Summary:
Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on the lack of proficiency testing (PT) records and an interview with the laboratory testing person, the laboratory failed to enroll in an approved PT program for the sub-specialties bacteriology, parasitology and virology after initiating patient testing in August 2020. Refer to D6088 FINDINGS The laboratory testing person confirmed on December 8, 2022, at approximately 11:00 AM, that the laboratory did not enroll in a PT testing program for sub-specialties bacteriology, parasitology, virology, performed on the BioFire Film Array analyzer, after initiating patient testing in August 2020. a. The laboratory is performing the GI panel (21 organisms/ analyte's) and Respiratory panel (19 organism/analyte's) on the BioFire Film Array analyzer. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- This STANDARD is not met as evidenced by: Based on a lack of safety procedures, surveyor's observation and an interview with the laboratory testing person, the laboratory failed to establish and have accessible a safety procedure to protect the laboratory staff from physical, chemical, biochemical, biohazard material and electrical hazards. Refer to D6084 FINDINGS: 1. The laboratory failed to establish and follow a safety manual for universal precautions. 2. Surveyor observed the BioFire box containing the pouches used for testing both the GI and Respiratory panel, it stated, " that universal precaution must be followed regarding eye protection , skin irritation and/corrosion, wear protective gloves, clothing, eye and face protection. 3. The laboratory testing person confirmed on December 8, 2022, at approximately 12:00 PM, that she only wears, gloves when performing the testing. D5002 BACTERIOLOGY CFR(s): 493.1201 If the laboratory provides services in the subspecialty of Bacteriology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1261, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on a review of BioFire operations manual, lack of laboratory procedures, temperature records and an interview with the laboratory director and testing person, the laboratory failed to have a complete procedure manual, validation of new BioFire and room temperature records for bacteriology testing from August 2020 through survey date. Refer to: D5209, D5291, D5311, D5413, D5421 and D5805 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 the lack of a training and competency assessment policy, personnel records and an interview with the laboratory director and testing person, the laboratory failed to establish and follow a training and competency assessment policy for the testing personnel, who perform moderate complexity testing. Refer to D6102, D6103 and D6107 FINDINGS: The laboratory failed to establish and follow a training and competency assessment policy to include the following: a. Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; monitoring the recording and reporting of test results; review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; direct observation of performance of instrument maintenance and function checks; assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and assessment of problem solving skill and capable of identifying problems that may adversely affect test performance or reporting of test results and either must correct the problems or immediately notify -- 2 of 7 -- the technical consultant, clinical consultant or director; and document all