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56 FRANKLIN STEET

WATERBURY, CT 06706

CONTRACTED SERVICES

Tag No.: A0083

1. Based on review of the clinical record, facility documentation and interview the hospital failed to provide oversight of dialysis services, a contracted service, to ensure patient safety. The findings include the following:

a. Review of Patient #68's clinical record directed a four hour dialysis treatment with 500 units of heparin prior to the treatment and 500 units hourly. The treatment record identified that half way through the dialysis treatment, the patient's dialyzer clotted, the physician was called and Heparin 1,000 units was administered hourly. Review of the clinical record failed to identify a physician's order for the change in the Heparin dose.

In addition, review of the flow sheet with the Nursing Director indicated that the patient rated pain as a of 3, on a scale of 1-10 scale with 10 being the worst possible pain, at the beginning of the dialysis treatment. At the end of treatment, the patient rated pain as a 7. The flow sheet failed to identify that the patient's pain was addressed by the dialysis staff.


b. Review of hemodialysis documentation indicated that the unit had two phoenix meters (used to obtain the machines conductivity level) and associated log of the daily conductivity level, for each meter. Review of the of the logs identified that the last entry for Log A was 7/16/11 and for Log B was 5/26/11. Although review of the unit documents indicated that hemodialysis treatments had been completed on 7/18/11 and 7/19/11 there were no entries on the log.


c. During a tour of the acute hemodialysis unit on 07/20/11 stickers on the reverse osmosis machines indicated that the machines had been maintained on an annual basis. During an interview with the Biomed Technician as to the what the frequency of the preventive maintenance was, he stated that he belived it was annual. The hospital failed to have a policy in place that directed the frequency in which preventive maintenance for the reverse osmosis machines and/or the carbon tanks was indicated. (i.e. no company policy, no manufacturers directions for use and/or no risk based analysis).





17921

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0174

Based on review of the clinical record, interview and review of the facility policy the facility failed to ensure that restraints were discontinued at the earliest possible time. The finding includes the following:

a. Patient #83 presented to the ED on 7/8/11 in police custody related to "bizarre" behaviors. The clinical record indicated that upon arrival to the ED on 7/8/11 at 11:30 PM, the patient was placed in four point locked restraints and Geodon (antipsychotropic medication) 10 mg IM and Ativan (antianxiety medication) 2 mg IM were administered. The restraint monitoring record identified that at 1:00 AM the patient was sleeping with the left leg and right arm restraints removed. The flow sheet indicated that for the period of 1:00 AM through 7:00 AM, the patient remained in two point locked restraints for behaviors identified as "sleeping" and/or "restless".

Review of the facility policy identified that restraints should be discontinued at the earliest possible time.

RN SUPERVISION OF NURSING CARE

Tag No.: A0395

Based on a review of clinical records, policy review, and interviews, the facility failed to ensure that five Patients (P #52, P# 53, P#70, P#48, and P#49) were evaluated and/or monitored by nursing staff in accordance with hospital policy. The findings include the following:


a. Patient #52 was admitted to the hospital on 7/15/11 with spontaneous rupture of membranes at thirty nine weeks gestation with Oxytocin administered for the induction/augmentation of labor. A physician's order dated 7/15/11 directed Oxytocin to start at 2 milliunits/minute and increase by 2 milliunits/minute every 30 minutes until contractions are 2-3 minutes apart and of moderate intensity by palpation or 50-60 mmHg above baseline, if an intrauterine pressure catheter is utilized. On 7/15/11 Oxytocin was initiated at 8:30 AM. During the period of 8:30 AM to 2:30 PM a complete set of vital signs had been obtained six times. Based on review of the facility policy vital signs should have been obtained nine times as Oxytocin was increased every half hour from 8:30 AM until 11:00 AM and again at 2:30 PM. Interview and review of the medical record with RN #11 on 7/18/11 at 11:30 AM failed to identify that vital signs were taken consistently in accordance with the hospital policy. Review of the hospital policy for "Oxytocin Induction/Augmentation" directs in part that blood pressure, pulse and respiration should be assessed with every increase/decrease of Oxytocin and monitored hourly during maintenance.


b. Patient #53 was admitted to the hospital on 7/15/11 with uterine contractions at thirty six weeks gestation with Oxytocin administered for the induction/augmentation of labor. A physician's order dated 7/16/11 directed Oxytocin to start at 2 milliunits/minute and increase by 2 milliunits/minute every 30 minutes until contractions are 2-3 minutes apart and of moderate intensity by palpation or 50-60 mmHg above baseline if an intrauterine pressure catheter is utilized. Oxytocin was initiated on 7/16/11 at 7:45 AM. During the period of 7:45 AM to 9:45 AM a complete set of vital signs had been obtained four times. Based on review of the facility policy vital signs should have been obtained five times as Oxytocin was increased every half hour from 7:45 AM to 9:45 AM. Interview and review of the medical record with RN #11 on 7/18/11 at 11:45 AM failed to identify that vital signs were taken consistently in accordance with the hospital policy.


c. Patient #70 had a robotic assisted hysterectomy on 7/18/11. Review of the post anesthesia care unit (PACU) record identified that the patient arrived to the unit at 11:05 AM and received Toradol at 12:10 PM. Review of the clinical record failed to reflect a pain assessment warranting the need for Toradol and/or a subsequent assessment to determine the efficacy of the medication.


d. Patient #48 presented to the hospital on 12/29/10 for a colonoscopy. The clinical record indicated that the colonoscopy was completed with no issues. The flow sheet reflected that the patient complained of a headache with Tylenol, two tablets were administered at 1:45 PM. The clinical record failed to identify that the patient's level of pain had been assessed prior to administration of pain medications and/or reassessed after the administration of the Tylenol. Review of facility policy "Pain Management Program" indicated that an assessment of the pain level in patients reporting pain and reassessment minimally consists of pain rating scale with documentation of the same.


e. Patient #49 was admitted to the hospital on 10/27/10 with right sided low back pain and lower extremity pain. The preoperative record reflected that the patient did not consume daily medications inclusive of Diovan prior to surgery as directed. The patient had a diskectomy and foraminotomy of the lumbar disks 4-5, and a fusion with screw placement completed at 2:00 PM. Review of the physician's orders dated 10/27/10 at 1:40 PM directed administration of Imdur 90 milligrams (mg) daily, Diovan 160 mg daily, Diltiazem 360 mg daily, and Crestor 20 mg daily with the directive to hold blood pressure medications for a systolic blood pressure less then 110 and a diastolic blood pressure less then 60. The medications were scheduled for 9:00 AM. Review of the Medication Administration Record (MAR) indicated that on 10/27/10, the patient did receive Cardiazem at 9:00 PM, however the patient did not receive the Diovan. The clinical record failed to reflect the rationale for not administering the medication and/or that the physician had been notified that the medication was not administered.

f. Review of Patient #49's MAR dated 10/29/10 indicated that Imdur and Diovan were held secondary to a blood pressure of 100/60 however review of the vital signs completed on 10/29/10 at 8:17 AM reflected a blood pressure of 150/96 as did the physician's progress note dated 10/29/10 at 9:00 AM. Review of the the vital sign data identified that the patient had a blood pressure of 100/60 at 12:00 PM. The clinical record failed to identify why the medication was held related to a blood pressure obtained three hours after the administration time designated.

g. Patient #48 presented to the hospital on 12/29/10 for a colonoscopy. Review of the anesthesia note identfied that the patient received Propofol 300 mg during the procedure. At 1:09 PM the colonoscopy was completed with no issues. Review of RN #11's nurse's note and interview on 7/20/11 at 1:00 PM identfied that at 1:45 PM the patient was unable to pass gas, was assisted to the sitting position, and stated he/she felt better. RN #11 stated that the patient offered no complaints of dizziness and was assisted to the bathroom and instructed to use the call light when ready. RN #11 stated that the call light sounded and as she proceeded to the bathroom she heard a "thump" and the patient was found on the floor. The patient sustained a laceration to the head that required stitches. Review of the clinical record failed to reflect if the patient was identfied as a risk to fall. Interview with the Director on 7/21/11 at 1:25 PM indicated that patients in the GI lab are not assessed for fall risk. Review of the indication for the "Fall risk" policy is to identify all patients at risk to fall.







29049

NURSING CARE PLAN

Tag No.: A0396

Based on review of the medical record and review of hospital policy, the hospital failed to ensure that one patient's (#47) care plan was individualized and complete. The findings include:
a. Patient #47 underwent a laproscopic, hand assisted right hemi-colectomy on 4/28/11. Review of the patient's clinical record identified that, post-operatively, Patient #47 lacked an appetite and failed to take increasing amounts of oral fluids as the diet progressed from clear liquids to full liquids and, ultimately, a regular diet. Blood tests dated 5/2/11 identified that the patient's albumin was 2.2 (norm 3.5-5). Review of the patient's oral fluid intake on 5/2 and 5/3/11 averaged 1200cc for the day. Review of the patient's post-operative plan of care, undated, identified that the nutrition portion remained blank. Although the clinical record reflected the patient's intake of fluids, the record failed to reflect percentage of regular diet consumed, decreased albumin and/or notification of the dietician. Review of the hospital policy for care planning identified that each patient should have a individualized plan of care based on the patient's needs and problems that is consistently revised and updated.
b. Patient #47 was readmitted to the hospital on 5/6/11 with question of an ischemic bowel/an anastomotic leak. Review of the patient care plan, undated, identified a low albumin level however, the rest of the care plan remained blank through 6/11/11.

FORM AND RETENTION OF RECORDS

Tag No.: A0438

Based on review of the clinical record, the hospital failed to ensure that physician's orders were complete. The finding includes:
a. Review of Patient #47's clinical record identified that on 5/6/11 at 1:00 PM, physician's orders directed to "resume old orders" without specifying what those specific orders were since the patient was a readmission of 5/6/11.
b. Review of physician's orders dated 5/8/11 at 12:45 PM, directed "resume all pre-op orders". The physician failed to indicate which of the many pre-op orders were to be resumed. Both orders were reviewed with the Director of the Critical Care. The hospital failed to ensure that physician orders were complete.

INFECTION CONTROL PROGRAM

Tag No.: A0749

1. Based on observation, interview with hospital personnel and review of hospital policy, the hospital failed to ensure that biological spore testing documentation was complete. The finding includes:
a. Review of the daily biological testing documentation for the sterrad and ETO (gas) sterilizers on 7/19/11 in the Central Sterile Department, identified that the documentation failed to have complete information to ensure accurate test results. For the dates 6/11/11, 6/13/11, 6/29/11, 6/30/11 and 7/3/11, documentation failed to include either the time, date and person who planted the test in the incubator and/or the time, date and person removing the test from the incubator at the stipulated time interval to ensure an accurate reading of sterility. Review of the policy for sterilization monitoring identified that a biological test (spore) should be completed daily, however, the policy failed to reflect the process staff should follow to ensure an accurate test readout. According to the hospital's plan of correction dated 12/30/2010, central sterile processing staff were reeducated regarding biological test documentation requirements and 100% of all biological testing logs were to be reviewed for accurate completion.

2. Based on observation, interviews and review of hospital policy, the hospital failed to ensure that infection control parameters were met in the invasive procedure areas. The finding includes:

a. During tour of the interventional radiology suite with the Division Director on 7/18/11, the door of the suite was propped open between the hallway and ante room and the door between the ante room and the procedure room was also propped open altering the air flow of air within the procedure room. According to the Perioperative Standards and Recommended Practices (2010) of the AORN, doors to the invasive procedure room should remain closed except for the admission and discharge of the patient and personnel from the room to ensure that air flow patterns and pressure gradient of the room are not altered.

b. Observation on 7/18/11 of an invasive procedure in process in the interventional room, identified that neither the physician (interventionalist) or the scrub tech wore head covering. A sterile field was opened and in use. Review of the hospital policies for surgical attire/sterile field directed that all head and facial hair should be covered when personnel are within the sterile field and/or during invasive procedures.

c. Observation of OR #1 on 7/19/11, identified that the corner of this OR contained a desk with stapler, paper clips and other miscellaneous office supplies on the top surface. The area contained numerous papers and binders lying on a shelf, impeding proper cleaning of the OR. Review of the hospital policy for cleaning of the OR identified that daily terminal cleaning included washing all furniture and equipment as well as damp wiping all horizontal surfaces.

d. During tour of the Operating Suite on 7/19/11, with the Division Director and Manager, observation of OR #6, in process, identified a personal briefcase hung over the back of the anesthesia medication cart. Although the Director and Manager identified that personal belongings should not be brought into the OR, the hospital failed to have a policy directing staff to leave personal belongings in the staff locker room.



29049

3. Based on observation, interviews and tours of the obstetrical unit and dietary department, the facility failed to ensure that infection control measures were maintained. The findings include:

On 7/18/11 at 9:45 AM during a tour of the maternity unit with the Director of Nursing for Maternal Child Health Services, an observation was made that infant formula had expired. Four ready to feed bottles of Similac had expiration dates of June 2011. The formula was located in the storage closet of the obstetrical unit. Subsequent to surveyor inquiry the Director of Nursing for Maternal Child Services indicated that she would ensure that all of the formula would be checked for dates, and that all expired formula would be discarded. Further interview with the Director of Nursing identified that several staff members are responsible for discarding infant formula, and she would ensure that a specific mechanism was in place to discard formula in a timely manner.

OPERATIVE REPORT

Tag No.: A0959

Based on review of the clinical record and review of hospital policy, the hospital failed to ensure that an immediate post-operative note was written for one patient (#60). The finding includes:
Review of the clinical record for Patient #60, who underwent a right carpal tunnel on 7/19/11, failed to provide evidence that an immediate operative note was written by the surgeon post surgery. Interview with the patient's recovery nurse also identified that a note had not been dictated and available to nursing staff review by the time the patient was discharged.

INTRAOPERATIVE ANESTHESIA RECORD

Tag No.: A1004

Based on review of the clinical record, interview and review of hospital policy, the hospital failed to ensure that the anesthesia provider documented the total amount of medication administered during the operative period. The finding includes:
a. Review of the anesthesia record dated 7/19/11 for Patient #60, identified that the patient underwent right carpal tunnel surgery. During this procedure the patient received a propofol infusion. The anesthesia record documentation failed to reflect the total amount of propofol administered to Patient #60 at the termination of the infusion. Additionally, a separate dose of propofol was administered at 8:00 AM, however, the total dose administered remains in question secondary to the legibility of the documentation. Interview with the covering anesthesiologist on 7/21/11 and review of anesthesia documentation policy, identified that each dose of propofol administered to the patient should have been legibly documented on the patient's anesthesia record.

POST-ANESTHESIA EVALUATION

Tag No.: A1005

Based on a review of clinical records, interview and review of hospital policy, for five patients (#47, 59, 60, 70, and 52) the hospital failed to ensure that post anesthesia evaluations were completed. The findings include:

a. Review of the clinical record for Patient #47, who underwent surgery on 5/6/11 and 5/23/11, failed to reflect that a post anesthesia evaluation was completed within 48 hours after surgery. During interview on 7/21/11, the covering anesthesiologist stated that all anesthesia providers should be documenting a post anesthesia evaluation within 48 hours following inpatient surgery according to hospital policy.

b. Patient #59 underwent a right temporal biopsy on 7/19/11 as an outpatient. Review of the patient's clinical record post discharge identified that the post anesthesia evaluation was incomplete. Review of the hospital policy for discharge criteria from outpatient surgery identified that any patient receiving monitored or general anesthesia would be cleared for discharge by an anesthesiologist. During interview on 7/21/11, the covering anesthesiologist stated that anesthesiologist should be evaluating outpatient surgical patients for anesthesia recovery prior to discharge.

c. Patient #60 underwent a right carpal tunnel on 7/19/11 as an outpatient. Review of the clinical record failed to reflect that the patient was been evaluated by an anesthesiologist prior to discharge.



15482

d. Patient #70 had a robotic assisted hysterectomy on 7/18/11. Review of the clinical record failed to identify that a post-operative anesthesia evaluation had been completed.

e. Patient #52 had a normal spontaneous vaginal delivery on 7/16/11 with epidural analgesia. Review of the clinical record failed to identify that a post-operative anesthesia evaluation had been completed.

No Description Available

Tag No.: A1045

On August 9, 2011, as part of the periodic CMS Federal Survey, the Nuclear Medicine, and Radiology Departments of St. Mary ' s Hospital were inspected for compliance with 42 CFR 482.26 and 482.53.

The inspection consisted of a review of records, procedures, equipment and facilities, including the following: (a) in-house physics reports and follow-up corrective actions; (b) personnel dosimetry records; records of receipt of radioactive materials; (d) quarterly inventories; (e) records of area surveys; (f) records of calibration of available radiation detection instrumentation; (g) calibration of the dose calibrator, including linearity, and constancy determinations; and (h) leak test records.


1) 42 CFR 482.53(c) Requires in part that nuclear medicine services equipment be maintained in a safe operating condition, inspected, tested and calibrated.

Contrary to the above, St. Mary ' s Hospital did not maintain their equipment in a safe operating condition. Specifically, there were periods when the nuclear medicine dose calibrator was not calibrated on a quarterly basis in 2010.