Summary:
Summary Statement of Deficiencies 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 record review and interview with the Office Manager, the laboratory did not have competency evaluations on 1 out of 1 (#B) Testing Person for 2 out of 2 years (2016-2017) reviewed. Findings Included: Review of Testing Person #B's employee records revealed no competency evaluations. During an interview on 02/05/18 at 12: 00 PM the Office Manager confirmed that no competency evaluations were performed on Testing Person #B. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interview with the Office Manager, the laboratory failed to verify the accuracy of testing at least twice a year for 2 out of 2 (2016-2017) years reviewed. Findings Included: Review of verification of test accuracy for Histopathology revealed peer reviews conducted on 03/05/17 and 06/02/16. No other peer reviews were provided. During an interview on 02/05/18 at 11:44 PM the Office Manager confirmed that there were no other peer reviews conducted. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on record review and interview with the Office Manager, the Laboratory Director failed to sign the procedure manual for approval when new policies were implemented in 2016. Findings Included: Review of the policy and procedure manual revealed that it was last signed by the Laboratory Director in 2015. During an interview on 02/05/18 at 12:55 PM the Office Manager confirmed that there were changes that were implemented in 2016 and that the Laboratory Director did not sign off on them as approved. 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: Based on observation and interview with the Office Manager the laboratory had expired reagents in the laboratory since 07/13/17. Findings Included: During a tour of the laboratory on 02/05/18 at 9:30 PM it was observed that Scott Tap Water Substitute (Lot # 1635801) had an expiration date of 12/28/17 and Eosin Y Stain Solution 1% in Alcohol (Lot # 1519041) expired on 07/12/17. During an interview on 02/05/18 at 10: 15 AM the Office Manager confirmed that the expired reagents have been used for testing because there were no other reagents to use. 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 observations and interview with the Office Manager the laboratory failed to perform preventative maintenance on 2 out of 2 microscopes for 1 (2017) out of 2 (2016-2017) years reviewed. Findings Included: During a tour of the laboratory on 02 /05/18 at 9:30 AM two microscopes were observed with a preventative maintenance sticker on both that said it was performed on 10/12/16 and that it was due 04/12/17. There was no documentation of the preventative maintenance being performed in 2017. During an interview on 02/05/18 at 10:15 AM the Office Manager confirmed that the 2017 preventative maintenance had not been performed. -- 2 of 2 --