HospitalInspections.org

26313


Based on the function of the Governing Body, which approves and complies with the Medical Staff Bylaws (cited in the Preamble of the 2010 Medical Staff Bylaws, pg 3 of 36), the Medical Staff Rules and Regulations dated 2010, and staff interviews, the Governing Body failed to ensure the medical staff were demonstrating accountability by carrying out their responsibilities as outlined in the 2010 Medical Staff Bylaws (2010 Medical Staff Bylaws, pg 5 of 36) and the 2010 Medical Staff Rules and Regulations as evidenced by:

(1) failing to perform medication reconciliation for 3 of 4 focused Ambulatory Clinic Records focused record reviewed for medication reconciliation out of a total of 23 Ambulatory Clinic Records reviewed out of a total of 44 sampled patient medical records (#5, #8, #10);

(2) failing to ensure clinical record documentation was clear, legible, timed, and dated for 3 of 4 focused Ambulatory Clinic Records focused record reviewed for clinic record clear, legible, timed, and dating of medical record entries out of a total of 23 Ambulatory Clinic Records reviewed out of a total of 44 sampled patient medical records (#5, #6, #7);

(3) failing to complete the sections of the Consent forms for Surgery, Procedure, Anesthesia, and Blood Transfusion for 4 of 4 focused Ambulatory Clinic Records for Consent forms (#14, #41, #42) and the Advanced Directive Acknowledgement for 1 of 4 focused Ambulatory Clinic Records (#43) out of a total of 23 Ambulatory Clinic Records reviewed out of a total of 44 sampled patient medical records:

(4) failing to have current information (i.e. approved privileges, CDS licenses, and ACLS certification) on 2 of 5 sampled medical staff credentialing folders (S40, S41) and 1 of 2 sampled Family Nurse Practitioners' credentialing folders (S42); and

(5) failing to ensure 2 of 4 contracted physicians (S38, Radiologist and S39, Pathologist) had appraisals of their performance every six months as indicated in the Medical Staff Bylaws out of 5 sample medical staff credentialing folders and 2 sample Nurse Practitioners' credentialing folders.
"responsible for adherence to both the letter and the Spirit of these Bylaws, the Rules and Regulations, and policies of the medical staff, the clinical department, ...and all other policies and regulations" (pg. 8 of 36)carrying
Findings:

(1) Failing to perform medication reconciliation for 3 of 4 focused Ambulatory Clinic Records focused record reviewed for medication reconciliation out of a total of 23 Ambulatory Clinic Records reviewed out of a total of 44 sampled patient medical records (#5, #8, #10):

Patient #5:
The patient was seen at the Primary Care Clinic on 1/4/11 and 5/9/11 for symptoms of GERD (Gastroesophageal Reflux Disease). A record review of Patient #5's clinical record revealed that the medication reconciliation was last reviewed on 9/30/10.

In an interview with S27 Outpatient Supervisor on 5/9/11 at 2:15 p.m., she confirmed that Patient #5's clinical record revealed missing documentation that the medication reconciliation occurred with each visit.

Patient #8:
The patient was seen at the Diabetic Foot Clinic on 10/27/10, 1/27/11, 1/29/11, 3/14/11, 4/18/11; and 5/6/11. A record review of Patient #8's "Home Medication and Allergy List", was observed to have been reconciled on 10/5/10 at 1357 (1:57 p.m.). No further documentation was present in the clinical record that Patient #8's home medicines had been reconciled since 10/5/10.

In an interview with S2DON on 5/11/11 at 3:05 p.m., she confirmed that no medication reconciliation and assessment was performed as per policy for Patient #8's visit to the Diabetic Foot Clinic.

Patient #10:
The patient was seen at the Asthma clinic on 5/4/11. A record review of Patient # 10's clinical record revealed that the medication reconciliation was last reviewed on 4/21/11 at 10:15 a.m.

In an interview with S2DON on 5/9/11 at 3:05 p.m., she confirmed that the medication reconciliation was not performed when Patient #10 visited the outpatient clinic on 5/4/11 as per hospital policy.

Record review of hospital wide policy titled "Medication Reconciliation Process" (pg 1 of 6) revealed the purpose of medication reconciliation was "to ensure that all patients are provided with complete and effective medication treatment while under the care of the organization. Medication reconciliation is a multidisciplinary process between Nursing, the pharmacist, and the physician with patient/family involvement."

On page 2 of 6 of the "Medication Reconciliation Process" revealed "outpatient areas where medication reconciliation shall be performed include (not all inclusive): Primary Care and Specialty Clinics, GI laboratory, Outpatient Oncology services, Certain imaging procedures, and Outpatient surgery."

On page 3 of 6 of the "Medication Reconciliation Process" revealed the Responsible Parties to ensure medication reconciliation process is carried out with each patient visit. The Responsible parties included nurses, pharmacists, physicians, APRN (Advance Practice Registered Nurse) and PA (Physician's Assistant).

Record review of the 2010 Medical Staff Rules and Regulations (pg 9 of 15) #7. Ambulatory Care Medical Records, A. Out-Patient Assessment revealed: a. .."There will be a Medication Reconciliation list started and an entry into CLIQ Medication Management on the initial visit for medications known to be prescribed for or used by the patient, and will be updated on each visit thereafter."

b. "For patients receiving ambulatory care services on a continuing basis it is the responsibility of the physician to complete the assessment form developed for outpatient clinics and must include the following information: Patients Chief Complaint and vital signs; Patients history and physical findings; Diagnostic impression; Medications/Orders; Instructions to the patient; and Known adverse and allergic drug reactions."

(2) Failing to the clinical record documentation was clear, legible, timed, and dated for 3 of 4 focused Ambulatory Clinic Records focused record reviewed for clinic record clear, legible, timed, and dating of medical record entries out of a total of 23 Ambulatory Clinic Records reviewed out of a total of 44 sampled patient medical records (#5, #6, #7):

Patient #5:
The patient received services at the Primary Care Clinic on 5/09/11. Record review of the Outpatient Clinic Visit Record revealed missing the written date on the form. Record review of the Outpatient Clinic Visit Record dated 5/9/11 and 1/4/11 revealed illegible documentation by both the physician and the assessment nurse.

On 5/9/11 at 2:35 p.m. an interview with S27 Outpatient Supervisor confirmed the Outpatient Clinic Visit Record dated 5/9/11 was missing the written date on the form. She also confirmed the Outpatient Clinic Visit Record dated 5/9/11 and 1/4/11 had illegible documentation by both the physician and the assessment nurse.

Patient #6:
The patient received services at the Diabetic Clinic on 5/9/11. Record review of the Outpatient Clinic Visit Record revealed illegible documentation by both the physician and the assessment nurse. Record review of the Outpatient Clinic Visit Record dated 4/7/11 revealed illegible documentation by the assessment nurse.

On 5/9/11 at 2:45 p.m. an interview with S27 Outpatient Supervisor confirmed the illegible documentation on Outpatient Clinic Visit Records dated 5/9/11 and 4/7/11.

Patient #7:
The patient received services at the Primary Care Clinic III on 5/9/11, 11/8/10, 8/3/10, and 5/3/10. Record review of the Outpatient Clinic Visit Records revealed illegible physician documentation.

On 5/9/11 at 3:00 p.m. in an interview with S2DON, she confirmed that these Outpatient Clinic Visit Records had illegible physician documentation.

Record review of the 2010 Medical Staff Rules and Regulations (pg 6 of 15) III. Health Information Management B. revealed the following: "All entries into the medical record must be in indelible ink and include month, day, year, and time." Under G. "No record can be updated or modified by preparing entries with dates and times that do not reflect the ACTUAL DATE and TIME (in the 2010 Medical Staff Rules and Regulations) that the information was written. Any late entries shall be labeled as such."

(3) Failing to complete the sections of the Consent forms for Surgery, Procedure, Anesthesia, and Blood Transfusion for 4 of 4 focused Ambulatory Clinic Records for Consent forms (#14, #41, #42) and the Advanced Directive Acknowledgement for 1 of 4 focused Ambulatory Clinic Records (#43) out of a total of 23 Ambulatory Clinic Records reviewed out of a total of 44 sampled patient medical records:

Patient # 14:
The patient received services in the Surgical Outpatient Clinic on 4/29/11 for an excision of a skin lesion. Record review of the Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgement of Receipt of Medical Information revealed missing documentation under "Patient Condition," "Material Risks of Treatment Procedure," "Risks Identified by the Louisiana Medical Disclosure Panel," "Risks Determined by your Doctor," "Risks determined by your doctor," "Additional risks (if any) Particular to this Patient because of a Complicating Medical Condition," "Risks Generally Associated with any Surgical Treatment/Procedure, including Anesthesia," Reasonable Therapeutic Alternatives and the Risks Associated with such Alternatives," and "Acknowledgement, Authorization, and Consent."

Record review of the Consent signed by Patient #14 revealed missing time of when Patient #14 signed the consent form.

On 5/11/11 at 3:00 p.m. in an interview with S 2 DON and S 25 Perioperative Director, both confirmed the consent signed by Patient #14 was not timed. Both S 2 and S 25 confirmed the Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgement of Receipt of Medical Information was incomplete and did not follow the hospital's policy.

Patient #41:
The patient received services in the Surgical Outpatient Clinic on 5/11/11 for removal of the gallbladder. Record review of the Advance Directive Acknowledgement dated on 4/15/11 was missing documentation of the time the patient had signed the document.

Record review of the Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgment of Receipt of Medical Information Transfusion of Blood and Blood Components dated 5/11/11 revealed missing documentation under "2. Treatment/Procedure: Transfusion of Blood and Blood Components--multiple units as required a) Description, nature of the treatment/procedure. " Other components of the informed consent which had missing documentation included "Risks Identified by the Louisiana Medical Disclosure Panel, " "Risks Determined by Your Doctor," "Risks Generally Associated with any Surgical Treatment/Procedure, including Anesthesia," and "Acknowledgement, Authorization, and Consent."

On 5/11/11 at 3:00 p.m. in an interview with S2DON and S25 Perioperative Director, both confirmed the consent signed by Patient #41 was incomplete and did not follow the hospital's policy.

Patient #42:
The patient received services in the Surgical Outpatient Clinic on 5/11/11 for a colonoscopy. Record review of the Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgement of Receipt of Medical Information, Colonoscopy revealed missing documentation under 3. Patient Condition; under 4. Material Risks of Treatment Procedure; and under 6. Acknowledgement, Authorization, and Consent.

Record review of the Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgement of Receipt of Medical Information, Transfusion of Blood and Blood Components dated 5/11/11 revealed missing documentation under 2. Treatment/Procedure: Transfusion of Blood and Blood Components a) Description, nature of the treatment/procedure; under 4. Material Risks of Treatment Procedure; and under 6. Acknowledgement, Authorization, and Consent.

On 5/11/11 at 2:35 p.m. in an interview with S2DON and S25 Perioperative Director, both confirmed the consent forms for the Colonoscopy and for Blood Transfusions were incomplete.

Patient #43:
The patient received services in the Surgical Outpatient Clinic on 5/9/11 for a colonoscopy. Record review of the Advance Directive Acknowledgement revealed missing time when the patient signed the form.

On 5/11/11 at 3:10 p.m. in an interview with S2DON and S26 Same Day Surgery Supervisor, both confirmed that the Advance Directive Acknowledgement did not contain the time Patient #43 had signed the form.

Record review of the hospital's policy titled "Patient Care Services" (pg 1 of 7) under Policy, 2. Content of the medical record, a. reveals the following: "The content of the medical record, which includes written documentation, must be sufficiently detailed, legible, and organized..." The hospital's policy had been revised 11/10 and approved by the Governing Body on 2/18/11.

Record review of the 2010 Medical Staff Rules and Regulations (pg 10 of 15) under IV. Informed Consent D. reveals the following: "Obtaining written informed consent from the patient or his/her legal representative for diagnostic and/or therapeutic/surgical procedures, blood transfusions and anesthesia is the responsibility of the practitioner planning to perform the procedure, as well as, a discussion of the relevant risks, benefits, and side effects related to alternatives, including the possible results of not receiving care, treatment, and services."

(4) Failing to have current information (i.e. approved privileges, CDS licenses, and ACLS certification) on 2 of 5 sampled medical staff credentialing folders (S40, S41) and 1 of 2 sampled Family Nurse Practitioners' credentialing folders (S42).

Record review of S40 Internist, Medical Staff's credentialing folder revealed that the Medical Staff Executive Committee granted privileges to S40 on 4/8/08. No documentation in S40, MD's credentialed folder indicated that the reapplication for granting of privileges to the hospital had been completed by S40 MD since 4/8/08. In conjunction, the last National Inquiry Database was obtained on 5/11/08 for S40.

Record review of S41, Internist, Medical Staff's credentialing folder revealed that S41's Louisiana Narcotics license (CDS) had expired on 7/10. The credentialing folder revealed no further documentation that S41, Internist had submitted his current CDS license as required by the Medical Staff Bylaws.

Record review of S43 RN, Family Nurse Practitioner's credentialing folder revealed that S43's Louisiana Narcotics (CDS) license had expired on 5/10/10. The credentialing folder revealed no further documentation that S43 RN had submitted her current CDS license as required by the Medical Staff Bylaws.

In an interview with S22 Quality Management Administrative Coordinator on 5/10/11 at 2:40 p.m., she confirmed that there was no documentation that S40 Internist's privileges had been granted by the Medical Staff Executive Committee since 5/11/08. She also confirmed S41, Internist's CDS license had expired on 7/10 and that S43 RN's CDS license had expired on 5/10/10. S22 stated she believed both of the medical staff had current licenses, but had not given her a copy to place in their credentialing file.

During this same interview, S22 stated she sends the medical staff a reminder about turning in the required information to her, so she can ensure the medical staff member's credentialing folder is up to date before the Medical Executive Committee meets on the last Thursday of the month.

Record review of 2010 Medical Staff Bylaws, Article IV: Duration of Membership, Conditions, and Categories A. Duration of Membership and Conditions (pg 10 of 36) 2. revealed the following membership condition " All appointments, reappointments, and modifications of appointments shall be for a maximum period of 24 months (2 years). Confirmation of renewed medical licensure and drug licensure is required ANNUALLY..." (The Bylaws had the word "annually" in capitalized letters).

(5) failing to ensure 2 of 4 contracted physicians (S38, Radiologist and S39, Pathologist) had appraisals of their performance every six months as indicated in the Medical Staff Bylaws out of 5 sample medical staff credentialing folders and 2 sample Nurse Practitioners' credentialing folders:

Record review of S38, Radiologist and S39, Pathologist medical staff credentialing folder revealed no appraisals done on these physicians' competencies.

In an interview with S22 Quality Management Administrative Coordinator on 5/10/11 at 2:40 p.m., she confirmed that the two contracted physicians (S38 and S39) did not have any appraisals in their credentialing folders. She also stated that the facility did not have a mechanism in place for ongoing professional practice evaluation for either the radiologist or the pathologist.

Record review of the 2010 Medical Staff Bylaws (pg 10 of 36), Article III. Medical Staff Membership D. Duties and Responsibilities, #13 revealed the following duties and responsibilities of the medical staff "The medical staff must periodically conduct appraisals of its members for qualification, or competencies to perform privileges for which he/she has been granted. The appraisal is to determine if that individual practitioner's membership or privileges should be continued, discontinued, revised, or changed. Appraisals are conducted at least every 6 months."

Based on record reviews of the "Patient Rights" and "Confidentiality" policies and "Patient Bill of Rights" handout, observations, and staff interviews, the hospital failed to ensure the patient's right to personal privacy was maintained during medical/nursing treatments and/or discussions about their health status/care as evidenced by:
1) S28 Licensed Practical Nurse (LPN) verbally gathering personal health data information with the door opened to Room "a" on the Medical Specialty Unit with Patient #20,
2) S31 Registered Nurse (RN) verbally gathering personal health information and assessing the patient (#27) with the door opened to Room "c" on the GYN Clinic Area, and
3) Patient #26's demographic information was visibly read while placed in the chart holder on Room " d " in the GYN Clinic Area by the surveyor and accessible to all patients and/or representatives passing in the hallway to be placed in an examination room and seen by the attending physician. Findings:

During a tour of the Medical Specialty Unit conducted with S2 Director of Nursing (DON) and S27 Outpatient Supervisor on 5/10/11 at 11:35 a.m., the patient was observed in room "c" with S28LPN. Further observation revealed S28 was asking the patient about his personal health information (name, date of birth, present and past medical health histories) with the door opened. At this time, S2 and S27 both confirmed S28LPN was gathering personal data about the patients' medical health status with the door opened. Both, S2 and S27 indicated S28LPN failed to follow the hospital's privacy/confidentiality policy to control disclosure of the patient's personal information to authorized persons.

In a face-to-face interview conducted on 5/10/11 at 11:55 a.m., S28LPN indicated Patient #20's door remained opened when she gathered personal health information from the patient. S28 further indicated the patient's right to privacy during data collection in Room "c" was not followed to limit the data to authorized persons as per policy.

A tour of the GYN Clinic Area conducted on 5/10/11 from 1:50 p.m. through 2:05 p.m., with S2DON and S25 Perioperative Director. At 1:55 p.m., the patient was observed in Room "d". Further observation revealed the surveyor heard S31RN ask the patient's name, date of birth and allergies while standing in the hallway about two (2) feet from the patient and staff member. During this time, both S2 and S25 confirmed S31RN had the door opened while verbally asking the patient's personal medical health information. S2 and S25 both indicated the patient's right to privacy/confidentiality during the gathering of health information was not followed as per policy by S31RN. At 2:00 p.m., Patient #26's name was observed placed in the chart holder hanging on the door. During this same observation, S25 Outpatient Director confirmed Patient #26's demographic information was visible to all patients and patient representatives passing in the hallway. S25 indicated Patient #26's right to privacy/confidentiality was not followed as per policy.

Review of the policy titled, "Patient Rights"; Policy number: 02-04-07; Effective date of 9/97; Revised date(s) of 05/05, 04/07, 11/07, 05/10, 11/10; with no approved, revised and/or reviewed date(s); presented on 5/10/11 at 3:00 p.m. as the hospital's current "Patient Rights" policy revealed it was hospital policy to respect the rights of all persons that come to this facility for treatment. The hospital supports the patient rights to personal privacy and confidentiality of information. Patients receive the Patient Bill of Rights booklet upon admission, registration for the Emergency Department, and upon request.

The policy titled, "Confidentiality, Security, and Integrity of Information", policy number: 2018710-012, Effective Date of May 1, 2007, with no documented approved, revised and/or reviewed date(s), presented on 5/10/11 at 12:30 p.m. as the hospital's current "Confidentiality" policy read, the hospital and its employees have a legal and ethical responsibility to safeguard the privacy of all patients and protect information that is defined as confidential. The confidential information includes oral communication, information contained in manual documentation. Patient records contain confidential information. The objective is to secure an understanding that information regarded as confidential must be maintained in the strictest of confidence and outline the minimal guidelines ensuring confidentiality and securing of information. The definition of confidentiality is controlling use and disclosure of personal information so that only authorized persons have access to such information. The PHI (Protected Health Information) is the individually identifiable health information that relates to the past, present, or future healthcare services provided to an individual. The protection of information from unauthorized disclosure, whether intentional or accidental is the definition of security. The Employees will safeguard information/data available in the course of the assigned job duties. The employee will maintain the integrity of the data. The employee will access only the data for which he/she is authorized, in the course of normal business activity.

Review of the "Patient Bill of Rights" booklet/handout provided to all patients upon admission into the hospital, presented on 5/10/11 at 1:35 p.m., revealed the patient had the right to personal privacy and confidentiality of information.

Based on record review and interview the hospital failed to ensure the patient received care in a safe setting as evidenced by:

1) failing to notify the physician responsible for the care of a patient for 8 hours and 10 minutes that the patient was found tying a sheet around her neck for 1 of 2 focused psychiatric patients in a total sample of 44. (#17)

2) failing to maintain LOS (line of sight) monitoring on patient after the physician ordered the patient to be on continuous line of sight observation. The PA (psychiatric assistant) walked out of the bathroom leaving the patient alone with the bath tub full. Upon return of the PA the patient was found under water. The patient stated she was "suicidal" and attempting to "drown herself." This affected 1 of 2 focused psychiatric patients in a total sample of 44. (#17)

3) failing to ensure the Registered Nurse (RN) accurately documented the initial assessment on the hospital's "Initial Screening for Self-Harm Potential" which resulted in a patient who met the SOS-1 (Suicide Observation Status Level One) (1:1, constant visual observation) being placed on SOS-3 Observation status for 1 of 2 focused psychiatric patients in a total sample of 44. (#16)

Findings:


1) Patient # 17

Review of the medical record of patient #17 revealed she was admitted to the psychiatric unit of the hospital on 04/23/11 under a Physician's Emergency Certificate (PEC). Patient #17 was subsequently placed under a Coroner's Emergency Certificate (CEC). Further review revealed a Judicial Commitment dated 05/06/11. Patient # 17 had an admission diagnosis of Chronic Paranoid Schizophrenia (CPS) and Bipolar Disorder (BPD) with Psychosis.

Review of the nurses' note's dated 05/03/11 at 2200 (10:00 p.m.) documented by S7RN in the medical record of patient #17 revealed "Patient in room talking to self. When asked to whom she was talking, she gestured to air conditioning vent, saying "(name of male) is there." When nurse left room, she attempted to tie a sheet around her neck. Patient watched by MHT (Mental Health Technician) while nurse obtained injection. Geodon 20 mg IM (intramuscular) given in R (right) gluteal (buttock). Patient tolerated well and observed direct line of sight until asleep."

Review of the physician's orders for patient # 17 revealed the following orders: "05/03/11 at 2000 (10:00 p.m.) (2 hours prior to the patient being found tying a sheet around her neck) Continue SOS III X (times) 24 hours." The next physicians order is dated 05/04/11 at 0610 (6:10 a.m.) (8 hours and 10 minutes after patient # 17 was found tying a sheet around her neck) and read: "Place on SOS II for safety due to suicidal gesture." The order is a verbal order from S6MD taken by S7RN.

Further review revealed no documented evidence that the physician was notified of patient #17 being found tying a sheet around her neck until the order on 05/04/11 at 0610 (6:10 a.m.) to increase the observation status to SOS II, that the Registered Nurse (RN) increased the observation status for patient # 17 according to hospital policy after a change in patient status at 2200 (10:00 p.m.), or documentation to indicate which staff member was assigned to monitor patient #17.

In a telephone interview on 05/10/11 at 9:30 a.m. with S7RN she stated that on 05/03/11 just prior to 2200 (10:00 p.m.) she was in the seclusion room with patient # 17. S7RN stated patient #17 was in the seclusion room with the door open. S7RN stated that she walked out of the seclusion room and turned around and went back into the room. S7RN stated that patient #17 was attempting to tie a sheet around her neck. S7RN stated she removed the sheet. S7RN stated patient #17 was "talking to the air conditioning vent" stating her boyfriend was in there. S7RN stated that patient #17 was saying "don't leave me, wait for me" to the vent. S7RN stated patient #17 was hallucinating and agitated. S7RN confirmed she administered Geodon 20 mg IM to patient #17 for "agitation." S7RN confirmed the physician was not notified of patient #17 being found tying a sheet around her neck at 2200 (10:00 p.m.). S7RN offered no reason the physician was not notified. S7RN stated that she "does not remember if patient #17 was placed on increased observation throughout the night."

In an interview with S11RN on 05/11/11 at 7:40 a.m. he stated he was on duty on the night shift of 05/03/11 - 05/04/11 with S7RN. S11RN stated that patient #17 had been moved to the open seclusion room that evening due to the patient being loud and disruptive to the milieu. S11RN stated he was "unaware" if the physician was notified of patient #17 attempting to tie a sheet around her neck on 05/03/11 at 2200 (10:00 p.m.).

In an interview on 05/10/11 at 9:15 a.m. with S3RN, Psyc Unit Manager, she confirmed there was no documented evidence indicated the physician was notified of patient #17 attempting to tie a sheet around her neck on 05/03/11 at 2200 (10:00 p.m.). She further confirmed that the observation status order was 8 hours and 10 minutes after the incident. S3RN, Psyc Unit Manager, stated there was no order to administer Geodon to a patient who was hallucinating. S3RN stated she would expect the RN to notify the physician immediately of the behavior of patient #17. S3RN stated that per hospital policy patient #17 should have been placed on SOS I observation status. S3RN confirmed there was no documented evidence of continuous observation of patient #17 or documentation of whom the RN assigned to be responsible for the continuous observation of patient #17.

In an interview on 05/10/10 at 10:00 with S6MD he stated patient #17 should have been placed on SOS - I when she was found tying the sheet around her neck on 05/03/11 at 2200 (10:00 p.m.) and he should have been notified of the change in the status of the patient. He further stated he should have been notified of the attempted drowning on 05/04/10 at 0620 (6:20 a.m.).

Review of a hospital policy titled "Suicide Precautions", policy number 03-11-07, effective 12/13/07, no date of last review or revision, reads in part: "Purpose: To ensure a safe environment for potentially self-destructive patients and to establish specific guidelines for staff observation of these patients. Procedure: Suicide precautions will be ordered by the Physician, but nursing personnel will implement suicide precautions while awaiting the order... All patients placed on suicide precautions will be assigned an acuity level based upon the severity of the suicidal thoughts, plan, or behavior. The levels are as follows: SOS I - One to One Observation at all times...patients on this level are considered highest risk and documentation must reflect the need for continued 1-to-1 or improvement in behaviors and thoughts, which allows the patient to be recatagorized to a lower level of observation. SOS II - Line of Sight Observation...SOS III - Every 15 minutes observation." Review of an attachment to this policy, policy 03-10-07b, "Initial Screening for Self-Harm Potential Behavioral Health Units" revealed any of the following "dictates the need for Level I (SOS I) Observation": Was there a potentially lethal suicide attempt in the past 24 hours?..."

Review of a hospital policy titled "Assessment and Reassessment", policy number 02-01-07, effective 09/97, last revised 11/10, reads in part: "Purpose: To assure care provided to each patient is based on assessment of the patient's relevant physical, psychological, and social needs...Policy: Each patient is assessed...to identify...the need for further assessment...Inpatients are assessed continuously throughout their hospital stay...Reassessments shall take place when there is a significant change in the patient's condition..."


2) Patient #17

Review of the physician's orders for patient # 17 revealed the following orders: "05/03/11 at 2000 (10:00 p.m.) (2 hours prior to the patient being found tying a sheet around her neck) Continue SOS III X (times) 24 hours." The next physicians order is dated 05/04/11 at 0610 (6:10 a.m.) (8 hours and 10 minutes after patient # 17 was found tying a sheet around her neck) and read: "Place on SOS II for safety due to suicidal gesture." The order is a verbal order from S6MD taken by S7RN.

Review of the documentation by S7RN for 0620 (6:20 a.m.) (10 minutes after the physician ordered SOS II - Line of Sight Observation) revealed "Patient urinated in bed. Was taken to bath tub, and tried to "drown self" in bath water. Accused this nurse of talking about her to "(name of male)" all night. Very paranoid, hearing voices per her admission and states she is "suicidal". Placed on SOS (safety observation status) II for safety."

In a telephone interview on 05/10/11 at 1:00 p.m. with S12PA (psychiatric assistant) she stated that when she reported for duty for the 7:00 p.m. shift on 05/03/11 that patient #17 was in the seclusion room. S12PA stated she was monitoring the halls. S12PA stated that patient #17 was not on 1-to-1 monitoring on the night shift of 05/03/11 - 05/04/11. S12PA further stated that she was not made aware of patient #17 tying a sheet around her neck earlier in the night. S12PA stated that after patient #17 urinated in her bed that she put patient #17 in the tub and went to help the other PA take patient vital signs, leaving patient #17 alone in a tub full of water. S12PA stated that when she returned she found patient #17 in the tub with her shirt on and she took patient #17's shirt off. S12PA stated that she then stepped out of the bathroom to retrieve items from the linen cart. S12PA stated that when she re-entered the bathroom patient #17 "had her head between her legs underwater." S12PA stated patient #17 said she was "trying to commit suicide."

In an interview on 05/10/11 at 9:15 a.m. with S3RN, Psyc Unit Manager, she confirmed there was no documented evidence of notification of the physician of the 2nd attempt of patient #17 to harm herself, no documentation of Line of Sight Observation and which staff member was assigned to perform the line of sight observation.

Review of documentation on the "Therapeutic Surveillance Flowsheet" revealed documentation for patient # 17's behavior for 0545 (5:45 a.m.) through 0645 (6:45 a.m.) that revealed patient #17 was "23/25 - Restless/Challenging Controls."

In an interview with S3RN, Psyc Unit Manager, and S11RN (on duty on night shift 05/03 - 05/04) both confirmed that the assignment sheets for 05/03/11 11:00 p.m. - 7:00 a.m., and 05/04/11 7:00 a.m. - 3:00 p.m. "were missing."

Review of a hospital policy titled "Suicide Precautions", policy number 03-11-07, effective 12/13/07, no date of last review or revision, reads in part: "Purpose: To ensure a safe environment for potentially self-destructive patients and to establish specific guidelines for staff observation of these patients. Procedure: Suicide precautions will be ordered by the Physician... The levels are as follows:..SOS II Line of Sight Observation..." Review of an attachment to this policy, policy 03-10-07b, "Initial Screening for Self-Harm Potential Behavioral Health Units" revealed any of the following "dictates the need for Level I (SOS I) Observation": Was there a potentially lethal suicide attempt in the past 24 hours?..."

3) Patient #16

Review of the medical record for patient #16 revealed she was a 19 year old female admitted on 05/06/11. Review of the PEC revealed the physician documented patient #16 was Suicidal, Danger to Self (having auditory hallucinations to kill herself), and Unwilling to seek Voluntary admission. Review of the CEC revealed the physician documented patient #16 was Suicidal, Violent, Danger to Self, Danger to Others, and Gravely Disabled.

Review of the Initial Nursing Assessment performed by S8LPN and S9RN revealed the following documentation: "Potential harm to self or others - Yes...Are you taking all of your medications as the doctor ordered - No, I want to die...Mental Health History - Anxiety, Depression, Suicidal Ideation, Overdose...In the past 3 days have you felt? Suicidal - Yes...Experienced Hallucinations - Yes. Helpless and Hopelessness - Yes...Behavioral/Activity - Anxious, Angry, Depressed. Affect/Mood - Depressed, Angry, Anxious. Assualtiveness - Potentially present. Suicide Potential: Significant sense of loss (checked) - grandmother in 2005. Significant sense of hardship (checked) - unable to pay bills at times. Substance Abuse or Dependence (checked) Marijuana...Previous patient suicide attempt (checked) - tried to kill self. Significant depression (checked) - (no explanation)...Hallucinations - visual - the devil..."

Review of an addendum to the Initial Nursing Assessment, attachment number 03-10-07b, Initial Screening for Self-Harm Potential Behavioral Health Units read in part: "Instructions: To be completed by the RN at the first part of the admission assessment. Please check 'yes' or 'no' to each question. SOS - I Screen (constant observation)...Are there statements of intent to harm self? "No" is checked...Is the patient unwilling and unable to contract NOT to harm oneself? "No" is checked. Is the patient experiencing auditory hallucinations that command self-harm? "No" is checked. A YES on any of the above questions dictates the need for Level 1 Observation."

The Initial Nursing Assessment and Initial Screening for Self-Harm Potential were reviewed by S3RN, Psyc Unit Director. S3RN stated the screening should have identified patient #16 as SOS - I observation status at the time of initial assessment.

In an interview on 05/10/11 at 10:05 with S6MD he reviewed the assessment findings of patient #16. S6MD stated that patient #16 should have been placed on SOS - I Observation and he should have been notified of the assessment findings.

Review of a hospital policy titled "Suicide Precautions", policy number 03-11-07, effective 12/13/07, no date of last review or revision, reads in part: "Purpose: To ensure a safe environment for potentially self-destructive patients and to establish specific guidelines for staff observation of these patients. Procedure: Suicide precautions will be ordered by the Physician, but nursing personnel will implement suicide precautions while awaiting the order... All patients placed on suicide precautions will be assigned an acuity level based upon the severity of the suicidal thoughts, plan, or behavior. The levels are as follows: SOS I - One to One Observation at all times...patients on this level are considered highest risk and documentation must reflect the need for continued 1-to-1 or improvement in behaviors and thoughts, which allows the patient to be recatagorized to a lower level of observation. SOS II - Line of Sight Observation...SOS III - Every 15 minutes observation." Review of an attachment to this policy, policy 03-10-07b, "Initial Screening for Self-Harm Potential Behavioral Health Units" revealed any of the following "dictates the need for Level I (SOS I) Observation": Was there a potentially lethal suicide attempt in the past 24 hours?..."

Based on record review and interview the hospital failed to ensure chemical restraint orders were not ordered on a prn (as needed) basis as evidenced by 2 of 2 focused psychiatric patient record reviews containing prn chemical restraint orders in a total sample of 44. (#16, #17) Findings:

Review of the medical record of patient #16 revealed the patient was admitted on 05/06/11 with a diagnosis of psychosis NOS (not otherwise specified). Review of the admission orders revealed a physician's order on the admission orders for Geodon 20 mg IM (intramuscular) BID (twice a day) prn (as needed) agitation and Ativan 2 mg IM BID prn agitation.

Review of the medical records of patient #17 revealed the patient was admitted on 04/23/11 with a diagnosis of Chronic Paranoid Schizophrenia and Bipolar Disorder with psychosis. Review of the physician's orders dated 04/23/11 at 11:20 a.m. revealed an order for 1) Geodon 20 mg IM (intramuscular) BID (twice a day) prn (as needed) agitation 2) Ativan 2 mg IM BID prn agitation.

Review of a Psychiatric Unit document titled "Definitions and Psychiatric Terms" revealed the following: "4. Agitation: A state of restlessness, an expression of emotional tension."

In an interview on 05/09/11 at 12:20 with S3RN, Psych Unit Director, she stated the order failed to define what level of agitation which or both of the medications would be administered.

In an interview on 05/10/11 at 10:00 a.m. with S6MD he reviewed the Geodon/Ativan orders for patient #16. The physician stated "agitation" would mean a patient who is "out of control, combative." S6MD stated that the order as written requires a nurse to make a decision of when to administer one or both of the medications. S6MD stated that, as written, the order is a prn chemical restraint order.

In an interview on 05/10/11 at 10:05 a.m. with S6MD he reviewed the Geodon/Ativan order for patient #17. S6MD stated that there was no order for Geodon to be administered for a patient hallucinating and talking to the air conditioning vent. S6MD stated he should have been notified of the change in patient status and orders given by him. S6MD stated that nursing should have placed patient #17 on SOS - I observation while awaiting orders from him.

Based on review of the "Patient Care Services" policy, the 2010 Medical Staff Bylaws, the Medical Staff Rules and Regulations dated 2010, and staff interviews, the hospital failed to ensure the medical staff were carrying out their responsibilities as outlined in the 2010 Medical Staff Rules and Regulations as evidenced by:
(1) failing to perform medication reconciliation for 3 of 4 focused Ambulatory Clinic Records focused record reviewed for medication reconciliation out of a total of 23 Ambulatory Clinic Records reviewed out of a total of 44 sampled patient medical records (#5, #8, #10);
(2) failing to ensure clinical record documentation was clear, legible, timed, and dated for 3 of 4 focused Ambulatory Clinic Records focused record reviewed for clinic record clear, legible, timed, and dating of medical record entries out of a total of 23 Ambulatory Clinic Records reviewed out of a total of 44 sampled patient medical records (#5, #6, #7);
(3) failing to complete the sections of the Consent forms for Surgery, Procedure, Anesthesia, and Blood Transfusion for 4 of 4 focused Ambulatory Clinic Records for Consent forms (#14, #41, #42) and the Advanced Directive Acknowledgement for 1 of 4 focused Ambulatory Clinic Records (#43) out of a total of 23 Ambulatory Clinic Records reviewed out of a total of 44 sampled patient medical records:
(4) failing to have current information (i.e. approved privileges, CDS licenses, and ACLS certification) on 2 of 5 sampled medical staff credentialing folders (S40, S41) and 1 of 2 sampled Family Nurse Practitioners' credentialing folders (S42); and
(5) failing to ensure 2 of 4 contracted physicians (S38, Radiologist and S39, Pathologist) had appraisals of their performance every six months as indicated in the Medical Staff Bylaws out of 5 sample medical staff credentialing folders and 2 sample Nurse Practitioners' credentialing folders. Findings:

(1) Failing to perform medication reconciliation for 3 of 4 focused Ambulatory Clinic Records focused record reviewed for medication reconciliation out of a total of 23 Ambulatory Clinic Records reviewed out of a total of 44 sampled patient medical records (#5, #8, #10):

Patient #5:
The patient was seen at the Primary Care Clinic on 1/4/11 and 5/9/11 for symptoms of GERD (Gastroesophageal Reflux Disease). A record review of Patient #5's clinical record revealed that the medication reconciliation was last reviewed on 9/30/10.

In an interview with S27 Outpatient Supervisor on 5/9/11 at 2:15 p.m., she confirmed that Patient #5's clinical record revealed missing documentation that the medication reconciliation occurred with each visit.

Patient #8:
The patient was seen at the Diabetic Foot Clinic on 10/27/10, 1/27/11, 1/29/11, 3/14/11, 4/18/11; and 5/6/11. A record review of Patient #8's "Home Medication and Allergy List", was observed to have been reconciled on 10/5/10 at 1357 (1:57 p.m.). No further documentation was present in the clinical record that Patient #8's home medicines had been reconciled since 10/5/10.

In an interview with S2DON on 5/11/11 at 3:05 p.m., she confirmed that no medication reconciliation and assessment was performed as per policy for Patient #8's visit to the Diabetic Foot Clinic.

Patient #10:
The patient was seen at the Asthma clinic on 5/4/11. A record review of Patient # 10's clinical record revealed that the medication reconciliation was last reviewed on 4/21/11 at 10:15 a.m.

In an interview with S2DON on 5/9/11 at 3:05 p.m., she confirmed that the medication reconciliation was not performed when Patient #10 visited the outpatient clinic on 5/4/11 as per hospital policy.

Record review of hospital wide policy titled "Medication Reconciliation Process" (pg 1 of 6) revealed the purpose of medication reconciliation was "to ensure that all patients are provided with complete and effective medication treatment while under the care of the organization. Medication reconciliation is a multidisciplinary process between Nursing, the pharmacist, and the physician with patient/family involvement."

On page 2 of 6 of the "Medication Reconciliation Process" revealed "outpatient areas where medication reconciliation shall be performed include (not all inclusive): Primary Care and Specialty Clinics, GI laboratory, Outpatient Oncology services, Certain imaging procedures, and Outpatient surgery."

On page 3 of 6 of the "Medication Reconciliation Process" revealed the Responsible Parties to ensure medication reconciliation process is carried out with each patient visit. The Responsible parties included nurses, pharmacists, physicians, APRN (Advance Practice Registered Nurse) and PA (Physician's Assistant).

Record review of the 2010 Medical Staff Rules and Regulations (pg 9 of 15) #7. Ambulatory Care Medical Records, A. Out-Patient Assessment revealed: a. .."There will be a Medication Reconciliation list started and an entry into CLIQ Medication Management on the initial visit for medications known to be prescribed for or used by the patient, and will be updated on each visit thereafter."

b. "For patients receiving ambulatory care services on a continuing basis it is the responsibility of the physician to complete the assessment form developed for outpatient clinics and must include the following information: Patients Chief Complaint and vital signs; Patients history and physical findings; Diagnostic impression; Medications/Orders; Instructions to the patient; and Known adverse and allergic drug reactions."

(2) Failing to the clinical record documentation was clear, legible, timed, and dated for 3 of 4 focused Ambulatory Clinic Records focused record reviewed for clinic record clear, legible, timed, and dating of medical record entries out of a total of 23 Ambulatory Clinic Records reviewed out of a total of 44 sampled patient medical records (#5, #6, #7):

Patient #5:
The patient received services at the Primary Care Clinic on 5/09/11. Record review of the Outpatient Clinic Visit Record revealed missing the written date on the form. Record review of the Outpatient Clinic Visit Record dated 5/9/11 and 1/4/11 revealed illegible documentation by both the physician and the assessment nurse.

On 5/9/11 at 2:35 p.m. an interview with S27 Outpatient Supervisor confirmed the Outpatient Clinic Visit Record dated 5/9/11 was missing the written date on the form. She also confirmed the Outpatient Clinic Visit Record dated 5/9/11 and 1/4/11 had illegible documentation by both the physician and the assessment nurse.

Patient #6:
The patient received services at the Diabetic Clinic on 5/9/11. Record review of the Outpatient Clinic Visit Record revealed illegible documentation by both the physician and the assessment nurse. Record review of the Outpatient Clinic Visit Record dated 4/7/11 revealed illegible documentation by the assessment nurse.

On 5/9/11 at 2:45 p.m. an interview with S27 Outpatient Supervisor confirmed the illegible documentation on Outpatient Clinic Visit Records dated 5/9/11 and 4/7/11.

Patient #7:
The patient received services at the Primary Care Clinic III on 5/9/11, 11/8/10, 8/3/10, and 5/3/10. Record review of the Outpatient Clinic Visit Records revealed illegible physician documentation.

On 5/9/11 at 3:00 p.m. in an interview with S2DON, she confirmed that these Outpatient Clinic Visit Records had illegible physician documentation.

Record review of the 2010 Medical Staff Rules and Regulations (pg 6 of 15) III. Health Information Management B. revealed the following: "All entries into the medical record must be in indelible ink and include month, day, year, and time." Under G. "No record can be updated or modified by preparing entries with dates and times that do not reflect the ACTUAL DATE and TIME (in the 2010 Medical Staff Rules and Regulations) that the information was written. Any late entries shall be labeled as such."

(3) Failing to complete the sections of the Consent forms for Surgery, Procedure, Anesthesia, and Blood Transfusion for 4 of 4 focused Ambulatory Clinic Records for Consent forms (#14, #41, #42) and the Advanced Directive Acknowledgement for 1 of 4 focused Ambulatory Clinic Records (#43) out of a total of 23 Ambulatory Clinic Records reviewed out of a total of 44 sampled patient medical records:

Patient # 14:
The patient received services in the Surgical Outpatient Clinic on 4/29/11 for an excision of a skin lesion. Record review of the Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgement of Receipt of Medical Information revealed missing documentation under "Patient Condition," "Material Risks of Treatment Procedure," "Risks Identified by the Louisiana Medical Disclosure Panel," "Risks Determined by your Doctor," "Risks determined by your doctor," "Additional risks (if any) Particular to this Patient because of a Complicating Medical Condition," "Risks Generally Associated with any Surgical Treatment/Procedure, including Anesthesia," Reasonable Therapeutic Alternatives and the Risks Associated with such Alternatives," and "Acknowledgement, Authorization, and Consent."

Record review of the Consent signed by Patient #14 revealed missing time of when Patient #14 signed the consent form.

On 5/11/11 at 3:00 p.m. in an interview with S2DON and S25 Perioperative Director, both confirmed the consent signed by Patient #14 was not timed. Both S2 and S25 confirmed the Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgement of Receipt of Medical Information was incomplete and did not follow the hospital's policy.

Patient #41:
The patient received services in the Surgical Outpatient Clinic on 5/11/11 for removal of the gallbladder. Record review of the Advance Directive Acknowledgement dated on 4/15/11 was missing documentation of the time the patient had signed the document.

Record review of the Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgment of Receipt of Medical Information Transfusion of Blood and Blood Components dated 5/11/11 revealed missing documentation under "2. Treatment/Procedure: Transfusion of Blood and Blood Components--multiple units as required a) Description, nature of the treatment/procedure. " Other components of the informed consent which had missing documentation included "Risks Identified by the Louisiana Medical Disclosure Panel, " "Risks Determined by Your Doctor," "Risks Generally Associated with any Surgical Treatment/Procedure, including Anesthesia," and "Acknowledgement, Authorization, and Consent."

On 5/11/11 at 3:00 p.m. in an interview with S2DON and S25 Perioperative Director, both confirmed the consent signed by Patient #41 was incomplete and did not follow the hospital's policy.

Patient #42:
The patient received services in the Surgical Outpatient Clinic on 5/11/11 for a colonoscopy. Record review of the Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgement of Receipt of Medical Information, Colonoscopy revealed missing documentation under 3. Patient Condition; under 4. Material Risks of Treatment Procedure; and under 6. Acknowledgement, Authorization, and Consent.

Record review of the Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgement of Receipt of Medical Information, Transfusion of Blood and Blood Components dated 5/11/11 revealed missing documentation under 2. Treatment/Procedure: Transfusion of Blood and Blood Components a) Description, nature of the treatment/procedure; under 4. Material Risks of Treatment Procedure; and under 6. Acknowledgement, Authorization, and Consent.

On 5/11/11 at 2:35 p.m. in an interview with S2DON and S25 Perioperative Director, both confirmed the consent forms for the Colonscopy and for Blood Transfusions were incomplete.

Patient #43:
The patient received services in the Surgical Outpatient Clinic on 5/9/11 for a colonoscopy. Record review of the Advance Directive Acknowledgement revealed missing time when the patient signed the form.

On 5/11/11 at 3:10 p.m. in an interview with S2DON and S26 Same Day Surgery Supervisor, both confirmed that the Advance Directive Acknowledgement did not contain the time Patient #43 had signed the form.

Record review of the hospital's policy titled "Patient Care Services" (pg 1 of 7) under Policy, 2. Content of the medical record, a. reveals the following: "The content of the medical record, which includes written documentation, must be sufficiently detailed, legible, and organized..." The hospital's policy had been revised 11/10 and approved by the Governing Body on 2/18/11.

Record review of the 2010 Medical Staff Rules and Regulations (pg 10 of 15) under IV. Informed Consent D. reveals the following: "Obtaining written informed consent from the patient or his/her legal representative for diagnostic and/or therapeutic/surgical procedures, blood transfusions and anesthesia is the responsibility of the practitioner planning to perform the procedure, as well as, a discussion of the relevant risks, benefits, and side effects related to alternatives, including the possible results of not receiving care, treatment, and services."

(4) Failing to have current information (i.e. approved privileges, CDS licenses, and ACLS certification) on 2 of 5 sampled medical staff credentialing folders (S40, S41) and 1 of 2 sampled Family Nurse Practitioners' credentialing folders (S42).

Record review of S40 Internist, Medical Staff's credentialing folder revealed that the Medical Staff Executive Committee granted privileges to S40 on 4/8/08. No documentation in S40, MD's credentialed folder indicated that the reapplication for granting of privileges to the hospital had been completed by S40 MD since 4/8/08. In conjunction, the last National Inquiry Database was obtained on 5/11/08 for S40.

Record review of S41, Internist, Medical Staff's credentialing folder revealed that S41's Louisiana Narcotics license (CDS) had expired on 7/10. The credentialing folder revealed no further documentation that S41, Internist had submitted his current CDS license as required by the Medical Staff Bylaws.

Record review of S43 RN, Family Nurse Practitioner's credentialing folder revealed that S43's Louisiana Narcotics (CDS) license had expired on 5/10/10. The credentialing folder revealed no further documentation that S43 RN had submitted her current CDS license as required by the Medical Staff Bylaws.

In an interview with S22 Quality Management Administrative Coordinator on 5/10/11 at 2:40 p.m., she confirmed that there was no documentation that S40 Internist's privileges had been granted by the Medical Staff Executive Committee since 5/11/08. She also confirmed S41, Internist's CDS license had expired on 7/10 and that S43 RN's CDS license had expired on 5/10/10. S22 stated she believed both of the medical staff had current licenses, but had not given her a copy to place in their credentialing file.

During this same interview, S22 stated she sends the medical staff a reminder about turning in the required information to her, so she can ensure the medical staff member's credentialing folder is up to date before the Medical Executive Committee meets on the last Thursday of the month.

Record review of 2010 Medical Staff Bylaws, Article IV: Duration of Membership, Conditions, and Categories A. Duration of Membership and Conditions (pg 10 of 36) 2. revealed the following membership condition " All appointments, reappointments, and modifications of appointments shall be for a maximum period of 24 months (2 years). Confirmation of renewed medical licensure and drug licensure is required ANNUALLY..." (The Bylaws had the word "annually" in capitalized letters).

(5) failing to ensure 2 of 4 contracted physicians (S38, Radiologist and S39, Pathologist) had appraisals of their performance every six months as indicated in the Medical Staff Bylaws out of 5 sample medical staff credentialing folders and 2 sample Nurse Practitioners' credentialing folders:

Record review of S38, Radiologist and S39, Pathologist medical staff credentialing folder revealed no appraisals done on these physicians' competencies.

In an interview with S22 Quality Management Administrative Coordinator on 5/10/11 at 2:40 p.m., she confirmed that the two contracted physicians (S38 and S39) did not have any appraisals in their credentialing folders. She also stated that the facility did not have a mechanism in place for ongoing professional practice evaluation for either the radiologist or the pathologist.

Record review of the 2010 Medical Staff Bylaws (pg 10 of 36), Article III. Medical Staff Membership D. Duties and Responsibilities, #13 revealed the following duties and responsibilities of the medical staff "The medical staff must periodically conduct appraisals of its members for qualification, or competencies to perform privileges for which he/she has been granted. The appraisal is to determine if that individual practitioner's membership or privileges should be continued, discontinued, revised, or changed. Appraisals are conducted at least every 6 months."








26313

Based on record reviews and staff interviews, the facility failed to ensure the Registered Nurse (RN) supervised and evaluate patients' health status and medications for patients receiving outpatient clinic services evidenced by lack of documentation that the medication reconciliation was performed with each outpatient clinic visit for 3 of 23 focused ambulatory clinic patients out of a total of 44 sampled patients, (#5, #8, #10); and failed to ensure the Registered Nurse (RN) supervised and evaluated the care for each patient and make assignments based on the patient's needs as evidenced by:

1) failing to ensure the medication reconciliation was performed with each outpatient clinic visits for 3 of 23 focused ambulatory clinic patients out of a total of 44 sampled patients (#5, #8, #10);

2) failing to notify the physician responsible for the care of a patient for 8 hours and 10 minutes that the patient was found tying a sheet around her neck for 1 of 2 focused psychiatric patients in a total sample of 44. (#17);

3) failing to maintain LOS (line of sight) monitoring on patient after the physician ordered the patient to be on continuous line of sight observation. The PA (psychiatric assistant) walked out of the bathroom leaving the patient alone with the bath tub full. Upon return of the PA the patient was found under water. The patient stated she was "suicidal" and attempting to "drown herself." This affected 1 of 2 focused psychiatric patients in a total sample of 44. (#17); and

4) failing to ensure the Registered Nurse (RN) accurately documented the initial assessment on the hospital's "Initial Screening for Self-Harm Potential" which resulted in a patient who met the SOS-1 (Suicide Observation Status Level One) (1:1, constant visual observation) being placed on SOS-3 Observation status for 1 of 2 focused psychiatric patients in a total sample of 44. (#16) Findings:

1) Failing to ensure the medication reconciliation was performed with each outpatient clinic visits for 3 of 23 focused ambulatory clinic patients out of a total of 44 sampled patients (#5, #8, #10) as evidenced by:

Patient #5:
The patient was seen at the Primary Care Clinic on 1/4/11 and 5/9/11 for symptoms of GERD (Gastroesophageal Reflux Disease). A record review of Patient #5's clinical record revealed that the medication reconciliation was last reviewed on 9/30/10.

In an interview with S27 Outpatient Supervisor on 5/9/11 at 2:15 p.m., she confirmed that Patient #5's clinical record revealed missing documentation that the medication reconciliation occurred with each visit as per policy.

Patient #8:
The patient was seen at the Diabetic Foot Clinic on 10/27/10, 1/27/11, 1/29/11, 3/14/11, 4/18/11; and 5/6/11. A record review of Patient #8's "Home Medication and Allergy List", was observed to have been reconciled on 10/5/10 at 1357 (1:57 p.m.). No further documentation was present in the clinical record that Patient #8's home medicines had been reconciled since 10/5/10.

In an interview with S2DON on 5/11/11 at 3:05 p.m., she confirmed that no medication reconciliation and assessment was performed as per policy for Patient #8's visit to the Diabetic Foot Clinic.

Patient #10:
The patient was seen at the Asthma clinic on 5/4/11. A record review of Patient # 10's clinical record revealed that the medication reconciliation was last reviewed on 4/21/11 at 10:15 a.m.

In an interview with S2DON on 5/9/11 at 3:05 p.m., she confirmed that the medication reconciliation was not performed when Patient #10 visited the outpatient clinic on 5/4/11 as per hospital policy.

Record review of hospital wide policy titled "Medication Reconciliation Process" (pg 1 of 6) revealed the purpose of medication reconciliation was "to ensure that all patients are provided with complete and effective medication treatment while under the care of the organization. Medication reconciliation is a multidisciplinary process between Nursing, the pharmacist, and the physician with patient/family involvement."

On page 2 of 6 of the "Medication Reconciliation Process" revealed "outpatient areas where medication reconciliation shall be performed include (not all inclusive): Primary Care and Specialty Clinics, GI laboratory, Outpatient Oncology services, Certain imaging procedures, and Outpatient surgery."

On page 3 of 6 of the "Medication Reconciliation Process" revealed the Responsible Parties to ensure medication reconciliation process is carried out with each patient visit. The Responsible parties included nurses, pharmacists, physicians, APRN (Advance Practice Registered Nurse) and PA (Physician's Assistant).

2) Failing to notify the physician responsible for the care of a patient for 8 hours and 10 minutes that the patient was found tying a sheet around her neck for 1 of 2 focused psychiatric patients in a total sample of 44. (#17)

Patient # 17
Review of the medical record of patient #17 revealed she was admitted to the psychiatric unit of the hospital on 04/23/11 under a Physician's Emergency Certificate (PEC). Patient #17 was subsequently placed under a Coroner's Emergency Certificate (CEC). Further review revealed a Judicial Commitment dated 05/06/11. Patient # 17 had an admission diagnosis of Chronic Paranoid Schizophrenia (CPS) and Bipolar Disorder (BPD) with Psychosis.

Review of the nurses' note's dated 05/03/11 at 2200 (10:00 p.m.) documented by S7RN in the medical record of patient #17 revealed "Patient in room talking to self. When asked to whom she was talking, she gestured to air conditioning vent, saying "(name of male) is there." When nurse left room, she attempted to tie a sheet around her neck. Patient watched by MHT (Mental Health Technician) while nurse obtained injection. Geodon 20 mg IM (intramuscular) given in R (right) gluteal (buttock). Patient tolerated well and observed direct line of sight until asleep."

Review of the physician's orders for patient # 17 revealed the following orders: "05/03/11 at 2000 (10:00 p.m.) (2 hours prior to the patient being found tying a sheet around her neck) Continue SOS III X (times) 24 hours." The next physicians order is dated 05/04/11 at 0610 (6:10 a.m.) (8 hours and 10 minutes after patient # 17 was found tying a sheet around her neck) and read: "Place on SOS II for safety due to suicidal gesture." The order is a verbal order from S6MD taken by S7RN.

Further review revealed no documented evidence that the physician was notified of patient #17 being found tying a sheet around her neck until the order on 05/04/11 at 0610 (6:10 a.m.) to increase the observation status to SOS II, that the Registered Nurse (RN) increased the observation status for patient # 17 according to hospital policy after a change in patient status at 2200 (10:00 p.m.), or documentation to indicate which staff member was assigned to monitor patient #17.

In a telephone interview on 05/10/11 at 9:30 a.m. with S7RN she stated that on 05/03/11 just prior to 2200 (10:00 p.m.) she was in the seclusion room with patient # 17. S7RN stated patient #17 was in the seclusion room with the door open. S7RN stated that she walked out of the seclusion room and turned around and went back into the room. S7RN stated that patient #17 was attempting to tie a sheet around her neck. S7RN stated she removed the sheet. S7RN stated patient #17 was "talking to the air conditioning vent" stating her boyfriend was in there. S7RN stated that patient #17 was saying "don't leave me, wait for me" to the vent. S7RN stated patient #17 was hallucinating and agitated. S7RN confirmed she administered Geodon 20 mg IM to patient #17 for "agitation." S7RN confirmed the physician was not notified of patient #17 being found tying a sheet around her neck at 2200 (10:00 p.m.). S7RN offered no reason the physician was not notified. S7RN stated that she "does not remember if patient #17 was placed on increased observation throughout the night."

In an interview with S11RN on 05/11/11 at 7:40 a.m. he stated he was on duty on the night shift of 05/03/11 - 05/04/11 with S7RN. S11RN stated that patient #17 had been moved to the open seclusion room that evening due to the patient being loud and disruptive to the milieu. S11RN stated he was "unaware" if the physician was notified of patient #17 attempting to tie a sheet around her neck on 05/03/11 at 2200 (10:00 p.m.).

In an interview on 05/10/11 at 9:15 a.m. with S3RN, Psych Unit Manager, she confirmed there was no documented evidence indicating the physician was notified of patient #17 attempting to tie a sheet around her neck on 05/03/11 at 2200 (10:00 p.m.). She further confirmed that the observation status order was 8 hours and 10 minutes after the incident. S3RN, Psych Unit Manager, stated there was no order to administer Geodon to a patient who was hallucinating. S3RN stated she would expect the RN to notify the physician immediately of the behavior of patient #17. S3RN stated that per hospital policy patient #17 should have been placed on SOS I observation status. S3RN confirmed there was no documented evidence of continuous observation of patient #17 or documentation of whom the RN assigned to be responsible for the continuous observation of patient #17.

In an interview on 05/10/10 at 10:00 with S6MD he stated patient #17 should have been placed on SOS - I when she was found tying the sheet around her neck on 05/03/11 at 2200 (10:00 p.m.) and he should have been notified of the change in the status of the patient. He further stated he should have been notified of the attempted drowning on 05/04/10 at 0620 (6:20 a.m.).

Review of a hospital policy titled "Suicide Precautions", policy number 03-11-07, effective 12/13/07, no date of last review or revision, reads in part: "Purpose: To ensure a safe environment for potentially self-destructive patients and to establish specific guidelines for staff observation of these patients. Procedure: Suicide precautions will be ordered by the Physician, but nursing personnel will implement suicide precautions while awaiting the order... All patients placed on suicide precautions will be assigned an acuity level based upon the severity of the suicidal thoughts, plan, or behavior. The levels are as follows: SOS I - One to One Observation at all times...patients on this level are considered highest risk and documentation must reflect the need for continued 1-to-1 or improvement in behaviors and thoughts, which allows the patient to be recatagorized to a lower level of observation. SOS II - Line of Sight Observation...SOS III - Every 15 minutes observation." Review of an attachment to this policy, policy 03-10-07b, "Initial Screening for Self-Harm Potential Behavioral Health Units" revealed any of the following "dictates the need for Level I (SOS I) Observation": Was there a potentially lethal suicide attempt in the past 24 hours?..."

Review of a hospital policy titled "Assessment and Reassessment", policy number 02-01-07, effective 09/97, last revised 11/10, reads in part: "Purpose: To assure care provided to each patient is based on assessment of the patient's relevant physical, psychological, and social needs...Policy: Each patient is assessed...to identify...the need for further assessment...Inpatients are assessed continuously throughout their hospital stay...Reassessments shall take place when there is a significant change in the patient's condition..."

3) Failing to maintain LOS (line of sight) monitoring on patient after the physician ordered the patient to be on continuous line of sight observation. The PA (psychiatric assistant) walked out of the bathroom leaving the patient alone with the bath tub full. Upon return of the PA the patient was found under water. The patient stated she was "suicidal" and attempting to "drown herself." This affected 1 of 2 focused psychiatric patients in a total sample of 44. (#17) .

Review of the physician's orders for patient # 17 revealed the following orders: "05/03/11 at 2000 (10:00 p.m.) (2 hours prior to the patient being found tying a sheet around her neck) Continue SOS III X (times) 24 hours." The next physicians order is dated 05/04/11 at 0610 (6:10 a.m.) (8 hours and 10 minutes after patient # 17 was found tying a sheet around her neck) and read: "Place on SOS II for safety due to suicidal gesture." The order is a verbal order from S6MD taken by S7RN.

Review of the documentation by S7RN for 0620 (6:20 a.m.) (10 minutes after the physician ordered SOS II - Line of Sight Observation) revealed "Patient urinated in bed. Was taken to bath tub, and tried to "drown self" in bath water. Accused this nurse of talking about her to "(name of male)" all night. Very paranoid, hearing voices per her admission and states she is "suicidal". Placed on SOS (safety observation status) II for safety."

In a telephone interview on 05/10/11 at 1:00 p.m. with S12PA (psychiatric assistant) she stated that when she reported for duty for the 7:00 p.m. shift on 05/03/11 that patient #17 was in the seclusion room. S12PA stated she was monitoring the halls. S12PA stated that patient #17 was not on 1-to-1 monitoring on the night shift of 05/03/11 - 05/04/11. S12PA further stated that she was not made aware of patient #17 tying a sheet around her neck earlier in the night. S12PA stated that after patient #17 urinated in her bed that she put patient #17 in the tub and went to help the other PA take patient vital signs, leaving patient #17 alone in a tub full of water. S12PA stated that when she returned she found patient #17 in the tub with her shirt on and she took patient #17's shirt off. S12PA stated that she then stepped out of the bathroom to retrieve items from the linen cart. S12PA stated that when she re-entered the bathroom patient #17 "had her head between her legs underwater." S12PA stated patient #17 said she was "trying to commit suicide."

In an interview on 05/10/11 at 9:15 a.m. with S3RN, Psych Unit Manager, she confirmed there was no documented evidence of notification of the physician of the 2nd attempt of patient #17 to harm herself, no documentation of Line of Sight Observation and which staff member was assigned to perform the line of sight observation.

Review of documentation on the "Therapeutic Surveillance Flowsheet" revealed documentation for patient # 17's behavior for 0545 (5:45 a.m.) through 0645 (6:45 a.m.) that revealed patient #17 was "23/25 - Restless/Challenging Controls."

In an interview with S3RN, Psych Unit Manager, and S11RN (on duty on night shift 05/03 - 05/04) both confirmed that the assignment sheets for 05/03/11 11:00 p.m. - 7:00 a.m., and 05/04/11 7:00 a.m. - 3:00 p.m. "were missing."

Review of a hospital policy titled "Suicide Precautions", policy number 03-11-07, effective 12/13/07, no date of last review or revision, reads in part: "Purpose: To ensure a safe environment for potentially self-destructive patients and to establish specific guidelines for staff observation of these patients. Procedure: Suicide precautions will be ordered by the Physician... The levels are as follows:..SOS II Line of Sight Observation..." Review of an attachment to this policy, policy 03-10-07b, "Initial Screening for Self-Harm Potential Behavioral Health Units" revealed any of the following "dictates the need for Level I (SOS I) Observation": Was there a potentially lethal suicide attempt in the past 24 hours?..."

4) Failing to ensure the Registered Nurse (RN) accurately documented the initial assessment on the hospital's "Initial Screening for Self-Harm Potential" which resulted in a patient who met the SOS-1 (Suicide Observation Status Level One) (1:1, constant visual observation) being placed on SOS-3 Observation status for 1 of 2 focused psychiatric patients in a total sample of 44. (#16)

Patient #16

Review of the medical record for patient #16 revealed she was a 19 year old female admitted on 05/06/11. Review of the PEC revealed the physician documented patient #16 was Suicidal, Danger to Self (having auditory hallucinations to kill herself), and Unwilling to seek Voluntary admission. Review of the CEC revealed the physician documented patient #16 was Suicidal, Violent, Danger to Self, Danger to Others, and Gravely Disabled.

Review of the Initial Nursing Assessment performed by S8LPN and S9RN revealed the following documentation: "Potential harm to self or others - Yes...Are you taking all of your medications as the doctor ordered - No, I want to die...Mental Health History - Anxiety, Depression, Suicidal Ideation, Overdose...In the past 3 days have you felt? Suicidal - Yes...Experienced Hallucinations - Yes. Helpless and Hopelessness - Yes...Behavioral/Activity - Anxious, Angry, Depressed. Affect/Mood - Depressed, Angry, Anxious. Assaultive - Potentially present. Suicide Potential: Significant sense of loss (checked) - grandmother in 2005. Significant sense of hardship (checked) - unable to pay bills at times. Substance Abuse or Dependence (checked) Marijuana...Previous patient suicide attempt (checked) - tried to kill self. Significant depression (checked) - (no explanation)...Hallucinations - visual - the devil..."

Review of an addendum to the Initial Nursing Assessment, attachment number 03-10-07b, Initial Screening for Self-Harm Potential Behavioral Health Units read in part: "Instructions: To be completed by the RN at the first part of the admission assessment. Please check 'yes' or 'no' to each question. SOS - I Screen (constant observation)...Are there statements of intent to harm self? "No" is checked...Is the patient unwilling and unable to contract NOT to harm oneself? "No" is checked. Is the patient experiencing auditory hallucinations that command self-harm? "No" is checked. A YES on any of the above questions dictates the need for Level 1 Observation."

The Initial Nursing Assessment and Initial Screening for Self-Harm Potential were reviewed by S3RN, Psych Unit Director. S3RN stated the screening should have identified patient #16 as SOS - I observation status at the time of initial assessment.

In an interview on 05/10/11 at 10:05 with S6MD he reviewed the assessment findings of patient #16. S6MD stated that patient #16 should have been placed on SOS - I Observation and he should have been notified of the assessment findings.

Review of a hospital policy titled "Suicide Precautions", policy number 03-11-07, effective 12/13/07, no date of last review or revision, reads in part: "Purpose: To ensure a safe environment for potentially self-destructive patients and to establish specific guidelines for staff observation of these patients. Procedure: Suicide precautions will be ordered by the Physician, but nursing personnel will implement suicide precautions while awaiting the order... All patients placed on suicide precautions will be assigned an acuity level based upon the severity of the suicidal thoughts, plan, or behavior. The levels are as follows: SOS I - One to One Observation at all times...patients on this level are considered highest risk and documentation must reflect the need for continued 1-to-1 or improvement in behaviors and thoughts, which allows the patient to be recatagorized to a lower level of observation. SOS II - Line of Sight Observation...SOS III - Every 15 minutes observation." Review of an attachment to this policy, policy 03-10-07b, "Initial Screening for Self-Harm Potential Behavioral Health Units" revealed any of the following "dictates the need for Level I (SOS I) Observation": Was there a potentially lethal suicide attempt in the past 24 hours?..."






26458

Based on record review and interview the hospital failed to ensure the Care Plan was updated in response to a change in patient status as evidenced by patient # 17 attempting self-harm twice with no documentation that addressed either of the patient's attempts at self-harm in the Master Treatment Care Plan for 1 of 2 focused psychiatric records reviewed in a total sample of 44. (#17) Findings:

Review of the Master Treatment Plan and Nursing Care Plan for patient #17 revealed no documentation regarding the 2 attempts of self-harm by patient #17.

In an interview on 05/10/11 at 8:30 a.m. with S3RN, Psych Unit Director, she confirmed the was no update or mention of the 2 attempts of self-harm by patient #17.

In an interview on 05/10/11 at 10:05 a.m. with S6MD he stated the care plan of patient #17 should have been updated to address the 2 attempts of self-harm by patient #17.

Review of a hospital policy titled "Treatment Plans",approved 08-30-90, effective 10/10/90, last revised 07/01/07, reads in part: "Policy: Each patient admitted to W.O. Moss regional Psychiatric Unit will have a written, individualized treatment plan, developed by a multi disciplinary treatment team, based on the assessments of the patient's clinical needs...4. Treatment Plan Update/Reviews:..the treatment plan will be updated whenever there is a change in the patient's mental or physical condition which would require a significant change in the treatment objectives or services identified on the treatment plan...The treatment plan will not be considered appropriate if the treatment team has not updated the goals and approaches at staffing and/or progress notes have indicated a need for revision..."

Based on observations, staff interviews, clinic record reviews and "Patient Care Services" policy review, the facility failed to ensure the clinical records were clear, legible, complete, dated, timed, and authenticated in written form by the person responsible for providing or evaluating the service as evidenced by 7 of 23 focused ambulatory clinical records out of a total of 44 medical records reviewed for missing documentation (#5, #6, #7, #14, #41, #42, #43). Findings:

Patient #5:
The patient received services at the Primary Care Clinic on 5/09/11. Record review of the Outpatient Clinic Visit Record revealed missing the written date on the form. Record review of the Outpatient Clinic Visit Record dated 5/9/11 and 1/4/11 revealed illegible documentation by both the physician and the assessment nurse.

On 5/9/11 at 2:35 p.m. an interview with S27 Outpatient Supervisor confirmed the Outpatient Clinic Visit Record dated 5/9/11 was missing the written date on the form. She also confirmed the Outpatient Clinic Visit Record dated 5/9/11 and 1/4/11 had illegible documentation by both the physician and the assessment nurse.

Patient #6:
The patient received services at the Diabetic Clinic on 5/9/11. Record review of the Outpatient Clinic Visit Record revealed illegible documentation by both the physician and the assessment nurse. Record review of the Outpatient Clinic Visit Record dated 4/7/11 revealed illegible documentation by the assessment nurse.

On 5/9/11 at 2:45 p.m. an interview with S27 Outpatient Supervisor confirmed the illegible documentation on Outpatient Clinic Visit Records dated 5/9/11 and 4/7/11.

Patient #7:
The patient received services at the Primary Care Clinic III on 5/9/11, 11/8/10, 8/3/10, and 5/3/10. Record review of the Outpatient Clinic Visit Records revealed illegible physician documentation.

On 5/9/11 at 3:00 p.m. in an interview with S2DON, she confirmed that these Outpatient Clinic Visit Records had illegible physician documentation.

Patient # 14:
The patient received services in the Surgical Outpatient Clinic on 4/29/11 for an excision of a skin lesion. Record review of the Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgement of Receipt of Medical Information revealed missing documentation under "Patient Condition," "Material Risks of Treatment Procedure," "Risks Identified by the Louisiana Medical Disclosure Panel," "Risks Determined by your Doctor," "Risks determined by your doctor," "Additional risks (if any) Particular to this Patient because of a Complicating Medical Condition," "Risks Generally Associated with any Surgical Treatment/Procedure, including Anesthesia," Reasonable Therapeutic Alternatives and the Risks Associated with such Alternatives," and "Acknowledgement, Authorization, and Consent."

Record review of the Consent signed by Patient #14 revealed missing time of when Patient #14 signed the consent form.

On 5/11/11 at 3:00 p.m. in an interview with S2DON and S25 Perioperative Director, both confirmed the consent signed by Patient #14 was not timed. Both S2 and S25 confirmed the Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgement of Receipt of Medical Information was incomplete and did not follow the hospital's policy.

Patient #41:
The patient received services in the Surgical Outpatient Clinic on 5/11/11 for removal of the gallbladder. Record review of the Advance Directive Acknowledgement dated on 4/15/11 was missing documentation of the time the patient had signed the document.

Record review of the Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgment of Receipt of Medical Information Transfusion of Blood and Blood Components dated 5/11/11 revealed missing documentation under "2. Treatment/Procedure: Transfusion of Blood and Blood Components--multiple units as required a) Description, nature of the treatment/procedure. " Other components of the informed consent which had missing documentation included "Risks Identified by the Louisiana Medical Disclosure Panel, " "Risks Determined by Your Doctor," "Risks Generally Associated with any Surgical Treatment/Procedure, including Anesthesia," and "Acknowledgement, Authorization, and Consent."

On 5/11/11 at 3:00 p.m. in an interview with S2 DON and S25 RN, Perioperative Director, both confirmed the consent signed by Patient #41 was incomplete and did not follow the hospital's policy.

Patient #42:
The patient received services in the Surgical Outpatient Clinic on 5/11/11 for a colonoscopy. Record review of the Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgement of Receipt of Medical Information, Colonoscopy revealed missing documentation under 3. Patient Condition; under 4. Material Risks of Treatment Procedure; and under 6. Acknowledgement, Authorization, and Consent.

Record review of the Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgement of Receipt of Medical Information, Transfusion of Blood and Blood Components dated 5/11/11 revealed missing documentation under 2. Treatment/Procedure: Transfusion of Blood and Blood Components a) Description, nature of the treatment/procedure; under 4. Material Risks of Treatment Procedure; and under 6. Acknowledgement, Authorization, and Consent.

On 5/11/11 at 2:35 p.m. in an interview with S2DON and S25 Perioperative Director, both confirmed the consent forms for the Colonoscopy and for Blood Transfusions were incomplete.

Patient #43:
The patient received services in the Surgical Outpatient Clinic on 5/9/11 for a colonoscopy. Record review of the Advance Directive Acknowledgement revealed missing time when the patient signed the form.

On 5/11/11 at 3:10 p.m. in an interview with S2DON and S26 Same Day Surgery Supervisor, both confirmed that the Advance Directive Acknowledgement did not contain the time Patient #43 had signed the form.

Record review of the hospital's policy titled "Patient Care Services" (pg 1 of 7) under Policy, 2. Content of the medical record, a. reveals the following: "The content of the medical record, which includes written documentation, must be sufficiently detailed, legible, and organized..." The hospital's policy had been revised 11/10 and approved by the Governing Body on 2/18/11.

Based on record reviews, observations and staff interviews, the hospital failed to ensure the facility was maintained to ensure adequate cleanliness and maintenance of equipment as evidenced by ensure the facility was maintained to ensure adequate cleanliness as evidenced by having:
1) black substance covering the inside rim of a " Thin Prep Pap Test " container/holder on the GYN unit on 5/10/11;
2) grayish substance covering: a) the portable manual blood pressure machine on Primary Care (PC) #2 unit on (5/9/11), b) the dehumidifier system in the Pediatric Holding Area on ;
c) the wall mount blood pressure machine in the Adult Holding Area on 5/10/11, d) the " Mobl Vac III " system in the Adult Holding Area on 5/10/11,
3) the " Dissector " set front label covered orange discoloration covering the two (2) metal screws that held the label on the set and orange streaks that ran from both screws approximately 2 inches in length and three (3) large liquid Nitrogen Tanks with grayish substance cached on the metal portable holders in the Medical Supply Area on 5/10/11;
4) the sink facet and knobs were covered with a white substance about one-eighth an inch (1/8) and Cidex Venting System covered with a grayish substance in the Endo Room on 5/10/11;
5) the forceps had a sticky substance noted on the right edge of the forceps in the Crash Cart located between the Adult Holding Area and Endo Room on 5/10/11;
6) the white rocker with black debris cached in the grooved seat area in the Recovery Room on 5/10/11;
7) a white rocker observed with black discolored substance in the grooved section of the seat area on the Recovery Room/PACU unit held on 5/10/11;
8) the surgical bed mattress room/suite had white debris observed covering the velcro area(s) on the back side of the black mattress pads and small black transfer board had tears/ripped areas about one-quarter (1/4) inch in width on both tip ends of the board in Surgery " A " room/suite on 5/10/11;
9) a Bovie Machine had orange discolored substance on the right side of the machine in Surgery " B " room/suite on 5/10/11;
10) in ER Room "a" , the floor at the end of the pelvic exam bed, a reddish/brown substance was observed; dust on the base of an IV pump pole was observed, and a black substance in the pelvic bed specimen table was observed; and in ER Room "b", a tape/tape residue on both side rails of the bed was observed; a reddish/brown substance on left side foot pedals of the bed was observed; and dust on the base of the IV pump stand was observed.

Findings:

1)
During a tour of the GYN clinic area on 5/10/11 from 1:50 p.m. to 2:05 p.m. with S2 Director of Nursing (DON) and S25 Perioperative Director, a white " Thin Prep Pap Test " container was observed on the countertop in an exam room. Further observation revealed there was black discolored substance that covered the inside rim of the container. During this same observation, S25 indicated the white container held the Pap specimens collected from the patients. S25 and S2 both confirmed the Pap container/holder was covered with a black substance and it was dirty. S25 reported all patient supplies/equipment must be clean and ready for patient usage at all times as per policy.

2)
A tour of the Primary Care Area (PC#2), Building " D " was conducted on 5/9/11 from 1:30 p.m. through 1:50 p.m. with S2 DON, S27 Outpatient Supervisor and S29 Licensed Practical Nurse (LPN). At 1:35 p.m., a portable manual blood pressure machine was observed covered with grayish substance. S2, S27 and S29 all agreed the portable blood pressure machine was dirty. S29 and S27 both indicated there was no cleaning process in place to ensure the portable blood pressure machine was clean and ready for patient use. S2 and S27 both stated that all patient equipment must be kept clean at all times as per policy. S2 and S27 agreed the policy to keep all patient equipment clean at all times was not being followed.

3)
During a tour of the Surgery Unit was held on 5/10/11 from 2:20 p.m. through 3:50 p.m. with S25 Perioperative Director, a de-humidifier (Whirlpool) system was observed covered with grayish substance at 2:20 p.m. in the Pediatric Holding Area. S25 confirmed the de-humidifier machine was used at the end of the day by the staff. S25 confirmed at this time the dehumidifier was covered with dust. S25 stated housekeeping cleaned the dehumidifier at the end of each day. S25 indicated the dehumidifier had not been cleaned for several weeks, months. She did not know that the dehumidifier was not being cleaned daily by housekeeping as per policy. S25 reported there is no system in place for the dehumidifier to be cleaned daily by staff. S25 indicated it is hospital policy for all patient equipment to be clean and ready for patient use in all care areas in the hospital.

In a face-to-face interview conducted on 5/10/11 at 2:30 p.m., S32 Housekeeping verified the dehumidifier system was covered with a gray substance. S32 indicated housekeeping did not clean the dehumidifier system during the routine cleaning of the surgical areas (holding).

The same tour of the Surgery Unit held on 5/10/11 with S25 Perioperative Director revealed there was a wall mounted blood pressure machine observed at 2:30 p.m. covered with a grayish substance in the Adult Holding Area. S25 confirmed the finding at this time. Further observation revealed at 2:30 p.m. there was a " Mobl Vac III " system observed covered with grayish/whitish substance in the Adult Holding Area. S25 verified at this time that the Vac system was dirty. S25 did not know the Vac system was not being cleaned by Housekeeping and/or sterile processing. S25 Perioperative Director indicated there was no system in place to ensure the Vac system was cleaned during the routine cleaning of the unit.

In an interview on 5/10/11 at 2:30 p.m., S32 Housekeeping indicated she did not clean the " Mobl Vac III " system during routine cleaning of the holding area. S32 stated the system comes clean from sterile processing.

During the same tour of the Surgery Unit conducted on 5/10/11 with S25 Perioperative Director, a white container with the label, " Micro Bore Extension Set, Dissector Sponge " set was observed at 2:45 p.m. in the Medical Supply Area sitting behind a clear plastic cover on the top shelf of the metal cart. Further observation revealed there was a label on the front of the container that was held in place by two (2) metal screws. There was orange discoloration observed at this time that extended about a quarter (1/4) inch on both metal screws. Both metal screws were observed further with orange streaks that ran down the front of the label to the end of the container approximately 2 inches in length. At 2:45, there were 3 large liquid Nitrogen Tanks observed in the Medical Supply Area. Further observation revealed all 3 green tank holders were cached with a grayish substance. S25 confirmed the 3 large Nitrogen Tank holders had a cached grayish substance on them. S25 indicated the Nitrogen Tanks are used as needed and are dirty.

4)
The same tour of the Surgery Unit held on 5/10/11 at 2:50 p.m. with S25 Perioperative Director revealed there were white spots covering the sink facet and knobs about one-eight an inch (1/8) in the Endo Room. There was a Cidex Venting System observed hanging from the wall about 2 and a half (2 ?) feet in length. Further observation revealed the venting system was covered with a brownish/orangish/grayish substances. S25 confirmed these findings during this observation in the Endo Room.

5)
During the same tour of the Surgery Unit held on 5/10/11 at 2:55 p.m. with S25 Perioperative Director revealed there was a Crash Cart located observed between the Adult Holding Area and the Endo Room. Further observation revealed there was a sticky substance noted on the right edge of the forceps used during intubation. S25 confirmed these findings during this observation.

6)
The same tour of the Surgery Unit held on 5/10/11 with S25 Perioperative Director revealed there was a white rocker observed with black debris cached in the grooved seat area in the Recovery Room at 3:15 p.m. on 5/10/11.

Review of the policy titled, " Nursing, General Infection Control " , Policy Number: IC 1.10, with no revised, reviewed or effective date(s), presented on 5/9/11 at 1:55 p.m. as the hospital ' s current " Patient Equipment/Supplies " revealed each person on the nursing unit are responsible for maintaining a clean, safe working environment. Separation of clean, sterile and soiled activities shall be kept separate. A clean area and dirty area are provided on each patient care unit. The nursing staff cleans the vital sign unit as needed between patient uses and at least weekly with disinfecting towelette. The equipment that remains in patient rooms will be cleaned thoroughly with hospital grade disinfectant or by detergent germicide after each patient use. Equipment will be cleaned prior to storage in a designated area on each unit. Used, unclean patient equipment will not be brought to the nurse station. Vital sign monitors are cleaned when visibly soiled using a disinfectant.

7)
During the same tour of the Surgery Unit held on 5/10/11 at 3:15 p.m. with S25 Perioperative Director, the Recovery Room/PACU unit revealed there was a white rocker observed with black discolored substance in the grooved section of the seat. S25 indicated the white rocker is used by staff to rock the pediatric patients while on the unit. S25 Director reported there was no system in place to ensure the rocker was routinely cleaned.

8)
The same tour of the Surgery Unit was held on 5/10/11 with S25 Perioperative Director. At 3:40 p.m., the surgical bed mattress in Surgery " A " room/suite had white debris observed covering the velcro area(s) on the back side of the black mattress pads used during the surgical procedures. At 3:50 p.m., there was a small black board used to transfer patients from the stretcher to the surgical bed observed with tears/ripped areas about one-quarter (1/4) inch in width on both tip ends of the board in Surgery " A " room/suite. S25 Director confirmed the findings during the Surgery Unit Tour of Surgery " A " room/suite.

9)
During the same tour of the Surgery Unit held on 5/10/11 with S25 Perioperative Director, at 3:55 p.m., there was a Bovie Machine observed in Surgery " B " room/suite with orange discolored substance on the right side of the machine. Further observation revealed this area was discolored. This area was used by the surgical nursing staff to move the machine to attach the machine to the patient during the surgical procedure. S25Director confirmed the findings during the Surgery Unit Tour of Surgery " B " room/suite.

Review of the policy titled, " Nursing, General Infection Control " , Policy Number: IC 1.10, with no revised, reviewed or effective date(s), presented on 5/9/11 at 1:55 p.m. as the hospital ' s current " Patient Equipment/Supplies " revealed each person on the nursing unit are responsible for maintaining a clean, safe working environment. Separation of clean, sterile and soiled activities shall be kept separate. A clean area and dirty area are provided on each patient care unit. The nursing staff cleans the vital sign unit as needed between patient uses and at least weekly with disinfecting towelette. The equipment that remains in patient rooms will be cleaned thoroughly with hospital grade disinfectant or by detergent germicide after each patient use. Equipment will be cleaned prior to storage in a designated area on each unit. Used, unclean patient equipment will not be brought to the nurse station. Vital sign monitors are cleaned when visibly soiled using a disinfectant.

The policy titled, "Operating Room", Effective Date of 09/81, Effective dates of 09/83, 08/85, 09/88, 10/91, 01/93, 07/95, 10/96, 06/99, 11/99, 11/02, 09/03, 09/04, 05/06k, 08/08, 10/08; with no policy number, presented as the hospital's current "Operating Room" policy on 5/11/11 at 11:30 a.m. was reviewed. The policy indicated prepartion of the OR should include visual inspection for cleanliness before carts, supplies, equipment, and instrument sets are brought into the room. All horizontal surfaces in the OR should be damp dusted with a germicidal agent before the first scheduled surgical procedure of the day. This includes equipment.

Review of the policy titled, "Environmental Services Surgical Services", Effective date of 10/98; Revised date of 06/99, 11/99, 11/05, 05/06, 11/07, with no policy number or reviewed dates; presented on 5/11/11 at 11:35 a.m. as the hospital's current OR Surgical Services" policy was reviewed. The policy indicated spot cleaning of walls are done as necessary by the Environmental Services and OR Personnel. Medical Supply Room, scrub sinks and utility carts are cleaned daily by the Environmental Services and OR Personnel. Terminal cleaning is performed in surgical procedure rooms and scrub/utitity areas, which include fixed and mounted equipment, all furniture, equipment, horizontal surfaces (e.g. scrub sinks, and utility carts) must be done weekly by Environmental Services and OR personnel.

10) On a tour of the environment in ER on 5/12/11, the following observations were found: in ER Room "a" , the floor at the end of the pelvic exam bed, a reddish/brown substance was observed; dust on the base of an IV pump pole was observed, and a black substance in the pelvic bed specimen table was observed.

In ER Room "b", a tape/tape residue on both side rails of the bed was observed; a reddish/brown substance on left side foot pedals of the bed was observed; and dust on the base of the IV pump stand was observed.

These observations were confirmed by S10RN Director of the Emergency Room on 5/11/11 at 9:00 a.m.






26458

Based on record reviews, observations, staff interviews, the hospital failed to ensure the surgical services maintained high standards of practice during the decontamination and sterilization processes for all surgical instruments as evidenced by failing to separate the clean, sterile and soiled activities and maintaining aseptic technique practices during sterilization of instruments as per policy. Findings:

A tour of the Decontamination/Sterilization Process was conducted on 5/11/11 with S2 Director of Nursing (DON) and S25 Perioperative Director. At 9:25 a.m. the surveyor entered into the Decontamination/Sterilization room. Further observation revealed both the decontamination area and the clean, sterile areas were both contained in the same room. The dirty area was located at the front entrance way to the decontamination and clean, sterile areas. There was a metal cart observed obstructing the middle of walkway used by staff to enter and exit this area. This area was approximately three (3) feet in width. Further observation revealed there was a horizontal red line on the floor approximately 3 feet in length from the decontaminated area. The clean, sterile area was located behind the red line. At 9:25 a.m., S45 Interim Sterile Processing Technician was observed decontaminating surgical instruments in the sink at the front of the room. At 9:26 a.m., S46CSWII was observed walking across the red line (clean, sterile area), past the dirty contaminated metal cart, and out of the room. At 9:26 a.m., S46 CSWII was observed re-entering into the contaminated area, walked past the dirty metal cart, and walked across the red line to the clean, sterile area. S2 and S25 both confirmed S46 became dirty when she passed by the dirty metal cart obstructing the walkway to enter and exit this area. At 9:40 a.m., S45 (dirty tech) was observed cleaning dirty instruments in the sink and S46 (clean, sterile tech) walked pass the red line (clean area) into the dirty sink area, where four (4) boxes of gloves were observed mounted on the wall approximately one (1) foot from the dirty sink area. Further observation revealed S46 (clean tech) and touched S45's (dirty tech's) gown with her left forearm as she stretched to reach and get a pair of gloves from the second box of gloves mounted on the wall. S46 was observed at this same time touching the front ledge of the dirty countertop with the front of her uniform. S25 Director confirmed S46 touched S45's dirty gown and touched the dirty countertop ledge when she got a pair of gloves from the wall. S2DON indicated at this same time that S46 was not clean after she touched both S45's dirty contaminated gown and the dirty countertop ledge. At this same time, S46CSWII indicated she touched S45's dirty gown and the dirty countertop ledge when she got a pair of gloves from the wall. S25Director and S2DON both indicated there was a distance of about 3 feet separating the dirty and clean areas in Decontamination/Sterilization room. S25 stated cross contamination of dirty and clean was observed during the Decontamination/Sterilization Process observed by S46CSWII. S25 further stated there was no person designated/assigned to remain clean at all times to prevent cross contamination during the Decontamination/Sterilization processes. At 10:50 a.m., S46CSWII (clean tech) was observed crossing the red line (clean, sterile area), passed by the dirty metal cart located in the middle of the walkway, and exited the room. S46 was then observed at this same time re-entering the dirty area, passed by and touched the dirty metal cart with the front of her uniform and left forearm then returned to the clean, sterile area located behind the red line. At this time, the surveyor informed S2DON and S25 Perioperative Director that the clean, sterile area was dirty. S2 and S25 both agreed there was cross contamination of all surgical instruments during the dirty and clean sterile processes in this area. Both S2 and S25 indicated there was no distinction separating the dirty and clean areas except for the red line drawn on the floor, which was no preventing cross contamination during the Decontamination/Sterilization processes as per policy.

The policy titled, "Cleaning-Decontamination, & Sterilization of Equipment, Supplies, and Instruments", Section C; Effective date of 06/91; Revised dates of 04/92, 11/94, 12/95, 09/01, 09/02, 09/03, 12/06, 12/07, 10/08, presented on 5/12/11 at 11:45 a.m. as the hospitals' current "Decontamination/Sterilization" policy, was reviewed. The policy indicated all contaminated items enter through entrance/unsterile door. After items are clean, place in designated clean area. Large work table is the designated clean area in Sterile Processing.

Review of the policy titled, " Nursing, General Infection Control " , Policy Number: IC 1.10, with no revised, reviewed or effective date(s), presented on 5/9/11 at 1:55 p.m. as the hospital ' s current " Patient Equipment/Supplies " revealed separation of clean, sterile and soiled activities shall be kept separate. A clean area and dirty area are provided on each patient care unit.

The policy titled, "Infection Prevention and Control Program", Reference #1001, with no policy number, reviewed, effective or revised dates, presented on 5/12/11 at 11:10 a.m. as the hospital's current "Infection Control" policy was reviewed. The policy indicated Surgery-related infection risk mitigation measures addressing aseptic technique practices used in surgery and invasive procedures performed outside the operating room, including sterilization of instruments.

Based on review of the "Informed Consent" policy, record reviews and staff interviews, the hospital failed to ensure a properly executed informed consent form for the operation were in the patient's chart before surgery as evidenced by failing to have the sections of the Consent form for Surgery, Procedure, Anesthesia, and Blood Transfusion completed prior to the patients having the procedures for 4 of 4 focused Ambulatory Clinic Records for completed Consent Forms out of a total of 23 Ambulatory Clinic Records reviewed and a total of 44 sampled patient medical records reviewed, (#14, #41, #42). Findings:

Patient # 14:
The patient received services in the Surgical Outpatient Clinic on 4/29/11 for an excision of a skin lesion. Record review of the Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgement of Receipt of Medical Information form revealed missing documentation under "Patient Condition," "Material Risks of Treatment Procedure," "Risks Identified by the Louisiana Medical Disclosure Panel," "Risks Determined by your Doctor," "Risks determined by your doctor," "Additional risks (if any) Particular to this Patient because of a Complicating Medical Condition," "Risks Generally Associated with any Surgical Treatment/Procedure, including Anesthesia," Reasonable Therapeutic Alternatives and the Risks Associated with such Alternatives," and "Acknowledgement, Authorization, and Consent."

Further review of the record revealed the there was missing time that Patient #14 signed the Surgical Consent form on 4/29/11. The physician signed the Surgical Consent form on 4/29/11 at 0830 (8:30 a.m.). Review of the "Site Verification Checklist dated 4/29/11 with no time documented and the "Intraoperative" Nursing Documentation dated 4/29/11 revealed the surgery "Time Out" was called at 0830 (8:30 a.m.). The patient was in the surgery room/suite at the same time the physician signed the patient's Surgical Consent form.

On 5/11/11 at 3:00 p.m. in an interview with S2DON and S25 Perioperative Director, both confirmed the consent signed by Patient #14 was not timed. Both S2 and S25 confirmed the Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgement of Receipt of Medical Information was incomplete and did not follow the hospital's policy. S2 and S25 both indicated the patient (#14) was in surgery when the physician signed the informed consent. Both, S2 and S25 further indicated the physician did not follow the policy for informed consents to be completed prior to performing the patient's surgerical procedure.

Patient #41:
The patient received services in the Surgical Outpatient Clinic on 5/11/11 for removal of the gallbladder. Record review of the Advance Directive Acknowledgement dated on 4/15/11 was missing documentation of the time the patient had signed the document.

Record review of the Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgment of Receipt of Medical Information Transfusion of Blood and Blood Components dated 5/11/11 revealed missing documentation under "2. Treatment/Procedure: Transfusion of Blood and Blood Components--multiple units as required a) Description, nature of the treatment/procedure. " Other components of the informed consent which had missing documentation included "Risks Identified by the Louisisana Medical Disclosure Panel, " "Risks Determined by Your Doctor," "Risks Generally Associated with any Surgical Treatment/Procedure, including Anesthesia," and "Acknowledgement, Authorization, and Consent."

On 5/11/11 at 3:00 p.m. in an interview with S2DON and S25 Perioperative Director, both confirmed the consent signed by Patient #41 was incomplete and did not follow the hospital's policy.

Patient #42:
The patient received services in the Surgical Outpatient Clinic on 5/11/11 for a colonscopy. Record review of the Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgement of Receipt of Medical Information, Colonscopy revealed missing documentation under 3. Patient Condition; under 4. Material Risks of Treatment Procedure; and under 6. Acknowledgement, Authorization, and Consent.

Record review of the Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgement of Receipt of Medical Information, Transfusion of Blood and Blood Components dated 5/11/11 revealed missing documentation under 2. Treatment/Procedure: Transfusion of Blood and Blood Components a) Description, nature of the treatment/procedure; under 4. Material Risks of Treatment Procedure; and under 6. Acknowledgement, Authorization, and Consent.

On 5/11/11 at 2:35 p.m. in an interview with S2DON and S25 Perioperative Director, both confirmed the consent forms for the Colonscopy and for Blood Transfusions were incomplete.

The policy titled, "Informed Consent for Medical Treatment", Policy number 5501-10; Issued date of June 19, 1996; Revised and Reissued date of October 8, 2001; Reviewed, Revised and Reissued date of December 10, 2007; Reviewed, Revised and Reissued date of April 16, 2010; presented as the hospitals current "Informed Consent" policy for Same Day Surgery Unit on 5/11/11 at 11:00 a.m., read all patients at the hospital must have a valid consent prior to receiving treatment.

The policy titled, "Informed Consent", Policy number: 2068020-001, Effective date of 09/01/1997, with no reviewed or revised dates, presented on 5/11/11 at 11:10 a.m. as the hospital's current "Informed Consent" policy, was reviewed. The policy indicated invasive procedures should not be performed on a patient without obtaining a consent. Before a patient gives his consent, the physician who will actually perform the medical or surgical procedure must clearly explain to the patient the following: nature of pertinent ailment or condition and general nature of proposed treatment or procedure, potential benefits and known risks, potential problems of recuperation, likelihood of success, possible results of non-treatment, and risks of any reasonalbe therapeutic alternatives. The medical staff surgeon is responsible for discussing with the patient the comtemplated surgery and for obtaining the patient's informed consent for that surgery, for placing appropriate documentation of these discussions and of the patient's informed consent in the medical record.

Review of the policy titled, "Patient Rights"; Policy number: 02-04-07; Effective date of 9/97; Revised date(s) of 05/05, 04/07, 11/07, 05/10, 11/10; with no approved, revised and/or reviewed date(s); presented on 5/10/11 at 3:00 p.m. as the hospital's current "Patient Rights" policy revealed it was hospital policy to respect the rights of all persons that come to this facility for treatment. The hospital supports the patient rights to informed consent for treatments and/or procedures including risk and benefits of the treatment and/or procedure. Patients receive the Patient Bill of Rights booklet upon admission, registration for the Emergency Department, and upon request.

Review of the "Patient Bill of Rights" booklet/handout presented on 5/10/11 at 1:35 p.m., revealed the patient had the right to informed consent for treatments and/or procedures including risk and benefits of the treatment and/or procedure.