North Shore Pathology Service, Apmc

Summary Statement of Deficiencies D0000 A Certification survey was performed on December 12, 2022 at North Shore Pathology Service, APMC, CLIA ID # 19D2081323. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on review of patient test requisitions and interview with personnel, the laboratory failed to ensure the test to be performed was documented for four (4) of seven (7) patient test requisitions reviewed. Findings: 1. Review of patient test requisitions revealed the following two (2) check boxes were included: a) "Gross and Microscopic Examination" b) "Cytology Examination" 2. Further review of patient test requisitions revealed the following four (4) patients did not have documentation of the examination to be performed: JS21-29613 JS21-49338 JS22-31856 JS22-47488 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 -- 3. In interview on December 12, 2022 at 2:05 pm, the Laboratory Director stated she does not see the patient requisitions, only the patient demographic information, gross description, and slides. The Laboratory Director confirmed the identified patient requisitions did not have documentation of the test (exam) to be performed. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure compliance with the applicable regulations. Refer to D5305. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Recertification survey was performed on June 8, 2021 at NorthShore Pathology Service, APMC, CLIA ID # 19D2081323. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's microscope maintenance logs and interview with personnel, the laboratory failed to document the annual microscope maintenance per laboratory policy for one (1) of two (2) years reviewed. Findings: 1. Review of the laboratory's "Preventative Maintenance Schedule" log for the Nikon microscope revealed the following tasks: a) "Cleaning: Frequency: Day of use" b) "Covering: Frequency: After use and during storage" c) "Decontamination: Frequency: After sample contact" d) "Replace lamp: Frequency: As needed" e) "Service: Frequency: As needed" f) "Annual Inspection: Frequency: Once annually" 2. Further review of the laboratory's "Preventative Maintenance Schedule" logs for the Nikon microscope for 2019 and 2020 revealed the laboratory did not perform the annual inspection in 2019. 3. In interview on June 8, 2021 at 1:23 pm, the Laboratory Director stated the annual inspection was not done in 2019. She further stated after she got a contract with a pathology group the annual inspection for the microscope was performed in 2020. 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 -- D6095 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(6) The laboratory director must ensure the establishment and maintenance of acceptable levels of analytical performance for each test system. This STANDARD is not met as evidenced by: Based on review of maintenance logs and interview with personnel, the Laboratory Director failed to ensure required maintenance was performed to ensure acceptable levels of performance. Refer to D5433. -- 2 of 2 --