The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

COOKEVILLE REGIONAL MEDICAL CENTER 1 MEDICAL CENTER BOULEVARD COOKEVILLE, TN 38501 July 10, 2014
VIOLATION: CONTENT OF RECORD - INFORMED CONSENT Tag No: A0466
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on medical record review, policy review, and interview, the facility failed to document informed consents for five (#5, #6, #7, #8, and #9) patients of five surgery patients reviewed.

The findings included:

Patient #5 was admitted to the facility on on [DATE], with diagnosis of Acute Appendicitis (an infected appendix/organ in the abdomen). Review of the Operative Report revealed Patient #5 had a Laproscopic Appendectomy (surgical removal of the infected organ/appendix with the use of a scope) with General Anesthesia (deep sedation requiring air way management and ventilation) on February 8, 2014. Further review of the medical record revealed no documentation of informed consent for general anesthesia.

Patient #6 was admitted to the facility on on [DATE], with diagnosis of Fractured Right Tibia and Fibula (two bones in the lower leg). Review of the Operative Report revealed Patient #6 had an Internal Fixation (surgical repair) of the Right Tibia with General Anesthesia on February 8, 2014. Further review of the medical record revealed no documentation of informed consent for general anesthesia.

Patient #7 was admitted to the facility on on [DATE], with diagnosis of Partial Molar Pregnancy (an abnormal growth of tissue in the uterus). Review of the Operative Report revealed Patient #7 had a Suction Dilatation and Currettage (surgical removal of the abnormal tissue from the uterus) with General Anesthesia on February 9, 2014. Further review of the medical record revealed no documentation of informed consent for general anesthesia.

Patient #8 was admitted to the facility on on [DATE], with diagnosis of Sinusitis (infected sinuses) and Deviated Nasal Septum (crooked nose). Review of the Operative Report revealed Patient #8 had a Septoplasty (surgical repair of the nose) and Bilateral Sinuplasty (surgical repair of the sinuses) with General Anesthesia on June 16, 2014. Further review of the medical record revealed no documentation of informed consent for general anesthesia.

Patient #9 was admitted to the facility on on [DATE], with diagnosis of Osteoporotic Compression Fracture of T6 and T7 (fracture of the spine in the upper back). Review of the Operative Report revealed Patient #9 had a Percutaneous Kyphoplasty (surgical repair of the spinal fracture) with General Anesthesia on June 16, 2014. Further review of the medical record revealed no documentation of informed consent for general anesthesia.

Review of the facility's policy number PC-080, titled Consent for Services-Surgical, Anesthesia, and Related Medical, last revised October 2006, revealed, "...Informed consent must be obtained for treatment and procedures...Informed consent is evidenced by an approved written Informed Consent Document...Appendix A is a list of procedures designated as requiring an informed consent..." Further review of the policy revealed Appendix A stated, "...Anesthesia including conscious sedation and spinal/epidural injections...".

Interview with the Risk Manager (RM) and Vice President of Quality (VPQ) on June 25, 2014, at 2:05 p.m., in the VPQ's office, confirmed an informed consent must be obtained prior to administration of anesthesia. Further interview confirmed there were no informed consents documented in the medical record for patients #5, #6, #7, #8, or #9. Further interview revealed the informed consents for anesthesia were not part of the facility's medical record.

Interview with the Director of Surgery (DOS) on June 25, 2014, at 2:30 p.m., in the VPQ's office, revealed the informed consent for anesthesia is obtained by anesthesia staff preoperatively. Further interview confirmed the informed consent for anesthesia was not kept in the facility's medical record.

C/O #
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on medical record review, observation, policy review, and interview, the facility failed to follow contact precautions for two (#4 and #10) patients of four contact isolation patients reviewed.

The findings included:

Patient #4 was admitted to the facility on on [DATE], with diagnosis of Cellulitis (a skin infection), Pneumonia (a lung infection), and Leukocytosis (an elevated white blood count usually indicating an infection).

Medical record review revealed the patient was seen on December 31, 2013, at 2:55 p.m., by a dermatologist (a medical doctor specializing in the treatment of skin disease).

Review of the dermatologist note dated December 31, 2013, revealed a differential diagnosis (a list of possible causes for symptoms in priority of seriousness and probablity) of, "...Hyperkeratosis/Dermatitis (thickening of the skin/infection of the skin), Eczema (a disease of the skin causing itching and redness) vs Psoriasis (a skin disease with scaley itchy plaques) vs Hyperkeratotic Scabies (Scabies is an infestation of the skin by the human itch mite, Hyperkeratotic Scabies is a severe form of the infestation)...".

Medical record review revealed no documentation of the patient being placed on isolation or being treated for scabies.

Medical record review revealed the patient was discharged on [DATE].

Medical record review revealed patient #4 was readmitted to the facility on on [DATE], for complaint of fall and mental status changes.

Medical record review revealed patient #4 was seen by an Infectious Disease Physician (a medical doctor specializing in the treatment of infectious diseases) on January 7, 2014, at 2:00 p.m., was diagnosed with Hyperkeratotic Scabies, and was immediately placed on contact isolation and treated with medications for scabies.

Review of the facility's, "Table for Type and Duration of Precautions for Selected Infections and Conditions" revealed scabies required, "...Type of Precautions...Contact...Duration of Precautions...24...hours after initiation of treatment..."

Interview with the facility's Infection Preventionist (IP) on June 24, 2014, at 3:00 p.m., in the Vice President of Quality's (VPQ) office, revealed patients were to be placed on isolation if scabies infestation was suspected.

Telephone interview with the dermatologist (MD #1) who examined patient #4 on December 31, 2014, confirmed MD #1 included Hyperkeratotic Scabies in the differential diagnosis. MD #1 confirmed the patient was not placed on contact isolation.

Interview with the Infectious Disease Physician (MD #2) on June 25, 2014, at 1:05 p.m., in the VPQ's office, confirmed patients with a differential diagnosis of scabies were to be placed on contact isolation.

Patient #10 was admitted to the facility on on [DATE], with diagnoses including Sepsis and Methicillin Resistant Staphlyococcus Aureus (MRSA, an infection that is resistant to drugs normally used to treat Staph infections).

Observation on June 25, 2014, at 1:24 p.m., of patient #10's room in the Intensive Care Unit (ICU), with the IP present, revealed a sign on the door stating, "Contact Isolation...gloves must be worn when entering room....gowns must be worn when entering room...". Further observation revealed a physician (MD #3) entered the patient's room without a gown or gloves.

Review of the facility's policy number IC-2-050, titled Isolation Policy, last revised May 2011, revealed, "...Contact Precautions...Gloves are worn whenever entering the room...A gown is worn whenever entering the room...".

Interview with the IP on June 25, 2014, at 1:24 p.m., in the ICU, confirmed patient #10 was on contact isolation. Further interview with the IP confirmed MD #3 had entered the contact isolation room without wearing a gown or gloves. Further interview with the IP confirmed a gown and gloves must be worn when entering a contact isolation room.

C/O #TN