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Based on review of hospital documents, surveyors observations and staff interviews, the hospital's governing body failed to:

a. ensure the hospital developed and implemented an effective and active Quality Assessment and Performance Improvement (QAPI) program. See tag A-0263;

b. ensure the hospital developed and implemented an effective infection control program to prevent, control and investigate infections and communicable diseases in patients and staff. See tag A-0747;

c. ensure ultrasound services were provided in safe manner. See tag A-528.

d. ensure the grievance process was effective. See tag A-123.

e. ensure the hospital identified and evaluated all contracted services for quality and safety. These deficient practices had the potential to affect all patients receiving services at the hospital.


Findings:

1. The governing body failed to review and act on recommendations from the medical staff when the medical staff were due for reappointment. Two (Staff AA and BB) of five physician files reviewed did not contain evidence to current reappointments.

Governing Body meeting minutes did not provide evidence the governing body had reviewed the credential files for Staff AA and BB with a decision for reappointment.


2. On 10/14/2015 at 12:45, Staff O identified Staff FF as the hospital's Medical Director/Chief of Radiology. The governing body failed to appoint a qualified medical staff member as Chief of Radiology.

On 10/16/2015, Staff J and R stated the hospital did not have a credential file for Staff FF.


3. All contracted services were not evaluated. Meeting minutes for containing QAPI, medical staff and governing body and the documents contained in the contract book did not contain evidence all the contracted services were evaluated. Findings include, but not limited to:
a. Staff P's (contracted ultrasound tech) personnel file did not contain orientation to the hospital or radiology procedures or designated skills procedure checks by the medical staff or radiologist. The health file did not contain evidence Staff P had been offered Hepatitis B immunization. No evaluation of the ultrasound services provided at the hospital had been performed.
~ On 10/15/2015 at 10:45, Staff P told the surveyor that he just sprayed disinfectant on the vaginal transducer probe and then wipe it off. The manufacturer's disinfection guidelines, provided by Staff P on 10/15/2015, documented the probe needed to be cleaned with high level disinfectant and not with a disinfectant spray. See tag A-528 for details.

b. There was no evaluation for the contracted pharmacist.
~ On 10/16/15 at 3:00 p.m., the pharmacist stated that he had not oriented or provided competency training and evaluation for Staff N, the pharmacy tech/drug room supervisor.
~ Surveyors requested to review the Consultant Pharmacist weekly reports for the past year. On 10/16/2015 at 2:10 p.m., Staff B and N told the surveyors that the last documented reports that could be found ended October 2014. On 10/16/2015 at 3:00 p.m., the pharmacist was interviewed, he stated he could not produce visit reports and cited the changes in computer programs as the possible reason.


4. Nine of eleven grievances reviewed for 2015 did not contain evidence a written response had been provided to the complainant with steps taken to investigate the grievance, the results of the grievance process, and the name and telephone number of the Administrative Support Manager to the Chief Executive officer and the date of Completion. On 10/15/2015 at 10:00 a.m., Staff R stated no written response had been provided to the complainants.

Based on observations, interviews and document review, it was determined the governing body failed to ensure the hospital had a comprehensive, ongoing and effective quality assessment and performance improvement (QAPI) program to improve health outcomes and reduce medical errors.

Findings:

1. The surveyors requested the current QAPI plan. The QAPI plan provided was for 2014. On the afternoon of 10/14/2015, Staff B and R staffed the hospital did not have QAPI plan for 2015 and used the 2014 QAPI Plan.

~ The 2014 QAPI plan documented the committee would meet monthly. On the morning of 10/15/2015, Staff R told the surveyors that the committee only met quarterly. The current QAPI plan had no been revised to reflect meetings were changed to quarterly meetings.


2. QAPI meeting minutes did not show the QAPI program analyzed data collected and developed corrective plans of action when needed with follow-up to ensure the correction was maintained or new corrective plans were developed.

~ Patient incidents/occurrences and medication errors were reported, but meeting minutes did not contain evidence of analysis and plans of action to reduce the incidents and improve patient safety and care.


3. The QAPI program reviewed and analyzed infections to identity and track avoidable healthcare-acquired infections.

~ Infection control and laboratory data tracked positive cultures.

~ QAPI meeting minutes only documented collection of the data, but did not show analysis or identification if corrective action needed to be implemented and followed for improvement of preventable hospital acquired infections.

~ On the afternoon of 10/15/2015, Staff B and R stated that infections were discussed, but not documented in QAPI meeting minutes.


4. The QAPI meeting minutes did not contain evidence QAPI projects were part of the QAPI program.

~ Meeting minutes did not show analysis of the projects and any corrective actions implemented from the projects

~ The meeting minutes did not provide evidence showing why projects were selected.


5. Review of the QAPI plan and meeting minutes did not provide evidence of who was the staff person that was responsible for the QAPI program. There was no clear identified roles or responsible parties identified in the meeting minutes and documents provided.


6. Adequate resources were not allocated for training on the QAPI program and the QAPI project process. The hospital had a QAPI tool for QAPI review and action, but it was not being used.

~ Review of QAPI meeting minutes, personnel files and interviews did not provide evidence those responsible for the QAPI program understood the QAPI process. Staff B and R told the surveyors that they had no training for developing, implementing and ensuring the QAPI program was effective.

~ Review of QAPI projects and meeting minutes showed lack of knowledge to analyze, implement and evaluate outcomes as evidenced by incomplete projects documented. Project documents were difficult to retrieve by those responsible and did not show corrective action taken when problems were identified.


7. QAPI meeting minutes did not show all departments/areas of the hospital was included in the QAPI process.

~Organ Procurement review was not included in the minutes. Two patients who died in the hospital were not reported to the organ procurement organization. Review of the Life Share Referral documents and Records #1 and 2 showed the organ procurement organization was not notified for possible organ and tissue referral.


8. The QAPI program did not include review of patients who were readmitted within 30 days to analyze whether the discharge plans met the patients needs.

QAPI meeting minutes did not show patient readmissions were analyzed to determine if:
a. The discharge plans met the patients needs after discharge;
b. Preventable readmissions could be identified; and/or
c. The discharge planning process needed to modified/changed.

On 10/15/2015, Staff R stated analysis of readmissions were not completed in QAPI.

Based on surveyor observations, review of hospital documents and staff interviews, the hospital failed to:

a. appoint a qualified medical staff member as the Chief of Radiology.

b. develop comprehensive policies and procedures for the radiology department based on nationally recognized standards of practice.

c. provide vaginal ultrasounds in a safe and sanitary manner by qualified staff.

Findings:

1. On 10/14/2015 at 12:45, Staff O identified Staff FF as the hospital's Medical Director/Chief of Radiology. The governing body failed to appoint a qualified medical staff member as Chief of Radiology.

~ Governing body meeting minutes did not contain evidence the governing body had appointed Staff FF as the Medical Director/Chief of Radiology.

~ On 10/16/2015, Staff J and R stated the hospital did not have a credential file for Staff FF.


2. On the afternoon of 10/14/2015, Staff O told the surveyors that radiology services included ultrasound. The radiology policies and procedures reviewed did not include policies and procedures for ultrasound procedures and the cleaning and storing of the ultrasound equipment, including the trans-vaginal ultrasound probe.

3. The 2015 Transvaginal Ultrasound Log showed that 3 procedures were performed from 9/15/15 to 10/1/15. On 10/15/15 10:45 a.m., Staff P confirmed he performed transvaginal ultrasounds.

a. When asked about cleaning/disinfecting, Staff P stated that he covered the probe with a probe cover before the procedure; removed and discarded the cover after the procedure; sprayed the probe with the disinfectant; and then dried the probe with a towel.

~ Staff P provided a document titled, "Radiology Transvaginal Transducer Cleaning Technique". The document defined the technique as follows: "use probe covers on all patients; after each patient use, remove the cover after use, clean transducer with soap and water and again with transseptic disinfectant."

~ Upon request, Staff P provided the manufacturer's cleaning and disinfection guidelines. The 2013 guideline recorded, "Warning: Disinfectant wipes and topical spray products are not FDA-cleared, high level disinfectants (HLD) ...if the possibility of cross-contamination or exposure to unhealthy or non-intact skin exist ...then high level disinfection should be performed." Staff P stated that no HLD disinfectant is currently available at the facility.

~ On 10/15/15 11:15 a.m., the surveyors notified Staff B (CNO) of these findings. She stated that no patients were scheduled for transvaginal ultrasounds on 10/15/15.

~ On 10/16/15 8:30 a.m., Staff B provided a memo written to Staff O (Radiology Director) stating as follows: " Effectively immediately Transvaginal Ultrasound Studies will be placed on hold until the proper cleaning supplies are obtained and competencies are completed.

b. On the afternoon of 10/14/2015, the surveyors requested Staff P's personnel file for training and competency verification.

~ On 10/15/2015 at 12:55 p.m., Staff J stated she did not have a training/competency file for Staff P and said the Department Manager would have the information.

~ On 10/15/2015 at 1:00 p.m., Staff O stated he did not have a file on Staff P. Staff O stated Staff J should have a file.

~ On 10/15/2015 at 2:00, the surveyors were provided a personnel file for Staff P. The file did not contain evidence of orientation to the hospital or the radiology unit. The file did not contain documentation by the medical staff or radiologist of skills competency. This finding was reviewed and verified with Staff J at the time of review.

Based on surveyors observations, review of hospital documents and interviews with hospital staff, the hospital failed to:

a. ensure the person identified as responsible for infection control/prevention had training in establishing and maintaining an effective on-going infection control program based on current principals and methods of infection control;

b. develop and implement an infection control program that monitored hospital-wide infection control practices to ensure a safe and sanitary environment and that infection control policies and procedures were adhered;

c. maintain an active effective on-going infection control program to prevent, control and investigate infections and communicable diseases; and

d. maintain an ongoing infection control program that reviews hospital practices and infections/communicable diseases, analyzes data on these practices and infections, develops qualitative plans of actions to and provides follow-up to ensure corrective actions are appropriate, working and sustained. Hospital leadership failed to ensure infection control concerns and issues are reviewed, analyzed and corrective actions are taken through the quality assessment and performance improvement process.

Findings:

1. On 10/14/2015, shortly after arrival, administrative staff identified Staff D as the infection control officer/preventionist (ICO).

~ Review of documents provided for Staff D did not demonstrate training and education in developing, implementing and maintaining an infection control/prevention program.

~ On the morning of 10/15/2015, Staff D told the surveyors that she did not have training in infection control principles. She stated she had just been asked to take the position on September 2015.

~ 2015 meeting minutes that contain infection control items did not contain evidence Staff D had been appointed as the ICO.


2. The infection control program did not conduct an hospital and community-wide Risk Assessment to identify the organism present in the hospital and community. This was confirmed with Staff B on the afternoon of 10/15/2015.

~ Review of meeting minutes contain infection control did not contain evidence the hospital's disinfectants had been review and approved.


3. The hospital did not have a prodecure for all practitioners to review the appropriateness of any antibiotics prescribed after 48-hours from the initial orders.

~ Meeting minutes containing infection control data did not demonstrate antibiotic use was being monitored to ensure appropriate antibiotics were being prescribed.


4. Meeting minutes containing infection control data did not contain evidence needle sticks, sharps injuries and other employee exposure events were being review and analyzed with corrective actions taken to reduce the events.


5. The infection control program did not contain immunizations histories and employee health.

~ Five of 19 employee health files did not contain complete immunizations as required. Prior meeting minutes (06/11/2015) recorded immunizations were not up-to-date, but no action was recorded and no follow-up was recorded in the meeting minutes.

~ Meeting minutes containing infection control data did not contain evidence employee illnesses were reviewed to ensure there were no transmissions of illness or diseases between patients and staff.


6. The infection control program did not maintain a current list of State Reportable Diseases with procedures for reporting.


7. The infection control program did not monitor all areas/departments of the hospital to ensure infection control policies and procedures and standards of practice were being followed.

~ Other than laboratory culture reports, the only surveillance/monitoring provided to the surveyors was hand hygiene. The data was so few in numbers that no analysis of compliance could be determined. Meeting minutes did not reflect analysis of hand hygiene compliance. Isolation practices and compliance and disinfectant applications were not monitored.

~ Observed on 10/14/2014, the hospital had a washer and dryer that was not commercial/hospital grade appliances. The washer, used for nursing home patients, was in the same room as the hospital's clean supplies.

~ On the afternoon of 10/14/2015, the surveyors noted "Point of Care" laboratory testing equipment in a hallway.

~ On 10/14/2015 and 10/15/2015, the surveyors noted the central sterile decontamination room and clean processessing room doors open to the public accessible corridor.

~ On 10/15/2015 at 1:45 p.m., Staff P told the surveyors that he "sprayed" disinfectant on the vaginal transducer probe. This did not follow manufacturer's guidelines for cleaning. See tag A-528 for details.

~ On the afternoon of 10/15/2015, one surveyor observed a biohazzard storage container in the room between isolation rooms.

~ On 10/15/2015 at 3:45 p.m., the counter top in the cental sterile decontamination room had wrapped sterile instruments on the counter.

~ On 10/16/2015, the surveyors found insulin available for use that had been opened March 2015.


8. The hospital did not have policies that addressed steps to take when there were discrepancies between a devide manufacturer's instructions and the sterilizer's manufacturer's instruction for completing sterilization. The hospital has an old steam autoclave. No manufacturer's instruction manual was provided for review.

9. The autoclave log did not identify the list of all items for each sterilization load with results of each load.

10. According to the QAPI Plan, QAPI program was responsible for review and analysis of infections to identity and track avoidable healthcare-acquired infections.

~ Infection control and laboratory data tracked positive cultures, but meeting minutes did not contain evidence of analysis or if any corrective actions were taken.

~ QAPI meeting minutes only documented collection of the data, but did not show analysis or identification if corrective action needed to be implemented and followed for improvement of preventable hospital acquired infections.

~On the afternoon of 10/15/2015, Staff B and R stated that infections were discussed, but not documented in QAPI meeting minutes.


11. Meeting minutes that contained infection control data did not contain evidence the hospital's leadership ensured the infection control program was reviewed, analyzed and implemented successful corrective actions plans.

Based on review of hospital documents and staff interviews, the hospital failed to provide the patients/complainants with a written notice of the complainant's grievance resolution containing all the required information in nine of eleven (#1, 2, 3, 4, 5, 7, 8, 9, and 10) grievances reviewed for the past year at the hospital. All eleven grievances had documentation that the grievances were resolved.

Findings:

Review of a hospital policy titled, "Grievance-Management", adopted on 07/30/2013, documented, "...The individual who initiated the grievance process will be informed in writing of the steps taken to investigate the grievance, the results of the grievance process, and the name and telephone number of the Administrative Support Manager to the Chief Executive officer and the date of Completion..."

~ On 10/15/2015 at 10:00 a.m., Staff R told the surveyors she was responsible for grievances. Staff R confirmed no written response had been sent/given to the complainant. Staff R stated she thought as long as the patient was in the hospital, the concern was not a grievance.

Based on surveyors' observations, review of hospital documents, and staff interviews, the hospital failed to develop and implement policies and procedures for restraints and seclusion that complied with the requirements.

Findings:

On 10/14/2015, the surveyors requested a copy of the hospital's restraint and seclusion policies. The only policy and procedure provided for review was entitled "Restraints" (no implementation/approval date recorded).

1. The policy and procedure provided did not include seclusion.

~ On 10/15/2015 at 2:15 p.m., Staff B confirmed the "Restraint" policy did not contain guidance or reference to seclusions. Staff B stated the hospital did not have a seclusion policy and procedure and did not use seclusion.

2. The policy and procedure did not identify the types of hospital approved restraints that were used in the hospital.

~ On the morning of 10/14/2015, the surveyors observed soft restraints in the hospital's storage room.

3. The policy and procedure contained inaccurate time frames. The policy recorded when a patient was restrained for behavioral health purposes, the physician or mid-level practitioner must evaluated the patient, in person at the following time frames: "...
A. 4 hours for patients ages 18 and older
B. 2 hours for patients ages 9 to 17
C. One hour for patients under age 9..."

~ 42 CFR 482.13(e)(12) requires "...When restraint of seclusion is used for the management of violent or self-destructive behavior...the patient must be seen fact-to-face within 1 hour after the initiation of the intervention...".

~ On 10/15/2015 at 2:15 p.m., the regulation and hospital policy and procedure was reviewed and findings confirmed with Staff B.

Based on interviews with hospital staff and review of personnel, education and training files, the hospital failed to ensure nursing staff were adequately trained and had demonstrated skills competency for their assigned care areas. Five (D, M, N, X and Y) of eight nursing staff files reviewed, of staff who provided patient care and had assignments in specialty areas, they did not have current job specific competencies, training and education for their assign tasks.

Findings:

On the morning of 10/14/2015, administrative staff told the surveyors Staff D was designated as the Infection Preventionist. Review of the personnel and training files for Staff D did not contain evidence of infection control training or education. On the morning of 10/14/15, Staff D said she did not have any infection control training.
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Staff M was the designated Sterile Processing technician. Review of the personnel and training files for Staff M showed the last evidence of sterile processing training was dated 1995. On the afternoon of 10/15/15, Staff M stated she did not know a Dart Test needed to be performed on the first load of the day to ensure adequate temperature for sterilization.

Staff B told the surveyors Staff N was the nurse responsible for the drug room. Review of the personnel and training files for Staff N did not contain evidence of orientation and competencies that was verified by the pharmacist for the position/responsibility. On 10/16/15 at 3:00 p.m., the pharmacist stated that he had not oriented or provided competency training and evaluation for Staff N.

On the afternoon of 10/14/2015, Staff B stated all nursing staff were responsible to work in the emergency department/room. On 10/16/15, surveyors reviewed the personnel files of 8 nursing staff for nursing skills competency. Four (Staff D, M ,X ,Y) of the 8 staff did not have current skills competencies.

Based on hospital document review and interviews with hospital staff, the hospital does not ensure the consultant pharmacist supervises and evaluates the performance and competency of pharmacy personnel who provide pharmacy services when the Consultant Pharmacist/Pharmacist in Charge is not on the premises.

Findings:

1. During the entrance conference on the morning of 10/14/215, Staff A and B told the surveyors Staff N was the nurse responsible for the drug room when the pharmacist was not available.

~ Review of Staff N's personnel and training files did not contain evidence of competency evaluations and orientation by the Consultant Pharmacist specific for the duties/responsibilities Staff N performed in the Drug Room.

~ On 10/16/15 at 3:00 p.m., the pharmacist stated that he had not oriented or provided competency training and evaluation for Staff N.


2. On 10/16/2015 at 12:15 p.m., the surveyors observed out of date insulin and Imodium medication in the medication room on the nursing unit available to patient use. This finding was verified with Staff II at the time of the observation.

~ Surveyors requested to review the Consultant Pharmacist weekly reports for the past year.

~ On 10/16/2015 at 2:10 p.m., Staff B and N told the surveyors that the last documented reports that could be found ended October 2014.

~ On 10/16/2015 at 3:00 p.m., the pharmacist was interviewed, he stated he could not produce visit reports and cited the changes in computer programs as the possible reason.

Based on surveyors' observations, review of hospital documents and interviews with hospital staff, the hospital failed to ensure the physical environment of the hospital was maintained to ensure the safety of patients and staff.

Findings:

Observations occurred on 10/15/2015 between 1:00 p.m. and 4:05 p.m.

1. Twelve size E medical oxygen tanks and several acetylene tanks were stored in the same room as the emergency generator.

2. The two-hour fire wall barrier separating the hospital from the nursing home had eight penetrations.

3. The two-hour fire wall barrier separating the hospital from the doctor's clinic had three penetrations.

4. Hospital doors did not have positive latching hardware on the clean and dirty linen rooms, maintenance room, and linen room beside patient room 109.

5. The hospital failed to provide a routine maintenance and periodic inspection and testing of the emergency power and transfer systems. On 10/15/2015 at 3:44 p.m., the maintenance supervisor and purchasing manager stated they did not have them.

6. The hydrocolator in physical therapy were not plugged directly into a ground-fault (FECI) receptacle.

7. The doors to the clean central sterile department was propped open.

8. For additional findings and details, see Life Safety Code survey (K-Tags).

Based on review of hospital documents and interviews with hospital staff, the hospital failed to review the discharge planning for patients readmitted within 30 days to analyze whether the discharge plans met the patients needs.

Findings:

1. Hospital staff provided a list of patients that were readmitted to the hospital. The list provided tracked patient readmission dates and documented the reason for readmission.

2. Review of quality (QAPI) meeting minutes did not show the patient readmissions were analyzed to determine if:
a. The discharge plans met the patients needs after discharge;
b. Preventable readmissions could be identified; and/or
c. The discharge planning process needed to modified/changed.

3. On 10/15/2015, Staff R stated analysis of readmissions were not completed in QAPI.

Based on review of hospital policies and procedures and staff interviews, the hospital failed to ensure the emergency room policies included a policy for emergency delivery when the physician is not present.

Findings:

1. The hospital is a small 37-bed general hospital. The hospital does not have an obstetric unit, but on 10/14/2015, nursing staff told the surveyors that pregnant women had presented to the emergency department in labor.

2. On the afternoon of 10/14/2015, Staff B told the surveyors that physicians and mid-level practitioners were not always present in the emergency room.

3. The emergency room policy manual did not contain a policy and procedure for nursing staff to follow for emergency delivery when the physician or mid-level practitioner was not present in the emergency department at the time of delivery.

4. On 10/15/2015 at 4:45 p.m., Staff B stated the hospital did not currently have a policy and procedure for nursing staff to follow if a laboring woman presented and the qualified practitioner was not present at the time of delivery.

Based on review of medical records and hospital documents and interviews with hospital staff, the hospital failed to ensure swing bed patients were provided ongoing activities based on each patient's comprehensive assessment and interests for six of six (Patient #16, 17, 19, 23 and 26) swingbed patients whose records were reviewed.

Findings:

1. Other than the comprehensive assessment, only Patient #19 had any swingbed activities charted. Medical records findings were review with Staff Z on the afternoon of 10/19/2015 and findings confirmed.

Patient #19, was admitted to the swingbed program on 09/26/2015 and discharged on 10/15/2015. The only swingbed activity provided was charted on 10/05/2015.

2. On 10/19/201 at 4:25 p.m., Staff E stated she did not always do activities with patients because she had other job responsibilities.