Hudson Valley Hematology-Oncology Associates Rllp

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on direct observation, review of the American Proficiency Institute (API) 2022 results, first event result of 2023, and interview with the primary laboratory testing person (TP#1), the laboratory failed to enroll in the correct API hematology specialty module. FINDINGS: 1. System for processing manual differentials was not present in the laboratory at the time of the survey. 2. The laboratory was enrolled in the API hematology specialty cell identification module. 3. The laboratory TP#1 confirmed on September 22, 2023, at approximately 11:30 A.M. that the laboratory did not perform manual differentials and/or cell identification. It was noted that automated Complete Blood cell Count (CBC) was performed on the Micros 60 hematology analyzer. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- 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 review of the API records for all three events in 2022; first and second event results of 2023; attestation forms, analyzer printouts, API test result forms, and API summary test reports; the laboratory failed to maintain completed, signed copies of the attestation forms. FINDINGS: 1. The laboratory director (LD) and Testing Personnel (TP) did not sign and date the attestation forms for the three events in 2022 as well as the first and second events of 2023. a. It was noted that the laboratory TP signed and dated the CBC Proficiency Testing (PT) sample attestation forms. b. The attestation forms did not however include TP identification responsible for performing test event cell identifications and manual differentials. 2. TP#1 confirmed on September 22, 2023, at 11:00 A.M. that the TP responsible for performing the color chrome slide review failed to sign and date the attestation forms for all three events in 2022 as well as the first and second events of 2023. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the API PT summary reports for 2022 as well as the first and second event results of 2023, the laboratory failed to successfully participate in analyte cell identification PT. The following score was assigned for slides BC-06, BC- 08, BC-09: 2022 second event = 40%. This was considered unsatisfactory PT performance. 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 review of the six testing personnel education records, the three new laboratory personnel training records, lack of competency assessment policy, and interview with TP#1, the laboratory failed to establish a written, approved policy for laboratory personnel competency assessment. FINDINGS: 1. Training for three of six testing personnel was performed by the LD in 2022, however there was no -- 2 of 9 -- documentation of six-month evaluations. a. Hire dates were not documented in the personnel files. b. It was noted that annual competency assessments were performed for the six testing personnel in May 2023. Refer to D6032. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of API PT summary reports and interview with TP#1, the laboratory failed to evaluate and document

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory's standard procedure (SOP) manual, lack of a written Quality Assessment (QA) procedure and an interview with the laboratory testing person, the laboratory failed to establish a written QA procedure to monitor, evaluate all phases of the laboratory's pre analytic, analytic and post analytic test systems. FINDINGS 1. The laboratory's standard operating procedure manual did not contain a written QA procedure to monitor, evaluate all phases of the laboratory's pre analytic, analytic and post analytic systems. 2. The testing person confirmed on January 4, 2022 at approximately 2:30 PM, that the laboratory did not have a written QA procedure to monitor, evaluate all phases of laboratory testing. D6021 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 quality assessment programs are established and maintained to assure the quality of laboratory services provided. 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 -- This STANDARD is not met as evidenced by: Based on review of the SOP manual, lack of a written QA procedure and confirmed in an interview with the laboratory testing person, the laboratory director failed to establish a written QA for all phases for the general laboratory system. Refer to D5291. -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 the surveyor's review of American Proficiency Institute (API) proficiency testing (PT) records for the second and third events of 2017, and all three events events of 2018, and an interview with the primary testing person, the laboratory failed to rotate the PT samples among all testing personnel who routinely perform hematology testing on the hematology instrument. Findings: A review of the PT attestation statements, and confirmed by the primary testing person, on the date of the onsite survey at 10:15 AM, 5 out of 5 hematology challenges were tested by the primary testing person. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: 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 -- Based on the surveyor's review of PT records and confirmed in an interview with the primary testing person, the laboratory director failed to ensure that hematology PT specimens were tested in the same manner as patient specimens. Refer to D2007 -- 2 of 2 --