Urology Associates Of Cape Cod, Pc

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Urology Associates of Cape Cod, PC laboratory on 10/22/2024 pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with testing person one (TP1) on 10/22/2024, the laboratory failed to establish safety procedures to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials as evidenced by the following: The surveyor toured the PCR laboratory on 10/22/2024. The tour revealed the following: An eye wash station was observed. Upon request for maintenance and safety procedures it was revealed that no safety procedure was established for the proper use and maintenance of the eye wash. TP1 confirmed in an interview on 10/22/2024 at 1:35 PM that the laboratory did not have safety procedures established for the use and maintenance of the eye wash to ensure protection from hazards. . D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. 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 record review and interview with testing person one (TP1) on 10/22/2024, the Technical Supervisor (TS) failed to evaluate and document the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tested patient specimens as evidenced by the following: The surveyor asked for to review the personnel competency records. The review revealed that a semiannual competency evaluation was not performed and documented for the one (1) out of one (1) Testing Person (TP) performing high complexity PCR testing. TP1 confirmed in an interview on 10/22/2024 at 11:25 AM that the TS failed to perform and document a semiannual competency evaluation for the one (1) out of one (1) TP in the first year of performing high complexity PCR testing. The laboratory performs 1,170 Microbiology tests annually. This is a repeat deficiency. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Urology Associates of Cape Cod laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: . Based on record review and interview with the Clinical Manager (CM) on 6/29 /2023, the laboratory failed to monitor and document temperature conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting as evidenced by the following: The surveyor asked to review the temperature records for the refrigerator, freezer, and room temperature for high complexity PCR testing for calendar years 2022 and 2023. The record review revealed that the laboratory was missing temperature records for September 2022, October 2022, November 2022, December 2022, January 2023, and February 2023. The CM confirmed in an interview on 6/29/2023 at 12:50 PM that the laboratory failed to maintain documentation of the laboratory's refrigerator, freezer, and room temperatures for the six (6) months from September 2022 to February 23, 2023. The laboratory performs 1,170 Microbiology tests annually. . D5429 MAINTENANCE AND FUNCTION CHECKS 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 -- CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document 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 record review and interview with the Clinical Manager (CM) on 6/29 /2023, the laboratory failed to document maintenance of analyzers defined by the manufacturer and with at least the frequency specified by the manufacturer as evidenced by the following: The surveyor asked to review maintenance records required by the manufacturer for the Quant Studio 5/King Fisher Thermo analyzer since the analyzer was implemented on 4/09/2022. The review revealed that the recommended weekly maintenance was not performed for the weeks of 6/20/2022 to 3 /13/2023 (38 weeks). The CM stated that the laboratory was performing the necessary weekly maintenance but was not recording it on the maintenance log sheet. The CM confirmed in an interview on 6/29/2023 at 12:55 PM that the manufacturer required weekly maintenance on the Quant Studio 5/King Fisher Thermo analyzer was not documented for the weeks from 6/20/2022 to 3/13/2023 (38 weeks). The laboratory performs 1,170 Microbiology tests annually. . D6115 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(2) The technical supervisor is responsible for verification of the test procedures performed and 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 procedure manual review and interview with the Clinical Manager (CM), the Laboratory Director (LD) failed to approve, sign, and date verification of a new test procedure's performance characteristics, including the precision and accuracy of the test and test system as evidenced by the following: The surveyor asked to review the validation for the one (1) new Quant Studio 5/King Fisher Thermo UTI PCR test (Urine for UTI and Antibiotic Resistance Testing/Rectal Swabs for Pathogens and Antibiotic Resistance Markers associated with UTI). The review revealed that the LD failed to review and approve the new procedure. The CM confirmed in an interview on 6/29/2023 at 12:40 PM that the LD failed to review and approve the validation for the UTI PCR test. The laboratory performs 1,170 Microbiology tests annually. . D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. -- 2 of 4 -- This STANDARD is not met as evidenced by: . Based on record review and interview with the Clinical Manager (CM) on 6/29 /2023, the Technical Supervisor failed to maintain documentation to verify the initial training of testing personnel as evidenced by the following: The surveyor asked to review the personnel and training records for the one (1) out of one (1) new Testing Person (TP). The review revealed that there was no documentation maintained to verify that the new TP received initial training when hired. The CM confirmed in an interview on 6/29/2023 at 12:45 PM that that no documentation was maintained to verify that the new TP received initial training when hired. The laboratory performs 1,170 Microbiology tests annually. . D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: . Based on record review and interview with the Clinical Manager (CM) on 6/29 /2023, the Technical Supervisor (TS) failed to evaluate and document the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tested patient specimens as evidenced by the following: The surveyor asked for to review the personnel competency records. The review revealed that a semiannual competency evaluation was not performed and documented for the one (1) out of one (1) Testing Person (TP) performing high complexity PCR testing. The CM confirmed in an interview on 6/29/2023 at 12:45 PM that the TS failed to perform and document a semiannual competency evaluation for the one (1) out of one (1) TP in the first year of performing high complexity PCR testing. The laboratory performs 1,170 Microbiology tests annually. . D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: . Based on record review and interview with the Clinical Manager (CM) on 6/29 /2023, the Technical Supervisor (TS) failed to evaluate and document the performance of individuals responsible for high complexity testing at least annually, after the first year the individual tested patient specimens as evidenced by the following: The surveyor asked for the personnel competency records for review. The review revealed that an annual competency evaluation was not performed and documented at least annually for the one (1) out of one (1) Testing Person (TP) performing high complexity PCR testing. The CM confirmed in an interview on 6/29/2023 at 12:45 -- 3 of 4 -- PM that the TS failed to perform and document an annual competency evaluation for the one (1) out of one (1) TP in 2023 after the first year of performing high complexity PCR testing. The laboratory performs 1,170 Microbiology tests annually. . -- 4 of 4 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Urology Associates of Cape Cod, P.C. laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on interview and observation, the laboratory failed to establish and maintain the accuracy of its testing procedures in accordance with 493.1236(c)(1) as evidenced by the following: a. The laboratory added Histopathology and Cytology testing on 6/20 /17. b. The practice's surgical director confirmed through interview on 11/27/18 at 12: 00 PM that the laboratory failed to establish procedures to verify accuracy of Histopathology and Cytology testing for 2017 and 2018. c. The laboratory performs 5,348 Histopathology and Cytology tests per year. D5028 HISTOPATHOLOGY CFR(s): 493.1219 If the laboratory provides services in the subspecialty of Histopathology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1273, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on record review, observation, and interview with the surgical director and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- clinical manager, the laboratory did not meet all the requirements specified in 493. 1230 through 493.1256, 493.1273, and 493.1281 through 493.1299. Findings include: -Refer to D5217: The laboratory did not evaluate the accuracy of each test twice annually. -Refer to D5401: The laboratory director failed to have a written procedure manual in place for all tests, assays, and examinations performed by the laboratory. - Refer to D5403: The laboratory failed to have a procedure manual which covered all aspects of test procedures. -Refer to D5435: The laboratory director failed to establish a maintenance protocol for the laboratory microscope used to report Histopathology diagnoses. -Refer to D5601: The laboratory failed to document a control slide of known reactivity of fluorescent and immunohistochemical stains with each patient slide or group of patient slides when special staining was performed D5032 CYTOLOGY CFR(s): 493.1221 If the laboratory provides services in the subspecialty of Cytology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1274, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on record review, observation, and interview with the surgical director and clinical manager, the laboratory did not meet all the requirements specified in 493. 1230 through 493.1256, 493.1274, and 493.1281 through 493.1299. Findings include: -Refer to D5217: The laboratory did not evaluate the accuracy of each test twice annually. -Refer to D5401: The laboratory director failed to have a written procedure manual in place for all tests, assays, and examinations performed by the laboratory. - Refer to D5403: The laboratory failed to have a procedure manual which covered all aspects of test procedures. -Refer to D5435: The laboratory director failed to establish a maintenance protocol for the laboratory microscope used to report Cytology diagnoses. -Refer to D5629: The laboratory failed to document non-gynecological annual statistical laboratory evaluations. -Refer to D5639: The laboratory failed to have a written policy and procedure regarding Cytology workload limits. -Refer to D5645: The laboratory failed to maintain records of Cytology workload limits. 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 interview and observation, the laboratory failed to verify procedures it performs that are not included in subpart I of this part at least twice annually as evidenced by the following: a. The laboratory added Histopathology and Cytology testing on 6/20/17. b. The practice's surgical director confirmed through interview on 11/27/18 at 12:00 PM that the laboratory failed to verify Histopathology and Cytology testing at least twice annually in 2017 and 2018. c. The laboratory performs 5,348 Histopathology and Cytology tests per year. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) -- 2 of 7 -- 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 observation and interview, the laboratory failed to have a written procedure manual in place for all tests, assays, and examinations performed by the laboratory as evidenced by the following: On the day of the survey, surveyors asked the surgical director to produce policies and procedures for Histopathology and Cytology testing. The surgical director confirmed in an interview on 11/27/18 at 12:15 PM that there were no written procedures available for Histopathology and Cytology testing. 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)