Connecticut Addiction Medicine

Summary Statement of Deficiencies D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) (2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1). This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to evaluate the accuracy of the liquid chromatography tandem mass spectrometry (LC/MS/MS) test system twice annually in the subspecialty of toxicology. Findings include: 1. Record review on 1/29/2026 of the laboratory's proficiency testing (PT) records for 2024 and 2025 revealed the following: a. Alternate PT assessments for Methylone, Ketamine, and Norketamine analytes were completed on 2/22/2024. b. Lack of documentation of biannual accuracy assessment for the analytes listed 1(a) above in 2024 and 2025. 2. Record review on 1/29/2026 of the laboratory's 'Proficiency' standard operating procedure revealed 'Alternate PT testing - If there is no PT program available for any analyte, the supervisor will prepare specimens to be tested by the testing personnel' . 3. Staff interview on 1/29/2026 at 12:55 PM with the laboratory's technical supervisor confirmed the above findings. 4. The laboratory performs 261,532 tests annually in the subspeciality of toxicology. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. 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 -- This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to follow their established policies and procedure and document monthly quality assessments (QA) reviews in the subspecialty of toxicology. Findings include: 1. Record review on 01/29 /2026 of the laboratory's monthly QA review forms revealed lack of documentation of QA reviews for the following months and year. a. August, September, October, November and December of 2024. b. February, March, April, May, July, August, September and October of 2025. 2. Record review on 01/29/2026 of the laboratory's QA policies and procedure revealed 'Monthly, the laboratory will review pre- analytical, analytical and post-analytical processes in the lab to assess overall quality, efficiency, effectiveness of policies and procedures, accuracy and timeliness of test results, competency of employees and problem identification and correction'. 3. Staff interview on 01/29/2026 at 1:15 PM with the laboratory's technical supervisor confirmed the above findings. 4. The laboratory performs 261,532 tests annually in the subspecialty of toxicology. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to have a policy in place to assess the competency of the laboratory general supervisor(GS). Findings include: 1. Review of the laboratory's personnel competency records on 9/29/22 revealed the following: a. The laboratory did not have policy in place to assess the competency of the GS. b. Lack of competency assessment documentation for the GS. 2. Staff interview with the technical supervisor on 9/29/22 at 10:10 AM confirmed the laboratory did not have a policy in place to assess the competency of the GS and they were not assessed. 3. The laboratory performs 689,378 tests in the sub-specialty of toxicology. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to assess the accuracy of its test system twice annually for the non-regulated analytes in the subspecialty of toxicology. Findings include: 1. Record review on 09/29/2022 of the "Alternative Proficiency Testing Results Review Form" for the year of 2021 revealed Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- only one event of alternative proficiency testing for methylone, ketamine and norketamine analytes was performed. 2. Staff interview on 09/29/2022 at 1:45 PM with the technical supervisor (TS) confirmed the above findings. The TS further commented that he/she was aware that the laboratory failed to conduct alternate proficiency testing twice a year on the analytes listed above. 3. The laboratory performs 689,378 tests annually in the subspecialty of toxicology. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor observation, record review and staff interview, the laboratory failed to discontinue the use of expired standards to conduct preventative maintenance prior to patient testing in the subspecialty of toxicology. Findings include: 1. Surveyor observation on 09/29/2022 at 11:44 AM of the laboratory refrigerator revealed the current standards in use are as follows: a. PPG positive standard with a lot number of M006024 and an expiration date of 07/23/2021. b. PPG negative standard with a lot number of M008075 and an expiration date of 07/22/2021. 2. Record review on 09/29 /2022 of the '4000-QTRAP MS/MS Detector Preventative Maintenance & Calibration Form' revealed the following: a. Use of expired PPG positive standard with a lot number of M006024 and an expiration date of 07/23/2021. b. Use of expired PPG negative standard with a lot number of M008075 and an expiration date of 07/22 /2021. c. PM start date of 12/29/2021 and a finish date of 12/30/2021. d. PM acceptance sign-off that was reviewed and approved by the technical supervisor. 3. Staff interview on 09/29/2022 at 12:19 PM with the technical supervisor (TS) and a telephone interview with the service engineer from 'mSPEC group' confirmed the above findings. The TS further commented that he/she was unaware that the PPG positive and negative standards had expired. 4. The laboratory performs 689,378 tests annually in the subspecialty of toxicology. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on surveyor observation and staff interview, the laboratory failed to perform function checks to ensure the accuracy of the device used for measuring precise volumes of liquids prior to patient testing in the subspecialty of toxicology. Findings include: 1. Surveyor observation on 09/29/2022 at 10:33 AM of the laboratory pre- analytical work bench area revealed the use of the following pipettes: a. 20 l volume -- 2 of 3 -- pipette with a calibration expiration date of 11/2021. b. 20 - 200 l volume pipette with a calibration expiration date of 11/2021. c. Repeater pipette with a calibration expiration date of 12/2021. 2. Staff interview on 09/29/2022 at 10:40 AM with the technical supervisor (TS) confirmed the above findings. The TS further commented that the pipette calibration should be done every 6 months. 3. The laboratory performs 689,378 tests annually in the subspecialty of toxicology. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on record review and staff interview, the laboratory failed to ensure high complexity testing personnel performing liquid chromatography mass spectrometer (LCMS) testing in the subspecialty of toxicology had the appropriate education and experience (Refer to D6171). D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to ensure that one of three testing personnel performing high complexity liquid chromatography mass spectrometer (LCMS) testing was qualified and had a bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology as required for performing and reporting confirmation toxicology results. Findings include: 1. Record review of personnel records on 8/18/2021 revealed testing personnel #1 (TP#1) was hired 7/8/2019 and did not meet the qualifications for high complexity testing personnel based on the following: a. TP#1 college transcript: Central Connecticut State University graduated 8/26/2018: Bachelor of Arts with a major in psychological science. b. TP#1 documented coursework did not have the required 24 semester hours of science courses. c. TP#1 did not have three months of laboratory training prior to reporting test results. 2. Staff interview with the laboratory technical supervisor (TS) on 8/18/2021 at 10:50 AM confirmed: a. TP#1 was hired 7/8/2019. b. -- 2 of 3 -- TP#1 attained a bachelor degree that did not include the necessary science courses to perform high complexity testing. c. TP#1 processed (integrated) quantitative test results received from the LCMS instruments including proficiency test results and TS randomly reviewed TP#1 work for accuracy. d. TS further stated TP#1 credentials were reviewed and approved by a prior supervisor. 3. The laboratory performs 631, 627 tests annually utilizing LCMS for the following analytes: Amphetamine, Methamphetamine, Buprenorphine, Norbuprenorphine, Fentanyl, Norfentanyl, 7- Aminoclonazepam, Nordiazepine, Oxazepam, Temazepam, Lorazepam, a- Hydroxyalprazolam, Cocaine Metabolite, Gabapentin, Ketamine, Norketamine, 6- MAM, MDMA, Methodone, EDDP, Methylone, Codeine, Hydrocodone, Hydromorphone, Morphine, Oxycodone, Oxymorphone, THC and Tramadol.. -- 3 of 3 --