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Based on record review, interview, and observation, the Governing Body failed to:

a. ensure that corporate policies were modified and approved for the specific services and functions provided by the hospital in 5 of 5 policies, and 2 of these 5 policies reviewed contained guidelines for services not provided by the hospital. This failed practice had the potential for the staff not to implement the guideline and standard of practice expectations of the Governing Body for the services the hospital provides. (Refer to below findings).

b. ensure the grievance program provided patients with correct grievance contact information, investigated all grievances and provided a written response of the results of their investigation findings to the individuals submitting the grievance for 10 ( Patients # 5, 23, 24, 25, 26, 27, 28, 29, 30, and 31) of 15 patients/ patient representatives filing grievances. This failed practice had the potential for patients and patient representatives to have difficulty in filing a grievance and receiving a response, and for the hospital to fail to utilize potential quality improvement information to improve patients' services. (Refer to A-0118, and A-0123),

c. Ensure the Medical Staff provided quality medical care, services and treatment to the patient. Failure of this practice resulted in one patient (Patient #5) of 20 medical records reviewed developing a gangrenous scrotal wound and subsequently being discharged without recognition and medical treatment of the wound. (Refer to A-0049)

d. Demonstrate responsibility for the conduct of the Quality Assessment and Performance Improvement program that included review, analysis, discussion of the QAPI data or omission of data provided to them by including but not limited to infection control, wound care program and pharmacy and therapeutic (P&T) committee for the goal of improved health outcomes. These failed practices resulted serious harm to one patient (Patient #5) who developed gangrene of the scrotum, potential harm to four patients (Patient #5, 8, 18 and 21) who received the wrong medication and the potential to harm all patients receive care at the hospital. (Refer to Tag A-0273, A-0283, A-0489).

e. demonstrate responsibility for the conduct of pharmaceutical services, as evidenced by expired medication being available for use, medications storage, control and distribution not in accordance to standards of practice, including excessive medication overrides, medications given without pharmacist verification, and pharmacy quality information not reported and actions implemented. This failed practice resulted in wrong medication being distributed and administered to 4 (Patients # 5,8,18, and 21) of 20 patients, nursing staff removing 70 medications from the pharmacy without pharmacist verification from 09/24/17-10/03/17, and contributed to 99 medication variances from 01/01/17-08/30/17. (Refer to A-0489)

f. Demonstrate responsibility for the conduct of the infection control program through review, analysis (including root causes), and discussion of infection control data to assist in the development of action plans to prevent and control infections and communicable diseases in patients and staff. Failure of these practices had the potential to cause harm to all patients, staff and visitors by increasing the risk of infections and communicable diseases. (Refer to Tag A-0749, A-0756)

Findings

a. Policy and Procedures

A review of minutes titled, "Governing Body Meeting Minutes for 02/23/17 " showed the Governing Body had approved multiple policies that were "Hospital-Wide" including, but not limited to corporate policies that were not modified for the specific services and functions provided by the hospital surveyed in 3 of 5 policies "Infection Control Plan", "Performance Plan", and "Risk Management Plan".

2 of 5 policies contained elements and/ or services not provided by the hospital were as follows:
* A review of the policy titled, "Restraints (date 03/15)" showed guidelines regarding the use of seclusions. On 10/04/17 at 10:00 am, Staff A stated the hospital does not use seclusion.
* A review of the policy titled, "Room Class Assignment/ Level of Care (date 01/13) documented guidelines to ensure proper payment for contracts. The policy documented guidelines for rehabilitation, psychatric service, hospice, and Intensive Care Unit; all of which were not services provided by the hospital.

On 09/25/17 at 1:00 pm, surveyors requested pharmacy policies and procedures and Staff A, CCO, provided corporate policies. On 10/04/17 at 1:54 pm, the Interim Corporate Pharmacist, Staff W, stated the corporate policies were only guides,

Based on record review, interview, and observation, the hospital failed to:

a. ensure the grievance program provided patients with correct grievance contact information, investigated all grievances and provided a written response of the results of their investigation findings to the individuals submitting the grievance for 10 ( Patients # 5, 23, 24, 25, 26, 27, 28, 29, 30, and 31) of 15 patients/ patient representatives filing grievances. This failed practice had the potential for patients and patient representatives to have difficulty in filing a grievance and receiving a response, and for the hospital to fail to utilize potential quality improvement information to improve patients' services. (Refer to A-0118, and A-0123),

b. to develop a policy which removed an employee from duty during the investigation of alleged of abuse, and thus maintain a safe environment free of potential abuse by eliminating continued exposure of any patient in contact with an employee who was alleged to have committed abuse. (Refer to A-0145)

c. provide patients with a safe environment by ensuring oversight of pharmaceutical services, including medication storage with all available medications not expired, control, and distribution in accordance to standards of practice, which minimized medication overrides and medications given without pharmacist verification, and ensured pharmacy quality information was reported and actions implemented which minimized the risk of medication errors and issues. This failed practice resulted in wrong medication being distributed and administered to 4 (Patients # 5,8,18, and 21) of 20 patients, in nursing staff removing 70 medications from the pharmacy without an initial pharmacist verification from 09/24/17-10/03/17, and had the potential to have contributed to the 99 medication variances from 01/01/17-08/30/17, which had the potential to adversely affect patients' health. (Refer to A-0489)

d. Provide patients with a safe environment by minimizing the risk of health related infections by designation of a qualified Infection Control Preventionist (ICP) who is trained in the principles and methods of infection control, ensuring hospital staff adhered to hand hygiene and appropriate PPE procedures, implementation and maintenance of an active infection control surveillance program, maintenance of sanitary physical environment, notification of hospital leadership of infection control problems and corrective action plans addressed, implemented and sustained. These failed practices potentially resulted in one patient (Patient #5) of 20 patients developing a gangrenous scrotal wound, an ineffective infection control program that increased the risk of infections and potential harm to all patients as evidenced by 21 infection control practice violations observed within a 35 minute period, staff and visitors by the lack of the ICP's knowledge regarding infection control principles and methods, and in-adequate surveillance, monitoring, investigation and follow-up. (Infection See A-0748, A-0749, and A-0756.)

Based on record review and interview, the hospital Quality Assurance and Performance Improvement (QAPI) program failed to:

A. Develop a program that measured and analyzed quality indicator data for infection control, wounds and medication errors to determine root causes, quality of care provided and program effectiveness. (See Tag A-0273)

B. Develop a hospital wide program that set a priority on the high risk/high volume and/or problem prone areas such as infection control, wounds and medication errors to ensure opportunities for improvement were identified, action plans implemented including periodic review to determine effectiveness and analysis of data to ensure sustained improvement. (See Tag A-0283)

These failed practices resulted in 21 observed infection control practice violations within 35 minutes, potential serious harm to one patient (Patient #5) who developed gangrene of the scrotum and four patients (Patient #5, 8, 18 and 21) who received the wrong medication and the potential to harm all patients receiving care due to the hospital's failure to identify infection control, wound and medication risks and quality improvement opportunities to improve patient outcomes.

Based on record review and interview the hospital failed to:

A. Ensure nursing assessment including the wound assessments were completed by nursing staff per hospital policy. This failed practice resulted in potential harm to one patient (Patient #5) who developed a gangrenous scrotal wound and worsening wounds in five (Patient #3, 4, 5, 8, and 11) of the 20 medical records reviewed. (See Tag A-0395)

B. Ensure nursing staff reviewed patient care plans daily and evaluated/updated the care plans weekly or when there was a change in clinical condition per hospital policy. This failed practice resulted in the potential harm to one patient (Patient #5) who developed a gangrenous scrotal wound, worsening wounds in five (Patient #3, 4, 5, 8 and 11) and three (Patient #3, 5 and 11) patients who had a change in clinical condition (See Tag A-0396).

C.

Based on record review, interview, and observation, the hospital failed to provide an organized and effective pharmaceutical service that:

a. ensured a pharmacist developed and supervised pharmacy services, including operational and quality control activities to meet the needs of the patients. (Refer to A-0492)

This failed practice resulted in wrong medication being distributed and administered to 4 (Patients # 5,8,18, and 21) of 20 patients, and had the potential to have contributed to the 99 medication variances from 01/01/17-08/30/17, which had the potential to adversely affect patients' health.

b. provided adequate number of pharmaceutical staff to provide timely and accurate services and meet the needs of the patients served. (Refer to A-0493)

This failed practice resulted in wrong medication being distributed and administered to 4 (Patients # 5,8,18, and 21) of 20 patients, and had the potential to have contributed to the 99 medication variances from 01/01/17-08/30/17, which had the potential to adversely affect patients' health.

c. ensured medications were ordered and dispensed in a safe manner in accordance with standard of practice, to include, but not limited to: pharmacist and nurse order verification, oversight of overridden medications, pharmacy dispensing practices, and medication discrepancies. (Refer to A-0500)

This failed practice resulted in wrong medication being distributed and administered to 4 (Patients # 5,8,18, and 21) of 20 patients, and had the potential to have contributed to the 99 medication variances from 01/01/17-08/30/17, which had the potential to adversely affect patients' health.

d. ensured outdated medications were not available for patient use. (Refer to A-0505)

This failed practice was observed in 2 of 2 crash carts, and the potential to adversely affect patients' health by using medications that were beyond the date of recommended use.

e. ensured medications were removed from the pharmacy by only authorized personnel authorized when a pharmacist was unavailable. (Refer to A-0506)

This failed practice resulted in nursing staff removing 70 medications from the pharmacy without an initial pharmacist verification from 09/24/17-10/03/17, and had the potential to compromise pharmacy security and increase the risk of medication errors.

f. ensured medication administration errors, adverse drug reactions, and incompatibilities were immediately reported to the attending physician and communicated to the hospital's quality assessment and performance improvement (QAPI) program. (Refer to A-0508)

This failed practice resulted in the lack of physician evaluation in 4 of 4 patients (Patient # 5, 8, 18, and 21) after medication error occurred, and increased the risk of adversely affecting patients' health.

Based on record review, interview and observation the hospital failed to:

A. Designate an Infection Control Preventionist (ICP) trained in principals and methods of infection control. Failure to designate a trained ICP had the potential to cause serious harm to one patient (Patient #5) of 20 medical records and the potential to harm to all patients and staff by increasing the risk of developing infections and communicable diseases due to ICP's lack of knowledge regarding infection control principles and methods of infection control. (See Tag a-0748)

B. Ensure staff adhered to hand hygiene practices, appropriate PPE procedures and other infection control measures per hospital policies and procedures. Failure of these practices had the potential to cause harm to all patients, staff and visitors by increasing the risk of infections and communicable diseases. (See Tag A-0749)

C. Ensure an active infection control surveillance program was implemented and maintained to identify infection control risks, and investigate/analyze infection control data to determine any root causes for infections in an effort to control or prevent infections and communicable diseases. These failed practices increased the risk of infections and potential harm to all patients, staff and visitors by lack of adequate surveillance, monitoring, investigation and follow-up. (See Tag A-0749)

D. Ensure the maintenance of a sanitary physical environment. This failed practice increased the risk of infections and potential harm to all patients, staff and visitors by lack of surveillance, monitoring, investigation and follow-up. (See Tag A-0749)


E. Ensure CEO, Medical Staff and CCO were notified of infection control problems and addressed corrective action plans were implemented and sustained. This failed practice created an ineffective infection control program that increased the potential for harm and infection to all patients, staff and visitors. (See Tag A-0756)

Based on record review and interview, the Governing Body failed to ensure the Medical Staff provided quality medical care, services and treatment resulting in serious harm to one patient (Patient #5). This failed practice resulted in one patient (Patient #5) of 20 patient records reviewed, who developing a gangrenous scrotal wound and was subsequently discharged without recognition or effective medical treatment of the wound.


Findings:

Review of hospital document titled "Governing Board Bylaws" showed the Governing Body was accountable for supervision and evaluation for the conduct of the hospital, including the care and treatment of the patients. The Governing Board had responsibility for monitoring and evaluating the quality of care within the hospital and overseeing Medical Staff responsibilities.

Review of hospital document titled "Medical Staff Bylaws and Rules and Regulations" showed the medical staff are accountable to the board for the quality of medical care, services and treatment to patients, and to strive to provide maintain consistent level of quality and efficiency in patient care at the hospital. Medical staff strive to ensure all patients receive the highest quality medical care. Medical staff are responsible for the oversight of the quality of care, treatment, and services provided to patients, ensuring a continuous quality of care that meets professional standards for the hospital.


One (Patient #5) of 20 medical records reviewed showed patient was admitted on 08/04/17, with wound dehiscence and infection of right below the knee amputation (BKA) stump for IV antibiotics and aggressive wound care. No wounds were noted to patient's scrotum or perirectal area on admission. Infectious Disease consult 08/10/17 found Methicillin-resistant Staphylococcus aureus (MRSA) and ampillicin-sensitive enterococcus infection in the patient's right BKA stump. Erythema (redness) of the groin and scrotum with rash was noted by Staff R (Infectious Disease physician) on 08/21/17, and an order for Clotrimazole 1% cream (antifungal medication) twice a day to be applied to the groin and scrotum.

Nursing staff noted scrotal edema on 08/31/17, at 4:00 pm, and left a note in the chart for the physician. Significant scrotal edema was noted by Staff T (Nephrologist) on 08/31/17. There was no evidence in the chart that additional action was taken. On 09/02/17, at 3:11 am, Staff TT noted patient's testicles were bleeding with discoloration and notified charge nurse and wound care. Nursing staff noted small to scant serosanguineous (thin pink to red tinged watery) drainage to scrotum and reddened surrounding tissue on 09/03/17. No evidence nursing staff notified physicians.

On 09/04/17, Staff R noted massive scrotal swelling and order was placed for scrotal elevation. Staff R noted an erosion to the scrotum on 09/05/17. Wound assessment was performed on 09/05/17 identifying a stage 2 pressure ulcer of the scrotum measuring 7.00 by 2.40 cm in length and width, depth unknown, and a perirectal infectious erythema wound measuring 20.00 by 9.00 cm length and width, depth unknown.

On 09/05/17, Staff Q (Internal Medicine physician - attending physician) notes scrotal swelling unchanged. From 09/06/17 through 09/11/17, staff continued to note scrotal swelling and Staff T noted an abrasion to the scrotum. On day of discharge 09/12/17, white blood cell count (WBC) reported at 7:22 am, was elevated at 20.4. Staff Q discharged summary showed patient was stable with no new medical complications other than severe depression. There was no mention of the scrotal swelling, Stage 2 pressure ulceration on the scrotum or the infectious ulceration on the perirectal area and elevated WBC.

On 09/27/17, at 2:35 pm, Staff C stated he/she had been notified by Patient #5's POA (Power of Attorney) informing him/her the patient had been transferred back to the hospital for gangrene of the scrotum (09/14/17). Staff C reported he/she looked at the Patient #5's chart and talked with Staff X the wound care nurse at the time, who said the patient was being treated for a fungal infection of the scrotum. Staff C stated he/she did not notify the attending physician or the infectious disease physician, the scrotal wound had been identified as gangrenous. Staff C reported the wound had been documented by the Staff X, the wound care nurse in the wound round system but was not reported into Action Que for purposes of incident reporting.


On 09/27/17, at 1:17 pm, Staff Q stated he/she was not aware Patient #5 had developed gangrene in the scrotal area. Staff Q reported he was not notified that Patient #5 and 8 had been given the wrong medications and he does not remember nursing staff notifying he/she that Patient #8 had change in status that was concerning.


On 10/04/17, at 9:42 am, Staff T stated he/she was not aware Patient #5 had developed gangrene of the scrotum. Staff T reported he/she was primarily looking at his renal function.


On 10/04/17, at 12:52 pm, Staff R stated he/she was not notified of Patient #5's scrotal swelling or wound being gangrene. Staff R stated he/she does not see from the progress notes that he/she noted scrotal swelling or that he/she looked at the patient's scrotum. Staff R stated wound care wound not necessarily notify him/her of the patient's wounds.

Based on record review, interview, and observation, the hospital failed to provide patients with the correct contact information to file a grievance with the Oklahoma State Department of Health.

This failed practice had the potential for increasing the difficulty for patients and patient representatives to file a grievance.

Findings:

A review of patient handout titled, "Patient Rights and Responsibilities" showed a patient could express a grievance by contacting the New Mexico Department of Health and provided the telephone number. This document was provided to the surveyors as part of the patient admission packet by the CEO and was posted on a bulletin board by the admission desk.

On 09/27/17 at 10:41 am, the CEO stated the patient handout was updated to include the Oklahoma Department of Health and telephone number.

Based on record review and interview, the hospital failed to identify 10 (Patients # 5, 23, 24, 25, 26, 27, 28, 29, 30, and 31) of 15 patients' complaints as grievances, and therefore, failed to follow the grievance process which included sending a response letter.

This failed practice of identifying and responding to grievances had the potential to result in the lack of required investigations and communication of findings, resolution to patients/ patient representatives, quality staff, and Governing Body.

Findings:

A review of the policy titled, "Patient- Family Grievances (date 03/16)" defined a complaint, but failed to define a grievance. The policy documented the Administrator would provide the patient/ patient representative with a written response within 5 days. (per CMS, aPatient Grievance is a formal or informal written or verbal complaint that is made to the hospital by a patient, or the patient 's representative, regarding the patient's care ,when the complaint is not resolved at the time of the complaint by staff present) or pertained to abuse or neglect issues.)

A review of "complaint/grievances" entered in to Action Cue (a computerized quality reporting system) from 01/01/17 - 09/30/17, showed 15 "complaints". 10 (Patient # 5,23,24,25,26,27,28,29,30, & 31) of 15 " complaints" regarding patient care issues required investigation, and could not be resolved at the time submitted. For the 10 patient concerns, Action Cue documented no grievance letters were sent within the policy timeframe.
The 10 patient/patient representative submission are as follows:
Patient #5: On 09/13/17, concern: the lack of recognition of the patient's gangrene.

Patient #23: On 04/21 17, concerns: a rough discharge and pain medication issues.

Patient # 24: On 06/14/16, concerns: care of patient. A response letter was sent 10/31/16. (>4 mths after the designated timeframe.)

Patient # 25: On 04/26/17, concerns: lack of care and staff communication.

Patient # 26: On 04/27/17, concerns: lack of receiving order physical therapy.

Patient # 27: On 05/20/17, concern: not being notified of mother's fall and CT scan.

Patient # 28: On 07/03/17, concern: medication issue.

Patient # 29: On 07/24/17, concern: lack of nursing care and medication administration issues.

Patient # 30: On 04/26/17, concern: nursing care issues.

Patient # 31: On 06/01/17, concern: nursing care issues.

On 10/04/17 at 9:38 am, Staff B stated the grievances were initially handled by Staff A. Staff A would talk to the person submitting the grievance and communicated identified issues as needed to the CEO. Staff B stated Staff A entered the grievance information into Action Cue. Staff B said the CEO, Staff C, finalized the report and either Staff B or the CEO would send out the grievance letter.

On 10/04/17 at 9:38 am, Staff C stated the hospital had no grievances since 03/17.

Based on record review, interview, and observation, the hospital failed to:

a. to develop a policy which removed an employee from duty during the investigation of alleged of abuse, and thus maintain a safe environment free of potential abuse by eliminating continued exposure of any patient in contact with an employee who was alleged to have committed abuse. (Refer to A-0145)

b. provide patients with a safe environment by ensuring oversight of pharmaceutical services, including medication storage with all available medications not expired, control and distribution in accordance to standards of practice, which minimized medication overrides and medications given without pharmacist verification, and ensured pharmacy quality information was reported and actions implemented which minimized the risk of medication errors and issues. This failed practice resulted in wrong medication being distributed and administered to 4 (Patients # 5,8,18, and 21) of 20 patients, in nursing staff removing 70 medications from the pharmacy without an initial pharmacist verification from 09/24/17-10/03/17, and had the potential to have contributed to the 99 medication variances from 01/01/17-08/30/17, which had the potential to adversely affect patients' health. (Refer to A-0489)

c. Provide patients with a safe environment by minimizing the risk of health related infections by designation of a qualified Infection Control Preventionist (ICP) who is trained in the principles and methods of infection control, ensuring hospital staff adhered to hand hygiene and appropriate PPE procedures, implementation and maintenance of an active infection control surveillance program, maintenance of sanitary physical environment, notification of hospital leadership of infection control problems and corrective action plans addressed, implemented and sustained. These failed practices potentially resulted in one patient (Patient #5) of 20 patients developing a gangrenous scrotal wound, an ineffective infection control program that increased the risk of infections and potential harm to all patients as evidenced by 21 infection control practice violations observed within a 35 minute period, staff and visitors by the lack of the ICP's knowledge regarding infection control principles and methods, and in-adequate surveillance, monitoring, investigation and follow-up. (Refer to A-0748, 0749)

Based on record review and interview, the hospital failed to develop a policy which removed an employee from duty during the investigation of alleged of abuse, and thus maintain a safe environment free of potential abuse by eliminating continued exposure of any patient in contact with an employee who was alleged to have committed abuse.

A review of policy titled, "Adult Abuse/ Neglect, Alleged or Suspected (no date)" failed to document the action taken by leadership towards employee suspected of abuse during the investigation of the incident.

A review of the "Acadiana Management Group's Employee Handbook" documented any employee who abused a patient or who intentionally neglected a patient and their needs would be terminated immediately and reported to their licensing board.

On 10/04/17 at 9:38 am, Staff C stated the hospital had no policy regarding removing an employee, alleged of abuse, from duty during the investigation of the matter and stated the hospital had no allegation of that nature.

Based on record review and interview, the hospital failed to measure and analyze quality indicator data to determine program effectiveness, root causes of issues, and quality of care provided for high volume, problem prone areas such as: infection control, wounds, and medication errors.

These failed practices resulted in 21 observed infection control practice violations within 35 minutes, potential harm to one patient (Patient #5) who developed gangrene of the scrotum and four patients (Patient #5, 8, 18 and 21) who received the wrong medication, the inability to develop and implement corrective actions to improve care for the 260 patients with wounds during 01/01/17 - 09/27/17 and the 99 medication variances documented from 01/01/17-08/30/17.

Findings:

a. Infection Control

Review of hospital document titled "Infection Prevention and Control Program 2017 Risk Assessment and Plan" showed analysis of data was performed to determine infection prevention and control practice effectiveness, identify outcomes and monitor trends. Root cause analysis performed for identified hospital associated infections.

Fourth Quarter 2016 Reporting

Review of hospital document titled "Infection Control Committee Meeting" dated 01/11/17 showed one CLABSI HAI infection for December 2016. Hand hygiene compliance (corporate benchmark 100% from Infection Control Function Report 2016) was less than 94% and follow-up showed continued surveillance and education. Meeting minutes failed to identify the actual compliance rate for hand hygiene compliance. There were 24 patients in isolation for MRSA and six patients for C-diff. Audits would be performed for education on hand washing and PPE for patients admitted with MDRO's. Meeting minutes failed to show evidence of discussion of data, analysis and investigation regarding surveillance activities including complaince with infection control practices by hospital staff for patients in isolation. No evidence of a review or analysis/root cause was performed to determine how the HAI (Hospital Acquired Infection) CLABSI occurred. Meeting minutes forwarded to quality committee, MEC and Governing Board on quarterly basis.

Review of hospital document titled "QAPI Meeting" dated 01/13/17 showed no evidence of discussion, analysis or corrective actions addressed for issues identified by infection control, such as surveillance activities for infection control practices by hospital staff for patients in isolation to ensure appropriate methods and compliance, the HAI CLABSI for December 2016, hand hygiene performance below facility goal of 95% (facility benchmark) and actions for MDRO prevalence.

Review of hospital document titled "MEC Meeting" dated 01/18/17 showed one case of CLABSI reported for the quarter. No evidence of discussion or analysis for the cause of the event or additional issues and analysis of data reported by infection control, including hand hygiene staff performance and MDRO prevalence. Meeting minutes failed to show evidence of discussion of data, analysis and investigation regarding surveillance activities for infection control practices by hospital staff for patients in isolation to ensure appropriate methods and compliance.

Review of hospital document titled "Annual GB Meeting" dated 02/23/17 showed fourth quarter quality data presented for informational purposes included HAI 0.53, CAUTI event 1 and CLASBI event 0. There was no evidence the GB discussed the HAI event to determine the cause and any corrective actions if needed. The meeting minutes failed to provide evidence of discussion and review of data, analysis and investigation of hospital staff compliance with hand hygiene practice that were below corporate benchmark goal of 100% and surveillance activities for infection control practices by hospital staff for patients in isolation to ensure appropriate methods and compliance.

First Quarter 2017 Reporting

Review of hospital document titled "Infection Control Committee Meeting" dated 04/12/17 showed hand hygiene had 27 observations conducted on day shift for the quarter. Compliance was 81% before contact and 92% after contact with the patient. Meeting minutes failed to show evidence of review and discussion of hand hygiene data, analysis and investigation of data to determine the cause for drop the in hand hygiene compliance and surveillance activities for infection control practices by hospital staff for patients in isolation to ensure appropriate methods and compliance.

Surveillance and education of staff requires continued follow up. There was one HAI MRSA and six CDAD events for the quarter. Action identified was to track, trend, and report to all departments. There was no evidence the HAIs were analyzed for opportunities for improvement, root cause analysis performed to determine any potential systemic cause, and action plans implemented to improve health outcomes for patients.

Review of hospital document titled "QAPI Meeting" dated 04/21/17 showed report of an action plan for hand hygiene improvement including a plan of correction observation to be conducted with employee education immediately if non-compliant. The meeting minutes failed to show evidence of review, discussion, analysis and investigation of infection control data regarding hand hygiene and surveillance activities for infection control practices by hospital staff for patients in isolation to ensure appropriate methods and compliance. There was no evidence of discussion regarding the HAIs for MRSA and CDAD for the quarter including analysis and investigation of these events to determine cause or implementation of an action plan.

Review of hospital document titled "MEC Meeting" dated 05/17/17 showed no evidence of discussion by medical staff regarding infection control issues or analysis of data reported by the infection control committee. The meeting minutes failed to provide evidence of discussion, analysis and investigation of hand hygiene compliance data and surveillance activities for infection control practices by hospital staff for patients in isolation to ensure appropriate methods and compliance.

Review of hospital titled "Quarterly GB Meeting" dated 05/25/17 showed quality data presented for informational purposes. First quarter data included wound worsening at 17.24%, no HAI/Cauti/CLABSI. There was no evidence of the one HAI MRSA and six CDAD events from the 1st quarter Infection Control Meeting minutes were analyzed and discussed. The meeting minutes showed no evidence of analysis or discussion of the wound worsening rate for the facility. Meeting minutes failed to show evidence of discussion, analysis and investigation of the hand hygiene compliance data and surveillance activities for infection control practices by hospital staff for patients in isolation to ensure appropriate methods and compliance.

Review of hospital document titled "MEC Meeting" dated 06/21/17" showed the medical staff was provided data for hand hygiene compliance of 86% for May 2017 for informational purposes. There was no evidence medical staff was provided any other infection control data including HAIs and MDRO prevalence in an effort to determine any corrective actions.

Second Quarter 2017 Reporting

Review of hospital document titled "Infection Control Committee Meeting" dated 07/12/17 showed hand hygiene had 105 (averaging 35 per month) observations conducted on day and night shifts for the quarter. Compliance was 60% before contact and 94% after touching a patient. Follow-up activities remained unchanged from the 04/12/17 meeting. Meeting minutes failed to show evidence of discussion, analysis and investigation of the decrease in the hand hygiene compliance percentage, including any interventions or corrective action plans. The minutes showed no evidence of discussion or analysis of surveillance activities for infection control practices by hospital staff for patients in isolation to ensure appropriate methods and compliance. Meeting minutes did show evidence of Four HAI CDAD, three CAUTI, four CLASBI, and one CRE identified for the 2nd quarter. HAI events showed an increase in the number of reportable CLASBI and CAUTI. Follow-up for HAI events included increased monitoring of PICC dressing changes. There was no evidence of analysis of the HAI CDAD and one CRE for any root causes or development of action plans. Meeting minutes forwarded to quality committee, MEC and Governing Board on quarterly basis.

Review of hospital document titled "Quarterly GB Meeting" dated 08/25/17 showed the Infection Control Function report was presented for informational purposes. This report was not attached for review and no discussion in meeting minutes regarding information reviewed from this report by Governing Board. Quality data listed in the meeting minutes for the second quarter included wound worsening percentage, HAI, Cauti and CLABSI. No quality data was identified for each of these quality indicators, the box for each were left blank in the meeting minutes. There was no evidence of analysis and discussion by the Governing Board in the meeting minutes of the four HAI, three CAUTI, four CLASBI and one CRE identified for the 2nd quarter by the infection control committee.

On 09/26/17 at 3:30 pm, Staff B stated the goals for the year are facility benchmarks the hospital is trying to meet for hand hygiene and have staff performing surveillance observations. Staff B reported the infection control committee identified surveillance observations were low and increased them to 50 per month. Staff B reported that the minutes for the meetings may not reflect the analysis or discussion of the infection control data. Staff B stated that he/she agreed the infection control committee meeting minutes only reported numbers and no analysis by the committee of the data.

On 09/27/17 at 2:35 pm, Staff C stated infection control data would be discussed first at infection control committee then it would be reported to the QAPI, then Medical Staff and finally to Governing Board. Staff C reported that all discussions in QAPI, Medical Staff and Governing Board do not always get transcribed into the minutes. Staff C stated the Governing Board minutes reflect reporting of data and no analysis.

On 10/04/17 at 9:40 am, Staff B stated it has been difficult to obtain 50 surveillance a month. Staff B reported the team has been averaging between 35 to 50 hand hygiene and infection control practice surveillance activities per month. Staff B stated when he/she observes staff coming out of a patient's room, staff may have already washed hands or if staff have a gown and/or gloves on he/she will have to take their word that the staff has completed hand washing or gown and/or gloves are clean when questioned. Staff B reported the surveillance team does not have a way to determine if the staff has cleaned their stethoscopes when they come out of a patient's room. Staff B stated he/she does not perform any type of root cause analysis on HAIs.

b. Wounds
On 10/03/17 at 3:03 pm, Staff A described the Wound Program's processes, and flow of information as follows:

Processes
Weekly, the Wound Care Nurse utilized a handheld device called, "Woundrounds", used at the bedside to record clinical data and images captured to measure, assess, and document patient wounds. The information from this device was downloaded to Corporate, who developed monthly reports, titled, "Wound Report" and "Action Cue-Wound Report" data dashboard.

The "Wound Report" included, but was not limited to: admission date, wound site, date identified, , wound measurement and description, addressed if the wound was facility acquired and calculated a "PUSH score". (PUSH-Pressure Ulcer Scale for Healing Tool is a formula that calculates a score for each Pressure Ulcer or Wound to assess wound healing with rating from 0=healed to 17 most severe.)

The Wound Care Nurse rounded with the Wound Physician each Friday, and modified the patient's plan of care as needed.

Flow of Information
On 06/14, a Wound Care Committee was created to work in conjunction with Corporate to utilize the "Wound Report" and "Action Cue-Wound Report" to evaluate to program and identify those patients with worsening wounds, and to develop action plans. The wound deterioration rate, or "worsening wounds" information was to be provided to the Quality Assurance Performance Improvement (QAPI), Medical Executive Committee (MEC), and Governing Body (GB) Committees.

The following timeline 01/17 to 09/17 illustrates the ineffectiveness of the Wound Care Program, lack of data collection, and analysis, compreshensive action plans, and communication of accurate data to leadership.

A review of the "Wound Report 01/01/17 - 09/27/17" showed 260 wounds were recorded.

01/17:
A review of "Action Cue-Wound Care Report" showed a wound deterioration rate of 0%.

A review of the "Wound Report for 01/17 showed Patient #35 was admitted on 01/04/17, and a facility acquired right ischial tuberosity wound was identified on 01/20/17 with a PUSH score of 10.

A review of the "Quality Committee Meeting Minutes 01/13/17" documented 10 acquired pressure wounds for 2016. There was no evidence of analysis by the facility of acquired wounds, trend of wound locations, and evaluation or treatment techniques to establish best practices.

On 09/27/17 at 1:43 pm, Staff C, CEO, stated on 01/17, the corporate compliance staff contacted him regarding the wound data submitted via "Woundrounds Manager", inquiring about the increase in worsening wound data. The CEO stated the corporate information did not match the description of the program status from the Wound Care Nurse.

02/17:
A review of "Action Cue-Wound Care Report" showed a wound deterioration rate of 40%, with no analysis or discussion of this data.

A review of the "Wound Report for 02/17 showed Patient #34 was admitted on 02/21/17, and a facility acquired bilateral buttock wound was identified on 03/08/17 with a PUSH score of 2.

A review of the "GB Meeting Minutes 02/23/17" showed a wound deterioration rate of 0% (Jan 2017 data), with no analysis or discussion of this data. No evidence that GB was aware of Corporate's concern of inaccurate data and worsening wounds

03/17
A review of the "Wound Report for 03/17" showed:
* Patient #32 had a facility acquired wound. Patient #32 was admitted on 03/15/17, and on 04/05/17, six more wounds were identified: bilateral buttock and sacrum with PUSH score of 11, left 4th & 5th toe with PUSH of 8, left base great toe with PUSH 6, and left plantar with PUSH 7.
* Patient # 36 was admitted on 03/30/17, and a facility acquired lateral aspect of left foot wound was identified on 06/12/17 with a PUSH score of 5, left heel wound was identified on 06/12/17 with a PUSH score of 10, and left lower leg and back wound were identified on 06/12/17 with a PUSH score of 9.
* Patient # 37 was admitted on 03/25/17, and a facility acquired left heel wound was identified on 05/16/17 with a PUSH score of 7.
* Patient # 39 was admitted on 03/27/17, and a facility acquired buttock wound was identified on 04/11/17 with a PUSH score of 6.
* Patient # 41 was admitted on 03/26/17, and a multiple facility acquired were identified on 04/05/17: buttock and sacral wounds with a PUSH score of 11, 4th & 5th toe wounds with a PUSH score of 8, left great toe wounds with a PUSH score of 6, and left plantar wounds with a PUSH score of 7.

A review of "Action Cue-Wound Care Report" showed a wound deterioration rate of 55.6%, with no analysis, discussion, or communication to leadership of the increase.

No quality information or leadership documentation was provided that addressed facility acquired wounds.

04/17
A review of "Action Cue-Wound Care Report" showed a Wound Deterioration Rate= 0%

A review of the "Wound Report for 04/17 showed Patient #38 was admitted on 03/10/17, and a facility acquired right heel wound was identified on 04/17/17 with a PUSH score of 9.

A review of the "Quality Committee Meeting Minutes 04/21/17 " contained Action Cue-Wound Care Report 01/01/07 - 04/17 data dashboard, with no analysis or discussion of this data. There was no evidence of analysis of the facility acquired wounds, trend of wound locations, or evaluation of treatment techniques to establish best practices.

A review of the "Medical Executive Meeting Minutes 04/26/17 " contained no data or discussion regarding wounds.

On 10/03/17 at 1:08 pm, Staff A stated the CEO, CCO, and Wound Care Nurse discussed developing a Wound Committee to address worsening wounds. She stated there was no documentation of these discussions.

05/17
A review of "Action Cue-Wound Care Report" showed no data for the Wound Deterioration Rate.

A review of the "GB Meeting Minutes 05/25/17" showed Wound Deterioration Rate as 17.24% with no explanation of what date the data represented.


06/17
A review of "Action Cue-Wound Care Report" showed no data for the Wound Deterioration Rate.

A review of the "Wound Report for 06/17 showed Patient #46 was admitted on 08/16/17, and a facility acquired forehead wound was identified on 08/29/17 with a PUSH score of none documented.

On 10/03/17 at 1:08 pm, Staff A stated on 06/17 she began meeting with Staff X, the Wound Care Nurse regarding 3 patient wound assessment involving inaccurate site, exudate, and description. Staff A stated on 09/10/17, Staff X resigned and the hospital formally created a Wound Care Committee to improve the wound care program. Staff A stated the committee met weekly, but did not keep minutes regarding discussions or program development. (This action was approximately 6 months after notification of corporate and data of worsening wounds.)

07/17
A review of the Wound Round Report for 07/17 showed Patient # 33 was admitted 07/19/17, but on 07/25/17, 2 facility acquired wounds were identified: a coccyx wound with PUSH 15, and left thigh back with PUSH 12.

08/17- 09/17
A review of the "Wound Round Report for 08/4/2017" showed Patient # 5 was admitted on with Right BKA wound and left foot ulcers wounds identified by the admitting Staff UU, RN. On 09/05/17, a facility acquired right ischial tuberosity (with a PUSH score of 2) and a scrotal wound (with PUSH score of 11) were identified.

On 09/11/17, Patient #5's scrotum wound round sheet identified an increased PUSH score from 11 to 12, and medical record showed no change in the plan of care. A review of Patient #5 medical record showed on 09/05/17, a perirectal wound was identified with PUSH 14, and this wound was not listed on the wound report. On 09/27/17 at 1:43 pm, the CEO, Staff C, stated a day after discharge, on 09/13/17, he was notified by the receiving nursing home that the scrotum was gangrenous. The medical staff, involved in his case, were not notified.

A review of the "Wound Report for 09/17 showed Patient # 4 was admitted on 09/12/17, and a facility acquired scrotal wound was identified on 09/25/17 with a PUSH score of 4.
A review of the "Wound Report for 09/17 showed Patient # 42 was admitted on 09/01/17, and a facility acquired right calf wound was identified on 09/13/17 with a PUSH score of 8.

On 10/03/17 at 1:08 pm, Staff A provided incomplete handwritten "notes" from the meetings 09/10/17, 09/15/17, 09/20/17. On 09/20/17, the notes documented Patient #22 had a worsening wound. Patient #22 was not found on the "Wound Report 01/01/17 - 09/27/17".

A review of "Action Plan 8/01/17 " documented a program of serial turning patients had begun, and a meeting was conducted with housekeeping to ensure use of waffle specialized mattresses. The hospital's general action plan included turning patients every 2 hours, placing patients on specialized mattresses, and discussing wounds weekly to update plans of care. The plan failed to address the wounds not associated with external pressure on tissue, such as on the nose, scrotum, face, and trach stoma. The action plan failed to include evaluation of the effectiveness of medication, dressing changes, nutrition, and debridement. The Wound Committee's action plan failed to address the nursing staff's lack of documentation of wound assessments.
* A review of policy titled, "Initial Assessment /Reassessment of Wounds (11/06) documented wounds would be assessed within 72 hours of admission and at least every 7 days by the Wound Nurse.
* A review of 14 (Patient #1, 2, 3, 4, 5, 7, 8, 11, 12, 13, 15, 16, 19 and 20) of 20 patient records reviewed failed to have a complete wound assessment documented each shift.

c. Medication Errors and Issues
Quality Issues
09/27/17 at 9:45 am, Staff W, Interim Corporate Pharmacist stated there were no current reports that reported pharmaceutical quality for the hospital, analysis of data, or formal action plans developed. Staff W stated she had developed goals to resolve issues she had identified:
*perform area monthly audits in any space that meds were stored.
*control substance- run 2 reports of nursing administration and waste report and evaluate.
* perform random audit check audits--60 audits per month --stated nursing audits charts to verify correct medication administration.
* review written variances
*investigate overrides within 12 hours to evaluate proper use of override and correct dispensing.
*place medication incidents in action cue.
*investigate discrepancies
10/02/17 at 11:08 am, Staff W stated she had not formally notified leadership of her evaluation of the needs and issues she had identified in her month of being interim pharmacist.

A review of the computer variance system "Action Cue" showed 99 medication variances from 01/01/17-08/30/17 and no medication variances September 2017 were documented. A review of the medication variances from 06/01/17 to 09/30/17 showed 8 wrong or missing antibiotic doses. Staff W stated data was not analyzed or comprehensive action plans developed.

10/02/17 at 11:08 am, Staff W stated medication variances for September 2017 were on her desk and had not been reviewed or entered into Action Cue. Staff W stated data was not analyzed or action plans developed.

A review of the hospital log titled, "After hours Medication Sign out Sheet from 09/22/17-10/03/17" showed lack of pharmacy coverage with 70 entries of nursing staff entering the pharmacy to obtain medication at various hours that including times from 8:30am to 4:30 pm. 10/02/17 at 11:08 am, Staff W stated it was her goal to reduce the number of entries of non-pharmaceutical staff. Staff W stated data was not analyzed or action plans developed.

A review of the hospital log titled, "Omnicell Narcotic Shift Sheet from 08/11/17 - 09/24/17" showed 7 discrepancies with 4 of 7 entries having no explanation as to the discrepancy found and or if it was reconciled. Staff W stated data was not analyzed or action plans developed.

10/02/17 at 11:08 am, Staff W stated it was her goal to discontinue the log and computerize tracking of discrepancies. Staff W stated she could not explain the 4 entries that had no information. Staff W stated data was not analyzed or action plans developed.

A review of an incident report dated 08/14/17 documented Staff D, who was the only pharmaceutical staff on duty, incorrectly filled a bin in the automatic drug center (ADC) with the diuretic medication instead of an anti-hypertensive medication. The error resulted in 4 patients receiving the wrong medication, and some of those patients receiving multiple doses of the wrong medication.
* 09/27/17 11:12 am, CEO stated he knew Patient #8 had died, but the Staff B, CCO, did not communicate the patient as involved with a Amlodipine/Amiloride medication error 2 days before his death.
* On 10/04/7 at 10.30 am, Staff A, CCO finalized incident report on 08/15/17 at 1617 after the patient died. The incident report was documented, "Pharmacist filled wrong bin, nurse caught error". The report failed to communicate Patient #8 died the day following 2 doses of the wrong medication. Staff A stated she knew of patient #8's death and of the medication error, but not connect or communicate the events together to the CEO.
* On 10/04/17 at 10:40 am, Staff B stated Patient #8's death would be evaluated in MEC, but the medication error that occurred would not be a part of the evaluation if it was not documented in the patient's medical record.
* On 10/02/17 at 11:15am, Staff W, the Interim Corporate Pharmacist stated she was Staff D's supervisor. She stated she had not been notified of the 08/12/17 medication incident in which Staff D, and did not know if Staff D had been counseled. Staff W stated the hospital needed a bar code scanning system to help minimize errors.

A review of the medical record of Patient # 18 showed on 07/17/17 Provider R wrote an order for clindamycin to be discontinued. On 07/20/17, Provider R rewrote the order to discontinue the clindamycin, because the medication was still being administered. A review of incident reports for 07/17 showed no variance regarding this medication error.

Meeting Minutes
A review of minutes titled, "P & T [Pharmacy & Therapeutics] Meeting Minutes 01/11/17, 04/19/17, & 07/19/17" all documented the following phrase: "medication variances: antibiotic timing, meds not given as ordered." The minutes from 01/17 and 04/17 documented overrides [were] "Primarily due to late overrides primarily due to late physician rounding and weekend orders when pharmacy is not open, and 07/17 "peaked when agency was high, meds were in bins nursing would ask Charge to get med without checking refrigerator and cabinet first." The P&T minutes failed to document the analysis of identified issues and discussion of any implementation of performance improvement initiatives.

A hospital document titled "P&T Function" (a computerized dashboard of performance measures). A review of dashboard titled, "P&T Function Oct., Nov., Dec 2016" showed unnecessary override rate benchmark as 7.33% and an Oct 2016 rate of 10%. No analysis or action plans were associated with this document. No P & T Function reports were provided to for 2017.

In the presence of Staff W, P & T [Pharmacy & Therapeutics] Meeting Minutes 01/11/17, 04/19/17, & 07/19/17" were reviewed. Staff W stated the current minutes provided little quality information and she was planning to change the format to provide improved quality information.

A review of minutes titled, "Quality Meeting 04/21/17" had the attachment of the "P&T Function Report 01/01/17 - 06/30/17" which showed:
* unnecessary override average of 14.29% (benchmark 7.33%),
* medication error average of 0.052% (benchmark .022)
* medication variance average of 0.059 (benchmark 0.028)
* narcotic count discrepancy average of 0.8% (benchmark 0.5%)
The minutes did not show evidence discussion or action plan for improvement.

09/27/17 11:12, Staff B, the Director of Quality, stated she was not provided information regarding medication variances. Staff B stated she does not go to P&T meeting. She stated she was never told when they were to be held. She stated she was not involved in medication error investigations. She stated Staff A was involved with the medication errors for the past weeks. She stated the former Pharmacist, Staff H, put medication incidents in Action Cue and without conducting an investigation. She stated she did not know if staff evaluated the patients' condition to see if the patient had a bad outcome

A review of the "Medical Executive Meeting Minutes" showed:
08/16/17 "P & T Function Report" was listed in the meetings minutes, but did not contain evidence of pharmacy discussions or attachments.
07/26/17 "April : 30 medication variances ...May: 10 medication variances ...15 medication variances ...Information presented without any discussion".
06/21/17 no evidence of medication errors or pharmacy issue were discussed. The Performance Measure Dashboard which was attached to the minutes showed April 2017 unnecessary overrides as 17.95% (benchmark 15.93%) and Medication Error rate as 0.132 (benchmark 0.05)
05/17/17 no evidence medication errors or pharmacy issues were discussed.

A review of minutes titled, "Governing Body Meeting Minutes for 02/23/17 and 08/25/17" documented, "P & T Report" (a computerized dashboard of performance measures for pharmacy), but had no attachments. Both minutes documented the "P & T Function Report ...the quality data was presented to the GB-[as] informational." The Governing Body minutes failed to document identified pharmacy issues and failed to discuss issue analysis and performance improvement initiatives.

Based on record review and interview, the hospital failed to develop a hospital wide program that set a priority on the high risk/high volume and/or problem prone areas such as infection control, wounds and medication errors to ensure programs reviewed data and was used to identify action plans and analysis of outcomes to ensure sustained improvement.

These failed practices resulted serious harm to one patient (Patient #5) who developed gangrene of the scrotum, worsening wounds in the 260 patients with wounds during 01/01/17 - 09/27/17, in 99 medication variances documented from 01/01/17-08/30/17.

Findings:

a. Infection Control

Review of hospital document titled "Infection Prevention and Control Program 2017 Risk Assessment and Plan" showed the IP is responsible for process and outcome surveillance activities to identify outbreaks and those that have the potential to cause an outbreak of infection. Analysis of data is performed to determine infection prevention and control practice effectiveness, identify outcomes and monitor trends. Data from the line listing reports are reviewed to monitor antimicrobial stewardship. Root cause analysis performed for identified hospital associated infections.

Review of policy titled "Infection Control Plan" showed the ICC is responsible for the collection and analysis of issues related to infection control, initiating investigative measures for potential infection control problems and evaluating the effectiveness of the Infection Control Program.

Review of hospital document titled "Action Plan" for handwashing adherence showed the plan was implemented on 04/18/17 and revised on 06/20/17. No evidence of how the action plan was revised on 06/20/17. Action step follow-up are not timely to determine effectiveness. Target dates are for March and April 2018 (almost a year after implementation of the action plan). There is no evidence in the action plan for investigating and analysis of the data obtained through surveillance observation to revise action plan steps in an effort to increase staff compliance with handwashing. No evidence of a measurable outcome goal to determine the effectiveness of the action plan and whether the hospital is meeting the facility benchmark for hand hygiene for the year.

Fourth Quarter 2016 Reporting

Review of hospital document titled "Infection Control Committee Meeting" dated 01/11/17 showed one CLABSI HAI infection for December 2016. Hand hygiene compliance was less than 94% and status identified continued surveillance and education. There were 24 patients in isolation for MRSA and six patients for C-diff. Audits will be performed for education on hand washing and PPE for patients admitted with MDRO's. No evidence of a review or analysis/root cause was performed to determine how the HAI CLABSI occurred. Meeting minutes forwarded to quality committee, MEC and Governing Board on quarterly basis.

Review of hospital document titled "QAPI Meeting" dated 01/13/17 showed no evidence of discussion, analysis or corrective actions addressed for issues identified by infection control, including the HAI CLABSI for December 2016, hand hygiene performance below facility goal of 95% and actions for MDRO prevalence.

Review of hospital document titled "MEC Meeting" dated 01/18/17 showed one case of CLABSI reported for the quarter. No evidence of discussion or analysis for the cause of the event or additional issues and analysis of data reported by infection control, including hand hygiene staff performance and MDRO prevalence.

Review of hospital document titled "Annual GB Meeting" dated 02/23/17 showed fourth quarter quality data presented for informational purposes included HAI 0.53, CAUTI event 1 and CLASBI event 0. There was no evidence the GB discussed the HAI event to determine the cause and any corrective actions if needed.

First Quarter 2017 Reporting

Review of hospital document titled "Infection Control Committee Meeting" dated 04/12/17 showed hand hygiene had 27 observations conducted on day shift for the quarter. Compliance was 81% before contact and 92% after contact with the patient. Surveillance and education of staff requires continued follow up. There was one HAI MRSA and six CDAD events for the quarter. Action identified was to track, trend, and report to all departments. There was no investigation and analysis of these events to determine the root cause for each HAI per the hospital risk assessment and plan. Action plan for hand hygiene did not identify timely evaluation of action steps to determine effectiveness and make revisions based on staff performance, and the outcome goal of on-going observation and evaluation to provide corrective interventions for patient safety is not a quantifiable goal. There was no evidence the HAIs were analyzed for opportunities for improvement, root cause analysis performed to determine any potential systemic cause, and action plans implemented to improve health outcomes for patients.

Review of hospital document titled "QAPI Meeting" dated 04/21/17 showed report of an action plan for hand hygiene improvement including a plan of correction observation to be conducted with employee education immediately if non-compliant. There was no evidence of discussion regarding the HAIs for MRSA and CDAD for the quarter including analysis and investigation of these events to determine cause or implementation of an action plan.

Review of hospital document titled "MEC Meeting" dated 05/17/17 showed no evidence of discussion by medical staff regarding infection control issues or analysis of data reported by the infection control committee.

Review of hospital titled "Quarterly GB Meeting" dated 05/25/17 showed quality data presented for informational purposes. First quarter data included wound worsening at 17.24%, no HAI/Cauti/CLABSI. There was no evidence of the one HAI MRSA and six CDAD events from the 1st quarter from the Infection Control Meeting analyzed for root cause and discussion. The meeting minutes showed no evidence of analysis or discussion of the wound worsening rate.

Review of hospital document titled "MEC Meeting" dated 06/21/17" showed the medical staff was provided data for hand hygiene compliance of 86% for May 2017 for informational purposes. There was no evidence medical staff was provided any other infection control data including HAIs and MDRO prevalence in an effort to determine any corrective actions.

2nd Quarter 2017 Reporting

Review of hospital document titled "Infection Control Committee Meeting" dated 07/12/17 showed hand hygiene had 105 (averaging 35 per month) observations conducted on day and night shifts for the quarter. Compliance was 60% before contact and 94% after touching a patient. Status/Update was unchanged from the 04/12/17 meeting. No evidence the hand hygiene action plan was revised or evaluated based on staff performance. Four HAI CDAD, three CAUTI, four CLASBI, and one CRE were identified for the 2nd quarter. Meeting minutes for HAI events showed an increase in number of reportable CLASBI and CAUTI. Status/Update included increased monitoring of PICC dressing changes and follow up discussion on 08/01/17. There was no evidence of analysis of the HAI CDAD and one CRE for any root causes or development of action plans. Meeting minutes forwarded to quality committee, MEC and Governing Board on quarterly basis.

Review of hospital document titled "Quarterly GB Meeting" dated 08/25/17 showed the Infection Control Function report was presented for informational purposes. This report was not attached for review and no discussion in meeting minutes regarding information reviewed from this report by Governing Board. Quality data listed in the meeting minutes for the second quarter included wound worsening percentage, HAI, Cauti and CLABSI. No quality data was identified for each of these quality indicators, the box for each were left blank in the meeting minutes. There was no evidence of analysis and discussion by the Governing Board in the meeting minutes of the four HAI, three CAUTI, four CLASBI and one CRE identified for the 2nd quarter by the infection control committee.

On 09/27/17 at 2:35 pm, Staff C stated infection control data would be discussed first at infection control committee then it would be reported to the QAPI, then Medical Staff and finally to Governing Board. Staff C reported that all discussions in QAPI, Medical Staff and Governing Board do not always get transcribed into the minutes. Staff C stated the Governing Board minutes reflect reporting of data and no analysis.

On 10/04/17 at 9:40 am, Staff B stated he/she does not use the infection control line listing log for any other than the numbers. Staff B reported he/she does not perform any type of root cause analysis on HAIs.


b. Wounds

On 10/03/17 at 3:03 pm, Staff A described the Wound Program's processes, and flow of information as follows:

Processes
Weekly, the Wound Care Nurse utilized a handheld device called, "Woundrounds", used at the bedside to record clinical data and images captured to measure, assess, and document patient wounds. The information from this device was downloaded to Corporate, who developed monthly reports, titled, "Wound Report" and "Action Cue-Wound Report" data dashboard.

The "Wound Report" included, but was not limited to: admission date, wound site, date identified, , wound measurement and description, addressed if the wound was facility acquired and calculated a "PUSH score". (PUSH-Pressure Ulcer Scale for Healing Tool is a formula that calculates a score for each Pressure Ulcer or Wound to assess wound healing with rating from 0=healed to 17 most severe.)

The Wound Care Nurse rounded with the Wound Physician each Friday, and modified the patient's plan of care as needed.

Flow of Information
On 06/14, a Wound Care Committee was created to work in conjunction with Corporate to utilize the "Wound Report" and "Action Cue-Wound Report" to evaluate to program and identify those patients with worsening wounds, and to develop action plans. The wound deterioration rate, or "worsening wounds" information was to be provided to the Quality Assurance Performance Improvement (QAPI), Medical Executive Committee (MEC), and Governing Body (GB) Committees.

The following timeline 01/17 to 09/17 illustrates the ineffectiveness of the Wound Care Program, lack of data collection, and analysis, compreshensive action plans, and communication of accurate data to leadership.

A review of the "Wound Report 01/01/17 - 09/27/17" showed 260 wounds were recorded.

01/17:
A review of "Action Cue-Wound Care Report" showed a wound deterioration rate of 0%.

A review of the "Wound Report for 01/17 showed Patient #35 was admitted on 01/04/17, and a facility acquired right ischial tuberosity wound was identified on 01/20/17 with a PUSH score of 10.

A review of the "Quality Committee Meeting Minutes 01/13/17" documented 10 acquired pressure wounds for 2016. There was no evidence of analysis by the facility of acquired wounds, trend of wound locations, and evaluation or treatment techniques to establish best practices.

On 09/27/17 at 1:43 pm, Staff C, CEO, stated on 01/17, the corporate compliance staff contacted him regarding the wound data submitted via "Woundrounds Manager", inquiring about the increase in worsening wound data. The CEO stated the corporate information did not match the description of the program status from the Wound Care Nurse.

02/17:
A review of "Action Cue-Wound Care Report" showed a wound deterioration rate of 40%, with no analysis or discussion of this data.

A review of the "Wound Report for 02/17 showed Patient #34 was admitted on 02/21/17, and a facility acquired bilateral buttock wound was identified on 03/08/17 with a PUSH score of 2.

A review of the "GB Meeting Minutes 02/23/17" showed a wound deterioration rate of 0% (Jan 2017 data), with no analysis or discussion of this data. No evidence that GB was aware of Corporate's concern of inaccurate data and worsening wounds

03/17
A review of the "Wound Report for 03/17" showed:
* Patient #32 had a facility acquired wound. Patient #32 was admitted on 03/15/17, and on 04/05/17, six more wounds were identified: bilateral buttock and sacrum with PUSH score of 11, Left 4th & 5th toe with PUSH of 8, left base great toe with PUSH 6, and left plantar with PUSH 7.
* Patient # 36 was admitted on 03/30/17, and a facility acquired lateral aspect of left foot wound was identified on 06/12/17 with a PUSH score of 5, left heel wound was identified on 06/12/17 with a PUSH score of 10, and left lower leg and back wound were identified on 06/12/17 with a PUSH score of 9.
* Patient # 37 was admitted on 03/25/17, and a facility acquired left heel wound was identified on 05/16/17 with a PUSH score of 7.
* Patient # 39 was admitted on 03/27/17, and a facility acquired buttock wound was identified on 04/11/17 with a PUSH score of 6.
* Patient # 41 was admitted on 03/26/17, and a multiple facility acquired were identified on 04/05/17: buttock and sacral wounds with a PUSH score of 11, 4th & 5th toe wounds with a PUSH score of 8, left great toe wounds with a PUSH score of 6, and left plantar wounds with a PUSH score of 7.
A review of "Action Cue-Wound Care Report" showed a wound deterioration rate of 55.6%, with no analysis, discussion, or communication to leadership of the increase.

No quality information or leadership documentation was provided that addressed facility acquired wounds.

04/17
A review of "Action Cue-Wound Care Report" showed a Wound Deterioration Rate= 0%

A review of the "Wound Report for 04/17 showed Patient #38 was admitted on 03/10/17, and a facility acquired right heel wound was identified on 04/17/17 with a PUSH score of 9.

A review of the "Quality Committee Meeting Minutes 04/21/17 " contained Action Cue-Wound Care Report 01/01/07 - 04/17 data dashboard, with no analysis or discussion of this data. There was no evidence of analysis of the facility acquired wounds, trend of wound locations, or evaluation of treatment techniques to establish best practices.

A review of the "Medical Executive Meeting Minutes 04/26/17 " contained no data or discussion regarding wounds.

On 10/03/17 at 1:08 pm, Staff A stated the CEO, CCO, and Wound Care Nurse discussed developing a Wound Committee to address worsening wounds. She stated there was no documentation of these discussions.

05/17
A review of "Action Cue-Wound Care Report" showed no data for the Wound Deterioration Rate.

A review of the "GB Meeting Minutes 05/25/17" showed Wound Deterioration Rate as 17.24% with no explanation of what date the data represented.


06/17
A review of "Action Cue-Wound Care Report" showed no data for the Wound Deterioration Rate.

A review of the "Wound Report for 06/17 showed Patient #46 was admitted on 08/16/17, and a facility acquired forehead wound was identified on 08/29/17 with a PUSH score of none documented.

On 10/03/17 at 1:08 pm, Staff A stated on 06/17 she began meeting with Staff X, the Wound Care Nurse regarding 3 patient wound assessment involving inaccurate site, exudate, and description. Staff A stated on 09/10/17, Staff X resigned and the hospital formally created a Wound Care Committee to improve the wound care program. Staff A stated the committee met weekly, but did not keep minutes regarding discussions or program development. (This action was approximately 6 months after notification of corporate and data of worsening wounds.)

A review of "Action Plan"06/09/17 showed a action plan being developed for increased worsening wounds. The plan documented a goal of 50% decrease in worsening wound rate by 08/01/17. The plan included 06/15/17 Staff training on turning.

07/17
A review of the Wound Round Report for 07/17 showed Patient # 33 was admitted 07/19/17, but on 07/25/17, 2 facility acquired wounds were identified: a coccyx wound with PUSH 15, and left thigh back with PUSH 12.

08/17- 09/17
A review of the "Wound Round Report for 08/4/2017" showed Patient # 5 was admitted on with Right BKA wound and left foot ulcers wounds identified by the admitting Staff UU, RN. On 09/05/17, a facility acquired right ischial tuberosity (with a PUSH score of 2) and a scrotal wound (with PUSH score of 11) were identified.
On 09/11/17, Patient #5's scrotum wound round sheet identified an increased PUSH score from 11 to 12, and medical record showed no change in the plan of care. A review of Patient #5 medical record showed on 09/05/17, a perirectal wound was identified with PUSH 14, and this wound was not listed on the wound report. On 09/27/17 at 1:43 pm, the CEO, Staff C, stated a day after discharge, on 09/13/17, he was notified by the receiving nursing home that the scrotum was gangrenous. The medical staff, involved in his case, were not notified.

A review of the "Wound Report for 09/17 showed Patient # 4 was admitted on 09/12/17, and a facility acquired scrotal wound was identified on 09/25/17 with a PUSH score of 4.
A review of the "Wound Report for 09/17 showed Patient # 42 was admitted on 09/01/17, and a facility acquired right calf wound was identified on 09/13/17 with a PUSH score of 8.

On 10/03/17 at 1:08 pm, Staff A provided incomplete handwritten "notes" from the meetings 09/10/17, 09/15/17, 09/20/17. On 09/20/17, the notes documented Patient #22 had a worsening wound. Patient #22 was not found on the "Wound Report 01/01/17 - 09/27/17".

A review of "Action Plan 8/01/17 " documented a program of serial turning patients had begun, and a meeting was conducted with housekeeping to ensure use of waffle specialized mattresses. The hospital's general action plan included turning patients every 2 hours, placing patients on specialized mattresses, and discussing wounds weekly to update plans of care. The plan failed to address the wounds not associated with external pressure on tissue, such as on the nose, scrotum, face, and trach stoma. The action plan failed to include evaluation of the effectiveness of medication, dressing changes, nutrition, and debridement. The Wound Committee's action plan failed to address the nursing staff's lack of documentation of wound assessments.
* A review of policy titled, "Initial Assessment /Reassessment of Wounds (11/06) documented wounds would be assessed within 72 hours of admission and at least every 7 days by the Wound Nurse.
* A review of 14 (Patient #1, 2, 3, 4, 5, 7, 8, 11, 12, 13, 15, 16, 19 and 20) of 20 patient records reviewed failed to have a complete wound assessment documented each shift.


c. Medication Errors and Issues
Quality Issues
09/27/17 at 9:45 am, Staff W, Interim Corporate Pharmacist stated there were no current reports that reported pharmaceutical quality for the hospital, analysis of data, or formal action plans developed. Staff W stated she had developed goals to resolve issues she had identified:
*perform area monthly audits in any space that meds were stored.
*control substance- run 2 reports of nursing administration and waste report and evaluate.
* perform random audit check audits--60 audits per month --stated nursing audits charts to verify correct medication administration.
* review written variances
*investigate overrides within 12 hours to evaluate proper use of override and correct dispensing.
*place medication incidents in action cue.
*investigate discrepancies
10/02/17 at 11:08 am, Staff W stated she had not formally notified leadership of her evaluation of the needs and issues she had identified in her month of being interim pharmacist.

A review of the computer variance system "Action Cue" showed 99 medication variances from 01/01/17-08/30/17 and no medication variances September 2017 were documented. A review of the medication variances from 06/01/17 to 09/30/17 showed 8 wrong or missing antibiotic doses. Staff W stated data was not analyzed or comprehensive action plans developed.

10/02/17 at 11:08 am, Staff W stated medication variances for September 2017 were on her desk and had not been reviewed or entered into Action Cue. Staff W stated data was not analyzed or action plans developed.

A review of the hospital log titled, "After hours Medication Sign out Sheet from 09/22/17-10/03/17" showed lack of pharmacy coverage with 70 entries of nursing staff entering the pharmacy to obtain medication at various hours that including times from 8:30am to 4:30 pm. 10/02/17 at 11:08 am, Staff W stated it was her goal to reduce the number of entries of non-pharmaceutical staff. Staff W stated data was not analyzed or action plans developed.

A review of the hospital log titled, "Omnicell Narcotic Shift Sheet from 08/11/17 - 09/24/17" showed 7 discrepancies with 4 of 7 entries having no explanation as to the discrepancy found and or if it was reconciled. Staff W stated data was not analyzed or action plans developed.

10/02/17 at 11:08 am, Staff W stated it was her goal to discontinue the log and computerize tracking of discrepancies. Staff W stated she could not explain the 4 entries that had no information. Staff W stated data was not analyzed or action plans developed.

A review of an incident report dated 08/14/17 documented Staff D, who was the only pharmaceutical staff on duty, incorrectly filled a bin in the automatic drug center (ADC) with the diuretic medication instead of an anti-hypertensive medication. The error resulted in 4 patients receiving the wrong medication, and some of those patients receiving multiple doses of the wrong medication.
* 09/27/17 11:12 am, CEO stated he knew Patient #8 had died, but the Staff B, CCO, did not communicate the patient as involved with a Amlodipine/Amiloride medication error 2 days before his death.
* On 10/04/7 at 10.30 am, Staff A, CCO finalized incident report on 08/15/17 at 1617 after the patient died. The incident report was documented, "Pharmacist filled wrong bin, nurse caught error". The report failed to communicate Patient #8 died the day following 2 doses of the wrong medication. Staff A stated she knew of patient #8's death and of the medication error, but not connect or communicate the events together to the CEO.
* On 10/04/17 at 10:40 am, Staff B stated Patient #8's death would be evaluated in MEC, but the medication error that occurred would not be a part of the evaluation if it was not documented in the patient's medical record.
* On 10/02/17 at 11:15am, Staff W, the Interim Corporate Pharmacist stated she was Staff D's supervisor. She stated she had not been notified of the 08/12/17 medication incident in which Staff D, and did not know if Staff D had been counseled. Staff W stated the hospital needed a bar code scanning system to help minimize errors.

A review of the medical record of Patient # 18 showed on 07/17/17 Provider R wrote an order for clindamycin to be discontinued. On 07/20/17, Provider R rewrote the order to discontinue the clindamycin, because the medication was still being administered. A review of incident reports for 07/17 showed no variance regarding this medication error.

Meeting Minutes
A review of minutes titled, "P & T [Pharmacy & Therapeutics] Meeting Minutes 01/11/17, 04/19/17, & 07/19/17" all documented the following phrase: "medication variances: antibiotic timing, meds not given as ordered." The minutes from 01/17 and 04/17 documented overrides [were] "Primarily due to late overrides primarily due to late physician rounding and weekend orders when pharmacy is not open, and 07/17 "peaked when agency was high, meds were in bins nursing would ask Charge to get med without checking refrigerator and cabinet first." The P&T minutes failed to document the analysis of identified issues and discussion of any implementation of performance improvement initiatives.

A hospital document titled "P&T Function" (a computerized dashboard of performance measures). A review of dashboard titled, "P&T Function Oct., Nov., Dec 2016" showed unnecessary override rate benchmark as 7.33% and an Oct 2016 rate of 10%. No analysis or action plans were associated with this document. No P & T Function reports were provided to for 2017.

In the presence of Staff W, P & T [Pharmacy & Therapeutics] Meeting Minutes 01/11/17, 04/19/17, & 07/19/17" were reviewed. Staff W stated the current minutes provided little quality information and she was planning to change the format to provide improved quality information.

A review of minutes titled, "Quality Meeting 04/21/17" had the attachment of the "P&T Function Report 01/01/17 - 06/30/17" which showed:
* unnecessary override average of 14.29% (benchmark 7.33%),
* medication error average of 0.052% (benchmark .022)
* medication variance average of 0.059 (benchmark 0.028)
* narcotic count discrepancy average of 0.8% (benchmark 0.5%)
The minutes did not show evidence discussion or action plan for improvement.

09/27/17 11:12, Staff B, the Director of Quality, stated she was not provided information regarding medication variances. Staff B stated she does not go to P&T meeting. She stated she was never told when they were to be held. She stated she was not involved in medication error investigations. She stated Staff A was involved with the medication errors for the past weeks. She stated the former Pharmacist, Staff H, put medication incidents in Action Cue and without conducting an investigation. She stated she did not know if staff evaluated the patients' condition to see if the patient had a bad outcome

A review of the "Medical Executive Meeting Minutes" showed:
08/16/17 "P & T Function Report" was listed in the meetings minutes, but did not contain evidence of pharmacy discussions or attachments.
07/26/17 "April : 30 medication variances ...May: 10 medication variances ...15 medication variances ...Information presented without any discussion".
06/21/17 no evidence of medication errors or pharmacy issue were discussed. The Performance Measure Dashboard which was attached to the minutes showed April 2017 unnecessary overrides as 17.95% (benchmark 15.93%) and Medication Error rate as 0.132 (benchmark 0.05)
05/17/17 no evidence medication errors or pharmacy issues were discussed.

A review of minutes titled, "Governing Body Meeting Minutes for 02/23/17 and 08/25/17" documented, "P & T Report" (a computerized dashboard of performance measures for pharmacy), but had no attachments. Both minutes documented the "P & T Function Report ...the quality data was presented to the GB-[as] informational." The Governing Body minutes failed to document identified pharmacy issues and failed to discuss issue analysis and performance improvement initiatives.

Based on record review and interview the RN failed to:

A. Ensure nursing assessment including the wound assessments were completed by nursing staff per hospital policy. This failed practice resulted in potential harm to one patient (Patient #5) who developed a gangrenous scrotal wound and worsening wounds in five (Patient #3, 4, 5, 8, and 11) of the 20 medical records reviewed. (See Tag A-0395)

B. Ensure licensed nursing staff notified physicians for changes in patient status for one of 20 patient's records reviewed (Patient #5). This failed practice resulted in the potential harm to one patient (Patient #5) who developed a gangrenous scrotal wound.

C. Ensure nursing staff reviewed patient care plans daily and evaluated/updated the care plans weekly or when there was a change in clinical condition per hospital policy. This failed practice resulted in the potential harm to one patient (Patient #5) who developed a gangrenous scrotal wound, worsening wounds in five (Patient #3, 4, 5, 8 and 11) and three (Patient #3, 5 and 11) patients who had a change in clinical condition (See Tag A-0396).

D. Ensure the Wound Care Nurse was qualified to perform the duties designated within the "Wound Care Position Description".

Findings:


Nursing Staff Assessment of Wounds

Review of policy titled "Initial Assessment/Reassessment of Wounds" showed wounds should be assessed and photographed by the admitting RN or Wound Care Nurse on admission and assessed by the Wound Care Nurse within 72 hours of admission. Any new wounds should be assessed and photographed by an RN or Wound Care Nurse along with an event report completed. Wounds are reassessed and photographed every 7 days by the Wound Care Nurse and as needed until the wound is resolved or the patient is discharged.

Review of policy titled "Method of Wound Documentation via Woundrounds" showed wounds and other skin conditions are entered into Woundrounds and include the measurements, drainage, descriptors and pictures ...if any skin issues are noted by nursing staff the physician should be notified and any orders written or transferred to the MAR.

Review of policy titled "Nursing Documentation Guidelines" showed all forms should have no blanks and be completed filled out. Proper documentation should be thorough and accurate to reflect quality of care provided and evidence nursing staff acted as required by licensure or as ordered. "Documentation part of nursing care." "If it's not documented, it's not done."

Three (Patient #4, 5, and 8) of 20 medical records showed nursing staff did not provide complete documentation of the patient's wound assessment each shift identifying the wound type, stage, location, drainage, color of drainage, surrounding tissue, odor and measurements.

Patient #4 admitted on 09/12/17 to the LTACH with stage IV sacral and ischial pressure wounds and acute on chronic respiratory failure. Patient was seen by the Staff F, current wound care nurse and a sacral Stage IV wound and unstageable left ischial tuberosity wound was identified on admission. On 09/25/17 Staff F assessed Patient #4 and noted a scrotal wound that was facility acquired. On 10/04/17 patient had developed a facility acquired redness on side and extending to back (no documentation on which side) with a PUSH score of 2. On 10/04/17 Staff F reassessed sacral wound which remained unchanged with a PUSH score of 15, moderate serosanguineous drainage and 10 cm in length x 8 cm width and 1.80 cm in depth. Left ischial tuberosity wound showed "probable improvement" with PUSH score of 14, moderate serosanguineous drainage and size of 4 cm in length x 3 cm in width x 1 cm depth. And assessment of scrotal wound showed worsening with PUSH score increase to 7 and identification by a red arrow, stage of wound identified at a Stage II, no sign of drainage and size noted at 3.o cm in length x 0.80 cm in width and no identified depth. Patient on antibiotics and no change in treatment plan identified.

Patient #5 of 20 medical records reviewed showed patient was admitted on 08/04/17 with wound dehiscence and infection of right below the knee amputation (BKA) stump for IV antibiotics and aggressive wound care. Staff V noted scrotum to be flushed and edematous on 08/31/17 at 4:00 pm, and left a note in the chart for the physician. On 09/01/17 1+ pitting scrotal edema was noted by nursing staff. On 09/02/17 at 3:11 am, Staff TT noted patient's testicles were bleeding with discoloration and notified charge nurse and wound care. Nursing staff noted small to scant serosanguineous (thin pin to red tinged watery) drainage to scrotum, reddened surrounding tissue and 2+ edema on 09/03/17. No evidence nursing staff notified physicians. On 09/04/17 Staff R (Infectious Disease physician) noted massive scrotal swelling and order was placed for scrotal elevation. Staff R noted an erosion to the scrotum on 09/05/17. Nursing staff noted a stage 2 wound on the scrotum with scant serous drainage on 09/05/17. Initial wound assessment performed by Staff X on 09/05/17 identifying a stage 2 pressure ulcer of the scrotum measuring 7.00 by 2.40 cm in length and width, depth unknown, PUSH score of 11, and a perirectal infectious erythema wound measuring 20.00 by 9.00 cm length and width, depth unknown, PUSH score of 14. From 09/04/17 through 9/05/17, 09/09/17, 09/11/17 and 09/12/17 vascular assessment including edema was documented as within normal limits, and o9/04/17 through 09/12/17 skin assessment was documented within normal limits or dry, pale skin. 9/06/17 scrotal edema and small serousanguineous drainage noted by nursing staff. On 09/10/17 nursing staff noted an enlarged scrotum with a dark area with cream applied as ordered. No documentation physician notified. Follow up wound assessment performed by Staff X on 09/11/17 showing an increase in the stage 2 scrotal wound measuring 10.00 by 4.00 cm length and width, depth unknown, PUSH score increased to 12, and no change in the infectious perirectal wound. There was no evidence Staff X notified Staff Q (Internal Medicine -attending physician), Staff R (Infectious Disease physician) or Staff NN (Surgeon, Consulting Wound Care), or change to treatment plan was made.

Patient # 8 was admitted to the LTACH on 08/04/17 with necrotizing fasciitis, surgical debridement of the left hand and amputation of the second finger, osteomyelitis of left hand, chronic kidney disease, and diabetes. On 08/04/17 at 6:46 pm, Staff X performed a wound assessment and identified a left hand surgical dehiscense full thickness with a PUSH score of 15, moderate serosanguineous drainage, and size 15.0 cm in length x 10.0 cm in width and unknown depth. A front right lower leg trauma abrasion partial thickness with PUSH score 4 and size of 0.60 cm in length x 0.70 cm in depth x 0.10 cm in depth. On reassessment by Staff X on 08/11/17 at 11:14 am of left hand wound remained unchanged, with PUSH score of 15. On 08/14/17 at 11:42 am, Staff X reassessed the right lower leg abrasion and the wound had worsened with a PUSH score of 5 and size increased to 1.00 cm in length, 0.70 in width, 0.10 in depth, although outcome was noted as "probable improvement" and current plan and comments were noted as "improving". From 08/05/17 through 08/09/17 nursing staff note wound assessments as "see wound care documentation" or no documentation other than left hand dressing clean, dry and intact. There is no evidence of assessment and documentation of the patient's right lower leg abrasion. On 08/11/17 the evening shift (7pm to 7am) nursing staff assessed patient's right lower leg as an abrasion to the right shin with no drainage and surrounding skin intact. And 08/12/17 to 08/14/17 nursing staff note wound assessments as either "left hand", "left hand moderate drainage" to "left hand dressing clean, dry, and intact".

On 09/26/17 at 12:30 pm, Staff A stated that the wound care nurse sees the patient at least once a week and the nursing staff are responsible for assessing wounds the rest of the time.

On 09/26/17 at 12:30 pm, Staff A and C reported nursing staff are responsible for complete documentation of the wound assessment in the nurses notes each shift. Staff A stated if the patient has a wound vac or dressing in place he/she would not expect staff to remove those to assess the wound; and reported expected assessment documentation would be based on what the staff see from the dressing or wound vac.

On 10/03/17 at 1:42 pm, Staff Z stated staff nurses are responsible for assessing the skin around a wound vac, the wound care nurse manages the wound vac system. Staff Z reported the nursing assessment sheet has a section for nursing staff to document patient wounds. Staff Z stated nursing are responsible for documenting what he/she sees but do not stage the wounds.

On 10/03/17 at 2:45 pm, Staff V stated she remembered Patient #5 having scrotal swelling. Staff V reported he/she noticed the patient's scrotum to be red and edematous on the second day he/she cared for the patient, and stated the patient's scrotum was not swollen the previous day. Staff V stated he/she noticed the scrotum was red during placement of a foley catheter stat-lock. Staff V reported he/she notified the charge nurse and left a note for the physician when he/she assessed the scrotum swelling had increased during the shift. Staff V stated he/she placed a towel under the scrotum in an effort to relieve the pressure on the scrotum

Change in Patient Status

Review of policy titled "Nursing Documentation Guidelines" showed an RN should complete a head to toe comprehensive reassessment when there is any unfavorable change in patient status. The reassessment should be documented in daily record in the patient's medical record and concerns addressed and communicated to the physician and other disciplines involved in the patient's care. "Documentation part of nursing care." "If it's not documented, it's not done."

Review of hospital documents titled "Position Description/Performance Evaluation" for the RN and LPN showed both are responsible for communication with physicians/COO and co-workers regarding changes in patients' clinical status and have the ability to respond quickly and accurately to these changes.

Review of policy titled "Vital Sign Policy" showed physician/LIP should be notified when patient experiences increasing respiratory distress, SPO2 of 88% or less after 2 results within 5 minutes, oral temperatures greater than 101 F, changes in mental status, systolic blood pressure greater than 40mmHg from baseline, diastolic blood pressure 90mmHg or greater.

Review of policy titled "Emergency Transfers" showed the following should be reported immediately to the physician unless otherwise stated: respirations 25 or greater with O2 saturations less than 90% on room air or less than 88% for COPD patients, temperature greater than or equal to 101.5, changes in mental status or any changes from the baseline assessment on admission.

One (Patient #5) of 20 medical records reviewed showed patient was admitted on 08/04/17 with wound dehiscence and infection of right below the knee amputation (BKA) stump for IV antibiotics and aggressive wound care. Staff V first identified scrotal swelling on 08/31/17 at 4:00 pm, and left a note in the chart for the physician. On 09/02/17 at 3:11 am, Staff TT noted patient's testicles were bleeding with discoloration and notified charge nurse and wound care. Initial wound assessment was not performed by Staff X until 09/05/17 identifying a stage 2 pressure ulcer of the scrotum measuring 7.00 by 2.40 cm in length and width, depth unknown, PUSH score of 11, a perirectal infectious erythema wound measuring 20.00 by 9.00 cm length and width, depth unknown, PUSH score of 14 and right ischial tuberosity stage 2 pressure ulcer measuring 3.00 by 3.00 by 0.10 cm length, width and depth, PUSH score of 11. No evidence Staff X discussed these new wounds with physicians including Staff Q (Internal Medicine - attending physician) and/or Staff NN (Surgeon - consulting wound care). Treatment included application of antifungal cream Clotrimazole and antimicrobial ointment Silverdene twice a day, cleansing with saline, use of Low Air Loss mattress and repositioning every two hours. Wound care treatment was provided by Staff X on 09/08/17 and assessment noted perirectal and scrotum wounds had deteriorated with no evidence of physicians being notified or treatment plan changed. On 09/10/17 nursing staff noted an enlarged scrotum with a dark area with cream applied as ordered. No evidence physician notified. Follow up wound assessment not performed until 09/11/17 and showed an increase in the stage 2 scrotal wound measuring 10.00 by 4.00 cm length and width, depth unknown, PUSH score increased to 12, no change in the infectious perirectal wound and healed right ischial tuberosity stage 2 pressure ulcer. There was no evidence Staff X notified Staff Q (Internal Medicine -attending physician), Staff R (Infectious Disease physician) or Staff NN (Surgeon, Consulting Wound Care), or change to treatment plan was made. Patient was discharged the following day on 09/12/17 with no changes to the treatment plan.

On 09/27/17 at 2:35 pm, Staff C stated he/she did not notify the attending and consulting physicians of the wound infection that was identified as gangrene for patient #5.

On 10/03/17 at 2:45 pm, Staff V stated she remembered Patient #5 having scrotal swelling. Staff V reported he/she noticed the patient's scrotum to be red and edematous on the second day he/she cared for the patient, and stated the patient's scrotum was not swollen the previous day.

On 09/27/17 at 1:43 pm, Staff A stated he/she reviewed patient #5's chart and Staff X should have notified the physician of the worsening scrotal wound and asked for changes in treatment plan.

On 09/27/17 at 1:17pm, Staff Q stated he/she was not aware that patient #8 had a change in clinical condition in the days prior to his death. Staff Q reported he/she was not aware that patient #5 had developed a wound and infection that was later identified as gangrene in the scrotal area.

On 10/04/17 at 9:42 am, Staff T stated he/she was aware patient #5 had scrotal swelling but was never notified the patient developed a wound infection that was later identified as gangrene.

On 10/04/17 at 12:52 pm, Staff R stated he/she was not aware patient #5 had developed scrotal swelling and wound infection that was later identified as gangrene.

Wound Care Nurse
A review of Position Descriptions showed the hospital had 2 position descriptions for the role of the Wound Care Nurse titled, "Wound Care RN" and Wound Care LPN". Both position descriptions required a demonstration of competency in performing a head to toe assessment. Both position desription required the ability to adequately assess and reassess wound, utilize techniques in wound care, and revise plans of care.

On 10/03/17 at 1:08 pm, Staff A stated Staff X, RN, had performed the duties of the Wound Care Nurse until 06/17. Staff A stated on 06/17 she began meeting with Staff X, the Wound Care Nurse regarding 3 patient wound assessment involving inaccurate site, exudate, and description. Staff A stated on 09/10/17, Staff X resigned and approached Staff F,LPN to fulfill the duties of the Wound Care nurse on a part-time basis.

A review of Staff F's personnel file contained no evidence of wound care competencies.

Based on record review and interview the hospital failed to ensure:

A. Ensure nursing staff reviewed patient care plans daily for three patients (Patient #4, 5 and 8) per hospital policy and procedure.

B. Nursing staff evaluated/updated the patient's plan of care weekly or when there was a change in clinical condition per hospital policy for two of 20 patient's (Patient #5 and 8) medical records reviewed.

This failed practice resulted in the potential harm to one patient (Patient #5) who developed a gangrenous scrotal wound and change in clinical condition, worsening wounds in three patients (Patient #4, 5 and 8) and all patients to have a delayed recognition by nursing staff and/or treatment of active problems.

Findings:

Review of policy titled "Assessment and Reassessment" showed the plan of care is reviewed regularly in consultation with members of the treatment team and patient/family. Plan of care should be revised as part of the ongoing assessment process and as appropriate to the patient's condition.

Review of policy titled "Plan of Care" showed the care plan should identify main and/or potential problems. The RN is responsible for discussing and notating patient and/or family involvement. Care plans are reviewed daily. Nursing staff are responsible for updating patient care plans when there are changes in patient conditions, new orders are written and as treatment changes. Care plans should be evaluated and/or updated weekly at the time of the team conferences and when goals are met or resolved. The outcome of the goal should be documented in the care plan at the time the patient is discharged.

Review of policy titled "Pain Assessment and Management" showed a patient's progress toward pain goals should be reviewed weekly and communicated to patient, family and team members. Goal of the patient should include a decrease in intensity or quality of pain, increase in function and participation and a decrease in complaints of pain.

Review of policy titled "Nursing Documentation Guidelines" showed the care plan should be reviewed daily, updated weekly and when there is a change in patient status or new diagnosis identified. The discharge nurse should provide a final update to the care plan. "Documentation part of nursing care." "If it's not documented, it's not done."

Three (Patient #4, 5, and 8) of 20 medical records showed no evidence nursing staff reviewed each patient's care plan daily and documented the review on the daily nursing assessment sheet.

Two (Patient #5 and 8) of 20 medical records showed no evidence nursing staff evaluated/updated the patient's plan of care weekly or when there was a change in clinical condition per hospital policy

Patient #4 admitted on 09/12/17 to the LTACH with stage IV sacral and ischial pressure wounds and acute on chronic respiratory failure. The nursing flowsheets showed no evidence by nursing staff signature the care plan was reviewed daily from 09/12/17 through date of review 10/03/17.

One (Patient #5) of 20 medical records reviewed showed patient was admitted on 08/04/17 with wound dehiscence and infection of right below the knee amputation (BKA) stump for IV antibiotics and aggressive wound care. Patient's Nursing Plan of Care was initiated on 08/04/17 and included infection actual wounds(s). The nursing flowsheets showed no evidence by nursing staff signature the care plan was reviewed daily from 08/05/17 through 09/12/17. The Nursing Plan of Care was not updated or evaluated based on the patient's identified goals (free from infections as evidenced by normal vital signs and WBC, infection recognized early for prompt treatment and improvement of clinical signs of infection) and nursing interventions (assess all locations for signs of infection, monitor WBC, vital signs as ordered). The Nursing Plan of Care has dates of 08/15/17 and 09/05/17 for the weekly review but there is no evidence the care plan was revised secondary to the patient developing a scrotal and perirectal wounds, vital signs showing recurring fevers, and WBC identifying leukocytosis.

Patient # 8 was admitted to the LTACH on 08/04/17 with necrotizing fasciitis, surgical debridement of the left hand and amputation of the second finger, osteomyelitis of left hand, chronic kidney disease, and diabetes. Patient's Nursing Plan of Care was initiated on 08/04/17 and included impaired physical mobility, impaired gas exchange, altered comfort/acute pain, risk of unstable blood glucose, altered urine elimination and actual infection of wound(s). The nursing flowsheets showed no evidence by nursing staff signature the care plan was reviewed daily from 08/05/17 through 08/15/17. There were no revisions, evaluations or updates made to the Nursing Plan of Care based on the patient's worsening wounds


On 10/03/17 at 1:42 pm, Staff Z stated that nursing staff are not responsible for the care plans and do not review or make changes to care plans.

On 10/03/17 at 2:45 pm, Staff A stated nursing staff are responsible for review of the care plans daily and should document on the daily nursing assessment. Staff A reported nursing staff should update care plans as part of interdisciplinary meetings on a weekly basis.

Based on record review, interview, and observation, the hospital failed to:
a. ensure medications were administered in accordance with the hospital's policy of seven rights of administration in one of one observation of medication pass for Patient #20.

b. train staff with the hospital's specific medication administration procedures for medication acquisition, preparation, verifications, transport, and adminstration to the patient, including patients in isolation.

This failed practice resulted in wrong medication being distributed and administered to four (Patients # 5,8,18, and 21) of 20 patients, and had the potential to have contributed to the 99 medication variances from 01/01/17-08/30/17, which had the potential to adversely affect patients' health.

Findings:

Patient Identification
A review of policy titled, "Administration of Medication (date 07/16)" documented one of the seven rights of medication administration included "right patient", but failed to instruct staff on the method of identifying the right patient.
(A review of U.S. Department of Health & Human Services Agency for healthcare Research and Quality refers to Joint Commission National Safety Goals 2017, which documents using at least two patient identifiers when providing care.)

On 10/03/17 at 11:15 am, Staff V was observed administering medication without demonstrating steps of identifying Patient #32 prior to medication administration.

On 10/05/17 at 3:45 pm, Staff A stated patient should be identified prior to medication administration.

Training

On 10/03/17 at 11:15 am, Staff V was observed preparing and administering medications to Patient #20.

On 10/03/17 at 11:15 am, Staff V stated a peer had taught her the process of obtaining medication from the automatic dispensing cell, organizing the medication on the counter, verifying medications, transporting the medication to the patient's room, and administering the medication. Staff V stated leadership had not provided specific instructions for the complete process of medication administration and documentation.

Based on record review and interview the hospital failed to ensure healthcare providers completed documentation into the patient's medical record necessary for patient safety, quality of care and continuity of care of among providers as evidenced by:

A. Ensure six of 20 patient's records reviewed (Patient #1, 2, 3, 5, 6, and 11) received a completed nursing assessment documented per hospital policy. This failed practice resulted in the potential for one patient (Patient #5) to develop a gangrenous scrotal wound, potentially three patients (Patient #3, 5 and 11) having deterioration in clinical condition and two patients (Patient #3 and #11) being transferred to an acute care facility for treatment

B. Ensure eight of 20 patient's records reviewed (Patient #1, 2, 3, 5, 6, 9, 10, and 11) had a 24 hour RN assessment documented in their medical record per hospital policy. This failed practice resulted in the potential for one (Patient #5) to develop a gangrenous scrotal wound and potentially three patients (Patient #3, 5 and 11) having deterioration in clinical condition.

C. Documentation by the supervising RN for comprehensive (head to toe) assessments performed by the LPN for 20 of 20 patient records reviewed (Patient #1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20). This failed practice resulted in the potential for one (Patient #5) to develop a gangrenous scrotal wound and potentially three patients (Patient #3, 5 and 11) having deterioration in clinical condition.

D. Evaluate the pain assessment/reassessment utilizing the pain intensity scales for 13 of 20 patient's records reviewed (Patient #1, 2, 3, 5, 6, 8, 9, 11, 12, 13, 15, 19, and 20) were documented in the medical record. This failed practice had the potential for 13 of 20 patients to have poorly controlled pain affecting their psychological and functional status.

E. Ensure the patient received daily hygiene care and perineal-care and was documented for 20 of 20 patient's records reviewed (Patient #1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20) per hospital policy. This failed practice resulted in the potential harm for one patient (Patient #5) who developed a gangrenous scrotal wound and worsening wounds in five (Patient #3, 4, 5, 8, and 11) patients of the 20 medical records reviewed.

F. Ensure vital signs were not completed and documented as ordered for 7 (Patient #1, 2, 3, 11, 13, 15, and 20) of 20 patient records reviewed. This failed practice had the potential to affect the clinical condition of the seven patients (Patient #1, 2, 3, 11, 13, 15 and 20) and timely response by nursing staff and physicians.


Findings:

A. Completion of Nursing Assessment

Review of policy titled "Nursing Documentation Guidelines" showed all forms should have no blanks and be completed filled out. Nursing staff should document throughout shift on nursing care flowsheet. Proper documentation should be thorough and accurate to reflect quality of care provided and evidence nursing staff acted as required by licensure or as ordered. "Documentation is part of nursing care" and "If it's not documented, it's not done".

On 09/26/17 at 11:10 am, Staff A and C stated the daily nursing assessment should be completely filled out with no blanks on the form unless it is not applicable to the patient and should be identified as such by marking the area with a line.

On 10/03/17 at 1:42 pm, Staff Z stated he/she as the RN completes the RN assessment every shift.

B. RN 24 Hour Assessment

Review of policy titled "Assessment and Reassessment" showed the RN is responsible for a head to toe assessment every 24 hours.

Review of policy titled "Nursing Documentation Guidelines" showed the RN is responsible for the daily comprehensive assessment ..."if it's not documented, it's not done".

Eight (Patient #1, 2, 3, 5, 6, 9, 10, and 11) of 20 medical records showed no evidence the RN completed the 24 hour comprehensive nursing assessment per hospital policy.

On 10/03/17 at 1:42 pm, Staff Z stated he/she as the RN completes the RN assessment every shift or reviews the LPN's assessment at least every 24 hours for their assigned patients.

On 10/03/17 at 3:00 pm, Staff A stated RNs are required to perform a 24 hour comprehensive nursing assessment on each patient; and reported RNs are aware of this requirement. Staff A stated the hospital was auditing a minimum of 10 patient charts per month for compliance with the completion of the RN 24 hour assessment but had not calculated a compliance rate.

C. RN Evaluation for LPN Assessments

Review of hospital document titled "Position Description/Performance Evaluation" for the RN showed the RN is responsible for providing direct and indirect care of patients in an LTAC setting.

Review of hospital document titled "Position Description/Performance Evaluation" for the LPN showed the LPN under the direct supervision of an RN is responsible for performing head to toe assessments and reassessments.

Review of the "Oklahoma Board of Nursing Patient Assessment Guidelines" showed a comprehensive (head to toe) assessment is an extensive data collection and analysis of the patient's condition to determine anticipated and emergent changes and should be conducted by the RN on an initial and ongoing basis. A focused assessment is an appraisal of the patient's situation and status at present, contributing to the comprehensive assessment and may be conducted by the LPN.

20 (Patient #1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20) of 20 medical records showed no evidence the RN evaluated the comprehensive (head to toe) assessments performed by the LPN.

On 09/26/17 at 11:10 am, Staff A stated he/she was not aware the RNs were responsible for evaluating and signing the shift assessments performed by the LPNs.

D. Pain Assessment/Reassessment

Review of policy titled "Pain Assessment and Management" showed patient to be assessed on history, current pain, sites of pain, and intensity of pain. Goal should be to assist patient in managing their pain to help them participate in their treatment plan. Initial assessment completed by RN utilizing most appropriate pain scale. Continuous pain assessments and effectiveness of interventions should be completed by all disciplines. Oral medications should be reassessed and effectiveness documented within one hour and IV medications within 30 minutes.

Review of policy titled "Nursing Documentation Guidelines" showed nursing staff should document a follow-up on PRN medications. Nursing staff should document throughout shift on flowsheets, MAR (medical administration record) and other records. Appropriate documentation should provide evidence staff acted according to orders and be thorough and accurate to meet the quality of care provided. "Documentation is part of nursing care." If it's not documented, it's not done."

13 (Patient #1, 2, 3, 5, 6, 8, 9, 11, 12, 13, 15, 19, and 20) of 20 medical records showed no evidence assessment and/or reassessment of the patient's pain using a pain scale score.

On 09/25/17 while on tour the surveyors observed trifold presentation boards set up for skills training. One board detailed pain assessment and reassessment and how to use the Numeric or Faces pain scale. Staff A stated the hospital had just provided a skills fair the week before and the presentation boards were used to provide education to staff.

On 09/26/17 at 12:30 pm, Staff A stated pain should be assessed at least once a shift; and reported if the patient reported pain, a pain score should be documented before an intervention and after to determine the effectiveness.

E. Daily Hygiene and Perineal-Care

Review of policy titled "Skin Care Protocol" showed a Braden Scale is completed at admission and daily. Patients should be bathed using mild soap and moisturizer used daily. Skin should be kept clean, dry and free of body wastes, perspiration and wound drainage.

Review of policy titled "Nursing Documentation Guidelines" showed nursing staff should document a follow-up on PRN medications. Nursing staff should document throughout shift on flowsheets, and other records. Appropriate documentation should provide evidence staff acted according to orders and be thorough and accurate to meet the quality of care provided. "Documentation is part of nursing care." If it's not documented, it's not done."

20 (Patient #1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20) of 20 medical records showed no evidence of documentation in the patient's medical record for daily hygiene and perineal-care.

On 10/03/17 at 2:45 pm, Staff A stated nursing staff are responsible for ensuring patients receive hygiene and personal care and it is documented in the medical record.


F. Vital Signs

Review of a policy titled "Vital Sign Policy" showed vital signs should be taken as ordered, more frequently as determined by nursing assessment or any time there is a change in patient condition.

Review of policy titled "Nursing Documentation Guidelines" showed nursing staff should document a follow-up on PRN medications. Nursing staff should document throughout shift on flowsheets, Graphic Sheets and other records. Appropriate documentation should provide evidence staff acted according to orders and be thorough and accurate to meet the quality of care provided. "Documentation is part of nursing care." If it's not documented, it's not done."

Review of hospital document titled "AMG Staff Meeting" dated July 10th and July 14th showed staff are responsible for performing chart audits for vital sign documentation.

7 (Patient #1, 2, 3, 11, 13, 15, and 20) of 20 medical records showed no evidence the RN ensured vital signs were completed and documented on the vital sign flowsheet as ordered for each patient during the assigned shift.

On 09/26/17 at 12:30 pm, Staff A stated vital signs are the responsibility of the nurse assigned to the patient to ensure they are obtained as ordered by the physician and documented on the vital sign flowsheet. Staff A reported 10 charts are audited monthly by staff for compliance.

a. Respiratory Care
The failure to document nebulizer treatments as ordered for 3 (Patient # 3, 14, and 17) of 3 patients requiring nebulizer treatment from a sample size of 20 patients, breath sounds before and after nebulizer treatments of 3 (Patient # 3, 14, and 17) of 3 patients requiring nebulizer treatment from a sample size of 20 patients, the risk of decannulation for 2 ( Patient# 3 and 17) of 2 patients with tracheostomies from a sample size of 20 patients, and . the performance of trach care for 2 ( Patient# 3 and 17) of 2 patients with tracheostomies from a sample size of 20 patients.

This failed practice of pulmonary hygiene potentially increased the risk of infections such as pneumonia and of trach stoma, and potentially increased the risk of trach decannulation.
b.
c.
d.



Findings:
a. Respiratory Care
On 10/05/17 at 10:35 am, Staff SS, Director of Respiratory Services stated the hospital's expectation for patients' receiving nebulizing treatments would include documentation of before and after treatment breath sounds. Staff SS stated for patients' with tracheostomies, trach care and the risk of decannulation of the trach should be documented each shift. Staff SS stated the form on which these activities documented had recently been changed in an effort to improve documentation. Staff SS stated there was no way to prove an undocumented treatment or assessment was done.

1. Nebulizer Treatments
A review of policy titled, "Aerosol Therapy (date 09/12) showed the procedure for administering nebulizer treatment, but failed to instruct staff regarding the requirements of documentation.

A review of policy titled, "Respiratory Therapy Routine (date 06/16) documented all respiratory staff were assigned all treaments as ordered and procedures should be documented.

* Patient #3
From 06/15/17 to 07/11/17, physician ordered nebulizing treatments every 4 hours (x6/day).
A review of Patient # 3's medical record showed for 96 of 156 treatments, staff failed to document patient #14 receiving the ordered nebulizer treaments.

* Patient # 14
From 09/27/17 to 10/05/17, physician ordered nebulizing treatments every 8 hours (x3/day).
A review of Patient #14's medical record showed for 2 of 24 treatments, staff failed to document patient #14 receiving the ordered nebulizer treaments.

* Patient # 17
From 09/27/17 to 10/04/17, physician ordered nebulizing treatments every 8 hours (x3/day).
A review of Patient #14's medical record showed for 8 of 24 treatments, staff failed to document patient #14 receiving the ordered nebulizer treaments.

2.. Breath Sounds
A review of policy titled, "Aerosol Therapy (date 09/12) showed the procedure for administering nebulizer treatment, and instructed staff to document patient assessments and reassessments, but failed to instruct staff regarding the the components of the assessment and reassessment.

* Patient #3
From 09/27/17 to 10/05/17, physician ordered nebulizing treatments every 4 hours (x6/day).
A review of Patient # 3's medical record showed on 136 of 312 before/ after breath sounds were not documented for Patient # 3 as part of receiving nebulizer treaments

* Patient # 14
On 09/27/17 - 10/05/17 (8 days), physician ordered nebulizing treatments every 8 hours (x3/day)
A review of Patient # 14's medical record showed on 1of 24 before/ after breath sounds were not documented for Patient # 14 as part of receiving nebulizer treaments

* Patient # 17
From 09/27/17 to 10/04/17, physician ordered nebulizing treatments every 8 hours (x3/day).
A review of Patient # 17's medical record showed on 13 of 24 before/ after breath sounds were not documented for Patient # 17 as part of receiving nebulizer treaments

3. Risk of Decannulation
A review of policy titled, "Respiratory Therapy Routine (date 06/16) documented respiratory staff should perform a initial assessment for all new admission and patients' assessment on each shift. The policy failed to outline the components of the assessments.

* Patient #3
A review of Patient # 3's medical record from 09/27/17 to 10/05/17 (8 days) showed for 0 of 16 shifts, staff failed to document the patient's risk of decannulation.

* Patient # 17
A review of Patient #17's medical record from 09/27/17 to 10/04/17 (7 days) showed for 1 of 14 shifts, staff failed to document the patient's risk of decannulation.

4. Trach Care
A review of policy titled, "Respiratory Therapy Routine (date 06/16) documented all respiratory staff were assigned to perform trach care twice per day and as needed unless ordered by the physician, and procedures should be documented.

* Patient #3
A review of Patient # 3's medical record from 09/27/17 to 10/05/17 (8 days) showed for 37 of 16 shifts, staff failed to document trach care was performed.

* Patient # 17
A review of Patient #17's medical record from 09/27/17 to 10/04/17 (14 days), showed 10 of 14 shifts document trach care was performed

Based on record review, interview, and observation, the hospital failed to operate pharmacy services in accordance with policies and procedures and standards of practice in a manner that minimized medication errors.

This failed practice resulted in wrong medication being distributed and administered to 4 (Patients # 5,8,18, and 21) of 20 patients, and had the potential to have contributed to the 99 medication variances from 01/01/17-08/30/17, which had the potential to adversely affect patients' health.

Findings:

Policies and Procedures

On 09/25/17 at 1:00 pm, surveyors requested pharmacy policies and procedures and Staff A, CCO, provided corporate policies. A review of the corporate policies showed the policies that were not specific to the hospital and were not designated as applicable to the hospital by the Governing Body. These policies were available on-line for staff use.

On 10/04/17 at 1:54 pm, the Interim Corporate Pharmacist, Staff W, stated the corporate policies were only guides, and the hospital's applicable pharmacy policies (updated 2016) were in a ring binder housed in the pharmacy,which provided limited access to staff and the CCO was unaware.

A review of 99 medication variances from 01/01/17-08/30/17 and 2016 dashboard (selected quality indicators) regarding pharmaceutical service showed no evidence the information was evaluated or utilized in the development of policies and procedures.

09/27/17 at 9:45 am, Staff W stated there were no current reports of pharmaceutical quality for the hospital. (Refer to QAPI tag A-0263)

Bypass of Pharmacist Medication Verification

The hospital had multiple pharmacy policies authorizing medication to be obtained from the ADC [automatic dispensing center] or from the pharmacy in emergent or urgent situations only when a pharmacist was not available.

The policies were inconsistent with defining authorized staff medication review in the absence of a pharmacist. (The review is a safety measure that ensures right patient, medication, dose, route, allergies, and contraindications.) One policy authorized staff as a qualified healthcare provider, but failed to define the type of staff and qualification required, other policies authorized staff as charge nurses and house supervisors.

The multiple pharmacy policies related to obtaining medications when a pharmacist was absent were inconsistent in defining when the pharmacist would perform a retrospective review after the administration of the medication. A policy documented the pharmacist would perform retrospective review, "at the next available opportunity", and another documented the time of review for overrides (obtaining a medication from the ADC without pharmacist review) as the next day.

The following 5 policies provided guidelines for order verification review prior to administration in the absence of a pharmacist.

1. A hospital document titled, "Review of Medication Orders-Pharmacy (dated 04/01/16) showed the exceptions for administering a medication without pharmacist verification included emergent situations and urgent situations when patient harm could result from delay in administration of a medication, or when a patient experiences a sudden change in clinical status.

2. A hospital policy titled, "Medication Dispensing- General (dated 04/01/16) documented:
* pharmacist shall review the prescriber's original order ...before the initial dose was dispensed with the exception to include emergent/ urgent situations when time does not permit a pharmacist's
perspective review.
*if an order was written when the pharmacy was closed or the pharmacist was otherwise unavailable, a qualified healthcare professional would review the medication order in the pharmacist's absence and
administer the medication..
*a pharmacist would complete a retrospective review of the medication order at the next available opportunity.

3. A hospital document titled, "Review of Medication Orders-Pharmacy (dated 04/01/16) showed after business hours, charge nurses were responsible to review medication orders.

4. A review of hospital policy titled, "ADC [automatic dispensing center] dated 06/01/16" documented:
* nursing personnel may take medications from the ADC prior to a pharmacist review for urgent or emergent medications after pharmacy hours utilizing an override procedure.
* only the house supervisors had access to override medication.
* the pharmacist would reconcile overrides daily.

5. A review of the hospital policy titled, "ADC- Overrides (dated 06/01/16) documented nursing personnel may take medications from the ADC prior to a pharmacist review for urgent or emergent medication after pharmacy hours utilizing an override procedure. The policy documented when a pharmacist was bypassed, a second licensed individual must verify the order and the medication, and only the house supervisors have access to override medication.

A review of the ADC log from 07/01/17-09/30/17 showed 118 medication overrides with medication including non-emergent/urgent multi-vitamin, vitamin C, and an anti-cholesterol medication.

A review of the hospital log titled, "After hours Medication Sign out Sheet from 09/22/17-10/03/17" showed nursing staff entered the pharmacy 70 times at various hours to obtain medications not verified by a pharmacist. These medications included 34 antibiotics, calcium, senna laxative, and artificial tears. The log showed 54 of the 70 entries failed to have initial acknowledgement from a pharmacist.

On 10/02/17 at 1:54 pm, Staff W stated the hospital had no formal review of medication administered without a pharmacist's review as to whether an emergent/urgent situation dictated the medication removal.

Refer to Tag A-500 for further findings regarding order verification, medication overrides, and medication discrepancies.

Pharmacist Dispensing Practices

A hospital policy titled, "Staffing/Hours of Operations (not dated)" showed 1 pharmacist was assigned on the weekends and holidays.

A review of an incident report dated 08/14/17 documented Staff D, the only pharmaceutical staff on duty, incorrectly filled a bin in the automatic drug center (ADC) with a diuretic medication instead of an anti-hypertensive medication.

On 08/12/17, Staff D, the weekend pharmacist, placed 50 Amiloride (diuretic) in the ADC bin labeled "Amlodipine"(anti-hypertensive). At the time of placement, 3 Amlodipine remained in the ADC bin labeled "Amlodipine".
On 08/14/17, Staff PP, RN, identified the error, and brought 41 remaining Amiloride tablets to Staff QQ, the former Pharmacist. The 3 Amlodipine tablets were no longer in the bin.
The incident report documented the CCO viewed an ADC report, which showed 10 tablets of medication were removed from the ADC bin labeled "Amlodipine" on 08/13/17 and 08/14/17. On 08/13/17, 4 patients (Patients # 5,8,18, and 21) received tablet(s) removed from this bin. On 08/14/17, 3 patients (Patient # 5, 8, and 21) received another tablet(s) from bin prior to error identification.

09/27/17 at 9:45 am, Staff W stated the pharmacy had only one person checking the medication to be dispensed on the weekends, but had a goal to create a process for a 2 person check.

10/02/17 at 1:35 pm, Staff W stated she had tagged the Amiloride and Amlodipine bin in the pharmacy with look alike/ sound alike labels, and ensured the medications were not next to another, but planned to obtain colored baskets. Staff W stated other look alike/ sound alike medications needed labels and colored baskets.

Based on record review, interview, and observation, the pharmacist failed to develop and supervise all pharmacy services to meet the needs of the patients.

This failed practice resulted in wrong medication being distributed and administered to 4 (Patients # 5,8,18, and 21) of 20 patients, and had the potential to have contributed to the 99 medication variances from 01/01/17-08/30/17, which had the potential to adversely affect patients' health.

Findings:

Staffing
A hospital policy titled, "Staffing/Hours of Operations (not dated)" showed the plan would ensure that a full range of services for patients will be provided. The policy documented pharmacy hours as Mon-Fri from 8:30am to 4:30 pm with a pharmacist and pharmacy technician, and showed 1 pharmacist would staff on the weekends and holidays as needed with no set schedule.

On 09/27/17 at 9:45 am, Staff W stated on 08/17, the hospital's Pharmacist was terminated, and another pharmacist was employed for only a few weeks. Staff W stated she was the corporate pharmacist, currently working as the interim pharmacist. Staff W stated she worked at the hospital 4 days/week on weekdays, and lived 2 hours away. Staff W stated she was available by phone 24/7. Staff W stated a part-time weekend pharmacist worked 4 hours each day or as patient need dictated. Staff W stated the Staff FF, the pharmacy technician, had been on military leave since 08/17. Staff W stated the hospital was advertising for a pharmacist position.
(On 10/02/17 at 1:00 pm, during a tour of the pharmacy, Staff FF and Staff GG were seen working in the pharmacy. Staff W stated Staff FF had returned from military duty and Staff GG was newly hired as part-time agency personnel. A review of Staff GG employment agreement was signed 09/26/17).

A review of the hospital log titled, "After hours Medication Sign out Sheet from 09/22/17-10/03/17" showed the lack of pharmacy coverage with 70 entries of nursing staff obtaining medication from the pharmacy at various hours that including times during the day. (Refer to Tag A-0493 and A-500)

Supervision
On 10/02/17 at 11:15am, Staff W stated she was Staff D's supervisor. She stated she was not notified of the 08/12/17 incident in which Staff D, the only pharmaceutical staff on duty, incorrectly filled a bin in the automatic drug center (ADC) with the diuretic medication instead of an anti-hypertensive medication. The incident involved 4 patients (Patients # 5,8,18, and 21). Staff W stated she did not know if Staff D had been counseled after the event or if a quality review had been performed.

A review of Staff D's personnel file showed no evidence of documentation regarding the dispensing error which occurred on 08/12/17.

Based on record review, interview, and observation, the hospital failed to provide adequate number of pharmaceutical staff to provide quality, timely, and accurate services and meet the needs of the patients served.

This failed practice resulted in wrong medication being distributed and administered to 4 (Patients # 5,8,18, and 21) of 20 patients, and had the potential to have contributed to the 99 medication variances from 01/01/17-08/30/17, which had the potential to adversely affect patients' health.

Findings:

Staffing
A hospital policy titled, "Staffing/Hours of Operations (not dated)" showed the plan would ensure that a full range of services for patients will be provided. The policy documented pharmacy hours as Mon-Fri from 8:30am to 4:30 pm with a pharmacist and pharmacy technician, and showed 1 pharmacist would staff on the weekends and holidays as needed with no set schedule.

On 09/27/17 at 9:45 am, Staff W stated the hospital's Pharmacist was terminated on 08/17, and another pharmacist was employed for only a few weeks. Staff W stated she was the corporate pharmacist was currently working as the interim pharmacist. Staff W stated she worked at the hospital 4 days/week on the weekdays, and lived 2 hours away. Staff W stated she was available by phone 24/7. Staff W stated a part-time weekend pharmacist worked 4 hours each day or as patient need dictated. Staff W stated the Staff FF, the pharmacy technician, had been on military leave since 08/17. Staff W stated the hospital was advertising to fill a pharmacist position.
(On 10/02/17 at 1:00 pm, during a tour of the pharmacy, Staff FF and Staff GG were seen working in the pharmacy. Staff W stated Staff FF had returned from military duty and Staff GG was newly hired as part-time agency personnel.)

A review of the hospital log titled, "After hours Medication Sign out Sheet from 09/22/17-10/03/17" showed the lack of pharmacy coverage with 70 entries of nursing staff entering the pharmacy to obtain medication at various hours that including times from 8:30am to 4:30 pm. (Refer to Tag A-0493 and A-500)

Supervision
On 10/02/17 at 11:15am, Staff W stated she was Staff D's supervisor. She stated she had not been notified of the 08/12/17 incident in which Staff D, the only pharmaceutical staff on duty, incorrectly filled a bin in the automatic drug center (ADC) with the diuretic medication instead of an anti-hypertensive medication. The incident involved 4 patients (Patients # 5,8,18, and 21). Staff W stated she did not know if Staff D had been counseled after the event or if a quality review had been performed.

A review of Staff D's personnel file showed no evidence of documentation regarding the dispensing error which occurred on 08/12/17.

Quality

Quality Issues
09/27/17 at 9:45 am, Staff W, Interim Corporate Pharmacist stated there were no current reports that reported pharmaceutical quality for the hospital, analysis of data, or formal action plans developed. Staff W stated she had developed goals to resolve issues she had identified:
*perform area monthly audits in any space that meds were stored.
*control substance- run 2 reports of nursing administration and waste report and evaluate.
* perform random audit check audits--60 audits per month --stated nursing audits charts to verify correct medication administration.
* review written variances
*investigate overrides within 12 hours to evaluate proper use of override and correct dispensing.
*place medication incidents in action cue.
*investigate discrepancies
10/02/17 at 11:08 am, Staff W stated she had not formally notified leadership of her evaluation of the needs and issues she had identified in her month of being interim pharmacist.

A review of the computer variance system "Action Cue" showed 99 medication variances from 01/01/17-08/30/17 and no medication variances September 2017 were documented. A review of the medication variances from 06/01/17 to 09/30/17 showed 8 wrong or missing antibiotic doses. Staff W stated data was not analyzed or comprehensive action plans developed.

10/02/17 at 11:08 am, Staff W stated medication variances for September 2017 were on her desk and had not been reviewed or entered into Action Cue. Staff W stated data was not analyzed or action plans developed.

A review of the hospital log titled, "After hours Medication Sign out Sheet from 09/22/17-10/03/17" showed lack of pharmacy coverage with 70 entries of nursing staff entering the pharmacy to obtain medication at various hours that including times from 8:30am to 4:30 pm. 10/02/17 at 11:08 am, Staff W stated it was her goal to reduce the number of entries of non-pharmaceutical staff. Staff W stated data was not analyzed or action plans developed.

A review of the hospital log titled, "Omnicell Narcotic Shift Sheet from 08/11/17 - 09/24/17" showed 7 discrepancies with 4 of 7 entries having no explanation as to the discrepancy found and or if it was reconciled. Staff W stated data was not analyzed or action plans developed.

10/02/17 at 11:08 am, Staff W stated it was her goal to discontinue the log and computerize tracking of discrepancies. Staff W stated she could not explain the 4 entries that had no information. Staff W stated data was not analyzed or action plans developed.

A review of an incident report dated 08/14/17 documented Staff D, who was the only pharmaceutical staff on duty, incorrectly filled a bin in the automatic drug center (ADC) with the diuretic medication instead of an anti-hypertensive medication. The error resulted in 4 patients receiving the wrong medication, and some of those patients receiving multiple doses of the wrong medication.
* 09/27/17 11:12 am, CEO stated he knew Patient #8 had died, but the Staff B, CCO, did not communicate the patient as involved with a Amlodipine/Amiloride medication error 2 days before his death.
* On 10/04/7 at 10.30 am, Staff A, CCO finalized incident report on 08/15/17 at 1617 after the patient died. The incident report was documented, "Pharmacist filled wrong bin, nurse caught error". The report failed to communicate Patient #8 died the day following 2 doses of the wrong medication. Staff A stated she knew of patient #8's death and of the medication error, but not connect or communicate the events together to the CEO.
* On 10/04/17 at 10:40 am, Staff B stated Patient #8's death would be evaluated in MEC, but the medication error that occurred would not be a part of the evaluation if it was not documented in the patient's medical record.
* On 10/02/17 at 11:15am, Staff W, the Interim Corporate Pharmacist stated she was Staff D's supervisor. She stated she had not been notified of the 08/12/17 medication incident in which Staff D, and did not know if Staff D had been counseled. Staff W stated the hospital needed a bar code scanning system to help minimize errors.

A review of the medical record of Patient # 18 showed on 07/17/17 Provider R wrote an order for clindamycin to be discontinued. On 07/20/17, Provider R rewrote the order to discontinue the clindamycin, because the medication was still being administered. A review of incident reports for 07/17 showed no variance regarding this medication error.

Meeting Minutes
A review of minutes titled, "P & T [Pharmacy & Therapeutics] Meeting Minutes 01/11/17, 04/19/17, & 07/19/17" all documented the following phrase: "medication variances: antibiotic timing, meds not given as ordered." The minutes from 01/17 and 04/17 documented overrides [were] "Primarily due to late overrides primarily due to late physician rounding and weekend orders when pharmacy is not open, and 07/17 "peaked when agency was high, meds were in bins nursing would ask Charge to get med without checking refrigerator and cabinet first." The P&T minutes failed to document the analysis of identified issues and discussion of any implementation of performance improvement initiatives.

A hospital document titled "P&T Function" (a computerized dashboard of performance measures). A review of dashboard titled, "P&T Function Oct., Nov., Dec 2016" showed unnecessary override rate benchmark as 7.33% and an Oct 2016 rate of 10%. No analysis or action plans were associated with this document. No P & T Function reports were provided to for 2017.

In the presence of Staff W, P & T [Pharmacy & Therapeutics] Meeting Minutes 01/11/17, 04/19/17, & 07/19/17" were reviewed. Staff W stated the current minutes provided little quality information and she was planning to change the format to provide improved quality information.

A review of minutes titled, "Quality Meeting 04/21/17" had the attachment of the "P&T Function Report 01/01/17 - 06/30/17" which showed:
* unnecessary override average of 14.29% (benchmark 7.33%),
* medication error average of 0.052% (benchmark .022)
* medication variance average of 0.059 (benchmark 0.028)
* narcotic count discrepancy average of 0.8% (benchmark 0.5%)
The minutes did not show evidence discussion or action plan for improvement.

09/27/17 11:12, Staff B, the Director of Quality, stated she was not provided information regarding medication variances. Staff B stated she does not go to P&T meeting. She stated she was never told when they were to be held. She stated she was not involved in medication error investigations. She stated Staff A was involved with the medication errors for the past weeks. She stated the former Pharmacist, Staff H, put medication incidents in Action Cue and without conducting an investigation. She stated she did not know if staff evaluated the patients' condition to see if the patient had a bad outcome

A review of the "Medical Executive Meeting Minutes" showed:
08/16/17 "P & T Function Report" was listed in the meetings minutes, but did not contain evidence of pharmacy discussions or attachments.
07/26/17 "April : 30 medication variances ...May: 10 medication variances ...15 medication variances ...Information presented without any discussion".
06/21/17 no evidence of medication errors or pharmacy issue were discussed. The Performance Measure Dashboard which was attached to the minutes showed April 2017 unnecessary overrides as 17.95% (benchmark 15.93%) and Medication Error rate as 0.132 (benchmark 0.05)
05/17/17 no evidence medication errors or pharmacy issues were discussed.

A review of minutes titled, "Governing Body Meeting Minutes for 02/23/17 and 08/25/17" documented, "P & T Report" (a computerized dashboard of performance measures for pharmacy), but had no attachments. Both minutes documented the "P & T Function Report ...the quality data was presented to the GB-[as] informational." The Governing Body minutes failed to document identified pharmacy issues and failed to discuss issue analysis and performance improvement initiatives.

Based on record review, interview, and observation, the hospital failed to ensure medications were ordered and dispensed in a safe manner in accordance with standard of practice, to include, but not limited to: pharmacist and nurse order verification, oversight of overridden medications, practices without double checks, and medication discrepancies.

This failed practice resulted in wrong medication being distributed and administered to 4 (Patients # 5,8,18, and 21) of 20 patients, and had the potential to have contributed to the 99 medication variances from 01/01/17-08/30/17, which had the potential to adversely affect patients' health.

Findings:

Bypass of Pharmacist Medication Verification

The hospital had multiple pharmacy policies related to obtaining and reviewing medications when a pharmacist was not available. All of the following were policies authorizing medication to be obtained from the ADC [automatic dispensing center] or from the pharmacy in emergent or urgent situations only.

The policies were inconsistent in documenting what staff was authorized to perform the medication review in the absence of a pharmacist. (The review is a safety measure that ensures right patient, medication, dose, route, allergies, and contraindications.) One policy authorized the staff as a qualified healthcare provider, but failed to define what staff and what qualification were required, other policies authorized the staff as charge nurses and house supervisors.

The multiple pharmacy policies related to obtaining medications when a pharmacist was not available were inconsistent in defining when the pharmacist would provide a retrospective review of the administration of the medication. One policy documented the pharmacist would perform retrospective review, "at the next available opportunity", and another policy documented the time of review for overrides as the next day.

The following 5 policies provided guidelines for order verification in the absence of pharmacy review prior to administration.

1. A hospital document titled, "Review of Medication Orders-Pharmacy (dated 04/01/16) showed the exceptions for administering a medication without pharmacist verification included emergent situations and urgent situations when patient harm could result from delay in administration of a medication, or when a patient experiences a sudden change in clinical status.

2. A hospital policy titled, "Medication Dispensing- General (dated 04/01/16) documented:
* A pharmacist shall review the prescriber's original order ...before the initial dose was dispensed with the exception to include emergent/ urgent situations when time does not permit a pharmacist's
retroperspective review.
* if an order was written when the pharmacy was closed or the pharmacist was otherwise unavailable, a qualified healthcare professional would review the medication order in the pharmacist's absence
and administer the medication..
* a pharmacist would complete a retrospective review of the medication order at the next available opportunity.

3. A hospital document titled, "Review of Medication Orders-Pharmacy (dated 04/01/16) showed after business hours, the charge nurses were responsible to review medication orders.

4. A review of hospital policy titled, "ADC [automatic dispensing center] dated 06/01/16" documented:
* nursing personnel may take medications from the ADC prior to a pharmacist review for urgent or emergent medications after pharmacy hours utilizing an override procedure.
* only the house supervisors had access to override medication.
* the pharmacist would reconcile overrides daily.

5. A review of the hospital policy titled, "ADC- Overrides (dated 06/01/16) documented nursing personnel may take medications from the ADC prior to a pharmacist review for urgent or emergent medication after pharmacy hours utilizing an override procedure. The policy documented when a pharmacist was bypassed, a second licensed individual must verify the order and the medication, and only house supervisors have access to override medication.

A review of the ADC log from 07/01/17-09/30/17 showed 118 medication overrides with medication including, but not limitied to non-emergent/urgent multi-vitamin, vitamin C, and an anti-cholesterol medication.

A review of the hospital log titled, "After hours Medication Sign out Sheet from 09/22/17-10/03/17" showed nursing staff entered the pharmacy 70 times at various hours to obtain medications not verified by a pharmacist. The medication included 34 antibiotics, calcium, senna laxative, and artificial tears. The log showed 54 of the 70 lacked initials of acknowledgement from a pharmacist.

On 10/02/17 at 1:54 pm, Staff W stated the hospital did not performed a formal review of medication administered prior to a pharmacist's review as to whether an emergent/urgent situation dictated the medication removal.

Nursing Medication Access, Verification, & Overrides
On 09/25/17 at 11:00 am, Staff A stated the nurses obtained medications for patients when the pharmacist was unavailable for medication review prior to administration in the following 2 ways:
1. accessing from the ADC (the process called an override). Staff A stated when the nurses performed the override, 2 nurses should verify the medication.
2. entering the closed pharmacy and obtaining the medication. (The medications accessed directly from the pharmacy were not available in the ADC).

ADC
A hospital policy titled, "Obtaining Medications when Pharmacy is Closed (dated 04/01/16) documented a second licensed individual shall check the order and the medication prior to dispensing and document in the transaction report of the ADC [automatic dispensing center]. The policy failed to address when the pharmacy was closed and the needed medication was not in the ADC.

A review of the hospital policy titled, "ADC- Overrides (dated 06/01/16) documented when a pharmacist was bypassed, and a second licensed individual must verify the order and the medication, and only the house supervisors have access to override medication.

A review of the ADC log from 07/01/17-09/30/17 showed 118 medication overrides. 107 of the 118 overrides did not have a nurse witness documented. On the log, Patient #22 had 27 overridden doses of Diazepam 5mg/1 ml injection. On 10/05/17 at 10:00am, Staff W stated the repeated overrides for Patient #22's Diazepam (multiple times daily for 7 days) from 08/07/17 through 08/14/17 was probably due a pharmacist did not program the medication into the patient's profile in the ADC.

10/03/17 at 1:38 pm, Staff Z, RN stated she did not override medication in ADC, because she was told not to do so.

10/03/17 at 1:45 pm, Staff V, LPN, stated she did not override medication. Staff V stated she would ask the pharmacist or the Charge Nurse to assist for medications not in ADC, or to obtain an antibiotic.

Entering Closed Pharmacy

A hospital policy titled, "Security of Staff and Medications (dated 06/01/16) documented only pharmacists and authorized personnel shall be permitted to have 'free access" to the pharmacy. The policy documented all other facility personnel shall have authorized admission in conjunction with their duties and while under the supervision of pharmacy staff. The security policy failed to define which personnel were authorized for "free access" to the pharmacy, and which personnel were allowed access per duty.

A review of the hospital log titled, "After hours Medication Sign out Sheet from 09/22/17-10/03/17" showed nursing staff entered the pharmacy 70 times at various hours to obtain medications not verified by a pharmacist.

On 10/03/17 at 12:234 pm, Staff FF stated generally the Charge Nurse, entered the closed pharmacy upon the request of another nurse for medication not available in the ADC. The Charge Nurse selected, logged, and gave the medication to the requesting nurse, who administered the medication. Staff FF showed the log titled, "After hours Medication sign out Sheet" which required one RN signature.

10/03/17 at 1:38 pm, Staff Z, RN, stated if no pharmacist was available to verify an order, and a medication was unavailable in the ADC, she would ask the pharmacy technician, Staff FF, or the charge nurse to obtain the medication. Staff FF or the Charge Nurse would go to pharmacy to obtain the medication. Staff Z stated the medication administeredwas documented in the medical record, but staff did not document the second nurse verification of the medication.

On 09/25/17 at 11:00am , Staff A stated there was no documentation of the 2 nurses who performed the medication review when medication was obtained from the closed pharmacy.

Pharmacist Dispensing Practices
A hospital policy titled, "Staffing/Hours of Operations (not dated)" showed staff plan for the weekends and holidays as 1 pharmacist.

A review of an incident report dated 08/14/17 documented Staff D, who was the only pharmaceutical staff on duty, incorrectly filled a bin in the automatic drug center (ADC) with the diuretic medication instead of an anti-hypertensive medication.

On 08/12/17, Staff D, the weekend pharmacist, placed 50 Amiloride tablets (diuretic) in the ADC bin labeled "Amlodipine"(anti-hypertensive). At the time of this placement, there were 3 Amlodipine remained in the ADC bin labeled "Amlodipine".
On 08/14/17, Staff PP, RN, identified the error, and brought 41 remaining Amiloride tablets to Staff QQ. The 3 Amlodipine tablets that were in the bin were gone.
The incident report documented the CCO viewed an ADC report, which showed 10 tablets of medication were removed from the ADC bin labeled "Amlodipine" on 08/13/17 and 08/14/17. On 08/13/17, 4 patients (Patients # 5,8,18, and 21) received tablet(s) removed from this bin. On 08/14/17, a total 3 patients (Patient # 5, 8, and 21) received another tablet(s) from this bin before the error was identified.

09/27/17 at 9:45 am, Staff W stated the pharmacy had only one person checking the medication to be dispensed on the weekends, but had a goal to create a process for a 2 person check.

10/02/17 at 1:54 pm, Staff W stated she had tagged the Amiloride and Amlodipine bin in the pharmacy with look alike/ sound alike labels, and ensured the medications were not next to another, but planned to obtain colored baskets. Staff W stated other look alike/ sound alike medications needed labels and colored baskets.

Medication Discrepancies

A review of hospital policy titled, "ADC [automatic dispensing center] dated 06/01/16" documented any discrepancies would be investigated immediately.

On 09/25/17 at 11:00 am, during a tour of the drug room, the surveyors observed 2 discrepancies seen in the ADC. Staff CC showed the unreconciled discrepancies as follows:
*09/25/17 Staff CC had Hydrocodone counted as 497 (wrong) when 47 tabs were in the bin.
*09/24/17 (from the day prior) Staff OO counted 11 tabs Clonazepam when 7 tabs were in bin.

09/25/17 11:00 am, Staff AA said discrepancies should be resolved each shift.

On 09/25/17 at 11;00 am, Staff V stated if she had a discrepancy in ADC, she contacted the pharmacist or charge, nurse. Staff V stated she verified the MAR was correct at the beginning of each shift.

09/27/17 at 9:45 am Staff W discussed narcotic discrepancies in the ADC and stated staff must bypass a warning message screen that announces a count error that staff ignore.


A review of the hospital log titled, "Omnicell Narcotic Shift Sheet from 08/11/17 - 09/24/17" showed 7 discrepancies with 4 of 7 entries having no explanation or how it was reconciled.

On 10/02/17 at 11:08 am, Staff W stated it was her goal to discontinue the log and computerize tracking of discrepancies. Staff W stated she could not explain the 4 entries that had no information.

Other Medication Errors
A review of the computer variance system "Action Cue" showed 99 medication variances from 01/01/17-08/30/17 and with no September 2017 medication variances. A review of the medication variances from 06/01/17 to 09/30/17 showed 8 wrong or missing antibiotic doses.

Based on record review, interview, and observation, the hospital failed to ensure outdated medication were not available for patient use.

This failed practice was observed in 2 of 2 crash carts, and had the potential to adversely affect patients' health by using medications that were beyond the date of recommended use.


Findings:

A review of policy titled, "Crash cart (date 04/16)" documented drugs are checked monthly by the pharmacist or designee, and if outdated drugs are found, they were replaced with in-stock date.

A hospital policy titled, "Expiration and Beyond-use Dates (dated 06/01/17) documented pharmacy services will routinely monitor for expired products and remove them from inventory when appropriate. The policy documented medication scheduled to expire during the next month following the inspection date should be removed from stock.

Crash Cart/ Pod
09/25/17 at 11:20 am, a crash cart on1st floor was observed to have the following expired medication:
*Normal Saline 1000 ml expired 08/31/17,
*D%W 250 ml expired 07/17,
*D5W 250 ml expired 08/17,

09/25/17 at 11:37 am, a crash cart on 2nd floor was observed to have the following expired medication:
*Normal Saline 500 ml expired 08/01/17,
*Normal Saline 1000 ml expired 08/01/17,
*D5W 500 ml expired 08/01/17,
*D5W 250 ml expired 07/17
*Normal Saline prefilled syringe x5 03/01/17

09/25/17 at 11:30 am, on 1st floor a pod counter, three 1000 ml bag of inhalation water for Veriflow were observed with expirations of 05/17.

On 10/02/17 at 11:30 am, Staff W said it was the pharmacist's responsibility on monthly basis to check crash carts and all areas where medication were kept for outdated medication.

Drug Room

A review of hospital policy titled, "Medication Administration (no date) documented discharged patient's medication should be returned to the pharmacy.

A review of hospital policy titled, "Multiple-Dose Medication (date 07/16)" documented multiple-dose medication may be used up to 28 days after initial entry. The policy documented the healthcare professional first puncturing the vial or opening the medication container must initial the vial/container, and place the date of first use on the container.

09/25/17 at 11:09 am, during a tour of the drug room, surveyors observed two vials of insulin (Humulog and Levemir), and one bottle of Promod (liquid oral nutrition) were opened with no date of opening. A jar of topical ointment was on counter for Patient #5, who was discharged on 09/12/17.

09/25/17 at 11:10 am, Staff A stated the beyond use date for an opened vial was 60 days, and multi-dose vials should be dated and initialed when opened for use.

Based on record review, interview, and observation, the hospital failed to ensure medications were removed from the pharmacy by only personnel authorized by policy when a pharmacist was unavailable.

This failed practice resulted in nursing staff removing 70 medications from the pharmacy without an initial pharmacist verification from 09/24/17-10/03/17, and had the potential to compromise pharmacy security and to increase the risk of medication errors.

Findings:

A hospital policy titled, "Security of Staff and Medications (dated 06/01/16) documented only pharmacists and authorized personnel shall be permitted to have 'free access" to the pharmacy. The policy documented all other facility personnel shall have authorized admission in conjunction with their duties and while under the supervision of pharmacy staff. The security policy failed to define which personnel were authorized for "free access" to the pharmacy, and which personnel were allowed access per duty.

A hospital document titled, "Review of Medication Orders-Pharmacy (dated 04/01/16) showed the exceptions for administering a medication without pharmacist verification included emergent situations and urgent situations when patient harm could result from delay in administration of a medication, or when a patient experiences a sudden change in clinical status.

On 10/03/17 at 12:234 pm, Staff FF stated generally the Charge Nurse, entered the closed pharmacy upon the request of another nurse for medication not available in the ADC. The Charge Nurse selected, logged, and gave the medication to the requesting nurse, who administered the medication.

A review of the hospital log titled, "After hours Medication Sign out Sheet from 09/22/17-10/03/17" showed 70 entries of nursing staff entering the pharmacy at various hours. The log showed on Mon. 09/25/17 at 4:00 pm, a medication was removed from the pharmacy, , but by Nurse #OO, a contracted hemodialysis nurse.

On 09/25/17 at 11am, Staff A stated only Charge Nurses were authorized to remove medication from the pharmacy.

On 10/02/17 at 1:54 pm, Staff W stated the hospital did not performed and a formal review of medication administered prior to a pharmacist's review as to whether an emergent/urgent situation dictated the medication removal.

Based on record review, interview, and observation, the hospital failed to ensure medication administration errors, adverse drug reactions, and incompatibilities were immediately reported to the attending physician and communicated to the hospital's quality assessment and performance improvement (QAPI) program.

This failed practice resulted in the lack of physician evaluation in 4 (Patient # 5, 8, 18, and 21) of 4 patients after medication error occurred, and had the potential to increase the risk of adversely affecting patients' health, and had the potential to have contributed to the 99 medication variances from 01/01/17-08/30/17.

A review of hospital policy titled, "Medication Errors (dated 07/01/17) documented:
* medication errors shall be reported in a timely manner to the practitioner who ordered the medication.
* the staff who discovered the medication error shall prepare the medication report, and a copy distributed to the Director of Nursing and Director of Pharmacy.
* defined the components of a required subsequent investigation.
* upon completion of the investigation, if necessary, education and follow-up should be provided.
* the Medication Safety Committee shall review all medication errors, evaluate the findings, act as necessary to reduce the incidence and severity of medications errors, assess the effectiveness of actions,
evaluate the care provided, and document findings, conclusion, recommendations, and actions taken.
* the medical staff , in collaboration with the pharmacy, nursing, and other staff appropriate shall periodically assess the hospital's effectiveness to detect significant errors.

Errors Reported to Attending Physician
A review of the medical records of 4 (Patient # 5, 8, 18, and 21) of 4 patients involved in medication errors showed no documentation of the error nor was the attending physician was notified.

09/27/17 at 11:35 pm, by telephone interview, Provider Q stated he was not aware of Amloipine/Amiloride error incident involving Patient #8.

Errors Reported to QAPI

Quality Issues
09/27/17 at 9:45 am, Staff W, Interim Corporate Pharmacist stated there were no current reports that reported pharmaceutical quality for the hospital, analysis of data, or formal action plans developed. Staff W stated she had developed goals to resolve issues she had identified:
*perform area monthly audits in any space that meds were stored.
*control substance- run 2 reports of nursing administration and waste report and evaluate.
* perform random audit check audits--60 audits per month --stated nursing audits charts to verify correct medication administration.
* review written variances
*investigate overrides within 12 hours to evaluate proper use of override and correct dispensing.
*place medication incidents in action cue.
*investigate discrepancies
10/02/17 at 11:08 am, Staff W stated she had not formally notified leadership of her evaluation of the needs and issues she had identified in her month of being interim pharmacist.

A review of the computer variance system "Action Cue" showed 99 medication variances from 01/01/17-08/30/17 and no medication variances September 2017 were documented. A review of the medication variances from 06/01/17 to 09/30/17 showed 8 wrong or missing antibiotic doses. Staff W stated data was not analyzed or comprehensive action plans developed.

10/02/17 at 11:08 am, Staff W stated medication variances for September 2017 were on her desk and had not been reviewed or entered into Action Cue. Staff W stated data was not analyzed or action plans developed.

A review of the hospital log titled, "After hours Medication Sign out Sheet from 09/22/17-10/03/17" showed lack of pharmacy coverage with 70 entries of nursing staff entering the pharmacy to obtain medication at various hours that including times from 8:30am to 4:30 pm. 10/02/17 at 11:08 am, Staff W stated it was her goal to reduce the number of entries of non-pharmaceutical staff. Staff W stated data was not analyzed or action plans developed.

A review of the hospital log titled, "Omnicell Narcotic Shift Sheet from 08/11/17 - 09/24/17" showed 7 discrepancies with 4 of 7 entries having no explanation as to the discrepancy found and or if it was reconciled. Staff W stated data was not analyzed or action plans developed.

10/02/17 at 11:08 am, Staff W stated it was her goal to discontinue the log and computerize tracking of discrepancies. Staff W stated she could not explain the 4 entries that had no information. Staff W stated data was not analyzed or action plans developed.

A review of an incident report dated 08/14/17 documented Staff D, who was the only pharmaceutical staff on duty, incorrectly filled a bin in the automatic drug center (ADC) with the diuretic medication instead of an anti-hypertensive medication. The error resulted in 4 patients receiving the wrong medication, and some of those patients receiving multiple doses of the wrong medication.
* 09/27/17 11:12 am, CEO stated he knew Patient #8 had died, but the Staff B, CCO, did not communicate the patient as involved with a Amlodipine/Amiloride medication error 2 days before his death.
* On 10/04/7 at 10.30 am, Staff A, CCO finalized incident report on 08/15/17 at 1617 after the patient died. The incident report was documented, "Pharmacist filled wrong bin, nurse caught error". The report failed to communicate Patient #8 died the day following 2 doses of the wrong medication. Staff A stated she knew of patient #8's death and of the medication error, but not connect or communicate the events together to the CEO.
* On 10/04/17 at 10:40 am, Staff B stated Patient #8's death would be evaluated in MEC, but the medication error that occurred would not be a part of the evaluation if it was not documented in the patient's medical record.
* On 10/02/17 at 11:15am, Staff W, the Interim Corporate Pharmacist stated she was Staff D's supervisor. She stated she had not been notified of the 08/12/17 medication incident in which Staff D, and did not know if Staff D had been counseled. Staff W stated the hospital needed a bar code scanning system to help minimize errors.

A review of the medical record of Patient # 18 showed on 07/17/17 Provider R wrote an order for clindamycin to be discontinued. On 07/20/17, Provider R rewrote the order to discontinue the clindamycin, because the medication was still being administered. A review of incident reports for 07/17 showed no variance regarding this medication error.

Meeting Minutes
A review of minutes titled, "P & T [Pharmacy & Therapeutics] Meeting Minutes 01/11/17, 04/19/17, & 07/19/17" all documented the following phrase: "medication variances: antibiotic timing, meds not given as ordered." The minutes from 01/17 and 04/17 documented overrides [were] "Primarily due to late overrides primarily due to late physician rounding and weekend orders when pharmacy is not open, and 07/17 "peaked when agency was high, meds were in bins nursing would ask Charge to get med without checking refrigerator and cabinet first." The P&T minutes failed to document the analysis of identified issues and discussion of any implementation of performance improvement initiatives.

A hospital document titled "P&T Function" (a computerized dashboard of performance measures). A review of dashboard titled, "P&T Function Oct., Nov., Dec 2016" showed unnecessary override rate benchmark as 7.33% and an Oct 2016 rate of 10%. No analysis or action plans were associated with this document. No P & T Function reports were provided to for 2017.

In the presence of Staff W, P & T [Pharmacy & Therapeutics] Meeting Minutes 01/11/17, 04/19/17, & 07/19/17" were reviewed. Staff W stated the current minutes provided little quality information and she was planning to change the format to provide improved quality information.

A review of minutes titled, "Quality Meeting 04/21/17" had the attachment of the "P&T Function Report 01/01/17 - 06/30/17" which showed:
* unnecessary override average of 14.29% (benchmark 7.33%),
* medication error average of 0.052% (benchmark .022)
* medication variance average of 0.059 (benchmark 0.028)
* narcotic count discrepancy average of 0.8% (benchmark 0.5%)
The minutes did not show evidence discussion or action plan for improvement.

09/27/17 11:12, Staff B, the Director of Quality, stated she was not provided information regarding medication variances. Staff B stated she does not go to P&T meeting. She stated she was never told when they were to be held. She stated she was not involved in medication error investigations. She stated Staff A was involved with the medication errors for the past weeks. She stated the former Pharmacist, Staff H, put medication incidents in Action Cue and without conducting an investigation. She stated she did not know if staff evaluated the patients' condition to see if the patient had a bad outcome

Based on record review, interview, and observation, the hospital failed to ensure:
a. outdated supplies such as medication and blood collection tubes were not available for patient use, and

b. emergent respiratory supplies were available for use on a daily basis.

This failed practice was observed in two of two crash carts, and had the potential to adversely affect patients' health by using medications and blood collection tubes that were beyond the date of recommended use, and increased the risk of a untoward respiratory patient outcome if critical supplies were unavailable during emergent situations.


Findings:
a. Outdated Supplies
Medication
A hospital policy titled, "Expiration and Beyond-use Dates (dated 06/01/17)" documented pharmacy services would routinely monitor for expired products and remove them from inventory when appropriate. The policy documented medication scheduled to expire during the next month following the inspection date should be removed from stock.

A review of policy titled, "Crash cart (date 04/16)" documented drugs are checked monthly by the pharmacist or designee, and if outdated drugs were found, the medication (s) was replaced with in-stock date.

Crash Cart/ Pod
09/25/17 at 11:20 am, a crash cart on 1st floor was observed to have the following expired medication:
*Normal Saline 1000 ml expired 08/31/17,
*D%W 250 ml expired 07/17, and
*D5W 250 ml expired 08/17,

09/25/17 at 11:37 am, a crash cart on 2nd floor was observed to have the following expired medication:
*Normal Saline 500 ml expired 08/01/17,
*Normal Saline 1000 ml expired 08/01/17,
*D5W 500 ml expired 08/01/17,
*D5W 250 ml expired 07/17, and
*Normal Saline prefilled syringe x5 03/01/17

09/25/17 at 11:30 am, on a counter in a 1st floor pod, three 1000 ml bag of inhalation water for Veriflow were observed with expirations dates of 05/17.

On 10/02/17 at 11:30 am, Staff W said it was the pharmacist's responsibility check crash carts and all areas where medication were kept on a monthly basis for outdated medication, and this activity had not been performed.

Drug Room

A review of hospital policy titled, "Medication Administration (no date) documented discharged patient's medication should be returned to the pharmacy.

A review of hospital policy titled, "Multiple-Dose Medication (date 07/16)" documented multiple-dose medication may be used up to 28 days after initial entry. The policy documented the healthcare professional first puncturing the vial or opening the medication container must initial the vial/container, and place the date of first use on the container.

09/25/17 at 11:09 am, during a tour of the drug room, surveyors observed two vials of insulin (Humulog and Levemir), and one bottle of Promod (liquid oral nutrition) were opened with no date of opening. A jar of topical ointment was on counter for Patient #5, who was discharged on 09/12/17.

09/25/17 at 11:10 am, Staff A stated the beyond use date for an opened vial was 30 days, and multi-dose vials should be dated and initialed when opened for use. Staff A stated the observed vials should be labeled according to policy.

Expired Supplies
A review of policy titled, "Crash cart (date 04/16)" documented crash carts would be inspected on the schedule set by the hospital and re-stocked after every use. The policy documented on a daily basis the cart should be inspected for the integrity of the securement device and the outside of the cart. The policy failed to designate the frequency of inspection for crash cart supplies within the cart.

A review of the document titled. "Emergency Crash Cart Checks for 09/17" contained the written instructions that at the end of the month, the entire cart needed to be opened and checked for outdated supplies.

A review of the log sheet titled, "Emergency Crash cart Checks for 28th floor 09/17" instructed the staff to check the cart at the beginning of each shift. The log from 09/01/17-09/25/17 showed for 3 of 50 shifts, staff did not document the integrity of the security lock, the presence of defibrillator pads, resuscitation backboard, cable, ambu bag, oxygen, and the functioning of suction machine.

Crash Cart/ Pod
09/25/17 at 11:20 am, a crash cart on 1st floor was observed to have the following expired blood collection tubes:
2 blue top expired 08/03/17 and 2 tiger top expired 07/31/17.

09/25/17 at 11:37 am, a crash cart on 2nd floor was observed to have the following expired blood collection tubes:
2 blue top expired 02/17and 03/17, 2 tiger top expired 04/17 and 08/17, 2 green top expired 05/17, and 1 red top expired 04/17.

09/25/17 at 11:10 am, Staff A stated the two crash carts should have been checked last month and expired supplies removed.

b. Respiratory Supplies

A review of policy titled, "Crash Cart (date 04/16)" documented crash carts would be inspected on the schedule set by the hospital and re-stocked after every use. The policy failed to address the frequency of inspection for the inner contents and security device for the emergent respiratory box, which contained critical airway management equipment.

A review of document titled, "Respiratory Therapy Code Box for 07/17- 08/17" contained the written instructions the box should be checked after each use and the first day of each month.

09/25/17 at 11:20 am, Staff SS stated the respiratory box was only checked once a month and no staff checked daily to ensure the the integrity of the securement device was intact.

09/25/17 at 11:20 am and 11:37am, the respiratory box was observed on top of two of two crash carts. A review of the log sheet titled, "Respiratory Therapy Code Box-28th Med Room" showed the outer box was checked on 07/03/17, 07/23/17, 08/04/17, and 08/11/17.

Based on record review and interview the hospital failed to designate in writing an ICP who is qualified by education, training or certification in principles and methods of infection control. This failed practice compromised one (Patient #5) of 20 patients' safety and had the potential to cause harm to all patients, staff and visitors by increasing the risk of developing infections and communicable diseases due to the ICPs lack of knowledge in infection control principles and methods of infection control.

Findings:

Review of hospital document titled "Infection Prevention and Control Program 2017 Risk Assessment and Plan" showed the infection control and prevention program is maintained by a qualified IP.

Review of policy titled "Infection Control Plan" showed the ICC is responsible for being a hospital resource for all hospital departments relating to infection control issues. The policy showed no evidence the IP/ICC was required to have initial and ongoing training, education or certification in principles and methods of infection control.

Review of hospital document titled "Quarterly GB Meeting" dated 08/25/17 showed no evidence of the ICC/ICP/IP designated in writing by the Governing Body.

Review of Staff B personnel file showed no evidence of initial or ongoing training, education or certification in infection control principals and methods.

On 09/26/17 at 9:15 am, surveyors requested evidence of Staff B's core competencies and training in infection control principles and methods. None were provided.

On 10/04/17 at 9:30 am, Staff B stated he/she cannot provide any evidence of initial or ongoing training or education in infection control; and reports he/she has done some modules through NHSN but they do not provide any certificates of completion. Staff B stated he/she had one week orientation for the ICP position.

On 10/04/17 at 9:40 am, Staff C and A stated there were no requirement for initial training or education in infection control prior to Staff B taking the position as the ICP; and reported he/she had received orientation by the previous ICP.

Based on record review, interviews and observations the ICP failed to:

A. Ensure staff adhered to CDC and/or WHO hand hygiene practices and appropriate use of personal protective equipment including gowns, gloves and masks. Four breaks in hand hygiene practices observed by surveyors on 10/03/17 in 35 minutes.

B. Ensure staff adhered to infection control practices for transporting, handling, storage and disinfecting patient-care equipment, instruments/devices, food-trays and bio-hazardous waste removed from isolation rooms. Surveyors observed within 35 minutes on 10/03/17 nine breaks in infection control practices for cleaning patient care equipment, instruments, food trays and/or removal of bio-hazardous waste from isolation rooms.

C. Investigate and analyze infection control data to determine root causes for infections in an effort to control and/or prevent infections and communicable diseases.

D. Ensure visitors were notified, provided education and adhered to CDC guidelines and recommendations for hand hygiene and appropriate use of personal protective equipment including gowns, gloves and masks when entering an isolation room. Two breaks in infection control practices for use of personal protective equipment by visitors were observed by surveyors on 10/03/17.

These failed practices resulted in one patient (Patient #5) of 20 medical records reviewed developing a gangrenous scrotal wound and the potential for harm and increased risk of infections for all patients, staff and visitors secondary to an ineffective infection program by a lack of active on-going surveillance program including monitoring, investigation and follow-up.

Findings:

Hand Hygiene and PPE Use

Review of policy titled "Guidelines for Transmission Based Isolation Precautions" showed for contact isolation staff should perform hand hygiene prior to applying PPE. Gloves and gown should be donned at the entry of isolation room. Prior to leaving, gloves should be removed then gown and hand hygiene performed.

Review of policy titled "Standard Precautions" showed that all persons can be potentially infected or colonized with an organisms that can be transmitted in a healthcare setting. These precautions includes the practices of hand hygiene and PPE. Hand hygiene should be performed before and after all patient contact, prior to applying PPE and after doffing PPE and at any time there is a transition from a contaminated site. PPE should be removed and discarded prior to leaving the patient's room.

Review of policy titled "Infection Control Plan" showed the components of surveillance included information about significant infections and high risk procedures, outbreak investigations, and staff education. Methods of surveillance include unit rounds, weekly communication with unit managers, department heads, and review of positive cultures and investigation of rare/resistant micro-organisms. Strategies to minimize, reduce or eliminate risks include auditing hand hygiene practices among all caregivers. The policy showed no evidence the surveillance methods included hand hygiene and PPE practices or who had the responsibility of monitoring these practices.

Review of hospital document titled "Infection Prevention and Control Program 2017 Risk Assessment and Plan" showed implementation of ICP rounds and process surveillance. Strategy evaluation to include surveillance trending and reporting compliance with hand hygiene and infection prevention practices.

Review of hospital document titled "Infection Control Committee Meeting" dated 04/12/17 showed hand hygiene had 27 observations conducted on day shift for the quarter. Compliance was 81% before contact and 92% after contact with the patient. Surveillance and education of staff requires continued follow up. Status/Update showed observations were too low for the quarter. It was determined a 50 observations should be performed each month with immediate educational counseling for repeat offenders. There was no evidence hand hygiene prior to or post doffing PPE and the appropriate donning/doffing and disposal of PPE was monitored, analyzed and trended.

Review of hospital document titled "Infection Control Committee Meeting" dated 07/12/17 showed hand hygiene had 105 (averaging 35 per month) observations conducted on day and night shifts for the quarter. Compliance was 60% before contact and 94% after touching a patient. Status/Update was unchanged from the 04/12/17 meeting. There was no evidence ICP or infection control committee initiated an investigation or action plan for significant decrease from 81% to 60% for staff compliance in hand hygiene before contact with a patient. The minutes showed no evidence of additional monitoring and analysis of hand hygiene practices and appropriate donning/doffing and disposal of PPE.

CDC Isolation Guidelines showed gowns should be removed before leaving the patient care area. In order to prevent contamination, the outside of the gown should be turned inward during removal and rolled into a bundle and discarded into a designated contamination waste or linen container.

Practical Guidelines for Infection Control in Health Care Facilities showed that PPE should be used correctly and effectively. PPE should be removed immediately before leaving a patient's room and hand hygiene performed before attending to another patient or going to another task.

On 10/04/17 at 9:40 am, Staff B stated the infection control committee decided to increase the hand hygiene audits to 50 per month; and reported it has been difficult to get 50 per month. Staff B stated the team usually averages between 35 to 50 audits per month. Staff B reported the biggest barriers to completing audits are time and getting the audits back from the team members. Staff B stated determining compliance can be difficult sometimes, we don't know when the staff comes out of the room if hand hygiene has been performed so we have to take their word for it.

On 09/25/17 at 9:50 am, surveyor observed a housekeeper throw trash in the trash bin in the soiled utility room and apply gloves without performing hand hygiene.

On 09/25/17 at 10:57 am, surveyor observed a staff nurse exit a room identified as a contact isolation room without performing hand hygiene.

On 10/02/17 at 10:05 am, surveyor observed a staff nurse exiting an isolation room 2828 with gown on. Staff nurse removed gown in hallway and placed in trash receptacle without performing hand hygiene and returned to nurses' station.

On 10/03/17 at 11:08 am, surveyor observed a housekeeper sweeping with a broom outside a patient room, place the broom on the housekeeper cart, don gloves without performing hand hygiene and enter a patient room.


On 10/03/17 at 11:17 am, surveyor observed a student nurse run out of a patient room in response to an emergency code ripping off PPE equipment (gloves and gown) and no performance of hand hygiene and proceed to another patient room.

On 10/03/17 at 11:27 am, surveyor observed a staff nurse exit an isolation patient room, removed PPE and did not perform hand hygiene.

On 10/03/17 at 11:45 am, surveyor observed a housekeeper with one glove on carrying blue bags with trash into the soiled utility room and no hand hygiene performed after glove removed.

Patient Care Equipment and Instruments/Devices

Review of policy titled "Cleaning of Non-Critical, Reusable Patient Care Equipment" showed all equipment must be cleaned immediately after use on a patient. Cleaning of equipment should follow the recommendation of the device manufacturer. Use of PPE as indicated. Glucometers cleaned between each patient.

Review of policy titled "Therapy Equipment Cleaning and Maintenance" showed all therapy equipment should be cleaned on a regular basis. Washables including hot pack covers, cushion covers, Hoyer slings, and etc. should be cleaned daily and between patient uses for those on contact precautions. Machine washed equipment are washed with facility approved detergent, then dried in dryer or air dried depending on the items specific requirements. The policy showed no evidence of designating individual equipment such as gait belts or Hoyer slings for patients in isolation.

Review of policy titled "Guidelines for Transmission Based Isolation Precautions" showed equipment should be cleaned and disinfected between patients when used for multiple patients. The policy showed no evidence of the process for cleaning and disinfecting for equipment, instruments and/or devices for patients in isolation.

Review of the Precision Xceed Pro Glucometer Monitor manufacturer recommendations titled "Cleaning the Exterior Surface" showed daily cleaning is recommended or more frequently as determined by facility policies and procedures for infection control. Monitor should only be cleaned using a damp cloth or sponge and a mild detergent.

On 09/25/17 at 11:04 am, surveyor observed a staff nurse exit a room identified as a contact isolation room with a Glucometer. Placed the glucometer on counter contaminating the counter, obtained a wipe, disinfected the glucometer, and placed it back down on the contaminated counter without first disinfecting the counter. Hand hygiene was not observed after cleaning the equipment.

On 10/03/17 at 11:10 am, surveyor observed a staff nurse take a portable blood pressure machine and glucometer into a contact isolation room. Equipment was brought outside the room and glucometer was laid on the counter contaminating the counter. Blood pressure machine was positioned next to an open linen cart where another staff member was placing linen into a linen cabinet. Staff nurse disinfected blood pressure machine with a disinfectant wipe and covered with plastic bag, then disinfected the glucometer with another disinfectant wipe. The counter was not disinfected and hand hygiene not performed by staff nurse.

On 10/03/17 at 11:10 am, surveyor observed glucometer box sitting next to sink within the splash zone with water on the top of the glucometer box.


On 10/03/17 at 11:17 am, surveyor observed staff nurse take MAR notebook into isolation patient room, place on bedside table, administer patient medication, pick MAR notebook up and exit patient room.

On 10/03/17 at 11:27 am, surveyors observed nursing staff take food menus into isolation patient rooms on two occasions for patients to make food selections and then pick the menus up and bring them out of the room without cleaning and disinfecting the menus. Surveyors also observed staff remove plastic food trays from isolation rooms and place them into a closed food cart identified as "dirty". Staff A stated all patient food trays are placed in this food cart and are delivered down to the contracted food service Sodexo and he/she did not know how these trays were cleaned or disinfected. Surveyors requested policies and procedures for cleaning and disinfecting food trays. No policies and procedures were received by the time of surveyor exit.

On 10/03/17 at 11:39 am, surveyor observed physical therapy assistant wearing a gait belt from one patient room to another and using the same belt on multiple patients. Staff RR stated that gait belts are used from one patient to another; and reported the belts are not designated for an individual patient even when the patient is on isolation. Staff RR stated the gait belts are placed in a blue bag to be washed and he/she is not sure who they are given to. Staff RR reported sometimes staff will take them home to wash.

Investigate/Analyze Infection Control Data

Review of hospital document titled "Infection Prevention and Control Program 2017 Risk Assessment and Plan" showed the IP is responsible for process and outcome surveillance activities to identify outbreaks and those that have the potential to cause an outbreak of infection. Analysis of data is performed to determine infection prevention and control practice effectiveness, identify outcomes and monitor trends. Data from the line listing reports are reviewed to monitor antimicrobial stewardship. Root cause analysis performed for identified hospital associated infections.

Review of policy titled "Infection Control Plan" showed the ICC is responsible for the collection and analysis of issues related to infection control, initiating investigative measures for potential infection control problems and evaluating the effectiveness of the Infection Control Program.

Review of hospital document titled "Infection Control Committee Meeting" dated 04/12/17 showed hand hygiene had 27 observations conducted on day shift for the quarter. Compliance was 81% before contact and 92% after contact with the patient. Surveillance and education of staff requires continued follow up. There was one HAI MRSA and six CDAD events for the quarter. There was no investigation and analysis of these events to determine the root cause for each HAI per the hospital risk assessment and plan. Action plan for hand hygiene did not identify timely evaluation of action steps to determine effectiveness and make revisions based on staff performance, and the outcome goal of on-going observation and evaluation to provide corrective interventions for patient safety is not a quantifiable goal. No evidence of implementation of an action plan for HAIs.

Review of hospital document titled "Infection Control Committee Meeting" dated 07/12/17 showed hand hygiene had 105 (averaging 35 per month) observations conducted on day and night shifts for the quarter. Compliance was 60% before contact and 94% after touching a patient. Status/Update was unchanged from the 04/12/17 meeting. No evidence the hand hygiene action plan was revised or evaluated based on staff performance.

Review of hospital document titled "Action Plan" for handwashing adherence showed the plan was implemented on 04/18/17 and revised on 06/20/17. No evidence of how the action plan was revised on 06/20/17. Action step follow-up are not timely to determine effectiveness. Target dates are for March and April 2018. There is no evidence in the action plan for investigating and analysis of the data obtained through surveillance observation to revise action plan steps in an effort to increase staff compliance with handwashing. No evidence of a measurable outcome goal to determine the effectiveness of the action plan and whether the hospital is meeting the facility benchmark for hand hygiene for the year.

On 09/26/17 at 3:30 pm, Staff B stated the goals for the year are facility benchmarks the hospital is trying to meet for hand hygiene and have staff performing surveillance observations. Staff B reported the infection control committee identified surveillance observations were low and increased them to 50 per month. Staff B stated that he/she agreed the infection control committee meeting minutes only reported numbers and no analysis by the committee of the data.

On 10/04/17 at 9:40 am, Staff B stated he/she does not use the infection control line listing log for any other than the numbers. Staff B reported he/she does not perform any type of root cause analysis on HAIs.


Visitors

Review of policy titled "Guidelines for Transmission Based Isolation Precautions" showed contact, airborne and droplet precautions should be practiced by all staff members to reduce the risk of transmission of microorganisms. The policy showed no evidence visitors to the hospital were required to adhere the transmission based isolation precautions.

On 09/25/17 at 11:15 am, Staff A stated there is no policy requiring a patient's family or visitors to wear PPE when entering an isolation room. Staff A reported staff discuss the importance of wearing PPE, but feel that they have the right to refuse.

On 09/25/17 at 11:00 am, surveyor observed a visitor in a contact isolation room without PPE on touching the patient.

On 10/03/17 at 11:10 am, surveyor observed a visitor in a contact isolation room #2825 with no PPE on.

On 10/03/17 at 11:27 am, surveyor observed a visitor in a contact isolation room #2606 coming out the room with no PPE and had not performed hand hygiene.

Based on record review and interview the hospital's Chief Executive Officer, Medical Staff and Chief Clinical Officer failed to ensure Infection Control activities and issues were processed through the Quality Assessment and Performance Improvement (QAPI) process; and

A. Periodic assessment of action plans to determine effectiveness of measures and make corrective actions if needed

B. Ensure corrective actions were followed to ensure improvement and alternative solutions/actions were not needed.

These failed practices resulted in one patient (Patient #5) of 20 medical records reviewed developing a gangrenous scrotal wound and the potential for harm and increased risk of infections for all patients, staff and visitors secondary to an ineffective infection program by a lack of active on-going surveillance program including monitoring, investigation and follow-up.

Findings:

Fourth Quarter 2016 Reporting

Review of hospital document titled "Infection Control Committee Meeting" dated 01/11/17 showed hand hygiene compliance was less than 94% and follow-up identified continued surveillance and education. Audits would be performed for education on hand washing and PPE for patients admitted with MDRO's. The meeting minutes failed to show evidence of review, discussion, analysis and investigation of infection control data regarding hand hygiene and surveillance activities for infection control practices by hospital staff for patients in isolation to ensure appropriate methods and compliance.

Review of hospital document titled "QAPI Meeting" dated 01/13/17 showed no evidence of discussion, analysis or corrective actions addressed for issues identified by infection control, including hand hygiene performance below facility goal of 95% and corporate goal of 100%. The meeting minutes failed to show evidence of review, discussion, analysis and investigation of infection control data regarding hand hygiene and surveillance activities for infection control practices by hospital staff for patients in isolation to ensure appropriate methods and compliance.

Review of hospital document titled "MEC Meeting" dated 01/18/17 showed no evidence of discussion or analysis of data reported by infection control, including hand hygiene and use of PPE staff performance. The meeting minutes failed to show evidence of review, discussion, analysis and investigation of infection control data regarding hand hygiene and surveillance activities for infection control practices by hospital staff for patients in isolation to ensure appropriate methods and compliance.

Review of hospital document titled "Annual GB Meeting" dated 02/23/17 showed fourth quarter quality data presented for informational purposes, There was no evidence hand hygiene and use of PPE was discussed including compliance below hospital and corporate benchmarks. The meeting minutes failed to show evidence of review, discussion, analysis and investigation of infection control data regarding hand hygiene and surveillance activities for infection control practices by hospital staff for patients in isolation to ensure appropriate methods and compliance.

First Quarter 2017 Reporting

Review of hospital document titled "Infection Control Committee Meeting" dated 04/12/17 showed hand hygiene had 27 observations with a compliance rate of 81% before contact and 92% after contact for the quarter. Action was to track, trend, and report to all departments. Meeting minutes did not show any discussion or analysis for the decrease in compliance in hand hygiene. Meeting minutes failed to show evidence of review, discussion and analysis of infection control data regarding hand hygiene and surveillance activities for infection control practices by hospital staff for patients in isolation to ensure appropriate methods and compliance.

Review of hospital document titled "QAPI Meeting" dated 04/21/17 showed report of an action plan for hand hygiene improvement including a plan of correction, observation to be conducted with employee education immediately if non-compliant. Meeting minutes failed to show evidence of review, discussion and analysis of infection control data regarding hand hygiene and surveillance activities for infection control practices by hospital staff for patients in isolation to ensure appropriate methods and compliance.

Review of hospital document titled "MEC Meeting" dated 05/17/17 showed no evidence of discussion by medical staff regarding infection control issues or analysis of data reported by the infection control committee.

Review of hospital document titled "MEC Meeting" dated 06/21/17" showed the medical staff was provided data for hand hygiene compliance of 86% for May 2017 for informational purposes. Meeting minutes failed to provide evidence of discussion regarding analysis of the decrease in hand hygiene compliance and any corrective actions to increase hand hygiene compliance. The meeting minutes also failed to show evidence of review, discussion and analysis of infection control data regarding hand hygiene and surveillance activities for infection control practices by hospital staff for patients in isolation to ensure appropriate methods and compliance.

On 09/26/17 at 3:30 pm, Staff B stated all the infection control data is reviewed in the infection control meetings before going to QAPI and MEC. Staff B reported the data is reviewed with the director for the program prior to the infection control meetings. Staff B stated the MEC and GB minutes are sent to the corporate office were they are transcribed. Staff B reported that the minutes for the meetings may not reflect the analysis or discussion of the infection control data.

On 09/27/17 at 2:35 pm, Staff C stated infection control data would be discussed first at infection control committee then it would be reported to the QAPI, then Medical Staff and finally to Governing Board. Staff C reported that all discussions in QAPI, Medical Staff and Governing Board do not always get transcribed into the minutes.