Summary:
Summary Statement of Deficiencies D3027 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(1) Test requisitions and authorizations. Retain records of test requisitions and test authorizations, including the patient's chart or medical record if used as the test requisition or authorization, for at least 2 years. This STANDARD is not met as evidenced by: . Based on procedure review, record review, and interview, the laboratory failed to retain patient written order requisitions for three (#4, 6, and 17) of 21 patient charts audited in 2016 and 2017. Findings include: 1. On January 23, 2018 at 10:39 a.m., "Technical Policies and Procedures - Testing Ordering" procedure review revealed "Records of test requisitions are saved for at least two years. 2. On January 23, 2018 at 12:36 p.m. record review for three of 21 patient charts audited revealed the laboratory was not able to provide the surveyor the documentation to show the tests requested. 3. On January 23, 2018 at 12:36 p.m. when queried, testing personnel #1 as listed on the CMS-209 was informed by the office staff that "requisitions were discarded starting in 2017". 4. During the interview on January 23, 2018 at 12:36 p. m., testing personnel #1 confirmed the laboratory did not retain patient written order requisitions in 2017. 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- . Based on document review and interview, the laboratory failed to meet Bacteriology requirements as specified in 493.1230 through 493.1256. Findings include: 1. The laboratory failed to establish performance specifications for the modified bacteriology FDA approved Quidel QuickVue Dipstick Strep A Test kit. Refer to D5423. 2. The laboratory failed to perform and document media checks for the "BBL TSA II" and the "BBL Group A Select SB (SSA)" media with each new batch, lot, or shipment for the ability to support growth and selectivity/inhibition. Refer to D5477. 3. The laboratory failed to maintain a record system that included the identity of the testing personnel. Refer to D5787. 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, the laboratory failed to ensure written competency policies were implemented for two (#8 and #9) of nine testing personnel performing urinary sediments in 2016 and 2017. Findings include: 1. On January 23, 2018 at 9:41 a.m., record review for the annual competency revealed there was no documentation to show competency was performed for two of nine testing personnel performing the urinary sediment examinations. 2. During the interview on January 23, 2018 at 9:41 a.m., testing personnel #1 as listed on the CMS-209 confirmed the annual competency was not completed as required. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: . Based on document review and interview, the laboratory failed to evaluate and document the