Based on Interview and record review, the facility failed to self report patients #1's allegation of sexual contact with another patient during the patients admission. The patient made the allegation through the school nurse after patient #1 was discharged , even though the school directly communicated this information to the facility. Specifically, on 6/2/2021 upon interview of the facility Director of Nursing at 11:30am, revealed that the Director of Nursing had not reported the allegation, nor had anyone else within her deparment reported the allgation which was reported to them. This deficient practice affected patient #1 rights when the facility failed to self report to the appropriate state health care regulatory agency in accordance with HSC, º161.132(a). Regulation 133.47(c)(3)(A) of the alleged incident. Findings included: Complaint #TX 292 Internal investigation 5/24/2021 completed by the facilty which revealed that the facility was contacted by patient#1' school nurse on 5/21/2021 which revealed the nature of allegation being alleged. No mitigating documantation was able to be produced by the facility that a self report was completed according to regulations. Specifically, on 6/2/2021 upon interview of the facility Director of Nursing at 11:30am, revealed that the Director of Nursing had not reported the allegation, nor had anyone else within her deparment reported the allgation which was reported to them.
Based on observation of the decontamination room, and interview the facility failed to ensure a sanitary environment in the decontamination room this deficient practice had the likelihood to cause harm to facility patients. Findings: A tour of the decontam room was conducted on 06/25/19 beginning at 2:40 p.m. a. Staff #10 was asked to show the area for the drain for sterilizer #3. A metal panel was leaned up against a wall at the back of the left side of the room. A rolling cart was positioned in front of the panel. The manager moved the panel which was not secured to the wall. Observation revealed deteriorating wood, deteriorating sheetrock, rusty pipes, pieces of insulation and debris on the floor. b. Staff # 10 was asked to show the area for the drain for sterilizer #2. A metal panel held in place by a fastener on each side and a lip at the top of the panel. A rolling cart was positioned in front of the panel. The manager opened the panel. Observation revealed deteriorating sheetrock, rusty pipes, pieces of insulation, and debris on the floor including green fabric. c. A hopper sink to the front right of the room could not be flushed, the left faucet handle had green corrosion around it and water dripping in a steady stream, the faucet was dripping constantly, and the ceramic bowl had greenish brown debris in the bowl and around the edges. d. The metal door below the scope cleaner next to the hopper sink was covered with dried drippings. e. A rolling cart on the front left side of the room was covered with dusty debris, dried drippings and there was rust on the bottom shelf. Observations revealed 2 metal case carts outside of OR#2 and OR#3 with rust on all 4 wheels of both carts. Staff #10 was interviewed on 6/25/19 and according to him:All metal pans are wiped out when they are returned after a case. Any metal pans that go into the room with a patient in the room are sent thru the washer sterilizer.
Based on observation of the decontamination room, and interview the facility failed to ensure a sanitary environment in the decontamination room this deficient practice had the likelihood to cause harm to facility patients. Observation of the washer sterilizer in use on 6/25/19 at that time revealed the presence of a metal tray in the washer sterilizer. 1:05 p.m. - Observation in the presence of staff member #10 revealed: A metal tray used for holding a Shake N Bake instrument set with dusty and sticky tannish debris in the bottom. Staff member #10 confirmed the observations. A metal tray used for holding a Red & Grey lami set with tannish debris and black flecks in the bottom that could be wiped out with a Sani cloth. staff member #10 confirmed the observations. Observation in the presence staff member #10 revealed: A metal tray that held a minor set was opened after having been sterilized by staff member #10. The minor set was lifted out of the tray. Tannish sticky debris with black and blue flecks was observed in the bottom of the tray that could be wiped up with a Sani cloth. Staff #10 was interviewed on 6/25/19 and according to him:All metal pans are wiped out when they are returned after a case. Any metal pans that go into the room with a patient in the room are sent thru the washer sterilizer.
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**
Based on review of a medical record of a [AGE]-year-old male patient, [AGE]-year-old female patient, and interview of staff. This requirement is not met as follows: Findings: a. In review of medical record of (patient #1) MRN # DO 461, a [AGE]-year-old male patient who was admitted to the facility for Major Depressive Disorder, Severe Psychotic features, and Suicidal plans that on 11/29/2018 at 3:35pm doctors order number 129-1310 was written for the (patient #a) to be 1:1 supervision/observation for safety reasons. Additionally, on 11/29/2018 at 6:10pm it was documented by the (assigned nurse #1), that (patient#1) was discontinued from 1:1 for safety/observation reasons. There were no doctors' orders documented in the record to support the nurses note. In review of medical record for (patient #2) MRN # DO 11, a [AGE]-year-old female who was emergency detained for anxiety/depression, suicidal ideations. On 12/1/2018 (patient #2) alleged that (patient #1) touched her leg, hair and breast. Camera footage from date 12/1/2018 between 5:00pm and 8:00pm revealed that (patient #1) had touched (patient #2's) leg and hair but could not see where (patient #1) touched her breast. There was no 1:1 staff present with (patient #1) in the video footage. b. On April 10, 2019 at 2:30pm in the facility conference room (Nurse # 1), was interviewed and reviewed the medical record for documentation in the record. She explained that the verbal order was given to her but she neglected to complete the order in the computer system. c. In review of the Texas Nurse Practice Act 217.11 Standards of Nursing Practice, it states in part: (1) Standards Applicable to all Nurses. All vocational nurses, registered nurses and registered nurses with advanced practice authorization shall: ... (D) Accurately and completely report and document: (i) the client's status including signs and symptoms; (ii) nursing care rendered; ... (v) client responses; and (vi) contacts with other health care team members concerning significant events regarding clients status
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**
Based on interview and record review, the facility failed to ensure the process and procedures for prompt resolution of patient complaints and grievances in accordance with their Complaint/Grievance policy, for 1 of 1 complaint reviewed regarding Patient #1 who made a complaint allegation of sexual abuse while an inpatient at the facility. Specifically, on 10/27/15 Patient #1's Case Worker notified the facility of a sexual abuse allegation while Patient #1 was an inpatient from 09/29/15 to 10/02/15. The sexual abuse allegation was immediately reported to the facility's Director of Nursing (DON), and Director of Intake. There was no evidence this allegation was thoroughly investigated by the facility for the possible identification of abuse or mistreatment; resolution, or the findings of this complaint. Findings Included: Review of the facility's Patient Complaint Information Form dated 10/27/15 regarding Patient #1 revealed the following: The facility's Patient Advocate (PA-A) received a report from Patient #1's referred Community Services Director that documented Patient #1 reported to her Mother the week of 10/18/15 that she had been sexually abused while at the facility. Patient #1 reported to her Case Worker at the Community Services Center and reported the following: Patient said she was admitted to [the facility] in the middle of the night, she was sedated, and when she woke in the morning, her private parts were sore, and she had bruises on her thigh. Patient did not report this to anyone at [the facility]. Patient is [AGE] year old female. When patient told her mom last week about the abuse, she requested her mom that she have a pregnancy test. Test was reported to be negative. Patient was admitted to [the facility] on 09/29/15 at 12:32 a.m. She was discharged home on 10/02/15 at 19:45 p.m. There was no other information provided by the caller from the Community Services Center. Case is reported by Community Services Center to CPS [Child Protective Services]. The facility identified the Occurrence Report as #2015- . Name of Director Notified documented the facility's Director of Nursing (DON) and Director of Intake. Review of the facility's Policy and Procedures titled, Patient Complaint and Grievance Management, last revised 03/2104 revealed, All verbal or written complaints regarding abuse, neglect, patient harm or hospital compliance with CMS [Centers for Medicare and Medicaid Services] requirements, are to be considered a grievance for the purposes of these requirements. The policy indicated in part: 6. Grievance Management Process, 3. All grievances will be thoroughly investigated by: -A review of the patient's perceptions of the incident; -A review of all related records; and -Interview with staff and caregivers involved in the incident or as described in the patient's complaint. 5. Once the investigation is complete, the investigator will write a letter to the patient or their representative with written notice of the decision. The letter will include at a minimum: -The name of the hospital contact person; -The steps taken on behalf of the patient to investigate the grievance; -The results of the grievance process; and -The date of completion. 9. Documentation a. The responsible director will document a summary of the investigation and all actions taken on the corresponding occurrence report. b. All correspondence and documentation from the investigation will be forwarded to and kept on file in the Risk Management Department. During an interview on 02/18/16 at 3:00 PM with the facility's Manager of Quality Management (QM) indicated there was no evidence of an investigation; and further stated a file could not be located for Patient #1's sexual abuse allegation received on 10/27/15. The Manager of QM confirmed that PA-A received the phone call, logged it into the Complaint/Grievance logs and the Director of Risk Management (RM) received the information. During an interview on 02/18/16 at 3:15 PM with the Director of RM indicated she had received a phone call from Patient #1's Community Services Case Worker regarding the allegation of sexual abuse made during her inpatient in 09/29/15 to 10/02/15. The Director of RM stated they Case Worker indicated that CPS and Texas State had been notified. The Director of RM indicated that the DON was responsible to complete the investigation and should have put notes into the Complaint/Grievance logs regarding the investigation and outcome. The Director or RM confirmed those procedures had not been completed by the DON. Further interview on 02/18/16 at 3:25 PM with the Manager of QM stated she spoke with the DON, and the DON stated she had discussions with staff; but had no documentation of interviews or an investigation. During an exit conference on 02/19/16 at 1:00 PM the facility was provided with the verbal findings of this complaint investigation and was offered the opportunity to provide any further additional information and/or evidence of an investigation regarding this specific complaint made by Patient #1 and reported to the facility on [DATE]. No evidence was provided.
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**
Based on interview and record review, the facility failed to ensure the patient's rights to be free from all forms of abuse or harassment by failing to investigate and report/respond to an allegation of sexual abuse in accordance with their Complaint/Grievance policy, for 1 of 1 patients reviewed (Patient #1) with a complaint allegation of sexual abuse while an inpatient. In addition, the facility's procedures for; how to report abuse/neglect/exploitation were inconsistent amongst policies, unclear, and not specific for reporting allegations of abuse/neglect against the facility and/or facility employees to the appropriate state health care regulatory agency; Department of State Health Services (DSHS) at (888) 973-0022. Specifically, on 10/27/15 Patient #1's Case Worker notified the facility of a sexual abuse allegation while Patient #1 was an inpatient from 09/29/15 to 10/02/15. The sexual abuse allegation was immediately reported to the facility's Director of Nursing (DON), and Director of Intake. This allegation was not reported to the state health care regulatory agency and; there was no evidence this allegation was thoroughly investigated by the facility for the possible identification of abuse or mistreatment. This deficient practice could affect the prevention of possible unidentified abuse, neglect, or mistreatment for all patients in the facility; by compromising their safety. Findings Included: Review of the facility's Patient Complaint Information Form dated 10/27/15 regarding Patient #1 revealed the following: The facility's Patient Advocate (PA-A) received a report from Patient #1's referred Community Services Director that documented Patient #1 reported to her Mother the week of 10/18/15 that she had been sexually abused while at the facility. Patient #1 reported to her Case Worker at the Community Services Center and reported the following: Patient said she was admitted to [the facility] in the middle of the night, she was sedated, and when she woke in the morning, her private parts were sore, and she had bruises on her thigh. Patient did not report this to anyone at [the facility]. Patient is [AGE] year old female. When patient told her mom last week about the abuse, she requested her mom that she have a pregnancy test. Test was reported to be negative. Patient was admitted to [the facility] on 09/29/15 at 12:32 a.m. She was discharged home on 10/02/15 at 19:45 p.m. There was no other information provided by the caller from the Community Services Center. Case is reported by Community Services Center to CPS [Child Protective Services]. The facility identified the Occurrence Report as #2015- . Name of Director Notified documented the facility's Director of Nursing (DON) and Director of Intake. Review of the facility's Policy and Procedures titled, Patient Complaint and Grievance Management, last revised 03/2104 revealed, All verbal or written complaints regarding abuse, neglect, patient harm or hospital compliance with CMS [Centers for Medicare and Medicaid Services] requirements, are to be considered a grievance for the purposes of these requirements. The policy indicated in part: 6. Grievance Management Process, 3. All grievances will be thoroughly investigated by: -A review of the patient's perceptions of the incident; -A review of all related records; and -Interview with staff and caregivers involved in the incident or as described in the patient's complaint. Review of the facility's policy titled, Abuse, Neglect, or Exploitation of an Adult, Elderly, or Disable Patient, last revised 02/2012 revealed inconsistent procedures which included: II. Reporting: Reporting Abuse and Neglect: 1. A person having cause to believe that an elderly or disabled person is in the state of abuse/neglect/exploitation shall report the immediately to the Department of Family and Protective Services (DFPS). 2. A person, including an employee, volunteer, or other person associated with an inpatient mental health facility, a treatment facility, or a hospital that provides comprehensive medical rehabilitation services, including a health care professional, who reasonable believes or who knows of information that would reasonably cause a person to believe that the facility or an employee of or health care professional associated with the facility has, is, or will be engaged in conduct that is or might be illegal, unprofessional, or unethical and that relates to the operation of the facility or mental health, chemical dependency, or rehabilitation services provided in the facility shall as soon as possible report the information supporting the belief to the appropriate state health care regulatory agency. No further information regarding the specific state health care regulatory agency was provided; or a phone number to the agency was provided within the policy. Further review of the policy revealed How to report: When an employee of [The facility] has reason to report abuse/neglect/exploitation and after the Attending Physician, Department Director, House Supervisor and Social Services have been notified a report will be filed with the Department of Family and Protective Services and documented in the patient's medical record. Review of the facility's Policy and Procedures titled, Child Abuse and Neglect, last revised 04/2012 revealed in the area of Reporting: If a professional has cause to believe that a child has been abused or neglected or may be abused or neglected, or that a child is a victim of an offense under Section 21.11, Penal Code, and the professional has cause to believe that the child has been abused, the professional shall make a report not later that the 48th hour after the professional first suspects that the child has been or may be abused or neglected or is a victim of an offense under Section 21.11, Penal Code. A professional may not delegate to or rely on another person to make the report. Further review of the policy states How to report: When an employee of [the facility] has reason to report child abuse and/or neglect and after the Attending Physician, Department Director, House Supervisor and Social Services have been notified a report will be filed with the Department of Family and Protective Services (DFPS) and documented in the patient's medical record. Record review of Patient #1's Nursing Notes on 09/29/15 at 01:10 AM revealed Patient #1 was admitted to the adolescent unit with suicidal ideation/attempt. Patient #1 reported she hears voices and sees shadows. Registered Nurse (RN)-A skin assessment revealed multiple superficial lacerations to the left inner forearm, 1 cut above the right knee. Examined the thighs and no cuts seen there. Review of Patient #1's Nursing Notes on 09/29/15 at 5:33 PM revealed RN-B assessment documented Patient #1 has superficial cuts to left arm and right thigh. Scabbing present. Review of Patient #1's Discharge Summary dated 10/02/15 revealed Patient #1 was to follow up with the Community Center Services for Individuals with Mental Health and Mental Retardation (MHMR) services. During an interview on 02/18/16 at 3:00 PM with the facility's Manager of Quality Management (QM) indicated there was no evidence of an investigation; and further stated a file could not be located for Patient #1's sexual abuse allegation received on 10/27/15. The Manager of QM confirmed that PA-A received the phone call, logged it into the Complaint/Grievance logs and the Director of Risk Management (RM) received the information. During an interview on 02/18/16 at 3:15 PM with the Director of RM indicated she had received a phone call from Patient #1's Community Services Case Worker regarding the allegation of sexual abuse made during her inpatient in 09/29/15 to 10/02/15. The Director of RM stated they Case Worker indicated that CPS and Texas State had been notified. The Director of RM indicated that the DON was responsible to complete the investigation and should have put notes into the Complaint/Grievance logs regarding the investigation and outcome. The Director or RM confirmed those procedures had not been completed by the DON. Further interview on 02/18/16 at 3:25 PM with the Manager of QM stated she spoke with the DON, and the DON stated she had discussions with staff; but had no documentation of interviews or an investigation. During an interview on 02/18/16 at 3:30 PM with the Vice President (VP) of QM stated she thought since the sexual abuse allegation had reportedly been reported to CPS (division under DFPS); that there was no further reporting necessary. The VP of QM indicated she was not aware that specific abuse/neglect allegations made against the facility and/or facility staff were supposed to be reported to the state health care regulatory agency; Department of State Health Services (DSHS). During an interview on 02/19/16 at 8:30 AM with the Complainant stated that Patient #1 had been seen for a sexual assault examination after she made an allegation of sexual abuse while in the behavioral facility from 09/29/15 to 10/02/15. The Complainant indicated that Patient #1 confirmed she did not tell anyone while an inpatient at the facility; but told her mother and Community Case Worker after she had been discharged and was completing her follow-up services. Patient #1 reported the allegation may have occurred on 09/29/15 and reported that she had bruises to her body and her vaginal area was sore when she woke. Patient #1 was sent and assessed for a sexual assault examination; however over a month had elapsed since the original event allegedly occurred. During an interview on 02/19/16 at 9:25 AM with Patient #1's mother stated Patient #1 reported to her an allegation of possible sexual abuse after she had been discharged from the facility a week or two before she told her. Patient #1's mother stated she was admitted [DATE] and she kept receiving phone calls from the facility for consent to give her daughter a sleeping pill and she finally agreed. Patient #1 stated to her; when she woke up the next day, later in the evening, she had bruises on her thighs, and her vagina hurt; and didn't know what happened. Patient #1's mother stated she took her daughter to the Community Services Case Worker following the allegation to seek further direction, treatment, and services. Patient #1's mother stated the Community Services Case Worker handled the allegation from there by referring her daughter for a sexual assault examination, notifying the facility, and notifying the local Police Department. Patient #1's mother stated that her daughter believed something happened to her during her inpatient stay and that her story has never changed.
Based on record review and interview, the facility failed to ensure that for one of one patients (patient #1) physical rehabilitation/physical therapy was obtained and/or documentation as to why Patient #1 was unable to receive the physical rehabilitation/physical therapy was available in her medical record. Findings included: Record review on 05/05/15 of Patient #1's Discharge Orders Inpatient, dated 02/02/15 at 1345 PM, revealed but was not limited to the following: Discharge Disposition: Physical rehabilitation/Physical Therapy. Medical Follow up (specify reason): Physical rehabilitation care for deconditioning syndrome. Discharge Diagnoses: Axis II: Deconditioning syndrome; decubiti ulcer. Record review on 05/05/15 of Patient #1's Discharge Evaluations and Summaries, dated 02/03/15 at 1545 PM, revealed but was not limited to the following: Continued Care Goals and Followup Appointment: Behavioral Health Care on 02/04/15 and ______ Community Health Center on 02/05/15. Record review of Patient #1's Discharge Summary, completed by the psychiatrist and dated 02/03/15, revealed but was not limited to the following: Our evaluation found no evidence of any ongoing depression symptoms. She was accordingly discharged with her primary concern that she had developed a deconditioining syndrome due to her prolonged recumbent posture in bed and in her muscles were weak and her posture was poor. We attempted to discharge her to a physical rehabilitation unit, but that was not feasible. We consequently made arrangements to have her be discharged to the home of a cousin, other relative, or a friend and arrange for home healthcare services to provide physical rehabilitation and physical therapy services. Review on 05/06/15 of _____ Community Health Center web site (www.amistadchc.com/id10.html) revealed this agency did not provide home health services and/or physical therapy services. Interview on 05/06/15 at 10:00 AM with Facility Discharge Planner #1 revealed that Patient #1 was unfunded so the discharge orders for physical rehabilitation/physical therapy/home healthcare services could not be implemented. She confirmed that the community health center that Patient #1 was referred to did not provide these services. She stated that due to time contraints she was unable to document every interaction regarding discharge planning. Interview on 05/06/15 at 10:30 AM with Facility Therapist #1 revealed Patient #1 was unfunded and therefore the facility was unable to refer her for the ordered services. He stated the psychiatrist had believed that she might be eligible for home healthcare services through a mental health home health care agency but because she did not have any current symptoms of mental illness, she was not eligible for their services. Interview on 05/05/15 at 4:00 PM with Patient #1's Case Manager #1 revealed that on 02/04/15, Patient #1 called him from her friend's house needing assistance. He went to Patient#1's friend's house. He stated Patient #1 was in excruciating pain and appeared disheveled and dirty. She was unable to walk and had to crawl to the bathroom the night before. She showed Case Manager #1 her bedsore which appeared reddened and inflamed. He called an ambulance and she was admitted into an acute care hospital. He indicated she remained in this acute care hospital approximately one month.
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**
Based on review of medical records, policy and procedure, and staff interview, the facility failed to ensure that a registered nurse evaluate and document the review of EKG strips for patients on continuous cardiac monitoring. The findings include the following: 1. Review of medical records on 3/24/14 at the facility nurse's station revealed that patients receiving continuous cardiac monitoring did not have consistent documentation that a registered nurse reviewed the patient's EKG rhythm strip. Also the patients receiving continuous cardiac monitoring did not have consistent documentation that a registered nurse reviewed the patient's EKG rhythm strip when out of parameter alarms occurred. The following was noted: a. (P31) admitted [DATE] with a physician order for telemetry monitoring. Review of the patient's telemetry folder for 3/21/14 to 3/24/14 did not provide evidence that the registered nurse assigned to the patient or the charge nurse reviewed/interpreted the patient's EKG rhythm strip. b. Review of EKG Alarm Table for (P31) from 3/21/14 to 3/24/14 revealed at 09:19 a.m. on 3/22/14 that the patient experienced a 13 beat run of [DIAGNOSES REDACTED]. There was no documentation that the registered nurse was notified. There was no documentation that the EKG rhythm strip was reviewed and no documentation found that the out of parameters alarm was addressed. No documentation found that the physician was notified. 2. Policy and Procedure Cardiac Monitoring stated The monitor tech will be under the supervision of the telemetry charge nurse and the charge nurse will serve as a clinical resource to the monitor tech. Any EKG changes will be documented and reported to the charge nurse and or the patient's nurse. The monitor tech will print and interpret monitor strips initially and every four hours. Any changes to patient's baseline will be printed immediately and charge nurse or patient's registered nurse will be notified. All strips are posted in the patient folder. 3. Staff interview with (S5) after her own review of the findings confirmed that the nurses do not routinely review/interpret the EKG rhythm strips every four hours. (S5) stated that the monitor tech interprets the strips. (S5) could not produce documentation that the RN was notified of out of parameter alarm and or documentation that the RN addressed the out of parameter alarm.
Based on observations, record reviews, and interviews, the facility failed to ensure a clean and sanitary environment for the kitchen. Findings included: Observations on 03/24/14 from 1145 AM to 1203 PM during a tour of the kitchen in the facility revealed the following: 1. Serving carts had accumulated grease on the edges of the cart. 2.. Serving trays had accumulated grease on the trays. 3. Ceilings in the walk-in refrigerators were dusty and dirty. 4.. Accumulated dirt was on the kitchen floor where food was stored. 5.. A bag of tortilla was noted on the floor of one of the food storage areas. 6. Open trash can with trash were observed near food preparation areas. 7. Water heating machines had been delimed the night before and the lime scale had not been removed from the trough. 8. Ovens were observed to have caked on grease. Record review on 03/24/14 of Walk-In Cooler Cleaning Schedule revealed the following: 1. Make sure wrap date and label correct, no expired stuff in the cooler. 2. Law meat at bottom shelf, ready to eat food on top shelf. 3. 18 below ceiling and 6 from bottom. 4. Floor mob and clean. Interview on 03/24/14 at 1200 PM with facility's Food Services Director (Staff #10)confirmed these findings.
Based on review of medical records, relevant facility documents, and staff interviews, the facility failed to administer compounded drugs in accordance with acceptable standards of practice in that the facility failed to maintain sufficient records to tract the flow of compounded drugs from entry through dispensation.This deficient practice had potential to cause harm to all patients. Refer to Tags A-0491, A-0500, A-0501.
Based on review of medical records, relevant facilty documents, and staff interviews, the facility failed to administer compounded drugs in accordance with acceptable standards of practice in that the facility failed to maintain sufficient records to tract the flow of compounded drugs from entry through dispensation. The findings included: a. Review of Medical Records on August 9-15, 2013 in the facility conference room revealed the following: On August 6, 2013, Intravenous Calcium Gluconate 2 grams with lot number 013M16, that was compounded at an outside pharmacy was found to be contaminated with Gram Positive Rods (Rhodococcus equi). This lot number was received by the facility on July 12, 2013. From July 9, 2013, to August 7, 2013, it was noted that (45) patients were given Intravenous Calcium Gluconate 2 grams. The facility was not able to identify which of the 45 patients received lot number 013M16 because the facility failed to document the lot number in the patient's medical record. b. Review of facility contracts (pharmacy contract between the hospital and the outside compounding pharmacy) on August 30, 2013, revealed the following: Contract dated November 20, 2012 stated (F) Beyond use Dating. The hospital is required to record the lot number and beyond use date in the patient's chart of the compounded preparation administered to a patient. c. Texas State of Board of Pharmacy Rule 291.133 required that: A pharmacy that provides sterile compounded preparations to practitioners for office use or to another pharmacy shall enter into a written agreement with the practitioner or pharmacy. The written agreement shall: (B) require the practitioner or receiving pharmacy to include on a patient's chart, medication order or medication administration record the lot number and beyond-use date of a compounded preparation administered to a patient. d. Interview conducted with (S3) on August 12, 2013, at 10:30 am, in the administration conference room confirmed that the facility does not document compounded medications lot numbers in the patient's medical record. (S3) stated it was an oversight on their part on following the contract provisions for documenting the lot number and beyond use date on each patient's medical records.
Based on review of medical records, relevant facility documents, and staff interviews, the facility failed to administer compounded drugs in accordance with acceptable standards of principles in that the facility failed to maintain sufficient records to follow the flow of compounded drugs from entry through dispensation. The findings included: a. Review of Medical Records on August 9-15, 2013, in the facility conference room revealed the following: On August 6, 2013, Intravenous Calcium Gluconate 2 grams with lot number 013M16, that was compounded at an outside pharmacy was found to be contaminated with Gram Positive Rods (Rhodococcus equi). This lot number was received by the facility on July 12, 2013. From July 9, 2013, to August 7, 2013, it was noted that (45) patients were given Intravenous Calcium Gluconate 2 grams. The facility was not able to identify which of the 45 patients received lot number 013M16 because the facility failed to document the lot number in the patient ' s medical record. b. Review of facility contracts (pharmacy contract between the hospital and the outside compounding pharmacy) on August 30, 2013, revealed the following: Contract dated November 20, 2012, stated (F) Beyond use Dating. The hospital is required to record the lot number and beyond use date in the patient's chart of the compounded preparation administered to a patient. c. Texas State of Board of Pharmacy Rule 291.133 required that: A pharmacy that provides sterile compounded preparations to practitioners for office use or to another pharmacy shall enter into a written agreement with the practitioner or pharmacy. The written agreement shall: (B) require the practitioner or receiving pharmacy to include on a patient's chart, medication order or medication administration record the lot number and beyond-use date of a compounded preparation administered to a patient. d. Interview conducted with (S3) on August 12, 2013, at 10:30 am, in the administration conference room confirmed the facility does not document compounded medications lot numbers in the patient's medical record. (S3) stated it was an oversight on their part on following the contract provisions for documenting the lot number and beyond use date on each patient's medical records.
Based on review of medical records,relevant facility documents, and staff interviews, the supervising pharmacist failed to administer compounded drugs in accordance with acceptable standards of practice in that the facility failed to maintain sufficient records to follow the flow of compounded drugs from entry through dispensation. The findings included: a. Review of Medical Records on August 9-15, 2013, in the facility conference room revealed the following: On August 6, 2013, Intravenous Calcium Gluconate 2 grams with lot number 013M16, that was compounded at an outside pharmacy was found to be contaminated with Gram Positive Rods (Rhodococcus equi). This lot number was received by the facility on July 12, 2013. From July 9, 2013, to August 7, 2013, it was noted that (45) patients were given Intravenous Calcium Gluconate 2 grams. The facility was not able to identify which of the 45 patients received lot number 013M16 because the facility failed to document the lot number in the patient ' s medical record. b. Review of facility contracts (pharmacy contract between the hospital and the outside compounding pharmacy) on August 30, 2013, revealed the following: Contract dated November 20, 2012, stated (F) Beyond use Dating. The hospital is required to record the lot number and beyond use date in the patient's chart of the compounded preparation administered to a patient. c. Texas State of Board of Pharmacy Rule 291.133 required that: A pharmacy that provides sterile compounded preparations to practitioners for office use or to another pharmacy shall enter into a written agreement with the practitioner or pharmacy. The written agreement shall: (B) require the practitioner or receiving pharmacy to include on a patient's chart, medication order or medication administration record the lot number and beyond-use date of a compounded preparation administered to a patient. d. Interview conducted with (S3) on August 12, 2013, at 10:30 am, in the administration conference room confirmed the facility does not document compounded medications lot numbers in the patient's medical record. (S3) stated it was an oversight on their part on following the contract provisions for documenting the lot number and beyond use date on each patient's medical records.
Based on interviews with hospital testing personnel, the facility failed to meet the Code of Federal Regulations 493.1283 Based on review of microbiology laboratory reports and interview with testing personnel, it was revealed that the laboratory testing personnel failed to document each step of bacterial isolate identification from media inoculation to organism isolation and identification. Findings include: 1. Review of microbiology culture reports revealed that not all identification steps are documented in the isolate report for identification. 2. Reference attached microbiology culture reports: I. Microbiology Culture Report Internal 1 II. Microbiology Culture Report Internal 2 III. Microbiology Culture Report Internal 3 IV. Microbiology Culture Report Internal 4 V. Microbiology Culture Report Internal 5 VI. Microbiology Culture Report Internal 6 3. Interview with testing personnel on 8/14/2013 at 4:45 pm indicated that We do run necessary additional biochemical tests in order to help identify organism isolates, but it is not always documented because we work so closely together that we usually know what is going on with everyone ' s cultures . Based on review of final patient test reports and interview with testing personnel revealed that the laboratory failed to provide the name and address of the laboratory location where the reference lab identification of bacterial isolates was performed. Findings include: 1. Review of microbiology culture reports revealed that the laboratory will send isolates to a reference lab when they are not able to be identified by the facility. The final reports from the reference lab will be sent back to the facility and then the facility will hand type in the results. The facility failed to enter the name and address of the reference lab where the organism was identified into the final culture report. 2. Interview with testing personnel on 8/14/2013 at 4:30 pm indicated that the name and address of the reference lab that is used to identify bacterial isolates is not routinely provided on the final microbiology culture report.
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