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1204 MOUND ST

NACOGDOCHES, TX 75961

PATIENT RIGHTS: GRIEVANCES

Tag No.: A0118

Based on interview and record review, the facility failed to ensure prompt resolution of grievances in 1 of 43 sampled patients ( Patient #39).

This deficient practice had the likelihood to affect all patients.

Findings include:


Review of the clinical record of Patient #39 revealed she was a 35 year old female who presented to the emergency department (ED) on 06/13/2017 at 5:31 a.m.. Patient #39 presented with complaints of abdominal cramping and pressure in the vaginal area. Patient #39 denied being pregnant and had a history of a tubal ligation.

Review of ED physician orders revealed on 06/13/2017 at 6:07 a.m., an order was written for a CT (computed tomography) of the "Abdomen Pelvis w/o Contrast Stat."


Review of ED physician orders revealed an order for a HCG (Human chorionic gonadotropin) Urine Qualitative which was written at 6:23 a.m. on 06/13/2017. Human chorionic gonadotropin is a hormone produced by the placenta after implantation. The presence of hCG is detected in some pregnancy tests.


Review of a facility's "Unusual Occurrence Form" revealed the following complaint was received on 06/13/2017:

"CT abdomen ordered on patient @ 0602;urine pregnancy ordered for patient @ 6:32 . Lab called at 0655 due to pregnancy in 'active' status. Urine pregnancy result positive at 0710. EDP notified of result by ....At time of EDP notification, patient was seen coming back from CT scan by RN. Patient was taken to CT scan prior to urine pregnancy test result."

"Corrective Action Taken
Radiology and EDP notified of error "

The report indicated that the investigation was assigned to Staff #'s 16, 14, and 3.

The resolution section was blank.

Underneath "Action Taken" section, the CT technologists stated she "interviewed the patient prior to scanning. The patient stated "no chance of pregnancy because she had a tubal". Patient was scanned only to find out that she had a positive pregnancy test. It was a tubal pregnancy and patient is being sent for a DNC(sic). I am following up with our Radiologists to see if we need to change our pregnancy protocol. This is extremely rare incident, but could possibly happen again. Procedure under review."


During an interview on 10/05/2017 after 1:00 p.m., Staff #16 confirmed they had not discussed the incident that occurred on 06/13/2017.The incident would be discussed during the October 2017 meeting. Staff #16 confirmed they had not put anything in place to correct the problem yet.


During an interview on 10/05/2017 after 2:00 p.m. the following was revealed:

Staff #3 confirmed the missing information and reported that she thought the issue had been discussed in the Radiation quality meeting.

Staff #14 reported she had not received a notice (via the intranet) about the incident. She had not done an investigation into the incident.

Staff #17 confirmed they had discussed a problem with screening of pregnant females in April 2017, but had not discussed the incident that occurred in June 2017 yet.

Over 3 ½ months later there had been no resolution and corrective action put into place to address and prevent this from occurring again.


Review of the facility's complaint and grievance policy named "PATIENT COMPLAINT AND GRIEVANCE PROCESS" date 07/01/2017 revealed the following:

Processing A Grievance

"The grievance will be dated using the date of receipt."

"The grievance will be completed in ComplyTrack(online reporting system-link available on the hospital intranet page) for reporting, investigation and/or action will be made."

QAPI

Tag No.: A0263

Based on observation, interview and record review :


A. the facility's Quality Assessment Process Improvement (QAPI) program failed to provide evidence of evaluation, assessment of documentation and measurable improvement in identified area needing improvement in 10 of 10 departments (Pharmacy, Infection Control, Imaging, Materials Management, Surgical, Therapy, Housekeeping/Laundry, Maintenance, Dietary/Nutritional, Health Information Management).

Refer to tag A 0273


B. the facility failed to have an effective patient safety program from January through June of 2017. The facility failed to document medication errors for 4 months (January,February, March and April), failed to analyze medication errors with intent to implement changes to improve error outcome, failed to establish adverse patient events (compliant, grievances and unusual occurrence) as part of the quality program and culture of safety within the facility, and failed to track adverse events with the intent to introduce changes that would improve outcomes.

Refer to tag A 0286


C. the hospital's leadership, (Governing Body, Administrator and Chief Nursing Officer) failed to ensure the facility's hospital wide Quality Assessment Process Improvement (QAPI) program included all department of the hospital participated in the QAPI program, ensured analysis of data collected, failed to document improvement measures and failed to educate the Staff in Quality requirements.

DATA COLLECTION & ANALYSIS

Tag No.: A0273

Based on observation, interview and document review, the facility's Quality Assessment Process Improvement (QAPI) program failed to provide evidence of evaluation, assessment of documentation and measurable improvement in identified area needing improvement in 10 of 10 departments (Pharmacy, Infection Control, Imaging, Materials Management, Surgical, Therapy, Housekeeping/Laundry, Maintenance, Dietary/Nutritional, Health Information Management).


Review of departmental reporting for QAPI revealed:


Pharmacy: January 17, 2017 2:00 PM, "No trends identified. When looking at error report, these are not actual medication errors that require an occurrence report. They are errors noted in the "MAC" (Data collection system) system. There were "11" medication errors which include "near misses", "2" ADRs (adverse drug reaction), 19 order entry errors. Will continue to track and send reports to unit managers.
February 14, 2017, 2:00 PM, "Staff #22 (Registered Pharmacist) has no report at this time due to problems with the data base.
March 14, 2017 2:00 PM, "No significant changes for this month. Review report, showing no adverse drug reactions in past three months, staff #22 is working on the report, he does not feel it is accurate. We are below goals on all targets".
April 11, 2017 2:00 PM, "Report reviewed, no updated ADR/order errors-staff #22 to send February report he is still working on errors: medications missing follow-up. Staff #22 researched this more the numbers do not include medications charted late. Those number is strictly medications that have no data documented".
May 9, 2017 2:00 PM, "Report reviewed".

Documentation from June, July, August and September were not made available for review.

The Five months reviewed documented no follow-up recommendations. The March pharmacy report was inaccurate, documenting no ADR's in the past three months. There were 2 ADR's in January , no report in February and a summary of the three months for March.

On 10/4/2017, in the nursing class room, an interview with staff #3, the Quality Director, confirmed the above findings.

The Quality Director also confirmed there was no written follow-up action or documentation of corrective action discussed or acted upon within the pharmacy report.

On 10/5/2017 in the class room the "Unusual Occurrence" reports revealed a pharmacy compounding error. A physician ordered Dextrose 15 % in Water (D15W). The pharmacy caught the error and notified the nursing staff that the D30W had been sent to the floor with a D15W label. Then after a second recalculation the D30W was determined to be D23W.

An interview with staff #22, the Registered Pharmacist, indicated he had educated his staff on correct compounding calculation tables but confirmed he had no evidence the education had occurred. There was no signature sheet or computer education confirmation sheet to verify the on line review had taken place.

Further discussion interview with staff #22 confirmed he did not in-service the nursing staff when medication errors, order entry errors or when adverse drug reactions were identified. He indicated that was the Nursing leadership's responsibility.

Infection Control: Not reflected in the QAPI program meeting minutes.

An interview with staff #3 confirmed the facility did not have an Infection Control Professional at present.

Imaging services: Not reflected in the QAPI program meeting minutes.

Material Management services: Not reflected in the QAPI program meeting minutes.

Surgical Services, including Pre-operative, peri-operative and Post-operative services : Not reflected in the QAPI meeting minutes. On 10/5/2017 in the afternoon a review of surgical temperature and humidity logs for the month of June revealed temperatures and humidity that were recorded out of range (temperature 68-73 degrees and humidity 20-60%) for safe surgical procedures and no evidence of corrective action taken.

Therapy services: Not reflected in the QAPI program meeting minutes.

House keeping and laundry services: Not reflected in the QAPI meeting minutes.

Maintenance: Not reflected in the QAPI program meeting minutes.

Dietary /Nutritional services: Not reflected in the QAPI meeting minutes.

HIM (Health Information Management): Not reflected in the QAPI meeting minutes.

PATIENT SAFETY

Tag No.: A0286

Based on document review and interview the facility failed to have an effective patient safety program from January through June of 2017. The facility failed to document medication errors for 4 months (January,February, March and April), failed to analyze medication errors with intent to implement changes to improve error outcome, failed to establish adverse patient events (compliant, grievances and unusual occurrence) as part of the quality program and culture of safety within the facility, and failed to track adverse events with the intent to introduce changes that would improve outcomes.


This deficient practice had the likelihood to effect all patients of the hospital.


Findings included:

On the morning of 10/5/2017, in the class room, staff #3, the Quality Director, explained the patient complaint and grievance resolution process. No policy was provided. The investigation process was done by each department manager and the information was given to staff #3. She would then resolve the complaint. She would contact the patient with a letter. There was no further review process.

The complaint and grievance logs were reviewed with the assistance of the Quality Director. The complaint/grievance log from March 2017 to September 2017 were reviewed. The log contained 76 patient complaints/grievances. Of the 76 complaints none were documented within the safety program meeting minutes. The review of the meeting minutes are found below.

A review of the January 17, 2017 "Performance Improvement and Patient Safety/Patient Care Services Committee" reflected following reports were reviewed:

"1. Falls Management Report: A review of the year 2016 was documented. There was no documentation to reflect attempted intervention had been successful in the reduction of falls or injuries related to falls.

2. Pain Management Report: Hospital's goal is less than 50. (Sic) 78 missed the required follow up on pain medication administration. Staff #22, (Registered Pharmacist) reminded managers that basically the nurses are administering medication without the correct order. Nurses are giving medication without following the pain scale. Staff brought up an incident that occurred on her unit where the nurse was able to pull the pain medication out of the MAK (electronic medication storage unit)) before the order was even put in the system. and the MAK show (Sic) it like it was already ordered. The RPH requesting that the staff get with him on specific error (sic) like that. RPH has a report that can assist with education. Also brought up by the committee the education needs to be done on mild, Moderate and Severe pain scale and the nurses giving the medication specific for those pain scale (sic) according to the orders."

The above discussion did not result in evidence of action taken to resolve pain medication being administered without assessment of pain reduction..

"3. Resuscitation Efforts and Rapid Response Team effectiveness Report: 2 Rapid Response in December. 1 on intermediate care, 1 on 3T (name of patient unit) 4 code blues called with 1 being called outside the critical care area. 2 codes were unsuccessful in the ER (emergency room)."

There was no documentation of discussion of methods to improve rapid response, no discussion of changes in the system that could have been beneficial to the team or provided a positive outcome for the patient.

"4. Restraint report: none for the month of December.

5. Critical Lab Value Report: Hospitals goal is 90-100. December at 65%. Staff will continue to work on reporting critical lab values timely. Remainder of report discusses issues with nursing documentation. No resolution or plan or correction was documented.

6. Registered Nurse Assessment Report. A total of 21 charts reviewed and for December hospital is at 100%.

7. H&P (History and Physical) compliance. For December 91% of the H&P's are (sic) the charts within 24 hours. Hospital is at 55% for the required elements. Asked if scores are brought up at credentialing meetings. CNO brings the information to the Medical executive committee. Facility is receiving denial in payment related to problems with H&P's. No resolution or plan of correction was documented."


The remainder of the above report documented Project Improvements. The report did not address complaints and/or grievances and failed to document actual medication errors.

The "Performance Improvement and Patient Safety/Patient Care Services Committee", dated February 14, 2017 listed the same departments and services as above. There was no presentation of medication errors reported and no review of patient complaints and grievances documented.

The "Performance Improvement and Patient Safety/Patient Care Services Committee", dated March 14, 2017 listed the same departments and services as above. There was no presentation of medication errors reported and no review of patient complaints and grievances documented.

The "Performance Improvement and Patient Safety/Patient Care Services Committee", dated April 111, 2017 listed the same departments and services as above. "A medication report was reviewed, no updated ADR (adverse drug reaction) order errors- RPH to send February report he is still working on errors; medication missing follow-up-RPH researched this more the numbers do not include medications charted late, this number is strictly medications that have no data documented". There was no discussion, explanation plan of correction or resolution for the incomplete report of failures noted in the report. There was no review of complaints and grievances.

The "Performance Improvement and Patient Safety/Patient Care Services Committee", dated May 9, 2017 listed the same departments and services as above". The medication management report was documented as "Report reviewed". No further documentation, discussion or resolution was documented. There was no documentation for patient complaints and/or grievances.

The "Performance Improvement and Patient Safety/Patient Care Services Committee", dated June 13, 2017 listed the dame departments and services as above. The medication Management Report was documented as "Report reviewed. ADR, 4 order entry errors, 5 medication errors. Will no longer report on errors with wrong patient and scanner errors". No further documentation was identified. No patient compliant or grievances were listed, or discussed and no corrective action to resolve any conflict was documented.

A review of unusual occurrences identified on 6/13/2017 "Orders for Pitocin induction (20 units in 1000 ml L/R premix) to be started to lowest port mainline IV of L/R at 5:30; upon entering room after report from staff RN #24, infusion rate was increased to 8 milli units/min or 24 ml/hr at 7:20 and again was rate increased to 10 milli units/min or 30 ml/hr, and fetal heart rate monitor at 7:38 by second staff RN #25. Rate increased per third staff RN #26 staff RN at 8:00 to 12 mill iunit/min or 36 ml/hr. Assisted up to bathroom at 8:05 and discovered IV Pitocin line was capped and looped onto infusion pump. Fluid hadn't been connected to main line IV and was infusing onto the floor. Port cleaned and Pitocin induction initiated at 08:05 and increased per clinical care guidelines."

The resolution of this event indicated "No investigation was required". The documented outcome was "I spoke with Dr. Koerner about event discussed issue (sic). Spoke to staff RN #1, she apologized, was in a rush had 3 deliveries and thought she attached the line. I also spoke with staff RN #2 about not checking the lines when assessment done. Encourage staff #1 to speak to and apologize to Dr. Koerner".

Category of Occurrence was "No Harm". The patients (mother and baby) were never mentioned in this investigation.

This unusual occurrence was not listed as a medication errors or found in the QAPI Safety committee report.












10135

Review of the clinical record of Patient #39 revealed she was a 35 year old female who presented to the emergency department (ED) on 06/13/2017 at 5:31 a.m.. Patient #39 presented with complaints of abdominal cramping and pressure in the vaginal area. Patient #39 denied being pregnant and had a history of a tubal ligation.

Review of ED physician orders revealed on 06/13/2017 at 6:07 a.m., an order was written for a CT (computed tomography) of the "Abdomen Pelvis w/o Contrast Stat."


Review of ED physician orders revealed an order for a HCG (Human chorionic gonadotropin) Urine Qualitative which was written at 6:23 a.m. on 06/13/2017. Human chorionic gonadotropin is a hormone produced by the placenta after implantation. The presence of hCG is detected in some pregnancy tests.


Review of a facility's "Unusual Occurrence Form" revealed the following complaint was received on 06/13/2017:

"CT abdomen ordered on patient @ 0602;urine pregnancy ordered for patient @ 6:32 . Lab called at 0655 due to pregnancy in 'active' status. Urine pregnancy result positive at 0710. EDP notified of result by ....At time of EDP notification, patient was seen coming back from CT scan by RN. Patient was taken to CT scan prior to urine pregnancy test result."

"Corrective Action Taken
Radiology and EDP notified of error "

The report indicated that the investigation was assigned to Staff #'s 16, 14, and 3.

The resolution section was blank.

Underneath Action Taken was that the CT technologists said she interviewed the patient prior to scanning. The patient stated "no chance of pregnancy because she had a tubal. Patient was scanned only to find out that she had a positive pregnancy test. It was a tubal pregnancy and patient is being sent for a DNC. I am following up with our Radiologists to see if we need to change our pregnancy protocol. This is extremely rare incident, but could possibly happen again. Procedure under review."


Review of Quality Improvement minutes dated 04/27/2017 revealed they" discussed the request from Diagnostic technologists for authorization form for pregnant women to sign if they elect to have study that requires radiation. We will be investigating this as part of our radiation safety policy and present it in the future to RSC (Radiation Safety Committee)."

Review of Quality Improvement minutes dated 07/20/2017 revealed no documentation of the incident that occurred on 06/13/2017 being addressed.

The facility identified concerns in the area of screening pregnant women in April 2017 and had the incident that occurred in June 2017 involving a pregnant female and by October 2017 they still not had addressed or implemented corrective actions.

During an interview on 10/05/2017 after 1:00 p.m., Staff #16 confirmed they had not discussed the incident that occurred on 06/13/2017. The incident would be discussed during the October 2017 meeting. Staff #16 confirmed they had not put anything in place to correct the problem yet.

During an interview on 10/05/2017 after 2:00 p.m., Staff #17 confirmed they had discussed a problem with screening of pregnant females in April 2017, but had not discussed the incident that occurred in June 2017 yet.


During an interview on 10/05/2017 after 2:00 p.m. , Staff #3 confirmed the missing information and reported that she thought the issue had been discussed in the Radiation quality meeting.

Over 3 ½ months later there had been no quality indicators and corrective action put into place to address and prevent this from occurring again.

QAPI EXECUTIVE RESPONSIBILITIES

Tag No.: A0309

Based on observation, interview and document review, the hospitals leadership, (Governing Body, Administrator and Chief Nursing Officer) failed to ensure all departments of the hospital participated in the QAPI program, ensured analysis of data collected, failed to document improvement measures and failed to educate the Staff in Quality requirements.


Findings included:


On 10/4/2017 in the class room an interview with staff #3 confirmed she was the Quality Director. Review of the documentation for the Quality program revealed data was presented in the first quarter "Quality Improvement Committee Minutes". Topics listed under "New Business";

"A. Performance Improvement Reports
Nursing: QI (Quality Indicators dashboards)
Fall Management
Medication Management
Pain Management
Critical Lab Values
History and Physical Compliance
B. Department Performance Improvement:
Rehab.
Core measures (Sepsis update)
Leapfrog
Joint Commission update.
HCAHPS
Environment of Care
Adjourn"

The above referenced Quality Improvement Committee minutes failed to include documentation of participation for all departments of the hospital, failed to indicate analysis of information that was collected and failed to reflect resolution to the problems that were identified.


A review of the facility's organizational chart indicated the following departments:
Accounting
Materials Management
Revenue Cycle
Information System
Clinical out comes
Contract Administration
HIM (Health Information Management)
These seven departments were found listed under the management of the Chief Financial Officer.

Emergency Department
Emergency ,management System
Perioperative
OR (Operating Room)
GI (Gastroenterology)
Day surgery
Cath Lab (Cardiac Catheterization)
Nursing Administration
Labor and Delivery
Obstetric and Pediatric
Critical Care
Medical Surgical
Laboratory
Medical Imaging
Women's Wellness
Therapy services
Cardiac Rehab
Cardiopulmonary services
Quality
Regulatory
Infection Control
Risk Management
Performance Improvement
In-Patient Rehabilitation.

The above listed 11 departments were under the management of the Chief Nursing Officer (CNO).

Of the 17 department and 12 additional sub departments, Nursing and In-patient Rehabilitation were reflected in the Quality meeting minutes.

On 10/4/2017 in the late morning an interview with staff #1, the CNO, confirmed staff #3 had no Quality management experience prior to being hired for the position of QAPI Director. The CNO further confirmed staff #3 had not had any Quality training or mentoring with an experienced QAPI manager since taking the position.

On 10/4/2017 in the afternoon an interview with staff #3 confirmed she was the QAPI/Risk manager and that the facility did not presently have an Infection Control Professional.

NURSING SERVICES

Tag No.: A0385

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


A. to ensure the Chief Nursing Officer had clear delineation of her responsibilities outlined. Review of the facility's organizational chart revealed the Chief Nursing Officer (CNO) was over Emergency Services, Perioperative Services, Cath Lab, Nursing Administration, Bomar Rehab, Quality, Hospitalist Navigator, Ancillary Services and Clinical informatics. Review of the organization chart revealed the lab physician and staff being directly under the CNO.

Refer to tag A0386 for additional information.


B. ensure adequate numbers of nursing staff as required by their nursing matrix. Based on interviews and record review, the facility failed to ensure adequate numbers of nursing staff as required by their nursing matrix on 2 of 3 units (Emergency department and 3 Tucker Medical/surgical unit) that were checked

Refer to tag A0392 for additional information.


C. ensure registered nurses properly evaluated the care of 1 of 43 sampled patients (Patient #25). Review of the clinical record of Patient #25 revealed, he was a 35 year old male who presented to the Emergency department (ED) on 03/16/2017 at 0056 a.m. with a chief complaint of being hit by a motor vehicle. The initial vital signs documented were blood pressure of 106/70, pulse of 80, respirations 17, temperature of 98.4 and oxygen saturation of 95 percent on room air. The patient was given intravenous fluids and a controlled substance for pain without physician's order.

Refer to tag A0395 for additional information.


D. ensure that medications were stored appropriately, prepared and administered in accordance with nationally accepted standards of practice. Multidose vials were observed opened and re-used by staff for multiple patients. Long acting medications were crushed prior to administration contrary to manufacturer's instruction.

Refer to tag A0405 for additional information.

ORGANIZATION OF NURSING SERVICES

Tag No.: A0386

Based on interview and record review, the facility failed to ensure the Chief Nursing Officer had clear delineation of her responsibilities outlined.

This deficient practice had the likelihood to cause harm to all patients.


Findings include:


Review of the facility's organizational chart revealed the Chief Nursing Officer (CNO) was over Emergency Services, Perioperative Services, Cath Lab, Nursing Administration, Bomar Rehab, Quality, Hospitalist Navigator, Ancillary Services and Clinical informatics. Review of the organization chart revealed the lab physician and staff being directly under the CNO.


During an interview on 10/05/2017 after 8:00 a.m., Staff #1 confirmed she was responsible for laboratory services.


Review of the personnel file of Staff #1 revealed the effective date she took over as CNO was 02/22/2016. There was an evaluation on the file dated 08/05/2016 which gave no description of what her duties were for all of these departments.

Review of the personnel file of Staff #18 revealed she was the new Manager/Director of the lab. Staff #18's job description was signed on 08/15/2017. The "Chief Nursing Officer" was listed as being her supervisor.

During an interview on 10/05/2017 after 1:00 p.m., Staff #10 confirmed there was no job description on file for Staff #1 as CNO. Staff #10 provided a copy of what was supposed to be on the file. The form was named "DESCRIPTION OF JOB AND PERFORMANCE EVALUATION."

STAFFING AND DELIVERY OF CARE

Tag No.: A0392

Based on interviews and record review, the facility failed to ensure adequate numbers of nursing staff as required by their nursing matrix on 2 of 3 units ( Emergency department and 3 Tucker Medical/surgical unit) that were checked.

This deficient practice had the likelihood to affect all patients.


Findings included:

Review of the "Staffing Guidelines for the Emergency Department" dated January 1986 revealed the following:

EMERGENCY DEPARTMENT

Shifts RNs/LVNs
7a to 7p 5
9a to 9p 1
12a to 12p 1
12p to 12a (a flex) 1 as needed
7p to 7a 5


Review of staffing from the time frame of 09/24/2017-10/03/2017 the following was found:

Day shift

10/01/2017 there was no 9 a-9p Nurse listed;
09/28/2017 there were 3 RNs on 7a-7p until 9a instead of 5 RNs.
09/27, 09/26 and 09/25/2017 there were 4 RNs on 7a-7p until 9a instead of 5 RNs.

Night shift

On 9/30, 9/27, 9/25, and 9/24/17, there were 4 RNs instead of 5 RNs working after 12a on the 7p-7a shift.

During interviews the following was reported about staffing:

There used to be 2 nurses between 12-12 a. The float nurse helped with providing staff with lunch breaks. The charge nurse gives staff lunch break relief now. The charge nurse has her own patients and takes over the other nurses patients while they are on break.

At times we can be short staffed. There used to be 1 nurse who came in from 9 a-9 and 2 nurses came in from 12-12 a. Recently we went to 1 nurse from 12-12 a.

During an interview on 10/05/2017 after 3:00 p.m., Staff #14 confirmed they were no longer using the float nurse from 12-12 a and that it had to do with the number of patients not the acuity of patients. Staff #14 confirmed the dates she did not meet the numbers of nurses that were required. Staff #14 reported that sometimes the Administrative nurses helped out, but they were not documenting when they worked the floor.



MEDICAL/SURGICAL (3 TUCKER)



Review of the "STAFFING MATRIX" for 3 Tucker revealed staffing numbers for RN's (Registered nurses), NA (nurses aide), and UC (unit clerk).

Review of staffing numbers from 09/23-10/03/2017 revealed documentation of LVNs (licensed vocational nurse) being used on 09/29, 09/28, 09/25, 09/24, and 09/23/2017.

During an interview on 10/06/2017 after 9:05 a.m., Staff 4 confirmed the staffing matrix did not mention using LVN's. The LVN's were being used in place of RN's.

RN SUPERVISION OF NURSING CARE

Tag No.: A0395

Based on interview and record review the facility failed to ensure registered nurses properly evaluated the care of 1 of 43 sampled patients (Patient #25).

This deficient practice had the likelihood to cause harm to all patients.


Findings include:


Review of the clinical record of Patient #25 revealed he was a 35 year old male who presented to the Emergency department (ED) on 03/16/2017 at 0056 a.m. with a chief complaint of being hit by a motor vehicle. The initial vital signs documented were blood pressure of 106/70, pulse of 80, respirations 17, temperature of 98.4 and oxygen saturation of 95 percent on room air.

Review of nursing notes and lab results revealed the following documentation on 03/16/2017:

0100 a.m. a blood pressure of 117/65 and a pulse of 87;
0105 a.m. the hemoglobin was 14.8 (reference range being 14.0-18.0) and hematocrit was 43.3 (reference range being 42.0-52.0);
0200 a.m. a blood pressure of 135/76 and a pulse of 87;
0400 a.m. a blood pressure of 121/68 and a pulse of 84;
0420 a.m. the hemoglobin was 13.8 (reference range being 14.0-18.0) and hematocrit was 40.5 (reference range being 42.0-52.0);
0438 a.m. the pain agent Toradol was administered intravenously;
0600 a.m. a blood pressure of 109/71 and a pulse of 99;
0700 a.m. a blood pressure of 117/67 and a pulse of 97;
0730 a.m. a blood pressure of 94/52 and a pulse of 93;
0730 a.m. the pain agent Dilaudid 0.5 milligrams was administered intravenously.

From time of arrival at 0056 a.m. to 0815 a.m., Patient #25 received a total of 5150 cc of normal saline.

At 0815 a.m. the blood pressure was 123/76 and the pulse was 91.

At 0940 a.m. the pain agent Dilaudid 0.5 milligrams was administered intravenously.

Review of physician orders revealed the following dated 03/16/2017:

At 1:01 a.m. "NORMAL SALINE 0/9% Intravenous 1000 mL Over 0.5 h for 1 bags."
At 3:01 a.m. ""NORMAL SALINE 0/9% Intravenous (1000 ML bag) @150mL/Hour Over 7H for 30 days"
At 7:30 a.m. "HYDROMORPHONE(dilaudid) "0.5 MG Intravenous ONE TIME STAT for 1 Doses"

There was no physician's order for the administration of 5150 cc of fluid and there was not an order for the second dose of Dilaudid that was administered.

At 10:54 a.m. the hemoglobin was 11.5 (reference range being 14.0-18.0) and hematocrit was 33.8 (reference range being 42.0-52.0) at 10:54 a.m.

Review of a physician's procedure note dated 03/16/2017 at 1:19 p.m., revealed Patient #25 had a renal laceration.

At 6:51 p.m. the hemoglobin had dropped to 8.9 (reference range being 14.0-18.0) and the hematocrit was 26.5 (reference range being 42.0-52.0).

At 10:58 p.m. the hemoglobin was 8.2 (reference range being 14.0-18.0) and hematocrit was 24.5 (reference range being 42.0-52.0) at 10:54 a.m.

03/17/2017

At 05:00 a.m. the hemoglobin had dropped to 6.4 (reference range being 14.0-18.0) and hematocrit was 18.6 (reference range being 42.0-52.0).

At 5:26 a.m. critical lab values were called to nursing.

At 6:00 a.m., physician's orders for a consent and transfusions were written.

Review of transfusion records revealed the first documented transfusion was started at 8:00 a.m. (3 hours after the critical lab results).

During an interview with Staff #14 on 10/04/2017 after 2:00 p.m., confirmed the medication error, there being no order to administer over 5000 cc of fluids and the delay in blood administration.

ADMINISTRATION OF DRUGS

Tag No.: A0405

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

A. ensure multi-dose vials of medication were properly stored and used.

B. ensure nurses used proper infection control techniques when compounding medications.

C. ensure medications were handled properly during administration.

D. ensure medications were not crushed when it was contraindicated.

E. ensure medications were administered timely and as ordered by the physician.



This deficient practice had the likelihood to cause harm to all patients.


Findings include:


During an observation on 10/04/2017 after 10:30 a.m. the following was observed:


A nursing medication storage cart was checked. One of the drawers had an open multi-dose vial of bacteriostatic water which did not have an open date on it.

Staff #13 was observed preparing for medication administration to Patient #22 on 10/04/2017 after 11:15 a.m. Staff #13 took a vial of steroid methyl Prednisonlone (40 milligrams) and the open vial of bacteriostatic water and was preparing to mix them. Staff #13 had to be reminded that we did not know how old the bottle of sterile water was, before she changed in out. After getting a new bottle of sterile water she preceded to remove the protective caps off the medication. Staff #13 drew the medication and sterile water up and mixed as required without sanitizing the top of the vials first.


Review of a facility's policy named "Multiple Dose Injectables" dated May 2015 revealed the following:

"Multiple dose vials may be used for up to twenty-eight days from the date of first entry into the vial, except where otherwise stated by policy or manufacturer. Vials must be labeled with the date and time of expiration upon first use. Multiple dose vials should be examined for contaminants before using. Any multiple use vial that is suspected to be contaminated should be discarded ..."
"When multiple dose vials need to be used:
Read the manufacturer's label to verify that the vial is a multiple dose vial
Inspect the vial for visible defects.
*Wipe the top of the vial with alcohol.
*Use aseptic technique when drawing out of the vial.
*Label vial with date and time of expiration."



Staff #13 had the following medications a bag of Iron sucrose, a packet of Cholestyramine (cholesterol med), Volsartan (hypertensive med) , Amiodorone 1/2 tablet (steroid med), Toprol XL(hypertensive med) and Lovenox injectable (ant-coagulant med). Staff #13 placed the medications in her uniform pocket and entered Patient #22's room.

Staff #13 crushed the medications tablets Valsartan, Amiodorone 1/2 tablet, and Toprol XL. They were all mixed in water in a cup and you could see pieces of the protective pill coatings floating in the water. Staff #13 administered the medications via gastrostomy tube.

Review of the facility's policy named "Medication-Crushing" dated May 2015 revealed the following:

"Do not crush doses formulated as extended-release, enteric coated, encapsulated beads, wax matrix, or sublingual products."

"Medications That Should Not Be Crushed"

"Toprol -XL"






Review of physician orders revealed Patient #22 was a 97 year old female with diagnoses which included heart failure.

`Review of the medication administration record on Patient #22 revealed the following due time for her medications:

Toprol XL was scheduled for 9:30 a.m. daily.
Amiodarone was scheduled for 9:30 a.m. and 9:00 p.m. every day.
Questran (Cholestyramine/Aspartame) was scheduled for 9:30 a.m. and 2:00 p.m. every day.
Lovenox was scheduled for 10:00 a.m. and 10:00 p.m. everyday.
Valsartan was scheduled for 9:30 a.m. daily.

Staff #13 was observed to administer all of the medications to Patient #22 on 10/04/2017 after 11:15 a.m (over 1-1.5 hours) after the time they were due.

Review the facility's policy named "STANDARDIZED HOURS FOR DRUG DISTRIBUTION" dated 05/01/2011 revealed the following:

"POLICY:
Medications shall be given 30 minutes before the stated time or 30 minutes after stated time (i.e. if medication is to be distributed at 0900, begin distributing the medications at 0830 and be finished at 0930)."

PHARMACIST RESPONSIBILITIES

Tag No.: A0492

Based on document review and interview the pharmacist failed to submit evidence of follow-up action when medication errors were identified, when order entry errors were identified, when adverse drug reactions were identified or when pharmacy staff made compounding errors.

This deficient practice had the likelihood to effect all patients of the hospital.

Findings included.

On 10/4/2017 a review of the "Performance Improvement and Patient Safety/Patient Care Services Committee" meeting minutes were reviewed. Notable findings are listed below.

January 17, 2017 2:00 PM, "No trends identified. When looking at error report, these are not actual medication errors that require an occurrence report. They are errors noted in the "MAC" system. There were "11" medication errors which include "near misses", "2" ADRs (adverse drug reaction), 19 order entry errors. Will continue to track and send reports to unit managers.
February 14, 2017, 2:00 PM, "Staff #22 (Registered Pharmacist) has no report at this time due to problems with the data base.
March 14, 2017 2:00 PM, "No significant changes for this month. Review report, showing no adverse drug reactions in past three months, staff #22 is working on the report, he does not feel it is accurate. We are below goals on all targets".
April 11, 2017 2:00 PM, "Report reviewed, no updated ADR/order errors-staff #22 to send February report he is still working on errors: medications missing follow-up. Staff #22 researched this more the numbers do not include medications charted late. Those number is strictly medications that have no data documented".
May 9, 2017 2:00 PM, "Report reviewed".

Documentation from June, July, August and September were not made available for review.

None of the Five months reviewed documented any follow-up recommended. The five months of reports simply listed the findings.

On 10/4/2017, in the nursing class room, an interview with staff #3, the Quality Director confirmed the above findings.

The Quality Director also confirmed there was no written follow-up action or documentation of corrective action discussed or acted upon within the pharmacy report.

On 10/5/2017 in the class room the "Unusual Occurrence" reports revealed a pharmacy compounding error. A physician ordered Dextrose 15 % in Water (D15W). The pharmacy caught the error and notified the nursing staff that the D30W had been sent to the floor with a D15W label. Then after a second recalculation the D30W was determined to be D23W.

An interview with staff #22, the Registered Pharmacist, indicated he had educated his staff on correct compounding calculation tables but confirmed he had no evidence the education had occurred. There was no signature sheet or computer education confirmation sheet to verify the on line review had taken place.

Further discussion interview with staff #22 confirmed he did not inservice the nursing staff when medication errors, order entry errors or when adverse drug reactions were identified. He indicated that was the Nursing leadership's responsibility.

RADIOLOGIC SERVICES

Tag No.: A0528

Based on interview and record review, the facility failed to ensure radiation policies and procedures were implemented to identify and protect pregnant women and women who were of child bearing age from hazards in 3 of 43 sampled patients (Patient #'s 39, 41 and 42).

Refer to tag A0536 for additional information.

SAFETY FOR PATIENTS AND PERSONNEL

Tag No.: A0536

Based on interview and record review, the facility failed to ensure radiation policies and procedures were implemented to identify and protect pregnant women and women who were of child bearing age from hazards in 3 of 43 sampled patients (Patient #'s 39, 41 and 42).

This deficient practice had the likelihood to cause harm to all women of child bearing age who presented for radiology services.


Findings include:


Review of the clinical record of Patient #39 revealed she was a 35 year old female who presented to the emergency department (ED) on 06/13/2017 at 5:31 a.m.. Patient #39 presented with complaints of abdominal cramping and pressure in the vaginal area. Patient #39 denied being pregnant and had a history of a tubal ligation.


Review of ED physician orders revealed on 06/13/2017 at 6:07 a.m., an order was written for a CT (computed tomography) of the "Abdomen Pelvis w/o Contrast Stat'.


Review of ED physician orders revealed an order for a HCG (Human chorionic gonadotropin) Urine Qualitative which was written at 6:23 a.m. on 06/13/2017. Human chorionic gonadotropin is a hormone produced by the placenta after implantation. The presence of hCG is detected in some pregnancy tests.


Review of a facility's lab report dated 06/13/2017 at 6:23 a.m., revealed Patient #39's hCG level was 133331 (reference ranges being <3 mIU/mL) for non-pregnant females. For an approximate gestational age of 5-6 weeks the range fell between 10000-100000.


Review of an undated and untimed radiology screening tool on Patient #39 revealed documentation that she was not pregnant and had a tubal.


Review a radiology report dated 06/13/2017 revealed the CT scan started at 7:10 a.m. and ended at 7:30 a.m.



Review of a final imaging report date 06/13/2017 at 7:30 a.m. revealed Patient #39 had a Computed Tomography of the abdomen and pelvis performed. Some of the following was documented:

"..The uterus is not enlarged. There are bilateral adnexal cystic structures, both measuring approximately 4 cm in diameter ...

No other abnormal masses, lymphadenopathy, or fluid collections area found ..."


Review of an ultrasound report dated 06/13/2017 at 9:25 a.m., revealed the following:

"IMPRESSION: No evidence of an intrauterine gestation with thick walled cystic structure located between the left ovary and the uterus somewhat concerning for ectopic pregnancy ..."

Review of physician orders dated 06/13/2017 for 12:02 p.m. revealed the following:

" ...Admit to Location: Day surgery Stat ...
...Diagnosis: left ectopic pregnancy Stat;
..Obtain Signed Consent open or lap left salpingectomy and possible left oophorectomy Stat ..."




Review of the clinical record of Patient #41 revealed she was a 24 year old female who presented for a CT scan on 09/08/2017 at 9:20 a.m. and was screened.

According to the "CT SCAN SCREENING FORM" the following information was listed:

"FOR FEMALE PATIENTS:

ARE YOU POST-MENOPAUSAL? YES NO

IF NO, ARE YOU PREGNANT OR BREASTFEEOING? YES NO

IF NO, DATE OF LAST MENSTRUAL PERIOD:" _____

The first question was left blank and the second was answered as being no. There was no documentation of the last menstrual period being recorded on the form. There was also no documentation of a pregnancy test being performed.



Review of the clinical record of Patient #42 revealed she presented on 09/08/2017. Review of the "CAT SCAN Screening Form" revealed there was no place on the form asking date of birth. Staff failed to document the last menstrual period on the form.

Patient #42's form was the Spanish version.



During an interview on 10/05/2017 after 1:00 p .m, Staff #16 confirmed the missing information on the forms and the condition of the forms for Spanish speaking patients.. Staff #16 reported that the techs were responsible for performing the screens. Staff #16 reported that the tech documented that the screen on Patient #39 was done at 7:30 a.m. (after the CT scan). The pregnancy test on Patient #39 was done in the ED and they did not obtain the results timely.

Staff #16 reported the last Quality meeting was on 07/20/2017. They had not discussed the incident on Patient #39 that occurred on 06/13/2017. The incident would be discussed during the October 2017 meeting. Staff #16 confirmed they had not put anything in place to correct the problem yet.

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on observation, interview and record review the facility failed to ensure there was an effective infection control program and staff used proper infection control techniques in 5 of 5 areas (Clean utility room on 3 Tucker, Clean supply room on 3 Tucker, 3 Tucker Nursing unit, Main Respiratory supply room and Emergency Department). The facility also failed to follow their policy and document corrective action for temperatures and humidities outside the range of safety for surgical supplies, medications and procedures for the month of June, July, August and September (4 months) 2017.




This deficient practice had the likelihood to cause harm on all patients.


Findings include:


During an observation on 10/04/2017 after 10:30 a.m. the following was observed:


Clean utility room on 3 Tucker

The tile flooring had a build-up of spills, debris and dirt.

Respiratory supplies and personal protective equipment ( PPE), open boxes of gloves were stored in cabinet that was soiled with spills.



Clean supply room on 3 Tucker

The tile flooring had a build-up of spills, debris and dirt. There were cracks in the tile where you could see the subfloor underneath. There was no way the floor could be properly cleaned with the cracks in the floor. The baseboards were soiled with a buildup of debris and had separated from the wall in different areas of the room.

The floor was soiled with paper, open patient supplies, and bagged patient supplies underneath the shelves.

The ice machine was also stored in the room with the clean supplies and it was soiled with a build-up of stains.

There was a table in the room which had clean patient use supplies stored on it. There was also a used towelette and glove on the table.

Staff #4 confirmed the observations.



Main Respiratory supply room

The temperature in the room was hot and there was no thermometer gauge in the room.

There were respiratory supplies, bags of respiratory inhalation solutions, bottles of humidifier solutions, and ventilators stored in a room.

There were bags of Sterile water for inhalation. The bags of sterile water were within plastic overwraps. The bags of solutions were sweating from the temperature of the room.


According to the label on the bags the recommended storage room temperature was 25 degrees Celsius or 77 degrees Fahrenheit. There was a direction to avoid excessive heat.

The tile flooring underneath the supplies was soiled with spills, paper and supplies. There were cracks in the tile where you could see the subfloor underneath. There was no way the floor could be properly cleaned with the cracks in the floor.

A scale used to weight patients was stored in the room and it was soiled with a build-up of dirt.

There were three ventilators in the room that had rusted wheel castors.

There were two water stained ceiling tiles in the room. One was recent and had started to bulge and the other one was dark brown.

Staff # 12 confirmed the condition of the room and that it was hot. She confirmed the condition of the bags. Staff #12 reported they had no thermometer in the room.


3 Tucker Nursing unit

A nursing medication storage cart was checked. One drawer was found to have a vial of medication, packets of pills, and unbagged medication cups. The inside of the drawer was soiled with dust and dirt build-up.

Another drawer had empty medication packets in it that needed to be discarded.


Another medication cart had an open multi-dose vial of bacteriostatic water which did not have an open date on it.

Staff #13 was observed preparing for medication administration to Patient #22 on 10/04/2017 after 11:15 a.m. Staff #13 took a vial of steroid methylPrednisonlone (40 milligrams) and the open vial of bacteriostatic water and was preparing to mix them. Staff #13 had to be reminded that we did not know how old the bottle of sterile water was, before she changed in out. After getting a new bottle of sterile water she preceded to remove the protective caps off the medication. Staff #13 drew the medication and sterile water up and mixed as required without sanitizing the top of the vials first.


Staff #13 had the following medications: a bag or Iron sucrose, a packet of Cholestyramine (cholesterol med), Volsartan (hypertensive med) , Amiodorone 1/2 tablet (steroid med), Toprol XL(hypertensive med) and Lovenox injectable (ant-coagulant med). Staff #13 placed the medications in her uniform pocket and entered Patient #22's room.
The medications were removed from her pocket once in the room and administered to Patient #22.


Emergency Department (Trauma room A)

A box of suture needles which expired on 07/2017 were found stored in a cabinet with other suture needles.

The flooring in the room had a build-up of wax and dirt.

Sterile packets of supplies were found stored in shelving which had had a see through plastic covering over it. The plastic covering had a build-up of dried spills on it.

Staff #14 confirmed the observations.




Emergency Department (Obstetrics room)

A sterile packet of operating room towels were found which expired 07/2017.

A sterile packet of hemostats were found in a drawer. The packet had 6 plus pairs of hemostats in it which had been sterilized this way.

According to the 2014 Edition of the Perioperative Standards and Recommended Practices by the Association of periOperative Registered Nurses the following was documented:

"Recommendation XII
Cleaned surgical instruments should be organized in a manner to allow the sterilant to contact all exposed surfaces.
Proper organization will facilitate sterilant contact on all surfaces and adequate drying.
XII. a. Instruments should be placed in a container tray or basket that is large enough to evenly distribute the metal mass in a single layer.

Instruments should be contained within the tray or basket in a manner that protects the instruments from damage and prevents puncturing of the sterilization wraps."




28659



On the afternoon of 10/5/2017 in the class room the temperature and humidity logs were reviewed and revealed the following:

June
1. Intravenous (IV) fluid warmer 96-104 degrees, 28/30 days the IV fluids were recorded as 105 degrees.
2. Anesthesia work room: (temperature 68-73 degrees, 30 of 30 days the temperature was below 68 degrees.
3. Clean supply room: 68-73 degrees, 14/30 days the temperature was below 68 degrees.

July
1. IV Fluid warmer :1/30 days the temperature was 105 degrees.
2. Surgical suite #2: 5/31 days the temperature was below 68 degrees. The humidity was above 60%, 2/31 days.
3. Surgical suite #3: 9/31 days the temperature was below 68 degrees. The humidity was above 60%, 1/31 days.
4. Surgical suite #4: 10/31 days the temperature was below 68 degrees. The humidity was above 60%, 8/31 days.

August
1. IV Fluid warmer: 3/31 days the temperature was 105 degrees. 3/31 days no temperature was recorded.
2. Anesthesia work room: 6/31 days the temperature was below 68 degrees.
3. Clean supply room: 23/31 days the temperature was below 68 degrees.
4. Surgical suite #4: 6/31 days the temperature was below 68 degrees
5. Surgical suite #6: 3/31 days the temperature was below 68 and the humidity was above 60%.
6. Surgical Suite #8: 8/31 days the temperature was below 68 degrees. The humidity was above 60% , 4/31 days
7. C-section room: 2/31 days the temperature was below 68. 3/31 days there was no temperature recorded. 3/31 days no humidity was recorded.

September
1. IV fluid warmer 1/30 days the temperature was recorded at 106 degrees.
2. Anesthesia work room: 8/30 days the temperature was below 68 Degree. Humidity within normal limits.
3. Clean supply room: 13/30 days the temperature was below 68 degrees. The humidity was within normal limits.
4. Surgical suite #7: 9/31 days no temperature or humidity was recorded.
6. Surgical suite #8: 6/30 days the temperature was below 68 degrees. The humidity was above 60% 5/30 days.
7. C-section room: 6/30 days the temperature was below 68 degrees. The humidity was above 60% 5/30 days.

None of the forms were observed with a documented intervention when the temperature or humidity was out of expected range and on days where not documented range was recorded there staff failed to indicate why there was no recorded value.

Discussion with the surgery manager regarding the infection control risks related to IV solution that were held at a warming temperature above the high normal limits for greater more than 2 weeks.

Baxter corporation, an industry leader in the manufacture of IV solution offers the following:

"Warming Recommendations for Large Volume Intravenous (IV) Solutions in plastic bags:
IV solutions of volumes 150mL or greater can be warmed in their plastic overpouches to
temperatures not exceeding 40°C (104°F), and for a period no longer than 14 days. Once the
VIAFLEX plastic containers have been in the warming cabinet for their maximum time period, the
containers should be removed from the warming cabinet and identified as having been warmed.
They should not be subsequently returned to the warmer."

The surgery manager confirmed the form used to record the temperature and humidity was the policy and that there was not a specific policy for 14 day limit on IV fluid in warmers.

The above findings were confirmed by the Staff #23, the surgery manager.