Summary:
Summary Statement of Deficiencies D0000 An entrance conference was held 11/19/2019 with the Histotechnician and Regional Clinical Manager. The survey process was discussed. An opportunity for questions and comments was given. Based upon the onsite survey conducted on 11/19/2019, this facility was found NOT to be in compliance with CLIA regulations found at 42 CFR for the specialties/subspecialties in which it was surveyed. 493.1219 Histopathology 493.1441 Laboratories performing high complexity testing; laboratory director An exit conference was held on 11/19/2019 with the Histotechnician and Regional Clinical Manager. The exit conference attendees were advised the laboratory was out of compliance and advised of conditions and deficiencies found during the survey. An opportunity for questions and comments was provided. 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 review of laboratory policy, Quality Control (QC) logs and confirmed in interview the laboratory failed to meet the requirements for the specialty of histopathology as evidenced by: 1. The laboratory failed to document for each day of use, test staining materials for intended reactivity to ensure the predictable staining characteristics for the Hematoxylin and Eosin (H&E) QC for 2 of 6 days in 2018 (11 /2018) and 1 of 4 days in 2019 (07/2019). Refer to D5473, II. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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 direct observation, manufacturer's instructions, and staff interview, the laboratory failed to ensure the proper storage conditions were maintained for potassium hydroxide (KOH) reagents for 11 of 11 months in 2019. Findings: 1. Review of manufacturer's safety data sheets for KOH 10% reagent revealed: "7 Handling and storage ... Requirements to be met by storerooms and receptacles: 15 - 30 C" 2. During a tour of the laboratory on 11/19/2019 at 11:43 am, the following were observed stored in the storage room in the storage closet across from the laboratory: 2 bottles of Potassium Hydroxide 10%, lot #9255, expiration date 09/21 /2021 3. During an interview on 11/19/2019 at 11:43 am, the histotechnician was asked if the temperature was monitored and documented in the storage closet and she stated no, confirming the above findings. The laboratory failed to ensure the proper storage conditions were maintained for KOH reagents. D5429 MAINTENANCE AND FUNCTION CHECKS 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 review of laboratory policy, cryostat maintenance logs, and confirmed in interview, the laboratory failed to perform the daily maintenance on cryostat A for 1 of 5 days in 2018 (11/2018). Findings: 1. Review of "QUALITY ASSURANCE MANUAL" laboratory policy revealed: "EQUIPMENT QUALTIY CONTROL- CRYOSTAT 1. Temperature is recorded daily and documented. 2. Temperature range is -25C to -35C. 3.