Urological Clinic Of Valdosta, Pc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on September 26, 2018. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records, review of the Laboratory Personnel Report form (CMS 209) and staff interview, the laboratory failed to rotate testing of PT samples among all testing personnel who test patient samples. Findings include: 1. Review of the CMS 209 revealed 2 employees listed as testing personnel. 2. Review of PT attestation statements for event 3 of 2016, both events in 2017 and event 1 of 2018 revealed testing personnel # 1 signed all PT attestations. 3. Interview with testing personnel # 1 (see CMS 209) and the office administrator in the office assigned to the surveyor on September 26,, 2018 at approximately 5 pm confirmed testing personnel # 2 test patient samples but has not participated in testing PT samples. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records from American Proficiency Institute (API) and staff interview, the laboratory failed to retain documentation signed by the testing personnel (TP) and laboratory director (LD) attesting to routine integration of samples into the patient workload for the 2nd testing event of 2017. Findings include: 1. Review of 2017 and 2018 attestation statements for PT from API in the speciality of endocrinology for testing of testosterone and PSA revealed no documentation of the attestation statement for the 2nd event of 2017. 2. Interview with the office administrator and testing personnel # 1, (see CMS 209) on September 26, 2018 at approximately 5 pm in the office assigned to the surveyor confirmed the attestation statement for the 2nd event of 2017 is not available. D5020 ENDOCRINOLOGY CFR(s): 493.1212 If the laboratory provides services in the subspecialty of Endocrinology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory records, lack of records to review and staff interview, the laboratoy failed to meet the requirement for testing testosterone and prostate specific antigen in the speciality of endocrinology. Findings include: Refer to: D 5211, D 5311, D 5413, D5441 D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of 2017 and 2018 American Proficiency Institute (API) proficiency testing (PT) records and staff interview the laboratory director failed to document review of PT evaluations for the 1st event of 2017 and the 1st event of 2018.. Findings include: 1. Review of 2017 and 2018 API PT records revealed no documentation that event 1 of 2017 and event 1 of 2018 PT evaluations were reviewed by the laboratory director. 2. Interview with the testing personnel #1 (see CMS 209) and the office administrator on September 26, 2018 at approximately 5 pm in the office assigned to the surveyor confirmed there is no documentation of PT evaluation review for event 1 of 2017 and event 1 of 2018. 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. -- 2 of 9 -- This STANDARD is not met as evidenced by: Based on review of laboratory records, lack of Quality assessment records to review, lack of a Quality Assessment (QA) policy and staff interview, the laboratory failed to establish and maintain a QA program. . Findings include: 1. Review of the laboratory's 2017 and 2018 records revealed no documentation of QA activity after March 7, 2017. 2. Review of the laboratory's policy and procedure manual revealed no QA policy. 3. Interview with TP # 1 (See CMS 209) and the office administrator on September 26, 2018 at approximately 5 pm in the office assigned to the surveyor confirmed the laboratory does not have a current QA policy and no documentation of QA activity after March 2017 is available. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on observation by the surveyor during a tour of the laboratory, review of the manufacturer's instructions for freezing specimens in serum separator tubes (SST), review of the specimen storage requirements, staff interview, and interview with the SST manufacturer's client services representative, the laboratory failed to follow manufacturer's instruction for storage of frozen specimens and failed to ensure specimens are stored at the proper temperature. Findings include: 1. Observation by the surveyor during a tour of the laboratory revealed specimens are stored in primary SST collection tubes and placed in a frost free freezer for storage until testing is performed. 2. Review of the manufacturer's recommendations for storing frozen specimens in SST tubes revealed the following statement, " It is not recommended to freeze the sample in the primary blood collection tube, on the gel barrier. The gel may separate when it is frozen and thawed, resulting in red cell contamination of the sample.". 3. Telephone interview with a client service representative from Becton Dickson (BD), the manufacturer of the SST tubes, on September 26, 2018 at approximately 3:30 pm in the physician's office confirmed specimens should not be stored frozen in SST tubes. 4. Review of the laboratory's instructions for specimen collection and preparation revealed specimens for PSA should be stored at negative 20 degrees or colder if not tested within 24 hours of collection and specimens for testosterone should be stored at negative 20 degrees or colder if not tested within 48 hours of collection. 5. Review of laboratory records revealed no documentation or temperature charts recording the temperature of the freezer where samples are stored. 6. Interview with TP # 1 (see CMS 209) and the office manager at approximately 4 pm in the office assigned to the surveyor confirmed specimens are stored frozen in SST primary collection tubes and the temperature of the freezer where they are stored is not monitored or recorded. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) -- 3 of 9 -- The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)