Urgent Care At Bedford Medical Park Laboratory

Summary Statement of Deficiencies 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: Based on record review and staff interview, the laboratory (lab) failed to follow Chemistry control procedures and failed to implement a quality assurance system that can identify and correct problems with Chemistry control testing in 2021, 2022, and 2023. Findings include: 1. The lab failed to follow it's procedure to perform i-STAT Chem8+ cartridge control testing for each new lot/shipment and monthly. Refer to D5445. 2. The lab's policies and procedures for monitoring i-STAT Chem8+ cartridge control testing failed to identify and correct problems associated with the lab's failure to perform control testing on each new lot/shipment and monthly. Refer to D5791. 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 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 -- laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory (lab) failed to perform control procedures for new lot/shipments of chemistry test cartridges before testing patient samples in 2021, 2022 and 2023. This is a repeat deficiency from the recertification survey completed 5/5/2021. Findings include: 1) Review on 4/6/2023 of the lab's procedure "i-STAT1 System - Chem8+ Cartridge" revealed instructions to perform quality control (QC) testing for each new lot or shipment of i-STAT Chem 8+ (Chem 8+) test cartridges, and monthly thereafter. Chem8+ test cartridges include the following measured analytes: chloride, potassium, sodium, blood urea nitrogen, ionized calcium, glucose, creatinine, and carbon dioxide. 2) Review on 4/6/2023 of control records from 5/5/2021 to 4/6/2023 revealed 10 new lots (H21125, H21290, H21323, H21328, H22114, H22138, H22176, H22263, H22311, and H23010) Chem 8+ test cartridges received during this period had been tested with QC monthly; with exception to July 2022, no QC was documented for July 2022. Further review of the QC records revealed no documentation of when the Chem8+ test cartridge lot numbers were changed and QC documented prior to patient testing. 3) Review on 4/6 /2023 of patient testing from September 2022 to April 2023 revealed 4 lot numbers (H22176, H22263, H22311, and H23010) of Chem8+ test cartridges had been used for patient testing. Further review revealed patient testing had occurred before QC testing was performed for all 4 of 4 Chem8+ lot numbers in use during this period; 11 patients had been tested before QC using Chem8+ lot H22176, 5 patients had been tested before QC using Chem8+ lot H22263, 10 patients had been tested before QC using Chem8+ lot H22311, and 14 patients had been tested before QC using Chem8+ lot H23010. 4) Interview on 4/6/2023 at 11:15 a.m. with a Technical Consultant (TC) confirmed the above findings. The TC revealed it had been the two TCs' responsibility to perform QC for each new lot/shipment until the lab changed the delivery address directly to the physical location of the lab, at which point the TCs did not know when a new delivery was made and the personnel at the lab were not notified to perform QC before putting each lot and shipment into use. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on record review, the laboratory's (lab) policies and procedures to monitor and correct problems with quality control (QC) testing failed to identify issues with chemistry QC testing in 2021, 2022, and 2023. Findings include: 1. Review on 4/6 /2023 of the lab's policy titled "i-STAT1 System - Chem8+ Cartridge" and the laboratory's

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 failed to perform quality control testing for routine chemistry following the laboratory's established control procedures in February, April, and May of 2021. Findings include: 1) Review on 5/5 /2021 of the Quality Control Plan in the laboratory's individualized quality control plan (IQCP) for the i-STAT Chem8+ Cartridge revealed on pages 8 and 9 instruction for liquid control materials to be performed for each new test cartridge lot number prior to patient testing and performed every 30 days for the test cartridge lot number in use. 2) Review on 5/5/2021 of Chem8+ Cartridge control testing from 5/1/2020 through 5/5/2021 revealed no control testing (before use or after 30 days of use) had been performed for the current lot number in use (H21026); and, the previous test cartridge lot (H20320) had been tested using control materials on 1/21/2021 and again 48 days later on 3/10/2021. 3) Review on 5/5/2021 of patient test records from April and May 2021 revealed the current lot number (H21026) of Chem8+ test cartridges had been put into use on 4/1/2021 and 296 tests (sodium, potassium, chloride, total carbon dioxide, glucose, blood urea nitrogen, creatinine, and ionized calcium) had been performed by the laboratory using this lot of Chem8+ Cartridges. 4) The laboratory performs an annual volume of 2,600 tests (sodium, potassium, chloride, 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 -- total carbon dioxide, glucose, blood urea nitrogen, creatinine, and ionized calcium) using the Chem8+ Cartridge. 5) Interview on 5/5/2021 at 10:30 a.m. with testing personnel confirmed the above findings. D6022 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory director (LD) failed to ensure quality control and quality assessment procedures outlined in the individualized quality control plan (IQCP) for the i-STAT Chem8+ Cartridge were maintained to identify failures in quality for routine chemistry testing in 2020 and 2021. Findings include: 1) The laboratory failed to perform quality control testing for the i-STAT Chem8+ Cartridge following the laboratory's established quality control plan outlined in the laboratory's IQCP. Refer to tag D5445. 2) Review on 5/5/2021 of the laboratory's Chem8+ Cartridge IQCP signed by the LD on 3/4/2020 revealed on page 9, under Quality Assurance, instruction that quality control (QC) records will be reviewed monthly. 3) There was no documentation that any of the QC records for Chem8+ Cartridge testing from May 2020 through May 5, 2021 had been reviewed monthly. 4) Interview on 5/5/2021 at 10:30 a.m. with testing personnel confirmed the above findings and revealed the QC records for Chem8+ cartridge testing had not been reviewed since beginning patient testing in May 2020 through May 5, 2021. -- 2 of 2 --