Pioneer Valley Urology, Pc

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on College of American Pathologists (CAP) proficiency testing (PT) record review and staff interview with Microbiology General Supervisor #1 (MGS1) and the Laboratory Director (LD), the laboratory failed to test PT samples in the same manner as patient samples. Findings include: 1. Record review on 1/8/2026 of the laboratory's 2024, 2025 and 2026 to date CAP Clinical Microscopy (CMP) PT records revealed: A. 2024 Event A, CM-A a. The attestation sheet shows 8 Testing Personnel (TP)'s signatures attesting to the performance of the urine sediment photo portion of the survey in the same manner as patient samples. b. The attestation sheet was signed by the LD attesting to the performance of the urine sediment photo portion of the survey in the same manner as patient samples. c. 6 answer sheets with the initials of 6 different TP. 0 of 6 of these answer sheets had the correct answer for all 3 CM-A photographs. d. A post-it note with the LD's initials on it with answers to the urine sediment photo portion of the survey. e. The results submitted to CAP were the LD's results who is not a routine TP for the microscopic examination of urine sediment. B. 2024 Event B, CM-B a. The attestation sheet shows 3 illegible signatures attesting to the performance of the urine sediment photo portion of the survey in the same manner as patient samples. b. The attestation sheet was signed by the LD attesting to the performance of the urine sediment photo portion of the survey in the same manner as patient samples. c. A post-it note with the LD's initials on it with answers to the urine sediment photo portion of the survey. d. The results submitted to CAP were the LD's results who is not a routine TP for the microscopic examination of urine sediment. C. 2025 Event A, CM-A a. The attestation sheet shows 4 TP's signatures attesting to 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 4 -- performance of the urine sediment photo portion of the survey in the same manner as patient samples. b. The attestation sheet was signed by the LD attesting to the performance of the urine sediment photo portion of the survey in the same manner as patient samples. c. An answer sheet with the initials of 3 TP all with the same date of 2 /11/2025 that was before the due date of 3/4/2025. d. 4 answer sheets with the initials of 4 other TP. 2. During staff interview on 1/8/2026 at 11:45 AM, MGS1 and the LD confirmed the above findings. 3. The laboratory performs 17 microscopic urine sediment examinations annually. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and confirmed through an interview with Microbiology General Supervisor #1 (MGS1) and the Laboratory Director (LD), the laboratory did not have an ongoing mechanism to evaluate the GS based on their CLIA responsibilities. Findings Include: 1. Record review on 1/8/2026 of the laboratory's 2024, 2025, and 2026 to date personnel competency records revealed the laboratory did not have documented competency evaluation for MGS1 and MGS2 based on their CLIA responsibilities. 2. Record review on 1/8/2026 of the laboratory's, 'Competency' procedure revealed the procedure did not contain any information about GS competency based on their CLIA responsibilities. 3. During staff interview on 1/8 /2026 at 1:30 PM with MGS1 and the LD, MGS1 and the LD confirmed the laboratory does not have a procedure in place to document competency assessment of the GS based on their CLIA responsibilities and they were not assessed. 4. The laboratory performs 560 tests annually in the specialty of Microbiology. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on College of American Pathologists (CAP) proficiency testing (PT) record review and staff interview with Microbiology General Supervisor #1 (MGS1) and the Laboratory Director (LD), the laboratory failed to verify at least twice annually the accuracy of the microscopic examination of urine sediment in the subspecialty of Urinalysis. Findings include: 1. Record review on 1/8/2026 of the laboratory's 2024, 2025 and 2026 to date CAP Clinical Microscopy (CMP) PT records revealed: a. The laboratory did not have PT results for 2025 Event 2. b. Code 33 (Specimen unsatisfactory) was entered in the test result column. 2. During staff interview with MGS1 on 1/8/2026 at 11:34 AM: a. The LD and MGS1 Confirmed the above findings. b. MGS1 Stated, "We had to temporarily move the lab and we did not receive the shipment. When we called for replacement specimens, we were told that we should put in code 33 and we would get a mulligan. We were unable to get replacement specimens." c. MGS1 also Stated, "We did not use an alternate method to -- 2 of 4 -- verify the accuracy of the microscopic examination of urine sediment." 3. During a telephone call on 1/8/2026 at 11:45 AM with CAP customer service representative #1 (CSR1), CSR1 stated: a. "The call was given a case number 02582360." b. "We were unable to provide replacement specimens, so we told the lab to enter code 33 unsatisfactory specimen." c. "We advised the caller to use an alternate method to verify the accuracy of the test." 4. The laboratory performs 17 microscopic urine sediment examinations annually. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on record review and interview with Microbiology General Supervisor #1 (MGS1) and the Laboratory Director (LD), the laboratory failed to have a written procedure for the microscopic examination of urine sediment. Findings Include: 1. Record review on 1/8/2026 of the laboratory's procedure manual revealed the procedure manual did not include a procedure for the microscopic examination of urine sediment. 2. Staff interview on 1/8/2026 at 11:00 AM with MGS1 and the LD confirmed the above findings. 3. The laboratory performs 17 microscopic urine sediment examinations annually. 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 surveyor observation and staff interview with Microbiology General Supervisor #1 (MGS1) and the Laboratory Director (LD), the laboratory failed to ensure instrument maintenance and function checks were performed on the fume hood. Findings include: 1 Surveyor observation on 1/8/2026 at 1:00 PM of a sticker attached to the fume hood located in the laboratory revealed: a. The last time the hood was checked for proper function was March 2022. b. The due date for the next function check was listed as March 2023. 2. Staff interview with MGS1 and the LD on 1/8/2026 at 1:10 PM confirmed the above findings. GS1 stated, "I am having a hard time getting someone in to do the function check, but I did vapor monitoring." 3. The laboratory performs 10,209 tests annually in the Specialty of Pathology. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: -- 3 of 4 -- Based on record review and staff interview with Microbiology General Supervisor #1 (MGS1) and the Laboratory Director (LD) who is also the Technical Consultant (TC), the TC failed to evaluate Testing Personnel (TP) performance annually to confirm TP ability to perform microscopic analysis of urine sediment in the subspecialty of Urinalysis. Findings include: 1. Record review on 1/8/2026 of the laboratory's CMS form 209 revealed 11 TP listed as performing microscopic analysis of urine sediment. 2. Record review on 1/8/2026 of the laboratory's 2024, 2025 and 2026 to date TP competency records revealed 11 of 11 TP who perform microscopic analysis of urine sediment did not have documented competency assessment. 3. Record review on 1/8 /2026 of the laboratory's College of American Pathologists (CAP) Clinical Microscopy (CMP) 2024 event A proficiency testing (PT) records revealed: a. 6 answer sheets with the initials of 6 different TP. 0 of 6 of these answer sheets had the correct answer for all 3 CM-A photographs. b. The answer sheets were not graded. c. Continuing education was not documented for the incorrect answers. 4. Staff interview on 1/8/2026 at 10:30 AM with MGS1 and the TC confirmed the above findings. 5. The laboratory performs 17 microscopic urine sediment examinations annually. -- 4 of 4 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Pioneer Valley Urology, PC 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. . D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on proficiency testing review and interview, the laboratory failed to maintain a copy of all proficiency testing records as evidenced by the following: a) A review of proficiency testing records for calendar years 2022 and 2023 (6 testing events) revealed the fact that a copy of the attestation statement provided by the PT program, signed by the analyst and the laboratory director were not available for the College of American Pathologist (CAP) reports for the clinical microscopy (CM series sent two times per year) and semen analysis (SM series sent two times per year)reports for the first and second testing event of 2022 and 2023. b) The clinical manager confirmed in 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 -- an interview on 11/17/23 at 12:10 PM that the attestation forms for the CAP proficiency were not being printed out and signed by the laboratory director and the personnel performing the testing. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on record review and confirmed through an interview with one laboratory histotechnician, the laboratory failed to have a record system which included the identity of the personnel who performed the test(s) as evidenced by the following: a) A review of 20 patient charts for laboratory testing performed between 1/3/23 and 11 /13/23 revealed the fact that the identity of the person performing the testing was not available for 2 out of the 20 charts reviewed for tissue grossing performed on 1/20/23 (medical record number 213118 - prostate needle biopsy) and 8/24/23 medical record number 90498 - bladder biopsy). b) Histotechnician number one confirmed in an interview on 11/17/23 at 12:22 PM that they were not documenting the identification of who performed the tissue grossing on the request forms as they previously had. The laboratory performs approximately 2,042 histology tissue grossing annually. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Pioneer Valley Urology, P.C. laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . 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 D0000 A CLIA recertification survey was conducted for the Pioneer Valley Urology, PC laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . 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 identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to assess postanalytic systems quality assessment activities as evidenced by the following: a) A review of the laboratory's procedure manual showed that the lab had no policies and procedures for monitoring post analytic systems. As a result, there was no ongoing assessment of these problems to identify trends or patterns that needed to be addressed and corrected. b) The general supervisor confirmed in an interview on 8/28/19 at 11:15 PM that there was no established policies or procedures for an ongoing assessment of postanalytic systems. 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 --