Valley Medical Group

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Valley Medical Group laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. Please refer to Conditions of Participation for Clinical Laboratories 42 CFR Part 493. 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 and record review, the laboratory failed to ensure laboratory reagents were not used when they had exceeded their expiration date as evidenced by the following: a) During a tour of the laboratory on 6/25/24 at 2:37 PM, the surveyor observed the following expired item in the laboratory area where Physician Performed Microscopy Procedures (PPMP) are performed: * One (1) bottle of Potassium Hydroxide (KOH), lot number 6124, expiration date 1/27/24. b) There were no other in-date reagents available in the laboratory. Based on this evidence the accuracy and reliability of microscopic examinations, utilizing this reagent, could not be assured. Three (3) patient samples for KOH had been tested since the reagent expired (1/29/24, 5/1/24, and 6/20/24). c) The laboratory performs approximately 82 KOH preparations annually. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems 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 -- identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and interviews it was determined that the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess, and correct problems in the postanalytic phases of testing as evidenced by the following: a) A review of post anaytical quality assessment procedures for calendar years 2023 and 2024 revealed that the laboratory routinely reviewed five (5) paient reports for all aspects of the testing process. b) A review of the procedure manual revealed no post analytic policies and procedures to be followed. D6040 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(2) The technical consultant is responsible for-- (b)(2) Verification of the test procedures performed and the establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based on record review and interview, the technical consultant failed to fulfill the responsibility for verification of the laboratory's test performance characteristics as evidenced by the following: a) Documentation was not available to verify that the technical consultant reviewed and approved validation studies of the C Reactive Protein (CRP) analyte for accuracy, linearity (reportable range), as well as day to day and within run precision prior to implementing the analyzer for patient testing and reporting. b) General Supervisor #2 confirmed in an interview on 6/25/24 at 4:40 PM that the designated technical consultant had not documented an approval for the CRP procedure. c) The laboratory performs approximately 2,799 CRP tests annually. . -- 2 of 2 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Valley Medical Group laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to indicate on the patient final test report the correct name of the laboratory address where testing was performed as evidenced by the following: a) A review was performed of forty (40) final patient test reports issued between 5/5/21 and 4/4/22. The review revealed the fact that the address of the laboratory in the Athena electronic medical record (EMR) indicated the previous address of 329 Conway St., Greenfield, MA 01301 for all forty final reports reviewed. a) The Technical Supervisor confirmed in an interview on 4/6 /22 at 4:00 P.M. that the patient final test reports did not indicate the correct name of the laboratory where the testing was performed. The laboratory issues reports based on 672,722 tests performed annually. . 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 --