Summary:
Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and the interview with the testing person the laboratory had expired reagents not labeled as "expired-not in use" or "not part of the laboratory" that was surveyed. Findings include: On January 8, 2018, the surveyor observed; 1) Chlorazol Black E, fungal stain, lot# 1171, expired 6/13. 2) KOH 10% -30 ml reagent, lot# 1330111, expired 10/28/14. 3) KOH 10% -30 ml reagent, lot# 1414909, expired 5 /29/15. 4) Calcium Gluconate, lot# 6011830, expired 5/17. The above expired reagents were not labeled as "expired not in use" or "not part of the laboratory" that was surveyed. An interview with the testing person at 11:15 AM confirmed the above- expired reagents in the laboratory next to the microscope and that they were not labeled as not in use, kept isolated, or were not part of the laboratory. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. 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 the laboratory failed to provide the "CONSENT FOR MOHS SURGERY AND REPAIR and the MOHS OPERATIVE REPORT that had the same facility address as the address of the physical location of the laboratory surveyed. The findings include: On January 8, 2018, during the record review, the surveyor observed; (1) CONSENT FOR MOHS SURGERY AND REPAIR & (2) MOHS OPERATIVE REPORT that did not have the facility address same as the physical location of the laboratory surveyed. The laboratory had provided the CONSENT FOR MOHS SURGERY AND REPAIR & MOHS OPERATIVE REPORT later via e-mail and so there was no interview with the testing person. -- 2 of 2 --