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2020 TALLY RD

LEESBURG, FL 34748

PATIENT RIGHTS: PERSONAL PRIVACY

Tag No.: A0143

Based on observation, record review and interview the facility failed to provide privacy for two ( #22, & #23) of twenty three patients reviewed in the facility.

Findings:

Observation of the Medical physician on the men's Psychiatric Care Unit on 10/27/2010 at approximately 8:35 AM revealed that she was completing an assessment at the nurses station with Patient # 22 discussing personal information regarding this patient in the presence of staff and other patients that were at the counter of the nurse's station, within a distance that all of the discussion could be overheard.

Observation of the Medical physician on the men's Psychiatric Care Unit on 10/27/2010 at approximately 9:00 AM revealed that she was completing an assessment at the nurses station with Patient # 23 discussing personal information regarding this patients previous surgical procedures, and his/her previous Psychiatric hospital visits, and discharge instructions, in the presence of staff and other patients that were at the counter of the nurse's station, also within a distance that all of the discussion could be overheard.

Interview with the Assistant Director of Nursing (ADON) on 10/27/2010 at approximately 11:00 AM, revealed him to state there was, "no reason why this is done, the physician has a room to do assessments in a private setting".

Continued observation on the men's Psychiatric Care Unit revealed an observation of laboratory technicians doing a blood draw from patient #23 in a room off of the nurse's station that did not have a door. The blood draw was visible from the station that staff and other patients were present and did observe this laboratory blood drawn being done without privacy.

Standard-level Tag for Pharmaceutical Service

Tag No.: A0490

27676

Based on observations, record review and interviews revealed the facility failed to provide pharmaceutical services in accordance with the facility's policies and procedures to minimize drug errors, and provide security for medications.

Findings:

1. Cross reference A0500: Based on observation, record review and interview the facility failed to implement a process to ensure control and distribution of medications, as per their own policies and procedures.


2. Cross reference A0502: Based on observation and interview the facility failed to maintain the security of drugs and biologicals for 2 of 3 (sample store room and men's psychiatric care unit) medication rooms observed.

3. Cross reference A0505: Based on observation and interview it was determined that the facility failed to ensure that outdated drugs were removed from 1 of 2 medication rooms in the facility.

DELIVERY OF DRUGS

Tag No.: A0500

Based on observation, record review and interview the facility failed to implement a process to ensure control and distribution of medications, as per their own policies and procedures.

1. Review of the pharmacy stock supply/pharmacy log reveals that for 48 of 48 entries from 10/22/2010 at 5:25 PM to 10/25/2010 at 3:00 AM the entry for patient's name was completed with an abbreviation indicating the unit, but the "why code" is not completed. The Log also reveals:
10/22/2010 at 5:25 PM Nicorette gum amount taken 30, no strength indicated.
10/22/2010 at 5:25 PM Baclofen amount taken 100 no strength indicated.
10/24/2010 at 3:40 AM Tylenol 325 mg amount taken 60.
10/24/2010 at 3:40 AM Campral 333 mg amount taken 40
10/25/2010 at 03:00 AM MVI amount taken 1000, no strength indicated.

Review of facility's policy entitled "DRUG PROCUREMENT BY STAFF OTHER THAN THE PHARMCIST", (with the revised date of April 2008) reveals the following:

I. Only the designated in-house supervisor (Registered Nurse) may enter the pharmacy to obtain medications not available from another source within th hospital.

II. When a medication ordered for a specific individual is not available on the nursing unit or in the medication box, and the dose must be administered before the pharmacy opens, the Nursing Supervisor should enter the pharmacy.

III. Obtain only the medication required for administration (plus one additional dose) until the pharmacy opens. All medications included in this directive must be in the form of dose packing or in packet form "Sample Dose Pack" from an authorized purveyor.

IV. The nursing supervisor shall leave a copy of the of the physician's order in the pharmacy on the counter for the purpose of verification by the pharmacist.

V. Upon completion of the filling sequence, leave the pharmacy, making sure the door is locked.

VI. Place the medication in the individual's medication box on the nursing unit.

VII. In the event that a required medication is not available in the hospital, the in-house supervisor shall notify the Pharmacist On-Call. The Pharmacist will assist in finding the medication and will procure the medication for delivery to the hospital.

During interview with the Director of Nursing (DON) on 10/27/2010 at 10:15 AM he stated that the in-house supervisor does not sign the medication out to a patient, but signs it out to the nursing unit. He also stated that no paper copies of orders are left on the counter because they are all in the computer now. According to the DON, he did not know why psychiatric medications were being signed out as they should be available on the unit and that medications like Tylenol were signed out in large number because they were only available as a stock supply and not in unit dose or sample form.

2. Observations on 10/25/2010 at 3:00 PM the sample store room was left unattended and unlocked.

During interview with the Administrator on 10/25/2010 at 3:00 PM he agreed that the sample supply room had been left unlocked and unattended.

During interview with the staff in the sample supply room the staff stated that all samples are signed in when received and that medications were recorded in a log when sent out except when sent to the pharmacy. She also stated that an inventory of all the medications currently in the room was not available.

Review of the facility supplied policy entitled, "MANAGEMENT OF MEDICATION SAMPLES", reveals the statement, "The [Pharmacy Assistance Coordinator] will inventory samples, including medication name, type, batch number, number of medications and expiration dates." The policy also states, "A monthly report will be provided to the Chief Financial Officer."

During interview with the pharmacist on 10/25/2010 at 3:10 PM he stated that he has no way of matching a medication signed out by the in-house supervisor during after hours access with a particular patient. He also stated that when the pharmacy runs out of medication they obtain medication from the sample supply room and that no formal receiving process is followed. The pharmacist stated that he is in the facility Monday through Friday from 1:00 PM to 4:00 PM.




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3. Observation of medication pass for patient #21, on 10/27/2010 at 9:15 AM on medical unit, revealed that Vitamin D 1200 units (u.) was ordered to be administered at 9:00 AM. The medication nurse stated that it was unavailable, and that she had placed a note in the communication log on 10/27/2010 to the physician to inform him that the Vitamin D 1200 units was unavailable.
During reconciliation of medications and supplements administered, it was noted that the Vitamin D 1200 units was not provided as the physician had prescribed it at 9:00 AM for 23 days from 10/04 to 10/27/2010.

Review of the medical record revealed that the physician had not been called and notified that the prescribed Vitamin D 1200 units had not been administered at 9:00 AM since 10/04/2010.

SECURE STORAGE

Tag No.: A0502

Based on observation and interview the facility failed to maintain the security of drugs and biologicals for 2 of 3 (sample store room and men's psychiatric care unit) medication rooms observed.

Findings:

Observations on 10/25/2010 at 3:00 PM the sample store room was left unattended and unlocked.

During interview with the Administrator on 10/25/2010 at 3:00 PM he agreed that the sample supply room had been left unlocked and unattended.





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Observations on 10/25/2010 at 12:15 PM upon entering the medication room on the men's Psychiatric Care unit revealed that the narcotic drawer was unlocked. Observation of the drawer revealed it contained 20 tablets of Ativan 0.5 milligrams (mg.) and 12 tablets of Ativan 1 mg.

Interview on 10/25/2010 at 12:15 PM with the medication nurse, he stated "I can't lock the narcotic box because it is broken".

Observations on 10/26/2010 at 8:45 AM upon entering the medication room on the men's Psychiatric Care unit revealed that the narcotic drawer was unlocked, which contained Ativan.

Interview on 10/25/2010 at 8:45 PM with the medication nurse, she stated "I was told by the nurse that I relieved this morning that I can't lock the narcotic box, and to leave it open because it is broken".

UNUSABLE DRUGS NOT USED

Tag No.: A0505

Based on observation and interview it was determined that the facility failed to ensure that outdated drugs were removed from 1 of 2 medication rooms in the facility.

Findings:

Observation of the medication room on the Psychiatric Care Unit (PCU) on 10/25/10 at 10:30 AM revealed a sample package of Campral 333 milligrams (mg.) containing 40 tablets that had an expiration date of 09/2010.

Interview with a nurse at 10:30 AM on 10/25/10 on the Psychiatric Care Unit (PCU) unit confirmed the findings.

DIETS

Tag No.: A0630

Based on record review, interview and observation, the facility failed to meet 1 of 22 (Patient #18) patient's nutritional needs by failing to conduct a nutritional assessment after the practitioner ordered a prescribed diet.

Findings:

A review of Patient #18's medical record revealed a physician's order, dated 10/20/2010 prescribing a 1500 milligrams (mg) Sodium with 1600 calorie Dash diet restriction due to a history of excessive edema. Further review of this patient's record did not reveal any indication that a nutritional assessment had been completed after the patient's admission on 10/20/2010 through 10/27/2010. There was no indication in the patient's medical record that a Nutritional Consult had been requested.

Review of the facility's record failed to reveal any indication that the Consultant Dietitian had been in the building during this time.

An interview was conducted with the Facility ' s Consultant Dietitian on 10/27/2010 at 9:30 AM regarding the specific modification of the 1500 mg sodium and the 1600 calorie restriction on the diet for Patient #18. It was confirmed the DASH diet is a " no added salt " diet, however the 1500 mg sodium restriction ordered by the physician does not need the specifications of a " no added salt " diet. Compared to the 1500 mg sodium diet, the DASH is much too lenient a restriction and is not restrictive as ordered. It was confirmed the Dietitian had not completed the nutritional assessment on Patient #18.

Per policy, it was confirmed the Dietitian has 96 hours in which to complete the assessment, with 7 days exceeding the 96 hour stipulation.

Review of the facility's Policy and Procedure regarding Nutritional Assessments, revealed that such specialty diet is considered a diet, warranting a consult and thorough assessment to evaluate the patient's needs.

Observation of the meal tray for Patient #18 on 10/25/2010 during the lunch meal revealed it to consist of a hot dog with bun with baked beans. There were no specific dietary alterations provided in the meal due to the excessively low sodium restriction.

An interview with the nurse on 10/26/2010 at 9:14 AM revealed there is no dietary assessment for Patient #1. According to the nurse, "If a consult is needed, then we call dietary and the Registered Dietician comes in."

A review of the departmental Policies & Procedures Policy Reference #160-01 revealed, " The Dietitian or designee participates in committee activities concerned with nutritional care, provides nutrition counseling and assessments, approves menus and plans modifications for special diets, oversees the Food Services Quality Improvement plan, develops and revises nutritional care policies and procedures, provides in-service training to Center staff and submits semi-annual reports to the Vice President concerning the extent of services provided. " " The department shall advise on all matters pertaining to the special nutritional needs of individuals and shall provide as needed and ordered by the physician, modified diets, between meals snacks and individual education. "

Policy Reference #160-01, Procedure #160-06 #III: " Where there is a question as to the need or appropriateness of a special diet, the Dietitian should be consulted. Requests for special diets which are recommended outside the Center should be reviewed by the Dietitian. "

The Policy, " Nutrition Assessment and Intervention " reveals: " All consults will be noted on the Dietary Consults and Assessments log (Dietary 016) with copies sent to the Quality Improvement department quarterly.

FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE

Tag No.: A0724

Based on observation, record review and interview, the facility failed to ensure that all dietary equipment was maintained, calibrated and in working order to ensure the safety of the food being served to the patients.

Findings:

An observation of the lunch meal on 10/25/2010 was observed in the main production kitchen at 10:50 AM with 2 State Surveyors, the Food Services Director and 2 Food Service workers. It was confirmed the food for this meal had been delivered by the contracted services company to the facility and had been verified at the point of delivery to be at the appropriate temperatures, as was documented on facility tracking logs. Areas of concern were identified which included:

a. During the observation of the tray line on 10/25/2010 at 11:00 AM, the Food Service Workers failed to calibrate their dial probe stem thermometer prior to the start of the meal. The thermometer, when calibrated utilizing the ice method, was found 4 degrees (*) off standard (28*F).

A review of the facility ' s policy (#160-40) regarding calibrating a thermometer revealed, " Clean and set food thermometer probe once a month. "

An interview was conducted with the facility ' s Consultant Dietitian and Food Services Director on 10/27/2010 at 9:30 AM regarding the lack of sanitary process by calibrating and cleaning the thermometer only once a month. It was reconfirmed the thermometer was out of compliance by 4*F, exceeding established standard of +/-2*F.

b. All temperatures were taken on the steam table to determine compliance with State Food Hygiene standards of hot foods held at 140 *F or above, utilizing a calibrated thermistor digital thermometer. It was confirmed the hot dogs which had been placed into buns and were positioned in a steam table pan, ready to be served, failed to meet the established 140*F, the temperatures were found to be at 115*F; 112*F; 119*F and 118*F.

A review of the facility ' s policy and procedure, Policy Reference #160-10 revealed: " In order to provide food at an acceptable temperature, the following procedures shall apply:
a.) The steam table should be set to maintain a temperature of 140 degrees Fahrenheit (*F) to 160 *F for all hot foods.
b.) Hot foods are to be transferred directly from the preparation area to the steam table and should not be permitted to stand without warmth.

Procedure 160-13 revealed: " Steam tables must be able to maintain hot foods at 140*F or above. Temperatures are to be checked before each meal and appropriate action taken if the temperature is not in acceptable range. The steam tables are not to be used for bringing foods up to serving temperature. "

c. An observation of the mechanical, low-temperature dish machine was conducted on 10/26/2010 at 1:12 PM. It was confirmed, through utilization of a chemical test strip, the dish machine was not operating effectively and not sanitizing. The test strip did not change color when checked after the rinse cycle had been completed on four different checks.

An interview was conducted with the facility Consultant Dietitian, Food Services Director and General Services Director on 10/27/2010 at 9:22 AM, regarding the sanitation areas observed in the kitchen. No further information could be provided at this time.

d. An observation of the refrigeration unit at start of line was observed leaking water onto the floor with towels observed on floor during 2 of 2 days of observations 10/25/2010 at 10:50 AM and 10/26/2010 at 1:00 PM.

A follow-up interview was conducted with the facility Administrator on 10/26/2010 at 1:35 PM regarding the observations of cold food in the kitchen and other sanitary concerns which were identified. No further information could be provided at that time.

INFECTION PREVENTION CONTROL ABX STEWARDSHIP

Tag No.: A0747

Based on observation, record review and interview, it was determined the facility failed to ensure the dietary department is designed and equipped to facilitate the safe, sanitary provision of food service to meet the nutritional needs of the patients, and to maintain appropriate infection control standards. The facility was not in compliance with the Infection Control Condition of Participation as the multiple issues were identified.


Findings:

An observation of the lunch meal on 10/25/2010 was observed in the main production kitchen at 10:50 AM with 2 State Surveyors, the Food Services Director and 2 Food Service workers. It was confirmed the food for this meal had been delivered by the contracted services company to the facility and had been verified at the point of delivery to be at the appropriate temperatures, as was documented on facility tracking logs. Areas of concern were identified which included:

a.) Two rat traps were located on the floor, in the corner of kitchen at the end of production table work areas.

b.) A tube of 9 inch disposable plates and 1 tube of 6 inch disposable plates were observed sitting on the floor in the corner of the dry storage room

c.) During the observation of the tray line on 10/25/2010 at 11:00 AM, the Food Service Workers failed to sanitize the facility thermometer when it was initially removed from the sheath prior to submerging it into the food. The thermometer was not sanitized as it was being utilized between individual pans of food.

d.) It was confirmed the facility Food Service staff failed to calibrate their dial probe stem thermometer prior to the start of the meal. The thermometer, when calibrated utilizing the ice method, was found 4 degrees (*) off standard (28*F).

A review of the facility ' s policy (#160-40) regarding calibrating a thermometer revealed, " Clean and set food thermometer probe once a month. "

An interview was conducted with the facility ' s Consultant Dietitian and Food Services Director on 10/27/2010 at 9:30 AM regarding the lack of sanitary process by calibrating and cleaning the thermometer only once a month. It was reconfirmed the thermometer was out of compliance by 4*F, exceeding established standard of +/-2*F.

e.) Observation of the refrigerators, milk box, ice cream freezer and reach-in freezer revealed no thermometers placed internally to obtain the ambient air temperature.

f.) All temperatures were taken on the steam table to determine compliance with State Food Hygiene standards of hot foods held at 140 *F or above, utilizing a calibrated thermistor digital thermometer. It was confirmed the hot dogs which had been placed into buns and were positioned in a steam table pan, ready to be served, failed to meet the established 140*F, the temperatures were found to be at 115*F; 112*F; 119*F and 118*F.

A review of the facility ' s policy and procedure, Policy Reference #160-10 revealed: " In order to provide food at an acceptable temperature, the following procedures shall apply:
a.) The steam table should be set to maintain a temperature of 140 degrees Fahrenheit (*F) to 160 *F for all hot foods.
b.) Hot foods are to be transferred directly from the preparation area to the steam table and should not be permitted to stand without warmth.

Procedure 160-13 revealed: " Steam tables must be able to maintain hot foods at 140*F or above. Temperatures are to be checked before each meal and appropriate action taken if the temperature is not in acceptable range. The steam tables are not to be used for bringing foods up to serving temperature. "

g.) An observation of the mechanical, low-temperature dish machine was conducted on 10/26/2010 at 1:12 PM. It was confirmed, through utilization of a chemical test strip, the dish machine was not operating effectively and not sanitizing. The test strip did not change color when checked after the rinse cycle had been completed on four different checks.

h.) An observation of the refrigeration unit at start of line was observed leaking water onto the floor with towels observed on floor during 2 of 2 days of observations 10/25/2010 at 10:50 AM and 10/26/2010 at 1:00 PM.

An interview was conducted with the facility Consultant Dietitian, Food Services Director and General Services Director on 10/27/2010 at 9:22 AM, regarding the sanitation areas observed in the kitchen. No further information could be provided at this time.

A follow-up interview was conducted with the facility Administrator on 10/26/2010 at 1:35 PM regarding the observations of cold food in the kitchen and other sanitary concerns which were identified. No further information could be provided at that time.