Associates In Digestive Diseases Pa

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual, observation of microscope and interview with the Clinical Consultant (CC), the laboratory failed to follow Microscope Maintenance Procedure (MMP) in the calendar year 2018. The finding includes: 1. The PM stated to perform preventive maintenance of microscope annually but there was no evidence of maintenance performed. 3. The CC confirmed on 6/6/19 at 1:00 pm that the laboratory did not follow MMP. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), Quality Assurance (QA) program and interview with the Clinical Consultant (CC), the Laboratory Director (LD) failed to ensure the QA program was maintained for laboratory testing from 8/30 /17 to the date of the survey. The finding includes: 1. The QA program stated "monthly quality reviews should be done for the 3 phases of laboratory testing" but there was not documented evidence a QA review was performed. 2. The CC confirmed 2/15/18 at 11:00 am that the QA program was not maintained. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --