Summary:
Summary Statement of Deficiencies 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 standard operating procedure manual (SOPM) review and interview with laboratory staff, the laboratory did not 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. Findings: 1. Record review showed that the laboratory's SOPM did not include a quality assessment (QA) procedure; and 2. During an interview on 10/23/18 at 10:05 AM the laboratory staff confirmed that the laboratory's SOPM did not include a QA procedure to identify and correct errors in quality as they occur. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on record review and interview with the laboratory staff, the laboratory did not monitor and document laboratory temperatures in order to assure accurate and reliable test results. Findings: 1. The laboratory performs dermatophyte testing at room temperature. The procedure, "Dermatophyte Testing Medium" states, "Incubate at room temperature (68F-86F) is satisfactory for growth of most dermatophytes." 2. A review of temperature records showed that there were room temperature records documented from 10/16/18 to 10/23/18. During an interview at 9:45 AM, laboratory staff stated that they were "not doing room temperatures prior to 2 weeks ago"; and 3. Record review showed that there were no refrigerator temperature records available at the time of the survey. During an interview at 9:45 AM, testing person #1 stated that they would check the refrigerator temperature every morning but did not document it. 4. During an interview on 10/23/18 at 10:30 AM, laboratory staff confirmed that refrigerator and room temperatures were not monitored and documented. 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: Note: This is a repeat deficiency. The laboratory was cited during the re-certification survey on 10/27/2016 for not recording the expiration dates of media used for dermatophyte testing. The