Walpole Medical Center, Pc

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Walpole Medical Center, PC laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: . Based on record review and confirmed through an interview with the laboratory consultant on 10/25/2022 the laboratory failed to verify the accuracy of analytes assigned a proficiency testing score that did not reflect laboratory test performance as evidenced by the following: The surveyor reviewed the American Proficiency Institute (API) proficiency testing results for calendar years 2020, 2021, and 2022 (four testing events). The review revealed that the proficiency testing service did not grade analyte results for Cocaine and Opiates for the first testing event of 2021. There was no documented self-grading performed by laboratory personnel for the above listed ungraded proficiency testing results. The laboratory consultant confirmed in an interview on 10/25/2022 at 12:00 PM that ungraded proficiency testing results had not been addressed. The laboratory performs 400 Cocaine and 600 Opiates tests annually. . D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 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 -- Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on the deficiencies cited herein, the laboratory failed to meet the the applicable analytic systems requirements in 493.1251 through 493.1283 as evidenced by the following: The laboratory failed to perform accuracy studies with their validation of the four new drug tests: Amphetamines, Benzodiazepines, Bupenorphine, and Oxycodone prior to patient testing on the Medica EasyRA analyzer. This is a repeat deficiency. Refer to D5421. . D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: . Based on record review and interview with the laboratory consultant on 10/25/2022 the laboratory failed to demonstrate that it can obtain performance specifications comparable to those established by the manufacturer of a new test system before reporting patient test results as evidenced by the following: The surveyor reviewed the validation studies for the four new drug tests implemented on 8/18/2022 on the Medica EasyRA analyzer. The review revealed that the laboratory did not perform accuracy studies with their validation of the four new drug tests prior to patient testing. The four new drug tests implemented were Amphetamines, Benzodiazepines, Bupenorphine, and Oxycodone. The laboratory consultant confirmed through interview on 10/25/2022 at 11:15 AM that the laboratory failed to perform accuracy studies prior to reporting patient test results for the four new drugs tested on the Medica EasyRA analyzer. The laboratory performs 6,000 Toxicology tests annually. This deficiency was cited at the last CLIA survey performed on 10/01/2020. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Walpole Medical Center PC laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 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 (PT) record review and interview with the Technical Consultant (TC), the laboratory did not document and maintain a copy of all PT records as evidenced by the following: The surveyor reviewed American Proficiency Institute (API) PT records for calendar years 2018, 2019, and 2020 (5 total testing events) on 10/1/2020. The review revealed that attestation statements provided by the PT program were not signed by the testing person or laboratory director for Event 1 in 2019 and Event 1 in 2020. The TC confirmed in an interview on 10/1/2020 at 10:45 AM that not all attestation statements were signed by the analyst and the laboratory director. . D3037 RETENTION REQUIREMENTS 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 -- CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: . Based on record review and confirmed through interview with the Technical Consultant (TC), the laboratory failed to retain all proficiency testing (PT) records for at least 2 years as evidenced by the following: The surveyor reviewed American Proficiency Institute (API) PT records for calendar years 2018, 2019, and 2020 (5 total testing events) on 10/1/2020. The review revealed that the laboratory failed to maintain raw data of the PT results from Event 1 in 2019. The technical consultant and testing person confirmed that the laboratory failed to retain all PT records for at least 2 years on 1/10/2020 at 10:45 AM. . D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: . Based on record review and interview the laboratory failed to demonstrate that it can obtain performance specifications comparable to those established by the manufacturer of a new test system before reporting patient test results as evidenced by the following: The laboratory implemented the Medica EasyRA analyzer for Toxicology testing on 11/22/2019. The surveyor reviewed validation studies for the new analyzer on 10/1/2020. The review revealed that the laboratory did not perform accuracy studies with their validation of the new analyzer prior to patient testing. The technical consultant confirmed through interview on 10/1/2020 at 9:35 AM that the laboratory failed to perform accuracy studies prior to reporting patient test results on the new Medica EasyRA analyzer. The laboratory performs 13,000 Toxicology tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An initial CLIA certification survey was conducted for the Walpole Medical Center, PC laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . 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 interview, 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 review of twelve (12) patient electronic medical records for laboratory testing performed between 10/25/17 and 9/17/18 revealed that the identity of the person performing the testing was not indicated on the laboratory's final report for all twelve (12) records reviewed. The laboratory technologist confirmed in an interview on 10/3/18 at 9:56 a.m. that the identity of the person performing the testing was not being consistently documented anywhere in the laboratory record system. 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 --