the patients' overall health condition and prolong hospitalization.

Findings:

a. A review of Patient 1's "History and Physical (H&P)," dated December 9, 2021, at 6:34 PM, the H&P showed, Patient 1 was admitted into the facility for continuation of care related to coronary artery occlusion (blockage in the artery that delivers blood and oxygen to patient's heart), status post thrombectomy (a type of surgery to remove clot from inside an artery), cerebrovascular accident (stroke-loss of blood flow to the brain), chronic anticoagulation (a group of medications to help prevent blood clots) with Heparin (medication to help prevent blood clot), and diabetes (a condition that body cannot control blood sugar).

A review of Patient 1's "Respiratory care," dated December 26, 2021, at 8:37 PM, showed, Patient 1 had a tracheostomy (trach - a tube placed into the trachea via the neck to assist with breathing), present upon admission.

During a concurrent interview and record review, on June 10, 2022, at 10:00 AM, in the board room, with the Senior Director of Clinical Operation (SDCO), Patient 1's "Nurses notes," for oral hygiene, dated February 6, 2022, through February 11, 2022, were reviewed. The "Nurses notes" for oral hygiene showed, the nursing staff did not complete oral care as follow:

On February 6, 2022: whole day
On February 7, 2022: whole day
On February 8, 2022: PM shift (7 PM to 7 AM)
On February 9, 2022: whole day
On February 10, 2022: whole day
On February 11, 2022: PM shift

The SDCO verified and confirmed, the nursing staff did not complete oral care every shift.

A follow-up interview, on June 10, 2022, at 10:05 AM, with the SDCO, the SDCO stated, she was unable to provide any additional documentation to show Patient 1 received oral care every shift. The SDCO further stated, the oral care should be completed once a shift for every airway-assisted (any devices to provide additional oxygen to patients) patient.

A review of the facility's policies and procedures (P&P) titled, "Core: Oral Hygiene for Airway Assisted Patients," release date June 2021, indicated as follow:

"Purpose: The purpose of this policy is to provide guidelines for oral hygiene of the artificial airway assisted patient or patients receiving continuous BiPAP [Bilevel positive airway pressure-a type of machine to deliver oxygen] therapy by mask.
Policy: the policy of [Hospital Name] is to ensure the following:
1. Oral hygiene will be provided to patients with artificial airways and to patients receiving continuous BiPAP therapy to address the risk factors associated with ventilator associated pneumonia (VAP-lung infection) through a comprehensive approach based on cleaning, debriding, suctioning and moisturizing the entire oral cavity ...
3. This protocol has been approved by the MEC and will be initiated as a component of a standard order ...
Procedure ...
6. Nursing
a. On the opposite 12 hours and PRN (e.g., 12a/12p) Nursing will: ...
v. Brush teeth, palate and gums with the suction toothbrush/swab using antiseptic/peroxide ..."

b. A review of Patient 2's H&P, dated January 26, 2022, the H&P showed, Patient 2 was admitted into the facility with the diagnoses including respiratory failure (a condition when lungs cannot get enough oxygen) with tracheostomy, urinary tract infection (UTI-an infection in any part of urinary system including kidneys, bladder, or urethra), and development delay.

During an interview, on June 8, 2022, at 3:45 PM, in the board room, with the SDCO, the SDCO stated, the nursing staff should perform oral care to non-airway-assisted patients as part of daily hygiene and do not need to get a physician's order. The SDCO further stated, the nursing staff need to document the completed oral care every day.

During a concurrent interview and record review, on June 8, 2022, at 5:30 PM, with the SDCO, Patient 2's "Nurses notes," for oral hygiene, dated April 1, 2022, through April 7, 2022, were reviewed. The "Nurses notes" for oral hygiene showed, the nursing staff did not complete oral care as follow:

On April 1, 2022: whole day
On April 2, 2022: whole day
On April 3, 2022: AM shift (7 AM to 7 PM)
On April 4, 2022: whole day
On April 5, 2022: whole day
On April 6, 2022: whole day
On April 7, 2022: whole day

The SDCO verified and confirmed, the nursing staff did not complete oral care every day. The SDCO stated, she was unable to provide any additional documentation to show Patient 2 received oral care with daily hygiene.

A review of the facility's P&P titled, "Core: Oral Hygiene for Airway Assisted Patients," release date June 2021, indicated as follow:

"Purpose: The purpose of this policy is to provide guidelines for oral hygiene of the artificial airway assisted patient or patients receiving continuous BiPAP [Bilevel positive airway pressure-a type of machine to deliver oxygen] therapy by mask.
Policy: the policy of [Hospital Name] is to ensure the following:
1. Oral hygiene will be provided to patients with artificial airways and to patients receiving continuous BiPAP therapy to address the risk factors associated with ventilator associated pneumonia (VAP-lung infection) through a comprehensive approach based on cleaning, debriding, suctioning and moisturizing the entire oral cavity ...
3. This protocol has been approved by the MEC and will be initiated as a component of a standard order ...
Procedure ...
6. Nursing
a. On the opposite 12 hours and PRN (e.g., 12a/12p) Nursing will: ...
v. Brush teeth, palate and gums with the suction toothbrush/swab using antiseptic/peroxide ..."

c. A review of Patient 3's H&P, dated November 30, 2021, the H&P showed, Patient 3 was admitted into the facility with diagnoses including respiratory failure, UTI, atrial fibrillation (abnormal heart rhythm), and congestive heart failure (CHF-a condition in which heart does not pump well to supply blood to body).

During an interview, on June 8, 2022, at 3:45 PM, in the board room, with the SDCO, the SDCO stated, the nursing staff should perform oral care to non-airway-assisted patients as part of daily hygiene and do not need to get a physician's order. The SDCO further stated, the nursing staff need to document the completed oral care every day.

During a concurrent interview and record review, on June 8, 2022, at 5:25 PM, with the SDCO, Patient 3's "Nurses notes," for oral hygiene, dated February 2, 2022, through February 9, 2022, were reviewed. The "Nurses notes" for oral hygiene showed, the nursing staff did not complete oral care as follow:

On February 2, 2022: whole day
On February 3, 2022: whole day
On February 5, 2022: whole day
On February 6, 2022: whole day
On February 7, 2022: whole day
On February 8, 2022: whole day
On February 9, 2022: whole day

The SDCO verified and confirmed, the nursing staff did not complete oral care every day. The SDCO stated, she was unable to provide any additional documentation to show Patient 3 received oral care with daily hygiene.

A review of the facility's P&P titled, "Core: Oral Hygiene for Airway Assisted Patients," release date June 2021, indicated as follow:

"Purpose: The purpose of this policy is to provide guidelines for oral hygiene of the artificial airway assisted patient or patients receiving continuous BiPAP [Bilevel positive airway pressure-a type of machine to deliver oxygen] therapy by mask.
Policy: the policy of [Hospital Name] is to ensure the following:
1. Oral hygiene will be provided to patients with artificial airways and to patients receiving continuous BiPAP therapy to address the risk factors associated with ventilator associated pneumonia (VAP-lung infection) through a comprehensive approach based on cleaning, debriding, suctioning and moisturizing the entire oral cavity ...
3. This protocol has been approved by the MEC and will be initiated as a component of a standard order ...
Procedure ...
6. Nursing
a. On the opposite 12 hours and PRN (e.g., 12a/12p) Nursing will: ...
v. Brush teeth, palate and gums with the suction toothbrush/swab using antiseptic/peroxide ..."



45413

d. A review of Patient 10's H&P, dated March 22, 2022, showed, Patient 10 was admitted to the facility with diagnoses including tracheostomy, multiple thoracic vertebral (bones that form spinal column) body fractures, subarachnoid hemorrhage (bleeding in the space between the brain the tissue covering), and intraparenchymal hemorrhage (bleeding in the brain) with midline shift.

During a concurrent interview and record review, on June 8, 2022, at 10:30 AM, in the board room, with the Clinical Analyst Administrator (CAA), Patient 10's "Nursing Flow Sheet," for oral care, dated March 22, 2022, through March 27, 2022, was reviewed. There was no documentation of oral care performed from March 22, 2022, through March 27, 2022. The CAA verified and confirmed, no documented oral care on the Nursing Flow Sheet or in the Nursing Progress notes to indicate that oral care was performed on the selected dates.

During an interview, on June 14, 2022, at 9:00 AM, with Registered Nurse 11 (RN 11), RN 11 stated, oral care is performed every shift for patients with a tracheostomy or ventilator (breathing machine) and it is documented in the medical record. RN 11 further stated, it is important to provide oral care to help prevent infection.

A review of the facility's policies and procedures (P&P) titled, "CORE: Oral Hygiene for airway Assisted Patients," release date June 2021, indicated as follows:
"Purpose: The purpose of this policy is to provide guidelines for oral hygiene of the artificial airway assisted patient or patients receiving continuous BiPAP therapy by mask.
Policy: The policy of Kindred Hospital is to ensure the following:
1. Oral hygiene will be provided to patients with artificial airways and to patients receiving continuous BiPAP therapy to address the risk factors associated with ventilator associated pneumonia (VAP) through a comprehensive approach based on cleaning, debriding, suctioning and moisturizing the entire oral cavity.
2. Oral hygiene will reduce bacterial colonization in the mouth and on the surface of the teeth of patients with artificial airways and patients receiving continuous BiPAP therapy ...
4. Unless clinical contraindications exist, the protocol will be initiated and continued when patients are admitted with an artificial airway, when an artificial airway is placed, or when continuous BiPAP therapy has been ordered.
5. A combined Respiratory Therapy and Nursing approach will allow for oral hygiene scheduled at 6 hour intervals in order to maintain an oral environment free from bacteria often associated with VAP ...
6. Nursing
a. On the opposite 12 hours and PRN (e.g. 12a/12p) Nursing will:
Gather supplies ...
Brush teeth, palate and gums with suction toothbrush/swab using antiseptic/peroxide rinse ...
7. Documentation ...
b. Documentation of the oral hygiene in general should be recorded in the specific discipline's chart sections (Respiratory or Nursing) ..."


42294

e. A review of Patient 15's H&P, dated March 18, 2022, indicated, Patient 15 was admitted for respiratory failure, post tracheostomy, and PEG (percutaneous endoscopic gastrostomy - procedure to place a feeding tube to provide nutrition directly to the stomach).

During a concurrent interview and record review, on June 9, 2022, at 9:30 AM, in the medical records office, with the Chief Clinical Officer (CCO), Patient 15's "Nurses notes," for Mouth care, dated April 17, 2022, through April 22, 2022, were reviewed. The CCO confirmed there was no mouth (oral) care provided by nursing during the following dates and times:

April 17, 2022: AM shift (7 AM to 7 PM)
April 18, 2022: AM shift and PM shift (7 PM to 7 AM)
April 19, 2022: AM shift and PM shift
April 22, 2022: AM shift and PM shift

The CCO also confirmed she was unable to find an order for nursing to provide oral care during the time reviewed.

During an interview, on June 14, 2022, at 9:03 AM, in the conference room, with RN 11, RN 11 stated oral care is done by nursing every shift and documented in the patient's medical record. RN 11 stated an order is required for nursing to provide mouth (oral) care and nurses document the oral care provided as a nursing action. RN 11 stated documentation of mouth care includes appearance of the mouth, lips and what type of oral care was provided. RN 11 further stated it is important to provide routine oral care for patients with a tracheostomy on a ventilator to prevent infection.

During a review of the facility's policy and procedure (P&P) titled, "Oral Hygiene for Airway Assisted Patients," dated June 2018, the P&P indicated,

"Purpose
The purpose of this policy is to provide guidelines for oral hygiene of the artificial airway assisted patient or patients receiving continuous BiPAP therapy.
Policy
The policy of [Name of Facility] is to ensure the following:
1. Oral hygiene will be provided to patients with artificial airways and to patients receiving continuous BiPAP therapy to address the risk factors associated with VAP through a comprehensive approach based on cleaning, debriding, suctioning and moisturizing the entire oral cavity.
2. Oral hygiene will reduce bacterial colonization in the mouth and on the surface of the teeth of patients with artificial airways and patients receiving continuous BiPAP therapy.
3. This protocol has been approved by the MEC and will be initiated as a component of a standard order.
4. Unless clinical contraindications exist, the protocol will be initiated and continued when patients are admitted with an artificial airway, when an artificial airway is placed, or when continuous BiPAP therapy has been ordered.
5. A combined Respiratory Therapy and Nursing approach will allow for oral hygiene scheduled at 6-hour intervals in order to maintain an oral environment free from bacteria often associated with VAP .....
Procedure
.... Nursing
1. On the opposite 12 hours and PRN (e.g. 12a/12p) Nursing will:
a. Prior to the intervention, explain and discuss the procedure with the patient.
b. Wash hands and don appropriate PPE.
c. Position patients head to the side or place in semi-fowler's position
d. Brush teeth, palate and gums with the suction toothbrush/swab using antiseptic/peroxide rinse
e. Brush for approximately 1-2 minutes, exerting gentle pressure while moving in short horizontal strokes
f. Apply mouth moisturizer to lips and mouth using applicator swab .....
Documentation
1. Documentation of the use of CHG must be recorded on the MAR (medication administration record).
2. Documentation of the oral hygiene in general should be recorded in the specific discipline's chart sections (Respiratory or Nursing).
3. Evidence of management of a Potential for Infection should be recorded in the patient's care plan ...."

f. A review of Patient 16's H&P, dated March 18, 2022, indicated, Patient 16 was admitted for respiratory failure, status post tracheostomy placement on March 1, 2022, with multiple medical problems which included cirrhosis (severe stage of liver disease affecting ability of liver to process nutrients, drugs, hormones, and natural toxins), intracranial bleed (bleeding within the skull), and seizure disorder (a brain disorder that can cause changes in behavior, movement, or feelings). The H&P also indicated Patient 16 was unresponsive and unable to contribute information regarding medical history.

During a concurrent interview and record review, on June 9, 2022, at 2:19 PM, in the medical records office, with the CCO, Patient 16's "Nurses notes," for mouth care, dated April 17, 2022, through April 22, 2022, were reviewed. The CCO confirmed there was no mouth (oral) care provided by nursing from April 17, 2022, through April 22, 2022. The CCO also confirmed she was unable to find an order for nursing to provide oral care during the time reviewed.

During an interview, on June 14, 2022, at 9:03 AM, in the conference room, with RN 11, RN 11 stated oral care is done by nursing every shift and documented in the patient's medical record. RN 11 stated an order is required for nursing to provide mouth care and nurses document the oral care provided as a nursing action. RN 11 stated documentation of mouth care includes appearance of the mouth, lips and what type of oral care was provided. RN 11 further stated it is important to provide routine oral care for patients with a tracheostomy on a ventilator to prevent infection.

During a review of the facility's P&P titled, "Oral Hygiene for Airway Assisted Patients," dated June 2018, the P&P indicated,

"Purpose
The purpose of this policy is to provide guidelines for oral hygiene of the artificial airway assisted patient or patients receiving continuous BiPAP therapy.
Policy
The policy of [Name of Facility] is to ensure the following:
1. Oral hygiene will be provided to patients with artificial airways and to patients receiving continuous BiPAP therapy to address the risk factors associated with VAP through a comprehensive approach based on cleaning, debriding, suctioning and moisturizing the entire oral cavity.
2. Oral hygiene will reduce bacterial colonization in the mouth and on the surface of the teeth of patients with artificial airways and patients receiving continuous BiPAP therapy.
3. This protocol has been approved by the MEC and will be initiated as a component of a standard order.
4. Unless clinical contraindications exist, the protocol will be initiated and continued when patients are admitted with an artificial airway, when an artificial airway is placed, or when continuous BiPAP therapy has been ordered.
5. A combined Respiratory Therapy and Nursing approach will allow for oral hygiene scheduled at 6-hour intervals in order to maintain an oral environment free from bacteria often associated with VAP .....
Procedure
.... Nursing
1. On the opposite 12 hours and PRN (e.g. 12a/12p) Nursing will:
a. Prior to the intervention, explain and discuss the procedure with the patient.
b. Wash hands and don appropriate PPE.
c. Position patients head to the side or place in semi-fowler's position
d. Brush teeth, palate and gums with the suction toothbrush/swab using antiseptic/peroxide rinse
e. Brush for approximately 1-2 minutes, exerting gentle pressure while moving in short horizontal strokes
f. Apply mouth moisturizer to lips and mouth using applicator swab .....
Documentation
1. Documentation of the use of CHG must be recorded on the MAR (medication administration record).
2. Documentation of the oral hygiene in general should be recorded in the specific discipline's chart sections (Respiratory or Nursing).
3. Evidence of management of a Potential for Infection should be recorded in the patient's care plan ...."

Based on interview, and record review, the facility failed to ensure the nursing staff was assigned to the area in accordance with their competency training for a universe of 38 patients when:

1. Three (3) nursing staff (RN 5, RN 6, and LVN 3) did not have an initial critical care (a special training for nursing staff to take care of seriously or critically ill patients) competency training documentation before assigned to the Intensive Care Unit (ICU) area.

2. Six (6) nursing staff (RN 2, RN3, RN 7, LVN 2, LVN 4, and LVN 5) did not have an annually updated critical care competency training and/or competency evaluation before assigned to the ICU area.

3. One (1) nursing staff (RN 12) did not have an annually updated Medical/Surgical (Med/Surg) and Telemetry (Tele-continuous electronic monitoring) competency training before assigned to assist in the Med/Surg and Tele area.

These failures had the potential to negatively affect patient's care due to incompetent or unqualified nursing staff such as preventable medication error, inaccurate assessment, and adjusting vasoactive (a group of medications that has the effect of either increasing or decreasing blood pressure and/or heart rate) medication without proper monitoring and/or known the effect of medication, which could harm patients' health and safety, causing prolonged hospitalization and/or lead up to death.

Findings:

1a. A review of "ICU Patient Care Assignment PM (7 PM to 7 AM)," dated June 1, 2022, showed RN 5 was assigned to an ICU patient.

During a concurrent interview and record review, on June 7, 2022, at 3 PM, in the board room, with the Senior Director of Clinical Operation (SDCO), RN 5's employee file, was reviewed. There was no critical care competency training. The SDCO stated, all nursing staff should have an initial critical care training including vasoactive medication before assign to the ICU area. The SDCO further stated, RN 5 was originally hired as a Med/Surg and Tele nurse before transferred to the ICU area on April 17, 2022.

During an interview, on June 9, 2022, at 5:10 PM, with RN 7, RN 7 stated, the facility does not have a current full time nursing educator and he would help introducing new nursing staff to the facility during orientation. RN 7 stated, he is an ICU nurse and sometimes he would be assigned as a nursing supervisor to oversee all nursing units. RN 7 verified and confirmed, the nursing staff should receive an initial as well as updated annual competency training to the unit they are assigned. RN 7 stated, he does not remember the last time he received his annual critical care competency, "it's been a while." RN 7 further stated, as a nursing supervisor, he assigned the nursing staff to different units. RN 7 stated, he has not seen a list of completed ICU competency nursing staff and would just rely on verbal confirmation from other nursing supervisors or nursing staff. RN 7 verified and confirmed, it was not appropriate to have LVN assigned to the ICU area without an oversight from RN and it was not appropriate for the nursing staff to be assigned to ICU patients without having initial critical care competency training.

During an interview, on June 10, 2022, at 4:10 PM, with the Director of Nurse (DON), the DON stated, the facility does not have a current full time nursing educator to provide training to nursing staff. The DON further stated it was difficult to keep track and oversight on all nursing competency training. The DON stated, the facility realizes many nursing staff do not have proper initial competency training. The DON confirmed, all nursing staff should have completed the competency to the assigned patient's care area.

A review of the facility's policies and procedures (P&P) titled, "CORE: Evaluation & Verification of Competency," release date June 2020, indicated as follows:

"Purpose: The purpose of this policy is to:
1. To assure that all individuals who work in the hospital demonstrate knowledge and skill to fulfill their assigned responsibilities.
2. Provide a method to measure the employee's performance based on objective data.
3. To validate competency on an on-going basis ...
Policy
1. Each member of the hospital staff is assigned clinical and/or managerial responsibilities based on educational preparation, applicable law and regulation, and an assessment of current competence. Components of the competency system include but are not limited to:
a. General Hospital Orientation and Department Specific Orientation
b. In-service Education
c. Continuing Education
d. Required Annual In-service (Unit/Department based)
e. Initial and Annual Competency Assessment/Skills Validation ...
4. The competence of staff members is assessed at but not limited to the following periods:
a. Initial employment and orientation.
b. Transfer to a new role (i.e., LPN to RN).
c. Prior to assignment to a new unit.
d. Change in job performance or job requirements.
e. At least semi-annually during the first year ...
g. Annually thereafter ...
5. Annual Competency Validation: ...
c. Specific departmental competencies will be selected annually, and as needed for revalidation. The annual Competency Worksheet may be utilized to identify role specific annual competencies ..."

1b. During a concurrent interview and record review, on June 7, 2022, at 3:15 PM, with the SDCO, the "ICU Patient Care Assignment," dated June 1, 2022, through June 6, 2022, were reviewed. The SDCO verified and confirmed there were many times Licensed Vocational Nurse (LVN) was assigned without RN oversight to patient's care including:

On June 1, 2022: AM shift (7 AM to 7 PM)
On June 2, 2022: AM shift
On June 3, 2022: AM shift: LVN 3 was assigned to an ICU patient, no RN oversight.
On June 4, 2022: AM shift
On June 6, 2022: AM shift

A follow-up concurrent interview and record review, on June 8, 2022, at 11:30 PM, with the SDCO, LVN 3's employee file, was reviewed. There was no critical care competency training. The SDCO stated, she was unable to provide any evidence of documentation to show LVN 3 received a critical care training.

During an interview, on June 9, 2022, at 5:10 PM, with RN 7, RN 7 stated, the facility does not have a current full time nursing educator and he would help introducing new nursing staff to the facility during orientation. RN 7 stated, he is an ICU nurse and sometimes he would be assigned as a nursing supervisor to oversee all nursing units. RN 7 verified and confirmed, the nursing staff should receive an initial as well as updated annual competency training to the unit they are assigned. RN 7 stated, he does not remember the last time he received his annual critical care competency, "it's been a while." RN 7 further stated, as a nursing supervisor, he assigned the nursing staff to different units. RN 7 stated, he has not seen a list of completed ICU competency nursing staff and would just rely on verbal confirmation from other nursing supervisors or nursing staff. RN 7 verified and confirmed, it was not appropriate to have LVN assigned to the ICU area without an oversight from RN and it was not appropriate for the nursing staff to be assigned to ICU patients without having initial critical care competency training.

During an interview, on June 10, 2022, at 4:10 PM, with the Director of Nurse (DON), the DON stated, the facility does not have a current full time nursing educator to provide training to nursing staff. The DON further stated it was difficult to keep track and oversight on all nursing competency training. The DON stated, the facility realizes many nursing staff do not have proper initial competency training. The DON confirmed, all nursing staff should have completed the competency to the assigned patient's care area.

A review of the facility's policies and procedures (P&P) titled, "CORE: Evaluation & Verification of Competency," release date June 2020, indicated as follows:

"Purpose: The purpose of this policy is to:
1. To assure that all individuals who work in the hospital demonstrate knowledge and skill to fulfill their assigned responsibilities.
2. Provide a method to measure the employee's performance based on objective data.
3. To validate competency on an on-going basis ...
Policy
1. Each member of the hospital staff is assigned clinical and/or managerial responsibilities based on educational preparation, applicable law and regulation, and an assessment of current competence. Components of the competency system include but are not limited to:
a. General Hospital Orientation and Department Specific Orientation
b. In-service Education
c. Continuing Education
d. Required Annual In-service (Unit/Department based)
e. Initial and Annual Competency Assessment/Skills Validation ...
4. The competence of staff members is assessed at but not limited to the following periods:
a. Initial employment and orientation.
b. Transfer to a new role (i.e., LPN to RN).
c. Prior to assignment to a new unit.
d. Change in job performance or job requirements.
e. At least semi-annually during the first year ...
g. Annually thereafter ...
5. Annual Competency Validation: ...
c. Specific departmental competencies will be selected annually, and as needed for revalidation. The annual Competency Worksheet may be utilized to identify role specific annual competencies ..."

1c. A review of "ICU Patient Care Assignment PM," dated June 2, 2022, showed, RN 6 was assigned to an ICU patient.

During a concurrent interview and record review, on June 8, 2022, at 2:25 PM, with the SDCO, RN 6's employee file, was reviewed. There was no critical care competency training.
The SDCO verified and confirmed, RN 6 did not have an initial critical care training on file. The SDCO further stated, the nursing staff should have received an initial as well as annually trained to their assigned area.

During an interview, on June 9, 2022, at 5:10 PM, with RN 7, RN 7 stated, the facility does not have a current full time nursing educator and he would help introducing new nursing staff to the facility during orientation. RN 7 stated, he is an ICU nurse and sometimes he would be assigned as a nursing supervisor to oversee all nursing units. RN 7 verified and confirmed, the nursing staff should receive an initial as well as updated annual competency training to the unit they are assigned. RN 7 stated, he does not remember the last time he received his annual critical care competency, "it's been a while." RN 7 further stated, as a nursing supervisor, he assigned the nursing staff to different units. RN 7 stated, he has not seen a list of completed ICU competency nursing staff and would just rely on verbal confirmation from other nursing supervisors or nursing staff. RN 7 verified and confirmed, it was not appropriate to have LVN assigned to the ICU area without an oversight from RN and it was not appropriate for the nursing staff to be assigned to ICU patients without having initial critical care competency training.

During an interview, on June 10, 2022, at 4:10 PM, with the Director of Nurse (DON), the DON stated, the facility does not have a current full time nursing educator to provide training to nursing staff. The DON further stated it was difficult to keep track and oversight on all nursing competency training. The DON stated, the facility realizes many nursing staff do not have proper initial competency training. The DON confirmed, all nursing staff should have completed the competency to the assigned patient's care area.

A review of the facility's policies and procedures (P&P) titled, "CORE: Evaluation & Verification of Competency," release date June 2020, indicated as follows:

"Purpose: The purpose of this policy is to:
1. To assure that all individuals who work in the hospital demonstrate knowledge and skill to fulfill their assigned responsibilities.
2. Provide a method to measure the employee's performance based on objective data.
3. To validate competency on an on-going basis ...
Policy
1. Each member of the hospital staff is assigned clinical and/or managerial responsibilities based on educational preparation, applicable law and regulation, and an assessment of current competence. Components of the competency system include but are not limited to:
a. General Hospital Orientation and Department Specific Orientation
b. In-service Education
c. Continuing Education
d. Required Annual In-service (Unit/Department based)
e. Initial and Annual Competency Assessment/Skills Validation ...
4. The competence of staff members is assessed at but not limited to the following periods:
a. Initial employment and orientation.
b. Transfer to a new role (i.e., LPN to RN).
c. Prior to assignment to a new unit.
d. Change in job performance or job requirements.
e. At least semi-annually during the first year ...
g. Annually thereafter ...
5. Annual Competency Validation: ...
c. Specific departmental competencies will be selected annually, and as needed for revalidation. The annual Competency Worksheet may be utilized to identify role specific annual competencies ..."

2a. During an interview, on June 7, 2022, in the ICU, with RN 3, RN 3 stated, he was hired as a Med/Surg and Tele nurse but always got transferred to ICU area. RN 3 stated, he does not remember receiving any critical care training prior to assign to the ICU area. RN 3 further stated, sometimes the unit would have an ICU experienced nurse to assist but many times he had to take care of all patient's care including monitoring and titrating Levophed infusion.

During a concurrent interview and record review, on June 7, 2022, at 3:10 PM, in the board room, with the SDCO, RN 3's employee file, was reviewed. RN 3's file showed critical care training was last completed on September 26, 2018. The SDCO stated, RN 3 should have received an updated ICU training annually.

During an interview, on June 9, 2022, at 5:10 PM, with RN 7, RN 7 stated, the facility does not have a current full time nursing educator and he would help introducing new nursing staff to the facility during orientation. RN 7 stated, he is an ICU nurse and sometimes he would be assigned as a nursing supervisor to oversee all nursing units. RN 7 verified and confirmed, the nursing staff should receive an initial as well as updated annual competency training to the unit they are assigned. RN 7 stated, he does not remember the last time he received his annual critical care competency, "it's been a while." RN 7 further stated, as a nursing supervisor, he assigned the nursing staff to different units. RN 7 stated, he has not seen a list of completed ICU competency nursing staff and would just rely on verbal confirmation from other nursing supervisors or nursing staff. RN 7 verified and confirmed, it was not appropriate to have an LVN assigned to the ICU area without an oversight from RN and it was not appropriate for the nursing staff to be assigned to ICU patients without having initial critical care competency training. RN 7 stated, most of ICU nursing staff are not up to date with annual ICU training.

During an interview, on June 10, 2022, at 4:10 PM, with the Director of Nurse (DON), the DON stated, the facility does not have a current full time nursing educator to provide training to nursing staff. The DON further stated it was difficult to keep track and oversight on all nursing competency training. The DON confirmed and stated, the facility has not been keeping up with annual competency for all nursing staff. The DON further stated, the facility has never verified or validated the nursing staff skills from a registry nurse agency. The DON confirmed, the facility would still be liable when a registry staff did not perform nursing responsibilities correctly or appropriately. The DON stated, all nursing staff should have completed the up-to-date annual competency to the assigned patient's care area.

A review of the facility's policies and procedures (P&P) titled, "CORE: Evaluation & Verification of Competency," release date June 2020, indicated as follows:

"Purpose: The purpose of this policy is to:
1. To assure that all individuals who work in the hospital demonstrate knowledge and skill to fulfill their assigned responsibilities.
2. Provide a method to measure the employee's performance based on objective data.
3. To validate competency on an on-going basis ...
Policy
1. Each member of the hospital staff is assigned clinical and/or managerial responsibilities based on educational preparation, applicable law and regulation, and an assessment of current competence. Components of the competency system include but are not limited to:
a. General Hospital Orientation and Department Specific Orientation
b. In-service Education
c. Continuing Education
d. Required Annual In-service (Unit/Department based)
e. Initial and Annual Competency Assessment/Skills Validation ...
4. The competence of staff members is assessed at but not limited to the following periods:
a. Initial employment and orientation.
b. Transfer to a new role (i.e., LPN to RN).
c. Prior to assignment to a new unit.
d. Change in job performance or job requirements.
e. At least semi-annually during the first year ...
g. Annually thereafter ...
5. Annual Competency Validation: ...
c. Specific departmental competencies will be selected annually, and as needed for revalidation. The annual Competency Worksheet may be utilized to identify role specific annual competencies ..."

2b. During a concurrent interview and record review, on June 7, 2022, at 3:15 PM, with the SDCO, the "ICU Patient Care Assignment," dated June 1, 2022, through June 6, 2022, were reviewed. The SDCO verified and confirmed there were many times an LVN was assigned without RN oversight to patient's care including:

On June 1, 2022: AM shift: LVN 2 was assigned to an ICU patient, no RN oversight
On June 2, 2022: AM shift: LVN 4 was assigned to two (2) ICU patient
On June 3, 2022: AM shift
On June 4, 2022: AM shift: LVN 5 was assigned to an ICU patient
On June 6, 2022: AM shift

A follow-up concurrent interview and record review, on June 7, 2022, at 3:25 PM, with the SDCO, LVN 2's employee file, was reviewed. LVN 2's file showed critical care training was last completed on October 6, 2017. The SDCO stated, even though LVN assigned to the ICU area they would only be practicing within their scope of practice and would have RN oversight to their assignment. The SDCO verified and confirmed, there was no evidence of documentation to show an RN oversight to LVN 2's assignment. The SDCO stated, LVN 2 should have received an updated ICU training annually.

A follow-up interview, on June 8, 2022, at 11:40 AM, with the SDCO, the SDCO stated, the critical care competency should be completed annually. The SDCO stated, the most recent competency that she was able to provide was dated in October 2017. The SDCO stated, she was unable provided any documentation to validate the annual competency for the nursing staff after 2017. The SDCO stated, the nursing educator is a responsible person to provide and update education to nursing staff and track the progress for all nursing staff. The SDCO further stated, the facility does not currently have a full-time nursing educator.

During an interview, on June 9, 2022, at 5:10 PM, with RN 7, RN 7 stated, the facility does not have a current full time nursing educator and he would help introducing new nursing staff to the facility during orientation. RN 7 stated, he is an ICU nurse and sometimes he would be assigned as a nursing supervisor to oversee all nursing units. RN 7 verified and confirmed, the nursing staff should receive an initial as well as updated annual competency training to the unit they are assigned. RN 7 stated, he does not remember the last time he received his annual critical care competency, "it's been a while." RN 7 further stated, as a nursing supervisor, he assigned the nursing staff to different units. RN 7 stated, he has not seen a list of completed ICU competency nursing staff and would just rely on verbal confirmation from other nursing supervisors or nursing staff. RN 7 verified and confirmed, it was not appropriate to have an LVN assigned to the ICU area without an oversight from RN and it was not appropriate for the nursing staff to be assigned to ICU patients without having initial critical care competency training. RN 7 stated, most of ICU nursing staff are not up to date with annual ICU training.

During an interview, on June 10, 2022, at 4:10 PM, with the Director of Nurse (DON), the DON stated, the facility does not have a current full time nursing educator to provide training to nursing staff. The DON further stated it was difficult to keep track and oversight on all nursing competency training. The DON confirmed and stated, the facility has not been keeping up with annual competency for all nursing staff. The DON further stated, the facility has never verified or validated the nursing staff skills from a registry nurse agency. The DON confirmed, the facility would still be liable when a registry staff did not perform nursing responsibilities correctly or appropriately. The DON stated, all nursing staff should have completed the up-to-date annual competency to the assigned patient's care area.

A review of the facility's policies and procedures (P&P) titled, "CORE: Evaluation & Verification of Competency," release date June 2020, indicated as follows:

"Purpose: The purpose of this policy is to:
1. To assure that all individuals who work in the hospital demonstrate knowledge and skill to fulfill their assigned responsibilities.
2. Provide a method to measure the employee's performance based on objective data.
3. To validate competency on an on-going basis ...
Policy
1. Each member of the hospital staff is assigned clinical and/or managerial responsibilities based on educational preparation, applicable law and regulation, and an assessment of current competence. Components of the competency system include but are not limited to:
a. General Hospital Orientation and Department Specific Orientation
b. In-service Education
c. Continuing Education
d. Required Annual In-service (Unit/Department based)
e. Initial and Annual Competency Assessment/Skills Validation ...
4. The competence of staff members is assessed at but not limited to the following periods:
a. Initial employment and orientation.
b. Transfer to a new role (i.e., LPN to RN).
c. Prior to assignment to a new unit.
d. Change in job performance or job requirements.
e. At least semi-annually during the first year ...
g. Annually thereafter ...
5. Annual Competency Validation: ...
c. Specific departmental competencies will be selected annually, and as needed for revalidation. The annual Competency Worksheet may be utilized to identify role specific annual competencies ..."

2c. During a concurrent interview and record review, on June 7, 2022, at 3:15 PM, with the SDCO, the "ICU Patient Care Assignment," dated June 1, 2022, through June 6, 2022, were reviewed. The SDCO verified and confirmed there were many times LVN was assigned without RN oversight to patient's care including:

On June 1, 2022: AM shift: LVN 2 was assigned to an ICU patient, no RN oversight
On June 2, 2022: AM shift: LVN 4 was assigned to two (2) ICU patient
On June 3, 2022: AM shift
On June 4, 2022: AM shift: LVN 5 was assigned to an ICU patient
On June 6, 2022: AM shift

A follow-up concurrent interview and record review, on June 8, 2022, at 11:25 PM, with the SDCO, LVN 4's employee file, was reviewed. LVN 4's file showed critical care training was last completed on October 5, 2017. The SDCO verified and stated, LVN 4 should have received an updated ICU training annually.

A follow-up interview, on June 8, 2022, at 11:40 AM, with the SDCO, the SDCO stated, the critical care competency should be completed annually. The SDCO stated, the most recent competency that she was able to provide was dated in October 2017. The SDCO stated, she was unable provided any documentation to validate the annual competency for the nursing staff after 2017. The SDCO stated, the nursing educator is a responsible person to provide and update education to nursing staff and track the progress for all nursing staff. The SDCO further stated, the facility does not currently have a full-time nursing educator.

During an interview, on June 9, 2022, at 5:10 PM, with RN 7, RN 7 stated, the facility does not have a current full time nursing educator and he would help introducing new nursing staff to the facility during orientation. RN 7 stated, he is an ICU nurse and sometimes he would be assigned as a nursing supervisor to oversee all nursing units. RN 7 verified and confirmed, the nursing staff should receive an initial as well as updated annual competency training to the unit they are assigned. RN 7 stated, he does not remember the last time he received his annual critical care competency, "it's been a while." RN 7 further stated, as a nursing supervisor, he assigned the nursing staff to different units. RN 7 stated, he has not seen a list of completed ICU competency nursing staff and would just rely on verbal confirmation from other nursing supervisors or nursing staff. RN 7 verified and confirmed, it was not appropriate to have an LVN assigned to the ICU area without an oversight from RN and it was not appropriate for the nursing staff to be assigned to ICU patients without having initial critical care competency training. RN 7 stated, most of ICU nursing staff are not up to date with annual ICU training.

During an interview, on June 10, 2022, at 4:10 PM, with the Director of Nurse (DON), the DON stated, the facility does not have a current full time nursing educator to provide training to nursing staff. The DON further stated it was difficult to keep track and oversight on all nursing competency training. The DON confirmed and stated, the facility has not been keeping up with annual competency for all nursing staff. The DON further stated, the facility has never verified or validated the nursing staff skills from a registry nurse agency. The DON confirmed, the facility would still be liable when a registry staff did not perform nursing responsibilities correctly or appropriately. The DON stated, all nursing staff should have completed the up-to-date annual competency to the assigned patient's care area.

A review of the facility's policies and procedures (P&P) titled, "CORE: Evaluation & Verification of Competency," release date June 2020, indicated as follows:

"Purpose: The purpose of this policy is to:
1. To assure that all individuals who work in the hospital demonstrate knowledge and skill to fulfill their assigned responsibilities.
2. Provide a method to measure the employee's performance based on objective data.
3. To validate competency on an on-going basis ...
Policy
1. Each member of the hospital staff is assigned clinical and/or managerial responsibilities based on educational preparation, applicable law and regulation, and an assessment of current competence. Components of the competency system include but are not limited to:
a. General Hospital Orientation and Department Specific Orientation
b. In-service Education
c. Continuing Education
d. Required Annual In-service (Unit/Department based)
e. Initial and Annual Competency Assessment/Skills Validation ...
4. The competence of staff members is assessed at but not limited to the following periods:
a. Initial employment and orientation.
b. Transfer to a new role (i.e., LPN to RN).
c. Prior to assignment to a new unit.
d. Change in job performance or job requirements.
e. At least semi-annually during the first year ...
g. Annually thereafter ...
5. Annual Competency Validation: ...
c. Specific departmental competencies will be selected annually, and as needed for revalidation. The annual Competency Worksheet may be utilized to identify role specific annual competencies ..."

2d. During a concurrent interview and record review, on June 7, 2022, at 3:15 PM, with the SDCO, the "ICU Patient Care Assignment," dated June 1, 2022, through June 6, 2022, were reviewed. The SDCO verified and confirmed there were many times an LVN was assigned without RN oversight to patient's care including:

On June 1, 2022: AM shift: LVN 2 was assigned to an ICU patient, no RN oversight
On June 2, 2022: AM shift: LVN 4 was assigned to two (2) ICU patient
On June 3, 2022: AM shift
On June 4, 2022: AM shift: LVN 5 was assigned to an ICU patient
On June 6, 2022: AM shift

A follow-up concurrent interview and record review, on June 8, 2022, at 11:35 PM, with the SDCO, LVN 5's employee file, was reviewed. LVN 5's file showed critical care training was last completed on October 5, 2017. The SDCO verified and stated, LVN 5 should have received an updated ICU training annually.

A follow-up interview, on June 8, 2022, at 11:40 AM, with the SDCO, the SDCO stated, the critical care competency should be completed annually. The SDCO stated, the most recent competency that she was able to provide was dated in October 2017. The SDCO stated, she was unable provided any documentation to validate the annual competency for the nursing staff after 2017. The SDCO stated, the nursing educator is a responsible person to provide and update education to nursing staff and track the progress for all nursing staff. The SDCO further stated, the facility does not currently have a full-time nursing educator.

During an interview, on June 9, 2022, at 5:10 PM, with RN 7, RN 7 stated, the facility does not have a current full time nursing educator and he would help introducing new nursing staff to the facility during orientation. RN 7 stated, he is an ICU nurse and sometimes he would be assigned as a nursing supervisor to oversee all nursing units. RN 7 verified and confirmed, the nursing staff should receive an initial as well as updated annual competency training to the unit they are assigned. RN 7 stated, he does not remember the last time he received his annual critical care competency, "it's been a while." RN 7 further stated, as a nursing supervisor, he assigned the nursing staff to different units. RN 7 stated, he has not seen a list of completed ICU competency nursing staff and would just rely on verbal confirmation from other nursing supervisors or nursing staff. RN 7 verified and confirmed, it was not appropriate to have an LVN assigned to the ICU area without an oversight from RN and it was not appropriate for the nursing staff to be assigned to ICU patients without having initial critical care competency training. RN 7 stated, most of ICU nursing staff are not up to date with annual ICU training.

During an interview, on June 10, 2022, at 4:10 PM, with the Director of Nurse (DON), the DON stated, the facility does not have a current full time nursing educator to provide training to nursing staff. The DON further stated it was difficult to keep track and oversight on all nursing competency training. The DON confirmed and stated, the facility has not been keeping up with annual competency for all nursing staff. The DON further stated, the facility has never verified or validated the nursing staff skills from a registry nurse agency. The DON confirmed, the facility would still be liable when a registry staff did not perform nursing responsibilities correctly or appropriately. The DON stated, all nursing staff should have completed the up-to-date annual competency to the assigned patient's care area.

A review of the facility's policies and procedures (P&P) titled, "CORE: Evaluation & Verification of Competency," release date June 2020, indicated as follows:

"Purpose: The purpose of this policy is to:
1. To assure that all individuals who work in the hospital demonstrate knowledge and skill to fulfill their assigned responsibilities.
2. Provide a method to measure the employee's performance based on objective data.
3. To validate competency on an on-going basis ...
Policy
1. Each member of the hospital staff is assigned clinical and/or managerial responsibilities based on educational preparation, applicable law and regulation, and an assessment of current competence. Components of the competency system include but are not limited to:
a. General Hospital Orientation and Department Specific Orientation
b. In-service Education
c. Continuing Education
d. Required Annual In-service (Unit/Department based)
e. Initial and Annual Competency Assessment/Skills Validation ...
4. The competence of staff members is assessed at but not limited to the following periods:
a. Initial employment and orientation.
b. Transfer to a

Based on interview and record review, the facility failed to ensure the nursing staff provided care for patients in accordance with patients' need and responsibilities of the nursing service appropriately of 35 sampled patients when:

1. The nursing staff had no documented evidence within the medical record of repositioning of patients every two hours for three patients (Patient 1, Patient 21, and Patient 23).

This failure had the potential to contribute to the developing and/or worsening of a pressure injury (PI-an injury to skin and underlying tissue resulting from prolonged pressure on the skin) could negatively impact Patients' health and safety, and a prolonged hospitalization.

2. The Nursing staff did not inform a responsible physician immediately in the event of patient's abnormal heart rate for one patient (Patient 19).

This failure had the potential to result in an unsafe care provided to patients with the delay in notification and treatment, which could potentially cause injuries, and/or death to patients.

3. The nursing staff did not administer a heparin lock flush (agent used to reduce blood clots) into a central line (small catheter or tube placed into a vein close to the heart that can be used to give medicine, fluids, blood, nutrition, and draw blood) ordered by a physician for one patient (Patient 14).

This failure had the potential to cause occlusion (blockage of the catheter by a thrombus or blood clot) of the central line which may lead to minor adverse events, such as bruising and swelling at the insertion site, or more significant complications such as infection and skin necrosis (death of skin tissue). Furthermore, failure to maintain patency of a central line has the potential to lead to further pain and suffering for the patient due to the possibility of needing another central line and further prolonging hospitalization.

4. Licensed Vocational Nurse (LVN) 7 did not identify patients prior to administering medication and PATIENT 20, PATIENT 21, PATIENT 25 did not have wrist bands and were non-verbal; LVN 7 did not check for gastrotomy tube (G-tube-a special tube that is placed directly into the stomach for food, fluids, and medications) placement prior to administering medication to 3 patients (PATIENT 20, PATIENT 21, PATIENT 25), and LVN 7 did not properly disinfect glucometer after use for 1 patient (PATIENT 21).

These failures increased the risk of administering medication to the wrong patient resulting in adverse events, cross contamination of disease from improperly disinfecting the glucometer after patient care, and the risk of peritonitis (redness and swelling of the lining of your belly or abdomen) from improperly placed gastronomy enteral feeding (g-tube: tube placed directly through stomach to deliver food).

Findings:

1a. A review of Patient 1's "History and Physical (H&P)," dated December 9, 2021, at 6:34 PM, the H&P showed, Patient 1 was admitted into the facility for continuation of care related to coronary artery occlusion (blockage in the artery that delivers blood and oxygen to patient's heart), status post thrombectomy (a type of surgery to remove clot from inside an artery), cerebrovascular accident (stroke-loss of blood flow to the brain), chronic anticoagulation (a group of medications to help prevent blood clots) with Heparin (medication to help prevent blood clot), and diabetes (a condition that body cannot control blood sugar).

A review of Patient 1's "Weekly wound care," dated December 16, 2021, at 10:47 AM, showed Patient 1 had an unstageable (full thickness tissue loss in which the base of wound covered by slough [yellow] and/or eschar [brown or black] in the wound bed) PI to sacralcoccygeal (location below the lumbar spine to the tailbone).

A review of Patient 1's "Plan of care: Reposition," dated February 13, 2022, at 2 PM, showed, reposition was ordered to be completed every two hours.

During a concurrent interview and record review, on June 9, 2022, at 11:15 AM, in the board room, with the Senior Director of Clinical Operation (SDCO), Patient 1's "Nurses notes" for reposition, dated February 17, 2022, through February 22, 2022, was reviewed. The "Nurses notes" for reposition showed the following:

On February 17, 2022, at 6:06 PM: to supine
On February 18, 2022, at 7:47 AM: to right

The SDCO verified and confirmed, the nursing staff did not document repositioning every two hours. The SDCO stated, every patient should have been repositioned every two hours.

A review of the facility's policies and procedures (P&P) titled, "Core: Clinical Guidelines for Pressure Injury," release date June 2019, the P&P showed the following:

"Purpose: this policy and procedures establishes guidelines for the RNs role in the prevention and treatment of pressure injuries based on Braden Risk score and subscales.
Policy ...
5. Standard interventions for all patients can include but not limited to:
a. High specification support surface
b. Skin and wound assessment
c. Repositioning orders (minimum every (q) two (2) hours turns)
d. Wound care consult
e. Nutritional consult
f. Decrease or eliminate friction and shear forces
g. Incontinence management
h. Consider bariatric patients and risk for injury as a result of high adipose tissue concentration (i.g. non body prominences, tissue pressure across buttocks, etc).
i. Repositioning ..."


45050

1b. During a review of Patient 21's H&P, dated November 30, 2021, the H&P indicated, Patient 21 had medical history of bilateral BKA (below-knee amputation); end-stage renal disease (kidneys cease functioning on a permanent basis), on dialysis (process of removing excess water and toxins from the blood), was admitted to [Hospital Name] with sepsis. Patient 21 had acute hypoxic (low oxygen) respiratory failure, lactic acidosis (lactic acid (chemical byproduct of respiration) builds up in the blood), and pulmonary edema (abnormal buildup of fluid in the lungs).

During a concurrent interview and record review, on June 8, 2022, at 10:30 AM, with Outcome Manager (OM), Patient 21's Electronic Medical Record (EMR) was reviewed. The reposition flowsheet indicated, on June 4, 2022, Patient 21 was repositioned on June 4, 2022, at 5:41 AM, and was repositioned again on June 4, 2022, at 8:10 PM. OM confirmed, there was no evidence of documentation found that Patient 21 was repositioned on June 4, 2022, from 5:41 AM to 8:10 PM.

During a review of the facility's P&P titled "CORE: Clinical Guidelines for Non-Pressure Related Wounds" dated June 2022, the P&P indicated,
"PURPOSE
This policy and procedures establish the RNs role in initial and routine patient skin and wound assessments.
POLICY
The policy of Kindred Hospital is to ensure:
1. The skin and wound assessment is conducted per the RN :
a. On admission
b. Each shift (including the day of discharge)
2. Each patient should have an individualized plan of care.
3. Principles of wound healing ...
4. Standard interventions for all patients can include but are not limited to:
a. Nutritional consult
b. Incontinence management
c. Wound care consult
d. Skin and wound assessment
e. Repositioning (minimum Q2 hour turns)
i. Turn and reposition the patients at a frequency based on the patient's individual needs.
ii. Consideration turning schedule of 01 hours if patient is unable to turn and reposition self, has poor nutrition, multiple wounds, a recent change of condition (acute decline in hemodynamics), poor cognition, skin is moist or at risk for friction/shear injury."

1c. During a review of Patient 23's H&P, dated May 23, 2022, the "H&P' indicated, Patient 23 had medical history of substance abuse, who sustained a motor vehicle accident on March 12, 2022, auto versus pedestrian accident. The patient sustained severe traumatic brain injury (brain dysfunction caused by an outside force) as well as bilateral (right and left side) lower extremity deformity. The patient was bradycardic (abnormally slow heart rate) and placed on Ambu bag (used for artificial respiration) and transferred to the hospital where she was intubated (breathing tube was placed through the mouth and down the throat).

During a concurrent interview and record review, on June 9, 2022, at 10:20 AM, with the Senior Director of Clinical Operations 2 (SDCO 2), Patient 23's Electronic Medical Record (EMR) was reviewed. The reposition flowsheet indicated, on June 6, 2022, Patient 23 was repositioned on June 6, 2022, at 5:29 AM, and was repositioned again on June 6, 2022, at 8:00 PM. The SDCO 2 confirmed, there was no evidence of documentation found that Patient 23 was repositioned on June 6, 2022, from 5:29 AM to 8:00 PM.

During a review of the facility's policy and procedure (P&P) titled "CORE: Clinical Guidelines for Non-Pressure Related Wounds" dated June 2022, the P&P indicated,
"PURPOSE
This policy and procedures establish the RNs role in initial and routine patient skin and wound assessments.
POLICY
The policy of Kindred Hospital is to ensure:
1. The skin and wound assessment is conducted per the RN:
a. On admission
b. Each shift (including the day of discharge)
2. Each patient should have an individualized plan of care.
3. Principles of wound healing ...
4. Standard interventions for all patients can include but are not limited to:
a. Nutritional consult
b. Incontinence management
c. Wound care consult
d. Skin and wound assessment
e. Repositioning (minimum Q2 hour turns)
i. Turn and reposition the patients at a frequency based on the patient's individual needs.
ii. Consideration turning schedule of 01 hours if patient is unable to turn and reposition self, has poor nutrition, multiple wounds, a recent change of condition (acute decline in hemodynamics), poor cognition, skin is moist or at risk for friction/shear injury."

2. During a review of Patient 19's H&P, dated May 20, 2022, the H&P indicated, Patient 19 had medical history of osteoarthritis (degeneration of joint cartilage and the underlying bone, it causes pain and stiffness) who initially presented to [Hospital Name] Emergency Department on April 16, 2022, as a trauma alert, she was an auto versus pedestrian and was found down initially hypotensive (low blood pressure).

During a review of Patient 19's "Cardiac strip", dated September 21, 2020, at 8:11 AM, the cardiac strip indicated, heart rate was 36 beats per minute (bpm). The normal resting heart rate for adults' ranges from 60 to 100 beats per minute.
During a concurrent interview and record review, on June 8, 2022, at 2:45 PM, with Outcome Manager (OM), Patient 19's "Electronic Medical Record (EMR)," dated September 21, 2020, was reviewed. The EMR indicated, Nurses notes, dated September 21, 2020, at 12:37 PM, the physician was informed regarding the episode of bradycardia (slow heart rate) this morning. OM stated, that took so long to inform the doctor. OM confirmed there was no change of condition documentation for Patient 19.

During a review of the facility's P&P titled, "4576 Rancho facility Specific Policy Physician Notification, When to Notify" revision date August 2013, the Policy and Procedure indicated,

"Purpose
1. To identify alternatives in communicating information about patients to physicians.
2. To ensure accurate documentation that a physician has been called.
Policy:
1. Physicians must be notified of new patient admissions unless otherwise indicated on the physician order form.
2. Physicians must be notified immediately for the following reasons including but not limited to:
a. Pain not relieved by medications ordered.
b. Pertinent changes in condition.
c. Acute Respiratory Distress
d. Cardiac arrest
e. Change in Cardiac Rhythm
f. Uncontrolled Bleeding
g. Change in Level of Consciousness
h. Panic Lab Values
i. Critical Diagnostic Results
j. Any Change of Condition"


42294

3. A review of Patient 14's H&P, dated May 19, 2022, indicated, Patient 14 was admitted for wound care and treatment of a right foot infection. The H&P also indicated Patient 14's medical problems included diabetes (condition characterized by high blood sugar levels because the body is unable to metabolize or turn the blood glucose into energy), end-stage renal disease (ESRD - kidney failure) on hemodialysis (a treatment to filter wastes and water from blood), past history of stroke with residual right-sided weakness and speech deficit, and dementia (conditions involving loss of cognitive functioning, such as thinking, remembering and reasoning).

During a concurrent interview and record review, on June 8, 2022, at 2:30 PM, in the medical records office, with the Chief Clinical Officer (CCO), Patient 14's "Medication Administration Record (MAR)," was reviewed. The MAR indicated, "Heparin lock flush, IV inj [injection], 1 ml [milliliter-unit measurement], push, ***FLUSH EACH PORT OF CENTRAL LINE PER PROTOCOL AND PRN*** Start today (05/20/22) [May 20, 2022], cont. [continue], stop after 45 days, renewable. Read back verification: Yes, order read back to provider. INSTRUCTION: *** HIGH RISK MEDICATION *** DOSE: Heparin Sodium 1000 Units = 1 ML"
On further review of Patient 14's MAR for heparin lock flush, dated May 20, 2022, there was no record of administration by nursing. The CCO confirmed and stated Patient 14's MAR indicated the heparin lock flush was not administered as ordered.

During a follow up interview and record review, on June 10, 2022, at 9:47 AM, in the medical records office, with the CCO, Patient 14's "MAR", dated June 9, 2022, was reviewed. The "MAR" indicated; Patient 14 was receiving intravenous (IV) antibiotics via CV (central venous) line.

During an interview, on June 10, 2022, at 10:03 AM, in Unit 200, with Registered Nurse (RN 9), RN 9 confirmed Patient 14 had a central line used to infuse IV antibiotics. RN 9 stated she flushed the central line with 10 cc (or 10 milliliters) normal saline after administering the antibiotics, then clamped the line. RN 9 further stated she did not use heparin to flush Patient 14's central line.

During an interview, on June 14, 2022, at 9:03 AM, in the conference room, with RN 11, she stated she normally flushes central lines with 10 milliliters normal saline. RN 11 further stated heparin is used if ordered by the physician. When using a port-a-cath (a type of implanted central line hidden underneath the skin), RN 11 stated she would use heparin to flush the line. RN 11 stated use of a heparin flush is documented in the patient's MAR.

During a review of the facility's policy and procedure (P&P) titled, "CORE: Central Line Placement, Maintenance and Dressing Change," dated September 2020, the P&P indicated,

"PURPOSE
This procedure provides nursing personnel with guidelines to be used when inserting, maintaining and changing dressings on central venous access devices (CVAD) such as Peripherally Inserted Central Catheter (PICC), Subclavian Catheters, IJ Catheters, Femoral Catheters, Implanted Ports, and Non-Tunneled and Non-Cuffed .....
POLICY
The policy of [Name of Facility] is to ensure central line site care and dressing changes will be performed routinely .....
18. Instill access device with heparinized solution to maintain patency per physician orders ...."

During a review of the facility's policy and procedure (P&P) titled, "CORE: Flushing and Locking," dated September 2020, the P&P indicated,
"PURPOSE
This procedure establishes guidelines for flushing and locking of vascular access devices. Flushing is performed prior to each infusion to assess vascular access device (VAD) function, after each infusion to prevent mixing of incompatible medications and solutions, after blood sampling and at least every 8 hours for lines without continuous or intermittent infusion therapy being administered.
POLICY
The policy of [Name of Facility] is to ensure the following:
1. Locking is performed to maintain device patency and prevent occlusion in an intermittently used VAD.
2. Single-use flushing and locking systems will be used ....
PROCEDURE
1. Supplies
a. Gloves
b. Antiseptic wipes
c. Preservative-free 0.9% sodium chloride (USP) prefilled syringe
d. Heparin lock solution (10-100 units/mL) prefilled syringe(s) if prescribed
e. 10-mL syringe(s) .....
6. Locking
a. Thoroughly disinfect the needleless injection connector for 5 seconds ....
b. Attach the syringe of locking solution to needleless injection connector while maintaining the sterility of the syringe tip.
c. Slowly inject solution into catheter.
d. Follow clamping sequence ...
e. Discard syringe and used supplies in appropriate receptacles.
f. Remove gloves and perform hand hygiene.
g. Document procedure in patient's permanent medical record ...."


41166

4. During a medication pass observation, on June 8, 2022, at 9:07 AM, with LVN 7 in the Med Surg Unit 100, LVN 7 was observed administering one (1) medication via g-tube to PATIENT 20, without first checking for g-tube placement. At 9:50 AM, LVN 7 was observed administering four (4) medications via g-tube to PATIENT 21, without first check for g-tube placement. At 10:04 AM, LVN 7 was observed administering three (3) medications via g-tube to PATIENT 25 without first elevating PATIENT 25's head and checking for g-tube placement.

During an interview, on June 8, 2022, at 12:04 PM, with LVN 7, LVN 7 acknowledged she did not check for g-tube placement prior to administering medications to PATIENT 20, PATIENT 21, and PATIENT 25. LVN 7 stated the importance of checking for g-tube placement prior to administering medications was, "To make sure it's in the stomach and not out, medication can go out of the stomach. Patient not able to absorb medication, probably not getting therapeutic effect of medication."

During an interview, on June 8, 2022, at 12:10 PM, with LVN 7, LVN 7 acknowledged she did not verify the identifications for Patients PATIENT 20, PATIENT 21, and PATIENT 25. LVN 7 stated, "Can have wrong patient in room, can misidentify patient if they move rooms around."
During an interview, on June 8, 2022, at 12:13 PM, with the Director of Pharmacy (DP), the DP stated, "Need to have patient wristband so we give correct drug to correct patient. Giving wrong drug to wrong patient can lead to death, can also ask them ... No, these patients cannot respond to you if you ask them."

During a medication pass observation, on June 8, 2022, at 2:36 PM, with LVN 7 in the Med Surg Unit 100, LVN 7 was observed wiping a glucometer for less than 1 minute with Sani-Cloth Germicidal (kills germs) disposable wipes, after checking PATIENT 21's blood sugar. When asked about the wet time (time that a disinfectant needs to stay wet on a surface to ensure efficacy), LVN 7 reviewed the manufacturer instructions for the disinfecting wipes, and stated it was for 1 minute. LVN 7 acknowledged she did not allow the manufacturer specified wet time of 1 minute when disinfecting the glucometer after patient care. LVN 7 acknowledged the risk of infection and stated, "Could spread contamination from room to room ... could spread disease from patient to patient."

A review of the Sani-Cloth Germicidal disposable wipe instructions indicated, "To disinfect: Unfold a clean wipe and thoroughly wet surface. Allow treated surface to remain wet for (1) minute."

During an interview, on June 8, 2022, at 2:52 PM, with Registered Nurse (RN) 8, RN 8 stated that the expectation was for nursing staff to check for placement of the g-tube. RN 8 stated, "You can end up giving patient Peritonitis from medication entering peritoneal cavity, clinical outcome could be death." RN 8 also stated nursing staff was expected to ensure patient was positioned a minimum of 30 degrees prior to medication administration. RN 8 stated, "You can see [degrees] at side of the bed. If not positioned correctly, patient could aspirate and get aspiration pneumonia and can cause cardiac arrest."

During an interview, on June 8, 2022, at 3:18 PM, with RN 8, RN 8 stated it was important to appropriately disinfect for infection control. RN 8 stated, "You can introduce another infection to patient, which could extend their stay or cause death depending on how immune compromised they are."

During a review of the hospital's Policy and Procedure (P&P) titled, "Administration of Oral Medications" dated June 2021, The P&P stated, "Only licensed nursing personnel (RNs [registered nurse], LPNs [licensed practical nurse]), Respiratory Therapists and other qualified healthcare professionals, in accordance with State regulations and Medical Staff approval, may administer medication. The 7 "Rs" of administering medications will be followed with each medication administration: "Right" patient ... Prior to medication administration, a patient must be positively identified by two forms of identification on the wristband issued at admission: never room number."

During a review of the hospital's P&P titled, "Administration of Medications via Feeding Tube" dated June 2021, the P&P stated, " ... verifying proper tube placement.:

During a review of the hospital's P&P titled, "Cleaning of Shared Patient Medical Equipment" dated June 2021, the P&P stated, "Ensure that all equipment is cleaned, disinfected using the appropriate contact times."

Based on interview, and record review, the facility failed to ensure the nursing staff administered medications as ordered and followed the acceptable standards of practice during medication administration of 35 sampled patients when

1. For Patient 2, the nursing staff did not administer meropenum (antibiotic or medication to treat bacterial infection) as ordered.

2. For Patient 1 and Patient 6, the nursing staff did not administer insulin (medication to control blood sugar) as ordered.

3. For Patient 7, the nursing staff administered lorazepam (medication to relieve anxiety) and morphine (medication to relieve pain) with no clinical assessment before and/or after administering medication.

4. For Patient 16, the nursing staff did not administer Keppra (medication used to treat seizures) as ordered.

5. For Patient 17, the nursing staff administered an incorrect dose of Carvedilol (medication used to treat heart failure that lowers blood pressure and heart rate) not ordered by the physician and did not administer the medication as ordered.

6. For Patient 15, the nursing staff administered PRN (as needed) morphine (medication to treat pain) and metoprolol (medication used to treat high blood pressure) without documenting pre-assessments and/or post-assessments in the medical record.

7. For Patient 19, the nursing staff withheld medications without appropriate medical reason documentation.

8. For Patient 19, the nursing staff did not administer Larasidone (Latuda-medication to treat symptoms of mental disorder) as ordered and did not provide appropriate medical reason for omission.

9. For Patient 24, a medication was given earlier than the ordered frequency.

10. For Patient 25, a medication was omitted (not given) at the scheduled time.

11. For Patient 21, Licensed Vocational Nurse (LVN) 7 administered incorrect doses for lansoprazole (medication for acid reflux), atorvastatin (medication to lower cholesterol), and renal vitamin (vitamin for kidney) to PATIENT 21, nursing staff did not administer sevelamer (medication to decrease phosphate levels) to PATIENT 21 according to physician's order, and nursing staff did not administer heparin (blood thinner) for 2 out of 2 sampled patients (PATIENT 20, PATIENT 34) according to the physician's order.

These failures had resulted in medication errors with unsafe medication administration and had the potential to cause adverse health outcomes such as antibiotic resistant, uncontrolled blood sugar, inadequate patient monitoring, ineffective pain management, unrelieved pain, risk of bleeding, and inadequate therapy for treatment, which could negatively affect patients' health, safety, prolonged hospitalization, and/or lead up to death.

Findings:

1. A review of Patient 2's "History and Physical (H&P)," dated January 26, 2022, the H&P showed, Patient 2 was admitted into the facility with diagnoses including respiratory failure (a condition when lungs cannot get enough oxygen) with tracheostomy (trach - a tube placed into the trachea via the neck to assist with breathing), urinary tract infection (UTI-an infection in any part of urinary system including kidneys, bladder, or urethra), and development delay.

During a concurrent interview and record review, on June 8, 2022, at 3:20 PM, in the board room, with the Senior Director of Clinical Operation (SDCO), Patient 2's "Physician Orders," for meropenum, dated March 30, 2022, at 7:45 PM, was reviewed. The "Physician Orders," for meropenum showed, meropenum 500 milligram (mg-unit dosing of medication) intravenous (IV-into the vein) was ordered to be administered every 8 hours at 6 AM, 2 PM, and 10 PM. The SDCO verified and confirmed the meropenum order.

A-follow up concurrent interview and record review, on June 8, 2022, at 3:25 PM, with the SDCO, Patient 2's "Medication Administration Record (MAR)," for meropenum, dated March 30, 2022, through April 6, 2022, was reviewed. The MAR, for meropenum showed as follow:

On April 1, 2022, at 6:17 AM: meropenum 500 mg given
On April 1, 2022, at 9:19 PM: meropenum 500 mg given

The SDCO verified and confirmed, meropenum was not given as ordered, the nursing staff did not administer meropenum on April 1, 2022, at 2 PM. The SDCO stated, the nursing staff should document the reason medication was not administered as ordered in the medical record. The SDCO further stated, she was unable to provide any documentation to justify the missing dose of meropenum.

During an interview, on June 8, 2022, at 5:10 PM, with the Director of Pharmacy (DP), the DP stated, antibiotic should be given as ordered. Missing antibiotic dose can increase the risk of bacteria regrowth, non-therapeutic therapy which can lead to antibiotic resistance, worsening infection, and could lead up to death.

A review of the facility's policies and procedures (P&P) titled, "Core: Administration of Medications via Injection," release date June 2020, indicated as follow:

"Purpose: This procedure establishes a system by which medications will be administered to patients' safety, accurately, and efficient by qualified personnel ...
Procedure ...
1. General Guidelines for Administration of Medication ...
Documentation
b. The 7 "R's" of administering medications will be followed with each medication administration:
i. "Right" patient
ii. "Right" medication
iii. "Right" dose
iv. "Right" time
v. "Right" route
vi. "Right" reason
vii. "Right" documentation ..."

2a. A review of Patient 1's H&P, dated December 9, 2021, at 6:34 PM, the H&P showed, Patient 1 was admitted into the facility for continuation of care related to coronary artery occlusion (blockage in the artery that delivers blood and oxygen to patient's heart), status post thrombectomy (a type of surgery to remove clot from inside an artery), cerebrovascular accident (stroke-loss of blood flow to the brain), chronic anticoagulation (a group of medications to help prevent blood clots) with Heparin (medication to help prevent blood clot), and diabetes (a condition that body cannot control blood sugar).

During an interview, on June 8, 2022, at 5:15 PM, in the board room, with the Director of Pharmacy (DP), the DP stated, insulin should be given as ordered. Too much or too little can be harmful to patients with imbalance blood sugar control which can be serious and lead up to death.

During a concurrent interview and record review, on June 9, 2022, at 4:35 PM, in the board room, with Registered Nurse 7 (RN 7), Patient 1's "Physician Orders," for insulin, dated January 1, 2022, at 4:15 PM, was reviewed. The "Physician Orders," for insulin showed, insulin 30 units was ordered to be administered subcutaneously (SQ-under the skin) every day. RN 7 verified and confirmed the insulin order with a fixed dosage of 30 units.

A follow-up concurrent interview and record review, on June 9, 2022, at 4:40 PM, with RN 7, Patient 1's MAR, for insulin, dated January 9, 2022, through February 19, 2022, was reviewed. The MAR indicated as follow:

On January 30, 2022, at 8:15 AM: 15 units of insulin given
On February 16, 2022, at 9 AM: 15 units of insulin given

RN 7 verified and confirmed the administration of insulin. RN 7 stated, the nursing staff did not follow a physician order for insulin administration. RN 7 further stated, he was unable to provide any documentation to indicate the nursing staff notified a physician or requested a lower dosage of insulin for Patient 1, and there was no physician progress note to show lower dosage of insulin was planned or ordered.

A review of the facility's P&P titled, "Core: Administration of Medications via Injection," release date June 2020, indicated as follow:

"Purpose: This procedure establishes a system by which medications will be administered to patients' safety, accurately, and efficient by qualified personnel ...
Procedure ...
1. General Guidelines for Administration of Medication ...
Documentation
b. The 7 "R's" of administering medications will be followed with each medication administration:
i. "Right" patient
ii. "Right" medication
iii. "Right" dose
iv. "Right" time
v. "Right" route
vi. "Right" reason
vii. "Right" documentation ..."

2b. During a review of Patient 6's H&P, dated February 23, 2022, the H&P showed, Patient 6 was admitted into the facility with the diagnoses including respiratory failure with tracheostomy, atrial fibrillation (abnormal heart rhythm), end stage renal disease (a condition that kidneys do not work normally), ileus (a condition in which the bowel does not work correctly), and dysphagia (difficulty swallowing) requiring a nasogastric tube (NG tube-a special tube that carries food and medicine to the stomach through the nose).

During a concurrent interview and record review, on June 8, 2022, at 9:05 AM, in the board room, with the SDCO, Patient 6's "Physician Orders," for insulin, dated May 5, 2022, at 11:54 PM, was reviewed. The "Physician Orders," for insulin showed, insulin was ordered to be administered SQ every 6 hours at 0:00 AM, 6 AM, 12 PM, and 6 PM based on the blood sugar (BS) results or sliding scale as follow:

BS less than 151: no insulin
BS 151 to 200: "give 1 unit" of insulin
BS 201 to 250: "give 2 units" of insulin
BS 251 to 300: "give 3 units" of insulin
BS 301 to 350: "give 4 units" of insulin
BS greater than 350: "give 5 units" of insulin and notify physician

The SDCO verified and confirmed the insulin order with the sliding scale.

A follow-up concurrent interview and record review, on June 8, 2022, at 9:10 AM, with the SDCO, Patient 6's MAR for insulin, dated June 3, 2022, at 0:02 AM, was reviewed. The MAR for insulin showed five (5) units of insulin was given. The SDCO verified and confirmed the dosage of insulin given to Patient 6.

A follow-up concurrent interview and record review, on June 8, 2022, at 9:15 AM, with the SDCO, Patient 6's "Laboratory Results" for glucose or blood sugar, dated June 2, 2022, at 11:54 PM, was reviewed. The blood sugar was 358. The SDCO verified and confirmed the blood sugar level of Patient 6.

A follow-up interview, on June 8, 2022, at 9:15 AM, with the SDCO, stated, the nursing staff should notify an ordering physician after five (5) units of insulin was given to Patient 6 as ordered. The SDCO stated, she was unable to provide any documentation to indicate a physician was notified after five (5) units of insulin was given.

During an interview, on June 8, 2022, at 5:15 PM, in the board room, with the Director of Pharmacy (DP), the DP stated, insulin should be given as ordered. Too much or too little can be harmful to patients with imbalance blood sugar control which can be serious and lead up to death.

A review of the facility's P&P titled, "Core: Management of Patient Receiving Subcutaneous Insulin," release date June 2019, indicated as follow:

"Purpose: This procedure establishes evidence based guidelines for consistent administration and care of the patient receiving subcutaneous insulin ...
Policy: the policy of [Hospital Name] is to ensure the following: ...
4. A physician order for subcutaneous insulin administration must be obtained prior to insulin administration. The physician will utilize the standard order set.
5. Insulin will be labeled as a "high-alert" medication.
6. Insulin dosing should be synchronized with provision of meals, enteral [liquid food by bypassing oral intake via a special tube], and parenteral [liquid food through the vein] nutrition ...
Procedure ...
2. Care of the patient
a. The nurse will check blood glucose levels at the prescribed intervals based on the patient's condition, protocol selected and the physician's order ..."


45413

3. A review of Patient 7's H&P, dated February 9, 2022, showed, Patient 7 was admitted into the facility with diagnoses including respiratory failure, hypertension (elevated blood pressure), lupus (a disease where your body's immune system attacks your own tissues and organs), sciatica (nerve pain that starts at the lower back and runs down each leg), and chronic pain.

During a concurrent interview and record review, on June 8, 2022, at 9:30 AM, in the board room, with the Clinical Analyst Administrator (CAA), Patient 7's "Medication Administration Record (MAR)," for lorazepam, dated February 9, 2022, through April 19, 2022, was reviewed. The MAR showed as follow:

On February 15, 2022, at 5:41 AM: no assessment after medication administration
On February 19, 2022, at 6:14 PM: no assessment after medication administration
On February 21, 2022, at 1:29 AM: no assessment before and after medication administration
On March 18, 2022, at 0:13 AM: no assessment after medication administration

The CAA verified and confirmed, there was no documentation on the MAR to indicate Patient 7 was assessed before and/or after with every lorazepam administration. The CAA stated, Patient 7 should have been assessed before administering lorazepam and after administration of lorazepam to demonstrate the effectiveness of medication.

A follow-up concurrent interview and record review, on June 8, 2022, at 9:30 AM, with the CAA, Patient 7's MAR, for morphine, dated February 9, 2022, through March 6, 2022, was reviewed. The MAR showed as follows:

On February 12, 2022, at 6:49 PM: no assessment before and after medication administration.
On February 14, 2022, at 10:27 PM: no assessment before medication administration.
On February 20, 2022, at 8:33 AM: no assessment before and after medication administration.
On February 21, 2022, at 9:31 AM: no assessment before medication administration.
On February 27, 2022, at 3:33 PM: no assessment before and after medication administration.
On February 28, 2022, at 1:54 PM: no assessment before and after medication administration.

The CAA verified and confirmed, there was no documentation on the MAR to indicate Patient 7 was assessed before and/or after with every morphine administration.

During an interview, on June 14, 2022, at 9:00 AM, with Registered Nurse 11 (RN 11), RN 11 stated, a patient is re-assessed about 30 minutes after administering an intravenous (IV-into the vein) medication for effectiveness and this is documented in the MAR.

A review of the facility's policies and procedures (P&P) titled, "Core: Administration of Medications via Injection," release date June 2020, indicated as follows:

"Purpose: This procedure establishes a system by which medications will be administered to patients safely, accurately, and efficiently by qualified personnel ...
Policy: The policy of [Hospital Name] is to ensure the following: ...
3. Documentation
a. The individual administering the medication(s) must document all medications after administration in the patient's medical record.
b. Clinical assessment necessary before administering a specific type or dose of medication must be documented on the medication administration record (MAR) (e.g., pulse before Digoxin (medication for heart condition), blood pressure before antihypertensive (high blood pressure).
c. Effectiveness/post assessment of medications will be documented in the medical record for PRN medications when warranted- analgesics (medication to relieve pain), antipyretics (medication to reduce fever) and any other medication that warrants a post assessment (e.g. B/P [blood pressure] rechecks after STAT [immediately] dose of antihypertensive) ..."

A review of the facility's policies and procedures (P&P) titled, "Core: Pain Management Plan," release date June 2020, indicated as follows:
"Purpose: To establish an organized approach for caregivers to assess and mange patient's pain. The Pain Management Plan delineates the necessary assessments, interventions, monitoring, and patient/family education to promote effective pain relief ...
Procedure
1. Assessments of Patients
a. The Registered Nurse performs a pain assessment during the patient admission assessment. Ongoing pain assessments and reassessments are performed by licensed nurses at least every shift, when a patient complains of pain and after an analgesic (pain reliever) is given to determine effectiveness of the analgesic. Each pain assessment and reassessment will be documented in the patient medical record ...
c. Ongoing Assessments/Reassessments by licensed nursing staff:..
ii. Reassessment of pain is conducted through:
1. Evaluation and documentation of response to pain interventions
2. Progress toward pain management goal including functional ability
3. Side effects of treatment
4. Risk factors for adverse events caused by the treatment
iii. When pain is identified, nursing assessment and documentation in the patient medical record includes the pain scale rating, location, duration, intensity and character ...
iv. Reassessment of pain relief interventions vary according to pain level of pain and patient status, pain relief interventions performed by the nurse and/or pharmacological agent administered and rout of administration, nursing judgment and according to physician orders if present.
1. Recommended timeframes for reassessment of effectiveness of pain relief may include:
a. 30 minute reassessment - IM injection and IV medication
b. 1 hour reassessment - oral medication and non-pharmacological interventions ...


42294

4. A review of Patient 16's H&P, dated March 18, 2022, indicated, Patient 16 was admitted for respiratory failure, status post tracheostomy placement on March 1, 2022, with multiple medical problems which included cirrhosis (severe stage of liver disease affecting ability of liver to process nutrients, drugs, hormones, and natural toxins), intracranial bleed (bleeding within the skull), and seizure disorder (a brain disorder that can cause changes in behavior, movement, or feelings). The H&P also indicated Patient 16 was unresponsive and unable to contribute information regarding medical history.

During a concurrent interview and record review, on June 9, 2022, at 3:07 PM, in the medical records office, with the Chief Clinical Officer (CCO), Patient's 16's MAR, was reviewed. The MAR for Keppra, dated April 4, 2022, at 3:01 PM, indicated, "levETIRAcetam: per feeding tube soln (solution; liquid medication given through feeding tube), 1000 (one thousand) mg (milligrams - unit of measurement), Start 04/04/22 (April 4, 2022) 22:00 (10:00 PM), q12h (every 12 hours), (10, 22) (10 AM, 10 PM), stop after 45 days, renewable. Read back verification: No, per rx (prescription) autosub (backordered) INSTRUCTION: Generic for Keppra. *** LOOK ALIKE/SOUND ALIKE *** DOSE: levETIRAcetam 1000 MG = 2 (two) Tablet"

On further review of Patient 16's MAR for Keppra, dated April 4, 2022, through April 28, 2022, the MAR indicated, Keppra was not administered on April 21, 2022, at 10 PM. The CCO verified there was no documentation indicating Keppra was administered on April 21, 2022, at 10 PM.

During an interview, on June 14, 2022, at 9:40 AM, in the conference room, with RN 11, RN 11 stated medications should be administered as ordered and a physician's order is needed to hold a medication.

During a review of the facility's policy and procedure (P&P) titled, "CORE: Administration of Oral Medications," dated June 2021, the P&P indicated,

"PURPOSE
This procedure establishes a system by which medications will be administered to patients safely, accurately, and efficiently by qualified personnel ...
POLICY
The policy of [Name of facility] is to ensure the following:
1. Administration
a. The Hospital PNT will be responsible for determining the scheduled administration times and making any recommendations for alterations, as needed, based on monitoring and evaluation data. The Electronic Medical Record defaults to standard times of administration ....
2. Competency ...
3. Documentation ...
d. If the medication is not administered ("held" due to blood pressure parameters, patient refused, etc.), the appropriate documentation on the MAR including reason must be recorded ...
PROCEDURE
Current Standards of Practice for Medication Administration are followed.
1. General Guidelines for Administration of Medication ...
b. The 7 "R's" of administering medications will be followed with each medication administration:
i. "Right" patient
ii. "Right" medication
iii. "Right" dose
iv. "Right" time
v. "Right" route
vi. "Right" reason
vii. "Right" documentation..."

5. A review of Patient 17's H&P, dated February 26, 2022, indicated, Patient 17 was admitted on February 25, 2022, for acute respiratory failure, status post tracheostomy on February 11, 2022, and status post cardiac arrest (when the heart stops beating suddenly) on February 3, 2022. The H&P also indicated Patient 17 had a history of multiple medical problems, including coronary artery disease (impaired blood flow and supply of oxygen to the heart), heart failure (heart does not pump enough blood for the body's needs), and end-stage renal disease (ESRD - kidney failure), on dialysis (a treatment to filter wastes and water from blood).

During a concurrent interview and record review, on June 9, 2022, at 4:06 PM, in the medical records office, with the CCO, Patient's 17's MAR, was reviewed. The MAR for carvedilol, dated March 31, 2022, at 9:32 AM, indicated, "carvedilol, per feeding tube tab (tablet) 25 (twenty-five) mg (milligram - unit of measurement), Start 3/31/22 (March 31, 2022) 10:00 (10:00 AM), bid (twice per day), (10, 22) (10 AM, 10 PM), stop after 45 days, renewable. (Hold for SBP<100 or HR<60) (Hold for systolic blood pressure [BP] less than 100 or heart rate [HR] less than 60) INSTRUCTION: Generic for Coreg (brand name of drug) DOSE: Carvedilol 25 (twenty-five) mg (milligrams) = 1 (one) Tablet." The MAR for carvedilol, dated March 31, 2022, through May 9, 2022, was reviewed. Carvedilol was not administered as ordered by the physician on:

On April 9, 2022, at 11:25 PM: not administered and no BP or HR documented
On April 11, 2022, at 11:55 AM: not administered and no BP or HR documented
On May 6, 2022, at 9:19 PM: not administered and no BP or HR documented
On May 7, 2022, at 9:06 PM: not administered and no BP or HR documented

The CCO verified there was no documentation in the MAR indicating carvedilol was given or reason medication was held.

On further review of Patient 17's MAR for carvedilol, dated March 31, 2022, through May 9, 2022, the MAR indicated, on April 4, 2022, at 8:56 PM, "12.5 mg given" and "HR 60". The CCO verified the dose given, 12.5 mg, was not the correct dose ordered by the physician.

During a follow up interview and record review, on June 10, 2022, at 9:21 AM, in the medical records office, with the CCO, Patient's 17's electronic medical record (EMR), was reviewed. The CCO was unable to find a physician order or documentation regarding the incorrect dose of carvedilol given on April 4, 2022, at 8:56 PM.

During an interview, on June 10, 2022, at 10:03 AM, in Unit 200, with RN 9, RN 9 stated blood pressure medications should be given as ordered. RN 9 stated parameters to hold a medication are followed if specified in the physician order. If there are no parameters, RN 9 stated she would call the physician to clarify whether to hold a medication.

During an interview, on June 14, 2022, at 9:40 AM, in the conference room, with RN 11, she stated blood pressure medications should be given as ordered. RN 11 stated, the parameters for holding a blood pressure medication should be followed, if specified in the physician order. RN 11 further stated, if the blood pressure or heart rate is low, she would hold the blood pressure medication and notify the physician and pharmacy for further guidance.

During a review of the facility's policy and procedure (P&P) titled, "CORE: Administration of Oral Medications," dated June 2021, the P&P indicated,
"PURPOSE
This procedure establishes a system by which medications will be administered to patients safely, accurately, and efficiently by qualified personnel ...
POLICY
The policy of [Name of facility] is to ensure the following:
1. Administration
a. The Hospital PNT will be responsible for determining the scheduled administration times and making any recommendations for alterations, as needed, based on monitoring and evaluation data. The Electronic Medical Record defaults to standard times of administration ....
2. Competency ...
3. Documentation ...
b. Clinical assessment necessary before administering a specific type or dose of medication must be documented on the medication administration record (MAR) (e.g., pulse before Digoxin, blood pressure before antihypertensive).
c. Effectiveness/post assessment of medications will be documented in the medical record for PRN medications when warranted- analgesics, antipyretics and any other medication that warrants a post assessment (e.g., B/P rechecks after STAT dose of antihypertensive).
d. If the medication is not administered ("held" due to blood pressure parameters, patient refused, etc.), the appropriate documentation on the MAR including reason must be recorded ...
PROCEDURE
Current Standards of Practice for Medication Administration are followed.
1. General Guidelines for Administration of Medication ...
b. The 7 "R's" of administering medications will be followed with each medication administration:
i. "Right" patient
ii. "Right" medication
iii. "Right" dose
iv. "Right" time
v. "Right" route
vi. "Right" reason
vii. "Right" documentation ..."

6. A review of Patient 15's H&P, dated March 18, 2022, indicated, Patient 15 was admitted for respiratory failure, post tracheostomy, and PEG (percutaneous endoscopic gastrostomy - procedure to place a feeding tube to provide nutrition directly to the stomach).

a. During a concurrent interview and record review, on June 9, 2022, at 11:00 AM, in the medical records office, with the CCO, Patient's 15's MAR for morphine, was reviewed: The MAR for PRN (as needed) morphine, dated February 17, 2022, at 11:02 PM, indicated, "morphine sulfate: IV (intravenous - into the vein) push inj (injection), 2 (two) mg (milligram - unit of measurement), Start 2/17/22 (February 17, 2022) 23:01 (11:01 PM), q1/2h (every one or two hours), prn pain (severe 7-10) (numeric pain scale: 0- no pain; 1-3 mild pain; 4-6 moderate pain; 7-10 severe pain), stop after 7 (seven) days, renewable. Read back verification: Yes, order read back to provider. (prn pain (severe 7-10) ***WHILE FENTANYL (medication used to treat severe pain that is 50 to 100 times more potent than morphine) OR MORPHINE GTT (drip) IS OFF*** INSTRUCTION: May be diluted in 3 (three) ml (milliliter - unit of measurement) NS (normal saline - a type of intravenous solution) and administered as IV push over 4 to 5 (four to five) minutes. *** LOOK ALIKE/SOUND ALIKE *** **BLACK BOX WARNING: Respiratory depression (slow, ineffective breathing) ** DOSE: Morphine 2 mg (milligram) = 1ML (ML - milliliter)"
The MAR for PRN (as needed) morphine dated February 26, 2022, at 9:09 AM, indicated, "morphine sulfate: IV (intravenous) inj (injection), 2 (two) mg (milligrams), push, Start today (02/26/22) (February 26, 2022), q2h (every two hours), prn (as needed) pain (severe 7-10), stop after 7 (seven) days, renewable. Read back verification: Yes, order read back to provider. (prn pain (severe 7-10)) INSTRUCTION: May be diluted in 3 (three) ml (milliliters) NS (normal saline) and administered as IV push over 4 to 5 (four to five) minutes. *** LOOK ALIKE/SOUND ALIKE *** ** BLACK BOX WARNING: Respiratory depression** DOSE: Morphine 2 (two) mg (milligrams) = 1 (one) ML (milliliter)"

The MAR for PRN morphine, dated February 17, 2022, through March 5, 2022, was reviewed. The following dates and times were missing pre-assessments and/or post-assessments for pain:

On February 24, 2022, at 12:28 PM: no pain assessment before and after medication administration
On February 24, 2022, at 1:55 PM: no pain assessment before and after medication administration
On February 24, 2022, at 5:54 PM: no pain assessment before medication administration
On February 24, 2022, at 9:15 PM: no pain assessment before medication administration
On February 25, 2022, at 00:12 AM: no pain assessment before medication administration
On February 25, 2022, at 4:01 AM: no pain assessment before medication administration
On March 1, 2022, at 4:07 AM: no pain assessment before medication administration
On March 3, 2022, at 12:42 PM: no pain assessment before medication administration
On March 3, 2022, at 3:45 PM: no pain assessment before medication administration
On March 5, 2022, at 12:57 PM: no pain assessment before medication administration

The CCO confirmed and was unable to find documentation of pre-assessments and/or post-assessments for pain during the time reviewed.

During an interview, on June 14, 2022, at 9:40 AM, in the conference room, with RN 11, RN 11 stated when administering as needed pain medication, a pain assessment should be done first. RN 11 stated the patient's pain level should be reassessed and documented in the MAR within 30 minutes if given IV push, or within one hour if oral pain medication was given.

During a review of the facility's policy and procedure (P&P) titled, "CORE: Pain Management Plan," dated June 2020, the P&P indicated,
"PURPOSE
To establish an organized approach for caregivers to assess and manage patient's pain. The Pain Management Plan delineates the necessary assessments, interventions, monitoring, and patient/family education to promote effective pain relief.
POLICY
The policy of [Name of facility] is to ensure safe and effective practice in pain assessment, pain management, and safe opioid prescribing through the use of the Pain Management Plan ....
PROCEDURE
1. Assessments of Patients ....
c. Ongoing Assessments/Reassessments by licensed nursing staff:
i. Pain is assessed at least every shift during regular shift assessments, with patient complaint of pain, as needed related to patient's treatment(s)/patient condition, after analgesic administration and other pain interventions.
ii. Reassessment of pain is conducted through:
1) Evaluation and documentation of response to pain interventions
2) Progress toward pain management goal including functional ability
3) Side effects of treatment
4) Risk factors for adverse events caused by the treatment.
iii. When pain is identified, nursing assessment and documentation in the patient medical record includes the pain scale rating, location, duration, intensity and character.
1) Nursing judgment and patient condition determine if patient vital signs and other signs and symptoms (as noted in b. iv. Assessments of Patients) associated with the patient's pain are assessed and documented by the licensed nurse.
iv. Reassessment of pain relief interventions vary according to patient level of pain and patient status, pain relief interventions performed by the nurse and/or pharmacological agent administered and route of administration, nursing judgment and according to physician orders if present.
1) Recommended timeframes for reassessment of effectiveness of pain relief may include:
a) 30 minute reassessment - IM injection and IV medication
b) 1 hour reassessment - oral medication and non-pharmacological interventions..."

b. During a concurrent interview and record review, on June 9, 2022, at 11:18 AM, in the medical records office, with the CCO, Patient's 15's MAR for PRN (as needed) metoprolol, was reviewed: The MAR for PRN metoprolol, dated February 17, 2022, at 11:01 PM, indicated, "metoprolol tartrate: IV (intravenous) push inj (injection), 2.5 (two and one half) mg (milligrams), Renew start 04/04/22 (April 4, 2022) 02:59 (2:59 AM), q4h (every four hours), prn (as needed) Systolic Blood Pressure greater than 150, or HR (Heart Rate) above 120, stop after 45 days, renewable. (prn Systolic Blood Pressure greater than 150, or HR above 120) INSTRUCTION: Generic for [Brand name prescription drug for treatment of high blood pressure]. **BLACK BOX WARNING: Avoid abrupt withdrawal** DOSE: Metoprolol Tartrate 2.5 MG (milligrams) = 2.5 ML (milliliters)"

The MAR, for Metoprolol, dated February 17, 2022, through March 31, 2022, was reviewed.

On March 6, 2022, at 12:42 PM: no blood pressure or heart rate measured before medication administration

The CCO confirmed and was unable to find documentation of blood pressure or heart rate measured before the medication was administered on March 6, 2022, at 12:42 PM.

During an interview, on June 14, 2022, at 9:40 AM, in the conference room, with RN 11, RN 11 stated the process for giving a PRN medication for blood pressure (BP) is to check the patient's blood pressure and heart rate before giving the medication. RN 11 further stated she would recheck the patient's blood pressure if the BP medicat

Based on interview and record review, the facility failed to ensure the nursing staff followed the pre-printed heparin (a medication used to treat and prevent blood clots) order set (an order used for standardizing a provider order entry following an evidence-based practice) when there was no second licensed staff verification of heparin dosage, the nursing staff did not follow physician's order with starting dose and/or rate adjustment, and did not clarify the order for two of 35 sampled patients (Patient 1 and 4).

These failures had resulted in medication errors which could potentially lead to excessive bleeding with unsafe medication administration and negatively affect patients' health and safety with prolonged hospitalization, and/or lead up to death.

Findings:

a. A review of Patient 1's "History and Physical (H&P)," dated December 9, 2021, at 6:34 PM, the H&P showed, Patient 1 was admitted into the facility for continuation of care related to coronary artery occlusion (blockage in the artery that delivers blood and oxygen to patient's heart), status post thrombectomy (a type of surgery to remove clot from inside an artery), cerebrovascular accident (stroke-loss of blood flow to the brain), chronic anticoagulation (a group of medications to help prevent blood clots) with Heparin, and diabetes (a condition that body cannot control blood sugar).

During an interview, on June 8, 2022, at 5:05 PM, in the board room, with the Director of Pharmacy (DOP), the DOP stated, the heparin continuous intravenous (IV-into the vein) is used to treat blood clots. The DOP further stated, the nursing staff need to follow a physician's order with heparin order set and monitor Activated Partial Thromboplastin Time (aPTT or PTT-a blood test to measure the time it takes for a blood clot to form) to adjust heparin dosage.

During a concurrent interview and record review, on June 9, 2022, at 3:40 PM, in the board room, with Registered Nurse 7 (RN 7), Patient 1's "Physician Orders," for Heparin, dated December 18, 2022, at 8:43 AM, was reviewed. The "Physician Orders," for Heparin showed, Heparin was ordered to be started at 18 units per kilogram per hour (units/kg/hr-unit dosing of medication) with the dosing weight of 56 kg, and titrate (adjust) heparin based on the PTT results as follow:

PTT less than 38 seconds: increase heparin drip by 4 units/kg/hr
PTT 38 to 47 seconds: increase heparin drip by 2 units/kg/hr
PTT 48 to 79 seconds: no rate change
PTT 80 to 95 seconds: decrease heparin drip by 2 units/kg/hr
PTT greater than 95 seconds: hold the heparin drip for one hour, then decrease heparin drip by 3 units/kg/hr

RN 7 verified and confirmed the order of heparin for Patient 1.

A follow-up concurrent interview and record review, on June 9, 2022, at 3:45 PM, with RN 7, Patient 6's "Medication Administration Record (MAR)," for heparin, dated December 18, 2022, through December 21, 2022, was reviewed. The MAR for heparin showed as follow:

On December 18, 2021, at 12:50 PM: infusion started at 11 units/kg/hr
On December 18, 2021, at 8 PM: hold infusion for PTT result of 129.2 seconds
On December 18, 2021, at 9 PM: restarted infusion at 8 units/kg/hr
On December 19, 2021, at 4 AM: infusion set at 10 units/kg/hr
On December 19, 2021, at 10:35 AM: infusion set at 11 units/kg/hr (increase 1 unit/kg/hr from previous dose)
On December 19, 2021, at 5 PM: infusion set at 12 units/kg/hr (increase 1 unit/kg/hr from previous dose)

RN 7 verified and confirmed, the heparin was started at 11 units/kg/hr instead of 18 units/kg/hr as ordered, and there was no second nurse verification. RN 7 further stated, the titration was increased by 1 units/kg/hr instead of 2 units/kg/hr as ordered, and there was no second nurse verification. RN 7 stated, nursing staff did not follow a physician order for the initial dose and adjustment of heparin as ordered. RN 7 further stated, every heparin dose adjustment/change needs to be verified with a second Registered Nurse (RN) nursing staff.

A review of the facility's policies and procedures (P&P) titled, "Core: Heparin Infusion Protocol," release date June 2019, indicated as follow:

"Purpose: this policy establishes guidelines for the safe and efficacious management of continuous intravenous unfractionated heparin. This policy facilitates achieving rapid therapeutic anticoagulation with heparin into the target activated partial thromboplastin time (aPTT) ...
Policy: the policy of [Hospital Name] is to ensure the following
1. The heparin infusion protocol will be based on a pre-established dosing guideline approved through the Pharmacy & Therapeutics (P&T) Committee under the authority of the Medical Executive Committee ...
3. Heparin infusions will be infused on a programmable IV pump: Verify each dose adjustment/change with a second licensed healthcare professional. Documentation of this verification will be in the medical record ..."

b. A review of Patient 4's H&P, dated December 10, 2021, the H&P showed, Patient 4 was admitted into the facility with the diagnoses including aortic valve endocarditis (infection to the main valve on the left heart), cardiomyopathy (a disease of the heart muscle that makes it hard to pump blood to the body), and status post mechanical valve placement (a surgical procedure that replace human valve with manufactured mechanical valve).

During an interview, on June 8, 2022, at 5:05 PM, in the board room, with the DOP, the DOP stated, the heparin continuous IV is used to treat blood clots. The DOP further stated, the nursing staff need to follow physician's order with a heparin order set and monitor PTT results to adjust heparin dosage.

During a concurrent interview and record review, on June 9, 2022, at 3:55 PM, in the board room, with RN 7, Patient 4's "Physician Orders," for Heparin, dated December 10, 2021, at 7:35 PM, was reviewed. The "Physician Orders," for Heparin showed, Heparin was ordered to be started "at 13 units/kg/hr" with the dosing weight of 65.5 kg with an instruction written below to "start at 18 units/kg/hr" and titrate (adjust) heparin based on the PTT results as follow:

PTT less than 38 seconds: increase heparin drip by 4 units/kg/hr
PTT 38 to 47 seconds: increase heparin drip by 2 units/kg/hr
PTT 48 to 79 seconds: no rate change
PTT 80 to 95 seconds: decrease heparin drip by 2 units/kg/hr
PTT greater than 95 seconds: hold the heparin drip for one hour, then decrease heparin drip by 3 units/kg/hr

RN 7 verified and confirmed, there was two different starting rates on the heparin order. RN 7 stated, the physician and/or pharmacist should have been called to clarify the order. RN 7 further stated, the nursing staff should document in the patient's medical record the name of staff who clarified the order along with any new order or no change of order.

A follow-up concurrent interview and record review, on June 9, 2022, at 4 PM, with RN 7, Patient 4's "Nurses notes," dated December 10, 2021, was reviewed. RN 7 stated, he was unable to provide any documentation to show nursing staff clarified the heparin order before starting the administration, on December 10, 2021. RN 7 further stated, he was unable to provide any evidence to show Patient 4 had heparin infusion prior to the heparin order on December 10, 2021, at 7:35 PM.

A follow-up concurrent interview and record review, on June 9, 2022, at 3:45 PM, with RN 7, Patient 6's MAR, for heparin, dated December 10, 2022, through December 17, 2022, was reviewed. The MAR for heparin showed as follow:

On December 13, 2021, at 8:40 AM: infusion set at 17 units/kg/hr
On December 13, 2021, at 5:03 PM: titrated infusion to 19 units/kg/hr

On December 14, 2021, at 7:30 AM: infusion set at 23 units/kg/hr
On December 14, 2021, at 5:20 PM: titrated infusion to 25 units/kg/hr

RN 7 verified and confirmed, the heparin titration rate and time were completed without second nurse verification. RN 7 stated, every heparin dose adjustment/change needs to be verified with a second nursing staff.

During a concurrent interview and record review, on June 10, 2022, at 5:15 PM, in the board room, with the DP, Patient 4's "Physician Orders," for Heparin, dated December 10, 2021, at 7:35 PM, was reviewed. The "Physician Orders," for Heparin showed, Heparin was ordered to be started "at 13 units/kg/hr" with the dosing weight of 65.5 kg with an instruction written below to "start at 18 units/kg/hr." The DP stated the initial rate of 13 units/kg/hr might be ordered that continued from the previous hospital and the initial rate of 18 units/kg/hr is the initial dosage from the facility order set. The DP further stated it could be "confusing" to see two different rates on the heparin order. The DP stated, the nursing staff should clarify the heparin order with an ordering physician and/or a pharmacist. The DP further stated, she was unable to find any documentation to indicate the nursing staff clarified the heparin order before starting the infusion.

A review of the facility's P&P titled, "Core: Heparin Infusion Protocol," release date June 2019, indicated as follow:

"Purpose: this policy establishes guidelines for the safe and efficacious management of continuous intravenous unfractionated heparin. This policy facilitates achieving rapid therapeutic anticoagulation with heparin into the target activated partial thromboplastin time (aPTT) ...
Policy: the policy of [Hospital Name] is to ensure the following
1. The heparin infusion protocol will be based on a pre-established dosing guideline approved through the Pharmacy & Therapeutics (P&T) Committee under the authority of the Medical Executive Committee ...
3. Heparin infusions will be infused on a programmable IV pump: Verify each dose adjustment/change with a second licensed healthcare professional. Documentation of this verification will be in the medical record ..."

Based on observation, interview and record review, the facility failed to ensure the correct choice of intravenous (IV-Into the vein) access was provided for medication and the nursing staff administered and adjusted the continuous IV medication appropriately and as ordered when:

1. There was no central venous catheter (CVC-a device that is inserted into a large vein for fluid and medication administration) access for a vasoactive (a group of medications that has the effect of either increasing or decreasing blood pressure and/or heart rate) drug administration for one of 35 sampled patients (Patient 5).

2. The nursing staff did not monitor and titrate (the process of adjusting the dose of a medication for the maximum benefit without adverse effects) down Dopamine (a medication to improve blood pressure) continuous IV infusion appropriately during high blood pressure (BP) measurements (any top number of blood pressure measurements above 130 considers high blood pressure) for two of 35 sampled patients (Patient 2 and Patient 5).

3. The nursing staff did not start, monitor, and/or titrate Norepinephrine (Levophed-a medication to treat life-threatening low blood pressure) continuous IV infusion appropriately and as ordered for two of 35 sampled patients (Patient 1 and Patient 6).

4. The nursing staff did not follow the physician's order for titrating morphine (medication to treat pain) IV drip (slow infusion of medication or fluids into the vein) for one of 35 sampled patients (Patient 15).

These failures had resulted in an unsafe medication administration and monitoring with an inappropriate IV access and had the potential to negatively impact the drug's intended therapeutic effect which could adversely affect patients' responses without proper dosing adjustment, ineffective pain management, and unrelieved pain, which could jeopardize patients' health and safety, leading up to actual harm and possible death.

Findings:

1. A review of Patient 5's "History and Physical (H&P)," dated May 11, 2022, the H&P showed, Patient 5 was admitted into the facility for continuation of care related to respiratory failure (a condition when lungs cannot get enough oxygen), encephalopathy (damage to the brain function), and generalized anasarca (a condition that leads to general swelling of the whole body).

During an observation, on June 7, 2022, at 10:10 AM, at Patient 5's bedside in the Intensive Care Unit (ICU), Patient 5 is observed lying in bed with an IV pump (a medical device used to set fluid and medication to patient via IV access) delivering Levophed with a rate of 10 microgram/minute (mcg/min-unit dosing medication).

A follow-up concurrent observation and interview, on June 7, 2022, at 10:15 AM, with Registered Nurse 3 (RN 3) and the Senior Director of Clinical Operation (SDCO), Patient 5 has one IV access to the right upper arm. The SDCO and RN 3 verified and confirmed, Patient 5 has a midline (a peripheral IV access inserted from upper arm to armpit area), and it is infusing Levophed. RN 3 stated, vasoactive medications should be infused through a CVC access.

A follow-up interview and record review, on June 7, 2022, at 10:25 AM, with RN 3 and the SDCO, Patient 5's "Medication Administration Record (MAR)," for Levophed, dated May 24, 2022, through June 7, 2022, was reviewed. The MAR for Levophed showed, Levophed was started on May 24, 2022, at 8 PM. RN 3 stated, Levophed has been infused continuously from May 24, 2022, until now.

A follow-up interview and record review, on June 7, 2022, at 3:50 PM, in the board room, with the SDCO, Patient 5's Outside Hospital Record title, "PICC [Peripherally Inserted Central Catheter-an IV access inserted in the upper arm and guided into a big vein above the heart] Insertion Record," dated May 11, 2022, at 1:49 PM, was reviewed. The "PICC Insertion Record" showed, the right upper extremity midline placement was completed. The SDCO stated, Patient 5's midline was inserted from the outside facility and the nursing staff has been using it for Levophed infusion. The SDCO further stated, Patient 5 should have a CVC access for Levophed infusion.

A review of the facility's P&P titled, "Core: Vasoactive Infusions," release date June 2020, indicated as follow:

"Purpose: this policy is intended to define and standardize the administration, monitoring, and documentation processes for vasoactive medications, to ensure patient safety and maximize positive patient outcomes; and delineate the responsibilities of the nurse in the administration, monitoring, and documentation of vasoactive infusions.
Policy: the policy of [Hospital Name] is to ensure the following: ...
8. All Vasoactive infusions will be administered via an IV pump.
9. All Vasoactive infusions, which are weight-based, will be based on the most current patient weight of record measured in Kg [Kilogram].
10. The preferred site of infusion will be via a central line.
11. A peripheral IV site may be utilized emergently if no central line is available. When a peripheral IV site is used, the site will be assessed regularly for possible infiltration and extravasation of the IV solution until a central line is available ..."

2a. A review of Patient 2's H&P, dated January 26, 2022, the H&P showed, Patient 2 was admitted into the facility with the diagnoses including respiratory failure with tracheostomy (trach - a tube placed into the trachea via the neck to assist with breathing), urinary tract infection (UTI-an infection in any part of urinary system including kidneys, bladder, or urethra), and development delay.

During an interview, on June 8, 2022, at 5 PM, in the board room, with the Director of Pharmacy (DOP), the DOP stated, vasoactive medications such as Dopamine and Levephed would be ordered to treat patients with hypotensive (low blood pressure) condition. The DOP further stated, the nursing staff should follow a physician's order for administering, monitoring, and titrating vasoactive medications. The DOP further stated patients are at risk for hypertensive crisis (a severe increase in blood pressure where the top number reached above 180) which could cause stroke and lead up to death if patients have a high blood pressure and are kept on a vasoactive medication.

During a record review of Patient 2's "Physician Orders," for Dopamine, dated March 6, 2022, at 6:40 PM, on June 9, 2022, at 4:25 PM, in the board room, with RN 7, the "Physician Orders," for Dopamine showed, Dopamine was ordered to start at 5 microgram/kilogram/minute (mcg/kg/min-unit of dosing medication) and titrate by 1 mcg/kg/min every one minute to keep systolic blood pressure (SBP-top numbers of blood pressure measurement) above 90 or mean arterial pressure (MAP-average blood pressure from measurement) above 65. Patient 2's weigh was 122 kg.

A follow-up concurrent interview and record review, on June 9, 2022, at 4:30 PM, with RN 7, Patient 2's MAR for Dopamine, dated March 6, 2022, through March 18, 2022, was reviewed. The MAR for Dopamine showed as follow:

On March 12, 2022, at 12 PM: infusion set at 3 mcg/kg/hr with BP 159/49
On March 12, 2022, at 2 PM: infusion set at 3 mcg/kg/hr with BP 185/89
On March 12, 2022, at 5 PM: infusion set at 3 mcg/kg/hr with no BP recorded

RN 7 verified and confirmed the infusion rate and blood pressure measurement. RN 7 stated dopamine infusion was kept at the same rate of 3 mcg/kg/min for Patient 2 with high BP measurement. RN 7 stated, high BP measurement will increase Patient 2's risk for complications, such as stroke. RN 7 further stated, dopamine should be titrated down and should not be kept infusing.

A review of the facility's P&P titled, "Core: Vasoactive Infusions," release date June 2020, indicated as follow:

"Purpose: this policy is intended to define and standardize the administration, monitoring, and documentation processes for vasoactive medications, to ensure patient safety and maximize positive patient outcomes; and delineate the responsibilities of the nurse in the administration, monitoring, and documentation of vasoactive infusions.
Policy: the policy of [Hospital Name] is to ensure the following: ...
12. Vasoactive infusions will be administered at the does prescribed. Infusions may be titrated for the desired effect as stated and ordered by the Prescriber. A Vasoactive drug will not be titrated above the recommended maximum dose. Dose titration will be based on an individual patient's clinical status and predefined hemodynamic goals ...
15. When titrating vital signs will be monitored every 5 minutes until blood pressure is stabilized (hemodynamic goals are met).
16. When titrating the nurse will document the dose infusing every 5 minutes with associated vital signs.
17. Once hemodynamic goals are met; vital signs will be monitored and documented every 15 minutes for one hour.
18. Thereafter at a minimum, vital signs will be monitored and documented every hour during vasoactive infusion unless otherwise ordered by the prescriber ..."

2b. A review of Patient 5's H&P, dated May 11, 2022, the H&P showed, Patient 5 was admitted into the facility for continuation of care related to respiratory failure, encephalopathy, and generalized anasarca.

During an observation, on June 7, 2022, at 10:10 AM, at Patient 5's bedside in the ICU, Patient 5 is observed lying in bed with an IV pump delivers Levophed with a rate of 10 mcg/min.

During a review of Patient 5's "Physician Orders," for Dopamine, dated May 20, 2022, at 8:05 PM, on June 7, 2022, at 3:55 PM, in the board room, with the SDCO, the "Physician Orders," for Dopamine showed, Dopamine was ordered to start at 5 mcg/kg/min and titrate by 1 mcg/kg/min every one minute to keep SBP above 90 or MAP above 65. Patient 5 weight was 143 kg.

A follow-up concurrent interview and record review, on June 7, 2022, at 4:05 PM, with the SDCO, Patient 7's MAR for Dopamine, dated May 20, 2022, through May 24, 2022, was reviewed. The MAR for Dopamine showed as follow:

On May 24, 2022, at 11 AM: infusion set at 3 mcg/kg/hr with BP 109/60
On May 24, 2022, at 2 PM: infusion set at 5 mcg/kg/hr with no BP recorded
On May 24, 2022, at 3 PM: infusion set at 5 mcg/kg/hr with BP 170/142

The SDCO verified and confirmed the infusion rate and blood pressure measurement. The SDCO stated, the nursing staff needs to document the BP to justify the increased in Dopamine infusion. The SDCO further stated, the nursing staff should titrate down the Dopamine infusion with high BP measurement.

During an interview, on June 8, 2022, at 5 PM, in the board room, with the Director of Pharmacy (DOP), the DOP stated, vasoactive medications such as Dopamine and Levephed would be ordered to treat patients with hypotensive condition. The DOP further stated, the nursing staff should follow a physician's order for administering, monitoring, and titrating vasoactive medications. The DOP further stated patients are at risk for hypertensive crisis which could cause stroke and lead up to death if patients have a high blood pressure and are kept on a vasoactive medication.

A review of the facility's P&P titled, "Core: Vasoactive Infusions," release date June 2020, indicated as follow:

"Purpose: this policy is intended to define and standardize the administration, monitoring, and documentation processes for vasoactive medications, to ensure patient safety and maximize positive patient outcomes; and delineate the responsibilities of the nurse in the administration, monitoring, and documentation of vasoactive infusions.
Policy: the policy of [Hospital Name] is to ensure the following: ...
12. Vasoactive infusions will be administered at the does prescribed. Infusions may be titrated for the desired effect as stated and ordered by the Prescriber. A Vasoactive drug will not be titrated above the recommended maximum dose. Dose titration will be based on an individual patient's clinical status and predefined hemodynamic goals ...
15. When titrating vital signs will be monitored every 5 minutes until blood pressure is stabilized (hemodynamic goals are met).
16. When titrating the nurse will document the dose infusing every 5 minutes with associated vital signs.
17. Once hemodynamic goals are met; vital signs will be monitored and documented every 15 minutes for one hour.
18. Thereafter at a minimum, vital signs will be monitored and documented every hour during vasoactive infusion unless otherwise ordered by the prescriber ..."

3a. A review of Patient 1's H&P, dated December 9, 2021, at 6:34 PM, the H&P showed, Patient 1 was admitted into the facility for continuation of care related to coronary artery occlusion (blockage in the artery that delivers blood and oxygen to patient's heart), status post thrombectomy (a type of surgery to remove clot from inside an artery), cerebrovascular accident (stroke-loss of blood flow to the brain), chronic anticoagulation (a group of medications to help prevent blood clots) with Heparin (medication to help prevent blood clot), and diabetes (a condition that body cannot control blood sugar).

During an interview, on June 8, 2022, at 5 PM, in the board room, with the DOP, the DOP stated, the vasoactive medications such as Dopamine and Levephed would be ordered to treat patients with hypotensive condition. The DOP further stated, the nursing staff should follow a physician's order for administering, monitoring, and titrating the vasoactive medications. The DOP further stated patients are at risk for stroke and hypertensive crisis which could lead up to death if patients have a high blood pressure and are kept on the vasoactive medication.

During a record review of Patient 1's "Physician Orders," for Levophed, dated January 12, 2022, at 6:35 PM, on June 9, 2022, at 5 PM, with RN 7, the "Physician Orders," for Levophed showed, Levophed was ordered to start at 5 mcg/min, and titrate by 1 mcg/min every one minute to keep SBP above 90 or MAP above 65.

A follow-up concurrent interview and record review, on June 9, 2022, at 5:05 PM, with RN 7, Patient 1's MAR for Levophed, dated January 12, 2022, through January 17, 2022, was reviewed. The MAR for Levophed showed as follow:

On January 12, 2022, at 8:45 PM: started at 10 mcg/min
On January 12, 2022, at 9 PM: infusion set at 3 mcg/min for BP 178/80
On January 13, 2022, at 7:57 AM: infusion set at 3 mcg/min, no BP documented
On January 13, 2022, at 9:01 AM: infusion set at 3 mcg/min for BP 148/59

RN 7 verified and confirmed, the nursing staff did not follow the physician order when starting the Levophed infusion. RN 7 stated, the nursing staff should decrease the Levophed dosage when a BP measurement is above 130. RN 7 further stated, high blood pressure would increase the risk of stroke and hypertensive crisis.

A review of the facility's P&P titled, "Core: Vasoactive Infusions," release date June 2020, indicated as follow:

"Purpose: this policy is intended to define and standardize the administration, monitoring, and documentation processes for vasoactive medications, to ensure patient safety and maximize positive patient outcomes; and delineate the responsibilities of the nurse in the administration, monitoring, and documentation of vasoactive infusions.
Policy: the policy of [Hospital Name] is to ensure the following: ...
12. Vasoactive infusions will be administered at the does prescribed. Infusions may be titrated for the desired effect as stated and ordered by the Prescriber. A Vasoactive drug will not be titrated above the recommended maximum dose. Dose titration will be based on an individual patient's clinical status and predefined hemodynamic goals ...
15. When titrating vital signs will be monitored every 5 minutes until blood pressure is stabilized (hemodynamic goals are met).
16. When titrating the nurse will document the dose infusing every 5 minutes with associated vital signs.
17. Once hemodynamic goals are met; vital signs will be monitored and documented every 15 minutes for one hour.
18. Thereafter at a minimum, vital signs will be monitored and documented every hour during vasoactive infusion unless otherwise ordered by the prescriber ..."

3b. A review of Patient 6's H&P, dated February 23, 2022, the H&P showed, Patient 6 was admitted into the facility with the diagnoses including respiratory failure with tracheostomy, atrial fibrillation (abnormal heart rhythm), end stage renal disease (a condition that kidneys do not work normally), ileus (a condition in which the bowel does not work correctly), and dysphagia (difficulty swallowing) requiring a nasogastric tube (NG tube-a special tube that carries food and medicine to the stomach through the nose).

During an observation, on June 7, 2022, at 9:47 AM, at Patient 6's bedside in the ICU, Patient 6 is observed lying in bed with an IV pump delivering Levophed with a rate of 5 mcg/min via a left internal jugular (IJ-neck vein) CVC.

During a review of Patient 6's "Physician Orders," for Levophed, dated May 24, 2022, at 4:25 PM, on June 8, 2022, at 8:45 AM, with the SDCO, the "Physician Orders," for Levophed showed, Levophed was order to start at 5 mcg/min and D/C [Discontinue] the order if the drip was off for 4 hours.

A follow-up concurrent interview and record review, on June 8, 2022, at 8:50 AM, with the SDCO, Patient 6's MAR for Levophed, dated June 5, 2022, through June 7, 2022, was reviewed. The MAR for Levophed showed as follow:

On June 5, 2022, at 9 PM: medication turned off
On June 6, 2022, at 8:10 AM: infusion suspended
On June 7, 2022, at 5:36 AM: infusion started at 5 mcg/min

The SDCO verified and confirmed Levophed was restarted back after it was turned off more than 24 hours. The SDCO stated, Levophed order was automatically discontinued or inactive after four hours when it was turned off on June 5, 2022, at 9 PM.

A reviewed of Patient 6's "Nurses notes," for Change of condition, dated June 7, 2022, at 5:36 AM, showed, Levophed was started for low blood pressure of 75/34.

A follow-up interview, on June 8, 2022, at 8:55 AM, with the SDCO, stated, the nursing staff should inform a physician when Patient 6's blood pressure was low and needed to restart Levophed infusion. The SDCO further stated, she was unable to find any documentation to show a physician was notified with the low blood pressure condition and before restarting of the Levophed infusion. The SDCO stated, she was unable to find a new order of Levophed for the administration on June 7, 2022, at 5:36 AM.

During an interview, on June 9, 2022, at 4:20 PM, in the board room, with RN 7, RN 7 stated, vasoactive medication such as Dopamine and Levophed, would be expired or inactive after the medication was turned for four hours. RN 7 further stated, the nursing staff should call a physician to report patient's condition and request a new order for vasoactive medication before restarting medication.

A review of the facility's P&P titled, "Core: Vasoactive Infusions," release date June 2020, indicated as follow:

"Purpose: this policy is intended to define and standardize the administration, monitoring, and documentation processes for vasoactive medications, to ensure patient safety and maximize positive patient outcomes; and delineate the responsibilities of the nurse in the administration, monitoring, and documentation of vasoactive infusions.
Policy: the policy of [Hospital Name] is to ensure the following: ...
12. Vasoactive infusions will be administered at the does prescribed. Infusions may be titrated for the desired effect as stated and ordered by the Prescriber. A Vasoactive drug will not be titrated above the recommended maximum dose. Dose titration will be based on an individual patient's clinical status and predefined hemodynamic goals ...
15. When titrating vital signs will be monitored every 5 minutes until blood pressure is stabilized (hemodynamic goals are met).
16. When titrating the nurse will document the dose infusing every 5 minutes with associated vital signs.
17. Once hemodynamic goals are met; vital signs will be monitored and documented every 15 minutes for one hour.
18. Thereafter at a minimum, vital signs will be monitored and documented every hour during vasoactive infusion unless otherwise ordered by the prescriber ..."



42294

4. A review of Patient 15's H&P, dated March 18, 2022, indicated, Patient 15 was admitted for respiratory failure, post tracheostomy, and PEG (percutaneous endoscopic gastrostomy - procedure to place a feeding tube to provide nutrition directly to the stomach).

During a concurrent interview and record review, on June 9, 2022, at 10:53 AM, in the medical records office, with the Chief Clinical Officer (CCO), Patient's 15's "Medication Administration Record (MAR)," for morphine IV drip, was reviewed:
The MAR for morphine IV (intravenous) drip, dated February 18, 2022, at 1:32 AM, indicated, "Morphine sulfate, IV drip, 50 (fifty) mg (milligrams - unit of measurement), Base solution: NS (normal saline - IV solution containing sodium chloride), 50 (fifty) ml (milliliters - unit of measurement), Do not exceed 30 (thirty) mg/hr (milligrams per hour - rate of infusion), Titrate to keep pain free. ***Conc (concentration) = 1 (one) mg/mL (milligrams/milliliter). Start at 1 (one) mg/hr (milligram per hour). Titrate up or down by 1 (one) mg/hr (milligram per hour) q (every) 15 (fifteen) min (minutes) to control pain. Must have physician order to d/c (discontinue)*** Start today (02/18/22) (February 18, 2022), cont. (continue), stop after 7 (seven) days, renewable. Read back verification: Yes, order read back to provider. (in 50 (fifty) mL (milliliters) of NaCl (sodium chloride or salt) 0.9% (0.9 grams of salt per 100 milliliters of solution) ....**High Alert Med: two nurses verify drug, dose, and pump setting** **Look alike/Sound alike** **BLACK BOX WARNING: Res ...DOSE: Sodium Chloride 0.9% 0.9% 50 ML Morphine Sulfate 50 (fifty) MG (milligrams) = 5 (five) ML (milliliters)"

The MAR for morphine IV drip, dated February 18, 2022, through February 23, 2022, was reviewed:

On February 20, 2022, at 7:10 PM: Morphine was given at 4 mg/hr
On February 20, 2022, at 7:20 PM: Morphine was titrated to 3 mg/hr
On February 20, 2022, at 7:30 PM: Morphine was titrated to 2 mg/hr

The CCO verified the morphine IV drip was adjusted every 10 minutes which did not follow the order to titrate up or down by 1 mg/hr every 15 minutes.
During an interview, on June 14, 2022, at 9:40 AM, in the conference room, with RN 11, RN 11 stated the process for initiating a morphine IV drip is to follow Pharmacy protocol which is ordered by the physician. RN 11 stated the morphine IV drip order is verified with another nurse and includes name of the patient, medication, and dose. RN 11 further stated the protocol for titrating up or down should be followed. RN 11 stated documentation should include the time rate was changed, name of staff who verified rate change, and the patient's pain level.

During a review of the facility's P&P titled, "CORE: Administration of Medications via Injection," dated June 2020, the P&P indicated,

"PURPOSE
This procedure establishes a system by which medications will be administered to patients safely, accurately, and efficiently by qualified personnel ...
POLICY
The policy of [Name of facility] is to ensure the following:
1. Administration
a. The Hospital PNT will be responsible for determining the scheduled administration times and making any recommendations for alterations, as needed, based on monitoring and evaluation data. The Electronic Medical Record defaults to standard times of administration ....
2. Competency ....
3. Documentation
a. The individual administering the medication(s) must document all medications after administration in the patient's medical record.
b. Clinical assessment necessary before administering a specific type or dose of medication must be documented on the medication administration record (MAR) (e.g., pulse before Digoxin, blood pressure before antihypertensive).
c. Effectiveness/post assessment of medications will be documented in the medical record for PRN medications when warranted- analgesics, antipyretics and any other medication that warrants a post assessment (e.g., B/P rechecks after STAT dose of antihypertensive).
d. If the medication is not administered ("held" due to blood pressure parameters, patient refused, etc.), the appropriate documentation on the MAR including reason must be recorded ...
PROCEDURE
Current Standards of Practice for Medication Administration are followed.
1. General Guidelines for Administration of Medication
a. Only licensed nursing personnel, (RNs, LPNs), Respiratory Therapists and other qualified healthcare professionals, in accordance with State regulations and Medical Staff approval, may administer medication.
b. The 7 "R's" of administering medications will be followed with each medication administration:
i. "Right" patient
ii. "Right" medication
iii. "Right" dose
iv. "Right" time
v. "Right" route
vi. "Right" reason
vii. "Right" documentation ..."

Based on interview, and record review, the facility failed to properly execute an informed consent form for a procedure when:

1. A telephone consent was obtained without the signature of a second witness for one patient (Patient 8) in a universe of 35 sampled patients.

2. The Informed Consent was not signed by the patient/ patient's legal representative for one patient (Patient 22) in a universe of 35 sampled patients.

These failures resulted in not ensuring adequate information provided and received for patient and patient's representatives to make an informed decision regarding a procedure which could negatively affect the patient and/or the patient's representatives' feelings toward care being provided.


45413

Findings:

1. A review of Patient 8's "History and Physical (H&P)," dated March 19, 2022, showed Patient 8 was admitted into the facility with diagnoses including respiratory failure (serious condition of difficulty breathing on one's own), pneumonia (lung inflammation), anoxic encephalopathy (brain injury related to lack of oxygen), chronic obstructive pulmonary disease (constriction of the airways), and history of laryngeal cancer (cancer of the throat).

During a concurrent interview and record review, on June 8, 2022, at 8:20 AM, in the board room, with the Clinical Analyst Administrator (CAA), Patient 8's "Informed Consent for Transfusion (transferring donated blood)," dated March 29, 2022, was reviewed. The Informed Consent for Transfusion showed no name or signature of a second witness for the telephone consent obtained. The CAA verified and confirmed that there was no documentation on the Informed Consent for Transfusion form to show a second witness was present. The CAA stated, a telephone consent needs the signature of two witnesses to confirm the information on the form was communicated and verbally accepted by the patient representative.

During an interview, on June 14, 2022, at 9:00 AM, with Registered Nurse 11 (RN 11), RN 11 stated, the doctor calls the family to obtain a telephone consent. Once the consent is given, the doctor, nurse, and second witness sign the consent form. It is important to have two witnesses for a telephone consent to verify that a family member is giving consent for the procedure.

A review of the facility's policies and procedure (P&P) titled, "Core: Informed Consent," release date June 2021, indicated as follows:

"Purpose: This policy/procedure establishes guidelines around the patient's right to be informed of surgical and special procedures that may be rendered and the patient's right to accept or refuse a particular procedure. Informed consent must be obtained and documented according to this policy before initiating a surgical or special procedure, except in an emergency ...
1. Procedure ...
c. Hospital staff members (including all nurse and other employees) may participate in the informed consent process by witnessing the patient's, the patient's representative, or physician's signature regarding informed consent ...
3. Telephone Consents ...
c. Consent received by phone from a patient's legal representative should be confirmed by two witnesses who also speak to the legal representative.
d. The details of the phone consent should be documented on the consent form and signed by the person obtaining the consent and by both witnesses ..."



45050

2. During a review of Patient 22's H&P, dated March 17, 2022, the H&P showed Patient 22 has history of diabetes (a disease that result in too much sugar in the blood), hypertension (abnormally high blood pressure), legally blind, and is on chronic hemodialysis (process of removing waste products and excess fluid from the body).

During a concurrent interview and record review, on June 9, 2022, at 10:47 AM, with the Senior Director of Clinical Operations 2 (SDCO 2), Patient 22's "Informed Consent for Surgical and Special Procedures" was reviewed. The Informed Consent for Surgical and Special Procedures indicated, on March 22, 2022, consent for central line (a special tube that is inserted into a large vein for fluid and medication administration) placement was not signed by the patient/ patient's legal representative. The SDCO 2 stated and confirmed, central line placement consent was not signed by the patient/ patient's legal representative and should have been obtained prior to the procedure.

During a review of the facility's policy and procedure (P&P) titled "CORE: Informed Consent" dated June 2021, the P&P indicated,

"PURPOSE
This policy/procedure establishes guidelines around the patient's right to be informed of surgical and special procedures that may be rendered and the patient's right to accept or refuse a particular procedure. Informed consent must be obtained and documented according to this policy before initiating a surgical or special procedure, except in an emergency.
POLICY
This policy of [Hospital Name] applies to all surgical and special procedures that involve material risk to the patient, regardless of their repetitive nature. Some items require informed consent by law or regulatory standard, such as HIV testing or blood/blood product administration.
DEFINITIONS
H-PC 08-006 A CORE: Procedures Requiring Informed Consent: An attachment to this policy that lists all procedures that require an informed consent.
PROCEDURE
1. Obtaining Informed consent ...
2. Mechanisms of Documenting Informed Consent. Informed consent must be documented on one of the following:
a. A completed Hospital-approved Informed Consent Form signed by the patient or patient's legal representative ...
3. Telephone consents ...
4. Duration of Consent ...
5. Requirements of Informed consent ...
d. Documentation of the informed consent must be completed prior to the procedure and documented in the patient's medical record as evidence that consent has been obtained.
6. Medical emergencies
c. The physician must show the need for proceeding without informed consent by documenting in the medical record the reasonable and diligent efforts as time allows to acquire consent from the next of kin or legal representative; and the immediacy and magnitude of the threat to the patient if the medical or surgical procedure were not immediately done."

Based on interview and record review, the facility failed to meet the pharmaceutical needs when the hospital failed to administer the patient's own medication (POM) Lurasidone (antipsychotic - drug to treat mental health or mood disorders) stored in the hospital as ordered by the prescriber due to inadequate communication between Nursing staff and the Pharmacy Department for one of 35 sampled patients (Patient 19).

This failure resulted in seven (7) medication omissions (missed doses) for Patient 19 and had the potential for Patient 19 to experience preventable mental health exacerbations and psychological distress.

Findings:


45050

During a review of Patient 19's "History and Physical (H&P)," dated May 20, 2022, the H&P showed, with past medical history of osteoarthritis (degeneration of joint cartilage and the underlying bone, it causes pain and stiffness) who initially presented to [Hospital Name] Emergency Department on April 16, 2022, as a trauma alert, she was an auto versus pedestrian and was found down initially hypotensive (low blood pressure).

During a review of Patient 19's "Patient's Own Medication Log", dated September 10, 2020, the "Patient's Own Medication Log" showed, Lurasidone 20 mg with the total of 17 pills received by hospital staff and the remaining of 12 pills stored in the hospital.

During a record review, on June 8, 2022, at 2:50 PM, with the Outcome Manager (OM), Patient 19's electronic "Medication Administration Record (MAR)," was reviewed. The MAR indicated, Physician order (telephone), dated October 1, 2020, for Lurasidone 20 mg, 1 tablet by mouth to be given every day. The MAR indicated, on October 9, 2020, through October 15, 2020, Patient 19's Home Med Lurasidone 20 milligram (mg-unit of measurement for dose) was not administered as follow:

On October 9, 2020: "not done (waiting for Pharmacy availability)"
On October 10, 2020: "not done (medication not available, daughter will bring in a few days)"
On October 11, 2020, through October 13, 2020: "not done (med not available)"
On October 14, 2020, through October 15, 2020: "not done (waiting for availability)"

The OM stated and confirmed Lurasidone 20 mg was not administered as ordered for Patient 19.

During an interview on June 9, 2022, at 03:09 PM, with Director of Pharmacy (DP), the DP stated for non-formulary medications, they (the hospital) ask family members to bring in home medications. The DP stated there was no communication documentation between nursing and pharmacy staff regarding Patient 19's Lurasidone. The DP further stated, there was no communication log between Pharmacy, Nursing, and Physicians to prevent missing medications especially patient's own medications.

During a review of the facility's policy and procedure (P&P) titled "CORE: Patient's Own Medications" dated June 2021, the P&P indicated,

"PROCEDURE ...
1. Patients' own medications may be administered while in the facility if at any of the following circumstances apply:
a. The ordered medication is non-formulary [not listed in the hospital's drug formulary] ...
2. The pharmacist will:
a. verify the medication
b. verity the quantity
c. unit dose/label the medication as patient own medications
d. dispense according to cart fill schedule
e. notify the patient and/or family member of need for additional medications 96 hour in advance of current supply exhaustion.
3. The medications will be secured in the patient's medication cabinet ..."


42004

Based on observations, record review and interviews, the hospital failed to prepare and administer Intravenous Venous (IV) drugs in accordance with the hospital's policies and procedures when nursing staff prepared and administered IV antibiotic medications to 2 patients (Patients PATIENT 32, PATIENT 33) without completing aseptic (germ-free) technique and applicable nursing competencies; oral vancomycin was administered to PATIENT 20 for over 2 months without an indication, and when Staff Pharmacist (SP) 1 did not clarify nurse heparin order for PATIENT 34.

These failures had the potential to result in a cross contamination amongst patients without proper nursing competencies, unnecessary medication administration, and lack of pharmacy oversight which could negatively affect patients' health, safety, prolonged hospitalization, and/or lead up to death.

Findings:

During a concurrent record review and interview, on June 7, 2022, at 4:02 PM, with Director of Pharmacy (DP), the hospital's night locker medication log at Med Surg 100 was reviewed. The medication log indicated Zosyn (IV antibiotic) 3.375 grams (gm) and vancomycin 1 gm were compounded from vials and added to IV solution bags on 6/4/22 by Registered Nurse (RN) 21. Zosyn 3.375 gm was administered to PATIENT 33 on June 4, 2022, at 2:30 AM, and vancomycin 1 gm was administered to PATIENT 33 on June 4, 2022, at 1:38 AM, the DP was unable to provide documentation of IV competency training within the last 12 months for RN 21. The medication log also indicated vancomycin 1 gm was compounded from a vial and added to IV solution bags on June 5, 2022, by RN 22 for PATIENT 32. DP was unable to provide documentation that vancomycin 1 gm was administered to PATIENT 32 as ordered by the physician. DP was unable to provide documentation of IV competency training for RN 22. DP stated RN 22 was a new nurse supervisor since August 9, 2021 and had not completed his competency training. DP stated, "Very important for nurse to know how to do IV to prevent error and contamination. Need to have proper technique and proper dosing so patient can get correct dose and safely. Patient may go to sepsis, may die, infection goes to bloodstream."

During an interview on June 8, 2022, at 2:23 PM, with Registered Nurse (RN 8), RN 8 stated, "We are competence once a year. Pharmacist watches us, tells us how much to put in bag form vial and send it to see if it grows. That tells us if our technique is sterile. I have done this particular procedure every year- that is how they determine we are able to do sterile technique without introducing bacterium into the bag. They [nursing staff] could compound inaccurately, mix wrong concentration, introduce bacterium into IV fluid. Depending on if it's an ampule, if they don't use a filter needle or change filter needle, what they're supposed to filter out will go right into bag. It could be a drastic outcome; it could kill patient."

During a review of the hospital's Director of Pharmacy job description, the job description stated, "Supports and serve as consultant to all Medical staff and clinical service personnel on pharmaceutical related issues Provides for orientation, in-service training, continuing education, annual performance and competency reviews of department personnel to ensure staffs competent to provide services."
During a review of the hospital's P&P titled, "Nursing Preparation of IV Admixtures in the Absence of a Pharmacist or in Urgent Situations" dated June 2021, the P&P stated, "Nurses authorized to prepare sterile products/IV admixtures must complete aseptic technique & other applicable nursing competencies"

During a concurrent record review and interview, on June 9, 2022, at 10:16 AM, with the DP, PATIENT 20's vancomycin order dated September 21, 2021, and laboratory results were reviewed. The physician vancomycin order indicated, vancomycin per feeding tube 125 milligrams (mg) via feeding tube every 6 hours was administered from September 21, 2021, through November 22, 2021. The laboratory results indicated clostridium difficile (bacteria that causes diarrhea and damage to the colon) tests were obtained on September 21, 2021, October 16, 2021, October 29, 2021, November 8, 2021, and December 1, 2021, and results for all the tests were negative.

During an interview, on June 10, 2022, at 10 AM, with DP, DP acknowledged it was inappropriate to continue vancomycin. DP stated, "Not justified for use of vancomycin to be continued in this case, patient did not have c-diff, we do antibiotic microbial stewardship. We do it daily but vancomycin for some reason was not on list, we don't monitor oral, we only monitor iv."

During a review of the hospital's Policy and Procedure (P&P) titled, "Antimicrobial Stewardship" dated December 2019, the P&P stated, "achieve best clinical outcomes related to antimicrobial use while minimizing toxicity and other adverse events ..."

A review of Lexicomp, nationally regarded drug reference indicated some adverse effects for oral vancomycin as hypotension (low blood pressure), constipation, anemia (low red blood cells), depression, insomnia (inability to sleep), and kidney failure.

During a concurrent record review and interview, on June 9, 2022, at 4:49 PM, with DP, PATIENT 34's heparin order dated May 21, 2022, was reviewed. The heparin order indicated, "Start at 15 units/kilograms (kg)/hour (hr). The heparin dose for PATIENT 34 calculated by pharmacy indicated, "Initial Infusion Rate: 16 units/kg/hr". DP acknowledged the incorrect dose of 15 units/kg/hr was initiated and administered for 6 hours. DP stated, "Pharmacist instead of putting in new order, she just verified nurse order, patient got too little heparin ... if dose low, patient will have clot ..."

During a review of the hospital's P&P titled, "Review of Medication Orders" dated June 2020, the P&P stated, "When a medication order is received in the Pharmacy and clarification or verification is needed the pharmacist is responsible for: contacting the prescribing practitioner b. Informing the nurse that a clarification is needed and that the medication will not be dispensed until the prescriber is contacted c. Resolving the problem relating to the medication order"

During a review of the hospital's P&P titled, "Ordering of Medications" dated June 2020, the P&P stated, "Incomplete medication orders: The pharmacist, when on duty is primarily responsible for contacting the physician to correct any incomplete or unclear medication order submitted for final verification into the pharmacy system."

Based on interview, and record review, the facility failed to ensure medication was reviewed, prescribed, and administered appropriately for two patients (Patient 1 and Patient 4) of 35 sampled patients when:

1. For Patient 1, the pharmacist prescribed an incorrect initial warfarin (coumadin-a medication to prevent blood clot) dosage.

2. For Patient 4, the pharmacist did not prescribe a coumadin for one day.

These failures had resulted in a medication error (any preventable event that may cause or lead to inappropriate use or patient harm) that contributed to the bleeding for Patient 1, had the potential to cause blood clot for Patient 4 with sub-therapeutic (lower level than expected) coumadin level. These failures could prolong hospitalization, cause serious harm and/or death to patients.

Finding:

1. A review of Patient 1's "History and Physical (H&P)," dated December 9, 2021, at 6:34 PM, the H&P showed, Patient 1 was admitted into the facility for continuation of care related to coronary artery occlusion (blockage in the artery that delivers blood and oxygen to patient's heart), status post thrombectomy (a type of surgery to remove clot from inside an artery), cerebrovascular accident (stroke-loss of blood flow to the brain), chronic anticoagulation (a group of medications to help prevent blood clots) with Heparin, and diabetes (a condition that body cannot control blood sugar).

During an interview, on June 8, 2022, in the board room, with the Director of Pharmacy (DP), the DP stated, coumadin should be given as ordered. The DP further stated a pharmacist can prescribe and adjust coumadin dosage per the facility's policies and protocols (P&P) based on the International Normalized Ratio (INR-a test to measure the time for the blood to clot) result. The DP stated, some of the risks for patients with coumadin including bleeding with too much coumadin and blood clot with too little coumadin. The DP further stated the INR results must be monitored closely to prevent any complication to patients with coumadin.

A review of Patient 1's "Physician orders," for coumadin, dated December 20, 2021, at 11:24 AM, showed coumadin 15 milligram (mg-unit dosing medication) was order to be given.

A follow-up interview and record review, on June 14, 2022, at 8:45 AM, with the DP, Patient 1's "Medication Administration Record (MAR)," for coumadin, dated December 20, 2021, was reviewed. The MAR for coumadin showed, Patient 1 received 15 mg of coumadin, on December 20, 2021, at 4:45 PM. The DP verified and confirmed the dosage received. The DP stated, Patient 1 was supposed to get five (5) mg of coumadin as an initial dosage for an INR goal of 2-3 seconds. The DP further stated, there was no documentation the nursing staff clarified the order with a pharmacist for the high initial dose of coumadin.

A follow-up interview, on June 14, 2022, at 8:55 AM, with the DOP, the DP stated, 15 mg of coumadin was "unintentional" prescribed to Patient 1 when she was working on two different patients. The DP further stated, she recognized the coumadin error on the follow day, December 21, 2021.

A review of Patient 1's "Nurses notes," for change of condition, dated December 21, 2021, at 2:53 PM, showed, Patient 1 had "bleeding from right dorsal [back] hand wound."

A review of Patient 1's "Physician orders," for packed red blood cells (PRBC-a type of blood transfusion product used for bleeding patients), dated December 22, 2021, at 7:40 AM, showed, 1 unit (bag) of PRBC was ordered to be given for Patient 1.

A review of the facility's P&P title, "Core: Oral Anti-Coagulation [a group of medications to prevent blood clot]," release date June 2019, indicated as follow:

"Purpose: this policy establishes guidelines to provide a standardized, multidisciplinary approach for the assessment, administration and monitoring of oral anticoagulation. To reduce the likelihood of patient harm associated with the use of oral anticoagulation including the newer target-specific oral anticoagulants; (TSOAs) ...
Policy ...
3. Lab-Drawing ...
b. Patients initiated on warfarin during their hospital stay will have daily INR levels drawn until at least two consecutive levels are within their targeted INR range. Once targeted INR range is achieved, PT/INR levels should be monitored two to three times weekly for 1 to 2 weeks: depending on the stability of INR results. A PT/INR level will be drawn a minimum of once per week. For guidelines, refer to: ... Guidelines for Warfarin Initiation ...
Guidelines for warfarin initiation: day 1, dose 5 mg ..."

2. A review of Patient 4's H&P, dated December 10, 2021, the H&P showed, Patient 4 was admitted into the facility with the diagnoses including aortic valve endocarditis (infection to the main valve on the left heart), cardiomyopathy (a disease of the heart muscle that makes it hard to pump blood to the body), and status post mechanical valve placement (a surgical procedure that replace human valve with manufactured mechanical valve).

During an interview, on June 8, 2022, in the board room, with the Director of Pharmacy (DP), the DP stated, coumadin should be given as ordered. The DP further stated a pharmacist can prescribe and adjust coumadin dosage per the facility's P&P based on the INR result. The DP stated, some of the risks for patients with coumadin including bleeding with too much coumadin and blood clot with too little coumadin. The DP further stated the INR results must be monitored closely to prevent any complication to patients with coumadin.

A review of Patient 4's "Test reported," for INR, dated December 20, 2021, at 12:46 PM, the INR result was 1.36 seconds. The target INR for "prevention of arterial [blood vessels] thromboembolism [blood clot] including patients with mechanical heart valves" is 3.5 seconds.

A review of Patient 4's "Physician orders," for coumadin, dated December 19, 2021, through December 21, 2021, showed as follow:

On December 19, 2021, at 11:22 AM: 16 mg of Coumadin was order
On December 20, 2021: no coumadin order on medical record
On December 21, 2021, at 10:07 AM: 15 mg of Coumadin was order

A follow-up interview and record review, on June 14, 2022, at 8:50 AM, with the DP, Patient 4's MAR for coumadin, dated December 20, 2021, was reviewed. The DP verified and confirmed, there was no coumadin ordered and given to Patient 4. The DP stated, Patient 4 was coumadin dependent with his medical condition. The DP further stated, Patient 4 was supposed to get 15 mg of coumadin for an INR goal of 2.5-3.5 seconds. The DP stated, there was no documentation the nursing staff clarified the order with a pharmacist for the omission of coumadin dosage.

A follow-up interview, on June 14, 2022, at 8:55 AM, with the DP, the DP stated, coumadin was "unintentional" missed prescribed to Patient 4 when she was working on two different patients. The DP further stated, she recognized the coumadin error on the follow day, December 21, 2021.

A review of the facility's P&P title, "Core: Oral Anti-Coagulation [a group of medications to prevent blood clot]," release date June 2019, indicated as follow:

"Purpose: this policy establishes guidelines to provide a standardized, multidisciplinary approach for the assessment, administration and monitoring of oral anticoagulation. To reduce the likelihood of patient harm associated with the use of oral anticoagulation including the newer target-specific oral anticoagulants; (TSOAs) ...
Policy ...
4. Treatment-monitoring
a. Patients on warfarin therapy will be monitored utilizing the PT/INR laboratory measure. Dosing adjustments will be based on this laboratory function.
i. Pharmacists are authorized to order PT/INR levels on behalf of the attending physician unless the physician has expressly revoked this privilege in writing.
ii. Guidelines for recommended dosing adjustments will be provided to the medical staff. For guidelines, refer to: ... Dose Adjustments for Warfarin Maintenance Therapy ...
Dose Adjustments for Warfarin Maintenance Therapy: INR sub-therapeutic level, action/recommendation: increase dose by 5-20% based on the cumulative weekly dose ..."

Based on interview and record review, the facility failed to ensure the Pharmacy sterile (germ-free) compounding (mixing medications) procedures were consistent with current United States Pharmacopeia (USP - establishes quality standards for drugs and drug compounding in the United States) sterile compounding standards of practice when:

1. The hospital failed to develop a formal written environmental sampling plan for airborne viable (living) particles (particles carrying living microbes such as bacteria or fungi) based on a risk assessment of compounding activities performed as required by the USP standard of practice.

2. The hospital could not demonstrate Gloved Fingertip Sampling (competency personnel competency assessment) was performed by two (Pharmacy Technician A and Pharmacy Technician B) of two Pharmacy staff with proper technique.

3. The hospital could not demonstrate Gloved Fingertip Sampling (competency personnel competency assessment) performed by one (Pharmacy Technician A) of two Pharmacy staff was incubated for the minimum timeframe as required by USP standard of practice.

These failures had the potential for lack of administrative oversight, unreliable competency evaluations for pharmacy staff, and/or inadequate risk assessment to determine the quality of the pharmacy compounding environment for a universe of 38 patients.

Findings:

1. During a review of the 2008 USP <797> in the section titled "INTRODUCTION", USP <797> indicated "The objective of this chapter is to describe conditions and practices to prevent harm, including death, to patients...The standards in this chapter are intended to apply to all persons who prepare CSPs [compounded sterile preparations] and all places where CSPs are prepared (e.g., hospitals ...)."

During a concurrent interview and record review, on June 9, 2022, at 9:11 AM, the 2008 USP <797> section titled "ENVIRONMENTAL VIABLE [capable of living] AIRBORNE PARTICLE TESTING PROGRAM" was reviewed with the DP. USP <797> indicated "Sampling Plan ...An appropriate environmental sampling plan shall be developed for airborne viable particles based on a risk assessment of compounding activities performed ... Selected sampling sites shall include locations ...in the segregated [separate] compounding areas at greatest risk of contamination (e.g., work areas near the ISO [abbreviation for International Organization for Standardization - a standard setting body] Class 5 [category of air cleanliness and quality]...environments, counters nears doors, pass-through boxes). The plan shall include sample location, method of collection, frequency of sampling, volume of air sampled, and time of day as related to activity in the compounding area and action levels ...Viable Air Sampling ...For low-, medium-, high-risk [risk categories] level compounding, air sampling shall be performed at locations that are prone to contamination during compounding activities and during other activities such as staging, labeling, gowning, and cleaning." The DP acknowledged the USP <797> requirements for a written environmental sampling plan.

During a review, on June 9, 2022, at 10:23 AM, the facility's policy and procedure titled, "CORE: Quality Assurance for Compounded Sterile Products (CSPs) CAI [Compounding Aseptic Isolator - where CSPs are mixed]" dated June 2019 was reviewed with the DP. Continued review of the policy indicated, "9) Environmental Viable Airborne & Surface Particle Testing - Sampling Plan
a. Facility shall select sampling sites that include locations within each ISO [International Organization for Standardization] Class 5 [measure of air cleanliness] environment ...and the segregated areas at greatest risk of contaminations (e.g., work areas nest [near] the ISO Class 5 environment, pass-through boxes)
b. The plan shall include sample location, method of collection, frequency of sampling, volume of air sampled, and time of day as related to activity in the compounding area and action levels.
c. The plan shall include a Summary of Air Sampling procedure."

During an interview, with the Director of Pharmacy (DP), on June 9, 2022, at 10:23 AM, the DP stated the hospital followed USP <797> standards of practice for sterile compounding. The DP acknowledged the facility documents could not demonstrate a formal written environmental sampling plan based on USP <797> section titled "ENVIRONMENTAL VIABLE [capable of living] AIRBORNE PARTICLE TESTING PROGRAM" and facility policy titled "CORE: Quality Assurance for Compounded Sterile Products (CSPs) CAI" dated June 2019, sections 9a, 9b, and 9c.

During a review of the 2008 USP <797> in the section titled "QUALITY ASSURANCE (QA) PROGRAM", USP <797> indicated "A provider of CSPs shall have in place a formal QA program intended to provide a mechanism for monitoring, evaluating, correcting, and improving the activities and processes described in this chapter ...Emphasis in the QA Program is placed on maintaining and improving the quality of systems and the provision of patient care. In addition, the QA program ensures that any plan aimed at correcting identified problems also includes the appropriate follow-up to make certain that effective corrective actions were performed. Characteristics of a QA program include the following ...Formalization in writing ...In developing a specific plan, focus is on establishing objective, measurable indicators for monitoring activities and processes that are deemed high risk, high volume, or problem prone."
During a review of the facility's policy and procedure titled, "CORE: Quality Assurance for Compounded Sterile Products (CSPs) CAI [Compounding Aseptic Isolator - where CSPs are mixed]" dated June 2019, the policy indicated "The formal Quality Assurance (QA) program will provide a mechanism for monitoring, evaluating, correcting, and improving the activities and processes related to State Pharmacy laws and regulations and USP <797>." Continued review of the policy indicated, "9) Environmental Viable Airborne & Surface Particle Testing - Sampling Plan
a. Facility shall select sampling sites that include locations within each ISO [International Organization for Standardization] Class 5 [measure of air cleanliness] environment ...and the segregated areas at greatest risk of contaminations (e.g., work areas nest [near] the ISO Class 5 environment, pass-through boxes)
b. The plan shall include sample location, method of collection, frequency of sampling, volume of air sampled, and time of day as related to activity in the compounding area and action levels.
c. The plan shall include a Summary of Air Sampling procedure."

2. During a review of the 2008 USP <797> in the section titled "INTRODUCTION", USP <797> indicated "The objective of this chapter is to describe conditions and practices to prevent harm, including death, to patients...The standards in this chapter are intended to apply to all persons who prepare CSPs [compounded sterile preparations] and all places where CSPs are prepared (e.g., hospitals ...)."

During a review of the 2008 USP <797> in the section titled "Gloved Fingertip Sampling", USP <797> indicated "Personnel shall "touch" the agar (culture medium for microbial growth) with the fingertips of both hands in separate plates in a manner to create a slight impression in the agar. The sampled gloves shall be immediately discarded, and proper hand hygiene performed after sampling."
During an interview with Pharmacy Technician B (PhT B) on June 8, 2022, at 10:16 AM, PhT B stated they used one set of gloves for all six initial Gloved Fingertip Sampling tests (three tests for the left hand and three tests for the right hand).

During an interview, with Pharmacy Technician A (PhT A), on June 8, 2022, at 10:36 AM, PhT A stated they used one set of gloves for all six initial Gloved Fingertip Sampling tests (three tests for the left hand and three tests for the right hand). PhT A stated they used the same glove for all tests and did not change the gloves in between the tests.

During an interview, with the Senior Director of Pharmacy Operations (SDPO), on June 8, 2022, at 10:36 AM, stated "No, not the process" when asked if the same set of gloves was to be used for all the initial Gloved Fingertip Sampling tests.

During an interview, with the Director of Pharmacy (DP), on June 9, 2022, at 8:27 AM, the DP stated, "Moving forward, the new employees will do three (3) different set of loves for the 3 different tests."

During an interview, with the DP, on June 9, 2022, at 10:23 AM, the DP stated the hospital followed USP <797> standards of practice for sterile compounding.

During a review of the facility's policy and procedure titled, "CORE: Quality Assurance for Compounded Sterile Products (CSPs) CAI" dated June 2019, the policy indicated "The formal Quality Assurance (QA) program will provide a mechanism for monitoring, evaluating, correcting, and improving the activities and processes related to State Pharmacy laws and regulations and USP <797>." Continued review of the policy indicated ...
"c. Gloved Fingertip Sampling
i. Glove fingertip sampling shall be used to evaluate the competency of personnel in performing hand hygiene and garbing procedures
ii. Immediately after the compounding personnel completes the hand hygiene and garbing procedure ...an evaluator will collect a gloved fingertip and thumb (all 5 finger) sample from both hands onto the appropriate agar media ...
iii. All employees will be successfully complete an initial gloved fingertip testing (all 5 fingers both left and right hand) no less than 3 times for each hand before being allowed to compound product for patient use."

3. During a review of the 2008 USP <797> in the section titled "INTRODUCTION", USP <797> indicated "The objective of this chapter is to describe conditions and practices to prevent harm, including death, to patients...The standards in this chapter are intended to apply to all persons who prepare CSPs [compounded sterile preparations] and all places where CSPs are prepared (e.g., hospitals ...)."

During a concurrent interview and record review, on June 9, 2022, at 9:07 AM, the six (6) November 2021 Gloved Fingertip Sampling for Pharmacy Technician A (PhT A) were reviewed with the Director of Pharmacy (DP). Three gloved fingertip tests for the left hand and three gloved fingertip tests for the right hand indicated the incubation period was less than 48 hours for all six tests. The DP acknowledged the incubation period was less than 48 hours for PhT A's six November 2021 Gloved Fingertip Sampling tests.

During a concurrent interview and record review, on June 9, 2022, at 9:07 AM, the 2008 USP <797> section titled "Incubation Period", was reviewed with the DP. USP <797> indicated "At the end of the designated sampling period for compounding personnel competency assessment activities ...the agar plates are recovered and covers secured and they are inverted and incubated at a temperature and for a time period conducive to multiplication of microorganisms ...for 48 to 72 hours." The DP acknowledged the 2008 USP <797> section titled "Incubation Period".

During an interview, with the DP, on June 9, 2022, at 10:23 AM, the DP stated the hospital followed USP <797> standards of practice for sterile compounding.

During a review of the facility's policy and procedure titled, "CORE: Quality Assurance for Compounded Sterile Products (CSPs) CAI" dated June 2019, the policy indicated "The formal Quality Assurance (QA) program will provide a mechanism for monitoring, evaluating, correcting, and improving the activities and processes related to State Pharmacy laws and regulations and USP <797>."

Based on observation, interview, and record review, the facility failed to ensure potentially outdated medications were not available for patient use. This occurred when one of one opened, undated, and partially used multi-dose insulin lispro (brand name Humalog - medication to treat high blood sugar) vial was stored without appropriate labeling to indicate the beyond use date (the date/time cannot be stored) in the hospital's Intensive Care Unit (ICU - critically ill patients).

This failure had the potential for patients to receive deteriorated (reduced quality) medications (universe of 4 patients).

Findings:

During a concurrent observation and interview, on June 8, 2022, at 4:19 PM, an inspection of the ICU medication room refrigerator was conducted with the Senior Director of Pharmacy Operations (SDPO), Senior Director of Clinical Operations (SDCO 2), and Registered Nurse 13 (RN 13). An opened, undated, and partially used multi-dose insulin lispro was observed stored in the medication refrigerator without proper labeling to indicate a beyond-use-date. The SDPO, SDCO 2, and RN 13 acknowledged the observation.

During a concurrent interview and record review, on June 8, 2022, at 4:36 PM, the facility's policy and procedure titled, "CORE: Medication Labeling" dated June 2019, was reviewed with SDCO 2 and RN 13. The policy indicated, "Multi-Dose Medications
a. All multi-dose medications for inpatients will contain the following information on the label and drug packaging ...Beyond use date." The SDCO 2 and RN 13 acknowledged the policy.

Based on observations and interviews, the hospital failed to provide nursing staff information relating to drug therapy and drug interactions when nursing staff could not access Micromedex (online database that provides drug information) to retrieve drug information and the 2015-2016 drug information book did not have up to date drug information for a universe of 38 patients.

This failure placed patients at risk for potential adverse outcomes as a result of nursing staff accessing outdated drug information during times when a pharmacist was unavailable or during a utility failure when electronic references (internet resources) may be unavailable.

Findings:

During an observation, on June 8, 2022, at 11:42 PM, on Med Surg Unit 100, Licensed Vocational Nurse (LVN) 7 was observed searching for a drug information for drug nephron-vite (vitamin to treat vitamin deficiency). When asked about the drug information resources provided by the hospital, LVN 7 stated, "No online med resource, Micromedex doesn't work." LVN 6 stated, "We have a drug reference book ... yes its 2015-2016 ... its not there [drug information for nephron-vite]."

During an interview, on June 10, 2022, at 12:21 PM, with Registered Nurse (RN) 8, RN 8 acknowledged the hospital's online drug reference did not work. RN 8 stated, "No, important for nurses to be able to look up drugs so they know how it works."

During a review of the hospital's Policy and Procedure (P&P) titled, "Availability of Resource Materials, dated June 2021, the P&P stated, "one copy of each clinical manual and reference materials will be accessible twenty-four (24) hours a day, seven days a week for clinical staff and leadership."

Based on interview, and record review, the hospital failed to control and prevent the transmission of Candida Auris (C. Auris-fungal infection) within the facility when six of 35 sampled patients (Patient 1, Patient 2, Patient 7, Patient 8, Patient 15, and Patient 16) acquired C. Auris infection during hospitalization.

This failure had resulted in patients being infected with a preventable infection from the cross-contamination (the transfer of harmful bacteria) within the facility and had the potential to cause adverse health outcomes, negatively impact patients' health, and subject the patients to a prolonged hospitalization.

Findings:

a. A review of Patient 1's "History and Physical (H&P)," dated December 9, 2021, at 6:34 PM, the H&P showed, Patient 1 was admitted into the facility for continuation of care related to coronary artery occlusion (blockage in the artery that delivers blood and oxygen to patient's heart), status post thrombectomy (a type of surgery to remove clot from inside an artery), cerebrovascular accident (stroke-loss of blood flow to the brain), chronic anticoagulation (a group of medications to help prevent blood clots) with Heparin (medication to help prevent blood clot), and diabetes (a condition that body cannot control blood sugar).

During a review of Patient 1's "Laboratory Results," for C. Auris, on June 8, 2022, at 11 AM, in the board room, with the Infection Preventionist (IP), the "Laboratory Results" for C. Auris showed as follow:

On December 13, 2021: C. Auris "not detected"
On December 28, 2022: C. Auris "detected"

During an interview, on June 8, 2022, at 11:20 AM, with the IP, the IP stated, Patient 1 was infected with C. Auris during the hospitalization.

A follow-up interview, on June 9, 2022, at 2 PM, with the IP, the Infection Control Preventionist (ICP), and the Physician in charge or Chief Infection Control (IDMD), the IDMD confirmed and stated, the facility was aware of the C. Auris outbreak.

A review of the facility's policies and procedures (P&P) titled, "Core: Infection Prevention and Control Program," release date June 2021, indicated as follow:

"Purpose: this policy establishes for the Infection Control Program. The facility-wide infection prevention program addresses risk reduction and/or prevention of Healthcare Associated Infections (HAIs) through established systems of collection, aggregation, analysis, and presentation of facility specific data along with strategies to improve patient outcomes.
Policy:
The policy of [Hospital Name] is to ensure the following:
1. An Infection Prevention and Control Program is designed and implemented to identify and reduce the risk of acquiring and transmitting infections among patients, staff, physicians, licensed independent practitioners (LIPs), volunteers, students, and visitors. It is maintained to provide safe, sanitary, and comfortable environment that involves each department.
2. The Infection Prevention and Control Program include processes to minimize healthcare associated infection through an organization-wide program. These processes include but are not limited to the:
a. Establishing an effective hospital and nursing center wide infection prevention and control program and plan to reduce risk of healthcare associated infections ..."

b. A review of Patient 2's H&P, dated January 26, 2022, the H&P showed, Patient 2 was admitted into the facility with the diagnoses including respiratory failure (a condition when lungs cannot get enough oxygen) with tracheostomy (trach - a tube placed into the trachea via the neck to assist with breathing), urinary tract infection (UTI-an infection in any part of urinary system including kidneys, bladder, or urethra), and development delay.

During a review of Patient 2's "Laboratory Results," for C. Auris, on June 8, 2022, at 11 AM, in the board room, with the Infection Preventionist (IP), the "Laboratory Results" for C. Auris showed as follow:

On January 25, 2022: C. Auris "not detected"
On March 22, 2022: C. Auris was "detected"

During an interview, on June 8, 2022, at 11:20 AM, in the board room, with the IP, the IP stated, Patient 2 was infected with C. Auris during the hospitalization.

A follow-up interview, on June 9, 2022, at 2 PM, with the IP, the ICP, and the IDMD, the IDMD confirmed and stated, the facility was aware of the C. Auris outbreak.

A review of the facility's P&P titled, "Core: Infection Prevention and Control Program," release date June 2021, indicated as follow:

"Purpose: this policy establishes for the Infection Control Program. The facility-wide infection prevention program addresses risk reduction and/or prevention of Healthcare Associated Infections (HAIs) through established systems of collection, aggregation, analysis, and presentation of facility specific data along with strategies to improve patient outcomes.
Policy:
The policy of [Hospital Name] is to ensure the following:
1. An Infection Prevention and Control Program is designed and implemented to identify and reduce the risk of acquiring and transmitting infections among patients, staff, physicians, licensed independent practitioners (LIPs), volunteers, students, and visitors. It is maintained to provide safe, sanitary, and comfortable environment that involves each department.
2. The Infection Prevention and Control Program include processes to minimize healthcare associated infection through an organization-wide program. These processes include but are not limited to the:
a. Establishing an effective hospital and nursing center wide infection prevention and control program and plan to reduce risk of healthcare associated infections ..."

c. A review of Patient 15's H&P, dated February 18, 2022, the H&P indicated, Patient B was admitted into the facility with the diagnoses including status post Corona Virus Infection (COVID 19-severe respiratory infection), respiratory failure, tracheostomy, and encephalopathy (damage to the brain function).

A follow-up interview, on June 9, 2022, at 5:14 PM, with the IP and the Infection Control Preventionist (ICP), the ICP stated, it is considered a hospital acquired infection if C. Auris was detected after three days admission without any record of recent exposure.

A follow-up interview and record review, with the IP and the ICP, Patient 15's "Laboratory Results," for C. Auris, were reviewed. The "Laboratory Results" showed as follow:

On February 17, 2022: C. Auris was "not detected"
On March 22, 2022: C. Auris was "detected"

The ICP verified and confirmed, Patient 15 acquired C. Auris during the hospitalization.

A review of the facility's P&P titled, "Core: Infection Prevention and Control Program," release date June 2021, indicated as follow:

"Purpose: this policy establishes for the Infection Control Program. The facility-wide infection prevention program addresses risk reduction and/or prevention of Healthcare Associated Infections (HAIs) through established systems of collection, aggregation, analysis, and presentation of facility specific data along with strategies to improve patient outcomes.
Policy:
The policy of [Hospital Name] is to ensure the following:
1. An Infection Prevention and Control Program is designed and implemented to identify and reduce the risk of acquiring and transmitting infections among patients, staff, physicians, licensed independent practitioners (LIPs), volunteers, students, and visitors. It is maintained to provide safe, sanitary, and comfortable environment that involves each department.
2. The Infection Prevention and Control Program include processes to minimize healthcare associated infection through an organization-wide program. These processes include but are not limited to the:
a. Establishing an effective hospital and nursing center wide infection prevention and control program and plan to reduce risk of healthcare associated infections ..."

d. During a review of Patient 16's H&P, dated March 17, 2022, the H&P indicated, Patient 16 was admitted with the diagnoses including respiratory failure, tracheostomy, encephalopathy, and required tube feeding (a medical device used to provide liquid nourishment, fluids, and medications by bypassing oral intake) through a gastrostomy tube (G-tube: a tube into the stomach wall for food, fluids, and medication).

A follow-up interview, on June 9, 2022, at 5:14 PM, with the IP and the Infection Control Preventionist (ICP), the ICP stated, it is considered a hospital acquired infection if C. Auris was detected after three days admission without any record of recent exposure.

A follow-up interview and record review, with the IP and the ICP, Patient 16's "Laboratory Results," for C. Auris, were reviewed. The "Laboratory Results" showed as follow:

On February 17, 2022: C. Auris was "not detected"
On April 4, 2022: C. Auris was "detected"

The ICP verified and confirmed, Patient 15 acquired C. Auris during the hospitalization.

A review of the facility's P&P titled, "Core: Infection Prevention and Control Program," release date June 2021, indicated as follow:

"Purpose: this policy establishes for the Infection Control Program. The facility-wide infection prevention program addresses risk reduction and/or prevention of Healthcare Associated Infections (HAIs) through established systems of collection, aggregation, analysis, and presentation of facility specific data along with strategies to improve patient outcomes.
Policy:
The policy of [Hospital Name] is to ensure the following:
1. An Infection Prevention and Control Program is designed and implemented to identify and reduce the risk of acquiring and transmitting infections among patients, staff, physicians, licensed independent practitioners (LIPs), volunteers, students, and visitors. It is maintained to provide safe, sanitary, and comfortable environment that involves each department.
2. The Infection Prevention and Control Program include processes to minimize healthcare associated infection through an organization-wide program. These processes include but are not limited to the:
a. Establishing an effective hospital and nursing center wide infection prevention and control program and plan to reduce risk of healthcare associated infections ..."



45413

e. A review of Patient 7's H&P, dated February 9, 2022, showed, Patient 7 was admitted into the facility with diagnoses including respiratory failure, hypertension (elevated blood pressure), lupus (a disease where your body's immune system attacks your own tissues and organs), sciatica (nerve pain that starts at the lower back and runs down each leg), and chronic pain.

During a concurrent interview and record review, on June 8, 2022, at 9:30 AM, in the board room, with the Clinical Analyst Administrator (CAA), Patient 7's "Lab Results," for C. Auris, collection date February 9, 2022, and March 22, 2022, was reviewed. The Lab Results showed as follows:

On February 9, 2022: Test reported February 10, 2022. C. Auris not detected (normal).
On March 22, 2022: Test reported March 24, 2022. C. Auris detected.

The CAA verified and confirmed, that upon admission Patient 7 was screened for C. Auris and the result was not detected. Patient 7 was tested again for C. Auris on March 22 and the result was detected meaning Patient 7 acquired C. Auris during hospitalization.

During an interview, on June 8, 2022, at 5:10 PM, in the board room, with the ICP and the IP, the ICP stated, anything acquired three days after admission is considered hospital acquired.

A review of the facility's P&P titled, "Core: Infection Prevention and Control Program," release date June 2021, indicated as follow:

"Purpose: this policy establishes for the Infection Control Program. The facility-wide infection prevention program addresses risk reduction and/or prevention of Healthcare Associated Infections (HAIs) through established systems of collection, aggregation, analysis, and presentation of facility specific data along with strategies to improve patient outcomes.
Policy:
The policy of [Hospital Name] is to ensure the following:
1. An Infection Prevention and Control Program is designed and implemented to identify and reduce the risk of acquiring and transmitting infections among patients, staff, physicians, licensed independent practitioners (LIPs), volunteers, students, and visitors. It is maintained to provide safe, sanitary, and comfortable environment that involves each department.
2. The Infection Prevention and Control Program include processes to minimize healthcare associated infection through an organization-wide program. These processes include but are not limited to the:
a. Establishing an effective hospital and nursing center wide infection prevention and control program and plan to reduce risk of healthcare associated infections ..."

f. A review of Patient 8's H&P, dated March 19, 2022, showed, Patient 8 was admitted into the facility with a diagnosis including respiratory failure, pneumonia (lung inflammation), anoxic encephalopathy, chronic obstructive pulmonary disease (constriction of the airways), and history of laryngeal cancer (cancer of the throat).

During a concurrent interview and record review, on June 8, 2022, at 8:20 AM, in the board room, with the CAA, Patient 8's "Lab Results," for C. Auris, collection date March 19, 2022, and April 5, 2022, was reviewed. The Lab Results showed as follows:

On March 19, 2022: Test reported on March 19, 2022. C. Auris not detected.
On April 5, 2022: Test reported on April 7, 2022. C. Auris not detected.

The CAA verified and confirmed, that upon admission Patient 8 was screened for C. Auris and the result was not detected. Patient 8 was tested again for C. Auris on March 22 and the result was detected meaning Patient 8 acquired C. Auris during hospitalization.

During an interview, on June 8, 2022, at 5:10 PM, in the board room, with the ICP and the IP, the ICP stated, anything acquired three days after admission is considered hospital acquired.

A review of the facility's P&P titled, "Core: Infection Prevention and Control Program," release date June 2021, indicated as follow:

"Purpose: this policy establishes for the Infection Control Program. The facility-wide infection prevention program addresses risk reduction and/or prevention of Healthcare Associated Infections (HAIs) through established systems of collection, aggregation, analysis, and presentation of facility specific data along with strategies to improve patient outcomes.
Policy:
The policy of [Hospital Name] is to ensure the following:
1. An Infection Prevention and Control Program is designed and implemented to identify and reduce the risk of acquiring and transmitting infections among patients, staff, physicians, licensed independent practitioners (LIPs), volunteers, students, and visitors. It is maintained to provide safe, sanitary, and comfortable environment that involves each department.
2. The Infection Prevention and Control Program include processes to minimize healthcare associated infection through an organization-wide program. These processes include but are not limited to the:
a. Establishing an effective hospital and nursing center wide infection prevention and control program and plan to reduce risk of healthcare associated infections ..."

Based on observation, interview and record review, the facility failed to ensure patient care was provided in a clean and safe manner to prevent infection control when:

1. Two (2) suction canisters were observed with liquid components and unknown of last date changed for one of 35 sampled patients (Patient 6).

This failure had resulted in unclean respiratory equipment used for Patient 6 and had the potential to increase the risk of acquiring a hospital infection from a dirty canister as a potential collecting reservoir of infection.

2. Central line (small catheter or tube placed into a vein close to the heart that can be used to give medicine, fluids, blood, nutrition, and draw blood) assessments and dressing changes were not done routinely for one of 35 sampled patients (Patient 16).

3. Dried, black grime was observed underneath the fingernails of one patient (Patient 14) in a universe of 35 patients, who was grabbing at an inserted central line.

These failures had the potential to the development and transmission of a central line-associated bloodstream infection (CLABSI- a serious bloodstream infection due to catheter use), which could negatively affect the patients' health and safety, leading to a prolonged hospitalization and possible death, due to a hospital acquired infection.

Findings:

1. A review of Patient 6's "History and Physical (H&P)," dated February 23, 2022, the H&P showed, Patient 6 was admitted into the facility with the diagnoses including respiratory failure (a condition when lungs cannot get enough oxygen), with tracheostomy (trach - a tube placed into the trachea via the neck to assist with breathing), atrial fibrillation (abnormal heart rhythm), end stage renal disease (a condition that kidneys do not work normally), ileus (a condition in which the bowel does not work correctly), and dysphagia (difficulty swallowing) requiring a nasogastric tube (NG tube-a special tube that carries food and medicine to the stomach through the nose).

During an observation, on June 7, 2022, at 9:47 AM, at Patient 6's bedside in the Intensive Care Unit (ICU), Patient 6 is observed lying in bed with two suctions canisters attached to the wall. One canister is observed being connected to a NG tube and has approximately 1400 cubic centimeter (CC-units of measurement) of brownish fluid contents. One canister is observed being connected to a trach and has approximately 400 cc of yellowish/greenish fluid contents. There was no label to indicate the last date change of both suction canisters.

A follow-up concurrent observation and interview, on June 7, 2022, at 9:50 AM, with Registered Nurse 2 (RN 2), RN 2 verified and confirmed the amounts in both suction canisters. RN 2 stated, the suction canisters should have been changed. RN 2 confirmed, there was no label of the last date changed on both canisters. RN 2 further stated suction canisters were changed yesterday and documented in Patient 7's medical record.

A follow-up concurrent observation and interview, on June 7, 2022, at 9:55 AM, with the Senior Director of Clinical Operation (SDCO), and the Director of Respiratory Therapy (DRT), Patient 6's suction canisters are observed. The SDCO and the DRT verified the amounts in both canisters. The DRT stated the canisters should have been changed when fluid levels reach 1000 cc and as needed (PRN).

A follow-up concurrent interview and record review, on June 8, 2022, at 8:40 AM, in the board room, with the SDCO, Patient 6's "Nurses notes," for Nasogastric feeding tube, dated May 31, 2022, through June 7, 2022, was reviewed. There was no documentation of the suction canister being changed. The SDCO stated, she was unable to validate the change of suction canister on June 6, 2022, as RN 2 stated. The SDCO further stated, she was unable to justify 1400 cc of content in the suction canister to happen overnight.

A review of the facility's policies and procedure (P&P) titled, "Core: Respiratory Care Routine Responsibilities," release date June 2021, indicated as follow:

"Purpose: This procedure establishes guidelines around routine responsibilities within the Respiratory Therapy Department ...
Policy: [Hospital Name] Respiratory Therapists will provide safe and organized respiratory care while following guidelines that define their routine responsibilities.
Procedure ...
1. All shifts
a. Verify physician's orders ...
2. Day shift
a. Perform tracheostomy or ET tube care.
b. Perform oral care per guidelines
c. Perform treatments as ordered.
d. Run Quality Control on Blood Gas Analyzer (if applicable).
e. Obtain patient charges and verify for accuracy.
f. Change equipment when scheduled ...
4. Equipment Change Schedule ...
h. Respiratory suction containers are to be changed when fluid levels reach 1000 cc and PRN ..."



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2. A review of Patient 16's H&P, dated March 18, 2022, indicated, Patient 16 was admitted for respiratory failure, status post tracheostomy placement, on March 1, 2022, with multiple medical problems which included cirrhosis (severe stage of liver disease affecting ability of liver to process nutrients, drugs, hormones, and natural toxins), intracranial bleed (bleeding within the skull), and seizure disorder (a brain disorder that can cause changes in behavior, movement, or feelings). The H&P also indicated Patient 16 was unresponsive and unable to contribute information regarding medical history.

During a concurrent interview and record review, on June 9, 2022, at 2:50 PM, in the conference room, with the Chief Clinical Officer (CCO), Patient 16's "Nurses notes", for Central venous line, dated April 17, 2022, through April 22, 2022, were reviewed. The "Nurses notes" indicated, Patient 16's central line was not assessed and/or the dressing was not changed during the following dates and times:

April 17, 2022: day shift (7 AM to 7 PM) and night shift (7 PM to 7 AM)
April 18, 2022: day shift and night shift
April 19, 2022: night shift
April 20, 2022: day shift and night shift
April 21, 2022: day shift
April 22, 2022: day shift and night shift

The COO confirmed she was unable to find documentation indicating Patient 16's central line was assessed and/or the dressing was changed during the time reviewed.

During an interview, on June 10, 2022, at 10:03 AM, in Unit 200, with RN 9, RN 9 stated central line dressings are changed every Sunday or as needed if soiled. RN 9 stated central line dressing changes and assessments are normally documented every shift as a nursing action.

During an interview, on June 14, 2022, at 9:03 AM, in the conference room, with RN 11, she stated central line dressings are supposed to be changed every seven days, assessed every shift, and should be documented in the patient's medical record.

During a review of the facility's policy and procedure (P&P) titled, "CORE: Central Line Placement, Maintenance and Dressing Change," dated September 2020, the P&P indicated,

"Purpose
This procedure provides nursing personnel with guidelines to be used when inserting, maintaining and changing dressings on central venous access devices (CVAD) ....
Policy
The policy of [Name of Facility] is to ensure central line site care and dressing changes will be performed routinely ... 5. Ongoing assessment daily and with dressing change of the IV site. Assess for complications (signs of infection and/or pain at site) and measurements as indicated. Notify MD of drainage, redness, pain, warmth, swelling, and/or patient develops fever ...8. Central vascular access device (CVAD) and Peripherally Inserted Central Catheters (PICC) site care and dressing changes will be performed every seven (7) days, the needleless injection connector will be changed as well. Perform site care and dressing changes sooner if dressing integrity becomes compromised, or if moisture, drainage, or blood is present at the insertion site ..."

3. A review of Patient 14's H&P, dated May 19, 2022, indicated, Patient 14 was admitted for wound care and treatment of a right foot infection. The H&P also indicated Patient 14's medical problems included diabetes (condition characterized by high blood sugar levels because the body is unable to metabolize or turn the blood glucose into energy), end-stage renal disease (ESRD - kidney failure) on hemodialysis (a treatment to filter wastes and water from blood), past history of cerebral vascular accident (CVA - also known as 'stroke', when blood flow to the brain is stopped, preventing blood flow and oxygen to the brain and can lead to brain damage) with residual right-sided weakness and speech deficit, and dementia (conditions involving loss of cognitive functioning, such as thinking, remembering and reasoning).

During an observation, on June 7, 2022, at approximately 11:30 AM, in Unit 200, Patient 14 was observed in his room. Patient 14 was noted to be non-verbal and non-interviewable, grabbing at his central line located on the left upper chest with his left hand. Patient 14 was observed with dried, black-colored substance underneath his fingernails.

During a follow up observation and interview, on June 7, 2022, at 11:50 AM, in Unit 200, with Licensed Vocational Nurse (LVN 9), LVN 9 stated Patient 14's fingernails were dirty because he frequently digs his fingers into his stool. LVN 9 verified Patient 14 was touching his central line with dirty fingernails and stated she will find someone to clean his fingernails.

During an interview, on June 14, 2022, at 9:03 AM, in the conference room, with RN 11, she stated she had taken care of Patient 14 recently prior to discharge. RN 11 verified Patient 14 would touch his central line with dirty fingers. RN 11 stated the staff tried to clean his fingernails with alcohol as much as possible. RN 11 further stated Patient 14 was at risk for infection from touching his central line with dirty fingers.

During a review of the facility's policy and procedure (P&P) titled, "CORE: Infection Prevention and Control Program," dated June 2021, the P&P indicated,

"Purpose
This policy establishes guidelines for the Infection Control Program. The facility-wide infection prevention program addresses risk reduction and/or prevention of Healthcare Associated Infections (HAIs) through established systems of collection, aggregation, analysis, and presentation of specific data along with strategies to improve patient outcomes ....
Policy
The policy of [Name of Facility] is to ensure the following:
1. An Infection Prevention and Control Program is designed and implemented to identify and reduce the risk of acquiring and transmitting infections among patients, staff, physicians, licensed independent practitioners (LIPs), volunteers, students, and visitors. It is maintained to provide a safe, sanitary, and comfortable environment that involves each department.
2. The Infection Prevention and Control Program include processes to minimize healthcare associated infection through an organization-wide program. These processes include but are not limited to the:
a. Establishing an effective hospital and nursing center wide infection prevention and control program and plan to reduce risk of healthcare associated infections.
b. Ongoing identification of risks associated with the transmission of infectious agents.
c. Establishing priorities and goals for preventing the development of healthcare associated infections within the hospital or nursing facility ....
i. Developing and implementing necessary policies and procedures as they pertain to infection prevention and control within the facility.
j. Implementing policies and procedures to prevent the spread of infections that include promoting consistent adherence to Standard Precautions and other infection control practices such as transmission-based precautions and proper hand washing ...."



45413

Based on interview and record review, the facility failed to ensure competency-based training and education was completed in a timely manner for infection prevention and control standards of practice and guidelines related to medication preparation and/or administration when:

1. The competence of five of five Licensed Vocational Nurses (LVN 2, LVN 10, LVN 11, LVN 12, and LVN 13) and five of five Registered Nurses (RN 16, RN 17, RN 18, RN 19, and RN 20) were not assessed on annual basis.

2. The competence of Registered Nurses (RN 10, RN 14, and RN 15) were not assessed for initial employment and orientation.

These failures resulted in RN 10, RN 14, and RN 15 administering medications to Patient 25 and Patient 27 before competency was demonstrated and/or the potential to result in preventable healthcare-associated infections (HAIs) due to cross-contamination (unintentional transfer of germs) for a universe of 38 patients.

Findings:

1.During a review of the facility document "Clinical Skills Initial Core Competency Checklist" for Licensed Vocational Nurses (LVNs) and Registered Nurses (RNs) the "SKILLS LIST" included "Infection Prevention" and "Medication Administration".

During a concurrent interview and record review with the Chief Operating Officer (COO) on June 9, 2022, at 2:02 PM, the facility document "Clinical Skills Initial Core Competency Checklist" was reviewed with the COO. The COO pointed to the "SKILLS LIST" including "Infection Prevention" and "Medication Administration" sections in the checklist. The COO stated five (5) hour competencies with clinical skills and the checklist covered aseptic technique for medication administration, including injectable medications.

During a concurrent interview and record review with the Employee Health Nurse (EHN) on June 9, 2022, at 4:58 PM, the five (5) hour LVN annual competencies were reviewed. The EHN acknowledged the annual competencies were completed more than one (1) year ago for:

a. LVN 2 last completed on July 23, 2020;
b. LVN 10 last completed on June 17, 2020;
c. LVN 11 last competed on October 22, 2020;
d. LVN 12 last completed on November 23, 2020;
e. LVN 13 last completed on September 15, 2020;

During a concurrent interview and record review with the EHN on June 9, 2022, at 5:06 PM, the five (5) hour RN annual competencies were reviewed. The EHN acknowledged the annual competencies were completed more than one (1) year ago for:

a. RN 16 last completed on 6/23/2020;
b. RN 17 last completed on 7/22/2020;
c. RN 18 last competed on 11/25/2020;
d. RN 19 last completed on 11/25/2020;
e. RN 20 last completed on 10/20/2020;

During an interview, with the Director of Pharmacy (DP), on June 14, 2022, at 9:06 AM, the DP stated aseptic technique is important when licensed nurses are administering medications because "bacteria will enter the sterile product and it will become contaminated for patients. It will be unsafe if not aseptic technique."

During a telephone interview, with the Director of Infection Control (DIC), on June 14, 2022, at 9:09 AM, the DIC stated aseptic technique during medication administration "must be done to protect patient's safety and reduce cross contamination."

During a review of the facility's policy and procedure titled, "CORE: Evaluation & Verification of Competency" dated June 2020, indicated "The competence of the staff members is assessed at but not limited to the following periods ...Annually thereafter."

During a review of the facility's "Infection Prevention and Control Plan" dated 2022, the document indicated, "PURPOSE ...To provide a system that prevent, identifies, reports, investigates, and controls infections and communicable diseases that occur in patients, healthcare personnel (including physicians and visitors that have potential for disease transmission and prevention ...To recommend risk reduction strategies by integrating principles of infection prevention and control and patient safety into all direct and indirect standards of practice by recommending practices that have the potential to affect rates of infection at this facility."

2. During a review of the facility document "Clinical Skills Initial Core Competency Checklist" for Registered Nurses (RNs) the "SKILLS LIST" included "Infection Prevention" and "Medication Administration".

During a review of the facility document titled "[Name of RN 10]'s Plan" dated June 10, 2022, indicated RN 10 "will not be placed on the work schedule until her competencies are completed."

During a review of the facility document titled "[Name of RN 14]'s Plan" dated June 14, 2022, indicated RN 14 "will not be placed on the work schedule until her competencies are completed."

During a review of the facility document titled "[Name of RN 15]'s Plan" dated June 14, 2022, indicated RN 15 "will not be placed on the work schedule until her competencies are completed."

During a concurrent interview and record review, with the Chief Operating Officer (COO), on June 9, 2022, at 2:02 PM, the facility document "Clinical Skills Initial Core Competency Checklist" was reviewed with the COO. The COO pointed to the "SKILLS LIST" including "Infection Prevention" and "Medication Administration" sections in the checklist. The COO stated five (5) hour competencies with clinical skills and the checklist covered aseptic technique for medication administration, including injectable medications.
During an interview with the Director of Pharmacy (DP) on June 14, 2022, at 9:06 AM, the DP stated aseptic technique is important when licensed nurses are administering medications because "bacteria will enter the sterile product and it will become contaminated for patients. It will be unsafe if not aseptic technique."

During a telephone interview with the Director of Infection Control (DIC) on June 14, 2022, at 9:09 AM, the DIC stated aseptic technique during medication administration "must be done to protect patient's safety and reduce cross contamination."

During a concurrent interview and record review with the Employee Health Nurse (EHN) on June 14, 2022, at 10:35 AM, the policy titled, "CORE: Evaluation & Verification of Competency" dated June 2020, and the facility document "Clinical Skills Initial Core Competency Checklist" was reviewed. The EHN stated the "Clinical Skills Initial Core Competency Checklist" is the documentation of staff competency for the "CORE: Evaluation & Verification of Competency" policy.

During a concurrent interview and record review with the EHN on June 14, 2022, at 10:35 AM, Patient 25's medical record was reviewed. The Medication Administration Record (MAR) indicated RN 14 administered doxazosin (heart medication) 2 milligrams (mg - a unit of measurement for dose) to Patient 25 on June 3, 2022, at 11:30 PM, and June 4, 2022, at 10:35 PM. The medical record indicated RN 14 administered levetiracetam (anti-seizure medication) 2,000 mg to Patient 25 on June 4, 2022, at 10:35 PM. The EHN acknowledged the MAR documentation indicated RN 14 administered medications to Patient 25.

During a concurrent interview and record review with the COO on June 14, 2022, at 11:35 AM, Patient 27's medical record was reviewed. The COO acknowledged the Patient 27's MAR indicated diphenhydramine (itching medication) 25 mg Intravenous (IV - into the patient's vein) Push (bolus):

a. Administered May 10, 2022, at 2:30 AM by RN 15
b. Administered May 22, 2022, at 4:59 PM by RN 10
c. Administered May 23, 2022, at 8:07 PM by RN 15
d. Administered May 24, 2022, at 5:35 AM by RN 15
e. Administered May 27, 2022, at 11:44 PM by RN 15
f. Administered May 28, 2022, at 6:43 AM by RN 15
g. Administered June 4, 2022, at 2:12 PM by RN 10
h. Administered June 6, 2022, at 8:33 PM by RN 15
i. Administered June 7, 2022, at 2:28 AM by RN 15
j. Administered June 7, 2022, at 8:29 AM by RN 10

During a review of the facility's policy and procedure titled, "CORE: Evaluation & Verification of Competency" dated June 2020, indicated "The competence of the staff members is assessed at but not limited to the following periods ...Initial employment and orientation." Continued review of the policy indicated "Procedure ...New Hire Orientation ...Prior to working independently, competency is assessed to ensure that the individual is competent to perform the assigned duties based on the job description and population served. This is accompanied by the use of testing, and/or position-specific orientation and skill check list."

During a review of the facility's "Infection Prevention and Control Plan" dated 2022, the document indicated, "PURPOSE ...To provide a system that prevent, identifies, reports, investigates, and controls infections and communicable diseases that occur in patients, healthcare personnel (including physicians and visitors that have potential for disease transmission and prevention ...To recommend risk reduction strategies by integrating principles of infection prevention and control and patient safety into all direct and indirect standards of practice by recommending practices that have the potential to affect rates of infection at this facility."

Based on interview, and record review, the facility failed to ensure all respiratory care services were documented when:

1. Heat Moisture Exchanger (HME-a device used to help prevent drying of secretion and filter air) were not documented of being changed every 48 hours for five of 35 sampled patients (Patient 1, Patient 2, Patient 3, Patient 6, and Patient 15).

2. Tracheostomy (trach - a tube placed into the trachea via the neck to assist with breathing) and/or oral (mouth) care were not documented in the medical record every shift for five of 35 sampled patients (Patient 1, Patient 2, and Patient 3, Patient 10, and Patient 23).

These failures had the potential to cause worsening in breathing problems from mucous plugs or blockages and increase the risk of infection from bacteria buildup that can spread and harm patients' health and safety and lead to prolonged hospitalization and/or death.

Findings:

1a. A review of Patient 1's "History and Physical (H&P)," dated December 9, 2021, at 6:34 PM, the H&P showed, Patient 1 was admitted into the facility for continuation of care related to coronary artery occlusion (blockage in the artery that delivers blood and oxygen to patient's heart), status post thrombectomy (a type of surgery to remove clot from inside an artery), cerebrovascular accident (stroke-loss of blood flow to the brain), chronic anticoagulation (a group of medications to help prevent blood clots) with Heparin (medication to help prevent blood clot), and diabetes (a condition that body cannot control blood sugar).

During an interview, on June 9, 2022, at 8:10 AM, in the board room, with the Director of Respiratory Therapy (DRT), the DRT stated, HME was scheduled to be changed every 48 hours as written in the facility's policies and procedures (P&P). The DRT further stated he believed it was a "documentation problem" that RT staff could not document to show HME was changed for any patients.

A follow-up concurrent interview and record review, on June 9, 2022, at 8:15 AM, with the DRT, Patient 1's medical record, was reviewed. The DRT verified and confirmed, there was no documentation of HME completed every 48 hours. The DRT stated the facility was aware of the HME documentation issue.

A review of the facility's P&P titled, "Core: Respiratory Care Routine Responsibilities," release date June 2021, indicated as follow:

"Purpose: This procedure establishes guidelines around routine responsibilities within the Respiratory Therapy Department ...
Policy: [Hospital Name] Respiratory Therapists will provide safe and organized respiratory care while following guidelines that define their routine responsibilities.
Procedure ...
1. All shifts
a. Verify physician's orders ...
2. Day shift
a. Perform tracheostomy or ET tube care.
b. Perform oral care per guidelines
c. Perform treatments as ordered.
d. Run Quality Control on Blood Gas Analyzer (if applicable).
e. Obtain patient charges and verify for accuracy.
f. Change equipment when scheduled ...
4. Equipment Change Schedule ...
k. Heat Moisture Exchange (HME) every 48 hours and PRN [as needed] ..."

1b. A review of Patient 2's H&P, dated January 26, 2022, the H&P showed, Patient 2 was admitted into the facility with the diagnoses including respiratory failure (a condition when lungs cannot get enough oxygen) with tracheostomy, urinary tract infection (UTI-an infection in any part of urinary system including kidneys, bladder, or urethra), and development delay.

During an interview, on June 9, 2022, at 8:10 AM, in the board room, with the Director of Respiratory Therapy (DRT), the DRT stated, HME was scheduled to be changed every 48 hours as written in the facility's policies and procedures (P&P). The DRT further stated he believed it was a "documentation problem" that RT staff could not document to show HME was changed for any patients.

A follow-up concurrent interview and record review, on June 9, 2022, at 8:15 AM, with the DRT, Patient 2's medical record, was reviewed. The DRT verified and confirmed, there was no documentation of HME completed every 48 hours. The DRT stated the facility was aware of the HME documentation issue.

A review of the facility's P&P titled, "Core: Respiratory Care Routine Responsibilities," release date June 2021, indicated as follow:

"Purpose: This procedure establishes guidelines around routine responsibilities within the Respiratory Therapy Department ...
Policy: [Hospital Name] Respiratory Therapists will provide safe and organized respiratory care while following guidelines that define their routine responsibilities.
Procedure ...
1. All shifts
a. Verify physician's orders ...
2. Day shift
a. Perform tracheostomy or ET tube care.
b. Perform oral care per guidelines
c. Perform treatments as ordered.
d. Run Quality Control on Blood Gas Analyzer (if applicable).
e. Obtain patient charges and verify for accuracy.
f. Change equipment when scheduled ...
4. Equipment Change Schedule ...
k. Heat Moisture Exchange (HME) every 48 hours and PRN [as needed] ..."

1c. A review of Patient 3's H&P, dated November 30, 2021, the H&P showed, Patient 3 was admitted into the facility with diagnoses including respiratory failure, UTI, atrial fibrillation (abnormal heart rhythm), and congestive heart failure (CHF-a condition in which heart does not pump well to supply blood to body).

During an interview, on June 9, 2022, at 8:10 AM, in the board room, with the Director of Respiratory Therapy (DRT), the DRT stated, HME was scheduled to be changed every 48 hours as written in the facility's policies and procedures (P&P). The DRT further stated he believed it was a "documentation problem" that RT staff could not document to show HME was changed for any patients.

A follow-up concurrent interview and record review, on June 9, 2022, at 8:15 AM, with the DRT, Patient 3's medical record, was reviewed. The DRT verified and confirmed, there was no documentation of HME completed every 48 hours. The DRT stated the facility was aware of the HME documentation issue.

A review of the facility's P&P titled, "Core: Respiratory Care Routine Responsibilities," release date June 2021, indicated as follow:

"Purpose: This procedure establishes guidelines around routine responsibilities within the Respiratory Therapy Department ...
Policy: [Hospital Name] Respiratory Therapists will provide safe and organized respiratory care while following guidelines that define their routine responsibilities.
Procedure ...
1. All shifts
a. Verify physician's orders ...
2. Day shift
a. Perform tracheostomy or ET tube care.
b. Perform oral care per guidelines
c. Perform treatments as ordered.
d. Run Quality Control on Blood Gas Analyzer (if applicable).
e. Obtain patient charges and verify for accuracy.
f. Change equipment when scheduled ...
4. Equipment Change Schedule ...
k. Heat Moisture Exchange (HME) every 48 hours and PRN [as needed] ..."

1d. A review of Patient 6's H&P, dated February 23, 2022, the H&P showed, Patient 6 was admitted into the facility with the diagnoses including respiratory failure with tracheostomy, atrial fibrillation, end stage renal disease (a condition that kidneys do not work normally), ileus (a condition in which the bowel does not work correctly), and dysphagia (difficulty swallowing) requiring a nasogastric tube (NG tube-a special tube that carries food and medicine to the stomach through the nose).

During an interview, on June 9, 2022, at 8:10 AM, in the board room, with the Director of Respiratory Therapy (DRT), the DRT stated, HME was scheduled to be changed every 48 hours as written in the facility's policies and procedures (P&P). The DRT further stated he believed it was a "documentation problem" that RT staff could not document to show HME was changed for any patients.

A follow-up concurrent interview and record review, on June 9, 2022, at 8:15 AM, with the DRT, Patient 6's medical record, was reviewed. The DRT verified and confirmed, there was no documentation of HME completed every 48 hours. The DRT stated the facility was aware of the HME documentation issue.

A review of the facility's P&P titled, "Core: Respiratory Care Routine Responsibilities," release date June 2021, indicated as follow:

"Purpose: This procedure establishes guidelines around routine responsibilities within the Respiratory Therapy Department ...
Policy: [Hospital Name] Respiratory Therapists will provide safe and organized respiratory care while following guidelines that define their routine responsibilities.
Procedure ...
1. All shifts
a. Verify physician's orders ...
2. Day shift
a. Perform tracheostomy or ET tube care.
b. Perform oral care per guidelines
c. Perform treatments as ordered.
d. Run Quality Control on Blood Gas Analyzer (if applicable).
e. Obtain patient charges and verify for accuracy.
f. Change equipment when scheduled ...
4. Equipment Change Schedule ...
k. Heat Moisture Exchange (HME) every 48 hours and PRN [as needed] ..."

1e. A review of Patient 15's H&P, dated February 18, 2022, the H&P indicated, Patient B was admitted into the facility with the diagnoses including status post Corona Virus Infection (COVID 19-severe respiratory infection), respiratory failure, tracheostomy, and encephalopathy (damage to the brain function).

During an interview, on June 9, 2022, at 8:10 AM, in the board room, with the Director of Respiratory Therapy (DRT), the DRT stated, HME was scheduled to be changed every 48 hours as written in the facility's policies and procedures (P&P). The DRT further stated he believed it was a "documentation problem" that RT staff could not document to show HME was changed for any patients.

A follow-up concurrent interview and record review, on June 9, 2022, at 8:15 AM, with the DRT, Patient 15's medical record, was reviewed. The DRT verified and confirmed, there was no documentation of HME completed every 48 hours. The DRT stated the facility was aware of the HME documentation issue.

A review of the facility's P&P titled, "Core: Respiratory Care Routine Responsibilities," release date June 2021, indicated as follow:

"Purpose: This procedure establishes guidelines around routine responsibilities within the Respiratory Therapy Department ...
Policy: [Hospital Name] Respiratory Therapists will provide safe and organized respiratory care while following guidelines that define their routine responsibilities.
Procedure ...
1. All shifts
a. Verify physician's orders ...
2. Day shift
a. Perform tracheostomy or ET tube care.
b. Perform oral care per guidelines
c. Perform treatments as ordered.
d. Run Quality Control on Blood Gas Analyzer (if applicable).
e. Obtain patient charges and verify for accuracy.
f. Change equipment when scheduled ...
4. Equipment Change Schedule ...
k. Heat Moisture Exchange (HME) every 48 hours and PRN [as needed] ..."

2a. During a review of Patient 1's "History and Physical (H&P)," dated December 9, 2021, at 6:34 PM, the H&P showed, Patient 1 was admitted into the facility for continuation of care related to coronary artery occlusion, status post thrombectomy, cerebrovascular accident, chronic anticoagulation with Heparin, and diabetes.

During an interview, on June 9, 2022, at 8:20 AM, in the board room, with the DRT, the DRT stated, RT should provide patients, who have a trach and require a ventilator (airway assisted machine to provide oxygen to patients), with trach and oral care every shift and document into the medical record after the tasks complete.

A review of Patient 1's order for "Tracheostomy care," dated December 9, 2021, at 3:53 AM, the "Tracheostomy care" showed trach care was ordered to be completed every shift and as needed (PRN).

During a concurrent interview and record review, on June 9, 2022, at 8:45 AM, with the DRT, Patient 1's "Tracheostomy care," dated December 26, 2021, through December 31, 2021, was reviewed. The "Tracheostomy care" showed as follow:

On December 28, 2021: no documentation for PM shift (7 PM to 7 AM)
On December 29, 2021: no documentation for PM shift

The DRT verified and confirmed trach care was not documented every shift. The DRT stated, he was unable to provide any documentation to show RT staff followed a physician's order for Patient 1's trach care.

A review of Patient 1's "Plan of care," Intervention, dated December 8, 2021, at 10:06 PM, showed, "Provide oral care-RT worklist" was ordered to be performed every shift.

During a concurrent interview and record review, on June 9, 2022, at 8:50 AM, with the DRT, Patient 1's "Provide oral care-RT worklist," dated December 26, 2021, through December 31, 2021, was reviewed. The "Provide oral care-RT worklist" showed as follow:

On December 28, 2021: no documentation for PM shift
On December 30, 2021: no documentation for PM shift

The DRT verified and confirmed oral care was not documented every shift. The DRT stated, he was unable to provide any documentation to show RT staff followed a physician's order for Patient 1's oral care.

A review of the facility's P&P titled, "Core: Respiratory Care Routine Responsibilities," release date June 2021, indicated as follow:

"Purpose: This procedure establishes guidelines around routine responsibilities within the Respiratory Therapy Department ...
Policy: [Hospital Name] Respiratory Therapists will provide safe and organized respiratory care while following guidelines that define their routine responsibilities.
Procedure ...
1. All shifts
a. Verify physician's orders ...
2. Day shift
a. Perform tracheostomy or ET tube care.
b. Perform oral care per guidelines
c. Perform treatments as ordered.
d. Run Quality Control on Blood Gas Analyzer (if applicable).
e. Obtain patient charges and verify for accuracy.
f. Change equipment when scheduled.
3. Night shift
a. Perform tracheostomy or ET tube care ..."

2b. A review of Patient 2's H&P, dated January 26, 2022, the H&P showed, Patient 2 was admitted into the facility with the diagnoses including respiratory failure with tracheostomy, UTI, and development delay.

During an interview, on June 9, 2022, at 8:20 AM, in the board room, with the DRT, the DRT stated, RT should provide patients, who have a trach and require a ventilator, with trach and oral care every shift and document into the medical record after the tasks complete.

A review of Patient 2's order for "Tracheostomy care," dated January 26, 2022, the "Tracheostomy care" showed trach care was ordered to be completed every shift.

During a concurrent interview and record review, on June 9, 2022, at 8:55 AM, with the DRT, Patient 2's "Tracheostomy care," dated March 13, 2022, through March 18, 2022, was reviewed. The "Tracheostomy care" showed as follow:

On March 13, 2022, at 10 PM: "not done, cancel this execution, procedure conflict."

The DRT verified and confirmed trach care was not done, on March 13, 2022. The DRT stated, the appropriate reason should be documented if the task was not able to be completed. The DRT further stated, he was unable to provide any documentation to show the procedure conflict that prevented RT to complete trach care.

During a concurrent interview and record review, on June 9, 2022, at 9:00 AM, with the DRT, Patient 2's "Provide oral care-RT worklist," dated March 13, 2022, through March 18, 2022, was reviewed. The DRT verified and confirmed, there was no documentation for oral care from March 13, 2022, through March 18, 2022. The DRT stated, he was unable to find a physician order for oral care and RT staff needs an order for a proper documentation. The DRT further stated, RT staff should have placed an oral care order from a standing order (written protocol that allows nursing staff to complete task without first obtain a physician order) for an airway-assisted patient to ensure oral care completed and documented every shift.

A review of the facility's P&P titled, "Core: Respiratory Care Routine Responsibilities," release date June 2021, indicated as follow:

"Purpose: This procedure establishes guidelines around routine responsibilities within the Respiratory Therapy Department ...
Policy: [Hospital Name] Respiratory Therapists will provide safe and organized respiratory care while following guidelines that define their routine responsibilities.
Procedure ...
1. All shifts
a. Verify physician's orders ...
2. Day shift
a. Perform tracheostomy or ET tube care.
b. Perform oral care per guidelines
c. Perform treatments as ordered.
d. Run Quality Control on Blood Gas Analyzer (if applicable).
e. Obtain patient charges and verify for accuracy.
f. Change equipment when scheduled.
3. Night shift
a. Perform tracheostomy or ET tube care ..."

2c. A review of Patient 3's H&P, dated November 30, 2021, the H&P showed, Patient 3 was admitted into the facility with diagnoses including respiratory failure, UTI, atrial fibrillation, and congestive heart failure.

During an interview, on June 9, 2022, at 8:20 AM, in the board room, with the DRT, the DRT stated, RT should provide patients, who have a trach and require a ventilator, with trach and oral care every shift and document into the medical record after the tasks complete.

During a concurrent interview and record review, on June 9, 2022, at 8:45 AM, with the DRT, Patient 3's "Tracheostomy care," dated December 26, 2021, through December 31, 2021, was reviewed. The "Tracheostomy care" showed as follow:

On December 26, 2021: no documentation for PM shift
On December 27, 2021: no documentation for PM shift
On December 28, 2021: no documentation for PM shift
On December 29, 2021: no documentation for PM shift
On December 30, 2021: no documentation for PM shift

The DRT verified and confirmed trach care was not documented every shift. The DRT stated, he was unable to provide any documentation to show RT staff followed the facility's policy for airway-assisted patient with performing trach care every shift.

A review of Patient 3's "Plan of care," Intervention, dated December 8, 2021, at 10:06 PM, showed, "Provide oral care-RT worklist" was ordered to be performed every shift.

During a concurrent interview and record review, on June 9, 2022, at 8:50 AM, with the DRT, Patient 3's "Provide oral care-RT worklist," dated December 26, 2021, through December 31, 2021, was reviewed. The "Provide oral care-RT worklist" showed as follow:

On December 31, 2021: no documentation for AM shift (7 AM to 7 PM)

The DRT verified and confirmed oral care was not documented every shift. The DRT stated, he was unable to provide any documentation to show RT staff followed the facility's policy for airway-assisted patient with performing oral care every shift.

A review of the facility's P&P titled, "Core: Respiratory Care Routine Responsibilities," release date June 2021, indicated as follow:

"Purpose: This procedure establishes guidelines around routine responsibilities within the Respiratory Therapy Department ...
Policy: [Hospital Name] Respiratory Therapists will provide safe and organized respiratory care while following guidelines that define their routine responsibilities.
Procedure ...
1. All shifts
a. Verify physician's orders ...
2. Day shift
a. Perform tracheostomy or ET tube care.
b. Perform oral care per guidelines
c. Perform treatments as ordered.
d. Run Quality Control on Blood Gas Analyzer (if applicable).
e. Obtain patient charges and verify for accuracy.
f. Change equipment when scheduled.
3. Night shift
a. Perform tracheostomy or ET tube care ..."


45413

2d. A review of Patient 10's H&P, dated March 22, 2022, showed, Patient 10 was admitted to the facility with diagnoses including tracheostomy, multiple thoracic vertebral (bones that form spinal column) body fractures, subarachnoid hemorrhage (bleeding in the space between the brain the tissue covering), intraparenchymal hemorrhage (bleeding in the brain) with midline shift.

During a concurrent interview and record review, on June 8, 2022, at 10:30 AM, in the board room, with the Clinical Analyst Administrator (CAA), Patient 10's "Respiratory Care Flow Sheet," for trach care, dated March 22, 2022, through March 27, 2022, was reviewed the Flow Sheet showed as follows:

March 23, 2022: no trach care documented.
March 25, 2022: no trach care documented.
March 26, 2022: no trach care documented.
March 27, 2022: no trach care documented.

The CAA verified and confirmed, no documented trach care on the Respiratory Care Flow sheet or in the Respiratory Care Progress Notes to indicate that trach care was performed on the dates shown above.

During an interview, on June 14, 2022, at 9:00 AM, with Respiratory Therapist (RT 1), RT 1 stated, the order for trach care is entered by RT upon admission and trach care is performed once per shift and documented on the RT flow sheet.

A review of the facility's P&P titled, "Core: Respiratory Care Routine Responsibilities," release date June 2021, indicated as follow:

"Purpose: This procedure establishes guidelines around routine responsibilities within the Respiratory Therapy Department ...
Policy: [Hospital Name] Respiratory Therapists will provide safe and organized respiratory care while following guidelines that define their routine responsibilities.
Procedure ...
1. All shifts
a. Verify physician's orders ...
2. Day shift
a. Perform tracheostomy or ET tube care.
b. Perform oral care per guidelines
c. Perform treatments as ordered.
d. Run Quality Control on Blood Gas Analyzer (if applicable).
e. Obtain patient charges and verify for accuracy.
f. Change equipment when scheduled.
3. Night shift
a. Perform tracheostomy or ET tube care ..."





45050

2e. During a review of Patient 23's H&P, dated May 23, 2022, the H&P indicated, Patient 23 had medical history of substance abuse, who sustained a motor vehicle accident on March 12, 2022, auto versus pedestrian accident. The patient sustained severe traumatic brain injury (brain dysfunction caused by an outside force) as well as bilateral (right and left side) lower extremity deformity. The patient was bradycardic (abnormally slow heart rate) and placed on Ambu bag (used for artificial respiration) and transferred to the hospital where she was intubated (breathing tube was placed through the mouth and down the throat).

During an interview, on June 9, 2022, at 7:45 AM, with the DRT, the DRT stated, RT does portion of oral care and oral care is done four (4) times a day. The DRT further stated, RT is responsible for those two (2) oral cares. The DRT stated oral care is done once per shift for RT and Nursing with total of 4 per day.

During a concurrent interview and record review, on June 9, 2022, at 10:30 AM, with the Senior Director of Clinical Operations 2 (SDCO 2) and the DRT, Patient 23's "Electronic Medical Record (EMR)" was reviewed. There was no evidence of RT oral care documentation found from June 1, 2022, through June 6, 2022. The SDCO 2 and the DRT confirmed, there was no RT oral care documentation from June 1, 2022, through June 6, 2022, for Patient 23.

During a concurrent interview and record review, on June 10, 2022, at 9:56 AM, with Registered Nurse 8 (RN 8), Patient 23's "Electronic Medical Record (EMR)" was reviewed. There was no evidence of RT oral care ordered from June 1, 2022, through June 6, 2022. RN 8 stated and confirmed, there was no RT oral care order for Patient 23 from June 1, 2022, through June 6, 2022. RN 8 further stated, "It should have been ordered." RN 8 stated the first order for RT oral care with Chlorhexidine gluconate (CHG) (cleaning product that kills germs) was dated, on June 7, 2022.

During a review of the facility's policy and procedure (P&P) titled "CORE: Oral Hygiene for Airway Assisted Patients" dated 6/2021, the P&P indicated,
"PURPOSE
The purpose of this policy is to provide guidelines for oral hygiene of the artificial airway assisted patient or patients receiving continuous BiPAP therapy by mask
POLICY
The policy of Kindred Hospital is to ensure the following:
1. Oral hygiene will be provided to patients with artificial airways and to patients receiving continuous BiPAP therapy to address the risk factors associated with ventilator associated pneumonia (VAP) through a comprehensive approach based on cleaning, debriding, suctioning and moisturizing the entire oral cavity ...
5. A combined Respiratory Therapy and Nursing approach will allow for oral hygiene scheduled at 6-hour intervals in order to maintain an oral environment free from bacteria often associated with VAP ...
Procedure ...
4. Every 12 hours and PRN (e.g. 6a/6p) the respiratory therapist will:
a. Brush teeth, palate and gums with the suction toothbrush/swab using antiseptic/peroxide rinse
b. Brush for approximately 1 -2 minutes, exerting gentle pressure while moving in short horizontal strokes
c. Swab the mouth with 15 ml CHG mouth rinse using swab and suction toothbrush if necessary
d. After 30 seconds, thoroughly suction CHG from mouth
e. Apply mouth moisturizer to lips and mouth using applicator swab ...
7. Documentation
a. Documentation of the use of CHG must be recorded on the MAR (medication administration record).
b. Documentation of the oral hygiene in general should be recorded in the specific discipline's chart sections (Respiratory or Nursing).
c. Evidence of management of a Potential for Infection should be recorded in the patient plan of care.
d. Documentation of the patient /family education should be recorded in the patient/family education chart section."