Medhelp Pelham

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on reviews of the Abbott Cell-Dyn Hematology maintenance records, the Abbott Cell-Dyn Emerald Quick Reference Guide, and an interview with the Technical Consultant (TC), the laboratory failed to document the semi-annual maintenance, as per manufacturer's instructions. This was noted for four of four semi- annual maintenances from 2024-2025. The findings include: 1. A review of the Hematology maintenance records revealed the 2024-2025 Abbott Cell-Dyn Emerald maintenance logs had no documentation of the semi-annual maintenance. 2. A further review of the Cell-Dyn Emerald Quick Reference Guide revealed on page 80, Semi- annual Maintenance - Lubricating the Pistons, "For optimal operation, ...be lubricated every six months ...". 3. The TC confirmed the above findings during the exit conference on 02-03-2026 at 1:07 PM. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system 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 -- performance and environmental conditions, and variance in operator performance. This STANDARD is not met as evidenced by: Based on a review of the Hematology Abbott Cell-Dyn Emerald Quality Control (QC) records and an interview with the Technical Consultant (TC), the laboratory failed to provide documentation to monitor for shifts and trends of test performance over time. The surveyor noted one of the four months reviewed from 2024-2025 was missing at the time of the survey. The findings include: 1. A review of the Abbott Cell-Dyn Emerald QC records revealed only the daily QC data from the instrument were retained in December 2024. No evidence of Levey-Jennings (LJ) charts or peer group data was available for review at the time of the survey. 2. The TC confirmed the above findings during the exit conference on 02-03-2026 at 1:07 PM. -- 2 of 2 --

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 a review of the Quidel Triage Meter (Cardiac Panel and D-Dimer) Quality Control (QC) documentation, the IQCP (Individualized Quality Control Plan) for the Biosite Triage Meter, patient test logs, and an interview with Testing Personnel #1, the laboratory failed to ensure two levels of quality control (QC) were within two standard deviations (2 SD) and documented monthly, as per the IQCP. This was noted for seven out of twenty-seven months reviewed by the surveyor. The findings include: 1. A review of the Quidel Triage Meter QC documentation revealed: a) On 05/19 /2020 Level 2 D-Dimer control was greater than 2 SD. The next acceptable QC run was 06/17/2020. b) On 06/17/2020 Level 2 Troponin (Cardiac Panel) was greater than 2 SD. The next acceptable QC run was 06/24/2020. c) On 07/17/2020 Level 1 Myoglobin (Cardiac Panel) was greater than 2 SD. The next acceptable QC run was 07 /27/2020 d) On 9/15/2020 and 10/14/2020 Level 1 Myoglobin (Cardiac Panel) was greater than 2 SD. The next acceptable QC run was 11/02/2020. e) On 12/03/2020 Cardiac Panel QC was performed, however the next run was not until 02/15/2021. This exceeded the monthly requirement for QC per the IQCP. f) On 05/04/2021 Creatine Kinase - MB and Troponin (Cardiac Panel) were greater than 2 SD. The next acceptable QC run was 05/11/2021. 2. A review of the IQCP for the Biosite Triage 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 -- Meter revealed, under External Control "Two levels of control must be ran and in range in order to test patients. Results must be compared to the QC range chart.... you should compare results to the 2 SD column. If it falls out of range, QC must be repeated." 3. A review of patient test logs revealed the following: a) for D-Dimer from 05/19/2020 to 06/17/2020 16 patient tests were performed. b) for Cardiac Panel from 06/17/2020 to 06/24/2020 3 patient tests were performed. c) for Cardiac Panel from 07 /17/2020 to 07/27/2020 1 patient test was performed. d) for Cardiac Panel from 09/15 /2020 to 11/02/2020 17 patient tests were performed. e) for Cardiac Panel from 01/03 /2021 to 02/15/2021 18 patient tests were performed. f) for Cardiac Panel from 05/04 /2021 to 05/11/2021 2 patient tests were performed. 4. During an interview on May 12, 2022 at 12:50 PM, Testing Personnel #1 confirmed the above findings. 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 a review of the Quality Control (QC) documentation for the Horiba Micros 60 Hematology analyzer and an interview with Testing Personnel #1, the laboratory failed to ensure at least two levels of QC were acceptable on April 1, 2020, prior to testing patient specimens and reporting the results. The laboratory tested three patient CBC (Complete Blood Count) specimens on this day when two out of three levels of QC were found unacceptable. This was noted for one day out fifteen months reviewed by the surveyor. The findings include: 1. A review of the Horiba Micros 60 QC for April 1, 2020 revealed the normal and high level QC were outside of the acceptable ranges. 2. During an interview on May 12, 2022 at 1:15 PM, Testing Personnel #1 confirmed two out of three levels of QC were unacceptable on April 1, 2020, and three patient CBCs were performed that day. D5781