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Based on review of clinical records and interview, it was determined the facility failed to assure staff assessed whether patients had advance directives in three (#10-12) of five (#8-12) surgical records as defined by Federal Law and Regulation 42 CFR 489.100. Failure to assess whether patients had advance directives did not assure staff were aware of patients' wishes to cease medical care or continue medical care in the event the patient became incapacitated. The failed practice was likely to affect all patients undergoing surgical procedures in the facility. Findings follow:

A. Review of the clinical records for Patients #10-12 revealed no evidence staff assessed whether the patients had executed an Advance Directive.
B. Findings listed as A were verified with the Director of Surgery during record review on 06/18/15 at 0935.

Based on observation, it was determined the facility failed to maintain the building physical structure, environment, and equipment in a state of good repair in that there was a loose ceiling panel, chipped paint on door frames, scuff marks on walls and clutter in three (Surgery 1, Scope Room and in Medical Records Storage Rooms #1 and #2) of five areas observed. The failed practices had the potential to affect all patients, staff, and visitors due to the potential for injury and the spread of infection. The facility had an average monthly census of three on 06/15/15. Findings follow:

A. During a tour of the facility on 06/15/15 at 1042 with the Administrator the following observations were made and verified:
1) A loose maintenance panel in the ceiling outside of Surgery 1.
2) Chipped paint on the door frames of Surgery 1 and the Scope Room.
3) Scuff marks on the walls in the corridor outside of Surgery 1.
B. During a tour on 06/16/15 at 1335 with the Director of Maintenance, it was observed and verified boxes of papers and folders, miscellaneous computer equipment, and dead insects on the floor in the Medical Records Storage Rooms (#1 and #2).

Based on review of the Generator Log, observation, and interview, it was determined the facility did not meet Life Safety Code requirements related to smoke barrier maintenance and generator load testing. Failure to exercise the generator as required had the potential to affect the health and safety of all building occupants because the reliability of the generators to supply electrical power to the facility in the event of the loss of normal power was not evaluated and could not be assured. Failure to maintain the smoke resistance of the fire walls had the potential to all building occupants because the spaces have the potential to allow smoke to enter adjacent smoke compartments during a smoke and fire event. The failed practice had the potential to affect all patients, staff, and visitors. The facility had an average monthly census of three on 06/15/15. See K25 and K114.

Based on review of Governing Board Meeting Minutes for June 2014 through April 2015, Medical Staff Meeting Minutes for July 2014 through April 2015, Medical Staff Bylaws/Rules and Regulations, and interview, it was determined the facility failed to ensure the Governing Board took responsibility to oversee care of patients as evidenced by failing to ensure the QAPI (Quality Assessment Performance Improvement) plan was evaluated annually by the Governing Board and Executive Committee as there was no QAPI plan developed or approved (See C331); there was no QA Plan developed nor an active QA program to assure quality care and treatment outcomes for the services offered (See C336); failed to ensure QAPI data was presented to the Governing Board and the Medical Staff. See (C337). Failure to develop a QA Plan and failure to present QA to the Governing Board and Medical Staff did not ensure those entities were aware of the quality indicators and which items needed corrective action. The failed practice created the potential to affect any patient in the facility due to no monitoring of QA to assure quality of care was delivered to patients.

Based on review of Policy and Procedure Manuals and interview, it was determined the facility failed to assure policies and procedures were reviewed and approved on an annual basis in 7 (Emergency Department, Risk Management, Radiology, Medical Surgical, Quality Assessment and Performance Improvement, Ultrasound, and Computerized Tomography (CAT)) of 11 (Emergency Department, Risk Management, Radiology, Medical Surgical, Quality Assessment and Performance Improvement, Ultrasound, Computerized Tomography, Dietary, Surgical Services, Respiratory Therapy, and Swing Bed) manuals. Failure to review and approve policies did not assure they remained current or that staff followed approved policies. The failed practice was likely to affect all patients and staff in the facility. Findings follow:

A. Review of the Emergency Department Policy and Procedure Manual revealed an Annual Review front cover sheet which had no evidence the policies had been reviewed or approved since 11/30/11.
B. Review of the Risk Management Policy and Procedure Manual revealed an Annual Review front cover sheet which had no evidence the policies had been reviewed or approved since 03/19/14.
C. Review of the Radiology Policy and Procedure Manual revealed an Annual Review front cover sheet which had no evidence the policies had been reviewed or approved since 07/25/13.
D. Review of the Medical Surgical Unit Policy and Procedure Manual revealed an Annual Review front cover sheet which had no evidence the policies had been reviewed or approved since 08/23/11.
E. Review of the Quality Assessment and Performance Improvement Policy and Procedure Manual revealed an Annual review front cover sheet which had no evidence the policies had been reviewed or approved since 03/19/14.
F. Review of the Ultrasound Policy and Procedure Manual revealed an Annual Review front cover sheet which had no evidence the policies had been reviewed or approved since 07/25/13.
G. Review of the CAT Scan Policy and Procedure Manual revealed an Annual Review front cover sheet which had no evidence the policies had been reviewed or approved since 07/25/13.
H. Findings listed as A-G were verified with the Director of Nursing on 06/17/15 at 1010.

Based on review of policies and procedures and interview, it was determined the facility failed to have a policy for Registered Nurses to follow when administering moderate sedation to patients undergoing endoscopic procedures. Failure to have a policy to follow for administering moderate sedation did not assure guidelines were established which identified medications approved for sedation; safe practices for administering sedation medications; risks and potential complications associated with sedation medications; or what training/competencies would be required of nurses to be able to administer sedation. The failed practice was likely to affect all patients undergoing moderate sedation administered by Registered Nurses in the facility. Findings follow:

A. Review of policies and procedures revealed no evidence a policy for moderate sedation was included.
B. During interview with the Director of Surgery on 06/16/15 at 1040, she confirmed Registered Nurses admininstered moderate sedation to patients undergoing endoscopic procedures.
C. Finding listed as A was verified on 06/16/15 at 1400 with the Director of Nursing.

Based on observation, review of policy, review of manufacturer's label and interview, it was determined the facility could not ensure irrigation solutions from single dose containers were not used for multiple uses/days. The practice was observed in one (Emergency Department) of three (Emergency Department, Surgical Services and Medical floor) areas toured. By not disposing of single dose containers after single use, the facility could not ensure the safety or efficacy of the solution past the first use. The failed practice had the potential to affect any patient who received treatment with the irrigation solutions beyond the first use. Findings follow:

A. A tour of Emergency Department on 06/16/15 at 1000 revealed the following:
1) Room #2: 3-Sodium Chloride 1000 milliliter (ml) containers for irrigation opened and dated 06/20/15, 06/20/15 and 06/27/15;
2) Room #3: 1-Sterile Water 1000 ml, opened but not dated; and
3) Medication Room: 1-Sterile Water 1000 ml, opened and dated 06/28/15.
B. Review of policy titled Disposition of Out-Dated or Deteriorated Drugs stated "All deteriorated, non-sterile, non-labeled, or damaged medication shall be destroyed by the pharmacist ..."
C. Review of the manufacturer's label stated "Single-Dose Container." Single dose containers do not have preservatives and therefore should only be used for a single dose and then disposed of.
D. During an interview on 06/16/15 at 1030, the Director of Nursing, explained they date the irrigation solutions for a 28 day expiration date once opened. The Director of Nursing verified the opened/dated irrigation solutions and the labels stated the solutions were for single use.

Based on review of policy, review of Medication Error Forms, review of Adverse Reaction Forms Reports and interview, it was determined the facility failed to notify the practitioner who ordered the medication of the medication error for 7 of 7 (#1-7) errors in 2014 and 3 of 3 (#1-3) adverse reactions from September 2014 through May 2015. By not reporting medication errors and adverse drug reactions to the prescribing physician responsible for the patient's care, the patients' physicians were not being kept abreast of the patient's condition and were not involved in the decisions of what to do after the error/reaction occurred. The failed practice had the potential to affect all patients. Findings follow:

A. Review of policy titled Incident Report Procedure stated "Medication error reports shall be completed for all medication errors...An Adverse Reaction Form shall be filled out for any adverse reaction to any medication given inside the hospital ...Physicians are required to sign the forms and may add his comments and/or recommendations."
B. Review of Medication Error Forms from 01/01/14 through 12/31/14 revealed no evidence medication errors #1-7 were reported to the prescribing physician.
C. Review of Adverse Reaction Forms from 09/01/14 through 05/30/15 revealed no evidence adverse reactions #1-3 were reported to the prescribing physician.
D. During an interview on 06/16/15 at 1343, the Director of Pharmacy along with the Director of Nursing verified the above listed medication variances and adverse reactions were not reported to the prescribing physician.

Based on observation and interview, it was determined the facility failed to assure sinks were clean and dust was not on overhead light fixtures in two (Pre-Operative/Post-Operative Room and Dirty Utility room in the Surgery Department) of seven (Emergency Room 2, Emergency Room 3, Pre-Operative/Post-Operative Room, Dirty Utility in Surgery Department, the Operating Room and Medical Surgical Unit) areas toured. Failure to assure light fixtures were free of dust and sinks were clean did not assure patients and staff were not exposed to contamination. The failed practices were likely to affect all patients undergoing surgical procedures in the facility. Findings follow:

A. On observation 06/16/15 at 1040 in the Pre-Operative/Post-Operative Room, heavy layers of dust was observed on two mobile overhead light fixtures which did not assure they were clean.
B. On observation 06/16/15 at 1045 in the Dirty Utility Room in the Surgery Department, a large white sink was half filled with yellow liquid and a brownish-green fuzzy substance surrounded the bottom of the basin which did not assure it was clean.
C. Findings listed as A and B were verified at the time of observation with the Director of Nursing and the Director of Surgery.

Based on observation and interview, it was determined the facility failed to assure supplies (disinfectants , alcohol, hydrogen peroxide and tracheotomy tray) used for patient care were not expired or compromised in four (Emergency Room 2, Emergency Room 3, Dirty Utility in Surgery Department, and the Operating Room) of seven (Emergency Room 2, Emergency Room 3, Pre-Operative/Post-Operative Room, Dirty Utility in Surgery Department, the Operating Room and Medical Surgical Unit) areas toured. Failure to assure supplies were not expired or compromised did not assure they were not contaminated or would be effective when used for patient care. The failed practice was likely to affect all patients in the facility. Findings follow:

A. On observation 06/16/15 at 1000 in Emergency Room 2, the dust cover was torn on the tracheotomy tray which did not assure it was sterile and not compromised. One 16 fluid ounce bottle of alcohol was expired 10/2014 and two bottles of Hydrogen Peroxide were expired 01/2014 and 04/2015.
B. Finding listed as A was verified at the time of observation with the Director of Nursing.
C. On observation 06/16/15 at 1040 in the Dirty Utility Room in the Surgery Department, Enzol (disinfectant) expired 11/2014 and one canister of Cavi-Wipe disinfectant wipes expired 2010.
D. On observation 06/16/15 at 1045 in the Operating Room, one canister of Cavi-Wipe disinfectant wipes expired 11/2014.
E. Findings listed as C and D were verified at the time of observation with the Director of Nursing and the Director of Surgery.


30634

Based on review of Physician and APN (Advanced Practice Nurse) health files and interview, it was determined there was no evidence the facility had a means to identify and control infections in that four (#4-#7) of seven (#1-#7) Physicians and one (#1) of two (#1 and #2) APNs did not have a current TB (tuberculin) skin test. The failed practice created the potential for an exposure of TB to go unnoticed and could affect any patient being treated by those Physicians or APNs. Findings follow.

A. Review of Physician and APN health files revealed Physicians #4-#7 and APN #1 did not have a current TB skin test.
B. During an interview on 06/17/15 at 1255, the Administrative Assistant confirmed the Physicians and APN did not have current TB skin test.

Based on observation, policy review, and interview, it was determined the facility failed to ensure food items in the freezer were labeled and dated so as to ensure first-in-first-out rotation of foods was utilized. The failed practice created the potential for outdated foods to be served and could affect any patient receiving foods from the freezers. Findings follow.

A. During a tour of the kitchen freezers on 06/15/15 from 1300-1315 the following items were observed to not be labeled and dated:
1) Sweet potatoes-five of five bags
2) Broccoli-10 of 10 bags
3) California blend vegetables-13 of 13 bags
4) Bell peppers-five of five bags
5) Sweet potato pie-four of four pies
6) Pecan pie-nine of nine pies
7) Apple pie-seven of seven pies
8) Double chocolate cake-three of three cakes
9) Carrot cake-three of three cakes
B. Review of policy titled "Storage of Foods" stated "All food labeled and dated." Review of policy titled "Receiving of Food and Supplies" stated "All food is dated and stored by proper storing procedure."
C. The Certified Dietary Manager confirmed at the time of the tour the food items were not dated.

Based on review of orientation check lists, review of competency check lists and interview, it was determined the facility failed to assure Registered Nurses were evaluated for competency in the practice of moderate sedation. Failure to assure Registered Nurses were competent in the practice of moderate sedation did not assure they would recognize adverse effects or would understand the risks and complications associated with sedation medications; or that they would respond to adverse effects, risks or complications when administering sedation medications. The failed practice was likely to affect all patients undergoing moderate sedation by Registered Nurses in the facility. Findings follow:

A. Review of orientation check lists and competency check lists revealed no evidence moderate sedation practices was included.
B. During interview with the Director of Surgery on 06/16/15 at 1040, when asked about endoscopic procedures, she commented the Registered Nurse in the procedure room administered moderate sedation under an order from the physician.
C. During interview with the Director of Nursing on 06/16/15 at 1400, she verified there were no competencies for Registered Nurses to administer moderate sedation.

Based on review of clinical records, review of policies and procedures and interview, it was determined the facility failed to assure care plans were developed to address the individual needs (i.e. diabetes, pain, muscle weakness, infection) of patients in four (#13-15, #20) of seven (#13-20) in-patient records. Failure to develop care plans individualized to meet patients' needs did not assure nursing staff were able to assess the patient's progress toward established goals or were able to plan interventions when goals were not being met. The failed practice had the potential to affect all patients in the facility. Findings follow:

A. Review of policy "Care Planning" revealed "within 12 hours of admission all patients shall have a written plan of care generated by the registered nurse; the plan of care shall be individualized, based on the diagnosis, patient assessment and personal goals of the patient and his/her family; the plan of care will be individualized to the needs of the patient".
B. Review of the clinical record for Patient #13 revealed "PMH (past medical history)" included the patient was diabetic. Review of the care plan for Patient #13 revealed no evidence management or maintenance of diabetes was included.
C. Review of the clinical record for Patient #14 revealed "history of present illness" included the patient fell onto concrete and complained of pain in the left shoulder, elbow, left chest wall with breathing, and left hip with movement. Review of the care plan for Patient #14 revealed no evidence pain management was included.
D. Review of the clinical record for Patient #15 revealed "PMH" included diabetes and urinary tract infection. Review of the care plan for Patient #15 revealed no evidence management or maintenance of diabetes or urinary tract infection was included.
E. Review of the clinical record for Patient #20 revealed "Diagnosis" included muscle weakness. Review of PMH revealed diabetes. Review of the care plan for Patient #20 revealed no evidence muscle weakness or diabetes was included.
F. Findings listed as B-E were verified with the Director of Surgery on 06/18/15 at 1045 during chart review and commented "those care plans are in the system, we just need to do a better job bringing them into the care plan."

Based on observation, review of policy and interview, it was determined the facility failed to store clinical records properly (per policy) in that 37 cases of clinical records were stored on the ground, pests were observed in the storage area and dust/debris was observed over several cases of clinical records. By not storing clinical records properly, the facility could not assure the integrity of the records. The failed practice had the likelihood to affect all patients' records stored in medical records. The findings follow:

A. On a tour of the Medical Records Department on 06/15/15 at 1030 with the Director of Medical Records, the following observations were made:
1) Main Medical Records office: 14 cases of clinical records stored on the ground;
2) Medical Records storage area: 12 cases of clinical records stored on the ground, and approximately one dozen deceased cock roaches; and
3) Medical Record back room storage area: 11 cases of clinical records stored on the ground and dust and debris accumulating on cases of records from a deteriorating ceiling.
B. Review of policy titled General Requirements-Protection of records from destruction stated "All patient records whether stored within the Health Information Management Department or other areas, either within the facility or away from the facility, shall be protected from destruction by fire, water, vermin, dust, etc."
C. During an interview on 06/15/15 at 1221, the Director of Medical Records verified the cases of clinical records stored on the floor, the dead cockroaches and the debris.

Based on review of Medical Staff Rules and Regulations, clinical record review and interview, it was determined the facility failed to assure histories and physicals included the patient's chief complaint; relevant past social and family histories; all pertinent findings resulting from an assessment of all the systems of the body; the patient's current medical problems; previous procedures; assessment of mental status; any medication reactions; and any existing comorbid conditions for five of five (#8-12) patients undergoing surgical procedures in the facility. Failure to address or include these items in the history and physical examination did not assure patients were assessed according to standards established and approved by the Medical Staff and was likely to affect all patients undergoing surgical procedures in the facility. Findings follow:

A. Review of Medical Staff Rules and Regulations revealed, "Medical History and Physical: a complete medical history and physical shall be dictated within 24 hours of admission. This should include: the chief complaint; details of the present illness; relevant past, social and family histories; all pertinent findings resulting from an assessment of all the systems of the body; provisional diagnosis; patient's current medical problems; known allergies; all known significant diagnoses; condition of the patient; previous procedures; medications and dosages; assessment of mental status; any medication reactions; and existing comorbid conditions. There must be a complete history and physical in the chart of every patient prior to surgery, except in emergencies."
B. Review of the clinical record for Patients #8, #10, #11, and #12 revealed no evidence chief complaint, relevant past, social and family histories, all pertinent findings resulting from an assessment of all the systems of the body, current medical problems, condition of the patient; previous procedures, assessment of mental status; any medication reactions, or existing comorbid conditions were included in the history and physical examination.
C. Review of the clinical record for Patient #9 revealed no evidence a history and physical examination was included.
D. Findings listed as B-C were verified with the Director of Surgery during record review 06/17/15 at 1100.

Based on review of Governing Board Meeting Minutes for June 2014 through April 2015, Medical Staff Meeting Minutes for July 2014 through April 2015, Medical Staff Bylaws/Rules and Regulations, and interview, it was determined the facility failed to ensure the QAPI (Quality Assessment Performance Improvement) plan was evaluated annually by the Governing Board and Executive Committee as there was no QAPI plan developed or approved (See C331); there was no QA Plan developed nor an active QA program to assure quality care and treatment outcomes for the services offered (See C336); failed to ensure QAPI data was presented to the Governing Board and the Medical Staff. See (C337). Failure to develop a QA Plan and failure to present QA to the Governing Board and Medical Staff did not ensure those entities were aware of the quality indicators and which items needed corrective action. The failed practice created the potential to affect any patient in the facility due to no monitoring of QA to assure quality of care was delivered to patients.

Based on review of Governing Board Meeting Minutes for June 2014 through April 2015, Medical Staff Bylaws, and interview, it was determined the facility failed to ensure the QAPI (Quality Assessment Performance Improvement) plan was evaluated annually by the Governing Board and Executive Committee as there was no QAPI plan developed or approved. The failed practice did not ensure the Governing Board and Executive Committee were aware of the quality indicators, and which items needed corrective action. Findings follow.

A. Review of Governing Board Meeting Minutes for June 2014 through April 2015 revealed the QA plan was not evaluated or approved by the Governing Body.
B. During an interview on 06/15/15 at 1045, the Administrator stated the QA plan was not approved by the Governing Board.
C. During an interview on 06/16/15 at 1315, he stated the facility did not have a QA plan in place.
D. Review of Medical Staff Rules and Regulations stated "The Executive Committee is responsible for the overall coordination of the Hospital's quality assessment and improvement program and shall fulfill the responsibilities and duties as delineated throughout the Hospital's quality assessment and improvement plan."
E. Review of policy titled "QA/PI" revealed "As a provider of healthcare related services, Dallas County Medical Center has established an ongoing comprehensive Quality Assurance Performance Improvement Plan."
F. On 06/16/15 at 1315 the Administrator stated the facility had been without a QA director for over a year and currently all QA was reported to him. When asked what he did with the information after it was submitted he stated, "I put it in the QA book." When asked if it ever gets reported to the Medical Staff or Governing Board, he stated, "I don't know that anything has been reported to them." When asked if the facility had a QA committee he stated, "Our QA director was the committee."
G. Review of policy titled "QA/PI" revealed "The multidisciplinary QA/PI Committee is composed of the following individuals: QA/PI Coordinator, Director of Nursing, Infection Control Nurse, Swing Bed Coordinator, Director of Laboratory, Director of Medical Records, Chief of Staff, Administrator, Director of Environmental Services, Director of Dietary." The QA policy stated, "The responsibilities of Administration include: ...To designate a QA/PI Coordinator and provide clinicians and support personnel for QA/PI activities ...To review data related to patient outcomes with the Medical Staff and the Governing Board ...To provide tools necessary to accomplish QA/PI initiatives."
I. No QAPI Meeting Minutes were presented for review.

Based on review of Governing Board Meeting Minutes for June 2014 through April 2015, Medical Staff Bylaws, policy review, and interview, it was determined there was no QA Plan developed nor an active QA Program to assure quality care and treatment outcomes for the services offered. The failed practice did not ensure the Governing Board and Executive Committee were aware of the quality indicators and which items needed corrective action. Findings follow.

A. Review of Medical Staff Rules and Regulations stated "The Executive Committee is responsible for the overall coordination of the Hospital's quality assessment and improvement program and shall fulfill the responsibilities and duties as delineated throughout the Hospital's quality assessment and improvement plan."
B. Review of policy titled "QA/PI" revealed "As a provider of healthcare related services, Dallas County Medical Center has established an ongoing comprehensive Quality Assurance Performance Improvement Plan."
C. Review of Governing Board Meeting Minutes for June 2014 through April 2015 and Medical Staff Meeting Minutes for July 2014 through April 2015 revealed no evidence the Governing Board or Medical Staff were aware of QA indicators or outcomes of QA projects.
C. On 06/16/15 at 1315, the Administrator stated the facility had been without a QA director for over a year and currently all QA was reported to him. When asked what he did with the information after it was submitted he stated "I put it in the QA book." When asked if it ever gets reported to the Medical Staff or Governing Board, he stated "I don't know that anything has been reported to them." When asked if the facility had a QA committee he stated "Our QA director was the committee."
D. Review of policy titled "QA/PI" revealed "The multidisciplinary QA/PI Committee is composed of the following individuals: QA/PI Coordinator, Director of Nursing, Infection Control Nurse, Swing Bed Coordinator, Director of Laboratory, Director of Medical Records, Chief of Staff, Administrator, Director of Environmental Services, Director of Dietary." The QA policy stated, "The responsibilities of Administration include: ...To designate a QA/PI Coordinator and provide clinicians and support personnel for QA/PI activities ...To review data related to patient outcomes with the Medical Staff and the Governing Board ...To provide tools necessary to accomplish QA/PI initiatives."
E. No QAPI Meeting Minutes were presented for review.

Based on review of Governing Board Meeting Minutes for June 2014 through April 2015, Medical Staff Meeting Minutes for July 2014 through April 2015, and interview, it was determined the facility failed to ensure QAPI (Quality Assessment Performance Improvement) data was presented to the Governing Body and Medical Staff. The failed practice did not ensure the Governing Board and Medical Staff were knowledgeable as to current QA indicators and results in the facility. Findings follow.

A. Review of Governing Board Meeting Minutes for June 2014 through April 2015 and Medical Staff Meeting Minutes for July 2014 through April 2015 revealed no evidence of QA discussions.
B. During an interview on 06/16/15 at 1315, when asked if QA was reported to Medical Staff or Governing Board the Administrator stated, "I don't know that anything has been reported to them."

Based on review of clinical records, review of policies and procedures and interview, it was determined the facility failed to assure care plans were developed to address the individual needs (i.e. confusion, falls, weakness) for two of two (#1-2) Swing-Bed patients. Failure to develop care plans individualized to meet patients' needs did not assure nursing staff were able to assess the patient's progress toward established goals or were able to plan interventions when goals were not being met. The failed practice had the potential to affect all patients in the facility. Findings follow:

A. Review of policy "Care Planning" revealed "within 12 hours of admission all patients shall have a written plan of care generated by the registered nurse; the plan of care shall be individualized, based on the diagnosis, patient assessment and personal goals of the patient and his/her family; the plan of care will be individualized to the needs of the patient".
B. Review of the clinical record for Patient #1 revealed "History of Present Illness" included a 2-day history of confusion and leg weakness with three falls. Review of the care plan for Patient #1 revealed no evidence confusion or weakness and falls was included.
C. Review of the clinical record for Patient 32 revealed no evidence a plan of care was included.
D. Findings listed as B and C were verified with the Director of Surgery on 06/18/15 at 1045 during record review.