Summary:
Summary Statement of Deficiencies 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 surveyor's review of the competency assessment policies and two histotechnicans personnel records, the laboratory failed to follow the laboratory's written competency assessment policies and perform a six months competency evaluation for the new histotech and an annual competency evaluation for part time histotech. FINDINGS: The surveyor's findings on April 9, 2019 at approximately 10: 00 AM found that the laboratory failed to follow the their established written competency assessment policies, that requires assessment at six months after training for new hire and annually thereafter. a. a six month competency evaluation for the new histotech hired on November 2, 2017 and training completed on May 2018 was not performed. b. an annual competency evaluation for the part time histotech was not performed in the 2018. 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 surveyor's review of the laboratory's Mohs' procedures and lack of twice Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- year verification records for Mohs slides, the laboratory failed to verify the accuracy of the Mohs slides in the calendar year 2018. Approximately 402 patient Mohs slides were interpreted and results reported for Mohs' surgery. 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 surveyor's review of laboratory's Quality Assessment (QA) policies and the lack of QA records for the calendar year 2018, the laboratory failed to follow their established QA policy and perform an annual QA review in the calendar year 2018. FINDINGS: The surveyor's findings on April 9, 2019 at approximately 10:30 AM found that the laboratory's QA policy states, "that an annual QA review is performed and review is documented for the following laboratory systems: 1. patient test management 2. complaint investigation and communication 3. personnel competency 4. comparison of test results 5. procedure manual 6. quality control 7. test reports and test requisition 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 surveyor's review of the current test requisition in use for Mohs' surgery, the laboratory failed to include the new address, when the laboratory moved to their current location on May 11, 2017. FINDINGS: The surveyor's findings on April 9, 2019 at approximately 10:00 AM found that the current test requisition in use has the histopathology processing laboratory's address at 5611 Main St., Williamsville NY 14221, which closed on May 11, 2017. The Mohs' laboratory was moved to the current address at 5604 Main St., Williamsville, NY 14221. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 -- 2 of 6 -- 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 surveyor's review of laboratory records, the laboratory failed to ensure that the: 1. current laboratory director sign and date the Dermatology/Mohs Procedure manual, refer to D5407; 2. laboratory follow the manufacturer's temperature requirements for the Lecia Cryostat CM 1850, refer to D5413; 3. containers used for staining Mohs slides were labeled, refer to D5415; 4. laboratory follow the established cryostat and microscope maintenance policy, refer D5429; 5. laboratory failed to identify and take