Upper Connecticut Valley Hospital

Summary Statement of Deficiencies D6088 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4) (e)(4) Ensure that the laboratory is enrolled in an HHS-approved proficiency testing program for the testing performed and that-- This STANDARD is not met as evidenced by: Based on record review and staff interview, the Laboratory Director (LD) failed to ensure the laboratory (lab) was enrolled in proficiency testing (PT) in event 1 of 2025 for immunohematology regulated analytes. Findings include: 1. Review on 8/12/2025 of CASPER report 0155D revealed no scores in Event 1 of 2025 for ABO and D (RHO) blood typing, antibody detection, and compatibility testing. 2. Review on 8/12 /2025 of the lab's PT orders for 2025 revealed the PT order for ABO and D (RHO) blood typing, antibody detection, and compatibility testing was completed 5/28/2025. 3. Interview on 8/12/2025 at 11:15 a.m. with the Lab Director and Technical Supervisor confirmed the lab did not enroll in PT Event 1 2025 for ABO and D (RHO) blood typing, antibody detection, and compatibility testing. 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 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(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. This STANDARD is not met as evidenced by: Based on observation, record review, and staff interview, the laboratory (lab) failed to follow their procedure for performing microscopic examinations of urine sediment in 2023. Findings include: 1. Observation on 9/20/2023 at 1:30 p.m. of the centrifuge used to spin urine specimens for microscopic examination of urine sediment revealed the centrifuge was set to spin at 3,300 revolutions per minute (rpm). 2. Review on 9/20 /2023 of the lab's procedure titled "Urinalysis, Routine and Microscopic" effective 11 /10/2021 revealed instruction on page 3 to centrifuge urine specimens at 1,500 rpm with a note stating "At greater speeds, or after prolonged centrifuging, microscopic structure tends to disintegrate." 3. Interview on 9/20/2023 at 1:30 p.m. with Testing Personnel confirmed the centrifuge was set to 3,300 rpm and the procedure states to spin at 1,500 rpm. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a 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 -- minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory (lab) failed to perform calibration verification for Lithium in 2023 and calibration verification procedures completed in April 2023 for Chloride failed to cover the reportable range. Findings include: 1. Review on 9/20/2023 of calibration verifications from 2023 revealed 2 of the 5 standards used for CL calibration verication, performed in April 2023, failed to meet acceptable criteria resulting in a verified range of 115.2 to 306.1 mmol/L. There was no documenation of calibration verification procedures for Lithium in 2023. 2. Review on 9/20/2023 of the lab's reportable range for CL revealed the range in use is 15 to 400 mmol/L. 3. Interview on 9/20/2023 at 4:15 p.m. with the Lab Director and Technical Supervisor confirmed the above findings. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and staff interivew, the laboratory (lab) failed to document control procedures performed to establish acceptable ranges for routine chemistry and toxicology tests in 2022 and 2023. Findings include: 1. Review on 9/21/2023 of the package inserts for brain natriuretic peptide (BNP) and high density lipoprotein cholesterol (HDL) control material revealed ranges for assayed BNP control material and the target values for unassayed HDL control material: BNP Level 1 = 77.9 - 115 pg/mL BNP Level 3 = 1,391 - 1,857 pg/mL HDL Level 1, target value = 37.5 mg/dL HDL Level 3, target value = 92.5 mg/dL 2. Review on 9/21/2023 of the control -- 2 of 3 -- acceptability ranges for brain natriuretic peptide (BNP) and high density lipoprotein cholesterol (HDL) revealed the following acceptable ranges: BNP Level 1 = 79 - 115 pg/mL BNP Level 3 = 1,390 - 1,858 pg/mL HDL Level 1 = 24.10 - 32.10 mg/dL HDL Level 3 = 66.72 - 78.08 mg/dL 3. Review on 9/21/2023 of the lab's procedure titled "Quality Control Lot Number Change" effective 9/1/2009 revealed instruction for using and implementing assayed and unassayed controls. Instruction included how to establish ranges for unassayed control materials. 4. The lab could not provide documentation of the studies used to establish ranges in use for BNP and HDL at the time of survey. 5. Interview on 9/21/2023 on 8:30 a.m. with the Lab Director and Technical Supervisor confirmed the above findings. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on record review and staff interview, the Technical Supervisors (TS) failed to perform annual competency assessments for 4 of 4 Testing Personnel (TP) in 2021, 2022 and 2023. Findings include: 1. Review on 9/20/2023 of personnel records revealed 4 TP performing high complexity testing for more than 2 years. Review of competency assessments revealed 1 of 4 TP did not receive competency assessments in 2021, 2022 or 2023; and the remaining 3 of 4 TP did not have competency assessments in 2022 and 2023. 2. Interview on 9/20/2023 at 10:15 a.m. with 2 of 2 TS confirmed the above finding. -- 3 of 3 --

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory's hematology control procedure for fibrin degradation products, collectively known as D-Dimer, failed to include instruction to perform two levels of control testing every 8 hours for the laboratory's nonmanual coagulation test system in 2019, 2020, and 2021. Findings include: 1) Review on 8/10/2021 of "Internal and External QC/QI Program" procedure, last revised July 2019, revealed instruction to perform two levels of D- Dimer controls every 24 hours of testing. The laboratory did not develop an individualized quality control plan (IQCP) to support the alternative control procedures. 2) Interview on 8/10/2021 at 10:25 a.m. with the Staff A (testing personnel) confirmed the laboratory did not develop an IQCP to support the frequency of D-Dimer control testing outlined in the procedure. 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 --

Summary Statement of Deficiencies D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory's blood gas analyzer failed to document automatic quality control (AQC)results in June and July 2019. Findings include: 1) Review on 7/26/2019 of ABL 80 Flex Co-Ox (ABL 80) analyzer quality control logs from May, June and July 2019 revealed AQC was run and results documented every 8 hours in May through June 20, 2019. Documentation of AQC results on June 21, 2019 included results at 5:00 a.m. and 1:00 p.m. but no results at 9: 00 p.m. There were no AQC results documented from the June 21, 2019 at 9:00 p.m. through July 26, 2019. 2) Observation on 7/26/2019 at 9:40 a.m. of the ABL 80 analyzer revealed the analyzer was in "green" status, indicating the analyzer was in good working order. 3) Interview on 7/26/2019 at 9:40 a.m. with the General Supervisor confirmed the above findings. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on record review and staff interview, the Technical Supervisor failed to ensure Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- competency assessments included assessment of test performance for 7 of 7 testing personnel performing microbiology, diagnostic immunology, chemistry, hematology, and immunohematology testing in 2018. Findings include: 1) Review on 7/25/2019 of competency assessments for 7 testing personnel in 2018 revealed no documentation of an assessment of test performance. 2) Interview with the General Supervisor on 7/25 /2019 at 12:00 p.m. confirmed the above findings and revealed the 7 testing personnel perform some testing within all specialties of testing; microbiology, diagnostic immunology, chemistry, hematology, and immunohematology specialties. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on record review and staff interview, the Laboratory Director failed to ensure that 1 of 4 new testing personnel met educational qualification requirements prior to testing patient results. Findings include: 1) Review on 7/25/2019 of personnel records revealed 1 of 4 new personnel (Staff A) had a bachelor's degree from Jamaica. Staff A's personnel record did not include an assessment of equivalency for the foreign education. 2) Interview on 7/26/2019 at 1:00 p.m. with the General Supervisor revealed the laboratory did not obtain an assessment of equivalency for Staff A's foreign education. 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 1 of 4 new testing personnel met qualifications requirements prior to performing high complexity testing. Refer to tag 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 -- 2 of 4 -- 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 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 provide documentation that 1 of 4 Testing Personnel met educational qualification requirements for performing high complexity testing. Findings include: 1) Review on 7/25/2019 of CMS-209 Personnel Form revealed 4 new testing personnel. 2) Review on 7/25/2019 of personnel records revealed 1 of 4 new testing personnel (Staff A) earned a Bachelor's degree from Jamaica. Staff A's personnel record failed to include an assessment of equivelancy for the foreign education. 3) Interview on 7/26/2019 at -- 3 of 4 -- 1:00 p.m. with the General Supervisor confirmed the laboratory did not obtain equivelancy assessment for Staff A's foreign education. -- 4 of 4 --