Valley Medical Group

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review conducted on 08/27/2026 of 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 -- Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report and American Proficiency Institute (API) 2026 records, the laboratory did not successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of Routine Chemistry for the analytes Cholesterol, HDL, Magnesium (MG), and Total Iron Binding Capacity (TIBC). Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review conducted on 08/27/2026 of CASPER 0155 report and American Proficiency Institute (API) 2026 testing records (events 1 and 2) the laboratory failed to achieve satisfactory performance (80% or better) for the same analytes for three consecutive testing events in the specialty of Routine Chemistry for the analytes Cholesterol, HDL, Magnesium (MG), and Total Iron Binding Capacity (TIBC). Findings include: 1. Review of the CASPER 0155 report revealed the following results: Routine Chemistry 2026 -1st Event the laboratory received an unsatisfactory score of 20% for Cholesterol, HDL. Routine Chemistry 2026- -1st Event laboratory received an unsatisfactory score of 40% for Magnesium (MG). Routine Chemistry 2026 -1st Event laboratory received an unsatisfactory score of 60% for Total Iron Binding Capacity (TIBC). Routine Chemistry 2026 -2nd Event the laboratory received an unsatisfactory score of 60% for Cholesterol, HDL Routine Chemistry 2026-2nd Event the laboratory received an unsatisfactory score of 40% for MG. Routine Chemistry 2026-2nd Event the laboratory received an unsatisfactory score of 40% for TIBC. 2. A review of the API Testing records confirmed the laboratory received the above results. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review conducted on 08/27/2026 of CASPER 0155 report and American Proficiency Institute 2026 records, the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure proficiency testing samples were tested as required. Refer to D6089 D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this -- 2 of 3 -- part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review conducted on 08/27/2026 of CASPER 0155 report and American Proficiency Institute 2026 records, the laboratory director failed to ensure proficiency testing samples were tested as required. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2096. -- 3 of 3 --

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 --