Atrium Center for Rehabilitation and Nursing

Deficiency Details, Complaint Survey, April 12, 2011

PFI: 1430
Regional Office: MARO--New York City Area

Back to Inspections page

F514 483.75(l)(1): CLINICAL RECORDS MEET PROFESSIONAL STANDARDS

Scope: Isolated

Severity: Potential for more than Minimal Harm

Corrected Date: May 30, 2011

The facility must maintain clinical records on each resident in accordance with accepted professional standards and practices that are complete; accurately documented; readily accessible; and systematically organized. The clinical record must contain sufficient information to identify the resident; a record of the resident's assessments; the plan of care and services provided; the results of any preadmission screening conducted by the State; and progress notes.

Citation date: April 12, 2011

NY00069218

Based upon interviews and record reviews, it was determined that the facility did not maintain records that are complete and accurately documented. Specifically,
a physician's order for Synthroid did not clearly specify dosage;
physician progress notes and physician orders were marginally legible and incomplete;none and
the pharmacist's drug regimen review did not clearly specify the presence or absence of drug regimen irregularities. This was evident for 1 of 1 residents. Resident #1.

This resulted in no actual harm with potential for more than minimal harm that is not immediate jeopardy.

The findings are:

Resident #1 is an 89 year old female admitted to the facility on 1/5/09. The hospital transfer information dated 1/5/09 documented the following medical conditions: Syncope, history of dementia, cerebrovascular accident, hypothyroidism, coronary artery disease, status post coronary artery bypass graft surgery, permanent pacemaker.

Because of physician progress note legibility issues, o n 10/19/10 at 11:45AM physician #1 was interviewed via phone and upon request, he verbally read his progress notes dated 1/22/09, 1/27/09 and his orders dated 1/22/09.

1 /22/09 physician #1's progress note: "Family notified us. Pt (patient) was previously on Synthroid. Dx (Diagnosis) of hypothyroidism but Synthroid not on PRI on transfer to NH (nursing home). . . . Called hosp (hospital) pharmacy. Patient was on Synthroid 50 micrograms." "P (Plan): Will get baseline TFT (thyroid function tests). Rx: (Treatment): Synthroid to begin 1/23."

1/22/09 physician #1's orders: "TFT 1/23. After blood is taken begin Synthroid 0.5 microgram OD (daily). (Hypothyroid)."

Because of legibility issues, on 1/22/09, it is difficult to discern if the physician ordered TFT, TSH or another test. The 1/22/09 order specifies Synthroid 0.5 however, because of legibility issues, it is difficult to discern mg, micrograms or other units. Synthroid tablets are not produced in a 0.5 microgram dosage.

On 1/22/09 at 11AM, nursing progress note documents: "MD ordered Synthroid 0.5mg daily to begin on 1/23/09 AM. Dx: hypothyroidism. THS to be done 1/23 AM then Synthroid to begin."

The nursing progress note's Synthroid dosage (Synthroid 0.5mg daily) differs from physician #1's 1/22/09 progress note dosage (Synthroid 50 micrograms), physician #1's 1/22/09 orders (Synthroid 0.5 microgram daily) and the medication administration record (MAR) (Synthroid / L- thyroxine 0.05mg daily). Synthroid 0.5mg daily is 10 times the dose documented in the medication administration records.

The nursing progress note documents "THS." THS is not a known thyroid test.

On 10/19/10 at 11:45AM, during the above telephone interview, physician #1 confirmed that his 1/22/09 order for Synthroid 0.5 micrograms differs from the medication administration record which documents that the resident received Synthroid / L thyroxine 0.05mg (milligrams) daily from 1/23/09 to 2/26/09.

On 1/23/09 at 4:09AM, a blood test report indicated:
"TSH (Thyroid Stimulating Hormone) 3rd generation L (low) <0.004 (less than 0.004)." (Normal values: "0.35 - 5.50 uIU/ml"). (uIU = microinternational units per milliliter).

On 10/19/10 at 11:45AM, during the above telephone interview, physician #1 verbally read his 1/27/09 progress note:
"See above. TSH (downward pointing arrows indicating very low TSH). Plan: Await full TFT' s."

On 2/4/09, a blood test revealed TSH 0.01 (Normal values: "0.35 - 5.50 uIU/ml").

The abnormal laboratory result was signed however, there are no physician progress notes that addressed the laboratory abnormality.
none
On 10/19/10 at 11:45AM, during the above telephone interview, p hysician #1 stated that on 1/22/09 he (physician #1) ordered TFT's (thyroid function tests) however, only a TSH (thyroid stimulating hormone) was performed. A thyroxine level (T4) was not done. On 1/27/09 physician #1 documented that the TSH was very low and that he was awaiting the full thyroid function tests (TFT's) including T4 and T3 (thyroid hormone levels: L - thyroxine level and triiodothyronine level).

(However, on 1/23/09 T4 and T3 levels may have been omitted from the blood test due to physician order legibility issues. Physician #1 stated that he ordered TFT's however, on 1/22/09 a nursing progress note indicates that the physician ordered THS).

Physician #1 stated that the signature on the next blood test report dated 2/4/09 (ordered by physician #2 on 2/3/09) was probably his (physician #1). Physician #1 stated that although the 2/4/09 results indicated a low TSH, the remainder of the thyroid function tests were not done.
(However, on 2/3/09 TSH was the only thyroid blood test ordered by physician #2 as verified during a telephone interview with the registered nurse/risk manager on 11/5/10 at 12:30PM).
Physician #1 stated that Synthroid was continued because TSH without T4 doesn't mean anything.

On 11/5/10 at 12:30PM, the registered nurse/ risk manager was interviewed via phone and reviewed physician #1's 1/22/09 progress notes. The risk manager stated that she could not determine if Synthroid 50 meq or mcg was written. The risk manager reviewed physician #1's 1/22/09 orders and stated that the order appears to indicate Synthroid 0.5mg OD.
(However, the medication administration record (MAR) documents that that Synthroid / L - thyroxine 0.05mg was administered daily from 1/23/09 through 2/26/09).
The risk manager reviewed physician #2's 2/3/09 and 2/27/09 progress notes and stated that she could not read parts of the notes.

On 2/10/09 " . . . Drug Regimen Review" "Pharmacist Progress notes",
both "NI" (no irregularities) and "NS" (irregularities non significant) are included within a circle written between these 2 abbreviations.

On 10/19/10 at 10:46AM the pharmacist consultant was interviewed via phone and stated that in the drug regimen review dated 2/10/09 he circled NS (irregularities non significant).

On 11/5/10 at 12:30PM, the registered nurse/ risk manager was interviewed via phone and reviewed the 2/10/09 drug regimen review. She stated that the circle appears between the abbreviations "NI" and NS".

The physician progress notes and orders on 1/22/09, 1/27/09, 2/3/09 and 2/27/09 are poorly legible causing difficulties in determining the intended dose of Synthroid ordered on 1/22/09 and the intended blood test ordered 1/22/09:
- The 1/22/09 order for thyroid function tests is poorly legible making it difficult to distinguish between TFT (thyroid function test), TSH (thyroid stimulating hormone) or some other test.
- The 1/22/09 order for Synthroid doesn't clearly specify milligrams or micrograms and the quantity 0.5 differs from both the 1/22/09 physician progress note and the medication administration records.
- 2/4/09 blood test results are signed by a physician however, there are no physician progress notes that addressed the laboratory abnormality.
none The pharmacist drug regimen review does not clearly document the presence or absence of non significant drug regimen irregularities.
These findings could result in medication errors and incorrect diagnostic testing.


415.22(a)

F329 483.25(l): DRUG REGIMEN IS FREE FROM UNNECESSARY DRUGS

Scope: Isolated

Severity: Potential for more than Minimal Harm

Corrected Date: May 30, 2011

Each resident's drug regimen must be free from unnecessary drugs. An unnecessary drug is any drug when used in excessive dose (including duplicate therapy); or for excessive duration; or without adequate monitoring; or without adequate indications for its use; or in the presence of adverse consequences which indicate the dose should be reduced or discontinued; or any combinations of the reasons above. Based on a comprehensive assessment of a resident, the facility must ensure that residents who have not used antipsychotic drugs are not given these drugs unless antipsychotic drug therapy is necessary to treat a specific condition as diagnosed and documented in the clinical record; and residents who use antipsychotic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs.

Citation date: April 12, 2011

NY00069218

Based upon record reviews and interviews it was determined that the facility did not ensure that residents' drug regimen are free from unnecessary drugs. Specifically, Synthroid/ levothyroxine / L -thyroxine (thyroid hormone) was an unnecessary drug because it was administered to a resident for the treatment of inadequate thyroxine (T4) production by the thyroid gland (hypothyroidism) however, the resident's blood tests results were consistent with excessive thyroxine production and / or blood levels (hyperthyroidism and/or thyrotoxicosis).

This was evident for 1 of 1 sampled residents. Resident #1.

This resulted in no actual harm with potential for more than minimal harm that is not immediate jeopardy.

The finding is:

Resident #1 is an 89 year old female admitted to the facility from the hospital on 1/5/09. The hospital transfer information on 1/5/09 included the following medical conditions: Syncope, history of dementia, cerebrovascular accident, hypothyroidism, coronary artery disease, status post coronary artery bypass graft surgery, permanent pacemaker.

The hospital's discharge medication list dated 1/5/09 did not include thyroid hormone replacement for hypothyroidism (L-thyroxine/Synthroid or other thyroid hormone preparations).

The initial MDS 2.0 dated 1/20/09 indicates short term and long term memory problems.

Because of physician progress note legibility issues, o n 10/19/10 at 11:45AM physician #1 was interviewed via phone and upon request verbally read his progress notes dated 1/22/09, 1/27/09 and his orders dated 1/22/09:

1/22/09 physician #1's progress notes: "Family notified us. Pt (patient) was previously on Synthroid. Dx (Diagnosis) of hypothyroidism but Synthroid not on PRI on transfer to NH (nursing home). Called hosp (hospital) pharmacy. Patient was on Synthroid 50 micrograms." "P (Plan): Will get baseline TFT (thyroid function test). Rx: (Treatment): Synthroid to begin 1/23."

1/22/09 physician #1's orders: "TFT 1/23. After blood is taken begin Synthroid 0.5 micrograms OD (daily). (Hypothyroidism)."

The manufacturer's packet insert for Synthroid (levothyroxine/ L-thyroxine generic equivalent) states: "Levothyroxine sodium is used for the following indications: Hypothyroidism - As replacement or supplemental therapy in congenital or acquired hypothyroidism . . . ."

The physician orders on 1/22/09 document Synthroid 0.5 micrograms however, Synthroid tablets are not produced in the 0.5 microgram dosage.

The medication administration records indicate that Synthroid 0.05mg (or 50 micrograms) / L-thyroxine 0.05mg (or 50 micrograms) was administered daily from 1/23/09 through 2/26/09.

On 1/23/09 at 4:10AM, the blood test report indicated: "TSH (Thyroid Stimulating Hormone) 3rd generation L (low) <0.004 (less than 0.004)." (Normal values: "0.35 - 5.50 uIU/ml").(uIU = microinternational units per milliliter).

The very low TSH level was consistent with TSH suppression due to the effects of excessive thyroxine production and/or blood levels which occurs in hyperthyroidism and/or thyrotoxicosis.

TSH was the only test result documented in the laboratory report dated 1/23/09.

The manufacturer of Synthroid (L - thyroxine) documents in the packet insert contraindications, warnings and precautions for the use of Synthroid (L - thyroxine) in elderly patients with pre existing hyperthyroidism /thyrotoxicosis and cardiovascular disease because Synthroid (L- thyroxine) can further elevate the body's thyroxine (T4) levels and exacerbate hyperthyroidism:none

" . . . particularly the elderly, or those with underlying cardiovascular disease, levothyroxine therapy is contraindicated if the serum TSH level is already suppressed due to the risk of precipitating overt thyrotoxicosis." . . .

The resident's medical record documents cardiovascular disease: permanent pacemaker, a history of coronary artery bypass surgery and cerebrovascular accident.

On 10/19/10 at 11:45AM physician #1 verbally read his progress notes dated 1/27/09:
"TSH (downward arrows indicating very low TSH). Plan: Await full TFT's (thyroid function tests)."

However, Synthroid (L - thyroxine) was not discontinued. Thyroid function tests which include thyroxine levels (total T4) and /or free thyroxine levels (free T4) in addition to TSH were not reordered on 1/27/09 and were not subsequently reordered until 2/27/09.

none On 2/3/09 physician #2's monthly progress note indicates that Synthroid /L-thyroxine 0.05mg 1 tab daily was effective even though the 1/23/09 blood test revealed a very low TSH consistent with TSH suppression from excessive thyroxine.

On 2/3/09 physician #2 monthly orders included Synthroid/ L-thyroxine 0.05mg 1 tablet orally daily and a blood test for TSH alone without a thyroxine level or other thyroid tests.
(The order for TSH alone without other thyroid tests was verified during a telephone interview with the registered nurse/risk manager on 11/5/10 at 12:30PM).

On 2/4/09 the blood test revealed TSH 0.01 (Normal values: "0.35 - 5.50 uIU/ml"). The low TSH was again at a level consistent with TSH suppression none due to excessive thyroxine.

The abnormal laboratory result was signed however, there are no physician progress notes that addressed the laboratory abnormalities.

On 2/27/09 physician #2 ordered, thyroid function tests: "TSH, Free T4, T3." The physician also ordered "CMP (comprehensive metabolic panel), CBC with differential."

On 2/27/09, 4:45PM nursing notes documented that the resident's chair alarm was heard, the resident was in the hallway on the floor, feet between leg rests of wheelchair on right side of forehead on the floor without visible injury. Physician #1 provided a telephone order to transfer the resident to the emergency room.

On 2/28/09, the hospital laboratory documented blood test results consistent with hyperthyroidism and thyrotoxicosis:

"Free thyroxine 4.13 (0.61 - 1.24) ng/dl" (Normal value = 0.61-1.24).
"hTSH 0.02 (0.34 - 5.6) uIU/ml" (hTSH = human thyroid stimulating hormone. Normal value = 0.34 - 5.6).
"suggests HYPERTHYROID".

The elevated free thyroxinenone was consistent with hyperthyroidism and thyrotoxicosis. The low TSH level was consistent with TSH suppression due to excessive blood thyroxine levels.

On 2/28/09 a hospital house staff admission note documented that Synthroid /L-thyroxine was held (not being administered).

On 2/28/09 another house staff note documented blood test results from a previous hospitalization consistent with hyperthyroidism and thyrotoxicosis (prior to the 1/5/09 nursing home admission):
"1/5/09 Free T4 3.94 TSH 0.01."

On 3/1/09 the hospital laboratory again reported blood test results consistent with hyperthyroidism and thyrotoxicosis:

"Free thyroxine 3.91 (0.61 - 1.24) ng/dl"
"hTSH 0.01 (0.34 - 5.6) uIU/ml"
"suggests HYPERTHYROIDISM".

On 10/19/10 at 11:45AM, physician #1 was interviewed via phone and stated that the resident's family informed the facility that the resident had a history of hypothyroidism and was receiving Synthroid. Physician #1 stated that he contacted the hospital pharmacy and was informed that the resident was receiving Synthroid 0.05mg once a day in the hospital prior to admission to the nursing home. On 1/22/09 physician #1 ordered thyroid function tests (TFT's) however, only a TSH was performed. A thyroxine level (T4) was not done. On 1/27/09 physician #1 documented that the TSH was very low and that he was awaiting the full thyroid function tests (TFT's) including T4 and T3 (thyroid hormone levels for thyroxine \ and triiodothyronine spectively). (However the 1/23/09 lab report documenting TSH <0.004 was a "complete report." No additional tests were pending).

Physician #1 stated that the signature on the next blood test report dated 2/4/09 (ordered by physician #2 on 2/3/09) was probably his (physician #1). Physician #1 stated that although the 2/4/09 results indicated a low TSH, the remainder of the thyroid function tests were not done. (However, on 2/3/09, the medical record indicates that physician #2 ordered only a repeat TSH without other thyroid tests).
Physician #1 stated that Synthroid was continued because TSH without T4 doesn't mean anything. (However, according to the manufacturer of Synthroid, low/suppressed TSH levels in elderly patients with cardiovascular disease is a contraindication to Synthroid).

Physician #1 stated that he was waiting for the full thyroid function tests (TFT's) which he ordered 1/22/09. Thyroid function tests were ordered by physician #2 on 2/27/09.
Physician #1 stated that he never actual physically saw or examined resident #1 during her stay. Physician #1 stated that it was not necessary to see a resident to write medication orders. When asked if Synthroid should have been withheld in this resident with cardiovascular disease and a low TSH consistent with hyperthyroidism, physician #1 stated that TSH by itself did not mean anything without a full panel of thyroid tests. Synthroid was continued based upon the hospital transfer diagnosis of hypothyroidism, family information that the resident had been receiving Synthroid for hypothyroidism and the hospital pharmacist who indicated that the resident had been receiving Synthroid in the hospital. (However, the hospital records preceding the nursing home admission on 1/5/09 indicate that on 12/30/08, Synthroid 0.05mg / L- thyroxine 0.05mg once a day was discontinued by an endocrinology consultant because blood test results on 12/27/08 revealed hyperthyroidism: Each of the following blood tests on 12/27/08, 12/31/08, 1/1/09, 1/2/09 and 1/5/09 revealed low TSH levels and elevated free thyroxine levels consistent with hyperthyroidism).

(Physician #1 continued Synthroid /L - thyroxine and did not reorder the tests that he indicated should have been performed on 1/23/09 and 2/4/09. On 2/27/09 physician #2 ordered, "TSH, Free T4, T3).

On 10/18/10 at 10:30AM physician #2 was interviewed and stated that when he saw the resident on 2/3/09 (for a monthly evaluation), he documented that Synthroid was effective because there were no signs of hypothyroidism. Regarding TSH below 0.004 on 1/23/09, physician #2 stated that he continued Synthroid because he requested repeat thyroid function tests to determined if the 1/23/09 TSH below 0.004 was an error. The resident's family indicated the resident was taking Synthroid in the hospital. On 2/27/09 physician #2 saw the resident because of poor intake and at that time ordered a thyroid profile.

The resident's blood tests on 1/23/09, 2/4/09 revealed low TSH levels which were consistent with excessive thyroxine production and /or blood levels, a contraindication to the use of Synthroid / L-thyroxine. However, Synthroid / L - thyroxine 0.05mg (thyroid hormone) was administered daily from 1/23/09 to 2/26/09 with the potential of increasing the resident's already elevated thyroxine levels and causing complications from hyperthyroidism and thyrotoxicosis.
After the resident was hospitalized on 2/27/09, blood tests on 2/28/09 and 3/1/09 revealed elevated free thyroxine levels (free T4) and low TSH levels, consistent with hyperthyroidism and thyrotoxicosis.

415.12(l)(1)

F428 483.60(c): RESIDENT DRUG REGIMEN REVIEWED MONTHLY BY PHARMACIST

Scope: Isolated

Severity: Potential for more than Minimal Harm

Corrected Date: May 30, 2011

The drug regimen of each resident must be reviewed at least once a month by a licensed pharmacist. The pharmacist must report any irregularities to the attending physician, and the director of nursing, and these reports must be acted upon.

Citation date: April 12, 2011

NY00069218

Based upon record reviews and interviews it was determined that the facility did not ensure that drug regimen irregularities are identified and reported. Specifically, Synthroid/ levothyroxine / L -thyroxine (thyroid hormone) administration was a drug regimen irregularity because it was administered to a resident for the treatment of inadequate thyroxine (T4) production by the thyroid gland (hypothyroidism) however, the resident's blood tests results were consistent with excessive thyroxine production and / or blood levels (hyperthyroidism and/or thyrotoxicosis). The pharmacist's drug regimen review did not document that Synthroid / L - thyroxine administration was a drug regimen irregularity and did not document that any recommendations was made to physician and director of nursing in reference to Synthroid / L-thyroxine.

This was evident for 1 of 1 sampled residents. Resident #1.

This resulted in no actual harm with potential for more than minimal harm that is not immediate jeopardy.

The finding is:

Resident #1 is an 89 year old female admitted to the facility from the hospital on 1/5/09. The hospital transfer information dated 1/5/09 documented the following medical conditions: Syncope, history of dementia, cerebrovascular accident, hypothyroidism, coronary artery disease, status post coronary artery bypass graft surgery, permanent pacemaker.

The hospital discharge medication list dated 1/5/09 did not include thyroid hormone replacement for hypothyroidism (Synthroid / L-thyroxine or other thyroid hormone preparations).

The initial MDS 2.0 dated 1/20/09 documents short term and long term memory problems.

The manufacturer's packet insert for Synthroid (levothyroxine/ L-thyroxine generic equivalent) states: "Levothyroxine sodium is used for the following indications: Hypothyroidism - As replacement or supplemental therapy in congenital or acquired hypothyroidism . . . ."

Because of physician progress note legibility issues, o n 10/19/10 at 11:45AM physician #1 was interviewed via phone and upon request, he verbally read his progress notes and orders dated 1/22/09:

1/22/09 physician #1's progress notes: "Family notified us. Pt (patient) was previously on Synthroid. Dx (Diagnosis) of hypothyroidism but Synthroid not on PRI on transfer to NH (nursing home). Called hosp (hospital) pharmacy. Patient was on Synthroid 50 micrograms." "P (Plan): Will get baseline TFT (thyroid function test). Rx: (Treatment): Synthroid to begin 1/23."

1/22/09 physician #1's orders: "TFT 1/23. After blood is taken begin Synthroid 0.5 micrograms OD (daily). (Hypothyroidism)."

However, Synthroid tablets are not produced in a 0.5 microgram dosage.

The medication administration records (MAR) indicate that Synthroid 0.05mg (or 50 micrograms) none / L-thyroxine 0.05mg (or 50 micrograms) was administered 1/23/09 - 2/26/09.
none
On 1/23/09 at 4:09AM, blood test report indicated:
"TSH (Thyroid Stimulating Hormone) 3rd generation L (low) <0.004 (less than 0.004)." (Normal values: "0.35 - 5.50 uIU/ml"). (uIU = microinternational units per milliliter).

The very low TSH level was consistent with TSH suppression due to the effects of excessive thyroxine levels and/or production which occurs in hyperthyroidism and thyrotoxicosis. TSH was the only blood test result documented in the laboratory report dated 1/23/09.

The manufacturer of Synthroid (L - thyroxine) documents in the packet insert contraindications, warnings and precautions in elderly patients with hyperthyroidism / thyrotoxicosis and cardiovascular disease because Synthroid (L- thyroxine) can further elevate thyroxine (T4) levels and exacerbate hyperthyroidism:none

". . . . particularly the elderly, or those with underlying cardiovascular disease, levothyroxine therapy is contraindicated if the serum TSH level is already suppressed due to the risk of precipitating overt thyrotoxicosis." . . .

The resident's medical record documents cardiovascular disease: permanent pacemaker, history of coronary artery bypass surgery and cerebrovascular accident.

On 2/3/09 physician #2 monthly orders included Synthroid / L-thyroxine 0.05mg 1 tablet orally daily and a blood test for TSH.

On 2/4/09 the blood test revealed TSH 0.01 (Normal values: "0.35 - 5.50 uIU/ml"). The low TSH was again at a level consistent with TSH suppression none due to excessive thyroxine levels and/or production.

On 2/10/09 pharmacist's ". . . .Drug Regimen Review"/ "Pharmacist Progress notes" documents both: "NI" (no irregularities) and "NS" (irregularities non significant). Both abbreviations are included within a circle written between these 2 abbreviations. The medication causing a non significant irregularity is not documented. Neither Synthroid / L- thyroxine / levothyroxine or any other medications are documented on the "Drug Regimen Review." The report does not document that any recommendations were made to the physician or director of nursing.

none On 2/27/09, 4:45PM nursing notes documented that the resident was found on the floor after falling from a chair and subsequently was transferred to the hospital.

On 2/28/09, the hospital laboratory report documented blood test results consistent with hyperthyroidism and thyrotoxicosis:

"Free thyroxine 4.13 (0.61 - 1.24) ng/dl" (Normal value = 0.61-1.24).
"hTSH 0.02 (0.34 - 5.6) uIU/ml" (hTSH = human thyroid stimulating hormone. Normal value = 0.34 - 5.6).
"suggests HYPERTHYROID".

On 2/28/09 a house staff admission note documented that levothyroxine (Synthroid) was held.

On 3/1/09 the hospital laboratory again reported blood test results consistent with hyperthyroidism and thyrotoxicosis:

"Free thyroxine 3.91 (0.61 - 1.24) ng/dl" "hTSH 0.01 (0.34 - 5.6) uIU/ml"
"suggests HYPERTHYROIDISM"

On 10/19/10 at 09:46AM and 10/28/10 at 4PM the pharmacist was interviewed via phone and stated that the drug regimen review shows that he circled the abbreviation "NS" to indicate non significant irregularity. The pharmacist stated that he did not document the drug irregularity because of the following:
- the pharmacist was waiting for follow up lab results after 4-6 weeks of Synthroid;
- physician #1's progress note indicated that the resident was not receiving Synthroid upon transfer to the nursing home from the hospital and the family reported a diagnosis of hypothyroidism treated with Synthroid previously;
- the hospital transfer note indicated a diagnosis of hypothyroidism;
- physician #1 contacted the hospital pharmacy which confirmed that the resident was receiving Synthroid in the hospital.
(However, the hospital records preceding the nursing home admission on 1/5/09 indicate that on 12/30/08, Synthroid 0.05mg once a day was discontinued by an endocrinology consultant because blood test results on 12/27/08 revealed hyperthyroidism: Each of the following blood tests on 12/27/08, 12/31/08, 1/1/09, 1/2/09 and 1/5/09 revealed low TSH levels and elevated free thyroxine levels consistent with hyperthyroidism).

The pharmacist stated that the blood test on 1/23/09 revealing TSH below 0.004 appeared erroneous. The lab result on 2/4/09 indicating TSH 0.01 was done too soon after the previous blood test result and the 2/4/09 TSH result was greater than the 1/23/09 result. The pharmacist stated that he was waiting for repeat thyroid function blood tests after 4 - 6 weeks of Synthroid therapy. At that time if the TSH was still low, he would have asked the physician to evaluate the Synthroid.
(However, the pharmacist's opinion that the 1/23/09 and 2/4/09 TSH results were erroneous was not based upon evidence. During the hospitalizations preceding and following the nursing home admission, thyroid blood tests were repeated at intervals of 24 hours and during both hospitalizations Synthroid / L- thyroxine was discontinued due to excessive thyroxine levels with low / suppressed TSH levels).

When asked to specify the effects of Synthroid that the pharmacist was expecting to see after 4-6 weeks of treatment, the pharmacist stated that he was waiting for repeat TSH results at the end of February 2009. When asked about the safety of Synthroid administration in this frail elderly resident with cardiac disease (pacemaker and coronary artery bypass surgery) and lab results indicating no need for Synthroid, the pharmacist stated that the dose of Synthroid was low and the pharmacist did not believe there would be immediate toxicity from Synthroid. (However the manufacturer of Synthroid packet insert includes a warning that " particularly the elderly, or those with underlying cardiovascular disease, levothyroxine therapy is contraindicated if the serum TSH level is already suppressed due to the risk of precipitating overt thyrotoxicosis.)"

The pharmacist stated that blood tests are usually done 4 - 6 weeks after Synthroid treatment. The pharmacist stated that during the next drug regimen review he would have seen lab results after 6 weeks of Synthroid and he would have written a note to the physician at that time.

The resident's blood tests on 1/23/09, 2/4/09 revealed low TSH levels which were consistent with excessive thyroxine production and /or blood levels a contraindication to the use of Synthroid / L-thyroxine. However, Synthroid / L - thyroxine 0.05mg was administered daily from 1/23/09 to 2/26/09 with the potential of increasing the resident's already elevated thyroxine levels and causing complications from hyperthyroidism and thyrotoxicosis. The 2/10/09 drug regimen review does not document Synthroid / L - thyroxine administration as a drug regimen irregularity and it does not document that a recommendation was made to the physican or director of nursing in reference to Synthroid / L-thyroxine. After the resident was hospitalized on 2/27/09, blood tests on 2/28/09 and 3/1/09 revealed elevated free thyroxine levels (Free T4) and low TSH, consistent with hyperthyroidism and thyrotoxicosis.

415.18(c)