Summary:
Summary Statement of Deficiencies D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing (PT) Program (year 2016 and 2017) records review and laboratory director interview on April 10, 2018 at 4:00 PM, it was determined that the laboratory failed to take and document remedial action when it obtained unacceptable analyte score of routine chemistry proficiency testing results in the first testing PT event (February 2017). The findings include: 1. The laboratory did not take nor document remedial action when it obtained unacceptable analyte score of proficiency testing results for total bilirubin (80 %) and for lactate dehydrogenase (80 %) proficiency testing results in the first PT event (February 2017). 2. The laboratory director confirmed on April 10, 2018 at 4:00 PM, that no remedial actions were taken nor documented during the year 2017. D2116 TOXICOLOGY CFR(s): 493.845(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program (year 2016 and 2017) records review and laboratory director interview on April 10, 2018 at 4:00 PM, it was determined that the laboratory failed to take and document remedial action when it obtained unacceptable analyte score of toxicology proficiency testing results in the first testing event (February 2017). The findings include: 1. The laboratory did not take nor document remedial action when it obtained unacceptable analyte score of proficiency testing results for valproic acid (80 %) proficiency testing results in the first PT event (February 2017). 2. The laboratory director confirmed on April 10, 2018 at 4:00 PM, that no remedial actions were taken nor documented during the year 2017. D3021 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(c)(1) Blood and blood products storage and distribution. If a facility stores or maintains blood or blood products for transfusion outside of a monitored refrigerator, the facility must ensure the storage conditions, including temperature, are appropriate to prevent deterioration of the blood or blood product. This STANDARD is not met as evidenced by: Based on review of patient's transfusion records review and interview with the laboratory director on April 10, 2018 at 3: 20 PM , it was found that the laboratory did not follow written instructions for evaluation of possible transfusion reactions. The findings include: a. The laboratory director was interviewed about the procedures for possible transfusion reactions detection and further evaluation. She stated that the nursing personnel in charge of the patient must be aware of any sign or symptom during and after the transfusion. If they notice any alteration they must call the laboratory, then the laboratory will start with the evaluation of the possible reaction. Regarding patient temperature requirement she stated during ionterview and the written instruction showed that any change within 1C of the initial patient temperature must be considered a possible transfusion reaction. b. Three patient's transfusion records were evaluated with the following findings: i. Patient identification 261739- Unit transfused on April 3, 2018: W236518370079. The record showed a change in patient temperature from 36.9 C to 39.4C. The possible transfusion reaction was not evaluated. ii. Patient identification 261739- Unit transfused on April 5, 2018: W236518072703 (fractioned unit) . The record showed a change in patient temperature from 36.2 C to 37.3C. The possible transfusion reaction was not evaluated. iii. Patient identification 186/186- Unit transfused on April 9, 2018: W036818052124. The record showed a change in patient temperature from 36.2 C to 37.5C. The possible transfusion reaction was not evaluated. D5014 GENERAL IMMUNOLOGY CFR(s): 493.1208 If the laboratory provides services in the subspecialty of General immunology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and -- 2 of 13 -- 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on Alere Determined HIV-1/2 Ag/Ab Combo performance specification procedures, quality control records patient records review and interview with the laboratory director and the MT's 7 and 8 on April 10, 2108 at 2:00 PM, it was determined that the laboratory failed to meet the requirements in the subspecialty of General Immunology for HIV tests. Refer to : D5421- the verification of performance specification was performed by the manufacturer company specialist. D5449- The laboratory did not include positive and negative control material D5401- The laboratory did not follow written instruction for patient rerun. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on direct observation, R & B body fluid hematology control manufacturer's instructions, Hematology procedures manual, body fluid testing and quality control records, R & B body fluid hematology control Kit insert records, hematology quality control records, platelets quality control graphs records, coagulation procedures manual, Prothrombin Time (PT) quality control records (years 2017 and 2018), International Normalized Ration (INR) values results records review, laboratory director and testing personnel (Medical Technologist #3) interview on April 10, 2018 at 3:20 PM, it was determined that the laboratory failed to meet the analytic requirements in the specialty of Hematology. Refer to D 5405 (The laboratory failed to follow quality control procedures when 8 out of 8 body fluid patients' specimens were processed for cells count by the hemocytometer from October 19, 2017 to April 4, 2018). Refer to D 5481 (The laboratory failed to take and document