Steven D Trombly Md

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: . Based on record review of the CMS database and the American Proficiency Institute proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS-approved proficiency testing program for the specialty of endocrinology. Findings include: 1. The laboratory failed to achieve satisfactory performance for Thyroid Stimulating Hormone (TSH). Refer to D2107. 2. The laboratory failed to achieve satisfactory performance for the specialty of endocrinology. Refer to D2108. D2107 ENDOCRINOLOGY Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- CFR(s): 493.843(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on record review of the CMS database and the American Proficiency Institute proficiency testing reports, the laboratory failed to achieve satisfactory performance for Thyroid Stimulating Hormone (TSH) for 2 (2nd and 3rd events of 2023) of 2 consecutive testing events. Findings include: TSH PT Event Score 2nd event 2023 0% 3rd event 2023 0% D2108 ENDOCRINOLOGY CFR(s): 493.843(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on record review of the CMS database and the American Proficiency Institute proficiency testing reports, the laboratory failed to achieve satisfactory performance for the specialty of endocrinology for 2 (2nd and 3rd events of 2023) of 2 consecutive testing events. Findings include: Endocrinology PT Event Score 2nd event 2023 66% 3rd event 2023 0% -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: . Based on record review of the CMS database and the American Proficiency Institute (API) proficiency testing reports and phone interview with the Technical Consultant, it was determined the laboratory failed to successfully participate in a CMS-approved proficiency testing program for hematology white blood cell identification and differential testing. Findings include: Review of the CMS database and the API proficiency testing reports and phone interview with the Technical Consultant revealed the laboratory failed to achieve satisfactory performance for hematology white blood cell identification and differential testing. Refer to D2121. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: . Based on record review of the CMS database and the American Proficiency Institute (API) proficiency testing reports and phone interview with the Technical Consultant, the laboratory failed to achieve at least 80 percent for white blood cell identification and differential for 2 (3rd event of 2021 and 1st event of 2022) out of 2 consecutive testing events. Findings include: 1. A record review of the CMS database and API proficiency testing reports revealed the following scores for 2 out of 2 consecutive testing events: White Blood Cell Differential PT Event Score 1st event 2022 20% 3rd event 2021 47% 2. A phone interview on 5/10/22 at 11:39 am with the Technical Consultant confirmed the laboratory received the scores listed above for white blood cell identification and differential. -- 2 of 2 --

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: . A. Based on record review, observation, and interview with the Technical Consultant (TC), the laboratory failed to follow its policy for specimen labeling for 3 (2 blood tubes and 1 urine specimen) specimens observed in the laboratory. Findings include: 1. A review of the laboratory's "Specimen Rejection Criteria" policy revealed a section stating, "Specimen must be properly labeled with: Patient Name and Date of Birth." 2. The surveyor observed the following specimens during a tour of the laboratory on 2/9/22 at 10:49 am: a. Two EDTA blood tubes with a sticker indicating the patient's name and full address. b. One urine cup with "G" on the lid. 3. An interview on 2/9/22 at 2:00 pm with the TC confirmed the laboratory had not followed their specimen labeling policy. B. Based on record review, observation, and interview with Testing Personnel #1 (TP1), the laboratory failed to follow its policy for specimen acceptability and rejection for 1 urine specimen observed in the laboratory. Findings include: 1. A review of the laboratory's "Urine Specimen Procedure" revealed a section stating, "Collection containers must be clean and made of inert disposable plastic. Do not reuse containers. Containers should have a capacity of 50 to 100 mL with a round opening at least two inches in diameter." and "Sterile containers with lids and no preservatives are required if the specimen is to be used for microbiological studies." 2. A review of the laboratory's "Specimen Rejection Criteria" revealed a section stating, "Specimen must be collected in designated tube or Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- container with proper anticoagulant, preservative or sterility." 3. The surveyor observed a small, clear plastic food container with a "G" on the lid containing a yellow liquid in the laboratory's refrigerator on 2/9/22 at 11:03 am. 4. An interview on 2/9/22 at 11:03 am with TP1 confirmed the contents of the container was patient urine, the specimen was not collected in the correct specimen container, and the specimen had not been rejected. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: . The laboratory failed to meet applicable analytic system requirements and correct identified problems. Findings include: 1. The laboratory failed to perform and document calibration procedures when calibration verification failed to meet the laboratory's acceptable limits. Refer to D5437. 2. The laboratory failed to perform calibration verification at least every 6 months. Refer to D5439. 3. The laboratory failed to perform

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: . Based on record review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS-approved proficiency testing program for the Endocrinology analyte: Triiodothyronine (T3). Findings include: Review of the CMS database and the API proficiency testing reports revealed the laboratory failed to achieve satisfactory performance for the Endocrinology analyte T3. Refer to D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on review of the CMS database and the American Proficiency Institute (API) final proficiency testing (PT) reports, the laboratory failed to achieve satisfactory performance for the Endocrinology analyte Triiodothyronine (T3) for 2 (1st and 2nd) of 2 consecutive testing events in 2021, which is unsuccessful performance. Findings include: T3 PT Event Score 1st event 2021 40% 2nd event 2021 60% -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: . Based on review of the CMS database and review of the American Proficiency Institute (API) final proficiency testing reports, the laboratory failed to successfully participate in a CMS approved proficiency testing program for the specialty of Endocrinology. Review of the CMS database and the API proficiency testing reports showed unsatisfactory performance for 2 (2nd 2019 and 1st 2020) of 3 testing events. Refer to D2107 and D2108 D2107 ENDOCRINOLOGY CFR(s): 493.843(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on review of the CMS database and review of the American Proficiency Institute (API) final proficiency testing (PT) reports, the laboratory failed to achieve satisfactory performance for the Endocrinology analyte Free Thyroxine for 2 (2nd 2019 and 1st 2020) of 3 consecutive testing events, which is unsuccessful performance. Findings include: Free Thyroxine PT Event Score 2nd event 2019 0% 1st event 2020 0% D2108 ENDOCRINOLOGY CFR(s): 493.843(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on review of the CMS data base and review of the American Proficiency Institute (API) final proficiency testing reports, the laboratory failed to achieve a satisfactory overall performance for Endocrinology which is unsatisfactory performance for the speciality of Endocrinology. Findings include: Unsatisfactory performance for 2 (2nd 2019 and 1 2020) of 3 testing events for the speciality of Endocrinology constitutes unsuccessful performance. Endocrinology PT event Score 2nd event 2019 66% 1st event 2020 66% -- 2 of 2 --

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: . Based on observation and interview with Testing Personnel #1 (TP1), the laboratory failed to label the hematology reagent with the name, contents, lot #, open date, and expiration date for the current reagent cube on the Beckman Coulter AcT diff hematology analyzer. Findings include: 1. During a tour of the laboratory on 12/18/19 at approximately 9:16 am, the surveyor observed a cube of reagent on a shelf below and connected to the Beckman Coulter AcT diff hematology analyzer. 2. The cube of reagent lacked documentation of the name of the reagent, contents, lot #, open date, and expiration date. 3. On 12/18/19 at approximately 9:16 am when queried, TP1 confirmed the reagent on the analyzer to be the Coulter diff Act Pak Reagent Kit which is "put on the analyzer at the beginning of each month." 4. During the interview on 12/18/19 at approximately 9:16 am, TP1 confirmed the hematology reagent cube on the hematology analyzer had no identification of it's name, contents, lot#, open date, and expiration date. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --