Saco River Medical Group Pc

Summary Statement of Deficiencies 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 Consultant (TC) failed to perform competency assessments annually for 5 of 14 Hematology testing personnel in 2021. Findings include: 1. Review of personnel records revealed annual competency assessments for 5 of 14 testing personnel performing complete blood counts (CBC) did not include an evaluation of test performance in 2021. 2. Interview on 6/2/2022 at 10:45 a.m. with the 2 TCs revealed participation in proficiency testing was used to evaluate test performance and confirmed 5 of 14 testing personnel did not participate in proficiency testing in 2021. The TCs further revealed there was no other method in place to evaluate test performance. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on record review and staff interview, the Technical Consultant (TC) failed to perform competency assessments semiannually for 1 of 1 new Hematology testing personnel in 2021 and 2022. Findings include: 1. Review of personnel records 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 -- revealed 1 (TP1) new testing personnel performing complete blood counts (CBC) beginning March 2021. Further review of TP1's personnel record revealed a competency assessment was performed in January 2022. There was no documentation of another semiannual competency assessment between March 2021 and March 2022. 2. Interview on 6/2/2022 at 10:45 a.m. with the TCs confirmed there was only 1 semiannual competency assessment for TP1 conducted in the first year of CBC testing. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Survey report revised on 11/13/20. D6020 revised to reflect the correct referenced tag in findings, changed to D5781 (from D5481). D6022 removed; Deficient practices cited under D6022 also cited under D6020, D6021 and D6026. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)